Tribrez
Rx5.5 mcg+10.4 mcg+182 mcg • Metered-Dose Inhaler (MDI)
Indications & Uses
Tribrez is indicated for:
Pharmacology
This inhaler combines three medicines: Budesonide, Glycopyrrolate and Formoterol Fumarate. It is a pressurized metered-dose inhaler, and the medicines are micronized and taken in by oral inhalation. Budesonide is an inhaled corticosteroid (ICS), glycopyrrolate is an anticholinergic, and formoterol fumarate is an inhaled long-acting beta2-adrenergic agonist (a LABA).
ICS medicines such as budesonide help to decrease inflammation in the lungs, and inflammation there can lead to breathing problems. Anticholinergic medicines such as glycopyrrolate, and LABA medicines such as formoterol fumarate, help the muscles around the airways stay relaxed. This prevents symptoms such as wheezing, cough, chest tightness and shortness of breath.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The usual adult dose of Formoterol Fumarate + Glycopyrrolate + Budesonide is two inhalations twice daily, once in the morning and once in the evening, taken by oral inhalation. Don't take more than two inhalations twice daily. After each use, rinse your mouth with water and don't swallow it.
Side Effects
Formoterol fumarate, glycopyrrolate and budesonide can cause serious asthma-related events, including hospitalisations, intubations and death. Other side effects are Candida albicans infection, an increased risk of pneumonia, immunosuppression and risk of infections, hypercorticism and adrenal suppression, and paradoxical bronchospasm. Hypersensitivity reactions, including anaphylaxis, can occur too, as can cardiovascular effects and a reduction in bone mineral density. The medicine can also worsen narrow-angle glaucoma and cataracts, and it can worsen urinary retention.
Cautions & Contraindications
Warnings & Precautions
This Formoterol Fumarate + Glycopyrrolate + Budesonide inhaler has not been shown to be safe or effective in patients with asthma, and it is not indicated for treating asthma. It has also not been studied in patients with acutely deteriorating COPD, so using it in that situation is not appropriate. It should not be used to relieve acute symptoms, that is, as rescue therapy for acute episodes of bronchospasm. It has not been studied for that purpose, and extra doses should not be used for it. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. When treatment with this inhaler begins, patients who have been using inhaled short-acting beta2-agonists on a regular basis (e.g., four times a day) should be told to stop that regular use and keep these drugs only for relief of acute respiratory symptoms. The doctor who prescribes this inhaler should also prescribe an inhaled short-acting beta2-agonist and show the patient how to use it. If a patient needs more and more of the inhaled beta2-agonist, that is a sign the disease is getting worse, and prompt medical attention is needed. The daily dose of this inhaler should not go above the recommended dose. As with other inhaled drugs containing beta2-adrenergic agents, it should not be used more often than recommended, at higher doses than recommended, or together with other medicines containing a LABA, because an overdose may result. Clinically significant cardiovascular effects and deaths have been reported with excessive use of inhaled sympathomimetic drugs. Patients using this inhaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. This inhaler contains budesonide, which is an ICS. Local infections of the mouth and pharynx with Candida albicans have occurred in people treated with orally inhaled products containing budesonide. If such an infection develops, it should be treated with a suitable local or systemic (i.e., oral) antifungal while treatment with this inhaler continues. Lower respiratory tract infections, including pneumonia, have been reported after inhaled corticosteroids. Doctors should stay alert for pneumonia in patients with COPD, because the clinical features of pneumonia and exacerbations often overlap. People using drugs that suppress the immune system are more open to infection than healthy people. Chicken pox and measles, for example, can run a more serious or even fatal course in susceptible children or adults using corticosteroids. Particular care is needed for patients moved from systemically active corticosteroids to an ICS, because deaths due to adrenal insufficiency have occurred during and after such a change to less systemically available ICS. Patients who were previously kept on 20 mg or more per day of prednisone (or its equivalent) may be the most susceptible. Effects of budesonide on the HPA axis are not seen with the therapeutic doses in this inhaler. But going above the recommended dose, or using it together with a strong cytochrome P450 3A4 (CYP3A4) inhibitor, may cause HPA dysfunction. Systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to them. If that happens, appropriate therapy should be started as needed. Caution is needed when considering this inhaler together with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin), because side effects linked to higher systemic exposure to budesonide may occur. Like other inhaled therapies, this inhaler can cause paradoxical bronchospasm, which may be life threatening. If it happens after a dose, treat it straight away with an inhaled short-acting bronchodilator, stop this inhaler immediately and start alternative therapy. Immediate hypersensitivity reactions have been reported after budesonide, glycopyrrolate or formoterol fumarate, which are the components of this inhaler. If there are signs of an allergic reaction, in particular angioedema (including difficulty in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, stop this inhaler at once and consider alternative treatment. Formoterol fumarate, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients, measured as increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias such as supraventricular tachycardia and extrasystoles. If these effects occur, this inhaler may need to be stopped. Beta-agonists have also been reported to cause electrocardiographic changes, such as flattening of the Twave, prolongation of the QTc interval and ST segment depression, although the clinical significance of these findings is unknown. So this inhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension.
Contraindications
Don't use this medicine if you have had a hypersensitivity reaction to budesonide, glycopyrrolate, formoterol or any of the excipients.
Pregnancy & Breastfeeding
There aren't enough well-controlled studies of this inhaler in pregnant women to say what the risk might be. The same is true for two of its individual components, Glycopyrrolate and Formoterol Fumarate. No data are available on how the inhaler affects a breastfed child or milk production. Budesonide, like other ICS, is present in human milk, but there are no data on whether Glycopyrrolate or Formoterol Fumarate pass into human milk.
When deciding whether to use this inhaler, the benefits of breastfeeding for the baby's development and health should be weighed against the mother's clinical need for the inhaler. Any possible adverse effects on the breastfed child, whether from the inhaler or from the mother's own underlying condition, should be weighed as well.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Hepatic impairment: In people with severe hepatic impairment, the body may be exposed to more budesonide and formoterol fumarate. Watch these patients for signs of increased drug exposure.
Renal impairment: If a patient has severe renal impairment, use this medicine only when the expected benefit is greater than the risk.
Pediatric use: This medicine is not indicated for children. The safety and effectiveness of this spray have not been established in pediatric patients.
Geriatric use: The available data show that no dose adjustment is needed for older patients. Still, some older people may be more sensitive to the medicine, and this cannot be ruled out.
Overdose
No cases of overdose have been reported with this inhaler (formoterol fumarate, glycopyrrolate and budesonide). So the overdose risks of each separate component, described below, apply to it. Treatment means stopping the inhaler and giving suitable symptomatic and/or supportive therapy. A cardioselective beta-receptor blocker may be considered, but only with care, because such medicine can cause bronchospasm. Cardiac monitoring is recommended if an overdose happens.
Budesonide: If it is used at excessive doses for a long time, systemic corticosteroid effects such as hypercorticism may occur.
Glycopyrrolate: High doses of glycopyrrolate, a component of this inhaler, may lead to anticholinergic signs and symptoms. These include nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation, or difficulties in voiding.
Formoterol Fumarate: An overdose of formoterol fumarate would likely exaggerate the effects that are typical for beta2-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia and hypokalemia. As with all sympathomimetic medicines, cardiac arrest and even death may be associated with overdosage of formoterol fumarate.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
The canister is pressurized, so don't puncture it, break it or burn it, even when it's empty, because it may explode. Keep it away from direct sunlight and heat. Clean your inhaler regularly as directed.
Don't store it above 30° C. Keep it in a dry place, protected from light, and out of the reach of children. Keep the spray away from your eyes.
Throw the inhaler away within three months of taking it out of the foil pouch. The canister should be at room temperature before you use it, as this gives the best results. Shake it well before each use.
Drug Interactions
Common questions about Tribrez 5.5 mcg+10.4 mcg+182 mcg
What is Tribrez 5.5 mcg+10.4 mcg+182 mcg Metered-Dose Inhaler (MDI)?
Tribrez 5.5 mcg+10.4 mcg+182 mcg Metered-Dose Inhaler (MDI) is a medicine that contains Formoterol Fumarate + Glycopyrrolate + Budesonide. It is made by Beximco Pharmaceuticals Ltd. It belongs to the Combined bronchodilators group of medicines.
What is Tribrez used for?
Tribrez is used for: Asthma, Chronic Obstructive Pulmonary Disease.
What are the side effects of Tribrez?
Formoterol fumarate, glycopyrrolate and budesonide can cause serious asthma-related events, including hospitalisations, intubations and death. Other side effects are Candida albicans infection, an increased risk of pneumonia, immunosuppression and risk of infections, hypercorticism and adrenal suppression, and paradoxical bronchospasm.
Can I take Tribrez during pregnancy or while breastfeeding?
There aren't enough well-controlled studies of this inhaler in pregnant women to say what the risk might be. The same is true for two of its individual components, Glycopyrrolate and Formoterol Fumarate. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Tribrez?
No cases of overdose have been reported with this inhaler (formoterol fumarate, glycopyrrolate and budesonide). So the overdose risks of each separate component, described below, apply to it. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Tribrez?
The canister is pressurized, so don't puncture it, break it or burn it, even when it's empty, because it may explode. Keep it away from direct sunlight and heat.
Can I take other medicines with Tribrez?
Some medicines can interact with Formoterol Fumarate + Glycopyrrolate + Budesonide, for example: Formoterol Fumarate, Ritonavir. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Tribrez?
Tribrez is a prescription (Rx) medicine. Take it as your doctor advises.