INDICATIONS AND USAGE
KAPSPARGO™ SPRINKLE extended-release capsules are beta1-selective adrenoceptor blocking agent indicated for the treatment of:
- Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and myocardial infarction
- Angina pectoris. Long-term treatment to reduce angina attacks and to improve exercise tolerance
- Heart failure, to reduce the risk of cardiovascular mortality and hospitalization in patients with heart failure
IMPORTANT SAFETY INFORMATION
KAPSPARGO Sprinkle is contraindicated in patients with:
- Known hypersensitivity to the product components
- Severe bradycardia, greater than first-degree heart block, or sick sinus syndrome without a pacemaker
- Cardiogenic shock or decompensated heart failure
Warnings and Precautions
- Abrupt Cessation of Therapy: Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol succinate, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly reinstate metoprolol succinate, and take measures appropriate for the management of unstable angina. Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing metoprolol succinate in patients treated only for hypertension.
- Heart Failure: Worsening cardiac failure may occur during up-titration of metoprolol succinate. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol succinate.
- Bronchospastic Disease: PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because beta1-selectivity is not absolute, use the lowest possible dose of metoprolol succinate. Bronchodilators, including beta2-agonists, should be readily available or administered concomitantly.
- Pheochromocytoma: If metoprolol succinate is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.
- Major Surgery: Avoid initiation of a high-dose regimen of extended-release metoprolol in patients undergoing noncardiac surgery, since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke, and death. Do not routinely withdraw chronic beta-blocker therapy prior to surgery.
- Masked Symptoms of Hypoglycemia: Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.
- Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may precipitate a thyroid storm.
- Peripheral Vascular Disease: Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
In clinical trials, most common adverse reactions were tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, and rash.
- Catecholamine-Depleting Drugs may have an additive effect when given with beta-blocking agents. Observe patients treated with metoprolol succinate plus a catecholamine depleter for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.
- Epinephrine: Patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive and may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
- CYP2D6 Inhibitors: Drugs that are strong inhibitors of CYP2D6, such as quinidine, fluoxetine, paroxetine, and propafenone, were shown to double metoprolol concentrations.
- Digitalis, Clonidine, and Calcium Channel Blockers: Concomitant use of glycosides, clonidine, diltiazem, and verapamil with beta-blockers can increase the risk of bradycardia. Beta-blockers including metoprolol may exacerbate the rebound hypertension that can follow the withdrawal of clonidine.
- Alcohol: Metoprolol succinate is released faster from KAPSPARGO Sprinkle in the presence of alcohol. Avoid alcohol consumption when taking KAPSPARGO Sprinkle.
Use in Specific Populations
- Hepatic Impairment: Consider initiating therapy with metoprolol at low doses, and gradually increase dosage to optimize therapy while monitoring closely for adverse events.
Reference: 1. Kapspargo Sprinkle [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; May 2018.