PHENAZOPYRIDINE HYDROCHLORIDE- phenazopyridine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

PHENAZOPYRIDINE HYDROCHLORIDE

Composition:

PHENAZOPYRIDINE HYDROCHLORIDE 100 mg

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 lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of

Product summary:

100 mg Tablets: Supplied in bottles of 10, 15 and 30 counts. Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “1” on one side and plain on the other. 200 mg Tablets: Supplied in bottles of 6, 9, 10, 15, 16, 30 and 100 counts. Appearance: Deep brown to maroon colored, round, film coated tablets debossed “AN” above “2” on one side and plain on the other. 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].

Authorization status:

unapproved drug other

Summary of Product characteristics

PHENAZOPYRIDINE HYDROCHLORIDE- PHENAZOPYRIDINE TABLET
REBEL DISTRIBUTORS CORP
_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
CAUTION: Federal law prohibits dispensing without prescription.
DESCRIPTION
Phenazopyridine Hydrochloride is light or dark red to dark violet,
odorless, slightly bitter, crystalline
powder. It has a specific local analgesic effect in the urinary tract,
promptly relieving burning and pain.
It has the following structural formula:
Phenazopyridine HCl tablets contain the following inactive
ingredients: carnauba wax, croscarmellose
sodium, hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, povidone,
pregelatinized starch.
CLINICAL PHARMACOLOGY
Phenazopyridine HCl 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 not known.
The pharmacokinetic properties of Phenazopyridine HCl have not been
determined. Phenazopyridine
HCl is rapidly excreted by the kidneys, with as much as 66% of an oral
dose being excreted unchanged
in the urine.
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain,
burning, urgency, frequency, and
other discomforts arising from irritation of the lower urinary tract
mucosa caused by infection, trauma,
surgery, endoscopic procedures, or the passage of sounds or catheters.
The use of Phenazopyridine
HCl for relief of symptoms should not delay definitive diagnosis and
treatment of causative conditions.
Because it provides only symptomatic relief, prompt appropriate
treatment of the cause of pain must be
instituted and Phenazopyridine HCl should be discontinued when
symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic
analges