Tiotropium

Tiotropium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Tiotropium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school.

Tiotropium must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

Tiotropium is available under the following different brand names: Spiriva HandiHaler and Spiriva Respimat.

Dosage Forms and Strengths

Capsule (Spiriva Handihaler; powder for oral inhalation)

• 18 mcg

Solution for inhalation (Spiriva Respimat)

• 1.25 mcg/actuation (adult and pediatric)
• 2.5 mcg/actuation

Dosage Considerations – Should be Given as Follows:

Chronic Obstructive Pulmonary Disease

• Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD); reduction of COPD exacerbations
• Spiriva Handihaler: 2 orally inhalations of 1 capsule (18 mcg) once/day via HandiHaler inhalation device
• Spiriva Respimat: 5 mcg (2 actuations; 2.5 mcg/actuation) inhaled orally once/day

Asthma

• Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged 12 years or older
• Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled orally once/day

Pediatric:

• Indicated for long-term, once-daily, maintenance treatment of asthma in patients aged 6 years or older
• Spiriva Respimat: 2.5 mcg (2 actuations; 1.25 mcg/actuation) inhaled orally once/day

Dosage Modifications

• CrCl less than 50 mL/min: Use only if benefit outweighs potential risk

Common side effects of tiotropium include:

• Upper respiratory tract infection
• Dry mouth
• Sinus infection (sinusitis)
• Abdominal pain
• Allergic reaction
• Blurred vision
• Cataract
• Chest pain (angina pectoris and nonspecific)
• Constipation
• Cough
• Depression
• Diarrhea
• Difficulty speaking
• Difficulty urinating
• Dizziness
• Fever
• Gastroesophageal reflux (GERD)
• Herpes zoster
• High blood pressure (hypertension)
• High blood sugar (hyperglycemia)
• High cholesterol
• Increased heart rate
• Indigestion/heartburn
• Infection
• Laryngitis
• Leg pain
• Muscle pain
• Nosebleed
• Numbness and tingling
• Rash
• Runny or stuffy nose
• Skeletal pain
• Sore throat
• Swelling (edema)
• Swelling and sores inside the mouth
• Urinary retention
• Urinary tract infection (UTI)
• Vomiting
• Yeast infection/oral thrush

Less common side effects of tiotropium include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, 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 has no known severe interactions with other drugs.
• Serious interactions of tiotropium include:
  • pramlintide
• Tiotropium has moderate interactions with at least 107 different drugs.
• Mild interactions of tiotropium include:
  • dimenhydrinate
  • donepezil
  • galantamine
  • tacrine

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of 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 health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains tiotropium. Do not take Spiriva HandiHaler and Spiriva Respimat if you are allergic to tiotropium or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• History of hypersensitivity to ipratropium or tiotropium
• History of severe hypersensitivity to milk proteins (excipient in powder contained in capsule)
• Lactose allergy

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Tiotropium?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Tiotropium?"

Cautions

• Not for acute use; not a rescue medication
• Immediate hypersensitivity reactions (e.g., angioedema, itching, rash); stop treatment immediately
• Capsule not to be swallowed; to be administered only by oral inhalation via HandiHaler device
• Worsening of narrow-angle glaucoma
• Worsening of urinary retention
• Potential for paradoxical bronchospasm
• Prostatic hyperplasia
• Bladder-neck obstruction
• Wash hands after handling capsules

Pregnancy and Lactation

• The limited human data with tiotropium therapy during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes; there are risks to mother and fetus associated with poorly controlled asthma in pregnancy
• Consult your doctor
• There are no data on presence of tiotropium in human milk, effects on breastfed infant, or effects on milk production. Tiotropium is present in milk of lactating rats, however, clinical relevance of these data are not clear
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition