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Drug Details

VECTAVIR

• Drug Class Description
  Nucleoside analogues (antivirals) .
• Generic Name
  Penciclovir
• Presentation
  Cream Smooth white cream of homogeneous appearance.
• Description
  Each gram of the cream contains: Active substance: 10 mg penciclovir Excipients: cetostearyl alcohol, propylene glycol.
• Indications
  Vectavir Cold Sore Cream is indicated for the treatment of cold sores (herpes labialis) .
• Adult Dosage
  

  Vectavir Cold Sore Cream should be applied at approximately two hourly intervals during waking hours. Vectavir Cold Sore Cream may be applied with a clean finger or with a single-use applicator (for packages which contain applicators), in the amount required for the size of the affected area of skin. Treatment should be continued for 4 days.

  Treatment should be started as early as possible after the first sign of an infection.

• Child Dosage
  Under 16 years, not recommended.
• Elderly Dosage
  

  No work has been carried out in children below 12 years of age

• Contra Indications
  

  Known hypersensitivity to penciclovir, famciclovir or any of the excipients of the formulation, eg. propylene glycol.

• Special Precautions
  

  The cream should only be used on cold sores on the lips and around the mouth. It is not recommended for application to mucous membranes (e.g. in the eyes, mouth, or nose or on the genitals). Particular care should be taken to avoid application in or near the eyes.

  Severely immunocompromised patients (eg AIDs patients or bone marrow transplant recipients) should be encouraged to consult a physician in case oral therapy is indicated.

  The cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). It also contains propylene glycol, which may cause skin irritation.

• Interactions
  None identified.
• Adverse Drug Reactions
  

  Vectavir Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Vectavir Cold Sore Cream and placebo in the rate or type of adverse reactions reported. The most common events are application site adverse events.

  Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10); common (1/100 to < 1/10); uncommon (1/1,000 to <1/100); rare ( 1/10,000 to < 1/1,000); very rare(<1/10,000); unknown (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  General disorders and administration site condition

  Common: application site reactions (including skin burning sensation, pain of skin, hypoaesthesia)

  Post-marketing surveillance has revealed the following adverse events (all reactions were either localised or generalised). Adverse events from post-marketing experience are difficult to calculate a frequency for and therefore the events are listed as unknown frequency.

  Immune system disorders

  hypersensitivity, urticaria

  Skin and subcutaneous disorders

  dermatitis allergic (including rash, pruritus, blisters and oedema).