Acyclovir 5% Cream 5gm
It is used to treat cold sores.
Drug Class
Antivirals
Pharmacologic Class
Synthetic nucleoside analog
Pregnancy Category
Category B
FDA Approved
Dec 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acyclovir cream is an antiviral medicine used to treat cold sores (herpes labialis) on the face and lips, and recurrent genital herpes lesions. It works by stopping the growth of the virus that causes these infections.
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.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Use the medication at the first sign of a cold sore.
Avoid applying the medication to healthy skin.
Do not rub the cold sore, as this may worsen the condition or cause it to spread to other areas around the mouth.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next 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 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.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Use the medication at the first sign of a cold sore.
Avoid applying the medication to healthy skin.
Do not rub the cold sore, as this may worsen the condition or cause it to spread to other areas around the mouth.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply the cream at the first sign of a cold sore or genital herpes lesion (e.g., tingling, itching, redness).
- Wash your hands thoroughly before and after applying the cream.
- Do not apply the cream to your eyes, inside your mouth, or inside your nose.
- Avoid touching the lesions unnecessarily to prevent spreading the virus to other parts of your body or to other people.
- Do not share towels, eating utensils, or personal items with others during an outbreak.
- Avoid sexual contact during a genital herpes outbreak, even when using the cream, to prevent transmission.
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 to affected area 5 times a day for 4 days (herpes labialis) or 5 times a day for 5 days (genital herpes recurrence).
Condition-Specific Dosing:
herpesLabialis:
Apply to affected area 5 times a day for 4 days.
genitalHerpesRecurrence:
Apply to affected area 5 times a day for 5 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established for all indications, but generally used in children 12 years and older for herpes labialis, similar to adult dosing.
Adolescent:
Apply to affected area 5 times a day for 4 days (herpes labialis).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed 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). Acyclovir is phosphorylated to its active form, acyclovir triphosphate, by viral thymidine kinase. Acyclovir triphosphate then inhibits viral DNA synthesis by competing with deoxyguanosine triphosphate for incorporation into viral DNA, leading to chain termination and irreversible inactivation of viral DNA polymerase.
Pharmacokinetics
Absorption:
Bioavailability:
<0.5% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical formulation)
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 (for systemically absorbed drug, which is minimal)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 days of initiation.
PeakEffect:
Not precisely defined for topical effect, but viral shedding reduction occurs early.
DurationOfAction:
Duration of treatment is 4-5 days.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, 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 if you experience any of the following side effects or if they persist or bother you:
- Skin irritation
- Burning or stinging sensations
- Itching
- Dry or cracked lips
- Flakiness of the skin
- Dry skin
- Peeling
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about 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.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, 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 if you experience any of the following side effects or if they persist or bother you:
- Skin irritation
- Burning or stinging sensations
- Itching
- Dry or cracked lips
- Flakiness of the skin
- Dry skin
- Peeling
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about 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, or tongue
- Difficulty breathing or swallowing (signs of allergic reaction)
- Worsening of lesions or no improvement after the recommended treatment duration
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 treatment, 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, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this 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 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 treatment, 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, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that this drug is not a cure for cold sores. If you have any questions or concerns, consult with your doctor.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor to ensure safe use. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor to ensure safe use. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely due to minimal systemic absorption. Ingestion of the cream may cause mild gastrointestinal upset.
What to Do:
If a large amount is ingested, contact a poison control center or seek medical attention. For accidental ingestion, call 1-800-222-1222.
Drug Interactions
Monitoring
Routine Monitoring
Clinical response (healing of lesions)
Frequency: Daily during treatment
Target: Reduction in lesion size, pain, and crusting
Action Threshold: Lack of improvement or worsening of lesions after 4-5 days of treatment may indicate resistance or alternative diagnosis.
Local adverse reactions (e.g., burning, stinging, dryness)
Frequency: Daily during treatment
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent local irritation may warrant discontinuation.
Symptom Monitoring
- Pain or discomfort at application site
- Redness or swelling of lesions
- Crusting or blistering
- Signs of secondary bacterial infection (e.g., pus, increased pain, fever)
Special Patient Groups
Pregnancy
Acyclovir is generally considered safe for topical use during pregnancy due to minimal systemic absorption. Systemic acyclovir is Pregnancy Category B, and topical exposure is significantly lower.
Trimester-Specific Risks:
First Trimester:
Low risk, minimal systemic exposure.
Second Trimester:
Low risk, minimal systemic exposure.
Third Trimester:
Low risk, minimal systemic exposure.
Lactation
Acyclovir is excreted in breast milk after systemic administration, but levels are low. Due to minimal systemic absorption from topical application, the amount transferred to breast milk is expected to be negligible. Considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy for herpes labialis have been established in adolescents 12 years of age and older. Use in younger children for cold sores or genital herpes should be based on clinical judgment and potential benefits outweighing risks, as data are limited. Generally well-tolerated.
Geriatric Use
No specific dose adjustments are required for elderly patients due to minimal systemic absorption. Elderly patients may have more sensitive skin, so monitor for local irritation.
Clinical Information
Clinical Pearls
- Acyclovir cream is most effective when applied at the very first sign of a cold sore or genital herpes lesion (e.g., tingling, itching, redness) before the blister appears.
- It does not prevent future outbreaks or cure herpes, but it can shorten the duration and severity of an outbreak.
- Ensure the affected area is clean and dry before application.
- Do not use this cream for cold sores inside the mouth or nose, or for shingles (herpes zoster) or chickenpox.
- Complete the full course of treatment (4 or 5 days) even if the lesions appear to be healing to ensure maximum efficacy.
Alternative Therapies
- Penciclovir cream (Denavir)
- Docosanol cream (Abreva) - OTC
- Oral antiviral medications (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 Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 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, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.