MIKOSTAT ORAL SUSP

Indications

Approved Uses

Treatment of oral candidiasis (oropharyngeal thrush).

Dosage & Administration

Dosing by Condition

Oral candidiasis: Adults/children: 400,000-600,000 IU (4-6 mL) PO four times daily (swish/retain then swallow); Infants: 200,000 IU (2 mL) PO four times daily; Premature/low-birth-weight neonates: 100,000 IU (1 mL) PO four times daily.

Initial Dose

400,000-600,000 units (4-6 mL) four times daily for adults with oral candidiasis.

Maintenance Dose

400,000-600,000 units (4-6 mL) four times daily for adults with oral candidiasis.

Maximum Dose

Up to 4,000,000 IU/day (typical adult maximum used for intestinal candidiasis; divided doses).

Children's Dosage

Neonates: 100,000 IU (1 ml) four times daily. Infants and children: 200,000-400,000 IU (2-4 ml) four times daily. Premature neonates: 50,000 IU (0.5 ml) four times daily

Dose Adjustment Notes

No dose adjustment is required in renal or hepatic impairment because systemic absorption is negligible.

How to Take

Shake well before each use; measure the dose with an oral syringe/measuring device; for oral candidiasis, distribute the dose around the mouth (e.g., half on each side), swish/retain in contact with lesions as long as possible, then swallow; continue therapy for at least 48 hours after symptoms resolve.

How to Prepare

Shake well before use (ready-to-use oral suspension).

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, abdominal pain/discomfort; oral irritation/unpleasant taste (occasionally).

Safety & Warnings

Contraindications

Hypersensitivity to nystatin or any component of the formulation.

Warnings & Precautions

Not effective for systemic fungal infections; ensure adequate contact time with oral mucosa (swish/retain in mouth before swallowing); discontinue if irritation or sensitization occurs; contains sucrose-use caution in diabetes and in patients with hereditary fructose intolerance/sucrose-isomaltase deficiency.

Age Restriction

No minimum age restriction; can be used in neonates, infants, children, and adults (dose/administration is age-appropriate).

Drug Interactions

Interaction Severity

No clinically significant drug-drug interactions are expected; if taken with Saccharomyces boulardii, nystatin may reduce the probiotic yeast’s viability (minor/avoid separating if possible).

Food Interaction

No clinically significant food interaction; for thrush, avoid eating or drinking for about 30 minutes after each dose to maximize mucosal contact time.

Special Populations

Children

Neonates: 100,000 IU (1 ml) four times daily. Infants and children: 200,000-400,000 IU (2-4 ml) four times daily. Premature neonates: 50,000 IU (0.5 ml) four times daily

Kidney Impairment

No renal dose adjustment needed.

Storage & Patient Advice

Preparation Instructions

Shake well before use (ready-to-use oral suspension).

Missed Dose

Take as soon as remembered; skip if near next dose. Do not take a double dose.

Stopping the Medicine

Continue for at least 48 hours after symptoms resolve (and complete the prescribed course); no taper is needed.

Overdose

Overdose is expected to cause mainly GI irritation (nausea, vomiting, diarrhea, abdominal pain); systemic toxicity is unlikely; management is supportive/symptomatic and seek medical care if large ingestion or severe symptoms.

Patient Counseling

Shake well; measure with an oral syringe/measuring device; place the dose around the mouth, swish/hold as long as possible then swallow; avoid eating/drinking for ~30 minutes after; complete the full course and continue at least 48 hours after symptoms resolve; store below 25°C (per SFDA) and do not freeze; seek care for rash, swelling, or persistent/worsening symptoms.

Monitoring Requirements

No routine laboratory monitoring; monitor clinical response, and if inadequate response/recurrence occurs, reassess adherence/technique and consider culture/susceptibility or alternative diagnosis.

Pharmacology

Mechanism of Action

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

Duration of Effect

Local effect persists only while the suspension remains in contact with oral mucosa; there is no meaningful systemic duration due to negligible absorption.

Half-Life

Not applicable (no meaningful systemic half-life due to negligible absorption).

Bioavailability

Negligible/insignificant oral bioavailability (not meaningfully absorbed from intact GI mucosa).

Metabolism

No clinically relevant systemic metabolism (acts locally; minimal absorption).

Excretion

Excreted almost entirely unchanged in feces.

Protein Binding

Not applicable (no meaningful systemic protein binding due to negligible absorption).

Product Information

Composition per Dose

Each 1 ml: 100,000 IU nystatin

Generic Availability

Yes

OTC Alternatives

No OTC alternative for oral thrush.

Application

Oral

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