Beclomethasone / Formoterol / Glycopyrrolate

Beclomethasone / Formoterol / Glycopyrrolate is a combination inhaled medicine. The supported product is:

• Trimbow: maintenance treatment of asthma in adults 18 years and older.
• Trimbow is not for relieving sudden bronchospasm.

The three ingredients work together. Beclomethasone is an inhaled corticosteroid that reduces inflammation in the airways. Formoterol is a long-acting beta2-agonist that relaxes airway muscle. Glycopyrrolate is an anticholinergic that blocks a muscle receptor (M3) to help open the airways.

Trimbow is breathed in through the mouth, twice a day, morning and evening. Each dose is 2 puffs. Your prescriber chooses the strength based on your asthma control.

• Prime before first use and again if unused for 30 days or longer.
• Rinse your mouth with water afterward and spit it out.
• Do not take more than 2 puffs twice daily.
• Discard the inhaler when the counter reads 000 or 2 months after first use.

The most common side effects in studies were:

Get help for sudden worse breathing after a dose, thrush, eye pain or vision changes, or trouble urinating.

• Not a rescue inhaler. Do not start it during a rapidly worsening asthma attack.
• Do not use with other LABA-containing medicines. Overdose can cause serious heart effects.
• Can cause mouth and throat thrush. Rinse after each dose.
• May worsen infections, including tuberculosis, and chickenpox or measles can be more serious.
• Adrenal problems can occur when switching from steroid tablets or at high doses.
• Use caution with heart disease, bone loss, glaucoma, urinary retention, seizures, thyroid overactivity, diabetes and ketoacidosis.
• Watch for low potassium and high blood sugar.

Several medicines can affect or be affected by Trimbow:

• Other LABAs: overdose risk.
• Other anticholinergic drugs: added side effects.
• Beta-blockers: can block benefit and trigger bronchospasm.
• MAO inhibitors, tricyclic antidepressants, macrolides and QTc-prolonging drugs: stronger heart effects.
• Diuretics, xanthines and steroids: more potassium loss.
• Other adrenergic drugs: stronger stimulant effects.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

• Do not use during status asthmaticus or other acute asthma episodes needing intensive care.
• Do not use if allergic to any ingredient.
• Not for people under 18.
• Pregnancy: human data are lacking, so use the lowest effective dose and discuss with your doctor. Uncontrolled asthma also carries risks.
• Breastfeeding: no human data on milk transfer.
• Severe liver impairment may raise formoterol levels, and severe kidney impairment calls for weighing benefit against risk.

Too much can cause fast or irregular heartbeat, chest pain, high or low blood pressure, tremor, nervousness, headache, seizures, nausea, dizziness and low potassium. Too much glycopyrrolate can cause blurred vision, dry mouth, constipation and trouble urinating. The label says treatment means stopping the medicine and giving supportive care with heart monitoring.

In a study of healthy volunteers, the usual dose caused a small rise in heart rate and no clinically relevant change in the QT interval, an electrical measure of the heart. Higher doses raised heart rate more. Systemic steroid effects are expected to be no greater than those of a beclomethasone inhaler.

After inhalation, all three drugs reach peak levels within about 5 minutes, though the active form of beclomethasone peaks at about 30 minutes. Beclomethasone is broken down quickly and leaves mostly in stool. Half-lives are about 5 hours for its active form and about 6.7 hours for formoterol. Small amounts of formoterol and glycopyrrolate leave unchanged in urine.

store near heat or open flame. Keep out of reach of children. Prior to first use: Store refrigerated at 36°F to 46°F (2°C to 8°C).