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, ARAMINE ® 1 (Metaraminol Bitartrate)] may be indicated. Methyldopa is dialyzable.

The oral LD 50 of methyldopa is greater than 1.5 g/kg in both the mouse and the rat.


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DOSAGE AND ADMINISTRATION

Adults

Initiation of Therapy

The usual starting dosage of methyldopa tablets is 250 mg two to 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 2 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 tablets are given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When methyldopa tablets are given with anti-hypertensives other than thiazides, the initial dosage of methyldopa tablets should be limited to 500 mg daily in divided doses; when methyldopa tablets are added to a thiazide, the dosage of thiazide need not be changed.

Maintenance of Therapy

The usual daily dosage of methyldopa tablets 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.

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 supplied as film-coated tablets containing either 250 mg or 500 mg of Methyldopa, USP.

The 250 mg tablets are beige film-coated, round, unscored tablets debossed with MYLAN on one side of the tablet and 611 on the other side. They are available as follows:

NDC 51079-200-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 500 mg tablets are beige film-coated, capsule-shaped, unscored tablets debossed with MYLAN on one side of the tablet and 421 on the other side. They are available as follows:

NDC 51079-201-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

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

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12198 R1
4/16

PRINCIPAL DISPLAY PANEL — 250 mg

NDC 51079-200-20

Methyldopa
Tablets, USP
250 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Methyldopa (calculated
as anhydrous) . . . . 250 mg

Usual Adult Dosage: See
accompanying prescribing
information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-6880 R6

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Methyldopa 250 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg

NDC 51079-201-20

Methyldopa
Tablets, USP
500 mg

100 Tablets (10 x 10)

Each film-coated tablet contains:
Methyldopa (calculated
as anhydrous) . . . . 500 mg

Usual Adult Dosage: See
accompanying prescribing
information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-6881 R5

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Methyldopa 500 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
METHYLDOPA methyldopa tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-200(NDC:0378-0611)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code MYLAN;611
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-200-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-200-01)
1 NDC:51079-200-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-200-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070076 09/01/1998 01/31/2020
METHYLDOPA methyldopa tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-201(NDC:0378-0421)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLDOPA (METHYLDOPA ANHYDROUS) METHYLDOPA ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
Product Characteristics
Color brown (beige) Score no score
Shape OVAL (capsule shaped) Size 19mm
Flavor Imprint Code MYLAN;421
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-201-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-201-01)
1 NDC:51079-201-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-201-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070076 09/01/1998 02/29/2020
Labeler — Mylan Institutional Inc. (039615992)

Revised: 11/2019 Mylan Institutional Inc.

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