Galantamine

Brand Canonpharma

In stock 777 Items

Available since: 2019-09-19

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Clinical Pharmacology

Selective, competitive and reversible acetylcholinesterase inhibitor. Stimulates nicotinic receptors and increases the sensitivity of the postsynaptic membrane to acetylcholine. Facilitates conduction of excitation in the neuromuscular synapse and restores neuromuscular conduction in cases of its blockade with muscle relaxants of non-depolarizing type of action. Increases the tone of smooth muscles, increases the secretion of the digestive and sweat glands, causes miosis. By increasing the activity of the cholinergic system, galantamine improves cognitive function in patients with Alzheimer's disease, but does not affect the development of the disease itself.

Indications

Alzheimer's dementia is a mild or moderate disease.
Poliomyelitis (immediately after the cessation of the febrile period, as well as during the recovery period and the period of residual effects).
Myasthenia gravis.
Progressive muscular dystrophy.
Cerebral palsy.
Neuritis.
Radiculitis.
Myopathy.

Composition

1 tablet contains:

Active substances: galantamine hydrobromide - 15.380 mg, in terms of galantamine - 12.00 mg.

Excipients: calcium hydrophosphate dihydrate, colloidal silicon dioxide (aerosil), copovidone (plasdone ES-630 or collidon VA-64), magnesium stearate, croscarmellose sodium (primelloza), microcrystalline cellulose.

Shell composition: Advantia Prima 319974RC09 (hydroxypropyl methyl cellulose), macrogol (polyethylene glycol), caprin / caprylic triglyceride (glyceryl caprylocaprate), titanium dioxide, aluminum lacquer based on quinoline yellow dye, aluminum lacquer based on brilliant blue, aluminum lacquer based on quinoline yellow dye, aluminum lacquer based on brilliant blue, aluminum lacquer based on quinoline yellow dye, aluminum lacquer based on brilliant blue, aluminum varnish based on quinoline yellow dye, aluminum lacquer based on brilliant blue, aluminum lacquer based on quinoline yellow dye, aluminum lacquer based on brilliant blue, aluminum lacquer based on quinoline yellow dye, aluminum lacquer based on brilliant blue, aluminum varnish based on quinoline yellow dye;

Galantamine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Galantamine	Canonpharma	Russia	pills
Nivalin	Sopharma	Bulgaria	ampoules

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Dosage and Administration

Orally, while eating, drinking water.

For adults

The daily dose is 8-32 mg, divided into 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 pills 4 mg 2 times / day. Within 4 weeks, the daily dose can be gradually increased to 16 mg - 1 tablet, 8 mg 2 times / day - in the morning and evening. During treatment with a drug, it is necessary to ensure the intake of a sufficient amount of fluid.

If during treatment it is necessary to stop taking the drug, then the treatment restoration should be started with the lowest dose and gradually increased.

Patients with moderate hepatic and renal dysfunction: the initial dose is 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.

Children (from 9 years)

Treatment of polio, 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.

Adverse reactions

Since the cardiovascular system: decrease or increase in blood pressure, orthostatic hypotension, heart failure, edema, atrioventricular block, atrial flutter or atrial fibrillation, lengthening of the QT interval, ventricular and supraventricular tachycardia, supraventricular extrasystole, “braidcardia”, bradycardia, an adrensculus, anastrophoid reflux syndrome, an afflictive disorder, an adrenal syndrome, an adrenal syndrome, an adrenal gland, anxiety

From the digestive system: abdominal distension, dyspepsia, gastrointestinal discomfort, anorexia, diarrhea, abdominal pain, nausea, vomiting, gastritis, dysphagia, dry mouth, increased salivation, diverticulitis, gastroenteritis, duodenitis, hepatitis, gastric mucosal perforation, duodenitis, hepatitis, gastroenteritis, duodenitis, hepatitis; lower gastrointestinal tract.

From the musculoskeletal system: muscle cramps, muscle weakness, fever.

Laboratory indicators: increased liver enzyme activity, anemia, hypocalcemia, increased blood sugar or alkaline phosphatase.

Hematologic: thrombocytopenia, purpura.

From the urinary system: urinary incontinence, hematuria, frequent urination, urinary tract infections, urinary retention, calculus, renal colic.

From the nervous system: often tremor, lethargy, taste perversion, visual and auditory hallucinations, behavioral responses, including agitation / aggression; transient cerebrovascular accident or stroke; headache, dizziness, convulsions, muscle spasms, paresthesias, ataxia, hypo or hyperkinesis, apraxia, aphasia, anorexia, drowsiness, aessonnitsa.

From the senses: rhinitis, nosebleeds, visual disturbances, accommodation spasm. Infrequently - tinnitus.

From the psyche: depression (very rarely with suicide), apathy, paranoid reactions, increased libido, delirium.

Are common: chest pain, increased sweating, weight loss, fatigue, dehydration (in rare cases - with the development of renal failure), bronchospasm.

Carefully: mild and moderate renal or hepatic dysfunction, sick sinus syndrome and other supraventricular conduction disorders, simultaneous use of drugs that slow heart rate (digoxin, beta-adrenergic blockers), general anesthesia, gastric ulcer and duodenal ulcer, increased risk of erosive ulcerative lesions of the digestive tract.

Drug interactions

It is not recommended to combine with other cholinomimetics.

It is an opioid antagonist of action on the respiratory center. Shows pharmacodynamic antagonism to m-anticholinergics (atropine, gomatropina methyl bromide, etc.), ganglioblokatoram, non-depolarizing muscle relaxants, quinidine, procainamide.

Aminoglycoside antibiotics can reduce the therapeutic effect of galantamine. Galantamine increases neuromuscular blockade during general anesthesia (including suxamethonia when used as a peripheral muscle relaxant). Drugs that reduce heart rate (digoxin, beta-blockers) increase the risk of worsening bradycardia.

Cimetidine may increase the bioavailability of galantamine.

All drugs that inhibit and isoenzymes of the cytochrome P450 system (CYP2D6 and CYP3A4) can increase plasma concentrations of galantamine while they are used at the same time, resulting in an increased incidence of cholinergic side effects (mainly nausea and vomiting). In this case, depending on the tolerance of the therapy to the specific patient, a reduction in the maintenance dose of galantamine may be necessary.

CYP2D6 isoenzyme inhibitors (amitriptyline, fluoxetine, fluvoxamine, paroxetine, quinidine) reduce the clearance of galantamine by 25-30%. For this reason, it is not recommended to administer simultaneously with ketoconazole, zidovudine, erythromycin.

Strengthens the inhibitory effect on the central nervous system of ethanol and sedatives.

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, who usually experience weight loss. In this regard, it is necessary to monitor the weight of the body in such patients.

During treatment it is necessary to ensure adequate fluid intake. 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 sick sinus syndrome and other conduction disorders, as well as when used with drugs that reduce heart rate (digoxin or beta-blockers).

When treating Galantamine, there is a risk of occurrence, and therefore 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 efficacy of the drug in patients with other types of dementia and memory impairment has not been established.

The drug is not intended to treat patients with mild cognitive impairment, i.e. with isolated memory impairment exceeding the expected level for their age and education, but not meeting the criteria for Alzheimer's disease.

Application for violations of the liver

Contraindicated in severe violations of the liver. With care at easy and moderate abnormal liver functions.

Application for violations of renal function

Contraindicated in severe renal impairment. With care at easy and moderate renal failures.

Use in Pediatrics

Contraindicated in children under 9 years.

Influence on ability to drive motor transport and control mechanisms

During the period of treatment should refrain from performing work requiring increased concentration of attention and speed of psychomotor reactions, including driving.

Overdosage

Symptoms: depression of consciousness (up to coma), convulsions, increased severity of side effects, severe muscle weakness, combined with hypersecretion of the glands of the tracheal mucosa and bronchospasm can lead to a fatal blockade of the respiratory tract.

Treatment: gastric lavage, symptomatic therapy. As an antidote - IV the introduction of atropine in doses of 0.5-1 mg. Subsequent doses of atropine are determined depending on the therapeutic response and the patient's condition.