Dilarof500 mcg

Dilarof 500 mcg is indicated: As add-on therapy to bronchodilator treatment. For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations. Dilarof 500 mcg should not be used as a rescue medication.

Antihistamines anti-allergies & hypo-sensitisation

Dilarof 500 mcg is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Dilarof 500 mcg.

The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.

The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.

A major step in Dilarof 500 mcg metabolism is the N-oxidation of Dilarof 500 mcg to Dilarof 500 mcg N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Dilarof 500 mcg is not recommended. The co-administration of Dilarof 500 mcg with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Dilarof 500 mcg systemic exposure and may result in increased adverse reactions. The co-administration of Dilarof 500 mcg with oral contraceptives containing gestodene and ethinyl estradiol may increase Dilarof 500 mcg systemic exposure and may result in increased side effects.

Hypersensitivity to Dilarof 500 mcg or to any of the excipients. Moderate to severe liver impairment.

General disorders: Fatigue.Metabolism and nutrition disorders: Decreased appetite, Weight decreased.Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.Nervous system disorders: Dizziness, Headache, Tremor.Psychiatric disorders: Anxiety, Depression, Insomnia.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Dilarof 500 mcg should not be used during pregnancy & lactation.

Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.

No case of overdose has been reported in clinical studies with Dilarof 500 mcg. However, during the Phase I studies of Dilarof 500 mcg, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg, The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.

Store below 30° C, keep away from light, moisture. Keep out of the reach of children.

Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Dilarof 500 mcg in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.Pediatrics (<18 years of age): Safety and effectiveness of Dilarof 500 mcg in children and adolescents below 18 years of age have not been established.Hepatic Impairment: Dilarof 500 mcg is not recommended for use in patients with moderate or severe liver impairment.Renal impairment: No dosage adjustment is necessary for patients with renal impairment

Antihistamines anti-allergies & hypo-sensitisation

Dilarof 500 mcg is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Dilarof 500 mcg.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Dilarof 500 mcg should not be used during pregnancy & lactation.

Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Dilarof 500 mcg in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.Pediatrics (<18 years of age): Safety and effectiveness of Dilarof 500 mcg in children and adolescents below 18 years of age have not been established.Hepatic Impairment: Dilarof 500 mcg is not recommended for use in patients with moderate or severe liver impairment.Renal impairment: No dosage adjustment is necessary for patients with renal impairment