GLYCOQUIC Pulmules
Glycopyrronium Inhalation Solution 25 mcg
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each 2 mL
unit-dose respule contains Glycopyrronium 25 mcg.
INDICATION: For the long-term maintenance treatment of
airflow obstruction in patients with chronic obstructive pulmonary
disease (COPD) including chronic bronchitis and/or emphysema.
DOSAGE AND METHOD OF ADMINISTRATION: One respule
twice-daily with high-efficiency nebulizer. Should be administered at
the same time of the day. More than 1 respule twice daily of
glycopyrronium inhalation solution is not recommended.
CONTRAINDICATIONS: contraindicated in patients with a
hypersensitivity to glycopyrronium or any of the ingredients. Not be
administered orally or parenterally.
WARNING AND PRECAUTION: Do not initiate glycopyrronium
inhalation during acute COPD episodes; not for rescue therapy.
Discontinue glycopyrronium if paradoxical bronchospasm or allergic signs
appear. Use with caution in narrow-angle glaucoma and in urinary
retention. UNDESIRABLE EFFECTS: Paradoxical
bronchospasm, immediate hypersensitivity reactions, worsening of
narrow-angle glaucoma, dyspnea and urinary tract infection, wheezing,
upper respiratory tract infection, nasopharyngitis, oedema peripheral,
fatigue and worsening of urinary retention.
DRUG INTERACTIONS: potential for an additive
interaction with concomitantly used anticholinergic medications.
USE IN SPECIAL POPULATION: Pregnant Women-There are no
adequate and well-controlled studies in pregnant women and on labor.
Glycopyrronium inhalation solution should only be used during
pregnancy/during labor if the expected benefit to the patient outweighs
the potential risk to the fetus. There are no data on the presence of
glycopyrronium or its metabolites in human milk, the effects on the
breastfed infant, or the effects on milk production. analyze risk
benefit before prescribing to lactating mother. No dose adjustment is
required for patients with mild to moderate renal impairment. No dose
adjustment is required for patients with hepatic impairment. These
highlights do not include all the information needed to use GLYCOQUIC
Pulmules effectively and safely. Please refer to full prescribing
information [available on request].
FOR FURTHER INFORMATION, CONTACT: Medical Affairs;
Alkem House; Senapati Bapat Marg, Lower Parel, Mumbai, Maharashtra: 400
013. Prepared on 7th June 2024. Source: Prescribing Information
GLYCOQUIC Pulmules