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Verapamil Hydrochloride (Calan Sr)

Trade Name : CALAN SR

G.D. Searle LLC Division of Pfizer Inc

TABLET, FILM COATED, EXTENDED RELEASE

Strength 240 mg/1

VERAPAMIL HYDROCHLORIDE P-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Verapamil Hydrochloride (Calan Sr) which is also known as CALAN SR and Manufactured by G.D. Searle LLC Division of Pfizer Inc. It is available in strength of 240 mg/1 per ml. Read more

Verapamil Hydrochloride (Calan Sr) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • CALAN SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). CALAN SR is available for oral administration as light green, capsule-shaped, scored, film-coated tablets (caplets) containing 240 mg of verapamil hydrochloride; as light pink, oval, scored, film-coated tablets (caplets) containing 180 mg of verapamil hydrochloride; and as light violet, oval, film-coated tablets (caplets) containing 120 mg of verapamil hydrochloride. The caplets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the caplet is divided in half.
  • The structural formula of verapamil HCl is:
  • Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs.
  • Inactive ingredients include alginate, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, talc, titanium dioxide, and coloring agents: 240 mgu2014D&C Yellow No. 10 Lake and FD&C Blue No. 2 Lake; 120 and 180 mgu2014iron oxide.
  • CALAN (verapamil HCl) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells.
  • CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 this drug.
  • 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 one 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.
  • Verapamil HCl caplets are contraindicated in:
  • No data
  • No data
  • Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil. The following reactions to orally administered verapamil occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients:
  • Elevated liver enzymes (see )
  • In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50/min at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.
  • The following reactions, reported in 1% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
  • Cardiovascular:
  • Digestive system:
  • Hemic and lymphatic:
  • Nervous system:
  • Skin:
  • Special senses:
  • Urogenital:
  • The frequency of cardiovascular adverse reactions that require therapy is rare; hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, the appropriate emergency measures should be applied immediately; eg, intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, dopamine HCl or dobutamine HCl may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.
  • Overdose with verapamil may lead to pronounced hypotension, bradycardia, and conduction system abnormalities (eg, junctional rhythm with AV dissociation and high degree AV block, including asystole). Other symptoms secondary to hypoperfusion (eg, metabolic acidosis, hyperglycemia, hyperkalemia, renal dysfunction, and convulsions) may be evident.
  • Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially CALAN SR), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the sustained-release formulation. Verapamil is known to decrease gastrointestinal transit time.
  • In overdose, caplets of CALAN SR have occasionally been reported to form concretions within the stomach or intestines. These concretions have not been visible on plain radiographs of the abdomen, and no medical means of gastrointestinal emptying is of proven efficacy in removing them. Endoscopy might reasonably be considered in cases of massive overdose when symptoms are unusually prolonged.
  • Treatment of overdosage should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solutions may increase calcium ion flux across the slow channel and have been used effectively in treatment of deliberate overdosage with verapamil. Continued treatment with large doses of calcium may produce a response. In a few reported cases, overdose with calcium channel blockers that was initially refractory to atropine became more responsive to this treatment when the patients received large doses (close to 1 g/hr for more than 24 hr) of calcium chloride. Verapamil cannot be removed by hemodialysis. Clinically significant hypotensive reactions or high degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures including cardiopulmonary resuscitation.
  • The dose of CALAN SR should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCl, CALAN SR, given in the morning. Lower initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (eg, the elderly or small people). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of CALAN SR are evident within the first week of therapy.
  • If adequate response is not obtained with 180 mg of CALAN SR, the dose may be titrated upward in the following manner:
  • When switching from immediate-release CALAN to CALAN SR, the total daily dose in milligrams may remain the same.
  • CALAN SR 120 mg caplets are light violet, oval, film coated, with CALAN debossed on one side and SR 120 on the other, supplied as:
  • CALAN SR 180 mg caplets are light pink, oval, scored, film coated, with CALAN debossed on one side and SR 180 on the other, supplied as:
  • CALAN SR 240 mg caplets are light green, capsule shaped, scored, film coated, with CALAN debossed on one side and SR 240 on the other, supplied as:
  • Store at 59u00b0 to 77u00b0F (15u00b0 to 25u00b0C) and protect from light and moisture. Dispense in tight, light-resistant containers.
  • Manufactured for:G.D. Searle LLCDivision of Pfizer, IncNY, NY 10017
  • LAB-0268-11.0Revised October 2019
  • NDC 0025-1901-31
  • Pfizer
  • Calan SRn- SUSTAINED-RELEASE
  • 120 mg
  • 100 Capletsn n
  • NDC 0025-1911-31
  • Pfizer
  • Calan SRn- SUSTAINED-RELEASE
  • 180 mg
  • 100 Capletsn n
  • NDC 0025-1891-31
  • Pfizer
  • Calan SRn- SUSTAINED-RELEASE
  • 240 mg
  • 100 Capletsn n
  • NDC 0025-1891-51
  • Pfizer
  • Calan SR(verapamil hydrochloride) capletsSUSTAINED-RELEASE
  • 240 mg
  • 500 CapletsRx only

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