BENZATROPINE PHEBRA SOLUTION FOR INJECTION 2 MG/2 ML [SIN16222P]

Product Info

BENZATROPINE PHEBRA SOLUTION FOR INJECTION 2 MG/2 ML

[SIN16222P]

4.1 THERAPEUTIC INDICATIONS

Benzatropine Injection is recommended for all forms of parkinsonism - including arteriosclerotic, post-encephalitic, idiopathic, as well as drug-induced extrapyramidal disorders (except tardive dyskinesia). It can be effective at any stage of the disease, even when a patient has become bedridden. Benzatropine Injection often is helpful in patients who have become unresponsive to other agents. Benzatropine Injection is a powerful anticholinergic agent which is mainly effective in relieving tremor and rigidity. Therapy is directed toward control of disturbing symptoms to permit the patient maximum integration of function with minimum discomfort.

In non-drug-induced parkinsonism, partial control of symptoms is usually achieved.

4.2 DOSE AND METHOD OF ADMINISTRATION

Benzatropine Injection is available as an injection for intravenous and intramuscular use. Each millilitre of the injection contains:

Because Benzatropine Injection is cumulative in action, therapy should be initiated with a small dose which then can be increased gradually at five- or six-day intervals. Increases in dosage should be made in increments of 0.5 mg, to a maximum of 6 mg.

The injection is especially useful for psychotic patients with acute dystonic reactions or other reactions that make oral medication difficult or impossible.

There is no significant difference in the onset of effect following intravenous or intramuscular injection. Improvement is noticeable within a few minutes after injection.

In emergency situations, when the patient's condition is alarming, administration of 1 to 2 mL of Benzatropine Injection will provide quick relief. If the signs of parkinsonism begin to return, the dose can be repeated.

Some patients experience greatest relief when taking the entire dose at bedtime; others react more favourably to divided doses, two to four times a day.

The long duration of action of Benzatropine Injection makes it particularly suitable for administration at bedtime when the effects may persist throughout the night. Consequently, Benzatropine Injection enables the patient to turn in bed more easily and to rise in the morning.

Therapy with other agents in parkinsonism should not be terminated abruptly when Benzatropine Injection is started, but reduced or discontinued gradually. Many patients obtain the greatest relief with a combination of Benzatropine Injection and other drugs.

Benzatropine Injection may be used concomitantly with combinations of carbidopa/ levodopa, or with levodopa in which case periodic dosage adjustment may be required in order to maintain optimum response.

Arteriosclerotic, idiopathic and postencephalitic parkinsonism

The usual daily dose of Benzatropine Injection is 1 to 2 mg, with a range of 0.5 to 6 mg parenterally.

Dosage must be individualised. In determining the dosage, the age and weight of the patient and the type of parkinsonism must be taken into consideration. Older patients, thin patients and patients with arteriosclerotic parkinsonism generally cannot tolerate large doses. However, most patients with postencephalitic parkinsonism require and, indeed, tolerate fairly large doses. Patients with a poor mental outlook are usually poor candidates for therapy.

In arteriosclerosis and idiopathic parkinsonism, therapy may be initiated with a single daily dose of 0.5 mg to 1 mg at bedtime. This dosage will be adequate in some patients, whereas 4 mg to 6 mg a day may be required by others.

In postencephalitic parkinsonism, therapy may be initiated in most patients with 2 mg a day in one or more doses. In highly sensitive individuals, therapy may be initiated with 0.5 mg at bedtime and increased as necessary.

Drug-induced parkinsonism

When treating extrapyramidal disorders due to central nervous system drugs such as phenothiazines or reserpine, a dosage of 1 to 4 mg once or twice a day is recommended.

Dosage should be varied to suit the needs of the patient. After one or two weeks of administration, Benzatropine Injection should be withdrawn to determine the continued need for medication.

If parkinsonism recurs, therapy with Benzatropine Injection can be reinstituted.

Usually the injection of 1 to 2 mL of Benzatropine Injection quickly relieves acute dystonic reactions.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

4.3 CONTRAINDICATIONS

Because of the atropine-like side effects, Benzatropine Injection is contraindicated in children under three years of age, and should be used with caution in older children.

Benzatropine Injection is contraindicated in patients who are hypersensitive to any component of this product.