These highlights do not include all the information needed to use KAPSPARGO safely and effectively. See full prescribing information for KAPSPARGO.
KAPSPARGO TM Sprinkle (metoprolol succinate) capsules, extended-release, for Oral Use
Initial U.S. Approval: 1992
INDICATIONS AND USAGE
KAPSPARGO Sprinkle is a beta1-selective adrenoceptor blocking agent indicated for the treatment of: (1)
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Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)
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Angina Pectoris. (1.2)
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Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. (1.3)
DOSAGE AND ADMINISTRATION
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Adult Hypertension: Usual initial dosage is 25 to 100 mg once daily. Titrate weekly (or longer) to optimal blood pressure. (2.1)
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Pediatric Hypertension 6 years of age and older: The recommended starting dose is 1 mg/kg, once daily and titrate to response. Do not exceed a maximum initial dose of 50 mg once daily. (2.1)
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Angina Pectoris: Usual initial dosage is 100 mg once daily. Titrate weekly based on clinical response. (2.2)
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Heart Failure: The recommended starting dose is 25 mg once daily doubled every two weeks to the highest dose tolerated or up to 200 mg. (2.3)
DOSAGE FORMS AND STRENGTHS
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KAPSPARGO extended-release capsules: 25 mg, 50 mg, 100 mg and 200 mg. (3)
CONTRAINDICATIONS
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Known hypersensitivity to product components. (4)
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Severe bradycardia, greater than first degree heart block, or sick sinus syndrome without a pacemaker. (4)
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Cardiogenic shock or decompensated heart failure. (4)
WARNINGS AND PRECAUTIONS
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Abrupt cessation may exacerbate myocardial ischemia. (5.1)
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Worsening cardiac failure may occur. (5.2)
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Bronchospastic Disease: Avoid beta blockers. (5.3)
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Pheochromocytoma: First initiate therapy with an alpha blocker. (5.4)
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Avoid initiation of high-dose extended-release metoprolol and do not routinely withdraw chronic beta blocker therapy prior to surgery. (5.5, 6.1)
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May mask tachycardia occurring with hypoglycemia. (5.6)
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Abrupt withdrawal in thyrotoxicosis might precipitate a thyroid storm. (5.7)
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May aggravate symptoms of arterial insufficiency. (5.8)
ADVERSE REACTIONS
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Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. (7.1)
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Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. (7.2)
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CYP2D6 Inhibitors are likely to increase metoprolol concentration. (7.3)
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Concomitant use of glycosides, clonidine, and diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. (7.4)
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Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. (7.4)
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Alcohol interferes with the extended release properties of this product. (7.5)
USE IN SPECIFIC POPULATIONS
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Hepatic Impairment: Consider initiating metoprolol succinate therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events. (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2018