Ganciclovir Powder For Solution For Injection 500Mg Drug Medication Dosage Information
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Ganciclovir: Powder for solution for injection (500mg)

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What is this Medicine?

GANCICLOVIR (gan SYE kloe veer) is an antiviral medicine. It is used to treat or prevent infections caused by certain kinds of viruses. It is commonly used to treat and prevent cytomegalovirus (CMV) infections of the eye or body.

In-Depth Information

Ganciclovir Sodium 500mg Powder for Injection (PREMIER ProRx)

NDC: 633230315
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Cytomegalovirus (CMV) Retinitis

Sometimes used for but not FDA approved for the following conditions:
Encephalitis, Progressive Outer Retinal Necrosis (PORN), Human Herpesvirus 8 (HHV-8) Infection, Cytomegalovirus (CMV) Disease Prophylaxis, Congenital Cytomegalovirus (CMV) Disease, Multicentric Castleman's Disease (MCD), Cytomegalovirus (CMV) Pneumonitis, Cytomegalovirus (CMV)-associated Gastrointestinal Disease, Acute Retinal Necrosis (ARN), Cytomegalovirus (CMV) Retinitis Prophylaxis

Storage Information
Use within 12 hours after reconstitution
Do not refrigerate reconstituted product
Store at controlled room temperature (between 68 and 77 degrees F)
Ganciclovir Sodium 500mg Powder for Injection (PREMIER ProRx)

Reported Side Effects for Ganciclovir Sodium 500mg Powder for Injection (PREMIER ProRx)

Cranial Nerve Palsies Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Breathing Difficulties Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Unable To Speak Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Anaphylactoid Reactions Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Hemolytic-uremic Syndrome Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Inflamed Blood Vessels Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Brain Attack Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Breakdown Of Muscle Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Infection Incidence:
<15.0%*
Severity: MILD
Onset: DELAYED
Liver Infection Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Cholestasis Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Decreased Memory Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Irritability Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Liver Failure Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Hallucinations Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Dysesthesia Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
High Pressure In Brain Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Low Blood Sodium Levels Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
High Triglycerides Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
High Calcium Levels Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Hemolytic Anemia Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Exfoliative Dermatitis Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Endophthalmitis Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Shortness Of Breath Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Cough Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Gallstones Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Suddenly Stopped Heart Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Dry Eyes Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Torsade De Pointes Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Stevens-Johnson Syndrome Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Electrolyte Imbalance Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Pulmonary Fibrosis Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Cataracts Incidence:
1.0-5.0%*
Severity: MODERATE
Onset: DELAYED
Anemia Incidence:
2.0-26.0%*
Severity: MODERATE
Onset: DELAYED
Low Platelet Count Incidence:
3.0-57.0%*
Severity: MODERATE
Onset: DELAYED
Low White Blood Cells Incidence:
3.0-29.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
5.0-6.0%*
Severity: MILD
Onset: RAPID
Chills Incidence:
7.0-10.0%*
Severity: MILD
Onset: RAPID
Nerve Pain Incidence:
8.0-9.0%*
Severity: MODERATE
Onset: DELAYED
Retinal Detachment Incidence:
8.0-20.0%*
Severity: SEVERE
Onset: DELAYED
Diaphoresis Incidence:
11.0-12.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
14.0-15.0%*
Severity: MILD
Onset: DELAYED
Low White Blood Cell Counts Incidence:
29.0-41.0%*
Severity: MODERATE
Onset: DELAYED
Fever Incidence:
38.0-48.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
41.0-44.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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