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Therapeutic Index

ISOTENEX

Each tablet contains:

 

Composition:

Isoniazid (INH).................................................................300 mg

 

Indications:

Tuberculosis in children. Prophylaxis in children in contact with open cases.


 
Description:

Mechanism of action Isoniazid is a prodrug and must be activated by bacterial catalase. The active  form inhibits the synthesis of mycolic acid in the mycobacterial cell wall. Isoniazid reaches therapeutic concentrations in serum, cerebrospinal fluid (CSF), and within caseous granulomas. Isoniazid is metabolized in the liver via acetylation. There are two forms of the enzyme responsible for acetylation, so that some patients metabolize the drug quicker than others. Hence, the half-life is bimodal with peaks at 1 hour and 3 hours in the US population. The metabolites are excreted in the urine. Doses do not usually have to be adjusted in case of renal failure. Isoniazid is bactericidal to rapidly-dividing mycobacteria, but is bacteriostatic if the mycobacterium is slow-growing. Side effects Adverse reactions include rash, abnormal liver function tests, hepatitis, sideroblastic anemia, peripheral neuropathy, mild central nervous system (CNS) effects, and drug interactions resulting in increased phenytoin (Dilantin) or disulfiram (Antabuse) levels. Peripheral neuropathy and CNS effects are associated with the use of isoniazid and are due to pyridoxine (vitamin B6) depletion, but are uncommon at doses of 5 mg/kg. Persons with conditions in which neuropathy is common (e.g., diabetes, uremia, alcoholism, malnutrition, HIV-infection), as well as pregnant women and persons with a seizure disorder, may be given pyridoxine (vitamin B6) (10-50 mg/day) with isoniazid. Hepatoxicity can be avoided with close Clinical monitoring of the patient, Specifically Nausea, Vomiting, Abdominal pain and appetite. INH therapy will also decrease the efficacy of hormonal birth control.

 

Side effects

Adverse reactions include rash, abnormal liver function tests, hepatitis, sideroblastic anemia, peripheral neuropathy, mild central nervous system (CNS) effects, and drug interactions resulting in increased phenytoin (Dilantin) or disulfiram (Antabuse) levels.

Peripheral neuropathy and CNS effects are associated with the use of isoniazid and are due to pyridoxine (vitamin B6) depletion, but are uncommon at doses of 5 mg/kg. Persons with conditions in which neuropathy is common (e.g., diabetes, uremia, alcoholism, malnutrition, HIV-infection), as well as pregnant women and persons with a seizure disorder, may be given pyridoxine (vitamin B6) (10-50 mg/day) with isoniazid.

 Hepatoxicity can be avoided with close Clinical monitoring of the patient, Specifically Nausea, Vomiting, Abdominal pain and appetite.

INH therapy will also decrease the efficacy of hormonal birth control.

Dosage : Adults: 3-5mg/kg body-wt. upto 300mg daily in a single dose. 

           Children: 10-20mg/kg body-wt. daily in single doses.

Presentations:                10 tablets             
                                              
MRP         Retailer        Stockiest
                                               4.95            3.96                3.56

 
 

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