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Carvid

Carvid Special Precautions

carvedilol

Manufacturer:

Therapharma

Distributor:

Therapharma
Full Prescribing Info
Special Precautions
Cessation of Carvedilol Therapy: Advise patients with coronary artery disease against abrupt discontinuation of therapy. Severe exacerbation of angina and occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients after the abrupt discontinuation of beta-blocker therapy. When discontinuation of carvedilol is planned, carefully observe patient and advise to limit physical activity to a minimum. Carvedilol should be discontinued over 1 to 2 weeks whenever possible. If angina worsens or acute coronary insufficiency develops, carvedilol should be promptly reinstituted, at least temporarily. It may be prudent not to discontinue carvedilol abruptly even in patients treated only for hypertension or heart failure since coronary artery disease is common and may be unrecognized.
Bradycardia: Carvedilol may cause bradycardia. Reduce carvedilol dose if pulse rate drops below 55 beats per minute.
Hypotension: Starting with a low dose, administration with food, and gradual up-titration should decrease the possibility of syncope or excessive hypotension. During initiation of carvedilol treatment, advise the patient to avoid situations such as driving or hazardous tasks, where injury could result should syncope occur.
Heart Failure/Fluid Retention: Worsening heart failure or fluid retention may occur during up-titration of carvedilol patients with heart failure. If such symptoms occur, diuretics should be increased and carvedilol dose should not be advanced until clinical stabilization occurs. Occasionally, decreasing carvedilol dose may be necessary or, in rare cases, temporarily discontinue carvedilol. Such episodes do not preclude subsequent successful carvedilol titration. Carvedilol should be used with caution in combination with digitalis glycosides, as both medicines slow AV conduction.
Non-allergic Bronchospasm: In general, patients with bronchospastic disease (e.g., chronic bronchitis and emphysema) should not receive beta-blockers. However, carvedilol should be used with caution in patients who do not respond to, or cannot tolerate, other antihypertensives. If carvedilol is used, it is prudent to use the lowest effective dose, so that inhibition of endogenous or exogenous beta-agonists is minimized.
Diabetes and Hypoglycemia: Beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective beta-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities and carvedilol should be used with caution. In congestive heart failure patients, there is a risk of worsening hyperglycemia which responds to intensification of hypoglycemic therapy. Blood glucose should be monitored when carvedilol dosing is started, adjusted, or discontinued.
Peripheral Vascular Disease: Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Exercise caution in such individuals.
Renal Function Deterioration: Rarely, reversible deterioration of renal function has been observed with carvedilol in patients with heart failure. Patients at risk are those with low blood pressure (systolic blood pressure <100 mmHg), ischemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency. Monitor renal function during up-titration of carvedilol and discontinue the drug or decrease dosage if worsening of renal function occurs.
Hepatic Injury: Reversible hepatic injury has occurred after short- and long-term therapy with minimal clinical symptomatology. No deaths due to liver function abnormalities have been reported. At the first symptom/sign of liver dysfunction, perform laboratory testing. If the patient has laboratory evidence of liver injury or jaundice, carvedilol should be stopped and not restarted.
Anesthesia and Major Surgery: If carvedilol treatment is to be continued perioperatively, particular care should be taken when anesthetic agents which depress myocardial function, such as ether, cyclopropane and trichloroethylene, are used.
Thyrotoxicosis: Beta-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm.
Pheochromocytoma: An alpha-blocker should be initiated prior to the use of any beta-blockers in patients with pheochromocytoma. There has been no experience with the use of carvedilol in this condition even if carvedilol has both alpha- and beta-blocking pharmacologic effects. Carvedilol should be used with caution in patients suspected of having pheochromocytoma.
Prinzmetal's Variant Angina: Agents with non-selective beta-blocking activity may provoke chest pain in patients with Prinzmetal's variant angina. In these patients, there is no clinical experience with carvedilol although the alpha-blocking activity of carvedilol may prevent such symptoms. Carvedilol should be used with caution in patients suspected of having Prinzmetal's variant angina.
Risk of Anaphylactic Reaction: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Raynaud's Phenomenon: Use with caution in patients suffering from peripheral circulatory disorders (e.g., Raynaud's phenomenon) as there may be exacerbation of symptoms.
Psoriasis: Patients with a history of psoriasis associated with beta-blocker therapy should take carvedilol only after consideration of the risk-benefit ratio.
Contact lenses: Wearers of contact lenses should bear in mind the possibility of decreased lacrimation.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: The safety and efficacy of carvedilol in patients below 18 years old have not been established.
Use in the Elderly: There were no notable differences in efficacy or the incidence of adverse events between older and younger patients.
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