Rx Item-Provocholine 100Mg Vial 6X20Ml By Methapharm

PROVOCHOLINE- methacholine chloride powder, for solution
Methapharm Inc.


Provocholine� (methacholine chloride)

PROVOCHOLlNE (METHACHOLINE CHLORIDE USP) IS A BRONCHOCONSTRICTOR AGENT FOR DIAGNOSTIC PURPOSES ONLY AND SHOULD NOT BE USED AS A THERAPEUTIC AGENT.

PROVOCHOLlNE SHOULD BE ADMINISTERED ONLY BY INHALATION. SEVERE BRONCHOCONSTRICTION AND REDUCTION IN RESPIRATORY FUNCTION CAN RESULT FROM THE ADMINISTRATION OF PROVOCHOLlNE�. PATIENTS WITH SEVERE HYPERREACTIVITY OF THE AIRWAYS CAN EXPERIENCE BRONCHOCONSTRICTION AT A DOSAGE AS LOW AS 0.025 MG/ML (0.125 CUMULATIVE UNITS). IF SEVERE BRONCHOCONSTRICTION OCCURS, IT SHOULD BE REVERSED IMMEDIATELY BY THE ADMINISTRATION OF A RAPID ACTING INHALED BRONCHODILATOR AGENT (BETA�AGONIST). BECAUSE OF THE POTENTIAL FOR SEVERE BRONCHOCONSTRICTION, PROVOCHOLlNE CHALLENGE SHOULD NOT BE PERFORMED IN ANY PATIENT WITH CLINICALLY APPARENT ASTHMA, WHEEZING, OR VERY LOW BASELINE PULMONARY FUNCTION TESTS (e.g., FEV1 LESS THAN 1 TO 1.5 LITER OR LESS THAN 70% OF THE PREDICTED VALUES). PLEASE CONSULT STANDARD NOMOGRAMS FOR PREDICTED VALUES1.



IF A PHYSICIAN IS PERFORMING THE TEST, ANOTHER PERSON MUST BE AVAILABLE IN THE BUILDING TO GIVE ASSISTANCE IF REQUIRED; OTHERWISE A PHYSICIAN MUST BE IN THE VICINITY TO BE ABLE TO RESPOND QUICKLY. THE PATIENT MUST NEVER BE LEFT UNATTENDED DURING THE TEST. PROVOCHOLINE INHALATION CHALLENGE SHOULD BE PERFORMED ONLY UNDER THE SUPERVISION OF A PHYSICIAN TRAINED IN AND THOROUGHLY FAMILIAR WITH ALL ASPECTS OF THE TEICHNIQUE OF METHACHOLINE CHALLENGE, ALL CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE MANAGEMENT OF RESPIRATORY DISTRESS.

EMERGENCY EQUIPMENT AND MEDICATION SHOULD BE IMMEDICATELY AVAILABLE TO TREAT ACUTE RESPIRATORY DISTRESS.

DESCRIPTION:

Provocholine is a parasympathomimetic (cholinergic)) bronchoconstrictor agent to be administered in solution only, by inhalation, for diagnostic purposes. Each 20 mL vial contains 100 mg and each 50 mL vial contains 1,600 mg of methacholine chloride powder which is to be reconsituted with 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0). See DOSAGE AND ADMINISTRATION for dilution procedures, concentrations and schedule of administration. CLINICAL PHARMACOLOGY:

Methacholine chloride is the �-methyl homolog of acetylcholine and differs from the latter primarily in its greater duration and selectivity of action. Bronchial smooth muscle contains significant parasympathetic (cholinergic) innervation.


Bronchoconstriction occurs when the vagus nerve is stimulated and acetylcholine is released from the nerve endings. Muscle constriction is essentially confined to the local site of release because acetylcholine is rapidly inactivated by acetylcholinesterase.INDICATIONS AND USAGE:

Provocholine is indicated for the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma.

RX ITEM-Provocholine 100Mg Vial 6X20Ml B
NDC 64281-0100-06 UPC/GTIN No.6-28777-10001-5 Mfg.Part No.10006 Item No.: RX738062 738062 NDC No.64281010006 UPC No.:628777100015 NDC No. 64281-0100-06 64281-100-06 6428110006 UPC/GTIN No. 6-28777-100

Provocholine 100Mg Vial 6X20Ml By Methap
Item No.: RX738062 738062 NDC No.64281010006 UPC No.:628777100015 NDC No. 64281-0100-06 64281-100-06 6428110006 UPC/GTIN No. 6-28777-10001-5

METHACHOLINE CHLORIDE INH
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Provocholine 100Mg Vial 6X20Ml
Item No.: RX738062 738062 NDC No.64281010006 UPC No.:628777100015 NDC No. 64281-0100-06 64281-100-06 6428110006 UPC/GTIN No. 6-28777-10001-5

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