Oxima Plus Acucap^®

Oxima Plus@Acucap is the preparation of Indacaterol and Glycopyrronium. Indacaterol is a long acting ß_2-agonist(LABA) which stimulates intracellularadenyl cyclase, causing conversion of ATP to cyclic AMP and increased cyclic AMP levels cause relaxation of bronchial smooth muscle. Glycopyrronium is a long acting muscarinic antagonist (LAMA) which is often referred to as an anticholinergic. It produces bronchodilation by inhibiting acetylcholine's effect on muscarinic receptors in the airway smooth muscle.

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Oxima Plus@Acucap is indicated for long term maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Route of administration: For oral inhalation use only. Acucap must not be swallowed.The recommended dose is the inhalation of the content of one capsule once daily using the Aculizer. Indacaterol & Glycopyrronium combination is recommended to be administered at the same time of the day, each day. If a dose is missed, it should be taken as soon as
possible on the same day. Patients should be instructed not to take more than one dose in a day.

Renal impairment: This can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk. Hepatic impairment: This can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of this combination in patients with severe hepatic impairment, therefore caution should be observed in these patients.

Elderly: This combination can be used at the recommended dose in elderly patients (75 years of age and older).

Pregnancy: This combination is pregnancy category C drug. This combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether this combination is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when this combination is administered to a nursing woman.

Use in children and adolescents
The safety and effcacy Of this combination in pediatric patients have not been established.

Indacaterol increases the risk of asthma related death. So, it is not indicated for the treatment of asthma. Do not initiate in acutely deteriorating COPD or to treat acute symptoms. If paradoxical bronchospasm occurs, discontinue this combination immediately and institute alternative therapy. Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, sensitivity to sympathomimetic drugs, diabetes mellitus and ketoacidosis. Use with caution in patients with narrow angle glaucoma, prostatic hyperplasia or bladder neck obstruction. Be alert to hypokalemia and hyperglycemia.

The common side effects of this combination are nasopharyngitis, hypertension, back pain and oropharyngeal pain.

This combination is contraindicated in patients with known hypersensitivity to indacaterol and glycopyrronium or any components of this product.

Drug interaction with medication:
Caution should be exercised when using with other adrenergic drugs, anticholinergic drugs, beta blockers, xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics. This combination 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 because the action Of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Drug interaction with food and others:
Not applicable.

Treatment Of overdose consists of discontinuation Of this combination together with institution of appropriate symptomatic and supportive therapy. The judicious use Of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of  overdose.

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Oxima Pluse Acucap Inhaler: Each Acucap capsule contains Indacaterol Maleate INN 143 mcg equivalent to Indacaterol 110 mcg and Glycopyrronium Bromide BP 63 mcg equivalent to Glycopyrronium 50 mcg.

Storage
Store in a cool (below 300C) and dry place protected from light. Keep away from the reach of children.

Packing
Oxima Plus@Acucap Inhaler: Carton of
20 Acucap capsules in blister pack.