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diabetes

Lantus

insulin glargine

By sanofi-aventis

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses and cannot be anticipated. It can be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • hypoglycemia (low blood sugar)
  • redness, itching, or swelling at the site of the injection
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

FDA ADVISORY

January 12, 2011

The FDA has issued new information concerning the use of Lantus® (insulin glargine). To read the full FDA Advisory, visit the FDA's web site at www.fda.gov.

A previous advisory was issued on July 1, 2009. To read the full FDA Advisory, visit the FDA's web site at www.fda.gov.

Allergic reactions: If you notice signs of a serious allergic reaction (swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash), stop using the medication and seek immediate medical attention.

Diabetic identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are using insulin.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual.

Mild-to-moderate hypoglycemia may be treated by consuming foods or drinks that contain sugar. People using insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). Symptoms of mild-to-moderate hypoglycemia may occur suddenly and can include:

  • cold sweat
  • confusion
  • fast heartbeat
  • headache
  • hunger
  • lightheadedness
  • nervousness or shakiness
  • numbness or tingling of the tongue, lips, or fingers
  • weakness

Signs of severe hypoglycemia can include:

  • disorientation
  • loss of consciousness
  • seizures

If you are unable to take sugar by mouth or are unconscious, you may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

The signs of low blood sugar may not be as noticeable when taking certain medications to lower blood pressure.

Other conditions: If you have an illness, unusual stress, or emotional disturbances, the dose of your insulin may need to be adjusted. Contact your doctor for instructions.

Pregnancy: It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.

This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if insulin glargine passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of insulin glargine have not been established in children with type 2 diabetes or children less than 6 years old with type 1 diabetes.

Seniors: Seniors may be more sensitive to this medication and need to monitor their blood glucose more closely to prevent low blood glucose.

What other drugs could interact with this medication?

There may be an interaction between insulin glargine and any of the following:

  • ACE inhibitors (e.g., ramipril, enalapril, lisinopril)
  • alcohol
  • angiotensin 2 receptor blockers (e.g., losartan, valsartan)
  • antidiabetes medications (e.g., gliclazide, glyburide)
  • atypical antipsychotic medications (e.g., olanzapine, clozapine)
  • beta-blockers (e.g., metoprolol, propranolol)
  • birth control pills
  • clonidine
  • corticosteroids (e.g., prednisone, prednisolone)
  • danazol
  • disopyramide
  • fibrates
  • fluoxetine
  • glucagons
  • guanethidine
  • isoniazid
  • lithium
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • pentamidine
  • phenothiazine
  • propoxyphene
  • protease inhibitors (e.g., ritonavir, indinavir)
  • reserpine
  • salicylates (e.g., aspirin)
  • somastatin (e.g., octreotide)
  • somatropin
  • sulfonamide antibiotics (e.g., sulfamethoxazole, sulfadiazine)
  • sympathomimetics (e.g., epinephrine, pseudoephedrine)
  • thiazide diuretics (e.g., hydrochlorothiazide)
  • thyroid medications (e.g., levothyroxine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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