Acyclovir suspension 200 mg/5mL
Acyclovir · SUSPENSION · Atlantic Biologicals Corp.
Acyclovir suspension is a suspension containing acyclovir at 200 mg/5mL, taken oral. Manufactured by Atlantic Biologicals Corp..
Key Facts
- Brand Name
- Acyclovir suspension
- Generic Name
- Acyclovir
- NDC Code (Product)
17856-2170- Manufacturer
- Atlantic Biologicals Corp.
- Strength
- 200 mg/5mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA217393
- Drug Class
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
- Marketing Start
- 03/09/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir is indicated for the treatment of chickenpox (varicella).
Dosage & Administration
DOSAGE AND ADMINISTRATION Acute Treatment of Herpes Zoster 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes Treatment of Initial Genital Herpes 200 mg every 4 hours, 5 times daily for 10 days. 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. 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 infecti…
Warnings
WARNINGS Acyclovir Oral Suspension is intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS : Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
Contraindications
CONTRAINDICATIONS Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Drug Interactions
Drug Interactions See CLINICAL PHARMACOLOGY : Pharmacokinetics.
Adverse Reactions
ADVERSE REACTIONS Herpes Simplex Short-Term Administration The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo. Long-Term Administration The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%). The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%). Herpes Zoster The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%). Chickenpox The most frequent adverse event reported during 3 clinical trials of treatment of …
Frequently Asked Questions
What is Acyclovir suspension used for?
Acyclovir suspension contains Acyclovir. It is a suspension taken oral. Consult your doctor for specific uses.
Is Acyclovir suspension a controlled substance?
Acyclovir suspension is not classified as a controlled substance by the DEA.
What is the generic name for Acyclovir suspension?
The generic name for Acyclovir suspension is Acyclovir. There are 12 other brand versions of Acyclovir.
What is the NDC code for Acyclovir suspension 200 mg/5mL?
The NDC (National Drug Code) for Acyclovir suspension 200 mg/5mL is 17856-2170, listed by Atlantic Biologicals Corp..