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Flavoxate Hydrochloride
Overview
What is Flavoxate Hydrochloride?
Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.
Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4
-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C
H
NO
•HCl. The molecular weight is 427.94. The structural formula appears below.
Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, hypromellose, polydextrose, magnesium stearate, titanium dioxide and triacetin.
What does Flavoxate Hydrochloride look like?
What are the available doses of Flavoxate Hydrochloride?
Sorry No records found.
What should I talk to my health care provider before I take Flavoxate Hydrochloride?
Sorry No records found
How should I use Flavoxate Hydrochloride?
Flavoxate hydrochloride 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 hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
What interacts with Flavoxate Hydrochloride?
Flavoxate hydrochloride 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.
What are the warnings of Flavoxate Hydrochloride?
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What are the precautions of Flavoxate Hydrochloride?
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 hydrochloride have not been performed.
Pregnancy
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 hydrochloride. 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 Mothers
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 hydrochloride is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children below the age of 12 years have not been established.
What are the side effects of Flavoxate Hydrochloride?
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
Gastrointestinal:
CNS:
Hematologic:
Cardiovascular:
Allergic
Ophthalmic:
Renal:
What should I look out for while using Flavoxate Hydrochloride?
Flavoxate hydrochloride 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.
Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
What might happen if I take too much Flavoxate Hydrochloride?
The oral LD
for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD
for flavoxate hydrochloride in mice is 1837 mg/kg.
It is not known whether flavoxate hydrochloride is dialyzable.
How should I store and handle Flavoxate Hydrochloride?
Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] . Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ ” on one side and plain on the other side. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. NDC 50268-324-15 10 tablets per card, 5 cards per carton Dispensed in a blister punch material for Institutional Use Only. Manufactured for:AvPAK Mfg.AV. Rev.Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ ” on one side and plain on the other side. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. NDC 50268-324-15 10 tablets per card, 5 cards per carton Dispensed in a blister punch material for Institutional Use Only. Manufactured for:AvPAK Mfg.AV. Rev.Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ ” on one side and plain on the other side. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. NDC 50268-324-15 10 tablets per card, 5 cards per carton Dispensed in a blister punch material for Institutional Use Only. Manufactured for:AvPAK Mfg.AV. Rev.Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ ” on one side and plain on the other side. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. NDC 50268-324-15 10 tablets per card, 5 cards per carton Dispensed in a blister punch material for Institutional Use Only. Manufactured for:AvPAK Mfg.AV. Rev.Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “ ” on one side and plain on the other side. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. NDC 50268-324-15 10 tablets per card, 5 cards per carton Dispensed in a blister punch material for Institutional Use Only. Manufactured for:AvPAK Mfg.AV. Rev.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Flavoxate hydrochloride 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 hydrochloride was excreted in the urine within 24 hours.
Non-Clinical Toxicology
Flavoxate hydrochloride 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.Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.
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.
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
Gastrointestinal:
CNS:
Hematologic:
Cardiovascular:
Allergic
Ophthalmic:
Renal:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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