Phenazalgin, 100 mg 12 pcs

Pharmacotherapeutic group: Other drugs used in urology.

ATX code: G04BX06

Pharmacological properties

Pharmacodynamics

Phenazopyridine, being excreted with urine, affects the mucous membrane of the lower urinary tract, where it has a local analgesic effect. This action helps to reduce dysuric phenomena including: pain, burning, 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 eliminated from the body by the kidneys. At 90% within 24 hours of taking 600 mg of phenazopyridine per day, with 41% as unchanged drug and 49% as metabolite.

Indications

Symptomatic therapy of dysuria (including pain, burning, rapid urination) caused by irritation of the mucous membrane of the lower urinary tract due to infections, trauma, surgery, endoscopic procedures, use of a probe or catheter.

Active ingredient

Phenazopyridine

Composition

1 tablet contains:

Active ingredient:

phenazopyridine hydrochloride – 100.00 mg,

Excipients:

sodium carboxymethyl starch – 26 mg,

microcrystalline cellulose – 115.5 mg,

colloidal silica – 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 dye – 0.279 mg, iron oxide yellow dye – 0.763 mg, iron oxide red dye – 0.37 mg.

How to take, the dosage

Overly, whole, after meals, with a full glass of water, do not chew the tablets.

Adults: 2 tablets (200 mg) 3 times a day.

The duration of use is not more than 2 days (also in combination with antimicrobials).

The efficacy and safety of Phenazopyridine has not been established when used in children under 18 years of age and in persons older than 65 years of age.

If the patient accidentally misses taking Phenazopyridine, take it as soon as possible; if the patient remembers the unaccepted dose of the drug in the period immediately before taking the next dose, it should not be doubled.

Interaction

Concomitant administration may increase bioavailability of ciprofloxacin. There are no data on other drug interactions.

Phenazopyridine may be administered together with antimicrobial agents if necessary.

Special Instructions

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

In patients with glucose-6-phosphate dehydrogenase deficiency, administration of phenazopyridine may lead to erythrocyte hemolysis and development of methemoglobinemia.

Phenazopyridine use may cause dark orange or reddish staining of urine (with an alkaline reaction) and orange-red staining of feces.

A yellowish coloring of the skin or sclerae may indicate accumulation of phenazopyridine as a result of renal dysfunction or overdose or taking the drug for more than 2 days, which requires stopping the drug.

Wearing contact lenses should be avoided because phenazopyridine may cause staining of contact lenses.

Phenazopyridine treatment should not exceed 2 days. 2,3,6-triaminopyridine (one of the metabolites of phenazopyridine) has demonstrated the ability to damage transverse striated muscle cells and cardiomyocytes in toxicological studies. Caution is advised when using phenazopyridine in patients with heart disease and neuromuscular disease.

Phenazopyridine is contraindicated in patients with any liver disease.

Phenazopyridine is contraindicated in patients with renal failure. The possibility of age-related decreased renal function should be borne in mind. There are no data on the use of phenazopyridine in patients older than 65 years, including those with impaired renal function.

Phenazopyridine may cause changes in the results of urine tests carried out by colorimetric, photometric and fluorimetric methods (determination of ketone bodies, porphyrins, urobilinogen).

In case of adverse reactions it is necessary to stop using the drug and consult a physician immediately!

Influence on driving, operating machinery

Potential side effect such as dizziness should be taken into account. If dizziness occurs, refrain from performing the specified activities.

Contraindications

• high sensitivity to phenazopyridine and excipients of the drug;
• disorders of liver function;
• renal insufficiency;
• anemia and methemoglobinemia;
• breastfeeding period.
• renal failure;
• anemia and methemoglobinemia;
• period of breastfeeding (safety not established);
• children under 18 years of age

With caution

• deficiency of glucose-6-phosphate dehydrogenase;
• heart failure;
• nervous-muscular disease;
• pregnancy;
• age over 65 years (no experience of use).

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Side effects

According to the classification of the World Health Organization (WHO), adverse reactions are presented according to their frequency of occurrence: Very common (≥1/10); common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000) and very rare (< 1/10000), frequency unknown – the incidence could not be determined from available data.

Central nervous system disorders: rarely headache, dizziness, aseptic meningitis.

Gastrointestinal and hepatic disorders: rarely – nausea, vomiting, diarrhea; very rarely – acute hepatotoxicity (associated with drug overdose), jaundice.

Renal and urinary tract 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 (with glucose-6-phosphate dehydrogenase deficiency), sulfohemoglobinemia, neuropenia, leukopenia, pancytopenia.

Other disorders: rarely – staining of stools orange-red, staining of urine dark orange or reddish color; very rare with long-term use – change of pigmentation of the skin and sclerae with yellowish coloring, swelling of the face, upper and lower extremities; yellowing of the nails, visual disturbance, eye irritation, pain in the ears, reversible loss of color vision.

Overdose

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

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

Treatment: discontinue the drug, induce vomiting and other measures aimed at eliminating phenazopyridine from the body, as well as symptomatic therapy. Intravenous administration of 1% methylene blue solution (1-2 mg/kg) is advisable to eliminate methemoglobinemia and related symptoms.

Pregnancy use

There was no evidence of teratogenic action of phenazopyridine in experiment (administration together with sulfacitin in rats at a dose up to 110 mg/kg/day and in rabbits at a dose up to 39 mg/kg/day). However, due to limited clinical data on the use of phenazopyridine in pregnant women, and its ability to cross the placental barrier during pregnancy, the drug should be used under strict indications and only when the expected benefits to the mother exceed the potential risk to the fetus.

It is unknown whether phenazopyridine is excreted with breast milk; therefore, it is not recommended to use the drug during breast-feeding. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.