Aclidinium-Formoterol

Aclidinium-Formoterol is a combination medication used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

• Aclidinium-Formoterol is available under the following different brand names: Duaklir Pressair.

Common side effects of Aclidinium-Formoterol include:

• upper respiratory tract infection
• headache
• back pain
• cough
• sinusitis
• influenza
• tooth abscess
• insomnia
• dizziness
• dry mouth
• sore throat
• muscle spasms
• musculoskeletal pain
• joint pain
• pain in extremities
• urinary tract infection (UTI)
• increased blood creatine phosphokinase

Serious side effects of Aclidinium-Formoterol include:

• hives
• difficult breathing
• swelling of the face, lips, tongue, or throat
• chest pain
• eye pain or redness
• fast or irregular heartbeats
• muscle cramps or weakness
• excessive thirst
• difficulty or discomfort urinating
• increased urinary frequency
• seeing halos or colors around lights
• worsening breathing symptoms

Rare side effects of Aclidinium-Formoterol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for inhalation

• (400 mcg/12 mcg)/actuation by breath-actuated dry powder metered-dose inhaler

Chronic obstructive pulmonary disease

Adult dosage

• 1 inhalation orally two times a day
• Not to exceed 1 inhalation two times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Aclidinium-Formoterol has severe interactions with the following drug:
  • umeclidinium bromide/vilanterol inhaled
• Aclidinium-Formoterol has serious interactions with at least 67 other drugs
• Aclidinium-Formoterol has moderate interactions with at least 350 other drugs
• Aclidinium-Formoterol has minor interactions with the following drugs:
  • bendroflumethiazide
  • bumetanide
  • chloroquine
  • chlorothiazide
  • chlorthalidone
  • cyclopenthiazide
  • dimenhydrinate
  • donepezil
  • ethacrynic acid
  • eucalyptus
  • furosemide
  • galantamine
  • green tea
  • hydrochlorothiazide
  • indapamide
  • methyclothiazide
  • metolazone
  • noni juice
  • rimantadine
  • sage

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Severe hypersensitivity to milk proteins
• Hypersensitivity to aclidinium bromide, formoterol fumarate, or any product component
• Not indicated for asthma; use of long-acting beta2-adrenergic agonists (LABAs), including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aclidinium-Formoterol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aclidinium-Formoterol?”

Cautions

• Safety and efficacy not established for patients with asthma; not indicated for asthma; use of LABA as monotherapy (without inhaled corticosteroids) for asthma associated with increased asthma-related deaths; available data do not suggest an increased risk of death with LABAs in patients with COPD
• Do not initiate acutely deteriorating COPD, which may be a life-threatening condition; Aclidinium-Formoterol is intended as maintenance treatment and should not be used for relief of acute symptoms (ie, rescue therapy for acute bronchospasm)
• Instruct patients who have been taking oral or inhaled, short-acting beta2-agonists regularly (eg, 4x/day) to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms
• As with other inhaled drugs containing beta-agonists, do not use more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result; clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs
• May cause paradoxical bronchospasm, which may be life-threatening; if paradoxical bronchospasm occurs, treat immediately with an inhaled short-acting bronchodilator; discontinue Aclidinium-Formoterol and institute alternant therapy
• Immediate hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, rash, bronchospasm, or itching, reported; discontinue Aclidinium-Formoterol and institute alternant therapy if this occurs
• Beta-agonists can produce clinically significant cardiovascular effects as measured by increases in pulse rate, systolic or diastolic or blood pressure, or symptoms; additionally, may cause ECG changes (eg, flattening of the T wave, prolongation of the QTc interval, and ST-segment depression), although clinical significance is unknown
• Caution with using sympathomimetic amines in patients with convulsive disorders, thyrotoxicosis, and in those who are unusually responsive to sympathomimetic amines; doses of the related beta-agonist albuterol, when administered IV, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis
• Caution with narrow-angle glaucoma; monitor for signs and symptoms of acute narrow-angle glaucoma (eg, eye pain or discomfort, blurred vision, visual halos, colored images in association with red eyes from conjunctival congestion, and corneal edema)
• May worsen urinary retention or bladder neck obstruction; monitor for signs and symptoms (. eg, difficulty passing urine, painful urination)
• Hypokalemia and hyperglycemia
  • Beta-agonists may produce significant hypokalemia, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects; this decrease is usually transient, not requiring potassium supplementation
  • Beta-agonist medications may produce transient hyperglycemia
  • Clinical trials of Aclidinium-Formoterol over 24-52 weeks' duration did not show evidence of an effect on serum glucose or potassium
• Drug interaction overview
  • Caution with coadministration with additional adrenergic drugs, by any administration route, because additive sympathetic effects
  • Concomitant treatment with xanthine derivatives or steroids may potentiate any hypokalemic effect of beta-adrenergic agonists
  • Caution if coadministered with other drugs that cause hypokalemia (eg, loop or thiazide diuretics)
  • Caution if beta2-agonists are coadministered with MAO inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval, because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents
  • Formoterol and beta-blockers may inhibit the effect of each other if coadministered; patients with COPD are not typically treated with beta-blockers; however, under certain circumstances              (eg, prophylaxis after MI), there may be no acceptable alternatives to the use of beta-blockers in patients with COPD; if needed, consider cautious use of cardioselective beta-blockers
  • Avoid coadministration of other anticholinergic medications with aclidinium, owing to additive effects

Pregnancy and Lactation

• There are no adequate and well-controlled studies of Aclidinium-Formoterol or its components in pregnant women to assess drug-associated risks
• Labor or delivery
  • No well-controlled human studies
  • Because of the potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom the benefits outweigh the risk
• Lactation
  • There are no available data on the breastfed child or milk production or presence in human milk
  • Both aclidinium bromide and formoterol fumarate are present in rat milk; when a drug is present in animal milk, the drug will likely be present in human milk