Daxas Tablets / Film-coated
Roflumilast
500mcg
NYCOMED GmbH
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | ALPHAMED DRUG STORE |
| Retail Price | 283.00 AED |
Indications
Daxas Tablets / Film-coated is used for:
Chronic obstructive pulmonary disease
Adult Dose
Chronic Obstructive Pulmonary Disease
Reduction of frequency of exacerbations or worsening of symptoms
500 mcg PO once daily
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Contra Indications
Roflumilast is contraindicated to patients with a history of hypersensitivity to Roflumilast or any of other ingredients of the tablet and if a patient has moderate to severe liver impairment.
Precautions
Roflumilast is not a bronchodilator and should not be used for the treatment of a sudden attack of breathlessness. Patients treated with this drug should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, this should be evaluated, and discontinuation of Roflumilast should be considered. Roflumilast should be given with caution in patients with severe immunological diseases (HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy and others), severe acute infectious diseases (tuberculosis or acute hepatitis), cancer (except basal-cell carcinoma), and severe impairment of the heart function.
Lactation: Probable that roflumilast, its metabolites, or both are excreted into milk; avoid use
Pregnancy-Lactation
Pregnancy
Data are not available regarding use in pregnant women
Lactation
Probable that roflumilast, its metabolites, or both are excreted into milk; avoid use
Interactions
Erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine; rifampicin, phenobarb, carbamazepine, phenytoin, theophylline, OC.
Adverse Effects
Side effects of Roflumilast :
1-10%
Diarrhea (9.5%), Weight loss (7.5%), Nausea (4.7%), Headache (4.4%), Back pain (3.2%), Insomnia (2.4%), Decreased appetite (2.1%), Dizziness (2.1%)
1-10%
Abdominal pain (1-2%), Anxiety (1-2%), Depression (1-2%), Dyspepsia (1-2%), Gastritis (1-2%), Muscle spasms (1-2%), Rhinitis (1-2%), Sinusitis (1-2%), Tremor (1-2%), Urinary tract infection (1-2%), Vomiting (1-2%)
Frequency Not Defined
Suicidality
Mechanism of Action
Selective phosphodiesterase (PDE)-4 inhibitor; PDE-4 inhibition leads to accumulation of intracellular cyclic adenosine monophosphate (cAMP) in lung tissue and is thought to be underlying mechanism of action.
Note
Daxas 500mcg Tablets / Film-coated manufactured by NYCOMED GmbH. Its generic name is Roflumilast. Daxas is availble in United Arab Emirates.
Farmaco UAE drug index information on Daxas Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.