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APO-TIOTROPIUM is a brand name for Tiotropium, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-TIOTROPIUM (tiotropium inhalation powder capsules) is indicated for: • long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. APO-TIOTROPIUM is not indicated as rescue medication…
Verbatim from this product's HC label. Tap a section to expand.
e. chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage. • Elderly patients, hepatically impaired patients, and renally impaired patients can use APO- TIOTROPIUM at the recommended dose.
However, as with all renally excreted drugs, APO- TIOTROPIUM use should be monitored closely in patients with moderate to severe renal impairment. • APO-TIOTROPIUM should not be used for the initial treatment of acute episodes of bronchospasm.
Patients should be prescribed a rapid onset, short duration inhaled bronchodilator to relieve acute symptoms such as shortness of breath and be advised to have this available for use at all times. • Patients should be made aware that for optimum benefit, APO-TIOTROPIUM must be used APO‐TIOTROPIUM (Tiotropium inhalation powder capsules) Page 5 of 46 regularly, even when asymptomatic.
• There is no experience with tiotropium inhalation powder capsules in infants and children and therefore should not be used in this age group. 2 Recommended Dose and Dosage Adjustment • The recommended dosage of APO-TIOTROPIUM is oral inhalation of the contents of one capsule (18 mcg) once daily using the APO-TIOTROPIUM Inhaler.
• The capsule must not be swallowed.
Pediatrics (< 18 years of age):
APO-TIOTROPIUM should not be used in patients under 18 years of age.
Geriatrics (≥ 65 years of age):
No dose adjustment is required for patients 65 years of age or older. 4 Administration APO-TIOTROPIUM should be administered once daily, at the same time of day, by oral inhalation only through the APO-TIOTROPIUM Inhaler. When prescribing APO-TIOTROPIUM, patients should be instructed on the correct use of the APO-TIOTROPIUM Inhaler.
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it (see PATIENT MEDICATION INFORMATION). 5 Missed Dose Patients should be advised that if they forget to take a dose, they should take one as soon as they remember but do not take two doses at the same time or on the same day.
Then take the next dose as usual. Patients should be advised that if they take more APO-TIOTROPIUM 18 microgram than they should – talk to their doctor immediately.
). Tiotropium should be used with caution in patients with recent myocardial infarction < 6 months; any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy in the past year; hospitalisation due to heart failure within the past year.
These patients were excluded from the clinical trials and these conditions may be affected by the anticholinergic mechanism of action. Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed.
The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery. Immune Hypersensitivity Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of tiotropium inhalation powder capsules.
If such a reaction occurs, therapy with APO-TIOTROPIUM should be stopped at once and alternative treatments should be considered. Given the similar structural formula of atropine to tiotropium, patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to APO-TIOTROPIUM.
There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder products containing lactose (with probable traces of milk protein); therefore, APO-TIOTROPIUM should be used with caution in patients with severe milk protein allergy.
Ophthalmologic Worsening of Narrow-Angle Glaucoma (see Anticholinergic Effects). APO-TIOTROPIUM should be used with caution in patients with narrow-angle glaucoma. Patients should be cautioned to avoid getting the drug powder into their eyes.
and 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). e. chronic bronchitis (with or without airflow limitation) or emphysema. Cessation of smoking produces dramatic symptomatic benefits and has been shown to confer a survival advantage.
• Elderly patients, hepatically impaired patients, and renally impaired patients can use APO- TIOTROPIUM at the recommended dose. However, as with all renally excreted drugs, APO- TIOTROPIUM use should be monitored closely in patients with moderate to severe renal impairment.
• APO-TIOTROPIUM should not be used for the initial treatment of acute episodes of bronchospasm. Patients should be prescribed a rapid onset, short duration inhaled bronchodilator to relieve acute symptoms such as shortness of breath and be advised to have this available for use at all times.
• Patients should be made aware that for optimum benefit, APO-TIOTROPIUM must be used APO‐TIOTROPIUM (Tiotropium inhalation powder capsules) Page 5 of 46 regularly, even when asymptomatic. • There is no experience with tiotropium inhalation powder capsules in infants and children and therefore should not be used in this age group.
2 Recommended Dose and Dosage Adjustment • The recommended dosage of APO-TIOTROPIUM is oral inhalation of the contents of one capsule (18 mcg) once daily using the APO-TIOTROPIUM Inhaler. • The capsule must not be swallowed.
Pediatrics (< 18 years of age):
APO-TIOTROPIUM should not be used in patients under 18 years of age.
Geriatrics (≥ 65 years of age):
No dose adjustment is required for patients 65 years of age or older. 4 Administration APO-TIOTROPIUM should be administered once daily, at the same time of day, by oral inhalation only through the APO-TIOTROPIUM Inhaler. When prescribing APO-TIOTROPIUM, patients should be instructed on the correct use of the APO-TIOTROPIUM Inhaler.
g. ipratropium), or to any component of this product (see 7 WARNINGS AND PRECAUTIONS and 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tiotropium in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma. , eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema).
Instruct patients to consult a physician immediately should any of these signs or symptoms develop. Miotic drops alone are not considered to be effective treatment. Renal As with all predominantly renally excreted drugs, APO-TIOTROPIUM should be used only if the expected benefit outweighs the potential risk in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 mL/min).
These patients should be monitored closely for potential adverse drug reactions. APO‐TIOTROPIUM (Tiotropium inhalation powder capsules) Page 9 of 46 Worsening of Urinary Retention (see Anticholinergic Effects). APO-TIOTROPIUM should be used with caution in patients with urinary retention.
, difficulty passing urine, painful urination). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
Reproductive Health:
Female and Male Potential • Fertility Clinical data on fertility are not available for tiotropium. A non-clinical study performed with tiotropium showed no indication of any adverse effect on fertility (see 16 NON-CLINICAL TOXICOLOGY).
Respiratory Paradoxical bronchospasm Inhaled medicines may cause inhalation-induced bronchospasm. If this occurs, treatment with APO-TIOTROPIUM should be discontinued immediately and other treatment options considered. 1 Pregnant Women Pregnant Women: There is a limited amount of data from the use of tiotropium in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). Because animal reproduction studies are not always predictive of human response, APO-TIOTROPIUM should be used during pregnancy only if the benefits outweigh any possible risk to the unborn child.
Labour and Delivery:
The safety and effectiveness of tiotropium inhalation powder capsules have not been studied during labour and delivery. 9%) is excreted in milk over two days. Clinical data from nursing women exposed to tiotropium bromide monohydrate are not available.
APO-TIOTROPIUM should not be used in nursing women unless the expected benefit outweighs any possible risk to the infant. 3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics No dose adjustment is required in patients 65 years of age and older. 1 Adverse Reaction Overview Adverse reactions to tiotropium inhalation powder capsules are similar in nature to reactions to other anticholinergic bronchodilators.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of tiotropium inhalation powder capsules. In controlled clinical studies, the commonly observed undesirable effects were anticholinergic undesirable effects such as dry mouth which occurred in approximately 4% of patients.
2 %). Other undesirable effects consistent with anticholinergic effects include palpitations, supraventricular tachycardia, atrial fibrillation, blurred vision, glaucoma, constipation and intestinal obstruction including ileus paralytic as well as urinary retention.
An increase in anticholinergic effects may occur with increasing age. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, […]
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it (see PATIENT MEDICATION INFORMATION). 5 Missed Dose Patients should be advised that if they forget to take a dose, they should take one as soon as they remember but do not take two doses at the same time or on the same day.
Then take the next dose as usual. Patients should be advised that if they take more APO-TIOTROPIUM 18 microgram than they should – talk to their doctor immediately. 5 OVERDOSAGE High doses of tiotropium bromide may lead to signs and symptoms of exaggerated anticholinergic effects, such as constipation, voiding difficulties or increased intraocular pressure causing pain, vision disturbances or reddening of the eye.
Should signs of serious anticholinergic toxicity appear, vital signs should be carefully monitored and appropriate therapy should be initiated. There were no systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg tiotropium in healthy volunteers.
Additionally, no relevant adverse effects, beyond bilateral conjunctivitis and dry mouth were observed following 7 day dosing with up to 141 mcg tiotropium/day in healthy volunteers, (which resolved while still under treatment). In a multiple dose study in COPD patients with a maximum daily dose of 36 cg tiotropium over four weeks, APO‐TIOTROPIUM (Tiotropium inhalation powder capsules) Page 6 of 46 dry mouth was the only observed adverse event attributable to tiotropium.
Accidental Ingestion Acute intoxication by inadvertent oral ingestion of APO-TIOTROPIUM capsules is unlikely since the drug has a low oral bioavailability. For management of a suspected drug overdose, contact your regional poison control centre.
5 mcg tiotropium bromide monohydrate) Gelatin, lactose monohydrate, polyethylene glycol, and titanium dioxide. The black imprinting ink contains: iron oxide black, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.
5 mcg tiotropium bromide monohydrate), with ”XI” printed on white opaque cap and opaque white body printed with “110”. APO-TIOTROPIUM capsules also contain lactose monohydrate as a “carrier”. The dry powder within the capsule is intended for oral inhalation only.
APO-TIOTROPIUM capsules are partially filled but contain exact amount of medication as declared on the label. APO-TIOTROPIUM capsules are packaged in an aluminum/aluminum blister card joined along a perforated-cut line. One blister card consists of 10 capsules.
The following pack types are available: • Carton of 30 APO-TIOTROPIUM capsules (3 blister cards) and one APO-TIOTROPIUM Inhaler. Refill packs: • Carton of 30 APO-TIOTROPIUM capsules (3 blister cards) APO-TIOTROPIUM INHALER The APO-TIOTROPIUM Inhaler is a reusable plastic device used for the administration of APO- TIOTROPIUM capsules.
To use the delivery system, an APO-TIOTROPIUM capsule is placed in the centre chamber of the APO-TIOTROPIUM Inhaler and the capsule is pierced by pressing and releasing the white piercing button on the side of the device. The tiotropium formulation is dispersed into the air stream when the patient inhales slowly and deeply through the mouthpiece.
5 mg of lactose monohydrate per capsule. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Not for Acute Use APO-TIOTROPIUM, as a once daily […]