Acyclovir Sodium 50mg/ml Inj, 10ml

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). Its antiviral activity is highly selective due to its preferential uptake and phosphorylation by virus-infected cells. Acyclovir is converted to acyclovir monophosphate by viral thymidine kinase, then to acyclovir triphosphate by cellular enzymes. Acyclovir triphosphate inhibits viral DNA replication by competing with deoxyguanosine triphosphate for incorporation into viral DNA and by inactivating the viral DNA polymerase.

Serious 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 or seek medical attention immediately:

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 burning, numbness, or tingling sensations
Changes in speech
Severe kidney problems, which may be indicated by:
+ Inability to pass urine
+ Blood in the urine
+ Changes in the amount of urine passed
+ Unexpected weight gain
Life-threatening blood disorders, such as thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which may be indicated by:
+ Feeling extremely tired or weak
+ 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 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 contact your doctor or seek medical help if you notice any of the following:

Upset stomach or vomiting
Feeling tired or weak
* Irritation at the injection site

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or 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.

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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 does not cure 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 other 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.

• Foscarnet (increased risk of renal impairment)
• Mycophenolate mofetil (increased mycophenolic acid exposure)

• Probenecid (decreases acyclovir renal clearance, increasing plasma levels and half-life)
• Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs, cyclosporine, tacrolimus, amphotericin B, iodinated contrast media - increased risk of renal dysfunction)
• Zidovudine (potential for increased neurotoxicity, though clinical significance is debated)

• Signs of renal dysfunction (decreased urine output, swelling, fatigue)
• Neurological changes (confusion, lethargy, agitation, tremors, seizures, hallucinations)
• Injection site reactions (pain, redness, swelling, phlebitis)
• Nausea, vomiting, diarrhea
• Headache
• Rash

Acyclovir is generally considered safe for use during pregnancy (Category B). Data from the Acyclovir Pregnancy Registry did not show an increased risk of birth defects compared to the general population. Use should be considered when the benefits outweigh the potential risks, especially for severe or life-threatening herpes infections.

Acyclovir is excreted into breast milk. However, the amount ingested by the infant is generally considered low, and adverse effects in breastfed infants are not commonly reported. The American Academy of Pediatrics considers acyclovir compatible with breastfeeding. Monitor the infant for diarrhea or rash.

Dosing is weight-based and varies significantly by age and indication. Neonates and infants require careful dosing and monitoring due to immature renal function. IV acyclovir is crucial for severe or disseminated HSV/VZV infections in pediatric patients.

Elderly patients are more likely to have decreased renal function, which necessitates dose adjustment. They are also at higher risk for neurological adverse effects. Monitor renal function and neurological status closely.

• Always ensure adequate hydration during IV acyclovir administration to prevent renal tubular crystallization and acute renal failure.
• Infuse acyclovir IV slowly over at least 1 hour to minimize the risk of renal toxicity and injection site reactions.
• Dose adjustments are critical in patients with renal impairment; calculate creatinine clearance before initiating therapy.
• Monitor for neurological symptoms (e.g., lethargy, confusion, seizures), especially in patients with renal dysfunction or those receiving high doses.
• Acyclovir is not a cure for herpes infections; it helps manage symptoms and reduce viral shedding.

• Valacyclovir (prodrug of acyclovir, oral only)
• Famciclovir (prodrug of penciclovir, oral only)
• Ganciclovir (for CMV, not typically HSV/VZV)
• Foscarnet (for resistant HSV/VZV, or in immunocompromised patients with severe disease)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.