PHENAZOPYRIDINE HYDROCHLORIDE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Northwind Pharmaceuticals, LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 patients w

Povzetek izdelek:

Dispense contents with 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]. Distributed in 1 bottle of 12 tablets and 1 bottle of 6 tablets. NDC 51655-340-87 100 mg, 6 count, 51655-340-27 100 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.

Status dovoljenje:

unapproved drug other

Lastnosti izdelka

PHENAZOPYRIDINE HYDROCHLORIDE- PHENAZOPYRIDINE HYDROCHLORIDE TABLET,
FILM COATED
NORTHWIND 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. 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:
Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose,
Polyethylene
Glycol, Polysorbate, Polyvinyl Alcohol, Pregelatinized Starch, PVPK30,
and 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.
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