Terizidone Macleods 250 Mg Capsules

Multidrug-resistant tuberculosis (MDR-TB). Treatment of MDR-TB in combination with other appropriate antimycobacterial medicines where sensitivity to TERIZIDONE MACLEODS 250 mg CAPSULES has been established.

Posology

Adults

One capsule every six to eight hours.

Method of administration

Oral use

• Hypersensitivity to terizidone, cicloserin or any of the excipients listed in section 6.1.
• Severe renal insufficiency.
• Epilepsy.
• Depression.
• Psychosis.
• Severe anxiety.
• Chronic alcoholism.
• Porphyria.

Warning: Neurological reactions are dose related and may be reduced by keeping the plasma concentrations below 30 u03bcg/ml. TERIZIDONE MACLEODS 250 mg CAPSULES should not be used as monotherapy in TB. TERIZIDONE MACLEODS 250 mg CAPSULES should be stopped if skin reactions or symptoms of neuro-toxicity develop (see Nervous system side effects). Large doses or the intake of alcohol increases the risk of seizures. Concurrent administration of pyridoxine has been suggested to prevent or relieve neurotoxic effects. Haematological, renal and hepatic functions should be monitored. Patients with mild to moderate renal impairment need lower doses.

Patients receiving TERIZIDONE MACLEODS 250 mg CAPSULES and taking alcohol are at an increased risk of convulsions. Neurotoxic effects may be potentiated by use of TERIZIDONE MACLEODS 250 mg CAPSULES with ethionamide, and concurrent use of TERIZIDONE MACLEODS 250 mg CAPSULES and isoniazid may result in increased CNS toxicity such as dizziness and drowsiness.

Pregnancy

Safety in pregnancy has not been established. TERIZIDONE MACLEODS 250 mg CAPSULES passes to the foetus, amniotic fluid, therefore should be avoided in pregnant women.

Breastfeeding

Safety in lactation has not been established. TERIZIDONE MACLEODS 250 mg CAPSULES should be avoided in breastfeeding women.

TERIZIDONE MACLEODS 250 mg CAPSULES may cause anxiety, disorientation, confusion, dizziness and drowsiness. Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery.

Tabulated list of adverse reactions

MedDRA System organ class

Frequency

Adverse reactions

Blood and lymphatic system disorders

Less frequent

Megaloblastic anaemia, sideroblastic anaemia

Immune system disorders

Less frequent

Hypersensitivity reactions

Metabolism and nutrition disorders

Less frequent

Folate and Vitamin B12 deficiency

Psychiatric disorders

Frequent

Depression, anxiety, confusion, disorientation, psychosis with suicidal tendencies, aggression, irritability, paranoia, mania.

Nervous system disorders

Less frequent

Dizziness, vertigo, headache, drowsiness, speech difficulties, tremor, paresis, hyperreflexia, dysarthria, paraesthesia, coma, convulsions.

Gastrointestinal disorders

Less frequent

Gastrointestinal irritation

Hepatobiliary disorders

Less frequent

Increase in serum aminotransferases (especially in patients with liver disease).

Skin and subcutaneous disorders

Less frequent

Skin reactions, photosensitivity.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Symptoms of overdose

Overdosage may lead to an accentuation of the side-effects listed above such as anxiety, confusion, somnolence, disorientation, depression, psychosis with suicidal tendencies, aggression, irritability and paranoia, vertigo, headache, drowsiness, speech difficulties, tremor, paresis, hyperreflexia, dysarthria, paraesthesia, coma, convulsions and heart failure, in which case a doctor should be consulted immediately.

Treatment of overdose

Treatment is symptomatic and supportive.