COMPOSITION :

Each 5 ml syrup contains : Ketotifen Fumarate equivalent to Ketotifen 1 mg.

Each tablet contains : Ketotifen Fumarate equivalent to Ketotifen 1 mg.

DESCRIPTION :

Zatin (Ketotifen) is an antiasthmatic drug with marked antianaphylactic properties and a specific antihistaminic

effect. Its antiasthmatic activity is attributed to a number of factors including inhibition of phosphodiesterases,

inhibition of PAF induced accumulation of eosinophils in the airways, inhibition of the release of histamine and

leukotrienes and functional antagonism of the effects of leukotrienes. Ketotifen is almost completely absorbed

after oral administration.Bioavailability is approximately 50% due to a first pass effect in the liver. Peak plasma

concentration is achieved within 2 - 4 hours. Protein binding is 75%. Ketotifen is eliminated biphasically with a

short half life of 3 - 5 hours and a longer one of 21 hours . 70% is excreted in urine as metabolites.

INDICATIONS :

Zatin is indicated in :

- Long term prevention of bronchial asthma, allergic bronchitis and asthmatic symptoms associated with hay fever.

- Prevention and treatment of multisystemic allergies, allergic rhinitis and allergic dermatoses.

DOSAGE & ADMINISTRATION :

Zatin is administrated with meals as follows :

Adults & Children over 12 years : 1 tablet twice daily, increased if necessary to 2 tablets twice daily. If

drowsiness is likely to be a problem, a dose of 0.5 - 1 tablet is given with evening meals.

Children over than 3 years : 5 ml of syrup twice daily.

Children 6 months - 3 years : 2.5 ml of syrup twice daily

(It may take several weeks for Zatin to achieve its full effect in preventing asthmatic attacks).

RESTRICTIONS ON USE :

Contraindications

Hypersensitivity to Ketotifen.

Precautions

Use with caution in prostatic hypertrophy, urinary retention ,susceptible to angle-gluacuma and pyloroduodenal

obstruction.

Effects on the ability to drive vehicles and use machines

Caution should be observed when taking Zatin as it may cause drowsiness.

Use in Pregnancy & Lactation

Usage should be avoided in pregnancy and lactation unless it's highly recommended by the doctor and its

advantages are higher than the risks

DRUG INTERACTIONS :

- Concomitant use with oral antidiabetic agents may lead to a reversible fall in the platelets count.

- Concomitant use with sedatives, hypnotics, antihistamines and alcohol may potentiate their effects.

ADVERSE EFFECTS :

- Common : Drowsiness.

- Less common : dryness of the mouth and slight dizziness at the beginning of treatment but normally disappear

quickly . Increased appetite and weight gain have been reported.

STORAGE INSTRUCTIONS :

Syrup : Store below 30°C.

Tablets : Store below 30°C in a dry place.

PRESENTATION :

Zatin Syrup : Bottle of 100 ml.

Zatin Tablet : Pack of 20 tablets & hospital pack of different sizes