KAPSPARGO 25 mg/1

Metoprolol Succinate · CAPSULE, EXTENDED RELEASE · Sun Pharmaceutical Industries, Inc.

No Recall HistoryCurrently in Shortage

Plain English

KAPSPARGO is a capsule, extended release containing metoprolol succinate at 25 mg/1, taken oral. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name: KAPSPARGO
Generic Name: Metoprolol Succinate
NDC Code (Product): 10631-008
Manufacturer: Sun Pharmaceutical Industries, Inc.
Strength: 25 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA210428
Marketing Start: 03/15/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue4,642 reports

diarrhoea3,783 reports

dyspnoea3,620 reports

nausea3,598 reports

dizziness2,987 reports

off label use2,923 reports

drug ineffective2,883 reports

headache2,703 reports

death2,521 reports

asthenia2,319 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE KAPSPARGO Sprinkle is a beta 1 -adrenergic blocker indicated for the treatment of: • 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) • Angina Pectoris. (1.2) • Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalizations in patients with heart failure. (1.3) 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 pu…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Adult Hypertension: Usual initial dosage is 25 to 100 mg once daily. Titrate weekly (or longer) to optimal blood pressure. (2.1) • 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) • Angina Pectoris: Usual initial dosage is 100 mg once daily. Titrate weekly based on clinical response. (2.2) • 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) 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 …

Contraindications

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. • Known hypersensitivity to product components. (4) • Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker. (4) • Cardiogenic shock or decompensated heart failure. (4)

Drug Interactions

7 DRUG INTERACTIONS • Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. (7.1) • CYP2D6 Inhibitors are likely to increase metoprolol concentration. (7.2) • Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. (7.3) 7.1 Catecholamine Depleting Drugs Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe patients treated with metoprolol succinate plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. 7.2 CYP2D6 Inhibitors Drugs that are strong inhibitors of CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these too are likely to increase metoprolol concentration. Increases in plasma concentration decrease the cardioselectivity of metoprolol [see Clinical Pharmacology (12.3)]. Monitor patients closely, when the combination cannot be avoided. 7.3 Digitalis, Clo…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions (5)] Worsening heart failure [see Warnings and Precautions (5)] Worsening AV block [see Contraindications (4)] • 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension and Angina: Most adverse reactions have been mild and transient. The most common (> 2%) adverse reactions are tiredness, dizziness, dep…

Frequently Asked Questions

What is KAPSPARGO used for?

KAPSPARGO contains Metoprolol Succinate. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is KAPSPARGO a controlled substance?

KAPSPARGO is not classified as a controlled substance by the DEA.

What is the generic name for KAPSPARGO?

The generic name for KAPSPARGO is Metoprolol Succinate. There are 12 other brand versions of Metoprolol Succinate.

What is the NDC code for KAPSPARGO 25 mg/1?

The NDC (National Drug Code) for KAPSPARGO 25 mg/1 is 10631-008, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

10631-008

Package NDC

10631-008-30

Other Metoprolol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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