Omastin Oral Suspension 35 mL (Fluconazole) — Antifungal Treatment for Oral, Oesophageal & Vaginal Candidiasis

PRESCRIPTION NOTICE: Omastin Oral Suspension is a Prescription Only Medicine (POM). It cannot legally be dispensed without a valid prescription from a licensed healthcare provider in Kenya. Do not use this medicine without medical supervision. Do not share this medicine with others even if they appear to have the same condition.

Omastin Oral Suspension is a prescription-only antifungal medicine containing fluconazole as the active ingredient, presented as a ready-to-use or reconstitutable oral suspension in a 35 mL bottle. Fluconazole is a triazole antifungal agent with broad-spectrum activity against Candida species and Cryptococcus neoformans, making Omastin particularly suitable for the treatment of oropharyngeal candidiasis (oral thrush), oesophageal candidiasis, and systemic or invasive candidal infections in both adults and paediatric patients.

The oral suspension formulation makes Omastin especially valuable in clinical scenarios where tablet administration is difficult or impractical — including young children, elderly patients, patients with dysphagia (difficulty swallowing), and immunocompromised individuals with painful oral or oesophageal candidiasis. If you have been prescribed Omastin suspension for oral thrush treatment in Kenya or any other candidal infection, this medicine must be taken strictly as directed by your healthcare provider for the full prescribed duration. The price of Omastin Oral Suspension in Kenya varies by pharmacy and is dispensed only on presentation of a valid prescription.

Key Benefits

• Broad-spectrum antifungal activity against Candida species — the most common cause of oral thrush, vaginal candidiasis, and oesophageal fungal infections in Kenya
• Liquid suspension format — ideal for children, the elderly, and patients who cannot swallow tablets
• Achieves excellent oral bioavailability — absorption is not significantly affected by food or gastric acid levels
• Penetrates well into saliva, mucous membranes, and deep tissue compartments — ensuring therapeutic concentrations at the site of infection
• Once-daily dosing in most indications — supports treatment adherence
• Effective in immunocompromised patients including those living with HIV — a significant consideration given Kenya’s epidemiological context
• Well-established safety and efficacy profile with decades of global clinical use
• Available as an oral liquid — allows flexible weight-based dosing in paediatric patients

What It Is & How It Works

Active Ingredient

Each 35 mL bottle contains:

How It Works

Fluconazole exerts its antifungal effect by selectively and potently inhibiting fungal cytochrome P450-dependent enzyme 14-alpha-demethylase (CYP51), a key enzyme in the biosynthesis of ergosterol — the primary sterol component of the fungal cell membrane. This inhibition produces two critical consequences for the fungal cell:

• Ergosterol depletion — without adequate ergosterol, the fungal cell membrane loses structural integrity, becomes abnormally permeable, and can no longer maintain essential cellular functions, ultimately leading to fungal cell death or growth arrest
• Accumulation of toxic sterol precursors — the blockade of 14-alpha-demethylase causes the accumulation of methylated sterol precursors (particularly lanosterol) that are toxic to the fungal cell membrane at high concentrations

Fluconazole demonstrates selectivity for fungal CYP51 over human CYP51, which is why it can inhibit fungal ergosterol synthesis at therapeutic doses without causing equivalent disruption to human sterol metabolism.

Following oral administration of the suspension, fluconazole is rapidly and almost completely absorbed, achieving peak plasma concentrations within 1–2 hours. It distributes widely throughout the body — penetrating saliva, sputum, vaginal secretions, cerebrospinal fluid, and urine — making it effective against both superficial and systemic fungal infections.

Classification

Omastin Oral Suspension is classified as a Prescription Only Medicine (POM) in Kenya. It must only be initiated, monitored, and adjusted by a licensed healthcare provider. A valid prescription is required for dispensing at any registered pharmacy in Kenya.

Formulation

Oral suspension. 35 mL bottle. The suspension may require reconstitution with water before use — follow the pharmacist’s or label instructions precisely. Shake well before each use. A calibrated oral syringe or dosing spoon should be used to measure doses accurately.

Uses & Indications

Omastin Oral Suspension is indicated for the treatment of:

• Oropharyngeal candidiasis (oral thrush) — white plaques and soreness in the mouth and throat caused by Candida species
• Oesophageal candidiasis — Candida infection of the oesophagus, commonly presenting with painful or difficult swallowing, particularly in immunocompromised patients
• Vaginal candidiasis (thrush) — symptomatic vulvovaginal candidiasis in adult women
• Candidal urinary tract infections — where systemic antifungal therapy is clinically indicated
• Invasive and disseminated candidiasis — including candidaemia in appropriate clinical settings under specialist supervision
• Cryptococcal meningitis — treatment and relapse prevention, particularly in HIV-positive patients, under specialist supervision
• Prophylaxis of fungal infections — in immunocompromised patients including those undergoing chemotherapy, bone marrow transplantation, or with advanced HIV disease

IMPORTANT: Omastin Oral Suspension is indicated for Candida and Cryptococcus infections. It is not effective against dermatophyte infections such as ringworm, athlete’s foot, or nail infections caused by dermatophytes — terbinafine or griseofulvin are more appropriate for these conditions. A correct microbiological diagnosis should ideally be established before initiating fluconazole therapy, particularly for recurrent or treatment-resistant infections.

Dosage & Administration

This medicine requires a valid prescription. Use only as prescribed by your healthcare provider. The following dosage information is provided for general reference only and does not constitute prescribing advice.

Paediatric Dosing

Administration Instructions

• Shake the bottle well before each use to ensure uniform suspension
• Measure each dose carefully using the calibrated oral syringe or dosing spoon provided — do not use a household teaspoon
• May be taken with or without food — absorption is not significantly affected by food intake
• Take at the same time each day to maintain consistent drug levels
• Complete the full prescribed course of treatment — even if symptoms resolve before the course is finished, premature discontinuation can lead to treatment failure and the emergence of resistant strains
• If a dose is missed, take it as soon as you remember — if it is almost time for the next dose, skip the missed dose and continue as normal; do not double dose
• For reconstitutable suspensions — follow the pharmacist’s instructions precisely for adding water, and note the beyond-use date after reconstitution (typically 14 days when stored appropriately)
• Store the reconstituted suspension as directed — see Storage Instructions below

Possible Side Effects

Like all medicines, Omastin Oral Suspension may cause side effects in some patients. Report any new or worsening symptoms to your healthcare provider promptly.

Common

• Nausea and stomach discomfort
• Headache
• Abdominal pain or bloating
• Diarrhoea
• Skin rash — discontinue and contact your doctor if rash is widespread or severe

Less Common

• Dizziness
• Altered taste sensation (dysgeusia)
• Elevated liver enzymes — usually asymptomatic and detected on blood testing
• Dry mouth
• Flatulence

WARNING: Rare but serious — seek immediate medical attention and discontinue Omastin if you experience: signs of severe liver damage (persistent nausea, severe fatigue, yellowing of the skin or eyes — jaundice, dark urine, pale stools, or right upper abdominal pain), severe or life-threatening skin reactions including Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (widespread blistering, skin peeling, or mucosal ulceration), serious cardiac arrhythmias including QT prolongation or Torsades de Pointes (palpitations, dizziness, fainting, or irregular heartbeat), or signs of adrenal insufficiency. Fluconazole-induced hepatotoxicity, though rare, can be serious — the risk is higher with prolonged use and in patients with pre-existing liver disease.

This is not a complete list of side effects. Report all side effects to your healthcare provider.

Warnings & Precautions

CONTRAINDICATION: Do NOT use Omastin if you are known to be hypersensitive to fluconazole, other azole antifungals, or any excipient in the formulation. Do NOT use concomitantly with medicines known to prolong the QT interval and that are metabolised via CYP3A4 — including terfenadine, astemizole, cisapride, pimozide, and quinidine — due to the risk of life-threatening cardiac arrhythmias.

Do Not Use If You:

• Are allergic to fluconazole or other azole antifungals (ketoconazole, itraconazole, voriconazole)
• Are taking terfenadine, astemizole, cisapride, pimozide, or quinidine — risk of serious and potentially fatal cardiac arrhythmias (QT prolongation and Torsades de Pointes)
• Have severe liver disease without specialist supervision

Use With Caution If You Have:

• Liver disease or elevated liver enzymes — fluconazole is hepatically metabolised; baseline and periodic liver function monitoring is recommended during prolonged therapy
• Kidney disease or renal impairment — fluconazole is primarily renally excreted; dose adjustment is required in moderate to severe renal impairment
• A history of cardiac arrhythmias or QT prolongation — fluconazole prolongs the QT interval; use with caution in patients with predisposing risk factors
• Hypokalaemia or hypomagnesaemia — electrolyte imbalances increase the risk of QT prolongation in the presence of fluconazole
• Adrenal insufficiency — rare cases of adrenal suppression have been reported with prolonged use

Do Not Combine With (Selected Key Interactions — Consult Pharmacist for Full Review):

• Warfarin and other anticoagulants — fluconazole significantly inhibits CYP2C9, substantially increasing warfarin levels and bleeding risk; close INR monitoring is essential
• Oral hypoglycaemic agents (sulphonylureas — glibenclamide, glipizide) — fluconazole inhibits their metabolism, increasing the risk of hypoglycaemia; monitor blood glucose carefully
• Phenytoin — fluconazole increases phenytoin plasma levels significantly; monitor phenytoin levels and adjust dose accordingly
• Cyclosporine and tacrolimus — fluconazole increases levels of both immunosuppressants; close therapeutic drug monitoring is required
• Rifampicin — significantly reduces fluconazole plasma levels, potentially resulting in treatment failure; dose adjustment may be required
• Statins metabolised by CYP3A4 (simvastatin, atorvastatin) — fluconazole increases statin levels and the risk of myopathy and rhabdomyolysis; consider statin dose reduction or temporary discontinuation
• Midazolam, triazolam, and other benzodiazepines — fluconazole markedly increases their levels, enhancing and prolonging sedation
• QT-prolonging medicines — additive risk of cardiac arrhythmias; avoid co-administration wherever possible

CLINICAL NOTE (Kenya-specific): Oropharyngeal and oesophageal candidiasis are among the most common opportunistic infections in people living with HIV in Kenya, where HIV prevalence remains significant. Fluconazole — the active ingredient in Omastin — is a cornerstone of antifungal therapy in HIV-positive patients and is included on the Kenya Essential Medicines List (KEML). Clinicians should be aware of the potential for fluconazole-resistant Candida species (particularly Candida krusei and Candida glabrata) in patients with a history of prolonged or recurrent fluconazole exposure, and should consider microbiological culture and sensitivity testing in treatment-resistant cases. Additionally, cryptococcal meningitis — for which fluconazole is a critical maintenance therapy — remains a leading cause of meningitis-related mortality in HIV-positive Kenyans; adherence to the full prescribed course is essential in these patients.

Keep out of reach of children. Store all medicines safely and securely.

Storage Instructions

• Store the unopened bottle below 25°C in a cool, dry place
• Protect from direct sunlight, heat, and moisture
• After reconstitution (if applicable): store in a refrigerator (2°C–8°C) and use within 14 days — do not freeze the reconstituted suspension
• Shake well before each use
• Keep the bottle tightly closed after each use
• Store out of reach and sight of children
• Do not use after the expiry date printed on the bottle or carton
• Do not transfer the suspension to another container
• Dispose of any remaining suspension after the course is complete or after the beyond-use date — return to your local registered pharmacy for safe disposal

Mandatory Disclaimer

This medicine requires a valid prescription. Do not use without medical advice. Omastin Oral Suspension (Fluconazole) is a Prescription Only Medicine (POM) that must be initiated, monitored, and adjusted exclusively by a licensed healthcare provider. Do not self-prescribe, purchase without a valid prescription, or share this medicine with others. Completing the full prescribed course is essential for treatment success and to prevent the development of antifungal resistance — a growing concern in Kenya and globally. Regular follow-up with your prescribing clinician, including liver function monitoring during prolonged courses, is strongly advised. This product information is provided for general educational reference only and does not constitute medical advice or replace the guidance of a qualified healthcare professional.

References

1. Kenya Essential Medicines List (KEML) & Kenya Clinical Guidelines — Fungal Infections and HIV-Associated Opportunistic Infections Management
2. World Health Organization (WHO) — Fluconazole: WHO Model Formulary Monograph & Guidelines for the Diagnosis, Prevention and Management of Cryptococcal Disease in HIV-Infected Adults, Adolescents and Children

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