Methyldopa (Page 3 of 3)

OVERDOSAGE

Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, constipation, distention, flatus, diarrhea, nausea, vomiting).

In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion. Otherwise, management includes special attention to cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity.

Sympathomimetic drugs [e.g., levarterenol, epinephrine, metaraminol bitartrate] may be indicated.

Methyldopa is dialyzable.

The oral LD50 of methyldopa is greater than 1.5 g/kg in both the mouse and the rat.

DOSAGE AND ADMINISTRATION

Adults

Initiation of Therapy

The usual starting dosage of methyldopa tablet is 250 mg two or three times a day in the first 48 hours. The daily dosage then may be increased or decreased, preferably at intervals of not less than two days, until an adequate response is achieved. To minimize the sedation, start dosage increases in the evening. By adjustment of dosage, morning hypotension may be prevented without sacrificing control of afternoon blood pressure.

When methyldopa is given to patients on other anti-hypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When methyldopa is given with anti-hypertensives other than thiazides, the initial dosage of methyldopa should be limited to 500 mg daily in divided doses; when methyldopa is added to a thiazide, the dosage of thiazide need not be changed.

Maintenance Therapy

The usual daily dosage of methyldopa is 500 mg to 2 g in two to four doses. Although occasional patients have responded to higher doses, the maximum recommended daily dosage is 3 g. Once an effective dosage range is attained, a smooth blood pressure response occurs in most patients in 12 to 24 hours. Since methyldopa has a relatively short duration of action, withdrawal is followed by return of hypertension usually within 48 hours. This is not complicated by an overshoot of blood pressure.

Occasionally tolerance may occur, usually between the second and third month of therapy. Adding a diuretic or increasing the dosage of methyldopa frequently will restore effective control of blood pressure. A thiazide may be added at any time during methyldopa therapy and is recommended if therapy has not been started with a thiazide or if effective control of blood pressure cannot be maintained on 2 g of methyldopa daily.

Methyldopa is largely excreted by the kidney and patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses (see PRECAUTIONS , Geriatric Use).

PEDIATRIC PATIENTS

Initial dosage is based on 10 mg/kg of body weight daily in two to four doses. The daily dosage then is increased or decreased until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3 g daily, whichever is less (see PRECAUTIONS , Pediatric Use).

HOW SUPPLIED

Methyldopa Tablets USP are available as white to off-white, round, convex, unscored, film-coated tablets, debossed “N11” on one side, and plain on the other side, containing 250 mg of methyldopa USP, packaged in bottles of 90 tablets.

PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

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

Iss. 12/2008

Manufactured In India By:

EMCURE PHARMACEUTICALS LTD.

Hinjwadi, Pune, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Repackaged by:

REBEL DISTRIBUTORS CORP.

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

Methyldopa 250mg
(click image for full-size original)
METHYLDOPA
methyldopa tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-351(NDC:0093-2931)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLDOPA (METHYLDOPA ANHYDROUS) METHYLDOPA ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
EDETATE DISODIUM
ETHYLCELLULOSES
HYPROMELLOSES
MAGNESIUM STEARATE
METHYLCELLULOSE (400 MPA.S)
POLYETHYLENE GLYCOLS
CALCIUM SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE (TYPE H)
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code N11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-351-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070098 02/23/2009
Labeler — Rebel Distributors Corp (118802834)
Registrant — PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Operations
PSS World Medical, Inc. 791528623 REPACK (42254-351)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 REPACK (42254-351)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 RELABEL (42254-351), REPACK (42254-351)
Establishment
Name Address ID/FEI Operations
SCRIPT PAK 964420108 RELABEL (42254-351), REPACK (42254-351)
Establishment
Name Address ID/FEI Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK (42254-351)
Establishment
Name Address ID/FEI Operations
Rebel Distirbutors Corp. 118802834 RELABEL (42254-351), REPACK (42254-351)

Revised: 12/2012 Rebel Distributors Corp

Page 3 of 3 1 2 3

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 © 2020. All Rights Reserved.