OFFICIAL INSTRUCTIONS ON THE USE OF CLENBUTEROL SOPHARMA
(translated from Russian)
MINISTRY OF HEALTH AND
OF THE RUSSIAN FEDERATION
on the use of the drug
for medical use
Brand Name: Clenbuterol Sofarma.
International Nonproprietary Name:
Dosage form: tablets
Composition per 1 tablet:
Active substance: 0.02 mg Clenbuterol hydrochloride
Excipients: lactose monohydrate - 70.00 mg, wheat starch - 31.48 mg, microcrystalline cellulose - 48.50 mg, colloidal silicon dioxide - 2.00 mg, magnesium stearate - 2.00 mg, povidone (povidone K25) - 6.0 mg
Description: Round flat tablets with a chamfer and dividing risk on one side, white or almost white.
Bronchodilating agent - selective beta-2-adrenergic agonist
ATX Code [R03CC13]
Selective beta-2-adrenostimulator, has a bronchodilator and secretolytic effect. It excites β2-adrenergic receptors, stimulates adenylate cyclase, and increases the content of cyclic adenosine monophosphate (cAMP) in the cells. The latter has an effect on the protein kinase system, as a result of which myosin loses its ability to bind to actin and bronchodilation occurs. It inhibits the release of mediators from mast cells, which cause bronchospasm and inflammation of the bronchi.
Prevents bronchospasm caused by histamine, serotonin and acetylcholine. Reduces edema or congestion in the bronchi, improves mucociliary clearance. The secretolytic effect of the drug is associated with a decrease in the viscosity of sputum and facilitate its release. Causes the expansion of blood vessels in the brain and skeletal muscles. It has a tocolytic effect. Side effects are associated with its ability, albeit weakly, to cause excitation of β1 - adrenoreceptors of the heart, as a result of which a positive inotropic and chronotropic effect is manifested.
It has a slight anabolic effect, can increase body temperature.
The maximum effect of the drug is observed after 2-3 hours and lasts up to 6-8 hours.
Quickly and completely absorbed in the gastrointestinal tract. It is metabolized to a small extent in the liver, as a result of which 8 metabolites are formed that do not have pharmacological activity. Isolation from plasma passes in two phases. The half-life of the first phase is 1 hour, the second 34 hours. For the most part, it is excreted unchanged through the kidneys, with 87% of the dose taken excreted within 168 hours.
Indications for use:
Chronic obstructive pulmonary disease, bronchial obstructive syndrome, bronchial asthma.
Hypersensitivity to clenbuterol or to excipients of the drug, thyrotoxicosis, tachyarrhythmia; hypertrophic obstructive cardiomyopathy; myocardial infarction (acute phase), severe coronary heart disease, lactase deficiency, lactose intolerance, glucose-galactose malabsorption, children under 6 years of age, pregnancy (I and III trimester).
With caution: hyperthyroidism, a history of myocardial infarction, coronary heart disease, arterial hypertension, prostate hypertrophy, diabetes mellitus, II trimester of pregnancy.
Pregnancy and lactation
It is necessary to avoid prescribing the drug in the first 3 months of pregnancy due to a possible adverse effect on the development of the fetus. Its prescription is not recommended in the last months of pregnancy and during childbirth due to the presence of tocolytic effect of the drug and the possible suppression of uterine tone. Special clinical studies of the penetration of the drug into breast milk have not been conducted, and therefore its administration to lactating women is not recommended.
Dosage and administration
Adults: 0.02 mg (one tablet) 2 times a day (morning and evening). Supporting dose is 0.01 mg (1/2 tablet) 2 times a day. In more severe conditions, in the first days, 0.04 mg (two tablets) is prescribed 2 times a day (morning and evening). After improving the patient's condition, the dose of the drug must be reduced.
Children: from 6 to 12 years old - 0.01 mg (1/2 tablet) 2 times a day (morning and evening). For children over 12 years old - 0.01 mg (1/2 tablet) 2-3 times a day or 0.02 mg (1 tablet) 2 times a day (morning and evening).
On the part of the central nervous system - a sense of fear, mental disorders, hyperkinesis, sleep disturbance, headache, redness of the face, sweating, trembling and restlessness, dizziness, patients with Parkinson's disease may experience increased tremors and muscle rigidity.
On the part of the cardiovascular system - palpitations, tachycardia, decreased or (more often) increased blood pressure.
On the part of the urinary system - urinary retention associated with spasm of the renal vessels and sphincter of the bladder.
On the part of metabolism, hyperglycemia may appear as a result of stimulation of glycogenolysis in patients with diabetes mellitus. The appearance of this side effect requires a decrease in the dose of the drug without stopping treatment.
On the part of the digestive system - dry mouth, nausea.
Allergic reactions are possible: skin rash, urticaria.
Others - hypokalemia.
It is manifested by an increase in adverse reactions: arrhythmia, tachycardia, increased blood pressure, cardialgia, tremor of the extremities. There is a risk of hypokalemia after an overdose, therefore, it is necessary to monitor the serum concentration of potassium.
Treatment: gastric lavage, intake of activated charcoal, the use of water-salt solutions, symptomatic (including with caution with selective beta-blockers).
Interaction with other drugs
Beta-blockers due to antagonism with clenbuterol can reduce or eliminate its bronchodilating effect.
Reduces the effect of hypoglycemic drugs.
With simultaneous use with cardiac glycosides, monoamine oxidase inhibitors and theophylline, the risk of developing heart rhythm disorders increases.
Reduces the effectiveness of antihypertensive drugs.
The effect of the drug is potentiated by tricyclic antidepressants, beta - adrenergic agonists and anticholinergics.
In combination with sympathomimetic drugs, toxicity mutually increases.
Halotane and other halogenated hydrocarbon anesthetics, as well as cyclopropane, can potentiate the proarrhythmogenic effect of β2 -adrenomimetics, including clenbuterol.
When treating patients with diabetes mellitus, it is necessary to periodically monitor the level of glucose in the blood. The use of the drug can lead to an increase in body weight due to the presence of an anabolic effect, and when prescribed to athletes, the drug can cause a positive result during the doping control.
During treatment with the drug, the development of resistance and rebound syndrome is possible.
The composition of the preparation contains wheat starch. Wheat starch may contain gluten, but only in small quantities, and therefore is considered safe for people with celiac disease.
Due to the possibility of tremor, dizziness and weakness, during the period of treatment with the drug, it is necessary to refrain from performing potentially dangerous activities that require special attention and quick reactions (driving a car and other vehicles, working with moving mechanisms).
Tablets 0.02 mg.
10 tablets per blister of PVC film / aluminum foil.
5 blisters each along with instructions for use in a cardboard pack.
In a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children!
3 years. Do not use after expiration date.
Terms of sale
Name and address of manufacturer
Bulgaria, 1220 Sofia, st. Ilienskoe highway №16