Glycopyrrolate (Inhalation route)
- Seebri Neohaler
Uses of This Medicine:
Inhaled glycopyrrolate is used to treat air flow blockage and prevent worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (difficulty with breathing).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Use of inhaled glycopyrrolate is not recommended in children. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled glycopyrrolate in the elderly.
|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.|
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.
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.
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.
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:
- Allergy to milk proteins Use with caution. This medicine contains lactose (milk sugar) and milk proteins.
- Bladder problems or
- Enlarged prostate or
- Glaucoma, narrow angle or
- Trouble urinating Use with caution. May make these conditions worse.
- COPD attack, severe Should not be used if you are having a severe COPD attack, or if symptoms of COPD attack have already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack.
Proper Use of This Medicine:
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.
Inhaled glycopyrrolate comes with patient information leaflet. Read the instructions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.
You will use this medicine with a special inhaler device called the Seebri™ Neohaler®. The medicine capsule should not be swallowed. It is placed only into the Neohaler inhaler that comes with the package. This device opens the capsule and loads the powder medicine from the capsule into the air chamber. You then inhale the powder through the mouthpiece. Your caregiver will show you how to use your inhaler.
Use this medicine at the same time each day.
Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.
To use the inhaler:
- Dry your hands before handling this medicine.
- Open a blister card of capsules. Do not remove a capsule until you are ready for a dose. Peel the backing to expose the capsule. Do not push the capsule through the foil to remove it from the blister.
- Remove the cap of the inhaler then hold the base firmly and tilt the mouthpiece to open the inhaler.
- Place the capsule into the capsule chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
- Close the inhaler fully. You should hear a clicking sound as you close it.
- Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
- Breathe out fully. Do not exhale into the mouthpiece.
- Place the mouthpiece in your mouth then close your lips around the mouthpiece.
- Breathe in quickly and deeply.
- Remove the inhaler from your mouth. Hold your breath for at least 50 to 10 seconds, or as long as you can and then exhale.
- Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.
- If there is still powder in the capsule, close the inhaler and repeat the inhalation process.
- Close the mouthpiece and then replace the cover.
- Do not wash the inhaler. Keep it dry.
- Use a new inhaler with each refill of your medicine.
- Do not use the inhaler for this medicine with any other medicine.
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 inhalation powder dosage form (used with Seebri™ Neohaler®):
- For maintenance treatment of COPD:
- Adults 1 capsule by oral inhalation two times a day (1 capsule in the morning and 1 capsule in the evening).
- Children Use is not recommended.
- For maintenance treatment of COPD:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 While Using This Medicine:
It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the other medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack have already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.
Talk to your doctor or get medical care right away if:
- your symptoms do not improve after using this medicine within a few days or if they become worse.
- your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.
This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.
If you develop a skin rash, hives, swelling of the tongue, lips, or face, or any allergic reaction to this medicine, check with your doctor right away.
Check with your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
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 of This Medicine:
- Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
- Fast heartbeat
- hives, itching, or skin rash
- joint pain, stiffness, or swelling
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled swallowing
- Incidence not known
- blurred vision
- decrease in the frequency of urination
- decrease in the urine volume
- decreased vision
- difficulty in passing urine (dribbling)
- eye pain or discomfort, or red eyes
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nausea or vomiting
- seeing halos around lights
- Less common
- Body aches or pain
- ear congestion
- loss of voice
- pain or tenderness around the eyes and cheekbones
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- Abdominal or stomach pain
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- loss of consciousness
- pain in the arms or legs
- trouble sleeping
- unexplained weight loss
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:
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:
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.
Last Updated: 9/15/2016