PROVOCHOLINE- methacholine chloride powder, for solution PROVOCHOLINE INHALATION SOLUTION- methacholine chloride inhalation sol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHACHOLINE CHLORIDE (UNII: 0W5ETF9M2K) (METHACHOLINE - UNII:03V657ZD3V)

Available from:

Methapharm Inc.

INN (International Name):

METHACHOLINE CHLORIDE

Composition:

METHACHOLINE 100 mg in 100 mg

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 apparent asthma. 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), severe dizziness, trouble breathing. - Baseline FEV1 < 60% predicted (adults or pediatric patients) or <1.5 L (adults) 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 or fetal outcomes. Animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. Diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant wo

Product summary:

How Supplied Each kit (NDC: 64281-110-05) contains six (6) plastic vials with twist-off cap each containing 3 mL of different concentrations of methacholine chloride as shown below. Cartons have six (6) kits (NDC 64281-110-06). a) base solution (contains no methacholine chloride) (NDC: 64281-111-00) b) 0.0625 mg/mL (0.1875 mg/3 mL) (NDC:64281-112-00) c) 0.25 mg/mL (0.75 mg/3 mL) (NDC:64281-113-00) d) 1 mg/mL (3 mg/3 mL) (NDC:64281-114-00) e) 4 mg/mL (12 mg/3 mL) (NDC:64281-115-00) f) 16 mg/mL (48 mg/3 mL) (NDC:64281-116-00) Storage and Handling

Authorization status:

New Drug Application

Summary of Product characteristics

PROVOCHOLINE- METHACHOLINE CHLORIDE POWDER, FOR SOLUTION
PROVOCHOLINE INHALATION SOLUTION- METHACHOLINE CHLORIDE INHALATION
SOLUTION
METHAPHARM INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROVOCHOLINE SAFELY
AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PROVOCHOLINE .
PROVOCHOLINE (METHACHOLINE CHLORIDE) FOR INHALATION SOLUTION, FOR ORAL
INHALATION USE
PROVOCHOLINE® (METHACHOLINE CHLORIDE) INHALATION SOLUTION, FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1986
WARNING: SEVERE BRONCHOCONSTRICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE BRONCHOCONSTRICTION CAN RESULT FROM PROVOCHOLINE ADMINISTRATION
(INCLUDING
THE LOWEST DOSE) (5.1)
USE OF PROVOCHOLINE IS CONTRAINDICATED IN PEDIATRIC AND ADULT PATIENTS
WITH BASELINE
FEV1 < 60% PREDICTED OR ADULTS
WITH FEV1 < 1.5 L (5.1)
USE OF PROVOCHOLINE IS NOT RECOMMENDED IN PATIENTS WITH CLINICALLY
APPARENT ASTHMA
OR WHEEZING (5.1)
IF SEVERE BRONCHOCONSTRICTION OCCURS, REVERSE IMMEDIATELY WITH A
RAPID-ACTING
INHALED BRONCHODILATOR AGENT (Β-AGONIST) (5.1)
INDICATIONS AND USAGE
Provocholine, a cholinergic agonist 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 apparent asthma (1) (1)
DOSAGE AND ADMINISTRATION
The methacholine challenge test should be conducted in a pulmonary
function laboratory or clinic, by
adequately trained personnel, for safety and accuracy (2.1)
Determine baseline FEV1 values to assess whether a patient is able to
undergo the methacholine
challenge test (2.1)
Recommended dosage(s) of Provocholine in the Methacholine Challenge
Test is administration of
increasing concentrations of Provocholine solution via nebulization
(2.2)
Administer using either the 5-Breath Dosimeter Dosing Method or the
2-Minute Tidal Breathing Dosing
Method with the doubling or quadrupling stepwise protocols (2.4, 2.5)
See th