Prevention of Herpes Simplex Virus Infection in Immunocompromised Subjects.

In the immunocompetent subject

Cutaneous or mucosal infections

Treatment of cutaneous or severe mucosal herpes infections (usually primary infections), in particular herpes, genital and herpetic gingivo-stomatitis, acute
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Due to its mode of action, aciclovir does not eradicate latent viruses. After treatment, the patient will remain exposed to the same frequency of recurrences as before.

Treatment of recurrences of herpes, genital.

Prevention of Virus Herpes Simplex infections, in subjects suffering from at least 6 recurrences per year.

Ophthalmological infections

Prevention of Recurrence of Ocular Infections at HSV

O epithelial keratitis, after 3 recurrences per year or in case of a factor, known trigger

O, stromal keratitis and kerato-uveitis after 2 recurrences per year.
O in the case of eye surgery.

Treatment of keratitis and kerato-uveitis at HSV

Reserved for adults and children over 6 years

In the immunodeficient

Prevention of infections with Herpes Simplex in the immunocompromised subject: 4 tablets per day, to be taken at regular intervals, throughout the phase, immunosuppression in which prophylaxis, anti-herpetic is desired. >

In the subject, immunocompetent

Cutaneous or mucosal infections

Treatment of cutaneous or severe mucosal herpes infections: 5 tablets daily, to be taken at regular intervals, for 5 to 10 days.
Treatment of recurrences of genital herpes: 5 tablets daily, to be taken at regular intervals, for 5 days. Treatment should be started as soon as possible, as soon as symptoms appear.

Prevention of infections with Herpes Simplex virus, in subjects suffering from at least 6 recurrences per year: 4 tablets per day, divided into 2 doses. The treatment will be re-evaluated at time intervals of 6 to 12 months, in order to evaluate any possible change related to the natural evolution of the disease. >
Ophthalmological infections

Prevention of Recurrence of Ocular Infections at HSV

Epithelial keratitis, after 3 recurrences per year, keratitis, stromal and kerato-uveitis after 2, recurrences per year: 4 tablets at 200 mg per day divided into 2 doses. Treatment will be re-evaluated at time intervals of 6 to 12 months in order to evaluate any possible changes related to the natural course of the disease. >
O in the case of eye surgery: 4 tablets, 200 mg daily divided into 2 doses

Treatment of eye infections at HSV

O Keratitis and kerato-uveitis 10 tablets at 200 mg daily divided into 5 doses
In renal insufficiency, the dosage will be adjusted according to the clearance of creatinine and may be
Clearance of creatinine

Dosage

> 50 ml / min

4 tablets / day

25 to 50 ml / min

Do not exceed 3 tablets / day

10 to 25 ml / min

Do not exceed 2 tablets / day


Do not give to the child before 6 years, because of the risk of misleading.

Not applicable.

Not applicable.

Orally, intestinal resorption is low. However, it has been described in renal insufficiency treated with doses of aciclovir not adapted to renal function, altered consciousness ranging from mental confusion with hallucinations to coma. Evolution has always been favorable after cessation of treatment and possible hemodialysis

Intravenous administration of a single dose of 80 mg / kg did not cause any adverse effect

Aciclovir is dialysable.

Pregnancy

Studies carried out in animals showed a teratogenic effect in a single species with a very high dosage

In clinical studies, the analysis of one thousand exposed pregnancies apparently revealed no malformative or fetotoxic effects, particularly aciclovir. However, only epidemiological studies could verify the absence of risk.

Therefore, the use of aciclovir should be considered during pregnancy only if necessary.

Aciclovir is not approved for use in genital herpes, recurrent pregnant women, especially at the end of pregnancy.
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Breastfeeding

In the case of a serious condition requiring maternal treatment by the general route, breastfeeding should be avoided. In other cases, if possible, prefer the use of a local treatment for which breastfeeding is possible.

A few benign skin rashes regressing to discontinuation of treatment have been described.


Digestive disorders, nausea, vomiting, diarrhea.

Neuropsychic disorders, headache, ebony sensations. Neurological disorders that are sometimes severe and may include confusion, restlessness, tremors, myoclonus, convulsions, hallucinations, psychosis, somnolence, coma have rarely been reported: they are usually inadequate, kidneys have received higher doses, The recommended dosage or elderly patients (see section 4.4).


The presence of these symptoms should lead to an overdose (see section 4.3).
Liver disorders, reversible increases in bilirubin and serum hepatic enzymes have been reported.

Hypersensitivity reactions and skin reactions: rash, skin, urticaria, pruritus and exceptionally, dyspnea, angioedema and anaphylactic reactions.
Hematological disorders: exceptional cases of thrombocytopenia and leukopenia

Kidney disorders, unusually increased blood urea and creatinine and renal insufficiency, acute, especially in the elderly or inadequate, renal if the dosage is exceeded

Miscellaneous effects: cases of fatigue have sometimes been reported.

Prevention of Herpes Simplex infections in immunocompromised subjects In the immunocompetent patient Cutaneous or mucosal infections Treatment of cutaneous or severe mucosal infections (usually primary infections), in particular Herpes, genital and herpetic gingivo-stomatitis, acute Because of its mode of action, aciclovir does not eradicate latent viruses. After treatment, the patient will remain exposed to the same frequency of recurrences as before, treatment of recurrences of herpes, genital, prevention of Herpes Simplex infections, subjects suffering from at least 6 recurrences Ophthalmologic infections Prevention of recurrences of ocular infections HSV epithelial keratitis After 3 recurrences per year or in case of factor, known triggering o Stromal keratitis and kerato-uveitis after 2 recurrences per episode In the case of eye surgery Treatment of keratitis and kerato-uveitis in HSV