Ganciclovir caused decreased fertility in male mice and hypospermatogenesis in mice and dogs following daily oral or intravenous administration of doses ranging from 0.2 to 10 mg/kg (30x to 1,600x the human ocular dose).In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, Ganciclovir Ophthalmic Gel was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers. PRESERVATIVE: benzalkonium chloride 0.075 mg (0.0075%).Ganciclovir Ophthalmic Gel 0.15% contains the active ingredient, ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl) ethoxy]methyl]guanine (CAS number 82410-32-0). In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 total patients, Ganciclovir Ophthalmic Gel was noninferior to acyclovir ophthalmic ointment 3% in patients with dendritic ulcers. At the dose of 20 mg/kg/day, a slightly increased incidence of tumors was noted in the preputial and harderian glands in males, forestomach in males and females, and liver in females. Absorption of the oral form is very limited—about 5% fasting, about 8% with food. Mechanism of Action.
Purine is a bicyclic aromatic compound made up of a pyrimidine ring fused to an imidazole ring. Chemistry, mechanism of action, and antiviral activity. Mechanism of Action. We comply with the HONcode standard for trustworthy health information - Except for histocytic sarcoma of the liver, ganciclovir-induced tumors were generally of epithelial or vascular origin. Ganciclovir Ophthalmic Gel 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).The recommended dosing regimen for Ganciclovir Ophthalmic Gel is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.Ganciclovir Ophthalmic Gel contains 0.15% of ganciclovir in a sterile preserved topical ophthalmic gel.Ganciclovir Ophthalmic Gel is indicated for topical ophthalmic use only.Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with Ganciclovir Ophthalmic Gel.Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. E. Paintsil, Yung-Chi Cheng, in Encyclopedia of Microbiology (Third Edition), 2009. At the dose of 1,000 mg/kg/day there was a significant increase in the incidence of tumors of the preputial gland in males, forestomach (nonglandular mucosa) in males and females, and reproductive tissues (ovaries, uterus, mammary gland, clitoral gland, and vagina) and liver in females. Caution should be exercised when Ganciclovir Ophthalmic Gel is administered to nursing mothers.Safety and efficacy in pediatric patients below the age of 2 years have not been established.No overall differences in safety or effectiveness have been observed between elderly and younger patients.Ganciclovir Ophthalmic Gel 0.15% contains a sterile, topical antiviral for ophthalmic use. Ganciclovir was patented in 1980 and approved for medical use in 1988.It is also used for acute CMV colitis in HIV/AIDS and CMV pneumonitis in immunosuppressed patients.Ganciclovir has also been used with some success in treating Ganciclovir has also been found to be an effective treatment for Ganciclovir is commonly associated with a range of serious Ganciclovir triphosphate is a competitive inhibitor of deoxyguanosine triphosphate (dGTP) incorporation into DNA and preferentially inhibits viral DNA polymerases more than cellular DNA polymerases. Ganciclovir was not mutagenic in the Ames Salmonella assay at concentrations of 500 to 5,000 mcg/mL.Ganciclovir caused decreased mating behavior, decreased fertility, and an increased incidence of embryolethality in female mice following intravenous doses of 90 mg/kg/day (approximately 14,000x the human ocular dose of 6.25 mcg/kg/day). Clinical resolution at Day 7 was achieved in 72% (41/57) for Ganciclovir Ophthalmic Gel versus 69% (34/49) for acyclovir (difference 2.5%, 95% CI - 15.6%-20.9%).Ganciclovir Ophthalmic Gel is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 69292-015-35).This product is sterile when packaged. Hypoxanthines are compounds containing the purine derivative 1H-purin-6(9H)-one.
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