Flavoxate Hydrochloride

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Flavoxate Hydrochloride Recall

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Questions & Answers

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Side Effects & Adverse Reactions

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

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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.

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History

There is currently no drug history available for this drug.

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Other Information

Flavoxate hydrochloride 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.

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, magnesium stearate, hypromellose, polydextrose. titanium dioxide and triacetin.

Sources

Flavoxate Hydrochloride Manufacturers

Tagi Pharma, Inc.

Flavoxate Hydrochloride | Tagi Pharma, Inc.

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.

No Recall
Epic Pharma, Llc

Flavoxate Hydrochloride | Prasco Laboratories

Nitrofurantoin Oral Suspension should be given with food to improve drug absorption and, in some patients, tolerance.

Adults

50-100 mg four times a day -- the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients

5-7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

The following table is based on an average weight in each range receiving 5 to 6 mg/kg of body weight per 24 hours, given in four divided doses. It can be used to calculate an average dose of Nitrofurantoin Oral Suspension (25 mg/5mL) for pediatric patients.

Table 3: Pediatric Dosing Table

Weight in Kilograms (kg)

Pediatric Doses (milliliters) and Frequency

7 kg to 11 kg

2.5 mL Four times Daily

12 kg to 21 kg

5 mL Four times Daily

22 kg to 30 kg

7.5 mL Four times Daily

31 kg to 41 kg

10 mL Four times Daily

42 kg or greater

See Adult Dose

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50-100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG TERM THERAPY.

No Recall
Golden State Medical Supply, Inc.

Flavoxate Hydrochloride | Golden State Medical Supply, Inc.

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.

No Recall
Physicians Total Care, Inc.

Flavoxate Hydrochloride | Physicians Total Care, Inc.

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.

No Recall
Paddock Laboratories, Llc

Flavoxate Hydrochloride | Paddock Laboratories, Llc

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.

No Recall
Carilion Materials Management

Flavoxate Hydrochloride | Carilion Materials Management

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.

No Recall
Avpak

Flavoxate Hydrochloride | Avpak

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.

No Recall