One patient had a further reduction in LDL-C (8.0%), Total-C (6.7%) and non-HDL-C (7.4%) following 6 weeks of treatment with 40 mg after up-titration.During an extended open-label treatment in 9 of these patients with 20 mg rosuvastatin for up to 90 weeks, the LDL-C reduction was maintained in the range of -12.1% to -21.3%.In the 7 evaluable children and adolescent patients (aged from 8 to 17 years) from the force-titration open label study with homozygous familial hypercholesterolaemia (see above), the percent reduction in LDL-C (21.0%), Total-C (19.2%) and non-HDL-C (21.0%) from baseline following 6 weeks of treatment with rosuvastatin 20 mg was consistent with that observed in the aforementioned study in children and adolescents with homozygous familial hypercholesterolaemia.The European Medicines Agency has waived the obligation to submit the results of studies with rosuvastatin in all subsets of the paediatric population in the treatment of homozygous familial hypercholesterolaemia, primary combined (mixed) dyslipidaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenicity potential. be reassessed. (total n=344). (itraconazole) Oral Solution is increased under fasted conditions reaching higher maximum plasma concentrations (C. max) in a shorter period of time. ketoconazole) and/or in vitro data:- 'Contraindicated': Under no circumstances is the drug to be co-administered with itraconazole, and up to two weeks after discontinuation of treatment with itraconazole.- 'Not recommended': It is recommended that the use of the drug be avoided during and up to two weeks after discontinuation of treatment with itraconazole, unless the benefits outweigh the potentially increased risks of side effects. patients receiving SPORANOX®. Statins interact synergistically with fluconazole, itraconazole, and ketoconazole. Crestor may be given at any time of day, ... Antacid: The simultaneous dosing of Crestor with an antacid suspension containing aluminium and magnesium hydroxide resulted in a decrease in rosuvastatin plasma concentration of approximately 50%. that patients with impaired hepatic function be carefully monitored when taking Itraconazole oral solution is indicated for use in adults.Consideration should be given to national and/or local guidance regarding the appropriate use of antifungal agents.For optimal absorption, Itraconazole oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake). The most common adverse events that led to treatment discontinuation were: myalgia (0.3% rosuvastatin, 0.2% placebo), abdominal pain (0.03% rosuvastatin, 0.02% placebo) and rash (0.02% rosuvastatin, 0.03% placebo). The efficacy and safety of SPORANOX® have not
Crestor also lowers the LDL-C/HDL-C, total C/HDL-C and non-HDL-C/HDL-C and the ApoB/ApoA-I ratios.A therapeutic effect is obtained within 1 week following treatment initiation and 90% of maximum response is achieved in 2 weeks. Six of 53 (11%) itraconazole-treated patients develop signs and symptoms suggestive of liver dysfunction.Transient or permanent hearing loss has been reported in ... Itraconazole 200 mg OD, 5 days. After two years of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see section 5.1).In a clinical trial of children and adolescents receiving rosuvastatin for 52 weeks, CK elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently compared to observations in clinical trials in adults (see section 4.8). taken into consideration, reflecting the greater frequency of decreased
Itraconazole oral solution should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections (see section 4.4). Itraconazole exposure is greater with the oral solution No direct correlation between CIMT decrease and reduction of the risk of cardiovascular events has yet been demonstrated.
Activated charcoal may be given if considered appropriate. If there is no response after 1 week, treatment should be continued for another week.
A pharmacodynamic interaction cannot be excluded (see section 4.5) and caution should be exercised with their combined use.
are contraindicated, not recommended or recommended for use with caution in In situations where co-administration of these medicinal products with Crestor is unavoidable, the benefit and the risk of concurrent treatment and Crestor dosing adjustments should be carefully considered (see section 4.5).- in patients with hypersensitivity to rosuvastatin or to any of the excipients.- in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).- in patients with severe renal impairment (creatinine clearance <30 ml/min).- during pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures.The 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Itraconazole is extensively metabolised by the liver into a large number of metabolites.