Калимин® 60 Of N
Producer: Teva (Tev) Israel
Code of automatic telephone exchange: N07AA02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 60 mg of pyridostigmine of bromide.
Excipients: microcrystallic cellulose, corn starch, поливидон K 25, silicon the dioxide besieged silicon dioxide highly disperse, magnesium stearate, glutaminic acid a hydrochloride, water.
Description.
White, biconvex, oblong tablets with risky, smooth surfaces, integral edges and an identical look.
Pharmacological properties:
Has cholinomimetic effect at the expense of reversible inhibition of acetylcholinesterase and strengthening of action of acetylcholine. Improves neuromuscular transmission, increases motility of digestive tract, raises a tone of a bladder, bronchial tubes, secretion of excretory glands, poorly expands vessels; causes bradycardia, causes a weak miosis, an accommodation spasm.
Pharmacokinetics. Bioavailability of 8 - 20%, at a myasthenia can go down to 4%. Time of achievement of the maximum concentration of 1.5-3 h, a concomitant use of food does not reduce bioavailability, but can delay time of achievement of the maximum concentration. Elimination half-life of 2.5 h. Does not get through a blood-brain barrier. Practically does not communicate proteins of plasma. It is partially metabolized in a liver to inactive metabolites. It is removed by kidneys in not changed look and in the form of metabolites. The average plasma clearance at healthy people equals 0.36-0.65 l/kg/h.
Indications to use:
• myasthenia;
• myasthenic syndrome;
• atony of muscles of digestive tract and bladder.
Route of administration and doses:
Inside.
Myasthenia: at initial symptoms of a disease Kalyminum of 60 N is applied in a dose of 1/2-1 tablet 1 - 2 times a day (there correspond 30-120 mg of pyridostigmine of bromide). At diseases Kalyminum of 60 N progressed apply in a dose of 1 - 3 tablet 2 - 4 times a day (there correspond 120 - 720 mg of pyridostigmine of bromide). The maximum daily dose of 12 tablets (there correspond 720 mg of pyridostigmine of bromide).
Atony of muscles of digestive tract and bladder: Kalyminum of 60 N is appointed in a dose on 1 tablet (60 mg of pyridostigmine of bromide) every 4 hour.
Features of use:
During treatment it is necessary to abstain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
The patient with diseases of kidneys drug is appointed in lower doses, the necessary dose is chosen individually for each patient depending on effect of drug.
In the course of treatment by the patient alcohol intake is strictly forbidden.
If the patient forgot to accept timely the next dose of drug, it is not necessary to accept the forgotten drug dose in addition to the ordered scheme of dosing.
Side effects:
Nausea, vomiting, diarrhea, abdominal pains, strengthening of a vermicular movement, hypersecretion of bronchial glands, hypersalivation, dacryagogue, perspiration, frequent urination, lowering of arterial pressure, bradycardia, miosis; spasms, fastsikulyation of muscles, muscular weakness. Skin rash (it is caused by the content in bromine drug).
Interaction with other medicines:
Atropine weakens side effects of pyridostigmine such as bradycardia and gipersekretsiiya. Pyridostigmine strengthens action of the depolarizing muscle relaxants, derivatives of morphine and barbiturates. It is incompatible with ethanol. M-holinoblokatory, ganglioblokator, quinidine, procaineamide, local anesthetics, tricyclic antidepressants, antiepileptic and protivoparkinsonichesky drugs reduce expressiveness of effect of pyridostigmine.
Contraindications:
Hypersensitivity, the previous introduction of the depolarizing muscle relaxants (succinylcholine, dekametony); an iritis, chronic obstructive bronchitis, bronchial asthma, obturatsionny intestinal impassability, a spasm of bilious and urinary tract, spastic conditions of bodies of digestive tract, a myatonia, shock during the postoperative period, the lactation period, a thyrotoxicosis, parkinsonism.
Considering the high content of active ingredient, Kalyminum of 60 N is not applied to treatment of an atony of muscles of digestive tract and a bladder at children 16 years are younger.
With care.
Arterial hypotension, heart and renal failure, acute myocardial infarction, peptic ulcer of a stomach and duodenum, bradycardia, diabetes mellitus, digestive tract operations, liver disease, pregnancy.
Overdose:
Symptoms: increase in secretion of the lacrimal, salivary and sweat glands, a dermahemia, sharp weakness, a vision disorder, a miosis, dizziness, nausea, vomiting, involuntary defecation and an urination, intestinal colic, a bronchospasm, the fluid lungs expressed or the increasing muscular weakness, paralysis of respiratory muscles, a lowering of arterial pressure, a collapse, bradycardia, paradoxical tachycardia or a cardiac standstill.
Treatment: intravenous slow administration of Atropini sulfas of-1-2 mg (if necessary - repeatedly in 2-4 h, depending on heart rate), recovery and maintenance of the vital functions of an organism.
Storage conditions:
Period of validity 3 years. Not to use drug after expiry date. List A. To store at a temperature not above 30 °C. To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
On 50 or on 100 tablets in a bottle of brown glass with a plastic cover with control of the first opening. On 1 bottle with the application instruction in a cardboard pack.