Glycate

Yes

Common side effects of glycopyrrolate are:

• dry mouth,
• urinary retention,
• blurred vision,
• dilated pupils,
• increased heart rate,
• sweating,
• weakness,
• dizziness,
• dry skin,
• constipation,
• urinary retention, and
• mental confusion.

Glycopyrrolate injection is available in 0.2 mg/ml strength in 1 ml and 2 ml single-use vials. It is also available in 5 ml and 20 ml multi-use vials. All vials contain benzyl alcohol 0.9% as preservative.

Store Glycopyrrolate injection at room temperature between 20 C and 25 C (68 F and 77 F).

• Nuro Pharma, Inc.

In the U.S.

• Cuvposa
• Glycate
• Robinul
• Robinul Forte

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antimuscarinic

Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (e.g., cerebral palsy) in children 3 to 16 years of age. This medicine is an anticholinergic.

Glycopyrrolate may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glycopyrrolate in children 3 to 16 years of age. However, safety and efficacy have not been established in children younger than 3 years of age.

Geriatric

No information is available on whether the risk of glycopyrrolate-induced adverse effects are increased in the elderly; however, it should be used with caution because elderly patients are more likely to have age related liver disease, kidney disease, heart disease, or prostate problems. This may require a dosage adjustment or careful monitoring in elderly patients receiving glycopyrrolate.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil
• Tiotropium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colostomy (bowel surgical procedure) or
• Congestive heart failure or
• Heart disease or
• Heart rhythm problems or
• Hiatal hernia with gastroesophageal reflux disease (GERD) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Ileostomy (bowel surgical procedure) or
• Liver disease or
• Nerve problems (e.g., neuropathy) or
• Prostatic hypertrophy (enlarged prostate) or
• Ulcerative colitis—Use with caution. May make these conditions worse.

• Glaucoma or
• Myasthenia gravis (severe muscle weakness) or
• Obstructive uropathy (urinary blockage due to enlarged prostate or other condition) or
• Paralytic ileus (bowel blockage) or
• Stomach or intestinal problems (e.g., ulcerative colitis, toxic megacolon, bowel obstruction), severe or
• Trouble urinating—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• constipation
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• difficulty with breathing
• ear congestion
• feeling of warmth
• fever
• headache
• loss of voice
• nasal congestion
• painful urination
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Abdominal or stomach discomfort or pain
• abdominal or stomach distension
• chest pain
• confusion
• convulsions
• dizziness
• dry heaves
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• pain or tenderness around the eyes and cheekbones
• rapid breathing
• shortness of breath or troubled breathing
• stuffy nose
• sunken eyes
• thirst
• tightness in the chest
• vomiting
• wheezing
• wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• low blood pressure
• muscle weakness
• trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Altered mood
• anxiety
• attack, assault, or force
• bloated
• change in taste
• chapped lips
• crying
• dry skin
• dry tongue
• excess air or gas in the stomach or intestines
• full feeling
• hyperventilation
• irregular heartbeats
• irritability
• loss of taste
• moaning
• nervousness
• pain
• paleness of the skin
• passing gas
• rash
• restlessness
• shaking
• trouble with sleeping
• uncontrolled eye movements

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Glycopyrrolate injectable contains benzyl alcohol and is not recommended for use in neonates.

Caution is recommended when glycopyrrolate is given to elderly patients because of the increased risk of side effects. The elderly appear to be more prone to the anticholinergic effects of glycopyrrolate on the CNS, which can result in confusion, agitation, delirium, or drowsiness.