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
Thursday, September 29, 2016
Megestrol
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:
- This medication is to be used as directed by the physician.
- Report any adverse reaction experiences while taking this medication.
- Use contraception while taking this medication if you are a woman capable of becoming pregnant.
- 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
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.
PAR PHARMACEUTICAL COMPANIES, INC.
PRINCIPAL DISPLAY PANEL 8 OZ
| Megestrol ACETATE Megestrol acetate suspension | ||||||||||||||||||||
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| 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) |
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
Tuesday, September 27, 2016
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.
- For anxiety:
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
- 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.
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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
Monday, September 26, 2016
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
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