Created by
“RuzDesign”

25.09.2009

FORECOX (R + H + Z + E)

FORECOX
Fixed – dose combination drug
INN: Rifampicin, Isoniazid, Pyrazinamide and Ethambutol

Since the inception of Macleods, we have always contributed significantly to fighting against Tuberculosis. Our endeavor has been to ensure availability of our products, all the time, at an economical cost. Every possible recommended dosage of R, H, E & Z, required by the Physician in the treatment of TB, are formulated by us. A path-breaking venture of bio-available Fixed Dose Combination of 4 drugs is one example which is formulated to take care of non-compliance of patient: a major cause for TB treatment failure. Macleods is the pioneer company in the world to launch a Four Drug Fixed Dose Combination of R, H, E & Z (FORECOX) & in correlating plasma bioavailability with urine excretion study for Rifampicin which is now endorsed by WHO & IUATLD. Fixed-dose combinations simplify treatment and simplify supply management and also minimize prescription errors. Fixed-dose combinations will guarantee that drugs need not be taken separately. Fixed-dose combinations thus reduce the potential of acquisition of drug resistance.

Fixed dose combination (FDC) formulations became popular in the treatment of tuberculosis (TB) because of the better patient compliance, reduced risk of monotherapy, and emergence of drug resistance in contrast to treatment with separate formulations of two to four first-line drugs. However, its successful implementation in national programs is limited by probable bioinequivalency of rifampicin if present in FDC form. In this regard, World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. Hence, bioequivalence study of four drug FDC tablet was conducted using 22 healthy male volunteers, according to WHO recommended protocol, to determine bioavailability of rifampicin, isonized and pyrazinamide compared to standard separate combination at the same dose level. The study was designed as two period, two treatment crossover experiment with a washout period of 1 week. Bioequivalence of rifampicin was estimated by plasma and urinary method for both rifampicin and its active metabolite, des-acetul rifampicin whereas isoniazid and pyrazinamide were estimated from plasma. Mean concentration time profiles and all the pharmacokinetic parameters of rifampicin, isoniazid and pyrazinamide from FDC tablet were comparable to individual formulations and passed the bioequivalence test with power of the test above 95%. Further, bioequivalence of both rifampicin and isoniazid shows that interaction of rifampicin and isoniazid in vitro is clinically insignificant. Thus, it was concluded that FDC formulation is bioequivalent for rifampicin, isoniazid and pyrazinamide and ensures the successful treatment of TB without comprising therapeutic efficacy of any of these components of anti-TB therapy. NIPER (National Institute of Pharmaceutical Education and Research) had undertaken the bioequivalence study on FORECOX. NIPER is one of the only two WHO accredited laboratories for conducting bioavailability / bioequivalence studies. In the studies, NIPER has concluded that Rifampicin in Forecox is bioequivalent to single drug formulations.

INDICATIONS: Pulmonary or extrapulmonary tuberculosis.

CONTRAINDICATIONS: Hypersensetivity, poor sight, epilepsy, disturbances of liver and kidneys, expressed atherosclerosis and contraindications to each of the ingredients.

PACKING: Tablets №   60, №    100; containing Rifampicin, Isoniazid, Pyrazinamide and Ethambutol. There are two variants of tablets 150 mg or 225 mg of Rifampicin, 75 mg or 150 mg of Isoniazid, 400 mg or 750 mg of Pyrazinamide, 275 mg or 400 mg of Ethambutol.

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