Simplovir IV Injection
Acyclovir IV
500mg/vial
Incepta Pharmaceuticals Ltd.
| Pack size | 1's Pack |
|---|---|
| Unite Price | 700.00 BDT |
Indications
Simplovir IV Injection is used for:
Herpes simplex infections, Herpes Simplex Virus Encephalitis, Mucocutaneous Herpes Simplex Virus Infection, Varicella Zoster (Chickenpox), Herpes zoster (shingles), Severe Genital Herpes
Adult Dose
Adult
IV
Herpes simplex (except herpes encephalitis) infections in Immunocompromised patients
I.V. 5 mg/kg body weight every 8 hours for 7 days provided renal function is not impaired.
Herpes simplex encephalitis in Normal OR in Immunocompromised patients
I.V. 10 mg/kg body weight every 8 hours for 10 days provided renal function is not impaired.
Varicella Zoster (Chickenpox), Herpes Zoster (Shingles) infections in Immunocompromised patients
I.V. 10 mg/kg body weight every 8 hours for 7 days provided renal function is not impaired.
In obese patients dosed with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained.
Consideration should therefore be given to dosage reduction in obese patients and especially in those with renal impairment or the elderly.
Child Dose
IV
Neonatal Herpes Simplex Virus Infection
Neonates and Infants up to 3 months of age is calculated on the basis of body weight.
PMA ?34 weeks: 20 mg/kg IV q8hr for 21 days for disseminated and CNS disease. or for 14 days for disease limited to the skin and mucous membranes.
PMA <34 weeks: 20 mg/kg IV q12hr for 21 days for disseminated and CNS disease. or for 14 days for disease limited to the skin and mucous membranes.
Children aged between 3 months -12 years (calculated on the basis of body surface area)
Herpes simplex (except herpes encephalitis) infections in Immunocompromised patients
250 mg/m2 every 8 hours calculated on the basis of body surface area.
Herpes Simplex Encephalitis in Normal patients
500 mg/m2 every 8 hours calculated on the basis of body surface area.
Varicella Zoster (Chickenpox), Herpes Zoster (Shingles) infections in Immunocompromised patients
500 mg/m2 every 8 hours calculated on the basis of body surface area.
OR
Herpes Simplex Virus Encephalitis
3 months-12 years: 20 mg/kg IV 8hourly for 10 days; up to 14-21 days reported
?12 years: 10-15 mg/kg IV q8hr for 14-21 days
Mucocutaneous Herpes Simplex Virus Infection
Treatment in immunocompromised patients
<12 years: 10 mg/kg IV q8hr for 7 days
?12 years: 5-10 mg/kg/day IV divided q8hr for 5-7 days; up to 14 days reported
Herpes Zoster (Shingles)
<12 years (immunocompromised): 20 mg/kg IV q8hr for 7 days
>12 years (immunocompromised): 30 mg/kg/day IV divided q8hr for 7-10 days
Varicella Zoster (Chickenpox)
Immunocompromised patients
<12 years: 20 mg/kg/dose IV q8hr for 7 days
>12 years: 10 mg/kg/dose IV q8hr for 7 days
Renal Dose
Renal impairment (IV)
CrCl 25-50 mL/min/1.73 m²: Give recommended dose q12hr
CrCl 10-25 mL/min/1.73 m²: Give recommended dose q24hr
CrCl <10 mL/min/1.73 m²: Give 50% of recommended dose q24hr
Administration
IV Preparation
Reconstitute with 10 mL (500-mg vial) or 20 mL (1000-mg vial) with Sterile Water
Add 10 mL or 20 mL of sterile water for inj to a vial labeled as containing 500 mg or 1,000 mg of aciclovir, respectively, to provide a soln containing 50 mg/mL.
The appropriate dose of reconstituted soln should then be withdrawn from the vial and diluted w/ 50-125 mL of a compatible IV infusion soln.
Injection
For IV infusion, dilute solution in D5W or 0.9% NaCl to a final concentration ?7 mg/mL.
Concentrations >10 mg/mL increase the risk of phlebitis
IV Administration
For IV infusion only
Avoid rapid infusion; infuse over 1 hr at constant rate to prevent renal damage
Maintain adequate hydration
Check for phlebitis, and rotate infusion sites
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.
Precautions
Avoid rapid infusion because of risk of renal damage
Renal failure, resulting in death, has occurred
Use with caution in immunocompromised patients (potential risk of thrombotic thrombocytopenic purpura [TTP]/hemolytic uremic syndrome [HUS])
Use with caution in patients with renal impairment
Treatment should begin within 24 hours of appearance of rash
Use with caution in patients receiving nephrotoxic drugs
Maintain adequate hydration during PO or IV therapy
Thrombocytopenic purpura/hemolytic uremic syndrome reported
Pregnancy-Lactation
Pregnancy
The use of aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks.
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of aciclovir. The registry findings have not shown an increase in the number of birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.
Caution should however be exercised by balancing the potential benefits of treatment against any possible hazard.
Breast-feeding
Following oral administration of 200mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3mg/kg/day.
Caution is therefore advised if aciclovir is to be administered to a nursing woman.
Fertility
There is no information on the effect of aciclovir on human female fertility.
In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.
Interactions
Probenecid, cimetidine and mycophenolate mofetil may increase the plasma concentration of aciclovir. Increased nephrotoxic effects w/ drugs that affect renal physiology (e.g. ciclosporin, tacrolimus).
Side Effects
Side effects of Acyclovir IV :
1-10%
Parenteral
Inflammation or phlebitis at injection site (9%)
Nausea (7%)
Vomiting (7%)
Rash or hives (2%)
Elevated transaminase levels (1-2%)
<1%
Abdominal pain
Aggression/confusion
Agitation
Alopecia
Anaphylaxis
Anemia
Angioedema
Anorexia
Ataxia
Coma
Disseminated intravascular coagulation (DIC)
Dizziness
Fatigue
Mode of Action
Activity against HSV types I and II and varicella-zoster virus is due to intracellular conversion of aciclovir to the monophosphate by viral thymidine kinase with subsequent conversion to the diphosphate and active triphosphate by cellular enzymes. This active form inhibits viral DNA synthesis and replication by interfering with viral DNA polymerase enzyme and being incorporated into viral DNA.
Note
Simplovir 500mg/vial IV Injection generic name is Acyclovir IV. Simplovir 500mg/vial IV Injection is manufactured by Incepta Pharmaceuticals Ltd.Simplovir is availble in all over Bangladesh.
Mes BD drug index information on Simplovir IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.