Insulin Human — Active Pharmaceutical Ingredient

Insulin Human is an active pharmaceutical ingredient found in 3 FDA-approved drug products. Forms: SOLUTION. Routes: SUBCUTANEOUS, INTRAVENOUS.

This content is for informational purposes only. Always consult a healthcare professional.

Insulin Human (3 brand names, 1 dosage form, 2 routes)

Available dosage forms: SOLUTION.

Routes of administration: SUBCUTANEOUS, INTRAVENOUS.

Brand Names

  • HUMULIN R
  • HUMULIN R KWIKPEN
  • MYXREDLIN

Boxed Warning

Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1)]. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications ( 4)]. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients [see Dosage and Administration ( 2.1), Warnings and Precautions ( 5.1)].

Indications and Usage

AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus.

Contraindications

AFREZZA is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ( 5.3)]. In patients with chronic lung disease, such as asthma or COPD, because of the risk of acute bronchospasm [see Warnings and Precautions ( 5.1)]. In patients with a previous severe hypersensitivity reaction to any regular human insulin product or any of the inactive ingredients in AFREZZA. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with AFREZZA [see Warnings and Precautions ( 5.7)].

Adverse Reactions

The following serious adverse reactions are described below and elsewhere in the labeling: Acute bronchospasm in patients with chronic lung disease [see Warnings and Precautions ( 5.1)] Hypoglycemia [see Warnings and Precautions ( 5.3)] Decline in pulmonary function [see Warnings and Precautions ( 5.4)] Lung cancer [see Warnings and Precautions ( 5.5)] Diabetic ketoacidosis [see Warnings and Precautions ( 5.6)] Hypersensitivity reactions [see Warnings and Precautions ( 5.7)]

Drug Interactions

Dosage modification may be needed when: AFREZZA is used concomitantly with certain drugs that increase and/or decrease the glucose lowering effect [see Drug Interactions ( 7)]. Switching from another insulin to AFREZZA [see Dosage and Administration ( 2.3) and Warnings and Precautions ( 5.2)]

Mechanism of Action

Insulin lowers blood glucose levels in adult patients with diabetes mellitus by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.

Overdosage

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3, 5.8)] . Mild episodes of hypoglycemia due to insulin overdose can usually be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. Severe episodes of hypoglycemia (due to insulin overdose) with coma, seizure, or neurologic impairment may be treated with intramuscular or subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia should be corrected appropriately. In the event of an overdose of AFREZZA, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

⚠ Caution
Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.