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Valganciclovir Tablets USP 450 mg – Valganciclovir is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).
Valganciclovir is indicated for the prevention of CMV disease in CMV-negative adults and children (aged from birth to 18 years) who have received a solid organ transplant from a CMV-positive donor.
Valganciclovir is administered orally, and whenever possible, should be taken with food.
For paediatric patients who are unable to swallow valganciclovir film-coated tablets, valganciclovir powder for oral solution can be administered.
Skin and subcutaneous tissues disorders:
Common: Night sweats, Pruritus, Rash, Alopecia
Renal and urinary disorders:
Common: Renal impairment, Creatinine clearance renal decreased, Blood creatinine increased
Respiratory, thoracic and mediastinal disorders:
Very common: Cough, Dyspnoea
Gastrointestinal disorders:
Very common: Diarrhoea, Nausea, Vomiting, Abdominal pain
Common: Dyspepsia, Flatulence, Abdominal pain upper, Constipation
Very common: Neutropenia, Anaemia
Common: Thrombocytopenia, Leukopenia, Pancytopenia
Rare: Aplastic anaemia, Agranulocytosis, Granulocytopenia
Immune system disorders:
Common: Hypersensitivity
Psychiatric disorders:
Common: Depression, Confusional state, Anxiety
Uncommon: Agitation, Psychotic disorder, Thinking abnormal, Hallucinations
Nervous system disorders:
Common: Insomnia, Neuropathy peripheral, Dizziness, Paraesthesia, Hypoaesthesia
Eye disorders:
Common: Visual impairment, Retinal detachment, Vitreous floaters, Eye pain, Conjunctivitis
Cross-hypersensitivity
Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible.
Mutagenicity, teratogenicity, carcinogenicity, fertility, and contraception
Prior to the initiation of valganciclovir treatment, patients should be advised of the potential risks to the foetus. Valganciclovir should be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers.
Valganciclovir has the potential to cause carcinogenicity and reproductive toxicity in the long term.
Myelosuppression
Severe leukopenia, neutropenia, anaemia, thrombocytopenia, pancytopenia, bone marrow failure and aplastic anaemia have been7 observed in patients treated with valganciclovir (and ganciclovir).
Valganciclovir should be used with caution in patients with pre-existing haematological cytopenia or a history of drug-related haematological cytopenia and in patients receiving radiotherapy.
Difference in bioavailability with oral ganciclovir
The bioavailability of ganciclovir after a single dose of 900 mg valganciclovir is approximately 60 %, compared with approximately 6 % after administration of 1000 mg oral ganciclovir (as capsules). When switching from induction to maintenance therapy and in patients who may switch from oral ganciclovir to valganciclovir as valganciclovir cannot be substituted for ganciclovir capsules on a one-to-one basis.
Renal impairment
In patients with impaired renal function, dosage adjustments based on creatinine clearance are required. Valganciclovir film-coated tablets should not be used in patients on haemodialysis.
Store below 30oC. Protect from light and moisture.
Keep the medicine out of reach of children.
10 × 1 × 10 Alu/Alu Blister.
Valgan 450 tablets are available in an Alu/Alu blister of 10 tablets. Such 01 blister in a monocarton and Such 10 monocartons in a unit carton with pack insert.
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