Miorix capsules with prolonged release 30 mg. №14

Description

Miorix composition
active substance: cyclobenzaprine hydrochloride;
1 capsule contains 30 mg of cyclobenzaprine hydrochloride;
excipients: spherical sugar, oradry clear YS-1-7006, ethylcellulose, diethyl phthalate.

Dosage form
Prolonged-release capsules are hard.

Pharmacological properties
Cyclobenzaprine relieves skeletal muscle spasm of local origin without affecting muscle function. Cyclobenzaprine acts on the central nervous system primarily at the level of the brainstem rather than at the level of the spinal cord, although additional effects on the latter may contribute to the overall ability of cyclobenzaprine to cause skeletal muscle relaxation. Experience shows that cyclobenzaprine results in a decrease in tonic somatic motor activity due to the effect on both gamma (γ) and alpha (α) motoneurons. Preclinical pharmacological studies have demonstrated similarities between the effects of cyclobenzaprine and structurally related tricyclic antidepressants, including reserpine antagonism, potentiation of norepinephrine, strong peripheral and central anticholinergic effects, and sedation.

Indication
Elimination of muscle spasm accompanied by acute pain from the musculoskeletal system, as a supplement to the regime of limited physical activity and physical therapy. The improvement is manifested by the elimination of muscle spasms and related signs and symptoms, namely: pain, hypersensitivity and limited movement.

Contraindication
Hypersensitivity reactions to any component of the drug, including anaphylactic reactions, urticaria, swelling of the face and / or tongue, itching. If hypersensitivity reactions are suspected, Miorix® should be discontinued.
Concomitant use with monoamine oxidase inhibitors (MAOIs) or for 14 days after discontinuation. Hyperpyretic crises, convulsions, and death have been reported in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors.
During the recovery phase after acute myocardial infarction and in the presence of cardiac arrhythmias and conduction, including blockade, or congestive heart failure.
Hyperthyroidism.

Children
There are no clinical data on the efficacy and safety of the drug in children, so Miorix is ​​not recommended for use in pediatric practice.

Use during pregnancy or breastfeeding
Pregnancy. Adequate and well-controlled studies of Miorix in pregnant women have not been performed. The drug can be used during pregnancy only in case of urgent need.
Breast-feeding. There are no data on the excretion of the drug in human breast milk. Because cyclobenzaprine is close to tricyclic antidepressants, some of which are known to be excreted in human breast milk, caution should be exercised when breast-feeding.

Method of application and dosage
The recommended dose for adults is 15 mg once a day. Some patients require an increase in dose to 30 mg once daily.
Miorix is ​​taken at about the same time each day.
The use of the drug for more than 2-3 weeks is not recommended.

Overdose
Symptoms. The most common symptoms of cyclobenzaprine overdose are drowsiness and tachycardia. Less common manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations. Rare but potentially critical manifestations of overdose include: cardiac arrest, chest pain, cardiac arrhythmia, severe hypotension, convulsions and neuroleptic malignant syndrome. ECG abnormalities, especially changes in the height or width of the QRS complex, are clinically significant indicators of cyclobenzaprine overdose.
Treatment. General. To prevent the rare but potentially critical manifestations described above, an ECG should be performed and cardiac monitoring should be started immediately. It is also necessary to protect the patient’s airways, provide intravenous access and begin decontamination of the stomach. Monitoring is also required to detect signs of CNS depression or respiration, hypotension, cardiac arrhythmia and / or blockage of cardiac conduction, seizures. If signs of poisoning occur at any time during this period, extensive monitoring will be required. Monitoring the level of the drug in the blood should not affect the patient’s management. Dialysis is probably ineffective due to low plasma concentrations of the drug.

Side effects:

• General disorders: fainting, malaise, chest pain, edema.
• From the cardiovascular system: tachycardia, arrhythmia, vasodilation, palpitations, hypotension, hypertension, myocardial infarction, blockade of cardiac conduction, stroke.
• From the digestive system: vomiting, anorexia, diarrhea, abdominal pain, gastritis, thirst, flatulence, edema of the tongue, liver dysfunction and rare cases of hepatitis, jaundice and cholestasis, paralytic intestinal obstruction, discoloration of the tongue, stomatitis, edema of the parotid gland .
• From the endocrine system: syndrome of inadequate secretion of antidiuretic hormone (ADH).
• From the blood and lymphatic system: purpura, bone marrow suppression, leukopenia, eosinophilia, thrombocytopenia.
• Hypersensitivity reactions: anaphylactic shock, angioneurotic edema, pruritus, facial edema, urticaria, rash.
• Metabolic, nutritional and immune disorders: increase or decrease in blood sugar, increase or loss of body weight.
• From the musculoskeletal system and connective tissue: local muscle weakness, myalgia.
• From the nervous system and psyche: seizures, ataxia, vertigo, dysarthria, tremor, hypertension, convulsions, muscle twitching, disorientation, insomnia, depressed mood, unusual sensations, anxiety, agitation, psychosis, abnormal thoughts and dreams, hallucinations , agitation, paresthesia, diplopia, serotonin syndrome, malignant neuroleptic syndrome, decreased or increased libido, gait disturbances, delirium, aggressive behavior, paranoia, peripheral neuropathy, Bell’s palsy, changes in electroencephalography (EEG), extrapyramidal symptoms.
• From the respiratory system: shortness of breath.
• From the skin and subcutaneous tissues: sweating, photosensitization, alopecia.
• From the senses: ageusia, tinnitus.
• From the kidneys and urinary tract: increase and / or decrease in the frequency of urination, urinary incontinence, dilatation of the urinary tract, impotence, testicular edema, gynecomastia, breast enlargement, galactorrhea.

Expiration date
4 years.

Storage conditions
Store Miorix at a temperature not exceeding 25 ° C. Keep out of reach of children.