盐酸缬更昔洛韦片适应症有什么?
The main ingredient of the tablet is valganciclovir hydrochloride, which was developed by the Swiss company Roche and is an oral anti-cytomegalovirus infection drug. What are the indications for Valganciclovir Hydrochloride Tablets?
In May 2001, the US FDA approved the marketing of Valcyte. It is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valcyte is used to prevent and treat secondary CMV infection in organ transplant recipients. On August 11, 2010, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved valganciclovir hydrochloride tablets (Valcyte) for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. Roche announced on August 31, 2009 that the U.S. Food and Drug Administration (FDA) has approved Valcyte (trade name: Valcyte; generic name: valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) infection in pediatric kidney and heart transplant patients aged 4 months to 16 years. Such children are considered to be a high-risk group for CMV infection.
The pharmacokinetics of valganciclovir hydrochloride tablets were evaluated in HIV- and CMV-seropositive patients, AIDS patients with CMV retinitis, and solid organ transplant patients. The parameters that determine the body's exposure to ganciclovir after taking Valganciclovir Hydrochloride Tablets are bioavailability and renal function. The bioavailability of ganciclovir following administration of valganciclovir hydrochloride tablets was similar across study populations. Valganciclovir hydrochloride tablets have similar body ganciclovir exposure in patients with heart, liver, and kidney transplants who take oral valganciclovir according to the renal function adjustment protocol.
Valganciclovir hydrochloride tablets are the prodrug of ganciclovir. Valganciclovir hydrochloride tablets can be well absorbed from the gastrointestinal tract and rapidly metabolized into ganciclovir in the small intestinal wall and liver. The absolute bioavailability of ganciclovir converted from valganciclovir is approximately 60%. The systemic exposure of valganciclovir hydrochloride tablets is small and transient. The 24-hour area under the curve AUC24 and peak concentration (Cmax) are only 1% and 3% of ganciclovir respectively. The proportional relationship between the oral dose of valganciclovir hydrochloride tablets of 450-2625 mg and the AUC of ganciclovir was only studied under postprandial conditions. Valganciclovir Hydrochloride Tablets When the recommended dose of 900 mg of Valganciclovir Hydrochloride Tablets was taken with food, the mean AUC24 and Cmax measured with ganciclovir were increased by approximately 30% and approximately 14%, respectively. Therefore, it is recommended to take the tablets with food.
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