Cytovene

DRUG DESCRIPTION

Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). CYTOVENE-IV is the brand name for ganciclovir sodium for injection.

CYTOVENE (ganciclovir) -IV is available as sterile lyophilized powder in strength of 500 mg per vial for intravenous administration only. Each vial of CYTOVENE-IV contains the equivalent of 500 mg ganciclovir as the sodium salt (46 mg sodium). Reconstitution with 10 mL of Sterile Water for Injection, USP, yields a solution with pH 11 and a ganciclovir concentration of approximately 50 mg/mL. Further dilution in an appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION).

Ganciclovir is a white to off-white crystalline powder with a molecular formula of C9H13N504 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 25C and an n-octanol/water partition coefficient of 0.022. The pKas for ganciclovir are 2.2 and 9.4.

Ganciclovir, when formulated as monosodium salt in the IV dosage form, is a white to off-white lyophilized powder with the molecular formula of C9H12N5Na04, and a molecular weight of 277.22. The chemical name for ganciclovir sodium is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37C.

The chemical structures of ganciclovir sodium and ganciclovir are:

CYTOVENE -IV
  (ganciclovir sodium for injection) Structural Formula Illustration

All doses in this insert are specified in terms of ganciclovir.

What are the possible side effects of ganciclovir (Cytovene)?

Serious side effects affecting the blood have been reported with the use of ganciclovir. Decreased levels of blood cells (white blood cells, red blood cells, and platelets) have occurred. Your doctor may monitor your blood with blood tests.

Stop taking ganciclovir and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • paleness and fatigue that may be signs...

Read All Potential Side Effects and See Pictures of Cytovene

What are the precautions when taking ganciclovir (Cytovene)?

Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, a low number of blood cells (red or white blood cells, platelets), radiation treatment.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of infection. Avoid contact with...

Read All Potential Precautions of Cytovene


Cytovene Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness, shaking (tremors), or pain/redness/irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, a low number of blood cells (red or white blood cells, platelets), radiation treatment.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug.

Based on animal studies, this medication may reduce fertility in men and women.

Women who are pregnant or who may become pregnant should not handle this medication.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. To prevent pregnancy, men with female partners should always use effective barrier protection (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women of child-bearing age who are using ganciclovir should use at least 2 reliable forms of birth control (such as birth control pills and condoms). Consult your doctor for more details.

It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. If you have HIV, do not breast-feed because breast milk can transmit HIV.


Cytovene Patient Information Including Side Effects

Brand Names: Cytovene

Generic Name: ganciclovir (oral and injectable) (Pronunciation: gan SYE kloe veer)

  • What is ganciclovir (Cytovene)?
  • What are the possible side effects of ganciclovir (Cytovene)?
  • What is the most important information I should know about ganciclovir (Cytovene)?
  • What should I discuss with my healthcare provider before taking ganciclovir (Cytovene)?
  • How should I take ganciclovir (Cytovene)?
  • What happens if I miss a dose (Cytovene)?
  • What happens if I overdose (Cytovene)?
  • What should I avoid while taking ganciclovir (Cytovene)?
  • What other drugs will affect ganciclovir (Cytovene)?
  • Where can I get more information?

What is ganciclovir (Cytovene)?

Ganciclovir is an antiviral drug. It slows the growth and spread of the cytomegalovirus.

Ganciclovir is used to treat and prevent infections caused by cytomegalovirus. This infection usually occurs in patients who have suppressed immune systems such as patients with AIDS and organ transplant patients.

Ganciclovir may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ganciclovir (Cytovene)?

Serious side effects affecting the blood have been reported with the use of ganciclovir. Decreased levels of blood cells (white blood cells, red blood cells, and platelets) have occurred. Your doctor may monitor your blood with blood tests.

Stop taking ganciclovir and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • paleness and fatigue that may be signs of anemia (a low level of red blood cells);
  • unusual bleeding or bruising;
  • fever or signs of infection; or
  • numbness or tingling in a part of your body.

Other, less serious side effects may be more likely to occur. Continue to take ganciclovir and talk to your doctor if you experience

  • nausea, vomiting, diarrhea, or decreased appetite;
  • increased sweating;
  • itching; or
  • decreased sperm production or infertility.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ganciclovir (Cytovene)?

If you are injecting ganciclovir at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Serious side effects affecting the blood have been reported with the use of ganciclovir. Decreased levels of blood cells (white blood cells, red blood cells, and platelets) have occurred. Your doctor may monitor your blood with blood tests.

Ganciclovir has caused birth defects in animals, and it is generally not recommended for use during pregnancy. Women should use an effective form of birth control during treatment with ganciclovir. Also, men should use a form of barrier contraception (e.g., condom) during and for at least 90 days following treatment with ganciclovir.

Take all of the ganciclovir that has been prescribed, even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

Take oral ganciclovir with food to increase its absorption by the body.

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