GLUCAGON kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

glucagon (UNII: 76LA80IG2G) (glucagon - UNII:76LA80IG2G)

Available from:

TYA Pharmaceuticals

INN (International Name):

glucagon

Composition:

glucagon 1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of hypoglycemia: Glucagon is indicated as a treatment for severe hypoglycemia. Because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient. For use as a diagnostic aid: Glucagon is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous. Glucagon is as effective for this examination as are the anticholinergic drugs. However, the addition of the anticholinergic agent may result in increased side effects. Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma. GLUCAGON FOR INJECTION (rDNA ORIGIN) BECOME FAMILIAR WITH THE FOLLOWING INSTRUCTIONS BEFORE AN EMERGENCY ARISES. DO NOT USE THIS KIT AFTER DATE STAMPED ON THE BOTTLE LABEL. IF YOU HAVE QUESTIONS CONCERN

Product summary:

NDC:64725-8031-1 in a KIT of 1 KITS Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection [rDNA origin]) (MS8031): 1 mg (1 unit) — (VL7529), with 1 mL of diluting solution (Hyporet * HY7530) (1s) NDC 0002-8031-01 ® ___________________________ * Hyporet (disposable syringe, Lilly). ® — Vials of Glucagon, as well as the Diluting Solution for Glucagon, may be stored at controlled room temperature 20° to 25°C (68° to 77°F)[see USP]. Before Reconstitution The USP defines controlled room temperature by the following: A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. — Glucagon for Injection (rDNA origin) should be used immediately. After Reconstitution Discard any unused portion.

Authorization status:

New Drug Application

Summary of Product characteristics

GLUCAGON- GLUCAGON
TYA PHARMACEUTICALS
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INFORMATION FOR THE PHYSICIAN GLUCAGON FOR INJECTION (RDNA ORIGIN)
DESCRIPTION
Glucagon for Injection (rDNA origin) is a polypeptide hormone
identical to human glucagon that
increases blood glucose and relaxes smooth muscle of the
gastrointestinal tract. Glucagon is
synthesized in a special non-pathogenic laboratory strain of bacteria
that has been genetically altered by
the addition of the gene for glucagon. _Escherichia coli_
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 N O S. The primary sequence of glucagon
is shown below.
Crystalline glucagon 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 (1 unit) 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. 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 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.
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 min