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Products - Anti-tuberculosis

MOLECURE

Brand Name : MOLECURE 1

Generic:

1 pack
Isobutol 532mg caspsule + Rifampicin 450mg capsule + PZA (500mg X 3 tablets)

Brand Name : MOLECURE 2

Generic:

1 pack
Isobutol 532mg caspsule + Rifampicin 450mg capsule

Indication:

Treatment of all forms of pulmonary and extrapulmonary TB.

Dosage:

First 2 months: MOLECURE 1 One (1) pack daily
Succeeding 4 months: MOLECURE 2 One(1) pack daily

Presentation:

MOLECURE 1 blister pack (20's)
MOLECURE 2 blister pack (20's)

Therapeutic Class.:

Systemic anti-infectious: anti-TB.

Actions:

ISOBUTOL acts on the Koch's bacillus at 2 levels 1) it inhibits the mechanism of oxidation of the bacillus. 2) it interferes with nucleic acid formation inside the bacillus. With Isobutol the therapeutic levels of isoniazid and ethambutol are extended. Isobutol therapeutic levels in blood maintains up to 18 hours after its administration. After 24 hours, it can still be detected in the bloos. This slowing down if the biodegradation and elimination allows an increase in the bioavailability of Isobutol, that is, as the therapeutic levels in the blood remain higher and longer.

RIFAMPICIN's antimicrobial action has been attributed to the formation of all complexes with ribonucleic acid (RNA) polymerase causing it to inhibit RNA synthesis. It does not, however, react with mammalian enzyme. Rifampicin must not be given as monotherapy as a relatively rapid "one step" selection resistance may occur.

PYRAZINAMIDE is active and bactericidal against mycobacteria slowly growing in acidic media like caseous foci, pulmonary cavities and the aerophasages. In order to prevent bacterial resistance, pyrazinamide should not be used as monotherapy.

Contraindication:

ISOBUTOL. To be used under strict medical supervision when using high doses in patients with impaired urinary excretion. In cases of epileptic patients, it must be administered with caution. It should not be given to patients with drug induced liver disease.

RIFAMPICIN. Administration of rifampicin should be avoided during pregnancy because teratogenicity have been observed in animals. Also, in patients with jaundice and those with history of previous hypersensitivity reactions to any of the rifampicins.

PYRAZINAMIDE. Do not administer to patients with severe acute or chronic liver disorder or in patients with renal dysfunction or gout. The drug should not be given to pregnant or nursing mother.

Precautions:

The therapeutic benefits must be weighed against all possible risk when administering these drugs in patients with chronic liver disease, also in chronic alcoholics and undernourished patients. Adjust dosage levels for patient with decreased renal functions. Patients must be advised to abstain from alcohol during treatment.

Adverse Reactions:

ISOBUTOL. In the wide clinical experimentation made, Isobutol has shown to have good tolerance. Only sporadic cases of gastric alterations have appeared which, in general, do not compel to stop the treatment. The appearance of neuropathies and ocular alterations has not been described, which are frequent in treatments with the basic drugs of its molecules. However, if in any special case these symptoms appear, it is recommended to stop treatment.

RIFAMPICIN. Hypersensitivity reactions have been reported. Occasionally pruritus, rash, sore mouth and tongue, urticaria and exudative conjunctivitis are manifested. Gastrointestinal disturbances, fever and generalized numbness, allergic immunologic reactions are rare. Generally, these occur during intermittent therapy or when treatment was resumed following interruptions of daily dose regimen. These are however reversible upon discontinuation of the therapy. The reliability of all contraceptives may be affected in some patients being treated with rifampicin. Alternative contraceptive measures may be considered.

PYRAZINAMIDE. Hepatotoxicity is the most serious side effect of pyrazinamide therapy and its frequency appears to be related to dose and duration of treatment. With doses of 3g daily up to 15% of patients may show signs of liver damage, though the incidents is reported to be lower with currently recommended daily doses.

Other side-effects include anorexia, nausea, vomiting, arthalagia, malaise, fever, sideroblastic anemia, and dysuria. Hyperuricaemis, commonly occurs and may lead to attacks of gout.

Availability:

Molecure 1 - box of 20 blister packs
Molecure 2 - box of 20 blister packs

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