Ethambutol Tablets USP 800mg Taj Pharma

1. Name of the medicinal product

Ethambutol Tablets USP 100mg Taj Pharma
Ethambutol Tablets USP 400mg Taj Pharma
Ethambutol Tablets USP 800mg Taj Pharma

2. Qualitative and quantitative composition

a) Ethambutol Tablets USP 100mg Taj Pharma
Each film-coated tablet contains:
Ethambutol Hydrochloride USP 100mg
Excipients: Q.S.

b) Ethambutol Tablets USP 400mg Taj Pharma
Each film-coated tablet contains:
Ethambutol Hydrochloride USP 400mg
Excipients: Q.S.

c) Ethambutol Tablets USP 800mg Taj Pharma
Each film-coated tablet contains:
Ethambutol Hydrochloride USP 800mg
Excipients: Q.S.

3. Pharmaceutical form

Film-coated tablet.

Yellow, grey and round biconvex, film coated tablet

4. Clinical particulars

• Therapeutic indications

For the primary treatment and re-treatment of tuberculosis and for prophylaxis in cases of inactive tuberculosis or large-tuberculin-positive reaction.

Ethambutol Taj Pharma should only be used in conjunction with other anti-tuberculosis drugs to which the patient’s organisms are susceptible.

Consideration should be given to official guidance on the appropriate use of antimicrobial agents.

• Posology and method of administration

Posology

For oral use.

Dosage should be determined according to the body weight of the patient. The usual daily dosage is 15-25mg/kg body weight given as a single dose.

Ethambutol Taj Pharma should not be used as a sole anti-tuberculosis agent, but should be given with at least one other anti-tuberculosis drug to avoid development of resistant strains.

Adults

For primary treatment and prophylaxis: Ethambutol Taj Pharma should be administered in a single daily dose of 15mg/kg body weight; concomitant drugs should be maintained at their usual recommended dosage.

For re-treatment: For the first 60 days of treatment, Ethambutol Taj Pharma should be administered in a single daily dose of 25mg/kg body weight. Thereafter the dosage should be reduced to 15mg/kg body weight; concomitant drugs should be maintained at their usual recommended dosage levels.

Children

For primary treatment and re-treatment: For the first 60 days of treatment, a single daily dose of 25mg/kg body weight. Thereafter the dosage should be reduced to 15mg/kg body weight; concomitant drugs being maintained at their usual recommended dosage levels.

For prophylaxis: A single daily dose of 15mg/kg body weight; concomitant drugs being maintained at their usual recommended dosage levels.

As children may be less likely or unable to report ocular toxicity, particular caution may be warranted (see Section 4.4).

Older people

Dosage as for adults. However, patients with decreased renal function may need to have the dosage adjusted as determined by blood levels of Ethambutol Taj Pharma.

• Contraindications

Known hypersensitivity to Ethambutol Taj Pharma or to any of the other ingredients.

Known optic neuritis and poor vision or retrobulbar neuritis, unless clinical judgement determines that the benefit outweighs the potential risk.

• Special warnings and precautions for use

Ocular toxicity:

Ethambutol Taj Pharma may produce a unique type of visual impairment which is generally reversible and which appears to be due to optic neuritis and to be related to dose and duration of treatment.

Ethambutol Taj Pharma causes ocular toxicity and patients should be advised to report any changes of visual acuity. Less than 1% of patients undergoing treatment with the higher dose regimen of 25mg/kg/day for two months, and 15mg/kg/day thereafter, have exhibited decrease in visual acuity. It is recommended that patients undergo a full ophthalmic examination before starting treatment. This should include visual acuity, colour vision, perimetry and ophthalmoscopy and should be monitored every four weeks during treatment. For patients with pre-existing visual defects or renal insufficiency the frequency of tests should be increased to every second or third week or more, depending on clinical assessment. Each eye should be tested separately as ocular toxicity can be unilateral or bilateral. Opthalmologic examination should include tests for black-white/chromatic visual acuity (e.g Snellen eye chart and 65-test) and opthalmoscopy.

Patients who are unable to report their visual acuity should be more closely monitored for any signs of deterioration during treatment with Ethambutol Taj Pharma. Ethambutol Taj Pharma should be used in young children and those with language or communication difficulties, where appropriate, with advice concerning the need to report visual side-effects being given to parents or other family members. However, routine ophtalmological examinations may be considered desirable when treating young children

Ethambutol Taj Pharma therapy should be stopped immediately if visual disturbances are observed (see section 4.8).

Any negative effects on vision are generally reversible when administration of the drug is discontinued promptly and recovery of visual acuity has usually occurred over a period of weeks to months after the drug was discontinued. Patients have then received Ethambutol Taj Pharma at lower doses without toxicity.

In rare cases, recovery may be delayed for up to one year or more or the effects may be irreversible.

Renal impairment:

Renal function should be checked before treatment with antituberculosis drugs and appropriate dosage adjustments made. Ethambutol Taj Pharma should preferably be avoided in patients with renal impairment, but if used the dose should be reduced and the plasma-drug concentration monitored. Toxic effects are more common if renal function is impaired.

Hepatic impairment:

Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment.

Other Warnings:

Consideration should be given to current clinical guidance on the appropriate use of antituberculous drugs.

• Interaction with other medicinal products and other forms of interaction

Aluminium hydroxide impairs the absorption of Ethambutol Taj Pharma. Acid suppressing drugs or antacids that do not contain aluminium hydroxide should be used during Ethambutol Taj Pharma therapy.

• Fertility, pregnancy and lactation

Pregnancy

The potential for risk in humans is unknown as there are no adequate and well controlled studies in pregnant or lactating women. Studies in animals have shown reproductive toxicity. Ethambutol Taj Pharma should not therefore be used during pregnancy, in women of childbearing potential or in lactating women unless the potential benefit to the mother is considered to outweigh any possible risks.

Breast-feeding

Ethambutol Taj Pharma/metabolites have been identified in breastfed newborns/ infants of treated women. There is insufficient information on the effects of Ethambutol Taj Pharma in newborns/ infants.

Breast-feeding is not recommended during Ethambutol Taj Pharma treatment unless the benefit of breast-feeding to the child is considered to outweigh any possible risks

• Effects on ability to drive and use machines

Ethambutol Taj Pharma may produce a unique type of visual impairment (see section 4.8). Dizziness, disorientation, numbness and paraesthesia of the extremities has been reported. Therefore, patients should be advised not to drive or operate machinery if they experience any of these effects.

• Undesirable effects

The most important adverse effect resulting from Ethambutol Taj Pharma use is retrobulbar neuritis with a reduction in visual acuity.

The adverse event data below contains all reactions that are considered at least possibly related to Ethambutol Taj Pharma and is based on data collected, mainly from published literature post authorisation.

The undesirable effects have been arranged by body system, organ class and absolute frequency, and are defined using the following convention:

* This effect is thought to be dose related, and frequency is dependent on both dose and duration of treatment. It occurs most frequently with doses of 25mg/kg body weight and after two months of therapy, however optic neuritis has also occurred after only a few days of therapy. The effect is often reversible upon discontinuation of therapy. To avoid permanent damage visual acuity should be checked regularly during treatment and therapy discontinued immediately when visual disturbances occur.

Visual disturbances may be unilateral or bilateral; therefore, each eye should be tested separately (see section 4.4). Typical signs include: blurred vision, eye pain, impairment of colour vision (red-green colour blindness), constriction of visual field (central or peripheral scotoma), and any loss in vision. Recovery of visual acuity has usually occurred over a period of weeks to months after the drug was discontinued, and patients have then received Ethambutol Taj Pharma at lower dosage without toxicity

¹Liver function tests should be performed in patients who develop symptoms suggestive of hepatitis or who become generally unwell during treatment.

Reporting of suspected adverse reactions

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

• Overdose

Symptoms: Gastrointestinal disturbances, vomiting, fever, headache, anorexia, dizziness, hallucinations and/or visual disturbances.

Treatment: There is no specific antidote, but gastric lavage should be employed if necessary.

5. Pharmacological properties

• Pharmacodynamic properties

– Other drugs for treatment of tuberculosis

Ethambutol Taj Pharma is bacteriostatic. It is effective against Mycobacterium tuberculosi and M.bovis with an MIC of 0.5 – 8µg per ml. The exact mechanism of action is unknown. While it has activity against some atypical mycobacteria including M.Kansasii, activity against other micro-organisms has not yet been reported.

It is effective against tubercle bacilli resistant to other tuberculostatics.

Cross-resistance has not yet been reported. Primary resistance to Ethambutol Taj Pharma is uncommon but resistant strains of M.tuberculosis are readily produced if Ethambutol Taj Pharma is used alone.

• Pharmacokinetic properties

Absorption: Ethambutol Taj Pharma is readily absorbed after oral administration and this absorption is not significantly impaired by food.

Distribution: After a single oral dose of 25mg/kg bodyweight, within 4 hours peak plasma concentrations of up to 5µg/ml are obtained, by 24 hours the concentration decreases to less than 1µg/ml. Ethambutol Taj Pharma readily diffuses into red blood cells and into the cerebrospinal fluid when the meninges are inflamed. It has also been reported to cross the placenta.

Metabolism and Excretion: Most of a dose is excreted unchanged in the urine and up to 20% in the faeces, within 48 hours. From 8 – 15% of a dose appears in the urine as inactive metabolites.

• Preclinical safety data

Ethambutol Taj Pharma has been shown to be teratogenic in pregnant mice and rabbits when given in high doses. When pregnant mice or rabbits were treated with high doses of Ethambutol Taj Pharma hydrochloride, fetal mortality was slightly but not significantly (P>0.05) increased. Female rats treated with Ethambutol Taj Pharma hydrochloride displayed slight but insignificant (>0.05) decreases in fertility and litter size. In foetuses born of mice treated with high doses of Ethambutol Taj Pharma hydrochloride during pregnancy, a low incidence of cleft palate, exencephaly and abnormality of the vertebral column were observed. Minor abnormalities of the cervical vertebra were seen in the newborn of rats treated with high doses of Ethambutol Taj Pharma hydrochloride during pregnancy. Rabbits receiving high doses of Ethambutol Taj Pharma hydrochloride during pregnancy gave birth to two foetuses with monophthalmia, one with a shortened right forearm accompanied by bilateral wrist-joint contracture and one with hare lip and cleft palate.

6. Pharmaceutical particulars

• List of excipients

Sodium Starch Glycolate

Maize Starch

Povidone

Colloidal Anhydrous Silica

Microcrystalline Cellulose

Magnesium Stearate

Opadry II 45F32810 (Polydextrose, Hypromellose, Titanium Dioxide, Macrogol, Iron Oxide Yellow

• Incompatibilities

None.

• Shelf life

3 years.

• Special precautions for storage

Do not store above 25°C.

• Nature and contents of container

Al/PVC/PVDC blisters.

Pack Size:

Each container contains: 14, 28, 30, 50, 56, 60, 80, 100, 120, 240, 360 and 500 film coated tablets.

Not all pack size may be marketed.

• Special precautions for disposal and other handling

None.

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

Ethambutol Tablets USP 800mg Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• 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 only. Do not pass it on to others; it may harm them, even if their symptoms are the same as yours.
• If you get any of the side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

  WHAT IS IN THIS LEAFLET

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

1. WHAT ETHAMBUTOL TABLETS ARE AND WHAT THEY ARE USED FOR

The active ingredient in your tablets is Ethambutol Taj Pharma hydrochloride, which belongs to a group of medicines called anti-tuberculosis drugs. These are used to treat and prevent tuberculosis which is an infectious disease mainly affecting the lungs.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETHAMBUTOL TABLETS

Do not take these tablets if you:

• are allergic (hypersensitive) to Ethambutol Taj Pharma, or to any of the other ingredients (these are listed in section 6, other information)
• have problems with your eyes or your eyesight (unless your doctor has decided it is essential).

Warnings and precautions:

Talk to your doctor or pharmacist before taking Ethambutol Taj Pharma Tablets if you have

• problems with your eyesight – your doctor will arrange for a full check of your eyesight before you start taking this medicine. If you notice any changes to your vision whilst taking this medicine, you MUST inform your doctor straight away. Young children or people with communication difficulties should be closely monitored by their parents or carers for any signs of problems with their eyesight.
• kidney problems as your doctor may decide to adjust the dose of Ethambutol Taj Pharma Tablets.

Other medicines and Ethambutol Taj Pharma Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ethambutol Taj Pharma Tablets should not be taken at the same time as antacid medicines containing aluminium hydroxide (used to relieve heartburn and indigestion), as this can make Ethambutol Taj Pharma less effective.

Although Ethambutol Taj Pharma is not known to be affected itself by any other drugs or to affect other drugs, make sure your doctor knows if you are taking any other medicines.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant or breast-feeding, or if you are trying for a baby, unless your doctor considers it essential. Speak to your doctor before taking the tablets.

Driving and using machinery

Ethambutol Taj Pharma can cause problems with eyesight, dizziness, disorientation or tingling/numbness in hands or feet. You should not drive or operate machinery if it has this effect on you.

3. HOW TO TAKE ETHAMBUTOL TABLETS

The tablets should be swallowed whole with a drink of water. They should be taken as a single dose once a day.

The doctor will decide what dose of tablets you need to take. The dose varies from person to person depending on age, weight and whether it is being used for treatment or prevention of tuberculosis.

If you suffer from any kidney problems your doctor may do blood tests to check whether you need to take a lower dose than usual.

Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems in which case, check with your doctor.

Adults:

For prevention and first time treatment of tuberculosis: The usual dose is 15mg per kg of body weight each day.

Second time (or subsequent) treatment of tuberculosis: The usual dose is 25mg per kg of body weight each day for the first 60 days, reducing to 15mg per kg of body weight each day for as long as necessary.

Children:

For prevention of tuberculosis: The usual dose is 15mg per kg of body weight each day.

First time, second time (or subsequent) treatment of tuberculosis: The usual dose is 25mg per kg of body weight each day for the first 60 days, reducing to 15mg per kg of body weight each day for as long as necessary.

Elderly:

The same dosages as for adults are usually used although reduced doses may be required in the elderly who have kidney problems; in these patients the doctor will carry out blood tests to determine the dose required.

If you take more tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.

Remember to take the pack and any remaining tablets with you.

If you forget to take a dose of Ethambutol Taj Pharma Tablets

If you forget to take a dose, take it as soon as you remember, however, if this is within a few hours of when your next dose is due, skip the missed dose and just carry on with the normal routine. Do not take a double dose to make up for the forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

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

Some side effects can be serious.

Stop taking Ethambutol Taj Pharma Tablets and tell your doctor straightaway if you notice the following effects:

• sudden wheeziness, difficulty breathing, swelling of the face, eyes, lips or throat, flushed appearance, irregular heartbeat. (These may be symptoms of a severe allergic reaction)
• any changes or problems with your eyesight including loss of vision, blurred vision, eye pain or colour blindness. Usually sight will return to normal after stopping treatment with Ethambutol Taj Pharma, but in rare cases the problem may take longer to return to normal or become permanent.
• Tell your doctor straightaway if you notice any of the following effects:
• skin rash and itching, a condition known as Stevens-Johnson syndrome which involves a skin rash, possibly with peeling and blistering and a sore mouth; other skin problems including hard lumps, red patches often on the backs of arms and hands and blisters or peeling
• you have pale stools or your skin or whites of your eyes become yellow (as these may be signs of a liver problem)
• you develop pain in the lower back or you experience difficulty or pain in urinating (as these may be signs of a kidney problem)
• you notice any unusual bleeding, bruising or discoloured skin (as these may be signs of a blood disorder).
• you notice any changes to your vision

The following other side effects have also been reported:

Common (may affect up to 1 in 10 people)

• eye problems; loss of vision due to inflammation of the optic nerve, colour blindness, loss of the sharpness; acuteness; keenness of vision

Uncommon (may affect up to 1 in 100 people)

• high levels of uric acid in the blood (hyperuricaemia)

Rare side effects (may affect up to 1 in 1000 people)

• numbness, pins and needles sensation
• low blood platelet count (which may result in bruising, nosebleeds, pinpoint red spots, prolonged bleeding after injury)
• minor allergic reactions such as rashes, itching and hives

Very rare side effects (may affect up to 1 in 10,000 people)

• blood disorders such as reduction in the number of white cells in the blood and low level of neutrophils, a type of white blood cell
• dizziness, confusion, disorientation, hallucinations, headache, fever, generally feeling unwell
• joint pains, burning pain, weakness in hands and feet
• fluid in the lungs or inflammation of the lungs which may cause breathlessness,cough and raised temperature
• kidney problems (lower back pain, pain or burning when passing urine, difficulty passing urine)
• gout (which results in warmth, swelling, reddish discoloration, and marked tenderness of joint especially common to affect big toe)
• blisters or peeling of skin (including following exposure to sunlight)

Not known (frequency cannot be estimated from the available data)

• shaking
• stomach problems, including loss of appetite, feeling or being sick, diarrhoea, flatulence (wind), stomach pain, metallic taste and weight loss
• hepatitis, jaundice, transient increase in liver enzymes, abnormal liver function tests in patients on multiple medications.

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.

5. HOW TO STORE ETHAMBUTOL TABLETS

Keep out of the sight and reach of children.

Do not store above 25ºC. Keep your medicine in the pack in which it was given to you. Do not transfer your medicine to another container.

Do not take this medicine after the expiry date (Exp.) stated. The expiry date refers to the last day of that month.

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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Ethambutol Taj Pharma Tablets are available in two strengths containing either 100mg or 400mg Ethambutol Taj Pharma hydrochloride as the active ingredient.

The other ingredients are Sodium Starch Glycolate, Maize Starch, Povidone, Colloidal Anhydrous Silica, Microcrystalline Cellulose, Magnesium Stearate and Colours Containing Polydextrose, Hypromellose, Titanium Dioxide, Macrogol and Yellow Iron Oxide; The 800mg Tablets Also Contain Black Iron Oxide.

What the medicine looks like and contents of the pack

Ethambutol Taj Pharma 100mg Tablets are yellow, round, film-coated tablets.
Ethambutol Taj Pharma 400mg Tablets are grey, round, film-coated tablets.
Ethambutol Taj Pharma 800mg Tablets are grey, round, film-coated tablets.

Al/PVC/PVDC blisters.

Pack Size:

Each container contains: 14, 28, 30, 50, 56, 60, 80, 100, 120, 240, 360 and 500 film coated tablets.

Not all pack size 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