Lonhala Magnair
- Generic Name: glycopyrrolate inhalation solution
- Brand Name: Lonhala Magnair
Lonhala Magnair (Glycopyrrolate Inhalation Solution) side effects drug center
Lonhala Magnair Side Effects Center
Lonhala Magnair (glycopyrrolate) Inhalation Solution is an anticholinergic indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Common side effects of Lonhala Magnair include:
- shortness of breath,
- urinary tract infection,
- wheezing,
- upper respiratory tract infection,
- runny or stuff nose,
- swelling of extremities,
- and fatigue.
The dose of Lonhala Magnair for maintenance treatment of COPD is the contents of one Lonhala vial twice-daily. Lonhala Magnair may interact with other anticholinergic drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Lonhala Magnair; it is unknown how it would affect a fetus. It is unknown if Lonhala Magnair passes into breast milk. Consult your doctor before breastfeeding.
Our Lonhala Magnair (glycopyrrolate) Inhalation Solution, for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Lonhala Magnair Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- wheezing, choking, or other breathing problems after using this medicine;
- blurred vision, tunnel vision, eye pain or redness, seeing halos around lights;
- nausea, vomiting; or
- painful or difficult urination, little or no urination.
Common side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat;
- feeling short of breath; or
- burning when you urinate.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Lonhala Magnair (Glycopyrrolate Inhalation Solution)
Lonhala Magnair Professional Information
SIDE EFFECTS
The following adverse reactions are described in greater detail in other sections:
- Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
- Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
- Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
- Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The LONHALA MAGNAIR safety database included 2379 subjects with COPD in two 12-week efficacy studies and one 48-week long-term safety study. A total of 431 subjects received treatment with LONHALA MAGNAIR 25 mcg twice-daily (BID). The safety data described below are based on the two 12-week trials and the one 48-week trial.
12-Week Trials
LONHALA MAGNAIR was studied in two 12-week placebo-controlled trials in subjects with COPD. In these trials, 431 subjects were treated with LONHALA MAGNAIR at the recommended dose of 25 mcg twice daily. The population had a mean age of 63 years (ranging from 40 to 87 years), with 56% males, 90% Caucasian, and a mean post-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 52% of predicted normal value (20%-80%) at study entry. The study population also included subjects with pre-existing cardiovascular disease as well as subjects with continued use of stable long-acting bronchodilator (LABA) ± inhaled corticosteroid (ICS) and ipratropium bromide background therapy. Subjects with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these studies.
Table 1 shows the most common adverse reactions incidence greater than or equal to 2.0% in the LONHALA MAGNAIR group and higher than placebo in the two 12-week placebo-controlled trials.
The proportion of subjects who discontinued treatment due to adverse reactions was 5% for the LONHALA MAGNAIR-treated subjects and 9% for placebo-treated subjects.
Table 1. Adverse Reactions with LONHALA MAGNAIR ≥2.0% Incidence and Higher than Placebo
| Placebo (N=430) N (%) |
LONHALA MAGNAIR 25 mcg BID (N=431) N (%) |
|
| Dyspnea | 13 (3.0) | 21 (4.9) |
| Urinary Tract Infection | 6 (1.4) | 9 (2.1) |
Other adverse reactions defined as events with an incidence of ≥1.0% but less than 2.0% with LONHALA MAGNAIR but more common than with placebo included the following: wheezing, upper respiratory tract infection, nasopharyngitis, oedema peripheral, and fatigue.
48-Week Trial
In a long-term open-label safety trial, 1086 subjects were treated for up to 48-weeks with LONHALA MAGNAIR 50 mcg twice-daily (N=620) or tiotropium (N=466). The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy studies described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the placebo-controlled studies of 12-weeks. Adverse reactions that occurred at a frequency greater than that seen in either active treatment dose in the pooled 12-week placebo controlled studies and ≥ 2.0% were: diarrhea, edema peripheral, bronchitis, nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, urinary tract infection, back pain, headache, Chronic Obstructive Pulmonary Disease, cough, dyspnea, oropharyngeal pain, and hypertension.
Read the entire FDA prescribing information for Lonhala Magnair (Glycopyrrolate Inhalation Solution)
&Copy; Lonhala Magnair Patient Information is supplied by Cerner Multum, Inc. and Lonhala Magnair Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.