SPIRIVA- tiotropium bromide capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

A-S Medication Solutions

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

Product: 50090-4414 NDC: 50090-4414-0 10 CAPSULE in a BLISTER PACK / 9 in a CARTON

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

SPIRIVA- TIOTROPIUM BROMIDE CAPSULE
A-S MEDICATION SOLUTIONS
----------
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 most common adverse reactions (>5