Methimazole (Page 2 of 2)

Nursing Mothers

Methimazole is present in breast milk. However, several studies found no effect on clinical status in nursing infants of mothers taking methimazole. A long-term study of 139 thyrotoxic lactating mothers and their infants failed to demonstrate toxicity in infants who are nursed by mothers receiving treatment with methimazole. Monitor thyroid function at frequent (weekly or biweekly) intervals.

Pediatric Use

Because of postmarketing reports of severe liver injury in pediatric patient treated with propylthiouracil, methimazole is the preferred choice when an antithyroid drug is required for a pediatric patient (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulocytopenia, thrombocytopenia, and aplastic anemia), drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemic coma), hepatitis (jaundice may persist for several weeks after discontinuation of the drug), periarteritis, and hypoprothrombinemia. Nephritis occurs very rarely. There have been postmarketing case reports of acute pancreatitis.

There are reports of a vasculitis, often associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications (see WARNINGS).

Minor adverse reactions include skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesia, loss of taste, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy.

OVERDOSAGE

Signs and Symptoms

Symptoms may include nausea, vomiting, epigastric distress, headache, fever, joint pain, pruritus, and edema. Aplastic anemia (pancytopenia) or agranulocytosis may be manifested in hours to days. Less frequent events are hepatitis, nephrotic syndrome, exfoliative dermatitis, neuropathies, and CNS stimulation or depression. No information is available on the median lethal dose of the drug or the concentration of methimazole in biologic fluids associated with toxicity and/or death.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.

In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.

DOSAGE AND ADMINISTRATION

Methimazole tablets are administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals.

Adult The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals. The maintenance dosage is 5 to 15 mg daily.

Pediatric Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.

HOW SUPPLIED

Methimazole tablets, USP 5 mg — round, white to off white bi-convex tablet. Debossed HP bisect 70 on one side and plain on the reverse side.

They are available in:

Bottles of 100 NDC 60429-380-01

Methimazole tablets, USP 10 mg — round, white to off white bi-convex tablet. Debossed HP bisect 71 on one side and plain on the reverse side.

They are available in:

Bottles of 100 NDC 60429-381-01

Bottles of 1000 NDC 60429-381-10 DISCONTINUED

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container.

Distributed by:

Avet Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

logo

51U000000174US05

Marketed/Packaged by:
GSMS, Inc.

Camarillo, CA USA 93012

Revised: 12/2019

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 5 mg(100 tablets)

Methimazole 5mg Tablets 100

NDC 60429-380-01

//medlibrary.org/lib/images-rx/methimazole-25/60429-380-01ol-223x300.jpg
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 10 mg(100 tablets)

Methimazole 10mg Tablets 1000

NDC 60429-381-10

//medlibrary.org/lib/images-rx/methimazole-25/60429-381-10lb-223x300.jpg
(click image for full-size original)
METHIMAZOLE
methimazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-380(NDC:23155-070)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHIMAZOLE (METHIMAZOLE) METHIMAZOLE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TALC
Product Characteristics
Color white (WHITE TO OFF WHITE) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code HP;70
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-380-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040734 12/14/2007
METHIMAZOLE
methimazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-381(NDC:23155-071)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHIMAZOLE (METHIMAZOLE) METHIMAZOLE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TALC
Product Characteristics
Color white (WHITE TO OFF WHITE) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code HP;71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-381-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-381-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040734 12/14/2007
Labeler — Golden State Medical Supply (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply 603184490 relabel (60429-380), repack (60429-380), relabel (60429-381), repack (60429-381)

Revised: 08/2020 Golden State Medical Supply

Page 2 of 2 1 2

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.