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Cytovene

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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


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Ganciclovir is an antiviral drug with activity against CMV .

Non-Clinical Toxicology
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.

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see ). Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs.





Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see ).





In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs.





Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol.





In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate.

Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia, have been observed in patients treated with CYTOVENE-IV. The frequency and severity of these events vary widely in different patient populations . CYTOVENE-IV is not recommended if the absolute neutrophil count is less than 500 cells/µL, hemoglobin is less than 8 g/dL, or the platelet count is less than 25,000 cells/µL. CYTOVENE-IV should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Granulocytopenia (neutropenia) usually occurs during the first or second week of treatment but may occur at any time during treatment. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug. Colony-stimulating factors have been shown to increase neutrophil and white blood cell counts in patients receiving CYTOVENE-IV solution for treatment of CMV retinitis.

Due to the frequency of neutropenia, anemia and thrombocytopenia in patients receiving CYTOVENE-IV, complete blood counts with differential and platelet counts should be performed frequently in all patients, especially in patients with renal impairment and in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia, or in whom neutrophil counts are less than 1000 cells/µL at the beginning of treatment .

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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