Zovirax 5% Ointment 15gm

Manufacturer QUALITY Active Ingredient Acyclovir Ointment(ay SYE kloe veer) Pronunciation ay SYE kloe veer
It is used to treat genital warts.It is used to treat shingles or certain other herpes infections.
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Drug Class
Antiviral
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Pharmacologic Class
Synthetic nucleoside analog
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Pregnancy Category
Category B
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FDA Approved
Mar 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Zovirax Ointment is an antiviral medicine applied to the skin to treat cold sores (herpes labialis) and genital herpes. It works by stopping the herpes virus from growing and spreading, helping the sores heal faster.
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How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.

Applying the Medication

This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.

Before applying the medication, wash your hands thoroughly. Clean the affected area of your skin and dry it well. Apply a thin layer of the medication to the affected area and gently rub it in.

To prevent the spread of infection, consider wearing a rubber glove when applying the ointment.

Storing and Disposing of Your Medication

Store the medication at room temperature, away from heat sources. Do not freeze the medication. Keep all medications in a safe and secure location, out of the reach of children and pets.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the ointment.
  • Avoid touching or rubbing the lesions to prevent spreading the virus to other body parts or to other people.
  • Do not share personal items (e.g., towels, lip balm) with others.
  • Apply the ointment with a finger cot or rubber glove to avoid self-contamination.
  • Keep the affected area clean and dry.
  • Avoid sexual contact when genital herpes lesions are present.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 days.

Condition-Specific Dosing:

herpesLabialis: Apply to lesions or impending lesions 5 times daily for 4 days.
genitalHerpes: Apply to lesions or impending lesions 6 times daily for 7 days.
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Pediatric Dosing

Neonatal: Not established (use with caution, consult specialist)
Infant: Not established (use with caution, consult specialist)
Child: Apply to adequately cover all lesions every 3 hours, 6 times daily for 7 days (for children â‰Ĩ12 years, follow adult dosing; for younger children, consult physician).
Adolescent: Apply to adequately cover all lesions every 3 hours, 6 times daily for 7 days.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No adjustment needed (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). Acyclovir is phosphorylated to its active triphosphate form by viral thymidine kinase, which then inhibits viral DNA polymerase, leading to chain termination and inhibition of viral DNA replication.
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Pharmacokinetics

Absorption:

Bioavailability: <0.02% (systemic after topical application)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Renal (if systemically absorbed)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Within 24-48 hours (clinical improvement)
PeakEffect: Not applicable (local effect)
DurationOfAction: Duration of treatment (7 days)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
- Skin irritation
- Burning or stinging
- Itching

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning, stinging, or itching at the application site
  • Rash or hives developing after application
  • Signs of worsening infection (e.g., increased redness, swelling, pus, fever)
  • No improvement in lesions after 7 days of treatment
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all prescription and over-the-counter (OTC) medications, natural products, and vitamins you are taking to your doctor and pharmacist.
All your health problems, as this medication may affect or be affected by other conditions.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so with this medication.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.

This medication does not cure herpes infections; discuss this with your doctor to understand its limitations. If you have genital herpes, note that this drug will not prevent the spread of the infection. To minimize the risk of transmission, avoid any sexual activity when you have sores or other symptoms of genital herpes. It is also important to be aware that genital herpes can be spread even when no symptoms are present. Always use a latex or polyurethane condom during sexual activity and consult with your doctor for guidance.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion of the ointment may cause mild gastrointestinal upset.

What to Do:

If accidental ingestion occurs, contact a poison control center or seek medical attention. For severe local reactions, discontinue use and wash the area. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of lesions

Rationale: To establish baseline severity and extent of infection.

Timing: Prior to initiation of treatment

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Routine Monitoring

Resolution of lesions

Frequency: Daily

Target: Healing, crusting, resolution

Action Threshold: Lack of improvement or worsening after 7 days of treatment

Local skin reactions (e.g., burning, stinging, itching, rash)

Frequency: Daily

Target: Minimal to none

Action Threshold: Severe or persistent irritation, allergic reaction

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Symptom Monitoring

  • Pain at lesion site
  • Itching
  • Burning
  • Stinging
  • Redness
  • Swelling
  • Blister formation
  • Crusting
  • Signs of secondary bacterial infection (e.g., pus, increased pain, fever)

Special Patient Groups

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Pregnancy

Acyclovir is generally considered safe for use during pregnancy, especially topical formulations due to minimal systemic absorption. Category B.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Acyclovir is excreted in breast milk after systemic administration, but levels are low. Due to minimal systemic absorption from topical application, the risk to a nursing infant is considered very low. L2 (likely compatible).

Infant Risk: Very low risk.
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Pediatric Use

Safe for use in children, though specific dosing for very young children should be determined by a physician. Ensure proper application and prevent accidental ingestion.

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Geriatric Use

No specific dose adjustments are required for elderly patients, as systemic absorption is minimal. Use with caution if skin integrity is compromised.

Clinical Information

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Clinical Pearls

  • Zovirax Ointment is for external use only; do not use in the eyes, mouth, or nose.
  • Start treatment as soon as possible after the first signs or symptoms of an outbreak (e.g., tingling, itching, redness) for best results.
  • The ointment does not prevent the spread of herpes virus to others or cure herpes infection.
  • Complete the full 7-day course of treatment, even if lesions appear to be healing sooner.
  • If lesions do not improve or worsen after 7 days, or if signs of bacterial superinfection occur, consult a healthcare provider.
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Alternative Therapies

  • Penciclovir cream (Denavir)
  • Docosanol cream (Abreva)
  • Oral acyclovir (Zovirax tablets/capsules)
  • Oral valacyclovir (Valtrex)
  • Oral famciclovir (Famvir)
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Cost & Coverage

Average Cost: $30 - $100 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.