For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6. Average steady-state peak and trough concentrations from 1-hour infusions administered every 8 hours are given in Table 1. Alternatively, acyclovir can be given for 714 days. Acyclovir decreased the duration of viral excretion, new lesion formation, duration of vesicles, and promoted healing of lesions. Renal failure, resulting in death, has occurred. Drug of choice for serious or disseminated herpes zoster in immunocompromised patients. HIV-infected adolescents: CDC and others recommend 10 mg/kg every 8 hours until cutaneous and visceral disease resolves. Severe local inflammatory reactions sometimes leading to breakdown of the skin have occurred when formulations of aciclovir for intravenous use have been inadvertently infused into extravascular tissues. Additive or synergistic antiviral effect against HSV-1 in vitro, Clinical importance unknown; use with caution, Manufacturer states that IV acyclovir should be used with caution in patients receiving intrathecal methotrexate, Neurotoxicity (profound drowsiness, lethargy) reported in at least 1 patient, Monitor patients closely during concomitant therapy. Acyclovir Sodium Injection contains Sodium Hydroxide, NF as inactive ingredient. Once diluted for administration, each dose should be used within 24 hours. Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p.o.) There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. In neonates (0 to three months of age) treated with doses of 10 mg/kg administered by infusion over a one-hour period every 8 hours the Cssmax was found to be 61.2 micromolar (13.8 microgram/ml) and the Cssmin.to be 10.1 micromolar (2.3 microgram/ml). 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. Reconstitute vial containing 500 mg or 1 g of acyclovir powder with 10 or 20 mL of sterile water for injection, respectively, to provide a solution containing 50 mg/mL. Physical compatibility and chemical stability of cisplatin in various diluents and in large-volume parenteral solutions. Start typing to retrieve search suggestions. Reconstitution and dilution should therefore be carried out under full aseptic conditions immediately before use and any unused solution discarded. HIV-infected children: CDC and others recommend 10 mg/kg or 500 mg/m2 3 times daily for 21 days. Uncommon: Decreases in haematological indices (anaemia, thrombocytopenia, leucopenia). Tell your doctor if you are pregnant. Give supplemental usual oral dose after each dialysis period. Treatment for neonatal herpes usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for disseminated or central nervous system disease. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Immunocompromised children <12 years of age: 10 mg/kg every 8 hours for 714 days. Infants and children with impaired renal function require an appropriately modified dose, according to the degree of impairment (see Dosage in renal impairment). Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . Adequate hydration should be maintained. Very rare: Reversible increases in bilirubin, hepatitis and jaundice. [PubMed 256991] 636. (See Renal Impairment under Dosage and Administration.). Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. 1 Infiltration, often used in reference to extravasation, refers to leakage of a non-vesicant drug or solution. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Refrigeration of this solution may cause a precipitate, which will redissolve at room temperature. HIV-infected children with mild immunosuppression and mild varicella: CDC and others recommend 20 mg/kg (up to 800 mg) 4 times daily for 710 days. This container closure is not made with natural rubber latex. In patients receiving haemodialysis the dose recommended above (5 or 10 mg/kg bodyweight) should be halved and administered every 24 hours and after dialysis. Plasma aciclovir levels dropped approximately 60% during dialysis. Child 12-17 years. Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of acyclovir and ranged from 0.6 to 4.1 times corresponding plasma levels. Most of the drug is excreted unchanged by the kidney. Acyclovir for Injection, USP is a sterile lyophilized powder for intravenous administration only. DESCRIPTION Doxycycline for Injection, USP is a broad-spectrum antibiotic syn-thetically derived from oxytetracycline. Further dilution in any appropriate intravenous solution must be performed before infusion . AAP recommends 80 mg/kg daily (up to 1 g daily) given in 3 divided doses. Chronic suppressive or maintenance therapy (secondary prophylaxis) of recurrent HSV infections [off-label] in immunocompromised adults, adolescents, and children, including HIV-infected individuals who have frequent or severe recurrences. HIV-infected or -exposed neonates: CDC and others recommend 20 mg/kg 3 times daily given for 14 days for infections of skin, eyes, or mouth or 21 days for disseminated or CNS infections. Shake well to ensure complete dissolution. CAS number: 59277-89-3. VA class: AM800 Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs. Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy. It allows continued monitoring of the benefit/risk balance of the medicinal product. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility. PACKAGE LABEL - PRINCIPAL DISPLAY - 10 mL Single-Use Container Label, PACKAGE LABEL - PRINCIPAL DISPLAY - 10 mL Single-Use Carton Label, PACKAGE LABEL - PRINCIPAL DISPLAY - 20 mL Single-Use Container Label, PACKAGE LABEL - PRINCIPAL DISPLAY - 20 mL Single-Use Carton Label, prednisone, acyclovir, valacyclovir, Valtrex, Zovirax, Deltasone, tetracaine topical, famciclovir, lysine, Abreva. At 450 mg/kg/day, plasma concentrations in both the mouse and rat bioassay were lower than concentrations in humans. CDC recommends 400 mg 3 times daily for 5 days, 800 mg twice daily for 5 days, or 800 mg 3 times daily for 2 days. Available as acyclovir and acyclovir sodium; dosage expressed in terms of acyclovir. The only major urinary metabolite detected is 9-carboxymethoxymethylguanine accounting for up to 14.1% of the dose in patients with normal renal function. The reconstituted or diluted solutions should not be refrigerated. Treatment of uncomplicated or complicated infectious mononucleosis, chronic infectious mononucleosis, and various disorders (e.g., oral hairy leukoplakia) associated with Epstein-Barr virus infections; efficacy appears to be variable. The dosage of aciclovir for infusion in neonates and infants up to three months of age is calculated on the basis of bodyweight. Children >1 year of age: elimination half-life similar to that in adults. Use with caution in patients with underlying neurologic abnormalities and in those with serious renal, hepatic, or electrolyte abnormalities or substantial hypoxia. The mean gestational ages (GA) were 37.5 and 37.9 weeks for the 45 mg/kg/day and 60 mg/kg/day doses, respectively. If not used immediately in-use storage times and conditions are the responsibility of the user. Adjust dosing schedule so that daily IV dose is given after hemodialysis on dialysis days. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Alternatively, acyclovir can be given for 714 days. The mean aciclovir half-life during haemodialysis was 5.7 hours. Crosses placenta following oral or IV administration; cord blood concentrations may be higher than maternal plasma concentrations. Less active against CMV than many other Herpesviridae. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until. 1979; 33:107-16. Do not administer by rapid IV infusion (over <10 minutes) or rapid IV injection. are not recommended. ), rabbit (50 mg/kg/day, s.c. and IV) or rat (50 mg/kg/day, s.c.). Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Acyclovir for Injection, USP is a sterile lyophilized powder for intravenous administration only. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. Manufacturer recommends 200 mg every 4 hours while awake (5 times daily) for 5 days. 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). In Study 2, 72 of the 88 enrolled neonates received 60 mg/kg/day. For reconstituted solutions, chemical and physical in-use stability has been demonstrated for at least 24 hours at 25oC. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Treatment of varicella (chickenpox) in immunocompromised adults, adolescents, and children, including HIV-infected individuals. To reconstitute each vial add the recommended volume of infusion fluid and shake gently until the contents of the vial have dissolved completely. Manufacturer recommends 200 mg every 4 hours while awake (5 times daily) for 10 days. Neonates: half-life depends principally on maturity of renal mechanisms for clearance. The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment. Acute renal failure and anuria, the patient may benefit from hemodialysis until maturity of mechanisms. Aciclovir half-life during haemodialysis was 5.7 hours indices ( anaemia, thrombocytopenia, leucopenia..: AM800 acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays in adults use caution! 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