GLUCAGON kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLUCAGON (UNII: 76LA80IG2G) (GLUCAGON - UNII:76LA80IG2G)

Available from:

A-S Medication Solutions

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BECOME FAMILIAR WITH THE FOLLOWING INSTRUCTIONS BEFORE AN EMERGENCY ARISES. DO NOT USE THIS KIT AFTER DATE STAMPED ON THE VIAL OF GLUCAGON. IF YOU HAVE QUESTIONS CONCERNING THE USE OF THIS PRODUCT, CONSULT A DOCTOR, NURSE OR PHARMACIST. Make sure that your relatives or close friends know that if you become unconscious, medical assistance must always be sought. Glucagon may have been prescribed so that members of your household can give the injection if you become severely hypoglycemic and are unable to take sugar by mouth. If you are unconscious, glucagon can be given while awaiting medical assistance. Show your family members and others where you keep this kit and how to use it. They need to know how to use it before you need it. They can practice giving a shot by giving you your normal insulin shots. It is important that they practice. A person who has never given a shot probably will not be able to do it in an emergency. IMPORTANT - Act quickly. Prolonged unconsciousness may be harmful. - These simple inst

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLUCAGON- GLUCAGON
A-S MEDICATION SOLUTIONS
----------
INFORMATION FOR THE PHYSICIAN
GLUCAGON FOR INJECTION
Rx Only
DESCRIPTION
Glucagon for Injection (synthetic origin) is a polypeptide hormone
identical to human
glucagon that increases blood glucose and relaxes smooth muscle of the
gastrointestinal tract. Glucagon is produced by solid state peptide
synthesis and is highly
purified.
Glucagon is a single-chain polypeptide that contains 29 amino acid
residues and has a
molecular weight of 3483.
The empirical formula is C
H
SN
O
S. The primary sequence of glucagon is shown
below.
Crystalline glucagon (synthetic origin) is a white to off-white
powder. It is relatively
insoluble in water but is soluble at a pH of less than 3 or more than
9.5.
Glucagon is available for use intravenously, intramuscularly, or
subcutaneously in a kit
that contains a vial of sterile glucagon and a syringe of sterile
diluent. The vial contains 1
mg of glucagon and 49 mg of lactose. Hydrochloric acid may have been
added during
manufacture to adjust the pH of the glucagon. One International Unit
of glucagon is
equivalent to 1 mg of glucagon.1 The diluent syringe contains 12 mg/mL
of glycerin,
Water For Injection, and hydrochloric acid.
CLINICAL PHARMACOLOGY
Glucagon increases blood glucose concentration and is used in the
treatment of severe
hypoglycemia. Glucagon acts only on liver glycogen, converting it to
glucose.
Glucagon administered through a parenteral route relaxes smooth muscle
of the
stomach, duodenum, small bowel, and colon.
153
225
43
49
PHARMACOKINETICS
Glucagon has been studied following intramuscular, subcutaneous, and
intravenous
administration in adult volunteers. Administration of the intravenous
glucagon showed
dose proportionality of the pharmacokinetics between 0.25 and 2.0 mg.
Calculations
from a 1 mg dose showed a small volume of distribution (mean, 0.25
L/kg) and a
moderate clearance (mean, 13.5 mL/min/kg). The half-life was short,
ranging from 8 to
18 minutes.
Maximum plasma concentrations of 7.9 ng/mL were achieved