Valganciclovir-NIKA - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Valganciclovir-NIKA

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Valganciclovir-NIKA is an antiviral drug.

Release form and composition

Valganciclovir-NIKA is produced in the form of coated tablets (4 pcs. In blisters made of aluminum foil, in a cardboard box 5 packs).

Composition of 1 tablet:

• active substance: valganciclovir (in the form of valganciclovir hydrochloride) - 450 mg;
• auxiliary components: povidone K-30, stearic acid, microcrystalline cellulose, crospovidone;
• tablet shell: polyethylene glycol, hydroxypropyl methylcellulose, glycerin, talc, iron oxide red, titanium dioxide.

Indications for use

• induction therapy of active CMV retinitis (cytomegalovirus retinitis) in patients with AIDS (acquired immunodeficiency syndrome) and the threat of vision loss;
• maintenance therapy after the end of induction treatment for CMV retinitis;
• therapy of inactive CMV retinitis;
• prevention of CMV infection during solid organ transplantation in recipients at high risk.

Contraindications

• period of pregnancy;
• period of breastfeeding;
• hypersensitivity to the main or auxiliary components of the drug, as well as ganciclovir.

In addition, the drug is contraindicated in men of reproductive age who are planning to conceive a child.

Method of administration and dosage

Valganciclovir-NIKA tablets are taken orally with meals. It is necessary to strictly adhere to the recommendations for dosing the drug in order to avoid overdose.

For induction therapy, patients with active CMV retinitis are prescribed 2 tablets of Valganciclovir-NIKA twice a day for 3 weeks. With prolonged induction therapy, the risk of myelotoxicity increases.

For patients with inactive CMV retinitis and for maintenance therapy after induction treatment, the drug is prescribed 2 tablets once a day. If the course of retinitis worsens, a second course of induction therapy is possible.

In order to prevent CMV infection after organ transplant, Valganciclovir-NIKA is prescribed 2 tablets once a day from 10 to 100 days after transplantation.

In renal failure, the dose is adjusted depending on the CC (creatinine clearance). With a CC of 40-59 ml / min, a single dose of the drug is halved, with a CC of 25-39 ml / min, in addition to halving a single dose, the frequency of use of the drug is reduced to once a day with induction therapy and up to once every 2 days with maintenance therapy, with CC 10-24 ml / min Valganciclovir-NIKA take 450 mg once a day every 2 days with induction therapy and 450 mg once a day 2 times a week with maintenance treatment.

It is not recommended to prescribe the drug to patients on hemodialysis.

In patients with severe leukopenia, anemia, pancytopenia, aplastic anemia, neutropenia, thrombocytopenia, and bone marrow suppression, treatment can be started only if the absolute platelet count is more than 25,000 cells per μl or the neutrophil count is more than 500 cells per μl, and the hemoglobin level is above 80 g / l.

Elderly patients are prescribed Valganciclovir-NIKA with caution, since its safety and efficacy for this group of patients have not been established.

Side effects

Side effects most frequently encountered in clinical trials in patients with AIDS and CMV retinitis: oral candidiasis, diarrhea, fever, weakness, headache, neutropenia.

Side effects that were most common in patients after organ transplantation and not related to taking the drug (mild or moderate): nausea, vomiting, diarrhea or constipation, headache, tremors, insomnia, hypertension, transplant rejection, swelling of the lower extremities, pain in back.

Side effects most common in patients after organ transplantation and associated or possibly associated with taking the drug: nausea, diarrhea, leukopenia, neutropenia.

Side effects that occurred in patients after organ transplantation (with a frequency of ≥ 2%) and were not observed in patients with CMV retinitis: hyperkalemia, hypertension, liver dysfunction, hypercreatininemia.

Side effects of Valganciclovir-NIKA, noted in more than 5% of patients with CMV retinitis and patients after solid organ transplant:

• digestive system: nausea, dyspepsia, vomiting, diarrhea or constipation, ascites, pain in the upper abdomen, abnormal liver function, abdominal enlargement;
• cardiovascular system: arterial hypo- or hypertension;
• respiratory system: nasal discharge, sinusitis, pharyngitis, productive cough, nasopharyngitis, shortness of breath, pneumonia, pleural effusion, upper respiratory tract infections, Pneumocystis pneumonia;
• central nervous system and sensory organs: insomnia, dizziness, tremor, headache, paresthesia, depression, peripheral neuropathy, blurred vision, retinal detachment;
• musculoskeletal system: arthralgia, muscle cramps, pain in the limbs and back;
• urinary system: dysuria, renal failure, urinary tract infections;
• hematopoietic system: anemia, leukopenia, neutropenia, thrombocytopenia;
• dermatological reactions: itching, dermatitis, acne, increased night sweats;
• laboratory parameters: hyperkalemia, hyperglycemia, hypercreatininemia, hypocalcemia, hypomagnesemia, hypokalemia, hypophosphatemia;
• infectious complications: oral candidiasis;
• other reactions: weakness, loss of appetite, anorexia, fever, weight loss, dehydration, cachexia, peripheral edema, graft rejection, postoperative pain, poor healing and increased drainage of the wound, complications, including infectious.

Side effects of Valganciclovir-NIKA, noted in less than 5% of patients and not mentioned above:

• central and peripheral nervous system: hallucinations, agitation, convulsions, confusion, mental disorders;
• urinary system: hypercreatininemia, decreased creatinine clearance;
• hematopoietic system: oppression of bone marrow function, pancytopenia, aplastic anemia;
• blood coagulation system: life-threatening bleeding (possibly caused by thrombocytopenia);
• other reactions: hypersensitivity to valganciclovir.

In the course of post-marketing use of Valganciclovir-NIKA, side effects such as anaphylaxis and decreased fertility in men were noted.

special instructions

The drug is not recommended for prescribing to children, since the safety and efficacy of its use in this group have not been established.

During treatment with Valganciclovir-NIKA, it is recommended to regularly monitor blood counts. Patients with neutropenia, thrombocytopenia, leukopenia, or anemia should be prescribed hematopoietic growth factors and / or interrupt drug treatment.

Women of childbearing age taking Valganciclovir-NIKA should use effective methods of contraception, and men are recommended to use barrier contraceptives during the period of drug treatment and at least 90 days after the end of therapy.

The tablets should not be crushed or broken, as the drug is potentially carcinogenic and teratogenic for humans. If the tablet is accidentally broken or crushed, avoid direct contact of the debris with mucous membranes or skin. The contact points must be thoroughly washed with soap and water, and if the drug gets into the eyes, rinse them abundantly with water.

During the treatment period, care should be taken when driving a car or other transport and performing any potentially hazardous work associated with a high concentration of attention and an increased reaction rate.

Drug interactions

Due to the high pharmacological activity of valganciclovir and the significant likelihood of interaction of the drug Valganciclovir-NIKA with other drugs / substances, recommendations on their compatibility can only be given by the attending physician.

Analogs

Valganciclovir-NIKA analogs are: Valganciclovir hydrochloride, Valganciclovir-Teva, Valcit, Tsivalgan.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

The shelf life of the drug is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!