Aerofen Tablet, Syrup

Aerofen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Aerofen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Aerofen 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

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

Aerofen 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. Aerofen possesses marked anti-anaphylactic properties and is effective in preventing asthmatic attack. Aerofen exerts sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its antianaphylactic properties. Experimental investigations in asthmatic subjects have shown that Aerofen is as effective orally as administered by inhalation as a selective mast cell stabiliser. Antihistamines were ineffective in those tests. The effectiveness of Aerofen 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 Aerofen may take several weeks to become fully established. Aerofen will not abort established attacks of asthma.

Aerofen 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.

Aerofen is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Asthma, Allergic, Eye pruritus, Seasonal Allergic Conjunctivitis

Trade Name Aerofen
Generic Ketotifen
Other Names Ketotifen, Ketotifene, Ketotifeno, Ketotifenum
Weight 1 mg, 1 mg/5ml
Type Tablet, Syrup
Formula C19H19NOS
Weight Average: 309.425
Monoisotopic: 309.118734925
Protein binding

Ketotifen is 75% protein-bound in plasma, though the specific proteins to which it binds are unclear.

Therapeutic Class Cromoglycate & related drugs
Manufacturer Silva Pharmaceuticals Ltd
Available Country Bangladesh
Last Updated: June 23, 2021 at 11:22 am

Dosage

Aerofen 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 Aerofen 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, Aerofen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Aerofen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Aerofen treatment on the individual is known. Patient should be advised to avoid alcoholic drinks. Aerofen may potentiate the effects of sedatives, hypnotic, antihistamines and alcohol.

The formulation of Aerofen 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 Aerofen concomitantly with oral antidiabetics and it has been suggested that this combination should therefore be avoided. Since Aerofen has the properties of the antihistamines, it may potentiate the effects of other CNS depressant drugs such as alcohol, antihistamines, hypnotics and sedatives.

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

Food Interaction

  • Take with or without food. The co-administration of food does not significantly affect ketotifen disposition.

Half Life

Aerofen clearance is biphasic - the half-life of the distribution phase is approximately 3-5 hours and the half-life of the elimination phase is 22 hours.

Pregnancy & Breastfeeding use

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

Contraindication

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

Hypersensitivity to Aerofen 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 Aerofen 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 Aerofen.

Storage Condition

Store at 25° C.

Aerofen contains Ketotifen see full prescribing information from innovator Monograph