Neonatal Herpes Simplex Virus Infection
Following doses based on research of the NIH National Institute of Child Health and Human Development that updated prescribing information was based on
Infuse IV over 1 hr
PMA 34 weeks: 20 mg/kg IV q8hr for 21 days
PMA < 34 weeks: 20 mg/kg IV q12hr for 21 days
Caution if renal function beyond the effect of prematurity occurs
What Is Acyclovir And How Does It Work
Acyclovir is approved by the Food and Drug Administration as a prescription drug that is commonly used as a topical, injectable, and oral treatment for genital herpes and cold sores. Herpes refers to a group of viruses that cause a variety of herpes infections including genital herpes, shingles, chicken pox , cold sores, and encephalitis . Herpes viral infections are very common. Genital herpes refers to a sexually transmitted disease that any sexually active person can contract and transmit.
Shingles and chicken pox are common skin conditions. Shingles and chicken pox are skin infections which are both caused by the herpes virus. They are not caused by the same virus that causes cold sores or genital herpes.
Many people who suffer from shingles or chicken pox infection will experience symptoms such as a rash, often with pain, which is treatable with this drug.
Genital herpes is an STD caused by two types of viruses: herpes simplex type 1 and herpes simplex type 2. Most people with genital herpes do not know they have it. Still, symptoms often appear days to weeks after exposure. Symptoms of genital herpes generally include:
- Flu-like symptoms such as fever, body aches, or swollen glands
- Blisters, sores, or rash in the genital area with or without pain, itching, tingling
- Blisters that pop open, causing painful sores.
Acyclovir may also help treat pain associated with an outbreak of genital herpes after the sores heal.
Treatment Of Acute Herpes Zoster
A meta-analysis of five randomized controlled trials considered the time to complete resolution of acute herpes zoster pain.1 When treatment was initiated within 48 hours, complete resolution of pain occurred sooner than with placebo . This also was true when treatment was initiated between 48 and 72 hours .
A single RCT2 compared valacyclovir with acyclovir . This study found that the mean times to complete resolution of pain were 44 days for valacyclovir and 51 days for acyclovir when treated within 48 hours .2 When treatment was initiated between 48 and 72 hours after the onset of symptoms, the mean times to complete resolution of pain were 36 days for valacyclovir and 48 days for acyclovir .
Another RCT3 compared two dosage regimens of famciclovir with placebo in 419 adults treated within 72 hours of symptom onset. Famciclovir slightly accelerated the rate of lesion healing compared with placebo .
In a single RCT4 with 55 patients, famciclovir was shown to have equal effectiveness to acyclovir . This small and possibly underpowered study found that there was no significant difference regarding the median time to full lesion crusting, the rate of full crusting at day 28, the median time to resolution of acute pain, or the rate of acute pain at 28 days.
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Carcinogenesis Mutagenesis Impairment Of Fertility
The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with 800 mg given orally 5 times a day or 200 mg given orally 5 times a day . Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules .
Acyclovirwas tested in lifetime bioassays in rats and mice at single daily doses ofup to 450 mg/kg administered by gavage. There was no statistically significantdifference in the incidence of tumors between treated and control animals,nor did acyclovir shorten the latency of tumors. Maximum plasma concentrationswere 3 to 6 times human levels in the mouse bioassay and 1 to 2 timeshuman levels in the rat bioassay.
Acyclovir was testedin 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positivein 5 of the assays.
Acyclovir did not impair fertilityor reproduction in mice or in rats . In the mouse study, plasma levels were 9 to 18 times human levels,while in the rat study, they were 8 to 15 times human levels. At higherdoses in rats and rabbits implantation efficacy, but not litter size, wasdecreased. In a rat peri- and post-natal study at 50 mg/kg/day, s.c.,there was a statistically significant decrease in group mean numbers of corporalutea, total implantation sites, and live fetuses.
What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture .
It is important to keep all medication out of sight and reach of children as many containers 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 â one that is up and away and out of their sight and reach.
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 for more information if you do not have access to a take-back program.
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Side Effects Of Herperax
General :Severe allergic reactions, fever, headache, pain, difficulty sleeping, angioedema and swelling in your hands or feet. Central Nervous System :Aggressive behavior, agitation, unsteadiness, coma, confusion, decreased consciousness, confusion, dizziness, hallucinations, numbness, burning, or tingling in the arms or legs, epilepsy, drowsiness and tremors. Gastrointestinal :Diarrhea, gastrointestinal distress, vomiting and nausea. Blood :Anemia, decrease in white blood cells and platelets. Liver Elevated liver function tests, liver inflammation and jaundice. Musculoskeletal :Muscle pain, temporary inability to move parts of your body. Skin :Hair loss, redness, itching, pale skin, rash or blisters and hives. Eye :Visual abnormalities. Genitourinary :Kidney failure, elevated blood urea nitrogen levels, blood in urine and urinating less than usual or not at all.
How Do Vzv Antivirals Work
Varicella-Zoster virus antivirals are used in the treatment of both varicella and zoster infections. VZV is also called human herpesvirus 3. The replication of VZV in infected cells can be blocked effectively by the administration of antiviral agents. VZV antiviral drugs get incorporated into viralDNA preventing further synthesis and viral replication.
The primaryinfection of VZV is varicella commonly known as chickenpox, and the reactivation of VZV – causes zoster or herpes zoster commonly known as shingles. VZV is highly contagious and transmitted predominantly by airborne droplet infection.
Acyclovir is active against most herpesviruses and is the standard therapeutic agent for the treatment of VZV infections. Acyclovir is converted into acyclovir monophosphate by the viral thymidine kinase enzyme, which is then converted into acyclovir triphosphate by the hostcell kinases. The formed ACV-TP competitively inhibits and inactivates virus DNA polymerase and prevents viral DNA synthesis and virus replication.
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Warnings For Certain Groups
For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of this drug in your body and cause more side effects.
This medication may also decrease your kidney function. This means your kidney disease may get worse. Your doctor will adjust your dose depending on how well your kidneys are working.
For pregnant women: Acyclovir is a category B pregnancy drug. That means two things:
Talk to your doctor if youre pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.
For women who are breastfeeding: Acyclovir may pass into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your baby. You may need to decide whether to stop breastfeeding or stop taking this medication.
For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.
For children: This drug hasnt been studied in children younger than 2 years.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors.
General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.
Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment .
Digestive: Diarrhea, gastrointestinal distress, nausea.
Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.
Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.
Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Special Senses: Visual abnormalities.
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Acyclovir May Interact With Other Medications
An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs youre taking.
To find out how this drug might interact with something else youre taking, talk to your doctor or pharmacist.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
This drug comes with several warnings.
What Other Information Should I Know
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to acyclovir.
Do not let anyone else take or use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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To Use Buccal Acyclovir Follow These Steps:
If the delayed-release buccal tablet comes off within the first 6 hours of application, reapply the same tablet. If it still will not stick, then apply a new tablet. If you accidentally swallow the tablet within the first 6 hours of application, drink a glass of water and place a new tablet on your gum. If the tablet falls off or is swallowed 6 or more hours after application, do not apply a new tablet until your next regular time.
Acyclovir May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:
- numbness, burning, or tingling in the arms or legs
- temporary inability to move parts of your body
- shaking of a part of your body that you cannot control
- loss of consciousness
Acyclovir may cause other side effects. Call your doctor if you have any unusual problems while you are taking or using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online or by phone .
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What Are Side Effects Associated With Using Acyclovir
Common side effects or health problems may include:
- Oral medication
- Severe allergic reaction
This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.
Prevention And Treatment Of Postherpetic Neuralgia
A systematic review6 considered 42 RCTs of therapies to prevent or reduce the incidence of postherpetic neuralgia pain. Acyclovir reduced the incidence of postherpetic neuralgia pain at three months .
Famciclovir reduced the duration of postherpetic neuralgia pain better than placebo.3 The time to resolution of pain in patients 50 years of age or older was significantly shorter for two dosages of famciclovir than for placebo .
Systemic steroids have demonstrated no additional benefit. Studies examining amitriptyline, narcotics, capsaicin, anticonvulsants, and percutaneous nerve stimulation for postherpetic neuralgia were of fair to poor quality and no conclusions could be drawn from these.
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Other Uses For This Medicine
Acyclovir is also sometimes used to treat eczema herpeticum to treat and prevent herpes infections of the skin, eyes, nose, and mouth in patients with human immunodeficiency virus , and to treat oral hairy leukoplakia .
This medication may be prescribed for other uses ask your doctor or pharmacist for more information.
More Common Side Effects
Some of the more common side effects of acyclovir oral tablet include:
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
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Dosage For Shingles Genital Herpes Or Chickenpox
- Shingles typical dosage: 800 mg every 4 hours, five times per day for 710 days.
- Genital herpes:
- Typical initial dosage: 200 mg every 4 hours, five times per day, for 10 days.
- Typical dosage for prevention of recurrent herpes: 400 mg twice per day, every day for up to 12 months. Other dosing plans may include doses ranging from 200 mg three times daily to 200 mg five times daily. Your doctor will decide how long you should take this drug to avoid a flare-up of the infection.
- Typical dosage for reinfection : 200 mg every 4 hours, five times per day, for 5 days. You should take this drug as soon as the first signs of a flare-up appear.
- Chickenpox typical dosage:
- Children who weigh 40 kg or less: 20 mg/kg of body weight, given four times per day for 5 days
- Children who weigh more than 40 kg: 800 mg four times per day for 5 days
Start this drug as soon as the first symptom of chickenpox appears. It isnt known if this drug is effective if your child starts it more than 24 hours after the first sign of chickenpox.
It hasnt been confirmed that acyclovir is safe and effective for children younger than 2 years.
What Is A Patient Information Leaflet And Why Is It Useful
The Patient Information Leaflet is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet.The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD.For further information call emc accessibility on 0800 198 5000.The product code for this leaflet is: PL 14894/0009 .
Aciclovir 800 mg Tablets
Package leaflet: Information for the user
Aciclovir 800 mg Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Aciclovir 800 mg Tablets are and what they are used for
Aciclovir can be used to
2. What you need to know before you take Aciclovir 800 mg Tablets
Do not take Aciclovir 800 mg Tablets:
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