Instructions for Galantamine pills
Description
Pills covered with a film capsule of blue color, round, two-headed; The cross section is almost white.
1 tab
halantamine hydrobromide 15.38 mg,
which corresponds to the halantamine content of 12 mg
Auxiliary substances: calcium hydrophosphate - 17 mg, silicon coloid dioxide - 3.15 mg, sodium crosscarmellosis - 12.6 mg, aqueous lactose - 106.6 mg, magnesium Arat - 1.4 mg, powidon K30 - 4.9 mg, cellulose microcrystalline - 48.97 mg.
Composition of the membrane: Opadra II blue - 6 mg (hypromellose (hydroxypropylmethylcellulose - 1.68 mg, lactose monogydrate - 2.16 mg, macrogol (polyethylene glycol) - 0.6 mg, titanium dioxide - 1.458 mg, diamond blue dye - 0.0942 mg, iron oxide black - 0.0078 mg).
ATX codes
N06DA04 Galantamine
Pharmacological groups / Group membership:
Selective inhibitor of acetylcholinesterase of the brain. Alzheimer's drug Galantamine
Active substance:
halantamine
Pharmacy Group:
Dementia cure
Retention Terms
In a dry, light-protected place at a temperature not exceeding 25°C. Keep away from children.
Overdose:
Symptoms: Compression of consciousness (up to coma), convulsions, increased intensity of side effects, pronounced muscle weakness combined with hypersecretion of the glands of the trachea mucous membrane and bronchospasm can lead to a lethal blockade of the respiratory tract.
Treatment: stomach washing, symptomatic therapy. As an antidote - in/in introduction of atropine at doses 0.5-1 mg. Subsequent doses of atropine are determined depending on the therapeutic response and the patient's condition.
Drug Interaction:
It is not recommended to combine with other cholinometers.
It is an antagonist of opioids by action in the respiratory center. It exhibits pharmacodynamic antagonism towards the mcholinolithic (atropine, gomapropin methylbromide, etc.), ganglioblocators, non-polar myorelexic there, china, prokainamidu.
Aminogenic antibiotics can reduce the therapeutic effects of halantamine. Galantamine increases the nerve-muscular blockage during general anesthesia (including when used as a peripheral myorelaxant suxametonium). Medicines that reduce heart rates (digoxine, beta-adrenoblokoly) increase the risk of worsening the bradycardia. Cimetide can increase the bioavailability of halantamine.
All drugs Galantamine that inhibit and isolate the P450 cytochromium system (CYP2D6 and CYP3A4) can increase the plasma concentrations of halantamine, while at the same time using them, which may increase the frequency of cholinergic side effects of objects (mainly nausea and vomiting). In this case, depending on the patient's tolerability of the therapy, it may be necessary to reduce the supporting dose of halantamine.
The inhibitors of the CYP2D6 isoferment (amitriptyl, fluoroxetin, fluvoksamin, paroxetine, hydideen) reduce the clearance of halantamine by 25-3 0%. For this reason, it is not recommended to assign ketoconazole, zidovudin, erythromycin at the same time. Intensifies the oppressive effect on the central nervous system of ethanol and sedatives
Side Action:
On the side of the cardiovascular system: decrease or increase of AD, orthostatic collapse, heart failure, edema, atrioventricular block, trembling or flicker of the atrium, elongation of the QT interval, ventricular and suture Praventricular tachycardia, pancreatic extrosistoly, tides, bradycardia, ischemia or myocardial heart attack.
From the digestive system: belly bloating, dyspepsy, gastrointestinal discomfort, anorexia, diarrhea, abdominal pain, nausea, vomiting, gastritis, dysphagia, dryness in the mouth, increased saliva, sabotage, gastroenteritis, duodenitis, hepatitis, perforation of the esophagus mucous membrane, bleeding from the upper and lower departments of the gastrointestinal tract a.
On the side of the musculoskeletal system: muscle spasms, muscle weakness, fever.
Laboratory indicators: increase of liver enzymes, anemia, hypocalmia, increase of sugar level or alkal phosphatase in the blood.
Hematological: thrombocytopenia, purpura.
On the side of the urinary system: urine incontinence, hematuria, frequent urination, urinary tract infections, urine delay, calculosis, kidney colic.
On the side of the nervous system: often tremor, sinkope, delay, perversion of taste, visual and auditory hallucinations, behavioral reactions, including arousal/aggression; a transient cerebrovascular disorder or stroke; headaches, dizziness, convulsions, muscle spasms, pastessia, ataxia, hypo- or hyperkines, aprexia, aphasia, anorexia, sleepiness, besson nick.
From the senses: Rinit, nose bleeding, visual impairment, accomodation spasm, not often - noise in the ears.
From the psyche: Depression (very seldom suicide), apathy, paranoid reactions, increased libido, delyria.
General: chest pain, increased sweating, reduced body weight, fatigue, dehydration (in rare cases with the development of kidney failure), bronchospasm.
Contraindications to use:
bronchial asthma;
bradycardia;
atrioventricular blockade;
arterial hypertension;
stenocardia;
chronic heart failure;
epilepsy;
hyperkinesis;
Heavy kidney (Creatinin clearance - less than 9 ml/min) and liver (more than 9 points: Child-Pugh) violations;
mechanical intestinal impassability;
chronic obstructive lung disease;
obstructive diseases or recent surgery of the gastrointestinal tract;
obstructive diseases or recent surgery of the urinary tract or prostate;
Children up to 9 years of age;
pregnancy and lactation;
hypersensitivity to any of the components of the drug.
With caution:
slight and moderate disorders of kidney or liver function;
Sine node weakness syndrome and other suprantricular conductivity disorders;
Simultaneous use of drugs Galantamine that slow the heart rate (digoxine, beta-adrenoblocators);
general anesthesia;
ulcerous stomach disease and duodenal intestine, increased risk of development of erosive-ulcerous lesions of the LCD.
Special Instructions:
Treatment with inhibitors of acetylcholinesterase is accompanied by a decrease in body weight. This is especially important in the treatment of patients with Alzheimer's disease, who are usually losing weight. In this regard, it is necessary to monitor the mass of the body in such patients.
During treatment, sufficient liquid consumption is required. Like other cholinometics, the drug Galantamine can cause vagotonic effects on the part of the cardiovascular system (including bradycardia), which should be taken into account in patients with syndrome of sine node weakness and other conductivity disorders, as well as at the same time Use with drugs that reduce heart rate (digoxine or beta-adrenoblocore).
In the treatment of Galantamin there is a risk of the appearance of syncope, therefore it is necessary to control arterial pressure more often, especially when taking the drug Galantamine at 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 Galantamine in patients with other types of dementia and memory disturbances is not established.
The drug Galantamine is not intended to treat patients with weak cognitive impairment, i.e., isolated memory disturbances that exceed the expected level for their age and education, but do not meet the criteria of Alzheimer's disease.
Impact on the ability to drive vehicles and mechanisms
During treatment, work that requires increased attention and speed of psychomotor reactions, including driving, should be avoided.
Application for kidney disorders
Contrary to severe kidney disorders. With caution in light and moderate kidney function disorders
Application for liver disorders
Contrary to severe liver function disorders. With caution in light and moderate liver disorders
Application of children
Contradicted to children under 9 years of age.
Nozology (ICD codes)
A80
Acute polio
F00
Dementia in Alzheimer's disease
G30
Alzheimer's Disease
G70
Myasthenia gravis and other nerve-muscular synapse disorders
G71.0
Muscular dystrophy
G72
Other myopathy
G80
Cerebral palsy
M54.1
Radiculopathy
M79.2
Neuralgia and Neuritius Unspecified