Combutol 1000 Tablet

COMBUTOL 1000 TABLET by LUPIN LTD

Name

• Brand Name: Combutol 1000 Tablet
• Common Name: Ethambutol

Composition

Combutol 1000 Tablet contains Ethambutol (1000 mg) as its active ingredient.

Uses

Combutol 1000 Tablet is an antibiotic primarily used to treat and prevent tuberculosis (TB), an infectious disease mainly affecting the lungs that can also spread to other body parts like the brain and spine. It is also used in the treatment of Mycobacterium avium complex and Mycobacterium kansasii. It works by destroying or slowing the growth of Mycobacterium tuberculosis bacteria. This medicine is typically prescribed as part of a combination therapy with other anti-tuberculosis drugs.

Dosage and Administration

This medicine should be taken orally as advised by your doctor, preferably at the same time every day, with or without food. Swallow the tablet whole with a glass of water; do not crush, break, or chew it. The standard adult dosage is typically 15-25 mg/kg of body weight per day, but the exact dosage and duration are determined by a healthcare professional. Do not skip doses and complete the entire course of treatment, even if symptoms improve, to prevent treatment failure and drug resistance. If a dose is missed, take it as soon as remembered, but skip it if it's almost time for the next dose; do not double the dose.

Side Effects

Common Side Effects: Nausea, vomiting, loss of appetite, headaches, dizziness, confusion, stomach pain, joint aches, and rash. Serious Side Effects (consult doctor immediately if experienced): Visual impairment, color blindness, blurred vision, eye pain, tingling or numbness in hands or feet, decreased urine output, swelling of legs and feet, yellowish skin and eyes, blistering or peeling skin, red or purple rash, and severe allergic reactions (difficulty breathing, sudden wheeziness, swelling of face/eyes/lips/throat, irregular heartbeat).

Precautions

• Vision: Combutol can cause vision problems, including optic neuritis, blurred vision, and color blindness. Regular vision monitoring is advised.
• Kidney and Liver Disease: Use with caution in patients with kidney or liver disease; dose adjustment and regular monitoring of kidney and liver function may be necessary.
• Diabetes: It can lower blood sugar levels; diabetic patients should monitor their blood sugar regularly.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding unless clearly necessary, with potential risks and benefits discussed with a doctor.
• Alcohol: Avoid alcohol consumption as it can lead to dizziness or drowsiness.
• Drug Interactions: Antacids containing aluminum should be taken at least 4 hours before or after Combutol 1000 Tablet to avoid drug interaction. Inform your doctor about all medications you are taking.
• Driving: May cause sight problems, dizziness, or tingling/numbness, impairing the ability to drive or operate machinery.
• Contraindications: Not recommended in conditions like optic neuritis, diabetic retinopathy, or diabetic nephropathy.

Storage

Store Combutol 1000 Tablet below 30°C, at room temperature (20-25°C). Protect from light and moisture, and keep out of reach of children.

COMBUTOL 1000 Tablet, manufactured by Lupin Ltd, contains Ethambutol Hydrochloride as its active ingredient. It is an antibiotic primarily used in the treatment of tuberculosis (TB).

Here are some frequently asked questions about COMBUTOL 1000 Tablet:

What is COMBUTOL 1000 Tablet used for?

COMBUTOL 1000 Tablet is an antibiotic used mainly for the treatment of active tuberculosis (TB), a serious infectious disease that primarily affects the lungs but can also spread to other parts of the body. It is typically prescribed in combination with other anti-tuberculosis medications to enhance effectiveness and prevent the development of drug resistance. It may also be used to treat disseminated Mycobacterium avium complex (MAC) infection and Mycobacterium kansasii.

How does COMBUTOL 1000 Tablet work?

COMBUTOL 1000 Tablet works by interfering with the ability of tuberculosis-causing bacteria to multiply. Specifically, it inhibits certain enzymes called arabinosyltransferases, which are crucial for building the bacterial cell wall components (arabinogalactan and lipoarabinomannan). This inhibition prevents the bacteria from forming their cell walls, stopping their growth and division, which helps your body fight off the infection.

What is the usual dosage for COMBUTOL 1000 Tablet?

The dosage of COMBUTOL 1000 Tablet can vary depending on individual body weight, medical history, and the specific treatment regimen prescribed by your doctor. For adults and children 13 years and older, a common daily dose is 15 to 25 milligrams (mg) per kilogram (kg) of body weight, taken once a day as part of a multi-drug regimen for tuberculosis. For example, daily doses might range from 800 mg for individuals weighing 40-55 kg, to 1200 mg for those weighing 56-75 kg, and 1600 mg for 76-90 kg. It is crucial to follow your doctor's instructions exactly.

What are the possible side effects of COMBUTOL 1000 Tablet?

Common side effects can include itching, rash, joint pain, headache, dizziness, nausea, vomiting, stomach pain, indigestion, and loss of appetite. More serious side effects that require immediate medical attention include:

• Vision problems: blurred vision, trouble focusing, loss of vision (which may be permanent), red-green color blindness, or eye pain.
• Liver damage: right upper belly pain, loss of appetite, nausea, dark urine, light-colored stools, or yellowing of the skin or eyes.
• Allergic reactions: hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.
• Other serious effects may include numbness or tingling in your hands or feet, confusion, hallucinations, fever, swollen glands, painful mouth sores, skin sores, easy bruising or bleeding.

Is COMBUTOL 1000 Tablet safe during pregnancy or breastfeeding?

• Pregnancy: Ethambutol (the active ingredient) has not been shown to increase the frequency of malformations or direct harm to the fetus in a large number of pregnant women. Untreated tuberculosis poses a greater risk to both the pregnant woman and the fetus than its treatment. However, animal studies have shown adverse effects at very high doses. It should be used with caution during pregnancy, and you should consult your doctor.
• Breastfeeding: Ethambutol is generally considered compatible with breastfeeding. The concentration of the drug in breast milk is very low and unlikely to cause toxicity in nursing infants. The CDC and American Academy of Pediatrics advise against discouraging breastfeeding for women taking ethambutol. However, infants should be monitored for jaundice. Consult your doctor if you are breastfeeding.

Can COMBUTOL 1000 Tablet be taken with other medications?

COMBUTOL 1000 Tablet should always be used with at least one other anti-tuberculosis drug and never as a sole treatment. It can interact with certain other medications:

• Antacids containing aluminum hydroxide may decrease the absorption of ethambutol. It is advisable to take antacids at least four hours before or after taking COMBUTOL 1000 Tablet.
• Medications for gout such as probenecid, allopurinol, or febuxostat may interact.
• BCG vaccine live has a serious interaction.
• Disulfiram, used for alcohol dependence, may increase the risk of neurological side effects.
• It may interfere with the absorption of copper and zinc; if taking supplements, separate the doses by at least two hours. Always inform your healthcare provider about all prescription and over-the-counter medicines, vitamins, herbal products, and other supplements you are currently using.

What precautions should be taken while taking COMBUTOL 1000 Tablet?

It is very important to complete the entire prescribed course of treatment with COMBUTOL 1000 Tablet, even if your symptoms improve or go away, to fully treat the infection and prevent bacteria from becoming resistant to the medicine. You will likely need regular vision tests and blood work to monitor your liver, kidney, and blood health while on this medication. Use with caution if you have kidney disease, liver disease, gout, or a history of optic neuritis, as these conditions may require dose adjustments or careful monitoring. Since dizziness or confusion are possible side effects, be cautious when driving or operating heavy machinery until you know how the medication affects you. COMBUTOL 1000 Tablet is generally not recommended for children under 13 years of age, or sometimes under 6 years, because it can be difficult for them to report vision changes.

What happens if a dose of COMBUTOL 1000 Tablet is missed?

If you miss a dose of COMBUTOL 1000 Tablet, 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 or extra doses to make up for the missed one. Missing doses can make the infection harder to treat and increase the risk of drug resistance.

How should COMBUTOL 1000 Tablet be stored?

COMBUTOL 1000 Tablet should be stored at room temperature, ideally between 68°F and 77°F (20°C and 25°C). Keep the medicine in its original, tightly closed container and protect it from light and moisture. Do not use the medication if the original seal is broken or missing. Always keep COMBUTOL 1000 Tablet and all other medicines out of the reach of children.