Vagison SG 100/Vagison SG 500

Vagison SG 100/Vagison SG 500

clotrimazole

Manufacturer:

Phil Inter Pharma

Distributor:

JMN Brothers Pharma
Full Prescribing Info
Contents
Clotrimazole.
Description
Vagison SG 100: Each vaginal softgel capsule contains: Clotrimazole 100 mg.
Vagison SG 500: Each vaginal softgel capsule contains: Clotrimazole 500 mg.
Excipients/Inactive ingredients: Polyethylene glycol 400, Polyethylene glycol 4000, Propylene glycol, Gelatin, Glycerin, Dimethicone 1000, Ethyl vanillin, Methyl paraben, Propyl paraben, Red No.40, Purified water.
Action
Pharmacology: Pharmacodynamics: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and it also exhibits activity against Trichomonas, Staphylococcus and bacteroides. It has no effect on Lactobacillus. Mechanism of action of clotrimazole is against dividing and growing organisms. It binds to phospholipids in the fungal cell membrane and alters cell wall permeability resulting in loss of essential intracellular elements.
In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporun canis and Candida species.
Pharmacokinetics: Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3-10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrimazole into pharmacologically inactive metabolites.
100 mg: The resulting peak plasma concentrations of clotrimazole after vaginal application of a 100 mg dose were less than 0.03 mcg/mL 1-2 days, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.
500 mg: The resulting peak plasma concentrations of clotrimazole after vaginal application of a 500 mg dose were less than 10 mcg/mL, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.
Indications/Uses
Clotrimazole (Vagison SG 100) is indicated for the treatment of susceptible fungal infections including vulvovaginal Candidiasis, Trichomonas.
Clotrimazole (Vagison SG 500) is indicated for the treatment of susceptible fungal infections including vulvovaginal Candidiasis, Trichomonas.
Dosage/Direction for Use
Vagison SG 100: For vaginal fungal infections: 100 mg daily at bedtime for 6 days, 200 mg for 3 days or a single dose of 500 mg soft cap in the treatment of vulvovaginal candidiasis.
Vagison SG 500: For vaginal fungal infections: Single dose of 500 mg softgel capsule or as prescribed by the physician.
Overdosage
No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.
Contraindications
Hypersensitivity to clotrimazole or any of the other ingredients.
Special Precautions
Local use only. This drug should not be orally administered.
Before using Clotrimazole, medical advice must be sought if any of the following are applicable: More than two infections of candidal vaginitis in the last 6 months.
Previous history of sexually transmitted disease or exposure to partner with sexually transmitted disease.
Pregnancy or suspected pregnancy.
Aged under 16 or over 60 years.
Known hypersensitivity to imidazoles or other vaginal antifungal products.
Clotrimazole should not be used if the patient has any of the following symptoms: Irregular vaginal bleeding.
Abnormal vaginal bleeding or a blood-stained discharge.
Vulval or vaginal ulcers, blisters or sores.
Lower abdominal pain or dysuria.
Effects on ability to drive and use machines: None reports.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. This product should be used only if clearly indicated during the first trimester of pregnancy.
Lactation:
It is not known whether this drug is excreted in human milk. Caution should be exercised when clotrimazole is used by a nursing woman.
Side Effects
Topical use: Local reactions (>1%) including irritation and mild burning, contact allergic dermatitis; stinging to skin or vaginal area may occur.
*Inform your doctor or pharmacist in case of any adverse reactions related to drug use.
Drug Interactions
Synergism or antagonism between clotrimazole and nystatin or amphotericin B or flucytosine against strains of C. albicans has not been reported.
Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Vagison SG 100: Vag cap (softgel) 100 mg x 6's.
Vagison SG 500: Vag cap 500 mg (light orange oval softgel capsule containing opalescent substance) x 6's.
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