Description
Release form
Film-coated tablets.
Packing
In the package 56 pcs.
Pharmacological action of
Selective, competitive and reversible acetylcholinesterase inhibitor. Stimulates nicotinic receptors and increases the sensitivity of the postsynaptic membrane to acetylcholine. It facilitates the excitation in the neuromuscular synapse and restores neuromuscular conduction in cases of its blockade by muscle relaxants of a non-depolarizing type of action. Increases the tone of smooth muscles, enhances the secretion of digestive and sweat glands, and causes myosis. By increasing the activity of the cholinergic system, galantamine improves cognitive function in patients with Alzheimer’s dementia, but does not affect the development of the disease itself.
Indications
Alzheimer’s dementia mild to moderate disease.
Poliomyelitis (immediately after the termination of the febrile period, as well as in the recovery period and the period of residual phenomena).
myasthenia gravis.
Progressive muscular dystrophy.
cerebral palsy.
Neuritis.
Sciatica.
myopathy.
Contraindications
Hypersensitivity to any of the components of the drug.
Bronchial asthma.
bradycardia.
Atrioventricular block.
Arterial hypertension.
Angina pectoris.
Chronic heart failure.
epilepsy.
Hyperkinesis.
Severe renal impairment (creatinine clearance less than 9 ml / min).
Severe hepatic (more than 9 points on the Child-Pugh scale) disorders.
Mechanical intestinal obstruction.
Chronic obstructive pulmonary disease.
Obstructive disease or recent surgery on the organs of the gastrointestinal tract.
Obstructive disease or recent surgical treatment of the urinary tract or prostate gland.
Children under 9 years old.
Pregnancy.
Lactation.
Precautions: mild to moderate renal or hepatic impairment, sinus node syndrome and other supraventricular conduction disturbances, concomitant use of drugs that slow the heart rate (digoxin, beta-blockers), general anesthesia, gastric and duodenal ulcer, increased the risk of erosive and ulcerative lesions of the gastrointestinal tract.
Use during pregnancy and lactation
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Special instructions
Treatment with acetylcholinesterase inhibitors is accompanied by a decrease in body weight. This is especially necessary to keep in mind when treating patients with Alzheimer’s disease, which usually have weight loss. In this regard, it is necessary to monitor body weight in such patients.
Adequate fluid intake must be provided during treatment. Like other cholinomimetics, the drug can cause vagotonic effects on the part of the cardiovascular system (including bradycardia), which must be taken into account in patients with sinus node syndrome and other conduction disorders, as well as when used with drugs that reduce heart rate (digoxin or beta-blockers).
With Galantamine, there is a risk of in connection with which it is necessary to control blood pressure more often, especially when taking the drug in higher doses (40 mg daily dose). In order to prevent such side effects, it is necessary to carefully select the dose of the drug at the beginning of treatment. The effectiveness of the drug in patients with other types of dementia and memory impairment has not been established.
The drug is not intended for the treatment of patients with mild cognitive impairment, i.e. with an isolated memory impairment exceeding the expected level for their age and education, but not meeting the criteria for Alzheimer’s disease.
Use in cases of impaired liver function
Contraindicated in severe impairment of liver function. Precautions for mild to moderate impaired liver function.
Use for impaired renal function
Contraindicated in severe renal impairment. Precautions for mild to moderate impaired renal function.
Pediatric use
Contraindicated in children under 9 years of age.
Influence on the ability to drive vehicles and control mechanisms
During treatment, you should refrain from performing work that requires an increased concentration of attention and speed of psychomotor reactions, including driving.
Composition
1 tablet contains:
Active substances: galantamine hydrobromide – 15.380 mg, in terms of galantamine – 12.00 mg.
Excipients: calcium hydrogen phosphate dihydrate, colloidal silicon dioxide (aerosil), copovidone (Esd-630 plasdon or VA-64 collidon), magnesium stearate, croscarmellose sodium (primrose), microcrystalline cellulose.
Shell composition: Advantia Prima 319974RC09 (hydroxypropyl methyl cellulose), macrogol (polyethylene glycol), caprine / capryl triglyceride (glyceryl caprylocaprate), titanium dioxide, aluminum varnish based on quinoline yellow dye, aluminum varnish based on blue diamond dye dye indigo carmine.
Dosage and administration
Inside, with food, with water.
Adults
The daily dose is 8-32 mg, divided in 2-4 doses.
With myasthenia gravis: the daily dose is divided into 3 doses.
In Alzheimer’s disease: treatment is recommended to start with taking 4 mg tablets 2 times / day. Within 4 weeks, the daily dose can gradually be increased to 16 mg – 1 tablet, 8 mg 2 times / day – in the morning and in the evening. During treatment with the drug, it is necessary to ensure the intake of a sufficient amount of fluid.
If discontinuation of the drug is required during treatment, then restoration of treatment must begin with the lowest dose and gradually increase it.
Patients with moderate impaired liver and kidney function: initial dose – 4 mg 1 time / day, which is taken in the morning, for at least 1 week, after which the dose is increased to 4 mg 2 times / day and taken for 4 weeks.
The total daily dose should not exceed 12 mg.
For children (from 9 years old)
Treatment of poliomyelitis, cerebral palsy:
From 9 to 11 years: daily dose – 4-12 mg, divided into 2-3 doses.
From 12 to 15 years: the daily dose is 4-16 mg, divided into 2-4 doses.
Side effects
From the cardiovascular system: decrease or increase in blood pressure, orthostatic hypotension, heart failure, edema, atrioventricular block, atrial flutter or blinking, lengthening of the QT interval, ventricular and supraventricular tachycardia, supraventricular extrasystole, hot flashes, bradycardia, ischemia or myocardial infarction.
From the digestive system: bloating, dyspepsia, gastrointestinal discomfort, anorexia, diarrhea, abdominal pain, nausea, vomiting, gastritis, dysphagia, dry mouth, increased excretion of saliva, diverticulitis, gastroenteritis, duodenitis, mucous membrane, duodenitis, hepatitis esophagus, bleeding from the upper and lower parts of the gastrointestinal tract.
From the side of the musculoskeletal system: muscle cramps, muscle weakness, fever.
Laboratory indicators: increased activity of liver enzymes, anemia, hypocalnemia, increased blood sugar or alkaline phosphatase.
Hematologic: thrombocytopenia, purpura.
From the urinary system: urinary incontinence, hematuria, rapid urination, urinary tract infections, urinary retention, calculosis, renal colic.
From the nervous system: often tremor, lethargy, taste perversion, visual and auditory hallucinations, behavioral reactions, including agitation / aggression, transient cerebrovascular accident or stroke, headache, dizziness, cramps, muscle cramps, paresthesia, ataxia, hypo or hyperkinesis, apraxia, aphasia, anorexia, drowsiness, and sleeplessness.
On the part of the sensory organs: rhinitis, nosebleeds, visual impairment, accommodation spasm. Infrequently – tinnitus.
From the psyche: depression (very rarely with suicide), apathy, paranoid reactions, increased libido, delirium.
General: chest pain, excessive sweating, weight loss, feeling tired, dehydration (in rare cases, with the development of renal failure), bronchospasm.
Drug Interactions
It is not recommended to combine with other cholinomimetics.
Is an opioid antagonist in the respiratory center. It exhibits pharmacodynamic antagonism to m-anticholinergics (atropine, homatropin methyl bromide, etc.), ganglion blockers, non-depolarizing muscle relaxants, quinidine, procainamide.
Aminoglycoside antibiotics may decrease the therapeutic effect of galantamine. Galantamine enhances neuromuscular blockade during general anesthesia (including the use of suxamethonium as a peripheral muscle relaxant). Medicines that reduce heart rate (digoxin, beta-blockers) increase the risk of aggravation of bradycardia.
Cimetidine may increase the bioavailability of galantamine.
All drugs that inhibit isoenzymes of the cytochrome P450 system (CYP2D6 and CYP3A4) can increase plasma concentrations of galantamine while they are used, as a result, the frequency of cholinergic side effects (mainly nausea and vomiting) may increase. In this case, depending on the tolerance of therapy to a particular patient, a reduction in the maintenance dose of galantamine may be necessary.
Inhibitors of the CYP2D6 isoenzyme (amitriptyline, fluoxetine, fluvoxamine, paroxetine, quinidine) reduce galantamine clearance by 25-30%. For this reason, it is not recommended to prescribe simultaneously with ketoconazole, zidovudine, erythromycin.
Enhances the central nervous system inhibitory effect of ethanol and sedatives.
Overdose
Symptoms: depression of consciousness (up to coma), convulsions, increased severity of side effects, pronounced muscle weakness in combination with hypersecretion of glands of the tracheal mucosa and bronchospasm.
Treatment: gastric lavage, symptomatic therapy. As an antidote – at / in the introduction of atropine at doses of 0.5-1 mg. Subsequent doses of atropine are determined depending on the therapeutic response and the patient’s condition.
Storage Conditions
Store in a dry, dark place at temperatures up to 25 ° C.
Keep out of the reach and sight of children.
Shelf life
2 years.
Deystvuyushtee substance
Galanthamine
Dosage form
tablets
Possible product names
Galantamine Canon tablets coated film 12 mg 56 pcs.
galantamine tab po 12mg x 56
galantamine TAB. P.P.O. 12MG No. 56
GALANTAMIN TAB. PO / PLEN. 12MG No. 56
Galantamine tablets 12 mg, 56 pcs.
Kanonfarma, Russia
