ACYCLOVIR 200 mg Capsule, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Acyclovir is used to treat viral infections like chickenpox, herpes zoster (shingles) and genital herpes (a sexually transmitted disease). Acyclovir is in a class of medications called antivirals. It works by stopping the spread of the virus in the body. Acyclovir will not cure herpes infections and may not stop the spread of herpes virus to other people.
Read the full MedlinePlus article ↗- Acyclovir doesn't cure herpes — it can't eliminate the virus from your body. What it does is slow down the virus's ability to copy itself, which shortens outbreaks, eases symptoms,...
- What exactly does acyclovir do — does it cure herpes?
- Timing really does matter with acyclovir. For cold sores, you want to start at the very first warning sign — that tingling or itching feeling — before a sore even appears. For geni...
- How soon do I need to start taking it for it to work?
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Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
15 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1791 | $5.37 / 30 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acyclovir 200 mg 00904-5789-61 | Major | 100 capsules | $0.097 | AB | Discontinued | — |
| Acyclovir 200 mg 00904-7519-61 | Major | 100 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 23155-0229-01 | Heritage | 100 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 23155-0962-01 | Avet | 100 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 61442-0114-01 | Carlsbad | 100 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 62135-0039-50 | Chartwell | 50 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 69076-0146-01 | Quinn | 100 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 72241-0028-05 | Modavar | 100 capsules | $0.097 | AB | Availability likely | — |
| acyclovir 200 mg 72578-0002-01 | Viona | 100 capsules | $0.097 | AB | Availability likely | — |
| Acyclovir 200 mg 75834-0124-01 | Nivagen | 100 capsules | $0.105 | AB | Discontinued | — |
| Acyclovir 200 mg 50090-5610-00 | A-S | 25 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 50090-7216-00 | A-S | 25 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 51407-0852-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 51655-0965-52 | Northwind | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 55154-0199-00 | Cardinal | 10 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 55154-7629-00 | Cardinal | 10 capsules | — | AB | Discontinued | — |
| Acyclovir 200 mg 60505-0042-05 | Apotex | 500 capsules | — | AB | Discontinued | — |
| Acyclovir 200 mg 63629-2009-01 | Bryant | 500 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 65841-0829-01 | Zydus | 100 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 68071-2299-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 68071-2526-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 69117-0039-01 | YILING | 100 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 70518-3436-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71205-0209-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mgthis 71205-0243-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71205-0578-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71209-0004-05 | Cadila | 100 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71335-0280-00 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71335-0470-00 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71335-1290-00 | Bryant | 90 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 71335-2261-00 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 71921-0146-01 | Florida | 100 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 72162-1704-00 | Bryant | 120 capsules | — | AB | FDA listed | — |
| Acyclovir 200 mg 72162-1908-00 | Bryant | 30 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 72789-0536-50 | PD-Rx | 50 capsules | — | AB | FDA listed | — |
| acyclovir 200 mg 82804-0245-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71205-0243-30 You're viewing this | 30 CAPSULE in 1 BOTTLE (71205-243-30) | 2019-03-01 | Active |
| 71205-0243-60 | 60 CAPSULE in 1 BOTTLE (71205-243-60) | 2019-03-01 | Active |
| 71205-0243-90 | 90 CAPSULE in 1 BOTTLE (71205-243-90) | 2019-03-01 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71205-0243-30?
What is the difference between NDC 71205-0243-30 and NDC 71205-0243-60?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Herpes Zoster Infections Acyclovir capsule is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir capsule is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir capsule is indicated for the treatment of chickenpox (varicella).
⏱️ Dosage and 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 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 should be modified as shown in Table 3: Table 3.
Dosage Modification for Renal Impairment Creatinine Adjusted Dosage Regimen Normal Dosage Regimen Clearance (mL/min/1.73 m 2 ) Dose (mg) Dosing Interval 200 mg every 4 hours >10 200 every 4 hours, 5x daily 0-10 200 every 12 hours 400 mg every 12 hours >10 0-10 400 200 every 12 hours every 12 hours 800 mg every 4 hours >25 800 every 4 hours, 5x daily 10-25 800 every 8 hours 0-10 800 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
⚠️ Warnings ▾
WARNINGS Acyclovir capsule 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.
🤒 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 chickenpox with oral acyclovir at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%). 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.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors. General Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.
Nervous Aggressive behavior, agitation, ataxia, coma,confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS ). Digestive Diarrhea, gastrointestinal distress, nausea.
Hematologic and Lymphatic Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia. Hepatobiliary Tract and Pancreas Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. Musculoskeletal Myalgia.
Skin Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Special Senses Visual abnormalities. Urogenital Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS ).
🔄 Drug Interactions ▾
Drug Interactions Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.
Drug Interactions See CLINICAL PHARMACOLOGY: Pharmacokinetics .
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category B. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels.
There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes.
The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatrics In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. Mean half-life after oral doses of 300 mg/m 2 and 600 mg/m 2 in pediatric patients aged 7 months to 7 years was 2.6 hours (range 1.59 to 3.74 hours).
Pediatric Use Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established.
🧓 Geriatric Use ▾
Geriatrics Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use ).
Geriatric Use Of 376 subjects who received acyclovir 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. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. The duration of pain after healing was longer in patients 65 and over.
Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events.
With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY , ADVERSE REACTIONS: Observed During Clinical Practice , and DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE Overdoses involving ingestion of up to 100 capsules (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 ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir pharmacokinetic parameters are summarized in Table 1. Table 1.
Acyclovir Pharmacokinetic Characteristics (Range) Parameter Range Plasma protein binding 9% to 33% Plasma elimination half-life 2.5 to 3.3 h Average oral bioavailability 10% to 20%* *Bioavailability decreases with increasing dose. In one multiple-dose, crossover study in healthy subjects (n = 23), it was shown that increases in plasma acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2. The decrease in bioavailability is a function of the dose and not the dosage form.
Table 2. Acyclovir Peak and Trough Concentrations at Steady State Parameter 200 mg 400 mg 800 mg Table 2. Acyclovir Peak and Trough Concentrations at Steady State 0.83 mcg/mL 1.21 mcg/mL 1.61 mcg/mL Table 2.
Acyclovir Peak and Trough Concentrations at Steady State 0.46 mcg/mL 0.63 mcg/mL 0.83 mcg/mL There was no effect of food on the absorption of acyclovir (n = 6); therefore, acyclovir capsules may be administered with or without food. The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine. acyclovir-02 acyclovir-03 Special Populations Adults with Impaired Renal Function The half-life and total body clearance of acyclovir are dependent on renal function. A dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION ).
Geriatrics Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use ). Pediatrics In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults.
Mean half-life after oral doses of 300 mg/m 2 and 600 mg/m 2 in pediatric patients aged 7 months to 7 years was 2.6 hours (range 1.59 to 3.74 hours). Drug Interactions Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.
Clinical Trials Initial Genital Herpes Double-blind, placebo-controlled studies have demonstrated that orally administered acyclovir significantly reduced the duration of acute infection and duration of lesion healing. The duration of pain and new lesion formation was decreased in some patient groups. Recurrent Genital Herpes Double-blind, placebo-controlled studies in patients with frequent recurrences (6 or more episodes per year) have shown that orally administered acyclovir given daily for 4 months to 10 years prevented or reduced the frequency and/or severity of recurrences in greater than 95% of patients.
In a study of patients who received acyclovir 400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively. Serial analyses of the 3-month recurrence rates for the patients showed that 71% to 87% were recurrence free in each quarter. Herpes Zoster Infections In a double-blind, placebo-controlled study of immunocompetent patients with localized cutaneous zoster infection, acyclovir (800 mg 5 times daily for 10 days) shortened the times to lesion scabbing, healing, and complete cessation of pain, and reduced the duration of viral shedding and the duration of new lesion formation.
In a similar double-blind, placebo-controlled study, acyclovir (800 mg 5 times daily for 7 days) shortened the times to complete lesion scabbing, healing, and cessation of pain; reduced the duration of new lesion formation; and reduced the prevalence of localized zoster-associated neurologic symptoms (parest…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Acyclovir Capsules USP 200 mg are available for oral administration as hard gelatin capsules with a white opaque body and an aqua blue opaque cap. “APO 042” is imprinted on each capsule in black ink. They are supplied as follows: Bottles of 30 (71205-243-30) Bottles of 60 (71205-243-60) Bottles of 90 (71205-243-90) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and protect from moisture. Manufactured by: Manufactured for: Apotex Inc.
Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: December 2005 Rev. 4
📋 Description ▾
DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir capsule is a formulation for oral administration. Each capsule of acyclovir contains 200 mg of acyclovir and the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
The capsule shell consists of FD&C blue #1, gelatin and titanium dioxide. The capsule black imprinting ink contains the following inactive ingredients: ammonium hydroxide, black iron oxide, n-butyl, ethyl alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.2.
The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula: acyclovir-01
💬 Information for Patients ▾
Information for Patients Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered acyclovir, or they have any other questions. Patients should be advised to maintain adequate hydration. Herpes Zoster There are no data on treatment initiated more than 72 hours after onset of the zoster rash.
Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Genital Herpes Infections Patients should be informed that acyclovir is not a cure for genital herpes. There are no data evaluating whether acyclovir will prevent transmission of infection to others.
Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.
Chickenpox Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course.