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PRESENT & FUTURE PRODUCTS

ACICLOVIR TOPICAL CREAM 5%

 ACICLOVIR Topical Cream 5%

 
CATEGORY :
Antiviral ( topical ) .

MECHANISM OF ACTIONS :
Aciclovir is converted to Acyclovir monophosphate . a nucleotide , by herpes simplex virus (HSV) – coded thymidine kinase . Aciclovir monophosphate is converted to the diphosphate and to the triphosphate .
Acyclovir triphosphate interferes with HSV , DNA polymerase and inhibits viral DNA replication . The triphosphate can be incorporated into growing chains of DNA by viral DNA polymarase , resulting in termination of the DNA chain .

PHARMACOKINETICS :
Absorption :
Intact skin – minimal , Acyclovir not detected in blood or urine .
Diseased skin ( herpes zoster ) – moderate , serum concentration up to 0.28 mcg per mL have been reported in patient with normal renal function and up to 0.78 mcg per mL in patient with impaired renal function .
Elemination :
Renal – up to approximately 9% of the total daily dose may be excreted in the urine .

INDICATIONS :
Aciclovir topical cream is indicated in the management of initial genital herpes and in limited non – life threatening mucocutaneous herpes simplex virus infections in immunocompromised patients .
Topical Aciclovir is not effective in the treatment of recurrent herpes genitalis or herpes febrilis infections in non immunocompromised patients , although topical Aciclovir may cause some reduction in the duration of viral shedding .
Also there is no evidence that topical Acyclovir will prevent the transmission of herpes infection to others or that it will prevent recurrent infections in the absence of signs and symptoms of infection .

CONTRAINDICATIONS :
Aciclovir cream is contraindicated in patients who develop hypersensitivity to the components of the formulation .

ADVERSE EFFECTS :
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent – Approximately 28% Mild pain , burning , or stinging
Incidence less frequent – Approximately 4% Pruritus ( itching ).
Incidence rare – Approximately 0.3% Skin rash .
 
W   A   R   N   I   N   G   S    :
Usage in pregnancy : category B
Usage in lactation : nursing mothers who have active herpetic lesions near or on the breast should avoid nursing .
Pediatric use : safety and effectiveness in pediatric patients have not been established .
Aciclovir cream is intended for cutaneous use only and should not be used in the eye .
 
DOSAGE :
Usual adult and adolescent dose .
Antiviral : topical , to the skin and mucous membranes , every three hours , six times a day , for seven days . Apply a sufficient quantity to cover all lesions adequately .
Usual pediatric dose : see usual adult and adolescent dose .
A finger cot or rubber glove should be used when applying Aciclovir to prevent autoinoculation of other body sites and transmission of infection to other persons .
Therapy should be initiated as early as possible following onset of signs and symptoms .

HOW SUPPLIED :
Topical cream 5% in 10 gram tubes .

STORAGE :
Store below 30º C .
  
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ACICLOVIR TOPICAL CREAM 5%

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VITAMIN A+D OINTMENT
  ACICLOVIR Topical Cream 5%
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