SUMMARY CMI

Ethambutol Lupin

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking Ethambutol?

Ethambutol Lupin contains the active ingredient ethambutol hydrochloride. Ethambutol Lupin is used to treat all forms of tuberculosis (including tuberculosis of the lung, skin, genital tract, urinary tract, bone and joint, eye and the brain).

For more information, see Section 1. Why am I taking Ethambutol Lupin? in the full CMI.

2. What should I know before I take Ethambutol Lupin?

Do not use if you have ever had an allergic reaction to ethambutol or any of the ingredients listed at the end of the CMI.

Do not use Ethambutol Lupin if you have sight problems, kidney or liver problems. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take Ethambutol Lupin? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ethambutol Lupin and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Ethambutol Lupin?

• Ethambutol Lupin tablets should be taken once every 24 hours with or without food, with a glass of water.
• The size of the dose to be taken will depend on whether you have previously received treatment for tuberculosis. It also depends on your bodyweight. Your doctor will calculate the dose you need and tell you how many tablets to take each day.

More instructions can be found in Section 4. How do I take Ethambutol Lupin? in the full CMI.

5. What should I know while taking Ethambutol Lupin?

For more information, see Section 5. What should I know while taking Ethambutol Lupin? in the full CMI.

6. Are there any side effects?

Blurred vision (eye problems), abdominal pain, fever, vomiting, dizziness, headache may occur commonly.

Anaphylactoid reaction (severe allergic reaction characterised by difficulty in breathing, flushed appearance, agitation or an irregular heartbeat), Stevens-Johnson syndrome (characterised by a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and/or genitals), toxic epidermal necrolysis (severe skin peeling and blistering) are the serious side effects that may occur.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Ethambutol Lupin

Active ingredient(s): ethambutol (as hydrochloride)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ethambutol Lupin. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Ethambutol Lupin.

Where to find information in this leaflet:

1. Why am I taking Ethambutol Lupin?
2. What should I know before I take Ethambutol Lupin?
3. What if I am taking other medicines?
4. How do I take Ethambutol Lupin?
5. What should I know while take Ethambutol Lupin?
6. Are there any side effects?
7. Product details

1. Why am I taking Ethambutol Lupin?

Ethambutol Lupin contains the active ingredient ethambutol hydrochloride. Ethambutol Lupin is an antibiotic that belongs to a group of medicines called antituberculosis drugs.

Ethambutol Lupin is used to treat all forms of tuberculosis (including tuberculosis of the lung, skin, genital tract, urinary tract, bone and joint, eye and the brain).

Your doctor may have prescribed Ethambutol Lupin for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

2. What should I know before I take Ethambutol Lupin?

Warnings

Do not take Ethambutol Lupin if:

• you are allergic to ethambutol, or any of the ingredients listed at the end of this leaflet.
  Some of the symptoms of an allergic reaction to ethambutol may include:
  - rash, itching or hives on the skin;
  - swelling of the face, lips, tongue or other parts of the body;
  - shortness of breath;
  - wheezing or troubled breathing.
  Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions including:
  - eye problems or feel your eyesight is being affected (for example, your vision becomes blurred);
  - kidney disease;
  - liver problems;
  - gout.
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Ethambutol Lupin and affect how it works.

Medicines that may reduce the effect of Ethambutol Lupin include:

• aluminium hydroxide (found in acid suppressing drugs or antacids).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ethambutol Lupin.

4. How do I take Ethambutol Lupin?

How much to take

• The size of the dose to be taken will depend on whether you have previously received treatment for tuberculosis. It also depends on your bodyweight.
• Ethambutol Lupin will be prescribed with other antituberculosis drugs. Your doctor will decide on the best combination of drugs for you to take.
• Follow the instructions provided when Ethambutol Lupin was prescribed, including the number of days it should be taken.

Initial Treatment

• If you have not been treated for tuberculosis before, the usual dose is 15 mg/kg of bodyweight of Ethambutol Lupin to be taken as a single dose once every 24 hours.

Re-Treatment

• If you have been treated for tuberculosis before, the usual dose is 25 mg/kg of bodyweight of Ethambutol Lupin to be taken as a single dose, once every 24 hours. After 60 days the dose will be lowered to 15 mg/kg of bodyweight.
• These dosages may be changed by your doctor.
• Continue taking it until your doctor tells you to stop.

When to take Ethambutol

• Ethambutol Lupin tablets should be taken once every 24 hours with or without food, with a glass of water.
• It can take up to 2 years of treatment with Ethambutol Lupin to cure you of tuberculosis. It is important that you keep taking the medicine for the full time of treatment.
• Do not stop taking it if you start feeling better. You must have regular checkups.
• If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

If you forget to take Ethambutol Lupin

Ethambutol Lupin should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much Ethambutol Lupin

If you think that you have used too much Ethambutol Lupin, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26); or
• contact your doctor; or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking Ethambutol Lupin?

Things you should do

• If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking Ethambutol Lupin.
• If you become pregnant while taking Ethambutol Lupin, tell your doctor immediately.
• Only use Ethambutol Lupin at the times and doses recommended by your doctor.

Remind any doctor, dentist or pharmacist you visit that you are using Ethambutol Lupin.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
• Do not use Ethambutol Lupin to treat any other medical complaints unless told to by your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Ethambutol Lupin affects you.

Ethambutol Lupin occasionally causes sight problems and may present symptoms which affect the ability to drive or use machinery (eg. numbness or paraesthesia (abnormal sensation like pins and needles) of the furthest parts of your body, disorientation and possible hallucinations).

Looking after your medicine

• Store below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight. For example, do not store it:

• in the bathroom or near a sink; or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Ethambutol Lupin contains

Do not take this medicine if you are allergic to any of these ingredients.

What Ethambutol Lupin looks like

Ethambutol Lupin 400 mg tablets are white to off white circular, biconvex, film-coated tablets, plain on both sides available in either blister pack (AUST R 365232) or HDPE bottle pack (AUST R 365231).

Not all packs may be marketed.

Who distributes Ethambutol Lupin

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

  [email protected]

  +61 3 9809 7900

  www.generichealth.com.au

This leaflet was prepared in July 2022.

Published by MIMS July 2023

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Ethambutol hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains 400 mg of ethambutol hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ethambutol Lupin 400 mg.

4 Clinical Particulars

4.1 Therapeutic Indications

Ethambutol Lupin is indicated for the treatment of pulmonary tuberculosis, as shown by a large number of studies by investigators throughout the world. It has also been used successfully in cases of primary tuberculosis and extrapulmonary forms of tuberculosis, including miliary tuberculosis, tuberculous meningitis, tuberculosis of bones and joints, genitourinary tuberculosis, tuberculosis of the skin and tuberculous eye diseases. It should not be used as the sole antituberculosis drug, but should be used in conjunction with at least one other antituberculosis drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety and appropriate in vitro susceptibility studies.
In patients who have not received previous antituberculosis therapy, i.e. initial treatment, the most frequently used regimens have included three of the following drugs - ethambutol, isoniazid, rifampicin and streptomycin - for the first 2-4 months. For example: ethambutol plus isoniazid plus rifampicin; or ethambutol plus isoniazid plus streptomycin then continuing with a two drug regimen such as ethambutol plus isoniazid; or ethambutol plus rifampicin.
In patients who have received previous antituberculosis therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment cases Ethambutol Lupin should be combined with at least one of the second-line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculosis drugs used with ethambutol have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilised.

4.2 Dose and Method of Administration

Ethambutol Lupin tablets are available only in a 400 mg strength. Other strengths of ethambutol hydrochloride tablets are available in another brand.

Oral.

Initial treatment.

Re-treatment.

Intermittent therapy.

4.3 Contraindications

Ethambutol Lupin is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgement determines that it may be used.
No absolute contraindications to the administration of ethambutol have been reported.

4.4 Special Warnings and Precautions for Use

Because this drug may have adverse effects on vision, physical examination should include ophthalmoscopy, finger perimetry and testing of colour discrimination. In patients with visual defects such as cataract, recurrent inflammatory conditions of the eye, optic neuritis and diabetic retinopathy, the evaluation of changes in visual acuity is more difficult, and care should be taken to be sure the variations in vision are not due to the underlying disease conditions. In such patients, consideration should be given to the relationship between benefits expected and possible visual deterioration, since evaluation of visual changes is difficult. (For recommended procedures, see next paragraphs under (see Section 4.8 Adverse Effects (Undesirable Effects)).
As with any potent drug, periodical assessment of organ functions, including the renal, hepatic and haematopoietic systems, should be made during long-term therapy.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Ethambutol may produce decreases in visual acuity that appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. Incidence with the recommended dosage has averaged about 2 to 3% of patients. This effect is generally reversible when administration of the drug is discontinued promptly. In rare cases, recovery may be delayed for up to one year or more irreversible blindness has been reported.
Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterised by one or more of the following events: decreased visual acuity, scotoma, colour blindness, and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis.
Patients should be advised to report promptly to their physician any change in visual acuity.
The change in visual acuity may be unilateral or bilateral and hence each eye must be tested separately and both eyes tested together. Testing of visual acuity should be performed before beginning ethambutol therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg/kg/day. Snellen eye charts are recommended for testing of visual acuity. Studies have shown that there are definite fluctuations of one or two lines of the Snellen chart in the visual acuity of many tuberculous patients not receiving ethambutol.
Table 2 may be useful in interpreting possible changes in visual acuity attributable to ethambutol.
In general, changes in visual acuity less than those shown in Table 2 may be due to chance variation, limitations of the testing method or physiological variability. Conversely, changes in visual acuity equalling or exceeding those shown in the table indicate the need for retesting and careful evaluation of the patient's visual status. If careful evaluation confirms the magnitude of visual change and fails to reveal another cause, ethambutol should be discontinued and the patient re-evaluated at frequent intervals. Progressive decreases in visual acuity during therapy must be considered to be due to ethambutol. If corrective glasses are used prior to treatment, these must be worn during visual acuity testing. During one to two years of therapy, a refractive error may develop which must be corrected in order to obtain accurate test results. Testing the visual acuity through a pinhole eliminates refractive error. When visual abnormality develops during ethambutol treatment, patients may have subjective visual symptoms before, or simultaneously with, the demonstration of decreases in visual acuity and all patients receiving ethambutol should be questioned periodically about blurred vision and other subjective eye symptoms.
Recovery of visual acuity generally occurs over a period of weeks to months after the drug has been discontinued. Some patients have received ethambutol again after such recovery without recurrence of loss of visual acuity.
Other adverse reactions reported include: anaphylactoid reaction, dermatitis, pruritus, joint pain, anorexia, nausea, vomiting, gastrointestinal upset, abdominal pain, fever, malaise, headache, dizziness, mental confusion, disorientation and possible hallucinations. Numbness and tingling of the extremities due to peripheral neuritis have been reported infrequently.
Rarely, Stevens-Johnson syndrome, toxic epidermal necrolysis. One case of reversible thrombocytopenia has been reported.
Elevated serum uric acid levels and precipitation of acute gout have been reported. Pulmonary infiltrates and eosinophilia also have been reported during ethambutol therapy. Transient impairment of liver function, as indicated by abnormalities in liver function tests, is not an unusual finding. Since ethambutol is used in conjunction with one or more other antituberculosis drugs, these changes may be related to the concurrent therapy. Moreover, extensive tests of liver function led to the conclusion that ethambutol, when given in recommended doses even for prolonged periods, does not cause hepatic damage.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

Animal pharmacology.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet contains the following excipients: maize starch, povidone, colloidal anhydrous silica, purified talc, magnesium stearate, ethylcellulose, hypromellose, propylene glycol, polyethylene glycol monomethyl ether, titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Ethambutol Lupin 400 mg tablets are available in blister or HDPE bottle pack containing 56 tablets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Ethambutol is an oral chemotherapeutic agent that is specifically effective against actively growing micro-organisms of the genus Mycobacterium, including Mycobacterium tuberculosis.
Ethambutol hydrochloride is a white crystalline powder that is freely soluble in water; soluble in alcohol and methanol; and very slightly soluble in ether and in chloroform. A 2% solution in water has a pH of 3.7 to 4.0.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.