ROFACT

It is recommended that ROFACT (rifampin) be administered once daily on an empty stomach (one hour before a meal) to ensure optimum absorption. In the treatment of pulmonary tuberculosis, ROFACT must be given in conjunction with at least one other antituberculosis agent.

In general, therapy should be continued until bacterial conversion has been established and maximum clinical improvement has occurred. If a ROFACT - PAS combination therapy is employed, it is recommended that the two drugs be administered at intervals of 8-12 hours.

Usual adult and adolescent dose Tuberculosis: - in combination with other antituberculosis medications: oral, 600 mg once a day for the entire treatment period; or 10 mg per kg of body weight, up to 600 mg, two or three times a week, depending on the treatment regimen.

Meningococcal infection (prophylaxis): - oral, 600 mg two times a day for two days. In patients with impaired liver function, a daily dose of 8 mg/kg should not be exceeded. A daily dosage of 10 mg/kg of body weight is recommended for frail and elderly persons.

Usual pediatric dose Infants up to 1 month of age - Tuberculosis: in combination with other antituberculosis medications - oral, 10 to 20 mg per kg of body weight once a day; or 10 to 20 mg per kg of body weight, two or three times a week, depending on the treatment regimen.

Meningococcal infection (prophylaxis): oral, 5 mg per kg of body weight every twelve hours for two days. Children 1 month of age and over - Tuberculosis: in combination with other antituberculosis medications - oral, 10 to 20 mg per kg of body weight, up to 600 mg, once a day; or 10 to 20 mg per kg of body weight, up to 600 mg, two or three times a week, depending on the treatment regimen.

Meningococcal infection (prophylaxis): oral, 10 mg per kg of body weight every twelve hours for two days. The maximum daily dose should not exceed 600 mg. 95 g/mol Description: Rifampin is an orange to red-brown, tasteless, crystalline powder.

It is highly soluble in chloroform and methylene chloride, readily soluble in methyl alcohol and ethyl acetate, and poorly soluble in acetone and water. Its melting point is 183 to 188o C.

ROFACT® Prescribing Information Page 11 of 27 COMPOSITION:

ROFACT 150 and 300 mg capsules contain: • rifampicin, USP Non-medicinal ingredients: Croscarmellose Sodium, NF; Magnesium Stearate, NF; Sodium Lauryl Sulfate, NF; Talc, USP. AVAILABILITY ROFACT 150 mg capsules contain 150 mg of rifampicin, USP in a coni-snap #4 elongated, maroon opaque coloured capsule branded radial "ICN R11".

Bottles of 100. ROFACT 300 mg capsules contain 300 mg of rifampicin, USP in a lok-type #1 capsule with brown opaque cap and scarlet opaque body branded "ICN R12". Bottles of 100. 250 var. hominis 71/22 var. hominis 71/23 var. hominis 71/26 var.

hominis 71/27 var. hominis 72/32 var. hominis 72/33 var. hominis 72/36 var. hominis 72/37 var. hominis 72/38 var. hominis 72/39 var. 037 Tubercle bacilli displaying resistance to rifampin have been isolated occasionally from patients. Mycobacteria resistant to 80 μg/mL of rifampin have been observed in patients under treatment for tuberculosis.

To minimize the development of resistance, rifampin should be administered with at least one other effective antitubercular drug. Cross resistance between rifampin and other antituberculous drugs has not been observed except in the case of related rifamycins.

ROFACT® Prescribing Information Page 13 of 27 PHARMACOLOGY The absorption of rifampin takes place from the upper portion of the gastrointestinal tract. Average peak blood levels of about 7 μg/mL are reached between 2 and 4 hours following oral administration of a 600 mg dose, but there is considerable subject variability.

7 μg/mL at 1 1/2, 2, 4, and 8 hours post administration, respectively. The absorption of rifampin is significantly delayed by a meal as evidenced by a reduction in the 'area under the curve' and in peak blood concentrations. Absorption of rifampin is seriously delayed and hindered by PAS (see INDICATIONS AND CLINICAL USE).

In an analysis of the distribution of rifampin in the body following a single oral dose of 450 mg, the drug was detected in a number of organs and body fluids as presented in the following tables. Rifampin Levels in Human Tissues and Body Fluids After Oral Administration of a Single 450 mg Dose Organ & Body Fluid Hours after administration Serum Level mg/mL mcg/mL or mcg/g Lung 5 4,08 11-12 1,35 0,98 11-12 2,05 0,95 Cavern Fluid 16 1,80 Pleural Exudate 4 1,55 0,14 Cerebrospinal Fluid 4 9,40* 0,83 5,90** 0,33** 0,39** Ascitic Fluid 4 2,35 0,45 1,30 0,30 0,37 0,13 1,15 0,19 Spleen 15-16 0,56 0,47 Bile 6 7,50 183,00 Liver 6 […]