PROVOCHOLINE Powder for solution (2020)

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Methapharm Inc.

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BOXED WARNING SECTION

WARNING: SEVERE BRONCHOCONSTRICTION Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric ...

1. Indications and Usage

Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically ...

2. Dosage and Administration

2.1 Important Handling Instructions Given that Provocholine is a potent bronchoconstrictor: Do not use Provocholine in pediatric and adult patients with baseline FEV1 <60% predicted or in adults ...

3. Dosage Forms and Strengths

Powder for Solution: 100 mg of white to off-white crystalline powder in amber glass vials (powder is reconstituted and then diluted prior to administration).

4. Contraindications

Provocholine is contraindicated in the following: Hypersensitivity to methacholine or other parasympathomimetic agents. Reactions have included rash, itching/swelling (especially of the face/tongue/throat), ...

5. Warnings and Precautions

5.1 Risk of Severe Bronchoconstriction Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric and adult ...

6. Adverse Reactions

The following adverse reactions associated with the use of Provocholine were identified in clinical studies or post marketing reports. Because some of these reactions were reported voluntarily from a population ...

7. Drug Interactions

Beta-Adrenergic Blockers The use of beta-adrenergic blockers may impair reversal of Provocholine-caused bronchoconstriction. Beta-Agonists, Anticholinergics, and Theophylline Beta-agonists, anticholinergics, ...

8.1. Pregnancy

Risk Summary The available data from published literature on Provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal ...

8.2. Lactation

Risk Summary There are no available data on the presence of methacholine chloride in human milk, the effect on the breastfed infant, or the effect on milk production. The developmental and health benefits ...

8.4. Pediatric Use

Provocholine is used in a methacholine challenge test for the diagnosis of bronchial airway hyperreactivity in pediatric patients 5 years of age and older who do not have clinically apparent asthma. The ...

8.5. Geriatric Use

The diagnosis of bronchial airway hyperreactivity is largely performed in pediatric and younger adult patients. Clinical studies of Provocholine did not include patients 65 years of age or older.

11. Description

Methacholine chloride, the active ingredient of Provocholine, is a parasympathomimetic (cholinergic) bronchoconstrictor agent. Provocholine (methacholine chloride) powder for solution is administered by ...

12.1. Mechanism of Action

Methacholine chloride is a cholinergic agonist. Bronchial smooth muscle contains significant parasympathetic (cholinergic) innervation. Methacholine chloride agonizes the muscarinic receptors which eventually ...

12.2. Pharmacodynamics

After oral inhalation of Provocholine, patients with asthma are more sensitive to Provocholine-induced bronchoconstriction than are healthy subjects. This difference in response is the pharmacological ...

12.3. Pharmacokinetics

There are no metabolic and pharmacokinetic data available on methacholine chloride.

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no studies with methacholine chloride that would permit an evaluation of its carcinogenic or mutagenic potential or of its effect on fertility.

16.1. How Supplied

Provocholine (methacholine chloride) powder for solution: in amber glass vials that contain 100 mg of methacholine chloride powder, white to off-white in color. Cartons have 6 vials (NDC 64281-100-06). ...

16.2. Storage and Handling

Powder for solution: Store the supplied powder at 59°F to 86°F (15°C to 30°C). Refrigerate the reconstituted and diluted solutions at 36°F to 46°F (2°C to 8°C) for up to 2 weeks [see Dosage and Administration ...

17. Patient Counseling Information

Risk of Severe Bronchoconstriction Inform the patient or caregiver that severe bronchoconstriction can result from Provocholine administration [see Warnings and Precautions (5.1)]. Cough, Chest ...