Description

Ketotifen  Syrup

 How Supplied                                                                                                                                                                                                                                                                                                                                                  

Syrup in glass bottle of 120 ml with leaflet and spoon in a box.Each 5 ml containing  1 mg ketotifen as (fumarate).

Category

systemic Asthma prophylactic; systemic Antiallergic

Mechanism of Action

 Ketotifen is a non – bronchodilator antiasthmatic drug which inhibits the effects of certain endogenous substances known to be inflammatory mediators, and thereby exerts antiallergic activity.Ketotifen possesses a powerful and sustained non-competitive histamine (H₁) blocking property. ketotifen’s antihistamine (H₁) effect seems to be distinct from its antiallergic properties.Properties of ketotifen which may contribute to its antiallergic activity and its ability to affect the underlying pathology of asthma.

 Pharmacokinetics

• Absorption:Following oral administration absorption is at least 60% , and possibly even greater. The rate of absorption is rapid with an absorption half life of 1 hour. Bioavailability is about 50% due to a large first pass effect.Bioavailability is not affected by the intake of food.
• Half – Life:Distribution – 3 to 5 hours;Elimination – 21 hours
• Elimination:Within 48 hours, urinary excretion amounts to 1% as unchanged drug and 60% to 70% as metabolites. Clearance is higher in children.
• Protein binding:high 75%

Pregnancy and breast feeding

Pregnancy : Adequate and well – controlled studies in humans have not been done.

And it is also distributed into human breast milk,Women who take this medication should not breast – feed.

Precautions :

• Regular visits to physician to check progress during therapy.
• Since drowsiness and, rarely, slight dizziness may occur in the early stages of therapy caution is advised, not driving, using machines, or doing anything else that requires alertness while taking ketotifen.
• Occasionally, symptoms of central nervous system (CNS) stimulation, such as excitation, irritability, insomnia, and nervousness have been observed, particularly in children.
• For patient with diabetes:recognizing that ketotifen syrup contains 4 gr of carbohydrate in every 5 ml;glucose concentrations may be affected.

Drug interaction

Inform your doctor if you are taking any of the following medicine:oral Antidiabetic agents; Alcohol; Antihistamines; hypnotics;sedatives.

Dosage and Administration

Usual adult dose:

• Asthma, atopic (prophylaxis) : 5ml (1 mg ),twice daily in the morning and evening.

Usual pediatric dose:

• Asthma, atopic (prophylaxis):

Infants and Children from 6 months to 3 years of age : 0.25ml(0.05 mg) per kg of body weight twice daily, in the morning and evening.

children older than 3 years of age : 5ml (1 mg ),twice daily in the morning and evening.

Side effects :

Those indicating need for medical attention:Flu;respiratory infection;cystitis;erythema multiforme ;hepatitis.

Those indicating need for medical attention only if they continue or are bothersome:

weight gain;abdominal pain;central nervous system (CNS) stimulation; dizziness;dryness of mouth;epistaxis;increased appetite;sedation;skin rash;sleep disturbance; swelling of eyelids.

Storage :

Store below 30^۫C,protect from Light and Moisture.keep out of reach of Children.

Date of revision :

October 2013

Manufactured by Pursina Pharmaceutical Co.  Tehran-Iran