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NIVALIN (Galantamine)


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Vegetotropic drugs

NIVALIN (Galantamine)

INN: GALANTAMINE

Код АТХ: N06DA 4

Composition:

One ampoule of 1 ml contains 1 mg (0.1%); 2.5 mg (0.25%); 5 mg (0.5%) or 10 mg (1%) galantamine hydrobromide. One tablet contains 5 mg or 10 mg galantamine hydrobromide.

Indications:

Nivalin is indicated during the convalescence and residual phase of poliomyelitis; in neuritis, radiculitis, polyneuritis; spastic paresis and paralysis; myopathy, myasthenia gravis, progressive muscular dystrophy; infantile cerebral paralysis, birth paralysis, nocturnal enuresis, residual paresis following a cerebral hemorrhage, and for elimination of the effect of nondepolarizing neuromuscular blockers. As an antidote in poisoning with Morphinum hydrochloricum. Mild to moderate dementia of Alzheimer’s type (tablets).

Dosage and administration:

The solution for injections is applied subcutaneously, intramuscularly or intravenously. The treatment starts at the lowest effective dose that is gradually increased. The maximum single dose in adults is 10 mg, and the maximum daily dose - 20 mg.

In children it is applied subcutaneously at the following daily doses: aged from 1 to 2 years: 0.25-1 mg; from 3 to 5 years: 0.5-5 mg; from 6 to 8 years: 0.75-7.5 mg; from 9 to 11 years: 1-10 mg; from 12 to 15 years: 1.25-12.5 mg; over 15 years: 12.5-15 mg.

As an anticurare agent, Nivalin is applied intravenously at the following doses: Children aged from 1 to 2 years: 1-2 mg; from 3 to 5 years: 1.5-3 mg; from 6 to 8 years: 2-5 mg; from 9 to 11 years: 3-8 mg; from 12 to 15 years: 5-10 mg. Adults – from 10 to 20 mg.

Nivalin solution for injections may be applied by electrophoresis in a quantity of 1-2 ml 0.25% solution.

Tablets are administered per os 1 hour after meals at following doses: children aged from 6 to 8 years: 5-10 mg daily; from 9 to 11 years: 5-15 mg daily; from 12 to 15 years: 5-25 mg; adults 10-40 mg daily, divided in 2-3 intakes.

The course of treatment continues for 1-2 months, and in degenerative diseases of CNS the treatment may continue up to 1 year.

Contraindications:

Nivalin is contraindicated in hypersensitivity to galantamine; bronchial asthma; bradycardia; atrioventricular block; angina pectoris; heart failure; epilepsy; hyperkinesis; obstruction of the intestinal or urinary tract. In pregnant women, it is used only after strict assessment of the doctor in charge.

Drug interactions:

Nivalin reduces the action of the M-cholinergic receptor blocking agents, ganglionblocking agents, nondepolarizing myorelaxants, quinine and novocainamide. Aminoglycoside antibiotics may reduce the therapeutic effect of Nivalin in myasthenia gravis. The action of neuromuscular blocking agents may be prolonged in concomitant administration with Nivalin.

Adverse reactions:

Adverse reactions are due to the parasympathetic effect of Nivalin and are manifested as: hypersalivation, sweating, vomiting, dizziness, more rarely bradycardia. In such cases, the dose should be reduced and treatment discontinued for 2-3 days.

Supplied:

10 or 100 ampoules of 1 ml (1 mg; 2.5 mg; 5 mg or 10 mg) solution for injections.

10, 20 or 60 tablets (5 mg).

10 or 20 tablets (10 mg).

Dispensing:

On doctor’s prescription.


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