Clemastine Fumarate

Teva Pharmaceuticals Usa, Inc.
Human Prescription Drug
NDC 0093-0308

Clemastine Fumarate is a human prescription drug labeled by 'Teva Pharmaceuticals Usa, Inc.'. National Drug Code (NDC) number for Clemastine Fumarate is 0093-0308. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Clemastine Fumarate drug includes Clemastine Fumarate - 2.68 mg/1 . The currest status of Clemastine Fumarate drug is Active.

Drug Information:

Drug NDC:	0093-0308
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:	Clemastine Fumarate
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:	Clemastine Fumarate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Teva Pharmaceuticals Usa, 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:	CLEMASTINE FUMARATE - 2.68 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:	01 Apr, 1992
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 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:	ANDA073283
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:	Teva Pharmaceuticals USA, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	857461
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:	0300930308017
UPC stands for Universal Product Code.
UNII:	19259EGQ3D
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0093-0308-01	100 TABLET in 1 BOTTLE (0093-0308-01)	01 Apr, 1992	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

Clemastine Fumarate

Tablet
Teva Pharmaceuticals USA, Inc.
NDC: 0093-0308

Clemastine Fumarate

Syrup
Ayurax, LLC
NDC: 73308-358

Product Elements:

Clemastine fumarate clemastine fumarate clemastine fumarate clemastine silicon dioxide starch, corn lactose, unspecified form povidone k30 stearic acid 93;308

Drug Interactions:

Drug interactions mao inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Indications and Usage:

Indications and usage clemastine fumarate tablets usp, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. clemastine fumarate tablets usp, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. it should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.

Warnings:

Warnings antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. usage in children safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years. usage in pregnancy experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus. usage with cns depressants clemastine has additive effects with alcohol and other cns depressants (hypnotics, sedatives, tranquilizers, etc.). usage in activities requiring mental alertness patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. usage in the elderly (approximately 60 years or older) antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

Dosage and Administration:

Dosage and administration dosage should be individualized according to the needs and response of the patient. clemastine fumarate tablets 2.68 mg the maximum recommended dosage is one tablet three times daily. many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.

Contraindications:

Contraindications usage in nursing mothers because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. usage in lower respiratory disease antihistamines should not be used to treat lower respiratory tract symptoms including asthma. antihistamines are also contraindicated in the following conditions: hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure. monoamine oxidase inhibitor therapy (see drug interactions section).

Adverse Reactions:

Adverse reactions transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances. antihistaminic compounds it should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. the most frequent adverse reactions are italicized. general: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose, and throat. cardiovascular system: hypotension, headache, palpitations, tachycardia, extrasystoles. hematologic system: hemolytic anemia, thrombocytopenia, agranulocytosis. nervous system: sedation, sleepiness, dizziness, disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, ve Read more...

rtigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. gi system: epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation. gu system: urinary frequency, difficult urination, urinary retention, early menses. respiratory system: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Drug Interactions:

Drug interactions mao inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Overdosage:

Overdosage antihistamine overdosage reactions may vary from central nervous system depression to stimulation. stimulation is particularly likely in children. atropine-like signs and symptoms: dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. if vomiting has not occurred spontaneously the conscious patient should be induced to vomit. this is best done by having him drink a glass of water or milk after which he should be made to gag. precautions against aspiration must be taken, especially in infants and children. if vomiting is unsuccessful gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. isotonic and 1/2 isotonic saline is the lavage solution of choice. saline cathartics , such as milk of magnesia, by osmosis draw water into the bowel and therefore, are valuable for their action in rapid dilution of bowel content. stimulants should not be used. vasopressors may be used to treat hypotension.

Description:

Description clemastine belongs to the benzhydryl ether group of antihistaminic compounds. the chemical name is (+)-(2 r )-2-[2-[[( r )- p -chloro-Î±-methyl-Î±-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1). c 21 h 26 c1no . c 4 h 4 o 4 m.w. 459.97 each tablet for oral administration contains 2.68 mg of clemastine fumarate, usp. inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid. chemical structure for clemastine

Clinical Pharmacology:

Clinical pharmacology clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. antihistamines appear to compete with histamine for cell receptor sites on effector cells. the inherently long duration of antihistaminic effects of clemastine fumarate has been demonstrated in wheal and flare studies. in normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5 to 7 hours, persisted for 10 to 12 hours and, in some cases, for as long as 24 hours. pharmacokinetic studies in man utilizing 3 h and 14 c labeled compound demonstrates that: clemastine is rapidly and nearly completely absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2 to 4 hours, and urinary excretion is the major mode of elimination.

How Supplied:

How supplied clemastine fumarate tablets usp, 2.68 mg are white, round, scored tablets debossed with "93" and "308". tablets are packaged in bottles of 100. (ndc 0093-0308-01) store at 20 o to 25 o c (68 o to 77 o f) [see usp controlled room temperature]. dispense in a tight, light-resistant container as defined in the usp, with a child-resistant closure (as required). manufactured for: teva pharmaceuticals parsippany, nj 07054 rev. j 4/2022

Package Label Principal Display Panel:

Package/label display panel ndc 0093-0308-01 clemastine fumarate tablets, usp 2.68 mg rx only 100 tablets label

Comments/ Reviews:

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