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Name:Flavoxate Hydrochloride
Manufacturer:Global Pharmaceuticals
Category:Prescription Marketed Drugs


FLAVOXATE HYDROCHLORIDE TABLETS, 100 mg

FLAVOXATE HYDROCHLORIDE - flavoxate hydrochloride tablet, film coated 
Global Pharmaceuticals

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FLAVOXATE HYDROCHLORIDE TABLETS, 100 mg

Rx Only

DESCRIPTION

Flavoxate HCl tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C24H25NO4•HCl. The molecular weight is 427.94. The structural formula appears below.

Chemical Structure

Each tablet for oral administration contains 100 mg flavoxate hydrochloride. The tablet contains the following inactive ingredients: cellulose acetate phthalate aqueous dispersion, dibasic calcium phosphate dihydrate, magnesium stearate, pregelatinized starch. The film-coating material contains hypromellose and macrogol.

CLINICAL PHARMACOLOGY

Flavoxate HCl counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate HCl was excreted in the urine within 24 hours.

INDICATIONS AND USAGE

Flavoxate HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate HCl tablets are not indicated for definitive treatment, but is compatible with drugs used for the treatment of urinary tract infections.

CONTRAINDICATIONS

Flavoxate HCl is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

WARNINGS

Flavoxate HCl should be given cautiously in patients with suspected glaucoma.

PRECAUTIONS

Information for Patients

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate HCl have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mother

It is not known whether this drug is excreted in human milk Because many drugs are excreted in human milk, caution should be exercised when flavoxate HCl is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established.

ADVERSE REACTIONS

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

OVERDOSAGE

The oral LD50 for flavoxate HCl in rats is 4273 mg/kg. The oral LD50 for flavoxate HCl in mice is 1837 mg/kg.

It is not known whether flavoxate HCl is dialyzable.

DOSAGE AND ADMINISTRATION

Adults and children over 12 years of age

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

HOW SUPPLIED

Flavoxate Hydrochloride Tablets, 100 mg—Each off-white, film-coated, round, convex tablet debossed with "G" on one side and "181" on the other side.

Bottles of 100 NDC 0115-1811-01
Bottles of 500 NDC 0115-1811-02

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container (USP).

Mfg. by:
IMPAX Laboratories, Inc.
Hayward, CA 94544

Dist. by:
Global Pharmaceuticals
Division of IMPAX Laboratories, Inc.
Philadelphia, PA 19124

Rx Only

Rev. 8/03
239-03

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

GLOBAL®

NDC 0115-1811-01

Flavoxate
Hydrochloride
Tablets

100 mg

Rx only

100 TABLETS

PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label

FLAVOXATE HYDROCHLORIDE 
flavoxate hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1811
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLAVOXATE HYDROCHLORIDE (FLAVOXATE) FLAVOXATE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
STARCH, CORN  
CELLACEFATE  
MAGNESIUM STEARATE  
HYPROMELLOSE 2910 (6 CPS)  
POLYETHYLENE GLYCOL 400  
Product Characteristics
Color WHITE (off-white) Score no score
Shape ROUND (convex) Size 11mm
Flavor Imprint Code G;181
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1811-01 100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
2 NDC:0115-1811-02 500 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076234 08/28/2003

Labeler - Global Pharmaceuticals (116732830)
Establishment
Name Address ID/FEI Operations
Impax Laboratories Inc 790947167 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Global Pharmaceuticals 116732830 REPACK

Revised: 09/2010 Global Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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