Product Elements:
Glucag0n glucagon kit glucagon glucagon injection, powder, for solution glucagon glucagon lactose, unspecified form anhydrous lactose hydrochloric acid diluting solution for glucagen diluent injection, solution glycerin water hydrochloric acid
Indications and Usage:
Indications & usage for the treatment of severe hypoglycemia: glucagon is indicated as a treatment for severe hypoglycemia (low blood sugar) which may occur in patients with diabetes mellitus. 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, as use of glucagon in combination with anticholinergic drugs may result in increased side effects, the use of glucagon in combination with anticholinergic drugs is not recommended.
Warnings:
Warnings glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both. in patients with insulinoma, intravenous administration of glucagon may produce an initial increase in blood glucose; however, because of glucagon's hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia. a patient developing symptoms of hypoglycemia after a dose of glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate. exogenous glucagon also stimulates the release of catecholamines. in the presence of pheochromocytoma, glucagon can cause the tumor to release catecholamines, which may result in a sudden and marked increase in blood pressure. if a patient develops a sudden increase in blood pressure, 5 to 10 mg of phentolamine mesylate may be administered intravenously in an attempt to control the blood pressure. generalized allergic reactions, including urticaria, respiratory
Read more... distress, and hypotension, have been reported in patients who received glucagon by injection. necrolytic migratory erythema (nme), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. nme lesions may affect the face, groin, perineum and legs or be more widespread. in the reported cases nme resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. should nme occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.
Dosage and Administration:
Dosage & administration general instructions for use: the diluent is provided for use only in the preparation of glucagon for parenteral injection and for no other use. glucagon should not be used at concentrations greater than 1 mg/ml. reconstituted glucagon should be used immediately. discard any unused portion. reconstituted glucagon solutions should be used only if they are clear and of a water-like consistency. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. directions for treatment of severe hypoglycemia: severe hypoglycemia should be treated initially with intravenous glucose, if possible. if parenteral glucose can not be used, dissolve the lyophilized glucagon using the accompanying diluting solution and use immediately. for adults and for pediatric patients weighing more than 44 lb (20 kg), give 1 mg by subcutaneous, intramuscular, or intravenous injection. for pediatric patients weighing less than 44 lb (
Read more...20 kg), give 0.5 mg or a dose equivalent to 20 to 30 mcg/kg.2-6 discard any unused portion. an unconscious patient will usually awaken within 15 minutes following the glucagon injection. if the response is delayed, there is no contraindication to the administration of an additional dose of glucagon; however, in view of the deleterious effects of cerebral hypoglycemia emergency aid should be sought so that parenteral glucose can be given. after the patient responds, supplemental carbohydrate should be given to restore liver glycogen and to prevent secondary hypoglycemia. directions for use as a diagnostic aid: dissolve the lyophilized glucagon using the accompanying diluting solution and use immediately. discard any unused portion. the doses in the following table may be administered for relaxation of the stomach, duodenum, and small bowel, depending on the onset and duration of effect required for the examination. since the stomach is less sensitive to the effect of glucagon, 0.5 mg intravenous or 2 mg intramuscular are recommended. * administration of 2 mg doses produces a higher incidence of nausea and vomiting than do lower doses. for examination of the colon, it is recommended that a 2 mg dose be administered intramuscularly approximately 10 minutes prior to the procedure. colon relaxation and reduction of patient discomfort may allow the radiologist to perform a more satisfactory examination. dosage
Contraindications:
Contraindications glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma.
Adverse Reactions:
Adverse reactions side effects may include nausea and vomiting. these reactions may also occur with hypoglycemia. generalized allergic reactions have been reported (see warnings ). in a three month controlled study of 75 volunteers comparing animal-sourced glucagon with glucagon manufactured through rdna technology, no glucagon-specific antibodies were detected in either treatment group. necrolytic migratory erythema (nme) cases have been reported postmarketing in patients receiving continuous infusions of glucagon (see warnings ).
Overdosage:
Overdosage signs and symptoms â if overdosage occurs, nausea, vomiting, gastric hypotonicity, and diarrhea would be expected without causing consequential toxicity. intravenous administration of glucagon has been shown to have positive inotropic and chronotropic effects. a transient increase in both blood pressure and pulse rate may occur following the administration of glucagon. patients taking β-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be transient because of glucagon's short half-life. the increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease. when glucagon was given in large doses to patients with cardiac disease, investigators reported a positive inotropic effect. these investigators administered glucagon in doses of 0.5 to 16 mg/hour by continuous infusion for periods of 5 to 166 hours. total doses ranged from 25 to 996 mg, and a 21-month-old infant received approximately 8.25 mg in 165 hours. side effects included nausea, vomiting, and decreasing serum potassium concentration. serum potassium concentration could be maintained within normal limits with supplemental potassium. the intravenous median lethal dose for glucagon in mice and rats is approximately 300 mg/kg and 38.6 mg/kg, respectively. because glucagon is a polypeptide, it would be rapidly destroyed in the gastrointestinal tract if it were to be accidentally ingested. treatment â to obtain up-to-date information about the treatment of overdose, a good resource is your certified regional poison control center. telephone numbers of certified poison control centers are listed in the physicians' desk reference (pdr). in managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. in view of the extremely short half-life of glucagon and its prompt destruction and excretion, the treatment of overdosage is symptomatic, primarily for nausea, vomiting, and possible hypokalemia. if the patient develops a dramatic increase in blood pressure, 5 to 10 mg of phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed. forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of glucagon.
Description:
Description glucagon for injection 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 escherichia coli bacteria that has been genetically altered by the addition of the gene for glucagon. glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3483. the empirical formula is c153h225n43o49s. 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 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. structure
Clinical Pharmacology:
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. 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 approximately 20 minutes after subcutaneous administration (see figure 1a). with intramuscular dosing, maximum plasma concentrations of 6.9 ng/ml were attained approximately 13 minutes after d
Read more...osing. glucagon is extensively degraded in liver, kidney, and plasma. urinary excretion of intact glucagon has not been measured. pharmacodynamics in a study of 25 volunteers, a subcutaneous dose of 1 mg glucagon resulted in a mean peak glucose concentration of 136 mg/dl 30 minutes after injection (see figure 1b). similarly, following intramuscular injection, the mean peak glucose level was 138 mg/dl, which occurred at 26 minutes after injection. no difference in maximum blood glucose concentration between animal-sourced and rdna glucagon was observed after subcutaneous and intramuscular injection. figure 1 mean (±se) serum glucagon and blood glucose levels after subcutaneous injection of glucagon (1 mg) in 25 normal volunteers clinical a clinical b
How Supplied:
How supplied glucagen(r) {glucagon (rdna orgin) for injection} is supplied in the following dosage forms. ndc 51662-1323-1 glucagen(r) {glucagon (rdna orgin) for injection} 1mg per kit hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms glucagon emergency kit for low blood sugar (ndc 0002-8031-01) contains 1 mg glucagon for injection (as a sterile, lyophilized white to off-white powder) in a single-dose vial and 1 ml of diluent for glucagon in a prefilled syringe. stability and storage: before reconstitution â vials of glucagon, as well as the diluent for glucagon, may be stored at controlled room temperature 20° to 25°c (68° to 77°f)[see usp]. 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 calculate
Read more...d 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. after reconstitution â glucagon for injection should be used immediately. discard any unused portion.
Package Label Principal Display Panel:
Package label, glucagon 1 mg emergency kit 1ct lilly rx only glucagon emergency kit for low blood sugar glucagon for injection 1 mg (1 unit) ndc 0002-8031-01 ms8031 marketed by: lilly usa, llc indianapolis, in 46285, usa glucagon: product of austria diluting syringe: product of germany label 1 label 2
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