Methimazole

Par Pharmaceutical, Inc.
Human Prescription Drug
NDC 49884-641

Methimazole is a human prescription drug labeled by 'Par Pharmaceutical, Inc.'. National Drug Code (NDC) number for Methimazole is 49884-641. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Methimazole drug includes Methimazole - 10 mg/1 . The currest status of Methimazole drug is Active.

Drug Information:

Drug NDC:	49884-641
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Methimazole
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Methimazole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Par Pharmaceutical, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	METHIMAZOLE - 10 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	29 Mar, 2000
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Oct, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040350
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	18 Dec, 2025
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Par Pharmaceutical, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197941 197942
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175918 N0000175917
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	554Z48XN5E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Thyroid Hormone Synthesis Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Thyroid Hormone Synthesis Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Thyroid Hormone Synthesis Inhibitor [EPC] Thyroid Hormone Synthesis Inhibitors [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
49884-641-01	100 TABLET in 1 BOTTLE (49884-641-01)	13 Apr, 2000	31 Oct, 2024	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Methimazole methimazole methimazole methimazole lactose monohydrate magnesium stearate starch, corn talc off-white em;5 methimazole methimazole methimazole methimazole lactose monohydrate magnesium stearate starch, corn talc off-white em;10

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. Ã-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.

Indications and Usage:

Indications and usage methimazole is indicated: in patients with gravesâ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy

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 Read more...

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 instructed to immediately report to their physicians any symptoms suggestive of agranulocytosis, such as fever or sore throat. leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur. the drug should be discontinued in the presence of agranulocytosis, aplastic anemia (pancytopenia), anca-positive vasculitis, hepatitis, or exfoliative dermatitis, and the patientâs bone marrow indices should be monitored. liver toxicity although there have been reports of hepatotoxicity (including acute liver failure) associated with methimazole, the risk of hepatotoxicity appears to be less with methimazole than with propylthiouracil, especially in the pediatric population. symptoms suggestive of hepatic dysfunction (anorexia, pruritus, right upper quadrant pain, etc.) should prompt evaluation of liver function (bilirubin, alkaline phosphatase) and hepatocellular integrity (alt, ast). drug treatment should be discontinued promptly in the event of clinically significant evidence of liver abnormality including hepatic transaminase values exceeding 3 times the upper limit of normal. hypothyroidism methimazole can cause hypothyroidism necessitating routine monitoring of tsh and free t4 levels with adjustments in dosing to maintain a euthyroid state. because the drug readily crosses placental membranes, methimazole can cause fetal goiter and cretinism when administered to a pregnant woman. for this reason, it is important that a sufficient, but not excessive, dose be given during pregnancy (see precautions, pregnancy ).

General Precautions:

General patients who receive methimazole should be under close surveillance and should be cautioned to report immediately any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise. in such cases, white-blood-cell and differential counts should be obtained to determine whether agranulocytosis has developed. particular care should be exercised with patients who are receiving additional drugs known to cause agranulocytosis.

Dosage and Administration:

Dosage and administration methimazole is administered orally. the total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals. adults 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.

Contraindications:

Contraindications methimazole is contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

Adverse Reactions:

Adverse reactions major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoieses (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. 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. to report suspected adverse reactions , contact par pharmaceutical at 1-866-828-9393 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

Pediatric Use:

Pediatric use because of postmarketing reports of severe liver injury in pediatric patients treated with propylthiouracil, methimazole is the preferred choice when an antithyroid drug is required for a pediatric patient. (see dosage and administration. )

Overdosage:

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 patientâs medical status.

Description:

Description methimazole (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. it differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. each tablet contains 5 or 10 mg (43.8 or 87.6 Î¼mol) methimazole, an orally administered antithyroid drug. each tablet also contains lactose monohydrate, magnesium stearate, corn starch, and talc. the molecular weight is 114.17, and the molecular formula is c 4 h 6 n 2 s. the structural formula is as follows: methimazole structural formula

Clinical Pharmacology:

Clinical pharmacology methimazole inhibits the synthesis of thyroid hormones and thus is effective in the treatment of hyperthyroidism. the drug does not inactivate existing thyroxine and triiodothyronine that are stored in the thyroid or circulating in the blood nor does it interfere with the effectiveness of thyroid hormones given by mouth or by injection. methimazole is readily absorbed in the gastrointestinal tract, metabolized in the liver, and excreted in the urine.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility in a 2 year study, rats were given methimazole at doses of 0.5, 3, and 18 mg/kg/day. these doses were 0.3, 2, and 12 times the 15 mg/day maximum human maintenance dose (when calculated on the basis of surface area). thyroid hyperplasia, adenoma, and carcinoma developed in rats at the two higher doses. the clinical significance of these findings is unclear.

How Supplied:

How supplied methimazole tablets, usp 5 mg - white to off-white, round, flat-faced, bevelled-edged tablets, scored with âem/5â on one side and plain on the other. they are available in: bottles of 100 ndc 49884-640-01 bottles of 500 ndc 49884-640-05 methimazole tablets, usp 10 mg - white to off-white, round, flat-faced, bevelled-edged tablets, scored with âem/10â on one side and plain on the other. they are available in: bottles of 100 ndc 49884-641-01 bottles of 500 ndc 49884-641-05 store at controlled room temperature 15Â° to 30Â°c (59Â° to 86Â°f). dispense in tight, light-resistant container. manufactured and distributed by: par pharmaceutical chestnut ridge, ny 10977 revised: 01/16 os640-01-1-11

Information for Patients:

Information for patients patients should be advised that if they become pregnant or intend to become pregnant while taking an antithyroid drug, they should contact their physician immediately about their therapy.

Package Label Principal Display Panel:

Principal display panel - 5 mg ndc 49884-640-01 methimazole tablets, usp 5 mg rx only 100 tablets each tablet contains: methimazole ................................ 5 mg usual dosage: see package insert for dosage information. warning: this drug may cause toxic reactions. if such reactions occur, discontinue the drug. constant supervision of patient is essential. keep this and all drugs out of reach of children. dispense in a tight, light-resistant container. keep tightly closed. store at controlled room temperature 15Â° to 30Â°c (59Â° to 86Â°f). r12/15 la640-01-1-05 manufactured and distributed by: par pharmaceutical chestnut ridge, ny 10977 methimazole tablets, usp 5 mg bottle label

Principal display panel - 10 mg ndc 49884-261-01 methimazole tablets, usp 10 mg rx only 100 tablets each tablet contains: methimazole ................................ 10 mg usual dosage: see package insert for dosage information. warning: this drug may cause toxic reactions. if such reactions occur, discontinue the drug. constant supervision of patient is essential. keep this and all drugs out of reach of children. dispense in a tight, light-resistant container. keep tightly closed. store at controlled room temperature 15Â° to 30Â°c (59Â° to 86Â°f). r12/15 la641-01-1-05 manufactured and distributed by: par pharmaceutical chestnut ridge, ny 10977 methimazole tablets, usp 10 mg bottle label

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