1. Indications and Usage
Diabetes Mellitus: Treatment of patients with diabetes mellitus who require insulin for the regulation of hyperglycemia.
2. Dosage and Administration
Route: Subcutaneous injection.
Timing: Administer approximately 30 minutes before a meal.
Injection Sites: Abdomen, thigh, buttocks, or upper arm. Sites must be rotated to prevent lipodystrophy.
3. Mechanism of Action
Receptor Binding: Binds to insulin receptors on muscle and adipose tissues, promoting glucose uptake.
Metabolic Effects: Inhibits hepatic glucose production and promotes glycogen synthesis.
Pharmacokinetics: Onset of action approximately 30 minutes; peak effect 2-4 hours; duration 6-8 hours.
4. Safety and Warnings
Hypoglycemia: The most common adverse reaction; risk increases with stricter glycemic control.
Hypersensitivity: Severe allergic reactions, including anaphylaxis, may occur.
Hypokalemia: Insulin therapy may cause a shift of potassium into cells, leading to lower serum potassium levels.
Transitions: Dose adjustments may be required when switching between insulin brands or types.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Hypoglycemia, injection site reactions, lipodystrophy, and weight gain.
Clinical Research: Clinical trials demonstrate efficacy in reducing fasting and postprandial glucose levels.
6. Drug Interactions
Agents Increasing Glucose: Corticosteroids, oral contraceptives, thyroid hormones, and sympathomimetics may increase insulin requirements.
Agents Decreasing Glucose: Oral antidiabetic drugs, ACE inhibitors, salicylates, and alcohol may potentiate hypoglycemic effects.
Beta-Blockers: May mask clinical signs of hypoglycemia (e.g., tachycardia and tremors).
7. Pharmaceutical Information
Active Ingredient: Recombinant human insulin.
Excipients: Metacresol, glycerin, dibasic sodium phosphate, zinc oxide, and water for injection.
Appearance: Clear, colorless liquid.
Storage: Unopened vials or pens should be refrigerated (2°C to 8°C). In-use pens may be kept at room temperature (below 30°C) for up to 28 days.
Novolin R Human Insulin Injection
Brand Name: 诺和灵® R（Novolin® R）
Generic Name: Human Insulin
Strength: 40 IU/mL, total 400 IU per 10 mL vial, 1 vial per box
Manufacturer: Novo Nordisk A/S (primary manufacturer); Novo Nordisk (China) Pharmaceutical Co., Ltd. (sub‑packager)
Marketing Authorization Holder: Novo Nordisk A/S
Approval Date in China: 2020
Registration Number: Import registration numbers: SJ20201029、SJ20201022; sub‑packaging approval number: SJ20171005
Storage:
Unopened vials: refrigerate at 2–8 ℃, avoid freezing and direct sunlight;
Vial in use: store below 25 ℃, finish use within 42 days after opening, do not re‑refrigerate;
Keep out of children’s reach, follow detailed storage rules on the official package insert.
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