Seebri Neohaler (glycopyrrolate)

Generic drug: glycopyrrolate

Brand name: Seebri Neohaler

Seebri Neohaler is an anticholinergic medicine known as glycopyrrolate.

• Anticholinergic medicines such as Seebri Neohaler help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. This makes it hard to breathe.
• Seebri Neohaler is used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
• Seebri Neohaler is for long-term use and should be taken 2 times each day to improve symptoms of COPD for better breathing.
• Seebri Neohaler is not used to treat sudden symptoms of COPD. Always have a short-acting beta -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.
• Seebri Neohaler should not be used in children. It is not known if Seebri Neohaler is safe and effective in children younger than 18 years of age.

Seebri Neohaler can cause serious side effects, including:

• sudden shortness of breath immediately after use of Seebri Neohaler. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Seebri Neohaler and call your healthcare provider or go to the nearest hospital emergency room right away.
• serious allergic reactions. Stop using Seebri Neohaler 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
  • swelling of the tongue, lips, and face
  • hives
  • 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
  • blurred vision
  • red eyes
  • nausea or vomiting
  • seeing halos or bright colors around lights

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

• new or worsened urinary retention. People who use Seebri Neohaler 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
  • urinating frequently
  • painful urination
  • urination in a weak stream or drips

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

Common side effects of Seebri Neohaler include upper respiratory tract infection, sore throat and runny nose.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Seebri Neohaler. For more information, ask your healthcare provider or pharmacist.

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

For oral inhalation only. Do not swallow Seebri capsules, as the intended effects on the lungs will not be obtained. Seebri capsules should only be used with the Neohaler device.

• The recommended dose of Seebri Neohaler is the inhalation of the contents of one Seebri capsule twice-daily using the Seebri Neohaler device.
• Seebri Neohaler should be administered at the same time of the day, (1 capsule in the morning and 1 capsule in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 capsule twice-daily) of Seebri Neohaler is not recommended.
• Store Seebri capsules in the blister, and only remove IMMEDIATELY BEFORE USE with the Neohaler device.
• No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or patients with mild to moderate renal impairment.

Sympathomimetics, Methylxanthines, Steroids

• In clinical studies, concurrent administration of short-acting and long-acting sympathomimetic (beta-agonists) bronchodilators (including indacaterol), methylxanthines, oral and inhaled steroids with Seebri Neohaler showed no increases in adverse drug reactions.

Anticholinergics

• There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of Seebri Neohaler with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects.

• There are no adequate and well-controlled studies with Seebri Neohaler in pregnant women.
• Because animal reproduction studies are not always predictive of human response, Seebri Neohaler should only be used during pregnancy if the potential benefit to the patient justifies the potential risk to the fetus.
• Women should be advised to contact their physician if they become pregnant while taking Seebri Neohaler.
• There are no adequate and well-controlled human trials that have investigated the effects of Seebri Neohaler during labor and delivery. It is not known whether Seebri Neohaler is excreted in human breast milk.
• Because many drugs are excreted in human milk, caution should be exercised when Seebri Neohaler is administered to a nursing woman.
• Since there are no data from well-controlled human studies on the use of Seebri Neohaler by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue Seebri Neohaler, taking into account the importance of Seebri Neohaler to the mother.