Combunex 800 Tablet

COMBUNEX 800 TABLET

COMBUNEX 800 TABLET is a prescription medicine manufactured by Lupin Ltd., primarily used in the treatment of tuberculosis.

Composition COMBUNEX 800 TABLET contains a fixed-dose combination of two active ingredients:

• Isoniazid: 300 mg
• Ethambutol: 800 mg

These agents work together by preventing the growth of the microorganisms responsible for tuberculosis infection. Isoniazid inhibits the TB bacteria from forming their protective covering, while Ethambutol slows their growth.

Uses COMBUNEX 800 TABLET is prescribed for:

• Treatment of Tuberculosis (TB), including both pulmonary (lungs) and extra-pulmonary forms (other parts of the body like kidneys, brain, spine, bone marrow). It is used in the continuation phase of TB treatment to prevent bacteria from multiplying and reduce the risk of drug resistance.

Dosage and Administration

• COMBUNEX 800 TABLET should be taken exactly as recommended by your doctor.
• It is generally advised to take the medicine on an empty stomach, preferably at a fixed time each day, to ensure optimal efficacy.
• Swallow the tablet whole with a glass of water; do not crush, break, or chew it.
• Do not exceed the prescribed dosage, as this may lead to harmful effects.
• Complete the entire course of treatment, even if symptoms improve, to ensure the infection is fully cured and to prevent recurrence and drug resistance. Abruptly discontinuing the medication can affect its potency.

Side Effects Common side effects may include:

• Nausea, vomiting
• Fever
• Dark-colored urine
• Sweating, increased saliva
• Weakness, general discomfort, fatigue, loss of appetite

Serious side effects, though rare, warrant immediate medical attention:

• Hepatitis (liver damage), jaundice, increased liver enzymes
• Vision problems such as blurred vision, color blindness, or optic neuritis (inflammation of the optic nerve). Regular eye checks are crucial.
• Nerve problems like peripheral neuropathy, characterized by tingling or numbness of hands and feet.
• Severe allergic reactions (rashes, itching, swelling, shortness of breath).
• Increased uric acid levels in the blood, leading to gout.
• Rare blood disorders.

Precautions

• Inform your doctor about all current medications you are taking, as well as any pre-existing medical conditions.
• Use with caution in patients with kidney diseases, epilepsy (fits), diabetes, a history of alcohol abuse, psychosis, malnourishment, or HIV infection.
• Pregnant or breastfeeding women should consult their doctor before using this medicine. It is known to make hormonal contraceptive pills less effective.
• Avoid consuming alcohol while on this medication, as it can cause excessive drowsiness and increase the risk of liver damage.
• This medicine may cause dizziness; therefore, avoid driving or operating heavy machinery if you experience these symptoms.
• Regular monitoring of liver function, vision, and thyroid function may be advised by your doctor during treatment.
• Avoid foods high in tyramine or histamine, such as cheese, smoked fish, meats, soya, tuna, and certain types of alcohol, as they can interact with the tablet.
• Not recommended for patients with severe liver problems or pre-existing sight problems. Not generally recommended for children under 13 years without careful monitoring due to the difficulty in preventing eye damage in younger children.

Storage

• Store COMBUNEX 800 TABLET below 30°C.
• Keep this medicine in a cool and dry place, out of the sight and reach of children.

Here are frequently asked questions about COMBUNEX 800 TABLET by LUPIN LTD:

What is COMBUNEX 800 Tablet used for?

COMBUNEX 800 Tablet is primarily used in the treatment of tuberculosis (TB), an infectious bacterial disease that mainly affects the lungs but can also spread to other parts of the body such as kidneys, brain, spine, and bone marrow.

How does COMBUNEX 800 Tablet work?

This medicine is a combination of two active ingredients: Isoniazid and Ethambutol. Isoniazid works by preventing the tuberculosis bacteria from forming their protective covering, which effectively kills them and eradicates the infection. Ethambutol slows the growth of these bacteria by inhibiting the production of mycolic acid, a crucial component for the formation of their cell wall.

What is the usual dosage for COMBUNEX 800 Tablet?

The typical dosage is one tablet daily, taken on an empty stomach, usually 30 minutes before or 2 hours after a meal. It's crucial to follow your doctor's instructions regarding the dosage and duration of treatment.

What are the possible side effects of COMBUNEX 800 Tablet?

Common side effects can include nausea, vomiting, fever, rash, sweating, salivation, numbness or tingling in the hands and feet (peripheral neuropathy), visual impairment (blurred vision, changes in color vision), fatigue, loss of appetite, dark urine, pale stools, chills, joint pain or swelling, abdominal pain, and headache. Serious side effects may involve liver damage (indicated by jaundice or dark urine) and severe allergic reactions.

Is COMBUNEX 800 Tablet safe during pregnancy or breastfeeding?

Pregnancy: COMBUNEX 800 Tablet may be unsafe to use during pregnancy and should be used with caution, only if the potential benefits outweigh the risks. Animal studies have shown harmful effects on the developing baby, and it may disrupt fetal growth. Breastfeeding: Traces of the medication can be transmitted from mother to baby through breast milk. It should only be used while breastfeeding if prescribed by a doctor after a careful assessment of benefits versus risks.

Can COMBUNEX 800 Tablet be taken with other medications?

COMBUNEX 800 Tablet can interact with various medications. These include certain antibiotics (e.g., Erythromycin), antiepileptics (e.g., Carbamazepine, Phenytoin), pain relievers (e.g., Acetaminophen), other antitubercular drugs (e.g., Rifampicin), anti-diabetics (e.g., Insulin isophane), anti-HIV medications, and antacids containing aluminum hydroxide. It can also reduce the effectiveness of hormonal contraceptive pills. Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should be taken while on COMBUNEX 800 Tablet?

It is vital to complete the full course of treatment as prescribed by your doctor, even if you start to feel better, to prevent drug resistance and recurrence of infection. Avoid consuming alcohol while taking this medicine, as it can increase the risk of liver damage and dizziness. Certain tyramine-rich and histamine-rich foods like cheese, smoked fish, and some types of alcohol should also be avoided as they can interact with the tablet. Regular monitoring of liver function, vision, and thyroid function is often recommended. Do not drive or operate heavy machinery if you experience dizziness or visual disturbances.

What happens if a dose of COMBUNEX 800 Tablet is missed?

If you miss a dose, 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 compensate for a missed one.

How should COMBUNEX 800 Tablet be stored?

Store COMBUNEX 800 Tablet in a cool and dry place, away from direct heat and moisture. Keep it in a safe cabinet and out of the sight and reach of children.