Mac-Pas (Granules) Instructions for Use

Marketing Authorization Holder

Macleods Pharmaceuticals Ltd. (India)

ATC Code

J04AA01 (Aminosalicylic acid)

Active Substance

Aminosalicylate sodium (USP)

Dosage Form

Mac-Pas

Enteric-coated granules, 600 mg/1 g: pkg.

Dosage Form, Packaging, and Composition

4 g – laminated aluminum foil sachets (25) – cardboard boxes.
4 g – laminated aluminum foil sachets – cardboard boxes.
4 g – laminated aluminum foil sachets (10) – cardboard boxes.
100 g – aluminum foil sachets (1) with a measuring spoon – plastic containers.
5 g – laminated aluminum foil sachets (10) – cardboard boxes.
5 g – laminated aluminum foil sachets – cardboard boxes.
5 g – laminated aluminum foil sachets (25) – cardboard boxes.
5.34 g – laminated aluminum foil sachets (25) – cardboard boxes.
5.34 g – laminated aluminum foil sachets – cardboard boxes.
5.34 g – laminated aluminum foil sachets (10) – cardboard boxes.
6 g – laminated aluminum foil sachets (10) – cardboard boxes.
6 g – laminated aluminum foil sachets – cardboard boxes.
6 g – laminated aluminum foil sachets (25) – cardboard boxes.
6.67 g – laminated aluminum foil sachets (25) – cardboard boxes.
6.67 g – laminated aluminum foil sachets – cardboard boxes.
6.67 g – laminated aluminum foil sachets (10) – cardboard boxes.
8.34 g – laminated aluminum foil sachets (10) – cardboard boxes.
8.34 g – laminated aluminum foil sachets – cardboard boxes.
8.34 g – laminated aluminum foil sachets (25) – cardboard boxes.

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Antitubercular agent

Pharmacological Action

Antituberculosis drug, which is the sodium salt of aminosalicylic acid.

Aminosalicylate sodium (sodium para-aminosalicylate) 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.

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.

T_1/2 is 30 min.

The total clearance depends on both the rate of metabolism and renal excretion.

Indications

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

ICD codes

Dosage Regimen

Administer orally. Swallow the granules whole; do not crush or chew the enteric-coated granules.

For adult patients, the total daily dosage is 10 g to 12 g. Divide this daily dose into two or three separate administrations.

For pediatric patients, calculate the total daily dosage as 150 mg to 300 mg per kilogram of body weight. Divide this daily dose into three or four separate administrations.

Always use this drug in combination with other antituberculosis agents to prevent the rapid development of resistance.

Take doses at regular intervals to maintain a consistent plasma concentration.

For patients using the bulk container, use only the provided measuring spoon to ensure accurate dosing.

Adjust the frequency of administration based on individual patient tolerance to minimize gastrointestinal adverse reactions.

Monitor renal and hepatic function routinely during therapy, as dosage adjustments may be necessary in patients with impairment.

Discontinue use immediately if signs of severe hypersensitivity, hepatotoxicity, or blood dyscrasias appear.

Adverse Reactions

Possible nausea, vomiting, diarrhea, hypokalemia.

Rarely skin reactions, fever, arthralgia, lymphadenopathy, hepatosplenomegaly, 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 for use 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 glucosuria using reagents containing copper is impaired.

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 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.