CANESTEN 100MG 6 VAG TAB

Indications

Approved Uses

Treatment of vulvovaginal candidiasis (vaginal yeast infection) due to Candida species.

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 100 mg intravaginally once daily at bedtime for 6 consecutive days (this product). Alternative clotrimazole vaginal regimens (product-dependent): 200 mg nightly for 3 days or 500 mg single dose.

Initial Dose

One 100mg tablet inserted vaginally at bedtime. [10, 23]

Maintenance Dose

100mg intravaginally once daily at bedtime for 6 consecutive nights

Maximum Dose

Intravaginal use: insert 1 vaginal tablet (100 mg) once daily at bedtime for 6 consecutive days (maximum frequency: once daily; maximum course: 6 tablets per treatment course unless directed by a clinician).

Children's Dosage

Not recommended for girls under 12 years without medical supervision

Dose Adjustment Notes

No dose adjustment is generally required in renal or hepatic impairment for vaginal use due to minimal systemic absorption.

How to Take

Insert 1 vaginal tablet (100 mg) high into the vagina once daily at bedtime for 6 consecutive nights; insert while lying on your back with knees bent (applicator may be used if supplied), and wash hands before/after use.

Side Effects

Common Side Effects

Local vaginal burning, itching, irritation, discomfort/cramps, and possible change/increase in vaginal discharge.

Side Effect Frequency

Common: local vulvovaginal burning, irritation, itching, and discomfort. Uncommon/rare: hypersensitivity reactions (e.g., rash, urticaria); very rare severe allergic reactions.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to clotrimazole or other imidazole antifungals/excipients.

Warnings & Precautions

For vaginal use only; stop and seek advice if severe irritation/allergy occurs; avoid use during menstruation (may reduce effectiveness); consult a doctor if first episode/uncertain diagnosis, if no improvement after completing the course or symptoms persist/worsen, if recurrent infections, or if red-flag symptoms (fever, pelvic/abdominal pain, foul-smelling discharge) occur; may damage latex condoms/diaphragms-use alternative contraception during treatment (and short period after).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant interactions are unlikely with vaginal use; potential interaction: increased tacrolimus/sirolimus levels (rare, mainly with systemic exposure). Also: may reduce effectiveness of latex condoms/diaphragms during treatment (and for a short period after).

Interaction Severity

MINOR/none expected for systemic drug interactions with vaginal clotrimazole due to minimal absorption; counsel that vaginal azole products can reduce the reliability of latex condoms/diaphragms during treatment and for a short period after (per labeling).

Food Interaction

Not applicable (vaginal route); no food restrictions.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

Not recommended for girls under 12 years without medical supervision

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed. [1, 5]

Liver Impairment

No hepatic dose adjustment needed for vaginal clotrimazole.

Storage & Patient Advice

Missed Dose

Insert the missed tablet as soon as remembered; if it is close to the next scheduled bedtime dose, skip the missed dose and continue as normal-do not use two tablets at once.

Stopping the Medicine

Complete the full 6-day course (100 mg vaginal tablet once daily) even if symptoms improve earlier; seek medical advice if not improved after the course or if symptoms recur.

Overdose

Vaginal overdose is unlikely to cause systemic toxicity; if accidentally swallowed, seek medical advice-manage supportively (possible GI upset such as nausea/vomiting/abdominal discomfort).

Patient Counseling

Insert 1 vaginal tablet (clotrimazole 100 mg) high into the vagina at bedtime for 6 consecutive nights; complete the full course even if symptoms improve. Avoid tampons, douching, and vaginal intercourse during treatment. Clotrimazole may weaken latex condoms/diaphragms during treatment (and for a short time after), so use alternative contraception. Use a sanitary pad if leakage occurs; wear breathable cotton underwear and keep the area dry. Seek medical advice if symptoms persist after completing the 6-day course, recur soon, you have frequent episodes (e.g., ≥2 in 6 months), or if this is your first suspected yeast infection/you are unsure of the diagnosis.

Monitoring Requirements

No routine laboratory monitoring is required; reassess if symptoms persist, recur, or are not improved after completing therapy, and evaluate for alternative diagnoses or complicated VVC.

Pharmacology

Mechanism of Action

Inhibits fungal ergosterol synthesis by inhibiting lanosterol 14-α-demethylase (CYP51), disrupting cell membrane structure and function (primarily fungistatic; can be fungicidal at higher concentrations).

Onset of Action

Symptom relief often begins within 1-3 days; complete resolution may take the full 6-day course (and a few days after).

Duration of Effect

Clinical effect is achieved over the 6-day course; clotrimazole may persist locally for some time after dosing, but patients should complete the full 6-day regimen.

Half-Life

Not clinically relevant/typically not specified for vaginal use due to minimal systemic absorption (when measurable, reported plasma half-life is around a few hours).

Bioavailability

Approximately 3% to 10% systemic absorption after vaginal administration.

Metabolism

The small absorbed fraction is extensively metabolized in the liver to inactive metabolites.

Excretion

Systemically absorbed clotrimazole is metabolized and excreted mainly via bile/feces, with a smaller portion via urine as metabolites.

Protein Binding

High plasma protein binding (approximately 90% or higher) for the absorbed fraction.

Product Information

Available Dosage Forms

For this SFDA-registered product: Vaginal tablet (100 mg).

Composition per Dose

Each vaginal tablet: 100mg clotrimazole

Generic Availability

Yes

OTC Alternatives

Other OTC intravaginal azoles such as miconazole or tioconazole (formulations vary by market).

Application

Vaginal

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.