Tiotropium/Olodaterol inhaled

Tiotropium/Olodaterol inhaled is a combination of prescription medications used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD). 

• Tiotropium/Olodaterol inhaled is available under the following different brand names: Stiolto Respimat

Common side effects of Tiotropium/Olodaterol inhaled include:

• back pain,
• bleeding gums,
• blood nose,
• white patches in the mouth or throat,
• difficulty having a bowel movement,
• difficulty with moving,
• dry skin,
• heartburn,
• irritation in the mouth,
• mouth ulcers,
• muscle pain or stiffness,
• pain in the joints,
• pain or tenderness around the eyes and cheekbones,
• pain when eating or swallowing,
• redness and swelling of the gums,
• redness, swelling, or soreness of the tongue,
• stuffy or runny nose,
• swelling or inflammation of the mouth,
• trouble sleeping, and
• voice changes

Serious side effects of Tiotropium/Olodaterol inhaled include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• chest pain,
• chills,
• cough,
• fever,
• sneezing,
• sore throat,
• tightness in the chest,
• bladder pain,
• vision loss,
• bloody or cloudy urine,
• blurred vision,
• confusion,
• decrease in the frequency of urination,
• vision changes,
• difficulty, burning, or painful urination,
• difficulty in passing urine (dribbling),
• dizziness,
• dry mouth,
• eye pain or discomfort,
• fainting,
• fast or irregular heartbeat,
• frequent urge to urinate,
• headache,
• itching,
• rash,
• hoarseness,
• irritation,
• joint pain, stiffness, or swelling,
• light-headedness,
• lower back or side pain,
• nausea,
• nervousness,
• pounding in the ears,
• rapid breathing,
• redness of the skin,
• slow or fast heartbeat,
• sunken eyes,
• tearing,
• thirst,
• difficulty swallowing,
• unusual tiredness or weakness,
• seeing halos around lights,
• vomiting, and
• wrinkled skin

Rare side effects of Tiotropium/Olodaterol inhaled include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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

Inhalation spray

• (3.124mcg/2.736mcg)/actuation (equivalent to 2.5mcg/2.5mcg)

Chronic Obstructive Pulmonary Disease

Adult dosage

• Inhale 2 actuation orally once a day at the same time of the 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.

• Tiotropium/Olodaterol inhaled has severe interactions with the following drug:
• umeclidinium bromide/vilanterol inhaled
• Tiotropium/Olodaterol inhaled has serious interactions with the following drugs:
  • amisulpride
  • chloroquine
  • fexinidazole
  • glucagon
  • glucagon intranasal
  • lefamulin
  • pramlintide
• Tiotropium/Olodaterol inhaled has moderate interactions with at least 223 other drugs.
• Tiotropium/Olodaterol inhaled has minor interactions with the following drugs:
  • dimenhydrinate
  • donepezil
  • galantamine

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 your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Use of a LABA without an inhaled corticosteroid; tiotropium/olodaterol inhaled is not indicated for asthma
• Hypersensitivity to tiotropium ipratropium, olodaterol, or other ingredients
• Postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash reported; hypersensitivity reactions were also reported in clinical trials with tiotropium/olodaterol inhaled

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tiotropium/Olodaterol inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tiotropium/Olodaterol inhaled?”

Cautions

• Safety and efficacy in patients with asthma are not established; not indicated for asthma; monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death (see Black Box Warnings)
• Available data do not suggest an increased risk of death with the use of LABA in patients with COPD
• Do not initiate acutely deteriorating COPD
• Do not use for relief of acute symptoms; concomitant short-acting beta2 agonists can be used as needed for acute relief
• Do not exceed the recommended dose; excessive use, or use in conjunction with other medications containing LABA, can result in clinically significant cardiovascular effects and may be fatal
• Immediate hypersensitivity reactions reported; discontinue immediately and consider alternatives if immediate hypersensitivity reactions, including angioedema, bronchospasm, or anaphylaxis, occur (see Contraindications)
• Life-threatening paradoxical bronchospasm can occur; discontinue immediately
• Caution with cardiovascular or convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines
• The drug is an anticholinergic and may increase intraocular pressure; this may result in precipitation or worsening of narrow-angle glaucoma; therefore, the drug should be used with caution in patients with narrow-angle glaucoma; avoid spraying into the eyes; if a patient sprays the drug into the their eyes they may cause acute eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos, or colored images in association with red eyes from conjunctival or corneal congestion; advise patients to consult their physician immediately if symptoms develop while using the drug
• Worsening of urinary retention may occur; caution with prostatic hyperplasia or bladder neck obstruction and instruct patients to consult a physician immediately if this occurs
• May cause hyperglycemia
• Beta2-adrenergic agonists may produce significant hypokalaemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects; a decrease in serum potassium is usually transient, not requiring supplementation
• Monitor patients with moderate-to-severe renal impairment (below 60 mL/min) for anticholinergic adverse effects; tiotropium is predominantly excreted really

Cardiovascular effects

• Can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms
• If symptoms occur, may need to discontinue therapy; there is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with albuterol
• In addition, beta-adrenergic agonists have been reported to produce electrocardiograms (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression
• Therapy should be used with caution in patients with cardiovascular disorders; especially coronary insufficiency, cardiac arrhythmias, and hypertension

Drug interactions overview

• Additional adrenergic drugs by any route may potentiate the sympathetic effects of olodaterol
• Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol
• ECG changes and/or hypokalemia may result from non-potassium sparing diuretics administration (loop or thiazide diuretics) and can be acutely worsened by beta-agonists, especially when the beta-agonist dose exceeds the recommended dose
• Exercise extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or other drugs that cause QT prolongation; drugs are known to prolong the QTc interval may increase the risk of ventricular arrhythmias
• Beta-blockers not only block the therapeutic effects of beta-agonists but may produce severe bronchospasm in COPD patients; use with caution
• May interact additively with concomitantly used anticholinergics; avoid use with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects

Pregnancy & Lactation

• There are no adequate and well-controlled clinical studies with or its components, tiotropium bromide, and olodaterol, in pregnant women to inform of drug-associated risk of adverse pregnancy-related outcomes
• Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

Labor and delivery

• There are no adequate and well-controlled human studies that have investigated effects on preterm labor or labor at term; because of the potential for beta-agonist interference with uterine contractility, use during labor should be restricted to those patients in whom benefits outweigh risks

Lactation

• There are no data on the presence of tiotropium or olodaterol in human milk, effects on the breastfed infant, or milk production
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition