🔰Muscoflex 4 mg Capsule🔰
🟦COMPOSITION:
◼️Each capsule contains 4 mg thiocolchicoside.
🟦PHARMACOLOGICAL PROPERTIES:
🟦Pharmacodynamics Properties:
◼️Thiocolchicoside is semi-sentetic a muscle relaxant derived from a natural glycoside colchicoside.
◼️In preclinical studies, the drug was reported to have selective affinity for gamma-aminobutyric acid (GABA) and glycinergic receptors.
◼️There is evidence that muscle relaxant actions may result from direct activation of the GABA receptor at the spinal level; these properties appear to mediate skeletal muscle relaxant activity.
◼️The glycinomimetic effect of thiocolchicoside can be seen at the different levels of nervous system.
◼️These properties appear to mediate its activity on rheumatologic and traumatic spasms as well as central derived spastic spasms.
◼️It shows no curarizan affect.
◼️ It doesn't cause motor plaque paralysis, and no problems with respiratory problems occur.
◼️Additionally, it has no affect on cardiovascular system.
🟦Pharmacokinetics Properties:
🟦 Absorbtion:
◼️The absorption of thiocolchicoside is rapid after oral administration, with peak plasma levels occurring in about 60 minutes.
◼️In healthy volunteers after administration of 8 mg, the oral bioavailability is found as 24% when compared to intramuscular administration.
🟦Distribution:
◼️ Total protein binding is 13%.
◼️Thiocolchicoside is bound to albumin.
◼️It disperse into body tissue and liquid. A mean apparent volume of distribution of 76 L was reported after single 4-mg intramuscular doses.
🟦Metabolism:
◼️Elimination half-time is between 2.5-5 hours.
◼️Metabolism site is mainly blood and liver enzymes do not take place in metabolisation.
🟦 Excretion:
◼️Approximately 20% of the given dose is excreted as unchanged metabolites with the urine, 75-81 % is excreted by bile in the feces.
🟦INDICATIONS:
◼️Thiocolchicoside is indicated in the symptomatic therapy of muscular, romatoligical, traumatic and neurological deseases with spasm and contracture in the below mentioned skeletal muscle.
➡️ Torticollis
➡️ Dorsalgy
➡️Degenerative vertebra diseases like lumbalgy
➡️Static pathology of vertebra
➡️ Traumatic and neurolojical origin disorders with spasticity
➡️ During rehabilitation
🟦CONTRAINDICATIONS:
◼️It is contraindicated in hypersensitivity to thiocolchicoside or colchicines, muscular hypotonia, flabby paralysis.
🟦WARNINGS/PRECAUTIONS:
◼️In case of diarrhea occurs; the dose must be lowered.
◼️ Dose adjustment is necessary in patients with renal failure.
◼️If nece ssary, capsules can be taken with a gastroprotective drug.
◼️ As it contains lactose-monohydrate, it musn't be used in congenital —galactosemi, fructose intolerance,glucose and galactose malabsorbtion, lactose and sucroseisomaltose deficiency .
🟦Pregnancy and lactation:
◼️Pregnancy category: B or C
◼️ Since there are no adequate, well-controlled studies in pregnant women, it must not use in pregnancy
➡️Lactation:
◼️Thiocolchicoside is secreted in breast milk.
◼️Administration to nursing mothers is thus not recommended.
🟦SIDE EFFECTS/ ADVERSE REACTIONS:
◼️Skin reactions such as rash, swelling, allergic and pseudo-allergic reactions (allergic vasculitis) can be seen rarely.
◼️Gastrointestinal effects like gastralgia and diarrhea can occur seldomly.
◼️IN CASE OF AN UNEXPECTED SIDE EFFECT CONSULT YOUR PHYSICIAN.
🟦DRUG AND OTHER INTERACTIONS:
◼️ No drug interaction have been reported.
◼️ It should not be used with the drugs having similar effects.
🟦ADMINISTRATION AND DOSAGE:
🟦Adult Dosage:
◼️ One or two capsules twice a day is recommended.
◼️Recommended therapy course is 5-7 days.
◼️Capsules should be taken with a glass of water after the meals.
◼️ In clinically severe cases, therapy should begin with intramuscular administration of ampoule (each ampoule contains 4 mg thiocolchicoside).
◼️Recommended therapy course for intramuscular administration is 3-5 days.
◼️Usage with concomitant to physical medicine in order to gain optimum effect it should be used before 1-2 hours.
🟦Pediatric Dosage :
◼️Thlocolchicoside is not recommended in children.
🟦OVERDOSAGE:
◼️No overdosage is reported. In case of overdosage symptomatic and supportive treatment can be done.
🟦STORAGE:
◼️ Store below 25°C, at room temperature. Keep out of reach of children and in its original package.
🟦HOW SUPPLIED:
◼️20 capsules in blister package SOLD WITH PRESCRIPTION ONLY. DO NOT USE WITHOUT CONSULTING YOUR PHYSICIAN. : 14.01.2005-205/22
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