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the package insert of the medicine Rebaten La.

what For?

Treatment of hypertension. Can be used as drugs only or in combination with other agents anti-hypertensive drugs, particularly thiazide diuretic. Rebaten LA is not indicated in emergencies hypertensive. Angina pectoris due to coronary atherosclerosis: prolonged treatment of patients with angina pectoris. Migraine: the prophylaxis of common migraine. The effectiveness of Rebaten LA in the treatment of migraine attack that is already installed is not established, it is not indicated for such use. Stenosis subaórtica hypertrophic: it is useful in the treatment of stenosis subaórtica hypertrophic, especially in the treatment of angina of effort, angina, stress, palpitations, and syncope. Rebaten LA (hydrochloride propranolol) also increases the tolerance to physical exercise. The effectiveness of the hydrochloride of propranolol in this disease appears to be consequent to the blocking of beta-receptors adrenergic receptors, reducing the high pressure gradient of output flow, which is exacerbated due to the stimulus of continuous beta-adrenergic receivers. The clinical improvement may be temporary.


When should I not use?

cardiogenic Shock, sinus bradycardia, atrioventricular block greater than first degree, bronchial asthma, congestive heart failure, unless the failure is secondary to a taquiarritmia treatable with Rebaten LA.


How to use?

Rebaten LA contains hydrochloride propranolol in the form of extended-release capsules for administration in a single daily dose. Care must be taken to ensure the therapeutic efficacy desired in those patients who made use of propranolol tablets and are changing for Rebaten LA. The ratio of 1 mg to 1 mg should not be considered when the replacement of propranolol tablets for Rebaten LA. Rebaten LA features the pharmacokinetic different, producing serum levels lower. There may be a need for a reassessment of the dosage to ensure therapeutic efficacy, especially near the end of the period of 24 hours. Hypertension: the dose should be individualized. The initial dose usual is 80 mg of Rebaten IT 1 time a day, whether used alone or in conjunction with a diuretic. The dose can be increased gradually until it reaches the appropriate control of blood pressure. The standard maintenance is 120 mg to 160 mg, 1 time a day. In some cases, may be required higher doses to 640 mg per day. The time needed to obtain complete response to hypertension for a given dose administered is variable, and may extend from few days to several weeks. Angina pectoris: dosage must be individualized. Starting with 80 mg of Rebaten LA once daily, the dose should be gradually increased at intervals of 3 to 7 days, until a satisfactory response is obtained. Although patients may respond individually to any dose, the average dose satisfactory seems to be around 160 mg, 1 time a day. In angina pectoris, the security with dosages exceeding 320 mg per day is not established. In the event of interruption of treatment, should reduce the dose gradually over several weeks. Migraine: dosage must be individualized. The recommended oral dose is 80 mg of Rebaten IT 1 time a day, gradually increasing until you reach the effective dose for the prophylaxis of migraine. The dose usually effective is usually achieved with the 160 mg to 240 mg, 1 time a day. If it is not obtained a satisfactory response within 4 to 6 weeks after reaching the maximum dose, treatment should be discontinued. Stopping the drug should be done gradually, during a few weeks. Stenosis subaórtica hypertrophic: the recommended dose is 80 mg to 160 mg of Rebaten IT 1 time a day. Overdosage: Rebaten it is not significantly dialyzable. In case of overdose or exaggerated response, you must employ the following measures: general: if ingestion has been recent, emptying of the gastric contents, preventing pulmonary aspiration. Bradycardia: administer atropine (0.25 mg to 1.0 mg). If there is no response to the blocking vagal, administer isoproterenol cautiously. Cardiac failure: digitalization and diuretics. Hypotension: vasopressores as norepinephrine or epinephrine (evidence suggests epinephrine as the drug of choice). Bronchospasm: administer a beta-2 agonist and/or a derivative of theophylline.

Side Effects

What are the evils that can cause me?

Many of the adverse effects are transient and of mild intensity, and rarely require the discontinuation of treatment. Cardiovascular: bradycardia; congestive heart failure; intensification of atrioventricular block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the type raynaud’s. Central nervous system: sensation of emptiness in the head; mental depression manifested by insomnia, lassitude, weakness, fatigue, mental depression reversible progressing to catatonia; visual disturbances; hallucinations; vivid dreams, an acute reversible acute characterized by disorientation in time and space, temporary loss of memory, emotional lability, mild sensory disturbances, and psychomotor performance impaired. Formulations of immediate release, fatigue, lethargy, and vivid dreams appear to be dose-dependent. Gastrointestinal: nausea; vomiting; pain epigastric; pain abdominal; diarrhea; constipation; arterial thrombosis mesenteric artery; ischemic colitis. Allergic: pharyngitis and agranulocytosis; rash erythematosus; fever associated with the pain and inflammation of the throat; laringoespasmo; difficulty breathing. Respiratory: bronchospasm. Hematologic: agranulocytosis; purpura not trombocitopênica; thrombocytopenic purpura. Autoimmune: in extremely rare cases, systemic lupus erythematosus (SLE) has been reported. Other: in rare situations were reported alopecia, reactions similar to those of systemic lupus erythematosus, rash psoriasiformes, dry eyes, male impotence, and Peyronie’s disease.

Warnings and Precautions

what should I know before using?

General: Rebaten LA should be used with caution in patients with hepatic or renal. The blocking of beta-receptors adrenergic receptors can cause reduction of intraocular pressure. Patients should be advised that Rebaten IT can interfere with screening test for glaucoma. The interruption of the drug can lead to the increase of intra-ocular pressure. Heart failure: the stimulation of the sympathetic can be a vital component in helping the function circulation in patients with congestive heart failure, and its inhibition by blocking the beta-adrenergic receptor can precipitate a heart failure more intense. Although beta-adrenergic blockers should be avoided in congestive heart failure, if necessary, can be used with careful monitoring in patients with a history of heart failure is well compensated and are receiving digitalis and diuretics. The beta-adrenergic blockers do not cancel out the inotropic action of digitalis on the muscles of the heart. The continuous use of beta-adrenergic blockers in patients without a history of heart failure can, in some cases, lead to heart failure. Therefore, at the first sign or symptom of heart failure, the patient should be digitalized and/or treated with diuretics, and the response strictly observed, or the use should be discontinued (gradually, if possible). Angina pectoris: there have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt cessation of treatment with Rebaten LA. Therefore, when discontinuation of Rebaten IT is desired, the dosage should be gradually reduced during at least a few weeks, and the patient should be warned about the possible consequences of the interruption or the termination of the treatment without the medical knowledge. If the treatment with Rebaten LA is interrupted and exacerbation of angina, it is advised to restart the treatment with Rebaten LA and take other measures appropriate for the treatment of angina pectoris, unstable. Since coronary heart disease can be difcult to recognize in patients atherosclerotic who are being Rebaten LA for other indications, it is advisable to follow the recommendations above. Bronchospasm non allergic (chronic bronchitis, emphysema): in general, patients with disease broncoespástica should not receive beta-adrenergic blockers. If necessary, Rebaten LA should be administered with caution since it may block bronchodilation produced by the action of endogenous catecholamines and exogenous on the beta receptors. Major surgery: the necessity or the desire to interrupt treatment with beta-adrenergic blockers prior to major surgery is controversial. It should be noted, however, that the decreased response of heart to the reflexes stimulating adrenergic receptors can increase the risks of general anesthesia and surgical procedures. Rebaten LA, like other beta-adrenergic blockers, is an inhibitor competitive agonists of receptors beta-adrenergic receptors and its effects can be reversed by the administration of some agents, such as dobutamine or isoproterenol. However, some patients may be subject to hypotension severe prolonged. The difficulty in starting and maintaining the heartbeat has also been reported with beta-adrenergic blockers. Diabetes and hypoglycemia: beta-blockers, when required, should be used with cautela in diabetic patients. The beta-adrenergic blockers can mask the tachycardia consequent to hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. After the hypoglycemia induced by insulin Rebaten IT can delay the recovery of normal levels of blood glucose. Thyrotoxicosis: blocking the beta-adrenergic receptor may mask certain clinical signs of hyperthyroidism. Therefore, the abrupt termination of Rebaten LA can be followed by an exacerbation of symptoms of hyperthyroidism, including crisis tireotóxica. Rebaten IT can change thyroid function tests, increasing T4 and T3 reverse, and decreasing T3. Syndrome Wolff-Parkinson-White: it was observed in several patients with this syndrome, after the use of Rebaten LA, the tachycardia was replaced by a bradycardia intense, requiring a pacemaker of the demand. In one case, this occurred after an initial dose of 5 mg propranolol. Laboratory tests: elevation of serum levels of urea in patients with heart disease to severe elevation of serum aminotransferase, alkaline phosphatase and dehydrogenase milk. Use during pregnancy: there are no studies adequate and well controlled in pregnant women. Therefore, the safety of the use of Rebaten LA during pregnancy is not established. Rebaten LA should not be used during pregnancy unless the expected benefits to the patient outweigh the potential risks to the fetus, according to medical criterion. Use during lactation: Rebaten LA is excreted in breast milk. Therefore, it should be used with caution in women who are breastfeeding. Use in pediatrics: safety and effectiveness of Rebaten LA in children are not established. – Drug interactions: patients receiving drugs depletoras of catecholamines such as reserpine, should be closely observed if they have Rebaten LA. The action blocking additional catecholamines can lead to a reduction in excessive sympathetic nerve activity, which may result in hypotension, bradycardia, severe, vertigo, attacks of syncope, or orthostatic hypotension. Be careful when the administration of drugs blocking calcium channels in patients who are receiving beta-blockers, especially verapamil intravenous, since both drugs may depress myocardial contractility or atrioventricular conduction. The gel of aluminum hydroxide significantly reduces the intestinal absorption of Rebaten LA. The ethyl alcohol reduces the absorption of Rebaten LA. Phenytoin, phenobarbitone and rifampin accelerate clearance of Rebaten LA. Chlorpromazine, when used concomitantly with Rebaten LA results in an increase of the serum level of both drugs. The antipirina and lidocaine have reduced clearance when used concomitantly with Rebaten LA. Concomitant administration of thyroxine and Rebaten IT can result in concentration of T3 lower than expected. The cimetidine decreases the hepatic metabolism of Rebaten LA, slowing their elimination and increasing blood levels of the drug. The clearance of theophylline is reduced when used concomitantly with Rebaten LA. Moderation of the effect of anti-hypertensive agents beta-blockers has been reported with the use of anti-inflammatory drugs non-hormonal. The occurrence of hypotension and cardiac arrest has been reported with the use of propranolol and haloperidol.