HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

glycopyrrolate (UNII: V92SO9WP2I) (glycopyrronium - UNII:A14FB57V1D)

Available from:

Sunovion Pharmaceuticals Inc.

INN (International Name):

glycopyrrolate

Composition:

glycopyrrolate 25 ug in 1 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LONHALA MAGNAIR is indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients [see Warnings and Precautions (5.3) ]. Risk Summary There are no adequate and well-controlled studies in pregnant women. LONHALA MAGNAIR should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Women should be advised to contact their physician if they become pregnant while taking LONHALA MAGNAIR. In animal reproduction studies, there were no teratogenic effects in Wistar rats and New Zealand White rabbits at inhaled doses approximating 1521 and 580 times, respectively, the maximum recommended human daily inhalation dose (MRHDID) based on an AUC comparison [see Data ]. The estimated background risk of major birth defects and miscarriage

Product summary:

LONHALA MAGNAIR is supplied as a 1 mL sterile, clear, colorless, aqueous solution in low-density polyethylene (LDPE) unit-dose vials overwrapped in foil. LONHALA MAGNAIR is available in a Starter Kit containing 60 unit-dose vials packaged with one MAGNAIR, and FDA approved patient labeling. LONHALA MAGNAIR is also supplied in a Refill Kit containing 60 unit-dose vials packaged with a MAGNAIR Replacement Handset and FDA approved patient labeling. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

LONHALA MAGNAIR- GLYCOPYRROLATE SOLUTION
SUNOVION PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LONHALA MAGNAIR
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LONHALA
MAGNAIR.
LONHALA MAGNAIR (GLYCOPYRROLATE) INHALATION SOLUTION, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1961
INDICATIONS AND USAGE
LONHALA MAGNAIR is an anticholinergic indicated for the long-term,
maintenance treatment of airflow
obstruction in patients with chronic obstructive pulmonary disease
(COPD). (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. Do not swallow LONHALA solution. Only use
LONHALA vials with MAGNAIR. (2)
Maintenance treatment of COPD: The contents of one LONHALA vial
twice-daily. (2)
DOSAGE FORMS AND STRENGTHS
LONHALA Inhalation Solution is supplied as a sterile solution for
inhalation in a unit-dose single-use low-
density polyethylene (LDPE) vial. Each 1 mL vial contains 25 mcg of
glycopyrrolate. (3)
CONTRAINDICATIONS
LONHALA MAGNAIR is contraindicated in patients with a hypersensitivity
to glycopyrrolate or any of the
ingredients. (4)
WARNINGS AND PRECAUTIONS
Do not initiate in acutely deteriorating COPD or to treat acute
symptoms. (5.1)
If paradoxical bronchospasm occurs, discontinue LONHALA MAGNAIR
immediately and institute
alternative therapy. (5.2)
Worsening of narrow-angle glaucoma may occur. Use with caution in
patients with narrow-angle
glaucoma and instruct patients to contact a physician immediately if
symptoms occur. (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 symptoms occur.
(5.5)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 2.0%
and higher than placebo) are
dyspnea and urinary tract infection. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUNOVION
PHARMACEUTICALS INC. AT 1-
877-737-7226 OR FDA AT 1-800-FDA-10