Novel sprinkle formulation for treatment of high blood pressure launched

Kapspargo Sprinkle, a U.S. Food and Drug Administration (FDA) approved, novel, patented formulation of metoprolol succinate, has been launched by Sun Pharma for the treatment of angina pectoris, hypertension, and to reduce the risk of cardiovascular mortality and heart failure hospitalization in patients with heart failure.

The formulation is the first and only extended-release sprinkle formulation of metoprolol succinate, a beta₁-selective (cardioselective) adrenoreceptor blocking agent. It can be sprinkled over soft food (such as applesauce, yogurt or pudding) or administered via a nasogastric tube, and are designed to facilitate long-term, once-daily administration, particularly for patients who have difficulty swallowing. Each pellet serves as a separate drug delivery unit that provides metoprolol continuously over the dosage interval.

“Roughly 40% of patients requiring long-term care have difficulty swallowing, a problem that may result in patient non-adherence to medications as well as medication errors,” Abhay Gandhi, CEO-North America, Sun Pharma, said in the company's press release “Kapspargo Sprinkle capsules may make it easier for patients to take their antihypertensive medication. This innovative product is the latest example of Sun Pharma’s use of advanced technology to create novel formulations of proven medications.”

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About Kapspargo Sprinkle

Kapspargo Sprinkle is a novel formulation of metoprolol succinate, a beta1-selective (cardioselective) adrenoreceptor blocking agent, for oral administration. It is available as extended-release capsules that comprise multiple unit systems containing metoprolol succinate in a multitude of controlled-release pellets. Each pellet acts as a separate drug delivery unit that is designed to deliver metoprolol continuously over the dosage interval. The extended-release capsules are available in dosage strengths of 25 mg, 50 mg, 100 mg and 200 mg.

It 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.

In clinical trials, most common adverse reactions were tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, and rash.

Indications

Kapspargo Sprinkle extended-release capsules are beta1-selective adrenoceptor blocking agent indicated for the treatment of:

• Angina pectoris. Long-term treatment to reduce angina attacks and to improve exercise tolerance.


• Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and myocardial infarction.


• Heart failure, to reduce the risk of cardiovascular mortality and hospitalization in patients with heart failure.

Instructions for its Administration

Kapspargo Sprinkle is to be administered once-daily in a single dose for all approved indications. For patients with swallowing difficulty, Kapspargo Sprinkle can be opened and its 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.