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SEEBRI BREEZHALER INHALATION POWDER, HARD CAPSULE 50MCG

Product Information

Registration Status: Active

SIN14431P

SEEBRI BREEZHALER INHALATION POWDER, HARD CAPSULE 50MCG is approved to be sold in Singapore with effective from 2013-08-11. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14431P.

This product contains Glycopyrronium 50mcg in the form of CAPSULE. It is approved for BUCCAL use.

This product is manufactured by Novartis Pharma Schweizerhalle AG (Post micronisation treatment of Intermediate) in SWITZERLAND, andNovartis Pharma Stein AG (manufacturer and secondary packager) in SPAIN.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Glycopyrronium (as the bromide salt glycopyrrolate) is a synthetic anticholinergic agent with a quaternary ammonium structure. A muscarinic competitive antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics. In October 2015, glycopyrrolate was approved by the FDA for use as a standalone treatment for Chronic obstructive pulmonary disease (COPD), as Seebri Neohaler.

Indication

For use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric secretions and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. Also used to treat chronic obstructive pulmonary disease (COPD).

Mechanism of Action

Glycopyrrolate binds competitively to the muscarinic acetylcholine receptor. Like other anticholinergic (antimuscarinic) agents, it inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, exocrine glands and, to a limited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.

Pharmacokinetics

Absorption
Rapidly absorbed (1-2 minutes) after intravenous injection
Distribution
Metabolism
Elimination

Toxicity

Side effects include dry mouth, difficult urinating, heachaches, diarrhea and constipation. The medication also induces drowsiness or blurred vision. LD50=709 mg/kg (rat, oral).

Active Ingredient/Synonyms

Glycopyrrolate cation | Glycopyrrolate ion | Glycopyrronium cation | Glycopyrronium ion | Glycopyrronium |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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