Methacholine Inhaled

Methacholine inhaled is a prescription medication indicated for use in a methacholine challenge test to diagnose bronchial airway hyperreactivity in adults and children aged above 5 years who do not have clinically apparent asthma.

• Methacholine inhaled is available under the following different brand names: Provocholine.

Common side effects of Methacholine inhaled include:

• headache
• sore throat
• lightheadedness
• nausea
• vomiting
• dizziness

Serious side effects of Methacholine inhaled include:

• severe bronchoconstriction

Rare side effects of Methacholine inhaled include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Inhalation solution kit

Powder for reconstitution and dilution

• 100 mg Methacholine powder (amber glass vials)

Base solution (contains no Methacholine)

Inhalation solution, ready-to-use

Each strength contains 3  mL/vial

• 0.0625 mg/mL
• 0.25 mg/mL
• 1 mg/mL
• 4 mg/mL
• 16 mg/mL

Diagnosis of bronchial airway hyperreactivity

Adult and pediatric dosage

• Administered via nebulization in increasing concentrations solutions using either doubling or quadrupling dosing concentrations

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Methacholine inhaled has severe interactions with no other drugs
• Methacholine inhaled has serious interactions with no other drugs
• Methacholine inhaled has moderate interactions with no other drugs
• Methacholine inhaled has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to methacholine or other parasympathomimetic agents; reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing
• Baseline FEV1 less than 60% predicted (adults or pediatric patients) or less than 1.5 L (adults)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Methacholine inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Methacholine inhaled?”

Cautions

• Severe bronchoconstriction can result from methacholine administration (including the lowest dose)
• Risk to clinicians administering the test
• Supplied powder or nebulized aerosol may cause bronchoconstriction in healthcare providers administering the test
• Precautionary steps include:
  • Do not inhale the supplied methacholine powder
  • Do not handle powder with a history of asthma or hay fever
  • Apply a low resistance filter to expiratory ports of the dosing apparatus, as necessary, to prevent release in room air
• Coexisting diseases and conditions
  • Not recommended for patients with uncontrolled hypertension, aortic aneurysm, or history of myocardial infarction or stroke diseases
  • Patients with epilepsy, vagotonia, peptic ulcer disease, thyroid disease, urinary tract obstruction, or other conditions that could be adversely affected by a cholinergic agent should undergo the Methacholine challenge only if the benefits to the individual outweigh the potential risks
• Drug interaction overview
  • Beta-adrenergic blockers
    • Beta-adrenergic blockers may impair reversal of methacholine-caused bronchoconstriction by inhaled beta-agonists
  • Beta-agonists, anticholinergics, and theophylline
    • These drugs inhibit the response of airways to methacholine
• Hold before the Methacholine challenge test for the following duration:
• Short-acting beta-agonists (e.g., albuterol): 6 hours
• Long-acting beta-agonists (e.g., salmeterol): 36 hours
• Short-acting anticholinergics (e.g., ipratropium): 12 hours
• Long-acting anticholinergics (e.g., tiotropium):168 hours and more
• Oral theophylline: 12-48 hours
• Oral or inhaled corticosteroids, and inhaled cromoglycates
• Regular use of oral or inhaled corticosteroids and inhaled cromoglycates (e.g., cromolyn sodium, nedocromil) may acutely decrease bronchial responsiveness to Methacholine
• However, these drugs may be continued with Methacholine use

Pregnancy and Lactation

• Data regarding use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Animal reproduction studies have not been conducted
• Clinical considerations
• Diagnosis of bronchial airway hyperreactivity with broncho-provocation challenge is not recommended during pregnancy because of the potential for hypoxia in the fetus
• If bronchial airway hyperreactivity is suspected, consider a trial of empiric treatment
• Lactation
  • Data are not available regarding the presence of methacholine in human milk, its effect on breastfed infants, or milk production