Description
Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (eg, cerebral palsy) in children 3 to 16 years of age. This medicine is an anticholinergic.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Tablet, Disintegrating
- Solution
Before Using
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.
Appropriate studies have not been performed on the relationship of age to the effects of glycopyrrolate in the pediatric population. Safety and efficacy have not been established.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of chlordiazepoxide and clidinium combination in the elderly. However, elderly patients are more sensitive to the effects (eg, stomach or bowel problems, trouble urinating, heart rhythm problems, falls, or fractures) of this medicine than younger adults.
Breastfeeding
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.
Drug Interactions
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 Chloride
- Potassium Citrate
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.
- Aclidinium
- Amantadine
- Amifampridine
- Amitriptyline
- Amoxapine
- Atropine
- Belladonna
- Benzhydrocodone
- Benztropine
- Biperiden
- Brompheniramine
- Buprenorphine
- Bupropion
- Carbinoxamine
- Carisoprodol
- Chlorpheniramine
- Chlorpromazine
- Clemastine
- Clidinium
- Clomipramine
- Clozapine
- Codeine
- Cyclobenzaprine
- Cyclopentolate
- Cyproheptadine
- Darifenacin
- Desipramine
- Dicyclomine
- Dihydrocodeine
- Dimenhydrinate
- Diphenhydramine
- Donepezil
- Doxepin
- Fentanyl
- Fesoterodine
- Flavoxate
- Fluphenazine
- Glucagon
- Glycopyrronium Tosylate
- Homatropine
Other Interactions
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 (eg, neuropathy) or
- Ulcerative colitis—Use with caution. May make these conditions worse.
- Enlarged prostate or
- Glaucoma or
- Myasthenia gravis (severe muscle weakness) or
- Paralytic ileus (bowel blockage) or
- Stomach or intestinal problems (eg, ulcerative colitis, toxic megacolon, bowel obstruction), severe or
- Urinary bladder blockage (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.
Proper Use
Take this medicine only as directed by your doctor. Your doctor may change your dose several times in order to find out what works best for you. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Take this medicine at least one hour before or two hours after meals.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Make sure your hands are dry before you handle the orally disintegrating tablet. Do not open the blister pack until you are ready to take it. Peel back the foil from the blister pack, then remove the tablet. Do not push the tablet through the foil. Do not break or cut the tablet. Place the tablet in your mouth. After it has melted, swallow without water.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For peptic ulcers:
- For oral dosage form (tablet):
- Adults and children 12 years of age and older—The initial dose is 1 milligram (mg) 3 times a day. Your doctor will adjust the dose as needed. However, the dose is usually not more than 8 mg per day.
- Children younger than 12 years of age—Use is not recommended.
- For oral dosage form (disintegrating tablet):
- Adults—1.7 milligrams (mg) 2 to 3 times a day. Your doctor will adjust the dose as needed. However, the dose is usually not more than 6.8 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablet):
- For severe drooling:
- For oral dosage form (solution):
- Children 3 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The dose is 0.02 milligram (mg) per kilogram (kg) of body weight 3 times a day. Your child's doctor may increase your child's dose as needed. However, the dose is usually not more than 1.5 to 3 mg per dose.
- Children younger than 3 years of age—Use and dose must be determined by your child's doctor.
- For oral dosage form (solution):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor or your child's doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check for unwanted effects.
You should not take potassium chloride tablets or other potassium supplements (in tablet or capsule forms) while using this medicine. Using these medicines together may cause delayed movement of the potassium supplement through the esophagus and stomach.
This medicine may cause constipation or diarrhea. Constipation or diarrhea can be an early symptom of a serious bowel problem. Check with your doctor if you or your child has constipation, diarrhea, stomach distention (swelling), pain, nausea, or vomiting.
Check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has irritability, crying, decrease in the frequency of urine, or difficult or painful urination.
If you or your child develops a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.
This medicine may make you or your child sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.
This medicine may make you or your child dizzy, confused, drowsy, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
More common
- 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
- painful urination
- redness of the face, neck, arms, and occasionally, upper chest
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Chest pain or tightness
- confusion
- dizziness
- dry heaves
- dry mouth
- fainting
- increase in heart rate
- lightheadedness
- pain or tenderness around the eyes and cheekbones
- rapid breathing
- stomach pain or discomfort
- stuffy nose
- sunken eyes
- thirst
- trouble breathing
- vomiting
- wrinkled skin
Incidence not known
- Change in taste
- difficulty swallowing
- fast heartbeat
- hives, itching, skin rash
- loss of taste
- pale or blue lips, fingernails, or skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Get emergency help immediately if any of the following symptoms of overdose occur:
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- muscle weakness
- sweating
- trouble breathing
- unusual tiredness or weakness
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:
Less common
- Altered mood
- anxiety
- attack, assault, or force
- bloated
- chapped lips
- crying
- dry skin
- dry tongue
- excess air or gas in the stomach or intestines
- full feeling
- hyperventilation
- irregular heartbeats
- irritability
- moaning
- nervousness
- pain
- paleness of the skin
- passing gas
- rash
- restlessness
- shaking
- trouble with sleeping
- uncontrolled eye movements
Incidence not known
- Decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
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.
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