PHENAZOPYRIDINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)

Available from:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Phenazopyridine HCL is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.) In p

Product summary:

Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. NDC 70934-740-12 100 mg, 12 count - Appearance: Reddish-brown, round, film coated tablets debossed "812" on one side and plain on the other. To report an adverse reaction, please contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENAZOPYRIDINE HYDROCHLORIDE- PHENAZOPYRIDINE HYDROCHLORIDE TABLET,
FILM COATED
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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PHENAZOPYRIDINE HYDROCHLORIDE
TABLETS, USP
RX ONLY
PHENAZOPYRIDINE HYDROCHLORIDE – WESTMINSTER PHARMACEUTICALS, LLC
Prescription Medications
PHENAZOPYRIDINE HYDROCHLORIDE, USP
PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE HYDROCHLORIDE TABLET
WESTMINSTER PHARMACEUTICALS LLC.
DISCLAIMER: This drug has not been found by FDA to be safe and
effective, and this labeling has not
been approved by FDA. Label 100 mg, Label 200 mg
RX ONLY
DESCRIPTION
Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly
bitter, crystalline powder. It has
a specific local analgesic effect in the urinary tract, promptly
relieving burning and pain.
Following is the structural formula:
Phenazopyridine HCl oral tablets contain the following inactive
ingredients: Crospovidone, Macrogol,
Polysorbate 80, Polyvinyl Alcohol, Talc.
CLINICAL PHARMACOLOGY
Phenazopyridine hydrochloride is excreted in the urine where it exerts
a topical analgesic effect on the
mucosa of the urinary tract. This action helps to relieve pain,
burning, urgency and frequency. The
precise mechanism of action is unknown.
PHARMACOKINETICS
The pharmacokinetic properties of Phenazopyridine hydrochloride have
not been determined.
Phenazopyridine and its metabolites are rapidly excreted by the
kidneys. In a small number of healthy
subjects, 90% of a 600 mg/day oral dose of Phenazopyridine
hydrochloride was eliminated in the urine
in 24 hours, 41% as unchanged drug and 49% as metabolites.
in 24 hours, 41% as unchanged drug and 49% as metabolites.
INDICATIONS AND USAGE
Phenazopyridine HCL is indicated for the symptomatic relief of pain,
burning, urgency frequency, and
other discomforts arising from irritation of the mucosa of the lower
urinary tr