Glycopyrrolate (Oral Inhalation)

• Tell all of your health care providers that you take glycopyrrolate. This includes your doctors, nurses, pharmacists, and dentists.
• If you are allergic to milk, talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
• Do not use more than what your doctor told you to use. Do not use more often or longer than what you were told. Doing any of these things may raise the chance of very bad side effects.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• If glycopyrrolate gets in the eyes, rinse with water right away. Call the doctor right away if this medicine gets in the eyes and blurred eyesight, worsened glaucoma, or eye pain happens.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using glycopyrrolate while you are pregnant.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble swallowing.
• Change in eyesight, eye pain, or very bad eye irritation.
• Seeing halos or bright colors around lights.
• Red eyes.
• Very upset stomach or throwing up.
• Trouble passing urine.
• Pain when passing urine.
• Passing urine more often.
• Passing urine in a weak stream or drips.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using glycopyrrolate (oral inhalation), use a rescue inhaler and get medical help right away.

• Store at room temperature.
• Store capsules in the original container. Use right after opening.
• Do not store capsules in the puffer (inhaler).
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take glycopyrrolate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to glycopyrrolate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• Anticholinergic Agent
• Anticholinergic Agent, Long-Acting

Competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor subtypes 1 to 3 (greater affinity for subtypes 1 and 3) in bronchial smooth muscle thereby causing bronchodilation

Absorption

Rapid

Distribution

Vd: Steady state: 83 L; Terminal phase: 376 L

Metabolism

Hepatic (minimal)

Excretion

Urine; bile

Clearance: Children (1 to 14 years): Mean range: 1 to 1.4 L/kg/hour; Adults: Mean range: 0.4 to 0.68 L/kg/hour

Time to Peak

Plasma: 5 minutes

Half-Life Elimination

33 to 53 hours

Protein Binding

38% to 41%

A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in mild and moderate impairment estimated glomerular filtration rate (eGFR) ≥30 mL/minute/1.73m2) and up to 2.2-fold in subjects with severe impairment and ESRD (eGFR <30 mL/minute/1.73m2).

1% to 10%:

Central nervous system: Fatigue (≥2%)

Gastrointestinal: Diarrhea (≥2%), nausea (≥2%), upper abdominal pain (≥2%)

Neuromuscular & skeletal: Arthralgia (≥2%), back pain (≥2%)

Respiratory: Upper respiratory tract infection (2% to 3%), bronchitis (≥2%), dyspnea (≥2%), nasopharyngitis (≥2%), pneumonia (≥2%), rhinitis (≥2%), wheezing (≥2%), oropharyngeal pain (2%), sinusitis (1%)

<1% (Limited to important or life-threatening): Angioedema, atrial fibrillation, cough, diabetes mellitus, dysuria, gastroenteritis, hypersensitivity reaction, insomnia, limb pain, paradoxical bronchospasm, productive cough, pruritus, skin rash, voice disorder, vomiting