Amlodipine Besylate (Amlodipine Besylate)

Trade Name : Amlodipine Besylate

Apotheca Inc.

TABLET

Strength 10 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 Apotheca Inc.. It is available in strength of 10 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

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About GNH

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, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
  • u00a0u00a0u00a0 o u00a0Amlodipine besylate tablets, USP are 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.
  • u00a0u00a0 o u00a0Chronic Stable Angina
  • u00a0u00a0 o u00a0Vasospastic Angina (Prinzmetalu2019s or Variant Angina)
  • u00a0u00a0 o u00a0Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
  • u00a0u00a0u00a0 o Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (n n n )n nn
  • Important Limitation:
  • 2.5 mg Tablets:
  • White, round, flat faced beveled edged tablets debossed with n n n on one side and n n n on the othern nn
  • 5 mg Tablets:
  • White, round, flat faced beveled edged tablets debossed with n n n on one side and n n n on the othern nn
  • 10 mg Tablets:
  • White, round, flat faced beveled edged tablets debossed with n n n on one side andn n n on the othern nn
  • 2.5 mg, 5 mg, and 10 mg Tablets (n n n )n nn
  • Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.
  • Known sensitivity to amlodipine (n n n )n n n
  • No data
  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, because of the gradual onset of action, acute hypotension is unlikely. (n n n )n n n
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. (n n n )n n n
  • Titrate slowly when administering calcium channel blockers to patients with severe hepatic impairment. (n n n )n n n
  • Most common adverse reactions are headache and edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are headache, fatigue, nausea, abdominal pain, and somnolence. (n n n )n nn
  • u2022 Do not exceed doses greater than 20 mg daily of simvastatin. (n n n )n nn
  • No data
  • Pregnancy: Use only if the potential benefit justifies the risk. (n n n )n n n
  • Nursing: Discontinue when administering amlodipine besylate tablets. (n n n )n n n
  • Pediatric: Effect on patients less than 6 years old is not known. (n n n )n n n
  • Geriatric: Start dosing at the low end of the dose range. (n n n )n n n
  • 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/mn n n basis) caused a marked peripheral vasodilation and hypotension.n nn
  • 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]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is Cn n n Hn n n CINn n n On n n u2022 Cn n n Hn n n On n n S, and its structural formula is:n nn
  • 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, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, 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 mg, 1.25 mg, or 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/mn n n basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. n n n For the rat, the highest dose was, on a mg/mn n n basis, about twice the maximum recommended human dose. n n n n
  • 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 dosen n n of 10 mg/day on a mg/mn n n basis).n nn
  • No data
  • 10 mg Tablets
  • Amlodipine besylate-10 mg Tablets (amlodipine besylate, USP equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets debossed with IG on one side and 239 on the other and supplied as follows:
  • NDC 12634-600-00 Bottles of 10
  • NDC 12634-600-01 Bottles of 100
  • NDC 12634-600-09 Bottles of 35
  • NDC 12634-600-40 Bottles of 40
  • NDC 12634-600-42 Bottles of 42
  • NDC 12634-600-45 Bottles of 45
  • NDC 12634-600-50 Bottles of 50
  • NDC 12634-600-52 Blister Pack of 12
  • NDC 12634-600-54 Blister Pack of 14
  • NDC 12634-600-57 Blister Pack of 20
  • NDC 12634-600-58 Blister Pack of 28
  • NDC 12634-600-59 Blister Pack of 30
  • NDC 12634-600-60 Bottles of 60
  • NDC 12634-600-61 Blister Pack of 10
  • NDC 12634-600-63 Blister Pack of 3
  • NDC 12634-600-66 Blister Pack of 6
  • NDC 12634-600-67 Blister Pack of 7
  • NDC 12634-600-69 Blister Pack of 9
  • NDC 12634-600-71 Bottles of 30
  • NDC 12634-600-74 Bottles of 24
  • NDC 12634-600-78 Bottles of 28
  • NDC 12634-600-79 Bottles of 25
  • NDC 12634-600-80 Bottles of 20
  • NDC 12634-600-81 Bottles of 21
  • NDC 12634-600-82 Bottles of 12
  • NDC 12634-600-84 Bottles of 14
  • NDC 12634-600-85 Bottles of 15
  • NDC 12634-600-90 Bottles of 90
  • NDC 12634-600-91 Blister Pack of 1
  • NDC 12634-600-92 Bottles of 2
  • NDC 12634-600-93 Bottles of 3
  • NDC 12634-600-94 Bottles of 4
  • NDC 12634-600-95 Bottles of 5
  • NDC 12634-600-96 Bottles of 6
  • NDC 12634-600-97 Bottles of 7
  • NDC 12634-600-98 Bottles of 8
  • NDC 12634-600-99 Bottles of 9
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature].
  • Rev: 10/15
  • SUMMARY OF INFORMATION ABOUT
  • AMLODIPINE BESYLATE TABLETS, USP
  • Read this information carefully before you start taking amlodipine besylate tablets 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 amlodipine besylate tablets, ask your doctor. Your doctor will know if amlodipine besylate tablets are right for you.
  • What are amlodipine besylate tablets?
  • Amlodipine besylate tablets are a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.
  • High Blood Pressure (hypertension)
  • High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablets 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. Amlodipine besylate tablets can relieve this pain.
  • Who should not use amlodipine besylate tablets?
  • Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine), 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 may cause the following side effects. Most side effects are mild or moderate:
  • It is rare, but when you first start taking amlodipine besylate tablets or 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 amlodipine. For a complete list, ask your doctor or pharmacist.
  • How do I store amlodipine besylate tablets?
  • Keep amlodipine besylate tablets away from children. Store amlodipine besylate tablets at room temperature (store between 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets 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 amlodipine besylate tablets the way your doctor told you to. Do not give amlodipine besylate tablets 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 amlodipine besylate tablets, or you can visit Camber Pharmaceuticals website at n or call 1-866-495-8330.n
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
  • Manufactured by:n n nInvaGen Pharmaceuticals, Inc.n n nHauppauge, NY 11788n
  • Repackaged and Distributed by
  • Apotheca Inc.
  • Phoenix, AZ 85006n n n n
  • No data

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