Beclomethasone / Formoterol / Glycopyrrolate

Beclomethasone / formoterol / glycopyrrolate is a triple-combination inhaled medicine used to manage asthma on a long-term, daily basis.

• Trimbow inhaler is approved for the maintenance treatment of asthma in adults aged 18 and older
• Trimbow is used regularly every day to prevent asthma symptoms — it is not used to treat a sudden attack
• Trimbow is not indicated for relief of acute bronchospasm (sudden airway tightening); a separate short-acting rescue inhaler is always needed for that

Trimbow combines three medicines, each targeting a different part of what goes wrong in asthma. Beclomethasone dipropionate is an inhaled corticosteroid — it dials down the chronic inflammation that makes airways swollen and irritable. Formoterol fumarate is a long-acting beta-agonist that latches onto beta-2 receptors in airway muscle, relaxing the muscle and widening the tubes so air flows more freely. Glycopyrrolate is a long-acting anticholinergic that blocks muscarinic M3 receptors on airway muscle — a completely separate pathway that also causes the muscle to relax and the airway to open up. Used together twice daily, these three actions give broader, more sustained asthma control than any one medicine alone.

Trimbow is taken by oral inhalation twice a day — once in the morning and once in the evening. Your prescriber will set the right dose strength for your level of asthma control; if the starting dose isn't enough, they may move you to a higher strength. The maximum is two inhalations twice daily — do not exceed that amount. There are no specific food restrictions, but always rinse your mouth with water and spit it out after each dose.

• Prime the inhaler (2 test sprays) before first use or after 30+ days of not using it
• Discard when the dose counter hits 000 or after 2 months from first use, whichever is sooner
• Never use Trimbow as a rescue inhaler — always have a fast-acting inhaler available for sudden symptoms

The most common side effects reported with Trimbow include:

• Upper respiratory tract infections and bronchitis
• High blood pressure or elevated blood pressure readings
• Hoarseness or voice changes (dysphonia)
• Back pain and muscle spasms
• Mouth or throat pain
• Sinus infection (sinusitis)
• Flu (influenza)
• Oral thrush — a fungal infection in the mouth or throat (Candida)

More serious reactions — including worsening breathing right after a dose (paradoxical bronchospasm), severe allergic reactions, fast or irregular heartbeat, and vision changes — require immediate medical attention. Rinsing your mouth after every dose is one of the easiest things you can do to prevent oral thrush.

Long-acting beta-agonist (LABA) safety: The formoterol in Trimbow belongs to a class that, when used alone, raises the risk of serious asthma-related events including death. In Trimbow, formoterol is always combined with an inhaled steroid, which removes this extra risk — but you must never add another LABA-containing product while using Trimbow.

• Not for acute attacks: Trimbow must not be used to treat a sudden asthma attack; always have a rescue inhaler
• Adrenal suppression: If switching from oral steroid tablets, taper slowly under medical supervision — stopping too fast can cause a dangerous drop in the body's natural steroid production
• Infections: The steroid component can reduce immune defenses; chickenpox and measles can be severe or fatal; avoid exposure and contact your doctor immediately if exposed
• Eye pressure: Long-term use may worsen narrow-angle glaucoma; report any eye pain or vision changes promptly
• Urinary retention: The glycopyrrolate component may make urination harder, especially in men with an enlarged prostate
• Bone density: Long-term inhaled steroid use can reduce bone strength; your doctor may monitor this
• Low potassium and high blood sugar: These can occur; people with diabetes need extra monitoring
• Heart effects: Use with caution if you have heart disease — formoterol can affect heart rate and rhythm

Trimbow can interact with several types of medicines, so always share your full medication list with your prescriber and pharmacist:

• Other LABAs (salmeterol, vilanterol, olodaterol, indacaterol, arformoterol) — never use alongside Trimbow; risk of overdose and serious heart effects
• MAO inhibitors and tricyclic antidepressants — greatly amplify the cardiovascular effects of formoterol; extreme caution required
• Beta-blockers (metoprolol, propranolol, atenolol) — can block Trimbow's bronchodilating effect and trigger severe bronchospasm; generally avoided in asthma
• Other anticholinergic medicines — additive side effects (dry mouth, urinary problems, eye pressure, constipation); avoid combining
• Diuretics, xanthine derivatives (theophylline), and systemic steroids — may worsen low potassium (hypokalemia) when combined with formoterol
• QT-prolonging drugs (certain antibiotics, antifungals, antipsychotics) — increased risk of abnormal heart rhythms

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Tell your doctor if you are allergic to beclomethasone dipropionate, formoterol fumarate, glycopyrrolate, or any inhaler ingredients — Trimbow is contraindicated with severe hypersensitivity
• Not for children or adolescents — approved only for adults 18 and older
• Pregnancy: Limited human safety data; animal studies showed some fetal harm at high doses — discuss the benefit-risk balance with your doctor; poorly controlled asthma in pregnancy also carries its own risks
• Breastfeeding: It is unknown whether these medicines pass into breast milk; discuss with your doctor
• Severe kidney impairment: Use only if benefit outweighs risk; extra monitoring may be needed
• Severe liver impairment: Formoterol levels may increase; monitor for increased beta-agonist side effects
• Heart disease or high blood pressure: Use with caution; formoterol can raise heart rate and blood pressure
• Narrow-angle glaucoma: Use with caution; both the anticholinergic and steroid components can worsen this condition
• Enlarged prostate or bladder obstruction: Glycopyrrolate may worsen difficulty urinating
• Active infections (TB, fungal, viral, ocular herpes): Inhaled steroids can worsen these; discuss with your doctor
• Diabetes, seizure disorders, or thyroid problems: Use with caution; formoterol may affect blood sugar, heart rate, and seizure threshold

Taking too much Trimbow can cause signs of excess beta-agonist stimulation from formoterol — such as fast heartbeat (up to 200 beats per minute), chest pain, irregular heart rhythm, tremor, headache, nervousness, low potassium, high blood sugar, seizures, and in severe cases, cardiac arrest. Too much of the glycopyrrolate component can cause anticholinergic effects like blurred vision, difficulty urinating, nausea, dizziness, and increased eye pressure. If you suspect an overdose, stop using Trimbow, get medical attention immediately, and cardiac monitoring is recommended.

At the recommended dose, Trimbow has not shown a clinically meaningful effect on the heart's QT interval (a measure of heart rhythm). At four times the recommended dose, a modest increase in QT interval was observed, and a dose-dependent increase in heart rate was seen. The inhaled steroid component (beclomethasone) at recommended doses has shown a favorable balance of local anti-inflammatory activity in the lungs with limited systemic steroid effects on the body's cortisol production.

All three components of Trimbow reach peak blood levels quickly after inhalation — typically within 5 minutes for each. Beclomethasone dipropionate is rapidly converted in the body to its active form, 17-BMP, which has a half-life (the time for half the drug to clear the body) of about 5 hours. Formoterol has a half-life of roughly 6.7 hours and is mainly processed in the liver. Glycopyrrolate is largely excreted unchanged in the urine, with only a small fraction absorbed into the bloodstream after inhalation. Higher doses of the beclomethasone component result in proportionally higher body exposure, while formoterol and glycopyrrolate exposure stays relatively consistent across the two available Trimbow dose strengths.

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).