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Drug Details

Aciclovir Tablets 800mg B.P.

• Presentation
  800mg tablets packaged in PVC/aluminum strips (each strip contains five tablets)
• Description
  Each tablet contains 800mg of Aciclovir B.P.
• Indications
  Aciclovir tablets are indicated for • The treatment of herpes zoster (shingles) and varicella (chickenpox) infections. Studies have shown that therapy with aciclovir can reduce the incidence of post-herpetic neuralgia.
• Adult Dosage
  

  Method of administration. Oral.

   

  Adults:

  Treatment of herpes zoster (shingles) and varicella (chickenpox) infections. 800mg five times daily at approximately 4-hourly intervals for 7 days. If patients are severely immunocompromised(e.g following marrow transplant) or if absorption from the G.I.T.is impaired, intravenous therapy should be considered.

  Treatment should commence as soon as possible after the start of an infection

   

  Children

  Treatment of varicella infections:

  Age 6 years and over 800mg four times daily

  Calculating the dosage as 20mg per kg body weight (not to exceed 800mg) four times daily is more precise. Treatment should continue for 5 days. There are no specific data available on the treatment of herpes zoster infections in immunocompetent children.

  Dosage m renal impairment- Aciclovir is excreted via the kidney In the treatment of herpes zoster infections and varicella, dosage of 800mg twice daily at approximately 12-hourly intervals is recommended for patients with severe renal impairment (creatinine clearance less than 10ml per minute) and 800mg three times daily at approximately 6 to 8 hourly intervals is recommended for patients with moderate renal impairment (creatinine clearance in the range of 10 - 25ml per minute)

   

  Elderly

  The total aciclovir body clearance declines along with creatinine clearance in the elderly Adequate hydration should be ensured in elderly patients receiving high oral doses of Aciclovir Particular attention should be given to dosage reduction in elderly patients who have impaired renal function

• Contra Indications
  

  Aciclovir tablets are contra-indicated in patients known to be hypersensitive to aciclovir or valaciclovir or any of the excipients.

• Special Precautions
  

  Aciclovir should be administered with caution to patients with renal or hepatic impairment and may aggravate existing renal dysfunction.

  Care should be taken to maintain adequate hydration in patients receiving higher dose oral regimens e.g. , for the treatment of herpes zoster infection (4 g daily), in order to avoid the risk of possible renal toxicity

  The data currently available from clinical studies are not sufficient to conclude that aciclovir therapy reduces the incidence of chickenpox-related complications in immunocompetent patients

  Results of various in-vitro and in-vivo mutagenicity tests indicate that aciclovir does not pose a genetic risk in man

  Aciclovir tablets have been shown to have no definite effects on sperm count, morphology or motility in man.

  There have been occasional reports of resistance to aciclovir.

• Interactions
  

  No clinically significant interactions have been identified. Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism and reduce aciclovir renal clearance Similarly, increases in plasma AUC's of aciclovir and of the inactive metabolite of mycophenolate mofetil have been shown when the drugs are co-administered. However, no dosage adjustment is necessary because of the wide therapeutic index of aciclovir.

• Adverse Drug Reactions
  

  Gastrointestinal: Nausea, vomiting, diarrhoea and abdominal pains have been reported in some patients. In clinical studies, no difference was found between placebo and aciclovir in the incidence of gastrointestinal events

  Haematological: Very rarely, anaemia, leucopenia and thrombocytopenia.

  Hypersensitivity and skin rashes including photosensitivity, urticaria, pruritis and rarely dyspnoea, angioedema and anaphylaxis

  Kidney: Rare reports of increases in blood urea and creatinine acute renal failure has been reported on very rare occasions.

  Liver: Rare reports of reversible rises in bilirubin and liver related enzymes. Hepatitis and jaundice have been reported on very rare occasions.

  Neurological: Headaches occasionally, reversible neurological reactions, notably dizziness, confusional states, hallucinations, somnolence, convulsions and coma have been reported, usually in patients with renal impairment in whom the dosage was in excess of that recommended or with other predisposing factors.

  Other: Fatigue. Occasional reports of accelerated diffuse hair loss. As this type of hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to aciclovir therapy is uncertain.