Valganciclovir 450 Tab

<p dir=\"ltr\" style=\"text-align: left;\">Store below 30 ^oC </p> <p dir=\"ltr\" style=\"text-align: left;\">Protect from light and moisture</p> <p dir=\"ltr\" style=\"text-align: left;\">Keep out of rich of children</p>

<p style=\"text-align: left;\">   Contact a poison control center</p>

<ul> <li dir=\"ltr\" style=\"text-align: left;\">The most common adverse reactions and laboratory abnormalities reported in at least one indication by greater than or equal to 20% of adult patients treated with tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting., upper respiratory tract infection</li> <li dir=\"ltr\" style=\"text-align: left;\">Other adverse drug reactions with Valganciclovir in clinical trials in either patient with CMV retinitis or solid organ transplant patients that occurred in at least 5% of patients are listed below</li> <li dir=\"ltr\" style=\"text-align: left;\">Eye disorders: retinal detachment, eye pain</li> <li dir=\"ltr\" style=\"text-align: left;\">Gastrointestinal disorders: dyspepsia, constipation, abdominal distention, mouth ulceration</li> <li dir=\"ltr\" style=\"text-align: left;\">General disorders and administration site conditions: fatigue, pain, malaise, asthenia, chills, peripheral edema</li> <li dir=\"ltr\" style=\"text-align: left;\">Hepatobiliary disorders: hepatic function abnormal</li> <li dir=\"ltr\" style=\"text-align: left;\">Infections and infestations: candida infections including oral candidiasis, upper respiratory tract infection, influenza, urinary tract infection, pharyngitis/nasopharyngitis, postoperative wound infection</li> <li dir=\"ltr\" style=\"text-align: left;\">Injury, poisoning, and procedural complications: postoperative complications, wound secretion</li> <li dir=\"ltr\" style=\"text-align: left;\">Metabolic and nutrition disorders: decreased appetite, hyperkalemia, hypophosphatemia, weight decreased</li> <li dir=\"ltr\" style=\"text-align: left;\">Musculoskeletal and connective tissue disorders: back pain, myalgia, arthralgia, muscle spasms</li> <li dir=\"ltr\" style=\"text-align: left;\">Nervous system disorders: insomnia, neuropathy peripheral,</li> <li dir=\"ltr\" style=\"text-align: left;\">dizziness Psychiatric disorders: depression, anxiety</li> <li dir=\"ltr\" style=\"text-align: left;\">Renal and urinary disorders: renal impairment, creatinine clearance renal decreased, blood creatinine increased, hematuria</li> <li dir=\"ltr\" style=\"text-align: left;\">Respiratory, thoracic and mediastinal disorders: cough, dyspnea</li> <li dir=\"ltr\" style=\"text-align: left;\">Skin and subcutaneous tissues disorders: dermatitis, night sweats, pruritus</li> <li dir=\"ltr\" style=\"text-align: left;\">Vascular disorders: hypotension</li> <li dir=\"ltr\" style=\"text-align: left;\">Blood and lymphatic disorders: febrile neutropenia, pancytopenia, bone marrow failure (including aplastic anemia)</li> <li dir=\"ltr\" style=\"text-align: left;\">Cardiovascular disorders: arrhythmia</li> <li dir=\"ltr\" style=\"text-align: left;\">Adverse Reactions in Pediatric Patients:</li> </ul> <ul dir=\"ltr\"> <li style=\"text-align: left;\">The most frequently reported adverse reactions (greater than 10% of patients) in pediatric kidney transplant patients treated with valganciclovir until Day 200 post-transplant were upper respiratory tract infection, urinary tract infection, diarrhea, leukopenia, neutropenia, headache, abdominal pain, tremor, pyrexia, anemia, blood creatinine increased, vomiting, and hematuria</li> </ul>

<p dir=\"ltr\" style=\"text-align: left;\">     However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for this drug. Drug-drug interaction studies with ganciclovir were conducted in patients with normal renal function. Following concomitant administration of Valganciclovir and other renally excreted drugs, patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug.  Imipenem-cilastatin- Cyclosporine or amphotericin B- Mycophenolate mofetil (MMF)- Other drugs associated with myelosuppression or nephrotoxicity (e.g., adriamycin, dapsone, doxorubicin, flucytosine, hydroxyurea, pentamidine, tacrolimus, trimethoprim/ sulfamethoxazole, vinblastine, vincristine, and zidovudine)- Probenecid Didanosine</p>

<p dir=\"ltr\" style=\"text-align: left;\">It is not recommended</p>

<p dir=\"ltr\" style=\"text-align: left;\">It is Pregnancy Category C and women of childbearing age should use contraception while using valganciclovir</p>

<p dir=\"ltr\" style=\"text-align: left;\">Hematologic Toxicity:</p> <ul dir=\"ltr\"> <li style=\"text-align: left;\">Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir or ganciclovir .this drug should be avoided if the absolute neutrophil count is less than 500 cells/μL, the platelet count is less than 25,000/μL, or the hemoglobin is less than 8 g/dLalso should also be used with caution in patients with pre-existing cytopenia and in patients receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. In patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia, treatment with hematopoietic growth factors may be considered</li> <li style=\"text-align: left;\">Acute renal failure may occur in:</li> <li style=\"text-align: left;\">Elderly patients with or without reduced renal function. Caution should be exercised when administering this drug to geriatric patients, and dosage reduction is recommended for those with impaired renal function</li> <li style=\"text-align: left;\">Patients receiving potential nephrotoxic drugs.</li> <li style=\"text-align: left;\">Patients without adequate hydration. Adequate hydration should be maintained for all patients</li> </ul>

<p dir=\"ltr\" style=\"text-align: left;\"> Is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation</p>

<ul> <li dir=\"ltr\" style=\"text-align: left;\">Valganciclovir should be taken with food</li> </ul> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Recommended Dosage in Adult Patients with Normal Renal Function</strong></p> <p dir=\"ltr\" style=\"text-align: left;\">For dosage recommendations in adult patients with renal impairment .</p> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Treatment Of CMV Retinitis</strong></p> <ul dir=\"ltr\" style=\"text-align: left;\"> <li>Induction: The recommended dosage is 900 mg (two 450 mg tablets) taken orally twice a day for 21 days</li> <li>Maintenance: Following induction treatment, or in adult patients with inactive CMV retinitis, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day</li> </ul> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Prevention Of CMV Disease</strong></p> <ul dir=\"ltr\" style=\"text-align: left;\"> <li>For adult patients who have received a heart or kidney-pancreas transplant, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day starting within 10 days of transplantation until 100 days post-transplantation</li> <li>For adult patients who have received a kidney transplant, the recommended dosage is 900 mg (two 450 mg tablets) taken orally once a day starting within 10 days of transplantation until 200 days post-transplantation</li> </ul> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Recommended Dosage in Pediatric Patients</strong></p> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Prevention Of CMV Disease in Pediatric Kidney Transplant Patients</strong></p> <p dir=\"ltr\" style=\"text-align: left;\">For pediatric kidney transplant patients 4 months to 16 years of age, the recommended once daily mg dose (7 x BSA x CrCl) should start within 10 days of post-transplantation until 200 days post-transplantation</p> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Prevention Of CMV Disease in Pediatric Heart Transplant Patients</strong></p> <p dir=\"ltr\" style=\"text-align: left;\">For pediatric heart transplant patients 1 month to 16 years of age, the recommended once daily mg dose (7 x BSA x CrCl) should start within 10 days of transplantation until 100 days post-transplantation</p> <p dir=\"ltr\" style=\"text-align: left;\">The recommended once daily dosage is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the equation below:</p> <p dir=\"ltr\" style=\"text-align: left;\">Pediatric Dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula). If the calculated Schwartz creatinine clearance exceeds 150 mL/min/1.73m², then a maximum value of 150 mL/min/1.73m² should be used in the equation. The k values used in the modified Schwartz formula are based on pediatric patient age, as shown in Table</p> <p dir=\"ltr\" style=\"text-align: left;\"> </p> <p dir=\"ltr\" style=\"text-align: left;\"> </p> <p dir=\"ltr\" style=\"text-align: left;\"> </p> <p dir=\"ltr\" style=\"text-align: left;\"> </p> <table class=\" alignleft\" dir=\"ltr\"> <tbody> <tr> <td> <p><strong>k value</strong></p> </td> <td> <p><strong>Pediatric Patient Age</strong></p> </td> </tr> <tr> <td> <p>0.33</p> </td> <td> <p>Infants less than 1 year of age with low birth weight for gestational age</p> </td> </tr> <tr> <td> <p>0.45</p> </td> <td> <p>Infants less than 1 year of age with birth weight appropriate for gestational age</p> </td> </tr> <tr> <td> <p>0.45</p> </td> <td> <p>Children aged 1 to less than 2 years</p> </td> </tr> <tr> <td> <p>0.55</p> </td> <td> <p>Boys aged 2 to less than 13 years Girls aged 2 to less than 16 years</p> </td> </tr> <tr> <td> <p>0.7</p> </td> <td> <p>Boys aged 13 to 16 years</p> </td> </tr> <tr> <td colspan=\"2\"> <p>*The k values provided are based on the Jaffe method of measuring serum creatinine, and may require correction when enzymatic methods are used¹.</p> </td> </tr> </tbody> </table> <p dir=\"ltr\" style=\"text-align: left;\"> Mosteller BSA (m²) = Height (cm) x Weight (kg)/ 3600</p> <p dir=\"ltr\" style=\"text-align: left;\"> Schwartz Creatinine Clearance mL/min /1.73m²)= k x Height (cm)/ Serum Creatinine (mg/ dL)</p> <p dir=\"ltr\" style=\"text-align: left;\"><strong>Table 1 : k Values According to Pediatric Patient Age*</strong></p> <p dir=\"ltr\" style=\"text-align: left;\">Monitor serum creatinine levels regularly and consider changes in height and body weight and adapt the dose as appropriate during prophylaxis period</p> <p dir=\"ltr\" style=\"text-align: left;\">All calculated doses should be rounded to the nearest 25 mg increment for the actual deliverable dose. The oral dispenser is graduated in 0.5 mL increments. A 50 mg dose is equivalent to 1 mL. If the calculated dose exceeds 900 mg, a maximum dose of 900 mg should be administered.  However, tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg). For example, if the calculated dose is between 405 mg and 495 mg, one 450 mg tablet may be taken. Before prescribing tablets, pediatric patients should be assessed for the ability to swallow tablets</p>

<p dir=\"ltr\" style=\"text-align: left;\">Adult Patients:</p> <ul dir=\"ltr\" style=\"text-align: left;\"> <li>Treatment of Cytomegalovirus (CMV) Retinitis</li> <li>It is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)</li> </ul> <p dir=\"ltr\" style=\"text-align: left;\">Prevention of CMV Disease:</p> <p dir=\"ltr\" style=\"text-align: left;\">Valganciclovir is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])                                                                                         </p> <p dir=\"ltr\" style=\"text-align: left;\">Pediatric Patients:</p> <ul dir=\"ltr\"> <li style=\"text-align: left;\">Prevention of CMV Disease</li> <li style=\"text-align: left;\">Valganciclovir is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk</li> </ul>

<p dir=\"ltr\" style=\"text-align: left;\">Valganciclovir is an antiviral drug with activity against CMV </p>