Phenazalgin^® (Tablets) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Manufactured By

OHFK, JSC (Russia)

ATC Code

G04BX06 (Phenazopyridine)

Active Substance

Phenazopyridine (Rec.INN registered by WHO)

Dosage Form

Phenazalgin®

Film-coated tablets, 100 mg: 6, 7, 10, 12, 14, 18, 20, 21, 24, 28, 30, 35, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brown in color, round, biconvex; on the cross-section, the core is brown with white specks, turns red upon exposure to air.

Excipients: sodium carboxymethyl starch – 26 mg, microcrystalline cellulose – 115.5 mg, colloidal silicon dioxide – 2.5 mg, talc – 3.75 mg, magnesium stearate – 2.25 mg.

Shell composition: hypromellose 6 – 3.9 mg, talc – 1.288 mg, polydextrose – 1.5 mg, titanium dioxide – 1.3 mg, macrogol 3350 – 0.6 mg, iron oxide black dye – 0.279 mg, iron oxide yellow dye – 0.763 mg, iron oxide red dye – 0.37 mg.

6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (3) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.
6 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

A drug with local analgesic action for use in urology

Pharmacotherapeutic Group

Other drugs used in urology

Pharmacological Action

Phenazopyridine, excreted in the urine, acts on the mucous membrane of the lower urinary tract, where it exerts a local analgesic effect. This helps reduce dysuric phenomena, including pain, burning, and frequent urination. The exact mechanism of action is unknown.

Pharmacokinetics

The pharmacokinetic properties of phenazopyridine have not been fully studied.

Phenazopyridine and its metabolites are rapidly excreted from the body by the kidneys: 90% within 24 hours when phenazopyridine is taken at a dose of 600 mg/day, with 41% as unchanged drug and 49% as a metabolite.

Indications

• Symptomatic therapy of dysuria (including pain, burning, frequent urination) caused by irritation of the mucous membrane of the lower urinary tract due to infections, injuries, surgical interventions, endoscopic procedures, use of a probe or catheter.

ICD codes

Dosage Regimen

The drug is taken orally after meals. The tablets should be swallowed whole, without chewing, and washed down with a full glass of water.

Adults are prescribed 2 tablets (200 mg) 3 times/day.

The duration of administration is no more than 2 days (including in combination with antimicrobial agents).

The efficacy and safety of phenazopyridine use in children and adolescents under 18 years of age and patients over 65 years of age have not been established.

If a dose is accidentally missed, it should be taken as soon as possible. If the patient remembers the missed dose just before the next dose is due, the dose should not be doubled.

Adverse Reactions

In accordance with the WHO classification, adverse reactions are presented according to their frequency of occurrence: very common (≥1/10); common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), frequency unknown – it was not possible to determine the frequency from the available data.

Nervous system disorders rare – headache, dizziness, aseptic meningitis.

Digestive system disorders rare – nausea, vomiting, diarrhea; very rare – acute hepatotoxicity (associated with drug overdose), jaundice.

Urinary system disorders uronephrolithiasis, acute nephrotoxicity (associated with drug overdose).

Immune system disorders rare – skin rash, itching, fever and other hypersensitivity reactions; very rare – bronchospasm.

Allergic reactions anaphylactoid reaction, allergic hepatitis.

Blood and lymphatic system disorders methemoglobinemia, hemolytic anemia (in glucose-6-phosphate dehydrogenase deficiency), sulfhemoglobinemia, neutropenia, leukopenia, pancytopenia.

Other rare – orange-red discoloration of feces, dark orange or reddish discoloration of urine; very rare with long-term use – change in skin and sclera pigmentation with yellowish discoloration, swelling of the face, upper and lower extremities; yellowing of nails, visual impairment, eye irritation, ear pain, reversible loss of color vision.

Contraindications

• Hypersensitivity to phenazopyridine and auxiliary components of the drug;
• Liver dysfunction;
• Renal failure;
• Anemia and methemoglobinemia;
• Breastfeeding period (safety not established);
• Age under 18 years.

With caution glucose-6-phosphate dehydrogenase deficiency, heart failure, neuromuscular diseases, pregnancy, age over 65 years (lack of experience in use).

Use in Pregnancy and Lactation

No data indicating the teratogenic effect of phenazopyridine were obtained in the experiment (administration together with sulfacytin to rats at a dose of up to 110 mg/kg/day and to rabbits at a dose of up to 39 mg/kg/day). However, due to the limited clinical data on the use of phenazopyridine in pregnant women, as well as its ability to cross the placental barrier, the drug should be used during pregnancy only for strict indications and only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is not known whether Phenazopyridine is excreted in breast milk, therefore the use of the drug during breastfeeding is not recommended. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

Use in Hepatic Impairment

Phenazopyridine is contraindicated in patients with any liver diseases.

Use in Renal Impairment

Phenazopyridine is contraindicated in patients with renal failure.

Pediatric Use

Contraindicated for use under 18 years of age.

Geriatric Use

The drug should be used with caution in patients over 65 years of age.

Special Precautions

The use of phenazopyridine to relieve dysuria symptoms due to infection should not delay diagnosis and the initiation of pathogenetic therapy. The drug should be used for symptomatic pain relief, not as a substitute for specific antimicrobial therapy.

In patients with glucose-6-phosphate dehydrogenase deficiency, the use of phenazopyridine may lead to hemolysis of red blood cells and the development of methemoglobinemia.

When using phenazopyridine, urine (with an alkaline reaction) may turn dark orange or reddish and feces may turn orange-red.

A yellowish color of the skin or sclera may indicate accumulation of phenazopyridine as a result of impaired renal function or overdose or taking the drug for more than 2 days, which requires discontinuation of the drug.

Wearing contact lenses should be avoided, as Phenazopyridine may cause staining of contact lenses.

The duration of treatment with phenazopyridine should not exceed 2 days.

2,3,6-triaminopyridine (one of the metabolites of phenazopyridine) in toxicological studies demonstrated the ability to damage striated muscle cells and cardiomyocytes. Caution is recommended when using phenazopyridine in patients with heart disease and neuromuscular diseases.

Phenazopyridine is contraindicated in patients with any liver diseases.

Phenazopyridine is contraindicated in patients with renal failure. The possibility of age-related decline in renal function should be taken into account. Data on the use of phenazopyridine in patients over 65 years of age, including those with impaired renal function, are lacking.

Phenazopyridine may cause changes in urine test results performed by colorimetric, photometric, and fluorimetric methods (determination of ketone bodies, porphyrins, urobilinogen).

If adverse reactions occur, the patient must stop using the drug and immediately consult a doctor.

Effect on the ability to drive vehicles and operate machinery

The potential for the development of such a side effect as dizziness should be taken into account. If dizziness occurs, one should refrain from performing these activities.

Overdose

Exceeding the recommended dose of phenazopyridine (especially in patients with reduced renal function, as well as in elderly patients) can lead to an increase in its serum concentration and the development of toxic reactions.

Symptoms methemoglobinemia (especially in patients with glucose-6-phosphate dehydrogenase deficiency), nephro- and hepatotoxic manifestations, as well as increased severity of other side effects of the drug.

Treatment discontinue the drug, induce vomiting and take other measures aimed at removing phenazopyridine from the body, symptomatic therapy is also recommended. To eliminate methemoglobinemia and associated symptoms, intravenous administration of a 1% solution of methylene blue (1-2 mg/kg) is advisable.

Drug Interactions

With simultaneous use, Phenazopyridine may increase the bioavailability of ciprofloxacin.

Information on interactions with other drugs is not available.

If necessary, Phenazopyridine can be prescribed in combination with antimicrobial drugs.

Storage Conditions

The drug should be stored out of the reach of children, in a light-protected place at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 5 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.