Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Cuvposa
  2. Glycate
  3. Robinul
  4. Robinul Forte

Descriptions


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.

This product is available in the following dosage forms:

  • Tablet
  • 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.

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

Information about this glycopyrrolate-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

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 (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.

Proper Use

Your doctor will tell you how much of this medicine to use and how often. The dose may need to be changed several times in order to find out what works best for you or your child. Do not use more medicine or use it more often than your doctor tells you to.

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.

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.

You should take this medicine at least one hour before or two hours after meals.

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 oral dosage form (solution):
    • For severe drooling:
      • 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 three 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 (tablet):
    • For peptic ulcers:
      • Adults and children 12 years of age and older—The initial dose is 1 mg three times daily. 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.

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 is 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. Stop using this medicine and check with your doctor if you or your child has constipation, diarrhea, abdominal or stomach distention (swelling), pain, nausea, or vomiting.

Stop using this medicine and check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has the following symptoms while using this medicine: crying, irritability, 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, stop taking the medicine and 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 drowsy or cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

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

  1. Body aches or pain
  2. chills
  3. constipation
  4. cough
  5. decrease in the frequency of urination
  6. decrease in urine volume
  7. difficulty in passing urine (dribbling)
  8. difficulty with breathing
  9. ear congestion
  10. feeling of warmth
  11. fever
  12. headache
  13. loss of voice
  14. nasal congestion
  15. painful urination
  16. redness of the face, neck, arms, and occasionally, upper chest
  17. runny nose
  18. sneezing
  19. sore throat
  20. unusual tiredness or weakness

Less common

  1. Abdominal or stomach discomfort or pain
  2. abdominal or stomach distension
  3. chest pain
  4. confusion
  5. convulsions
  6. dizziness
  7. dry heaves
  8. dry mouth
  9. fainting
  10. increase in heart rate
  11. lightheadedness
  12. pain or tenderness around the eyes and cheekbones
  13. rapid breathing
  14. shortness of breath or troubled breathing
  15. stuffy nose
  16. sunken eyes
  17. thirst
  18. tightness in the chest
  19. vomiting
  20. wheezing
  21. wrinkled skin

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

  1. low blood pressure
  2. muscle weakness
  3. 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:

Less common

  1. Altered mood
  2. anxiety
  3. attack, assault, or force
  4. bloated
  5. change in taste
  6. chapped lips
  7. crying
  8. dry skin
  9. dry tongue
  10. excess air or gas in the stomach or intestines
  11. full feeling
  12. hyperventilation
  13. irregular heartbeats
  14. irritability
  15. loss of taste
  16. moaning
  17. nervousness
  18. pain
  19. paleness of the skin
  20. passing gas
  21. rash
  22. restlessness
  23. shaking
  24. trouble with sleeping
  25. 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.