Lantus is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

Lantus is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), blood-glucose-lowering agent.

The primary activity of insulin, including Lantus, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Before Taking Lantus

Tell your healthcare provider about all of your medical conditions including if you:

• have liver or kidney problems. Your dose may need to be adjusted.
  
• are pregnant or plan to become pregnant. It is not known if Lantus may harm your unborn baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your healthcare provider will decide which insulin is best for you during your pregnancy.
  
• are breast-feeding or plan to breast-feed. It is not known whether Lantus passes into your milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk to your healthcare provider about the best way to feed your baby.
  
• are taking any other prescription and non-prescription medicines, vitamins, or herbal supplements.
  

Important Notes:

Do not dilute or mix Lantus with any other insulin or solution. It will not work as intended, and you may lose blood sugar control, which could be serious. Do not change your insulin without first speaking with your doctor. The syringe must not contain any other medication or residue. You should not use Lantus if you are allergic to insulin. Lantus is a long acting insulin that you should inject once daily, at the same time each day. You must test your blood sugar levels while using an Lantus.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal, human), or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage. Concomitant oral antidiabetes treatment may need to be adjusted.

Side Effects:

The most common side effect of insulin, including Lantus, is hypoglycemia, which may be serious.

Hypoglycemia can occur with:

• Taking too much insulin
  
• Not enough carbohydrate intake
  
• Vomiting or diarrhea
  
• Alcohol intake
  
• Medicines that affect insulin. Be sure to discuss all of your medicines with your healthcare provider. Do not start any new medications until you know how they may affect your insulin dose.
  
• Medical conditions that can affect your blood sugar levels or insulin
  
• Too much glucose use by the body. This can happen if you exercise too much or have a fever.
  
• Injecting insulin the wrong way or in the wrong injection area.
  

Symptoms of hypoglycemia include:

• anxiety
  
• irritability
  
• restlessness
  
• trouble concentrating
  
• personality changes
  
• mood changes
  
• tingling in your hands, feet, lips or tongue
  
• dizziness, light-headedness or drowsiness
  
• nightmares or trouble sleeping
  
• headache
  
• blurred vision
  
• slurred speech
  
• palpitations (fast heart beat)
  
• sweating
  
• tremor (shaking)
  
• unsteady walking
  

Other possible side effects may include injection site reactions, including changes in fat tissue at the injection sire, and allergic reactions, including itching and rash. In rare cases, some allergic reactions may be life threatening. Tell your doctor about other medicines and supplements you are taking because they can change the way insulin works.