Active ingredient: Phenazopyridine Hydrochloride

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Phenazopyridine Hydrochloride uses


INDICATIONS AND USAGE

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

CONTRAINDICATIONS

Phenazopyridine Hydrochloride HCl should not be used in patients who have previously exhibited sensitivity to it. The use of 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 Phenazopyridine Hydrochloride 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 Hydrochloride HCl may interfere with urinalysis based on spectrometry or color reactions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Although no association between 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 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 Phenazopyridine Hydrochloride HCl, or its metabolites in human milk.

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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 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

Phenazopyridine Hydrochloride available forms, composition, doses:


Indications and Usages:

ATC codes:


ICD-10 codes:


Phenazopyridine Hydrochloride destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."URISTAT UTI RELIEF PAK (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [INSIGHT PHARMACEUTICALS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "phenazopyridine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "phenazopyridine". http://www.drugbank.ca/drugs/DB0143... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Phenazopyridine Hydrochloride?

Depending on the reaction of the Phenazopyridine Hydrochloride after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Phenazopyridine Hydrochloride not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Phenazopyridine Hydrochloride addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Phenazopyridine Hydrochloride, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Phenazopyridine Hydrochloride consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Phenazopyridine Hydrochloride drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 51-100mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
51-100mg1
100.0%

One visitor reported time for results

What is the time duration Phenazopyridine Hydrochloride drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 3 days to notice the result from using Phenazopyridine Hydrochloride drug. The time needed to show improvement in health condition after using the medicine Phenazopyridine Hydrochloride need not be same for all the users. It varies based on other factors.
Visitors%
3 days1
100.0%

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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