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Phenazopyridine Hydrochloride

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Overview

What is Phenazopyridine Hydrochloride?

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.

Inactive Ingredients:



What does Phenazopyridine Hydrochloride look like?



What are the available doses of Phenazopyridine Hydrochloride?

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What should I talk to my health care provider before I take Phenazopyridine Hydrochloride?

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How should I use Phenazopyridine Hydrochloride?

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 Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See 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.


What interacts with Phenazopyridine Hydrochloride?

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.



What are the warnings of Phenazopyridine Hydrochloride?

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What are the precautions of Phenazopyridine Hydrochloride?

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 Phenazopyridine 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, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine 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 Phenazopyridine HCl. There are, however, no adequate and well controlled studies pregnant women. Because animal production 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 Phenazopyridine HCl, or its metabolites in human milk.


What are the side effects of Phenazopyridine Hydrochloride?

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 Section).


What should I look out for while using Phenazopyridine Hydrochloride?

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.


What might happen if I take too much Phenazopyridine Hydrochloride?

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 should I store and handle Phenazopyridine Hydrochloride?

RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.RISPERDAL Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.RISPERDAL 1 mg/mL Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.RISPERDAL M-TAB Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).Keep out of reach of children.Product: 50436-0701NDC: 50436-0701-1 9 TABLET, COATED in a BOTTLEProduct: 50436-0701NDC: 50436-0701-1 9 TABLET, COATED in a BOTTLE


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Clinical Information

Chemical Structure

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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.

Non-Clinical Toxicology
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.

Drug Interactions

Studies to evaluate possible interactions between naltrexone hydrochloride and drugs other than opiates have not been performed. Consequently, caution is advised if the concomitant administration of naltrexone hydrochloride and other drugs is required.

The safety and efficacy of concomitant use of naltrexone hydrochloride and disulfiram is unknown, and the concomitant use of two potentially hepatotoxic medications is not ordinarily recommended unless the probable benefits outweigh the known risks.

Lethargy and somnolence have been reported following doses of naltrexone hydrochloride and thioridazine.

Patients taking naltrexone hydrochloride may not benefit from opioid containing medicines, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. In an emergency situation when opioid analgesia must be administered to a patient receiving naltrexone hydrochloride, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged (see )

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 Phenazopyridine HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.

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 Section).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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