Acyclovir 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 multiplying, 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 the information provided. 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 applying the medication and make sure it is dry.
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 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 the information provided. 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 applying the medication and make sure it is dry.
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 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 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 only to the affected skin areas; do not use in the eyes, mouth, or nose.
- Wear loose-fitting clothing if treating genital herpes to avoid irritation.
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 5 times per day for 4 days.
Condition-Specific Dosing:
herpesLabialis:
Apply 5 times per day for 4 days.
genitalHerpes:
Apply 5 times per day for 4 days.
Pediatric Dosing
Neonatal:
Not established (systemic acyclovir preferred for neonatal herpes)
Infant:
Not established (systemic acyclovir preferred for infants)
Child:
Apply sufficient quantity to adequately cover all lesions 5 times per day for 4 days (for children âĨ12 years, similar to adult dosing). For younger children, consult specific guidelines.
Adolescent:
Apply sufficient quantity to adequately cover all lesions 5 times per day 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 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). Its inhibitory activity is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme phosphorylates acyclovir to acyclovir monophosphate, which is then converted to acyclovir diphosphate by cellular guanylate kinase and further to acyclovir triphosphate by other cellular enzymes. Acyclovir triphosphate inhibits viral DNA replication by competing with deoxyguanosine triphosphate for incorporation into viral DNA and by inactivating the viral DNA polymerase.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<0.1%)
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:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Local antiviral effect begins upon application, clinical improvement typically seen within days.
PeakEffect:
Not applicable for systemic effect; local effect peaks with consistent application.
DurationOfAction:
Duration of local antiviral activity is maintained with repeated applications as per dosing regimen.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, this medication can cause severe and potentially life-threatening side effects. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
- 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
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Skin irritation
- Burning or stinging sensations
- Itching
This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding 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.
While rare, this medication can cause severe and potentially life-threatening side effects. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
- 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
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Skin irritation
- Burning or stinging sensations
- Itching
This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding 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.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or itching at the application site
- Rash or hives developing away from the application site
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Difficulty breathing or swallowing
- Worsening of lesions or signs of bacterial infection (e.g., pus, fever)
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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 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, 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 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, 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 is highly unlikely due to minimal systemic absorption. If ingested, symptoms might include nausea, vomiting, diarrhea, headache, or confusion, but are rare and generally mild.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Lesion healing
Frequency: Daily
Target: Reduction in lesion size, pain, and crusting; progression to healing.
Action Threshold: Lack of improvement or worsening of lesions after 4 days of treatment.
Symptom Monitoring
- Local irritation (burning, stinging, itching)
- Rash
- Allergic reactions (e.g., angioedema, urticaria)
- Signs of secondary bacterial infection (e.g., pus, increased redness, fever)
Special Patient Groups
Pregnancy
Acyclovir is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and human data from registries (e.g., Acyclovir in Pregnancy Registry) have not shown an increased risk of birth defects. Generally considered safe for use during pregnancy when indicated.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects observed.
Second Trimester:
No increased risk of birth defects observed.
Third Trimester:
No increased risk of birth defects observed.
Lactation
Acyclovir is excreted into breast milk after systemic administration, but topical application results in minimal systemic absorption. Therefore, infant exposure via breast milk is expected to be negligible. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the infant.
Pediatric Use
Topical acyclovir ointment is generally safe and effective for children, particularly adolescents, for the treatment of herpes labialis and genital herpes. Dosing is similar to adults for children 12 years and older. For younger children, use under medical supervision and consider specific guidelines.
Geriatric Use
No specific dose adjustments are required for elderly patients using topical acyclovir due to minimal systemic absorption. Use with caution in patients with pre-existing skin conditions that might affect absorption, though this is rare.
Clinical Information
Clinical Pearls
- Acyclovir ointment is most effective when applied at the first sign of a herpes outbreak (e.g., tingling, itching, redness).
- It does not cure herpes, but it can help reduce the duration and severity of outbreaks.
- Ensure the affected area is clean and dry before application.
- Do not use this ointment for cold sores inside the mouth or nose, or for eye infections.
- If lesions do not improve after 4 days of treatment, or if they worsen, consult a healthcare provider.
Alternative Therapies
- Penciclovir topical cream (Denavir)
- Docosanol topical cream (Abreva)
- Oral antiviral medications (e.g., acyclovir, valacyclovir, famciclovir) for more severe or frequent outbreaks.
Cost & Coverage
Average Cost:
Varies, typically $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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.