VALGANCICLOVIR 50 mg/mL
valganciclovir · FOR SOLUTION · airis PHARMA PVT LTD
VALGANCICLOVIR is a for solution containing valganciclovir at 50 mg/mL, taken oral. Manufactured by airis PHARMA PVT LTD.
Key Facts
- Brand Name
- VALGANCICLOVIR
- Generic Name
- valganciclovir
- NDC Code (Product)
71151-003- Manufacturer
- airis PHARMA PVT LTD
- Strength
- 50 mg/mL
- Dosage Form
- FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210169
- Marketing Start
- 02/28/2022
Recall History
Teva Pharmaceuticals USA, Inc.
Presence of foreign substance: Brown/black particles found during stability testing.
Hetero Labs Limited Unit V
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Valganciclovir for oral solution is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Pediatric Patients ( 1.2 ) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.2 Pediatric Patients Prevention of CMV Disease: 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 [see Clinical Studies ( 14.2 )] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Pediatric Dosage ( 2.3 ) Prevention of CMV disease in kidney transplant patients 4 months to 16 years of age Dose once a day within 10 days of transplantation until 200 days post-transplantation according to dosage algorithm (note the calculation of creatinine clearance using a modified Schwartz formula in children) Prevention of CMV disease in heart transplant patients 1 month to 16 years of age Dose once a day within 10 days of transplantation until 100 days post-transplantation according to dosage algorithm (note the calculation of creatinine clearance using a modified Schwartz formula in children) Valganciclovir for oral solution should be taken with food. ( 2.1 , 12.3 ) 2.1 General Dosing Information Valganciclovir for oral solution should be taken with food [see Clinical Pharmacology ( 12.3 )] . Valganciclovir for oral solution (50 mg/mL) must be prepared by the pharmacist prior to dispensing to the patient [see Dosage and Administration ( 2.4 )] . 2.3 Recommended Dosage in Pediatric Patients Prevention of CMV Disease in Pediatric Kidney Transplant Patients : For pediatric kidney transplant patients 4 months to 16 years of age, the recommended once…
Contraindications
4 CONTRAINDICATIONS Valganciclovir for oral solution 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 [see Adverse Reactions ( 6.1 )]. Hypersensitivity to valganciclovir or ganciclovir. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS In vivo drug-drug interaction studies were not conducted with valganciclovir. However, because valganciclovir is rapidly and extensively converted to ganciclovir, drug-drug interactions associated with ganciclovir will be expected for valganciclovir. 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. Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 9. Table 9 Established and Other Potentially Significant Drug Interactions with Ganciclovir Name of the Concomit a nt Drug Change in the Concentration of Ganciclovir or Concomitant Drug Clinical Comment Imipenem-cilastatin Unknown Coadministration with imipenem cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem-cilastati…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions ( 5.1 ) ]. Acute Renal Failure [see Warnings and Precautions ( 5.2 ) ]. Impairment of Fertility [see Warnings and Precautions ( 5.3 )] . Fetal Toxicity [see Warnings and Precautions ( 5.4 )] . Mutagenesis and Carcinogenesis [see Warnings and Precautions ( 5.5 )] . 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 valganciclovir tablets are diarrhea, pyrexia, fatigue, nausea, tremor, neutropenia, anemia, leukopenia, thrombocytopenia, headache, insomnia, urinary tract infection, and vomiting. The most common reported adverse reactions and laboratory abnormalities reported in greater than or equal to 20% of pediatric solid organ transplant recipients treated with valganciclovir for oral solution or tablets are diarrhea, pyrexia, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache. Adult patients: Most common adverse reactions and laboratory abno…
Frequently Asked Questions
What is VALGANCICLOVIR used for?
VALGANCICLOVIR contains valganciclovir. It is a for solution taken oral. Consult your doctor for specific uses.
Is VALGANCICLOVIR a controlled substance?
VALGANCICLOVIR is not classified as a controlled substance by the DEA.
What is the generic name for VALGANCICLOVIR?
The generic name for VALGANCICLOVIR is valganciclovir. There are 12 other brand versions of valganciclovir.
What is the NDC code for VALGANCICLOVIR 50 mg/mL?
The NDC (National Drug Code) for VALGANCICLOVIR 50 mg/mL is 71151-003, listed by airis PHARMA PVT LTD.
Other Valganciclovir Brands
See all →- valganciclovir hydrochloride450 mg/143598-356
- Valganciclovir50 mg/mL59651-444
- Valganciclovir450 mg/160429-846
- VALGANCICLOVIR HYDROCHLORIDE50 mg/mL70069-810
- Valganciclovir hydrochloride for Oral50 mg/mL0591-2579
- Valcyte450 mg/161269-480
- Valganciclovir450 mg/131722-832
- Valganciclovir450 mg/150268-787
- Valganciclovir450 mg/10904-6796
- Valganciclovir450 mg/142291-973
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)