Acyclovir 5% Ointment 2x5gm
It is used to treat genital warts.It is used to treat shingles or certain other herpes infections.
Drug Class
Antivirals
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 to the skin to treat cold sores (herpes labialis) and genital herpes lesions. It helps to stop the virus from growing and spreading, which can help the sores heal faster and reduce 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 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 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 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 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.
- Do not share the ointment with others.
- Avoid sexual contact when genital lesions are present to prevent transmission.
- Apply with a gloved finger or cotton swab to avoid self-contamination or spreading the virus.
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 a sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 days.
Condition-Specific Dosing:
herpesLabialis:
Apply a sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 days.
genitalHerpes:
Apply a sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established for all pediatric age groups; however, generally applied similarly to adults for children âĨ12 years. Consult physician for younger children.
Adolescent:
Apply a sufficient quantity to adequately cover all lesions every 3 hours, 6 times daily for 7 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 acyclovir monophosphate by virus-specific thymidine kinase. The monophosphate is further converted to diphosphate by cellular guanylate kinase and to 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 (<0.5% systemically 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:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within 1-2 days (clinical improvement)
PeakEffect:
Not precisely quantifiable for topical
DurationOfAction:
Duration of treatment (7 days)
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 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 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 not mentioned here. 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 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 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 not mentioned here. 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
- Rash or hives developing away from the application site
- Swelling of the face, lips, or tongue
- Difficulty breathing or swallowing (signs of allergic reaction)
- Worsening of lesions or no improvement after 7 days of treatment
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 interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
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 interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
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. Always 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, 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 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. Always 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, 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:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts may cause nausea, vomiting, headache, or dizziness, but is rare.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (Call 1-800-222-1222). For topical overdose, wash off excess ointment.
Drug Interactions
Monitoring
Symptom Monitoring
- Resolution of lesions
- Reduction in pain/discomfort
- Signs of local irritation or allergic reaction (e.g., rash, itching, burning, stinging)
- Signs of secondary bacterial infection
Special Patient Groups
Pregnancy
Acyclovir is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and human data suggest low risk. Topical absorption is minimal, making it generally considered safe for use during pregnancy when indicated.
Trimester-Specific Risks:
First Trimester:
Low risk, minimal systemic absorption.
Second Trimester:
Low risk, minimal systemic absorption.
Third Trimester:
Low risk, minimal systemic absorption.
Lactation
Acyclovir is excreted into breast milk after systemic administration, but topical application results in minimal systemic absorption and thus minimal excretion into breast milk. It is considered L2 (safer) for use during lactation. Caution should be exercised to avoid direct contact of the infant with treated skin areas.
Infant Risk:
Low risk to infant.
Pediatric Use
Safety and efficacy in pediatric patients under 12 years of age have not been established. For adolescents (âĨ12 years), dosing is generally similar to adults. Use in younger children should be under medical supervision.
Geriatric Use
No specific dosage adjustments are required for elderly patients, as systemic absorption is minimal. However, elderly patients may have more sensitive skin and should be monitored for local irritation.
Clinical Information
Clinical Pearls
- Acyclovir ointment is most effective when applied at the first sign of a herpes lesion (e.g., tingling, itching, redness).
- It is not a cure for herpes but can help manage outbreaks and reduce healing time.
- The ointment should be applied to cover the lesions completely, not just dabbed on.
- Patients should be advised that topical acyclovir does not prevent transmission of herpes virus to others.
- If lesions do not improve after 7 days of treatment, or if they worsen, patients should consult their healthcare provider.
Alternative Therapies
- Penciclovir cream (Denavir)
- Docosanol cream (Abreva)
- Oral antiviral agents (e.g., oral acyclovir, valacyclovir, famciclovir) for more severe or frequent outbreaks.
Cost & Coverage
Average Cost:
Varies widely, typically $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 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.