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ACYCLOVIR SODIUM is a brand name for Acyclovir, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Acyclovir Sodium Injection is indicated for: • the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) infections and varicella-zoster (shingles) infections in immunocompromised adults and children. • severe initial episodes of herpes simplex infections in patients who may not be…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Caution: Acyclovir Sodium Injection is for slow intravenous infusion only, over a period of at least 1 hour. Healing Process Because complete re-epithelialization of herpes-disrupted integument necessitates recruitment of several complex repair mechanisms, the physician should be aware that the disappearance of visible lesions is somewhat variable and will occur later than the cessation of virus excretion.
Diagnosis Whereas cutaneous lesions associated with herpes simplex and varicella-zoster infections are often pathognomonic, Tzanck smears prepared from lesion exudate or scrapings may assist in diagnosis. Acyclovir Sodium Injection Page 5 of 32 Positive cultures for herpes simplex virus offer the only absolute means for confirmation of the diagnosis.
Appropriate examinations should be performed to rule out other sexually transmitted diseases. The Tzanck smear does not distinguish varicella-zoster from herpes simplex infections. 2 Recommended Dose and Dosage Adjustment Herpes Simplex Infections Mucosal and Cutaneous Herpes Simplex (HSV-1 and HSV-2) in Immunocompromised Patients: Adults: 5 mg/kg infused at a constant rate over at least 1 hour, every 8 hours for 7 days in adult patients with normal renal function.
Pediatric patients aged 1 year to < 18 years: equivalent plasma concentrations are attained by infusing 250 mg/m2 at a constant rate over at least 1 hour, every 8 hours for 7 days.
Severe Initial Clinical Episodes of Herpes Genitalis in Immunocompetent Patients:
The same dose given above, administered for 5 days.
Varicella Zoster Infections Zoster in Immunocompromised Patients:
Adults: 10 mg/kg infused at a constant rate over at least 1 hour, every 8 hours for 7 days in adult patients with normal renal function. Pediatric patients aged 1 year to < 18 years: equivalent plasma concentrations are attained by infusing 500 mg/m2 at a constant rate over at least 1 hour, every 8 hours for 7 days.
Obese patients should be dosed at 10 mg/kg (Ideal Body Weight). A maximum dose equivalent to 500 mg/m2 every 8 hours should not be exceeded for any patient. Patients with Acute or Chronic Renal Impairment Use the recommended doses and method of administration; and adjust the dosing interval as indicated in the following table.
, 10 CLINICAL PHARMACOLOGY, and 14 CLINICAL TRIALS). 4 Geriatrics Clinical studies of Acyclovir Sodium Injection did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients.
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased renal function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 2 Clinical Trial Adverse Reactions Adult and Pediatric Clinical Trials The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at approximately 5 mg/kg (250 mg/m2) and approximately 200 patients who received approximately 10 mg/kg (500 mg/m2).
The most frequent adverse reactions reported during intravenous acyclovir administration were inflammation or phlebitis at the injection site in approximately 9% of the patients, and transient elevations of serum creatinine or BUN in 5% to 10% [the higher incidence occurred usually following rapid (< 10 minutes) intravenous infusion].
Nausea and/or vomiting occurred in approximately 7% of the patients (the majority occurring in non-hospitalized patients who received 10 mg/kg). Itching, rash or hives occurred in approximately 2% of patients. Elevation of transaminases occurred in 1 to 2% of patients.
Approximately 1% of patients receiving intravenous acyclovir have manifested encephalopathic changes characterized by either lethargy, obtundation, tremors, confusion, hallucinations, agitation, seizures or coma (see 7 WARNINGS AND PRECAUTIONS).
). A 6-hour hemodialysis results in a 60% decrease in plasma acyclovir concentration. Data concerning peritoneal dialysis are incomplete but indicate that this method may be significantly less efficient in removing acyclovir from the blood.
2 Recommended Dose and Dosage Adjustment, Patients with Acute or Chronic Renal Impairment). For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 Dosage Forms, Strengths, Composition and Packaging Acyclovir Sodium Injection (equivalent to acyclovir 50 mg / mL) is available in two sizes: Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Intravenous Solution, 50 mg / mL, acyclovir sodium Water for Injection Acyclovir Sodium Injection Page 7 of 32 10 mL single-dose vial containing acyclovir sodium equivalent to 500 mg acyclovir, packaged in trays of 10 vials.
20 mL single-dose vial containing acyclovir sodium equivalent to 1 gram of acyclovir, packaged in trays of 10 vials. 7 WARNINGS AND PRECAUTIONS General Acyclovir Sodium Injection is for slow intravenous infusion only. 2 Recommended Dose and Dose Adjustment).
No data exist at this time, that demonstrate that the use of acyclovir will prevent transmission of herpes simplex infection to other persons. Immune In severely immunocompromised patients, the physician should be aware that prolonged or repeated courses of acyclovir may result in selection of resistant viruses associated with infections which may not respond to continued acyclovir therapy.
This, however, remains to be clearly established and should be considered as a factor when undertaking therapy. The effect of the use of acyclovir on the natural history of herpes simplex or varicella-zoster infection is unknown. Neurologic Approximately 1% of patients receiving intravenous acyclovir have manifested encephalopathic changes characterized by either lethargy, obtundation, tremors, confusion, hallucinations, agitation, seizures or coma.
Acyclovir Sodium Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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73 m2) Percent of Recommended Dose Dosing Interval (hours) > 50 100 8 25 to 50 100 12 10 to 25* 100 24 0 to 10* 50 24 to 48 *Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during dialysis is approximately 5 hours, which results in a 60% decrease in plasma concentrations following a 6-hour dialysis period.
Recommended doses should be administered every 24 to 48 hours, and after hemodialysis. 3 Reconstitution Diluted Solutions for Intravenous Infusion Acyclovir Sodium Injection Page 6 of 32 The calculated dose of the solution should be removed and added to an appropriate intravenous solution listed below at a volume selected for administration during each 1-hour infusion.
Infusion concentrations exceeding 10 mg/mL are not recommended. Since the solution does not contain any preservatives, any unused portion of the vial should be discarded (see 11 STORAGE, STABILITY AND DISPOSAL). 9% Sodium Chloride Injection Normal Saline Injection Lactated Ringer's Injection Once diluted, the admixtures are to be administered within 24 hours of the initial preparation.
The admixtures are not to be refrigerated. The diluted solution should be inspected visually for discolouration, haziness, particulate matter and leakage prior to administration. Discard unused portion. , blood products, protein hydrolysates or amino acids, fat emulsions).
3 Less Common Clinical Trial Adverse Reactions Adverse reactions which occurred at a frequency of less than 1% and which were probably or possibly related to intravenous acyclovir administration were: anemia, anuria, hematuria, hypotension, edema, anorexia, light-headedness, thirst, headache, diaphoresis, fever, neutropenia, thrombocytopenia, abnormal urinalysis (characterized by an increase in formed elements in urine sediment) and pain on urination.
Other reactions have been reported with a frequency of less than 1% in patients receiving acyclovir, but a causal relationship between acyclovir and the reaction could not be determined. These include pulmonary edema with cardiac tamponade, abdominal pain, chest pain, thrombocytosis, leukocytosis, neutrophilia, ischemia of digits, hypokalemia, purpura fulminans, pressure on urination, hemoglobinemia and rigors.
5 Post-Market Adverse Reactions Severe local inflammatory reactions, including tissue necrosis, have occurred following inadvertent infusion of acyclovir into extravascular tissues.
Acyclovir should be used with caution in those patients who have underlying neurologic abnormalities and those with serious renal, hepatic, or electrolyte abnormalities or significant hypoxia. It should also be used with caution in patients who have manifested prior neurologic reactions to cytotoxic drugs or those receiving concomitant intrathecal methotrexate or interferon.
5 mg/mL at 37°C in water) is exceeded. This phenomenon is reflected by a rise in serum creatinine and blood urea nitrogen (BUN) and a decrease in creatinine clearance. With sufficient renal tubular compromise, urine output decreases.
, amphotericin B and aminoglycoside antibiotics); or had pre-existing renal compromise or damage; or had the dose administered by rapid intravenous injection (less than 10 minutes). Observed alterations in renal function have been transient, in some instances resolving spontaneously without change in acyclovir dosing regimen.
In other instances, renal function improved following increased hydration, dosage adjustment, or discontinuation of acyclovir therapy. Acyclovir Sodium Injection Page 8 of 32 Administration of acyclovir by intravenous infusion must be accompanied by adequate hydration.
Since maximum urine concentration occurs within the first 2 hours following infusion, particular attention should be given to establishing sufficient urine flow during that period in order to prevent precipitation in renal tubules.
Recommended urine output is ≥ 500 mL/g of drug infused. 2 Recommended Dose and Dose Adjustment). 1 Pregnant Women Sensitivity/Resistance No data exist at this time, that demonstrate that the use of acyclovir will prevent transmission of herpes simplex infection to other persons.
Consideration should be given to an alternative treatment regimen if after 5 days of treatment there is no expected clinical improvement in the signs and symptoms of the infection. Strains of herpes simplex virus which are less susceptible to acyclovir have been isolated from herpes lesions and have also emerged during intravenous treatment with acyclovir.
1 Pregnant Women Acyclovir should not be used during pregnancy unless the potential benefit outweighs the risk of potential harm to the fetus. Teratology studies carried out to date in animals have been negative in general. In a non-standard test in rats, there were fetal abnormalities such as head and tail anomalies, and maternal toxicity.
However, such studies are not always predictive of human response and the potential for high concentrations of acyclovir to cause chromosome breaks in vitro should also be considered when making this decision (see 16 NON-CLINICAL TOXICOLOGY).
2 Breast-feeding Acyclovir is excreted in human milk. Caution should therefore be exercised when acyclovir is administered to a nursing mother. 3 Pediatrics The safety and efficacy of Acyclovir Sodium Injection has been evaluated in pediatric patients aged 1 years to < 18 years of age (see 1 INDICATIONS, 4 DOSAGE AND ADMINISTRATION,