Beclometasone + Formoterol + Glycopyrronium

100 HFA Inhaler: Each puff contains-

• Beclometasone Dipropionate BP 100 mcg
• Formoterol Fumarate Dihydrate BP 6 mcg
• Glycopyrronium Bromide BP equivalent to Glycopyrronium 10 mcg

200 HFA Inhaler: Each puff contains-

• Beclometasone Dipropionate BP 200 mcg
• Formoterol Fumarate Dihydrate BP 6 mcg
• Glycopyrronium Bromide BP equivalent to Glycopyrronium 10 mcg

For Asthma: Recommended doses: Adults (18 years and older): 2 inhalations twice daily (morning and evening, approximately 12 hours apart). The recommended starting dosages are based on patients’ asthma severity.

For COPD: Recommended doses: 2 inhalations twice daily. The maximum dose is two inhalations twice daily. Patients should be advised to take the inhaler every day even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short acting beta-2 agonist should be used for immediate relief. After inhalation, the patient should rinse the mouth with water without swallowing.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Glycopyrronium elimination is mainly through the renal route, so there could be potential drug interactions with medications that affect renal excretion. Beclometasone has a low dependence on CYP3A metabolism, so interactions are unlikely. However, caution and monitoring are advised when used with strong CYP3A inhibitors. Non-cardioselective beta-2 blockers, Quinidine, Disopyramide, and other medications can prolong the QT interval and increase the risk of ventricular arrhythmias when used with inhaled Formoterol. Concomitant use of Monoamine oxidase inhibitors or similar medications can precipitate hypertensive reactions. There is an increased risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons. Xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalemic effect of beta-2 agonists, which can increase the risk of arrhythmias, especially in patients treated with digitalis glycosides.

Hypersensitivity to active substances or any of the excipients.

Side effects include dysphonia, oral candidiasis, muscle spasms and dry mouth. In asthma, side effects tend to occur in the first 3 months after the start of treatment and then become less frequent.

There is no adequate data on the use of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide in pregnant women. Glucocorticoid agents are known to cause effects in the early gestation phase, while beta-2 sympathomimetic agents like formoterol have tocolytic effects. Therefore, as a precautionary measure, it is preferable to avoid the use of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide during pregnancy and labor. Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Infants and neonates born to mothers receiving substantial doses of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide should be observed for adrenal suppression.

This inhaler is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute disease exacerbation. This can worsen asthma symptoms and cause paradoxical bronchospasm, which can be life threatening.It should not be used more than the prescribed dose.It should be used with caution in patients with cardiac arrhythmias, especially third-degree atrioventricular block and tachyarrhythmias, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure). This should be administered with caution in patients with active or quiescent pulmonary tuberculosis and in patients with fungal and viral infections in the airways. Patients with certain conditions like hyperthyroidism, or diabetes mellitus should use it with caution, Patients should be advised to have their rescue inhaler available at all times.

An overdose may produce signs and symptoms due to the individual component’s actions, including those seen with an overdose of other beta-2 agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects. If overdose occurs, the patient's symptoms should be treated supportively with appropriate monitoring as necessary.

Before opening store in the refrigerator at 2-8°C temperature. Do not freeze. During use, keep the inhaler below 25°C temperature for a maximum upto 4 months. Keep away from light and wet places. Keep out of reach of children. Store the inhaler with the mouthpiece down.