CANESTEN 500/MG VGINAL TAB W\APPLICATOR 1/VAG TAB

Indications

Approved Uses

Treatment of vulvovaginal candidiasis (vaginal yeast infection/thrush) caused by Candida species.

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: Insert ONE 500 mg vaginal tablet once (single-dose), preferably at bedtime.

Initial Dose

One 500mg tablet inserted vaginally as a single dose.

Maintenance Dose

Single dose regimen - no maintenance dose required

Maximum Dose

Intravaginal: 1 vaginal tablet (500 mg) inserted once as a single dose. Do not repeat more than once within 7 days unless directed by a doctor.

Children's Dosage

Not recommended for children under 16 years of age unless advised by a doctor.

Dose Adjustment Notes

No renal or hepatic dose adjustment is required for a single-dose 500 mg vaginal clotrimazole tablet due to minimal systemic absorption; advise medical review if symptoms persist >7 days, are severe, or recur frequently.

How to Take

Insert ONE 500 mg vaginal tablet high into the vagina, preferably at bedtime, using the provided applicator (or insert with a finger if applicator use is not advised, e.g., pregnancy). Wash hands before and after use and remain lying down briefly after insertion.

Side Effects

Common Side Effects

Local vaginal/vulvar burning, stinging, itching, irritation; increased vaginal discharge; lower abdominal/pelvic cramps occur less commonly.

Side Effect Frequency

Common (≥1% to <10%): local vaginal burning, itching, irritation/redness; may include lower abdominal/pelvic discomfort. Uncommon (<1%): hypersensitivity reactions (e.g., rash/urticaria), increased vaginal discharge. Rare: severe allergic reactions.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to clotrimazole or any excipients (azole/imidazole cross‑sensitivity is a precaution).

Warnings & Precautions

For vaginal use only; avoid eyes/oral use. Do not use during menstruation if possible. Avoid tampons, douches, intravaginal spermicides during treatment. May damage latex condoms/diaphragms-use alternative contraception during treatment and for several days after. Seek medical advice if first episode, recurrent/persistent symptoms, atypical symptoms (fever, lower abdominal pain, foul-smelling discharge), or if pregnant.

Age Restriction

OTC self-treatment generally for adults and adolescents ≥16 years; not recommended for children <16 years without medical advice (and not for pre‑pubertal children). Seek medical advice if >60 years with first episode/atypical symptoms.

Driving Warning

Safe

Drug Interactions

Drug Interactions

May reduce effectiveness of latex condoms/diaphragms during treatment and for several days after; clinically significant systemic drug interactions are unlikely, but caution/monitoring is reasonable with narrow-therapeutic-index calcineurin/mTOR inhibitors (e.g., tacrolimus/sirolimus) if used concomitantly.

Interaction Severity

MODERATE/clinically relevant: May weaken latex condoms/diaphragms during treatment and for several days after use. Other systemic drug interactions (e.g., tacrolimus/sirolimus/warfarin) are unlikely to be clinically significant with a single vaginal dose but use caution in high-risk patients.

Food Interaction

No food interactions (not applicable for vaginal administration).

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

Not recommended for children under 16 years of age unless advised by a doctor.

Elderly

Standard adult dosing, but consult a doctor before use if over 60 years of age.

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Missed Dose

If you forget to insert the single dose at the intended time, insert it as soon as you remember (preferably at bedtime); do not insert a second tablet to make up for it.

Stopping the Medicine

Single-dose therapy (500 mg once intravaginally); no tapering required-stop after the one dose and reassess if symptoms persist/return.

Overdose

Overdose via vaginal use is unlikely; if accidentally swallowed, GI upset (nausea/vomiting/abdominal discomfort) may occur-manage supportively and seek medical advice/poison center guidance if significant ingestion or symptoms.

Patient Counseling

Single-dose treatment: insert ONE 500 mg tablet high in the vagina at bedtime. Expect possible mild burning/irritation and some discharge. Avoid tampons, douching, and vaginal products during treatment; consider avoiding intercourse. This product may weaken latex condoms/diaphragms during use and for several days after-use alternative contraception. Seek medical advice if not improved within 3 days, not resolved within 7 days, symptoms are severe/atypical, first episode, pregnancy, or if symptoms recur frequently (e.g., within ~2 months).

Monitoring Requirements

No routine monitoring; reassess if symptoms persist beyond 7 days or recur within 2 months

Pharmacology

Mechanism of Action

Clotrimazole inhibits fungal ergosterol synthesis by inhibiting lanosterol 14-α-demethylase (CYP51), disrupting cell membrane integrity and function.

Onset of Action

Symptom relief usually begins within 24-72 hours (1-3 days).

Duration of Effect

Single-dose regimen constitutes a full course; symptom improvement is typically within 1-3 days, but complete resolution may take up to 7 days.

Half-Life

Not clinically relevant/typically not reported for the vaginal tablet because systemic absorption is minimal; any absorbed clotrimazole has a short plasma half-life (on the order of a few hours).

Bioavailability

Minimal systemic absorption; approximately 3-10% of a vaginal dose is absorbed.

Metabolism

If absorbed, clotrimazole is rapidly and extensively metabolized in the liver to inactive metabolites; the vaginal tablet acts primarily locally.

Product Information

Available Dosage Forms

For this SFDA-registered product: Vaginal tablet (with applicator). (Clotrimazole as an ingredient is also available in other dosage forms in general markets, but those are not this product.)

Composition per Dose

Each vaginal tablet: 500mg clotrimazole

Generic Availability

Yes

OTC Alternatives

Other OTC intravaginal azoles for VVC (availability varies by country): miconazole vaginal suppositories/ovules or cream; other clotrimazole multi-day vaginal regimens. Oral fluconazole 150 mg is an alternative only where it is OTC and appropriate.

Application

Vaginal

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