Azo Gantanol

Phenazopyridine Hydrochloride:

• Indications and usage
• Contraindications
• Adverse reactions
• Precautions
• Dosage and administration
• Overdosage
• How supplied
• Azo Gantanol (Phenazopyridine Hydrochloride) reviews

INDICATIONS AND USAGE

Azo Gantanol (Phenazopyridine Hydrochloride) 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 Azo Gantanol (Phenazopyridine Hydrochloride) 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 Azo Gantanol (Phenazopyridine Hydrochloride) 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 Azo Gantanol (Phenazopyridine Hydrochloride) HCl should not exceed two days because there is a lack of evidence that the combined administration of Azo Gantanol (Phenazopyridine Hydrochloride) HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)

CONTRAINDICATIONS

Azo Gantanol (Phenazopyridine Hydrochloride) HCl should not be used in patients who have previously exhibited sensitivity to it. The use of Azo Gantanol (Phenazopyridine Hydrochloride) HCl is contraindicated in patients with renal insufficiency.

ADVERSE REACTIONS

Headache, rash, pruritus and occasional gastrointestinal disturbance. At anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section).

PRECAUTIONS

precautions

General:

A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind.

NOTE: Patients should be informed that Azo Gantanol HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

Laboratory Test Interaction:

Due to its properties as an azo dye, Azo Gantanol (Phenazopyridine Hydrochloride) HCl may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term administration of Azo Gantanol (Phenazopyridine Hydrochloride) HCl has induced neoplasia in rats (large intestine) and mice (liver).

Although no association between Azo Gantanol (Phenazopyridine Hydrochloride) HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

Pregnancy Category B:

Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Azo Gantanol (Phenazopyridine Hydrochloride) HCl. There are, however, no adequate and 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:

No information is available on the appearance of Azo Gantanol (Phenazopyridine Hydrochloride) HCl, or its metabolites in human milk.

DOSAGE AND ADMINISTRATION

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.

200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Azo Gantanol (Phenazopyridine Hydrochloride) HCl should not exceed 2 days.

OVERDOSAGE

Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and “bite cells” (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

HOW SUPPLIED

100 mg Tablets: Supplied in bottles of 100 (NDC 60846-501-01) counts.

Appearance: Deep brown to maroon colored, round, film coated tablets debossed "PY" above "1" on one side and plain on the other.

200 mg Tablets: Supplied in bottles of 1-- (NDC 60846-502-01) counts.

Appearance: Deep brown to maroon colored, round, film coated tablets debossed "PY" 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).

Manufactured for:

Gemini Laboratories, LLC

Bridgewater, NJ 08807

Rev. 05-2015-01

Sulfamethoxazole:

• Azo Gantanol (Sulfamethoxazole) reviews

Indication: For the treatment bacterial infections causing bronchitis, prostatitis and urinary tract infections.

Azo Gantanol (Sulfamethoxazole) is a sulfonamide drug that inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA) for binding to dihydropteroate synthetase (dihydrofolate synthetase). Azo Gantanol (Sulfamethoxazole) is bacteriostatic in nature. Inhibition of dihydrofolic acid synthesis decreases the synthesis of bacterial nucleotides and DNA. Azo Gantanol (Sulfamethoxazole) is normally given in combination with Trimethoprim, a dihydrofolate reductase inhibitor, which inhibits the reduction of dihydrofolic acid to tetrahydrofolic acid. Studies have shown that bacterial resistance develops more slowly with the combination of the two drugs than with either Trimethoprim or Azo Gantanol (Sulfamethoxazole) alone.