International generic name (More at www.nivalin.com) Galantamine
Drug form and composition Solution for injection. 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. Tablets. One tablet contains 5 mg or 10 mg Galantamine hydrobromide.
Indications Nivalin is indicated during the convalescence and residual phase of poliomyelitis; neuritis; radiculitis; polineuritis; spastic paresis and paralysis; myopathia; myasthenia gravis; progressive muscular dystrophy; cerebral paralysis in children; birth paralysis; nycturia; residual paresis following a brain hemorrhage and some forms of impotence; mild and moderate Alzheimer’s disease; in order to suppress the effect of the nondepolarizing neuro-muscular blockers. As an antidote in morphine intoxication.
Dosage and administration The solution for injection is applied subcutaneous, intramuscularly or intravenously. The treatment is started with the lowest effective dose, which is gradually increased. Maximal single dose in adults is 10 mg, the maximal dose is 20 mg /24 hours. In children is used subcutaneous in following daily doses: 1-2 years - 0.25 - 1 mg; 3-5 years - 0.5-5 mg; 6-8 years - 0.75-7.5 mg; 9-11 years - 1-10 mg; 12-15 years - 1.25-12.5 mg; over 15 years - 12.5-15 mg. As a curare antidote Nivalin is used intravenously in following doses: In children 1-2 years - 1-2 mg; 3-5 years - 1.5-3 mg; 6-8 years - 2-5 mg; 9-11 years - 3-8 mg; 12-15 years - 5-10 mg; In adults - 10-20 mg. Nivalin solution for injection could be applied by electrophoresis in dose 1-2 ml, 0.25% solution. Tablets are used orally, 1 hour after nutrition in following doses: children 6-8 years - 5-10 mg daily; 9-11 years - 5-15 mg daily; 12-15 years - 5-25 mg; in adults 10-40 mg daily, divided in 2-3 takes. The treatment should continue 1-2 months; 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; gastrointestinal tract or urinary tract obstruction.
Special warnings and precautions In patients with renal failure Nivalin should be used with care and in lower doses, depending on the creatine clearence. In pregnant and nursing women the treatment with Nivalin is not advisable.
Drug interactions Nivalin reduces the action of the M-choline receptor blocking agents, ganglion-blocking agents, nondepolarizing myorelaxants; chinine and novocain-amide. Amynoglycoside antibiotics may reduce the therapeutic effect of Nivalin in miasthenia gravis. The action-time of the neuromuscular blocking agents may be protracted in concomitant administration of Nivalin.
Adverse reactions Adverse reactions are result of the parasympathetic action of Nivalin and include hypersalivation; sweating; vomiting; dizziness, rarely bradycardia. In such cases the dose should be reduced or the treatment should be discontinued within 2-3 days.
Pharmacological mechanisms The active agent of Nivalin is the alkaloid galantamine, isolated by an original technology from the flower Leukojum aestivum. It possesses a powerful reversible inhibiting effect on the enzyme acetylcholine esrterase, predominantly in the CNS and less significant in the peripheral nervous system. It passes easy the hematoencephal barrier, which makes the preparation equally effective both in oral and parenteral administration. Nivalin facilitates impulse conduction in the CNS and VNS, as well as in neuromuscular synapse with resultant restoration of the neuromuscular conduction, enhancement of the smooth muscle tone, gastrointestinal and sweat gland secretion increase, and excitation of the respiratory center by reflector and central mechanisms. Nivalin improves memory function in patients with cognitive deficiency, due to different types dementia.
Supplied 10 or 100 ampoules of 1 ml (0.1%; 0.25%; 0.5% or 1%). 60 tablets of 5 mg. 20 tablets of 10 mg.
Expiry Solution for injection and tablets- 5 years. |