Acyclovir

Name: Acyclovir

What are the side effects of acyclovir?

The most common side effects are

  • nausea,
  • vomiting,
  • diarrhea and
  • headache.

Other reported side effects include:

  • agitation,
  • confusion,
  • rash,
  • anemia, and
  • muscle pain,
  • hypersensitivity reactions,
  • seizures,
  • agitation,
  • confusion,
  • anemia,
  • hepatitis, and
  • muscle pain.

What else should I know about acyclovir?

What preparations of acyclovir are available?
  • Capsules: 200 mg.
  • Tablets: 400 and 800 mg.
  • Suspension: 200 mg/5 ml.
  • Injection: 50 mg/ml.
  • Powder for injection: 500 and 1000 mg.
  • Ointment: 5%.

How should I keep acyclovir stored?

Acyclovir should be stored at room temperature, between 15 C 25 C (59 F to 77 F).

Indications

Indications And Clinical Use

ZOVIRAX® (acyclovir) is indicated for the following conditions:

  • The treatment of initial episodes of herpes genitalis.
  • The suppression of unusually frequent recurrences of herpes genitalis (6 or more episodes per year).
  • The acute treatment of herpes zoster (shingles) and varicella (chickenpox).

The results of clinical studies suggest that some patients with recurrent genital herpes may derive clinical benefit from the administration of oral ZOVIRAX® if taken at the first sign of an impending episode. Those most likely to benefit are patients who experience severe, prolonged recurrences; such intermittent therapy may be more appropriate than suppressive therapy when these recurrences are infrequent.

Early treatment of acute herpes zoster (shingles) in immunocompetent individuals with oral ZOVIRAX® resulted in decreased viral shedding; decreased time to healing; less dissemination; and alleviation of acute pain.

Treatment of varicella (chickenpox) in immunocompetent patients with oral ZOVIRAX® reduced the total number of lesions, accelerated the progression of lesions to the crusted and healed stages, and decreased the number of residual hypopigmented lesions. In addition, ZOVIRAX® decreased fever and constitutional symptoms associated with chickenpox.

The prophylactic use of acyclovir in chickenpox has not been established.

Geriatrics ( ≥ 65 Years of Age): Use in the geriatric population may be associated with differences in safety due to age-related changes in renal function and a brief discussion can be found in the appropriate sections (see WARNINGS AND PRECAUTIONS).

Pediatrics ( < 2 Years Old): No data are available.

Introduction

Antiviral; purine nucleoside analog derived from guanine.403 409

What is the most important information i should know about acyclovir (zovirax)?

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

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

Herpes infections are contagious and you can infect other people, even while you are being treated with acyclovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

What happens if i miss a dose (zovirax)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Where can i get more information?

Your pharmacist can provide more information about acyclovir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.06. Revision date: 12/15/2010.

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What should I avoid while taking acyclovir?

Avoid brushing your teeth, chewing gum, or wearing an upper denture while you have a buccal tablet in your mouth. You may rinse your mouth gently. Drink plenty of liquids to prevent dry mouth.

Herpes infections are contagious and you can infect other people, even while you are being treated with acyclovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

Taking this medicine will not prevent you from passing genital herpes to your sexual partner. Avoid sexual intercourse while you have active lesions or the first symptoms of an outbreak. Genital herpes may still be contagious through "viral shedding" from your skin, even if you have no symptoms.

For Healthcare Professionals

Applies to acyclovir: buccal tablet, compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral suspension, oral tablet

General

The more commonly reported adverse reactions include malaise, nausea, vomiting, diarrhea, and headache.[Ref]

Gastrointestinal

Nausea and vomiting are more frequent in elderly subjects.[Ref]

Common (1% to 10%): Nausea, vomiting, diarrhea, abdominal pain, gingival pain (buccal tablet), aphthous stomatitis (buccal tablet)
Uncommon (0.1% to 1%): Sore throat
Postmarketing reports: Gastrointestinal distress[Ref]

Renal

Rare (0.01% to 0.1%): Elevated blood urea nitrogen, elevated creatinine,
Very rare (less than 0.01%): Acute renal failure, renal pain
Frequency not reported: Crystalluria, renal impairment
Postmarketing reports: Renal failure, hematuria[Ref]

Renal pain may be associated with renal failure and crystalluria. Renal impairment is generally reversible but may progress to acute renal failure.[Ref]

Local

Common (1% to 10%): Application site pain and application site irritation, local inflammation at injection site, phlebitis
Frequency not reported: Tissue necrosis[Ref]

Severe local inflammatory reactions, including tissue necrosis, have occurred following infusion into extravascular tissues. Application site pain and application site irritation have occurred with the buccal tablets.[Ref]

Nervous system

Dizziness, somnolence, and coma more frequent in elderly subjects.[Ref]

Common (1% to 10%): Headache, dizziness
Very rare (less than 0.01%): Ataxia, coma, convulsions, encephalopathy, dysarthria
Frequency not reported: Giddiness, shaking, taste disturbance, medication taste
Postmarketing reports: Decreased consciousness, delirium, paresthesia, seizure, tremors[Ref]

Dermatologic

Common (1% to 10%): Erythema, rashes (including photosensitivity), pruritus, hives
Uncommon (0.1% to 1%): Urticaria, accelerated diffuse hair loss
Frequency not reported: Diaphoresis
Postmarketing reports: Alopecia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis[Ref]

Cardiovascular

Frequency not reported: Palpitation, chest pain
Postmarketing reports: Hypotension, peripheral edema[Ref]

Hematologic

Very rare (less than 0.01%): Anemia, leukopenia, thrombocytopenia, neutropenia
Frequency not reported: Hematologic changes including megaloblastic anemia
Postmarketing reports: Leukocyclastic vasculitis, lymphadenopathy, disseminated intravascular coagulation, hemolysis[Ref]

Hepatic

Rare (0.01% to 0.1%): Reversible bilirubin and liver related enzymes
Very rare (less than 0.01%): Hepatitis, jaundice
Postmarketing reports: Hyperbilirubinemia[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis
Frequency not reported: Angioedema[Ref]

Ocular

Frequency not reported: Pars planitis
Postmarketing reports: Visual abnormalities[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain
Postmarketing reports: Myalgia[Ref]

Other

Common (1% to 10%): Lethargy, fatigue, fever
Frequency not reported: Vertigo
Postmarketing reports: Fever[Ref]

Genitourinary

Frequency not reported: Menstrual abnormalities, abnormal urinalysis (characterized by an increase in formed elements in urine sediment) anuria, dysuria, hematuria[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia
Frequency not reported: Thirst[Ref]

Psychiatric

Hallucinations, psychosis, confusion, aggressive behavior, agitation may be more marked in older adults and those with renal impairment.[Ref]

Very rare (less than 0.01%): Agitation, confusion, hallucinations, psychotic symptoms
Frequency not reported: Depression, insomnia
Postmarketing reports: Aggressive behavior[Ref]

Respiratory

Rare (0.01% to 0.1%): Dyspnea[Ref]

Some side effects of acyclovir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Herpes Simplex Encephalitis

3 months to 12 years old: 10 to 20 mg/kg IV every 8 hours

12 years or older: 10 mg/kg IV every 8 hours

Duration of therapy: 10 days (manufacturer); 21 days (CDC)

Comments:
-The Center for Disease Control and Prevention (CDC) recommends 21 days of IV therapy to treat HSV encephalitis.
-Acyclovir is the drug of choice for local and disseminated herpes simplex infection in infants and children.
-CDC STD Treatment Guidelines and the Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Exposed and HIV-Infected Children may be consulted for additional guidance.

Use: For the treatment of Herpes Simplex Encephalitis

Usual Pediatric Dose for Herpes Simplex - Suppression

Neonatal period (less than 1 year): 300 mg/m2 orally 3 times a day for 6 months

Secondary Prophylaxis in HIV-Exposed and HIV-infected Children:
20 mg/kg orally twice a day
Maximum dose: 800 mg

Comments:
-Suppressive therapy following treatment of neonatal HSV disease involving the CNS or skin, eyes, and mouth may prevent cutaneous recurrences and possibly provide superior neurodevelopmental outcomes.
-Beyond the neonatal period, recurrent HSV episodes can be treated successfully and chronic prophylaxis is generally not warranted; however, it may be considered for children with severe and recurrent mucocutaneous (oral or genital) disease.
-Secondary prophylaxis should be re-evaluated periodically (at least annually) as the frequency and severity of infection changes over time.
-Guidelines for the Prevention and Treatment of Opportunistic Infections Among HIV- Exposed and HIV-Infected Children and HIV- Infected Adults and Adolescents may be consulted for additional guidance.

Use: For the secondary prophylaxis of recurrent HSV disease.

Upsides

  • Acyclovir may be used in the treatment of herpes zoster virus (shingles). Acyclovir does not completely rid the body of the herpes zoster virus.
  • Acyclovir may be used to treat initial and recurrent episodes of genital herpes. Acyclovir does not cure genital herpes or completely rid the body of the herpes virus.
  • Acyclovir may be used in the treatment of varicella (chickenpox).
  • Acyclovir is available in a number of different formulations including a tablet, capsule, suspension, buccal tablet, cream, and injection.
  • Generic acyclovir is available.

Acyclovir Pregnancy Warnings

Animal studies have shown this drug readily crosses the placenta. Teratogenicity was not seen when administered to animal models throughout the period of major organogenesis. From 1984 to 1999, a Pregnancy Registry established by the manufacturer and the Centers for Disease Control and Prevention (CDC) collected data for 749 pregnancies (756 outcomes) and found the rate of birth defects for women exposed to systemic drug during the first trimester of pregnancy approximated that of the general population. However, given the small size of the registry, the data is not sufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of this drug during pregnancy. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Benefit should outweigh risk AU TGA pregnancy category: B3 US FDA pregnancy category: B Comments: -This drug has been safely used to treat genital herpes in women in all stages of pregnancy. -Women who acquire genital herpes simplex virus (HSV) during late pregnancy should be managed in consultation with maternal-fetal medicine and infectious-disease specialists. -Suppressive therapy late in pregnancy has been shown to reduce the frequency of cesarean delivery among women with recurrent genital herpes by diminishing the frequency of recurrences at term; such treatment may not protect against transmission to neonates in all cases. -Recommended regimen for HSV suppressive therapy in pregnant women with recurrent genital herpes: 400 mg orally 3 times a day starting at 36 weeks gestation.

Important Information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

How should I take acyclovir?

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

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

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the buccal tablet (Sitavig):

  • Keep the tablet in its blister pack until you are ready to take it. Use a dry finger to remove the tablet.

  • Do not chew or swallow a buccal tablet. Place the flat side of the tablet against your upper gum, behind your lip and above your canine tooth. Place the tablet on the same side of the mouth as your cold sore.

  • Close your mouth and gently press on the outside of your lip over the tablet, holding it in place for 30 seconds. Avoid touching or pressing on the tablet once it is in place.

  • Allow the tablet to dissolve in your mouth throughout the day. You may eat and drink normally while the buccal tablet is in place.

  • During the first 6 hours of wearing time: If the tablet falls off or does not stick well, you may replace it with a new tablet. If you accidentally swallow the tablet, drink a glass of water and put a new tablet in place.

Tell your doctor if you have any changes in weight. Acyclovir doses are based on weight (especially in children and teenagers), and any changes may affect the dose.

Drink plenty of water while you are taking acyclovir to keep your kidneys working properly.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely treated. Acyclovir will not treat a viral infection such as the flu or a common cold.

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.

Acyclovir side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising or bleeding, purple or red pinpoint spots under your skin; or

  • signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • nausea, vomiting;

  • diarrhea;

  • general ill feeling;

  • headache; or

  • mouth pain while using an acyclovir buccal tablet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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