COMPOSITION :
Rizatol® Film coated tablet 500 mg, each film coated tablet contains : Ethambutol HCl 500 mg.
DESCRIPTIONS :
Rizatol® contains Ethambutol HCl as active ingredients is available in film coated tablet 500 mg.
INDICATIONS :
Rizatol® is indicated in combination with other anti-tuberculosis drugs for tuberculosis treatment caused by Mycobacterium tuberculosis.
Rizatol® is also used in infections treatment caused by atypical mycobacteria, such as Mycobacterium avium complex.
DOSAGE AND ADMINISTRATIONS :
Tablets should be administered in combination with other antituberculosis drugs.
- Usual dose : 15 – 25 mg/kgBW daily as single dose.
- Initial treatment : Patients who have never received antituberculosis treatment previously, Rizatol® dose : 15 mg/kgBW in single dose every 24 hours. Can be administered concomitantly with single oral dose Isoniazid.
- Repeated treatment : Patients who had received antituberculosis treatment previously, Rizatol® dose : 25 mg/kgBW in single dose every 24 hours. Can be given with other sensitive anti tuberculosis concomitantly. Usually with a drug that has never been given before. After 60 days Rizatol® administration, Rizatol® dose become 15 mg/kgBW as a single dose.
During Rizatol® treatment with daily doses of 25 mg/kgBW, patients are advised to conduct an eye examination every month.
- Intermittent treatment : One of the alternative methods of administering Rizatol®, in case of initial treatment and repeated treatment, the dose that has been mentioned above that is 15 or 25 mg/kgBW for 2 months or more, depend on type and duration of disease and bacteriological and radiological response (or at least one negative sputum obtained). After that, Rizatol® can be administered at a dose of 50 mg/kgBW 2 times a week. When Rizatol® administered with Isoniazid, given at a dose of 14 mg/kgBW 2 times a week with Pyridoxine 10 mg for every 100 mg Isoniazid. Generally Isoniazid is given at a daily dose for adults is 300 mg, or 5 mg/kgBW/day. For children the usual daily dose is 5 – 20 mg daily/kgBW. Dosage is based on weight ranges that shown in the table.
Dosage table based on weight ranges :
| Dosage mg/kgBW | Dosage mg/kgBW | ||
| Body weight range
(kg) |
Daily dose
(mg) |
Body weight range
(kg) |
Daily dose
(mg) |
| < 37 | 500 | < 38 | 900 |
| 37 – 43 | 600 | 38 – 42 | 1000 |
| 43 – 50 | 700 | 42 – 45.5 | 1100 |
| 50 – 57 | 800 | 45.5 – 50 | 1200 |
| 57 – 64 | 900 | 50 – 54 | 1300 |
| 64 – 71 | 1000 | 54 – 58 | 1400 |
| 71 – 79 | 1100 | 58 – 62 | 1500 |
| 79 – 84 | 1200 | 62 – 67 | 1600 |
| 84 – 90 | 1300 | 67 – 71 | 1700 |
| 90 – 97 | 1400 | 71 – 75 | 1800 |
| >97 | 1500 | 75 – 79 | 1900 |
| 79 – 83 | 2000 | ||
| 83 – 87 | 2100 | ||
| 87 – 91 | 2200 | ||
Rizatol® can be administered with or without meal. Giving with food may increase gastrointestinal tolerability.
Impaired renal function : Rizatol® should be administered in caution in patients with impaired renal function.
The recommended dose :
| CrCl
(ml/minute) |
Dosage |
| < 30 | 15 – 20 mg, every 48 hours with monitoring Ethambutol HCl of plasma levels |
Other alternatively, the dose may be reduced :
| CrCl
(ml/minute) |
Dosage |
| 20 – 50 | Normal |
| 10 – 20 | 7.5 – 15 mg/kgBW/day |
| < 10 | 5 – 7.5 mg/kgBW/day |
Children and adolescents : There is no study about the relationship between age and the effects of Rizatol® in children under 13 years.
Duration of treatment :
Duration of antituberculosis treatment depends on the selected regimen, clinical condition of the patient, radiography response, the results of smear and culture and sensitivity testing of Mycobacterium tuberculosis isolates from patients or from the suspected source.
If treatment is interrupted, the treatment schedule should be extended depending on duration of drug lost, duration of treatment (initial or finale) or status of the patient.
OVERDOSAGE :
Symptoms : Anorexia, vomiting, indigestion, fever, headache, dizziness, hallucinations and/or visual impairment.
Treatment : Vomiting and gastric lavage would be useful if it happens within a few hours after taking the drug. Furthermore, hemodialysis or peritoneal dialysis may be performed. There is no specific antidote and the treatment is supportive.
CONTRAINDICATIONS :
- Patients who are hypersensitive against active substances or drug’s excipient.
- Optic neuritis patients.
- Patients who are not able to assess and report visual side effects or changes in visual function (such as children and unconscious patients).
WARNINGS AND PRECAUTIONS :
- Patients should report the case of visual impairment.
- Examination of visual function should be carried out before starting the treatment and every 4 weeks during treatment. Patients who have a visual impairment or renal function disorder, before treatment must perform visual function tests every two weeks or more often if necessary.
- Eye examination includes color blindness tests should be monitored against symptoms of toxicity in eye.
- Treatment with Ethambutol HCl should be stopped immediately in case of visual impairment and consult the doctor immediately.
- Ethambutol HCl eliminated through the renal, resulting in patients with renal impairment need dosage adjustments.
- Not recommended for use in children aged under 13 years.
- Liver toxicity including fatal case have been reported. Liver function assessment should be carried out at the initial treatment and periodically inspected.
- In the long-term treatment, advised to check the function of the renal, liver and hematopoietic periodically.
- In some patients must be aware the relationship between expected benefits and visual impairment that may occur.
- Pregnancy and lactation : Ethambutol HCl is not recommended in pregnant and lactating women, because the safety data is not yet known.
- Effects on driver and operate machinery : There is no study of the effects on ability to drive and operate machinery. However, it must be considered the side effects of Ethambutol HCl, especially eye toxicity.
PRESENTATION :
Rizatol® Film coated tablet 500 mg Box, 10 strips @ 10 film coated tablets
Reg. No. DKL8502307117A1
STORAGE :
STORE BELOW 30oC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
