Zovirax 5% Ointment 30gm
It is used to treat genital warts.It is used to treat shingles or certain other herpes infections.
Drug Class
Antiviral
Pharmacologic Class
Synthetic nucleoside analog
Pregnancy Category
Category B
FDA Approved
Mar 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acyclovir ointment is an antiviral medicine used to treat cold sores (herpes labialis) and genital herpes lesions. It works by stopping the herpes virus from growing and spreading, which helps the sores heal faster and reduces pain.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Clean the affected area before application and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
To prevent the spread of infection, consider wearing a rubber glove when applying the ointment.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Clean the affected area before application and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
To prevent the spread of infection, consider wearing a rubber glove when applying the ointment.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the ointment.
- Avoid touching or scratching the lesions to prevent spreading the virus to other parts of your body or to other people.
- Do not share personal items (e.g., towels, razors) with others.
- Avoid sexual contact when genital herpes lesions are present to prevent transmission.
- Keep the affected area clean and dry.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply sufficient quantity to adequately cover all lesions 5 times daily for 4 days.
Condition-Specific Dosing:
herpesLabialis:
Apply to lesions or impending lesions 5 times daily for 4 days.
genitalHerpes:
Apply to lesions 5 times daily for 4 days.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in neonates for topical ointment).
Infant:
Not established (safety and efficacy not established in infants for topical ointment).
Child:
Apply to lesions 5 times daily for 4 days (safety and efficacy established in children 12 years of age and older).
Adolescent:
Apply to lesions 5 times daily for 4 days.
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
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 synthesis by competitive inhibition of viral DNA polymerase, incorporation into and termination of the growing viral DNA chain, and inactivation of the viral DNA polymerase.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 0.5% (systemic absorption from topical application is minimal).
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:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Not applicable (minimal systemic absorption).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Symptom relief and lesion healing may begin within 1-2 days.
PeakEffect:
Optimal healing typically observed by end of 4-day treatment.
DurationOfAction:
Effect persists as long as applied, contributing to healing during treatment period.
Safety & Warnings
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 immediately or seek emergency medical attention:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or 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 if you experience any of the following side effects or if they persist or bother you:
- Skin irritation
- Burning or stinging
- Itching
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or 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 if you experience any of the following side effects or if they persist or bother you:
- Skin irritation
- Burning or stinging
- Itching
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or itching at the application site that does not go away.
- Development of a new rash or worsening of existing skin irritation.
- Signs of a severe allergic reaction such as swelling of the face, lips, tongue, or throat; difficulty breathing; or severe dizziness (seek immediate medical attention).
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with them.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with them.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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, be aware 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 note that genital herpes can be spread even when no symptoms are present. To reduce this risk, use a latex or polyurethane condom during sexual activity and consult with your doctor for further 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.
This medication does not cure herpes infections; discuss this with your doctor to understand its limitations. If you have genital herpes, be aware 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 note that genital herpes can be spread even when no symptoms are present. To reduce this risk, use a latex or polyurethane condom during sexual activity and consult with your doctor for further 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.
Overdose Information
Overdose Symptoms:
- Overdose with topical acyclovir ointment is highly unlikely due to minimal systemic absorption. Ingesting large amounts could theoretically lead to nausea, vomiting, headache, or confusion, but this is rare.
What to Do:
If accidental ingestion occurs, contact a poison control center or seek medical attention. For topical overdose, simply wipe off excess ointment. Call 1-800-222-1222
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of lesion type and extent
Rationale: To confirm diagnosis and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Lesion healing and resolution of symptoms (e.g., pain, itching)
Frequency: Daily during treatment
Target: Progressive reduction in lesion size, crusting, and healing; decrease in discomfort.
Action Threshold: Lack of improvement or worsening of lesions after 4 days may indicate resistance or alternative diagnosis.
Local adverse reactions (e.g., burning, stinging, itching, rash)
Frequency: Daily during treatment
Target: Absence or mild, transient reactions.
Action Threshold: Severe or persistent local reactions warrant discontinuation.
Symptom Monitoring
- Burning sensation at application site
- Stinging sensation at application site
- Itching
- Rash
- Dryness or flaking of skin
- Pain or discomfort from lesions
Special Patient Groups
Pregnancy
Acyclovir is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Systemic absorption from topical application is minimal, suggesting a low risk.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Acyclovir is excreted in human milk following systemic administration. However, systemic absorption from topical acyclovir ointment is minimal, making infant exposure via breast milk unlikely to be clinically significant. Considered L2 (likely compatible).
Infant Risk:
Low risk. Monitor infant for any unusual symptoms, though unlikely.
Pediatric Use
Safety and efficacy in pediatric patients under 12 years of age have not been established for topical acyclovir ointment. For children 12 years and older, dosing is similar to adults. Use with caution and under medical supervision in younger children.
Geriatric Use
No specific dosage adjustments are required for elderly patients using topical acyclovir ointment due to minimal systemic absorption. However, elderly patients may have more fragile skin, so monitor for local irritation.
Clinical Information
Clinical Pearls
- Acyclovir ointment is most effective when applied at the first sign of a cold sore or genital herpes lesion (e.g., tingling, itching, redness).
- It is not a cure for herpes, but it can help reduce the duration and severity of outbreaks.
- Ensure the ointment covers the entire lesion area adequately.
- Do not apply to mucous membranes (e.g., inside the mouth or nose, eyes) as it is formulated for external skin lesions.
- If lesions do not improve after 4 days of treatment, or if they worsen, consult a healthcare provider.
Alternative Therapies
- Penciclovir cream (Denavir)
- Docosanol cream (Abreva) - for cold sores only
- Oral antiviral medications (e.g., acyclovir, valacyclovir, famciclovir) for more severe or frequent outbreaks.
Cost & Coverage
Average Cost:
$30 - $100 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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 information. 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 details about the medication taken, the amount, and the time it happened.