Amlodipine Besylate (Page 4 of 4)

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 time 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 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 6-17 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 of amlodipine per tablet) are white, round, flat-faced, beveled edge tablets debossed “K” on one side and “320” on the other side and supplied as follows:

NDC 66893-320-02 Bottle of 90

NDC 66893-320-04 Bottle of 300

Amlodipine besylate tablets 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, round, flat-faced, beveled edge tablets debossed “K” on one side and “321” on the other side and supplied as follows:

NDC 66893-321-02 Bottle of 90

NDC 66893-321-04 Bottle of 300

Amlodipine besylate tablets 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white, round, flat-faced, beveled edge tablets debossed “K” on one side and “322” on the other side and supplied as follows:

NDC 66893-322-02 Bottle of 90

NDC 66893-322-04 Bottle of 300

Store bottles at 20º-25ºC (68º-77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).

* Viagra® is a registered trademark of Pfizer, Inc.

Rx only

Manufactured by:

Kali Laboratories, Inc.

Somerset, NJ 08873

IN0140-02

Revised: 10/05

AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66893-320
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine Besylate (Amlodipine) Amlodipine 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Colloidal Silicon Dioxide
Dibasic Calcium Phosphate Anhydrous
Magnesium Stearate
Microcrystalline Cellulose
Sodium Starch Glycolate
Stearic Acid
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code K;320
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66893-320-02 90 TABLET (90 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:66893-320-04 300 TABLET (300 TABLET) in 1 BOTTLE, PLASTIC None
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66893-321
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine Besylate (Amlodipine) Amlodipine 5 mg
Inactive Ingredients
Ingredient Name Strength
Colloidal Silicon Dioxide
Dibasic Calcium Phosphate Anhydrous
Magnesium Stearate
Microcrystalline Cellulose
Sodium Starch Glycolate
Stearic Acid
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code K;321
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66893-321-02 90 TABLET (90 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:66893-321-04 300 TABLET (300 TABLET) in 1 BOTTLE, PLASTIC None
AMLODIPINE BESYLATE
amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66893-322
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amlodipine Besylate (Amlodipine) Amlodipine 10 mg
Inactive Ingredients
Ingredient Name Strength
Colloidal Silicon Dioxide
Dibasic Calcium Phosphate Anhydrous
Magnesium Stearate
Microcrystalline Cellulose
Sodium Starch Glycolate
Stearic Acid
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code K;322
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66893-322-02 90 TABLET (90 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:66893-322-04 300 TABLET (300 TABLET) in 1 BOTTLE, PLASTIC None
Labeler — Kali Laboratories, Inc., A Wholly Owned Subsidiary of Par Pharmaceutical Companies

Revised: 08/2007 Kali Laboratories, Inc., A Wholly Owned Subsidiary of Par Pharmaceutical Companies

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.