Combutol 400

COMBUTOL 400 by LUPIN LTD

Combutol 400 is an antitubercular medication manufactured by Lupin Ltd.

• Composition Each tablet of Combutol 400 contains 400 mg of Ethambutol Hydrochloride, which is its active ingredient.

• Uses Combutol 400 is prescribed for the treatment and prevention of tuberculosis (TB), a serious infectious disease caused by the bacterium Mycobacterium tuberculosis. It is effective against various forms of TB, including pulmonary tuberculosis, tuberculous meningitis (affecting membranes around the brain), abdominal tuberculosis, and urogenital tuberculosis (affecting the kidneys and bladder). This medicine works by inhibiting the growth of the TB-causing bacteria and is typically used in combination with at least one other antitubercular drug to enhance effectiveness and prevent drug resistance.

• Dosage and Administration Combutol 400 should be taken exactly as advised by a healthcare professional. Tablets should be swallowed whole with water and not crushed or chewed. It can be taken with or without food, ideally at the same time each day. It is crucial to complete the full course of treatment, even if symptoms improve, to prevent the infection from returning or worsening and to avoid the development of drug-resistant TB. The specific dose and duration are determined by the doctor based on the patient's age, body weight, and medical condition.

• Side Effects

  • Common Side Effects: Inflammation of the optic nerve, loss of sharpness of vision, headache, nausea, vomiting, upset stomach, loss of appetite, dizziness, confusion, abdominal pain, fever, chills, joint pain and swelling, skin rash, and tingling or numbness in the hands or feet.
  • Serious Side Effects: Seek immediate medical attention if you experience severe allergic reactions (difficulty breathing, sudden wheezing, swelling of the face, eyes, lips, or throat, irregular heartbeat), significant changes in eyesight (including vision loss, blurred vision, eye pain, or color blindness), blistering or peeling of the skin, decreased urine output or swelling of legs and feet (indicating kidney problems), or yellowish discoloration of the skin and eyes (suggesting liver problems).

• Precautions Combutol 400 is not recommended for patients with pre-existing optic neuritis (eye problems), those allergic to Ethambutol, pregnant women (unless considered absolutely necessary by a doctor), or breastfeeding women. It is also not recommended for children under 13 years of age. Caution is advised for patients with kidney problems (dose adjustment may be needed), liver problems (liver function should be monitored), diabetes (blood sugar levels should be regularly monitored as it can alter them), blood disorders, and elderly patients (over 65 years of age). Antacids containing aluminum hydroxide should be taken at least 4 hours before or after Combutol 400 to avoid drug interaction. Alcohol consumption should be avoided or limited. Patients should inform their doctor about all other medications and supplements they are taking. This medicine may cause visual disturbances or dizziness, so it is advisable to avoid driving or operating machinery if these side effects occur.

• Storage Store Combutol 400 tablets at room temperature, not exceeding 30°C, in a dry container. Keep the medicine away from direct sunlight, heat, and moisture, and out of the reach of children.

COMBUTOL 400 by LUPIN LTD (Ethambutol 400mg) - Frequently Asked Questions

What is COMBUTOL 400 used for?

COMBUTOL 400 (Ethambutol 400mg) is an antibiotic primarily used to treat and prevent tuberculosis (TB), an infectious disease that mainly affects the lungs but can also impact other parts of the body such as the brain, spine, and kidneys. It is typically used in combination with other anti-tuberculosis medications.

How does COMBUTOL 400 work?

Ethambutol, the active ingredient in COMBUTOL 400, works by obstructing the formation of the bacterial cell wall, specifically by inhibiting enzymes called arabinosyltransferases. This action prevents the TB bacteria (Mycobacterium tuberculosis) from multiplying and helps the body fight off the infection.

What is the usual dosage of COMBUTOL 400?

The dosage of COMBUTOL 400 varies depending on the patient's weight, age, and whether it's an initial or retreatment. For adults and children 13 years and older, typical daily doses range from 15 to 25 mg per kilogram of body weight once a day. It can also be prescribed 2 or 3 times a week, often as part of a directly observed therapy (DOT) regimen. It is crucial to follow your doctor's exact instructions regarding dosage and duration.

What are the possible side effects of COMBUTOL 400?

Common side effects may include vision problems (such as blurred vision, trouble focusing, red-green color blindness, or even permanent vision loss), joint pain, nausea, vomiting, headaches, dizziness, stomach pain, indigestion, loss of appetite, and skin rash. More serious, but less common, side effects can include liver problems, numbness or tingling in hands or feet (peripheral neuropathy), confusion, hallucinations, and severe allergic reactions. It is essential to report any changes in vision or other concerning symptoms to your doctor immediately.

Is COMBUTOL 400 safe during pregnancy or breastfeeding?

For pregnancy, untreated TB poses a greater risk than the treatment itself. While ethambutol crosses the placenta, it is generally considered acceptable for use during pregnancy, often as part of a multi-drug regimen. For breastfeeding, ethambutol is generally considered compatible, with minimal levels found in breast milk that are unlikely to harm the infant. However, the baby should be monitored for jaundice. It is crucial to discuss the risks and benefits with your healthcare provider.

Can COMBUTOL 400 be taken with other medications?

COMBUTOL 400 can interact with certain medications. For example, antacids containing aluminum can reduce the absorption of ethambutol, so it's advised to take ethambutol at least 4 hours before or after such antacids. It may also interact with medications for gout (like allopurinol and febuxostat) and potentially certain herbal products like St. John's wort. Always inform your doctor and pharmacist about all prescription, over-the-counter medications, vitamins, and herbal supplements you are taking.

What precautions should be taken when using COMBUTOL 400?

Before starting COMBUTOL 400, inform your doctor if you have kidney problems, liver problems, gout, or any pre-existing eye conditions like optic neuritis. Regular vision tests and blood work (to monitor liver and kidney function) are typically recommended during treatment. It is also important to complete the full prescribed course of treatment, even if you start feeling better, to prevent drug resistance and a relapse of the infection. COMBUTOL 400 is generally not recommended for children under 13 due to difficulties in monitoring visual side effects. If you have active TB, you might need to stay home for the first two weeks of treatment and wear a mask in public spaces.

What happens if a dose of COMBUTOL 400 is missed?

If you miss a dose of COMBUTOL 400, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one. Missing doses can make the infection more resistant to treatment.

How should COMBUTOL 400 be stored?

COMBUTOL 400 tablets should be stored at room temperature, ideally between 68°F and 77°F (20°C and 25°C). Keep the medication in its original container, tightly closed, and away from excess heat and moisture. Ensure it is stored out of the reach of children.