Bula do remedy Cincordil

the package insert of the medicine Cincordil.

what For?

Prophylaxis of angina pectoris and as adjuvant therapy in congestive heart failure that does not respond adequately to the glycosides cardioativos and/or diuretics. Cincordil can reduce the frequency, duration, and severity of angina attacks; but is not indicated for the treatment of acute attacks of angina.

Contraindications

When should I not use?

Patients with hypersensitivity to nitrates and nitrites.

Dosage

How to use?

The recommended dosage of Cincordil is 20 to 120 mg daily in divided doses in 2 or 3 sockets. The majority of the patients require a dosage in the range of 40 to 60 mg per day. It is recommended initially 10 to 20 mg daily Cincordil for patients who never received therapy prophylactic prior with nitrates. Patients who were previous use of isosorbide dinitrate as a medication prophylactic, can directly receive the dosage usually therapy Cincordil. – Overdose: the symptoms of an overdose with nitrates are: fall immediate of the blood pressure, headache and persistent throbbing, vertigo, palpitation, visual disturbances, erythema, and sweating (then the skin becomes cold and cianótica), nausea and vomiting (possibly with colic and even diarrhea sangüinolenta), syncope (especially in upright position), where with cyanosis and anoxia, hiperpnéia initial, dyspnea and bradipnéia, slow pulse (dicrótico and intermittent), increased intracranial pressure with symptoms of confusion, fever, paralysis and coma followed by convulsions clonic and death possibly due to circulatory collapse. The dose of Cincordil that is associated to the signs and symptoms of an overdose or that threatens life is not known. We suggest the following treatment in an overdose: rapid removal of the material ingested by gastric lavage (in case of ingestion recent, and with the patient conscious). Keep the patient lying down on the shock position and comfortably warm. Movements in the liabilities of the ends can assist in venous return. If necessary, you should administer oxygen and carry out artificial respiration. On the occurrence of where to administer 1 to 2 mg/kg methylene blue 1% intravenously. The epinephrine is ineffective in reversing the events of hypotension severe associated with the overdose. Therefore, epinephrine and compounds related to it are counter-indicated in this situation. It is not known whether the drug is dialyzable.

Side Effects

What are the evils that can cause me?

With the use of the Cincordil can occur vasodilation skin with erythema. Headache vascular is common and can, eventually, become intense and persistent. The headache is usually relieved by use of analgesics or through the temporary reduction of the dosage. This symptom tends to disappear after the first two weeks of use of the medicine. Can occasionally occur episodes passengers of dizziness and weakness, as well as other signs of cerebral ischemia associated with postural hypotension. Some individuals may exhibit sensitivity sharp to the effects hipotensores of nitrates, even with the therapeutic dose the usual. Reactions intense nausea, vomiting, weakness, tiredness, pallor, sweating and collapse may occur. The alcohol can intensify this effect. Measures which facilitate venous return (for example, low head or the position of Trendelenberg, deep breathing, movement of extremities) usually reverse these symptoms. Skin rash and/or exfoliative dermatitis may occasionally occur. Nausea and vomiting are uncommon.

Warnings and Precautions

what should I know before using?

as Well as other vasodilators, Cincordil can cause side effects paradoxical in patients sensitive, with increased ischemia that may extend the injury to myocardial and cause failure congestive advanced. If the use of nitrates organic is indicated in myocardial recent, one must proceed to the hemodynamic monitoring and frequent clinical evaluations due to the potential deleterious effects of hypotension. Even with small doses of Cincordil can occur response hipotensora severe, particularly with the patient in the standing position. The hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina pectoris. The drug should be used with caution in patients who have reduction of the blood volume due to treatment with diuretics, or in patients with systolic blood pressure low (below 90 mmHg). In the treatment of heart failure, acute or chronic, pulmonary capillary pressure should not fall below 15 mmHg and the systolic blood pressure should not fall below the range of physiological in patients with normal blood pressure or hypertensive. The systolic pressure should be maintained in the range of 90-100 mmHg in patients with hypotension pre-existing. Orthostatic hypotension symptomatic severe has been reported when calcium channel blockers and nitrates, organic are used in combination. The dose adjustment of these drugs may be necessary. The treatment with Cincordil may aggravate the angina caused by hypertrophic cardiomyopathy. It is possible the occurrence of tolerance to the Cincordil and tolerance to cross with other nitrates and nitrites. The importance of tolerance with the use of this drug in the control of patients with angina pectoris has not yet been determined. Clinical studies in patients with angina report acute attacks of angina, and rebound in the hemodynamic effects, more easily provoked, after the suspension of the use of nitrates. Therefore, it seems prudent that the interruption of treatment with Cincordil be done slowly and gradual. Use during pregnancy: there are no studies adequate and well-controlled with Cincordil in pregnant women. Once their safety has not been established, Cincordil 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: the excretion of isosorbide mononitrate in breast milk has not been studied. Because many drugs are excreted by this route, the decision between stopping breastfeeding or treatment with Cincordil should be made taking into consideration the importance of the drug to the mother and the potential risk to the child. Paediatric use: the safety and effectiveness of Cincordil in children have not been established. Drug interactions: nitrates may cause hypotension as a result of peripheral vasodilatation. The alcohol can intensify this effect. Patients who are receiving treatment with Cincordil must be properly oriented in this respect. Patients who are receiving treatment with antihypertensive drugs, beta-adrenergic blockers or fenotiazínicos simultaneously with Cincordil should be carefully observed because of the possible effects hipotensores cumulative. Orthostatic hypotension symptomatic severe has been reported with the concomitant use of nitrates and organic calcium channel blockers. – Interactions with laboratory tests: nitrates and nitrites may interfere with the reaction Zlatis-Zak, causing false results in the dosage of serum cholesterol levels.