Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4063
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GlucaGen Diagnostic Kit (Kit)
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Directions for treatment of severe hypoglycemia: Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing GlucaGen powder and inject all the liquid from the syringe into the vial. Roll the vial gently until powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency. The reconstituted GlucaGen gives a concentration of approximately 1 mg/ml glucagon. The reconstituted GlucaGen should be used immediately after reconstitution. Discard any unused portion. Inject 1 ml (adults and children, weighing more than 55 lbs) or��ml (children weighing less than 55 lbs) subcutaneously (s.c), intramuscularly (i.m), or intravenously (i.v). If the weight is not known: Children younger than 6 to 8 years should be given half dose (=��ml) and children older than 6 to 8 should be given the adult dose (1ml).Emergency assistance should be sought if the patient fails to respond within 15 minutes after subcutaneous or intramuscular injection of glucagon. The glucagon injection may be repeated while waiting for emergency assistance.Intravenous glucose MUST be administered if the patient fails to respond to glucagon. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent recurrence of hypoglycemia. Directions for use as a diagnostic aid: GlucaGen should be reconstituted with the supplied 1 ml of Sterile Water for Reconstitution (if supplied) or 1 ml Sterile Water for Injection, USP. Using a syringe, withdraw all of the Sterile Water for Reconstitution (if supplied) or 1 ml Sterile Water for Injection, USP and inject into the GlucaGen vial. Roll the vial gently until powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency. The reconstituted GlucaGen gives a concentration of approximately 1 mg/ml glucagon. The reconstituted GlucaGen should be used immediately after reconstitution. Discard any unused portion. When the diagnostic procedure is over, give oral carbohydrate to restore the liver glycogen and prevent occurrence of secondary hypoglycemia. References for diagnostic aid use only: Duration of action - Hyperglycemic action - 60 to 90 minutes Smooth muscle relaxation Intravenous: 0.25 to 0.5 mg (IU) - 9 to 17 minutes 2 mg (IU) - 22 to 25 minutes Intramuscular: 1 mg (IU) - 12 to 27 minutes 2 mg (IU) - 21 to 32 minutes
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GlucaGen (glucagon [rDNA origin] for injection) manufactured by Novo Nordisk A/S is produced by expression of recombinant DNA in a Saccharomyces cerevisiae vector with subsequent purification. The chemical structure of the glucagon in GlucaGen is identical to naturally occurring human glucagon and to glucagon extracted from beef and pork pancreas. Glucagon with the empirical formula of CHNOS, and a molecular weight of 3483, is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is: His-Ser-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Tyr-Ser- 1 2 3 4 5 6 7 8 9 10 11 Lys-Tyr-Leu-Asp-Ser-Arg-Arg-Ala-Gln-Asp-Phe- 12 13 14 15 16 17 18 19 20 21 22 Val-Gln-Trp-Leu-Met-Asn-Thr 23 24 25 26 27 28 29 GlucaGen 1 mg (1 unit) is supplied as a sterile, lyophilized white powder in a 2 ml vial, alone, or accompanied by Sterile Water for Reconstitution (1 ml) also in a 2 ml vial (10 pack or diagnostic kit). It is also supplied as a HypoKit with a disposable prefilled syringe containing 1 ml Sterile Water for Reconstitution. Glucagon, as supplied at pH 2.5-3.5, is soluble in water. Active Ingredient in each vial Glucagon as hydrochloride 1 mg (corresponding to 1 unit). Other Ingredients Lactose monohydrate (107 mg) When the glucagon powder is reconstituted with Sterile Water for Reconstitution (if supplied) or with Sterile Water for Injection, USP, it forms a solution of 1 mg (1 unit)/ml glucagon for subcutaneous (sc), intramuscular (im), or intravenous (iv) injection. GlucaGen is an antihypoglycemic agent, and a gastrointestinal motility inhibitor.
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Intramuscular (im) injection of GlucaGen resulted in a mean Cmax (CV%) of 1686 pg/ml (43%) and median Tmax of 12.5 minutes. The mean apparent half-life of 45 minutes after im injection probably reflects prolonged absorption from the injection site. Glucagon is degraded in the liver, kidney, and plasma. Antihypoglycemic Action: Glucagon induces liver glycogen breakdown, releasing glucose from the liver. Blood glucose concentration rises within 10 minutes of injection and maximal concentrations are attained at approximately a half hour after injection (see Figure). Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Recovery from insulin induced hypoglycemia (mean blood glucose) after im injection of 1 mg GlucaGen in Type I diabetic men Gastrointestinal Motility Inhibition: Extra hepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.
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Glucagon is contraindicated in patients with known hypersensitivity to glucagon or any constituent in GlucaGen and in patients with pheochromocytoma or with insulinoma.
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GlucaGen HypoKit includes: 1 vial containing 1 mg (1 unit) GlucaGen (glucagon [rDNA origin] for injection) 1 disposable syringe containing 1 ml Sterile Water for Reconstitution NDC 0169-7065-15 OR GlucaGen' Diagnostic Kit includes: 1 vial containing 1 mg (1 unit) GlucaGen (glucagon [rDNA origin] for injection) 1 vial containing 1ml Sterile Water for Reconstitution NDC 55390-004-01 OR The GlucaGen 10-pack includes: 10x1 vial containing 1 mg (1 unit) GlucaGen (glucagon [rDNA origin] for injection) NDC 55390-004-10 Edition: December 2004
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General: In order for GlucaGentreatment to reverse hypoglycemia, adequate amounts of glucose must be stored in the liver (as glycogen). Therefore, GlucaGen should be used with caution in patients with conditions such as prolonged fasting, starvation, adrenal insufficiency or chronic hypoglycemia because these conditions result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by GlucaGen treatment. Caution should be observed when glucagon is used in diabetic patients or in elderly patients with known cardiac disease to inhibit gastrointestinal motility.<br/>Information for Patients: Refer patients and family members to the "INFORMATION FOR PATIENTS" for instructions describing the method of preparing and injecting GlucaGen. Advise the patient and family members to become familiar with the technique of preparing glucagon before an emergency arises. Instruct patients to use 1 mg for adults or��the adult dose (0.5 mg) for children weighing less than 55 lbs (25 kg). To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Family members should be informed to arouse the patient as quickly as possible because prolonged hypoglycemia may result in damage to the central nervous system. Patients should be advised to inform their physician when hypoglycemic reactions occur so that the treatment regimen may be adjusted if necessary.<br/>Laboratory Tests: Blood glucose measurements may be considered to monitor the patient's response.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals to evaluate carcinogenic potential have not been performed. Several studies have been conducted to evaluate the mutagenic potential of glucagon. The mutagenic potential tested in the Ames and human lymphocyte assays, was borderline positive under certain conditions for both glucagon (pancreatic) and glucagon (rDNA) origin. In vivo, very high doses (100 and 200 mg/kg) of glucagon (both origins) gave a slightly higher incidence of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that GlucaGen is not different from glucagon pancreatic origin and does not pose a genotoxic risk to humans. GlucaGen was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility.<br/>Pregnancy - Pregnancy Category B: Reproduction studies were performed in rats and rabbits at GlucaGen doses of 0.4, 2.0, and 10 mg/kg. These doses represent exposures of up to 100 and 200 times the human dose based on mg/m2 for rats and rabbits, respectively, and revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GlucaGen is administered to a nursing woman. No clinical studies have been performed in nursing mothers, however, GlucaGen is a peptide and intact glucagon is not absorbed from the GI tract. Therefore, even if the infant ingested glucagon it would be unlikely to have any effect on the infant. Additionally, GlucaGen has a short plasma half-life thus limiting amounts available to the child.<br/>Pediatric use: For the treatment of hypoglycemia: The use of glucagon in pediatric patients has been reported to be safe and effective. For use as a diagnostic aid: Safety and effectiveness in pediatric patients have not been established.
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Signs and Symptoms No reports of overdosage with GlucaGen have been reported. It is expected, if overdosage occurred, that the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate.1 In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. The IV and SC LD50 for GlucaGen in rats and mice ranges from 100 to greater than 200 mg/kg body weight. Treatment Standard symptomatic treatment may be undertaken if overdosage occurs. 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. It is unknown whether GlucaGen is dialyzable, but such a procedure is unlikely to provide any benefit given the short half-life and nature of the symptoms of overdose.
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glucagon hydrochloride
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GlucaGen Diagnostic Kit (Kit)
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Severe side effects are very rare, although nausea and vomiting may occur occasionally especially with doses above 1 mg or with rapid injection (less than 1 minute).Hypotension has been reported up to 2 hours after administration in patients receiving GlucaGen as premedication for upper GI endoscopy procedures. Glucagon exerts positive inotropic and chronotropic effect and may, therefore, cause tachycardia and hypertension. Adverse reactions indicating toxicity of GlucaGen have not been reported. A transient increase in both blood pressure and pulse rate may occur following the administration of glucagon. Patients taking��-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. (see OVERDOSAGE). Allergic reactions may occur in rare cases. .
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GlucaGen should be administered cautiously to patients suspected of having pheochromocytoma or insulinoma. Secondary hypoglycemia may occur and should be countered by adequate carbohydrate intake following glucagon treatment. Glucagon may release catecholamines from pheochromocytomas and is contraindicated in patients with this condition. Allergic reactions may occur and include generalized rash, and in rare cases anaphylactic shock with breathing difficulties, and hypotension. The anaphylactic reactions have generally occurred in association with endoscopic examination during which patients often received other agents including contrast media and local anesthetics. The patients should be given standard treatment for anaphylaxis including an injection of epinephrine if they encounter respiratory difficulties after GlucaGeninjection.
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For the treatment of hypoglycemia: GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes treated with insulin. Because GlucaGendepletes glycogen stores, the patient should be given supplemental carbohydrates as soon as he/she awakens and is able to swallow, especially children or adolescents. Medical evaluation is recommended for all patients who experience severe hypoglycemia. For use as a diagnostic aid: GlucaGen is indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. 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. Because GlucaGen depletes glycogen stores, the patient should be given oral carbohydrates as soon as the procedure is completed.
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GlucaGen Diagnostic Kit
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