Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Only Rev. 2011 Phenazopyridine Hydrochloride - phenazopyridine hydrochloride tablets USP 100 mg and 200 mg Only
CAUTION
SPL UNCLASSIFIED SECTION
Federal law prohibits dispensing without prescription.
DESCRIPTION
DESCRIPTION SECTION
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. The Phenazopyridine HCL Granule DC 68% Blend contains the following inactive ingredients:- Pregelatinized Starch Maize (Corn Starch) Microcrystalline Cellulose (MCC) Silicon Dioxide Magnesium Stearate Croscarmellose Sodium Tablets are coated with the following:- Opadry II Brown Hydroxypropyl Methylcellulose (HPMC)
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
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
INDICATIONS & USAGE SECTION
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 HCI 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 Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section ).
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
Headache, rash, pruritus and occasional gastrointestinal disturbance. An 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 SECTION
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
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 Phenazopyridine HCl should not exceed 2 days. Call your doctor or physician for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS , contact Vilvet Pharmaceuticals, Inc at 888-705-4369 or FDA at 1-800-FDA-1088, www.fda.gov/medwatch.
OVERDOSAGE
OVERDOSAGE SECTION
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. If overdose is suspected, contact the poison control center at 1-800-222-1222, or your local emergency room immediately .
HOW SUPPLIED
HOW SUPPLIED SECTION
100 mg Tablets: Supplied in bottles of 100ct (NDC 71186-003-25 Appearance: Reddish-brown, round, film coated tablets, debossed "VIP102" on one side and plain on other side. 200 mg Tablets: Supplied in bottles of 100ct (NDC 71186-004-25) Appearance: Reddish-brown, round, film coated tablets, debossed "VIP103" on one side and plain on other side. DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
RX Only Manufactured for: Vilvet Pharmaceuticals, Inc (888) 705-4369 Rev. /2011
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vilvet Pharmaceutical Inc. NDC 71186-003-25 Phenazopyridine Hydrochloride Tablets, USP 100 mg Rx only 100 Tablets Vilvet Pharmaceuticals
PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vilvet Pharmaceutical Inc. NDC 71186-004-25 Phenazopyridine Hydrochloride Tablets, USP 200 mg Rx only 100 Tablets Vilvet Pharmaceuticals
