Acyclovir 5% Ointment 5gm
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. It works by stopping the growth of the virus that causes these infections, helping the sores heal faster and reducing 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 the lesions unnecessarily to prevent spreading the virus to other body parts or to other people.
- Do not share the ointment with others.
- Avoid sexual contact when lesions are present to prevent transmission of genital herpes.
- Keep the affected area clean and dry.
Available Forms & Alternatives
Available Strengths:
- Acyclovir 200mg/5ml Oral Susp
- Acyclovir 200mg Capsules
- Acyclovir 400mg Tablets
- Acyclovir 800mg Tablets
- Acyclovir Sodium 50mg/ml Inj, 20ml
- Acyclovir 800mg Tablets
- Acyclovir 5% Ointment 15gm
- Acyclovir 5% Ointment 30gm
- Acyclovir Sodium 50mg/ml Inj, 10ml
- Acyclovir 5% Ointment 2x5gm
- Acyclovir 5% Ointment 15gm
- Acyclovir 200mg Capsules
- Acyclovir 5% Ointment 30gm
- Acyclovir 5% Ointment 5gm
- Acyclovir 5% Cream 5gm
- Acyclovir 5% Cream 5gm
Dosing & Administration
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.
Pediatric Dosing
Neonatal:
Not established (safety and efficacy not established in neonates for topical use).
Infant:
Not established (safety and efficacy not established in infants for topical use).
Child:
Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 days (for children 12 years and older, similar to adult dosing).
Adolescent:
Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 days.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required due to minimal systemic absorption.
Moderate:
No dosage adjustment required due to minimal systemic absorption.
Severe:
No dosage adjustment required due to minimal systemic absorption.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment required due to minimal systemic absorption.
Moderate:
No dosage adjustment required due to minimal systemic absorption.
Severe:
No dosage adjustment required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Acyclovir is a synthetic purine nucleoside analog 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. Acyclovir triphosphate inhibits viral DNA synthesis by competing with deoxyguanosine triphosphate for viral DNA polymerase, incorporating into viral DNA, and causing chain termination.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 0.5% of the applied dose).
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:
Renal (if systemically absorbed, primarily unchanged drug and CMMG).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Local antiviral effect begins upon application; clinical improvement typically seen within days.
PeakEffect:
Not applicable (local action).
DurationOfAction:
Duration of effect is maintained with frequent application as directed.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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
While not everyone experiences side effects, it's essential to be aware of the potential risks. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
- Skin irritation
- Burning or stinging
- Itching
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, don't hesitate to reach out to your doctor. For additional guidance on side effects, you can also contact the FDA at 1-800-332-1088 or report side effects online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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
While not everyone experiences side effects, it's essential to be aware of the potential risks. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
- Skin irritation
- Burning or stinging
- Itching
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have concerns or questions about side effects, don't hesitate to reach out to your doctor. For additional guidance on side effects, you can also contact the FDA at 1-800-332-1088 or report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening of lesions or development of new lesions despite treatment.
- Severe burning, stinging, itching, or rash at the application site.
- Signs of allergic reaction such as swelling of the face, lips, tongue, or throat; difficulty breathing; or severe rash.
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.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 the details with your doctor. 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 the risk of transmission, use a latex or polyurethane condom during sexual activity; 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 the details with your doctor. 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 the risk of transmission, use a latex or polyurethane condom during sexual activity; 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to local irritation.
What to Do:
If swallowed, or if severe local irritation occurs, contact a poison control center or seek medical attention. Call 1-800-222-1222.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of lesions
Frequency: Daily
Target: Complete healing
Action Threshold: Lack of improvement or worsening after 7 days of treatment
Local skin reactions (e.g., burning, stinging, itching, rash)
Frequency: Daily
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent local reactions
Symptom Monitoring
- Pain relief
- Reduction in itching
- Crusting and healing of lesions
- Absence of new lesion formation
Special Patient Groups
Pregnancy
Acyclovir is Pregnancy Category B. While systemic absorption from topical application is minimal, use during pregnancy should be considered only if the potential benefits outweigh the potential risks. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption, generally considered low risk.
Second Trimester:
Minimal systemic absorption, generally considered low risk.
Third Trimester:
Minimal systemic absorption, generally considered low risk.
Lactation
Acyclovir is excreted in breast milk following systemic administration. However, systemic absorption from topical application is minimal, making the amount transferred to breast milk negligible. Generally considered compatible with breastfeeding, but caution is advised. Consult with a healthcare provider.
Infant Risk:
Low risk due to minimal systemic absorption by the mother.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established for topical acyclovir ointment. For adolescents (12 years and older), dosing is similar to adults.
Geriatric Use
No specific dosage adjustments are required for elderly patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact the safety or efficacy of topical acyclovir.
Clinical Information
Clinical Pearls
- Acyclovir ointment is most effective when applied at the first sign of a cold sore or genital herpes outbreak (e.g., tingling, itching, redness).
- It is for external use only. Do not apply to eyes, inside the mouth, or nose.
- Do not dilute the ointment or mix it with other creams or lotions.
- Patients should be advised that acyclovir ointment does not prevent transmission of herpes virus to others and does not cure herpes infections.
- Ensure the affected area is clean and dry before application.
Alternative Therapies
- Penciclovir cream (Denavir)
- Docosanol cream (Abreva)
- Oral antiviral agents (e.g., acyclovir, valacyclovir, famciclovir) for more severe or frequent outbreaks.
Cost & Coverage
Average Cost:
$20 - $100 per 5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 this 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.