PYRIDIUM Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
PYRIDIUM.
Summary product information
Route of Administration Dosage Form/Strength Non-medicinal Ingredients oral Tablet 100 mg Core: Lactose monohydrate, pregelatinized corn starch, arabic gum, magnesium stearate, Aerosil 200, sodium carboxymethyl ...
Indications and clinical use
Adults (≥18 years old) PYRIDIUM (Phenazopyridine Hydrochloride) is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts resulting from irritation of the mucosa ...
Contraindications
PYRIDIUM is contraindicated in: patients who are hypersensitive to the drug or its ingredients. patients with renal insufficiency or any liver disease.
Warnings and precautions
Serious Warnings and Precautions A yellowish color of the skin or sclerae may indicate accumulation of phenazopyridine resulting from impaired renal function or overdose or taking the drug for more than ...
Adverse reactions
Adverse Drug Reaction Overview <u>Gastrointestinal:</u> nausea, vomiting and diarrhea. <u>Nervous System:</u> headache, aseptic meningitis. <u>Integumentary:</u> rash, pruritus, discoloration, jaundice. ...
Drug interactions
Drug-Drug Interactions The medical literature suggests that no significant interactions have been reported besides the one mentioned below <b>Table 1. Established or Potential Drug-Drug Interactions:</b> ...
Dosage and administration
Recommended Dose and Dosage Adjustment <u>Adults:</u> 200 mg 3 times daily after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration ...
Overdosage
For management of a suspected drug overdose contact your regional Poison Control Centre. Exceeding the recommended dose in patients with normal renal function or administering the recommended dose to patients ...
Action and clinical pharmacology
Mechanism of Action Phenazopyridine is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the lower urinary tract. This action helps to relieve pain, burning, urgency and ...
Storage and stability
Store at controlled room temperature, 15-30°C.
Dosage forms, composition and packaging
Composition <b>PYRIDIUM 100 mg:</b> Each light brown, round, biconvex coated tablet, contains: phenazopyridine HCl 100 mg. <u>Non-medicinal ingredients:</u> Core: Lactose monohydrate, pregelatinized corn ...
Pharmaceutical information
Drug Substance <u>Proper Name:</u> Phenazopyridine hydrochloride <u>Chemical Name:</u> 2, 6-pyridinediamine, 3-(phenylazo)-, monohydrochloride. <u>Empirical Formula:</u> C<sub>11</sub>H<sub>11</sub>N<sub> ...
Detailed pharmacology
Phenazopyridine Hydrochloride exerts a topical analgesic effect on the mucosa of the lower urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action ...
Toxicology
Toxic reactions to phenazopyridine, an azo dye, appear to be rare. Metabolism of phenazopyridine results in the formation of large quantities of aniline, and the production of methemoglobinemia by phenazopyridine ...
Marketing authorization holder
8250 Décarie Blvd, suite 110, Montréal, QC, Canada, H4P 2P5
Submission control number
232039
Date of revision
July 8, 2020
References
1: Alano FA Jr, Webster GD Jr. Acute renal failure and pigmentation due to phenazopyridine (Pyridium). Ann Intern Med. 1970 Jan;72(1):89-91. 2: Cahan DH. Phenazopyridine overdose and renal failure. JAMA. ...
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