Ultivent-M Cozycap | 50 mcg Cozycap
Price: 0.00Generic: Glycopyrronium + Indacaterol + Mometasone Furoate
Manufactured By: Square Pharmaceuticals PLCVariant: Cozycap 150 mcg, Cozycap 160 mcg
Composition
Each Ultivent-M Cozycap contains Glycopyrronium Bromide EP equivalent to Glycopyrronium 50 mcg & Indacaterol Maleate INN equivalent to Indacaterol 110 mcg.
Description
Ultivent-M Cozycap is a once daily fixed dose combination of Glycopyrronium, a long acting muscarinic receptor antagonist (LAMA) and Indacaterol, a long acting β2 receptor agonist (LABA). When Glycopyrronium & Indacaterol are administered together, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve bronchial smooth muscle relaxation.
Indication
Ultivent-M Cozycap is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It should not be used in acute episodes of bronchospasm. Ultivent-M Cozycap is not indicated for asthma.
Dosage and Administration
Ultivent-M Cozycap is recommended for once-daily administration at the same time each day. Ultivent-M Cozycap capsules must be administered only by the oral inhalation route and only using the revolizer™ device. Ultivent-M Cozycap capsules must not be swallowed. If a dose is missed, it should be taken as soon as possible. Patients should not take more than one dose in a day.
Contraindications
It is contraindicated in patients with hypersensitivity to Glycopyrronium or Indacaterol, or to any other component of this combination; Patients with severe hypersensitivity to milk proteins and All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication.
Side Effects
Adverse reactions that have been associated with muscarinic antagonists include cardiovascular effects (atrial arrhythmias and tachycardia), ocular disorders (e.g., blurred vision), urinary retention, gastrointestinal disorders, dry mouth and cough. Adverse reactions that have been associated with β2-agonists include immediate hypersensitivity reactions (urticaria, rash, bronchospasm, edema and angioedema), cardiovascular effects (tachycardia, arrhythmia, palpitations, myocardial ischaemia, hypertension or. hypotension), hypokalemia, hyperglycemia, headache, nervousness, insomnia, muscle spasms, fatigue, malaise and tremor. The most common adverse drug reactions related to the drug product (reported >3% and greater than placebo) were cough and oropharyngeal pain (including throat irritation).
Use-in Special Populations
- Geriatric: Ultivent-M Cozycap can be used at the recommended dose in elderly patients (65 years of age and older).
- Pediatric: The safety and efficacy of Ultivent-M Cozycap in pediatric population under 18 years of age have not been established.
- Renal impairment: Ultivent-M Cozycap 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 (estimated glomerular filtration rate below 30 ml/min/1.73 m2), it should be used only if the expected benefit outweighs the potential risk.
- Hepatic impairment: Ultivent-M Cozycap can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of in patients with severe hepatic impairment, therefore caution should be observed in these patients.
Warning and Precautions
Long-acting β2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma. This combination should be used with caution in patients with narrow angle glaucoma or urinary retention. β2-adrenergic agonists may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects.
Administration of this combination Ultivent-M Cozycap may result in paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, this combination Ultivent-M Cozycap should be discontinued immediately and alternative therapy instituted. β2 receptor agonists may produce significant hypokalemia is some patients, which has the potential to produce adverse cardiovascular effects. Inhalation of high doses of β2 agonists may produce increases in plasma glucose. Upon initiation of treatment with this combination plasma glucose should be monitored more closely in diabetic patients.
Use in Pregnancy and Lactation
Pregnancy: Pregnancy category C There are no data from the use of this combination in pregnant women available. Therefore, this combination should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Lactation: It is not known whether Indacaterol, Glycopyrronium and their metabolites are excreted in human milk. The use of this combination by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Drug Interactions
No specific interaction studies were conducted for Glycopyrronium and Indacaterol combination. Information on the potential for interactions is based on the potential for each individual component. The concomitant use of Glycopyrronium and Indacaterol with β-adrenergic blockers, anticholinergics or sympathomimetic agents is not recommended.
Sympathomimetic agents may potentiate the adverse events of Indacaterol. Caution is required with the concomitant use of hypokalemic treatment.
Over dosage
There is no information on clinically relevant overdosing with this combination. An overdose could lead to exaggerated effects typical of β2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia & hyperglycemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalized.
Storage condition
Store below 30ºC, keep away from light & moisture. Keep out of the reach of the children. Pharmaceutical Precautions Ultivent-M Cozycap must not be swallowed. Only to be used with revolizer™ device. Remove Ultivent-M Cozycap capsule from the blister pack only immediately before use it in the revolizer™.