GANCICLOVIR capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

GANCICLOVIR (UNII: P9G3CKZ4P5) (GANCICLOVIR - UNII:P9G3CKZ4P5)

Tilgjengelig fra:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

GANCICLOVIR

Sammensetning:

GANCICLOVIR 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ganciclovir capsules are indicated for the prevention of CMV disease in solid organ transplant recipients and in individuals with advanced HIV infection at risk for developing CMV disease. Ganciclovir capsules are also indicated as an alternative to the intravenous formulation for maintenance treatment of CMV retinitis in immunocompromised patients, including patients with AIDS, in whom retinitis is stable following appropriate induction therapy and for whom the risk of more rapid progression is balanced by the benefit associated with avoiding daily IV infusions (see CLINICAL TRIALS ). SAFETY AND EFFICACY OF GANCICLOVIR HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR NEONATAL CMV DISEASE; NOT FOR THE TREATMENT OF ESTABLISHED CMV DISEASE OTHER THAN RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS. THE SAFETY AND EFFICACY OF GANCICLOVIR CAPSULES HAVE NOT BEEN ESTABLISHED FOR TREATING ANY MANIFESTATION OF CMV DISEASE OTHER THAN MAINTENANCE TREATMENT OF CMV RETINITIS. Ganciclovir is contraindicated in pati

Produkt oppsummering:

Ganciclovir 250 mg capsules are opaque green cap/opaque green body; size ‘1’ hard gelatin capsules, printed “RX636” on cap and body in black ink, containing white to off-white granular powder. They are supplied as follows: NDC 63304-636-60 Bottles of 60 NDC 63304-636-90 Bottles of 90 NDC 63304-636-28 Bottles of 180 NDC 63304-636-10 Bottles of 1000 Ganciclovir 500 mg capsules are opaque ivory yellow cap/opaque green body, size ‘0’ elongated hard gelatin capsules, printed “RX637” on cap and body in black ink, containing white to off-white granular powder. They are supplied as follows: NDC 63304-637-60 Bottles of 60 NDC 63304-637-90 Bottles of 90 NDC 63304-637-28 Bottles of 180 NDC 63304-637-05 Bottles of 500 Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. * Retrovir® is a registered trademark of Glaxo Wellcome. # Videx® is a registered trademark of Bristol-Myers Squibb.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

GANCICLOVIR- GANCICLOVIR CAPSULE
RANBAXY PHARMACEUTICALS INC.
----------
GANCICLOVIR CAPSULES
RX ONLY
FOR ORAL ADMINISTRATION
WARNING
THE CLINICAL TOXICITY OF GANCICLOVIR INCLUDES GRANULOCYTOPENIA,
ANEMIA AND THROMBOCYTOPENIA. IN ANIMAL STUDIES GANCICLOVIR WAS
CARCINOGENIC, TERATOGENIC AND CAUSED ASPERMATOGENESIS.
GANCICLOVIR CAPSULES ARE INDICATED _ONLY_ FOR PREVENTION OF CMV
DISEASE IN PATIENTS WITH ADVANCED HIV INFECTION AT RISK FOR CMV
DISEASE, FOR MAINTENANCE TREATMENT OF CMV RETINITIS IN
IMMUNOCOMPROMISED PATIENTS, AND FOR PREVENTION OF CMV DISEASE
IN SOLID ORGAN TRANSPLANT RECIPIENTS (SEE INDICATIONS AND USAGE).
BECAUSE GANCICLOVIR CAPSULES ARE ASSOCIATED WITH A RISK OF MORE
RAPID RATE OF CMV RETINITIS PROGRESSION, THEY SHOULD BE USED AS
MAINTENANCE TREATMENT ONLY IN THOSE PATIENTS FOR WHOM THIS RISK
IS BALANCED BY THE BENEFIT ASSOCIATED WITH AVOIDING DAILY
INTRAVENOUS INFUSIONS.
DESCRIPTION
Ganciclovir is a synthetic guanine derivative active against
cytomegalovirus (CMV).
Ganciclovir is available as 250 mg and 500 mg capsules. Each capsule
contains 250 mg or 500 mg
ganciclovir, USP respectively, and inactive ingredients croscarmellose
sodium, FD&C blue #2, gelatin,
iron oxide black, iron oxide yellow, lecithin, magnesium stearate,
microcrystalline cellulose, povidone,
shellac, simethicone, and titanium dioxide.
Ganciclovir is a white to off-white crystalline powder with a
molecular formula of C H N 0 and a
molecular weight of 255.23. The chemical name for ganciclovir is
9-[[2-hydroxy-1-
(hydroxymethyl)ethoxy]methyl]guanine. Ganciclovir is a polar
hydrophilic compound with a solubility
of 2.6 mg/mL in water at 25° C and an n-octanol/water partition
coefficient of 0.022. The pK s for
ganciclovir are 2.2 and 9.4. The molecular structure of ganciclovir
is:
All doses in this insert are specified in terms of ganciclovir.
VIROLOGY
_Mechanism of Action_: Ganciclovir is an acyclic nucleoside analogue
of 2'-deoxyguanosine that inhibits
9
13
5
4
a
replication of herpes viruses. Ganciclovir has been shown to be act