Amlodipine Besylate (Page 4 of 5)


2
These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

OVERDOSAGE

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/m2 basis) caused a marked peripheral vasodilation and hypotension.

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. Reports of intentional overdosage include a patient who ingested 250 mg and was asymptomatic and was not hospitalized; another (120 mg) was hospitalized, underwent gastric lavage and remained normotensive; the third (105 mg) was hospitalized and had hypotension (90/50 mmHg) which normalized following plasma expansion. A case of accidental drug overdose has been documented in a 19-month-old male who ingested 30 mg amlodipine (about 2 mg/kg). During the emergency room presentation, vital signs were stable with no evidence of hypotension, but a heart rate of 180 bpm. Ipecac was administered 3.5 hours after ingestion and on subsequent observation (overnight) no sequelae were noted.

If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

DOSAGE AND ADMINISTRATION

Adults

The usual initial antihypertensive oral dose of amlodipine besylate is 5 mg once daily with a maximum dose of 10 mg once daily. Small, fragile, or elderly individuals, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine to other antihypertensive therapy.

Dosage should be adjusted according to each patient’s need. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient’s response to each dose level. Titration may proceed more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. See ADVERSE REACTIONS section for information related to dosage and side effects.

Children

The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients. See CLINICAL PHARMACOLOGY.

Coadministration with Other Antihypertensive and/or Antianginal Drugs

Amlodipine has been safely administered with thiazides, ACE inhibitors, beta-blockers, long-acting nitrates, and/or sublingual nitroglycerin.

HOW SUPPLIED

Amlodipine besylate tablets 2.5 mg (amlodipine besylate equivalent to 2.5 mg amlodipine per tablet) are white to off-white, oval, flat beveled edged uncoated tablets, embossed “RDY” on one side and “269” on other side and are supplied in bottles of 90, 100, 500 and unit dose packages of 100 (10 × 10).

Bottles of 90 NDC 55111-269-90
Bottles of 100 NDC 55111-269-01
Bottles of 500 NDC 55111-269-05
Unit dose packages of 100 NDC 55111-269-78

Amlodipine besylate tablets 5 mg (amlodipine besylate equivalent to 5 mg amlodipine per tablet) are white to off-white, oval, flat beveled edged uncoated tablets, embossed “RDY” on one side and “270” on other side and are supplied in bottles of 90, 100, 300, 500 and unit dose packages of 100 (10 × 10).

Bottles of 90 NDC 55111-270-90
Bottles of 100 NDC 55111-270-01
Bottles of 300 NDC 55111-270-03
Bottles of 500 NDC 55111-270-05
Unit dose packages of 100 NDC 55111-270-78

Amlodipine besylate tablets 10 mg (amlodipine besylate equivalent to 10 mg amlodipine per tablet) are white to off-white, oval, flat beveled edged uncoated tablets, embossed “RDY” on one side and “271” on other side and are supplied in bottles of 90, 100, 500 and unit dose packages of 100 (10 × 10).

Bottles of 90 NDC 55111-271-90
Bottles of 100 NDC 55111-271-01
Bottles of 500 NDC 55111-271-05
Unit dose packages of 100 NDC 55111-271-78

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistant containers (USP).

Viagra® is a registered trademark of Pfizer Pharmaceuticals.

Rx only

Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachepalli – 502 325 INDIA

Issued: 0707

PATIENT INFORMATION

Amlodipine Besylate Tablets

Read this information carefully before you start amlodipine 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, ask your doctor. Your doctor will know if amlodipine is right for you.

What is Amlodipine Besylate?

Amlodipine besylate is the besylate salt of amlodipine, 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 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 can relieve this pain.

Who should not use Amlodipine Besylate Tablets?

Do not use amlodipine besylate 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?

Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies.

Tell your doctor if you:

  • ever had heart disease
  • ever had liver problems
  • are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine is the best treatment for you.
  • are breastfeeding. Do not breastfeed while taking amlodipine. You can stop breastfeeding or take a different medicine.

How should I take Amlodipine?

  • Take amlodipine besylate once a day with or without food. You can take amlodipine with most drinks, including grapefruit juice.
  • It may be easier to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. Do not take more than one dose of amlodipine at a time.
  • If you miss a dose, take it as soon as you remember. Do not take amlodipine if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time.
  • Other medicines: You can use nitroglycerin and amlodipine together. If you take nitroglycerin for angina, don’t stop taking it while you are taking amlodipine.
  • While you are taking amlodipine, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor.
  • If you took too much amlodipine, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

What should I avoid while taking Amlodipine?

  • Do not breastfeed. It is not known if amlodipine will pass through your milk.
  • Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

What are the possible side effects of Amlodipine?

Amlodipine may cause the following side effects. Most side effects are mild or moderate:

  • headache
  • swelling of your legs or ankles
  • tiredness, extreme sleepiness
  • stomach pain, nausea
  • dizziness
  • flushing (hot or warm feeling in your face)
  • arrhythmia (irregular heartbeat)
  • heart palpitations (very fast heartbeat)

It is rare, but when you first start amlodipine 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?

Keep amlodipine away from children. Store amlodipine besylate tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Keep amlodipine out of the light. Do not store in the bathroom.

Keep amlodipine in a dry place.

General advice about amlodipine besylate

Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine the way your doctor told you to. Do not give amlodipine 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, or you can visit the website at www.drreddys.com or call 866-733-39523.

Manufactured by:
Dr. Reddy’s Laboratories Limited Bachepalli – 502 325 INDIA

Issued: 0707

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