What is Alvesco 160 used for?

Alvesco is indicated in treatment to control persistent asthma in adults and adolescents (12 years and older).

What pharmaceutical form is Alvesco 160 available in?

Alvesco 160: Aerozol inhalacyjny, roztwór 160 mcg/dawkę inh.

What are the side effects of Alvesco 160?

Approximately 5% of patients experienced adverse reactions in clinical trials with Alvesco given in the dose range 40 to 1280 micrograms per day. In the majority of cases, these were mild and did not require discontinuation of treatment with Alvesco. Frequency System Organ Class Uncommon (>1/1,000, <1/100) Rare (1/10,000 – 1/,1000) Unknown Cardiac Disorders Palpitations** Gastrointestinal Disorders Nausea, vomiting* Bad taste Abdominal pain* Dyspepsia* General disorders and adm

Who should NOT take Alvesco 160?

Hypersensitivity to ciclesonide or to any of the excipients listed in section 6.1.

Does Alvesco 160 interact with other medications?

In vitro data indicate that CYP3A4 is the major enzyme involved in the metabolism of the active metabolite of ciclesonide M1 in man. In a drug-drug interaction study at steady state with ciclesonide and ketoconazole as a potent CYP3A4 inhibitor, the exposure to the active metabolite M1 increased approximately 3.5-fold, whereas the exposure to ciclesonide was not affected. Therefore the concomitant administration of potent inhibitors of CYP 3A4 (e.g. ketoconazole, itraconazole a

Can Alvesco 160 be used during pregnancy?

Fertility and Pregnancy There are no adequate and well-controlled studies in pregnant women. In animal studies glucocorticoids have been shown to induce malformations (see section 5.3). This is not likely to be relevant for humans given recommended inhalation doses. As with other glucocorticoids, ciclesonide should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. The lowest effective dose of ciclesonide needed to ma

What precautions should be taken with Alvesco 160?

Patients should be carefully instructed in the proper use of their inhaler (see Patient Information Leaflet). As with most inhaled medicinal products in pressurised containers, the therapeutic effect of this medicinal product may decrease when the container is cold. However, Alvesco delivers a consistent dose from –10°C to 40°C. No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

What ATC class does Alvesco 160 belong to?

Alvesco 160: ATC R03BA08. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Alvesco 160

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Other drugs for obstructive airway diseases, Inhalants, Glucocorticoids, ATC Code: R03B A08 Mechanism of action Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor.‍‍‍‍‍‍‍‍‍‍‍‍‍ Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-des-methylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite. Clinical efficacy and safety In four clinical trials, ciclesonide has been shown to reduce airway hyperresponsiveness to adenosine monophosphate in hyperreactive patients with maximal effect observed at the dose of 640 micrograms. In another trial, pretreatment with ciclesonide for seven days significantly attenuated the early and late phase reactions following inhaled allergen challenge. Inhaled ciclesonide treatment was also shown to attenuate the increase in inflammatory cells (total eosinophils) and inflammatory mediators in induced sputum. A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640, and 1,280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC (0-24) /24 hours) nor was a dose-dependent effect seen. In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks. After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo. Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV 1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta-2 agonist. In a 12-week study of 680 severe asthmatics, previously treated with 500-1,000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of an exacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134). Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively. A further 52 week trial involving 367 patients with mild to moderate asthma was unable to demonstrate a significant difference in the effect of higher doses of Ciclesonide (320 or 640 mcg per day) as compared to a lower dose (160 mcg per day) on asthma control.

Alvesco 160

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