Acyclovir topical

Name: Acyclovir topical

Acyclovir Topical Dosage

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Treatment with acyclovir topical should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Wash your hands before and after applying acyclovir topical cream.

Apply only enough cream to cover the cold sore or tingly area. Rub in gently until the cream disappears. Acyclovir topical cream may be applied 5 times daily for 4 days. Follow your doctor's instructions.

Wear a glove or a finger cot or use a cotton swab when applying acyclovir topical ointment to avoid spreading the virus to other body parts and to other people.

Apply only enough ointment to cover the genital lesion(s) completely. This medication may be applied every 3 hours up to 6 times daily. Acyclovir topical ointment may be applied every 3 hours, up to 6 times daily for 7 days. Follow your doctor's instructions.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Lesions caused by herpes viruses should be kept as clean and dry as possible. Wearing loose clothing may help to prevent irritation of the lesions.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Since this medication is applied to the skin, an overdose is unlikely to occur.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

How should this medicine be used?

Topical acyclovir comes as a cream and an ointment to apply to the skin. Acyclovir cream is usually applied five times a day for 4 days. Acyclovir cream may be applied at any time during a cold sore outbreak, but it works best when it is applied at the very beginning of a cold sore outbreak, when there is tingling, redness, itching, or a bump but the cold sore has not yet formed. Acyclovir ointment is usually applied six times a day (usually 3 hours apart) for 7 days. It is best to begin using acyclovir ointment as soon as possible after you experience the first symptoms of infection. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use topical acyclovir exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your symptoms should improve during your treatment with topical acyclovir. If your symptoms do not improve or if they get worse, call your doctor.

Acyclovir cream and ointment are for use only on the skin. Do not let acyclovir cream or ointment get into your eyes, or inside your mouth or nose, and do not swallow the medication.

Acyclovir cream should only be applied to skin where a cold sore has formed or seems likely to form. Do not apply acyclovir cream to any unaffected skin, or to genital herpes sores.

Do not apply other skin medications or other types of skin products such as cosmetics, sun screen, or lip balm to the cold sore area while using acyclovir cream unless your doctor tells you that you should.

To use acyclovir cream, follow these steps:

  1. Wash your hands.
  2. Clean and dry the area of skin where you will be applying the cream.
  3. Apply a layer of cream to cover the skin where the cold sore has formed or seems likely to form.
  4. Rub the cream into the skin until it disappears.
  5. Leave the skin where you applied the medication uncovered. Do not apply a bandage or dressing unless your doctor tells you that you should.
  6. Wash your hands with soap and water to remove any cream left on your hands.
  7. Be careful not to wash the cream off of your skin. Do not bathe, shower, or swim right after applying acyclovir cream.
  8. Avoid irritation of the cold sore area while using acyclovir cream.

To use acyclovir ointment, follow these steps:

  1. Put on a clean finger cot or rubber glove.
  2. Apply enough ointment to cover all of your sores.
  3. Take off the finger cot or rubber glove and dispose of it safely, so that it is out of reach of children.
  4. Keep the affected area(s) clean and dry, and avoid wearing tight-fitting clothing over the affected area.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. Read this information before you start using acyclovir and each time you refill your prescription.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, with the cap on and tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Never leave this medication in your car in cold or hot weather.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Acyclovir Dosage and Administration

Administration

Topical Administration

Apply topically to lesions of the lips and surrounding skin as a 5% cream or ointment,101 112 and apply to lesions of the skin as a 5% ointment.101

Do not apply 5% cream or ointment in or near the eyes.101 112 For external use only; do not apply inside mouth or nose.101 112

The 5% cream should be used only for treatment of herpes labialis (perioral herpes, cold sores, fever blisters) and should not be used to treat genital herpes.112

After applying 5% cream, rub until the cream disappears.112 Do not use with occlusive dressings unless otherwise directed by clinician.112 Do not bathe, shower, or swim immediately after application.112

When applying 5% ointment, use finger cot or rubber glove to prevent autoinoculation of other sites and transmission of herpes virus to other individuals.101

Dosage

Pediatric Patients

Herpes Labialis Topical

Children ≥12 years of age: Apply 5% cream to affected area 5 times daily for 4 days.112 Use sufficient quantity to adequately cover lesions or symptomatic area (e.g., area with tingling).112

Initiate at the earliest sign or symptom of herpes labialis (i.e., during the prodrome or when lesions appear).112

Do not exceed recommended dosage, frequency, and duration of therapy.112

Adults

Herpes Labialis Topical

Apply 5% cream to affected area times 5 times daily for 4 days.112 Use sufficient quantity to adequately cover lesions or symptomatic area (e.g., area with tingling).112

Initiate at the earliest sign or symptom of herpes labialis (i.e., during the prodrome or when lesions appear).101 112

Do not exceed recommended dosage, frequency, and duration of therapy.101 112

Genital Herpes Treatment of First Episodes Topical

Rub 5% ointment gently into the affected area every 3 hours 6 times daily for 7 days.101 Use sufficient quantity to adequately cover all lesions;101 usual dose varies according to total lesion area but should approximate a 1.25-cm (0.5-inch) ribbon of ointment for a skin surface area of 2.5 cm2 (4 inch2).101

Initiate at the earliest sign or symptom of genital herpes (i.e., during the prodrome or when lesions appear).101

Do not exceed recommended dosage, frequency, and duration of therapy.101

Mucocutaneous Herpes Simplex Virus (HSV) Infections Non-life-threatening, Nongenital, Mucocutaneous HSV Infections Topical

Immunocompromised adults: Rub 5% ointment gently into the affected area every 3 hours 6 times daily for 7 days.101 Use sufficient quantity to adequately cover all lesions;101 usual dose varies according to total lesion area but should approximate a 1.25-cm (0.5-inch) ribbon of ointment for a skin surface area of 2.5 cm2 (4 inch2).101

Do not exceed recommended dosage, frequency, and duration of therapy.101

Stability

Storage

Topical

Cream

≤25°C (may be exposed to 15°–30°C).112

Ointment

15°–25°C in dry place.101

Pharmacology

Acyclovir is converted to acyclovir monophosphate by virus-specific thymidine kinase then further converted to acyclovir triphosphate by other cellular enzymes. Acyclovir triphosphate inhibits DNA synthesis and viral replication by competing with deoxyguanosine triphosphate for viral DNA polymerase and being incorporated into viral DNA.

Absorption

Topical: Plasma concentrations following topical application of the cream were below the limit of detection in 5/6 male volunteers (<0.01 μM) and 0.014 μM in one subject. Following application of the ointment to patients with varicella-zoster infection, acyclovir plasma concentrations were <0.01 to 0.28 mcg/mL in patients with normal renal function and <0.01 to 0.78 mcg/mL in a patient with renal impairment.

Buccal tablet: Single dose application of buccal tablets containing 50 mg of acyclovir to the buccal mucosa provided mean maximum salivary concentrations 8 hours after tablet application. Plasma concentrations were delayed (undetectable at 5 hours) and subsequently below antiviral activity concentration (0.018 to 0.055 mcg/mL).

Excretion

Urine (Buccal tablet: Primarily renally excreted unchanged; Cream: 0.04% of the daily dose; Ointment: <0.02% to 9.4% of the daily dose)

Dosing Adult

Genital HSV: Topical ointment: Initial episode: 1/2” ribbon of ointment for a 4” square surface area every 3 hours (6 times daily) for 7 days

Herpes labialis (cold sores):

Topical cream: Apply 5 times daily for 4 days

Buccal tablet: Apply one 50 mg tablet as a single dose to the upper gum region (canine fossa).

Mucocutaneous HSV (non-life-threatening, immunocompromised): Topical ointment: 1/2” ribbon of ointment for a 4” square surface area every 3 hours (6 times daily) for 7 days

Administration

Oral: Buccal tablet: Apply within 1 hour after onset of prodromal symptoms and before appearance of any signs of lesions. Apply tablet with a dry finger immediately after removing it from packaging blister. Place tablets to the upper gum just above the incisor tooth (canine fossa) on the same side of the mouth as the prodromal symptoms and hold in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The rounded side of the tablet should be placed on the upper gum (for comfort purposes, does not affect efficacy). Do not crush, chew, suck, or swallow. If tablet falls off within the first 6 hours, reposition the same tablet immediately or apply a new tablet. If tablet is swallowed within the first 6 hours, drink a glass of water and apply a new tablet. If tablet falls out or is swallowed after the first 6 hours, do not reapply. Patients may eat and drink normally while tablet is in place. Avoid gum chewing, brushing teeth, wearing an upper denture or touching/pressing the tablet after placement. Rinse mouth gently if teeth need to be cleaned while the tablet is in place. Drink plenty of liquids in case of dry mouth.

Topical: Cream or ointment: Apply as early as possible following the onset of prodromal symptoms or when lesions appear.

Cream: Not for use on the genitals. Ensure the face and/or lips are clean and dry. Not for use in the eye, mouth or mucous membranes. Wash hands with soap and water prior to application and after application. Apply an amount to sufficiently cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area. Do not apply other topical products to the affected area during therapy.

Ointment: Not for use in the eye. Apply using a finger cot or rubber glove to avoid transmission to other parts of the body or to other persons.

What should I discuss with my healthcare provider before using acyclovir topical?

You should not use this medicine if you are allergic to acyclovir or valacyclovir (Valtrex).

To make sure acyclovir topical is safe for you, tell your doctor if you have:

  • weak immune system (caused by disease or by using certain medicine).

FDA pregnancy category B. Acyclovir topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Herpes virus can be passed from an infected mother to her baby during childbirth. If you have genital herpes, it is very important to prevent herpes lesions during your pregnancy so that you do not have a genital lesion when your baby is born.

It is not known whether acyclovir topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. You should not breast-feed if you have a herpes lesion on or near your breast.

Acyclovir topical should not be used on a child younger than 12 years old.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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