Acyclovir (Page 4 of 4)
Chronic Suppressive Therapy for Recurrent Disease:
400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.
The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir oral suspension.
Intermittent Therapy:
200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.
Treatment of Chickenpox:
Children (2 years of age and older):
20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.
Adults and Children over 40 kg:
800 mg 4 times daily for 5 days.
Intravenous acyclovir oral suspension is indicated for the treatment of varicellazoster infections in immunocompromised patients.
When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.
Patients With Acute or Chronic Renal Impairment:
In patients with renal impairment, the dose of acyclovir oral suspension should be modified as shown in Table 3:
| Normal Dosage Regimen | Creatinine Clearance (mL/min/1.73 m2) | Adjusted Dosage Regimen | |
| Dose (mg) | Dosing Interval | ||
| 200 mg every 4 hours | > 10 0-10 | 200 200 | every 4 hours, 5x daily every 12 hours |
| 400 mg every 12 hours | > 10 0-10 | 400 200 | every 12 hours every 12 hours |
| 800 mg every 4 hours | > 25 10-25 0-10 | 800 800 800 | every 4 hours, 5x daily every 8 hours every 12 hours |
Hemodialysis:
For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.
Peritoneal Dialysis:
No supplemental dose appears to be necessary after adjustment of the dosing interval.
HOW SUPPLIED
Acyclovir oral suspension, USP (off-white, artificial banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL) – Bottle of 1 pint (473 mL).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
Distributed by:
Akorn Operating Company LLC
Gurnee, IL 60031
Rev.810:03 08/22
PRINCIPAL DISPLAY PANEL
AKORN
ACYCLOVIR ORAL SUSPENSION, USP
200 mg/5 mL
Each teaspoonful (5 mL) contains:
Acyclovir……………………………………….200 mg
Methylparaben……………………………………0.1%
Propylparaben…………………………………..0.02%
(Added as preservatives)
USUAL DOSAGE: See package insert for dosage and full prescribing information.
Dispense in a tight container as defined in the USP.
Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature].
Protect from light.
Rx only
SHAKE WELL BEFORE USING
16 fl oz (473 mL)
Distributed by:
Akorn Operating Company LLC
Gurnee, IL 60031
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| Labeler — Akorn (117696873) |
| Registrant — Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Akorn | 117696873 | MANUFACTURE (50383-810) | |
Revised: 09/2022 Akorn
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