VAGID® (Clotrimazole Pessaries BP 100mg)

VAGID® (Clotrimazole Pessaries BP 100mg)

VAGID® (Clotrimazole Vaginal Pessaries BP 100mg)

Clotrimazole acts against by fungi inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

Under appropriate test conditions, the MIC values of these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate. The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In-vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.

Pharmacokinetic properties

After vaginal use that only a small amount of clotrimazole (3-10% of the base) is absorbed. Clotrimazole used intravaginally does not lead to measurable systemic effects or side effects.

Indications

VAGID is used for the treatment of vaginal candidiasis. Clotrimazole can kill the yeast that cause vaginal yeast infections and can relieve the associated itching and burning. SHOULD NOT BE USED FOR VULVUR ITCHING DUE TO CAUSES OTHER THAN YEAST INFECTION.

Dose and Method of administration

One pessary to be inserted for 6 consecutive nights OR as directed by the physician. The pessary is to be inserted in vaginal as gently and deeply in a comfortable position preferably lying on the back. Incase of refractory and recurring infection the dose and/or duration may be doubled. For better results the treatment should be commenced after menstruation or completed before start of menstruation.

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Contraindications

Contraindicated in people with known sensitivity or allergy to any ingredient of the product. The medicine is not recommended for use in children. There is a possibility that this preparation may damage latex (rubber) condoms and diaphragms (caps) and the effectiveness of these contraceptives may consequently be reduced.

Precautions & warnings

In case of experiencing the symptoms of vaginal thrush for the first time, having more than two infections in the last six months, pregnancy, age group of under 16 or over 60 years person should make sure to consult a doctor before using this medicine.

In case of the following symptoms patients should consult a physician: irregular or abnormal vaginal bleeding, blood-stained or foul-smelling vaginal discharge, vulva or vaginal ulcers, blisters or sores, lower abdominal pain, pain while passing urine, fever, chills, nausea, vomiting or diarrhea.

Pessary is not to be taken by mouth. It is for vaginal use only.

An alternative method of contraception should be used at least for 5 days after using this medicine, or preferably avoid having sex until the infection is cured. It is important to treat sexual partner with symptoms of thrush simultaneously. Consult a doctor if the symptoms have not got better within a week of using the pessary since, the infection may not be due to yeast.

Pregnancy and breast feeding

In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimester has not been associated with ill effects. There are no adequate and well controlled studies in pregnant women during first trimester of pregnancy.

Since very little of this medicine is absorbed into the bloodstream from the vagina it is unlikely that any of the medicine will pass into breast milk. Vagid pessaries may be used during pregnancy or lactation if benefits outweigh the risk only under medical supervision.

Interactions

Pessaries 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. Concomitant medication with vaginal clotrimazole and oral lacrolimus might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.

Adverse effects

Since the drug is not absorbed through the vagina it is unlikely to produce systemic side effects. Allergic reactions such as syncope, hypotension, dyspenia, urticaria, pruritus may occur. Other reactions observed may be genital peeling, pruritus, rash, oedema, erythema, discomfort, burning , irritation, pelvic pain, vaginal haemorrhage and abdominal pain.

Overdosage

No risk of acute intoxication is seen as it is unlikely to occur following a vaginal use of an overdose 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.

Storage:

Keep in a dry place, below 30°C. protect from light

Keep out of reach of children.

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How to use vaginal suppository

  1. Remove the applicator form the packaging. Pull out the plunger as far as the backstop. Remove one suppository from the blister and place firmly into the applicator. Suppository fit tightly into the applicator and needs to be squeezed into the the holder just far enough to be held in place during insertion (about 1 cm)
  2. Carefully insert the applicator as deep as is comfortable into the vagina. Holding the applicator in place, slowly press the plunger until it stops, so that the suppository is inserted into the vagina
  3. Carefully remove the applicator and wash with warm (not boiling) soapy water, rinse and dry carefully.
VAGID® (Clotrimazole Pessaries BP 100mg)
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