Asmafen Eye Drops, Tablet, Syrup

Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils.  Also, it stabilizes mast cells & basophils and inhibits PAF (platelet activating factor) and is effective in preventing asthmatic attacks.

Uses

Ketotifen is used for the prophylactic treatment of bronchial asthma, symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Ketotifen has antiallergic properties and has been used similarly, to Sodium Chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing asthmatic attack. Ketotifen exerts sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its antianaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as administered by inhalation as a selective mast cell stabiliser. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Ketotifen eye drop is used for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and eyelids) of allergic conjunctivitis including vernal kerato-conjunctivitis, vernal-keratitis, blepharitis, blepharo-conjunctivitis, and giant papillary conjunctivitis.

Trade Name Asmafen
Generic Ketotifen Fumarate
Weight 025%, 1 mg, 1 mg/5ml
Type Eye Drops, Tablet, Syrup
Therapeutic Class Cromoglycate & related drugs
Manufacturer Globe Pharmaceuticals Limited
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:22 am

Dosage

Asmafen dosage

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases. 

Children above 2 years: 1 mg twice daily with food. Patient’s known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Adults and children 3 years and older: 1 drop in the affected eye(s) twice daily, every 8-12 hours, not more than twice per day.

Children under 3 years of age: Consult with a doctor.

Side Effects

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days.

Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug instillation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival haemorrhage.

Precaution

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If intercurrent infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patient should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotic, antihistamines and alcohol.

The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.

Interaction

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetics and it has been suggested that this combination should therefore be avoided. Since Ketotifen has the properties of the antihistamines, it may potentiate the effects of other CNS depressant drugs such as alcohol, antihistamines, hypnotics and sedatives.

If Ketotifen eye drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

Pregnancy & Breastfeeding use

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

Contraindication

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided.

Hypersensitivity to Ketotifen or any of the components

Acute Overdose

Symptoms: Drowsiness, confusion, dyspnoea, bradycardia or tachycardia, disorientation, convulsions, severe hypotension, reversible coma.

Management: Supportive and symptomatic.

No case of overdose has been reported. Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of Ketotifen which is 60% of a recommended oral daily dose for a 3 years old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of Ketotifen.

Storage Condition

Store at 25° C.

Asmafen contains Ketotifen Fumarate see full prescribing information from innovator Monograph