GLYCOQUIC F
Glycopyrrolate and Formoterol Fumarate Powder for Inhalation
QUALITATIVE AND QUANTITATIVE COMPOSITION: Each hard
gelatin capsule contains - Glycopyrronium 25 mcg and Formoterol Fumarate
12 mcg. INDICATION: It is indicated as a maintenance
bronchodilator treatment to relieve symptoms in patients with chronic
obstructive pulmonary disease (COPD).
DOSAGE AND METHOD OF ADMINISTRATION: The recommended
dose is the inhalation of the content of one capsule of Glycoquic F
Pulmicaps twice daily using the ALKEM's INNOHALER device. Glycoquic F
Pulmicaps must not be swallowed. It should be administered at the same
time of the day each day.
CONTRAINDICATIONS: Contraindicated in patients with a
history of hypersensitivity to glycopyrronium, formoterol, lactose, or
any other component of the drug product. Not indicated for the
treatment of asthma. WARNINGS AND PRECAUTIONS: Should
not be initiated during acutely deteriorating or potentially life-
threatening episodes of COPD. Not be used for the relief of acute
symptoms such as bronchospasm. Can produce paradoxical bronchospasm.
Should be used with caution in patients with severe hypersensitivity to
milk proteins. Should be used with caution in patients with
cardiovascular disorders and urinary symptoms.
UNDESIRABLE EFFECTS: Safety and efficacy have not been
established in pediatric patients. Geriatric patients do not require
dosage adjustments based on available data.
DRUG INTERACTIONS: Formal interaction studies have not
been performed, but the document outlines potential interactions with
adrenergic drugs, xanthine derivatives, steroids, and diuretics.
Concomitant use of monoamine oxidase inhibitors or tricyclic
antidepressants can prolong QTc interval.
USE IN SPECIAL POPULATIONS: In Renal Impairment: Can be
used, if the expected benefit outweighs the potential risk.
In Hepatic Impairment: The pharmacokinetics have not
been studied in hepatic impairment, but since formoterol fumarate is
predominantly cleared by hepatic metabolism, close monitoring is
required. Pregnant Women and Lactating Women: No
adequate and well-controlled studies in pregnant & lactating women.
Animal studies show no structural abnormalities or fetal survival issues
at high exposures. Should be used, only if the potential benefit
justifies the potential risk to the foetus. These highlights do not
include all the information needed to use Glycoquic F Pulmicaps
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 4th July 2024. Source: Prescribing Information
Glycoquic F Pulmicaps.