Kalimin® 60 N (Kalymin® 60 N)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePyridostigmine bromidePyridostigmine bromide
Dosage form: & nbsppills
Composition:

1 tablet contains:

active substance: pyridostigmine bromide 60 mg.

Excipients: microcrystalline cellulose, corn starch, povidone-K25, colloidal silicon dioxide, purified water, magnesium stearate, glutamic acid hydrochloride.

Description:

White, biconcave, oblong tablets with a risk on one side, possibly the presence of roughness, which is due to the production process and does not affect the quality of the product.

Pharmacotherapeutic group:Cholinesterase inhibitor
ATX: & nbsp

N.07.A.A.02   Pyridostigmine bromide

Pharmacodynamics:

Has a holinomimetic effect due to reversible inhibition of cholinesterase and increased action of acetylcholine. It improves neuromuscular transmission, strengthens the motility of the gastrointestinal tract, raises the tone of the bladder, bronchi, the secretion of the exocrine glands, causes bradycardia, a weak myosis, a spasm of accommodation. Does not have a central action.

Pharmacokinetics:

Bioavailability of 8-20%, with myasthenia gravis can be reduced to 4%. The time to reach the maximum concentration in the blood plasma is 1.5-3 hours, simultaneous intake of food does not reduce bioavailability, but can delay the time to reach maximum concentration. The half-life is 2.5 hours. It does not penetrate the blood-brain barrier. Virtually does not bind to plasma proteins. Partially metabolized in the liver with the formation of 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.

Contraindications:
  • Hypersensitivity to pyridostigmine bromide and other components of the drug;
  • previous administration of depolarizing muscle relaxants (suxamethonium, decamethonium bromide);
  • irit;
  • chronic obstructive bronchitis, bronchial asthma;
  • mechanical intestinal obstruction;
  • obstruction of the bile-excreting and urinary tract;
  • spastic conditions of the gastrointestinal tract;
  • myotonia;
  • shock in the postoperative period;
  • pregnancy;
  • lactation period;
  • age to 18 years.
Carefully:

Hypotension, decompensated heart failure, renal failure, acute myocardial infarction, peptic ulcer, bradycardia, diabetes, Parkinson's disease, cholelithiasis without obstruction, urolithiasis in the absence of obstruction, conditions after operations on the gastrointestinal tract, hepatic failure, hyperthyroidism .

Pregnancy and lactation:

Pyridostigmine has no teratogenic effects, but has fetotoxic. 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.

Dosing and Administration:

Inside, washing down with water.

When the initial symptoms of disease the recommended dose - ½-1 tablet (30-60 mg) 1-2 times a day.

When the disease progresses, 1-3 tablets (60-180 mg) 2-4 times a day.

The maximum daily dose is 12 tablets (720 mg).

Dosage pyridostigmine bromide in myasthenia gravis conducted strictly individually depending on the severity of the disease and the response of patients to therapy.Therefore, the dose regimens recommended for this indication should be considered as indicative.

Treatment of patients with kidney disease. Patients with kidney disease drug prescribe the drug in lower doses, t. K. pyridostigmine bromide in unmodified 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 effects:

Allergic reactions, excessive sweating, increased salivation and lacrimation, increased secretion of bronchial glands, nausea, vomiting, diarrhea, cramping abdominal pain due to increased intestinal peristalsis, 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 lower blood pressure. In very rare cases, rashes appear on the skin.

Overdose:

Symptoms: increased secretion of lacrimal, salivary and sweat glands, skin hyperemia, severe weakness, impaired vision, miosis, dizziness, nausea, vomiting, involuntary defecation and urination,intestinal colic, bronchospasm, pulmonary edema, marked or increasing muscle weakness, paralysis of the respiratory muscles, lowering of arterial 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 2-4 hours later. Also should be applied Activated carbon, 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.

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-cholinoblockers, ganglion blockers, quinidine, procainamide, local anesthetics, tricyclic antidepressants, antiepileptic and antiparkinsonian drugs reduce the severity of the action of pyridostigmine bromide.

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.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:

Tablets of 60 mg.

Packaging:

For 100 tablets in a bottle of brown glass with a plastic lid with the control of the first autopsy.

1 bottle with instructions for use in a cardboard box.

Storage conditions:

List A.

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

After the first autopsy - 6 months.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N015236 / 01
Date of registration:06.10.2008 / 11.09.2012
Expiration Date:Unlimited
The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
Manufacturer: & nbsp
Information update date: & nbsp26.11.2017
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