Insulin Glargine, Recombinant (Subcutaneous)

Overview

Insulin glargine, recombinant is a long-acting form of insulin that works slowly, over a period of 24 hours. Naturally secreted by the islets of Langerhans in the pancreas, insulin is one of the hormones that helps the body convert food into energy. This is achieved by using the glucose in the blood as quick energy. Additionally, insulin helps the body store extra energy for later use. An individual suffering from diabetes mellitus cannot produce enough insulin or does not use insulin properly. This results in high blood sugar levels. Like other forms of insulin, insulin glargine is taken in combination with other forms of insulin or with oral diabetes medications to regulate the blood sugar levels.

Produced under brand names Basaglar, Lantus, Lantus SoloStar, and TouJeo, insulin glargine is available only with the doctor's prescription. Administered subcutaneously, insulin glargine has a low aqueous solubility at pH 7 (neutral pH). However, it is completely soluble at pH 4. Upon administration, the acidic solution is neutralized resulting in the formation of microprecipitates from which small doses of insulin glargine are slowly released into the body. This results in a fairly constant concentration/time profile over 24 hours with no noticeable peak. This constant profile allows insulin glargine to be administered as a daily basal insulin dosage.

Conditions treated by insulin glargine

Type Of Medicine

  • Synthetic hormone (insulin)

Side Effects

Along with the desired effects, insulin glargine may cause some unwanted effects on the body. While the side effects vary from patient to patient, you may want to contact your healthcare provider if some of these side effects become severe and life-threatening.

Check with your healthcare provider or the emergency room immediately if you are worried about these insulin glargine side effects:

  • Change in behavior as if the patient is intoxicated
  • Anxiety and confusions
  • Chills
  • Blurred vision
  • Cold sweats
  • Seizures and convulsions
  • Cold sweats
  • Cool, pale skin
  • Impaired speech
  • Dizziness or lightheadedness
  • Irregular heartbeat
  • Drowsiness
  • Headache and nausea
  • Excessive hunger
  • Nightmares
  • Tingling in the hands, lips, and feet
  • Unexplained fatigue and weakness
  • Nervousness
  • Restless sleep

Less common insulin glargine side effects

  • Rapid pulse
  • Skin rash or itching over your entire body
  • Profuse sweating
  • Breathing difficulty

Very rare insulin glargine side effects

  • Bloating or swelling of the face and limbs
  • Unending cough
  • Reduced urination
  • Swallowing with difficulty
  • Hives
  • Dry mouth
  • Cramps and muscle pain
  • Increased thirst
  • Swelling or puffing of the eyelids around the eyes, lips, tongue, and face
  • Vomiting
  • Rapid weight gain

Some insulin glargine side effects are mild and may not need medical attention since they always go away as the body adjusts to the medication. Also, your healthcare provider may be able to advise you on how to prevent or manage these side effects. However, you may check with your healthcare provider if any of these side effects persist or are bothersome:

  • Sore throat
  • Fever
  • Stuffy or runny nose
  • Depression of the skin at the injected spot
  • Thickening, itching, pain, swelling, or redness of the skin at the injection site

Dosage

A nurse or trained healthcare provider may administer insulin glargine. You may also learn how to self-medicate at home. As already indicated, this medication is injected under the skin. Do NOT inject this medication into the vein or muscle.

If self-medicating, always double-check both the strength (concentration) of your insulin as well as your prescribed dosage. Remember, concentration and dose do not mean the same thing. Dosage refers to the number of units of insulin you are to use while concentration refers to the number of units present in each milliliter (mL), such as 100units/mL (U-100). This does not necessarily mean you will have to use 100 units at a time.

Each package of insulin glargine, recombinant comes with the patient's information sheet. It is important that you read and understand the following:

  • How to prepare your medication
  • How to administer the medication
  • How to safely dispose of the needles, syringes, and other injective devices

It is best to inject the medication into different parts of the body each time you treat yourself (e.g under the skin on your arm, thigh, stomach or abdomen). Ask your healthcare provider any questions you might have with respect to self-medication.

Since this medication lowers your blood glucose levels over a period of 24 hours, it should be administered once per day at bedtime. The insulin glargine solution should be clear and colorless. Do not inject yourself with this medication if it cloudy, colored or thickened.

While on this medication, carefully follow the special meal plan as given by your doctor. This is the most important component of managing your blood sugar, and it is necessary if this medication is to work as intended. Additionally, exercise regularly and test for sugar in your urine or blood as directed by your healthcare provider.

The disposable needle and syringe should not be used multiple times. Also, do not inject the same spot twice in a row. Never share your injection cartridge or pen with another patient as this can increase the risk of spread of diseases such as HIV and hepatitis. Your blood sugar needs to be checked on a regular basis. In addition, you may also need to take other tests as recommended by your healthcare provider.

Your dosage may be adjusted if you fall ill, get an infection, or if immediately before and after a major surgical procedure. Your healthcare provider may recommend that you stop insulin glargine therapy if any of these situations arise. Ask your healthcare provider how to adjust your dosage should there be a need to do so. Do not change your insulin glargine dosage or schedule without your healthcare provider's approval.

It is important that you know the signs of hypoglycemia (low blood sugar) and how to recognize them: hunger, headache, general body weakness, tremors, sweating, irritability and difficulty concentrating. Always have a source of sugar close by in case you experience these symptoms. Sugar sources may include glucose gel, orange juice, or milk. If your hypoglycemia becomes extreme and cannot drink or eat, use a glucagon injection. Your healthcare provider may prescribe for you a glucagon emergency kit with instruction on how to inject yourself.

Additionally, watch out for signs of extremely high blood sugar levels (hyperglycemia). These may include increased urination, hunger, frequent thirst, dryness of mouth, persistent drowsiness, blurred vision, a feeling of fruity breath odor, dryness of the skin and rapid weight loss. Closely monitor your blood sugar levels when you are ill or depressed, if you are traveling, exercising more than you should, drink alcohol or if you skip a meal. These can affect your blood glucose levels and with it a change in dosage.

Insulin glargine, recombinant is only part of the treatment program that should also include proper diet, weight management, exercise, foot, eye, and dental care, as well as a close monitoring of your blood sugar levels. Strictly follow your medication, diet, and exercise routines. A change in any of these factors can have a significant effect on your blood sugar levels.

Wear your medical alert tag or carry your ID card indicating that you are on insulin. Any healthcare provider who treats you should know that you are diabetic.

Dosing

Insulin glargine, recombinant dosing varies from patient to patient. Follow your healthcare provider's prescription or as directed on the label. The following information is only for average insulin glargine, recombinant dosage. If your healthcare provider has recommended a different dose, do not change it unless with their approval.

The amount of medication you take depends on the medicine's strength, the number of daily doses, time recommended in between doses, as well as the duration you take the medication.

Injectable dosage for type 1 diabetes

  • Adults and children over six years old  Dosage is based on the patient's blood sugar levels and must be determined by the healthcare provider
  • Children under 6 years old ' use and dosage of insulin glargine, recombinant must be determined by the healthcare provider

Injectable dosage for type 2 diabetes

  • Adults' dosage is based on the patient's blood sugar level and must be determined by the healthcare provider
  • Children ' us'e and dosage must be determined by the healthcare provider

Missed dose

Take a missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not double dose to make up for the missed dosage. Additionally, do not use more than one dose in a 24-hour period unless advised so by your healthcare provider.

Overdose
Insulin glargine overdose may cause life threatening hypoglycemia. As such, it is important that you seek medical attention as soon as you suspect that you have overdosed this medication.

Interactions

Although certain medications should never be combined, there are cases where two medications may be used together even if there is a possibility of an interaction. In such cases, your healthcare provider may recommend a change in dosage as well as other precautionary measures. When you are on insulin glargine, recombinant, it is specifically important that your healthcare provider know if you are taking any of the following medications.

  • Balofloxacin
  • Besifloxacin
  • Ciprofloxacin
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Lanreotide
  • Levofloxacin
  • Liraglutide
  • Metreleptin
  • Lomefloxacin
  • Nadifloxacin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pazufloxacin
  • Pramlintide
  • Octreotide
  • Pasireotide
  • Pefloxacin
  • Pioglitazone
  • Rosiglitazone
  • Thioctic Acid
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin

Combining insulin glargine, recombinant with the following medications may increase the severity of the side effects. However, using both medications may be the best treatment for your condition. In an event that both medications are prescribed together, your healthcare provider may recommend a change in dosage, how you use one or both medications.

  • Acebutolol
  • Albiglutide
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Dulaglutide
  • Esmolol
  • Exenatide
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Lixisenatide
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Practolol
  • Procarbazine
  • Propranolol
  • Rasagiline
  • Safinamide
  • Selegiline
  • Sotalol
  • Timolol
  • Tranylcypromine

Certain foods should not be used when on insulin glargine medication. Alcohol and tobacco products too should be avoided while on this medication.

Certain pre-existing medical conditions may affect the use of insulin glargine, recombinant. Be sure to inform your healthcare provider if you have any of the following medical conditions before taking up insulin glargine, recombinant therapy.

  • Congestive heart failure
  • Low blood potassium levels (hypokalemia)
  • Infection or illness
  • Emotional disturbances
  • Depression
  • Hypoglycemia
  • Kidney and liver diseases

Warnings

Never use this medication if you are allergic to any form of insulin. Also, inform your healthcare provider of any allergy you might be having, including food, animal, and drug allergies. To be sure that you can safely take this medication, inform your doctor if you have a history of kidney and liver diseases.

The FDA classifies insulin glargine, recombinant as a pregnancy category C medication. It is not clear whether this medication can harm an unborn baby. Be sure to seek your doctor's advice should you conceive while on this or any insulin-based therapy. Additionally, it is not known whether this medication can be passed on to the nursing baby via breast milk. Thus, nursing mothers should not take this medication without informing their healthcare providers.

Insulin pens and cartridges should never be shared under any circumstance. For safety purposes, a single pen or cartridge to be used by more than one patient as this can promote spread of bloodborne diseases like HIV/AIDS and hepatitis viruses.

Your healthcare provider should monitor your progress on a regular basis, especially during the first few weeks of insulin glargine therapy. During your appointment, the doctor may recommend blood tests to check for undesired side effects.

Avoid alcohol while on any insulin treatment as alcohol consumption may cause a severe decrease in your blood sugar levels.

Too much insulin glargine in your system can cause low blood sugar (hypoglycemia). This condition can also occur if you combine insulin glargine with some antibiotic medications, miss or delay a meal, exercise more than you should, or if you take alcohol. It is important that you learn the symptoms of low blood sugar you usually have and treat them as soon as possible before they lead to unconsciousness (passing out).

To counter symptoms of hypoglycemia, take glucose gel or tablets, honey, corn syrup, sugar cubes, or drink a non-diet soft drink, fruit juice, or sugar dissolved in water. Also, check your blood sugar levels on a regular basis. Call your doctor or the emergency room immediately if these symptoms do not improve even after taking glucose.

Call the emergency room immediately if you experience severe symptoms such as seizures (convulsions) or lose consciousness. Always have your glucose kit ready, together with the syringe and needle, and know how to use them. Members of your household too should know how to give this medication.

Skipping a dose or under-dosing may result in high blood sugar level (hyperglycemia). This may also occur if you combine your insulin glargine with antibiotic medications, fail to follow your meal plan, develop a fever or infection or fail to exercise. It is important that you know your hyperglycemia symptoms and respond with appropriate insulin glargine medication.

Insulin glargine, recombinant, may make you feel dizzy and drowsy. Avoid driving or operating machinery that requires you to stay alert until you know how this medication affects you.

Insulin glargine may trigger serious allergic reactions, including anaphylaxis, which requires immediate medical attention because it is life-threatening. Call your healthcare provider or the emergency room immediately if you experience itching, rashes, breathing and swallowing difficulty, or any swelling of the limbs or mouth while on insulin glargine therapy.

Insulin glargine can lower your blood potassium levels. Avoid medications, supplements, as well as salt substitutes that contain potassium unless you have discussed this with your healthcare provider.

Storage

Do not freeze insulin glargine, recombinant. Dispose of any medication that has become frozen.

Storing unopened vials'keep the medication in the carton and store in a cool place away from moisture and light. Get rid of any insulin glargine not used before its expiration date as labeled in the container. Injection pens should be stored with their caps on.

Unopened vials may be stored at room temperature for up to 28 days. Any drug not used within this period should be disposed of.

Storing opened vials ' all 'œin-use' vials and unloaded cartridges should be stored at room temperature or in the refrigerator away from direct sunlight. All open medications should be used within 28 days.

All medications should be stored out of reach of children and pets. Seek advice from your pharmacist on how to safely dispose of used syringes and needles, as well as any unused or expired medication. Do not flush any medication your kitchen sink.

Summary

Insulin glargine, recombinant is a synthetic form of a hormone that is naturally produced by the beta cells in the islets of Langerhans in the pancreas. It works by regulating the blood's glucose (sugar) levels. Additionally, insulin helps the body store up energy for later use. Type 2 diabetes hinders the body's natural ability to produce insulin or the ability of the produced insulin to work properly. This causes a rise in blood sugar levels.

Insulin glargine is a slow acting form of insulin. Like other forms of insulin, insulin glargine is administered to keep the blood sugar levels as close to normal as possible. This long-acting insulin is injected under the skin and works slowly over a period of 24 hours to regulate the blood sugar level. Insulin glargine may be used in combination with other forms of insulin or with other diabetes medication to keep blood sugar levels properly regulated.

Produced in a solution form, this medication is only available with the healthcare provider's prescription. The medication is injected under the skin once per day. To get the most benefit out of it, it is recommended that you get your daily insulin glargine dose at the same time every day. It is important that you carefully follow the directions on your prescription label and ask your pharmacist or healthcare provider for clarifications on what you do not understand.

Like with any other medication, insulin glargine does come with its share of side effects. Be sure contact your healthcare provider, or the emergency room, if your insulin glargine side effects are severe or life-threatening. Some of the side effects that you may want to report immediately include anaphylaxis reactions.

Insulin glargine is produced in vials and in dosing pens that hold cartridges of medication. It is important that you know the type of container your insulin glargine comes in as well as the supplies that come with the medication such as needles, syringes, and pens. Do NOT share your medication, pens, and cartridges with other patients as this may increase your risk of contracting bloodborne diseases like HIV and hepatitis. Additionally, never reuse syringes and needles. If your medication is coming in a pen, always remove the needle immediately after injecting your dose. All used needles and syringes should be discarded in a puncture-proof container. Ask your healthcare provider or pharmacist how to safely dispose of used medical equipment.

Insulin glargine comes in a clear and colorless solution form. Do not use this medication if it is cloudy, colored, or contains solid precipitate, if the medication has passed its expiration date. In addition, do not dilute or mix your medication with any other form of insulin. Finally, do not use this medication in an external insulin pump.

You can inject this medication on the skin in your thigh, upper arm, or abdomen. Never inject insulin glargine, recombinant into a muscle or vein. Also, do not inject the medication in the same spot twice. Try to avoid injecting the same spot more than once every two weeks.