Rifampicin/Isoniazid/Pyrazinamide Tablets USP 225mg/150mg/750mg


Rifampicin/Isoniazid/Pyrazinamide Tablets USP 120mg/50mg/300mg
Rifampicin/Isoniazid/Pyrazinamide Tablets USP 225mg/150mg/750mg

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Important things you need to know about Rifampicin/Isoniazid/Pyrazinamide Tablets

  • It is very important that you take Rifampicin/Isoniazid/Pyrazinamide Tablets exactly as your doctor has told you
  • You must keep taking it until your doctor tells you to stop
  • If you are taking any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows
  • Rifampicin/Isoniazid/Pyrazinamide Tablets make all your body fluids an orange or red colour. Do not worry – this is normal and not harmful
  • Take Rifampicin/Isoniazid/Pyrazinamide Tablets on an empty stomach. This means at least 30 minutes before food or 2 hours after food
  • While you are taking Rifampicin/Isoniazid/Pyrazinamide Tablets, you should not eat matured cheeses, cured meat, some fish (like tuna, salmon and mackerel) or drink wine and beer (see ?Taking Rifampicin/Isoniazid/Pyrazinamide Tablets with food and drink?)
  • If you get a temperature, are sick, begin to feel more unwell, lose your appetite or have yellowing of the skin, gums or eyes, you must talk to your doctor straight away

Read the rest of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet

  1. What Rifampicin/Isoniazid/Pyrazinamide Tablets are and what they are used for
  2. What you need to know before you take Rifampicin/Isoniazid/Pyrazinamide Tablets
  3. How to take Rifampicin/Isoniazid/Pyrazinamide Tablets
  4. Possible side effects
  5. How to store Rifampicin/Isoniazid/Pyrazinamide Tablets
  6. Contents of the pack and other information

  7. What Rifampicin/Isoniazid/Pyrazinamide Tablets are and what they are used for

Rifampicin/Isoniazid/Pyrazinamide Tablets contain three different medicines called Isoniazid, Rifampicin and Pyrazinamide. They all belong to a group of medicines called anti-tuberculous drugs. They work by killing the bacteria that cause tuberculosis.

Rifampicin/Isoniazid/Pyrazinamide Tablets are used to treat tuberculosis (also known as TB).

  • What you need to know before you take Rifampicin/Isoniazid/Pyrazinamide Tablets

Do not take Rifampicin/Isoniazid/Pyrazinamide Tablets if:

  • You are allergic (hypersensitive) to
  • Isoniazid
  • Rifampicin
  • Pyrazinamide
  • any of the other ingredients of the Rifampicin/Isoniazid/Pyrazinamide Tablets (see Section 6: Further information)
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • You have yellowing of the skin and eyes (jaundice)
  • You are taking saquinavir or ritonavir for an HIV infection (see ?Taking other medicines? section below)

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rifampicin/Isoniazid/Pyrazinamide Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifampicin/Isoniazid/Pyrazinamide Tablets

  • You have liver problems
  • You have any kidney problems and if you are having more than 600mg Rifampicin per day
  • You have diabetes. Your diabetes may become more difficult to control while taking this medicine
  • You have or have ever had gout (pain or swelling in the joints)
  • You are coughing up blood
  • You have epilepsy
  • You have or have ever had mental health problems (such as depression or schizophrenia)
  • You feel numb or weak in your arms and legs (peripheral neuropathy)
  • You have an HIV infection
  • You are underweight or malnourished
  • You drink alcohol every day or you are an alcoholic
  • You inject yourself with drugs
  • You are a black or Hispanic woman
  • You have a rare blood problem called ?porphyria?
  • You have a problem with bleeding or a tendency to bruise easily
  • You doctor has told you that your body takes a long time to get rid of some drugs (you have a slow acetylator status)
  • You wear contact lenses. Taking Rifampicin/Isoniazid/Pyrazinamide Tablets may permanently stain soft contact lenses
  • The person taking this medicine is a child
  • You are aged 65 years or older

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Rifampicin/Isoniazid/Pyrazinamide Tablets.

Blood Tests

Your doctor will need to check your blood before you take this medicine. This will help your doctor know if any changes happen to your blood after taking this medicine. If you are aged 35 years or older, you will also need to have monthly blood tests to check how your liver is working.

Take special care with Rifampicin/Isoniazid/Pyrazinamide Tablets

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of Rifampicin/Isoniazid/Pyrazinamide Tablets.

  • SJS/TEN can appear initially as reddish target spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
  • DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
  • AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities.

The highest risk for occurrence of serious skin reactions is within 2 days to 2 months after treatment initiation depending on the condition. If you develop a serious rash or another of these skin symptoms, stop taking Rifampicin/Isoniazid/Pyrazinamide Tablets and contact your doctor or seek medical attention immediately.

Other medicines and Rifampicin/Isoniazid/Pyrazinamide Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rifampicin/Isoniazid/Pyrazinamide Tablets can affect the way some other medicines work. Also, some medicines can affect the way Rifampicin/Isoniazid/Pyrazinamide Tablets work.

In particular, do not take this medicine, and tell your doctor, if you are taking:

  • Saquinavir or ritonavir used for HIV infection

The following medicines can make Rifampicin/Isoniazid/Pyrazinamide Tablets work less well:

  • Antacids used for indigestion. Take Rifampicin/Isoniazid/Pyrazinamide Tablets at least 1 hour before taking antacids
  • Other medicines used for TB such as P-aminosalicylic acid (PAS) and cycloserine. PAS and Rifampicin/Isoniazid/Pyrazinamide Tablets should be taken at least 8 hours apart

Tell your doctor if you are taking any of the following medicines:

Heart and blood medicines

  • Medicines for high blood pressure
  • Medicines for heart problems or to control your heartbeat
  • Medicines used to thin the blood such as warfarin
  • Medicines used to lower cholesterol
  • Water tablets (diuretics) such as eplerenone

Mental health, epilepsy and motor neurone medicines

  • Medicines for thought disorders known as ?antipsychotics? such as haloperidol
  • Medicines to calm or reduce anxiety (hypnotics, anxiolytics)
  • Medicines to help you sleep (barbiturates)
  • Medicines used for epilepsy such as phenytoin and carbamazepine
  • Some medicines used for depression such as amitriptyline and nortriptyline
  • Riluzole – used for motor neurone disease

Medicines for infections and the immune system

  • Some medicines used for an HIV infection such as stavudine and zalcitabine
  • Some medicines used for viral infections such as indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, nevirapine, daclatasvir, simeprevir, sofosbuvir and telaprevir
  • Medicines used for fungal infections
  • Medicines used for bacterial infections (antibiotics)
  • Medicines used for lowering your immune systems such as ciclosporin, sirolimus and tacrolimus
  • Praziquantel – used for tapeworm infections
  • Atovaquone – used for pneumonia

Hormone and cancer medicines

  • Some hormone medicines (estrogen, systemic hormones, progestogens) used for contraception or some types of cancer such as ethinylestradiol, levonorgestrel or dydrogesterone
  • Some hormone medicines (anti-estrogens) used for breast cancer or endometriosis such as tamoxifen, toremifene and gestrinone
  • Some medicines used for cancer (cytotoxics) such as imatinib
  • Levothyroxine (thyroid hormone) used for thyroid problems
  • Irinotecan – used for cancer

Pain, inflammation and gout medicines

  • Non-steroidal anti-inflammatory drugs (NSAIDS) such as etoricoxib, aspirin and indomethacin
  • Medicines used for pain such as codeine, morphine, fentanyl or pethidine
  • Corticosteroids used for inflammation such as hydrocortisone, betamethasone and prednisolone
  • Methadone – used for heroin withdrawal
  • Sulfinpyrazone – used for gout

Other medicines

  • Medicines used for diabetes
  • Medicines used to relax muscles before surgery (anaesthetics) such as halothane
  • Medicines used for erection problems such as tadalafil
  • Some medicines used for feeling sick or being sick such as ondansetron and aprepitant
  • Probenecid (used with a medicine called cidofovir to stop kidney damage)
  • Other antibiotic medicines such as cefazolin
  • Quinine – used for malaria
  • Theophylline – used for wheezing or difficulty in breathing

Taking Rifampicin/Isoniazid/Pyrazinamide Tablets with food and drink

Isoniazid may interact with foods containing histamine or tyramine (e.g. matured cheeses, cured meat, some fish like tuna, salmon and mackerel, wine and beer), causing symptoms including headache, sweating, flushing, fast, uneven or forceful heartbeat (palpitations), dizziness, feel lightheaded or faint (due to low blood pressure). These foods should be avoided if you are receiving Isoniazid. Your doctor will be able to advise further.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, plan to get pregnant or think you are pregnant. Rifampicin/Isoniazid/Pyrazinamide Tablets may make the contraceptive ?pill? work less well. This means you should change to a different type of contraception. Instead, you must use a reliable barrier method of contraception such as condoms or the ?coil? while taking Rifampicin/Isoniazid/Pyrazinamide Tablets. If you have any questions or are unsure about this talk to your doctor or pharmacist.

You should not breast-feed if you are taking Rifampicin/Isoniazid/Pyrazinamide Tablets. This is because small amounts may pass into the mothers? milk. If you are breast-feeding or planning to breastfeed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel dizzy or faint, have problems with vision or have other side effects that could affect your ability to drive while taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Rifampicin/Isoniazid/Pyrazinamide Tablets

Rifampicin/Isoniazid/Pyrazinamide Tablets contain:

  • Sucrose: If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Rifampicin/Isoniazid/Pyrazinamide Tablets
  • Sodium: These tablets contains less than 1 mmol sodium (23mg) per daily dose and are essentially ?sodium-free.

  • How to take Rifampicin/Isoniazid/Pyrazinamide Tablets

Always take Rifampicin/Isoniazid/Pyrazinamide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Keep taking this medicine

  • You must take the tablets every day for the whole time the doctor has told you to take them
  • Do not stop and start taking the tablets. This may increase the risk of side effects and your TB will not be treated properly

How to take the tablets

  • Take this medicine by mouth
  • Swallow the tablets whole, with a drink of water
  • Take at least 30 minutes before a meal or 2 hours after a meal
  • Take all your tablets together each day, as a single dose
  • Do not give this medicine to children
  • If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

Your doctor may ask you to take Vitamin B6 during treatment with Rifampicin/Isoniazid/Pyrazinamide Tablets, especially if you are malnourished, elderly or a diabetic.

How much to take

The usual dose is:

Adults and the Elderly

  • Between 3 and 6 tablets each day. The amount depends on your body weight
  • If you are elderly, your doctor may monitor your treatment more closely


This medicine is not recommended for use in children.

If you take more Rifampicin/Isoniazid/Pyrazinamide Tablets than you should

If you take more Rifampicin/Isoniazid/Pyrazinamide Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

You may feel sick (nausea), be sick (vomiting), have stomach pain, itching or a headache. You may also feel tired, sleepy, dizzy, light-headed, have blurred or strange visions (hallucinations) and faint or feel faint. Other signs of taking too much include swelling of the face, eyes or eyelids, slurring of speech, difficulty breathing, fast heartbeat, uneven heartbeats, fits and heart attack.

If you forget to take Rifampicin/Isoniazid/Pyrazinamide Tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten tablets.


Taking Rifampicin/Isoniazid/Pyrazinamide Tablets may affect the results of some blood tests. In particular, tests for folate, vitamin B12 and liver function. If you are going to have a blood test, it is important to tell your doctor that you are taking Rifampicin/Isoniazid/Pyrazinamide Tablets.

  • Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking and go to a hospital straight away if you notice any of the following serious side effects:

  • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, wheezing, swelling of your lips, face, throat or tongue
  • Serious skin rashes including Steven-Johnson syndrome, toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2.
  • Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2.
  • A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis). See also section 2.
  • You bruise more easily than usual. Or you may have a painful rash of dark red spots under the skin which do not go away when you press on them (purpura). This could be because of a serious blood problem
  • You have severe bleeding (haemorrhage)
  • You have chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine. This could be signs of a serious type of anaemia
  • You have blood in your urine or an increase or decrease in the amount of urine you produce. You may also get swelling, especially of the legs, ankles or feet. This may be caused by serious kidney problems
  • You have a sudden severe headache. This could be a sign of bleeding in the brain
  • Shortness of breath and wheezing
  • You get confused, sleepy, cold clammy skin, shallow or difficult breathing, a racing heartbeat or your skin is paler than normal. These could be signs of shock
  • You get more infections more easily than normal. Signs include fever, sore throat or mouth ulcers. This could be because you have a low number of white blood cells
  • You have bleeding from your nose, ear, gums, throat, skin or stomach. Signs may include a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools

If you experience any of the following side effects contact your doctor as soon as possible:

  • Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis, frequency not known).
  • Yellowing of the skin or whites of the eyes, or urine getting darker and stools paler, fatigue, weakness, malaise, loss of appetite, nausea or vomiting caused by liver problems (hepatitis, may affect up to 1 in 100 people).

Talk to your doctor straight away if you notice any of the following serious side effects:

  • Mental problems with unusual thoughts and strange visions (hallucinations)
  • Your stomach ulcer gets worse
  • Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called ?Pseudomembranous colitis?
  • Your fits get worse or you start to have fits
  • Flu-like symptoms including chills, fever, headache, dizziness and bone pains

Tell your doctor as soon as possible if you have any of the following side effects:

  • Water retention (oedema) which may cause swollen face, stomach, arms or legs
  • Muscle weakness or pain or loss of muscle reflexes
  • Dizziness, feel lightheaded and faint especially when you stand or sit up quickly (due to low blood pressure)
  • Swollen fingers, toes or ankles
  • Being unable to concentrate, feeling nervous, irritable or depressed
  • Balance problems with dizziness (vertigo)
  • Feeling very tired and weak or difficulty sleeping (insomnia)
  • Unusual skin sensations such as feeling numb, tingling, pricking, burning or creeping on the skin (paraesthesia)
  • Short-term memory loss, anxiety, being less alert or responsive
  • Blurred or distorted eyesight
  • Wasting of muscles or other body tissues
  • Weight loss, night sweats and fever. These could be signs of a blood condition called eosinophilia
  • Feeling sick or being sick

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

  • Acne
  • Loss of appetite (anorexia)
  • Headache
  • Skin flushing or itching
  • Painful, red, swollen joints
  • Pain or discomfort when passing urine
  • Irregular periods
  • Constipation, diarrhoea, stomach discomfort or dry mouth
  • Breast enlargement in men
  • Increased thirst, going to the toilet more often and feeling tired. Your blood sugar may be high
  • Inflammation of the blood vessels.

Other side effects you should discuss with your doctor if you are concerned about them

  • You notice a discolouration (yellow, brown, orange or red colour) in your teeth, urine, sweat, phlegm (sputum), saliva or tears. This is quite common and you need not worry. However, the colour may permanently stain soft contact lenses. The colour in tears may last for some time after you have stopped having Rifampicin/Isoniazid/Pyrazinamide Tablets.

Blood tests

  • A blood test may show changes in the way the liver is working

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  • How to store Rifampicin/Isoniazid/Pyrazinamide Tablets
    • Storage condition

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Rifampicin/Isoniazid/Pyrazinamide Tablets after the expiry date which is stated on the carton and blister packs. The expiry date refers to the last day of that month.

Store below 25?C. Store in the original container.

Medicines should not be disposed of via water waste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Cross-resistance to Rifampicin has only been shown after the development of resistance to other rifamycins.

  • Pharmacokinetic properties


Rifampicin is readily absorbed from the stomach and the duodenum. Peak serum concentrations of the order of 10 ?g/ml occur about 2-4 hours after a dose of 10mg/kg body weight on an empty stomach.

In normal subjects the biological half-life of Rifampicin in serum averages about 3 hours after a 600mg dose and increases to 5.1 hours after 900mg dose. With repeated administration, the half-life decreases and reaches average values of approximately 2-3 hours. At a dose of up to 600mg/day, the half-life does not differ in patients with renal failure and, consequently, no dosage adjustment is required. The half-life of Rifampicin may be decreased when Isoniazid is administered concurrently.

After absorption, Rifampicin is rapidly eliminated in the bile and an enterohepatic circulation ensues. During this process, Rifampicin undergoes progressive deacetylation, so that nearly all the drug in the bile is in this form in about 6 hours. This metabolite retains essentially complete antibacterial activity. Intestinal reabsorption is reduced by deacetylation and elimination is facilitated. Up to 30% of a dose is excreted in the urine with about half of this being unchanged drug. Absorption of Rifampicin is reduced when the drug is ingested with food.

Rifampicin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid. Rifampicin is about 80% protein bound. Most of the unbound fraction is not ionized and therefore is diffused freely in tissues.


After oral administration, Isoniazid produces peak blood levels within 1 to 2 hours, which decline to 50% or less within 6 hours. Ingestion of Isoniazid with food may reduce its absorption. It diffuses readily into all body fluids (cerebrospinal, pleural, and ascitic fluids), tissues, organs and excreta (saliva, sputum and faeces). The drug also passes through the placental barrier and into the milk in concentrations comparable to those in the plasma. From 50 to 70% of a dose of Isoniazid is excreted in the urine in 24 hours.

Isoniazid is metabolised primarily by acetylation and dehydrogenation. The rate of acetylation is genetically determined. Approximately 50% of Black and Europeans are ‘Slow inactivators’, the majority of Asians are ‘rapid inactivators’.

Pyridoxine deficiency (B6) is sometimes observed in adults with high doses of Isoniazid, probably due to its competition with pyridoxal phosphate of the enzyme apotryptophanase.


Pyrazinamide is well absorbed from the gastrointestinal tract and rapidly distributed throughout the body, with peak plasma levels in 2 hours. It is hydrolysed to pyrazines acid and then metabolised to 5-hydroxypyrazinoic acid. Glomerular filtration is the primary route of excretion. It is bactericidal in acid pH and has intracellular antibacterial activity against M. tuberculosis.

Pharmacokinetic studies in normal volunteers have shown that the three ingredients in Rifampicin/Isoniazid/Pyrazinamide have comparable bioavailability whether they are given together as individual dose forms or as Rifampicin/Isoniazid/Pyrazinamide.

  • Preclinical safety data

Not applicable

  • Pharmaceutical particulars
    • List of excipients


Sodium Carboxymethylcellulose

Sodium Lauryl Sulphate

Calcium Stearate


Acacia Gum


Light Magnesium Carbonate


Titanium Dioxide

Colloidal Silicon Dioxide

Aluminium Hydroxide Gel

Iron Oxide

  • Incompatibilities

None stated

  • Shelf life

3 years from the date of manufacture

  • Special precautions for storage

Do not store above 25?C. Store in the original container.

  • Contents of the pack and other information

What Rifampicin/Isoniazid/Pyrazinamide Tablets contain:

  • Each tablet contains Rifampicin/Isoniazid/Pyrazinamide 120mg/50mg/300mg and 225mg/150mg/750mg. These are the active ingredients
  • The other ingredients are Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Lauryl Sulphate, Calcium Stearate, Sucrose, Acacia Gum, Talc, Light Magnesium Carbonate, Kaolin, Colloidal Silicon-Dioxide, Aluminium Hydroxide Gel and Colours Titanium Dioxide and Iron Oxide
    • What Rifampicin/Isoniazid/Pyrazinamide Tablets look like and contents of the pack

The tablets are light pink, smooth, shiny, round and sugar-coated.

Pack size:

10, 15, 20, 30, 50, 100, 120, 240, 360, and 500 or 1000 tablets

Not all pack size may be marketed.

  • Nature and contents of a container

PVC and PVC/PVDC aluminium foil blisters packed in cardboard cartons.

  • Special precautions for disposal and another handling

Not applicable

Manufactured in India by:
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)