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Sun Pharma Launches Novel Drug Kapspargo Sprinkle™ in USA

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First USFDA approved, extended-release sprinkle formulation of
metoprolol succinate indicated for treatment of patients with
Hypertension, Angina Pectoris and Heart Failure

Extended-release-coated pellets may be sprinkled over soft food or
administered via a nasogastric tube to facilitate long-term, once-daily
administration for patients who have difficulty swallowing

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN,
NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" including its subsidiaries
and/or associate companies) today announced that Sun Pharma has launched
Kapspargo Sprinkle (metoprolol succinate) extended-release capsules in
the US, for the treatment of hypertension (to lower blood pressure),
angina pectoris (chest pain), and heart failure (to reduce the risk of
cardiovascular mortality and heart-failure hospitalization in patients
with heart failure).

Kapspargo Sprinkle, a U.S. Food and Drug Administration (FDA) approved,
novel, patented formulation of metoprolol succinate, is the first and
only extended-release sprinkle formulation of this beta1-selective
adrenoreceptor blocking agent (beta-blocker). It is covered by United
States Patent numbers 9,504,655 and 9,700,530, expiring Jul 09, 2035.

Kapspargo Sprinkle pellets 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.

"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," said Abhay Gandhi, CEO-North
America, Sun Pharma. "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."

About Kapspargo Sprinkle extended-release capsules

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 a multiple unit system 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.

Kapspargo Sprinkle is contraindicated in patients with (1) known
hypersensitivity to the product components; (2) severe bradycardia,
greater than first-degree heart block, or sick sinus syndrome without a
pacemaker; and (3) 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.

Important Administration Instructions

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.

The extended-release pellets contained in Kapspargo Sprinkle capsules
allow for administration through a nasogastric tube. This involves
opening and adding the contents of a capsule to an all-plastic oral tip
syringe and adding 15 mL of water, followed by gentle shaking of the
syringe for approximately 10 seconds and prompt delivery through a 12
French or larger nasogastric tube. Ensure no granules are left in the
syringe. Rinse with additional water if needed.

Kapspargo Sprinkle extended-release capsules require no crushing,
therefore it eliminates the risk of leaving trace medication behind
after crushing.

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

Contraindications

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.

Adverse Reactions

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

Drug Interactions

  • 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.

Please
see full Prescribing Information

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Disclaimer:

Statements in this "Document" describing the Company's objectives,
projections, estimates, expectations, plans or predictions or industry
conditions or events may be "forward looking statements" within the
meaning of applicable securities laws and regulations. Actual results,
performance or achievements could differ materially from those expressed
or implied.

About Sun Pharmaceutical Industries Ltd. (CIN -
L24230GJ1993PLC019050):

Sun Pharma is the world's fifth largest specialty generic pharmaceutical
company and India's top pharmaceutical company. A vertically integrated
business, economies of scale and an extremely skilled team enable us to
deliver quality products in a timely manner at affordable prices. It
provides high-quality, affordable medicines trusted by customers and
patients in over 150 countries across the world. Sun Pharma's global
presence is supported by 41 manufacturing facilities spread across 6
continents, R&D centres across the globe and a multi-cultural workforce
comprising over 50 nationalities. In India, the company enjoys
leadership across 13 different classes of doctors with 32 brands
featuring amongst top 300 pharmaceutical brands in India. Its footprint
across emerging markets covers over 100 markets and 6 markets in Western
Europe. Its Global Consumer Healthcare business is ranked amongst Top 10
across 3 global markets. Its API business footprint is strengthened
through 14 world class API manufacturing facilities across the globe.
Sun Pharma fosters excellence through innovation supported by strong R&D
capabilities comprising about 2,000 scientists and R&D investments of
approximately 8% of annual revenues. For further information, please
visit www.sunpharma.com
& follow us on Twitter @SunPharma_Live.

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