INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PYRIDIUM

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

PYRIDIUM
(tablet)

COMPOSITION:
Each tablet contains 100 mg Phenazopyridine hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A: 18 Medicines acting on genito-urinary system.

PHARMACOLOGICAL ACTION:
Urinary tract analgesic. Phenazopyridine is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. Up to 90% of a dose is excreted within 24 hours, 65% as unchanged drug and the remainder as metabolites. One of the metabolites is paracetamol.

INDICATIONS:
Short term symptomatic relief of pain, burning, urgency and frequency arising from irritation of the lower urinary tract mucosa. These symptoms may result from infection, trauma, surgery, endoscopic procedures, or passage of sounds or catheters. The underlying cause of the irritation must be determined and treated (e.g. antibacterial therapy for infection).

CONTRA-INDICATIONS:
Hypersensitivity to phenazopyridine. Contra-indicated in glomerulonephritis, uraemia, impaired renal function and severe hepatitis. PYRIDIUM should not be used for repeated or prolonged treatment without full diagnostic investigation.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency-patients have an increased risk of severe haemolytic anaemia.
Safety in pregnancy and lactation has not been established.

WARNINGS:

1.	The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis of the underlying cause. Prompt appropriate treatment of the cause of pain must be instituted and phenazopyridine should be discontinued when symptoms are controlled.
2.	When phenazopyridine is used concurrently with an antibacterial agent in the treatment of a urinary tract infection, the duration of phenazopyridine therapy should not exceed 2 days.
3.	If symptoms persist or recur, a doctor should be consulted.

DOSAGE AND DIRECTIONS FOR USE:
Tablets should not be chewed.
Adults: Two tablets three times daily with or after meals.
When used concurrently with an antibacterial agent for the treatment of a urinary tract infection, the duration of PYRIDIUM therapy should not exceed two days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The following side-effects have been reported:
Central Nervous System: Headache.
Gastrointestinal: Nausea, vomiting and diarrhoea.
Dermatologic and Hypersensitivity: Rash, pruritus, discolouration, anaphylactoid reaction and hypersensitivity hepatitis.
Haematologic: Methaemoglobinaemia, haemolytic anaemia, potential haemolytic agent in G6PD deficiency, sulfhaemoglobinaemia.
Other: Visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, discolouration of body fluids, and aseptic meningitis.
Precautions:
PYRIDIUM produces an orange to red colour in the urine and faeces and may stain clothing*. Staining of contact lenses has been reported. A yellowish colour of the skin or sclerae may indicate accumulation of phenazopyridine resulting from impaired renal function and necessitates discontinuance of the drug.
PYRIDIUM may mask pathological conditions and interfere with laboratory test values using colourimetric, spectrophotometric or fluorometric analysis methods.
May cause false urine sugar and urine ketone test results in diabetics.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Exceeding the recommended dose in patients with normal renal function or administering the recommended dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions.
Methaemoglobinaemia generally follows a massive, acute overdose. Methylene blue, 1 to 2mg/kg bodyweight given intravenously as a 1% solution, may be used to treat the methaemoglobinaemia. This will usually lead to a reduction of the methaemoglobinaemia and disappearance of the cyanosis which is an aid in diagnosis.
Oxidative Heinz body haemolytic anaemia also may occur, and "bite cells" (degmacytes) may be present in a chronic overdosage situation. Red blood cell G6PD deficiency may predispose to haemolysis; however, haemolysis may occur at normal doses in patients with G6PD Mediterranean.
Hepatic impairment and occasional renal failure may also occur.
Treatment of overdosage is symptomatic and supportive.

IDENTIFICATION:
A dark maroon, round, smooth, biconvex sugar-coated tablet.

PRESENTATION:
Blisters of 25 tablets.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
H/18/1728

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 December 1996

*A 0,25% solution of sodium hydrosulphite (available from photographic development outlets) has been used to remove phenazopyridine stains.

        Revised: FEB00;JULY99;APRIL97

Updated on this site: January 2005
Source: Pharmaceutical Industry
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