Monopas (Granules) Instructions for Use
ATC Code
J04AA01 (Aminosalicylic acid)
Active Substance
Aminosalicylate sodium (USP Pharmacopeia)
Clinical-Pharmacological Group
Antituberculosis drug
Pharmacotherapeutic Group
Antitubercular agent
Pharmacological Action
Antituberculosis agent, which is the sodium salt of aminosalicylic acid. Aminosalicylate sodium (sodium para-aminosalicylate) 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 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
| 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 orally. Take granules after meals to minimize gastrointestinal irritation.
For adult patients, the total daily dosage is 10-12 grams. Divide this daily dose into 2-3 separate, equally sized administrations.
For pediatric patients, calculate the total daily dosage based on body weight: 150-300 mg per kg per day. Divide this calculated daily dose into 3-4 separate, equally sized administrations.
Always use this drug as part of a combination therapy regimen with other antituberculosis agents. Never use as monotherapy due to the rapid development of bacterial resistance.
For all patients, adjust the dosage and monitor closely when there is pre-existing renal impairment or hepatic impairment.
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
Use is 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 performance of tests for glycosuria that use 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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Granules, enteric-coated, 600 mg/1 g: 100 g sachets
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
 |
Monopas | Granules, enteric-coated, 600 mg/1 g: 100 g sachets |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 600 mg |
100 g – sachets (1) with a measuring spoon – cardboard packs.
Granules, enteric-coated, 600 mg/1 g: 4 g sachets: 1, 10, 50, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Monopas | Granules, enteric-coated, 600 mg/1 g: 4 g sachets: 1, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 4 g |
4 g – sachets (1) with a measuring spoon – cardboard packs.
4 g – sachets (10) with a measuring spoon – cardboard packs.
4 g – sachets (25) with a measuring spoon – cardboard packs.
4 g – sachets (50) with a measuring spoon – cardboard packs.
4 g – sachets (100) with a measuring spoon – cardboard packs.
Granules, enteric-coated, 600 mg/1 g: 6.67 g sachets: 1, 10, 50, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Monopas | Granules, enteric-coated, 600 mg/1 g: 6.67 g sachets: 1, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 600 mg |
6.67 g – sachets (1) with a measuring spoon – cardboard packs.
6.67 g – sachets (10) with a measuring spoon – cardboard packs.
6.67 g – sachets (25) with a measuring spoon – cardboard packs.
6.67 g – sachets (50) with a measuring spoon – cardboard packs.
6.67 g – sachets (100) with a measuring spoon – cardboard packs.
Granules, enteric-coated, 600 mg/1 g: 5 g sachets: 1, 10, 50, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Monopas | Granules, enteric-coated, 600 mg/1 g: 5 g sachets: 1, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 5 g |
5 g – sachets (1) with a measuring spoon – cardboard packs.
5 g – sachets (10) with a measuring spoon – cardboard packs.
5 g – sachets (25) with a measuring spoon – cardboard packs.
5 g – sachets (50) with a measuring spoon – cardboard packs.
5 g – sachets (100) with a measuring spoon – cardboard packs.
Granules, enteric-coated, 600 mg/1 g: 5.34 g sachets: 1, 10, 50, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Monopas | Granules, enteric-coated, 600 mg/1 g: 5.34 g sachets: 1, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 5.34 g |
5.34 g – sachets (1) with a measuring spoon – cardboard packs.
5.34 g – sachets (10) with a measuring spoon – cardboard packs.
5.34 g – sachets (25) with a measuring spoon – cardboard packs.
5.34 g – sachets (50) with a measuring spoon – cardboard packs.
5.34 g – sachets (100) with a measuring spoon – cardboard packs.
Granules, enteric-coated, 600 mg/1 g: 8.34 g sachets: 1, 10, 50, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Monopas | Granules, enteric-coated, 600 mg/1 g: 8.34 g sachets: 1, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 600 mg |
8.34 g – sachets (1) with a measuring spoon – cardboard packs.
8.34 g – sachets (10) with a measuring spoon – cardboard packs.
8.34 g – sachets (25) with a measuring spoon – cardboard packs.
8.34 g – sachets (50) with a measuring spoon – cardboard packs.
8.34 g – sachets (100) with a measuring spoon – cardboard packs.
Granules, enteric-coated, 600 mg/1 g: 6.7 g sachets: 1, 10, 50, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Monopas | Granules, enteric-coated, 600 mg/1 g: 6.7 g sachets: 1, 10, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Granules, enteric-coated | 1 g |
| Sodium para-aminosalicylate | 600 mg |
6.67 g – sachets (1) with a measuring spoon – cardboard packs.
6.67 g – sachets (10) with a measuring spoon – cardboard packs.
6.67 g – sachets (25) with a measuring spoon – cardboard packs.
6.67 g – sachets (50) with a measuring spoon – cardboard packs.
6.67 g – sachets (100) with a measuring spoon – cardboard packs.
![Monopas [Granules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Monopas [Granules] 2")