Itravil AP Clobenzorex 60 mg 30 caps Extended release

THERAPEUTIC INDICATIONS

Anorectics. Indicated for the treatment of people with a body mass index (BMI) less than or greater than 30 kg / m2 and who have not responded to a diet. Especially for those patients with diabetes, heart disease and hypertension.

CLINICAL PHARMACOLOGY

The clobenzorex, after oral administration is well absorbed from the gastrointestinal tract, reaches its maximum concentration (Cmax) of one to one and a half after its administration and its concentration varies from 8 to 47 ng / ml. It is excreted in the urine, being one of the main metabolites amphetamine (15% of the administered dose) and p-hidroxiclobenzorex (1.5 to 6% of the administered dose).The clobenzorex is a sympathomimetic amine with pharmacological activity similar to that of other drugs used to treat obesity. It acts on the ventrolateral nucleus of the hypothalamus, increasing the release of norepinephrine and dopamine, and decreases its recapture in presynaptic nerve endings, above, has the effect of increasing concentrations of norepinephrine. Norepinephrine decreases appetite, activating the receptor to-4 And ß1 in the hypothalamic nuclei.

CONTRAINDICATIONS

Not be given to patients hypersensitive to the components of the formula.Not be given to elderly people or children under 12 years.Not be given to patients with:– Pulmonary arterial hypertension or severe.– Psychiatric disorders, including anorexia nervosa and depression.– Advanced arteriosclerosis.– Hyperthyroidism.– Prostatic hypertrophy or obstructive disease of the urinary tract.– Antidepressants or monoamine oxidase inhibitors (MAOIs).– History of cardiovascular or cerebrovascular disease.– Background or who are prone to drug and / or alcohol.

GENERAL PRECAUTIONS

Patients on a regimen of MAOIs must stay at least 15 days before drug administration to start treatment with clobenzorex, because it may cause hypertensive crisis. Clobenzorex should not be administered in partnership with other centrally acting anorectic agent, increasing the risk of causing pulmonary hypertension and the consequences can be deadly. The prescribing physician before clobenzorex should exclude secondary organic causes of obesity. During therapy is recommended include dietary, medical and psychotherapeutic. Do not stop treatment abruptly, unless because of an adverse reaction so warrant. Medication administration at night can cause nervousness and insomnia.

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION

It should not be used during pregnancy or lactation.

ADVERSE REACTIONS

Have been reported cases of pulmonary arterial hypertension, severe disease with life threatening risks. One symptom is: the occurrence or aggravation of exertional dyspnea in this case should be discontinued treatment immediately.

Central nervous system: Clobenzorex Prolonged use may develop drug tolerance, dependence and withdrawal. The most common adverse reactions are: psychotic reactions, or psychosis, depression, nervousness, agitation, sleep disturbances and dizziness. Seizures have occasionally been reported, headache.

Cardiovascular effects: Most often include tachycardia, palpitations, hypertension and chest pain. Have been rarely reported cardiovascular or cerebrovascular accidents, particularly stroke, angina, myocardial infarction, heart failure and cardiac arrest in patients treated with anorectic agents.

Gastrointestinal effects: Dry mouth and constipation.

Effect on Urinary Tract Dysuria, urinary retention.

DRUG INTERACTIONS AND OTHER GENDER

Clobenzorex not be administered concomitantly with:– Antidepressants or MAO inhibitors (MAOIs).– Guanethidine or its derivatives, since both share the same active site of action. Guanethidine and its derivatives could be displaced by deleting its antihypertensive effect.– Phenylethylamine derivatives, appetite suppressants, and tricyclic antidepressants may potentiate the effects of the latter.– Sympathomimetic agents and general anesthetics, can cause arrhythmias.It should be administered 14 days after stopping treatment with an MAOI, because it may cause hypertensive crisis.

Please consult your personal physician before taking any medication.