Novolog (insulin aspart recombinant)
NOVOLOG (insulin aspart recombinant) – an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. The primary activity of insulin, including insulin aspart, is regulation of glucose metabolism. Insulin and its analogs blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.
FDA approved uses: Novolog is indicated to improve glycemic control in adults and children with diabetes mellitus.
Available dosage forms: Solution for injection 100 units/mL (U-100) in:
Usual dosage: The starting dose must be individualized. Subcutaneous injection – NovoLog should generally be given immediately (within 5-10 minutes) prior to the start of a meal. Use in pumps – Change the NovoLog in the reservoir at least every 6 days, change the infusion set, and the infusion set insertion site at least every 3 days. NovoLog should not be mixed with other insulins or with a diluent when it is used in the pump. Intravenous use – NovoLog should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. NovoLog has been shown to be stable in infusion fluids such as 0.9% sodium chloride.
Contraindications: Do not use in patients with hypersensitivity to NOVOLOG or one of its excipients. Do not use during episodes of hypoglycemia.
Adverse reactions (side effects) of these medications: The most common side effects of Novolog include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash and pruritus. Other adverse reactions seen in clinical trials or post-marketing include: Accidental injury, headache, sinusitis, nausea, diarrhea, hyporeflexia, onychomycosis, sensory disturbance, urinary tract infection, chest pain, skin disorder, and abdominal pain.
Common drug interactions: The following are examples of drugs that may increase the blood-glucose-lowering effect of insulins including NOVOLOG 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 NOVOLOG: 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: Do not change your insulin regimen except when directed by your physician. 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 NOVOLOG and other insulins, have been reported. To avoid medication errors between NOVOLOG and other insulins, always check the insulin label before each injection. Hypoglycemia (low blood sugar) may occur if you take too much insulin. Know your symptoms of low blood sugar. Follow your healthcare provider’s instructions for treating low blood sugar. Read all instructions that come with this product before use.
Full prescribing information may be found at the manufacturer‘s official website Novolog.com or at the U.S. Food and Drug Administration’s website at Novolog Info at Drugs@FDA
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