Metoprolol Succinate Extended-release (Page 5 of 5)

Postmarketing Experience

The following adverse reactions have been reported with metoprolol succinate extended-release tablets in worldwide postmarketing use, regardless of causality:

Cardiovascular: 2nd and 3rd degree heart block, cardiogenic shock in patients with acute myocardial infarction.

Gastrointestinal: hepatitis, vomiting.

Hematologic: thrombocytopenia.

Musculoskeletal: arthralgia.

Nervous System/Psychiatric: anxiety/nervousness, hallucinations, paresthesia.

Reproductive, male: impotence.

Skin: increased sweating, photosensitivity, urticaria.

Special Sense Organs: taste disturbances.

OVERDOSAGE

Acute Toxicity

There have been a few reports of overdosage with metoprolol succinate extended-release tablets and no specific overdosage information was obtained with this drug, with the exception of animal toxicology data. However, since metoprolol succinate extended-release tablets (metoprolol succinate salt) contain the same active moiety, metoprolol, as conventional metoprolol tablets (metoprolol tartrate salt), the recommendations on overdosage for metoprolol conventional tablets are applicable to metoprolol succinate extended-release tablets.

Signs and Symptoms

Overdosage of metoprolol succinate extended-release tablets may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness/coma, nausea, vomiting, and cyanosis.

Treatment

In general, patients with acute or recent myocardial infarction or congestive heart failure may be more hemodynamically unstable than other patients and should be treated accordingly. When possible the patient should be treated under intensive care conditions. On the basis of the pharmacologic actions of metoprolol, the following general measures should be employed:

Elimination of the Drug: Gastric lavage should be performed.

Bradycardia: Atropine should be given intravenously. If the response is inadequate, isoproterenol or any other agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary.

Hypotension: A vasopressor should be administered, e.g., levarterenol or dopamine.

Bronchospasm: A beta2 -stimulating agent and/or a theophylline derivative should be administered.

Cardiac Failure: A digitalis glycoside and diuretics should be administered. In shock resulting from inadequate cardiac contractility, administration of dobutamine, isoproterenol or glucagon may be considered.

DOSAGE AND ADMINISTRATION

Metoprolol succinate extended-release tablets are intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release metoprolol to metoprolol succinate extended-release tablets, the same total daily dose of metoprolol succinate extended-release tablets should be used. Dosages of metoprolol succinate extended-release tablets should be individualized and titration may be needed in some patients.

Metoprolol succinate extended-release tablets are scored and can be divided; however, the whole or half tablet should be swallowed whole and not chewed or crushed.

Hypertension

The usual initial dosage is 25 to 100 mg daily in a single dose, whether used alone or added to a diuretic. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. Dosages above 400 mg per day have not been studied.

Due to AstraZeneca’s marketing exclusivity rights, this generic drug product is not labeled for pediatric use. Dosage and administration information in pediatric patients 6 years and older is approved for AstraZeneca’s metoprolol succinate extended-release tablets.

Angina Pectoris

The dosage of metoprolol succinate extended-release tablets should be individualized. The usual initial dosage is 100 mg daily, given in a single dose. The dosage may be gradually increased at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually over a period of 1 to 2 weeks (see WARNINGS).

Heart Failure

Dosage must be individualized and closely monitored during up-titration. Prior to initiation of metoprolol succinate extended-release tablets, the dosing of diuretics, ACE inhibitors, and digitalis (if used) should be stabilized. The recommended starting dose of metoprolol succinate extended-release tablets is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 mg once daily in patients with more severe heart failure. The dose should then be doubled every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of metoprolol succinate extended-release tablets. If transient worsening of heart failure occurs, it may be treated with increased doses of diuretics, and it may also be necessary to lower the dose of metoprolol succinate extended-release tablets or temporarily discontinue it. The dose of metoprolol succinate extended-release tablets should not be increased until symptoms of worsening heart failure have been stabilized. Initial difficulty with titration should not preclude later attempts to introduce metoprolol succinate extended-release tablets. If heart failure patients experience symptomatic bradycardia, the dose of metoprolol succinate extended-release tablets should be reduced.

HOW SUPPLIED

Metoprolol succinate extended-release tablets for oral administration are supplied as follows:

50 mg: White, lightly mottled, film-coated round tablets containing 47.5 mg of metoprolol succinate equivalent to 50 mg of metoprolol tartrate, USP and debossed “369” on one side with a bisect on the other side.

NDC 58177-369-04………………….…Bottles of 100

NDC 58177-369-09………………….…Bottles of 1000

NDC 58177-369-11………………….…Packages of 100 (10 x 10 cards)

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO 63044

P4878-903/09

100 Tablets Bottle Label

NDC 58177-369-04

Metorpolol Succinate

Extended-Release Tablets, USP

50 mg*

100 Tablets

Rx Only

ETHEX

100 Tablets Bottle Label
(click image for full-size original)

1000 Tablets Bottle Label

NDC 58177-369-09

Metorpolol Succinate

Extended-Release Tablets, USP

50 mg*

1000 Tablets

Rx Only

ETHEX

1000 Tablets Bottle Label
(click image for full-size original)

100 Tablets Blister Pack Label

NDC 58177-369-11

Metorpolol Succinate

Extended-Release Tablets, USP

50 mg*

100 Tablets

(10 x 10 Unit Dose Packs)

Rx Only

ETHEX

100 Tablets Blister Pack Label
(click image for full-size original)
METOPROLOL SUCCINATE EXTENDED-RELEASE metoprolol succinate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-369
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
metoprolol succinate (METOPROLOL) metoprolol succinate 47.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CARBOXYMETHYLCELLULOSE SODIUM
CARNAUBA WAX
CROSCARMELLOSE SODIUM
GLYCERYL BEHENATE
HYPROMELLOSE
MALTODEXTRIN
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL
POVIDONE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color white (white, lightly mottled) Score 2 pieces
Shape OVAL (OVAL) Size 10mm
Flavor Imprint Code 369
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58177-369-04 100 TABLET, FILM COATED, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
2 NDC:58177-369-09 1000 TABLET, FILM COATED, EXTENDED RELEASE (1000 TABLET) in 1 BOTTLE None
3 NDC:58177-369-11 100 TABLET, FILM COATED, EXTENDED RELEASE (100 TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077176 11/01/2009
Labeler — Ethex Corporation (615424686)
Registrant — KV Pharmaceutical (006291405)
Establishment
Name Address ID/FEI Operations
KV Pharmaceutical (EC IV) 161097225 MANUFACTURE
Establishment
Name Address ID/FEI Operations
KV Pharmaceutical (Westport) 152053658 MANUFACTURE
Establishment
Name Address ID/FEI Operations
KV Pharmaceutical (EC I) 034060843 ANALYSIS
Establishment
Name Address ID/FEI Operations
KV Pharmaceutical (Metro 2) 961097503 ANALYSIS

Revised: 03/2010 Ethex Corporation

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