azurity™ pharmaceuticals. STOP IMPORTANT: • When reconstituted each mL contains 25 mg Vancomycin • Add liquid contents of the Diluent bottle to … (see Caution is advised when administering Aciclovir to patients with impaired renal function. The mean recovery of valacyclovir (92.2%), acyclovir (84.2%) and IS (103.7%) from spiked plasma samples was consistent and reproducible.
Acyclovir tablets should be administered to a nursing mother with caution and only when indicated.Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established.Of 376 subjects who received acyclovir tablets in a clinical study of herpes zoster treatment in immunocompetent subjects ≥50 years of age, 244 were 65 and over while 111 were 75 and over. 9-carboxymethoxy-methylguanine is the only significant metabolite of aciclovir and accounts for 10 to 15% of the dose excreted in the urine. Progression to acute renal failure however, can occur in exceptional cases.Renal pain may be associated with renal failure and crystalluria.Very rare: fatigue, fever, local inflammatory reactionsSevere local inflammatory reactions sometimes leading to breakdown of the skin have occurred when aciclovir has been inadvertently infused into extravascular tissue.Reporting suspected adverse reactions after authorisation of the medicinal product is important. If lithium is administered concurrently with high dose aciclovir IV, the lithium serum concentration should be closely monitored because of the risk of lithium toxicity. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir tablets 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). Adequate hydration should be maintained in patients given i.v.
Caution should therefore be exercised by balancing the potential benefits of treatment against any possible hazard. Acyclovir pharmacokinetic parameters are summarized in Table 1.There was no effect of food on the absorption of acyclovir (n = 6); therefore, acyclovir tablets may be administered with or without food.Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Alternatively, the reconstituted solution may be further diluted to give an aciclovir concentration of not greater than 5 mg/ml (0.5% w/v) for administration by infusion. Reconstituted Aciclovir has a pH of approximately 11 and should not be administered by mouth. Treatment for neonatal herpes infections usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for disseminated or central nervous system disease.The duration of prophylactic administration of Aciclovir is determined by the duration of the period at risk.The required dose of aciclovir for infusion should be administered by slow intravenous infusion over a one-hour period.
After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. Findings from reproduction toxicology studies are included in Section 5.3.Following oral administration of 200 mg five times a day, aciclovir has been detected in human breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. Increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil, an immunosuppressant agent used in transplant patients, have been shown when the drugs are coadministered. For most events, suitable data for estimating incidence were not available. Most of the drug is excreted unchanged by the kidney. In the elderly, total aciclovir body clearance declines in parallel with creatinine clearance.
For instructions on reconstitution and dilution of the product before administration see section 6.6.In obese patients dosed with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained (see 5.2 Pharmacokinetic properties). An experimental study on five male subjects indicates that concomitant therapy with aciclovir increases AUC of totally administered theophylline with approximately 50%. Several FDA-approved drug labels may be available for acyclovir. MUST BE REFRIGERATED. Caution is therefore advised if Aciclovir is to be administered to a nursing woman.Aciclovir i.v. 150 mL final volume after reconstitution.
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