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“The recommended drug of choice
for vaginal candidiasis”

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FORMULATION

Each softgel capsule contains: Clotrimazole ……… 100 mg

PRODUCT DESCRIPTION: Clotrimazole (Vagison SG 100) is a light yellow oval softge l capsule containing opalescent substance.

CONTRAINDICATIONS: Hypersensitivity to clotrimazole or any of the other ingredients.

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 exh ibits activity againts Trichomonas, Staphylococcus and Bacteroides. lt has no effect on lactobacil;us.

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 int race l lu lar elements.

In vitro, clot rim azo le exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidennophyton floccosum , Microsporum canis and Candida species.

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. The resulting peak plasma concentrations of clotrimazole after vaginal application of a 100mg dose were less than 0.03 mcg/ ml after 1- 2 days, reflecting that clotrimazole applied intravaginally does not lead to measurable systemic effects or side effects.

Clotrimazole (Vagison SG 100) is indicated for the treatment of susceptible fungal infections including vulvovaginal Candidiasis, Trichomonas.

For vaginal fungi infections: 100mg daily at bedtime for 6 days, 200mg for 3 days, or a single dose of 500mg soft cap in the treatment of vulvovaginal candidiasis .

Local use only. This drug should not be orally administered.

Before using Clotrimazole ( Vagiso n SG 100), medical advice must be sought if any of the following are applicable :

  • More than two infect io ns of candida/ vaginitis in the last 6 months
  • Previous history of sexually transmitted disease or exposure to partner with sexually transmitted
  • Pregnancy or suspected pregnancy.
  • Aged under 16 or over 60 years.
  • Known hypersensitivity to imidazoles or other vaginal antifungal products.

Clotrimazole ( Yagiso n SG I 00) should not be used if the patient has any of the following symptoms:

  • Irregular vaginal bleeding.
  • Abnormal vaginal bleeding or a blood-stained discharge.
  • Vulva or vaginal ulcers, blisters or sores.
  • Lower abdominal pain or dysuria.

Synergism or antagonism between clotrimazole and nystatin or amphoteric in B or flucytosine against strains of C.albicans has not 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.

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.

Topical use: Local reactions (> 1 %)   including irritation and mild burning, contact allergic dermatitis; stinging to skin or vaginal area may occur.

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.

Store at temperatures not exceeding 30°C.

Foods, Drugs, Devices and Cosmetics Ac t prohibits dispensing without prescription.

For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph

Seek medical attention immediately at the first sign of any adverse drug reaction.