acyclovir sodium
Pharmaranks rates Acyclovir Sodium 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Acyclovir Sodium is a herpes simplex virus nucleoside analog dna polymerase inhibitor used to treat Chickenpox, Herpes Genitalis, Herpes Labialis, Herpes Zoster Ophthalmicus.
Herpes Simplex Virus Nucleoside Analog Dna Polymerase Inhibitor · by Eugia Pharma
Generic of Zovirax
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Acyclovir Sodium
- Form
- Injectable
- Strength
- Acyclovir Sodium EQ 50MG BASE/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- chickenpox, herpes genitalis, herpes labialis
- Manufacturer
- Eugia Pharma
- Half-life
- about 2.5 to 3.3 hours (how long it stays in your system)
- What the pharmacy pays
- ~$4.83 for 30 — not your price
- FDA application
- ANDA203701
What is Acyclovir Sodium?
From the FDA label:Acyclovir Sodium Injection is a synthetic nucleoside analog, active against herpes viruses. It is a sterile, aqueous solution for intravenous infusion, containing 50 mg acyclovir per mL in Water for Injection, USP. The concentration is equivalent to 54.9 mg of acyclovir sodium per mL in Water for Injection, USP. The sodium content is approximately 5.1 mg/mL. The pH range of the solution is 10.85 to 11.50. Further dilution of Acyclovir Sodium Injection in an appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION, Administration ). The chemical name of acyclovir sodium is 9-[(2-Hydroxyethoxy)methyl] guanine, and has the following structural formula: Acyclovir USP is a white to off-white, crystalline powder. Acyclovir sodium is the sodium salt of acyclovir, which is formed in situ , with the molecular formula C 8 H 10 N 5 NaO 3 and a molecular weight of 247.19. The maximum solubility in water at 25°C exceeds 100 mg/mL. At physiologic pH, acyclovir sodium exists as the unionized form with a molecular weight of 225 and a maximum solubility in water at 37°C of 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. Acyclovir Sodium Chemical Structure
How to use
CAUTION - RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (see WARNINGS and PRECAUTIONS ). INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see WARNINGS ). Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections. A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient. Dosage HERPES SIMPLEX INFECTIONS MUCOSAL AND CUTANEOUS HERPES SIMPLEX (HSV-1 AND HSV-2) INFECTIONS IN IMMUNOCOMPROMISED PATIENTS Adults and Adolescents (12 years of age and older) 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days. Pediatrics (Under 12 years of age) 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 7 days. SEVERE INITIAL CLINICAL EPISODES OF HERPES GENITALIS Adults and Adolescents (12 years of age and older) 5 mg/kg infused at a constant rate over 1 hour, every 8 hours for 5 days. HERPES SIMPLEX ENCEPHALITIS Adults and Adolescents (12 years of age and older) 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days. Pediatrics (3 months to 12 years of age) 20 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days . Neonatal Herpes Simplex Virus Infections (Birth to 3 months) 10 mg/kg infused at a constant rate over 1 hour, every 8 hours for 10 days. In neonatal herpes simplex infections, doses of 15 mg/kg or 20 mg/kg (infused…
Side effects
The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at approximately 5 mg/kg (250 mg/m 2 ) 3 times daily, and approximately 300 patients who received approximately 10 mg/kg (500 mg/m 2 ) 3 times daily. The most frequent adverse reactions reported during administration of acyclovir were inflammation or phlebitis at the injection site in approximately 9% of the patients, and transient elevations of serum creatinine or BUN in 5% to 10% (the higher incidence occurred usually following rapid [less than 10 minutes] intravenous infusion). Nausea and/or vomiting occurred in approximately 7% of the patients (the majority occurring in nonhospitalized patients who received 10 mg/kg). Itching, rash, or hives occurred in approximately 2% of patients. Elevation of transaminases occurred in 1% to 2% of patients. The following hematologic abnormalities occurred at a frequency of less than 1%: anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, and neutrophilia. In addition, anorexia and hematuria were observed. Observed During Clinical Practice In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of Acyclovir Sodium Injection in clinical practice. Because they are reported voluntarily from a population…
Warnings
Important safety information
Acyclovir Sodium Injection is intended for intravenous infusion only, and should not be administered topically, intramuscularly, orally, subcutaneously, or in the eye. Intravenous infusions must be given over a period of at least 1 hour to reduce the risk of renal tubular damage (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ). 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.
Who should not take Acyclovir Sodium
Acyclovir Sodium Injection is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Overdose — what happens if you take too much
Overdoses involving ingestions of up to 20 g have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses, and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine, and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION ).
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
See CLINICAL PHARMACOLOGY, Pharmacokinetics .
How long does Acyclovir Sodium stay in your body?
The elimination half-life of acyclovir sodium is about 2.5 to 3.3 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Acyclovir is cleared almost entirely by the kidneys — 62% to 91% of a dose leaves the body as unchanged drug — so the half-life tracks kidney function closely. The IV label tabulates it by creatinine clearance: 2.5 hours at CrCl above 80, 3 hours at 50–80, 3.5 hours at 15–50, and 19.5 hours in anuric patients, roughly an eightfold increase in severe kidney failure. Older adults reach higher plasma levels than younger adults, which the label attributes to age-related decline in renal function rather than to age itself; no separate geriatric half-life is given. There is no active metabolite that outlasts the parent — the only major urinary metabolite named is 9-carboxymethoxymethylguanine (up to 14.1% of the dose), and the label does not report a half-life for it. Liver impairment is not addressed in the pharmacokinetics section, consistent with renal rather than hepatic elimination. No extended-release oral acyclovir is marketed in the US; tablets, capsules, oral suspension and IV all reflect the same short elimination half-life. One drug effect worth naming: probenecid taken with acyclovir lengthens the mean half-life and raises overall exposure.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Acyclovir Tablets, USP — FDA prescribing information, Clinical Pharmacology (DailyMed).
Drug class
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
- Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
- Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
May treat (source: NIH RxClass)
- chickenpox
- herpes genitalis
- herpes labialis
- herpes zoster ophthalmicus
- aids-related opportunistic infections
- epstein-barr virus infections
See how Acyclovir Sodium ranks — best-rated herpes simplex virus nucleoside analog dna polymerase inhibitor for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Acyclovir Sodium treat?
- Acyclovir Sodium (Acyclovir Sodium) may be used to treat chickenpox, herpes genitalis, herpes labialis, herpes zoster ophthalmicus, AIDS-related opportunistic infections, epstein-barr virus infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Acyclovir Sodium rated?
- pharmaranks gives Acyclovir Sodium a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Acyclovir Sodium cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $4.83 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Acyclovir Sodium?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Acyclovir Sodium. To pay less, Acyclovir Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Acyclovir Sodium?
- Acyclovir Sodium is marketed by Eugia Pharma. You can see Eugia Pharma's full profile, rating, and other products on pharmaranks.
- Is Acyclovir Sodium a brand-name or generic drug?
- Acyclovir Sodium is a generic medication; its active ingredient is Acyclovir Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Acyclovir Sodium available over the counter?
- No. Acyclovir Sodium is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Acyclovir Sodium come in?
- Acyclovir Sodium is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Acyclovir Sodium?
- Acyclovir Sodium is classified as herpes simplex virus nucleoside analog dna polymerase inhibitor, herpes zoster virus nucleoside analog dna polymerase inhibitor, herpesvirus nucleoside analog dna polymerase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Acyclovir Sodium FDA-registered?
- Acyclovir Sodium is on record with the U.S. FDA under application number ANDA203701. You can verify this on its official FDA label.
- Has Acyclovir Sodium been recalled by the FDA?
- Yes. Acyclovir Sodium has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Acyclovir Sodium safe?
- There's no single safe-or-not verdict. pharmaranks gives Acyclovir Sodium a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Acyclovir Sodium?
- Acyclovir Sodium's side effects are taken directly from its FDA label. From the label: The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at approximately 5 mg/kg (250 mg/m 2 ) 3 times daily,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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acyclovir sodium
70/100