COMPOSITION :

Each 5 ml syrup contains : Pizotifen maleate equivalent to Pizotifen 0.25 mg.

Each f/c tablet contains : Pizotifen maleate equivalent to Pizotifen 0.5 mg.

DESCRIPTION :

Pizofen (Pizotifen maleate) is a tricyclic (Benzocycloheptathiophene) compound has similar structure to cyproheptadine (appetite stimulant drug) and the tricyclic antidepressants . It possess a powerful antiserotonin , antitryptamine,

and marked antihistaminic activity. It also possess a weak anticholinergic activity and sedative properties . Pizotifen

inhibits the contraction effect of serotonin on cranial vessels. Pizotifen is well and fast absorbed from G.I. tract, and

peak plasma concentrations occur about 5 hours after oral administration. Over 90% of Pizotifen is bound to plasma

proteins and over half a dose is excreted in the urine chiefly as metabolites. The primary metabolite of pizotifen

(N-glucuronide conjugate) has a long elimination half-life of about 23 hours.

INDICATIONS :

- Appetite stimulant and increase the body weight in underweight patients whether it is organic in origin (due to

infectious or parasitic disease or diarrhea, or occurring during convalescence) or psychogenic (anorexia nervosa,

anorexia in the elderly) as an adjunct to treatment of the underlying disease.

- Mood elevation in elderly by reducing symptoms such as hopelessness, depression, dejection and oppression, as

well as asthenia, anxiety, restlessness, sleep disturbances and impairment of concentration or impairment of memory.

- Prophylaxis of vascular headache such as migraine and cluster headache and it reduces the recurrent of headache

attacks.

DOSAGE & ADMINISTRATION :

Children : At age 2 - 6 years : 5 - 10 ml (0.25 – 0.5 mg) of Pizofen syrup daily.

At age 6 - 12 years : 10 - 20 ml (0.5 – 1 mg) of Pizofen syrup in 2 or 3 divided doses daily, the dose can

be increased gradually to max. 30 ml (1.5 mg) of Pizofen syrup divided in 3 doses

daily. A dose of 20 ml can be given as a single dose at evening.

Adults & Elderly : An initial dose of 1 tablet (0.5 mg) per day , that can be gradually increased to 3 tablets (1.5 mg)

daily either in three divided doses or as a single dose at night to avoid drowsiness. The maximum dose for adults is

3mg as a single dose and 4.5 mg in divided doses.

RESTRICTION ON USE :

Contraindications

- Hypersensitivity to Pizotifen or any ingredients of product.

- In patients who are taking monoamine oxidase inhibitors (MAOIs).

Precautions

- Caution is required in patients with narrow angle glaucoma , urinary retention , kidney problems and patients with a

history of epilepsy.

- Pizotifen is not effective in relieving a migraine attack once in progress.

Effects on the ability to drive vehicles and use machines.

Patients should be cautioned against driving vehicles or use machines as it may cause drowsiness .

Use in Pregnancy & Lactation

There are no well adequate studies on pregnant woman, so Pizofen should be avoided during pregnancy unless if

necessary under physician supervision. It is not recommended during lactation.

DRUG INTERACTIONS :

- The central effects of sedatives, hypnotics, antihistamines and antidepressants may be enhanced by Pizotifen.

- Pizotifen antagonizes the hypotensive effect of antihypertensive drugs.

ADVERSE EFFECTS :

The most common side effect is drowsiness, also weight gain, dry mouth, dizziness and constipation may occur.

Nervousness may occur in children.

OVERDOSAGE :

Symptoms resulted from overdosage may include : drowsiness ,dizziness, nausea ,hypotension, dyspnea, convulsions

(particularly in children), coma.

Treatment : It is recommended to remove the drug by gastric lavage at the first hour of ingestion. Symptomatic

treatment should be given and convulsions may be treated with short acting benzodiazepines.

STORAGE INSTRUCTIONS :

Syrup : Store below 30OC, protect from light.

Tablets : Store below 30OC, in a dry place. Protect from light.

PRESENTATION :

Pizofen Syrup : Bottle of 100 ml.

Pizofen Tablets : Pack of 20 tablets.