TIOTROPIUM BROMIDE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

TIOTROPIUM BROMIDE MONOHYDRATE (UNII: L64SXO195N) (TIOTROPIUM - UNII:0EB439235F)

Dostupné z:

Lupin Pharmaceuticals, Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium bromide inhalation powder is indicated to reduce exacerbations in COPD patients. Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any components of this product [see Warnings and Precautions (5.2)] . In clinical trials and postmarketing experience with tiotropium bromide inhalation powder, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported [see Warnings and Precautions (5.2)] . Risk Summary The limited human data with tiotropium bromide inhalation powder use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Based on animal reproduction studies, no structural abnormalities were observed when tiotropium was administered by inhalation to pregnant rats and rabbits during the period of organogenesis at doses 790 and 8 times, respectively, the maximum recommended human daily inhalation dose (MRHDID). Increased post-implantation loss was observed in rats and rabbits administered tiotropium at maternally toxic doses 430 times and 40 times the MRHDID, respectively [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In 2 separate embryo-fetal development studies, pregnant rats and rabbits received tiotropium during the period of organogenesis at doses up to approximately 790 and 8 times the MRHDID, respectively (on a mcg/m2 basis at inhalation doses of 1471 and 7 mcg/kg/day in rats and rabbits, respectively). No evidence of structural abnormalities was observed in rats or rabbits. However, in rats, tiotropium caused fetal resorption, litter loss, decreases in the number of live pups at birth and the mean pup weights, and a delay in pup sexual maturation at tiotropium doses of approximately 40 times the MRHDID (on a mcg/m2 basis at a maternal inhalation dose of 78 mcg/kg/day). In rabbits, tiotropium caused an increase in post-implantation loss at a tiotropium dose of approximately 430 times the MRHDID (on a mcg/m2 basis at a maternal inhalation dose of 400 mcg/kg/day). Such effects were not observed at approximately 5 and 95 times the MRHDID, respectively (on a mcg/m2 basis at inhalation doses of 9 and 88 mcg/kg/day in rats and rabbits, respectively). Risk Summary There are no data on the presence of tiotropium in human milk, the effects on the breastfed infant, or the effects on milk production. Tiotropium is present in milk of lactating rats; however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tiotropium bromide inhalation powder and any potential adverse effects on the breastfed child from tiotropium bromide inhalation powder or from the underlying maternal condition. Data The distribution of tiotropium bromide into milk was investigated after a single intravenous administration of 10 mg/kg to lactating rats. Tiotropium and/or its metabolites are present in the milk of lactating rats at concentrations above those in plasma. Tiotropium bromide inhalation powder is not indicated for use in children. The safety and effectiveness of tiotropium bromide inhalation powder in pediatric patients have not been established. Based on available data, no adjustment of tiotropium bromide inhalation powder dosage in geriatric patients is warranted [see Clinical Pharmacology (12.3)]. Of the total number of patients who received tiotropium bromide inhalation powder in the 1-year clinical trials, 426 were <65 years, 375 were 65 to 74 years, and 105 were ≥75 years of age. Within each age subgroup, there were no differences between the proportion of patients with adverse events in the tiotropium bromide inhalation powder and the comparator groups for most events. Dry mouth increased with age in the tiotropium bromide inhalation powder group (differences from placebo were 9.0%, 17.1%, and 16.2% in the aforementioned age subgroups). A higher frequency of constipation and urinary tract infections with increasing age was observed in the tiotropium bromide inhalation powder group in the placebo-controlled studies. The differences from placebo for constipation were 0%, 1.8%, and 7.8% for each of the age groups. The differences from placebo for urinary tract infections were –0.6%, 4.6%, and 4.5%. No overall differences in effectiveness were observed among these groups. Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) treated with tiotropium bromide inhalation powder should be monitored closely for anticholinergic side effects [see Dosage and Administration (2), Warnings and Precautions (5.6), and Clinical Pharmacology (12.3)] . The effects of hepatic impairment on the pharmacokinetics of tiotropium were not studied.

Prehľad produktov:

Tiotropium bromide inhalation powder consists of tiotropium bromide inhalation powder capsules and the LupinHaler device. Tiotropium bromide inhalation powder capsules contain 18 mcg of tiotropium in a hypromellose capsule with white opaque cap and white opaque body, imprinted with "LU" on cap and "T18" on body. The LupinHaler device is a white colour inhaler with a green piercing button. It is also imprinted with LupinHaler, Tiotropium Bromide Inhalation Powder and the LUPIN company Logo. It is also imprinted to indicate that Tiotropium Bromide Inhalation Powder Capsules should not be stored in the LupinHaler device and that the LupinHaler device is only to be used with Tiotropium Bromide Inhalation Powder Capsules. Tiotropium bromide inhalation powder capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. Tiotropium bromide inhalation powder capsules should always be stored in the blister and only removed immediately before use. The drug should be used immediately after the packaging over an individual tiotropium bromide inhalation powder capsule is opened. The following packages are available: Keep out of reach of children. Do not get powder into eyes. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. The Tiotropium Bromide Inhalation Powder Capsules should not be exposed to extreme temperature or moisture. Do not store Tiotropium Bromide Inhalation Powder Capsules in the LupinHaler device.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TIOTROPIUM BROMIDE- TIOTROPIUM BROMIDE CAPSULE
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIOTROPIUM BROMIDE
INHALATION POWDER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TIOTROPIUM BROMIDE INHALATION POWDER.
TIOTROPIUM BROMIDE INHALATION POWDER, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Tiotropium bromide inhalation powder is an anticholinergic indicated
for the long-term, once-daily,
maintenance treatment of bronchospasm associated with chronic
obstructive pulmonary disease (COPD),
and for reducing COPD exacerbations (1)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY. DO NOT SWALLOW TIOTROPIUM BROMIDE INHALATION
POWDER CAPSULES.
ONLY USE TIOTROPIUM BROMIDE INHALATION POWDER CAPSULES WITH THE
LUPINHALER™ DEVICE (2)
Two inhalations of the powder contents of a single tiotropium bromide
inhalation powder capsule (18
mcg) once daily (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: Tiotropium bromide inhalation powder capsules
contain 18 mcg tiotropium powder for
use with LupinHaler device (3)
CONTRAINDICATIONS
Hypersensitivity to tiotropium, ipratropium, or any components of
tiotropium bromide inhalation powder
capsules (4)
WARNINGS AND PRECAUTIONS
Not for acute use: Not a rescue medication (5.1)
Immediate hypersensitivity reactions: Discontinue tiotropium bromide
inhalation powder at once and
consider alternatives if immediate hypersensitivity reactions,
including angioedema, urticaria, rash,
bronchospasm, or anaphylaxis, occur. Use with caution in patients with
severe hypersensitivity to milk
proteins. (5.2)
Paradoxical bronchospasm: Discontinue tiotropium bromide inhalation
powder and consider other
treatments if paradoxical bronchospasm occurs (5.3)
Worsening of narrow-angle glaucoma may occur. Use with caution in
patients with narrow-angle
glaucoma and instruct patients to consult a physician immediately if
this occurs. (5.4)
Worsening of urinary retention m