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Simpas (Tablets) Instructions for Use

ATC Code

J04AA02 (Aminosalicylate sodium)

Active Substance

Aminosalicylate sodium (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Antitubercular agent

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. It has a weaker effect compared to other antituberculosis drugs.

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

Pharmacokinetics

Absorption is high. In case of meningeal inflammation, it penetrates into the cerebrospinal fluid to a moderate extent.

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

50% of the dose is determined in the urine as an acetylated derivative. T1/2 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

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 tablets orally. Always use in combination with other antituberculosis drugs to prevent the rapid development of resistance.

For adult patients, the total daily dose is 10 to 12 grams. Divide this daily dose into 2 or 3 separate administrations.

For pediatric patients, calculate the total daily dose as 150 to 300 mg per kg of body weight. Divide this daily dose into 3 or 4 separate administrations.

Adjust the dosage with particular caution in patients with any degree of renal or hepatic impairment. Monitor renal and hepatic function during therapy.

Take doses at regular intervals to maintain stable serum concentrations. Do not administer as monotherapy.

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 insufficiency, 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

Contraindicated during pregnancy.

Aminosalicylic acid is excreted in small amounts in breast milk.

Use in Hepatic Impairment

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

Use in Renal Impairment

Contraindicated in renal insufficiency. 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, the conduction of tests for glycosuria using reagents containing copper is impaired.

Drug Interactions

Aminosalicylic acid increases the T1/2 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 2°C (36°F) to 25°C (77°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

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Simpex Pharma, Pvt. Ltd. (India)

Manufactured By

Simpex Pharma, Pvt. Ltd. (India)

Labeled By

Pharma International Company Russia-CIS, LLC (Russia)

Dosage Form

Bottle Rx Icon Simpas Enteric-coated tablets, 2 g: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric-coated tablets pink, capsule-shaped; the tablet core is white or almost white on the break.

1 tab.
Sodium aminosalicylate dihydrate 2 g

Excipients: pregelatinized starch – 80 mg, sorbitol – 15 mg, copovidone – 10 mg, magnesium stearate – 9 mg, talc – 6 mg, croscarmellose sodium – 30 mg.

Excipients (shell): Acryl-Ease Pink – 220 mg (methacrylic acid and ethyl acrylate copolymer [1:1] – 40%, titanium dioxide – 14.83%, talc – 36.98%, triethyl citrate – 4.8%, colloidal silicon dioxide – 1.25%, sodium bicarbonate – 1.2%, iron oxide red dye – 0.3%, sodium lauryl sulfate – 0.5%, iron oxide yellow dye – 0.14%).

50 pcs. – polyethylene bags (1) – polyethylene bottles (1) – cardboard packs.
100 pcs. – polyethylene bags (1) – polyethylene bottles (1) – cardboard packs.

Marketing Authorization Holder

Simpex Pharma, Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Simpas Enteric-coated film-coated tablets, 1 g: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Enteric tablets, film-coated pink, capsule-shaped; the tablet core is white or almost white on the break.

1 tab.
Sodium aminosalicylate dihydrate (sodium para-aminosalicylate dihydrate) 1 g

Excipients: pregelatinized starch – 114 mg, sorbitol – 36 mg, copovidone – 8 mg, magnesium stearate – 6 mg, talc – 12 mg, croscarmellose sodium – 24 mg.

Excipients (shell): Acryl-Ease – 100 mg (methacrylic acid and ethyl acrylate copolymer [1:1] – 75.25 mg, titanium dioxide – 7.05 mg, talc – 6.3 mg, triethyl citrate – 7.8 mg, colloidal silicon dioxide – 1.2 mg, sodium bicarbonate – 1.7 mg, iron oxide red – 0.2 mg, sodium lauryl sulfate – 0.5 mg).

50 pcs. – polyethylene bags (1) – polyethylene bottles (1) – cardboard packs.
100 pcs. – polyethylene bags (1) – polyethylene bottles (1) – cardboard packs.

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