Ultibro Breezhaler Novartis medicine for reduced obstructive lung disease (5 blisters x 6 tablets)

Dosage form Box of 30 tablets
Specifications Glycopyrronium, indacaterol

Ingredient

Composition information	Content
Glycopyrronium	50mcg
Indacaterol	110mcg

Uses

indications

Ultibro Breezhaler 110/50 mcg is indicated in the following cases:

Ultibro Breezhaler is a bronchodilator prescribed one -time daily use in maintenance treatment to reduce symptoms and reduce exacerbations in patients with chronic lung disease (COPD). Breezhaler, they bring outstanding efficiency due to different modes of operation aimed at different receptors and roads to achieve smooth muscle relaxation. Due to the different density of beta 2 receptors and M3 receptors in the central and peripheral airway, beta 2 anti -Beta 2 drugs should be more effective in dilating peripheral airway, while cholinergic resistant compounds can be more effective in the central respiratory tract. Therefore, to relax the bronchi in both peripheral and the center of the lungs in humans, the combination of Beta 2 - Adrenergic and Muscarinic antagonists may be beneficial.

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.

Before taking Ultibro Breezhaler Novartis medicine for reduced obstructive lung disease (5 blisters x 6 tablets)

How to use

only use Ultibro Breezhaler capsules in the mouth and use only with Ultibro Breezhaler inhaler. Do not swallow Ultibro Breezhaler capsule.

Dosage

The recommended dose is the use of Ultibro Breezhaier once a day with the amount of drug contained in 1 capsule 110/50 mcg.

Renal function decline:

Can be used at the recommended dose for patients with mild to medium impaired renal function. Ultibro Breezhaler should only be used for patients with severe renal impairment or end -stage kidney disease requiring dialysis if the effectiveness of the drug is superior to the risk.

Liver function decline:

Can use Ultibro Breezhaier at the recommended dose for patients with mild to moderate liver function impairment. There is no data on patients with severe liver failure.

Children:

Do not use Ultibro Breezhaler for patients under 18 years old.

Elderly:

Can use Ultibro Breezhaler at the recommended dose for patients over 75 years old.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? Fertilization or urination.

Support support and treatment of symptoms are indicated in this case. In serious cases, patients should be hospitalized. Using selective beta blockers on the heart can be considered to treat the symptoms of Beta2-adrenergic strength but under the supervision of the doctor and should be very careful because of the use of beta-adrenergic blockers can cause bronchospasm.

What do

do when you forget a dose? If you miss a dose, it should be done as soon as possible during the same day. Patients should be instructed not to take more than one dose in a day.

Side Effects

When using Ultibro Breezhaler 110/50 mcg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Respiratory respiratory infections, pharyngitis, sinusitis, rhinitis, cough, sore throat including throat irritation.

kidney: Urinary tract infection. Systemic: dizziness, headache, indigestion, tooth decay, musculoskeletal, fever, chest pain.

Uncommon, 1/1000

Hypersensitivity, diabetes and hyperglycemia, insomnia, paresthesia, glaucom, myocardial ischemia, atrial fibrillation, tachycardia, chest drum, orange bleeding, 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.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Ultibro Breezhaler 110/50 mcg contraindications in the following cases:

Patients with hypersensitivity to Indacaterol, an ingredient of Ultibro Breezhaler, or any ingredient of the drug.

Be cautious when used

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

Bronchial asthma:

Do not use Ultibro Breezhaler to treat bronchial asthma due to lack of data for this indication. Do not use in acute cases: Ultibro Breezhaler is not specified 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 bronchial manifestation appears, Ultibro Breezhaler should be stopped immediately and take appropriate treatment.

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

Should 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.

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.

Lactation period

It is not known whether indacaterol, glycopyrronium and their metabolites are excreted into 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 the interaction of Ultibro Breezhaler 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, and non-potassium diuretics can increase the hypotension effect of Beta2-adrenergic bronze medications.

Interactions related to metabolism and transportation:

The level of drug exposure is increased due to strong and powerful inhibitors and CYP3A4 and P-GP (such as ketoconazole, 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.

Storage

Do not store drugs above 30 ° C. Avoid moisture.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.