Instructions Muscomed solution for injection 4 mg/2 ml ampoule 2 ml No. 6
Composition
active ingredient: thiocolchicoside;
1 ampoule (2 ml) contains thiocolchicoside 4 mg;
Excipients: sodium chloride, diluted hydrochloric acid, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent solution of light yellow color.
Pharmacotherapeutic group
Muscle relaxants with a central mechanism of action. ATC code M03B X05.
Pharmacological properties
Pharmacodynamics
Muscomed contains the active ingredient thiocolchicoside, a semi-synthetic muscle relaxant derived from the natural glycoside colchicoside. It exhibits selective affinity for gamma-aminobutyric acid (GABA) and glycine receptors, which determines the action of the drug at different levels of the nervous system, both in local spasms and in spasms of central origin.
Muscomed does not have a curare-like effect, does not cause paralysis, and does not affect the cardiovascular and respiratory systems.
Pharmacokinetics
When administered intramuscularly, thiocolchicoside is rapidly distributed in the blood, peak plasma concentration is reached after 15-45 minutes. After a single intramuscular injection of 4 mg of thiocolchicoside, the maximum plasma concentration is 61 ng/ml.
Protein binding (mainly to albumin) is 13%. The mean apparent volume of distribution is 76 L after a single intramuscular injection of 4 mg.
The half-life is 2.5-5 hours. Approximately 20% of the dose is excreted in the urine as unchanged metabolites, 75-81% is excreted in the feces.
Indication
For additional short-term relief of painful muscle contractures.
Contraindication
– Hypersensitivity to the components of the drug;
– muscle hypotension;
– mild paralysis.
Interaction with other medicinal products and other types of interactions
There are no data on drug interactions. However, caution is recommended when taking it simultaneously with other muscle relaxants.
When used simultaneously with drugs that depress the central nervous system (CNS), including alcohol, antihypertensive drugs, and curare-like drugs, increased muscle relaxation and CNS depression, and the development of hypotension are possible.
When used simultaneously with anticoagulants, the risk of bleeding increases.
Application features
Muscomed should be used with caution in patients with impaired renal or hepatic function. The drug should be used with caution in patients with epilepsy or at risk of seizures.
Use during pregnancy or breastfeeding
Muscomed is contraindicated during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
Muscomed is administered intramuscularly in a dose of 2 ml (4 mg) 2 times a day. The recommended duration of treatment with the injectable form of the drug is 3-5 days. If necessary, continue treatment with oral forms of the drug for 5-7 days in a total daily dose of 16 mg of thiocolchicoside (8 mg 2 times a day).
When preparing for physiotherapy procedures, the muscle relaxation period is 30-40 minutes after intramuscular injection.
Children
The drug is contraindicated in children under 16 years of age.
Overdose
There are no data on overdose.
Symptoms: possible increase in adverse reactions.
Treatment: symptomatic, supportive therapy.
Adverse reactions
Rare: skin rash, edema, allergic and pseudoallergic reactions (allergic vasculitis), stomach pain, diarrhea.
Very rare: hypotension, irritability and drowsiness.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
2 ml of solution in a colorless glass ampoule; 6 ampoules in a contour blister pack; 1 blister pack in a cardboard box.
Vacation category
According to the recipe.
Producer
Mefar Ilach San. A.Sh., Turkey / Mefar Ilac San. AS, Turkey.
Location of the manufacturer and address of its place of business
Ramazanoglu Mach. Ansar Jad. No. 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey / Ramazanoglu Mah. Ensar Cad. No. 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey.
Applicant
WORLD MEDICINE ILAС SAN. VE TIC. AS, Turkey.
