Pasconat (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

J04AA02 (Aminosalicylate sodium)

Active Substance

Aminosalicylate sodium (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Agents active against mycobacteria; antituberculosis agents; aminosalicylic acid and its derivatives

Pharmacological Action

Antituberculosis agent, which is the sodium salt of aminosalicylic acid. Aminosalicylate sodium (para-aminosalicylate sodium) has a bacteriostatic effect.

It is active only against Mycobacterium tuberculosis. Compared to other antituberculosis drugs, it has a weaker effect.

When used as monotherapy, resistance to aminosalicylic acid develops rapidly.

Pharmacokinetics

Absorption is high. With inflammation of the meninges, it penetrates into the cerebrospinal fluid to a moderate degree.

It easily passes through histohematic barriers and is distributed in tissues. It undergoes metabolism.

50% of the dose is determined in the urine as an acetylated derivative. T_1/2 is 30 min. The total clearance depends both on the rate of metabolism and on renal excretion.

Indications

Treatment of tuberculosis when it is not possible to use other, more potent agents.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A15	Respiratory tuberculosis, bacteriologically and histologically confirmed
A17	Tuberculosis of nervous system
A18	Tuberculosis of other organs

ICD-11 code	Indication
1B10.0	Respiratory tuberculosis, bacteriologically or histologically confirmed
1B11.Z	Tuberculosis of nervous system, unspecified
1B12	Tuberculosis of other systems and organs

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer Pasconat solution orally.

For adult patients, the total daily dosage is 10 to 12 grams.

Divide the total daily dose into two or three equally spaced administrations.

For pediatric patients, calculate the total daily dosage based on body weight: 150 to 300 mg per kg per day.

Divide the total daily pediatric dose into three or four equally spaced administrations.

Always use Pasconat in combination with other antituberculosis agents to prevent the development of resistance.

Adjust the dosage frequency for all patients based on individual gastrointestinal tolerance.

Monitor renal and hepatic function closely during therapy, especially in patients with pre-existing impairment.

Do not use as monotherapy due to the rapid development of bacterial resistance.

Adverse Reactions

Possible nausea, vomiting, diarrhea, hypokalemia.

Rarely skin reactions, fever, arthralgia, lymphadenopathy, hepatosplenomegaly, a syndrome similar to infectious mononucleosis, jaundice, encephalitis, renal failure, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, agranulocytosis, eosinophilia, leukopenia, thrombocytopenia.

In isolated cases psychoses.

With long-term use in high doses hypothyroidism, goiter.

Contraindications

Renal and/or hepatic failure, hepatitis, liver cirrhosis, amyloidosis of internal organs, gastric and duodenal ulcer, myxedema, epilepsy, pregnancy, hypersensitivity to aminosalicylic acid and its salts.

Use in Pregnancy and Lactation

Use during pregnancy is contraindicated.

Aminosalicylic acid is excreted in small amounts in breast milk.

Use in Hepatic Impairment

Contraindicated in hepatic failure, hepatitis, liver cirrhosis. Use with particular caution in patients with impaired liver function.

Use in Renal Impairment

Contraindicated in renal failure. Use with particular caution in patients with impaired renal function.

Pediatric Use

Used according to indications in children.

Geriatric Use

Use with caution, taking into account the state of renal function.

Special Precautions

Aminosalicylic acid and its salts should be used in combination with other antituberculosis drugs.

Use with particular caution in patients with impaired renal and liver function.

In the presence of aminosalicylates, tests for glycosuria that use reagents containing copper are disrupted.

Drug Interactions

Aminosalicylic acid increases the T_1/2 of isoniazid.

The side effects of aminosalicylates and salicylates are additive.

Probenecid may increase the toxicity of aminosalicylate by impairing its renal excretion and increasing plasma concentration.

Storage Conditions

Store at 8°C (46°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer