KAPSPARGO

KAPSPARGO- metoprolol succinate capsule, extended release
Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE

1.1 Hypertension

KAPSPARGO Sprinkle is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

KAPSPARGO Sprinkle may be administered with other antihypertensive agents.

1.2 Angina Pectoris

KAPSPARGO Sprinkle is indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.

1.3 Heart Failure

KAPSPARGO Sprinkle is indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure.

2 DOSAGE AND ADMINISTRATION

2.1 Hypertension

Adults: The usual initial dosage is 25 mg to 100 mg once daily in a single dose. Adjust dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. Dosages above 400 mg per day have not been studied.

Pediatric Hypertensive Patients 6 Years of age or older: The recommended starting dose of KAPSPARGO Sprinkle is 1 mg/kg once daily, the maximum initial dose should not exceed 50 mg once daily. Adjust dosage according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].

KAPSPARGO Sprinkle has not been studied in pediatric patients less than 6 years of age [see Use in Specific Populations (8.4)].

2.2 Angina Pectoris

Individualize the dosage of KAPSPARGO Sprinkle. The usual initial dosage is 100 mg once daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 to 2 weeks [see Warnings and Precautions (5)].

2.3 Heart Failure

Prior to initiation of KAPSPARGO Sprinkle, stabilize the dose of other heart failure drug therapy and ensure that the patient is not fluid overloaded. The recommended starting dose of KAPSPARGO Sprinkle is 25 mg once daily for two weeks. KAPSPARGO Sprinkle is not suitable for initial therapy in patients who are expected to require a starting dose less than 25 mg daily. Dosage must be individualized and closely monitored during up-titration. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of KAPSPARGO Sprinkle. If a patient experiences symptomatic bradycardia, reduce the dose of KAPSPARGO Sprinkle. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of KAPSPARGO Sprinkle or temporarily discontinuing it. The dose of KAPSPARGO Sprinkle should not be increased until symptoms of worsening heart failure have been stabilized. Initial difficulty with titration should not preclude later attempts to introduce KAPSPARGO Sprinkle.

For patients who are taking metoprolol succinate extended-release tablets at a dose of 25 mg to 200 mg once daily, substitute KAPSPARGO Sprinkle for metoprolol succinate extended-release tablets, using the same total daily dose of metoprolol succinate.

2.4 Administration

KAPSPARGO Sprinkle should be swallowed whole. For patients unable to swallow an intact capsule, alternative administration options are available. Directions for use with soft food (applesauce, pudding, or yogurt) For patients with swallowing difficulty, KAPSPARGO Sprinkle can be opened and contents can be sprinkled over soft food. The contents of the capsules should be swallowed along with a small amount (teaspoonful) of soft food (such as applesauce, pudding, or yogurt). The drug/food mixture should be swallowed within 60 minutes and not stored for future use. Nasogastric tube administration Open and add contents of capsule to an all plastic oral tip syringe and add 15 mL of water. Gently shake the syringe for approximately 10 seconds. Promptly deliver through a 12 French or larger nasogastric tube. Ensure no pellets are left in the syringe. Rinse with additional water if needed.

3 DOSAGE FORMS AND STRENGTHS

25 mg capsule: Light yellow opaque cap and white opaque body both imprinted with ‘RL14 ‘ in black ink containing white to off-white pellets.

50 mg capsule: Dark yellow opaque cap and white opaque body both imprinted with ‘RL15 ‘ in black ink containing white to off-white pellets.

100 mg capsule: White opaque cap and white opaque body both imprinted with ‘RL16 ‘ in black ink containing white to off-white pellets.

200 mg capsule: Yellow opaque cap and yellow opaque body both imprinted with ‘RL17′ in black ink containing white to off-white pellets.

4 CONTRAINDICATIONS

Metoprolol succinate is contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.

5 WARNINGS AND PRECAUTIONS

5.1 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.

5.2 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 [see Dosage and Administration (2)]. It may be necessary to lower the dose of metoprolol succinate or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of metoprolol succinate.