📌 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 with a similar structure to cyproheptadine (an appetite stimulant drug) and the tricyclic antidepressants. It possesses a powerful antiserotonin, antitryptamine, and marked antihistaminic activity. It also possesses weak anticholinergic activity and sedative properties. Pizotifen inhibits the contraction effect of serotonin on cranial vessels. Pizotifen is well and rapidly absorbed from the 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 body weight in underweight patients, whether it is organic in origin (due to infectious or parasitic disease, diarrhoea, or occurring during convalescence) or psychogenic (anorexia nervosa, anorexia in the elderly), as an adjunct to treatment of the underlying disease.
• Mood elevation in the elderly by reducing symptoms such as hopelessness, depression, dejection and oppression, as well as asthenia, anxiety, restlessness, sleep disturbances and impairment of concentration or memory.
• Prophylaxis of vascular headache such as migraine and cluster headache, and it reduces the recurrence 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 2-3 divided doses daily. The dose can be increased gradually to a maximum of 30 ml (1.5 mg) of Pizofen syrup divided into 3 doses daily. A dose of 20 ml can be given as a single dose in the evening.
• Adults & Elderly: An initial dose of 1 tablet (0.5 mg) per day, which 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 3 mg as a single dose and 4.5 mg in divided doses.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to Pizotifen or any ingredients of the 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 using machines, as it may cause drowsiness.

Use in Pregnancy & Lactation

There are no well‑adequate studies on pregnant women, so Pizofen should be avoided during pregnancy unless necessary and 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 antagonises 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: Symptoms resulting from overdosage may include: drowsiness, dizziness, nausea, hypotension, dyspnoea, convulsions (particularly in children), coma.

Treatment: It is recommended to remove the drug by gastric lavage within the first hour of ingestion. Symptomatic treatment should be given, and convulsions may be treated with short‑acting benzodiazepines.

📌 STORAGE INSTRUCTIONS

• Syrup: Store below 30°C, protect from light.
• Tablets: Store below 30°C in a dry place. Protect from light.

📌 PHARMACEUTICAL FORMS

• Pizofen Syrup: Bottle of 100 ml.
• Pizofen Tablets: Pack of 20 tablets.