Aclidinium

Name: Aclidinium

Aclidinium Interactions

If this medication gets in your eyes, rinse with water.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
  • bronchodilators such as aclidinium, ipratropium, or tiotropium;
  • cold or allergy medicine that contains an antihistamine;
  • medication for Parkinson's disease;
  • medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

This list is not complete. Other drugs may interact with aclidinium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Aclidinium side effects

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medication;

  • blurred vision, nausea, vomiting, eye pain or redness, or seeing halos or bright colors around lights;

  • increased urination, painful or difficult urination;

  • little or no urinating; or

  • worsening or no improvement in your symptoms.

Common side effects may include:

  • stuffy nose, sore throat, sinus pain;

  • cough; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation, as bromide:

Tudorza Pressair: 400 mcg/actuation (1 ea) [contains milk protein]

Brand Names U.S.

  • Tudorza Pressair

Use Labeled Indications

Chronic obstructive pulmonary disease: Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including bronchitis and emphysema

Contraindications

Hypersensitivity to aclidinium or any component of the formulation; severe hypersensitivity to milk proteins

Dosing Geriatric

Refer to adult dosing.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the US labeling (has not been studied); however, aclidinium is not hepatically eliminated. The Canadian labeling indicates that no dosage adjustment is necessary.

Aclidinium Precautions

Aclidinium can cause serious side effects.

Aclidinium can cause sudden shortness of breath immediately after use. If this happens, stop taking aclidinium and call your doctor right away or go to the nearest hospital emergency room.

Aclidinium has caused eye problems, such as new or worsened increased pressure in your eyes (acute narrow-angle glaucoma). This is a serious condition that can lead to permanent loss of vision if not treated.

Symptoms of acute narrow-angle glaucoma may include:

  • eye pain 
  • eye discomfort
  • upset stomach or vomiting
  • blurred vision
  • seeing halos or bright colors around lights
  • red eyes

If you have these symptoms of increased eye pressure, stop taking aclidinium and tell your doctor right away.

Aclidinium can cause new or worsened urinary retention (inability to urinate). Urinary retention can be caused by a blockage in your bladder or, if you are a male, 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 of urinary retention, stop taking aclidinium and tell your doctor right away.

Aclidinium has caused serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Tell your doctor or get emergency medical treatment if you get any symptoms of a serious allergic reaction. Use aclidinium exactly as your doctor prescribes it. Do not use it more often than prescribed or take more medicine than prescribed for you.

Inform MD

Before you receive aclidinium, tell your doctor about all your medical conditions, including if you:

  • have eye problems, especially glaucoma
  • have prostate problems
  • have bladder problems, or problems passing urine
  • have a severe allergy to milk proteins

Tell your doctor if you are pregnant or breastfeeding.

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

 

For the Consumer

Applies to aclidinium: inhalation aerosol powder

Along with its needed effects, aclidinium 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 while taking aclidinium:

Incidence not known
  • Decrease in the frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • eye pain and blurred vision
  • painful urination

Some side effects of aclidinium 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:

More common
  • Fever
  • headache
  • muscle aches
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
Less common
  • Cough
  • diarrhea
  • pain or tenderness around the eyes and cheekbones
  • sneezing
  • troubled breathing
  • vomiting
Rare
  • Chest pain or discomfort
  • difficulty with moving
  • dilated neck veins
  • dry mouth
  • extreme fatigue
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • loss of consciousness
  • muscle pain or stiffness
  • nausea
  • pain, swelling, or redness in the joints
  • slow or irregular heartbeat
  • stomachache
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • unexplained weight loss

Liver Dose Adjustments

No adjustment recommended.

Aclidinium Pregnancy Warnings

Animal studies have revealed evidence of teratogenicity. However, no evidence of structural alterations was observed at doses 15 and 20 times the recommended human daily dose, respectively. This drug and/or its metabolites were shown to cross the placenta in rats. Developmental toxicity studies in animals revealed delayed ossification of fetuses in rats (inhalation administration), and decreased fetal weight in rabbits (oral administration) at doses that resulted in maternal toxicity. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Aclidinium Breastfeeding Warnings

UK, AU: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

Excretion of small amounts of this drug and/or metabolites into the milk of lactating female rats, and decreased pup weights were observed. There are no human studies that have investigated the effects on breast-fed infants.

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