Zylofen

Company Name: Memphis Co. for Pharm. & Chem. Ind.

Trade Name: Zylofen tablets

Generic Name: Ketotifen fumarate

Composition:
Each tablet contains:
Ketotifen fumarate                                          1.38 mg
(equivalent to ketotifen base 1 mg)

Excipients:

Microcrystalline cellulose, Croscarmellose sodium, Magnesium stearate.             
                                             
Pharmaceutical form: Tablets

Pharmacological actions:
Zylofen is a non bronchodilator anti-asthmatic drug which inhibits the effects of certain endogenous substances known to be inflammatory mediators. Iin addition, Zylofen is a potent anti-allergic substance possessing a powerful and sustained non competitive histamine (H1) blocking property.

Pharmacokinetics:
- After oral administration, the absorption of Zylofen is at least 60% and possibly even greater.

- Maximum plasma concentration is reached within 2 to 4 hours.

- The absorption half–life is one hour, and the percentage of protein binding is 75% and is also concentration–independent.

Indications:
- Zylofen tablet is used in treatment of allergic conjunctivitis and allergic rhinitis.

- Zylofen is a prophylactic agent used in the treatment of mild atopic asthmatic children.
 

Dosage & administration:
- One tablet  twice daily with food, increased if necessary to two tablets twice daily.

- Initial treatment in readily sedated patients: half tablet – one tablet at night.

- Children 3 years and over: one tablet twice daily.

Contraindications:
Hypersensitivity to ketotifen or any component of the drug.

Side effects:
- Paradoxical stimulation may occur rarely, especially with high doses or in children and elderly.

- Drowsiness, may diminish after a few days of treatment.

- Headache, psychomotor impairment, and antimuscarinic effects such as: urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances.

- Excitation, irritability, nervousness, less commonly cystitis, rarely weight gain, very rarely Stevens–Johnson syndrome.

- Other rare side effects: hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmias, hypersensitivity reactions including (bronchospasm, angioedema, anaphylaxis, rashes, and photosensitivity reactions ), blood disorders, liver dysfunction, and angle–closure glaucoma.

Drug interactions:
- Antidepressants such as MAOIs or tricyclics increase the antimuscarinic and sedative effect of Zylofen.

- Avoid concomitant use of Zylofen with anti-arrhythmics such as (procainamide and propafenone), metformin antidiabetics and antimuscarinics.

- Anxiolytics and hypnotics increase the sedative effect of Zylofen.

Pregnancy and lactation:
Zylofen is contraindicated in pregnancy and during breast feeding.

Precautions & warnings:
- Zylofen should be used with caution in prostatic hypertrophy, urinary retention, susceptibility to angle – closure glaucoma, pyloroduodenal obstruction, hepatic disease or epilepsy.

- Dose reduction may be necessary in renal impairment.

- Children and the elderly are more susceptible to side effects of Zylofen.

- Zylofen should be avoided in porphyria.
 
Therapeutic category: Antihistaminic

 Legal category: POM

Package:

Storage:

 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you.Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.