SINATEN 16 VAGINAL TABLET

Indications

Approved Uses

Treatment of vulvovaginal candidiasis (Candida vaginitis).

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 1 vaginal tablet (100,000 IU) intravaginally once daily at bedtime for 14 days; in more severe/refractory cases, some references allow 1 tablet twice daily for 14 days if prescribed.

Initial Dose

1 vaginal tablet (100,000 IU) inserted intravaginally once daily at bedtime

Maintenance Dose

1 vaginal tablet (100,000 IU) once daily at bedtime for the full 14-day course

Maximum Dose

2 vaginal tablets per day (total 200,000 IU/day) intravaginally.

Dose Adjustment Notes

No dose adjustments are recommended for renal or hepatic impairment as systemic absorption is minimal.

How to Take

Insert 1 vaginal tablet high/deep into the vagina (with a finger or applicator if supplied), preferably at bedtime; wash hands before/after; use a panty liner if leakage occurs; continue the course even during menstruation unless your prescriber advises otherwise.

Side Effects

Common Side Effects

Local vaginal irritation (burning, itching, stinging) and increased discharge; hypersensitivity rash is uncommon.

Side Effect Frequency

Common: local vaginal irritation/burning/itching; Uncommon/Rare: hypersensitivity reactions (e.g., rash/contact dermatitis) and increased vaginal discharge.

Safety & Warnings

Contraindications

Hypersensitivity to nystatin or any component of the formulation.

Warnings & Precautions

For vaginal use only; discontinue if irritation/sensitization occurs; if no clinical response, reassess diagnosis; consider avoiding intercourse or using non-latex/alternative contraception during treatment if the formulation may weaken latex barrier methods; complete the prescribed course.

Age Restriction

Use in children (including prepubertal) only if specifically prescribed; routine self-use is not recommended in prepubertal girls and diagnosis should be confirmed.

Driving Warning

Safe

Drug Interactions

Drug Interactions

No clinically significant systemic drug interactions are expected; however, some vaginal products can reduce the effectiveness of latex condoms/diaphragms-advise checking the product leaflet and using alternative contraception during treatment if applicable.

Interaction Severity

No clinically significant systemic drug interactions expected; however, advise that some vaginal products/excipients may reduce the reliability of latex condoms/diaphragms during treatment (use alternative/backup contraception).

Food Interaction

Not applicable (vaginal administration; no food interaction expected).

Alcohol Interaction

Safe

Special Populations

Breastfeeding

Safe

Elderly

Standard adult dosing; no specific adjustment required

Kidney Impairment

No adjustment needed.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Complete the full 14-day course even if symptoms improve; do not discontinue early to prevent recurrence

Overdose

Overdose is unlikely due to minimal systemic absorption; excessive intravaginal use may cause local irritation, and accidental ingestion is generally low toxicity but may cause GI upset-manage with supportive care and seek medical advice if large amounts are ingested or symptoms occur.

Patient Counseling

Insert high/deep intravaginally preferably at bedtime; complete the full prescribed course (often 14 days) even if symptoms improve and even during menstruation; wash hands before/after; expect possible leakage/use a liner; avoid douching/tampons/other intravaginal products unless advised; consider avoiding intercourse during treatment and use backup contraception because vaginal products may reduce latex condom/diaphragm reliability; seek medical advice if severe irritation occurs or symptoms persist/return; store below 30°C in original blister (SFDA-verified).

Monitoring Requirements

No routine monitoring required; clinical reassessment if symptoms persist after completing the full course

Pharmacology

Mechanism of Action

Binds to ergosterol in susceptible fungal cell membranes, forming pores that increase membrane permeability and cause leakage of intracellular contents, leading to fungal cell death.

Onset of Action

Symptom improvement often begins within 24-72 hours, but complete resolution may require completing the full course.

Duration of Effect

Local antifungal activity persists while the tablet is present; clinical effect is achieved over the full treatment course (typically 14 days) rather than a single-dose duration.

Half-Life

Not applicable / not clinically meaningful (negligible systemic absorption with vaginal use).

Bioavailability

Negligible systemic absorption after vaginal administration; nystatin is not meaningfully absorbed from intact mucous membranes/skin and is poorly absorbed orally.

Metabolism

No meaningful systemic metabolism (negligible systemic absorption with vaginal use).

Excretion

Primarily excreted unchanged in feces if any is swallowed/absorbed; with vaginal use, systemic absorption is negligible and clinically relevant excretion is not expected.

Protein Binding

Not applicable / not clinically meaningful (negligible systemic absorption with vaginal use).

Product Information

Available Dosage Forms

For SINATEN specifically: vaginal tablet (SFDA-verified). For nystatin in general: topical cream/ointment/powder; oral suspension; oral tablets/capsules/pastilles (market-dependent).

Composition per Dose

Each vaginal tablet: 100,000 IU Nystatin

OTC Alternatives

If an OTC option is appropriate/available locally, intravaginal azoles such as clotrimazole or miconazole are common alternatives; note SINATEN is SFDA-listed as prescription-only in Saudi Arabia.

Application

Vaginal

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