Acyclovir 200mg/5ml Oral Susp

Manufacturer ACTAVIS MID ATLANTIC Active Ingredient Acyclovir Suspension(ay SYE kloe veer) Pronunciation ay SYE kloe veer
It is used to treat shingles or certain other herpes infections.It is used to treat chickenpox.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiviral
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Pharmacologic Class
Synthetic purine nucleoside analog
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Pregnancy Category
Category B
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FDA Approved
Jan 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Acyclovir is an antiviral medicine used to treat infections caused by herpes viruses, such as cold sores, genital herpes, chickenpox, and shingles. It works by stopping the virus from growing and spreading in your body.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.

Before taking a liquid dose, shake the bottle well to ensure the medication is evenly mixed. Measure the liquid dose carefully using the measuring device provided with the medication. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.

If you are taking this medication to treat cold sores, chickenpox, shingles, or genital herpes, start taking it as soon as symptoms appear. The medication may not be effective if you start taking it too late. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets to ensure their safety.

When you no longer need your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs that may be available.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed, even if you start to feel better. Do not skip doses or stop early.
  • Drink plenty of fluids while taking this medicine to help prevent kidney problems.
  • Acyclovir does not cure herpes infections and does not prevent the spread of the virus to others. Use safe sex practices (e.g., condoms) to reduce the risk of transmission.
  • Avoid activities that require mental alertness until you know how this medicine affects you, as it can cause dizziness or drowsiness in some people.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies significantly by indication. E.g., Genital Herpes (initial): 200 mg 5 times daily for 10 days; Herpes Zoster: 800 mg 5 times daily for 7-10 days.
Dose Range: 200 - 800 mg

Condition-Specific Dosing:

Genital Herpes (initial): 200 mg 5 times daily for 10 days
Genital Herpes (chronic suppression): 400 mg twice daily
Herpes Zoster (shingles): 800 mg 5 times daily for 7-10 days
Varicella (chickenpox): 800 mg 4 times daily for 5 days
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Pediatric Dosing

Neonatal: Not established for oral suspension; IV dosing used for severe infections (e.g., HSV encephalitis).
Infant: Not established for oral suspension; IV dosing used for severe infections.
Child: Varicella (chickenpox): 20 mg/kg (max 800 mg) 4 times daily for 5 days, initiated at earliest sign/symptom. Mucocutaneous HSV: 20 mg/kg (max 400 mg) 3 times daily for 7-10 days.
Adolescent: Dosing typically follows adult guidelines for specific indications (e.g., genital herpes, zoster) or pediatric weight-based dosing for varicella.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 25-50 mL/min: Dose reduction needed (e.g., for zoster, 800 mg 3 times daily).
Moderate: CrCl 10-25 mL/min: Dose reduction needed (e.g., for zoster, 800 mg twice daily).
Severe: CrCl <10 mL/min: Significant dose reduction needed (e.g., for zoster, 800 mg once daily).
Dialysis: Administer dose after dialysis. Supplemental dose may be needed after hemodialysis due to significant removal.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended.

Pharmacology

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Mechanism of Action

Acyclovir is a synthetic purine nucleoside analog with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). It is converted to acyclovir monophosphate by viral thymidine kinase, then to acyclovir triphosphate by cellular enzymes. Acyclovir triphosphate inhibits viral DNA synthesis and replication by competing with deoxyguanosine triphosphate for incorporation into viral DNA, leading to chain termination.
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Pharmacokinetics

Absorption:

Bioavailability: 10-20% (oral)
Tmax: 1.5-2 hours
FoodEffect: Food does not significantly affect the extent of absorption.

Distribution:

Vd: 0.8 L/kg
ProteinBinding: 9-33%
CnssPenetration: Yes (CSF concentrations are approximately 50% of plasma concentrations)

Elimination:

HalfLife: 2.5-3.3 hours (normal renal function)
Clearance: Primarily renal clearance via glomerular filtration and tubular secretion.
ExcretionRoute: Renal (urine)
Unchanged: 62-91% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Variable, depends on viral replication cycle and host immune response. Clinical improvement typically seen within days.
PeakEffect: Not directly quantifiable as a single time point for antiviral effect; peak plasma concentrations reached in 1.5-2 hours.
DurationOfAction: Plasma half-life is 2.5-3.3 hours, requiring frequent dosing to maintain therapeutic levels.
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

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
Behavioral problems
Mood changes
Feeling confused
Hallucinations (seeing or hearing things that are not there)
Seizures
Shakiness
Feeling dizzy or sleepy
Abnormal sensations, such as burning, numbness, or tingling
Changes in speech

Kidney Problems

This medication can cause severe and potentially life-threatening kidney problems. Contact your doctor right away if you experience:

Inability to pass urine
Blood in the urine
Changes in the amount of urine passed
Unexpected weight gain

Blood Problems

In rare cases, this medication can cause severe and potentially life-threatening blood problems, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). Seek medical help immediately if you experience:

Extreme fatigue or weakness
Bruising or bleeding
Dark urine or yellow skin and eyes
Pale skin
Changes in the amount of urine passed
Changes in eyesight
Weakness or numbness on one side of the body
Trouble speaking or thinking
Changes in balance
Fever

Other 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 contact your doctor if you notice any of the following:

Upset stomach or vomiting
Feeling tired or weak

These are not all the possible side effects of this medication. If you have concerns 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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of kidney problems (e.g., little or no urination, painful urination, swelling in your feet or ankles, feeling tired or short of breath)
  • Signs of neurological problems (e.g., confusion, agitation, hallucinations, seizures, unusual behavior)
  • Severe skin rash or blistering
  • Easy bruising or bleeding, unusual weakness
  • Signs of an allergic reaction (e.g., hives, difficulty breathing, swelling of your face/lips/tongue/throat)
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and minimize potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.

To guarantee your safety, it is vital to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

To stay hydrated, drink plenty of non-caffeinated liquids every day, unless your doctor advises you to limit your fluid intake.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Herpes Infection Considerations

This medication is not a cure for herpes infections. Consult your doctor to understand the treatment goals and expectations.

If you have genital herpes, note that this medication will not prevent the spread of the infection. Avoid any sexual activity when you have active sores or symptoms of genital herpes. Additionally, genital herpes can still be transmitted even when you do not have visible symptoms. To minimize the risk of transmission, use a latex or polyurethane condom during sexual activity and consult your doctor for further guidance.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Diarrhea
  • Headache
  • Confusion
  • Hallucinations
  • Seizures
  • Renal failure (elevated serum creatinine and BUN)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Hemodialysis can significantly remove acyclovir from the blood.

Drug Interactions

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Major Interactions

  • Foscarnet (increased risk of renal toxicity)
  • Mycophenolate mofetil (increased concentrations of both drugs)
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Moderate Interactions

  • Probenecid (decreases renal clearance of acyclovir, increasing acyclovir plasma levels)
  • Cimetidine (may increase acyclovir AUC, though less significant than probenecid)
  • Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cyclosporine, tacrolimus - increased risk of renal dysfunction)

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine)

Rationale: Acyclovir is primarily renally eliminated; baseline assessment is crucial for dose adjustment, especially in patients with pre-existing renal impairment or those at risk.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Renal function (BUN, serum creatinine)

Frequency: Periodically, especially in patients with renal impairment, elderly, or those receiving high doses or concomitant nephrotoxic drugs.

Target: Within normal limits or stable for patient's baseline.

Action Threshold: Significant increase in BUN/creatinine; consider dose adjustment or discontinuation.

Hydration status

Frequency: Daily, especially during high-dose therapy.

Target: Adequate fluid intake.

Action Threshold: Signs of dehydration; encourage increased fluid intake to prevent renal crystallization.

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Symptom Monitoring

  • Signs of renal dysfunction (e.g., decreased urine output, edema)
  • Neurological symptoms (e.g., lethargy, confusion, hallucinations, seizures - rare, but more common in renal impairment)
  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Rash or allergic reactions

Special Patient Groups

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Pregnancy

Category B. Studies in animals have not shown fetal harm, and human data from pregnancy registries (e.g., Acyclovir in Pregnancy Registry) have not shown an increased risk of birth defects. Use during pregnancy should be considered when the benefits outweigh the potential risks, especially for severe or life-threatening infections.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects observed in human data.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
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Lactation

Acyclovir is excreted into breast milk. The amount ingested by a breastfed infant is generally low and considered safe by many experts (L2). Monitor infant for adverse effects like rash or diarrhea, though these are rare.

Infant Risk: Low risk (L2 - likely compatible).
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Pediatric Use

Dosing is weight-based for many indications (e.g., varicella). Oral suspension is particularly useful for pediatric patients. Close monitoring for neurological side effects and adequate hydration is important, especially in infants and young children.

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Geriatric Use

Elderly patients are more likely to have age-related decreases in renal function, which can lead to higher acyclovir plasma concentrations. Dose adjustment based on renal function is often necessary. They are also at increased risk for neurological side effects.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of adequate hydration during acyclovir therapy, especially with high doses, to prevent renal crystallization and acute renal failure.
  • Acyclovir is most effective when initiated at the earliest sign or symptom of a viral infection (e.g., within 24 hours of rash onset for varicella/zoster, or at first prodromal symptoms for herpes simplex).
  • Counsel patients that acyclovir is not a cure for herpes infections and does not prevent transmission. Safe sex practices are still necessary.
  • Oral suspension requires shaking well before each use to ensure uniform dosing.
  • Patients with impaired renal function, the elderly, and those receiving high doses are at higher risk for neurotoxicity (e.g., lethargy, confusion, hallucinations, seizures); monitor closely.
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Alternative Therapies

  • Valacyclovir (prodrug of acyclovir, better bioavailability, less frequent dosing)
  • Famciclovir (prodrug of penciclovir, similar spectrum, less frequent dosing)
  • Penciclovir (topical for herpes labialis)
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Cost & Coverage

Average Cost: Relatively inexpensive per 125 mL bottle (200mg/5mL)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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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 your 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 taken, the amount, and the time it happened.