Aciclovir 200mg Tablets

… r treatment (See section 5.1). Aciclovir should also be used with caution in patients with underlying neurological abnormalities, severe hepatic or electrolyte abnormalities or significant hypoxia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… r treatment (See section 5.1). Aciclovir should also be used with caution in patients with underlying neurological abnormalities, severe hepatic or electrolyte abnormalities or significant hypoxia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment (See section 5.1). Aciclovir should also be used with caution in patients with underlying neurological abnormalities, severe hepatic or electrolyte abnormalities or significant hypoxia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… r treatment (See section 5.1). Aciclovir should also be used with caution in patients with underlying neurological abnormalities, severe hepatic or electrolyte abnormalities or significant hypoxia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… e data currently available from clinical studies is not sufficient to conclude that treatment with acyclovir reduces the incidence of chickenpox-associated complications in immunocompetent patients. This medicine contains less than 1 mmol sodium (23mg) per dosage unit, that is to say, essentially 'sodium-free'. Cases of severe cutaneous adverse reactions (SCARs), including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), drug reaction with …

Hydration status: Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. The risk of renal impairment is increased by use with other nephrotoxic drugs. The data currently available from clinical studies is not sufficient to conclude that treatment with acyclovir reduces the incidence of chickenpox-associated complications in immunocompetent patient …

… aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment (See section 5.1). Aciclovir should also be used with caution in patients with underlying neurological abnormalities, severe hepatic or electrolyte abnormalities or significant hypoxia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Hydration status: Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. The risk of renal impairment is increased by use with other nephrotoxic drugs. The data cur …

… ave developed SCARs with the use of aciclovir or valaciclovir must not receive aciclovir (see Contraindications and Adverse Reactions) Use in patients with renal impairment and in elderly patients: Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2 Posology and Method of Administration). Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8 Undesirable Effects). Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclo …

… ain. Caution should therefore be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3. Lactation Following oral administration of 200mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These …

… lasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman. Fertility There is no information on the effect of aciclovir on human female fertility. See clinical studies in section 5.2

… n should therefore be exercised by balancing the potential benefits of treatment against any possible hazard. Findings from reproduction toxicology studies are included in Section 5.3. Lactation Following oral administration of 200mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3 mg/kg/day. Caution is therefore advised if aciclovir is to be administered to a nursing woman. Fertility There is no information on the effect of aciclovir on human female fertility. See clinical studies in section 5.2

Pregnancy A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of aciclovir. The registry findings have not shown an increase in the number of b …

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