Isoniazid Tablets USP 150mg Taj Pharma

  1. Name of the medicinal product

Isoniazid Tablets USP 50mg Taj Pharma
Isoniazid Tablets USP 100mg Taj Pharma
Isoniazid Tablets USP 150mg Taj Pharma
Isoniazid Tablets USP 300mg Taj Pharma

  1. Qualitative and quantitative composition

a) Isoniazid Tablets USP 50mg Taj Pharma
Each uncoated tablet contains:
Isoniazid USP 50mg
Excipients: Q.S.

b) Isoniazid Tablets USP 100mg Taj Pharma
Each uncoated tablet contains:
Isoniazid USP 100mg
Excipients: Q.S.

c)Isoniazid Tablets USP 150mg Taj Pharma
Each uncoated tablet contains:
Isoniazid USP 150mg
Excipients: Q.S.

d) Isoniazid Tablets USP 300mg Taj Pharma
Each uncoated tablet contains:
Isoniazid USP 300mg
Excipients: Q.S.

For excipients see 6.1

  1. Pharmaceutical form

White biconvex uncoated tablets

  1. Clinical particulars
    • Therapeutic indications

Isoniazid Taj Pharma is indicated in the treatment of all forms of pulmonary and extra-pulmonary tuberculosis.

  • Posology and method of administration

Official guidance should always be consulted when selecting the dose regimens to be used for adults and children (according to age and body weight), the duration of therapy and the total content of the combination treatment regimen.

Posology

Adults

The dose of Isoniazid Taj Pharma for the treatment of tuberculosis is commonly 4 to 5mg per kilogram body-weight daily given by mouth in single or divided doses up to a maximum of 300mg daily. Up to 10mg per kilogram body-weight daily may be given particularly during the first 1 to 2 weeks of treatment of tuberculous meningitis. A dose of 15mg per kilogram has been given two or three times weekly in intermittent treatment regimens.

Elderly

No dosage reduction is necessary in the elderly, but caution should be exercised due to the possible decrease in renal and hepatic function.

Paediatric population

The usual daily dose for children aged three months and above is from 10 up to 15mg per kilogram body-weight daily in single or divided doses.

Isoniazid Taj Pharma should not be used in children aged 0 to 3 months because of the lack of specific data.

Method of Administration

Isoniazid Taj Pharma tablets should be taken preferably on an empty stomach, i.e. at least 30 minutes before a meal or 2 hours after a meal.

  • Contraindications

Patients who are known to be hypersensitive to Isoniazid Taj Pharma or drug-induced liver disease

  • Special warnings and precautions for use

All patients should have baseline liver function tests performed and repeated at regular intervals during treatment. If serum AST rises to more than three times normal, or there is any increase in bilirubin, treatment should be withdrawn. Special precautions are required in patients with impaired liver function. Any deterioration in liver function in these patients is an indication for stopping treatment.

Isoniazid Taj Pharma should not be given to patients who have experience severe adverse reactions including drug-induced liver disease. Care should be taken in giving Isoniazid Taj Pharma to patients suffering from convulsive disorders, diabetes mellitus, chronic alcoholism, or impaired liver or kidney function or to patients taking other potentially hepatoxic agents. If symptoms of hepatitis such as malaise, fatigue, anorexia, and nausea develop Isoniazid Taj Pharma should be discontinued immediately.

Isoniazid Taj Pharma should be used with caution in patients with a history of psychosis.

Advanced age, female gender, slow acetylators, malnutrition, HIV infection, pre-existing liver disease, and extra-pulmonary tuberculosis were identified as risk factors for Isoniazid Taj Pharma-induced hepatotoxicity.

Patients who are at risk of neuropathy or pyridoxine deficiency, including those who are diabetic, alcoholic, malnourished, uraemic, pregnant, or infected with HIV, should be given pyridoxine.

  • Interaction with other medicinal products and other forms of interaction

When Isoniazid Taj Pharma is given to patients who inactivate it slowly or to patients receiving paraminosalicyclic acid concurrently, tissue concentrations may be enhanced, and adverse effects are more likely to appear. There may be an increased risk of liver damage in patients receiving rifampicin and Isoniazid Taj Pharma but liver enzymes are raised only transiently.

Isoniazid Taj Pharma can inhibit the hepatic metabolism of a number of drugs, in some cases leading to increased toxicity. These include the antiepileptics carbamazepine, primidone, and phenytoin, the benzodiazepines diazepam and triazolam, chlorzoxazone, and disulfiram.

Isoniazid Taj Pharma is an inhibitor of monoamine oxidase (MAO) and diamine oxidase (DAO), therefore can reduce tyramine and histamine metabolism, causing symptoms such as headache, sweating, palpitations, flushing, and hypotension. Patients should be advised against ingesting foods rich in tyramine and/or histamine during treatment with Isoniazid Taj Pharma, such as cured meat, some cheeses (e.g. matured cheeses), wine, beer and some fish (e.g. tuna, mackerel, salmon).

Isoniazid Taj Pharma has been reported to cause substantial elevations of serum concentrations of carbamazepine and symptoms of carbamazepine toxicity at Isoniazid Taj Pharma doses of 200mg daily or more. The concurrent used is not recommended unless the effects can be closely monitored and suitable downward dosage adjustments made (a reduction between one-half or one-third was reported effective).

Concomitant benzodiazepine (diazepam) and Isoniazid Taj Pharma therapy has been reported to result in an increased risk of benzodiazepine toxicity (sedation, respiratory depression).

Isoniazid Taj Pharma may reduce the therapeutic effects of levodopa.

Concomitant administration of Isoniazid Taj Pharma with itraconazole may result in significant decreases in itraconazole serum concentrations and therapeutic failure. Co administration is not recommended.

Isoniazid Taj Pharma may decrease ketoconazole serum levels. Concurrent use should be well monitored and dosage increases made if necessary.

Because the clearance of Isoniazid Taj Pharma was found doubled when zalcitabine was given in HIV-positive patients, concurrent use of Isoniazid Taj Pharma and zalcitabine should be monitored to ensure Isoniazid Taj Pharma effectiveness.

There may be an increased risk of distal sensory neuropathy when Isoniazid Taj Pharma is used in patients taking stavudine (d4T).

There may be a potential interaction between Isoniazid Taj Pharma and foods containing histamine or tyramine.

  • Pregnancy and lactation

Isoniazid Taj Pharma crosses the placenta. Therefore, Isoniazid Taj Pharma should only be used in pregnant women or in women of child-bearing potential if the potential benefit justifies the potential risk to the foetus. It is considered that untreated tuberculosis represents a far greater hazard to a pregnant woman and her foetus than does treatment of the disease. Pyridoxine supplementation is recommended.

Isoniazid Taj Pharma passes into breast milk. When administered to nursing mother, breast-fed infants should be monitored for possible signs of Isoniazid Taj Pharma toxicity. Administration of pyridoxine to the breast-feeding mother and infant may be considered.

  • Effects on ability to drive and use machines

No specific statement, but unlikely to effect the ability to drive or use machinery.

  • Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Frequency not known: cannot be estimated from the available data

The frequency of the reactions described below cannot be determined from the data available.

Blood and lymphatic system disorders

Frequency not known: Agranulocytosis, Aplastic anaemia, Haemolytic anaemia

Ear and labyrinth disorders

Frequency not known: Deafness, Tinnitus, Vertigo

These have been reported in patients with end stage renal impairment

Vertigo may be troublesome with doses of 10mg per kg body weight

Gastrointestinal disorders

Frequency not known: Constipation, Dry mouth Nausea, Pancreatitis acute, Vomiting and other gastrointestinal effects

General disorders and administration site conditions

Frequency not known: Pyrexia

Hepatobiliary disorders

Frequency uncommon: Hepatitis

Frequency not known: Acute hepatic failure, Liver injury, Jaundice

The risk of these undesirable effects increases with age, especially over the age of 35; it may be serious and sometimes fatal with the development of necrosis.

Investigations

Frequency not known: Hepatic enzyme increased

Metabolism and nutrition disorders

Frequency not known: Acidosis, Hypoglycaemia, Nicotinic acid deficiency

Nicotinic acid deficiency may be related to an Isoniazid Taj Pharma-induced pyridoxine deficiency which affects the conversion of tryptophan to nicotinic acid.

Musculoskeletal and connective tissue disorders

Frequency not known: Systemic lupus erythematosus, lupus-like syndrome

Nervous system disorders

Frequency not known: Neuropathy peripheral, Optic neuritis, Seizure

Hyperreflexia may be troublesome with doses of 10mg per kg body weight

Psychiatric disorders

Frequency not known: Elevated mood, Psychotic disorder

Although Isoniazid Taj Pharma usually has a mood elevating effect, mental disturbances, ranging from minor personality changes to major mental derangement have been reported; these are usually reversed on withdrawal of the drug

Renal and urinary disorders

Frequency not known: Dysuria

Reproductive system and breast disorders

Frequency not known: Gynaecomastia

Respiratory, thoracic and mediastinal disorders

Frequency not known: Interstitial lung disease

Skin and subcutaneous tissue disorders

Frequency rare: Toxic epidermal necrolysis, eosinophilia systemic symptoms, Frequency not known: Erythema multiforme, Stevens-Johnson syndrome,

Vascular disorders

Frequency not known: Vasculitis

Miscellaneous

Withdrawal symptoms, which may occur on the cessation of the treatment, include headache, insomnia, excessive dreaming, irritability and nervousness.

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.

  • Overdose

The most commonly reported adverse events associated with Isoniazid Taj Pharma overdose are nausea, vomiting and central nervous system toxicity such as vertigo, seizures and coma.

Treatment of overdosage consists of gastric lavage following intubation and the control of convulsions by anti-convulsants given intravenously as well as the intravenous injection of large doses of pyridoxine. Any acidosis is corrected with sodium bicarbonate. Forced diuresis may be tried and haemodialysis or peritoneal dialysis has been used.

  1. Pharmacological properties
    • Pharmacodynamic properties

Isoniazid Taj Pharma has no significant antibacterial action against any micro-organisms except the mycobacteria; against mycobacterium tuberculosis it is bacteriostatic in extremely low concentrations.

Isoniazid Taj Pharma is used mainly in the treatment of pulmonary tuberculosis but it appears to be effective also in the treatment of extrapulmonary lesions, including meningitis and genito-urinary disease.

  • Pharmacokinetic properties

Absorption

Readily and completely absorbed after oral administration.

Distribution

Readily diffuses into all tissues and fluids including the cerebrospinal fluid. Isoniazid Taj Pharma is retained in the skin and in infected tissue; it crosses the placenta and is secreted in the milk of lactating mothers.

Protein binding

Isoniazid Taj Pharma does not appear to be bound in the blood.

Half-life

Plasma elimination half-life, in rapid acetylators about 1.2 hours and in slow acetylators about 3.5 hours.

Metabolic reactions

Acetylation, hydrolysis and glycine conjugation, hydrazone formation, and n-methylation; acetylation is polymorphic and two groups of acetylators have been identified, rapid and slow acetylators. The rate of hydrolysis is more rapid in the rapid acetylators than in the slow ones. The metabolites formed include acetyl Isoniazid Taj Pharma, isonicotinic acid, isonicotinuric acid, isonicotinoyl-hydrazones of pyruvic and glutaric acids, and n-methylIsoniazid Taj Pharma.

Excretion

Over 90% of a dose is excreted in the urine in 24 hours, most being excreted in the first 12 hours, 4-32% is unchanged, but no more than 10% of a dose is excreted in the faeces.

  • Preclinical safety data

Not applicable since Isoniazid Taj Pharma tablets have been used in clinical practice for many years and its effects in man are well known.

  1. Pharmaceutical particulars
    • List of excipients

Lactose 170 Mesh

Maize Starch

Microcrystalline Cellulose

Alginic Acid

Magnesium Stearate

Purified Water

  • Incompatibilities

None

  • Shelf life

36 months

  • Special precautions for storage

Store below 25°C

  • Nature and contents of container

Pack Size:

Isoniazid Taj Pharma 50mg,100mg and 300mg tablets come in a coloured plastic container with a lid. Containers may contain 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250 and 500 uncoated tablets.

Not all pack sizes may be marketed.

  • Special precautions for disposal and other handling

No special precautions are required

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

Isoniazid Tablets USP 150mg Taj Pharma

Patient Information Leaflet:

Isoniazid Tablets USP 50mg/100mg/150mg/300mg Taj Pharma

Read all 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 pharmacist
  • 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 yours
  • In this leaflet, Isoniazid Taj Pharma 50mg & 100mg Tablets USP are called Isoniazid Taj Pharma.

In this leaflet:

  1. What Isoniazid Taj Pharma is for
  2. Before you take Isoniazid Taj Pharma
  3. How to take Isoniazid Taj Pharma
  4. Possible side effects
  5. How to store Isoniazid Taj Pharma
  6. Further information.
  1. What Isoniazid Taj Pharma is for

Isoniazid Taj Pharma belongs to a group of medicines called antibacterials. Isoniazid Taj Pharma works by killing bacteria that cause tuberculosis (also known as TB).

Isoniazid Taj Pharma is used to treat tuberculosis inside the lungs (pulmonary TB) and outside the lungs (extra-pulmonary TB)

Tuberculosis is a serious infectious disease that can be passed on to other people. If left untreated it can spread through your body and may be fatal. It is important that you receive effective treatment for this condition.

  1. Before you take Isoniazid Taj Pharma

Do not take Isoniazid Taj Pharma if:

  • You are allergic to Isoniazid Taj Pharma or any of the other ingredients of Isoniazid Taj Pharma (see Section 6)
  • You have ever had serious liver problems after taking any medicine.

If any of the above applies to you, talk to your doctor or pharmacist.

Check with your doctor before taking Isoniazid Taj Pharma if:

  • You have epilepsy or have ever had convulsions (fits)
  • You have diabetes
  • You drink a lot of alcohol regularly
  • You have, or have had, problems with your liver or kidneys.
  • You suffer or have suffered from psychosis (mental disturbances with hallucinations or delusions)
  • You are malnourished (severely underfed)
  • You have HIV infection
  • You have extra-pulmonary TB (outside the lungs)

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

  • Stavudine (used for the treatment of HIV)
  • Any medicine for the treatment of epilepsy such as carbamazepine, phenytoin or primadone
  • Disulfiram (for the treatment of alcoholism)
  • Rifampicin, paraminosalicyclic acid or any other drug used to treat TB
  • The benzodiazepine diazepam (for the treatment of anxiety)
  • Levodopa (for the treatment of Parkinson’s disease)
  • Itraconazole or ketaconazole (for the treatment of fungal infections)
  • Any other medicine, including medicines obtained without a prescription.

These medicines can interfere with how well your treatment works.

Taking Isoniazid Taj Pharma with food and drink

Isoniazid Taj Pharma should be taken on an empty stomach, so take it at least 30 minutes before a meal or two hours after a meal. This helps your body absorb Isoniazid Taj Pharma more easily. Avoid drinking alcohol with Isoniazid Taj Pharma. This may damage your liver. Isoniazid Taj Pharma 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 Taj Pharma. Your doctor will be able to advise further.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Isoniazid Taj Pharma.

Warning about sugar in Isoniazid Taj Pharma

This product contains a sugar (lactose). If you have been told that you are intolerant to some sugars, contact your doctor before taking this medicine.

  1. How to take Isoniazid Taj Pharma

Always take Isoniazid Taj Pharma exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Remember: Isoniazid Taj Pharma should not be taken with food. You should swallow Isoniazid Taj Pharma tablets whole with a glass of water.

Adults

The usual dose of Isoniazid Taj Pharma is 4mg to 5mg per kilogram (kg) of your bodyweight per day, up to a maximum of 300mg daily. This may be taken as a single dose or as divided doses throughout the day. Your doctor will tell you exactly how much medicine to take and when to take it.

Higher doses (up to 10mg per kg per day) may be used to treat tuberculous meningitis (tuberculosis causing inflammation of the brain’s membranes).

Elderly

If you are elderly, your doctor may tell you to take a slightly lower dose because your liver and kidneys are not working as well as they should.

Use in children

The usual dose of children above the age of three months is 10 to 15mg per kg of body weight per day. This may be taken by your child as a single dose or as divided doses throughout the day.

Your doctor will tell you exactly how much medicine your child should take and when to take it.

Children under three months should not take Isoniazid Taj Pharma.

Medical check-ups

While you are taking this medicine, your doctor may ask you to have check-ups and blood tests.

These are to:

  • Check that your liver is working properly
  • Make sure your medicine is working properly
  • Check the dose you are taking is right for you.

If you take more Isoniazid Taj Pharma than you should

Do not take more Isoniazid Taj Pharma than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.

Taking too much Isoniazid Taj Pharma may cause; feeling and being sick, dizziness or feeling if the room is spinning round, fits and acidosis (upset of the acid balance in the body). These effects may require emergency treatment in hospital.

If you forget to take Isoniazid Taj Pharma

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

If you stop taking Isoniazid Taj Pharma

Do not stop taking Isoniazid Taj Pharma without first talking to your doctor. It is important you take the full course of this medicine, as directed by your doctor, in order to clear the infection that causes tuberculosis.

If you stop taking this medicine suddenly you may get withdrawal symptoms including a headache, difficulty in sleeping, having more dreams, feeling irritable and feeling nervous.

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

  1. Possible side-effects

Like all medicines Isoniazid Taj Pharma can cause side effects, although not everybody gets them.

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).
  • Severe extensive skin damage (separation of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis, TEN, may affect up to 1 in 1,000 people)
  • A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome, may affect up to 1 in 1,000 people).
  • 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).

Other side effects:

  • Convulsions (fits)
  • Severe stomach pain
  • Connective tissue disorders such as Lupus syndrome which can affect the skin and kidneys (symptoms may include a butterfly -shaped rash over the cheeks and nose, tiredness, a high temperature, feeling or being sick, joint pain and weight loss)
  • Mental disturbances including psychotic reactions such as hallucinations and delusions
  • Blood disorders which may make you more likely to get infections
  • High blood sugar levels, although you may not notice any symptoms
  • Inflammation of blood vessels (vasculitis) – (frequency not known)
  • Acidosis (upset of the acid balance in the body) which may make you feel or be sick, be drowsy or have breath that smells of “pear drops”
  • Gynaecomastia (increased size of breasts in men)
  • Low levels of vitamin B6 and nutrition problems. This can make you feel irritable, have difficulty sleeping, weak muscles, cracks at the corner of the mouth or lose weight
  • Eye problems such as visual disturbances and eye pain
  • If you have severe problems with your kidneys, you may get loss of hearing and ringing in your ears
  • Tingling or numbness in the hands or feet (pins and needles)
  • Constipation
  • Difficulty in starting to pass urine
  • Upset stomach and diarrhoea
  • Fever
  • Feeling and being sick
  • Loss of appetite and chills
  • Dry mouth
  • Overactive reflexes
  • Dizziness or feeling if the room is spinning round (vertigo)
  • Red or itchy skin rash or peeling of the skin.

Side effects with this medicine are more common in people aged over 35 and in people who break down Isoniazid Taj Pharma more slowly. The risk of having side effects increases with high doses of Isoniazid Taj Pharma.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

  1. How to store Isoniazid Taj Pharma

Keep out of the sight and reach of children.

Do not use Isoniazid Taj Pharma after the expiry date on the pack. 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. Return any medicine you no longer need to your pharmacist.

  1. Further information

What Isoniazid Taj Pharma contains

  • The active substance in Isoniazid Taj Pharma Tablets USP is Isoniazid Taj Pharma.
  • Isoniazid Taj Pharma tablets come in three strengths: 50mg,100mg, 150mg and 300mg. Each uncoated tablet 50mg/100mg/150mg/300mg Isoniazid Taj Pharma Taj Pharma

The other ingredients in Isoniazid Taj Pharma are Lactose 170 Mesh, Maize Starch, Microcrystalline Cellulose, Alginic Acid, Magnesium Stearate and Purified Water.

What Isoniazid Taj Pharma looks like and contents of the pack

Isoniazid Taj Pharma tablets are round, white, uncoated tablets.

Isoniazid Tablets USP 50mg Taj Pharma
Isoniazid Tablets USP 100mg Taj Pharma
Isoniazid Tablets USP 150mg Taj Pharma
Isoniazid Tablets USP 300mg Taj Pharma

Pack Size:

Isoniazid Taj Pharma 50mg,100mg and 300mg tablets come in a coloured plastic container with a lid. Containers may contain 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250 and 500 uncoated tablets.

Not all pack sizes may be marketed.

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

Related Products

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.