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Provocholine Dosage

Generic name: METHACHOLINE CHLORIDE 100mg in 100mg
Dosage form: powder, for inhalation solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Before Provocholine 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 FEV compared with the baseline value after inhalation of the control sodium chloride solution (Note: Use the same diluent that the Provocholine powder has been reconstituted with for the baseline spirometry). This target value should be calculated and recorded before Provocholine 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, shake each vial to obtain a clear solution (Note: When preparing dilutions, use only the same kind of diluent to prepare all concentrations).

100 MG: DILUTION SEQUENCE-MULTIPLE PATIENT TESTING (2-5 PATIENTS)

[Requires 2 vials of Provocholine)

 Vials  Instructions  Concentrations

 A & 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. These will be designated vials A1 and A2.  25 mg/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

1,600 MG: DILUTION SEQUENCE-MULTIPLE PATIENT TESTING (16-40 PATIENTS)

[Requires 1 vial of Provocholine]

Vials

Instructions

Concentrations

Stock Solution   

Add 40 mL of 00.9% saline or 0.9% saline with 0.4% phenol to the 50 mL vial containing 1,600 mg of

Provochoine. This vial of 40 mg/mL will be designated as the stock colution to obtain the balance of the dilutions needed to perform the test.

DO NOT ADMINISTER TO PATIENTS

40 mg/mL

DO NOT ADMINSTER TO PATIENTS 

 A   

Remove 25 mL from the vial labeled stock solution and transfer to another vial and add 15mL og 0.9% saline or 0.9% saline with 0.4% phenol. This is vial A.

 25 mg/mL
 B

Remove 10 mL from the vial labeled stock solution and transfer to another vial add 30mL of 0.9% saline or

0.9% saline with 0.4% phenol. This is vial B.   

 10 mg/mL
 C

Remove 3 mL from the vial labeled stock colution and transfer to another vial add 45mL of 0.9% saline or

0.9% saline with 0.4% phenol. This is vial C.

 2.5 mg/mL
 D Remove 5 mL from vial C and transfer to another vial add 45mL of 0.9% saline or 0.9% saline with 0.4% phenol. This is vial D.  0.25 mg/mL 
 E  Remove 1 mL from vial D and transfer to another vial add 9 mL of 00.9% saline or 0.9% saline with 0.4%
phenol. This is vial E. Vial E must be prepared on the day of the challenge.
 0.025 mg/mL

100 MG: DILUTION SEQUENCE SINGLE PATIENT TESTING

 Vials  Instructions  Concentrations
 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. 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 stability of dilutions A through D.  Vial E must be prepared on the day of challenge.

A Sterile bacterial-retentive filter (porosity 0.22µm) should be used when transferring a solution from each vial (at least 2mL) 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.  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 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.  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 mg/mL  5  50.0  63.88
 25 mg/mL  5  125.0  188.88

An inhaled beta-agonist may be administered after Provocholine 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.

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