Caterol ConviCap(Indacaterol Maleate)
Therapeutic Group: Long acting Selective Beta-2 Adrenoceptor Stimulants
Presentation
Caterol 75 Convicap: Each capsule contains Indacaterol Maleate INN equivalent to 75 µg
Indacaterol. Caterol 150 Convicap: Each capsule contains Indacaterol Maleate INN equivalent to 150 µg Indacaterol.
Description
Indacaterol Maleate is a selective β2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8hydroxy-1H-quinolin-2-one maleate. Indacaterol Maleate has a molecular weight of 508.56, and its empirical formula is C24H28N2O3 • C4H4O4. Indacaterol Maleate is white to very slightly grayish or very slightly yellowish powder. Indacaterol Maleate is freely soluble in Nmethylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate, and n-octanol.
Indications
Indacaterol Maleate is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
Dosage & Administration
The recommended dose is 75-150 µg according to patient’s condition once a day, The
maximum dose is 300 microgram once daily with regard to breathlessness, particularly for
patients with severe COPD.
Side Effects
The common side effects experienced are Cough, Orophary Headache, Nausea. Few side effects may result like musculos disorders: muscle spasm, musculoskeletal pain, periphera
hyperglycemia, sinusitis, upper respiratory tract infection.
Precautions
Indacaterol should not be initiated in patients with acutely deteriorating COPD.
Use in Pregnancy & Lactation
Pregnancy Category C.There are no adequate and well-controlled studies with Indacaterol in pregnant women.Indacaterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Lactation:Caution should be used when Indacaterol is administered to nursing women.
Drug Interaction
Adrenergic drugs, xanthine derivatives, steroids, or diuretics, non-potassium sparing
diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, QTc prolonging drugs,
beta-blockers, inhibitors of cytochrome P450 3A4 and P-gp efflux transporter may interact
with Indacaterol.
Over Dose
In COPD patients, single doses of 10 times, the maximum recommended therapeutic dose were associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval. An overdose of Indacaterol is likely to lead to exaggerated effects typical of β2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia.
Storage
Protect from light, store in cool & dry place.Do not store above 30°C.Keep out of the reach of children.Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.
Commercial Pack
Caterol 75 Convicap: Each box contains 5 alu-alu blister strips of 6 capsules. Caterol 150 Convicap: Each box contains 5 alu-alu blister strips of 6 capsules.
