Tofen
Generic Name
Ketotifen Fumarate 0.025% Ophthalmic Solution
Manufacturer
XYZ Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tofen 0025 eye drop | ৳ 100.00 | N/A |
Description
Overview of the medicine
Tofen 0.025% Eye Drop contains Ketotifen Fumarate, an antihistamine and mast cell stabilizer, used to relieve itching of the eye due to allergic conjunctivitis.
Uses & Indications
Dosage
Adults
Instill one drop in the affected eye(s) twice a day, every 8 to 12 hours.
Elderly
No dosage adjustment necessary.
Renal_impairment
Not applicable for ophthalmic use due to minimal systemic absorption.
How to Take
For ophthalmic use only. Tilt head back, pull down lower eyelid to form a pouch, apply drop, then close eye gently. Do not touch the dropper tip to any surface.
Mechanism of Action
Ketotifen exerts its action through two primary mechanisms: it acts as a non-competitive H1-receptor antagonist, blocking the histamine-mediated effects (e.g., itching), and it stabilizes mast cells, thereby inhibiting the release of inflammatory mediators like histamine and leukotrienes from mast cells.
Pharmacokinetics
Onset
Within minutes (typically 5-10 minutes)
Excretion
Primarily renal excretion of metabolites, but extent is minimal with ocular use.
Half life
Plasma half-life is approximately 12 hours, but systemic absorption is very low.
Absorption
Minimal systemic absorption after ocular administration. Plasma levels are generally below the limit of detection.
Metabolism
Primarily hepatic metabolism via N-demethylation and glucuronidation, but extent is minimal with ocular use.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
Drug Interactions
Systemic antihistamines
May increase drowsiness if significant systemic absorption occurs, but generally negligible with ophthalmic use.
CNS depressants (e.g., alcohol)
Potential for increased drowsiness if systemically absorbed, but highly unlikely with ophthalmic use.
Storage
Store at room temperature (15-30°C). Protect from light and moisture. Do not freeze.
Overdose
Overdose is unlikely with ophthalmic administration due to minimal systemic absorption. In case of accidental ingestion, seek medical advice.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs risk. Excretion in breast milk is unknown, use with caution in nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to ketotifen or any component of the formulation.
Drug Interactions
Systemic antihistamines
May increase drowsiness if significant systemic absorption occurs, but generally negligible with ophthalmic use.
CNS depressants (e.g., alcohol)
Potential for increased drowsiness if systemically absorbed, but highly unlikely with ophthalmic use.
Storage
Store at room temperature (15-30°C). Protect from light and moisture. Do not freeze.
Overdose
Overdose is unlikely with ophthalmic administration due to minimal systemic absorption. In case of accidental ingestion, seek medical advice.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs risk. Excretion in breast milk is unknown, use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months unopened. Discard 28 days after opening.
Availability
Pharmacies, drugstores
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available, patent expired for original formulation
Clinical Trials
Numerous clinical trials have established the efficacy and safety of Ketotifen Fumarate 0.025% for the treatment of allergic conjunctivitis, demonstrating significant reduction in ocular itching compared to placebo.
Lab Monitoring
- No specific lab monitoring required for ophthalmic use.
Doctor Notes
- Advise patients on proper instillation technique to avoid contamination.
- Reassure patients about minimal systemic absorption and low risk of systemic side effects.
- Counsel on avoiding contact lens use during active allergic conjunctivitis.
Patient Guidelines
- Do not wear contact lenses if your eyes are red.
- Wait at least 10 minutes after using the eye drops before inserting contact lenses.
- Do not touch the tip of the dropper to your eye or any other surface.
- If you use other eye medications, wait at least 5 minutes between applications.
Missed Dose Advice
If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use extra drops to make up for a missed dose.
Driving Precautions
May cause temporary blurred vision or drowsiness. Exercise caution when driving or operating machinery until vision is clear and you know how the medication affects you.
Lifestyle Advice
- Avoid allergens that trigger your allergic conjunctivitis.
- Maintain good eye hygiene.
- Avoid rubbing your eyes excessively.
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Global Brand Names
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