Hasalbu may be available in the countries listed below.
Ingredient matches for Hasalbu
Salbutamol
Salbutamol is reported as an ingredient of Hasalbu in the following countries:
- Vietnam
International Drug Name Search
Tuesday, October 25, 2016
Leucovorin Kalbe
Leucovorin Kalbe may be available in the countries listed below.
Ingredient matches for Leucovorin Kalbe
Calcium Folinate
Calcium Folinate is reported as an ingredient of Leucovorin Kalbe in the following countries:
- Indonesia
International Drug Name Search
Carafate
Generic Name: sucralfate
Dosage Form: oral suspension
Carafate (sucralfate) Suspension
Carafate Description
Carafate Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
Carafate Suspension for oral administration contains 1 g of sucralfate per 10 mL.
Carafate Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methylcellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone USP, and sorbitol solution USP. Therapeutic category: antiulcer.
Carafate - Clinical Pharmacology
Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:
- Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
- In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
- In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.
- In vitro, sucralfate adsorbs bile salts.
These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1-g dose of sucralfate.
Clinical Trials
In a multicenter, double-blind, placebo-controlled study of Carafate Suspension, a dosage regiment of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.
| ||||
| Treatment | n | Week 2 Healing Rates | Week 4 Healing Rates | Week 8 Healing Rates |
| Carafate Suspension | 145 | 23(16%)* | 66(46%)† | 95(66%)‡ |
| Placebo | 147 | 10(7%) | 39(27%) | 58(39%) |
Equivalence of sucralfate suspension to sucralfate tablets has not been demonstrated.
Indications and Usage for Carafate
Carafate (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Contraindications
There are no known contraindications to the use of sucralfate.
Precautions
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the posthealing frequency or severity of duodenal ulceration.
Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of sucralfate suspension might be necessary.
Special Populations: Chronic Renal Failure and Dialysis Patients
When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
Drug Interactions
Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of Carafate to alter the absorption of some drugs, Carafate should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose).
There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
Pregnancy
Teratogenic effects. Pregnancy Category B.
Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of Carafate Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the 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 or other drug therapy. (See DOSAGE AND ADMINISTRATION)
This drug 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. (See PRECAUTIONS Special Populations: Chronic Renal Failure and Dialysis Patients) 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
Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%).
Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:
Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting
Dermatological: pruritus, rash
Nervous System: dizziness, insomnia, sleepiness, vertigo
Other: back pain, headache
Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving sucralfate tablets. Similar events were reported with sucralfate suspension. However, a causal relationship has not been established.
Cases of hyperglycemia have been reported with sucralfate
Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.
Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration.
Overdosage
Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Carafate Dosage and Administration
Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day. Carafate should be administered on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.
While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Elderly: 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 or other drug therapy. (See PRECAUTIONS Geriatric Use)
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How is Carafate Supplied
Carafate (sucralfate) Suspension 1 g/10 mL is a pink suspension supplied in bottles of 14 fl oz (NDC 58914-170-14).
SHAKE WELL BEFORE USING. AVOID FREEZING.
Store at controlled room temperature 20-25°C (68-77°F)[see USP].
Rx Only
Prescribing Information as of December 2010
Axcan Pharma US, Inc.
22 Inverness Center Parkway
Birmingham, AL 35242
USA
www.axcan.com
Principal Display Panel
Carafate Suspension, Box
Carafate Suspension, Foil
Carafate Suspension, Bottle
| Carafate sucralfate suspension | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019183 | 12/16/1993 | |
| Labeler - Axcan Pharma Inc. (787651231) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi Aventis US, Inc. | 783243835 | MANUFACTURE, pack, analysis | |
More Carafate resources
- Carafate Side Effects (in more detail)
- Carafate Dosage
- Carafate Use in Pregnancy & Breastfeeding
- Drug Images
- Carafate Drug Interactions
- Carafate Support Group
- 11 Reviews for Carafate - Add your own review/rating
- Carafate Monograph (AHFS DI)
- Carafate Consumer Overview
- Carafate Advanced Consumer (Micromedex) - Includes Dosage Information
- Carafate MedFacts Consumer Leaflet (Wolters Kluwer)
- Sucralfate Professional Patient Advice (Wolters Kluwer)
Compare Carafate with other medications
- Duodenal Ulcer
- Duodenal Ulcer Prophylaxis
- GERD
- Hyperphosphatemia of Renal Failure
- Stomach Ulcer
- Stomatitis
- Stress Ulcer Prophylaxis
Transient Ischemic Attack Medications
Definition of Transient Ischemic Attack:
A transient ischemic attack (TIA) is an episode in which a person has stroke -like symptoms for up to 1-2 hours. A TIA is often considered a warning sign that a true stroke may happen in the future if something is not done to prevent it.Drugs associated with Transient Ischemic Attack
The following drugs and medications are in some way related to, or used in the treatment of Transient Ischemic Attack. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Learn more about Transient Ischemic Attack
Micromedex Care Notes:
- Transient Ischemic Attack
Medical Encyclopedia:
- Transient ischemic attack
Harvard Health Guide:
- Symptoms and treatment for Transient Ischemic Attack (TIA)
Drug List:
Clobex
Generic Name: clobetasol (Topical application route)
kloe-BAY-ta-sol PROE-pee-oh-nate
Commonly used brand name(s)
In the U.S.
- Clobevate
- Clobex
- Cormax
- Embeline
- Embeline E
- Embeline Scalp Application
- Olux
- Olux/Olux-E Complete Pack
- Olux-E
- Temovate
- Temovate E
In Canada
- Clobetasol Propionate
- Dermovate
- Dermovate Scalp Application
- Med Clobetasol Scalp Application
- Ratio-Clobetasol
Available Dosage Forms:
- Cream
- Ointment
- Gel/Jelly
- Spray
- Solution
- Foam
- Emollient Cream
- Lotion
- Shampoo
Therapeutic Class: Corticosteroid, Very Strong
Pharmacologic Class: Clobetasol
Uses For Clobex
Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution and foam are used for scalp problems, the lotion and spray are used for moderate to severe plaque psoriasis, and the shampoo is used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).
This medicine is available only with your doctor's prescription.
Before Using Clobex
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical gel, foam, cream, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical gel, foam, cream, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical spray, lotion, or shampoo have not been established in children and use is not recommended.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobetasol topical in the elderly.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Cushing's syndrome (adrenal gland disorder) or
- Diabetes or
- Hyperglycemia (high blood sugar) or
- Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.
- Infection of the skin at or near the place of application or
- Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.
- Perioral dermatitis (skin problem) or
- Rosacea (skin problem)—Should not be used in patients with these conditions.
Proper Use of clobetasol
This section provides information on the proper use of a number of products that contain clobetasol. It may not be specific to Clobex. Please read with care.
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.
This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.
To use the cream, foam, gel, lotion, ointment, or spray:
- Wash your hands with soap and water before and after using this medicine.
- Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
- With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
- Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
To use the foam, scalp solution, or shampoo:
- Wash your hands with soap and water before and after using this medicine.
- Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
- Do not cover the scalp (e.g., shower cap, bathing cap) while it is being treated.
- Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
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 redness, itching, and swelling of the skin:
- For topical dosage forms (cream, gel, or ointment):
- Adults—Apply to the affected area of the skin two times per day.
- Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.
- Children younger than 12 years of age—Use is not recommended.
- For topical dosage form (lotion):
- Adults—Apply to the affected area of the skin two times per day.
- Children—Use is not recommended.
- For topical dosage forms (cream, gel, or ointment):
- For plaque psoriasis:
- For topical dosage form (foam):
- Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.
- Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.
- Children younger than 12 years of age—Use is not recommended.
- For topical dosage form (spray):
- Adults—Spray to the affected area of the skin two times per day.
- Children—Use is not recommended.
- For topical dosage form (foam):
- For scalp problems:
- For topical dosage form (foam or scalp solution):
- Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
- Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
- Children younger than 12 years of age—Use is not recommended.
- For topical dosage form (shampoo):
- Adults—Apply to the affected area of the scalp once a day.
- Children—Use is not recommended.
- For topical dosage form (foam or scalp solution):
Missed Dose
If you miss a dose of this medicine, apply 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.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Precautions While Using Clobex
It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.
Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.
Make sure your doctor knows that you are using clobetasol gel. You may need to stop using this medicine several days before having surgery.
Do not use cosmetics or other skin care products on the treated areas.
Clobex 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
- Burning or stinging at the application site
- Burning sensation of the skin
- dry skin
- flushing or redness of the skin
- itching, scaling, severe redness, soreness, or swelling of the skin
- skin irritation
- skin rash, encrusted, scaly and oozing
- thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
- Burning, itching, and pain in hairy areas, or pus at the root of the hair
- hair loss
- redness and scaling around the mouth
- thinning of the hair
- thinning, weakness, or wasting away of the skin
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:
More common
- Cough
- sore throat
- Burning, itching, and pain in hairy areas, or pus at the root of the hair
- changes in skin coloring
- body aches or pain
- congestion
- cough
- dryness or soreness of the throat
- fever
- headache
- hoarseness
- raised, dark red, wart-like spots on the skin, especially when used on the face
- skin discomfort
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble with swallowing
- unusual tiredness or weakness
- voice changes
- Acne or pimples
- burning and itching of the skin with pinhead-sized red blisters
- increased hair growth on the forehead, back, arms, and legs
- lightening of normal skin color
- lightening of treated areas of dark skin
- reddish purple lines on the arms, face, legs, trunk, or groin
- softening of the skin
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: Clobex side effects (in more detail)
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More Clobex resources
- Clobex Side Effects (in more detail)
- Clobex Use in Pregnancy & Breastfeeding
- Clobex Drug Interactions
- Clobex Support Group
- 16 Reviews for Clobex - Add your own review/rating
- Clobex Prescribing Information (FDA)
- Clobex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)
- Clobex Concise Consumer Information (Cerner Multum)
- Cormax Prescribing Information (FDA)
- Embeline Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Olux Prescribing Information (FDA)
- Olux Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Olux-E Prescribing Information (FDA)
- Olux-E Emollient Foam MedFacts Consumer Leaflet (Wolters Kluwer)
- Temovate Prescribing Information (FDA)
Compare Clobex with other medications
- Atopic Dermatitis
- Dermatitis
- Lichen Planus
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mitotane
MYE-toe-tane
Oral route(Tablet)
Mitotane should be temporarily discontinued immediately following shock or severe trauma since adrenal suppression is its prime action. Exogenous steroids should be administered in such circumstances, since the depressed adrenal may not immediately start to secrete steroids .
Commonly used brand name(s)
In the U.S.
- Lysodren
Available Dosage Forms:
- Tablet
Therapeutic Class: Adrenocortical Suppressant
Uses For mitotane
Mitotane is used to treat some types of cancer in the adrenal glands. mitotane acts on a part of the body called the adrenal cortex. Mitotane reduces the amount of steroids (cortisone-like hormones) that are produced by the adrenal cortex. These hormones are important for various functions of the body, including growth. However, too much of these hormones can cause problems.
mitotane is available only with your doctor's prescription.
Before Using mitotane
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 mitotane, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to mitotane 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 mitotane in the pediatric population. 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 mitotane in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving mitotane.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 mitotane, 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 mitotane with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Rotavirus Vaccine, Live
Using mitotane 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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Sunitinib
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using mitotane 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.
- Midazolam
- Warfarin
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of mitotane. Make sure you tell your doctor if you have any other medical problems, especially:
- Injury, serious or
- Shock or
- Trauma, severe—Should not be used in patients with these conditions.
- Liver disease—The effects may be increased because of slower removal of the medicine from the body.
Proper Use of mitotane
Medicines used to treat cancer are very strong and can have many side effects. Before receiving mitotane, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take mitotane only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Do not stop taking mitotane without first checking with your doctor. To do so may increase the chance of unwanted effects.
Swallow the tablet whole. Do not crush, break, or chew it. If contact with broken or crushed tablets occurs, wash your hands immediately.
Dosing
The dose of mitotane 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 mitotane. 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):
- For cancer of the adrenal glands:
- Adults—At first, 2 to 6 grams (g) per day, given in divided doses three or four times a day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For cancer of the adrenal glands:
Missed Dose
If you miss a dose of mitotane, 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.
Precautions While Using mitotane
It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by mitotane.
Your doctor may want you to carry an identification card or wear a bracelet stating that you are taking mitotane.
Check with your doctor right away if you get a serious injury, infection, or illness of any kind. mitotane may weaken your body's defenses against infection or inflammation.
Adrenal insufficiency may develop in patients using mitotane. Check with your doctor right away if you have more than one of the following symptoms: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
mitotane will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; tricyclic antidepressants (medicine for depression); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using mitotane.
mitotane may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to mitotane before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
mitotane may cause some people to have changes in their behavior or memory, or to become depressed. This usually occurs in people who take mitotane for more than 2 years. If you or your caregiver notice any changes in behavior while you are taking mitotane, talk to your doctor right away.
mitotane 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
- Darkening of the skin
- diarrhea
- dizziness or lightheadedness
- drowsiness
- loss of appetite
- mental depression
- nausea or vomiting
- skin rash
- unusual tiredness or weakness
- Blood in the urine
- blurred vision
- double vision
- Shortness of breath
- wheezing
- Chills
- cloudy urine
- cold sweats
- confusion
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- feeling of warmth
- fever
- frequent urination
- headache
- lower abdominal cramping
- nervousness
- painful urination
- pounding in the ears
- redness of the face, neck, arms, and occasionally, upper chest
- slow or fast heartbeat
- vision changes
- white area over the eye
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:
More common
- Feeling of constant movement of self or surroundings
- indigestion
- passing of gas
- sensation of spinning
- sleepiness
- stomach pain, fullness, or discomfort
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- Aching muscles
- flushing or redness of the skin
- muscle twitching
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: mitotane 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 mitotane resources
- Mitotane Side Effects (in more detail)
- Mitotane Dosage
- Mitotane Use in Pregnancy & Breastfeeding
- Mitotane Drug Interactions
- Mitotane Support Group
- 0 Reviews for Mitotane - Add your own review/rating
- mitotane Concise Consumer Information (Cerner Multum)
- Mitotane Professional Patient Advice (Wolters Kluwer)
- Mitotane MedFacts Consumer Leaflet (Wolters Kluwer)
- Mitotane Monograph (AHFS DI)
- Lysodren Prescribing Information (FDA)
Compare mitotane with other medications
- Adrenal Cortical Carcinoma
Clomiphene Citrate
Class: Estrogen Agonists-Antagonists
ATC Class: G03XC
VA Class: HS400
CAS Number: 50-41-9
Brands: Clomid, Serophene
Introduction
Estrogen agonist-antagonist; a nonsteroidal ovulatory stimulant.a b
Uses for Clomiphene Citrate
Female Infertility
Used to induce ovulation in appropriately selected anovulatory women desiring pregnancy in whom ovulatory dysfunction has been demonstrated.a b (See General under Dosage and Administration and also see Contraindications under Cautions.)
Optimum results obtained in patients with adequately functioning anterior pituitary gland, adrenals, ovaries, and thyroid, including women with polycystic ovary syndrome, amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of unknown etiology.a b Better results usually obtained in patients with adequate serum estrogen concentrations; however, reduced serum estrogen concentrations do not always preclude successful therapy.a b
Use recommended only in women who are not pregnant, without ovarian cysts or ovarian enlargement (unless enlargement is due to polycystic ovarian syndrome), with normal liver function, and with no abnormal vaginal bleeding.a b (See General under Dosage and Administration and also see Contraindications under Cautions.)
Ineffective in patients with primary pituitary or ovarian failure;a b not a substitute for appropriate therapy of other conditions that may cause ovulatory dysfunction (e.g., thyroid or adrenal disease).b
Manufacturer states that clomiphene is not recommended to induce ovulation associated with in vitro fertilization programs.a
Clomiphene Citrate Dosage and Administration
General
Should be prescribed by clinicians experienced in management of gynecologic and endocrine disorders.a
Carefully evaluate patient prior to each course of therapy to exclude pregnancy, ovarian enlargement, or ovarian cyst formation.a (See the following sections under Cautions: Ovarian Enlargement and Cyst Formation, and Ovarian Hyperstimulation Syndrome, and Adequate Patient Evaluation and Monitoring, and Contraindications.)
Prior to initiating therapy, carefully evaluate patient for adequate endogenous estrogen levels, for primary pituitary or ovarian failure, and for the presence of endometriosis, endometrial carcinoma, or uterine fibroids.a b Exclude or treat all impediments to achieving ovulation and conception (e.g., thyroid disorders, adrenal disorders, hyperprolactinemia, male partner infertility).a b (See Adequate Patient Evaluation and Monitoring and also see Uterine Fibroids, under Cautions.)
Therapy may be started at any time in patients with no recent uterine bleeding.b If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, initiate regimen on the fifth day of the menstrual cycle.b Once ovulation has been established, initiate each subsequent course of therapy on the fifth day of the menstrual cycle.b Reevaluate patient if ovulatory menses does not occur.a
Majority of responding patients will ovulate after the first course of therapy, generally within 5–10 days.a b
Prolonged amenorrhea may be less responsive and may require ≥2 cycles of therapy. b
Likelihood of conception decreases with each succeeding course of therapy.b
Administration
Oral Administration
Administer orally once daily.b
Dosage
Available as clomiphene citrate; dosage expressed in terms of the salt.a b
Adults
Female Infertility
Oral
Initially, 50 mg once daily for 5 days.a b
If ovulation occurs after initial course of therapy, continue with initial dosage of 50 mg once daily for 5 days starting on the fifth day of the menstrual cycle in subsequent treatment cycles.a b If 3 ovulatory responses occur, but pregnancy is not achieved, further treatment not recommended.a
If ovulation does not occur after initial course of therapy, increase to 100 mg daily for 5 days, starting ≥30 days after previous course of therapy.a b If ovulation does not occur after 3 courses of therapy, further treatment not recommended; reevaluate patient.a b
≥6 cycles of therapy (including 3 ovulatory cycles) not recommended.a
Prescribing Limits
Adults
Female Infertility
Oral
Maximum 100 mg daily for 5 days.a b
Maximum 6 cycles of therapy (including 3 ovulatory cycles); safety of long-term cyclic use not conclusively demonstrated.a b
Special Populations
No special population dosage recommendations at this time.a b
Cautions for Clomiphene Citrate
Contraindications
Pregnancy.a b (See Fetal/Neonatal Morbidity and Morality under Cautions.)
Liver disease or history of liver dysfunction.a b
Abnormal uterine bleeding of undetermined origin.a b
Ovarian cysts or enlargement (unless due to polycystic ovarian syndrome).a b (See Ovarian Hyperstimulation Syndrome under Cautions.)
Uncontrolled thyroid or adrenal dysfunction.a
Presence of an organic intracranial lesion (e.g., pituitary tumor).a
Known hypersensitivity to clomiphene or any ingredient in the formulation.a
Warnings/Precautions
Warnings
Fetal/Neonatal Morbidity and Mortality
May cause fetal harm; teratogenicity and fetotoxicity demonstrated in animals.a b
Contraindicated in pregnant women.a b Carefully observe patients to determine if ovulation occurs; record basal body temperature throughout all treatment cycles, and discontinue therapy if pregnancy is suspected.a b Exclude pregnancy, ovarian cyst, or ovarian enlargement between treatment cycles.a
Ocular Effects
Dose-related adverse ocular effects (i.e., blurring of vision, scotomata, electroretinographic changes in retinal function, phosphenes, diplopia, photophobia, decreased visual acuity) reported;a b adverse ocular effects generally disappear a few days to weeks following discontinuance of therapy.a b
Visual symptoms may result from intensification and prolongation of after-images and may be precipitated by a brightly lit environment.a b
Discontinue therapy if visual symptoms occur; prompt ophthalmologic evaluation recommended.a
Ovarian Enlargement and Cyst Formation
Risk of uncomplicated ovarian enlargement and cyst formation; may be accompanied by abdominal or pelvic pain, or distension.a b Generally regresses within days or weeks after discontinuing therapy.a b
Monitor for signs and symptoms of excessive ovarian stimulation (e.g., pelvic pain).b If ovarian enlargement or cyst development occurs, withhold therapy until ovaries return to pretreatment size; maximum enlargement of ovaries may not occur until several days after therapy is discontinued.a If benefits of continuing therapy outweigh risks, reduce dosage or duration of the next course of therapy.a
Ovarian Hyperstimulation Syndrome (OHSS)
Risk of potentially severe OHSS; may progress rapidly and is initially manifested by abdominal pain and distension, nausea, vomiting, diarrhea, and weight gain.a Other symptoms include gross ovarian enlargement, ascites, dyspnea, oliguria, and pleural effusion.a Pericardial effusion, anasarca, hydrothorax, acute abdomen, hypotension, renal failure, pulmonary edema, intraperitoneal and ovarian hemorrhage, deep-venous thrombosis, torsion of the ovary, acute respiratory distress, elevated urinary steroid levels, electrolyte imbalances, and hypoproteinemia may occur.a Fatalities due to hypovolemia, hemoconcentration, and thromboembolism reported.a
Transient liver function test abnormalities, which may be accompanied by morphologic changes (as detected by liver biopsy) have been reported.a
If ovaries are abnormally enlarged, discontinue therapy until ovaries return to pretreatment size; reduce dosage or duration of the next course of therapy.a b Perform abdominal and pelvic examinations with caution due to fragility of enlarged ovaries.a
Hepatic Effects
Increased retention of sulfobromophthalein has occurred.b One case of jaundice (due to bile stasis) has been reported.b
Polycystic Ovary Syndrome
Potential for exaggerated response (e.g, ovarian hyperstimulation) to usual dosages of clomiphene in patients with polycystic ovary syndrome who are overly sensitive to gonadotropin.a b (See Ovarian Hyperstimulation Syndrome under Cautions.) Initially, administer lowest recommended dose and shortest treatment duration.a (See Dosage under Dosage and Administration.)
Ovarian Cancer
Risk of borderline or invasive ovarian tumors; may be associated with prolonged therapy.a Careful evaluation to rule out ovarian cancer recommended if ovarian cysts do not regress spontaneously.a
General Precautions
Adequate Patient Evaluation and Monitoring
Prior to initiating therapy and each subsequent course of therapy, perform a thorough pelvic examination and rule out pregnancy, ovarian enlargement, or ovarian cyst.a (See Contraindications under Cautions.)
Prior to initiating therapy, evaluate for adequate endogenous estrogen levels (e.g., from vaginal smears, endometrial biopsy, urinary estrogen assay, and bleeding response to progesterone).a
Prior to initiating therapy, evaluate liver function.a
If abnormal vaginal bleeding is present, evaluate carefully to rule out neoplastic lesions.a
Perform endometrial biopsy prior to initiating therapy in women with increased risk of endometriosis or endometrial carcinoma (e.g., older women).a
Uterine Fibroids
Possible enlargement of existing uterine fibroids; use with caution in women with uterine fibroids.a
Plural Gestation
Risk of multiple ovulations with resulting plural gestations, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy;a may be associated with higher dosages.b (See Prescribing Limits under Dosage and Administration.)
Specific Populations
Pregnancy
Category X.a (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications, under Cautions.)
Lactation
Not known whether clomiphene is distributed into milk. a Caution if used in nursing women.a Clomiphene may reduce lactation in some women.a
Men
Testicular tumors and gynecomastia reported; however, causal relationship between testicular tumors and clomiphene not determined.a
Common Adverse Effects
Ovarian enlargement; abdominal or pelvic discomfort including distention, bloating, or pain; hot flushes (flashes).b
Interactions for Clomiphene Citrate
No known drug interactions.a
Clomiphene Citrate Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration.a b
Elimination
Metabolism
Exact metabolic fate not clearly established; drug appears to be metabolized in the liver.b
Elimination Route
Excreted in the feces (42%) and urine (8%).a b
Half-life
5 days;b however, radioactivity detected in feces up to 6 weeks following oral administration of radiolabeled drug.a b
Stability
Storage
Oral
Tablets
Tight, light resistant containers at 15–30°C; protect from heat and excess humidity.a b
ActionsActions
Exhibits estrogenic and anti-estrogenic properties;a b precise mechanism of action in ovulation induction of anovulatory women unknown.b
Interacts with estrogen-receptor containing tissues (e.g., hypothalamus, pituitary, ovary, endometrium, vagina, cervix).a May compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of estrogen receptors.a
Appears to stimulate release of the pituitary gonadotropins, FSH and LH, which results in development and maturation of the ovarian follicle, ovulation, and subsequent development and function of the corpus luteum.a b May also directly affect the biosynthesis of ovarian hormones.b
No known progestational, androgenic, or antiandrogenic effects; does not appear to affect pituitary-adrenal or pituitary-thyroid function.a b
Advice to Patients
Importance of discussing purpose and risks of therapy and required monitoring procedures.a
Risk of multiple pregnancy; importance of informing patients about potential complications and risks associated with multiple pregnancies.a b
Importance of properly timed sexual intercourse (i.e., coinciding with expected time of ovulation).a Importance of using a basal body temperature graph or an appropriate ovulation predicting test to determine if ovulation has occurred.a b
Risk of visual disturbances (e.g., blurring, diplopia, photophobia);a b importance of informing clinicians if any adverse visual symptoms occur.a b Use caution when driving or operating machinery, particularly under conditions of variable lighting.a b
Importance of informing clinicians if pelvic or abdominal pain, weight gain, discomfort, or distention occurs.a
Importance of advising women of risk of fetal harm if administered during pregnancy; importance of excluding pregnancy before each course of treatment.a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a b
Importance of informing patients of other important precautionary information.a b (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 50 mg* | Clomid (scored) | Sanofi-Aventis |
Serophene (scored) | Serono |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Clomid 50MG Tablets (SANOFI-AVENTIS U.S.): 5/$89.39 or 10/$160.89
ClomiPHENE Citrate 50MG Tablets (PAR): 30/$84.99 or 90/$251.98
Serophene 50MG Tablets (SERONO): 5/$55.99 or 10/$105.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
a. Sanofi-aventis. Clomid (clomiphene) prescribing information. Bridgewater, NJ; 2006 Jun.
b. AHFS drug information 2007. McEvoy GK, ed. Clomiphene. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3107-3108.
More Clomiphene Citrate resources
- Clomiphene Citrate Side Effects (in more detail)
- Clomiphene Citrate Dosage
- Clomiphene Citrate Use in Pregnancy & Breastfeeding
- Drug Images
- Clomiphene Citrate Support Group
- 10 Reviews for Clomiphene Citrate - Add your own review/rating
- Clomid Prescribing Information (FDA)
- Clomid Consumer Overview
- Clomid Advanced Consumer (Micromedex) - Includes Dosage Information
- Clomid MedFacts Consumer Leaflet (Wolters Kluwer)
- Clomiphene Prescribing Information (FDA)
- Serophene Prescribing Information (FDA)
Compare Clomiphene Citrate with other medications
- Female Infertility
- Lactation Suppression
- Oligospermia
- Ovulation Induction
Sulpirid Milinda
Sulpirid Milinda may be available in the countries listed below.
Ingredient matches for Sulpirid Milinda
Sulpiride
Sulpiride is reported as an ingredient of Sulpirid Milinda in the following countries:
- Germany
International Drug Name Search
Amobantes
Amobantes may be available in the countries listed below.
Ingredient matches for Amobantes
Eszopiclone
Zopiclone is reported as an ingredient of Amobantes in the following countries:
- Japan
International Drug Name Search
Eperbel-S
Generic Name: belladonna, ergotamine, and phenobarbital (bel uh DON uh, er GOT uh meen, and feen oh BAR bit al)
Brand Names: Bel-Phen-Ergot, Bellamine, Bellamor, Bellaphen-S, Bellaspas, Bellergal-S, Duragal-S, Eperbel-S, Spastrin
What is Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Belladonna is a naturally occurring mixture that produces many effects in the body. It reduces spasms within the stomach and intestines, the bladder, and the biliary (liver) system. Belladonna also reduces the secretions of many organs, which helps control conditions such as excess stomach acid.
Ergotamine narrows the blood vessels involved in circulation to the head. Ergotamine can also alter blood flow patterns involved in vascular headaches, such as migraines.
Phenobarbital is a barbiturate that reduces brain and nervous system activity.
The combination of belladonna, ergotamine, and phenobarbital is used to treat symptoms of menopause including hot flashes, sweating, increased heart rate, dizziness, restlessness, headache, anxiety, and trouble sleeping.
Belladonna, ergotamine, and phenobarbital may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Do not use this medication if you have a history of stroke or blood clots, or if you have glaucoma, heart disease, liver disease, kidney disease, porphyria, or high blood pressure. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. This medication contains phenobarbital, which may be habit-forming. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to gradually reduce the dose. Avoid drinking alcohol, which can increase some of the side effects of belladonna, ergotamine, and phenobarbital.
Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by belladonna, ergotamine, and phenobarbital.
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What should I discuss with my health care provider before taking Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Do not use this medication if you have:
narrow-angle glaucoma;
heart disease;
liver disease;
kidney disease;
porphyria;
a history of circulation problems, stroke, or blood clots;
high blood pressure; or
if you are pregnant or breast-feeding.
Before using belladonna, ergotamine, and phenobarbital, tell your doctor if you have:
a stomach problem called pyloric obstruction; or
angina (chest pain).
If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category X. This medication can cause birth defects. Do not use belladonna, ergotamine, and phenobarbital if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. This medication contains phenobarbital, which may be habit-forming. You may have withdrawal symptoms when you stop using this medication after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to gradually reduce the dose.
How should I take Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
To be sure this medication is helping your condition, your doctor may need to check your progress on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Do not stop using this medication without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store this medicine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a belladonna, ergotamine, and phenobarbital overdose may include extremely dry mouth, nausea, vomiting, stomach pain, problems with vision, numbness or pain, blue fingers or toes, cold feeling, extreme drowsiness, confusion, feeling light-headed, fainting, or seizure (convulsions).
What should I avoid while taking Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Avoid drinking alcohol, which can increase some of the side effects of belladonna, ergotamine, and phenobarbital.
Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by belladonna, ergotamine, and phenobarbital.
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Eperbel-S (belladonna, ergotamine, and phenobarbital) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Other less serious side effects are more likely to occur, such as:
blurred vision;
dry mouth;
warmth or tingly feeling;
drowsiness; or
changes in behavior (in children).
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Eperbel-S (belladonna, ergotamine, and phenobarbital)?
Before taking this medication, tell your doctor if you are using any of the following drugs:
a blood thinner such as warfarin (Coumadin);
birth control pills;
erythromycin (E-Mycin, Ery-Tab, Erythrocin, E.E.S.); or
troleandomycin (Tao).
If you are using any of these drugs, you may not be able to use belladonna, ergotamine, and phenobarbital, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect belladonna, ergotamine, and phenobarbital. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Eperbel-S resources
- Eperbel-S Use in Pregnancy & Breastfeeding
- Eperbel-S Drug Interactions
- Eperbel-S Support Group
- 0 Reviews for Eperbel-S - Add your own review/rating
- Bellamine S MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Eperbel-S with other medications
- Hot Flashes
- Menopausal Disorders
- Perimenopausal Symptoms
- Postmenopausal Symptoms
Where can I get more information?
- Your pharmacist has more information about belladonna, ergotamine, and phenobarbital written for health professionals that you may read.
What does my medication look like?
Belladonna, ergotamine, and phenobarbital is available with a prescription under the brand names Bellergal, Bellamine, Bellaspas, Duragal-S, and Spastrin. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Monday, October 24, 2016
Cocaine Hydrochloride Topical Solution
Dosage Form: topical solution
COCAINE HYDROCHLORIDE
Topical Solution
CII
Rx only
| NOT FOR INJECTION OR OPHTHALMIC USE. |
Cocaine Hydrochloride Topical Solution Description
Each mL contains:
Cocaine hydrochloride 40 mg or 100 mg As aqueous solution.
The topical solution contains the following inactive ingredients: citric acid, D&C Yellow No. 10, FD&C Green No. 3, sodium benzoate, and water.
NOTE (for Glass Bottle): External surface of unopened bottle may be sterilized by ethylene oxide only. Do not steam autoclave.
Cocaine hydrochloride USP is a crystalline, granular, or powder substance having a saline, slightly bitter taste that numbs tongue and lips. Cocaine hydrochloride is a local anesthetic.
Cocaine Hydrochloride Topical Solution - Clinical Pharmacology
Cocaine blocks the initiation or conduction of the nerve impulse following local application, thereby effecting local anesthetic action. Cocaine is absorbed from all sites of application, including mucous membranes and the gastrointestinal mucosa. Cocaine is degraded by plasma esterses, with the half-life in the plasma being approximately one hour.
Indications and Usage for Cocaine Hydrochloride Topical Solution
Cocaine Hydrochloride Topical Solution is indicated for the introduction of local (topical) anesthesia of accessible mucous membranes of the oral, laryngeal and nasal cavities.
Contraindications
Cocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to the drug or to the components of the topical solution.
Warnings
RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED.
Carcinogenesis, Mutagenesis
Long-term studies to determine the carcinogenic and mutagenic potential of cocaine are not available.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with cocaine. It is also not known whether cocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cocaine should be given to a pregnant woman only if needed.
Precautions
The safety and effectiveness of Cocaine Hydrochloride Topical Solution depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various anesthetic procedures.
The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status.
Cocaine Hydrochloride Topical Solution should be used with caution in patients with severely traumatized mucosa and sepsis in the region of the proposed application. Use with caution in persons with known drug sensitivities.
Adverse Reactions
Adverse reactions may be due to high plasma levels as a result of excessive and rapid absorption of the drug. Reactions are systemic in nature and involve the central nervous system and/or the cardiovascular system. A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient.
CNS reactions are excitatory and/or depressant, and may be characterized by nervousness, restlessness and excitement. Tremors and eventually clonic-tonic convulsions may result. Emesis may occur. Central stimulation is followed by depression, with death resulting from respiratory failure.
Small doses of cocaine slow the heart rate, but after moderate doses, the rate is increased due to central sympathetic stimulation.
Cocaine is pyrogenic, augmenting heat production in stimulating muscular activity and causing vasoconstriction which decreases heat loss. Cocaine is known to interfere with the uptake of norepinephrine by adrenergic nerve terminals, producing sensitization to catecholamines, causing vasoconstriction and mydriasis.
Cocaine causes sloughing of the corneal epithelium, causing clouding, pitting, and occasionally ulceration of the cornea. The drug is not meant for ophthalmic use.
Overdosage
The fatal dose of cocaine has been approximated at 1.2 g., although severe toxic effects have been reported from doses as low as 20 mg.
Symptoms
The symptoms of cocaine poisoning are referable to the CNS, namely the patient becomes excited, restless, garrulous, anxious and confused. Enhanced reflexes, headache, rapid pulse, irregular respiration, chills, rise in body temperature, mydriasis, exophthalmos, nausea, vomiting and abdominal pain are noticed. In severe overdoses, delirium, Cheyne-Stokes respiration, convulsions, unconsciousness, and death from respiratory arrest result. Acute poisoning by cocaine is rapid in developing.
Treatment
The specific treatment of acute cocaine poisoning is the intravenous administration of a short-acting barbiturate or diazepam. Artificial respiration may be necessary. It is important to limit absorption of the drug. If entrance of the drug into circulation can be checked, and respiratory exchange maintained, the prognosis is favorable since cocaine is eliminated fairly rapidly.
Cocaine Hydrochloride Topical Solution Dosage and Administration
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Cocaine Hydrochloride Topical Solution can be administered by means of cotton applicators or packs, instilled into a cavity, or as a spray.
How is Cocaine Hydrochloride Topical Solution Supplied
4% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.
NDC 0527-1728-74: Unit-of-Use Glass Bottle filled to contain 4 mL, one 4 mL bottle per carton.
NDC 0527-1728-73: Multi-Dose Bottle of 10 mL.
10% Cocaine Hydrochloride Topical Solution, clear, blue-green solution.
NDC 0527-1729-74: Unit-of-Use Glass Bottle filled to contain 4 mL, one 4 mL bottle per carton.
NDC 0527-1729-73: Multi-Dose Bottle of 10 mL.
DEA Order Form Required.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Avoid freezing.
Keep out of reach of children.
Rev. 03/08
Manufactured
By
Cody Laboratories, Inc.
Cody, WY 82414
For
Lannett Company, Inc.
Philadelphia, PA 19136
PRINCIPAL DISPLAY PANEL - 4 mL/4% label
NDC 0527-1728-74
Unit of Use 4 mL
LANNETT
Dispense with confidence
Rx Only
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 40 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 4 mL/4% box
NDC 0527-1728-74
LANNETT
Dispense with Confidence
Unit-of Use
4 mL
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
40 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/4% label
NDC 0527-1728-73
Multi-Dose 10 mL
LANNETT
Dispense with confidence
Rx Only
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 40 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/4% box
NDC 0527-1728-73
LANNETT
Dispense with Confidence
Multi-Dose
10 mL
4%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
40 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 4 mL/10% label
NDC 0527-1729-74
Unit of Use 4 mL
LANNETT
Dispense with confidence
Rx Only
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 100 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 4 mL/10% box
NDC 0527-1729-74
LANNETT
Dispense with Confidence
Unit-of Use
4 mL
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
100 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/10% label
NDC 0527-1729-73
Multi-Dose 10 mL
LANNETT
Dispense with confidence
Rx Only
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains Cocaine HCl 100 mg
NOT FOR INJECTION
OR OPHTHALMIC USE
PRINCIPAL DISPLAY PANEL - 10 mL/10% box
NDC 0527-1729-73
LANNETT
Dispense with Confidence
Multi-Dose
10 mL
10%
CII
COCAINE
HYDROCHLORIDE
Topical Solution
Each mL contains:
Cocaine Hydrochloride
100 mg
Rx Only
NOT FOR
INJECTION OR
OPHTHALMIC USE
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved other | 12/01/2008 | ||
| COCAINE HYDROCHLORIDE cocaine hydrochloride solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved other | 12/01/2008 | ||
| Labeler - Lannett Company, Inc. (002277481) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Cody Laboratories, Inc. | 028153216 | ANALYSIS, MANUFACTURE | |
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