Rimstar 4 Special Precautions

Caution is advised in patients with impaired renal, liver and visual function, diabetes mellitus, chronic alcoholism and undernourished patients, in patients with a history of gout and in patients suffering from convulsive disorders and acute porphyria.
The ethambutol component causes Rimstar 4 not to be recommended for children <8 years and in patients who are not able to communicate visual disturbances out of other reasons. The main reason is that the visual disturbances that may occur as a result of using Rimstar 4 and that require immediate discontinuation of the therapy are difficult to diagnose in little children.
Blood counts and liver function tests (SGPT and SGOT) should be performed periodically (especially in prolonged treatment) and at baseline, if possible.
Patients with current chronic liver disease or impaired liver function should be treated with caution and under strict medical supervision. Careful monitoring of liver function should be carried out and attention should be paid to possible prodromal symptoms of hepatitis eg, fatigue, weakness, malaise, anorexia, nausea or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, treatment should be discontinued promptly. The occurrence of severe and sometimes fatal hepatitis-associated infections may develop even after many months of treatment.
The occurrence of peripheral neuritis may be prevented by pyridoxine.
In patients with visual defects, Rimstar 4 should be used with care. Ethambutol HCl may affect acuity, color discrimination and visual field. It is advised to check the visual ability before starting treatment and to monitor this ability during treatment. If disturbances arise, treatment should be discontinued.
During Intermittent Therapy and Resumption of Therapy after its Interruption: Both temporary interruption of treatment and noncompliance (if the medication is not taken regularly) should, if possible, be avoided as potentially serious side effects can occur. If severe acute hypersensitivity reactions set in eg, thrombocytopenia, purpura, hemolytic anemia, dyspnea and asthma-like attacks, shock or renal failure, or other signs of hypersensitivity appear eg, fever or skin reactions, Rimstar 4 should be withdrawn.
Contact the physician where temporary withdrawal of Rimstar 4 is unavoidable.
Effects on the Ability to Drive or Operate Machinery: The ability to drive or operate machinery may be influenced by doses of ≥10 mg/kg of isoniazid by adversely affecting the reactions of the nervous system eg, peripheral neuropathy.
Use in pregnancy & lactation: Rimstar 4 should not be given during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Administration of rifampicin during the last few weeks of pregnancy can cause postnatal hemorrhage in the mother and newborn infant. This may necessitate treatment with vitamin K preparations. Although rifampicin, isoniazid, pyrazinamide and ethambutol pass into breast milk, no adverse effects on breastfed infants have been observed.
Since it is theoretically possible that isoniazid might exert neurotoxic effects on the child, prophylactic administration of pyridoxine to the mother during pregnancy and to the mother and child during breastfeeding is recommended.