Please wait while the formulary information is being retrieved.
Drug overview for SPIRIVA (tiotropium bromide):
Generic name: TIOTROPIUM BROMIDE (TYE-oh-TROE-pee-um)
Drug class: Anticholinergic Agents Long-Acting (Inhaled)
Therapeutic class: Respiratory Therapy Agents
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: Respiratory Therapy Agents
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 (tiotropium bromide) have been approved by the FDA:
Indications:
Bronchospasm prevention with COPD
Maintenance therapy for asthma
Professional Synonyms:
COPD with bronchospasms prophylaxis
Therapy to achieve long-term asthma control
Indications:
Bronchospasm prevention with COPD
Maintenance therapy for asthma
Professional Synonyms:
COPD with bronchospasms prophylaxis
Therapy to achieve long-term asthma control
The following dosing information is available for SPIRIVA (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.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| SPIRIVA HANDIHALER 18 MCG CAP | Maintenance | Adults inhale the contents of one capsule (18 mcg) using 2 inhalations by inhalation route once daily via handihaler |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TIOTROPIUM 18 MCG CAP-INHALER | Maintenance | Adults inhale the contents of one capsule (18 mcg) using 2 inhalations by inhalation route once daily via handihaler |
The following drug interaction information is available for SPIRIVA (tiotropium bromide):
There are 0 contraindications.
There are 4 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Pramlintide/Inhaled Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Pramlintide slows gastric emptying. Anticholinergics may result in additive or synergistic effects.(1) CLINICAL EFFECTS: Concurrent use of pramlintide and anticholinergics may result in additive or synergistic effects.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of pramlintide states that pramlintide therapy should not be considered in patients requiring the use of drugs that stimulate gastrointestinal motility or in patients taking drugs that alter gastrointestinal motility.(1) Patients receiving inhaled anticholinergics should be evaluated for signs of systemic effects, which may include constipation. DISCUSSION: Patients using drugs that alter gastrointestinal motility have not been studied in clinical trials for pramlintide.(1) Constipation has been reported as a side effect of inhaled anticholinergic agents such as ipratropium(2) and tiotropium.(3) |
SYMLINPEN 120, SYMLINPEN 60 |
| Clozapine/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine has potent anticholinergic properties and inhibits serotonin receptors, including 5-HT3.(1-4) Both of these properties may cause inhibition of gastrointestinal (GI) smooth muscle contraction, resulting in decreased peristalsis.(3,4) These effects may be compounded by concurrent use of anticholinergic agents.(1-6) CLINICAL EFFECTS: Concurrent use of clozapine with other anticholinergic agents may increase the risk of constipation (common) and serious bowel complications (uncommon), including complete bowel obstruction, fecal impaction, paralytic ileus and intestinal ischemia or infarction.(1-6) PREDISPOSING FACTORS: The risk for serious bowel complications is higher with increasing age, higher frequency of constipation, and in patients on higher doses of clozapine or multiple anticholinergic agents.(1,5) PATIENT MANAGEMENT: Avoid the use of other anticholinergic agents with clozapine.(1-6) If concurrent use is necessary, evaluate the patient's bowel function regularly. Monitor for symptoms of constipation and GI hypomotility, including having bowel movements less than three times weekly or less than usual, difficulty having a bowel movement or passing gas, nausea, vomiting, and abdominal pain or distention.(2) Consider a prophylactic laxative in those with a history of constipation or bowel obstruction.(2) Review patient medication list for other anticholinergic agents. When possible, decrease the dosage or number of prescribed anticholinergic agents, particularly in the elderly. Counsel the patient about the importance of maintaining adequate hydration. Encourage regular exercise and eating a high-fiber diet.(2) DISCUSSION: In a prospective cohort study of 26,720 schizophrenic patients in the Danish Central Psychiatric Research Registry, the odds ratio (OR) for ileus was 1.99 with clozapine and 1.48 with anticholinergics. The OR for fatal ileus was 6.73 with clozapine and 5.88 with anticholinergics. Use of anticholinergics with 1st generation antipsychotics (FGA) increased the risk of ileus compare to FGA alone, but this analysis was not done with clozapine.(5) A retrospective cohort study of 24,970 schizophrenic patients from the Taiwanese National Health Insurance Research Database found that the hazard ratio (HR) for clozapine-induced constipation increased from 1.64 when clozapine is used alone, to 2.15 when used concomitantly with anticholinergics. However, there was no significant difference in the HR for ileus when clozapine is used with and without anticholinergics (1.95 and 2.02, respectively).(6) In the French Pharmacovigilance Database, 7 of 38 cases of antipsychotic-associated ischemic colitis or intestinal necrosis involved clozapine, and 5 of these cases involved use of concomitant anticholinergic agents. Three patients died, one of whom was on concomitant anticholinergics.(3) In a case series, 4 of 9 cases of fatal clozapine-associated GI dysfunction involved concurrent anticholinergic agents.(4) |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
| Eluxadoline/Anticholinergics; Opioids SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Eluxadoline is a mixed mu-opioid and kappa-opioid agonist and delta-opioid antagonist and may alter or slow down gastrointestinal transit.(1) CLINICAL EFFECTS: Constipation related adverse events that sometimes required hospitalization have been reported, including the development of intestinal obstruction, intestinal perforation, and fecal impaction.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid use with other drugs that may cause constipation. If concurrent use is necessary, evaluate the patient's bowel function regularly. Monitor for symptoms of constipation and GI hypomotility, including having bowel movements less than three times weekly or less than usual, difficulty having a bowel movement or passing gas, nausea, vomiting, and abdominal pain or distention.(1) Instruct patients to stop eluxadoline and immediately contact their healthcare provider if they experience severe constipation. Loperamide may be used occasionally for acute management of severe diarrhea, but must be discontinued if constipation develops.(1) DISCUSSION: In phase 3 clinical trials, constipation was the most commonly reported adverse reaction (8%). Approximately 50% of constipation events occurred within the first 2 weeks of treatment while the majority occurred within the first 3 months of therapy. Rates of severe constipation were less than 1% in patients receiving eluxadoline doses of 75 mg and 100 mg.(1) |
VIBERZI |
| Glucagon (Diagnostic)/Anticholinergics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Glucagon and anticholinergic agents may have additive effects on inhibition of gastrointestinal motility.(1) CLINICAL EFFECTS: Concurrent use of glucagon with anticholinergic agents may increase the risk of gastrointestinal hypomotility, including constipation and bowel complications.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Concurrent use of glucagon as a diagnotic aid is not recommended with the use of anticholinergic agents.(1) If concurrent use is necessary, evaluate the patient's bowel function. Monitor for symptoms of constipation and gastrointestinal hypomotility. DISCUSSION: Both glucagon and anticholinergic agents may have additive effects on inhibition of gastrointestinal motility and increase the risk of gastrointestinal adverse effects.(1) |
GLUCAGON HCL |
There are 5 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Solid Oral Potassium Tablets/Inhaled Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concentrated potassium may damage the lining of the GI tract. Anticholinergics delay gastric emptying, resulting in the potassium product remaining in the gastrointestinal tract for a longer period of time.(1-16) CLINICAL EFFECTS: Use of solid oral dosage forms of potassium in patients treated with inhaled anticholinergics could potentially result in gastrointestinal erosions, ulcers, stenosis and bleeding.(1-16) PREDISPOSING FACTORS: Diseases or conditions which may increase risk for GI damage include: preexisting dysphagia, strictures, cardiomegaly, diabetic gastroparesis, elderly status, or insufficient oral intake to allow dilution of potassium.(1-10,21) Other drugs which may add to risk for GI damage include: nonsteroidal anti-inflammatory drugs (NSAIDs), bisphosphonates, or tetracyclines.(21) PATIENT MANAGEMENT: Regulatory agency and manufacturer recommendations regarding this interaction: - In the US, all solid oral dosage forms (including tablets and extended release capsules) of potassium are contraindicated in patients receiving anticholinergics at sufficient dosages to result in systemic effects.(2-8) Patients receiving such anticholinergic therapy should use a liquid form of potassium chloride.(2) - In Canada, solid oral potassium is contraindicated in any patient with a cause for arrest or delay in tablet/capsule passage through the gastrointestinal tract and the manufacturers recommend caution with concurrent anticholinergic medications.(1,9-10) Evaluate each patient for predisposing factors which may increase risk for GI damage. In patients with multiple risk factors for harm, consider use of liquid potassium supplements, if tolerated. For patients receiving concomitant therapy, assure any potassium dose form is taken after meals with a large glass of water or other fluid. To decrease potassium concentration in the GI tract, limit each dose to 20 meq; if more than 20 meq daily is required, give in divided doses.(2) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Patients should be instructed to immediately report any difficulty swallowing, abdominal pain, distention, severe vomiting, or gastrointestinal bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. DISCUSSION: In clinical trials, there was a higher incidence of gastric and duodenal lesions in patients receiving a high dose of a wax-matrix controlled-release formulation with a concurrent anticholinergic agent. Some lesions were asymptomatic and not accompanied by bleeding, as shown by a lack of positive Hemoccult tests.(1-17) Several studies suggest that the incidence of gastric and duodenal lesions may be less with the microencapsulated formulation of potassium chloride.(14-17) Constipation has been reported as a side effect of inhaled anticholinergic agents such as ipratropium(22) and tiotropium.(23) |
KLOR-CON 10, KLOR-CON 8, KLOR-CON M10, KLOR-CON M15, KLOR-CON M20, POTASSIUM CHLORIDE, POTASSIUM CITRATE ER, UROCIT-K |
| Solid Oral Potassium Capsules/Inhaled Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concentrated potassium may damage the lining of the GI tract. Anticholinergics delay gastric emptying, resulting in the potassium product remaining in the gastrointestinal tract for a longer period of time.(1-16) CLINICAL EFFECTS: Use of solid oral dosage forms of potassium in patients treated with inhaled anticholinergics could potentially result in gastrointestinal erosions, ulcers, stenosis and bleeding.(1-16) PREDISPOSING FACTORS: Diseases or conditions which may increase risk for GI damage include: preexisting dysphagia, strictures, cardiomegaly, diabetic gastroparesis, elderly status, or insufficient oral intake to allow dilution of potassium.(1-10,21) Other drugs which may add to risk for GI damage include: nonsteroidal anti-inflammatory drugs (NSAIDs), bisphosphonates, or tetracyclines.(21) PATIENT MANAGEMENT: Regulatory agency and manufacturer recommendations regarding this interaction: - In the US, all solid oral dosage forms (including tablets and extended release capsules) of potassium are contraindicated in patients receiving anticholinergics at sufficient dosages to result in systemic effects.(2-8) Patients receiving such anticholinergic therapy should use a liquid form of potassium chloride.(2) - In Canada, solid oral potassium is contraindicated in any patient with a cause for arrest or delay in tablet/capsule passage through the gastrointestinal tract and the manufacturers recommend caution with concurrent anticholinergic medications.(1,9-10) Evaluate each patient for predisposing factors which may increase risk for GI damage. In patients with multiple risk factors for harm, consider use of liquid potassium supplements, if tolerated. For patients receiving concomitant therapy, assure any potassium dose form is taken after meals with a large glass of water or other fluid. To decrease potassium concentration in the GI tract, limit each dose to 20 meq; if more than 20 meq daily is required, give in divided doses.(2) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. Patients should be instructed to immediately report any difficulty swallowing, abdominal pain, distention, severe vomiting, or gastrointestinal bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. DISCUSSION: In clinical trials, there was a higher incidence of gastric and duodenal lesions in patients receiving a high dose of a wax-matrix controlled-release formulation with a concurrent anticholinergic agent. Some lesions were asymptomatic and not accompanied by bleeding, as shown by a lack of positive Hemoccult tests.(1-17) Several studies suggest that the incidence of gastric and duodenal lesions may be less with the microencapsulated formulation of potassium chloride.(14-17) Constipation has been reported as a side effect of inhaled anticholinergic agents such as ipratropium(22) and tiotropium.(23) |
POTASSIUM CHLORIDE |
| Methacholine/Beta-Agonists; Anticholinergics; Theophylline SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway.(1) CLINICAL EFFECTS: The result of the methacholine challenge test may not be accurate.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The following drugs should be held before a methacholine challenge for the the duration indicated:(1) - short-acting beta-agonists: 6 hours - long-acting beta-agonists: 36 hours - short-acting anti-cholinergics: 12 hours - long-acting anti-cholinergics: at least 168 hours (7 days) - oral theophylline: 12-48 hours DISCUSSION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway and cause inaccurate test results. |
METHACHOLINE CHLORIDE, PROVOCHOLINE |
| Zonisamide/Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Zonisamide can cause decreased sweating and elevated body temperature. Agents with anticholinergic activity can predispose patients to heat-related disorders.(1-2) CLINICAL EFFECTS: Concurrent use of zonisamide with agents with anticholinergic activity may increase the incidence of oligohidrosis and hyperthermia, especially in pediatric or adolescent patients.(1-2) Overheating and dehydration can lead to brain damage and death. PREDISPOSING FACTORS: Pediatric and adolescent patients and patients with dehydration may be more likely to experience heat-related disorders.(1) PATIENT MANAGEMENT: The UK and US manufacturers of zonisamide state that caution should be used in adults when zonisamide is prescribed with other medicinal products that predispose to heat-related disorders, such as agents with anticholinergic activity.(1-2) Pediatric and adolescent patients must not take anticholinergic agents (e.g. clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin) concurrently with zonisamide.(1) Monitor for signs and symptoms of heat stroke: skin feels very hot with little or no sweating, confusion, muscle cramps, rapid heartbeat, or rapid breathing. Monitor for signs and symptoms of dehydration: dry mouth, urinating less than usual, dark-colored urine, dry skin, feeling tired, dizziness, or irritability. If signs or symptoms of dehydration, oligohidrosis, or elevated body temperature occur, discontinuation of zonisamide should be considered. DISCUSSION: Case reports of decreased sweating and elevated temperature have been reported, especially in pediatric patients. Some cases resulted in heat stroke that required hospital treatment and resulted in death.(1) |
ZONEGRAN, ZONISADE, ZONISAMIDE |
| Topiramate/Anticholinergics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Topiramate can cause decreased sweating and elevated body temperature. Agents with anticholinergic activity can predispose patients to heat-related disorders.(1-2) CLINICAL EFFECTS: Concurrent use of topiramate with agents with anticholinergic activity may increase the incidence of oligohidrosis and hyperthermia, especially in pediatric or adolescent patients.(1-2) Overheating and dehydration can lead to brain damage and death. PREDISPOSING FACTORS: Pediatric and adolescent patients and patients with dehydration may be more likely to experience heat-related disorders.(1) PATIENT MANAGEMENT: The manufacturer of topiramate states that caution should be used when topiramate is prescribed with other medicinal products that predispose to heat-related disorders, such as agents with anticholinergic activity (e.g. clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin) concurrently with zonisamide.(1) Monitor for signs and symptoms of heat stroke: skin feels very hot with little or no sweating, confusion, muscle cramps, rapid heartbeat, or rapid breathing. Monitor for signs and symptoms of dehydration: dry mouth, urinating less than usual, dark-colored urine, dry skin, feeling tired, dizziness, or irritability. If signs or symptoms of dehydration, oligohidrosis, or elevated body temperature occur, discontinuation of zonisamide should be considered. DISCUSSION: Case reports of decreased sweating and elevated temperature have been reported, especially in pediatric patients. Some cases resulted in heat stroke that required hospital treatment.(1) A 64-year old woman developed non-exertional hyperthemia while taking multiple psychiatric medications with topiramate.(2) |
EPRONTIA, QSYMIA, QUDEXY XR, TOPAMAX, TOPIRAMATE, TOPIRAMATE ER, TROKENDI XR |
The following contraindication information is available for SPIRIVA (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 8 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Angle-closure glaucoma |
| Benign prostatic hyperplasia |
| Bladder outflow obstruction |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Urinary retention |
The following adverse reaction information is available for SPIRIVA (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 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Chest pain Epistaxis |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Aggravated glaucoma Angina Angioedema Atrial fibrillation Dehydration Glaucoma Hypersensitivity drug reaction Hypertension Ileus Infection Ocular hypertension Paroxysmal supraventricular tachycardia |
There are 37 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bronchitis Cough Headache disorder Pharyngitis Sinusitis Xerostomia |
Arthritis Constipation Dizziness Gastroesophageal reflux disease Oral candidiasis Palpitations Pruritus of skin Rhinitis Skin rash Urinary tract infection Voice change Vomiting |
| Rare/Very Rare |
|---|
|
Arthralgia Blurred vision Dry skin Dysphagia Dysuria Fever Gingivitis Glossitis Insomnia Laryngitis Muscle spasm Paradoxical bronchospasm Skin ulcer Sore throat Stomatitis Tachycardia Tonsillitis Urinary retention Urticaria |
The following precautions are available for SPIRIVA (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.
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.
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.
The following prioritized warning is available for SPIRIVA (tiotropium bromide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for SPIRIVA (tiotropium bromide)'s list of indications:
| Bronchospasm prevention with COPD | |
| J44 | Other chronic obstructive pulmonary disease |
| J44.8 | Other specified chronic obstructive pulmonary disease |
| J44.89 | Other specified chronic obstructive pulmonary disease |
| J44.9 | Chronic obstructive pulmonary disease, unspecified |
| Maintenance therapy for asthma | |
| J45 | Asthma |
| J45.2 | Mild intermittent asthma |
| J45.20 | Mild intermittent asthma, uncomplicated |
| J45.3 | Mild persistent asthma |
| J45.30 | Mild persistent asthma, uncomplicated |
| J45.4 | Moderate persistent asthma |
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.5 | Severe persistent asthma |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.9 | Other and unspecified asthma |
| J45.90 | Unspecified asthma |
| J45.909 | Unspecified asthma, uncomplicated |
Formulary Reference Tool