Acyclovir 5% Ointment 15gm
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 applied directly to the skin to treat cold sores (herpes labialis) and genital herpes lesions. It helps the sores heal faster and can reduce pain and discomfort associated with the outbreak.
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 irritation or burning.
Wash your hands thoroughly before and after applying the medication.
Clean the affected area before application and dry it well.
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 irritation or burning.
Wash your hands thoroughly before and after applying the medication.
Clean the affected area before application and dry it well.
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 your hands thoroughly with soap and water before and after applying the ointment.
- Apply the ointment using a finger cot or a rubber glove to avoid spreading the virus to other parts of your body or to other people.
- Apply enough ointment to completely cover the lesions or areas where you feel a lesion starting.
- Do not use this ointment in your eyes, mouth, or nose. If it gets into your eyes, rinse them immediately with water.
- Avoid sexual contact when lesions are present to prevent spreading genital herpes.
- Even with treatment, the virus can still be spread. Avoid touching the lesions and wash hands frequently.
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 per day for 4 days.
genitalHerpes:
Apply to lesions or impending lesions 6 times per day for 7 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children âĨ12 years, same as adult dosing. For younger children, consult specific guidelines, generally similar application.
Adolescent:
Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
Not applicable due to minimal systemic absorption.
Moderate:
Not applicable due to minimal systemic absorption.
Severe:
Not applicable due to minimal systemic absorption.
Dialysis:
Not applicable due to minimal systemic absorption.
Hepatic Impairment:
Mild:
Not applicable due to minimal systemic absorption.
Moderate:
Not applicable due to minimal systemic absorption.
Severe:
Not applicable due to 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). It is converted to acyclovir monophosphate by viral thymidine kinase, then to acyclovir triphosphate by cellular enzymes. Acyclovir triphosphate inhibits viral DNA synthesis by competing with deoxyguanosine triphosphate for viral DNA polymerase, and by incorporation into viral DNA, leading to chain termination.
Pharmacokinetics
Absorption:
Bioavailability:
Very low (<0.01%)
Tmax:
Not well-defined for topical application; plasma concentrations generally below detectable limits.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not applicable for topical application due to minimal systemic absorption.
ProteinBinding:
Not applicable for topical application due to minimal systemic absorption.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for topical application due to minimal systemic absorption.
Clearance:
Not applicable for topical application due to minimal systemic absorption.
ExcretionRoute:
Not applicable for topical application due to minimal systemic absorption.
Unchanged:
Not applicable for topical application due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within days of initiation of therapy.
PeakEffect:
Reduction in lesion healing time and pain, typically observed over the course of treatment.
DurationOfAction:
Effect lasts as long as applied; clinical benefit seen over the treatment course.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
- 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, 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 or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Skin irritation
- Burning or stinging
- Itching
Important Note
This list does not include all possible 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 or seek medical help right away:
- 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, 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 or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Skin irritation
- Burning or stinging
- Itching
Important Note
This list does not include all possible 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 subside.
- Development of a rash or hives, swelling of the face, lips, or tongue, or difficulty breathing (signs of an allergic reaction).
- Worsening of lesions or no improvement after the recommended treatment period.
- Signs of bacterial superinfection (e.g., pus, increased redness, warmth).
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 as a result of the allergy.
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 between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage 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 as a result of the allergy.
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 between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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 is not a cure for 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 active 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, always 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, notify 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 is not a cure for 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 active 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, always 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, notify 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 is highly unlikely due to minimal systemic absorption. Ingesting the ointment may cause mild gastrointestinal upset.
What to Do:
If a large amount is accidentally ingested, contact a poison control center (1-800-222-1222) or seek medical attention. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Clinical assessment of lesion healing
Frequency: Daily during treatment
Target: Reduction in lesion size, crusting, and healing
Action Threshold: Lack of improvement or worsening of lesions after several days of treatment.
Local adverse reactions (e.g., burning, stinging, itching)
Frequency: Daily during treatment
Target: Absence or mildness of reactions
Action Threshold: Severe or persistent local irritation, pain, or allergic reaction.
Symptom Monitoring
- Pain associated with lesions
- Itching or burning sensation at application site
- Redness or swelling of lesions
- Development of new lesions
Special Patient Groups
Pregnancy
Acyclovir is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and human data from systemic use suggest no increased risk of birth defects. Due to minimal systemic absorption of topical acyclovir, the risk to the fetus is considered very low.
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 into breast milk following systemic administration, but concentrations are low. Due to minimal systemic absorption from topical application, the amount transferred to breast milk is negligible. Considered compatible with breastfeeding.
Infant Risk:
L1 (Lowest Risk) - No increase in adverse effects in the infant.
Pediatric Use
Generally safe for use in children. Dosing for adolescents (âĨ12 years) is typically the same as adults. For younger children, use with caution and consult a healthcare provider, though systemic absorption is minimal.
Geriatric Use
No specific dose adjustments or precautions are generally required for geriatric patients using topical acyclovir, as systemic absorption is minimal and renal/hepatic impairment would not significantly impact topical safety or efficacy.
Clinical Information
Clinical Pearls
- Initiate treatment at the first sign or symptom of a herpes episode (e.g., tingling, itching, redness, or appearance of lesions) for best results.
- Acyclovir ointment is for external use only. Do not apply to mucous membranes (e.g., inside the mouth, nose, or eyes).
- This ointment does not prevent the transmission of herpes virus to others. Patients should be advised to avoid contact with lesions and practice good hygiene.
- If lesions do not improve or worsen after the recommended treatment period, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Penciclovir cream (Denavir) - another topical antiviral for herpes labialis.
- Docosanol cream (Abreva) - an over-the-counter topical for cold sores.
- Oral antiviral medications (e.g., Acyclovir, Valacyclovir, Famciclovir) for systemic treatment of herpes infections, often preferred for more severe or frequent outbreaks.
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.