Phenazolinum may be available in the countries listed below.
Ingredient matches for Phenazolinum
Antazoline
Antazoline is reported as an ingredient of Phenazolinum in the following countries:
- Poland
International Drug Name Search
Monday, October 17, 2011
Saturday, October 15, 2011
Taricin
Taricin may be available in the countries listed below.
Ingredient matches for Taricin
Ofloxacin
Ofloxacin is reported as an ingredient of Taricin in the following countries:
- Russian Federation
International Drug Name Search
Friday, October 7, 2011
Betamethasone Valerate
Dosage Form: cream
Betamethasone Valerate
Cream USP, 0.1%
Rx only
For External Use Only. Not for Ophthalmic Use.
Betamethasone Valerate Description
Betamethasone Valerate Cream USP, 0.1% contains a topical corticosteroid, Betamethasone Valerate. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Betamethasone Valerate is chemically designated as Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-17 [(1-oxopentyl) oxy], (11β, 16β)-.
MF: C27H37FO6
MW: 476.58
Each gram of Betamethasone Valerate Cream USP, 0.1% contains: 1.2 mg Betamethasone Valerate (equivalent to 1.0 mg betamethasone), in an aqueous vanishing cream base of mineral oil, white petrolatum, polyethylene glycol 1000, ceteareth-15, cetyl alcohol, stearyl alcohol, propylene glycol, purified water, and 4-chloro-m-cresol as preservative.
Betamethasone Valerate - Clinical Pharmacology
Betamethasone Valerate cream as a topical corticosteroid has anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Betamethasone Valerate cream can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, Betamethasone Valerate cream is handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Indications and Usage for Betamethasone Valerate
Betamethasone Valerate cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
Betamethasone Valerate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Precautions
General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use).
If irritation develops, use of Betamethasone Valerate cream should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Betamethasone Valerate cream should be discontinued until the infection has been adequately controlled.
Information For Patients
Patients using Betamethasone Valerate cream should receive the following information and instructions:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
- The treated skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under occlusive dressing.
- Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Laboratory Tests
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pregnancy Category C
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Betamethasone Valerate cream should be used during pregnancy only if the potential benefit justifies potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when Betamethasone Valerate cream is administered to a nursing woman.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of Betamethasone Valerate cream to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
| Burning | Hypertrichosis | Maceration of the Skin |
| Itching | Acneiform Eruptions | Secondary Infection |
| Irritation | Hypopigmentation | Skin Atrophy |
| Dryness | Perioral Dermatitis | Striae |
| Folliculitis | Allergic Contact Dermatitis | Miliaria |
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Betamethasone Valerate Dosage and Administration
Betamethasone Valerate Cream USP, 0.1% is generally applied to the affected skin areas one to three times daily. Dosage once or twice a day is often effective.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.
How is Betamethasone Valerate Supplied
Betamethasone Valerate Cream USP, 0.1% is supplied in 15 gram (NDC 51672-1269-1) and 45 gram (NDC 51672-1269-6) tubes.
STORAGE
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Revised: March 2005
PK-0759-4 128
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
NDC 51672-1269-1
15 g
Betamethasone Valerate
Cream USP, 0.1%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx only
Keep this and all medications out of the reach of children.
TARO
| Betamethasone Valerate Betamethasone Valerate cream | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA072041 | 01/06/1988 | |
| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE | |
More Betamethasone Valerate resources
- Betamethasone Valerate Use in Pregnancy & Breastfeeding
- Betamethasone Valerate Drug Interactions
- Betamethasone Valerate Support Group
- 13 Reviews for Betamethasone Valerate - Add your own review/rating
- Alphatrex Advanced Consumer (Micromedex) - Includes Dosage Information
- Alphatrex Concise Consumer Information (Cerner Multum)
- Beta-Val Advanced Consumer (Micromedex) - Includes Dosage Information
- Beta-Val Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Diprolene Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Luxiq Foam MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Betamethasone Valerate with other medications
- Atopic Dermatitis
- Dermatitis
- Dermatological Disorders
- Lichen Planus
- Lichen Sclerosus
Thursday, October 6, 2011
Azatrilem
Azatrilem may be available in the countries listed below.
Ingredient matches for Azatrilem
Azathioprine
Azathioprine is reported as an ingredient of Azatrilem in the following countries:
- Mexico
International Drug Name Search
Sunday, October 2, 2011
Enalapril / Hydrochlorothiazide RPG
Enalapril/Hydrochlorothiazide RPG may be available in the countries listed below.
Ingredient matches for Enalapril/Hydrochlorothiazide RPG
Enalapril
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril/Hydrochlorothiazide RPG in the following countries:
- France
Hydrochlorothiazide
Hydrochlorothiazide is reported as an ingredient of Enalapril/Hydrochlorothiazide RPG in the following countries:
- France
International Drug Name Search
Monday, September 19, 2011
Romyk
Romyk may be available in the countries listed below.
Ingredient matches for Romyk
Roxithromycin
Roxithromycin is reported as an ingredient of Romyk in the following countries:
- Germany
International Drug Name Search
Thursday, September 15, 2011
dapsone
Generic Name: dapsone (DAP sone)
Brand Names:
What is dapsone?
Dapsone is an antiinfective medication.
Dapsone is used in the treatment of dermatitis herpetiformis (a skin condition) and leprosy (Hansen's disease).
Dapsone may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about dapsone?
In rare cases, dapsone has been associated with serious, and sometimes fatal blood and liver problems. Contact your doctor immediately if you experience a sore throat, fever, pale skin, bruising or pinpoint red spots on the skin, or yellowing of the skin or eyes. These may be symptoms of blood or liver problems. Contact your doctor immediately if you develop a rash while taking dapsone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions.
What should I discuss with my healthcare provider before taking dapsone?
Do not take dapsone without first talking to your doctor if you have
glucose 6-phosphate dehydrogenase (G6PD) deficiency;
methemoglobin reductase deficiency (hemoglobin M); or
- liver disease.
You may not be able to take dapsone, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.
Dapsone is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take dapsone without first talking to your doctor if you are pregnant or could become pregnant during treatment. Dapsone passes into breast milk and may affect a nursing baby. Do not take dapsone without first talking to your doctor if you are nursing a baby.
How should I take dapsone?
Take dapsone exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Taking dapsone with food may decrease stomach upset, should it occur.
It is important to take dapsone regularly to get the most benefit.
Your doctor may want you to have blood tests or other forms of monitoring during treatment with dapsone.
Store dapsone at room temperature away from moisture and heat.
See also: Dapsone dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication, unless otherwise directed by your doctor.
What happens if I overdose?
Seek emergency medical attention if an overdose is suspected.
Symptoms of a dapsone overdose may include nausea, vomiting, excitation, seizures, and bluish skin color.
What should I avoid while taking dapsone?
Avoid prolonged exposure to sunlight. Dapsone may increase the sensitivity of the skin to sunlight and sunburn may be more likely to occur. If exposure to the sun is unavoidable, wear a sunscreen and protective clothing.
Dapsone side effects
In rare cases, dapsone has been associated with serious, and sometimes fatal blood and/or liver problems. Contact your doctor immediately if you experience a sore throat, fever, pale skin, bruising or pinpoint red spots on the skin, or yellowing of the skin or eyes. These may be symptoms of blood or liver problems. Contact your doctor immediately if you develop a rash while taking dapsone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions. If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
bluish skin color;
muscle weakness;
numbness or tingling;
abdominal pain;
difficulty breathing;
dark colored urine or pale colored stools; or
unusual tiredness.
Other, less serious side effects may be more likely to occur. Notify your doctor if you experience
nausea or vomiting;
blurred vision;
ringing in the ears;
headache;
insomnia; or
increased sensitivity of the skin to sunlight.
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. You may report side effects to FDA at 1-800-FDA-1088.
Dapsone Dosing Information
Usual Adult Dose for Leprosy -- Lepromatous:
50 to 100 mg orally once a day for 2-5 years.
Usual Adult Dose for Leprosy -- Tuberculoid:
100 mg orally once a day for 6 months. Rifampin is additionally recommended to reduce the incidence of dapsone resistance. If the disease relapses, this regimen should be repeated.
Usual Adult Dose for Dermatitis Herpetiformis:
50 mg orally once a day continued on a life-long basis. Dosage may be advanced to 300 mg/day. Dosage reduction to a minimum maintenance level as soon as possible is recommended.
Usual Adult Dose for Pneumocystis Pneumonia:
100 mg orally once a day for 14 to 21 days. Used in combination with trimethoprim.
Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:
100 mg orally twice a week. Therapy should be continued on a life-long basis. The addition of pyrimethamine appears to significantly increase the activity of dapsone for PCP prophylaxis.
Usual Adult Dose for Toxoplasmosis -- Prophylaxis:
100 mg orally twice a week continued on a life-long basis.
Usual Pediatric Dose for Leprosy:
1 to 2 mg/kg (up to 100 mg) orally once a day.
Usual Pediatric Dose for Pneumocystis Pneumonia Prophylaxis:
> 1 month:
2 mg/kg/day (up to 100 mg) orally once a day.
Alternate dosing:
> 1 month:
4 mg/kg orally once weekly. Maximum dose = 200 mg.
Usual Pediatric Dose for Toxoplasmosis -- Prophylaxis:
> 1 month:
2 mg/kg/day (or 15 mg/m2) orally once a day. Maximum dose = 25 mg. Dapsone should be administered as part of combination therapy for prophylaxis of toxoplasmosis.
What other drugs will affect dapsone?
Many other drugs can interact with dapsone, especially those that may also affect the blood. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with dapsone without first talking to your doctor.
More dapsone resources
- Dapsone Dosage
- Dapsone Use in Pregnancy & Breastfeeding
- Drug Images
- Dapsone Drug Interactions
- Dapsone Support Group
- 6 Reviews for Dapsone - Add your own review/rating
- dapsone Advanced Consumer (Micromedex) - Includes Dosage Information
- Dapsone Prescribing Information (FDA)
- Dapsone Professional Patient Advice (Wolters Kluwer)
- Dapsone Monograph (AHFS DI)
- Dapsone MedFacts Consumer Leaflet (Wolters Kluwer)
Compare dapsone with other medications
- Bullous Pemphigoid
- Dermatitis Herpetiformis
- Leprosy
- Leprosy, Lepromatous
- Leprosy, Tuberculoid
- Leukocytoclastic Vasculitis
- Pemphigoid
- Pemphigus
- Pneumocystis Pneumonia
- Pneumocystis Pneumonia Prophylaxis
- Toxoplasmosis, Prophylaxis
Where can I get more information?
- Your pharmacist has more information about dapsone written for health professionals that you may read.
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