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Mavilex

 

COMPOSITION

Each tablet contains Clenbuterol HCI 0.02 mg.


DESCRIPTION

MAVILEX TABLET is an oval, scored tablet, white in colour with markings 'DUO' and '861'.

ACTIONS AND MODE OR MECHANISMS OF ACTIONS

It is a broncholytic agent which acts through selective stimulation of the β2-receptors. It differs from other β2-specific sympathomimetics by its low dose, long biological half-life and rapid and complete absorption by oral administration. It has no significant effects on β1-cardiac receptors.

PHARMACOLOGY

Pharmacokinetics: Invasion half-life of Clenbuterol is 1 hour the distribution corresponds to an open two compartment model with a side-compartment. Elimination from plasma takes place in 2 phases, the half-life of the a-phase being 1 hour and that of β-phase 34 hours. Elimination is primarily renal (87% after 168 hours) 43% of Clenbuterol is recovered unchanged in the urine. Dose intervals of 12 hours suffice to maintain a plasma level. Five metabolites have been found in humans.

INDICATIONS

Prophylaxis and therapy of bronchospasm in bronchial asthma, acute and chronic bronchitis associated with emphysema.

CONTRAINDICATIONS

Thyrotoxicosis, idiopathic hypertrophic subvalvular aortic stenosis, tachycardia, tachyarrhythmia. Known sensitivity to sympathomimetic amines.

SIDE EFFECTS/ADVERSE REACTIONS

Side effects rarely occur at the recommended doses. Some patients could have, at the beginning of the treatment, tremor, nervousness, extrasystoles, tachycardia, palpitations, vertigo, anxiety, headache and nausea. In these cases the dose should be reduced.

PRECAUTIONS/WARNINGS

Warnings: Although animal studies have shown no teratogenic effect, Mavilex should not be given during the first three months of pregnancy.

Precautions: Care must be exercised when additional sympathomimetic agents or IMAO drugs are administered. Mavilex should be used with caution in patients with hypertension, coronary heart disease, hyperthyroidism and diabetes. Caution should be used when treating patients with recent cardiac infarction.

INTERACTIONS

Beta-blockers and Mavilex counteract the action of each other.

Clenbuterol is a direct-acting sympathomimetic agent with general properties similar to those of Salbutamol. Theophylline may increase the risk of hypokalaemia if given with high doses of Clenbuterol.

RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF ADMINISTRATION

The recommended total daily dose for adults and children over 12 years is 0.04 mg/day. In severe bronchospasm the dose may be increased to 0.08 mg/day twice daily; as therapy continues, the dose may often be reduced to 0.02 mg/day. The recommended total daily dose for children is 0.0012 mg/kg body weight, ranging from 0.0008 - 0.0015 mg Mavilex.

Tablet: Adults and children over 12 years: 0.02 mg twice daily.
Twice daily doses morning and evening provide for constant blood levels. The duration of treatment depends upon the symptoms and there is no objection to long-term treatment.

SYMPTOMS AND TREATMENT FOR OVERDOSE AND ANTIDOTES

Overdosage may cause restlessness, anxiety, flushing, tachycardia, pronounced tremor or rise in blood pressure. With tremor, enzymes specific to muscle cells increase in the serum. A dose of 0.6 mg Clenbuterol was tolerated without complications after a β-blocker was given approximately 90 minutes after administration.

Treatment: Symptoms disappear immediately upon administration of β-blocker. Treatment of overdosage should be cumulative at short interval, depending upon the clinical picture. It should be noted that the action of Clenbuterol can extend beyond that of the antagonist, so that it may be necessary to repeat the administration of β-blocker.

PACKING/PACK SIZES
In strips of 100's, 250's, 500's and 1000's.
In securitainers of 100, 250, 500 and 1000 tablets

STORAGE

Store below 25C. Protect from light.

Shelf life 3 years. Keep out of reach of children.

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