Ultibro Breezhaler 110/50MCG Novartis Treatment of chronic lung disease (3 blisters x 10 tablets)

The combination of Indacaterol and Glycopyrronium in Ultibro Breezhaler shows the effect of starting quickly within 5 minutes after taking the drug. The effectiveness is constant in the entire period of 24 -hour drug.

The average bronchodilator effect obtained from FEV1 measurements in sequence for 24 hours is 320ml after 26 weeks of treatment. The effect is significantly greater for Ultibro Breezhaler, when compared to Indacaterol, Glycopyrronium or Tiotropium simply (110 ml difference, for each comparison).

There is no evidence that anaphylaxis shock for the effect of Ultibro Breezhaler over time when compared to the placebo or its monochromatic ingredients.

Dynamic pharmacokinetics

After inhaling the Ultibro Breezhaler, the average time to achieve the peak concentration of plasma of Indacaterol and Glycopyrronium is about 15 minutes and 5 minutes. Based on in vitro performance data, Indacaterol dose is expected to be similar to Ultibro Breezhaler and Indacaterol single -therapy products. Contact in a stable state with Indacaterol after inhaling the same Ultibro Breezhaler or a little lower than the body contact after inhaling the single -therapy product Indacaterol.

After inhaling the Ultibro Breezhaler, the absolute bioavailability of Indacaterol is estimated in the range of 61 to 85% of the distributed doses, and of Glycopyrronium is about 47% of the distributed doses. Contact in a stable state with glycopyrronium after inhaling Ultibro Breezhaler similar to the body contact after inhaling the Glycopyrronium monotherapy.

Hypersensitivity, diabetes and hyperglycemia, insomnia, paresthesia, glaucom, myocardial ischemia, atrial fibrillation, tachycardia, brushed chest drum, nosebleeds, dry mouth, itching/rash, cramps, muscle pain, bladder obstruction and urine stasis, peripheral edema, fatigue.

Instructions on how to handle ADR:

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Be cautious when using

Unused Ultibro Breezhaler with drugs containing beta-adrenergic-acting copper-active substances or prolonged multicolored Muscarinic antagonists.

Bronchial asthma:

Do not use Ultibro Breezhaler to treat bronchial asthma due to lack of data for this indication. Not used in acute cases: Ultibro Breezhaler is not indicated to treat acute bronchospasm.

Hypersensitivity to indacaterol:

If the signs of allergic reactions appear (especially shortness of breath or difficulty swallowing, swelling of the tongue, lips and face, urticaria, skin rash), should stop taking the drug immediately and take appropriate treatment.

paradoxical bronchospasm:

Like other inhaled therapies, Ultibro Breezhaler can lead to paradoxical bronchospasm, sometimes life -threatening. If the paradoxic bronchospasm appears, Ultibro Breezhaler should be stopped immediately and have appropriate treatment.

Anti -anti -anti -cholinergic effects related to glycopyrronium:

Be cautious when using Ultibro Breezhaler for patients with glaucom angle or urinary retention.

Patients with severe renal function:

Use only Ultibro Breezhaler for patients with severe renal impairment (glomerular filtration rate is estimated at less than 30 ml/min/1.73m2) including patients with end -stage renal impairment that need dialysis in case the benefit of the drug is superior to risk and should be closely monitored with adverse reactions of the drug.

The whole body effect of beta isomers:

Be cautious when using Ultibro Breezhaler for patients with cardiovascular disease (coronary artery disease, acute myocardial infarction, arrhythmia, hypertension), patients with epilepsy or thyroid poisoning and patients with abnormal response to Beta2-adrenergic drugs. Ultibro Breezhaler should not be used more or more times or at higher doses.

Cardiovascular effects of beta isomers:

Ultibro Breezhaler can cause clinical effects on some patients expressed by increased heart rate, blood pressure, with or asymptomatic. In this case, it is necessary to consider stopping the drug. Clinical significance related to the extended QTC has not been recorded in the clinical trials of Ultibro Breezhaler using the recommended dose.

Hypotension of beta homogeneous substances:

Clinical significance related to hypokalemia has not been recorded in clinical studies with Ultibro Breezhaler using recommended doses.

Hyperglycaric blood glucose with beta isomers:

Patients with diabetes should be monitored more closely when starting with Ultibro Breezhaler. Ultibro Breezhaler has not been studied in diabetes patients with no blood sugar well.

The ability to drive and operate machinery

This drug does not have or affect the ability to drive and use machinery. However, dizziness can affect the ability to drive and use machines.

Use drugs for women during pregnancy and lactation

pregnancy:

There is no data in using Ultibro Breezhaier for pregnant women. Indacaterol may inhibit labor due to uterine smooth muscle relaxation effect. Ultibro Breezhaier should only be used during pregnancy if the effectiveness of the drug is superior to the risk of the fetus.

breastfeeding period:

It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in breast milk. Existing pharmacokinetic/toxic data shows the excretion of indacaterol, glycopyrronium and their metabolites in the milk of breastfeeding mice. Ultibro Breezhaier should only be used for women who are breastfeeding when the benefits of the drug are superior to the risk of the drug on infants.

Interactive drug

There is no study of drug interaction - specific drugs performed on Ultibro Breezhaler. Information about Ultibro Breezhaler's interaction ability is based on the ability to interact each ingredient of the drug.

Interactions related to indacaterol:

Do not use Ultibro Breezhaler and beta-adrenergic blockers (including eye drops). In case of necessity, the selection of beta-adrenergic blockers should be selected on the heart, but should be used carefully. Be cautious when used with drugs that can extend QTC (Monoamine Oxidase inhibitors, three -round antidepressants ...) because it can increase the risk of ventricular arrhythmia. Simultaneous use with other sympathetic drugs (solitary or in the form of coordination) may increase the adverse effect of Indacaterol. Simultaneously used with methylxanthin derivatives, steroids, non-potassium diuretics can increase the hypotension effect of beta2-adrenergic medications.

Interactions related to metabolism and transportation:

The level of drug exposure is increased due to drug interactions with strong and specific inhibitors CYP3A4 and P-GP (such as ketoconazol, erythromycin, verapamil and ritonavir) but no effect on the safety of the drug.

Interactions related to glycopyrronium:

Simultaneous use of Ultibro Breezhaier with inhaled antiviral drugs is not recommended. It is expected that there is no drug interaction when using glycopyrrinium simultaneously with cimetidine or other organic cation transportation inhibitors.