Active Substance: Hydrocortisone 17- butyrate.
Overview
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This medicine contains an important and useful components, as it consists of
Hydrocortisone 17- butyrateis available in the market in concentration
Lamivudine + Zidovudine
Before beginning treatment with **Lamivudine** and **Zidovudine**, patients should consult with their healthcare provider due to the following precautions: - **Liver Disease**: Both Lamivudine and Zidovudine can affect liver function. Patients with pre-existing liver conditions, including chronic hepatitis, should be monitored closely for signs of hepatotoxicity, as both drugs can cause liver enzyme elevation. - **Renal Impairment**: Both drugs are primarily excreted via the kidneys, so patients with renal impairment may require dose adjustments to avoid drug accumulation and toxicity. Patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min) should be carefully monitored. - **Bone Marrow Suppression**: Zidovudine, in particular, is known to cause bone marrow suppression, which may lead to anemia, neutropenia, or thrombocytopenia. Blood counts should be regularly checked, especially during prolonged treatment. - **Lactic Acidosis and Hepatic Steatosis**: Rare but serious side effects of both Lamivudine and Zidovudine include lactic acidosis and hepatic steatosis, particularly in cases of prolonged therapy or advanced disease. Symptoms such as nausea, vomiting, abdominal discomfort, and shortness of breath should be immediately reported. - **Pregnancy**: Lamivudine and Zidovudine are commonly used during pregnancy to reduce the risk of HIV transmission from mother to child. However, the potential risks and benefits should always be discussed with a healthcare provider, as the drugs pass into breast milk. - **Drug Interactions**: Other medications can interact with Lamivudine and Zidovudine, affecting their efficacy or increasing the risk of adverse reactions. Patients should inform their healthcare provider of any other medications they are taking, including over-the-counter drugs and supplements.
The combination of **Lamivudine** and **Zidovudine** is indicated for the treatment of **HIV infection**. This combination is used in both adults and pediatric patients as part of a **highly active antiretroviral therapy (HAART)** regimen. Key indications include: - **HIV Management**: The primary indication for Lamivudine and Zidovudine is the treatment of HIV infection. Both drugs are nucleoside reverse transcriptase inhibitors (NRTIs), which help inhibit the replication of the HIV virus by blocking the reverse transcription process, thereby preventing the virus from multiplying and spreading. - **Prevention of Mother-to-Child Transmission**: Zidovudine is frequently used in pregnant women with HIV to reduce the risk of transmission of the virus to the unborn child. Lamivudine is often included in combination therapy for its synergistic effect in controlling viral load.
The combination of **Lamivudine** and **Zidovudine** is contraindicated in the following situations: - **Hypersensitivity**: Patients who are allergic to Lamivudine or Zidovudine, or any components of the formulation, should not use this combination. - **Severe Hepatic Impairment**: Both Lamivudine and Zidovudine should not be used in patients with severe hepatic dysfunction (e.g., decompensated cirrhosis), as the drugs may exacerbate liver injury or failure. - **Severe Renal Impairment**: Lamivudine and Zidovudine are excreted via the kidneys. In patients with severe renal impairment (e.g., creatinine clearance <30 mL/min), the use of this combination may lead to drug accumulation, increasing the risk of toxicity. - **Bone Marrow Suppression**: Zidovudine can cause significant suppression of bone marrow function, leading to anemia, neutropenia, and thrombocytopenia. In patients with pre-existing blood disorders, this combination may not be appropriate unless the potential benefits outweigh the risks.
Common side effects of **Lamivudine** and **Zidovudine** include: - **Gastrointestinal Issues**: Nausea, diarrhea, vomiting, and abdominal pain are common, particularly during the early stages of treatment. - **Fatigue and Malaise**: Fatigue is a frequent side effect of both Lamivudine and Zidovudine. Some patients experience general weakness or malaise. - **Anemia**: Zidovudine can lead to anemia due to bone marrow suppression. This may cause fatigue, dizziness, and pallor, particularly in patients with prolonged use. - **Neutropenia**: Decreased white blood cell counts, resulting in increased susceptibility to infections, may occur with Zidovudine. - **Headache and Dizziness**: Some patients may experience headaches, dizziness, or lightheadedness. - **Lactic Acidosis**: A rare but serious side effect of both drugs is lactic acidosis, a condition in which lactic acid builds up in the blood, leading to symptoms such as deep, rapid breathing, fatigue, and abdominal discomfort. - **Hepatic Steatosis**: Both drugs have been associated with fat accumulation in the liver, which may lead to liver enlargement and discomfort.
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Both **Lamivudine** and **Zidovudine** are nucleoside reverse transcriptase inhibitors (NRTIs) that work by inhibiting the enzyme **reverse transcriptase**, which is essential for HIV replication. Here's a breakdown of their mechanisms: - **Lamivudine**: Lamivudine is converted into its active form (lamivudine triphosphate) inside the cells. This active form competes with the natural nucleosides needed for viral RNA replication. When incorporated into the growing viral DNA chain, it causes premature chain termination, effectively halting HIV replication. - **Zidovudine**: Zidovudine works similarly by being converted to its active form (zidovudine triphosphate) inside infected cells. It competes with the natural nucleoside thymidine, and when incorporated into the viral DNA chain, it prevents further elongation, thereby stopping HIV replication. By inhibiting reverse transcriptase, these two drugs prevent HIV from converting its RNA into DNA, an essential step in the virus’s replication cycle, thus lowering the viral load and slowing disease progression.
The combination of **Lamivudine** and **Zidovudine** may interact with various medications, food, or supplements, influencing their efficacy or causing adverse effects: - **Rifampin**: Rifampin, a medication used for tuberculosis, can increase the metabolism of Zidovudine, potentially reducing its effectiveness. Dosing adjustments or alternative therapies may be necessary. - **Other Antiretrovirals**: The combination of Lamivudine and Zidovudine with other HIV drugs, such as protease inhibitors (e.g., lopinavir) or non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz), may require careful management to avoid increased side effects or reduced efficacy. - **Valproic Acid**: This anticonvulsant may interact with Zidovudine, increasing the risk of side effects such as blood disorders. Close monitoring is necessary. - **Ganciclovir and Acyclovir**: Both antiviral medications, when used with Zidovudine, may increase the risk of hematologic toxicities, including neutropenia and thrombocytopenia. - **Herbal Supplements**: Herbal products such as St. John’s Wort, commonly used for depression, may reduce the effectiveness of Lamivudine and Zidovudine by affecting their metabolism through cytochrome P450 enzymes. Patients should always inform their healthcare provider about any other medications, supplements, or over-the-counter drugs they are taking to avoid potential interactions.
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The typical dose for **adults** using **Lamivudine** and **Zidovudine** for the treatment of HIV is: - **Lamivudine**: 150 mg twice daily or 300 mg once daily, depending on the prescribed regimen. - **Zidovudine**: 300 mg twice daily. This dosing may be adjusted based on individual patient needs, including kidney function, drug interactions, and the presence of side effects.
The pediatric dosing for **Lamivudine** and **Zidovudine** varies depending on the child's age and weight: - **Lamivudine**: The typical dose for children is 4 mg/kg twice daily (maximum dose of 150 mg twice daily for children over 12 years of age). - **Zidovudine**: For children aged 6 weeks to 12 years, the recommended dose is 4 mg/kg twice daily (up to a maximum of 300 mg twice daily for children over 12 years). The dosing must be adjusted according to the child's weight and kidney function, and regular monitoring for side effects like anemia is important. **Final Note**: The combination of **Lamivudine** and **Zidovudine** remains an effective treatment for **HIV** and is an essential part of antiretroviral therapy. As with any medication regimen, adherence to dosing schedules, close monitoring for side effects, and regular follow-up with healthcare providers are essential for achieving the best outcomes. Always consult with a healthcare provider to ensure this combination therapy is suitable for the patient's specific health needs.
For patients with renal impairment, dose adjustments may be necessary for both **Lamivudine** and **Zidovudine** due to their renal excretion: - **Lamivudine**: For moderate renal impairment (creatinine clearance 30-49 mL/min), the dose should be reduced to 150 mg once daily. In severe renal impairment (creatinine clearance <30 mL/min), further dose adjustments are necessary. - **Zidovudine**: For moderate-to-severe renal dysfunction, Zidovudine doses are often reduced to 100 mg twice daily or adjusted as appropriate. Close monitoring of kidney function is essential when using this combination in patients with renal impairment.
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