Glycopyrrolate

Glycopyrrolate is a prescription medication used to treat chronic obstructive pulmonary disease (COPD) as well as peptic ulcers. 

It belongs to a group of drugs called anticholinergics. These work by relaxing and opening the air passages to the lungs to make breathing easier. It works to treat ulcers, by blocking the activity of a certain natural substance in the body and, therefore, decreases stomach acid production. 

This medication is available in capsule form to use with a specially designed inhaler. The capsules are inserted into the Neohaler and inhaled once a day. Do not swallow Seebri capsules. Instead, using the Seebri Neohaler, the capsule is punctured, and the powder inside the capsule is inhaled into the lungs. 

This medication also comes as a tablet to take by mouth. It is usually taken 2 or 3 times a day.

Common side effects of glycopyrrolate include dry mouth and runny nose.

Glycopyrrolate is a prescription medication used to treat chronic obstructive pulmonary disease (COPD) and peptic ulcers. 

When treating COPD:

• Glycopyrrolate is not used to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
• Glycopyrrolate should not be used in children. It is not known if glycopyrrolate is safe and effective in children younger than 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Glycopyrrolate may be found in some form under the following brand names:

• Cuvposa

• Lonhala Magnair

• Robinul

• Seebri Neohaler

Serious side effects have been reported with glycopyrrolate. See the “Glycopyrrolate Precautions” section.

Common side effects glycopyrrolate when used with inhaler include the following:

• Upset stomach, indigestion
• Pain in extremities (e.g. arms or legs)
• Sinus congestion (Feeling of pressure or pain in the cheeks and forehead)
• Dry mouth
• Gastroenteritis (nausea, vomiting, diarrhea, abdominal pain)
• Difficulty sleeping
• Symptoms of the common cold (runny or stuffy nose, cough, sore throat, sneezing)
• Pain in muscles, bones or joints
• Cavities
• Rash
• Tiredness
• Weakness
• Throat irritation
• Nose bleeds
• Tingling or numbness
• Itching

Common side effects of glycopyrrolate tablets include:

• Dry mouth
• Decreased sweating
• Urinary retention
• Blurred vision
• Fast heart rate
• Loss of taste
• Headaches
• Nervousness
• Mental confusion
• Drowsiness
• Weakness
• Dizziness
• Difficulty sleeping
• Nausea
• Vomiting
• Constipation
• Bloated feeling 

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take anticholinergics such as tiotropium, ipratropium, and aclidinium.

This is not a complete list of glycopyrrolate drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with glycopyrrolate, when used to treat COPD, including the following:

• Sudden shortness of breath immediately after use of glycopyrrolate. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop taking glycopyrrolate and call your healthcare provider or go to the nearest hospital emergency room right away.
• Serious allergic reactions. Stop using glycopyrrolate and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of the tongue, lips, and face
  • difficulty breathing or swallowing
• New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
  • eye pain or discomfort
  • nausea or vomiting
  • blurred vision
  • red eyes
  • seeing halos or bright colors around lights
• New or worsened urinary retention. People who use glycopyrrolate may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
  • difficulty urinating
  • painful urination
  • urinating frequently
  • urination in a weak stream or drips

If you have these symptoms, stop taking glycopyrrolate and call your healthcare provider right away before using another dose.

Glycopyrrolate is not used to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Glycopyrrolate should not be used in children. It is not known if glycopyrrolate is safe and effective in children younger than 18 years of age.

Serious side effects have been reported with glycopyrrolate, when used to treat peptic ulcers, including the following:

• Issues with temperature. In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of glycopyrrolate tablets.
• Diarrhea. Diarrhea may be an early symptom of incomplete blockage in the intestines, especially in patients with ileostomy or colostomy. 
• Drowsiness or blurred vision. Glycopyrrolate tablets may produce drowsiness or blurred vision. Do not engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work until you know how this medication affects you. 

Do not use glycopyrrolate for COPD if you are allergic to glycopyrrolate or to any of its ingredients.

Do not take glycopyrrolate for peptic ulcers if you:

• are allergic glycopyrrolate or to any of its ingredients
• have glaucoma
• have myasthenia gravis
• have severe ulcerative colitis or toxic megacolon 
• have a blockage in your digestive tract or bowel
• have a blockage in your bladder

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of glycopyrrolate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using/taking glycopyrrolate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to glycopyrrolate or any of its ingredients. Glycopyrrolate capsules, to be used with the inhaler, contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy.
• have kidney problems
• have eye problems such as glaucoma. Glycopyrrolate may make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. Glycopyrrolate may make these problems worse.
• have hyperthyroidism
• have heart condition
• have high blood pressure
• have ulcerative colitis
• have a hiatal hernia associated with reflux esophagitis
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Glycopyrrolate falls into category C. No well-controlled studies have been done in humans. It is not known if glycopyrrolate can harm your unborn baby. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. Contact your physician immediately if you become pregnant while using glycopyrrolate.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if glycopyrrolate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using glycopyrrolate.

Use glycopyrrolate exactly as prescribed. Do not use/take glycopyrrolate more often than prescribed for you.

This medication is available in capsule form to use with a specially designed inhaler as well as available in tablets. 

Glycopyrrolate capsules to be used with inhaler:

• This medication is available in capsule form to use with a specially designed inhaler. Use 1 glycopyrrolate capsule inhaled through the Neohaler inhaler 2 times each day (1 capsule in the morning and 1 capsule in the evening). 
• Do not swallow capsules. Only use glycopyrrolate capsules with the Neohaler inhaler.
• Do not use 2 capsules at 1 time. Do not use more than 2 capsules in a day. 
• To make sure the full dose has been taken, you should open the inhaler to check that there is no powder left in the capsule. As long as the capsule is empty, you have received 1 full dose.
• Do not use glycopyrrolate unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. 
• Peel the backing foil away from the blister to open it, do not push the capsule through the foil.
• Always use the new Neohaler inhaler that is provided with each new prescription.
• This medication does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have a rescue inhaler prescribed for you.
• Do not stop using glycopyrrolate or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with glycopyrrolate, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.

Glycopyrrolate tablets to treat peptic ulcers:

• This medication comes as a tablet to take by mouth. It is usually taken 2 or 3 times a day.

If you miss a dose of glycopyrrolate, take it as soon as you remember. Take your next dose at your usual time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Seebri Neohaler (glycopyrrolate) to treat COPD is one capsule twice a day (1 capsule in the morning and 1 capsule in the evening). 

The recommended dose range of glycopyrrolate to treat peptic ulcers is 1 mg-2 mg two or three times per day. 

If you take too much glycopyrrolate, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Glycopyrrolate to be used with Neohaler

• Store glycopyrrolate (inhaler and blister-packaged capsules) at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not remove glycopyrrolate capsules from the blister card it comes in until you are ready to use a dose of Seebri Neohaler.
• Do not store glycopyrrolate capsules in the Neohaler inhaler.
• Keep Neohaler in a dry place away from moisture.

Glycopyrrolate tablets:

• Store glycopyrrolate tablets at 20° to 25°C (68° to 77°F) 

Keep glycopyrrolate and all medicines out of the reach of children.