MAC-PAS - instructions for use, dose, side effects, contraindications

Excipients: sodium disulfite (6.0 mg), calcium carbonate (18.0 mg), microcrystalline cellulose (130.0 mg), methylcellulose (15.0 mg), crospovidone (31.0 mg), hydrogenated vegetable oil (80, 0 mg), butylhydroxytoluene (0.02 mg).

Composition of the shell of granulesethyl cellulose (6.400 mg), stearic acid (22.655 mg), dibutyl phthalate (8.235 mg), methacrylic acid and methyl methacrylate copolymer [1: 2] (72.375 mg), titanium dioxide (7.275 mg), vegetable hydrogenated oil (1.760 mg), chocolate flavor (0,984mg).

Description:

Granules of cylindrical (rod-shaped) form from white to light beige in various sizes.

Pharmacotherapeutic group:Anti-tuberculosis drug

ATX: & nbsp

J.04.A.A.01 Aminosalicylic acid

Pharmacodynamics:

Aminosalicylic acid has a bacteriostatic effect against Mycobacterium tuberculosis, reduces the likelihood of bacterial resistance to streptomycin and isoniazid. The mechanism of action is associated with inhibition of the synthesis of folic acid and with the suppression of the formation of mycobacterium, a component of the mycobacterial wall, which leads to a decrease in the capture of iron M. tuberculosis. Aminosalicylic acid acts on the mycobacteria that are in the active state propagation, and virtually no effect on Mycobacterium in the resting stage. Slightly affects the pathogen, located intracellularly.

Under the influence of gastric juice aminosalicylic acid quickly turns into an inactive metabolite. Acid-resistant shell protects the granules from the destructive effects of gastric juice. In a neutral environment, for example, in the small intestine, the granule membrane dissolves and the drug releases.

Pharmacokinetics:

Characterized by high absorption; moderately penetrates into the cerebrospinal fluid (only with inflammation of the meninges). Easily passes the histohematological barriers and is distributed in the tissues. The mean time to reach the maximum plasma concentration (TC_max) is 6 hours (varies from 1.5 to 24 hours). The concentration of the drug 2 mg / ml in plasma persists for 7.9 hours (variability from 5 to 9 hours), and 1 mg / ml - on average, for 8.8 hours (variability from 6 to 11.5 hours). Binding to proteins - 50-60%. Metabolised in the liver and partially in the stomach. Half-life (T_1/2) is 0.5 to 1 hour. 80% of aminosalicylic acid is excreted by the kidneys, while 50% - in the form of an acetylated derivative. The total clearance depends on both the metabolic rate and the excretion of the kidneys.

Indications:

Tuberculosis of various forms and localizations, including tuberculosis with multiple drug resistance to other anti-tuberculosis drugs.

Contraindications:

- Individual intolerance to the drug;

- Hypersensitivity;

- Kidney and liver diseases (renal / hepatic insufficiency, hepatitis);

- Stomach ulcer and duodenal ulcer, enterocolitis (exacerbation),

- Myxedema (exacerbation);

- Epilepsy;

- Chronic heart failure;

- Lactation period.

Pregnancy and lactation:

MAK-PAS® can be used in pregnancy if the expected benefit to the mother exceeds the potential risk to the fetus.

If you need to use the drug MAK-PAS ® during lactation should stop breastfeeding.

Dosing and Administration:

Assign inward in the form of granules, which should be taken after meals, washed down with water, 9-12 grams per day, breaking into 2-3 doses, or as prescribed by the doctor (for lunch and dinner).

Children are prescribed 0.2 g / kg body weight per day in 3-4 doses (daily dose not more than 10 g). Exhausted adult patients (with a body weight of less than 50 kg), as well as with poor tolerance, the drug is prescribed in a dose of 6 g per day.

You can appoint the entire daily dose in one dose, but with poor tolerability, the daily dose is divided into 2-3 doses.

With concomitant diseases of the gastrointestinal tract and the initial forms of amyloidosis, the maximum daily dose is 4-6 g.

Side effects:

Decreased appetite, nausea, vomiting, flatulence, abdominal pain, diarrhea or constipation, hepatomegaly, increased activity of "liver" transaminases, hyperbilirubinemia; proteinuria, hematuria, crystalluria, partially expressed malabsorption syndrome. Rarely - thrombocytopenia, leukopenia (up to agranulocytosis), drug-induced hepatitis, B 12-deficient megaloblastic anemia.

Allergic reactions: dermatitis (urticaria, purpura, enanthema), eosinophilia, bronchospasm, arthralgia, fever.

With prolonged use in high doses or when exceeding the dose - hypothyroidism, goiter, myxedema.

Overdose:

No cases of an overdose of aminosalicylic acid were observed.

Interaction:

Aminosalicylic acid is compatible with other antituberculous drugs.

Aminosalicylic acid increases the concentration of isoniazid in the blood.

It is not recommended to have a joint reception with rifampicin, since aminosalicylic acid reduces its concentration. If necessary, joint therapy with rifampicin taking drugs should be divided: rifampicin - before breakfast, sodium aminosalicylate - after dinner and overnight.

Violates the absorption of erythromycin and lincomycin.

Disrupts the assimilation of cyanocobalamin (vitamin B₁₂) (risk of developing anemia). Suction of Vitamin B₁₂ when taking 5.0 g of aminosalicylic acid is broken by 55%, which leads to significant changes in red blood cells. Thus, when treating patients with aminosalicylic acid for more than 1 month, vitamin therapy is necessary B₁₂. Aminosalicylic acid can enhance the effect of anticoagulants (coumarin derivatives or indanedione).

Antacids do not interfere with drug absorption.

Special instructions:

Used in combination with other antituberculous drugs.

At the first sign indicating an allergic reaction, the drug should be immediately discontinued and desensitizing therapy should be performed.

During the treatment, it is necessary to systematically examine urine and blood and check the functional state of the liver (activity of "liver" transaminases).

Decreased kidney function against tuberculous intoxication or specific damage is not a contraindication to the appointment.The development of proteinuria and hematuria require a temporary discontinuation of the drug.

Effect on the ability to drive transp. cf. and fur:

Not installed.

Form release / dosage:

Granules coated with enteric coating, 600 mg / g.

Packaging:

For 100 g of the drug in aluminum bags, laminated from the outside, tightly sealed. Each pack in a plastic container together with instructions for use and a measuring spoon. The container is sealed with an aluminum membrane, the top is closed with a plastic cover.

4.0 grams, 5.0 grams, 5.34 grams, 5.52 grams, 6.0 grams, 6.67 grams, 6.7 grams, 8.34 grams, 9.2 grams of the drug in aluminum bags laminated to the outside. For 1, 10, 25, 50 or 100 packets together with instructions for use in a cardboard box.

When packing at a Russian enterprise (LLC Dobrolek, FGBU "RNTS named after NN Blokhin", JSC "Rafarma") 6.67 g of the drug in aluminum bags, laminated from the outside. For 25 packages, along with instructions for use in a cardboard box. Or by 8.34 g of the drug in aluminum bags laminated from the outside. For 10 packs together with instructions for use in a cardboard box.

For 100 g of the drug in aluminum bags, laminated from the outside, tightly sealed. Each pack in a plastic container together with instructions for use and a measuring spoon.The container is sealed with an aluminum membrane, the top is closed with a plastic cover.

Storage conditions:

List B.

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015260 / 01

Date of registration:13.08.2009 / 22.08.2016

Expiration Date:Unlimited

The owner of the registration certificate:McLeodz Pharmaceuticals Co., Ltd. McLeodz Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

MACLEODS PHARMACEUTICALS, Ltd. India

Representation: & nbspAdvansd Trading, OOOAdvansd Trading, OOO

Information update date: & nbsp25.03.2018

Illustrated instructions

Instructions

MAK-PAS® (MAC-PAS®)