Phenazalgin tablets p / o 100mg, No. 12

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

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

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

Duration of admission is no more than 2 days (including in combination with antimicrobial agents).

The efficacy and safety of Phenazopyridine when used in children under 18 and over 65 has not been established.

If you accidentally skip taking Phenazopyridine, you should take it as soon as possible, if the patient remembers about the missed dose of the drug in the period immediately before taking the next dose, then it should not be doubled.

for one tablet:

Active substance:

Phenazopyridine hydrochloride - 100.00 mg

Excipients:

Sodium carboxymethyl starch - 26 mg

Microcrystalline cellulose - 115.50 mg

Colloidal silicon dioxide - 2.50 mg

Talc - 3.75 mg

Magnesium stearate - 2.25 mg

Shell composition: 3900 mg

Hypromellose 6 - 1.288 mg

Talc - 1,500 mg

Polydextrose - 1,300 mg

Titanium dioxide - 0.600 mg

Macrogol 3350 - 0.279 mg

Iron dye black oxide - 0.763 mg

Iron dye yellow oxide - 0.370 mg

Iron dye oxide red

• hypersensitivity to phenazopyridine and auxiliary components of the drug;

• liver dysfunction;

• renal failure;

• anemia and methemoglobinemia;

• breastfeeding period (safety not established);

• children under 18 years of age

Carefully

• deficiency of glucose-6-phosphate dehydrogenase;

• heart failure;

• neuromuscular diseases;

• pregnancy;

• age over 65 years (no experience of use).

Trade name

PhenazalginЃ

International non-proprietary or group name

phenazopyridine

Dosage form

Film-coated tablets

Composition for one tablet:

Active substance:

Phenazopyridine hydrochloride - 100.00 mg

Excipients:

Sodium carboxymethyl starch - 26 mg

Microcrystalline cellulose - 115.50 mg

Colloidal silicon dioxide - 2.50 mg

Talc - 3.75 mg

Magnesium stearate - 2.25 mg

Shell composition: 3900 mg

Hypromellose 6 - 1.288 mg

Talc - 1,500 mg

Polydextrose - 1,300 mg

Titanium dioxide - 0.600 mg

Macrogol 3350 - 0.279 mg

Iron dye black oxide - 0.763 mg

Iron dye yellow oxide - 0.370 mg

Iron dye oxide red

Description

Round, biconvex, brown coated tablets, the cross section of the core is brown with white blotches, it turns red in air.

Pharmacotherapeutic group

Other drugs used in urology.

Pharmacological properties

Pharmacodynamics

Phenazopyridine, excreted in the urine, acts on the mucous membrane of the lower urinary tract, where it has a local analgesic effect. This action helps to reduce dysuria, including pain, burning sensation, and increased 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 by the kidneys. 90% during the day when taking 600 mg of phenazopyridine per day, with 41% in the form of an unchanged drug and 49% in the form of a metabolite.

Indications for use

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

Contraindications

• hypersensitivity to phenazopyridine and auxiliary components of the drug;

• liver dysfunction;

• renal failure;

• anemia and methemoglobinemia;

• breastfeeding period (safety not established);

• children under 18 years of age

Carefully

• deficiency of glucose-6-phosphate dehydrogenase;

• heart failure;

• neuromuscular diseases;

• pregnancy;

• age over 65 years (no experience of use).

Application during pregnancy and during breastfeeding

There were no data indicating that phenazopyridine had a teratogenic effect in the experiment (administration together with sulfacitin 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, in view of the limited clinical data on the use of phenazopyridine in pregnant women, as well as its ability to pass through the placental barrier during pregnancy, the drug should be used according to 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, and therefore it is not recommended to use the drug during breastfeeding. If it is necessary to use the drug during lactation, it is recommended to stop feeding.

Method of administration and dosage

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

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

Duration of admission is no more than 2 days (including in combination with antimicrobial agents).

The efficacy and safety of Phenazopyridine when used in children under 18 and over 65 has not been established.

If you accidentally skip taking Phenazopyridine, you should take it as soon as possible, if the patient remembers about the missed dose of the drug in the period immediately before taking the next dose, then it should not be doubled.

Side effect

In accordance with the classification of the World Health Organization (WHO), adverse reactions are presented in accordance with the frequency of their development: very often (? 1/10); often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10000, <1/1000) and very rarely (<1/10000), the frequency is unknown - according to the available data, it was not possible to establish the frequency of occurrence.

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

Gastrointestinal and liver 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: rarely - skin rash, itching, fever and other hypersensitivity reactions; very rarely - bronchospasm.

Allergic reactions: anaphylactoid reaction, allergic hepatitis.

Disturbances from the blood and lymphatic system: methemoglobinemia, hemolytic anemia (with a deficiency of glucose-6-phosphate dehydrogenase), sulfohemoglobinemia, neuropenia, leukopenia, pancytopenia.

Other violations: rarely - staining of feces in an orange-red color, staining of urine in a dark orange or reddish color; very rarely with prolonged use - a change in the pigmentation of the skin and sclera with a yellowish color, swelling of the face, upper and lower extremities; yellowing of nails, blurred vision, eye irritation, ear pain, 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) can lead to an increase in its concentration in the blood serum 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: cancel the drug, induce vomiting and take other measures aimed at removing phenazopyridine from the body, as well as symptomatic therapy. To eliminate methemoglobinemia and associated symptoms, intravenous administration of 1% methylene blue solution (1-2 mg / kg) is advisable.

Interaction with other medicinal products

When taken simultaneously, it may increase the bioavailability of ciprofloxacin. No other drug interactions have been reported.

If necessary, phenazopyridine can be administered in conjunction with antimicrobial drugs.

special instructions

The use of phenazopyridine to relieve symptoms of dysuria due to infection should not delay the 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 a deficiency of glucose-6-phosphate dehydrogenase, taking phenazopyridine can lead to hemolysis of erythrocytes and the development of methemoglobinemia.

When using phenazopyridine, it is possible to stain urine (with an alkaline reaction) in a dark orange or reddish color and feces in an orange-red color.

Yellowish 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 can cause staining of contact lenses.

Treatment with phenazopyridine should not exceed 2 days. 2,3,6-triaminopyridine (one of the metabolites of phenazopyridine) in toxicological studies has demonstrated the ability to damage striated muscle cells and cardiomyocytes. It is recommended to be careful when using phenazopyridine in patients with heart disease and neuromuscular diseases.

Phenazopyridine is contraindicated in patients with any liver disease.

Phenazopyridine is contraindicated in patients with renal impairment. It should be borne in mind the possibility of a decrease in kidney function associated with age. There are no data on the use of phenazopyridine in patients over 65 years of age, including those with impaired renal function.

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

If undesirable reactions occur, you must stop using the drug and immediately consult a doctor!

Influence on the ability to drive vehicles, mechanisms

The potential for side effects such as dizziness should be taken into account. If dizziness occurs, you should refrain from performing these activities.

Release form

Film-coated tablets, 100 mg.

On 6 or 7, or 10 tablets in a blister strip of PVC film and aluminum foil.

1, 2, 3, 4 or 5 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

Store in a dark place at a temperature not exceeding 30 ? C. Keep out of the reach of children!

Shelf life

5 years

Do not use the drug after the expiry date indicated on the package.

Vacation conditions

Dispensed by prescription.