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Valacyclovir 1 g Tablet, Film Coated, 30-count

by NuCare Pharmaceuticals,Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (68071-4805-3)
NDC 68071-4805-03
🏷️ FDA NDC (as labeled) 68071-4805-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.4291/unit — full pricing hub ↓
Also comes in: 60 tablets 68071-4805-06 90 tablets 68071-4805-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68071-4805-3
Product NDC 68071-4805
11-digit billing NDC 68071480503
RxCUI 313564
UNII G447S0T1VC
UPC 0368071480535
Application # ANDA203047
SPL Set ID 84601168-8829-f4a3-e053-2991aa0a3c20
Established class (EPC) Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor; Nucleoside Analog [
Mechanism of action DNA Polymerase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-25
Route ORAL
Dosage form TABLET, FILM COATED
Substance VALACYCLOVIR HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68071-4805-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68071-4805-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors
How it works DNA Polymerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA203047 (ANDA)
Labeler code68071
First marketedMay 2015
Product typeHuman Prescription Drug
Portfolio1,015 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Valacyclovir is used to treat certain viral infections including: herpes labialis (cold sores) varicella infections including herpes zoster (shingles) and chicken pox genital herpes (a sexually transmitted infection) It is in a class of medications called antivirals. It works by stopping the spread of the herpes virus in the body. Valacyclovir helps treat and control outbreaks of genital herpes but should be used with safe sexual practices. Valacyclovir will not cure genital herpes.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Unfortunately, no — valacyclovir controls the virus but doesn't eliminate it from your body. The herpes virus stays dormant in your nerve cells after the infection. What valacyclov...
  • Can valacyclovir cure my herpes infection for good?
  • The sooner the better — really. For cold sores, you should start at the very first tingle, itch, or burning sensation, before a blister even forms. For genital herpes outbreaks, st...
  • When should I start taking it during an outbreak?
📖 Read our full Valacyclovir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeCapsule
ImprintI;87
Size23 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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 $0.4291 $12.87 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Valacyclovir Hydrochloride 1 g 00378-4276-77 Mylan 90 tablets $0.405 AB Availability likely —
Valacyclovir Hydrochloride 1 g 50268-0789-15 AvPAK 1 tablet $0.405 AB Availability likely —
Valacyclovir 1 g 62135-0614-30 Chartwell 30 tablets $0.405 AB Availability likely —
Valacyclovir Hydrochloride 1 g 68084-0309-21 American 1 tablet $0.405 AB Availability likely —
Valacyclovir 1000 mg 69367-0263-09 Westminster 90 tablets $0.405 AB Availability likely —
Valacyclovir 1 g 82009-0041-90 Quallent 90 tablets $0.405 AB Availability likely —
Valacyclovir Hydrochloride 1 g 16714-0697-01 NorthStar 30 tablets $0.506 AB Discontinued —
Valtrex 1 g 00173-0565-04 GlaxoSmithKline 30 tablets $20.244 AB Availability likely —
Valacyclovir 1 g 31722-0705-01 Camber 100 tablets — AB FDA listed —
Valacyclovir 1 g 43063-0771-06 PD-Rx 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 49483-0691-01 TIME 100 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 50090-1173-00 A-S 15 tablets — AB FDA listed —
Valacyclovir 1 g 50090-2575-00 A-S 15 tablets — AB FDA listed —
Valacyclovir 1000 mg 50090-7270-00 A-S 15 tablets — AB FDA listed —
Valacyclovir 1000 mg 50090-7484-00 A-S 21 tablets — AB FDA listed —
Valacyclovir 1 g 51407-0108-30 Golden 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 51655-0703-21 Northwind 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 57237-0043-05 Rising 500 tablets — AB FDA listed —
valacyclovir hydrochloride 1 g 59746-0325-01 Jubilant 100 tablets — AB FDA listed —
Valacyclovir 1 g 60760-0469-42 St 42 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 60760-0757-42 St. 42 tablets — AB FDA listed —
valacyclovir hydrochloride 1 g 63187-0538-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 63187-0776-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir 1 g 63187-0950-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir 1 g 63304-0905-03 SUN 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 65862-0449-01 Aurobindo 100 tablets — AB FDA listed —
Valacyclovir 1 g 67046-1347-03 Coupler 30 tablets — AB FDA listed —
Valacyclovir 1 g 67296-1297-01 RedPharm 21 tablets — AB Discontinued —
Valacyclovir 1000 mg 67296-2146-01 Redpharm 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68071-1548-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir 1000 mg 68071-3624-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68071-4727-02 NuCare 2 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68071-4728-01 NuCare 21 tablets — AB FDA listed —
Valacyclovir 1 gthis 68071-4805-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir 1 g 68788-7587-00 Preferred 6 tablets — AB FDA listed —
Valacyclovir 1000 mg 68788-8705-00 Preferred 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68788-8820-00 Preferred 6 tablets — AB FDA listed —
Valacyclovir 1 g 69117-0011-01 Yiling 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 70518-0541-01 REMEDYREPACK 14 tablets — AB FDA listed —
Valtrex 1 g 70518-2039-01 REMEDYREPACK 14 tablets — AB FDA listed —
Valacyclovir 1 g 70518-2402-01 REMEDYREPACK 4 tablets — AB Discontinued —
Valacyclovir Hydrochloride 1 g 70518-3359-00 REMEDYREPACK 4 tablets — AB Discontinued —
Valacyclovir 1000 mg 70518-4100-00 REMEDYREPACK 30 tablets — AB FDA listed —
Valacyclovir 1 g 71335-0630-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 71335-1862-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir 1000 mg 71335-2534-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir 1000 mg 72189-0594-04 Direct 4 tablets — AB FDA listed —
Valacyclovir 1 g 72789-0452-21 PD-Rx 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 76420-0600-02 Asclemed 2 tablets — AB FDA listed —
Valacyclovir 1000 mg 82804-0006-06 Proficient 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 82804-0093-10 Proficient 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 82868-0106-21 Northwind 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 85766-0026-01 Sportpharm 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
May 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Valacyclovir — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Valacyclovir. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$28.02M
Claims incl. refills
952.8K
Beneficiaries
727.1K
Spend / beneficiary
$38.54
Spend / claim
$29.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Valacyclovir — the ingredient across all brands.

Top reported reactions

Fatigue4,317
Nausea3,985
Diarrhoea3,648
Headache2,964
Pyrexia2,753
Pain2,709
Pneumonia2,436

Age at onset

Neonate88
Infant20
Child78
Adolescent127
Adult6,940
Elderly6,504

Reporter sex

70,056 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization26,094
Life-threatening3,284
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 6,514 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68071-4805-01 90 TABLET, FILM COATED in 1 BOTTLE (68071-4805-1) 2019-03-18 Active
68071-4805-03 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (68071-4805-3) 2026-04-14 Active
68071-4805-06 60 TABLET, FILM COATED in 1 BOTTLE (68071-4805-6) 2019-03-18 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68071-4805-03?
NDC 68071-4805-03 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 68071-4805-03 and NDC 68071-4805-06?
Both are Valacyclovir 1 g Tablet, Film Coated — the drug itself is identical. NDC 68071-4805-03 is the 30-count package, while NDC 68071-4805-06 is the 60 tablets package.
What NDC number is used to bill for this package of Valacyclovir 1 g Tablet, Film Coated?
Bill NDC 68071-4805-03 — the 11-digit billing format is 68071480503. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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 — Not published for this NDC No photo available yet for this listing.
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68071-4805-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68071-4805-03, written without dashes as 68071480503. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68071-4805-03, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (4805) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (68071-4805-06), 90 tablets (68071-4805-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NuCare Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS & USAGE Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-infected patients • Reduction of transmission • Herpes Zoster Pediatric Patients (1.2) • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use (1.3) • The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.

1.1Adult patients Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults.

The efficacy of treatment with valacyclovir tablets, USP when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 24 hours after the onset of signs and symptoms has not been established.

Suppressive Therapy: Valacyclovir tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults. The efficacy and safety of valacyclovir tablets, USP for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-infected patients have not been established. Reduction of Transmission: Valacyclovir tablets, USP are indicated for the reduction of transmission of genital herpes in immunocompetent adults.

The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines ).

Herpes Zoster: Valacyclovir tablets, USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets, USP when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets, USP for treatment of disseminated herpes zoster have not been established.

1.2Pediatric Patients Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age. The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox: Valacyclovir tablets, USP are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age.

Based on efficacy data from clinical studies with oral acyclovir, treatment with valacyclovir tablets, USP should be initiated within 24 hours after the onset of rash [see Clinical Studies (14.4)].

1.3Limitations of Use The efficacy and safety of valacyclovir tablets, USP have not been established in: • Immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients with a CD4+ cell count ≥100 cells/mm 3 . • Patients <12 years of age with cold sores (herpes labialis). • Patients <2 years of age or ≥18 years of…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION • Valacyclovir tablets, USP may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets, USP for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3)]. Adult Dosage (2.1) Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients 1 gram once daily Alternate dose in patients with ≤9 recurrnces/yr 500 mg once daily HIV-infected patients 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage (2.2) Cold Sores (≥12 years of age) 2 grams every 12 hours for 1 day Chickenpox (2 to <18 years of age) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets, USP.

(2.3)

2.1Adult Dosing Recommendations Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir tablets, USP for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Genital Herpes: Initial Episode: The recommended dosage of valacyclovir tablets, USP for treatment of initial genital herpes is 1 gram twice daily for 10 days.

Therapy was most effective when administered within 48 hours of the onset of signs and symptoms. Recurrent Episodes: The recommended dosage of valacyclovir tablets, USP for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.

Suppressive Therapy: The recommended dosage of valacyclovir tablets, USP for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily. In HIV-infected patients with a CD4+ cell count ≥100 cells/mm 3 , the recommended dosage of valacyclovir tablets, USP for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Reduction of Transmission: The recommended dosage of valacyclovir tablets, USP for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner. Herpes Zoster: The recommended dosage of valacyclovir tablets, USP for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.

2.2Pediatric Dosing Recommendations Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir tablets, USP for the treatment of cold sores in pediatric patients ≥12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Chickenpox: The recommended dosage of valacyclovir tablets, USP for treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age is 20 mg/kg administered 3 times daily for 5 days.

The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

2.3Extemporaneous Preparation of Oral Suspension Ingredients and Preparation per USP-NF: valacyclovir tablets, USP 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL. Prepare Suspension at Time of Dispensing as Follows: • Prepare SSV according to the USP-NF…

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS & STRENGTHS Tablets: • 500 mg: blue, film-coated, capsule shaped tablets, debossed with 'I' on one side and '86' on other side. • 1 gm: white to off-white, film-coated, capsule shaped tablets, debossed with 'I' on one side and '86' on other side with partial scorebar on both sides. Tablets: 500 mg (unscored), 1gm (partially scored) (3)

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS Valacyclovir hydrochloride tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)]. Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation.(4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of valacyclovir hydrochloride in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. (5.1) • Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher than recommended doses of valacyclovir hydrochloride for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients.

Use with caution in elderly patients and reduce dosage in patients with renal impairment. (2.4,5.2) •Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy): May occur in both adult and pediatric patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher than recommended doses of valacyclovir hydrochloride for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions.

Use with caution in elderly patients and reduce dosage in patients with renal impairment. (2.4, 5.3)

5.1Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS) TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir hydrochloride at doses of 8 grams per day. Treatment with valacyclovir hydrochloride should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.

5.2Acute Renal Failure Cases of acute renal failure have been reported in: • Elderly patients with or without reduced renal function. Caution should be exercised when administering valacyclovir hydrochloride to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)]. • Patients with underlying renal disease who received higher than recommended doses of valacyclovir hydrochloride for their level of renal function.

Dosage reduction is recommended when administering valacyclovir hydrochloride to patients with renal impairment [see Dosage and Administration (2.4), Use in Specific Populations (8.6)]. • Patients receiving other nephrotoxic drugs. Caution should be exercised when administering valacyclovir hydrochloride to patients receiving potentially nephrotoxic drugs. • Patients without adequate hydration. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid.

Adequate hydration should be maintained for all patients. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)].

5.3Central Nervous System Effects Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher than recommended doses of valacyclovir hydrochloride for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Valacyclovir hydrochloride should be discontinued if central nervous system adverse reactions occur [see Adverse Reactions (6.3), Use in Specific Populations (8.5, 8.6)].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1)]. • Acute Renal Failure [see Warnings and Precautions (5.2)]. • Central Nervous System Effects [see Warnings and Precautions (5.3)]. The most common adverse reactions reported in at least 1 indication by >10% of adult patients treated with valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride compared to placebo are headache, nausea, and abdominal pain.

The only adverse reaction reported in >10% of pediatric patients <18 years of age was headache. • The most common adverse reactions reported in at least one indication by >10% of adult patients treated with valacyclovir hydrochloride and more commonly than in patients treated with placebo are headache, nausea, and abdominal pain. (6.1) • The only adverse reaction occurring in >10% of pediatric patients <18 years of age was headache.(6.2) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

6.1Clinical Trials Experience in Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Cold Sores (Herpes Labialis): In clinical studies for the treatment of cold sores, the adverse reactions reported by patients receiving valacyclovir hydrochloride 2 grams twice daily (n = 609) or placebo (n = 609) for 1 day, respectively, included headache (14%, 10%) and dizziness (2%, 1%).

The frequencies of abnormal ALT (>2 x ULN) were 1.8% for patients receiving valacyclovir hydrochloride compared with 0.8% for placebo. Other laboratory abnormalities (hemoglobin, white blood cells, alkaline phosphatase, and serum creatinine) occurred with similar frequencies in the 2 groups. Genital Herpes: Initial Episode: In a clinical study for the treatment of initial episodes of genital herpes, the adverse reactions reported by ≥5% of patients receiving valacyclovir hydrochloride 1 gram twice daily for 10 days (n = 318) or oral acyclovir 200 mg 5 times daily for 10 days (n = 318), respectively, included headache (13%, 10%) and nausea (6%, 6%).

For the incidence of laboratory abnormalities see Table 2. Recurrent Episodes: In 3 clinical studies for the episodic treatment of recurrent genital herpes, the adverse reactions reported by ≥5% of patients receiving valacyclovir hydrochloride 500 mg twice daily for 3 days (n = 402), valacyclovir hydrochloride 500 mg twice daily for 5 days (n = 1,136) or placebo (n = 259), respectively, included headache (16%, 11%, 14%) and nausea (5%, 4%, 5%). For the incidence of laboratory abnormalities see Table 2.

Suppressive Therapy: Suppression of Recurrent Genital Herpes in Immunocompetent Adults: In a clinical study for the suppression of recurrent genital herpes infections, the adverse reactions reported by patients receiving valacyclovir hydrochloride 1 gram once daily (n = 269), valacyclovir hydrochloride 500 mg once daily (n = 266), or placebo (n = 134), respectively, included headache (35%, 38%, 34%), nausea (11%, 11%, 8%), abdominal pain (11%, 9%, 6%), dysmenorrhea (8%, 5%, 4%), depression (7%, 5%, 5%), arthralgia (6%, 5%, 4%), vomiting (3%, 3%, 2%), and dizziness (4%, 2%, 1%).

For the incidence of laboratory abnormalities see Table 2. Suppression of Recurrent Genital Herpes in HIV-Infected Patients: In HIV-infected patients, frequently reported adverse reactions for valacyclovir hydrochloride (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13%, 8%),…

🔄 Drug Interactions 19 words ▾

7 DRUG INTERACTIONS No clinically significant drug-drug or drug-food interactions with valacyclovir hydrochloride are known [see Clinical Pharmacology (12.3)].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy: Teratogenic Effects pregnancy Category B. There are no adequate and well-controlled studies of valacyclovir hydrochloride or acyclovir in pregnant women. Based on prospective pregnancy registry data on 749 pregnancies, the overall rate of birth defects in infants exposed to acyclovir in-utero appears similar to the rate for infants in the general population.

Valacyclovir hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. Animal reproduction studies performed at oral doses that provided up to 10 and 7 times the human plasma levels during the period of major organogenesis in rats and rabbits, respectively, revealed no evidence of teratogenicity.

8.3Nursing Mothers Following oral administration of a 500 mg dose of valacyclovir hydrochloride to 5 nursing mothers, peak acyclovir concentrations (C max ) in breast milk ranged from 0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum concentrations. The acyclovir breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal serum AUC. A 500 mg maternal dosage of valacyclovir hydrochloride twice daily would provide a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day.

This would result in less than 2% of the exposure obtained after administration of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir to the nursing infant. Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Caution should be exercised when valacyclovir hydrochloride is administered to a nursing woman.

8.4Pediatric Use Valacyclovir hydrochloride is indicated for treatment of cold sores in pediatric patients ≥12 years of age and for treatment of chickenpox in pediatric patients 2 to <18 years of age [see Indications and Usage(1.2, Dosage and Administration (2.2)]. The use of valacyclovir hydrochloride for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents (≥12 years of age) with a history of recurrent cold sores [see Clinical Studies (14.1)]. The use of valacyclovir hydrochloride for treatment of chickenpox in pediatric patients 2 to <18 years of age is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by efficacy and safety data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox [see Dosage and Administration (2.2), Adverse Reactions (6.2), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

The efficacy and safety of valacyclovir have not been established in pediatric patients: • <12 years of age with cold sores • <18 years of age with genital herpes • <18 years of age with herpes zoster • <2 years of age with chickenpox • for suppressive therapy following neonatal HSV infection. The pharmacokinetic profile and safety of valacyclovir oral suspension in children <12 years of age were studied in 3 open-label studies. No efficacy evaluations were conducted in any of the 3 studies.

Study 1 was a single-dose pharmacokinetic, multiple-dose safety study in 27 pediatric patients 1 to <12 years of age with clinically suspected varicella-zoster virus (VZV) infection [see Dosage and Administration (2.2), Adverse Reactions (6.2),…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Valacyclovir hydrochloride is indicated for treatment of cold sores in pediatric patients ≥12 years of age and for treatment of chickenpox in pediatric patients 2 to <18 years of age [see Indications and Usage(1.2, Dosage and Administration (2.2)]. The use of valacyclovir hydrochloride for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents (≥12 years of age) with a history of recurrent cold sores [see Clinical Studies (14.1)]. The use of valacyclovir hydrochloride for treatment of chickenpox in pediatric patients 2 to <18 years of age is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by efficacy and safety data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox [see Dosage and Administration (2.2), Adverse Reactions (6.2), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

The efficacy and safety of valacyclovir have not been established in pediatric patients: • <12 years of age with cold sores • <18 years of age with genital herpes • <18 years of age with herpes zoster • <2 years of age with chickenpox • for suppressive therapy following neonatal HSV infection. The pharmacokinetic profile and safety of valacyclovir oral suspension in children <12 years of age were studied in 3 open-label studies. No efficacy evaluations were conducted in any of the 3 studies.

Study 1 was a single-dose pharmacokinetic, multiple-dose safety study in 27 pediatric patients 1 to <12 years of age with clinically suspected varicella-zoster virus (VZV) infection [see Dosage and Administration (2.2), Adverse Reactions (6.2), Clinical Pharmacology (12.3), Clinical Studies (14.4)]. Study 2 was a single-dose pharmacokinetic and safety study in pediatric patients 1 month to <6 years of age who had an active herpes virus infection or who were at risk for herpes virus infection. Fifty-seven subjects were enrolled and received a single dose of 25 mg/kg valacyclovir oral suspension.

In infants and children 3 months to <6 years of age, this dose provided comparable systemic acyclovir exposures to that from a 1 gram dose of valacyclovir in adults (historical data). In infants 1 month to <3 months of age, mean acyclovir exposures resulting from a 25 mg/kg dose were higher (Cmax: ↑30%, AUC: ↑60%) than acyclovir exposures following a 1 gram dose of valacyclovir in adults. Acyclovir is not approved for suppressive therapy in infants and children following neonatal HSV infections; therefore valacyclovir is not recommended for this indication because efficacy cannot be extrapolated from acyclovir.

Study 3 was a single-dose pharmacokinetic, multiple-dose safety study in 28 pediatric patients 1 to <12 years of age with clinically suspected HSV infection. None of the children enrolled in this study had genital herpes. Each subject was dosed with valacyclovir oral suspension, 10 mg/kg twice daily for 3 to 5 days.

Acyclovir systemic exposures in pediatric patients following valacyclovir oral suspension were compared with historical acyclovir systemic exposures in immunocompetent adults receiving the solid oral dosage form of valacyclovir or acyclovir for the treatment of recurrent genital herpes. The mean projected daily acyclovir systemic exposures in pediatric patients across all age-groups (1 to <12 years of age) were lower (Cmax: ↓20%, AUC: ↓33%) compared with the acyclovir systemic exposures in adults receiving valacyclovir 500 mg twice daily, but were higher (daily AUC: ↑16%) than systemic exposures in adults receiving acyclovir 200 mg 5 times daily.

Insufficient data are available to support valacyclovir for the treatment of recurrent genital herpes in this age-group because clinical information on recurrent genital herpes in young children is limited; therefore, extrapolating efficacy data from adults to this population is not…

🧓 Geriatric Use 92 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of valacyclovir hydrochloride, 906 were 65 and over, and 352 were 75 and over. In a clinical study of herpes zoster, the duration of pain after healing (post-herpetic neuralgia) was longer in patients 65 and older compared with younger adults. 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 [see Dosage and Administration (2.4), Warnings and Precautions (5.2, 5.3), Clinical Pharmacology (12.3)].

🆘 Overdosage 59 words ▾

10 OVERDOSAGE Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5), (8.6)]. Precipitation of acyclovir in renal tubules may occur when the solubility(2.5 mg/mL)is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4)].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Valacyclovir is an antiviral drug [see Clinical Pharmacology (12.4)].

12.3Pharmacokinetics The pharmacokinetics of valacyclovir and acyclovir after oral administration of valacyclovir hydrochloride have been investigated in 14 volunteer studies involving 283 adults and in 3 studies involving 112 pediatric subjects from 1 month to <12 years of age. Pharmacokinetics in Adults: Absorption and Bioavailability: After oral administration, valacyclovir hydrochloride is rapidly absorbed from the gastrointestinal tract and nearly completely converted to acyclovir and L- valine by first-pass intestinal and/or hepatic metabolism.

The absolute bioavailability of acyclovir after administration of valacyclovir hydrochloride is 54.5% ± 9.1% as determined following a 1 gram oral dose of valacyclovir hydrochloride and a 350 mg intravenous acyclovir dose to 12 healthy volunteers. Acyclovir bioavailability from the administration of valacyclovir hydrochloride is not altered by administration with food(30 minutes after an 873 Kcal breakfast, which included 51 grams of fat). Acyclovir pharmacokinetic parameter estimates following administration of valacyclovir hydrochloride to healthy adult volunteers are presented in Table 3.

There was a less than dose-proportional increase in acyclovir maximum concentration (C max ) and area under the acyclovir concentration-time curve (AUC) after single-dose and multiple-dose administration (4 times daily) of valacyclovir hydrochloride from doses between 250 mg to 1 gram. There is no accumulation of acyclovir after the administration of valacyclovir at the recommended dosage regimens in adults with normal renal function. Table 3.

Mean (±SD) Plasma Acyclovir Pharmacokinetic Parameters Following Administration of Valacyclovir Hydrochloride to Healthy Adult Volunteers Dose Single-Dose Administration (N = 8) Multiple-Dose Administration a (N = 24, 8 per treatment arm) C max (±SD) (mcg/mL) AUC (±SD) (hr●mcg/mL) C max (±SD) (mcg/mL) AUC (±SD) (hr●mcg/mL) 100 mg 0.83 (±0.14) 2.28 (±0.40) ND ND 250 mg 2.15 (±0.50) 5.76 (±0.60) 2.11 (±0.33) 5.66 (±1.09) 500 mg 3.28 (±0.83) 11.59 (±1.79) 3.69 (±0.87) 9.88 (±2.01) 750 mg 4.17 (±1.14) 14.11 (±3.54) ND ND 1,000 mg 5.65 (±2.37) 19.52 (±6.04) 4.96 (±0.64) 15.70 (±2.27) a Administered 4 times daily for 11 days.

ND = not done. Distribution: The binding of valacyclovir to human plasma proteins ranges from 13.5% to 17.9%. The binding of acyclovir to human plasma proteins ranges from 9% to 33%.

Metabolism: Valacyclovir is converted to acyclovir and L-valine by first-pass intestinal and/or hepatic metabolism. Acyclovir is converted to a small extent to inactive metabolites by aldehyde oxidase and by alcohol and aldehyde dehydrogenase. Neither valacyclovir nor acyclovir is metabolized by cytochrome P450 enzymes.

Plasma concentrations of unconverted valacyclovir are low and transient, generally becoming non-quantifiable by 3 hours after administration. Peak plasma valacyclovir concentrations are generally less than 0.5 mcg/mL at all doses. After single-dose administration of 1 gram of valacyclovir hydrochloride, average plasma valacyclovir concentrations observed were 0.5, 0.4, and 0.8 mcg/mL in patients with hepatic dysfunction, renal insufficiency, and in healthy volunteers who received concomitant cimetidine and probenecid, respectively.

Elimination: The pharmacokinetic disposition of acyclovir delivered by valacyclovir is consistent with previous experience from intravenous and oral acyclovir. Following the oral administration of a single 1 gram dose of radiolabeled valacyclovir to 4 healthy subjects, 46% and 47% of administered radioactivity was recovered in urine and feces, respectively, over 96 hours. Acyclovir accounted for 89% of the radioactivity excreted in the urine.

Renal clearance of acyclovir following the administration of a single 1 gram dose of valacyclovir hydrochloride to 12 healthy volunteers was approximately 25…

🧬 Mechanism of Action 13 words ▾

12.1Mechanism of Action Valacyclovir is an antiviral drug [see Clinical Pharmacology (12.4)].

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Valacyclovir Tablets USP, 1 gm are white to off-white, film-coated, capsule shaped tablets, debossed with I on one side and 87 on other side with partial scorebar on both sides. They are supplied in NDC 68071-4805-6 BOTTLES OF 6 NDC 68071-4805-3 BOTTLES OF 30 NDC 68071-4805-1 BOTTLES OF 21 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP.

📋 Description 154 words ▾

11 DESCRIPTION Valacyclovir hydrochloride is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.

In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L -valine2-[(2-amino-1,6-dihydro-6-oxo-9 H -purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula: Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13 H 23 N 6 O 5 Cl and a molecular weight of 378.81.

Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2.

Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling.

17.1Importance of Adequate Hydration Patients should be advised to maintain adequate hydration.

17.2Cold Sores (Herpes Labialis) Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). Patients should be instructed that treatment for cold sores should not exceed 1 day (2 doses) and that their doses should be taken about 12 hours apart.

Patients should be informed that valacyclovir hydrochloride is not a cure for cold sores.

17.3Genital Herpes Patients should be informed that valacyclovir hydrochloride is not a cure for genital herpes. 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 is frequently transmitted in the absence of symptoms through asymptomatic viral shedding.

Therefore, patients should be counseled to use safer sex practices in combination with suppressive therapy with valacyclovir hydrochloride. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists.

Valacyclovir hydrochloride has not been shown to reduce transmission of sexually transmitted infections other than HSV-2. 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. There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode.

There are no data on the safety or effectiveness of chronic suppressive therapy of more than 1 year's duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months' duration in HIV-infected patients.

17.4Herpes 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.

17.5Chickenpox Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox. Manufactured for: Camber Pharmaceuticals,Inc. Piscataway, NJ 08854 Manufactured by: HETERO TM HETERO LABS LIMITED Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India Structure2 Structure1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68071-4803-03 · NuCare 68071-4808-03 · NuCare →
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