Vlganciclovir Tablets USP 450 mg – Vlganciclovir is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS).
Vlganciclovir 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.
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 vlganciclovir treatment, patients should be advised of the potential risks to the foetus.
Vlganciclovir should be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers.
Vlganciclovir 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 vlganciclovir (and ganciclovir).
Vlganciclovir 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 vlganciclovir 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 vlganciclovir as vlganciclovir 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. Vlganciclovir film-coated tablets should not be used in patients on haemodialysis.
Vlganciclovir is administered orally, and whenever possible, should be taken with food.
For paediatric patients who are unable to swallow vlganciclovir film-coated tablets, vlganciclovir 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, PancytopeniaRare: 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
Store below 30oC. Protect from light and moisture.
Keep the medicine out of reach of children.
10 × 1 × 10 Alu/Alu Blister.
Vlgan 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.
Contact us directly to receive full information on the product, the formulation, the science behind it, stability data, and more. Our Business Development Manager is a click away.
Questions are useful tools, they open lines of communication; give us information; improve interactions, facilitate analysis, and many more.
A pharma CMO is a special kind of an organization, offering contract manufacturing services to pharmaceutical companies for various kinds of drug formulations.
Reduce overall costs and time to market :
Contract manufacturers already have the needed infrastructure and technical staff, so working with a CMO or CDMO can decrease the cost of manufacturing your pharmaceutical products.
Scalability and flexible production capacity :
You can produce what you need when you need it without worrying about excess capacity. Additionally, CMOs understand the importance of quality and compliance, so you don't have to sacrifice safety for scalability.
Save on upgrading and maintaining equipment :
If you have your manufacturing facility, you’ll have to pay to upgrade your equipment as technology advances—which can get expensive. A CMO/CDMO’s only function is to make and distribute products, so part of their core business responsibility is to update their equipment whenever needed and perform maintenance.
Ease supply chain issues :
During the pandemic, there were several instances of supply chain issues, including medicine shortages. CMOs are generally better equipped than startups to handle a supply chain crisis.
Bandwidth to focus on core competencies
When your company resources aren’t directly allocated to manufacturing and distribution, you have more time to focus on other tasks, like marketing your new drug, researching, or working on drug discovery.
We have 7+ manufacturing sites with a minimum of WHO GMP certification and other country-specific approvals like NAFDAC approved, PPK Kenya Approved, TFDA Tanzania Approved, EU-GMP Approved.
We have below manufacturing capacity:
For Tablet, Capsule, and soft gel: up to 1 million units per shift
For Syrup: up to 0.05 Million per shift
For Ampoule and Vial: up to 0.1 million units per shift
For Ointment and Cream: up to 0.1 million units per shift
For Suppository: 0.1 Million units per shift
