Savera (400mg) 28 Tablets

Savera (400mg) 28 Tablets

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  • Manufacturer BIOTEST PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Sofosbuvir

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Description

    Sofosbuvir, a medication used in the treatment of chronic hepatitis C virus (HCV) infection, acts by directly inhibiting the HCV NS5B RNA-dependent RNA polymerase. This enzyme is crucial for viral replication as it catalyzes the synthesis of new viral RNA strands from the viral RNA template. Sofosbuvir is a nucleotide analog that mimics the structure of a natural substrate of the NS5B polymerase. When incorporated into the growing RNA chain, Sofosbuvir acts as a chain terminator, effectively blocking the extension of the RNA strand and halting viral replication. It competes with the natural substrate for binding to the active site of the NS5B polymerase, leading to the formation of incomplete and non-functional viral RNA molecules. This mechanism of action specifically targets the HCV polymerase, interfering with viral replication without affecting host cell processes, making it a potent and selective antiviral agent.

  • Ingredients

    Sofosbuvir
  • Drug Class

    Nucleotide analogue inhibitor

  • Dosage Form

    Tablet

  • Uses

    The following are the uses of Sofosbuvir Tablet:

    • Used for the treatment of chronic Hepatitis C infections.
    • Used for preventing the Hepatitis C virus from multiplying.
    • Used for increasing the chances of curing Hepatitis C.
    • Used to treat various types of Hepatitis C genotypes.
    • Used for patients with specific liver conditions, like cirrhosis.
  • In case of Overdose

    In the case of an overdose of Sofosbuvir Tablets, it is important to remain calm and take immediate action. Seek emergency medical care or contact a poison control center right away. Do not induce vomiting unless advised by a healthcare professional. The symptoms of an overdose may include headache, fatigue, and gastrointestinal issues, but the specific effects can vary. Quick response and appropriate medical intervention are crucial to managing any potential complications.

  • Missed Dose

    In the case of a missed dose of Sofosbuvir Tablet, it is important to take the medication 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. If you miss multiple doses, contact your healthcare provider for guidance, as they may recommend adjusting your dosage or provide specific instructions to ensure the effectiveness of the treatment.

  • How To Use

    To take Sofosbuvir Tablets, swallow the tablet whole with a glass of water, preferably at the same time each day, following the dosage instructions provided by your healthcare professional, typically taken once daily with or without food.

  • When Not to Use

    Following are the conditions when Sofosbuvir Tablet should not be used:

    • Do not take if you have a history of hypersensitivity or allergic reactions to Sofosbuvir or any of the excipients in the tablet formulation.
    • Not recommended for individuals with severe kidney impairment or those on dialysis.
    • Avoid using Sofosbuvir if you have a history of liver transplantation or liver cancer.
    • Should not be used in patients with decompensated cirrhosis.
    • Discontinue use if signs of liver failure or severe adverse reactions occur during treatment.
    • Not suitable for individuals with a known hepatitis B virus (HBV) infection, as it can lead to HBV reactivation.
    • Do not use in children or adolescents, as the safety and efficacy in this population have not been established.
  • Side Effects

    The side effects of Sofosbuvir Tablet may include:

    • Fatigue
    • Headache
    • Nausea
    • Insomnia
    • Diarrhea
    • Irritability
    • Skin rash
    • Anemia
  • Precautions & Warnings

    Following are the precautions and warnings for Sofosbuvir Tablet:

    • Patients with a history of hepatitis B or C virus infection should be monitored closely as Sofosbuvir can cause reactivation of these viruses.
    • Regular monitoring of liver function tests is essential during treatment, especially in patients with underlying liver disease.
    • Sofosbuvir may cause fatigue and dizziness; patients should exercise caution when driving or operating heavy machinery.
    • It is important to complete the full course of treatment as prescribed, even if symptoms improve, to ensure the effectiveness of the medication.
    • Patients with kidney disease or those undergoing hemodialysis may require dosage adjustments.
    • Sofosbuvir may interact with other medications, including antiretrovirals and certain herbal supplements, so patients should inform their healthcare provider of all medications they are taking.
    • This medication is not recommended for use in children as its safety and efficacy have not been established in the pediatric population.
  • Drug Interactions

    Following are the drug interactions for Sofosbuvir Tablet:

    • Co-administration with amiodarone can cause symptomatic bradycardia and potential heart block, requiring close monitoring.
    • Rifampin reduces the effectiveness of Sofosbuvir, potentially leading to treatment failure.
    • Sofosbuvir may increase concentrations of certain antiretroviral drugs, such as atazanavir and darunavir, requiring dosage adjustments.
    • St. John's Wort (Hypericum perforatum) decreases the plasma concentration of Sofosbuvir, potentially compromising its therapeutic effect.
    • Sofosbuvir may increase the risk of adverse events when used with other hepatotoxic medications.
    • It may decrease the effectiveness of hormonal contraceptives, requiring alternative or additional contraceptive methods.
    • The use of sofosbuvir with other direct-acting antiviral agents (DAAs) may require dosage adjustments to avoid drug interactions and ensure optimal therapeutic outcomes.
  • Food Interactions

    Following are the food interactions for Sofosbuvir Tablet:

    • Avoid excessive alcohol consumption as it may increase the risk of liver-related side effects and reduce the effectiveness of Sofosbuvir.
    • Grapefruit and grapefruit juice should be consumed with caution as they can alter the metabolism of Sofosbuvir, potentially leading to increased drug levels and a higher risk of side effects.
    • High-fat meals may slightly decrease the absorption of Sofosbuvir, so it is recommended to take the medication on an empty stomach or with a low-fat meal for optimal absorption.
    • Sofosbuvir may interact with vitamin and herbal supplements, especially those containing St. John's Wort, as they can affect the liver enzymes responsible for metabolizing the drug.
    • Avoid consuming products containing high levels of riboflavin (vitamin B2) as they can interfere with the absorption of Sofosbuvir.
    • Patients with lactose intolerance should be cautious as some Sofosbuvir tablets may contain lactose.
    • Certain herbal teas or supplements, particularly those with enzyme-inducing properties, should be used with caution as they may affect Sofosbuvir's metabolism.
    • Always inform your healthcare provider about your dietary habits and any supplements you are taking to ensure safe and effective use of Sofosbuvir.
  • Storage/Disposal

    Sofosbuvir tablets should be stored in a cool, dry place, preferably at room temperature between 68°F and 77°F (20°C and 25°C). Protect the tablets from excessive heat, moisture, and direct sunlight, and keep them in their original packaging or a tightly sealed container. It is crucial not to store the medication in the bathroom or kitchen, as these areas can expose it to heat and moisture. Always check the expiration date, and if the tablets are expired or no longer needed, do not throw them into the trash or flush them down the toilet. Contact your pharmacist or local waste disposal company for guidance on safe disposal methods. Keep the medication out of the reach of children and pets to prevent accidental consumption.

  • Quick Tips, if any

    Following are the quick tips for Sofosbuvir Tablet:

    • Ensure you take the medication as directed by your doctor for effective treatment.
    • Swallow the tablet whole with a full glass of water; do not crush or chew.
    • Maintain a consistent daily routine for taking the tablet to enhance treatment effectiveness.
    • Consider taking the tablet with food to minimize potential stomach discomfort.
    • Inform your doctor if you have any liver or kidney issues before starting this medication.
    • Regularly monitor your liver function while on this medication as advised by your doctor.
    • Store the tablets in a cool, dry place, away from direct sunlight and moisture.
    • Do not share this medication with others, even if their symptoms are similar.
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