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Cytovene
Overview
What is Cytovene?
CYTOVENE-IV contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).
Chemically, ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine and ganciclovir sodium is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The chemical structures of ganciclovir sodium and ganciclovir are:
Ganciclovir is a white to off-white crystalline powder. 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 pKs for ganciclovir are 2.2 and 9.4.
CYTOVENE-IV (ganciclovir), formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to off-white lyophilized powder. The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C.
Each vial contains ganciclovir sodium equivalent to 500 mg ganciclovir.
Inactive ingredients may include hydrochloric acid (QS) and sodium hydroxide (QS) added to adjust the pH.
All doses in this package insert are specified in terms of ganciclovir.
What does Cytovene look like?
What are the available doses of Cytovene?
For injection: Single dose vial containing 500 mg of ganciclovir as a sterile lyophilized white to off-white powder for reconstitution with 10 mL of preservative-free Sterile Water for Injection, USP for intravenous use
What should I talk to my health care provider before I take Cytovene?
How should I use Cytovene?
CYTOVENE-IV is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) .
CYTOVENE-IV is administered only intravenously. ()
What interacts with Cytovene?
Sorry No Records found
What are the warnings of Cytovene?
Sorry No Records found
What are the precautions of Cytovene?
Sorry No Records found
What are the side effects of Cytovene?
Sorry No records found
What should I look out for while using Cytovene?
CYTOVENE-IV is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation.
What might happen if I take too much Cytovene?
Reports of adverse reactions after overdoses with CYTOVENE-IV, some with fatal outcomes, have been received from clinical trials and during post-marketing experience. One or more of the following adverse reactions has been reported with overdoses:
Hematological toxicity:
Hepatotoxicity:
Renal toxicity:
Gastrointestinal toxicity:
Neurotoxicity:
Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of CYTOVENE-IV . Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered in patients with cytopenias .
How should I store and handle Cytovene?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not refrigerate or freeze. Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014Metoprolol Tartrate Tablets, USP 50 mg - Watson 462Metoprolol Tartrate Tablets, USP 100 mg - Watson 463Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Do not store above 30°C (86°F).Dispense in a tight, light-resistant container (USP). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchManufactured by: Verna, Salcette Goa 403 722 INDIADistributed by: Parsippany, NJ 07054 USARevised: October 2014
