Product image of valganciclovir hydrochloride 50 mg/mL (Valganciclovir Hydrochloride) 50 mg/mL FOR SOLUTION supplied by GNH India

valganciclovir hydrochloride 50 mg/mL

Active Ingredient:
Valganciclovir Hydrochloride
Form:
FOR SOLUTION
Brand:
valganciclovir hydrochloride
Origin:
USA

valganciclovir hydrochloride 50 mg/mL (Valganciclovir Hydrochloride FOR SOLUTION) 50 mg/mL

Valganciclovir, the active ingredient in valganciclovir hydrochloride 50 mg/mL, is an antiviral presented as a 50 mg/mL oral solution for oral use. It is used to treat cytomegalovirus (CMV) retinitis in patients with AIDS and to prevent CMV disease in transplant recipients. GNH India supplies valganciclovir hydrochloride 50 mg/mL as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, transplant centers, and pharmacies worldwide.

GNH India is a trusted global supplier of high-quality pharmaceuticals, ensuring that healthcare providers have access to essential medications for the treatment and prevention of serious infections.

Strength

50 mg/mL

Pack Size

1 BOTTLE in 1 CARTON (0904-7419-04) / 100 mL in 1 BOTTLE

Manufacturer / TM Owner

MAJOR PHARMACEUTICALS

1
Pack/s
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Indications & Clinical Uses

Valganciclovir hydrochloride 50 mg/mL is an antiviral medication used to treat and prevent cytomegalovirus (CMV) infections.

  • CMV retinitis in patients with AIDS: Treats an eye infection that can cause blindness.
  • Prevention of CMV disease in transplant patients: Used in kidney, heart, and kidney-pancreas transplant recipients at high risk of CMV disease.
  • Pediatric use: Prevents CMV disease in kidney and heart transplant patients aged 4 months to 16 years.

How It Works

  • Valganciclovir is a prodrug of ganciclovir. After oral absorption, it is converted to ganciclovir, which is phosphorylated by viral kinases and inhibits viral DNA polymerase. This action prevents the synthesis of viral DNA, thereby stopping the replication of the cytomegalovirus (CMV).

Side Effects

Valganciclovir hydrochloride 50 mg/mL can cause various side effects, ranging from common to serious.

Common Side Effects

  • Nausea and vomiting.
  • Diarrhea.
  • Fever.
  • Headache.
  • Fatigue.
  • Decreased appetite.
  • Neutropenia (low white blood cell count).
  • Anemia (low red blood cell count).

Serious or Rare Side Effects

  • Severe leukopenia (low white blood cell count).
  • Thrombocytopenia (low platelet count).
  • Bone marrow suppression.
  • Aplastic anemia.
  • Impairment of fertility.
  • Fetal toxicity.
  • Mutagenesis and carcinogenesis.

Precautions & Warnings

Valganciclovir hydrochloride 50 mg/mL should be used with caution and under medical supervision.

  • Hematologic monitoring: Regular blood tests are required to monitor for leukopenia, neutropenia, anemia, and thrombocytopenia.
  • Renal function: Dose adjustment may be necessary in patients with renal impairment.
  • Pregnancy: Avoid use during pregnancy due to potential fetal toxicity.
  • Fertility: May cause temporary or permanent infertility in males and females.
  • Nephrotoxic drugs: Caution should be exercised when administering with other nephrotoxic drugs.
  • Store below 25°C: Keep in the original pack, protect from moisture.

Avoid Interactions

Valganciclovir hydrochloride 50 mg/mL can interact with other medications, potentially affecting its efficacy or increasing the risk of side effects.

Major Interactions (Avoid)

  • Imipenem-cilastatin: Increased risk of seizures.
  • Zidovudine: Increased risk of neutropenia.
  • Mycophenolate mofetil: Increased risk of neutropenia.
  • Didanosine: Increased risk of pancreatitis.
  • Other nephrotoxic drugs: Increased risk of renal toxicity.

Moderate Interactions (Monitor Closely)

  • Probenecid: May increase valganciclovir levels.
  • Cimetidine: May increase valganciclovir levels.
  • Antacids: May decrease valganciclovir absorption.
  • Oral contraceptives: May decrease the effectiveness of oral contraceptives.
  • Other myelosuppressive drugs: Increased risk of bone marrow suppression.

Frequently Asked Questions

Valganciclovir hydrochloride 50 mg/mL is used to treat cytomegalovirus (CMV) retinitis in patients with AIDS and to prevent CMV disease in transplant recipients, including kidney, heart, and kidney-pancreas transplant patients at high risk of CMV infection.

Valganciclovir is a prodrug of ganciclovir. After oral absorption, it is converted to ganciclovir, which is phosphorylated by viral kinases and inhibits viral DNA polymerase. This action prevents the synthesis of viral DNA, thereby stopping the replication of the cytomegalovirus (CMV).

The dosage of valganciclovir hydrochloride 50 mg/mL is determined by a healthcare provider based on the patient's condition, age, and renal function. It is important to follow the prescribed dosage and administration instructions provided by the healthcare professional.

Valganciclovir should be avoided during pregnancy due to potential fetal toxicity. It is also not recommended during breastfeeding as it may pass into breast milk. Pregnant or breastfeeding women should consult their healthcare provider for alternative treatment options.

To order valganciclovir hydrochloride 50 mg/mL from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will then reply with pricing, availability, shipping, and the necessary import paperwork.

Valganciclovir is specifically indicated for the treatment and prevention of CMV infections. It is more convenient to administer than ganciclovir, as it can be taken orally. The choice between valganciclovir and other antiviral drugs depends on the specific condition being treated and the patient's medical history.

Valganciclovir hydrochloride 50 mg/mL should be stored below 25°C, in the original pack, and protected from moisture. It is important to follow the storage instructions provided to maintain the medication's effectiveness and safety.

Valganciclovir hydrochloride 50 mg/mL is administered orally, with the solution prepared by the pharmacist prior to dispensing. It should be taken with food as directed by the healthcare provider. The dosage and duration of treatment will be determined by the healthcare professional based on the patient's condition.

The most serious risks associated with valganciclovir include severe leukopenia, neutropenia, anemia, thrombocytopenia, bone marrow suppression, and aplastic anemia. Regular blood tests are required to monitor for these potential side effects. Patients should also be monitored for signs of renal toxicity and impairment of fertility.

Valganciclovir hydrochloride 50 mg/mL should not be used by individuals with a known hypersensitivity to valganciclovir, ganciclovir, or any of the excipients in the formulation. It should also be avoided in patients with severe renal impairment, severe bone marrow suppression, or during pregnancy unless the potential benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

References

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