Acyclovir (Page 4 of 4)
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 is indicated for the treatment of varicella-zoster 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 capsules and tablets should be modified as shown in Table 3:
| Table 3: Dosage Modification for Renal Impairment | |||
| Normal Dosage Regimen | Creatinine Clearance (mL/min/1.73 m2) | Adjusted Dosage Regimen | |
| Dose (mg) | Dosing Interval | ||
| 200 mg every 4 hours | > 10 | 200 | every 4 hours, 5x daily |
| 0 to 10 | 200 | every 12 hours | |
| 400 mg every 12 hours | > 10 | 400 | every 12 hours |
| 0 to 10 | 200 | every 12 hours | |
| 800 mg every 4 hours | > 25 | 800 | every 4 hours, 5x daily |
| 10 to 25 | 800 | every 8 hours | |
| 0 to 10 | 800 | 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.
Bioequivalence of Dosage Forms
Acyclovir suspension was shown to be bioequivalent to acyclovir capsules (n = 20) and 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).
HOW SUPPLIED
Acyclovir capsules USP are available containing 200 mg acyclovir. Each opaque blue cap and body size #1 hard gelatin capsule is imprinted with black ink N 940 and 200 on opposing cap and body portion of the capsule.
They are supplied as follows:
NDC 0093-8940-01 Bottles of 100
NDC 0093-8940-05 Bottles of 500
NDC 0093-8940-93 Unit dose boxes of 100
Acyclovir tablets USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N943 on one side and 400 on the other side.
They are supplied as follows:
NDC 0093-8943-01 Bottles of 100
NDC 0093-8943-05 Bottles of 500
NDC 0093-8943-93 Unit dose boxes of 100
Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N947 on one side and 800 on the other side.
They are supplied as follows:
NDC 0093-8947-01 Bottles of 100
NDC 0093-8947-05 Bottles of 500
NDC 0093-8947-93 Unit dose boxes of 100
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Manufactured In Canada By:
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. H 8/2012
Principal Display Panel
| ACYCLOVIR acyclovir tablet | ||||||||||||||||||
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| Labeler — MedVantx, Inc. (806427725) |
| Registrant — Teva Pharmaceuticals USA Inc (118234421) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Blenheim Pharmacal, Inc. | 171434587 | REPACK (66116-414) | |
Revised: 02/2013 MedVantx, Inc.
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