Combutol 200

COMBUTOL 200 by LUPIN LTD

Combutol 200 is an antimicrobial medication manufactured by Lupin Ltd., primarily used in the treatment of tuberculosis.

• Name:

  • Brand Name: COMBUTOL 200
  • Common Name: Ethambutol Hydrochloride

• Composition:

  • Each tablet contains 200 mg of Ethambutol Hydrochloride.

• Uses: Combutol 200 is prescribed for the treatment and prevention of tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis. This bacterial infection mainly affects the lungs but can also spread to other organs like the brain and spine. It is typically used in combination with other anti-tuberculosis drugs to combat the infection and reduce bacterial load. It may also be used to treat disseminated Mycobacterium avium complex (MAC) infection.

• Dosage and Administration: Combutol 200 is taken orally, usually once daily, with or without food, preferably at the same time each day. The exact dosage and duration of treatment are determined by a healthcare professional based on the patient's age, weight, and the severity of the infection. For initial treatment, adults and children 13 years and older typically receive 15 mg/kg of body weight once daily. It is crucial to complete the full course of medication as prescribed, even if symptoms improve, to prevent treatment failure and drug resistance. Antacids containing aluminum should be taken at least 4 hours before or after Combutol 200.

• Side Effects:

  • Common Side Effects: Loss of appetite, nausea, vomiting, upset stomach, headaches, dizziness, confusion, joint pain, and numbness or tingling in the hands or feet (peripheral neuropathy).
  • Serious Side Effects:
    • Optic neuritis: This can lead to blurred vision, decreased visual acuity, red-green color blindness, or sudden changes in vision, potentially resulting in permanent vision loss if not addressed promptly.
    • Hepatotoxicity: Symptoms of liver problems may include jaundice (yellowing of skin/eyes), dark urine, fatigue, and persistent nausea or vomiting.
    • Rarely, severe allergic skin reactions like Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) may occur.
    • It can also affect uric acid levels, potentially exacerbating or causing gout.

• Precautions: Patients should inform their doctor about any known allergies to ethambutol or other medications, as well as pre-existing conditions such as kidney disease, liver disease, gout, diabetes, or eye disorders (e.g., optic neuritis, cataracts). Regular eye examinations are recommended before and during treatment to monitor for vision changes. Combutol 200 is generally not recommended for children under 13 years of age, or under 5-6 years, due to the difficulty in monitoring visual side effects. Pregnant or breastfeeding individuals should consult their doctor to weigh the potential benefits and risks.

• Storage: Store Combutol 200 tablets at room temperature, ideally between 20°C to 25°C (68°F to 77°F). Keep the medicine in its original, tightly closed container, away from excessive heat, moisture, and direct light. Do not freeze, and keep it out of reach of children.

COMBUTOL 200 by LUPIN LTD contains Ethambutol Hydrochloride, an antitubercular medicine used to treat tuberculosis (TB) and certain other Mycobacterium infections.

Here are some frequently asked questions about COMBUTOL 200:

What is COMBUTOL 200 used for?

COMBUTOL 200 is primarily used to treat tuberculosis (TB), an infectious disease that mainly affects the lungs but can also spread to other parts of the body like the brain and spine. It is typically used in combination with other anti-TB medications.

How does COMBUTOL 200 work?

COMBUTOL 200, containing Ethambutol, works by inhibiting the growth of Mycobacterium tuberculosis bacteria. It does this by obstructing the formation of the bacterial cell wall, specifically by inhibiting the enzyme arabinosyl transferase, which prevents cell division and reduces the number of binding sites for mycolic acid. This action is bacteriostatic against actively growing TB bacilli.

What is the usual dosage of COMBUTOL 200?

The dosage of COMBUTOL 200 varies depending on the patient's weight, treatment history, and specific regimen, and it is always prescribed by a doctor. For adults and children 13 years and older, a common dose can be 15 to 25 mg per kilogram of body weight once a day. For re-treatment or in some initial phases, higher doses like 25 mg/kg daily for 60 days, then reduced to 15 mg/kg/day, may be used. In patients with renal insufficiency, the dose may be adjusted to 15-25 mg/kg three times a week.

What are the possible side effects of COMBUTOL 200?

Common side effects can include problems with vision (such as blurred vision, eye pain, red-green color blindness, or even permanent vision loss), joint pain, nausea, headaches, loss of appetite, and feeling tired. More serious side effects can include liver problems, allergic reactions, and numbness or tingling in the hands and feet. It is crucial to report any changes in vision to your doctor immediately.

Is COMBUTOL 200 safe during pregnancy or breastfeeding?

Untreated TB poses a greater risk to a pregnant woman and fetus than the treatment itself. Ethambutol is generally considered compatible with pregnancy, and human pregnancy data do not suggest an embryo-fetal risk, although the FDA has raised concerns about potential eye issues in the baby if used during pregnancy. For breastfeeding mothers, ethambutol is generally considered safe, as the concentrations in breast milk are small and not known to produce toxicity in the nursing newborn. However, it's always important to consult your doctor.

Can COMBUTOL 200 be taken with other medications?

Yes, COMBUTOL 200 can interact with certain medications. For example, antacids containing aluminum can decrease the absorption and efficacy of ethambutol, so it's advised to take ethambutol at least 4 hours before or 2 to 4 hours after such antacids. Ethambutol may also interact with certain gout medications (like allopurinol and febuxostat) and disulfiram, increasing the risk of side effects. Limited research suggests potential interactions with high doses of vitamin B6 and St. John's wort. It's important to inform your doctor about all prescription, over-the-counter medications, vitamins, and herbal supplements you are taking.

What precautions should be taken while taking COMBUTOL 200?

It is crucial to have regular check-ups with your doctor, including vision tests and blood work to monitor liver and kidney function, as ethambutol can cause optic neuritis (vision problems) and liver damage. COMBUTOL 200 is generally not recommended for children under five or six years of age because they may not be able to report vision changes effectively. Patients with existing eye problems (like optic neuritis, cataracts, or diabetic retinopathy), kidney disease, or liver disease should use this medicine with caution. Do not stop taking the medication without consulting your doctor, as this can lead to drug resistance or worsening of the infection.

What happens if a dose of COMBUTOL 200 is missed?

If you miss a dose of COMBUTOL 200, 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 a missed one. It is very important to complete the full prescribed course of treatment, even if you start to feel better.

How should COMBUTOL 200 be stored?

COMBUTOL 200 tablets should be stored at room temperature, ideally between 68°F and 77°F (20°C and 25°C), and away from excess heat, moisture, and direct light. Keep the medicine in its original container, tightly closed, and out of the reach of children. Do not use the medication if the original seal is broken or missing, and dispose of expired medicine safely.