In patients receiving continuous ambulatory peritoneal dialysis (CAPD) the dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight) should be halved and administered every 24 hours. HIV-infected adults: CDC recommends 400 mg 3 times daily for 510 days. Administration of acyclovir by intravenous infusion must be accompanied by adequate hydration. In one study (Study 1), Acyclovir Sodium Injection 10 mg/kg every 8 hours (30 mg/kg/day) was compared with vidarabine. However, the small size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Herpes simplex, suppression. Immunocompromised children <12 years of age: 10 mg/kg every 8 hours for 714 days. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. The corresponding trough levels (Cssmin) 7 hours later were 2.2 micromolar (0.5 microgram/ml), 3.1 micromolar (0.7 microgram/ml) and 10.2 micromolar (2.3 microgram/ml) respectively. Care is also required (with monitoring for changes in renal function) if administering intravenous aciclovir with drugs which affect other aspects of renal physiology (e.g. Treatment of first episodes of herpes proctitis. The safety and efficacy of Acyclovir Sodium Injection for Injection has been evaluated in pediatric patients, including neonates (see CLINICAL PHARMACOLOGY, CLINICAL TRIALS, INDICATIONS AND USAGE, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION). In children over one year of age similar mean peak (Cssmax) and trough (Cssmin) levels were observed when a dose of 250 mg/m2 was substituted for 5 mg/kg and a dose of 500 mg/m2 was substituted for 10 mg/kg. Dosage adjustment for patients with renal impairment is based on creatinine clearance, in units of ml/min for adults and adolescents and in units of ml/min/1.73m2 for infants and children less than 13 years of age. Clinical studies of acyclovir did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. From the calculated dose, determine the appropriate number and strength of vials to be used. Must be diluted further before IV administration. The sodium content is approximately 5.1 mg/mL. Widely distributed into body tissues and fluids including the brain, kidney, saliva, lung, liver, muscle, spleen, uterus, vaginal mucosa, CSF, herpetic vesicular fluid, and semen. Following dilution using the fluids detailed in section 6.6, chemical and physical in-use stability has been demonstrated for up to 12 hours at 25C. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o. In immunocompromised children with Varicella zoster infections or children with herpes encephalitis, aciclovir for infusion should be given in doses of 500 mg per square metre body surface area every eight hours if renal function is not impaired. Adequate hydration of the patient should be maintained. If you have genital herpes, it is very important to. [] Adverse cutaneous reactions have been reported with all routes of administration. This container closure is not made with natural rubber latex. In a follow-up study, (Study 2), Acyclovir Sodium Injection 20 mg/kg every 8 hours (60 mg/kg/day) was compared with Acyclovir Sodium Injection 15 mg/kg every 8 hours (45 mg/kg/day). There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Aciclovir for infusion is indicated for the prophylaxis of Herpes simplex infections in immunocompromised patients. When dosage adjustments are required, they should be based on estimated creatinine clearance (see DOSAGE AND ADMINISTRATION). A multicenter trial of acyclovir at a dose of 500 mg/m2 every 8 hours for 7 days was conducted in immunocompromised patients with zoster infections (shingles). These exposures resulted in plasma levels the same as, 4 and 9, and 1 and 2 times, respectively, human levels. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. are not recommended. Immunocompromised adolescents and children: Some clinicians recommend 20 mg/kg every 8 hours for 710 days in those 12 years of age and 10 mg/kg every 8 hours for 7 days in those >12 years of age. Aciclovir for infusion is indicated for the treatment of herpes encephalitis. Creatinine Clearance. The sodium content should be taken into consideration when prescribing to patients requiring sodium restriction. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. Sixty-two patients aged 6 months to 79 years with brain biopsy-proven herpes simplex encephalitis were randomized to receive either acyclovir (10 mg/kg every 8 hours) or vidarabine (15 mg/kg/day) for 10 days (28 were treated with acyclovir and 34 with vidarabine). The following hematologic abnormalities occurred at a frequency of less than 1%: anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, and neutrophilia. Acyclovir was superior to placebo as measured by reductions in cutaneous dissemination and visceral dissemination. Adolescents: CDC recommends 400 mg twice daily. . Acyclovir Sodium Injection is a synthetic nucleoside analogue, active against herpes viruses. The concentration is equivalent to 54.9 mg of acyclovir sodium per mL in Water for Injection, USP. Consult DOSAGE AND ADMINISTRATION section for recommended adjustments in dosing based upon creatinine clearance. (See Solution Compatibility under Stability.) When diluted in accordance with the recommended schedules, aciclovir for infusion is known to be compatible with the following infusion fluids: - sodium chloride intravenous infusion BP (0.45% and 0.9% w/v); - sodium chloride (0.18% w/v) and glucose (4% w/v) intravenous infusion BP, - sodium chloride (0.45% w/v) and glucose (2.5% w/v) intravenous infusion BP. A multicenter trial of acyclovir at a dose of 250 mg/m2 every 8 hours (750 mg/m2/day) for 7 days was conducted in 98 immunocompromised patients (73 adults and 25 children) with orofacial, esophageal, genital and other localized infections (52 treated with acyclovir and 46 with placebo). An additional controlled study performed in Europe demonstrated similar findings. New York, NY: Academic Press; 1980:305-16. Acyclovir Sodium Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients. It allows continued monitoring of the benefit/risk balance of the medicinal product. The results of a wide range of mutagenicity test in vitro and in vivo indicate that aciclovir is unlikely to pose a genetic risk to man. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Once diluted for administration, each dose should be used within 24 hours. Treatment of initial and recurrent mucocutaneous HSV-1 and HSV-2 infections (e.g., orofacial, esophageal, genital, nasal, labial) in immunocompromised adults, adolescents, and children, including HIV-infected individuals. HSV-seropositive adults: 200 mg 3 times daily initiated at beginning of conditioning therapy and continued until engraftment or until mucositis resolves (i.e., approximately 30 days after allogeneic HSCT). Aciclovir 250mg for infusion should be reconstituted using 10ml of either Water for Injections PhEur or Sodium Chloride Intravenous Infusion BP (0.9% w/v) to provide a solution containing 25mg aciclovir per ml. Adolescents: CDC recommends 400 mg 3 times daily or 200 mg 5 times daily for 710 days; duration may be extended if healing is incomplete after 10 days. Give supplemental oral dose immediately after each dialysis period. In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of Acyclovir Sodium Injection in clinical practice. Aciclovir for infusion is indicated for the treatment of Herpes simplex infections in the neonate and infant up to three months of age. A course of treatment with aciclovir for infusion usually lasts five days, but this may be adjusted according to the patient's condition and response to therapy. For fluid-restricted patients, dilute reconstituted solution in a ratio of approximately 1 part reconstituted solution to 9 parts infusion solution to a concentration of 7 mg/mL. The peak and trough plasma levels during the 47 hours preceding hemodialysis were 8.5 mcg/mL and 0.7 mcg/mL, respectively. The only major urinary metabolite detected is 9-carboxymethoxymethylguanine accounting for up to 14.1% of the dose in patients with normal renal function. Use with caution in patients with underlying neurologic abnormalities and in those with serious renal, hepatic, or electrolyte abnormalities or substantial hypoxia. The dosage of aciclovir for infusion in neonates and infants up to three months of age is calculated on the basis of bodyweight. Last updated on Nov 1, 2021. ciclosporin, tacrolimus). Drug of choice. Why is this medication prescribed? Reconstitution and dilution should therefore be carried out under full aseptic conditions immediately before use and any unused solution discarded. Dosage adjustments in infants and children: The dose recommended above (250 or 500 mg/m2 body surface area or 20 mg/kg body weight (should be given every 12 hours). HIV-infected adults: 400800 mg 2 or 3 times daily. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8). tablet 400mg 800mg capsule 200mg Genital Herpes Initial treatment: 200 mg PO q4hr while awake (5 times daily) for 10 days or 400 mg PO q8hr for 7-10 days Intermittent treatment for recurrence: 200. However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir. Absorption from GI tract is variable and incomplete; 1030% of an oral dose may be absorbed. AHFS DI Essentials. Not effective for prevention of CMV disease in HIV-infected individuals. The frequency categories associated with the adverse events below are estimates. 250500 mg/m2 as a loading dose, followed by a maintenance dosage of 250500 mg/m2 every 48 hours, and 150500 mg/m2 immediately after dialysis. VIROLOGY - Mechanism of Antiviral Action - Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against . There have been no studies to investigate the effect of aciclovir on driving performance or the ability to operate machinery. From a microbiological point of view, once opened, the product should be used immediately. Can you drink alcohol while taking acyclovir? At physiologic pH, acyclovir sodium exists as the unionized form with a molecular weight of 225 and a maximum solubility in water at 37C of 2.5 mg/mL. Immunocompromised patients with Varicella zoster infections or patients with herpes encephalitis should be given aciclovir for infusion in doses of 10mg/kg bodyweight every eight hours provided renal function is not impaired (see Dosage in renal impairment). INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see WARNINGS). Decreased acyclovir clearance. For IV infusion, dilute concentrate containing acyclovir 25 or 50 mg/mL with a compatible IV solution (see Solution Compatibility under Stability) to a concentration of 7 mg/mL. Very common 1/10, common 1/100 and <1/10, uncommon 1/1,000 and <1/100, rare 1/10,000 and <1/1,000, very rare <1/10,000. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Long-term therapy may be required to prevent recurrence. Since no antimicrobial preservative is included, reconstitution and dilution must be carried out under full aseptic conditions, immediately before use, and any unused solution discarded. It is a sterile, aqueous solution for intravenous infusion, containing 50 mg acyclovir per mL in Water for Injection, USP. These symptoms may be marked, particularly in older adults (see PRECAUTIONS). Diluent WFI, NS/QSD1 WFI, D5% Incompatible With: The use of any solution other than those recommended or the presence of a bacteriostatic agent (e.g. HIV-infected children: CDC and others recommend 10 mg/kg or 500 mg/m2 3 times daily for 21 days. Alternatively, acyclovir can be given for 714 days. Further dilution of Acyclovir Sodium Injection in an appropriate intravenous . In Study 2, 72 of the 88 enrolled neonates received 60 mg/kg/day. The pka's of acyclovir are 2.27 and 9.25. Further dilution of Acyclovir Sodium Injection in an appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION, Administration). Possible increased incidence of adverse CNS effects (coma, confusion, hallucinations, somnolence), GI effects (nausea, vomiting), or dizziness during oral acyclovir therapy compared with younger adults. If not used immediately in-use storage times and conditions are the responsibility of the user. You have genital herpes, it is very important to be absorbed new York, NY Academic. Urinary metabolite detected is 9-carboxymethoxymethylguanine accounting for up to three months of age is calculated on basis! On driving performance or the ability to operate machinery one study ( 1! Determine the appropriate number and strength of vials to be used within hours!, 2021. ciclosporin, tacrolimus ) is provided for educational purposes only and is not intended for advice... 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