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DAXAS is a brand name for Roflumilast, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................... 4…
Verbatim from this product's HC label. Tap a section to expand.
DAXAS (roflumilast) is contraindicated in: Patients who are hypersensitive to roflumilast or to any ingredient in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING section.
Patients who have moderate or severe hepatic impairment (Child-Pugh B or C). WARNINGS AND PRECAUTIONS General Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, is not indicated for the relief of acute bronchospasms. DAXAS (roflumilast) should not be used more frequently than once daily.
DAXAS should not be used on its own but as add-on therapy to bronchodilator treatment. Hypersensitivity reactions may occur after administration of DAXAS. DAXAS is not recommended in patients who are hypersensitive to roflumilast or to any ingredient in the formulation (see CONTRAINDICATIONS).
DAXAS tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take DAXAS. Carcinogenesis and Mutagenesis Roflumilast has been demonstrated to produce carcinoma of the olfactory epithelium in hamsters.
Carcinogenesis was related to a rodent-specific toxic metabolite. The relevance of this finding to humans is unknown (see TOXICOLOGY, Carcinogenicity). Due to lack of relevant experience, treatment with DAXAS should not be initiated or existing treatment with DAXAS should be stopped in patients with cancer (except basal cell carcinoma).
Cardiovascular Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied in the clinical trials, and therefore treatment of these patients is not recommended. Supra-ventricular arrhythmia including atrial fibrillation had been reported as a common adverse event (>1%) in the clinical trials (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
If the patient develops supra-ventricular arrhythmia, the risk and benefit of continuing with DAXAS should be evaluated cautiously. COPYRIGHT 2010-2017 ASTRAZENECA CANADA INC. Page 5 of 32 Infections Due to lack of relevant experience, treatment with DAXAS should not be initiated or existing treatment with DAXAS should be stopped in patients with severe acute infectious diseases.
Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited and DAXAS should be used with caution in these patients. Neuropsychiatric An increased number of neuropsychiatric events such as anxiety, depression, insomnia/sleep disorders, dizziness, headache and tremor have been reported in patients treated with DAXAS in comparison with those treated with placebo (see ADVERSE REACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Roflumilast in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Rare instances of suicide behaviours/ideation, and completed suicide, have been reported in patients treated with DAXAS with or without prior history of depression, and causal relation to roflumilast treatment could not be ruled out.
Physicians should discuss neuropsychiatric adverse events with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physician if these events do occur. Physicians should carefully evaluate the risks and benefits of continuing treatment with DAXAS if such events occur.
DAXAS is not recommended in patients who have a history of depression associated with suicidal behaviours or ideation. 2% of patients in the placebo group. 02%) patient in the placebo group. 1% in the placebo group withdrew prematurely from the studies due to diarrhea.
8% of patients treated with placebo. 1%). In the pivotal studies, DAXAS treated patients lost an average of 2 kg of weight while the weight in the placebo group remained stable (see ADVERSE REACTIONS). After discontinuation of DAXAS, the majority of patients had regained body weight after 3 months.
g. diarrhea and weight decrease) with their patients and/or caregivers. Patients and/or caregivers should be instructed to monitor their weight regularly. Physicians should carefully evaluate the risks and benefits of continuing treatment with DAXAS if weight decrease does occur.
Treatment with DAXAS should not be initiated or existing treatment with DAXAS should be stopped in patients with an unexplained and pronounced weight decrease. COPYRIGHT 2010-2017 ASTRAZENECA CANADA INC. Page 6 of 32 Hepatic/Biliary The clinical data with roflumilast 250 mcg in patients with mild to moderate hepatic impairment (classified as Child-Pugh A and B) showed an increased AUC and Cmax in hepatic impairment patients when compared with healthy subjects (see ACTION AND CLINICAL PHARMACOLOGY).
Pharmacokinetic studies have not been performed with roflumilast 500 mcg in hepatically impaired patients. Clinicians should consider the risk-benefit of administering DAXAS to patients who have mild liver impairment (Child-Pugh A).
DAXAS is not recommended for use in patients with moderate or severe liver impairment (see CONTRAINDICATIONS). g. g. methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticosteroids; this […]