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Drug overview for SPIRIVA HANDIHALER (tiotropium bromide):
Generic name: TIOTROPIUM BROMIDE (TYE-oh-TROE-pee-um)
Drug class: Anticholinergic Agents Long-Acting (Inhaled)
Therapeutic class:
Tiotropium bromide, a synthetic quaternary ammonium antimuscarinic agent, is a long-acting orally inhaled bronchodilator.
No enhanced Uses information available for this drug.
Generic name: TIOTROPIUM BROMIDE (TYE-oh-TROE-pee-um)
Drug class: Anticholinergic Agents Long-Acting (Inhaled)
Therapeutic class:
Tiotropium bromide, a synthetic quaternary ammonium antimuscarinic agent, is a long-acting orally inhaled bronchodilator.
No enhanced Uses information available for this drug.
DRUG IMAGES
SPIRIVA HANDIHALER 18 MCG CAP
The following indications for SPIRIVA HANDIHALER (tiotropium bromide) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for SPIRIVA HANDIHALER (tiotropium bromide):
Tiotropium bromide solution is administered by oral inhalation using a specific inhaler (Spiriva(R) Respimat(R)) that delivers a metered-dose spray. Tiotropium bromide in fixed combination with olodaterol hydrochloride is administered by oral inhalation using a specific inhaler (Stiolto(R) Respimat(R)) that delivers a metered-dose spray. Both inhalers deliver the drugs in an aqueous solution and mechanically produce a fine aerosol mist from the orally inhaled solution.
Tiotropium bromide alone or in fixed combination with olodaterol should be administered once daily at the same time every day.
Before first use of either Spiriva(R) Respimat(R) or Stiolto(R) Respimat(R), the inhaler cartridge should be placed into the inhaler. The manufacturer's prescribing information should be consulted for detailed information on preparation of the inhalers. The discard date (3 months after the cartridge is inserted into the inhaler) should be written on the inhaler label.
After the cartridge has been inserted into either the Spiriva(R) Respimat(R) or the Stiolto(R) Respimat(R) inhaler, the unit must be primed prior to first use. Beginning with the inhaler held upright and the cap closed, the clear base should be turned in the direction of the black arrows on the label until a click is heard (one-half turn). The cap should then be flipped until it fully snaps open, the inhaler should be pointed away from the face, the dose release button pressed, and then the cap closed.
These steps (turning the clear base until it clicks, opening the cap, actuating the inhaler, and replacing the cap) should be repeated until a spray is visible, and then for 3 additional times. The initial actuation step of the priming process (without the 3 additional repetitions) should be repeated after a period of nonuse (i.e., more than 3 days). If the inhaler is not used for more than 21 days, the entire initial priming process should be repeated.
To administer a dose of tiotropium alone or in fixed combination with olodaterol, the patient should hold the inhaler upright with the cap closed and turn the clear base in the direction of the black arrows on the label until a click is heard (one-half turn). The cap should be flipped until it snaps fully open. Before inhaling the dose, the patient should exhale slowly and completely.
The patient should then close the lips around the end of the mouthpiece, without covering the air vents. With the inhaler pointing toward the back of the throat, the patient should press the dose release button while taking a slow, deep inhalation through the mouth; the patient should continue inhaling as long as possible. The patient should then hold the breath for 10 seconds (or as long as comfortable).
This procedure should be repeated once more to administer the full dose (2 inhalations) of tiotropium alone or in combination with olodaterol. After the full dose is administered, the cap of the inhaler should be closed.
The mouthpiece of either the Spiriva(R) Respimat(R) or the Stiolto(R) Respimat(R) inhaler, including the metal part inside, should be cleaned using only a damp tissue or cloth at least once weekly. If the outside of the inhaler gets dirty, it can be wiped with a damp cloth. The function of the inhaler is not affected by minor discoloration in the mouthpiece.
Tiotropium bromide alone or in fixed combination with olodaterol should be administered once daily at the same time every day.
Before first use of either Spiriva(R) Respimat(R) or Stiolto(R) Respimat(R), the inhaler cartridge should be placed into the inhaler. The manufacturer's prescribing information should be consulted for detailed information on preparation of the inhalers. The discard date (3 months after the cartridge is inserted into the inhaler) should be written on the inhaler label.
After the cartridge has been inserted into either the Spiriva(R) Respimat(R) or the Stiolto(R) Respimat(R) inhaler, the unit must be primed prior to first use. Beginning with the inhaler held upright and the cap closed, the clear base should be turned in the direction of the black arrows on the label until a click is heard (one-half turn). The cap should then be flipped until it fully snaps open, the inhaler should be pointed away from the face, the dose release button pressed, and then the cap closed.
These steps (turning the clear base until it clicks, opening the cap, actuating the inhaler, and replacing the cap) should be repeated until a spray is visible, and then for 3 additional times. The initial actuation step of the priming process (without the 3 additional repetitions) should be repeated after a period of nonuse (i.e., more than 3 days). If the inhaler is not used for more than 21 days, the entire initial priming process should be repeated.
To administer a dose of tiotropium alone or in fixed combination with olodaterol, the patient should hold the inhaler upright with the cap closed and turn the clear base in the direction of the black arrows on the label until a click is heard (one-half turn). The cap should be flipped until it snaps fully open. Before inhaling the dose, the patient should exhale slowly and completely.
The patient should then close the lips around the end of the mouthpiece, without covering the air vents. With the inhaler pointing toward the back of the throat, the patient should press the dose release button while taking a slow, deep inhalation through the mouth; the patient should continue inhaling as long as possible. The patient should then hold the breath for 10 seconds (or as long as comfortable).
This procedure should be repeated once more to administer the full dose (2 inhalations) of tiotropium alone or in combination with olodaterol. After the full dose is administered, the cap of the inhaler should be closed.
The mouthpiece of either the Spiriva(R) Respimat(R) or the Stiolto(R) Respimat(R) inhaler, including the metal part inside, should be cleaned using only a damp tissue or cloth at least once weekly. If the outside of the inhaler gets dirty, it can be wiped with a damp cloth. The function of the inhaler is not affected by minor discoloration in the mouthpiece.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for SPIRIVA HANDIHALER (tiotropium bromide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for SPIRIVA HANDIHALER (tiotropium bromide):
Drug contraindication overview.
Known hypersensitivity to tiotropium, ipratropium, or any ingredient in the formulation.
Known hypersensitivity to tiotropium, ipratropium, or any ingredient in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for SPIRIVA HANDIHALER (tiotropium bromide):
Adverse reaction overview.
Adverse reactions occurring in at least 3% of patients with COPD receiving tiotropium oral inhalation powder in long-term clinical trials and at a frequency at least 1% greater than with placebo include upper respiratory tract infection, dry mouth, sinusitis, pharyngitis, urinary tract infection, chest pain (nonspecific), rhinitis, dyspepsia, headache, abdominal pain, edema (dependent), arthralgia, constipation, depression, insomnia, vomiting, infection, moniliasis, epistaxis, myalgia, and rash. Adverse reactions occurring in more than 3% of patients with COPD receiving tiotropium oral inhalation solution in clinical trials and more frequently than with placebo include pharyngitis, cough, dry mouth, and sinusitis. Adverse reactions occurring in more than 2% of patients with asthma receiving tiotropium oral inhalation solution in clinical trials and more frequently than with placebo include pharyngitis, headache, bronchitis, and sinusitis. Adverse effects occurring in more than 3% of patients with COPD receiving tiotropium 5 mcg daily in fixed combination with olodaterol 5 mcg daily and more frequently than in patients receiving either drug alone include nasopharyngitis, cough, and back pain.
Adverse reactions occurring in at least 3% of patients with COPD receiving tiotropium oral inhalation powder in long-term clinical trials and at a frequency at least 1% greater than with placebo include upper respiratory tract infection, dry mouth, sinusitis, pharyngitis, urinary tract infection, chest pain (nonspecific), rhinitis, dyspepsia, headache, abdominal pain, edema (dependent), arthralgia, constipation, depression, insomnia, vomiting, infection, moniliasis, epistaxis, myalgia, and rash. Adverse reactions occurring in more than 3% of patients with COPD receiving tiotropium oral inhalation solution in clinical trials and more frequently than with placebo include pharyngitis, cough, dry mouth, and sinusitis. Adverse reactions occurring in more than 2% of patients with asthma receiving tiotropium oral inhalation solution in clinical trials and more frequently than with placebo include pharyngitis, headache, bronchitis, and sinusitis. Adverse effects occurring in more than 3% of patients with COPD receiving tiotropium 5 mcg daily in fixed combination with olodaterol 5 mcg daily and more frequently than in patients receiving either drug alone include nasopharyngitis, cough, and back pain.
There are 0 severe adverse reactions.
There are 0 less severe adverse reactions.
The following precautions are available for SPIRIVA HANDIHALER (tiotropium bromide):
Safety and efficacy of orally inhaled tiotropium powder have not been established in children younger than 18 years of age. Tiotropium oral inhalation powder is not indicated for use in pediatric patients. Safety and efficacy of orally inhaled tiotropium solution for the treatment of asthma have been established in pediatric patients 6-17 years of age in several clinical trials up to 1 years' duration.
In 3 of these trials, 327 adolescents 12-17 years of age with asthma received tiotropium oral inhalation solution at a dosage of 2.5 mcg once daily. In 3 additional studies, 345 patients 6-11 years of age with asthma received tiotropium oral inhalation solution at a dosage of 2.5
mcg once daily. Safety and efficacy of the drug in these pediatric patients were similar to the effects in patients 18 years of age or older with asthma receiving the drug. Safety and efficacy of orally inhaled tiotropium solution have not been established in children younger than 6 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
In 3 of these trials, 327 adolescents 12-17 years of age with asthma received tiotropium oral inhalation solution at a dosage of 2.5 mcg once daily. In 3 additional studies, 345 patients 6-11 years of age with asthma received tiotropium oral inhalation solution at a dosage of 2.5
mcg once daily. Safety and efficacy of the drug in these pediatric patients were similar to the effects in patients 18 years of age or older with asthma receiving the drug. Safety and efficacy of orally inhaled tiotropium solution have not been established in children younger than 6 years of age.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) Limited human data regarding use of orally inhaled tiotropium solution during pregnancy are inadequate to inform a drug-associated risk. However, poorly or moderately controlled asthma during pregnancy may increase the maternal risk of preeclampsia and the infant's risk for prematurity, low birth weight, and small size for gestational age.
The level of asthma control should be closely monitored in pregnant women and therapy adjusted as needed to maintain optimal control. Animal studies have not revealed evidence of structural abnormalities at tiotropium dosages of approximately 790 or 8 times the maximum recommended human daily inhalation dosage administered to pregnant rats or rabbits, respectively, during the period of organogenesis. However, tiotropium administration resulted in fetal resorption, fetal loss, decreased number of live pups at birth, decreased mean pup weights, and delays in pup sexual maturation in rats receiving approximately 40 times the maximum recommended human daily inhalation dosage.
In pregnant rabbits, tiotropium administration resulted in increased postimplantation fetal loss at dosages of approximately 430 times the maximum recommended human daily inhalation dosage. These adverse fetal effects were not observed at tiotropium dosages approximately 5 or 95 times the maximum recommended human daily inhalation dosage in pregnant rats and rabbits, respectively.
The level of asthma control should be closely monitored in pregnant women and therapy adjusted as needed to maintain optimal control. Animal studies have not revealed evidence of structural abnormalities at tiotropium dosages of approximately 790 or 8 times the maximum recommended human daily inhalation dosage administered to pregnant rats or rabbits, respectively, during the period of organogenesis. However, tiotropium administration resulted in fetal resorption, fetal loss, decreased number of live pups at birth, decreased mean pup weights, and delays in pup sexual maturation in rats receiving approximately 40 times the maximum recommended human daily inhalation dosage.
In pregnant rabbits, tiotropium administration resulted in increased postimplantation fetal loss at dosages of approximately 430 times the maximum recommended human daily inhalation dosage. These adverse fetal effects were not observed at tiotropium dosages approximately 5 or 95 times the maximum recommended human daily inhalation dosage in pregnant rats and rabbits, respectively.
Tiotropium is distributed into milk in rodents. The drug and/or its metabolites are present in milk of lactating rats at concentrations higher than those in plasma. It is not known whether tiotropium is distributed into milk in humans.
Effects of the drug on breast-fed infants or milk production also are not known. The benefits of breast-feeding and the woman's clinical need for tiotropium should be considered along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. The manufacturer recommends that orally inhaled tiotropium be used with caution in nursing women.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Effects of the drug on breast-fed infants or milk production also are not known. The benefits of breast-feeding and the woman's clinical need for tiotropium should be considered along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. The manufacturer recommends that orally inhaled tiotropium be used with caution in nursing women.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Tiotropium | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insufficient human data available |
The frequency of dry mouth, constipation, and urinary tract infection increased with age in clinical trials of tiotropium. However, no overall differences in efficacy were observed in geriatric patients relative to younger adults. The manufacturer states that adjustment of tiotropium dosage in geriatric patients is not necessary.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Tiotropium Bromide | Urogenital-Use caution in men with benign prostatic hyperplasia; may decrease urinary flow and cause urinary retention. Incidence of urinary tract infection increases with age. Other-Use caution in elderly with narrow angle glaucoma. Gastrointestinal-Anticholinergic effects may worsen constipation in predisposed elderly. | N | N | N | N | N | N |
The following prioritized warning is available for SPIRIVA HANDIHALER (tiotropium bromide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for SPIRIVA HANDIHALER (tiotropium bromide)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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