Levemir (insulin detemir recombinant)
LEVEMIR (insulin detemir recombinant) – a long acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. The primary activity of insulin, including insulin detemir, is regulation of glucose metabolism. Insulins, including insulin detemir, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver.
FDA approved uses: Levemir is indicated to improve glycemic control in adults and children with diabetes mellitus. Important Limitations of Use: Not recommended for treating diabetic ketoacidosis. Use intravenous, short-acting insulin instead.
Available dosage forms: Solution for injection 100 units/mL (U-100) in:
Usual dosage: The starting dose should be individualized based on the type of diabetes and whether the patient is insulin-naïve. Administer subcutaneously once daily or in divided doses twice daily. Once daily administration should be given with the evening meal or at bedtime. Rotate injection sites within an injection area (abdomen, thigh, or deltoid) to reduce the risk of lipodystrophy. Converting from other insulin therapies may require adjustment of timing and dose of Levemir. Closely monitor glucoses especially upon converting to Levemir and during the initial weeks thereafter.
Contraindications: Do not use in patients with hypersensitivity to Levemir or one of its excipients.
Adverse reactions (side effects) of these medications: The most common side effects of Levemir include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash and pruritus. Other adverse reactions seen in clinical trials or post-marketing include: Upper respiratory infections, headache, pharyngitis, back pain, bronchitis, cough, influenza-like illness, abdominal pain, gastroenteritis, pyrexia, viral infection, nausea, rhinitis, and vomiting.
Common drug interactions: The following are examples of drugs that may increase the blood-glucose-lowering effect of insulins including Levemir and, therefore, increase the susceptibility to hypoglycemia: oral anti-diabetic products, pramlintide, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, and sulfonamide antibiotics.
The following are examples of drugs that may reduce the blood-glucose-lowering effect of insulins including Levemir: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine).
Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine.
Special instructions for patients: Changes to insulin regimens must be made cautiously and only under medical supervision. Lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia may occur. The ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Accidental mix-ups between Levemir and other insulins, have been reported. To avoid medication errors between Levemir and other insulins, always check the insulin label before each injection. Levemir must NOT be diluted or mixed with any other insulin or solution. Levemir must not be used in any type of insulin pump. If you use too much insulin, your blood sugar may be too low (hypoglycemia). Follow your physician’s instructions for how to manage low blood sugar.
Full prescribing information may be found at the manufacturer‘s official website Levemir.com or at the U.S. Food and Drug Administration’s website at Levemir Info at Drugs@FDA
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