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Amlodipine Besylate (Amlodipine Besylate)

Trade Name : Amlodipine Besylate

NCS HealthCare of KY, Inc dba Vangard Labs

TABLET

Strength 2.5 mg/1

AMLODIPINE BESYLATE Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]

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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 Amlodipine Besylate (Amlodipine Besylate) which is also known as Amlodipine Besylate and Manufactured by NCS HealthCare of KY, Inc dba Vangard Labs. It is available in strength of 2.5 mg/1 per ml. Read more

Amlodipine Besylate (Amlodipine Besylate) 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
  • Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
  • u00a0u00a0u00a0u00a0u00a0u00a0 Hypertension ()
  • ou00a0 Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure.u00a0 Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Coronary Artery Disease ()
  • ou00a0u00a0u00a0 Chronic Stable Anginau00a0u00a0u00a0u00a0u00a0u00a0
  • ou00a0u00a0u00a0 Vasospastic Angina (Prinzmetal's or Variant Angina)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • ou00a0u00a0u00a0 Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fractionu00a0 < 40%
  • u00a0u00a0u00a0u00a0u00a0 Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ()
  • ou00a0u00a0u00a0 Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ()
  • u00a0u00a0u00a0u00a0u00a0 Pediatric starting dose: 2.5 mg to 5 mg once daily. ()
  • Important Limitation:
  • Tablets: 2.5 mg White to off-white round flat faced bevelled edged tablets debossed with 'U' on one side and '241' on the other side.
  • Tablets: 5 mg White to off-white round flat faced bevelled edged tablets debossed with 'U' on one side and '242 on the other side.
  • Tablets: 10 mg White to off-white round flat faced bevelled edged tablets debossed with 'U' on one side and '243 on the other side
  • Tablets: 2.5 mg, 5 mg, and 10 mg ()
  • Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.
  • Known sensitivity to amlodipine ()
  • No data
  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ()
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. ()
  • Titrate slowly in patients with severe hepatic impairment ()
  • Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. () u00a0
  • No data
  • Do not exceed doses greater than 20 mg daily of simvastatin. ()
  • No data
  • Pregnancy: Use only if the potential benefit justifies the risk. ()
  • Nursing: Discontinue when administering amlodipine. ()
  • Pediatric: Effect on patients less than 6 years old is not known. ()
  • Geriatric: Start dosing at the low end of the dose range. ()
  • Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited.
  • Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/mbasis) caused a marked peripheral vasodilation and hypotension.
  • If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
  • Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker.
  • Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (u00b1)-2-[(2-aminoethoxy)methyl]u00a04-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is CHClNOu2022CHOS and its structural formula is:
  • Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
  • No data
  • Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. For the rat, the highest dose was, on a mg/m basis, about twice the maximum recommended human dose.u00a0
  • Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level.
  • There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose of 10 mg/day on a mg/m basis).
  • No data
  • No data
  • SUMMARY OF INFORMATION ABOUT
  • Amlodipine Besylate Tablets USP
  • Read this information carefully before you start taking and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about , ask your doctor. Your doctor will know if are right for you.
  • What are amlodipine besylate tablets?
  • Amlodipine besylate tablets
  • High Blood Pressure (hypertension)
  • High blood pressure comes from blood pushing too hard against your blood vessels. relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.
  • Angina
  • Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. can relieve this pain.
  • Who should not use amlodipine besylate tablets?
  • Do not use if you are allergic to amlodipine (the active ingredient in ), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients.
  • What should I tell my doctor before taking amlodipine besylate tablets?
  • Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you:
  • How should I take amlodipine besylate tablets?
  • What should I avoid while taking amlodipine besylate tablets?
  • What are the possible side effects of amlodipine besylate tablets?
  • Amlodipine besylate tablets
  • It is rare, but when you first start takingor increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.
  • Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of . For a complete list, ask your doctor or pharmacist.
  • How do I store amlodipine besylate tablets?
  • Keep away from children. Store at 20u00ba to 25u00b0C (68u00b0 to 77u00ba F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant containers. Keep out of the light. Do not store in the bathroom. Keep in a dry place.
  • General advice about amlodipine besylate tablets
  • Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use the way your doctor told you to. Do not give to other people, even if they have the same symptoms you have. It may harm them.
  • You can ask your pharmacist or doctor for information about , or you can contact Unichem Pharmaceuticals (USA), Inc., at 1u00a0866-562-4616
  • Additional Summary of Information About leaflets can be obtained by calling Unichem at 1-866-562-4616.
  • Manufactured by:
  • UNICHEM LABORATORIES LTD.
  • Pilerne Ind. Estate, Pilerne, Bardez,
  • Goa 403 511, India.
  • and
  • UNICHEM LABORATORIES LTD.
  • Ind Area, Meerut Road, Ghaziabad u2013 201 003, India
  • Marketed by:
  • Hasbrouck Heights, NJ 07604
  • 03-R-06/2016
  • 13008422
  • No data
  • No data
  • No data

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