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Registered Kenya · PPB

RIFAMPICIN 150/ ISONIAZID 75 TABLETS

RIFAMPICIN 150/ ISONIAZID 75 TABLETS

H2007/18521 RIFAMPICIN 150/ ISONIAZID 75 TABLETS NEW/INNOVATOR antiinfectives for systemic use INN generic

What it does

Isoniazid is a medication used to treat tuberculosis, a serious infection that mainly affects the lungs.

Commonly used for: tuberculosis (TB), pulmonary tuberculosis

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2007/18521
Registration date
2026-04-01 16:37:00
Expiry date
2031 April 01
Status
Registered
Active ingredient
RIFAMPICIN 150/ ISONIAZID 75 TABLETS
Strength
-
Pack size
STRIPS
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
J04AM - Combinations of drugs for treatment of tuberculosis
RxNorm RxCUI
6038
Manufacturer / MAH
Reddys Pharma
Applicant / LTR
SVIZERA LABS PRIVATELIMITED
Country of origin
FOREIGN
Manufacturer location
P5CC+63J, Gajuwaka, Andhra Pradesh 530049, India

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:05:00 · updated 2026-09-18 02:10:39

Drug Interactions

292
Check interactions

Pharmacodynamic Warnings

Isoniazid appears in TABLE 1: Drugs that cause hepatotoxicity

Isoniazid appears in TABLE 12: Drugs that cause peripheral neuropathy

Severe (78)

Abemaciclib - decreases exposure

Rifampicin is predicted to markedly decrease the exposure to abemaciclib. Avoid.

Severe Study

Abiraterone - decreases exposure

Rifampicin is predicted to decrease the exposure to anti-androgens (abiraterone). Avoid.

Severe Study

Acalabrutinib - decreases exposure

Rifampicin is predicted to decrease the exposure to acalabrutinib. Avoid.

Severe Study

Anti-Androgens - decreases exposure

Rifampicin is predicted to decrease the exposure to anti-androgens (abiraterone). Avoid.

Severe Study

Antiarrhythmics - decreases exposure

Rifampicin is predicted to decrease the exposure to antiarrhythmics (disopyramide, dronedarone). Avoid.

Severe Study

Moderate (72)

Alprazolam - decreases exposure

Rifampicin is predicted to decrease the exposure to benzodiazepines (alprazolam). Adjust dose.

Moderate Theoretical

Amlodipine - decreases exposure

Rifampicin is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nimodipine). Monitor and adjust dose.

Moderate Study

Antiepileptics - decreases exposure

Rifampicin slightly decreases the exposure to antiepileptics (brivaracetam). Adjust dose.

Moderate Study

Antiepileptics - decreases concentration

Rifampicin decreases the concentration of antiepileptics (fosphenytoin, phenytoin). Use with caution and adjust dose.

Moderate Study

Antifungals,azoles - decreases exposure

Rifampicin slightly decreases the exposure to antifungals, azoles (fluconazole). Adjust dose.

Moderate Study

Unknown (142)

Abrocitinib - decreases exposure

Rifampicinispredictedtodecreasetheexposuretoabrocitinib. Avoid.oStudy

Unknown Study

Afatinib - decreases exposure

Rifampicin is predicted to decrease the exposure to afatinib.

Unknown Study

Agomelatine - decreases exposure

Rifampicinispredictedtodecreasetheexposureto agomelatine.oTheoretical

Unknown Theoretical

Alfentanil - decreases exposure

Rifampicin is predicted to decrease the exposure to opioids (alfentanil, fentanyl).

Unknown Study

Aliskiren - decreases exposure

Rifampicin decreases the exposure to aliskiren.

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About isoniazid

Isoniazid is a medication used to treat tuberculosis, a serious infection that mainly affects the lungs.

What it treats

  • tuberculosis (TB)
  • pulmonary tuberculosis

How it works

Isoniazid works by stopping the growth of bacteria that cause tuberculosis.

Who it's for

This medicine is for individuals diagnosed with tuberculosis.

Cautions

  • • Be cautious if you are taking other medications that can harm the liver.
  • • Be careful if you are using drugs that can cause nerve damage.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About rifampicin

Rifampicin is an antibiotic used to treat bacterial infections, especially tuberculosis.

What it treats

  • tuberculosis (TB)
  • bacterial infections

How it works

Rifampicin works by stopping the growth of bacteria, helping to clear infections from the body.

Who it's for

Rifampicin is for adults and children who have specific bacterial infections, particularly those with tuberculosis.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Isoniazid

BNF-referenced

Isoniazid is an antimycobacterial agent used primarily in the treatment and prevention of tuberculosis (TB). It functions as a prodrug that requires activation by bacterial catalase, leading to inhibition of mycolic acid synthesis, an essential component of the mycobacterial cell wall. Isoniazid is effective against actively dividing Mycobacterium tuberculosis and is known for its specificity towards mycobacterial infections.

Indications

  • Treatment of active tuberculosis
  • Prevention of tuberculosis in susceptible individuals, especially close contacts of infected persons

Dosage

Adults: 10 mg/kg daily (maximum per dose 300 mg) for 3 months, to be taken by mouth or via intramuscular or intravenous

Mechanism of action

Isoniazid is activated by the bacterial catalase-peroxidase KatG, which reduces the ferric form of the enzyme and enables it to react with oxygen to form an oxyferrous enzyme complex. The active form of isoniazid then inhibits the synthesis of mycolic acids by forming a covalent adduct with NAD, inhibiting the enoyl reductase InhA. This inhibition is crucial for the integrity of the mycobacterial cell wall, leading to the bactericidal activity of isoniazid against actively growing Mycobacterium tuberculosis.

Pharmacodynamics

Isoniazid is a bactericidal agent particularly effective against the Mycobacterium genus, including M. tuberculosis, M. bovis, and M. kansasii. It exhibits bactericidal properties during periods of rapid mycobacterial growth and becomes bacteriostatic when the bacteria are in a dormant state. Given its mechanism of action, isoniazid is highly selective, targeting mycobacteria without significant effects on other types of bacteria.

Pharmacokinetics

Isoniazid is well-absorbed following oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It is widely distributed in body tissues and crosses the blood-brain barrier. The drug is metabolized in the liver primarily through acetylation, with variable metabolism rates observed in different populations due to genetic polymorphisms in acetylation. The elimination half-life ranges from 1 to 4 hours, and the drug is excreted in the urine, predominantly as metabolites.

Contra-indications

  • History of hypersensitivity to isoniazid
  • Acute liver disease
  • Severe hepatic impairment
  • Previous history of isoniazid-induced liver injury

Adverse effects

  • Hepatitis
  • Peripheral neuropathy
  • Optic neuritis
  • Gastrointestinal disturbances
  • Rash
  • Fever
  • Agranulocytosis
  • Hematological disorders
  • Lupus-like syndrome

Interactions

  • Carbamazepine: Increased risk of hepatotoxicity
  • Cycloserine: Increased risk of CNS toxicity
  • Phenytoin: Increased concentration of phenytoin
  • Levodopa: Decreased effects of levodopa
  • Lomitapide: Increased exposure
  • Antiepileptics: Unknown interactions leading to increased concentrations

Precautions

  • Monitor liver function during treatment
  • Use with caution in patients with renal impairment
  • Patients with diabetes or a history of peripheral neuropathy should be monitored closely
  • Ocular monitoring for young children on treatment

Pregnancy

Not known to be harmful; however, prophylactic pyridoxine is recommended.

Breast-feeding

Amount too small to be harmful; monitor infant for possible toxicity.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Oral tablets
  • Oral suspension
  • Intramuscular injection
  • Intravenous injection
BNF 85 (British National Formulary) p.667 BNF for Children 2019-2020 p.404 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Rifampicin

BNF-referenced

Rifampicin is a bactericidal antibiotic that is primarily used to treat infections caused by mycobacteria, particularly tuberculosis. It works by inhibiting RNA synthesis in bacteria, making it effective against both intracellular and extracellular strains of Mycobacterium tuberculosis. It is often used in combination with other antitubercular agents to prevent the development of drug resistance.

Indications

  • Tuberculosis, in combination with other drugs
  • Prevention of tuberculosis in susceptible close contacts
  • Brucellosis in combination with other antibacterials
  • Legionnaires disease in combination with other antibacterials
  • Serious staphylococcal infections in combination with other antibacterials
  • Endocarditis in combination with other drugs

Dosage

Children: For children aged 1–11 years: 10 mg/kg every 12 hours (maximum per dose 600 mg

Adults: 600 mg daily for 6 months, or 600 mg every 12 hours for 2 days in specific conditions such as endocarditis.

Mechanism of action

Rifampicin binds to the beta-subunit of microbial DNA-dependent RNA polymerase, inhibiting the enzyme and impeding RNA synthesis. This action forms a stable drug-enzyme complex that suppresses the initiation of chain formation in RNA synthesis, although it does not affect chain elongation. Importantly, rifampicin has no activity against mammalian RNA polymerase, highlighting its selective antibacterial properties.

Pharmacodynamics

Rifampicin exhibits broad-spectrum antimicrobial activity, particularly against Mycobacterium tuberculosis. It is bactericidal, effective in killing both intracellular and extracellular bacteria. The drug's efficacy is enhanced when used in combination with other antitubercular medications, helping to reduce the risk of developing multi-drug resistant tuberculosis.

Pharmacokinetics

Rifampicin is well absorbed after oral administration, with peak plasma concentrations occurring within 2 to 4 hours. It is extensively metabolized in the liver, primarily by cytochrome P450 enzymes, and has a half-life of approximately 3 to 5 hours. The drug is excreted mainly in bile, with some renal excretion. It also has the potential to induce liver enzymes, which may affect the metabolism of co-administered drugs.

Contra-indications

  • Acute porphyrias
  • Jaundice

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhoea
  • Abdominal discomfort
  • Thrombocytopenia
  • Leucopenia
  • Acute kidney injury
  • Adrenal insufficiency
  • Agranulocytosis
  • Discoloration of soft contact lenses

Interactions

  • Severe interaction with atovaquone (increases exposure)
  • Severe interaction with abemaciclib (decreases exposure)
  • Severe interaction with acalabrutinib (decreases exposure)
  • Severe interaction with anti-androgens (decreases exposure)
  • Severe interaction with abiraterone (decreases exposure)
  • Severe interaction with darolutamide (decreases exposure)
  • Severe interaction with antiarrhythmics (decreases exposure)
  • Severe interaction with disopyramide (decreases exposure)
  • Severe interaction with dronedarone (decreases exposure)
  • Severe interaction with isavuconazole (decreases exposure)

Pregnancy

Rifampicin should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Rifampicin is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Oral capsules
  • Oral suspension
  • Injectable solution
BNF 85 (British National Formulary) p.662 BNF for Children 2019-2020 p.401 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Isoniazid

PubChem CID 3767

Molecular formula: C6H7N3O

Mechanism of action

Isoniazid is a prodrug and must be activated by bacterial catalase. Specficially, activation is associated with reduction of the mycobacterial ferric KatG catalase-peroxidase by hydrazine and reaction with oxygen to form an oxyferrous enzyme complex. Once activated, isoniazid inhibits the synthesis of mycoloic acids, an essential component of the bacterial cell wall. At therapeutic levels isoniazid is bacteriocidal against actively growing intracellular and extracellular <i>Mycobacterium tuberculosis</i> organisms. Specifically isoniazid inhibits InhA, the enoyl reductase from <i>Mycobacterium tuberculosis</i>, by forming a covalent adduct with the NAD cofactor. It is the INH-NAD adduct that acts as a slow, tight-binding competitive inhibitor of InhA. Although the mechanism of action of isoniazid is unknown, several hypotheses have been proposed. These include effects on lipids, nucleic acid biosynthesis, and glycolysis. ... /It has been suggested that/ a primary action of isoniazid /is/ to inhibit the biosynthesis of mycolic acids, important constituents of the mycobacterial cell wall. Because mycolic acids are unique to mycobacteria, this action would explain the high degree of selectivity of the antimicrobial activity of isoniazid. Exposure to isoniazid leads to a loss of acid fastness and a decrease in the quantity of methanol-extractable lipid of the microorganisms. Isoniazid is bacteriostatic for "resting" bacilli but is bactericidal for rapidly dividing microorganisms. The minimal tuberculostatic concentration is 0.025 to 0.05 ug/ml.

Pharmacodynamics

Isoniazid is a bactericidal agent active against organisms of the genus Mycobacterium, specifically <i>M. tuberculosis</i>, <i>M. bovis</i> and <i>M. kansasii</i>. It is a highly specific agent, ineffective against other microorganisms. Isoniazid is bactericidal when mycobacteria grow rapidly and bacteriostatic when they grow slowly.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: Rifampicin

PubChem CID 135398735

Molecular formula: C43H58N4O12

Mechanism of action

Rifampin works by binding to the beta-subunit of microbial DNA-dependent RNA polymerase (RNAP), thereby inhibiting the enzyme and impeding RNA synthesis. It reduces the affinity of RNAP for short RNA transcripts. It has no activity against the mammalian RNAP enzyme. Although rifampin is most active during cell multiplication ... /it/ appears to have some effect on resting cells. Electron microscopy has revealed changes in cytoplasm and disappearance of ribosomes in tubercle bacilli exposed to rifampin, indicating inhibition of DNA-dependent RNA polymerase. Rifampin inhibits DNA-dependent RNA polymerase of mycobacteria and other microorganisms by forming a stable drug-enzyme complex, leading to suppression of initiation of chain formation (but not chain elongation) in RNA synthesis. More specifically, the beta subunit of this complex enzyme is the site of action of the drug, although rifampin binds only to the holoenzyme. Nuclear RNA polymerase from a variety of eukaryotic cells does not bind rifampin, and RNA synthesis is correspondingly unaffected. While rifampin can inhibit RNA synthesis in mammalian mitochondria, considerably higher concentrations of the drug are required than for the inhibition of the bacterial enzyme. High concentrations of rifamycin antibiotics also inhibit viral DNA-dependent RNA polymerases and reverse transcriptases. Rifampin is bactericidal for both intracellular and extracellular microorganisms. Developmental expression of CYPlAl, CYPlA2 and CYP3A6 in the rabbit have been studied. Cytochromes P450IAl, P450IA2 and P450IIIA6 exhibited comparable patterns of developmental expression. Present at low level (less than 0.05 mnol/ng) in the new born animal up to week 3, these proteins sharply accumulated between weeks 3 and 4 to reach a maximum by week 4 (P450IAl, 0.2 nmol/mg; P450IA2, 0.8 nmol/ng; P450IIIA6, 0.12 nmol/mg) and decr in the adult (P450IAl, 0.2 nmol/mg; P450IA2, 0.4 mnol/mg; P450IIIA6, 0.09 nmol/mg). Cytochromes P450IAl and P450IA2 were not expressed in the untreated fetus. Onset of CYP3A6 gene expression occurred at day 30 of gestation and both transcription and mRNA accumulation were transplacentally inducible by rifampicin only shortly before birth, i.e. after treatment of the females between days 28 and 30 of gestation. Both long (1.85 kb) and short (1.7 kb) mRNA transcripts were expressed in untreated or rifampicin treated fetuses. CYP3A6 gene expression was also induced by rifampicin in l week old and 2 week old animals. Developmental expression of CYPlAl and CYPlA2 genes was shown to be closely related to the diet change accompanying weaning which occurs at weeks 3-4. In animals subjected to either delayed (week 6) or early (week 2) weaning, sharp accumulation of messages, proteins and related activities were delayed or anticipated accordingly with respect to normal weaning. Artificially scheduled weaning gave similar results when repeated with biological grade lucern (grown in the absence of chemical fertilizers, pesticides) ... the main constituent of commercial rabbit chow. While CYP3A6 gene expression could be brought forward by early weaning at week 2, both message and protein did not exhibit incr accumulation after delayed weaning at week 6, and remained at the low level of the new born animal. Treatment of l week old and 2 week old animals with triiodothyronine or of 3 week old animals with propylthiouracil, an antithyroid factor, did not modify the normal pattern of developmental expression of genes CYPlAl, CYPlA2 and CYP3A6. ...

Pharmacodynamics

Rifampin is an antimicrobial agent with bactericidal effects and a broad-spectrum activity. It is active against intracellular and extracellular _Mycobacterium tuberculosis_.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.