trimbow

For oral inhalation only. ( 2.1 ) 2 inhalations of TRIMBOW 100/6/12.5 mcg micrograms (mcg) twice daily administered by oral inhalation) or 2 inhalations of TRIMBOW 200/6/12.5 mcg twice daily administered by oral inhalation. ( 2.1 ) 2.1 Dosage and Administration Overview Administer 2 inhalations twice daily, in the morning and evening. Do not use more than 2 inhalations twice daily, or 4 inhalations in 24 hours. After inhaling, the patient should rinse the mouth with water without swallowing it to help reduce the risk of oropharyngeal candidiasis. No dose adjustment is required in geriatric patients (65 years of age and older), or in patients with mild to moderate renal impairment [see Use in Specific Populations ( 8.7 )] . 2.2 Recommen d ed Dosage for Maintenance Treatment of Asthma The recommended starting dosage of TRIMBOW is 100 mcg beclomethasone dipropionate, 6 mcg formoterol fumarate, and 12.5 mcg glycopyrrolate (two actuations of TRIMBOW 100/6/12.5 mcg) or 200 mcg beclomethasone dipropionate, 6 mcg formoterol fumarate, and 12.5 mcg glycopyrrolate (two actuations of TRIMBOW 200/6/12.5 mcg), twice daily by oral inhalation. When choosing the starting dose strength of TRIMBOW (100/6/12.5 mcg or 200/6/12.5 mcg), consider the patients’ disease severity, their previous asthma therapy including the inhaled corticosteroid (ICS) dose as well as the patients’ current control of…

The following clinically significant adverse reactions are described elsewhere in labeling: Serious Asthma-Related Events – Hospitalizations, Intubations, Death [ see Warnings and Precautions ( 5.1 ) ] Oropharyngeal Candidiasis [ see Warnings and Precautions ( 5.4 ) ] Immunosuppression and Risk of Infections [ see Warnings and Precautions ( 5.5 )] Hypercorticism and Adrenal Suppression [ see Warnings and Precautions ( 5.7 ) ] Paradoxical Bronchospasm [ see Warnings and Precautions ( 5.9 )] Cardiovascular Effects [ see Warnings and Precautions ( 5.11 )] Reduction in Bone Mineral Density [ see Warnings and Precautions ( 5.12 )] Worsening of Narrow-Angle Glaucoma [ see Warnings and Precautions ( 5.13 )] Worsening of Urinary Retention [ see Warnings and Precautions ( 5.14 ) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, headache, bronchitis, hypertension, respiratory tract infection viral, pharyngitis, blood pressure increased, viral upper respiratory tract infection, dysphonia, upper respiratory tract infection, influenza, oropharyngeal pain, back pain, rhinitis, anemia, sinusitis, laryngitis,…

TRIMBOW is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [ see Wa rnings and Precautions ( 5.2 ) ] . Hypersensitivity to beclomethasone dipropionate, formoterol fumarate, glycopyrrolate or to any of the excipients [see Warnings and Precautions ( 5.10 ) and Description ( 11 )] . Primary treatment of status asthmaticus or asthma requiring intensive measures. ( 4 ) Severe hypersensitivity to any of the ingredients. ( 4 )

TRIMBOW contains beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate; therefore, the risks associated with overdosage for the individual components described below apply to TRIMBOW. Treatment of overdosage consists of discontinuation of TRIMBOW together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage. Beclomethasone Dipropionate If used at excessive doses for prolonged periods, systemic corticosteroid effects, such as hypercorticism may occur [ see Warnings and Precautions ( 5.7 ) ] . Formoterol Fumarate An overdose of formoterol fumarate would likely lead to an exaggeration of effects that are typical for beta 2 -agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest, and even death may be associated with overdosage of formoterol fumarate. Glycopyrrolate High doses of glycopyrrolate, a component of TRIMBOW, may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness,…

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects. ( 7.1 ) Other adrenergic drugs may potentiate effect: Use with caution. ( 7.2 ) Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution. ( 7.3 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system. ( 7.4 ) Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.5 ) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.6 ) Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of TRIMBOW with other anticholinergic-containing drugs. ( 7.7 ) 7.1 Inhibitors of Cytochrome P450 3A4 As beclomethasone dipropionate is mainly metabolized by esterase enzymes, with limited involvement of CYP450, interactions with CYP450 inhibitors are unlikely, but systemic effects with strong CYP3A inhibitors cannot be excluded. Caution should be exercised when considering the coadministration of TRIMBOW with known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.8 ), Clinical Pharmacology ( 12.3 )]. 7.2 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol fumarate, a component of TRIMBOW, may be potentiated [see Warnings and Precautions ( 5.3 )]. 7.3 Xanthine Derivatives, Steroids, or Diuretics Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate the hypokalemic effect of beta 2 -adrenergic agonists such as formoterol fumarate, a component of TRIMBOW. 7. 4 Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging Drugs Formoterol fumarate, like other beta 2 -agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias. 7. 5 Beta-adre ner gic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as formoterol fumarate, but may also produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution. 7. 6 Non-Potassium-Sparing Diuretics The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics. 7. 7 Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of TRIMBOW with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.13 , 5.14 )].