CLOTRIZOLE VAGINAL TAB+APPLICATOR 6/VAG TAB

Indications

Approved Uses

Vulvovaginal candidiasis (vaginal yeast infection). [1, 4]

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 100 mg intravaginally once daily at bedtime for 6 days (this product); alternative clotrimazole regimens include 200 mg nightly for 3 days or 500 mg as a single intravaginal dose (product-dependent).

Initial Dose

One 100mg tablet inserted vaginally at bedtime.

Maintenance Dose

100mg intravaginally once daily for 6 days

Maximum Dose

Vaginal use: Insert 1 vaginal tablet (100 mg) intravaginally once daily at bedtime for 6 days. Maximum: 1 vaginal tablet in 24 hours unless directed by a clinician.

Children's Dosage

Not for use in children under 16 years. [3, 4] For adolescents 12 years and older, standard adult dosing applies.

Dose Adjustment Notes

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

How to Take

Insert 1 vaginal tablet (100 mg) high into the vagina once daily at bedtime for 6 consecutive nights, using the applicator if provided; wash hands before/after and remain lying down briefly after insertion to reduce leakage.

Side Effects

Common Side Effects

Local vaginal burning, itching, irritation/stinging, and redness; occasionally lower abdominal/pelvic discomfort or cramps.

Side Effect Frequency

Common: local vaginal burning/irritation/itching; Uncommon/Rare: abdominal or pelvic cramps/pain, rash/urticaria, hypersensitivity reactions; Frequency not known: severe allergic reactions (e.g., angioedema) and unusual vaginal symptoms (e.g., bleeding/peeling) depending on labeling source.

Safety & Warnings

Contraindications

Hypersensitivity to clotrimazole or any excipients.

Warnings & Precautions

For vaginal use only; avoid eyes; stop and seek advice if severe irritation/allergy occurs; avoid tampons, douches, and spermicides during treatment; latex condoms/diaphragms may be weakened; seek medical advice if no improvement within ~3 days, symptoms persist beyond ~7 days, recur, or if fever, pelvic/abdominal/back pain, or foul-smelling discharge occurs; confirm diagnosis before self-treatment if first episode/uncertain.

Age Restriction

OTC self-treatment generally for ≥12 years; <12 years only with medical advice (some local labels may set higher cutoffs such as <16-follow the product leaflet).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant systemic drug interactions are unlikely with vaginal use; however, it may reduce the effectiveness of latex condoms/diaphragms during treatment (and for a short period after), and caution is reasonable with narrow-therapeutic-index CYP3A4 substrates (e.g., tacrolimus/sirolimus) though risk is low.

Interaction Severity

Latex condoms/diaphragms: clinically relevant interaction-vaginal azole formulations can weaken latex; advise alternative contraception during treatment and for several days after. Tacrolimus/sirolimus: potential interaction (increased levels) is mainly a concern with oral/systemic azoles; with vaginal clotrimazole it is usually low risk but use caution/monitor if clinically indicated (e.g., transplant patients). Warfarin: interaction is unlikely with vaginal use but advise vigilance for bleeding if used concomitantly.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

Not for use in children under 16 years. [3, 4] For adolescents 12 years and older, standard adult dosing applies.

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Liver Impairment

No dose adjustment needed for hepatic impairment for vaginal clotrimazole.

Storage & Patient Advice

Missed Dose

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

Stopping the Medicine

Complete the full 6-day course (one 100 mg vaginal tablet nightly for 6 nights) even if symptoms improve; seek medical advice if symptoms persist/return.

Overdose

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

Patient Counseling

Use 1 tablet intravaginally at bedtime for 6 nights and complete the course; wash hands before/after, insert high in the vagina (applicator if provided), and consider a pad for leakage. Avoid tampons/douching during treatment; consider avoiding intercourse if painful. This product may weaken latex condoms/diaphragms-use alternative contraception during treatment and for several days after. Seek medical advice if no improvement in ~3 days, symptoms persist >7 days, recur, or if pregnant/diabetic/immunocompromised or symptoms are atypical (fever, pelvic pain, foul odor).

Monitoring Requirements

No routine laboratory monitoring is required; reassess/seek medical advice if symptoms do not improve within ~3 days, are not resolved by 7 days, recur soon after treatment, or if this is a first episode/atypical presentation.

Pharmacology

Mechanism of Action

Inhibits fungal ergosterol synthesis by inhibiting lanosterol 14-α-demethylase (a fungal CYP450 enzyme), disrupting cell membrane structure and function and inhibiting growth (fungistatic; can be fungicidal at higher local concentrations).

Onset of Action

Symptom improvement typically begins within 1-3 days, with full resolution often by the end of therapy; persistent symptoms beyond 7 days warrant evaluation.

Duration of Effect

Local antifungal activity persists during the treatment course, and measurable vaginal drug levels may persist for up to ~3 days after the last dose.

Half-Life

Not well-defined/clinically not applicable for vaginal clotrimazole due to minimal systemic absorption; for the small absorbed fraction, reported terminal plasma half-life is approximately 2-5 hours.

Bioavailability

Systemic absorption after vaginal administration is low, approximately 3-10% of the dose.

Metabolism

Rapid hepatic metabolism to inactive metabolites for the systemically absorbed fraction (primarily via CYP-mediated oxidative metabolism, commonly cited CYP3A4 and CYP2C9 involvement).

Excretion

The small absorbed fraction is extensively metabolized in the liver and eliminated mainly via biliary/fecal excretion, with minimal renal excretion.

Protein Binding

High protein binding (~90% or higher; commonly cited around 90-99%) for the systemically absorbed fraction.

Product Information

Available Dosage Forms

Vaginal tablet, vaginal cream, topical cream, topical solution, topical lotion, oral lozenge (troche)

Composition per Dose

Each vaginal tablet: 100mg Clotrimazole.

Generic Availability

Yes

OTC Alternatives

Other OTC intravaginal azoles such as miconazole (cream/suppositories) and other clotrimazole formulations; oral fluconazole may be OTC in some countries but is prescription-only in others.

Application

Vaginal

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