Nifurtox

Nifurtox may be available in the countries listed below.

Ingredient matches for Nifurtox

Fluconazole

Fluconazole is reported as an ingredient of Nifurtox in the following countries:

• Argentina


• Peru

International Drug Name Search

Megestrol

Generic Name: Megestrol acetate

Dosage Form: oral suspension

Megestrol Description

Megestrol acetate oral suspension contains Megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52.

The chemical formula is C24H32O4 and the structural formula is represented as follows:

Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized Megestrol acetate per mL.

Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum.

Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2.

Megestrol - Clinical Pharmacology

Several investigators have reported on the appetite enhancing property of Megestrol acetate and its possible use in cachexia. The precise mechanism by which Megestrol acetate produces effects in anorexia and cachexia is unknown at the present time.

There are several analytical methods used to estimate Megestrol acetate plasma concentrations, including gas chromatography-mass fragmentography (GC-MF), high pressure liquid chromatography (HPLC) and radioimmunoassay (RIA). The GC-MF and HPLC methods are specific for Megestrol acetate and yield equivalent concentrations. The RIA method reacts to Megestrol acetate metabolites and is, therefore, non-specific and indicates higher concentrations than the GC-MF and HPLC methods. Plasma concentrations are dependent, not only on the method used, but also on intestinal and hepatic inactivation of the drug, which may be affected by factors such as intestinal tract motility, intestinal bacteria, antibiotics administered, body weight, diet and liver function.

The major route of drug elimination in humans is urine. When radiolabeled Megestrol acetate was administered to humans in doses of 4 to 90 mg, the urinary excretion within 10 days ranged from 56.5 to 78.4% (mean 66.4%) and fecal excretion ranged from 7.7 to 30.3% (mean 19.8%). The total recovered radioactivity varied between 83.1 and 94.7% (mean 86.2%). Megestrol acetate metabolites which were identified in urine constituted 5 to 8% of the dose administered. Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the radioactivity not found in urine and feces.

Plasma steady state pharmacokinetics of Megestrol acetate were evaluated in 10 adult, cachectic male patients with acquired immunodeficiency syndrome (AIDS) and an involuntary weight loss greater than 10% of baseline. Patients received single oral doses of 800 mg/day of Megestrol acetate oral suspension for 21 days. Plasma concentration data obtained on day 21 were evaluated for up to 48 hours past the last dose.

Mean (±1SD) peak plasma concentration (Cmax) of Megestrol acetate was 753 (±539) ng/mL. Mean area under the concentration time-curve (AUC) was 10476 (±7788) ng x hr/mL. Median Tmax value was five hours. Seven of 10 patients gained weight in three weeks.

Additionally, 24 adult, asymptomatic HIV seropositive male subjects were dosed once daily with 750 mg of Megestrol acetate oral suspension. The treatment was administered for 14 days. Mean Cmax and AUC values were 490 (±238) ng/mL and 6779 (±3048) hr x ng/mL, respectively. The median Tmax value was three hours. The mean Cmin value was 202 (±101) ng/mL. The mean % of fluctuation value was 107 (±40).

The effect of food on the bioavailability of Megestrol acetate oral suspension has not been evaluated.

DESCRIPTION OF CLINICAL STUDIES

The clinical efficacy of Megestrol acetate oral suspension was assessed in two clinical trials. One was a multicenter, randomized, double-blind, placebo-controlled study comparing Megestrol acetate (MA) at doses of 100 mg, 400 mg, and 800 mg per day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 270 patients entered on study, 195 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12 week period or had one post baseline weight measurement but dropped out for therapeutic failure. The percent of patients gaining five or more pounds at maximum weight gain in 12 study weeks was statistically significantly greater for the 800 mg (64%) and 400 mg (57%) MA-treated groups than for the placebo group (24%). Mean weight increased from baseline to last evaluation in 12 study weeks in the 800 mg MA-treated group by 7.8 pounds, the 400 mg MA group by 4.2 pounds, the 100 mg MA group by 1.9 pounds and decreased in the placebo group by 1.6 pounds. Mean weight changes at 4, 8 and 12 weeks for patients evaluable for efficacy in the two clinical trials are shown graphically. Changes in body composition during the 12 study weeks as measured by bioelectrical impedance analysis showed increases innon-water body weight in the MA-treated groups (see CLINICAL STUDIES table). In addition, edema developed or worsened in only 3 patients.

Greater percentages of MA-treated patients in the 800 mg group (89%), the 400 mg group (68%) and the 100 mg group (72%), than in the placebo group (50%), showed an improvement in appetite at last evaluation during the 12 study weeks. A statistically significant difference was observed between the 800 mg MA-treated group and the placebo group in the change in caloric intake from baseline to time of maximum weight change. Patients were asked to assess weight change, appetite, appearance, and overall perception of well-being in a 9 question survey. At maximum weight change only the 800 mg MA-treated group gave responses that were statistically significantly more favorable to all questions when compared to the placebo-treated group. A dose response was noted in the survey with positive responses correlating with higher dose for all questions.

The second trial was a multicenter, randomized, double-blind, placebo-controlled study comparing Megestrol acetate 800 mg/day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 100 patients entered on study, 65 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12 week period or had one post baseline weight measurement but dropped out for therapeutic failure. Patients in the 800 mg MA-treated group had a statistically significantly larger increase in mean maximum weight change than patients in the placebo group. From baseline to study week 12, mean weight increased by 11.2 pounds in the MA-treated group and decreased 2.1 pounds in the placebo group. Changes in body composition as measured by bioelectrical impedance analysis showed increases in non-water weight in the MA-treated group (see CLINICAL STUDIES table). No edema was reported in the MA-treated group. A greater percentage of MA-treated patients (67%) than placebo-treated patients (38%) showed an improvement in appetite at last evaluation during the 12 study weeks; this difference was statistically significant. There were no statistically significant differences between treatment groups in mean caloric change or in daily caloric intake at time to maximum weight change. In the same 9 question survey referenced in the first trial, patients’ assessments of weight change, appetite, appearance, and overall perception of well-being showed increases in mean scores in MA-treated patients as compared to the placebo group.

In both trials, patients tolerated the drug well and no statistically significant differences were seen between the treatment groups with regard to laboratory abnormalities, new opportunistic infections, lymphocyte counts, T4 counts, T8 counts, or skin reactivity tests (see ADVERSE REACTIONS section).

The following figures are the results of mean weight changes for patients evaluable for efficacy in trials 1 and 2.

Indications and Usage for Megestrol

Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

Contraindications

History of hypersensitivity to Megestrol acetate or any component of the formulation. Known or suspected pregnancy.

Warnings

Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Megestrol acetate is not intended for prophylactic use to avoid weight loss.

(See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility section.)

The glucocorticoid activity of Megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing’s Syndrome have been reported in association with the chronic use of Megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealedthe frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic Megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic Megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).

Precautions

General

Therapy with Megestrol acetate oral suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease and renal or psychiatric diseases.

Effects on HIV viral replication have not been determined.

Use with caution in patients with a history of thromboembolic disease.

Use in Diabetics

Exacerbation of pre-existing diabetes with increased insulin requirements have been reported in association with the use of Megestrol acetate.

Information for Patients

Patients using Megestrol acetate should receive the following instructions:

1. This medication is to be used as directed by the physician.


2. Report any adverse reaction experiences while taking this medication.


3. Use contraception while taking this medication if you are a woman capable of becoming pregnant.


4. Notify your physician if you become pregnant while taking this medication.

Drug Interactions

Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when Megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of Megestrol acetate were not studied.

Animal Toxicology

Long-term treatment with Megestrol acetate may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts and increased neutrophil counts was observed in a two-year chronic toxicity/carcinogenicity study of Megestrol acetate conducted in rats.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis

Data on carcinogenesis were obtained from studies conducted in dogs, monkeys and rats treated with Megestrol acetate at doses 53.2, 26.6 and 1.3 times lower than the proposed dose (13.3 mg/kg/day) for humans. No males were used in the dog and monkey studies. In female beagles, Megestrol acetate (0.01, 0.1 or 0.25 mg/kg/day) administered for up to 7 years induced both benign and malignant tumors of the breast. In female monkeys, no tumors were found following 10 years of treatment with 0.01, 0.1 or 0.5 mg/kg/day Megestrol acetate. Pituitary tumors were observed in female rats treated with 3.9 or 10 mg/kg/day of Megestrol acetate for 2 years. The relationship of these tumors in rats and dogs to humans is unknown but should be considered in assessing the risk-to-benefit ratio when prescribing Megestrol acetate oral suspension and in surveillance of patients on therapy. (See WARNINGS section)

Mutagenesis

No mutagenesis data are currently available.

Impairment of Fertility

Perinatal/postnatal (segment III) toxicity studies were performed in rats at doses (0.05 to 12.5 mg/kg) less than that indicated for humans (13.3 mg/kg); in these low dose studies, the reproductive capability of male offspring of Megestrol acetate-treated females was impaired. Similar results were obtained in dogs. Pregnant rats treated with Megestrol acetate showed a reduction in fetal weight and number of live births, and feminization of male fetuses. No toxicity data are currently available on male reproduction (spermatogenesis).

Pregnancy

Pregnancy Category X. (See WARNINGS and PRECAUTIONS: Carcinogenesis, Mutagenesis, impairment of Fertility: Impairment of Fertility.) No adequate animal teratology information is available at clinically relevant doses.

Nursing Mothers

Because of the potential for adverse effects on the newborn, nursing should be discontinued if Megestrol acetate oral suspension is required.

Use in HIV Infected Women

Although Megestrol acetate has been used extensively in women for the treatment of endometrial and breast cancers, its use in HIV infected women has been limited.

All 10 women in the clinical trials reported breakthrough bleeding.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease of other drug therapy.

Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Clinical Adverse Events: Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing Megestrol acetate oral suspension.

ADVERSE EVENTS% of Patients Reporting
	Trial 1 (N = 236)				Trail 2 (N=87)		Open Label Trial
Megestrol Acetate mg/day No. of Patients	Placebo 0 N=34	100 N=68	400 N=69	800 N=65	Placebo 0 N=38	800 N=49	1200 N=176
Diarrhea	15	13	8	15	8	6	10
Impotence	3	4	6	14	0	4	7
Rash	9	9	4	12	3	2	6
Flatulence	9	0	1	9	3	10	6
Hypertension	0	0	0	8	0	0	4
Asthenia	3	2	3	6	8	4	5
Insomnia	0	3	4	6	0	0	1
Nausea	9	4	0	5	3	4	5
Anemia	6	3	3	5	0	0	0
Fever	3	6	4	5	3	2	1
Libido Decreased	3	4	0	5	0	2	1
Dyspepsia	0	0	3	3	5	4	2
Hyperglycemia	3	0	6	3	0	0	3
Headache	6	10	1	3	3	0	3
Pain	6	0	0	2	5	6	4
Vomiting	9	3	0	2	3	6	4
Pneumonia	6	2	0	2	3	0	1
Urinary Frequency	0	0	1	2	5	2	1

Adverse events which occurred in 1 to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with Megestrol acetate and patients treated with placebo.

Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma

Cardiovascular System - cardiomyopathy and palpitation

Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis

Hemic and Lymphatic System - leukopenia

Metabolic and Nutritional - LDH increased, edema and peripheral edema

Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking

Respiratory System - dyspnea, cough, pharyngitis and lung disorder

Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder

Special Senses - amblyopia

Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia

Postmarketing - Postmarketing reports associated with Megestrol acetate oral suspension included thromboembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections).

Overdosage

No serious unexpected side effects have resulted from studies involving Megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. Megestrol acetate has not been tested for dialyzability, however, due to its low solubility it is postulated that dialysis would not be an effective means of treating overdose.

Megestrol Dosage and Administration

The recommended adult initial dosage of Megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

How is Megestrol Supplied

Megestrol acetate oral suspension is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized Megestrol acetate per mL.

NDC 49884-907-38 Bottles of 240 mL (8 fl. oz.)

NDC 49884-907-61 Bottles of 480 mL (16 fl. oz.)

STORAGE

Store the oral suspension between 20° to 25°C (68° to 77°F). [See USP]. Dispense in a tight container. Protect from heat.

SPECIAL HANDLING

Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS sections). Women at risk of pregnancy should avoid such exposure.

Manufactured by:

PAR PHARMACEUTICAL COMPANIES, INC.

Spring Valley, NY 10977

Patent No.:

6,028,065

6,268,356

6,593,318

6,593,320

Revised: 12/09

PRINCIPAL DISPLAY PANEL 8 OZ

Megestrol ACETATE   Megestrol acetate   suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49884-907 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Megestrol ACETATE (Megestrol) Megestrol ACETATE 40 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color white (milky white) Score      Shape Size Flavor LEMON, LIME Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 49884-907-38 240 mL In 1 BOTTLE, PLASTIC None 2 49884-907-61 480 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075671	07/25/2001

Labeler - Par Pharmaceutical, Inc. (092733690)

Registrant - Par Pharmaceutical, Inc. (092733690)

Revised: 07/2011Par Pharmaceutical, Inc.

More Megestrol resources

• Megestrol Side Effects (in more detail)
• Megestrol Dosage
• Megestrol Use in Pregnancy & Breastfeeding
• Drug Images
• Megestrol Drug Interactions
• Megestrol Support Group
• 13 Reviews for Megestrol - Add your own review/rating

• Megestrol MedFacts Consumer Leaflet (Wolters Kluwer)


• Megace Monograph (AHFS DI)


• Megace Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Megace Advanced Consumer (Micromedex) - Includes Dosage Information


• Megace ES Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Megace ES Consumer Overview

Compare Megestrol with other medications

• Abnormal Uterine Bleeding
• AIDS Related Wasting
• Anorexia
• Breast Cancer, Palliative
• Cachexia
• Endometrial Cancer
• Endometrial Hyperplasia
• Hot Flashes
• Weight Loss

Flurbiprofen Sodium Ophthalmic Solution

Ingredient matches for Flurbiprofen Sodium Ophthalmic Solution

Flurbiprofen

Flurbiprofen sodium salt (a derivative of Flurbiprofen) is reported as an ingredient of Flurbiprofen Sodium Ophthalmic Solution in the following countries:

• United States

International Drug Name Search

Motonalin

Motonalin may be available in the countries listed below.

Ingredient matches for Motonalin

Tizanidine

Tizanidine hydrochloride (a derivative of Tizanidine) is reported as an ingredient of Motonalin in the following countries:

• Japan

International Drug Name Search

Diazepam Intensol

Generic Name: diazepam (Oral route)

dye-AZ-e-pam

Commonly used brand name(s)

In the U.S.

• Diazepam Intensol


• Valium

Available Dosage Forms:

• Tablet


• Solution


• Capsule, Extended Release

Therapeutic Class: Antianxiety

Pharmacologic Class: Benzodiazepine, Long Acting

Uses For Diazepam Intensol

Diazepam is used to relieve symptoms of anxiety and alcohol withdrawal. This medicine may also be used to treat certain seizure disorders and help relax muscles or relieve muscle spasm.

Diazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

Before Using Diazepam Intensol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diazepam in infants below 6 months of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diazepam in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving diazepam.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil


• Amobarbital


• Anileridine


• Aprobarbital


• Buprenorphine


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlorzoxazone


• Codeine


• Dantrolene


• Ethchlorvynol


• Etravirine


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Itraconazole


• Ketorolac


• Levorphanol


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Morphine


• Morphine Sulfate Liposome


• Naproxen


• Oxycodone


• Oxymorphone


• Pentobarbital


• Phenobarbital


• Primidone


• Propoxyphene


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Thiopental


• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline


• Amprenavir


• Clarithromycin


• Dalfopristin


• Disulfiram


• Erythromycin


• Fluvoxamine


• Ginkgo


• Isoniazid


• Mirtazapine


• Phenytoin


• Quinupristin


• Rifapentine


• Roxithromycin


• St John's Wort


• Theophylline


• Troleandomycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of, or


• Drug abuse or dependence, or history of—Dependence on diazepam may develop.

• Breathing problems or lung disease, severe or


• Glaucoma, narrow-angle or


• Liver disease, severe or


• Myasthenia gravis or


• Sleep apnea (temporary stopping of breathing during sleep)—Should not be used in patients with these conditions.

• Depression, or history of—Use with caution. May make this condition worse.

• Kidney disease or


• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of diazepam

This section provides information on the proper use of a number of products that contain diazepam. It may not be specific to Diazepam Intensol. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To use the oral solution:

• Measure the oral liquid with the medicine dropper from the package.


• Mix each dose with water, juice, soda or a soda-like beverage before you take it. You may also mix the liquid with a semisolid food such as applesauce or pudding.


• Take the entire mixture right away. It should not be saved to use later.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets or solution):
  
  • For anxiety:
    
    • Adults—2 to 10 milligrams (mg) two to four times per day.
    
    
    • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
    
    
    • Children 6 months of age and older—At first, 1 to 2.5 milligrams (mg) three or four times per day. Your child's doctor may increase the dose if needed.
    
    
    • Infants below 6 months of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For alcohol withdrawal:
    
    • Adults—10 milligrams (mg) three or four times for the first 24 hours, then 5 mg three to four times per day as needed.
    
    
    • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For muscle spasm:
    
    • Adults—2 to 10 milligrams (mg) three or four times per day.
    
    
    • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
    
    
    • Children 6 months of age and older—At first, 1 to 2.5 milligrams (mg) three or four times per day. Your child's doctor may increase the dose if needed.
    
    
    • Infants below 6 months of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For seizures:
    
    • Adults—2 to 10 milligrams (mg) two to four times per day.
    
    
    • Older adults—At first, 2 to 2.5 milligrams (mg) once or twice per day. Your doctor may gradually increase the dose if needed.
    
    
    • Children 6 months of age and older—At first, 1 to 2.5 milligrams (mg) three or four times per day. Your child's doctor may increase the dose if needed.
    
    
    • Infants below 6 months of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Destroy any medicine that you do not need by flushing it down the toilet.

Precautions While Using Diazepam Intensol

It is very important that your doctor check the progress of you or your child at regular visits to see if the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you or your child stop taking this medicine. Check with your doctor before taking any of the above while you or your child are using this medicine.

If you or your child develop any unusual or strange thoughts and behavior while taking diazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not stop taking this medicine without checking with your doctor first. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

Diazepam Intensol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Shakiness and unsteady walk


• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Abdominal or stomach pain


• agitation


• anxiety


• black, tarry stools


• blistering, flaking, or peeling of skin


• blurred vision


• changes in patterns and rhythms of speech


• chills


• confusion


• cough


• dark urine


• decrease in frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• discouragement


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• false beliefs that cannot be changed by facts


• fast heartbeat


• fast or irregular breathing


• feeling sad or empty


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• feeling, seeing, or hearing things that are not there


• fever


• headache


• hyperexcitability


• increased muscle spasms or tone


• irritability


• itching


• lack of appetite


• lack of memory of what takes place after a certain event


• loss of appetite


• loss of bladder control


• loss of interest or pleasure


• lower back or side pain


• mood or other mental changes


• nausea


• nervousness


• nightmares


• outbursts of anger


• painful or difficult urination


• pale skin


• rash


• restlessness


• seizures


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• sleeplessness


• slurred speech


• sore throat


• sweating


• trembling or shaking of the hands or feet


• tremor


• trouble concentrating


• trouble in speaking


• trouble sleeping


• ulcers, sores, or white spots in the mouth


• unable to sleep


• unpleasant breath odor


• unusual behavior


• unusual bleeding or bruising


• unusual feeling of excitement


• unusual tiredness or weakness


• vomiting of blood


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness


• difficult or troubled breathing


• irregular, fast or slow, or shallow breathing


• lack of coordination


• loss of consciousness


• loss of strength or energy


• muscle pain or weakness


• pale or blue lips, fingernails, or skin


• sleepiness


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Constipation


• decreased interest in sexual intercourse


• diarrhea


• difficulty in swallowing


• double vision


• dry mouth


• feeling of constant movement of self or surroundings


• inability to have or keep an erection


• increase in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• increased watering of mouth


• indigestion


• loss of sexual ability, desire, drive, or performance


• passing of gas


• seeing double


• sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Diazepam Intensol side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Diazepam Intensol resources

• Diazepam Intensol Side Effects (in more detail)
• Diazepam Intensol Use in Pregnancy & Breastfeeding
• Diazepam Intensol Drug Interactions
• Diazepam Intensol Support Group
• 0 Reviews for Diazepam Intensol - Add your own review/rating

Compare Diazepam Intensol with other medications

• Alcohol Withdrawal
• Anxiety
• Endoscopy or Radiology Premedication
• Hyperekplexia
• ICU Agitation
• Light Anesthesia
• Light Sedation
• Muscle Spasm
• Seizure Prevention
• Seizures
• Status Epilepticus
• Temporomandibular Joint Disorder
• Tetanus

Ulcigard D

Ulcigard D may be available in the countries listed below.

Ingredient matches for Ulcigard D

Domperidone

Domperidone is reported as an ingredient of Ulcigard D in the following countries:

• India

Omeprazole

Omeprazole is reported as an ingredient of Ulcigard D in the following countries:

• India

International Drug Name Search

Dextromethorphan Gel Syrup

Pronunciation: DEX-troe-meth-OR-fan
Generic Name: Dextromethorphan
Brand Name: ElixSure Cough

Dextromethorphan Gel Syrup is used for:

Temporarily relieving cough due to the common cold, hay fever, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

Dextromethorphan Gel Syrup is a cough suppressant. It works in the cough center of the brain to reduce a dry or nonproductive cough.

Do NOT use Dextromethorphan Gel Syrup if:

• you are allergic to any ingredient in Dextromethorphan Gel Syrup


• you are taking or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dextromethorphan Gel Syrup:

Some medical conditions may interact with Dextromethorphan Gel Syrup. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have chronic cough, chronic bronchitis, asthma, emphysema, chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

Some MEDICINES MAY INTERACT with Dextromethorphan Gel Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of toxic side effects may be increased by Dextromethorphan Gel Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dextromethorphan Gel Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dextromethorphan Gel Syrup:

Use Dextromethorphan Gel Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dextromethorphan Gel Syrup may be taken with or without food. Take with food if stomach upset occurs.


• Shake well before using.


• Use the teaspoon provided with Dextromethorphan Gel Syrup to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Dextromethorphan Gel Syrup and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dextromethorphan Gel Syrup.

Important safety information:

• Dextromethorphan Gel Syrup may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Dextromethorphan Gel Syrup. Using Dextromethorphan Gel Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition.


• Dextromethorphan Gel Syrup contains dextromethorphan. Before you being taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your health care provider or pharmacist.


• Diabetes patients - Some brands of Dextromethorphan Gel Syrup may contain sugar and affect your blood sugar level. Read the label carefully before using Dextromethorphan Gel Syrup.


• Dextromethorphan Gel Syrup is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Dextromethorphan Gel Syrup can cause harm to the fetus. If you become pregnant while taking Dextromethorphan Gel Syrup, discuss with your doctor the benefits and risks of using Dextromethorphan Gel Syrup during pregnancy. It is unknown if Dextromethorphan Gel Syrup is excreted in breast milk. Do not breast-feed while taking Dextromethorphan Gel Syrup.

Possible side effects of Dextromethorphan Gel Syrup:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dextromethorphan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Proper storage of Dextromethorphan Gel Syrup:

Store Dextromethorphan Gel Syrup between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep Dextromethorphan Gel Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Dextromethorphan Gel Syrup, please talk with your doctor, pharmacist, or other health care provider.


• Dextromethorphan Gel Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dextromethorphan Gel Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dextromethorphan resources

• Dextromethorphan Side Effects (in more detail)
• Dextromethorphan Use in Pregnancy & Breastfeeding
• Dextromethorphan Drug Interactions
• Dextromethorphan Support Group
• 8 Reviews for Dextromethorphan - Add your own review/rating

Compare Dextromethorphan with other medications

• Cough

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate

DEXTROAMPHETAMINE SACCHARATE,

AMPHETAMINE ASPARTATE MONOHYDRATE,

DEXTROAMPHETAMINE SULFATE AND

AMPHETAMINE SULFATE TABLETS

CII

5 mg, 10 mg, 20 mg and 30 mg

(Mixed Salts of a Single-Entity Amphetamine Product)


Rx only

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

DESCRIPTION

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.

EACH TABLET CONTAINS:	5 mg	10 mg	20 mg	30 mg
Dextroamphetamine
Saccharate……………………………...	1.25 mg	2.5 mg	5 mg	7.5 mg
Amphetamine
Aspartate Monohydrate ……...………..	1.25 mg	2.5 mg	5 mg	7.5 mg
Dextroamphetamine
Sulfate USP………………………….	1.25 mg	2.5 mg	5 mg	7.5 mg
Amphetamine
Sulfate USP…………………………....	1.25 mg	2.5 mg	5 mg	7.5 mg
Total amphetamine
base equivalence ………………………	3.13 mg	6.3 mg	12.6 mg	18.8 mg

In addition, each tablet for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

Colors: 5 mg,  and 10 mg, tablets contain FD&C Blue #2 Aluminum Lake

              20 mg and 30 mg tablets contain D&C Red #27 Aluminum Lake as a color additive

CLINICAL PHARMACOLOGY

Pharmacodynamics

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t1/2) for d-amphetamine was shorter than the t1/2 of the l-isomer (9.77-11 hours vs. 11.5-13.8 hours). The PK parameters (Cmax, AUC0-inf) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.

The effect of food on the bioavailability of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate has not been studied.

Metabolism and Excretion

Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.

Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.

With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose is recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that effect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine's metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased, (See PRECAUTIONS).

INDICATIONS AND USAGE

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

Attention Deficit Hyperactivity Disorder (ADHD)

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use

The effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

CONTRAINDICATIONS

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result.)

WARNINGS

Serious Cardiovascular Events

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug (see CONTRAINDICATIONS).

Adults

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).

Hypertension And Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see ADVERSE REACTIONS], and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g. electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Suppression of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

PRECAUTIONS

General

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets should be used with caution in patients who use other sympathomimetic drugs.

Tics

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications.

Information for Patients

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with amphetamine or dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets.

The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Drug Interactions

Acidifying agents – Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines.


Urinary acidifying agents – (ammonium chloride, sodium acid phosphate, etc.) Increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.


Adrenergic blocker – Adrenergic blockers are inhibited by amphetamines.


Alkalinizing agents – Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Co-administration of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets and gastrointestinal alkalizing agents, such as antacids, should be avoided. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.


Antidepressants, tricyclic – Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.


MAO inhibitors – MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.


Antihistamines – Amphetamines may counteract the sedative effect of antihistamines.


Antihypertensives – Amphetamines may antagonize the hypotensive effects of antihypertensives.


Chlorpromazine – Chlorpromazine blocks dopamine and norepinephrine receptors, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.


Ethosuximide – Amphetamines may delay intestinal absorption of ethosuximide.


Haloperidol – Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.


Lithium carbonate – The anorectic and stimulatory effects of amphetamines may be inhibited by lithium carbonate.


Meperidine – Amphetamines potentiate the analgesic effect of meperidine.


Methenamine therapy – Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.


Norepinephrine – Amphetamines enhance the adrenergic effect of norepinephrine.


Phenobarbital – Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.


Phenytoin – Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.


Propoxyphene – In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.


Veratrum alkaloids – Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Carcinogenesis/Mutagenesis and Impairment of Fertility

No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m2 body surface area basis.

Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets (immediate-release)(d- to l- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro. d,l-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets (immediate-release)(d- to l- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose of 30 mg/day on a mg/m2 body surface area basis).

Pregnancy

Teratogenic Effects

Pregnancy Category C.  Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Usage in Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under INDICATIONS AND USAGE.

Geriatric Use

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets have not been studied in the geriatric population.

ADVERSE REACTIONS

Cardiovascular

Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, seizures, stroke.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic

Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine

Impotence, changes in libido.

DRUG ABUSE AND DEPENDENCE

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroampetamine sulfate and amphetamine sulfate are Schedule II controlled substance.

Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to levels many times higher than recommended.Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

OVERDOSAGE

Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Symptoms

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse.

Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

TREATMENT

Consult with a Certified Poison Control Center for up to date guidance and advise.  Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic and sedation.  Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard.  Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present.  If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine has been suggested.  However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.  Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treate amphetamine intoxication.

DOSAGE AND ADMINISTRATION

Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Hyperactivity Disorder

Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Narcolepsy

Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

HOW SUPPLIED

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg, 10 mg, 20 mg, and 30 mg.

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 5 mg: Blue, round, compressed tablets, debossed cor over 130 on one side and Quadrisect on the other side.

In bottles of 100 tablets      (NDC 64720-130-10)

In bottles of 1000 tablets    (NDC 64720-130-11)

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 10 mg: Blue, round, compressed tablets, debossed cor over 132 on one side and Quadrisect on the other side.

In bottles of 100 tablets     (NDC 64720-132-10)

In bottles of 1000 tablets   (NDC 64720-132-11)

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 20 mg: Pink, round, compressed tablets, debossed cor over 135 on one side and Quadrisect on the other side.

In bottles of 100 tablets     (NDC 64720-135-10)

In bottles of 1000 tablets   (NDC 64720-135-11)

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets 30 mg: Pink, round, compressed tablets, debossed cor over 136 on one side and Quadrisect on the other side.

In bottles of 100 tablets     (NDC 64720-136-10)

In bottles of 1000 tablets   (NDC 64720-136-11)

Dispense in a tight, light-resistant container as defined in the USP.

Store at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature).

Protect from moisture.

LB# 177-05

Rev. January 2011

Manufactured and Distributed by:

Corepharma LLC

Middlesex, NJ 08846

For additional copies of the printed patient information/medication guide, please visit www.corepharma.com or call 1-800-850-2719

Medication Guide for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets CII

(DEX-troe-am-FET-uh-meen SACK-uh-rate/ am-FET-uh-meen ass-PAR-tate MAH-no-HIGH-drate/ DEX-troe-am-FET-uh-meen SULL-fate/ am-FET-uh-meen SULL-fate)

Read the Medication Guide that comes with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS? THE FOLLOWING HAVE BEEN REPORTED WITH USE OF DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS AND OTHER STIMULATE MEDICINES. 1. HEART-RELATED PROBLEMS: sudden death in patients who have heart problems or heart defects stroke and heart attack in adults increased blood pressure and heart rate TELL YOUR DOCTOR IF YOU OR YOUR CHILD HAVE ANY HEART PROBLEMS, HEART DEFECTS, HIGH BLOOD PRESSURE, OR A FAMILY HISTORY OF THESE PROBLEMS. YOUR DOCTOR SHOULD CHECK YOU OR YOUR CHILD CAREFULLY FOR HEART PROBLEMS BEFORE STARTING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE TABLETS.  YOUR DOCTOR SHOULD CHECK YOUR OR YOUR CHILD'S BLOOD PRESSURE AND HEART RATE REGULARLY DURING TREATMENT WITH DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS. CALL YOUR DOCTOR RIGHT AWAY IF YOU OR YOUR CHILD HAS ANY SIGNS OF HEART PROBLEMS SUCH AS CHEST PAIN, SHORTNESS OF BREATH, OR FAINTING WHILE TAKING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS. 2. MENTAL (PSYCHIATRIC) PROBLEMS: ALL PATIENTS new or worse behavior and thought problems new or worse bipolar illness new or worse aggressive behavior or hostility CHILDREN AND TEENAGERS new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms TELL YOU DOCTOR ABOUT ANY MENTAL PROBLEMS YOU OR YOUR CHILD HAVE, OR ABOUT A FAMILY HISTORY OF SUICIDE, BIPOLAR ILLNESS, OR DEPRESSION.  Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What are Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets?

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETMAINE SULFATE AND AMPHETAMINE SULFATE TABLETS ARE CENTRAL NERVOUS SYSTEM STIMULANT PRESCRIPTION MEDICINE.  THEY ARE USED FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD).  DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS MAY HELP INCREASE ATTENTION AND DECREASE IMPULSIVENESS AND HYPERACTIVITY IN PATIENTS WITH ADHD.  DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS SHOULD BE USED AS A PART OF A TOTAL TREATMENT PROGRAM FOR ADHD THAT MAY INCLUDE COUNSELING OR OTHER THERAPIES.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET ARE ALSO USED IN THE TREATMENT OF A SLEEP DISORDER CALLED NARCOLEPSY.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS ARE A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE THEY CAN BE ABUSED OR LEAD TO DEPENDENCE.  KEEP DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS IN A SAFE PLACE TO PREVENT MISUSE AND ABUSE.  SELLING OR GIVING AWAY DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS MAY HARM OTHERS AND IS AGAINST THE LAW. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

WHO SHOULD NOT TAKE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS?

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS SHOULD NOT BE TAKEN IF YOU OR YOUR CHILD:

• have heart disease or hardening of the arteries


• have moderate to severe high blood pressure


• have hyperthyroidism


• have an eye problem called glaucoma


• are very anxious, tense, or agitated


• have a history of drug abuse


• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI


• are sensitive to, allergic to, or had a reaction to other stimulant medicines

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS ARE NOT RECOMMENDED FOR USE IN CHILDREN LESS THAN 3 YEARS OLD.


DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS MAY NOT BE RIGHT FOR YOU OR YOUR CHILD.  BEFORE STARTING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS TELL YOUR  OR YOUR CHILD'S DOCTOR ABOUT ALL HEALTH CONDITIONS (OR A FAMILY HISTORY OF) INCLUDING:

• heart problems, heart defects, high blood pressure


• mental problems including psychosis, mania, bipolar illness, or depression


• tics or Tourette’s syndrome


• liver or kidney problems


• thyroid problems


• seizures or have had an abnormal brain wave test (EEG)

TELL YOUR DOCTOR IF YOU OR YOUR CHILD ARE PREGNANT, PLANNING TO BECOME PREGNANT, OR BREASTFEEDING..

CAN DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS BE TAKEN WITH OTHER MEDICINES?

TELL YOU DOCTOR ABOUT ALL OF THE MEDICINES THAT YOU OR YOUR CHILD TAKE INCLUDING PRESCRIPTION AND NONPRESCRIPTION MEDICINES, VITAMINS, AND HERBAL SUPPLEMENTS.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS AND SOME MEDICINES MAY INTERACT WITH EACH OTHER AND CAUSE SERIOUS SIDE EFFECTS.  SOMETIMES THE DOSES OF OTHER MEDICINES WILL NEED TO BE ADJUSTED WHILE TAKING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS.  YOUR DOCTOR WILL DECIDE WHETHER DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CAN BE TAKEN WITH OTHER MEDICINES.

ESPECIALLY TELL YOUR DOCTOR IF YOU OR YOUR CHILD TAKE:

• anti-depression medicines including MAOIs


• seizure medicines


• blood thinner medicines


• blood pressure medicines


• stomach acid medicines


• cold or allergy medicines that contain decongestants

KNOW THE MEDICINES THAT YOU OR YOUR CHILD TAKE.  KEEP A LIST OF YOUR MEDICINES WITH YOU TO SHOW YOUR DOCTOR AND PHARMACIST.

DO NOT START ANY NEW MEDICINE WHILE TAKING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS WITHOUT TALKING TO YOUR DOCTOR FIRST. 

HOW SHOULD DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS BE TAKEN?

• Take Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.


• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.


• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets can be taken with or without food.


• From time to time, your doctor may stop Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe