
D-Fen1.5 mg
Drug International Ltd.
Pizotifen is indicated for the prophylaxis (prevention) of recurrent vascular headache of the migraine type, including classical migraine, common migraine, and cluster headache.
Pizotifen is indicated for the prophylaxis (prevention) of recurrent vascular headache of the migraine type, including classical migraine, common migraine, and cluster headache.
Pizotifen is not effective for treating an acute migraine attack that has already started, and it is not an analgesic. It is intended only to reduce the frequency and severity of future attacks, and its full preventive benefit typically takes several weeks to become apparent.
| Regimen | Dose |
|---|---|
| Starting dose | 0.5 mg once daily at bedtime, increased gradually according to response |
| Usual maintenance dose | 1.5 mg daily, taken as a single bedtime dose or in divided doses (e.g. three times daily) |
| Maximum dose | 4.5 mg daily (up to 3 mg may be given as a single dose) |
| Age | Dose |
|---|---|
| 2 years and older | Usually up to 1 mg at night, or up to 1.5 mg daily in divided doses, under medical supervision |
Safety and efficacy of Pizotifen in children under 2 years of age have not been established.
Dosage adjustment or caution may be necessary in patients with significant hepatic or renal impairment (see Use in Special Populations).
Note: Pizotifen is a preventive treatment and must be taken regularly every day, even when headache-free, to be effective. It is not for use during an acute migraine attack. Treatment should not be stopped abruptly after prolonged use (see Precautions and Warnings).
Side effects of Pizotifen are largely related to its antihistaminic and anticholinergic activity.
Patients should seek medical advice if side effects are severe, persistent, or if signs of liver problems (yellowing of skin/eyes, dark urine) or allergic reaction occur.
Pizotifen is contraindicated in the following situations:
Pizotifen should be used with caution rather than being absolutely contraindicated in conditions such as angle-closure glaucoma, urinary retention, epilepsy, and hepatic/renal impairment — see Precautions and Warnings for details.
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