Lamivir Hbv 100mg (10tab)

LAMIVIR HBV 100MG (10TAB) by CIPLA LTD.

Name

• Brand Name: LAMIVIR HBV 100MG
• Common Name: Lamivudine (as a 100 mg tablet)

Composition

• Active Ingredient: Lamivudine 100 mg

Uses

LAMIVIR HBV Tablet is an antiviral medication used to manage certain viral infections.

• Chronic Hepatitis B Virus (HBV) Infection: It is indicated for the treatment of chronic hepatitis B virus infection, especially when there is evidence of viral replication and active liver inflammation. It works by preventing the HBV virus from multiplying in the body, helping to control the infection and improve the immune system's function.
• Human Immunodeficiency Virus (HIV) Infection: It is also used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection. It helps to decrease the amount of HIV in the body, lowering the risk of HIV-related complications and improving lifespan. However, LAMIVIR-HBV tablets contain a lower dose of lamivudine than typically used for HIV-1 treatment, and monotherapy is not appropriate for HIV-1.

Dosage and Administration

• Adults (Chronic Hepatitis B): The recommended oral dose for the treatment of chronic hepatitis B in adults is 100 mg once daily.
• Administration: It can be taken with or without food. Taking it with food may increase its absorption.
• Important Note: It is crucial to take this medicine as prescribed by a doctor and to not discontinue it without medical consultation, as it may worsen the condition, especially for hepatitis B. If taken for HIV, it must be used in combination with other antiretroviral medications. Doses may need adjustment for patients with renal impairment.

Side Effects

Common side effects may include:

• Headache
• Nausea and vomiting
• Diarrhoea
• Fatigue/weakness
• Dizziness
• Sleep disturbances/insomnia
• Muscle pain (myalgia) or joint pain (arthralgia)
• Cough
• Rash

Serious side effects, though rare, can include lactic acidosis and severe hepatomegaly with steatosis (fatty liver), which can be life-threatening.

Precautions

• Allergies: Do not take if you are allergic to Lamivudine or any other ingredients in the tablet.
• HIV-1 Resistance Risk: LAMIVIR-HBV is not approved for HIV-1 treatment alone due to its lower lamivudine dose. If used in patients with unrecognized or untreated HIV-1 infection, it can lead to rapid emergence of HIV-1 resistance. HIV counseling and testing should be offered before and periodically during treatment.
• Exacerbation of Hepatitis B: Severe acute exacerbations of hepatitis B have been reported upon discontinuation of anti-hepatitis B therapy, including lamivudine. Hepatic function should be monitored closely for several months after stopping treatment.
• Liver Disease: Use with caution if you have a history of liver disease. This medication could worsen the condition.
• Kidney Impairment: Caution is advised, and dosage adjustments may be necessary if you have kidney problems.
• Pancreatitis: A history of pancreatitis may increase the risk of adverse effects.
• Alcohol: Limit or avoid alcohol intake as it may increase the risk of side effects and can further damage the liver.
• Pregnancy and Breastfeeding: Caution is advised during pregnancy. Women with HIV should not breastfeed due to the risk of HIV transmission, and a small amount of Lamivir HBV Tablet can pass into breast milk.
• Driving and Machinery: Lamivir HBV Tablet can cause dizziness or sleepiness; caution is advised when driving or operating machinery.
• Drug Interactions: Inform your doctor about all other medicines, herbal preparations, and supplements you are taking. Interactions can occur with interferons, other antiviral medications (e.g., ribavirin, emtricitabine), antibiotics (e.g., trimethoprim/sulfamethoxazole), and sorbitol.

Storage

• Store at room temperature, ideally between 15-30°C.
• Keep in a cool, dry place, away from direct sunlight, heat, and excessive moisture.
• Keep out of reach of children and pets.
• Always check the expiry date and do not use past this date.

What is LAMIVIR HBV 100MG used for?

LAMIVIR HBV 100MG is primarily used for the treatment of chronic hepatitis B virus (HBV) infection in adults who show evidence of hepatitis B viral replication and active liver inflammation. It can also be used in combination with other antiretroviral medications to manage Human Immunodeficiency Virus (HIV) infection. It is important to note that the 100mg dosage is not appropriate for treating HIV-1 infection alone, as it is a subtherapeutic dose and can lead to rapid emergence of HIV-1 resistance if HIV is unrecognized or untreated.

How does LAMIVIR HBV 100MG work?

LAMIVIR HBV 100MG contains lamivudine, which is a synthetic nucleoside analog. Once inside the body, lamivudine is converted into its active form, lamivudine triphosphate. This active metabolite works by inhibiting the viral enzyme reverse transcriptase, which is crucial for the hepatitis B virus to multiply. By blocking this enzyme, it prevents the virus from replicating, thereby reducing the viral load and slowing the progression of the infection. For HIV, it similarly inhibits HIV-1 reverse transcriptase.

What is the usual dosage of LAMIVIR HBV 100MG?

For adults with chronic hepatitis B virus infection, the recommended oral dose of LAMIVIR HBV 100MG is one 100 mg tablet once daily. The tablet can be taken with or without food. Dosage adjustments are necessary for patients with impaired kidney function, and your healthcare provider will determine the appropriate dose based on your renal function. The safety and effectiveness of this medication have not been fully established in pediatric patients, particularly those younger than 2 years of age for HBV.

What are the possible side effects of LAMIVIR HBV 100MG?

Common side effects associated with LAMIVIR HBV 100MG include headache, nausea, vomiting, diarrhea, fatigue, dizziness, sleep disturbances (insomnia), muscle pain, cough, sore throat, and rash. More serious, but rare, side effects can include lactic acidosis (a build-up of lactic acid in the blood) and severe hepatomegaly with steatosis (enlarged liver with fat). It is important to note that severe acute exacerbations of hepatitis B have been reported in patients who have stopped anti-hepatitis B therapy, including lamivudine.

Is LAMIVIR HBV 100MG safe during pregnancy or breastfeeding?

Pregnancy: LAMIVIR HBV 100MG is classified as a Pregnancy Category C drug. This means that while animal studies have shown some adverse effects, there are no adequate and well-controlled studies in pregnant women. It should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. Untreated hepatitis B infection can also be harmful to both the mother and the unborn child.

Breastfeeding: Lamivudine, the active ingredient, is present in human milk. While the safety of LAMIVIR HBV 100MG during breastfeeding has not been fully established, limited human data suggest it is probably safe and does not pose a significant risk to the baby. However, it is generally recommended to consult a healthcare provider to weigh the potential benefits and risks before taking this medication while breastfeeding. For HIV-positive mothers, breastfeeding is typically not recommended due to the risk of HIV transmission to the infant.

Can LAMIVIR HBV 100MG be taken with other medications?

LAMIVIR HBV 100MG should not be taken concurrently with other medications that contain lamivudine or emtricitabine. It may interact with certain other medicines, including interferons (e.g., Intron A), other antiviral drugs (e.g., ribavirin), and some antibiotics like trimethoprim/sulfamethoxazole. Some medications can either decrease or increase the serum concentration of lamivudine. Always inform your doctor about all prescription and over-the-counter medications, herbal preparations, and supplements you are currently taking to avoid potential drug interactions.

What precautions should be taken while taking LAMIVIR HBV 100MG?

Several precautions should be taken:

• HIV-1 Testing: It is crucial to be tested for HIV-1 infection before starting and periodically during treatment with LAMIVIR HBV. If you have unrecognized or untreated HIV-1, using LAMIVIR HBV alone can lead to the rapid emergence of HIV-1 resistance.
• Liver and Kidney Function: Close monitoring of liver and kidney function is necessary before and during treatment, especially since dose adjustments are required for renal impairment, and severe exacerbations of hepatitis B can occur if the medication is stopped.
• Lactic Acidosis/Hepatotoxicity: Be aware of symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (liver damage), and seek medical attention if they occur.
• Alcohol Consumption: Limit or avoid alcohol intake as it may increase the risk of liver damage and other side effects.
• Driving and Operating Machinery: This medicine may cause dizziness or sleepiness, so exercise caution when driving or operating heavy machinery until you know how it affects you.
• Viral Resistance: The hepatitis B virus can develop resistance to lamivudine over time, which may lead to worsening liver disease.

What happens if a dose of LAMIVIR HBV 100MG is missed?

If you miss a dose of LAMIVIR HBV 100MG, 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, as this may increase the risk of side effects.

How should LAMIVIR HBV 100MG be stored?

LAMIVIR HBV 100MG should be stored at room temperature, ideally between 15-30°C. Keep the tablets in a cool, dry place, away from excessive heat, direct sunlight, and moisture. Ensure that the medicine is kept out of reach of children and pets. Always check the expiry date on the packaging and do not use any tablets past this date.