Methimazole 5 mg/1
Methimazole · TABLET · NORTHSTAR RX LLC
Methimazole is a tablet containing methimazole at 5 mg/1, taken oral. Manufactured by NORTHSTAR RX LLC.
Key Facts
- Brand Name
- Methimazole
- Generic Name
- Methimazole
- NDC Code (Product)
72603-315- Manufacturer
- NORTHSTAR RX LLC
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040734
- Drug Class
- Thyroid Hormone Synthesis Inhibitor [EPC]
- Marketing Start
- 08/01/2024
Recall History
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE
Dosage & Administration
DOSAGE AND ADMINISTRATION
Warnings
WARNINGS First Trimester Use of Methimazole and Congenital Malformations Methimazole crosses the placental membranes and can cause fetal harm when administered in the first trimester of pregnancy. Rare instances of congenital defects, including aplasia cutis, craniofacial malformations (facial dysmorphism; choanal atresia), gastrointestinal malformations (esophageal atresia with or without tracheoesophageal fistula), omphalocele and abnormalities of the omphalomesenteric duct have occurred in infants born to mothers who received methimazole in the first trimester of pregnancy. If methimazole is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus. Because of the risk for congenital malformations associated with use of methimazole in the first trimester of pregnancy, it may be appropriate to use other agents in pregnant women requiring treatment for hyperthyroidism. If methimazole is used, the lowest possible dose to control the maternal disease should be given. Agranulocytosis Agranulocytosis is a potentially life-threatening adverse reaction of methimazole therapy. Patients should be inst…
Contraindications
CONTRAINDICATIONS
Drug Interactions
Drug Interactions Anticoagulants (oral) Due to potential inhibition of vitamin K activity by methimazole, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures. ß-adrenergic blocking agents Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid. Digitalis glycosides Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be needed. Theophylline Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.
Adverse Reactions
ADVERSE REACTIONS
Frequently Asked Questions
What is Methimazole used for?
Methimazole contains Methimazole. It is a tablet taken oral. Consult your doctor for specific uses.
Is Methimazole a controlled substance?
Methimazole is not classified as a controlled substance by the DEA.
What is the generic name for Methimazole?
The generic name for Methimazole is Methimazole. There are 2 other brand versions of Methimazole.
What is the NDC code for Methimazole 5 mg/1?
The NDC (National Drug Code) for Methimazole 5 mg/1 is 72603-315, listed by NORTHSTAR RX LLC.