Pyrazinamide Tablets USP 1000mg Taj Pharma

Pyrazinamide Tablets USP 1000mg Taj Pharma

  1. Name of the medicinal product

Pyrazinamide Tablets USP 500mg
Pyrazinamide Tablets USP 750mg
Pyrazinamide Tablets USP 1000mg

  1. Qualitative and quantitative composition

Each tablet contains
Pyrazinamide                  500 mg
Excipients                        q.s

Each tablet contains
Pyrazinamide                  750 mg
Excipients                        q.s

Each tablet contains
Pyrazinamide                  1000 mg
Excipients                        q.s

For a full list of excipients, see section 6.1.

  1. Pharmaceutical form

Tablets

  1. Clinical particulars

4.1 Therapeutic indications

‘Pyrazinamide’ is indicated in patients with active tuberculosis caused by Mycobacterium tuberculosis. ‘Pyrazinamide’ is not active against the atypical mycobacteria. ‘Pyrazinamide’ should only be given in combination with other antituberculous agents.

4.2 Posology and method of administration

Recommended dosage for standard unsupervised 2-month treatment:

Adults: Under 50kg bodyweight: maximum of 3 tablets or 1.5g daily. 50kg and over bodyweight: maximum of 4 tablets or 2g daily.

Children: 35mg/kg daily.

Recommended dosage for intermittent supervised 2-month treatment:

Adults: Under 50kg bodyweight: maximum of 4 tablets or 2g 3 times a week. 50kg and over bodyweight: maximum of 5 tablets or 2.5g 3 times a week.

Children: 50mg/kg 3 times a week.

Pyrazinamide’ should be administered with at least one other effective antituberculous drug. The use of ‘Pyrazinamide’ in combination therapy does not modify the accepted dosages of other antituberculous agents.

Use in the elderly: The general considerations outlined above should also apply to elderly patients.

Immunocompromised patients: Multi-resistant M. tuberculosis may be present in immunocompromised patients. The organism should always be cultured to confirm its type and drug sensitivity. Confirmed M. Tuberculosis infection sensitive to first-line drugs should be treated with a standard 6 month regimen; after completing treatment, patients should be closely monitored. The regimen may need to be modified if infection is caused by resistant organisms and specialist advice is needed.

In meningeal or pericardial tuberculosis, a corticosteroid should be started at the same time as antituberculosis therapy.

4.3 Contraindications

‘Pyrazinamide’ is contra-indicated in patients with:

  • hypersensitivity to pyrazinamide or to any of the excipients
  • hepatic disease
  • hyperuricaemia and/or gouty arthritis
  • acute porphyria.

‘Pyrazinamide’ is also contra-indicated in breast-feeding mothers (see section 4.6 Pregnancy and lactation).

4.4 Special warnings and precautions for use

‘Pyrazinamide’ should only be used when close daily observation of the patient is possible, and when laboratory facilities are available for performing frequent liver-function tests and blood uric acid determinations.

Pre-treatment examinations should include in-vitro sensitivity tests of recent cultures of M. tuberculosis from the patient as measured against the usual antituberculous drugs. Side effects for ‘Pyrazinamide’ primarily involve the liver and vary from asymptomatic elevations of liver function tests to serious clinical manifestations of hepatic disease; therefore, liver-function tests, especially aspartate transferase (AST) and alanine transferase (ALT) determinations, should be carried out prior to therapy, and then every two to four weeks during therapy. Therapy with ‘Pyrazinamide’ should be withdrawn and not reinstated if signs of hepatocellular damage occur.

Patients or their carers should be told how to recognize signs of liver disease, and advised to discontinue treatment and seek immediate medical attention if symptoms such as persistent nausea, vomiting, malaise or jaundice develop.

Reduction in the size and/or frequency of dose is recommended for patients with renal insufficiency.

Pre-treatment examinations should include renal function, hepatic function and particularly base-line uric acid determinations. Pyrazinamide inhibits excretion of urates, frequently resulting in hyperuricaemia which is usually asymptomatic. If hyperuricaemia accompanied by an acute gouty arthritis occurs, therapy should be discontinued and not reinstated. Close monitoring is advised to detect any increasing difficulty in the management of patients with a history of gout or diabetes mellitus.

Pyrazinamide should be used with caution in pregnant women.

4.5 Interaction with other medicinal products and other forms of interaction

Pyrazinamide antagonizes the effect of uricosuric agents such as probenecid and sulfinpyrazone. Pyrazinamide may reduce the contraceptive effects of oestrogens and should be avoided 3 days before and after oral typhoid vaccination since it may inactivate the vaccine.

4.6 Pregnancy and lactation

Pregnancy: There have been no well-controlled studies in pregnant women. ‘Pyrazinamide’ should only be used if the potential benefit justifies the risk to the foetus.

Lactation: ‘Pyrazinamide’ is contra-indicated in breast-feeding mothers. If its use is deemed essential, the patient should stop breast-feeding.

4.7 Effects on ability to drive and use machines

There are no data to suggest that ‘Pyrazinamide’ affects the ability to drive or use machines.

4.8 Undesirable effects

A hepatic reaction is the most common side effect of ‘Pyrazinamide’ and may occur at any time during therapy. This varies from a symptomless abnormality of hepatic cell function, detectable only by laboratory tests, through a mild syndrome of fever, anorexia, malaise, liver tenderness, hepatomegaly and spleenomegaly, to more serious reactions such as clinical jaundice, and rare cases of hepatic failure and death.

Other side effects-active gout, sideroblastic anaemia, arthralgias, anorexia, nausea and vomiting, flushing, dysuria, malaise, fever, rash, hypersensitivity reactions such as urticaria and pruritus, aggravation of peptic ulcer and occasionally photosensitivity.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Liver toxicity and hyperuricaemia may occur with overdosage.

The stomach should be emptied by gastric lavage if necessary.

There is no specific antidote. General supportive measures should be employed. Liver function should be monitored closely, and a high- carbohydrate, low – fat diet employed. Care should be taken to avoid exposure of the patient to other potential hepatotoxic agents, including alcohol. Benzodiazepines may be given if there is evidence of central nervous system stimulation.

Probenecid may be given for hyperuricaemia.

The plasma half-life of pyrazinamide is about nine to ten hours.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antimycobacterials, other drugs for treatment of tuberculosis.

Pyrazinamide exhibits tuberculostatic activity in vitro only at slightly acidic pH. The growth of tubercle bacilli within monocytes in vitro is completely inhibited by pyrazinamide at a concentration of 12.5 μg/ml.

Pyrazinamide is active only at an acid pH, and it is therefore active mainly on the tubercle bacilli located within the cell. It is these bacteria which are probably responsible for microbial persistance and thus for relapses after chemotherapy has stopped.

Pyrazinamide has low bacterial activity compared with isoniazide. It is thought that when these are used in combination, isoniazide is the key bactericidal drug, whilst pyrazinamide has a sterilising role, acting on a special bacterial population inhibited by the acid environment inside the macrophage or the walls of tuberculous cavities.

5.2 Pharmacokinetic properties

Pyrazinamide is readily absorbed from the gastrointestinal tract. Peak concentrations occur about 2 hours after an oral dose and have been reported to be 33 µg per ml after 1.5 g and 59 µg per ml after 3 g.

Serum concentrations then decline, with a plasma half-life of about 9-10 hours.

About 30% of the dose is excreted in the urine as pyrazinoic acid and 4% as unchanged pyrazinamide within 24 hours.

5.3 Preclinical safety data

No relevant information.

  1. Pharmaceutical particulars

6.1 List of excipients

Lactose, maize starch, magnesium stearate, silicon dioxide, and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

60 months for bottles

36 months for blisters

6.4 Special precautions for storage

Store at temperatures below 25°C.

6.5 Nature and contents of container

Amber glass bottles or HDPE bottles containing 100 tablets and PVC/Al blister packs containing 30 or 60 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

None.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

 

Pyrazinamide Tablets USP 500mg, 750mg, 1000mg Taj Pharma

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pyrazinamide Tablets

(pyrazinamide)

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor or
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as
  • If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or
In this leaflet:
  1. What Pyrazinamide Tablets are and what they are used for
  2. Before you take Pyrazinamide Tablets
  3. How to take Pyrazinamide Tablets
  4. Possible side-effects
  5. How to store Pyrazinamide Tablets
  6. Further information
1.  WHAT PYRAZINAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Pyrazinamide Tablets contain pyrazinamide, which is an antituberculous agent. Pyrazinamide Tablets are used for treating tuberculosis, commonly called ‘TB’. These products work by killing a particular type of bacteria which causes tuberculosis. Pyrazinamide Tablets are always given in combination with other antituberculous agents.

2.  BEFORE YOU TAKE PYRAZINAMIDE TABLETS
Do not take Pyrazinamide Tablets if you:
  • are allergic (hypersensitive) to pyrazinamide or any of the other ingredients of Pyrazinamide Tablets (see section 6 – Further information for details)
  • are breast-feeding
  • have liver disease
  • have gouty arthritis (arthritis associated with inflammation of the joints)
  • have an abnormally high concentration of uric acid in your blood
  • have a condition that results in a high level of porphyrin in your urine and extreme sensitivity to
Take special care with Pyrazinamide Tablets if you:
  • are or think you may be pregnant
  • have kidney problems
  • have a history of gout (inflammation of the joints)
  • have diabetes
  • suffer from lactose intolerance
  • have received the oral typhoid vaccination, since Pyrazinamide may stop it from working, Pyrazinamide should be avoided 3 days before and after the vaccination
  • are taking oral contraceptives (the pill), since Pyrazinamide tablets may stop the pill from working. Use extra barrier contraception methods (e.g. condoms) whilst you are taking Pyrazinamide tablets and for one month
Surgery and tests

While taking Pyrazinamide Tablets you will be closely monitored. Your doctor or healthcare professional will probably take regular blood samples from you before and whilst taking Pyrazinamide Tablets. Your blood will be tested to make sure that your liver is working properly and that the levels of uric acid, a chemical usually found in urine and blood, do not increase. If the results of the blood test are abnormal, your doctor will ask you to stop taking your medicine.

If you develop the following persistent symptoms: feeling sick, being sick, lacking in energy or a yellowing of the skin or eyes, stop taking Pyrazinamide tablets and contact your doctor immediately, as these may be signs of liver disease.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Take care if you are taking the following medicines:

  • probenecid or sulfinpyrazone for

Your doctor will also prescribe other antituberculosis medicines for you to take with Pyrazinamide Tablets.

Pregnancy and breast-feeding

Pyrazinamide tablets should be used with caution during pregnancy. Do not use Pyrazinamide tablets if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Important information about the ingredients of Pyrazinamide Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.  HOW TO TAKE PYRAZINAMIDE TABLETS

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

Adults and the elderly

The usual dose is 3 tablets or 1.5 mg daily if you weigh under 50kg and your doctor is not supervising your medication on a daily basis. If you weigh more than 50kg, this may be increased to 4 tablets or 2g daily.

If your doctor is supervising your medication on a daily basis, the dose for adults under 50kg is a maximum of 4 tablets or 2g   3 times a week.   If you weigh over 50kg, the dose is a maximum of  5 tablets or 2.5g 3 times a week.

The number of tablets you take each day will depend on your kidney function and your bodyweight.

Children

Pyrazinamide Tablets are supplied according to the weight of your child.

If the medication is not supervised on a daily basis, the dose is 35mg/kg daily.

If the medication is supervised on a daily basis, the dose is 50mg/kg 3 times a week.

If you take more Pyrazinamide Tablets than you should

If you take more Pyrazinamide Tablets than you should, tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Pyrazinamide Tablets

If you forget to take a dose at the right time, take it as soon as you remember then go on as before.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Pyrazinamide Tablets

Do not stop taking the tablets without discussing it with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.  POSSIBLE SIDE-EFFECTS

Like all medicines, Pyrazinamide Tablets can cause side-effects, although not everybody gets them.

A rare side-effect is sudden liver failure which can be fatal.

The most common side-effect is a liver reaction, which may occur at any time during therapy with Pyrazinamide Tablets. Symptoms of a liver reaction may include:

  • abnormal blood test results
  • fever
  • loss of appetite
  • feeling unwell
  • tender liver
  • enlarged liver
  • enlarged spleen
  • yellowing of the skin or eyes (jaundice).

Uncommon side-effects of Pyrazinamide Tablets include:

  • gout
  • anaemia – the symptoms of which are tiredness, general weakness and paleness of the skin
  • pain in the joints
  • loss of appetite
  • feeling sick
  • being sick
  • flushing (redness of the face)
  • difficulty in, or pain when passing urine
  • feeling unwell
  • fever
  • itching
  • raised red patches on the skin
  • skin reactions caused by sunlight e.g. rash
  • worsening of an ulcer in the stomach/intestines.

If any of the side-effects get serious or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

5.  HOW TO STORE PYRAZINAMIDE TABLETS
Keep out of the sight and reach of children.

Do not use Pyrazinamide Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C.

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

6.  FURTHER INFORMATION
What Pyrazinamide Tablets contain

The active substance in Pyrazinamide Tablets is pyrazinamide

The other ingredients are lactose, maize starch, magnesium stearate, silicon dioxide and purified water.

What Pyrazinamide Tablets look like and the contents of the pack

Pyrazinamide Tablets are white, discoid, compressed, flat, bevelled tablets. One side is scored and marked GP 504. They are supplied in bottles of 100 tablets or blister packs of 30 or 60 tablets. Not all packs sizes may be marketed.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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