盐酸缬更昔洛韦片的中文说明书

Chinese instructions for the tablet

Product name: Wansaiwei

Generic name: Valganciclovir hydrochloride tablets

Indications:

Valganciclovir hydrochloride tablets are suitable for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir hydrochloride tablets are suitable for preventing CMV infection in high-risk solid organ transplant patients.

Usage and dosage:

Standard dosage: Valganciclovir hydrochloride tablets are administered orally and should be taken with food. Valganciclovir hydrochloride tablets can be rapidly converted into ganciclovir in large amounts. The bioavailability of valganciclovir hydrochloride tablets as measured by ganciclovir is 10 times higher than that of ganciclovir capsules, so the dosage and usage instructions of valganciclovir hydrochloride tablets described below should be strictly followed.

Induction therapy of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice daily for 21 days. Prolonged induction therapy may increase the risk of bone marrow toxicity.

Maintenance treatment of CMV retinitis: After induction therapy, or in patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily. Induction therapy may be repeated in patients with worsening retinitis.

Prevention of CMV infection in transplant patients: For patients who have received solid organ transplants, the recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 100 days after transplantation.

Adverse reactions: Gastrointestinal disorders: abdominal distension, cholangitis, dyspepsia, dysphagia, hiccups, esophagitis, fecal incontinence, flatulence, gastritis, gastrointestinal disorders, gastrointestinal bleeding, oral ulcers, pancreatitis, tongue dysfunction. Systemic: ascites, asthenia, bacterial, fungal and viral infections, bleeding, malaise, mucosal disease, pain, photosensitivity, chills, sepsis. Liver disorders: hepatitis, jaundice. Skin and appendages: Acne, alopecia, seborrheic dermatitis, dry skin, increased sweating, urticaria. Central and peripheral nervous system: abnormal dreaming, amnesia, anxiety, ataxia, coma, dry mouth, emotional instability, hyperkinesia syndrome, hypertonia, hyposexuality, myoclonus, nervousness, drowsiness, abnormal thinking, tremor.

Notes: 1. Blood diseases: severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia and bone marrow failure, including aplastic anemia. May occur at any time during treatment and worsen with continued use; cell counts usually begin to recover within 3-7 days of stopping treatment. Do not use if the absolute neutrophil count is <500 cells/MM3, platelet count <25,000/m3, or hemoglobin <8 g/dl; use with caution in patients with myelosuppression, cytopenia, or patients receiving myelosuppressive drugs/radiation. Monitor CBC and platelet counts at baseline and frequently during treatment, especially in infants and patients with renal impairment, patients with prior drug-induced leukopenia, and patients with neutrophil counts <1000 cells/mm3 at the start of treatment. 2. Carcinogenicity/teratogenicity: It may temporarily or permanently inhibit sperm production and fertility; it may cause birth defects and cancer in humans. Due to its teratogenicity, women should take a pregnancy test before initiating pregnancy and use effective contraception during treatment and for 30 days after treatment; men should use barrier contraception during treatment and for 90 days after treatment. 3. Renal impairment: Use with caution in patients with impaired renal function; dose adjustment is required. 4. Elderly: Acute renal failure may occur in elderly patients with or without renal damage. Use with caution and adjust dosage according to renal function. 5. Liver transplant recipients: Not suitable for liver transplant patients (a higher incidence of tissue-infiltrating cytomegalovirus (CMV) was observed in the trial compared with oral ganciclovir).

Taboo:

Valganciclovir Hydrochloride Tablets should not be used in patients with a known allergic reaction to valganciclovir, ganciclovir, or any other ingredient in the medicine. Due to the similar chemical structures of valganciclovir hydrochloride tablets to aciclovir and valaciclovir, there may be cross-allergic reactions between these drugs.

Warning:

Ganciclovir has been found to be mutagenic, teratogenic, deficient in spermatogenesis and carcinogenic in animal experiments. Therefore, tablets are also considered to have potential teratogenic and carcinogenic effects in the human body, possibly causing birth defects and cancer. Valganciclovir hydrochloride tablets are also thought to cause temporary or permanent suppression of spermatogenesis.