Oxima Acucap ^®

No Data

No Data

Oxima^® Acucap Inhaler is indicated for long term, maintenance bronchodilator treatment of airflow limitation in patients with chronic obstructive pulmonary disease (COPD). Oxima^® Acucap is not indicated for the treatment of asthma.

Adult:

The recommended and usual dosage of Oxima^® Acucap Inhaler is the once daily inhalation of the content of one 75 mcg or 150 mcg capsule using the Aculizer. The dosage should only be increased on medical advice. Once daily inhalation of the content of one 300 mcg capsule, using the Aculizer, has only been shown to provide additional clinical benefit to some patients. The maximum dose is 300 mcg once daily. This dose should not be exceeded. Patients with COPD who require corticosteroids should retain this treatment.

Patients with renal impairment: No dosage adjustment is required for renally impaired patients.

Patients with hepatic impairment: No dosage adjustment is required for patients with mild and moderate hepatic impairment. There is no data available for subjects with severe hepatic impairment. 

Pregnancy: lndacaterol is a pregnancy category B drug. Because there are no adequate and well controlled studies in pregnant women, indacaterol should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Lactation: It is not known whether indacaterol is excreted in human milk. Because many drugs are excreted in human milk, the use of indacaterol by breastfeeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. 

No Data

Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long acting
inhaled 132 agonist (salmeterol). Since indacaterol is similar to salmeterol, it might cause these serious breathing problems.

USE IN CHILDREN AND ADOLESCENTS

Oxima^® Acucap Inhaler should not be used in patients under 18 years of age. 

Most common side effects of indacaterol are nasopharyngitis, cough, upper respiratory tract infection, headache and muscle spasms.

lndacaterol is contraindicated in patients with a known history of hypersensitivity to indacaterol or any component of this product.

lndacaterol shows interaction with adrenergic drugs, xanthine derivatives, steroids or diuretics. Concomitant treatment with xanthine derivatives, steroids or diuretics may potentiate any hypokalemic effect of indacaterol. The ECG changes or hypokalemia that may result from the administration of non potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by 13 agonists. lndacaterol as with other 132 agonists should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants or other drugs known to prolong the QTc interval. Beta adrenergic receptor antagonists (13 blockers) and indacaterol may interfere with the effects of each other when administered concurrently. 

An overdose of indacaterol is likely to lead to exaggerated effects typical of 132 adrenergic stimulants. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalized. Use of cardio selective 13 blockers may be considered, but only under the supervision of a physician and with extreme caution since the use of 13 adrenergic blockers may provoke bronchospasm.

Oxima^® Acucap Inhaler is a preparation of lndacaterol Maleate which is an ultra long acting 132 adrenergic agonist. The pharmacological effects of lndacaterol is to stimulate intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3, 5-adenosine monophosphate ( cyclic monophosphate ). Increased cyclic AMP level causes relaxation of bronchial smooth muscle. lndacaterol has more than 24 fold greater agonist activity at 132 receptors compared to 131 receptors and 20 fold greater agonist activity compared to l33 receptors. 

Oxima^® Acucap must not be swallowed. It should be used with Aculizer. Remove Acucap from the blister pack just prior to use, as Acucap exposed to moisture may not tear easily. Store in a cool {below 25°C) and dry place. Protect from light. Keep away from the reach of children.

Oxima^® 75 Acucap Inhaler: Each Acucap capsule contains I ndacaterol Maleate INN 97 mcg equivalent to lndacaterol 75 mcg.

Oxima^® 150 Acucap Inhaler: Each Acucap capsule contains lndacaterol Maleate INN 194 mcg equivalent to lndacaterol 150 mcg.

Oxima^® 300 Acucap Inhaler: Each Acucap capsule contains lndacaterol Maleate INN 389 mcg equivalent to lndacaterol 300 mcg.

Oxima^® 75 Acucap Inhaler: Carton of 30 Acucap capsules in blister pack.
Oxima^® 150 Acucap Inhaler: Carton of 20 Acucap capsules in blister pack.
Oxima^® 300 Acucap Inhaler: Carton of 10 Acucap capsules in blister pack.