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Provocholine

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Provocholine

Indications
Dosage
How Supplied

INDICATIONS

Provocholine® (methacholine chloride powder for inhalation) is indicated for the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma.

DOSAGE AND ADMINISTRATION

Before Provocholine® (methacholine chloride powder for inhalation) inhalation challenge is begun, baseline pulmonary function tests must be performed. A subject to be challenged must have an FEV1 of at least 70% of the predicted value.

The target level for a positive challenge is a 20% reduction in the FEV1 compared with the baseline value after inhalation of the control sodium chloride solution (Note: Use the same diluent that the Provocholine® (methacholine chloride) powder has been reconstituted with for the baseline spirometry). This target value should be calculated and recorded before Provocholine (methacholine chloride) '" challenge is started.

Dilutions: (Note: Do not inhale powder. Do not handle this material if you have asthma or hay fever.) All dilutions should be made with 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0) using sterile, empty USP Type I borosilcate glass vials. After adding the sodium chloride solution, §hake each vial to obtain a clear solution (Note: When preparing dilutions, use only the same kind of diluent to prepare all concentrations).

DILUTION SEQUENCE-MULTIPLE PATIENT TESTING
(2-5 PATIENTS) [REQUIRES 2 VIALS OF PROVOCHOLINE® (methacholine chloride) ]

Vials   Concentrations
A1&A2 Add 4 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol(pH 7.0) to each of two 20 mL vials containing 100 mg of Provocholine® (methacholine chloride powder for inhalation). These wil be designated vials A1 and A2. 25mg/mL
B Remove 3 mL from vial A1, transfer to another vial and add 4.5 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial B. 10 mg/mL
C Remove 1 mL from vial A2, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial C. 2.5 mg/mL
D Remove 1 mL from vial C, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial D. 0.25 mg/mL
E Remove 1 mL from vial D, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial E. Vial E must be prepared on the day of challenge. 0.025 mg/mL
DILUTION SEQUENCE - SINGLE PATIENT TESTING
A Add 4 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0) to the 20 mL vial containing 100 mg of Provocholine® (methacholine chloride powder for inhalation). This is vial A. 25 mg/mL
B Remove 1 mL from vial A, transfer to another vial and add 1.5 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial B. 10 mg/mL
C Remove 1 mL from vial A, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial C. 2.5 mg/mL
D Remove 1 mL from vial C, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial D. 0.25 mg/mL
E Remove 1 mL from vial D, transfer to another vial and add 9 mL of 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). This is vial E. Vial E must be prepared on the day of the challenge. 0.025 mg/mL

Dilutions A through D should be stored at 36° to 46°F (2° to 8°C) in a refrigerator and can be stored for not more than 2 weeks. (The unreconstituted powder should be stored at 59°F to 86°F (15° to 30°C)]. After this time, discard the vials and prepare new dilutions.

Freezing does not affect the stabilty of dilutions A through D. Vial E must be prepared on the day of challenge.

A sterile bacterial-retentive filter (porosity 0.22 μ m) should be used when transferring a solution from each vial (at least 2 mL) to a nebulizer.

Procedure: A standardized procedure for inhalation has been developed.

The challenge is performed by giving a subject ascending serial concentrations of Provocholine® (methacholine chloride) . At each concentration, five breaths are administered by a nebulizer that permits intermittent delivery time of 0.6 seconds by a breath-actuated timing device (dosimeter).

At each of five inhalations of a serial concentration, the subject begins at functional residual capacity (FRC) and slowly and completely inhales the dose delivered. Within 5 minutes, FEV1 values are determined. The procedure ends either when there is a 20% or greater reduction in the FEV1 compared with the baseline sodium chloride solution value (i.e., a positive response) or if 188.88 total cumulative units have been administered (see table below) and the FEV1 has been reduced by 14 % or less (i.e., a negative response). If there is a reduction of 15% to 19% in the FEV1 compared with baseline, either the challenge may be repeated at that concentration or a higher concentration may be given as long as the dosage administered does not result in total cumulative units exceeding 188.88.

The following is a suggested schedule for the administration of Provocholine® (methacholine chloride powder for inhalation) challenge. Cumulative units are calculated by multiplying the number of breaths by the concentration administered. Total cumulative units is the sum of cumulative units for each concentration administered.

Serial Concentration Number of Breaths Cumulative Units per
Concentration
Total
Cumulative
Units
0.025 mg/mL 5 0.125 0.125
0.25 mg/mL 5 1.25 1.375
2.5 mg/mL 5 12.5 13.88
10.0 mg/mL 5 50.0 63.88
25.0 mg/mL 5 125. 188.88

An inhaled beta-agonist may be administered after Provocholine® (methacholine chloride) challenge to expedite the return of the FEV1 to baseline and to relieve the discomfort of the subject. Most patients revert to normal pulmonary function within 5 minutes following bronchodilators or within 30 to 45 minutes without any bronchodilator.

HOW SUPPLIED

20 mL amber vials containing 100 mg of methacholine chloride powder which is to be reconstituted with 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0) - boxes of 12 (NDC 64281-100-12) or boxes of 6 (NDC 64281-00-06). Store the powder at 59° to 86°F (15° to 30°C). Refrigerate the reconstituted solutions (dilutions A-D) at 36° to 46°F (2° to 8°C) for not more than 2 weeks. Dilution E must be prepared on the day of the challenge.

Methapharm Inc., 81 Sinclair Boulevard, Brantford, Ontario, Canada N3S 7X6. Toll Free: 800.287.7686, Tel: 519.751.3602, Fax: 519.751.9149. Email: sales@methapharm.com. Web: www.methapharm.com. January 2008 - PP/R-04. FDA revision date: 7/28/2008

Last reviewed on RxList: 9/25/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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