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Fluticasone, Umeclidinium, and Vilanterol

Medically reviewed by Drugs.com. Last updated on Jul 12, 2020.

Pronunciation

(floo TIK a sone, ue me kli DIN ee um, & VYE lan ter ol)

Index Terms

  • Fluticasone Furoate, Umeclidinium, and Vilanterol
  • Umeclidinium, Fluticasone, and Vilanterol
  • Vilanterol, Umeclidinium, and Fluticasone

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Trelegy Ellipta: Fluticasone fuorate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg per inhalation (28 ea, 60 ea); Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg per inhalation (28 ea, 60 ea) [contains lactose monohydrate]

Brand Names: U.S.

  • Trelegy Ellipta

Pharmacologic Category

  • Anticholinergic Agent
  • Anticholinergic Agent, Long-Acting
  • Beta2 Agonist
  • Beta2 Agonist
  • Beta2-Adrenergic Agonist
  • Corticosteroid, Inhalant (Oral)

Pharmacology

Fluticasone: A corticosteroid with anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.

Umeclidinium: Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.

Vilanterol: A long-acting beta-2 agonist, relaxes bronchial smooth muscle by selective action on beta-2 receptors with little effect on heart rate.

Use: Labeled Indications

Asthma: Maintenance treatment of asthma in patients ≥18 years of age.

Chronic obstructive pulmonary disease: Maintenance treatment of chronic obstructive pulmonary disease.

Limitations of use: Not indicated for the relief of acute bronchospasm.

Contraindications

Hypersensitivity to fluticasone, umeclidinium, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins; primary treatment of status asthmaticus or other acute episodes of chronic obstructive pulmonary disease or asthma where intensive measures are required.

Dosing: Adult

Asthma: Oral inhalation: Dry powder inhaler: One inhalation (fluticasone furoate 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg or fluticasone furoate 200 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily (maximum dose: 1 inhalation/day).

Chronic obstructive pulmonary disease: Oral inhalation: Dry powder inhaler: One inhalation (fluticasone furoate 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg) once daily (maximum dose: 1 inhalation/day).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral inhalation: Dry powder inhaler: For oral inhalation only; administer at the same time each day. Discard device 6 weeks after it is removed from the foil tray or when the dose counter reads “0” (whichever comes first). Do not open the cover of the inhaler until ready for use; each time cover is opened, 1 dose of medicine is prepared. Exhale fully before taking one long, steady, deep breath through the mouthpiece (do not breathe through nose); hold breath for 3 to 4 seconds and exhale slowly and gently. Following administration, rinse mouth with water after use (do not swallow). If mouthpiece needs cleaning, wipe with a dry tissue.

Storage

Store between 20°C and 25°C (68°F and 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Store in a dry place away from direct heat or sunlight. Store inside the unopened moisture-protective foil tray and only remove from the tray immediately before initial use. Discard 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable.

Drug Interactions

Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Anticholinergic Agents: Umeclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Avoid combination

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Fluticasone (Oral Inhalation). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Oral Inhalation). Consider therapy modification

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Consider therapy modification

Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Consider therapy modification

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Avoid combination

Procarbazine: May enhance the adverse/toxic effect of Sympathomimetics. Management: Consider alternatives to this combination when possible. Procarbazine prescribing information states that this combination should be avoided. Consider therapy modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Monitor therapy

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Adverse Reactions

Also see Fluticasone and Umeclidinium monographs.

1% to 10%:

Central nervous system: Headache (4%), voice disorder (≥1%)

Gastrointestinal: Diarrhea (2%), dysgeusia (2%), constipation (≥1%), oral candidiasis (≥1%), gastroenteritis (1%)

Genitourinary: Urinary tract infection (≥1%)

Infection: Influenza (≥1%)

Neuromuscular & skeletal: Back pain (4%), arthralgia (≥1%)

Respiratory: Pneumonia (8%), bronchitis (≥1%), pharyngitis (≥1%), rhinitis (≥1%), sinusitis (≥1%), upper respiratory tract infection (≥1%), cough (1%), oropharyngeal pain (1%)

Frequency not defined:

Respiratory: Paradoxical bronchospasm

<1%, postmarketing, and/or case reports: Anaphylaxis

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Fluticasone may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, including adrenal crisis, in patients sensitive to these effects. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled corticosteroids; deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic steroids to a less systemically available inhaled corticosteroid. Patients receiving ≥20 mg/day of prednisone (or equivalent) may be most susceptible. Fluticasone/umeclidinium/vilanterol does not provide the systemic steroid dose needed to treat patients having trauma, surgery, or infections. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy is associated with an increased risk of severe exacerbations and asthma-related deaths (SMART 2006; Walters 2007); additional data from other clinical trials suggest risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current guidelines recommend the use of an as-needed low dose inhaled corticosteroid with formoterol for patients with infrequent symptoms (GINA 2020). A similar increase in the risk of death associated with LABAs has not been demonstrated in patients with chronic obstructive pulmonary disease (COPD).

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue fluticasone/umeclidinium/vilanterol and institute alternative therapy

• Hypersensitivity: Hypersensitivity reactions (urticaria, angioedema, rash), including anaphylaxis may occur; discontinue if a hypersensitivity reaction occurs.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use, if possible, in patients with ocular herpes, active or quiescent tuberculosis infections of the respiratory tract; or untreated viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox or measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered.

• Lower respiratory infections: An increase in the incidence of pneumonia and other lower respiratory tract infections (some fatal) have been reported in patients with COPD following use; monitor COPD patients closely since pneumonia symptoms may overlap symptoms of exacerbations.

• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing fluticasone therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.

• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus. In patients presenting to primary care or acute care facility, short-acting beta-2 agonists are recommended for the acute management of exacerbations (GINA 2020).

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral content such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease, especially coronary insufficiency, arrhythmias, and hypertension; beta-agonists may cause elevation in blood pressure, heart rate, and increase risk of arrhythmias (eg, supraventricular tachycardia, extrasystoles); may also cause ECG changes (eg, flattening of the T wave, QTc prolongation, ST segment depression).

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.

• Hepatic impairment: Fluticasone exposure may be increased up to threefold in patients with hepatic impairment; use with caution in patients with moderate or severe impairment and monitor closely.

• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium (effect is usually transient).

• Ocular disease: Use with caution in patients with increased intraocular pressure, cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.

• Prostatic hyperplasia/bladder neck obstruction: Umeclidinium may worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction (eg, painful urination, difficulty passing urine); use with caution.

• Seizure disorders: Use with caution in patients with seizure disorders.

• Thyrotoxicosis: Use with caution in patients with thyrotoxicosis.

Special populations:

• Pediatric: Data from controlled clinical trials suggest LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 cm per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: May contain lactose; anaphylactic reactions have been reported in patients with severe milk protein allergy using other lactose-containing powder products.

Other warnings/precautions:

• Appropriate use: Do not use for acute episodes of asthma or COPD. Do not initiate in patients with significantly worsening, potentially life-threatening, or acutely deteriorating asthma or COPD. Do not exceed the recommended dose.

• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose (eg, patients on prednisone may decrease dose by 2.5 mg weekly during inhaled corticosteroid therapy). Monitor lung function, beta-agonist use, and COPD symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal.

• Transfer to oral inhaler: When transferring to oral inhaler, previously suppressed allergic conditions (arthritis, rhinitis, conjunctivitis, eczema, eosinophilic conditions) may be unmasked.

• Patient information: Patients must be instructed to use short-acting beta2-agonists (eg, albuterol) for acute COPD symptoms and to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of inhaled short-acting beta2-agonists may indicate deterioration of COPD, and medical evaluation to assess treatment regimen must not be delayed.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; bone mineral density (at baseline and periodically thereafter); blood pressure, heart rate; serum potassium (hypokalemic patients) and glucose (diabetic patients); ocular changes (intraocular pressure, cataracts); signs/symptoms of oral or systemic infection, hypercortisolism, or adrenal suppression

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. Refer to individual monographs.

Patient Education

What is this drug used for?

• It is used to treat COPD (chronic obstructive pulmonary disease).

• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Back pain

• Joint pain

• Flu-like symptoms

• Common cold symptoms

• Change in taste

• Nausea

• Vomiting

• Diarrhea

• Constipation

• Throat pain

• Throat irritation

• Mouth irritation

• Mouth pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.

• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat.

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss.

• Severe headache

• Severe dizziness

• Passing out

• Vision changes

• Chest pain

• Fast heartbeat

• Abnormal heartbeat

• Anxiety

• Tremors

• Eye pain

• Severe eye irritation

• Seeing halos or bright colors around lights

• Trouble urinating

• Painful urination

• Change in amount of urine passed

• Thrush

• Bone pain

• Lung problems like shortness of breath or other trouble breathing, cough that is new or worse

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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