Ributin Cap

RIBUTIN CAP (Rifabutin)

Name

• Common Name: Rifabutin
• Brand Name: RIBUTIN CAP (by Lupin Ltd)

Composition Each capsule contains 150 mg of Rifabutin.

Uses RIBUTIN CAP is an antibiotic primarily used for the prevention and treatment of Mycobacterium avium complex (MAC) disease in patients with advanced Human Immunodeficiency Virus (HIV) infection. MAC is a bacterial infection that can cause serious symptoms. It may also be used in combination with other medications to treat active tuberculosis (TB) in HIV-infected individuals, or as a second-choice option for H. pylori infections.

Dosage and Administration The typical adult dosage for the prevention of MAC is 300 mg once a day, or 150 mg two times a day with food. It can be taken with or without food, but taking it with food may help if it causes an upset stomach. If swallowing is difficult, the capsule contents can be mixed with applesauce. It is crucial to complete the entire prescribed course of treatment, even if symptoms improve, to prevent the infection from returning or developing resistance.

Side Effects

• Common: Rifabutin commonly causes a harmless reddish-orange to brown-orange discoloration of urine, stools, saliva, sweat, and tears. This can permanently stain soft contact lenses. Other common side effects include nausea, heartburn, burping, gas, diarrhea, abdominal pain, altered taste, rash, muscle pain, and headache.
• Serious: Serious side effects, though rare, can include severe allergic reactions (anaphylaxis, angioedema, DRESS syndrome), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), eye inflammation (uveitis), and bone marrow suppression leading to low white blood cell and platelet counts.

Precautions Rifabutin can interact with many other medications, including hormonal contraceptives (reducing their effectiveness) and certain HIV antivirals, requiring dosage adjustments. Patients should not take Rifabutin for MAC prevention if they have active tuberculosis, as this could lead to drug resistance. Regular blood tests are recommended to monitor for potential blood disorders and liver function changes. Patients should inform their doctor if they experience eye pain, redness, blurred vision, or severe diarrhea.

Storage Store RIBUTIN CAP in a closed container at room temperature, away from heat, moisture, and direct light, typically between 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat. Keep out of reach of children.

RIBUTIN CAP, manufactured by LUPIN LTD, contains the active ingredient Rifabutin. It is an antimycobacterial antibiotic primarily used to prevent and treat certain bacterial infections, especially in individuals with compromised immune systems, such as those with HIV.

What is RIBUTIN CAP used for?

RIBUTIN CAP is primarily used for the prevention and treatment of Mycobacterium avium complex (MAC) disease, a bacterial infection, in individuals with advanced Human Immunodeficiency Virus (HIV) infection. It is also used to treat tuberculosis (TB) in patients with HIV infection. In some cases, it may be used in combination with other medications for active tuberculosis or to help eliminate H. pylori bacteria.

How does RIBUTIN CAP work?

RIBUTIN CAP (Rifabutin) works as an antimycobacterial agent. It functions by inactivating bacterial RNA-polymerase, an enzyme that is crucial for bacteria to produce and replicate essential proteins. By disrupting this process, Rifabutin effectively kills or stops the growth of the infection-causing bacteria, but it does not affect mammalian cells.

What is the usual dosage for RIBUTIN CAP?

For the prevention of Mycobacterium avium complex (MAC), the typical adult dosage is 300 milligrams (mg) once a day, or 150 mg two times a day. It can be taken with or without food, but taking it with food may help reduce stomach upset. If you experience nausea or vomiting, your doctor might recommend a lower dose taken twice daily with food. If you have difficulty swallowing the capsule, its contents can be mixed with applesauce. The dosage for children must be determined by a doctor.

What are the possible side effects of RIBUTIN CAP?

Many people experience a harmless red-orange discoloration of body fluids, such as urine, saliva, tears, sweat, and skin. This is normal and will cease after completing the medication, but it can permanently stain soft contact lenses. Common side effects can include nausea, heartburn, burping, gas, diarrhea, abdominal pain, rash, headache, muscle pain, drowsiness, dizziness, and a decreased white blood cell count (leukopenia/neutropenia) or platelet count (thrombocytopenia). More serious side effects, though less common, include eye inflammation (uveitis) causing pain, redness, or vision changes, and severe skin reactions like Stevens-Johnson Syndrome.

Is RIBUTIN CAP safe during pregnancy or breastfeeding?

Pregnancy: RIBUTIN CAP is generally considered safe for use during pregnancy if prescribed by a doctor, falling under Pregnancy Category B. However, adequate and well-controlled studies in pregnant women are limited. Animal studies at high doses have shown some potential risks to the fetus. It should be used only if the potential benefit outweighs the potential risk. Rifabutin may also reduce the effectiveness of hormonal contraceptives, so alternative or additional birth control methods should be considered.

Breastfeeding: RIBUTIN CAP is likely safe to use during breastfeeding. The amount of rifabutin that passes into breast milk is considered insufficient to treat tuberculosis in the infant, and breastfeeding is generally not discouraged. However, the infant should be monitored for signs of liver toxicity, and breast milk may appear orange.

Can RIBUTIN CAP be taken with other medications?

RIBUTIN CAP can interact with many other medications. It is crucial to inform your doctor and pharmacist about all prescription, over-the-counter drugs, vitamins, and herbal supplements you are taking. Significant interactions include:

• Hormonal Contraceptives: Rifabutin can decrease their effectiveness, requiring alternative birth control.
• HIV/AIDS Medications: Rifabutin can interact with many antiretroviral drugs, potentially altering their concentrations. It is contraindicated with certain HIV medications like saquinavir, ritonavir, and cabotegravir/rilpivirine injectable suspension.
• Antifungal Medications: Such as itraconazole, ketoconazole, posaconazole, or voriconazole.
• Antacids: Should be taken at least one hour apart from RIBUTIN CAP.
• Other Antimycobacterials: Caution is needed when co-administering with drugs like clarithromycin, which may necessitate a reduced dose of rifabutin. Due to the complexity of drug interactions, always consult your healthcare provider.

What precautions should be taken while taking RIBUTIN CAP?

• Do not take RIBUTIN CAP if you have a known allergy to rifabutin or any other rifamycin.
• It should not be used as the sole treatment for active tuberculosis, as this can lead to drug resistance. Patients must be evaluated for active TB before starting treatment for MAC prophylaxis.
• Regular blood tests (including complete blood count and liver function tests) are necessary before and during treatment to monitor for blood disorders and liver issues.
• Report any changes in vision, eye pain, or severe skin rashes to your doctor immediately.
• Use with caution if you have kidney or liver disease, as dose adjustments may be required.
• Avoid wearing soft contact lenses due to the risk of permanent discoloration.
• Do not share this medicine with others, and complete the full prescribed course even if your symptoms improve.
• Exercise caution when driving or operating machinery if you experience dizziness.

What happens if a dose of RIBUTIN CAP is missed?

If you miss a dose of RIBUTIN CAP, 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.

How should RIBUTIN CAP be stored?

RIBUTIN CAP should be stored at room temperature, typically between 68-77°F (20-25°C), and can tolerate excursions between 59-86°F (15-30°C) for short periods. Keep the capsules in a cool, dry place, away from heat, moisture, and direct light, and out of the reach of children. The container should be kept tightly closed.