Amlodipine Besylate (Amlodipine Besylate)

Trade Name : Amlodipine Besylate

West-Ward Pharmaceuticals Corp.

TABLET

Strength 2.5 mg/1

Storage and handling for Amlodipine Besylate

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

Disclaimer

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 West-Ward Pharmaceuticals Corp.. 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

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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.

About GNH

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Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

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Important Limitation:
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2.5 mg Tablets: Round, white, biconvex tablets debossed with product identification u201c54u201d over u201c513u201d on one side and plain on the other side.
5 mg Tablets: Round, white, biconvex tablets debossed with product identification u201c54u201d over u201c771u201d on one side and plain on the other side.
10 mg Tablets: Round, white, biconvex tablets debossed with product identification u201c54u201d over u201c233u201d on one side and plain on the other side.

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Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

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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. ()
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or n

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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 besylate tablets 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/m basis) 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 besylate tablets are highly protein bound, hemodialysis is not likely to be of benefit.

Amlodipine Besylate Tablets USP are the besylate salt of amlodipine, a long-acting calcium channel blocker.
Amlodipine besylate is chemically described as 3,5-pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester, (u00b1) -, monobenzenesulfonate. Its empirical formula is CHClNOu2022CHOS, and its structural formula is
Amlodipine besylate USP is a white or almost white powder with a molecular weight of 567.05. It is freely soluble in methanol, sparingly soluble in alcohol, and slightly soluble in 2-propanol and in water. Each tablet contains amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg amlodipine for oral administration. Each tablet also contains the following inactive ingredients: dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

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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.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 dose* of 10 mg/day on a mg/m basis).

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Amlodipine Besylate Tablets USP
2.5 mg tablets are supplied as round, white, biconvex tablets debossed with product identification u201c54u201d over u201c513u201d on one side and plain on the other side.
NDC 0054-0100-22: Bottle of 90 Tablets
NDC 0054-0100-31: Bottle of 1,000 Tablets
5 mg tablets are supplied as round, white, biconvex tablets debossed with product identification u201c54u201d over u201c771u201d on one side and plain on the other side.
NDC 0054-0101-22: Bottle of 90 Tablets
NDC 0054-0101-28: Bottle of 300 Tablets
NDC 0054-0101-31: Bottle of 1,000 Tablets
10 mg tablets are supplied as round, white, biconvex tablets debossed with product identification u201c54u201d over u201c233u201d on one side and plain on the other side.
NDC 0054-0102-22: Bottle of 90 Tablets
NDC 0054-0102-28: Bottle of 300 Tablets
NDC 0054-0102-31: Bottle of 1,000 Tablets
Storage
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). [See USP Controlled Room Temperature.] Protect from light.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003559/12Revised December 2017

Amlodipine Besylate Tablets USP
(am loeu2019 di peen besu2019 i late)
Rx Only
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):
Angina:
Who should not use amlodipine besylate tablets?
Do not use amlodipine besylate tablets if you are allergic to amlodipine, (the active ingredient in amlodipine besylate tablets), 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?
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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 besylate tablets. 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 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). [See USP Controlled Room Temperature.] Keep amlodipine besylate 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 may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch/
You can ask your pharmacist or doctor for information about amlodipine besylate tablets or call 1-800-962-8364.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003559/12Revised December 2017

Amlodipine Besylate Tablets USP, 2.5 mg
0054-0100-22, Rx only

Amlodipine Besylate Tablets USP, 5 mg
0054-0101-22, Rx only

Amlodipine Besylate Tablets USP, 10 mg
0054-0102-22, Rx only

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