Composition, form of production and packaging
Tablets of white color, biconvex, oblong, with a risk on one side, there may be roughness.
1 tab.
pyridostigmine bromide 60 mg
Excipients: microcrystalline cellulose - 336 mg, corn starch - 120 mg, polyvidon K25 - 60 mg, silicon dioxide colloid - 63 mg, purified water - 16 mg, magnesium stearate - 3 mg, glutamic acid hydrochloride - 2 mg.
100 pieces. - bottles of dark glass (1) - packs of cardboard.
Tablets of white color, biconvex, oblong, with a risk on one side, there may be roughness.
1 tab.
pyridostigmine bromide 60 mg
Excipients: microcrystalline cellulose - 336 mg, corn starch - 120 mg, polyvidon K25 - 60 mg, silicon dioxide colloid - 63 mg, purified water - 16 mg, magnesium stearate - 3 mg, glutamic acid hydrochloride - 2 mg.
100 pieces. - bottles of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Has cholinomimeticheskos action due to reversible inhibition of cholinesterase and increased action of acetylcholine. It improves the neuromuscular transmission, increases the motility of the gastrointestinal tract, raises the tone of the bladder, the bronchi, the secretion of the exocrine glands, causes bradycardia, a weak miosis, a spasm of accommodation. Does not have a central action.
PHARMACOKINETICS
Bioavailability of 8-20%, with myasthenia may drop to 4%. Time to reach C max 1.5-3 h, simultaneous ingestion does not reduce bioavailability, but can delay the time to reach C max . T 1/2 - 2.5 hours. It does not penetrate the blood-brain barrier. Virtually does not bind to plasma proteins. Partially metabolized in the liver to inactive metabolites. It is excreted by the kidneys in the unmodified form and in the form of metabolites. The average plasma clearance in healthy people is 0.36-0.65 l / kg / h.
INDICATIONS
- myasthenia gravis.
DOSING MODE
Inside, washing down with water.
With the initial symptoms of the disease - 1 / 2-1 tab. (30-60 mg) 1-2 times / day.
With the progression of the disease - 1-3 tablets. (60-180 mg) 2-4 times / day.
The maximum daily dose is 12 tablets. (720 mg).
Dosing of pyridostigmine bromide with myasthenia gravis is strictly individual, depending on the severity of the disease and the response of patients to treatment.Therefore, the dose regimens recommended for this indication should be considered as indicative.
Patients with kidney disease drug is prescribed in lower doses, because pyridostigmine bromide in unchanged form is excreted from the body mainly by the kidneys.Therefore, the necessary dose of the drug is selected individually for each patient, depending on the action of the drug.
SIDE EFFECT
Allergic reactions, excessive sweating, increased salivation and lacrimation, increased secretion of bronchial glands, nausea, vomiting, diarrhea, cramping abdominal pain due to increased intestinal motility, frequent urination, muscle tremor, skeletal muscle spasms, muscle weakness and accommodation disorders. When using the drug in higher doses, it is possible to develop bradycardia and reduce eAD. In very rare cases, rashes appear on the skin.
CONTRAINDICATIONS
- previous administration of depolarizing muscle relaxants (suxamethonium, decamethonium);
- irit;
- chronic obstructive bronchitis;
- bronchial asthma;
- mechanical intestinal obstruction;
- Obstruction of the biliary and urinary tract;
- Spastic conditions of the digestive tract;
- myotonia;
- shock in the postoperative period;
- Pregnancy;
- lactation period;
- age up to 18 years;
- Hypersensitivity to the components of the drug.
Carefully
Arterial hypotension, decompensated heart failure, renal failure, acute myocardial infarction, stomach ulcer, bradycardia, diabetes mellitus, parkinsonism, cholelithiasis in the absence of obstruction, urolithiasis in the absence of obstruction, condition after GI operations, hepatic insufficiency, hyperthyroidism.
PREGNANCY AND LACTATION
Pyridostigmine bromide does not have teratogenic effects, but has fetotoxicity. The drug is able to cause premature birth, especially when used in the last weeks of pregnancy.
Pyridostigmine bromide penetrates into breast milk. When prescribing the breastfeeding should be interrupted.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with kidney disease drug is prescribed in lower doses, because pyridostigmine bromide in unchanged form is excreted from the body mainly by the kidneys.Therefore, the necessary dose of the drug is selected individually for each patient, depending on the action of the drug.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Carefully.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
SPECIAL INSTRUCTIONS
In the process of treatment, patients are strictly forbidden to drink alcohol.
If the patient forgot to take a regular dose of the drug in a timely manner, do not take a double dose of the drug during the next dose.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, care should be taken when driving vehicles and engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: increased secretion of lacrimal, salivary and sweat glands, skin hyperemia, severe weakness, visual impairment, miosis, dizziness, nausea, vomiting, involuntary defecation and urination, intestinal colic, bronchospasm, pulmonary edema, marked or growing muscle weakness, paralysis of the respiratory muscles , decreased blood pressure, collapse, bradycardia, paradoxical tachycardia, or cardiac arrest.
Treatment: a specific antidote is atropine, which is administered intravenously (slowly) at a dose of 1-2 mg. Depending on the pulse rate, if necessary, the initial dose is administered again after 2-4 hours. Also, use activated charcoal, other enterosorbents and gastric lavage. It is necessary to control the water-electrolyte balance of the body, monitoring breathing and cardiac activity. With pulmonary insufficiency or cardiac arrest, appropriate resuscitation should be carried out.
DRUG INTERACTION
Atropine weakens the m-cholinomimetic effect of pyridostigmine bromide (bradycardia and hypersecretion), but not its effect on skeletal muscles.
Pyridostigmine bromide enhances the effect of depolarizing muscle relaxants, morphine and its derivatives, barbiturates.
Incompatible with ethanol.
M-holinoblokatory, ganglioblokatory, quinidine, procainamide, local anesthetics, tricyclic antidepressants, antiepileptic and antiparkinsonian drugs reduce the severity of the action of pyridostigmine bromide.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List A. Store at a temperature of no higher than 25 В° C. Keep out of the reach of children.
Shelf life - 3 years. After the first opening of the package - 6 months.
