APIS
| Active Pharmaceutical Ingredient | Latin Name | Molecular Formula | Defination | Structural Formula |
| Aciclovir Tablets | Aciclovir Tabulettae | C8H11N5O3 | 9-((2-Hydroxyethoxy)methyl)guanine |  |
Details
Aciclovir Tablet Pharmacotherapeutic Profile
Clinical Indications Matrix
| Pathogen | Clinical Manifestation | Therapeutic Window | Target Population |
|---|---|---|---|
| HSV-1/2 | • Acute primary/recurrent mucocutaneous lesions • Genital herpes (suppressive therapy) |
Onset ≤48h post-prodrome | Immunocompetent adults |
| VZV | • Herpes zoster eruption • Varicella exanthem |
Lesion age <72h (zoster) Rash onset <24h (varicella) |
Renal-sufficient patients |
| HSV prophylaxis | Post-transplant immunosuppression | Initiate pre-chemotherapy | Hematopoietic stem cell recipients |
Contraindication Spectrum
Absolute:
• Hypersensitivity to purine nucleoside analogues
• Propylene glycol hypersensitivity (PEG-400 intolerance)
Relative:
• Pregnancy category B3 (AU TGA classification)
• Lactation status: Secretion ratio 0.6-1.5 (milk/plasma)
Adverse Effect Stratification
A. Frequent (≥1/100)
Gastrointestinal: Nausea (12-18%), diarrhea (8-15%)
Neurological: Cephalgia (6-9%)
B. Clinically Significant (≥1/1000)
Hepatobiliary: ALT elevation >3×ULN (0.7%)
Renal: CrCl reduction ≥25% baseline (0.5%)
C. Critical Monitoring Events
Neurotoxicity triad (CrCl <50 mL/min):
Confusional state (GCS ≤14)
Visual hallucinations
Myoclonus
Risk Mitigation Protocol
Renal Dosing Adjustment
| eGFR (mL/min/1.73m²) | Dose Frequency | Hydration Requirement |
|---|---|---|
| >50 | q8h | 1500 mL/day |
| 25-50 | q12h | 2000 mL/day |
| <25 | q24h | Contraindicated |
Neurotoxicity Management Pathway
Suspected CNS toxicity → Immediate serum level testing → Hemodialysis if [Aciclovir] >25 μg/mL
Interactions
For Aciclovir Tablets:
Probenecid is reported to block the renal clearance of aciclovir.
Known Symptoms Of Overdosage And Particulars Of Itstreatment:
See Side-effects and Special Precautions. Ingestion of doses of aciclovir in excess of 5 gwarrants close observation of the patient. Aciclovir is dialysable. Treatment issymptomatic and supportive.
Storage Instructions:
Do not store above 30 °C.Keep in a dry place, protected from light.Keep out of the reach of children.
Manufactured by:
Reyoung Pharmaceutical Co.,ltd.
No.1, Ruiyang Road,Yiyuan County,Shandong Province,China.
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