SPIRIVA HANDIHALER- tiotropium bromide capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (Mezinárodní Name):

TIOTROPIUM BROMIDE MONOHYDRATE

Složení:

TIOTROPIUM 18 ug

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

SPIRIVA HANDIHALER (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. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients. SPIRIVA HANDIHALER 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 SPIRIVA HANDIHALER, 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 SPIRIVA HANDIHALER 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

Přehled produktů:

SPIRIVA HANDIHALER consists of SPIRIVA capsules and the HANDIHALER device. SPIRIVA capsules contain 18 mcg of tiotropium and are light green, with the Boehringer Ingelheim company logo on the SPIRIVA capsule cap and "TI 01" on the SPIRIVA capsule body, or vice versa. The HANDIHALER device is gray colored with a green piercing button. It is imprinted with SPIRIVA HANDIHALER (tiotropium bromide inhalation powder), the Boehringer Ingelheim company logo. It is also imprinted to indicate that SPIRIVA capsules should not be stored in the HANDIHALER device and that the HANDIHALER device is only to be used with SPIRIVA capsules. SPIRIVA capsules are packaged in an aluminum/aluminum blister card and joined along a perforated-cut line. SPIRIVA 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 SPIRIVA capsule is opened. The following packages are available: Keep out of reach of children. Do not get powder into eyes. Storage Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. The SPIRIVA capsules should not be exposed to extreme temperature or moisture. Do not store SPIRIVA capsules in the HANDIHALER device.

Stav Autorizace:

New Drug Application

Charakteristika produktu

SPIRIVA HANDIHALER- TIOTROPIUM BROMIDE CAPSULE
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPIRIVA HANDIHALER
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPIRIVA
HANDIHALER.
SPIRIVA® HANDIHALER® (TIOTROPIUM BROMIDE INHALATION POWDER), FOR
ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
SPIRIVA HANDIHALER 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 SPIRIVA CAPSULES. ONLY USE
SPIRIVA CAPSULES
WITH THE HANDIHALER DEVICE (2)
Two inhalations of the powder contents of a single SPIRIVA capsule (18
mcg) once daily (2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: SPIRIVA capsules contain 18 mcg tiotropium powder
for use with HANDIHALER device
(3)
CONTRAINDICATIONS
Hypersensitivity to tiotropium, ipratropium, or any components of
SPIRIVA capsules (4)
WARNINGS AND PRECAUTIONS
Not for acute use: Not a rescue medication (5.1)
Immediate hypersensitivity reactions: Discontinue SPIRIVA HANDIHALER
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 SPIRIVA HANDIHALER 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 may occur. Use with caution in patients
with prostatic hyperplasia or
bladder-neck obstruction and instruct patients to consult a physician
immediately if this occurs. (5.5)
ADVERSE REACTIONS
The mos