Formoterol and Glycopyrronium bromide interacts in the following cases:
There are no relevant data on the use of glycopyrronium/formoterol in patients with severe hepatic impairment and the medicinal product should be used only if the expected benefit outweighs the potential risk. These patients should be monitored for potential adverse reactions.
There are no data on the use of glycopyrronium/formoterol in pregnant women. Single-dose studies in humans found that very small amounts of glycopyrronium passed the placental barrier. In animal studies, formoterol and glycopyrronium, individually, have caused adverse effects in reproduction studies at very high doses/systemic exposure levels.
Glycopyrronium/formoterol should only be used during pregnancy if the expected benefits outweigh the potential risks.
It is not known whether glycopyrronium or formoterol are excreted in human milk. Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported.
Administration of glycopyrronium/formoterol to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the infant.
Studies in rats have shown adverse effects on fertility only at dose levels higher than the maximum human exposure to formoterol. Glycopyrronium did not cause any adverse effects on fertility in rats. It is unlikely that glycopyrronium/formoterol administered at the recommended dose will affect fertility in humans.
Glycopyrronium/formoterol combination has no or negligible influence on the ability to drive and use machines. However dizziness and nausea are common side effects which should be taken into account when driving or using machines.
The safety profile is characterised by anticholinergic and β2-adrenergic class effects related to the individual components of the combination. The most commonly reported adverse reactions in patients receiving glycopyrronium/formoterol were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).
The tabulated list of adverse reactions is based on clinical trials and post-approval experience with glycopyrronium/formoterol as well as experience with the individual components and related products.
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Adverse reactions by frequency and system organ class (SOC):
| System Organ Class | Preferred term | Frequency |
|---|---|---|
| Immune system disorders | Hypersensitivity reactions including rash and pruritus | Uncommon |
| Metabolism and nutrition disorders | Hyperglycaemia1 | Uncommon |
| Psychiatric disorders | Anxiety | Common |
| Agitation Restlessness Insomnia | Uncommon | |
| Nervous system disorders | Headache1 Dizziness | Common |
| Tremor1 | Uncommon | |
| Cardiac disorders | Tachycardia Palpitations Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles) | Uncommon |
| Gastrointestinal disorders | Dry mouth2, Nausea | Common |
| Musculoskeletal and connective tissue disorders | Muscle spasms1 | Common |
| Renal and urinary disorders | Urinary tract infection | Common |
| Urinary retention2 | Uncommon | |
| General disorders and administration site conditions | Chest pain | Common |
1 adverse reaction relates to formoterol
2 adverse reaction relates to glycopyrronium
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