Methimazole

Chartwell Rx, Llc
Human Prescription Drug
NDC 62135-206

Methimazole is a human prescription drug labeled by 'Chartwell Rx, Llc'. National Drug Code (NDC) number for Methimazole is 62135-206. 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:	62135-206
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:	Chartwell Rx, Llc
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:	27 Mar, 2001
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 Dec, 2025
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:	ANDA040411
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:	31 Dec, 2023
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:	Chartwell RX, LLC
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.
UPC:	0362135206307 0362135206017 0362135205300 0362135205904 0362135205010 0362135206901 0362135206185 0362135205058 0362135205188
UPC stands for Universal Product Code.
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
62135-206-01	100 TABLET in 1 BOTTLE (62135-206-01)	04 Nov, 2021	N/A	No
62135-206-18	180 TABLET in 1 BOTTLE (62135-206-18)	04 Nov, 2021	N/A	No
62135-206-30	30 TABLET in 1 BOTTLE (62135-206-30)	04 Nov, 2021	N/A	No
62135-206-90	90 TABLET in 1 BOTTLE (62135-206-90)	04 Nov, 2021	N/A	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 lactose monohydrate silicon dioxide talc starch, corn anhydrous lactose magnesium stearate methimazole methimazole ce;36 methimazole methimazole lactose monohydrate silicon dioxide talc starch, corn anhydrous lactose magnesium stearate methimazole methimazole ce;37

Indications and Usage:

Indications and usage methimazole tablets, usp are 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 lo Read more...

west possible dose to control the maternal disease should be given. agranulocytosis agranulocytosis is potentially a 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 or aplastic anemia (pancytopenia), 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, pruritis, 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 ). vasculitis cases of vasculitis resulting in severe complications have been reported in patients receiving methimazole therapy. these cases of vasculitis include: leukocytoclastic cutaneous vasculitis, acute kidney injury and glomerulonephritis, alveolar/pulmonary hemorrhage, cns vasculitis, and neuropathy. most cases were associated with anti-neutrophilic cytoplasmic antibodies (anca)-positive vasculitis. in some cases, vasculitis resolved/improved with drug discontinuation; however, more severe cases required treatment with additional measures including corticosteroids, immunosuppressant therapy, and plasmapheresis. if vasculitis is suspected, discontinue therapy and initiate appropriate intervention.

Dosage and Administration:

Dosage and administration methimazole tablets, usp 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 mg 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 mg 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. there are reports of a vasculitis, often associated with the presence of anti-neutrophilic cytoplasmic antibodies (anca), resulting in severe complications (see warnings ).

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, usp (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 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole usp, an orally administered antithyroid drug. each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. the molecular weight is 114.16, and the molecular formula is c 4 h 6 n 2 s. the structural formula is as follows: image description

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 tri-iodothyronine 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.

How Supplied:

How supplied methimazole tablets, usp, for oral administration, are available as 5 mg white, round scored tablet, de-bossed with "ce" over "36" on one side and functional score on the other side and supplied as: ndc 62135-205-30 bottles of 30 ndc 62135-205-90 bottles of 90 ndc 62135-205-01 bottles of 100 ndc 62135-205-18 bottles of 180 ndc 62135-205-05 bottles of 500 10 mg white, round scored tablet, de-bossed with "ce" over "37" on one side and functional score on the other side and supplied as: ndc 62135-206-30 bottles of 30 ndc 62135-206-90 bottles of 90 ndc 62135-206-01 bottles of 100 ndc 62135-206-18 bottles of 180

Package Label Principal Display Panel:

Package label.principal display panel methimazole tablets, usp 5 mg - ndc 62135-205-30 - 30 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-90 - 90 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-01 - 100 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-18 - 180 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-05 - 500 tablets label methimazole tablets, usp 10 mg - ndc 62135-206-30 - 30 tablets label methimazole tablets, usp 10 mg - ndc 62135-206-90 - 90 tablets label methimazole tablets, usp 10 mg - ndc 62135-206-01 - 100 tablets label methimazole tablets, usp 10 mg - ndc 62135-206-18 - 180 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-30 - 30 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-90 - 90 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-01 - 100 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-18 - 180 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-18 - 500 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-30 - 30 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-90 - 90 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-01 - 100 tablets label methimazole tablets, usp 5 mg - ndc 62135-205-18 - 180 tablets label

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