Nevirapine Oral liquid 50 mg/ 5 mL (p)

Nevirapine Oral Liquid 50 mg/5 mL (P)


Description

  • Antiretroviral Agent: Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with potent antiviral activity against the Human Immunodeficiency Virus Type 1 (HIV-1).
  • Pediatric Formulation: The oral liquid formulation of 50 mg/5 mL (equivalent to 10 mg/mL) is specifically designed for pediatric patients (indicated by “P”) who cannot swallow tablets.
  • Concentration: This formulation allows for accurate and flexible dose calculation based on the child’s body weight or body surface area.
  • Combination Therapy: It is always used as part of a combination regimen with at least two other antiretroviral agents from different drug classes to prevent the development of viral resistance.

Advantages

  • Accurate Weight-Based Dosing: The liquid formulation is essential for achieving precise dose adjustments for infants and children, ensuring both efficacy and safety.
  • Ease of Administration: The oral liquid is easy to administer to infants and young children, which is crucial for improving medication compliance and treatment outcomes.
  • Improved Adherence: The palatability of the liquid formulation, which is often flavored, improves acceptance and adherence in pediatric patients.
  • Established Efficacy: It is a well-established and highly effective component of first-line antiretroviral therapy (ART) regimens for children in many parts of the world.

Uses

  • Pediatric HIV-1 Infection: Indicated for the treatment of HIV-1 infection in children from birth to 18 years of age, as part of a combination regimen.
  • Prevention of Mother-to-Child Transmission: It is a key medication used to prevent the transmission of HIV from a mother to her baby during and after delivery, with specific dosing regimens for newborns.
  • Initial Therapy: It is a common component of initial ART regimens for children, and its use requires a 14-day “lead-in” period to reduce the risk of severe side effects.
  • Patients with Dysphagia: The liquid formulation is also a viable option for adult patients who have difficulty swallowing pills.

Nature

  • NNRTI Class: Nevirapine belongs to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of drugs.
  • Mechanism of Action: Nevirapine works by binding directly and non-competitively to a specific site on the HIV-1 reverse transcriptase enzyme. This binding causes a conformational change that inactivates the enzyme and blocks the synthesis of viral DNA.
  • Severe Side Effects: A key characteristic of nevirapine is the potential for serious adverse effects, including severe rash (e.g., Stevens-Johnson syndrome) and hepatotoxicity (liver damage), particularly during the first few weeks of therapy. Close monitoring is essential.
  • Drug Interactions: Nevirapine is an inducer of liver enzymes (CYP450 system), which means it can increase the metabolism of other drugs, potentially leading to a loss of their therapeutic effect.

Storage

  • Temperature: The oral liquid should be stored at a controlled room temperature, typically between 20∘C to 25∘C (68∘F to 77∘F), protected from light.
  • Shaking: The bottle must be shaken well before each use to ensure the drug is evenly suspended, as it is an oral suspension.
  • Dosing Accuracy: A calibrated oral syringe or measuring device should be used for accurate dosing. Do not use household spoons.
  • Expiration Date: The medication should not be used after the expiration date on the label. Any unused portion should be properly discarded.

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