Indications

Glycopyrronium Bromide oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Composition

Pharmacology

Glycopyrrolate is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate indirectly reduces the rate of salivation by preventing the stimulation of these receptors. Glycopyrrolate inhibits the action of acetylcholine on salivary glands thereby reducing the extent of salivation.

Dosage & Administration

Glycopyrronium Bromide oral solution must be measured and administered with an accurate measuring device. Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver. Glycopyrronium Bromide oral solution should be dosed at least one hour before or two hours after meals. The presence of high-fat food reduces the oral bioavailability of this oral solution if taken shortly after a meal

Contraindications

Glycopyrronium Bromide oral solution is contraindicated in: Patients with medical conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis). Patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the gastrointestinal (GI) tract may be arrested or delayed with coadministration of Glycopyrronium Bromide oral solution.

Side Effects

Gastrointestinal : Abdominal distention, abdominal pain, stomach discomfort, chapped lips, flatulence, retching, dry tongue General Disorders : Irritability, pain Infections : Pneumonia, sinusitis, tracheostomy infection, upper respiratory tract infection, urinary tract infection Investigations : Heart rate increase Metabolism and Nutrition : Dehydration Nervous System : Headache, convulsion, dysgeusia, nystagmus Psychiatric : Agitation, restlessness, abnormal behavior, aggression, crying, impulse control disorder, moaning, mood altered Respiratory : Increased viscosity of bronchial secretion, nasal congestion, nasal dryness Skin : Dry skin, pruritus, rash Vascular : Pallor

Pregnancy & Lactation

There are no available data in pregnant women for Glycopyrronium Bromide to inform decisions concerning any drug-associated risks. There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Glycopyrronium Bromide and any potential adverse effects on the breastfed infant from Glycopyrronium Bromide or from the underlying maternal condition.

Precautions & Warnings

Constipation or Intestinal Pseudo-obstruction : Constipation is a common dose-limiting adverse reaction that sometimes leads to glycopyrrolate discontinuation. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase. Intestinal pseudo-obstruction has been reported and may present as abdominal distention, pain, nausea or vomiting. Incomplete Mechanical Intestinal Obstruction : Diarrhea may be an early symptom of incomplete mechanical intestinal obstruction, especially in patients with ileostomy or colostomy. If the incomplete mechanical intestinal obstruction is suspected, discontinue treatment with Glycopyrronium Bromide and evaluate for intestinal obstruction. High Ambient Temperatures : In the presence of high ambient temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as Glycopyrronium Bromide. Advise patients/caregivers to avoid exposure of the patient to hot or very warm environmental temperatures. Operating Machinery or an Automobile : Glycopyrronium Bromide may produce drowsiness or blurred vision. As appropriate for a given age, warn the patient not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking Glycopyrronium Bromide. Anticholinergic Drug Effects : Use Glycopyrronium Bromide with caution in patients with conditions that are exacerbated by anticholinergic drug effects including: Autonomic neuropathy Renal disease Ulcerative colitis- Large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate "toxic megacolon", a serious complication of the disease Hyperthyroidism Coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition

Therapeutic Class

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.