What You Should Know About Taking Lantus Solostar U-100 Insulin Subcutaneous When Pregnant, Nursing, Or Administering To Children Or Adults Over 60
No Known Risk: EXCRETION MAY BE EXPECTED SINCE HUMAN INSULIN IS A COMPONENT OF BREASTMILK management or monitoring precaution: Initial dose, incremental increases and maintenance dose should be conservative. Giving Lantus Solostar Insulin Pen to a child under 12 management or monitoring precaution: Safety and efficacy not established age < 6 years. Not studied in type 2 diabetes. Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Continue reading >>
What Are The Possible Side Effects Of Insulin Glargine (lantus, Lantus Opticlik Cartridge, Lantus Solostar Pen)?
LANTUS® (insulin glargine) Injection DESCRIPTION LANTUS (insulin glargine injection) is a sterile solution of insulin glargine for subcutaneous use. Insulin glargine is a recombinant human insulin analog that is a long-acting, parenteral blood-glucose-lowering agent [see CLINICAL PHARMACOLOGY]. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows oncedaily dosing as a basal insulin. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, insulin glargine is 21A-Gly-30Ba-L-Arg-3030b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. Insulin glargine has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 Units (3.6378 mg) insulin glargine. The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. The 3 mL prefilled pen presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for inje Continue reading >>
Using Insulin In Pregnancy: Fda Approves Levemir
Novo Nordisk’s Levemir (insulin detemir) has been classified as Category B for pregnant women. “This is the most thrilling news since the discovery of insulin,” says Dr. Lois Jovanovic, CEO and Chief Scientific Officer of the Sansum Diabetes Research Institute and world-renowned expert in diabetes and pregnancy. “I am thrilled.” Given that Dr. Jovanovic is so unequivocally positive, the news deserves a bit more explanation for those of us who aren’t experts and aren’t pregnant. Levemir is the first long-acting insulin other than NPH to be classified as Category B. But what exactly does that mean? And why are we so worried about insulin in pregnancy anyway? The FDA, Dr. Jovanovic explains, needs to make sure drugs taken by women during pregnancy are safe for the baby, and not going to cause any birth defects or abnormalities. The FDA therefore assigns drugs to a category that indicates how they should be used in pregnancy. Category A drugs are things like vitamins—not just okay to use, but actually good for the pregnant woman and the fetus. Category B drugs are not necessarily positive for pregnancy, but all animal and human studies must indicate that the drug is safe for the mother and the baby. Category C drugs are not known to cause birth defects, but have not been sufficiently tested in humans to really be certainly safe. Up until now, untested insulin analogues, and all long-acting insulin analogues other than NPH, fell into Category C—not known to be harmful, but not known to be safe either. Now, normal, non-diabetic women produce their own insulin, and that insulin is obviously safe for fetuses. What, then, makes insulin analogues different and riskier? The answer is that insulin analogues may behave similarly to human insulin in the body, but th Continue reading >>
Insulin Glargine During Pregnancy
Insulin Glargine during Pregnancy [bold]Body: [/bold]The long-ac [bold]Body: [/bold]The long-acting analog Glargine is a new insulin with 24-h persistence. This peakless action profile accounts for stable daily plasma glucose profile significant risk reduction for nocturnal hypoglycemia. Only a few reports have described the use of insulin glargine during human pregnancy, so its use is not recommended at present. This observational, multi-centre (three) trial studied the maternal and perinatal outcome of Glargine Insulin and Human long-acting Insulin (Protaphan). Forty-seven consecutive pregnant subjects with type 1 diabetes using Insulin Glargine before conception during 2003-2005 were studied. The control group consisted of 50 pregnant subjects using long-acting insulin (Protaphan) at the same time and who were matched for age, parity, duration of diabetes and diabetes complications. All women injected short-acting insulin analogues before meals. There was no difference for gestational age at delivery, pregnancy complications and perinatal outcome (weight of the new-born, shoulder dystocia, respiratory distress, infections, first plasma glucose after birth). One newborn (Glargine group) had congenital malformation (anencephaly). None of the women experienced significant progression of retino- nor nephropathy. Although mean glycemic control (HbA1c) was similar at first trimester of pregnancy ( 6.9 % in Protaphan group and 7.4% in Glargine group) the decrease from first trimester to third trimester was greater in Glargine Insulin group compared to Protaphan group (P=0.04). There was a tendency towards lower number of hypoglycemic episodes in the Glargine group (11/47) than in the Protaphan group ( 21/50)(P=0.07). In conclusion, treatment with Glargine insulin during pre Continue reading >>
Taking Insulin During Pregnancy
When your blood glucose levels stay raised despite meal planning and physical activity, insulin must be added to your management plan to keep you and your baby healthy. Pregnancy requires that your body produce extra amounts of insulin. Insulin is a hormone that is made by the pancreas. If your pancreas does not make enough insulin, injections can help you meet the need. Your health care provider and diabetes educator will teach you how to inject insulin safely and comfortably. Determining the right insulin and dosage Tip Keep a record of the type and amount of insulin you take. It is important that you know and remember your insulin type every time you speak with a health care provider. Your health care provider will decide what kind of insulin is right for you, how much to use and when you should take it, based on: your weight (which changes weekly) how far along your pregnancy is your meal plan your most recent blood glucose levels Sometimes, you may need more than one type of insulin. Different types of insulin work at different speeds, and your health care provider may combine insulins to achieve the best results for you. Time-action of different insulins Insulins Starts working Peaks Stops working Rapid acting: Humalog® (lispro) NovoLog® (aspart) Apidra® (glulisine) 5 to 15 minutes 1 to 2 hours 2 to 4 hours Intermediate acting: NPH (N) 2 to 4 hours 4 to 8 hours 10 to 16 hours Basal*: Lantus® (glargine) Levemir® (detemir) 2 hours No peak 24 hours *Lantus® and Levemir® cannot be mixed with any other insulin. How to help insulin work best Take your insulin at the same times each day as directed. Talk with your health care provider if you feel sick. Follow any instructions your health care provider gives you. Don't change your meal plan, physical activity, pres Continue reading >>
Levemir And Getting Pregnant
Diabetes Forum The Global Diabetes Community Find support, ask questions and share your experiences. Join the community I have Type 1 for 19yrs already and I'm planning getting pregnant. I take Humalog and Levemir and my diabetologist doesn't want to change Levemir for other shorter acting insulin. Has anyone been taking Levemir being pregnant (as it is not clinically tested on pregnant women and studies on animals show embryo malformations)?? What are your views on this? Hi, this is a very good question. I was taken off novorapid and put on to humalog when I got pregnant 9 years ago. Still worry about it, as I no longer trust any synthetic insulin. I'm quite sure it's also not recommended to take Lantus in pregnancy. Purified animal insulins has been tried and tested for years and years, synthetic 'human' insulins only came about in the 80s, and the analogues in last 10 years or so. I know what I would trust, and in retrospect I would much rather have been educated about what I was taking for my diabetes. I just trusted the doctors. I was on synthetic insulins for 19 years until, due to ill health and poor blood sugar control, I changed to hypurin porcine insulin a year ago. Life has improved for me beyond belief! You should do some internet research on synthetic and purified animal insulins. Not just for the sake of a safe pregnancy but for your own health. The truth is because these 'analogue' insulins suchas Novorapid, Humalog, Lantus, and Levemir have only been available for a limited time, no-one really knows the long-term effects on us, let alone our children. You are obviously concerned and wise to be so, and not to take your doctor's word. Can u tell me where you got info bout the embryo malformation? I was swapped from apidra to novorapid (but i was told that Continue reading >>
Diabetes Management Guidelines
Endocrine Society Guideline on Diabetes and Pregnancy Source: Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249. Available here. Refer to source document for full recommendations, including strength of recommendations and quality of evidence. Jump to a topic or click back/next at the bottom of each page Antihyperglycemic Therapy During Pregnancy Insulin therapy Long-acting insulin detemir Initiate during pregnancy in women who require insulin therapy and for whom appropriate doses of NPH insulin have caused/may cause hypoglycemia* Continue if used successfully prior to pregnancy* Insulin glargine Continue if used successfully prior to pregnancy† Rapid-acting insulin lispro and aspart Use in preference to regular soluble insulin‡ Continuous SC insulin infusion Recommended when treatment has been prior to pregnancy§ Do not initiate during pregnancy unless other insulin strategies – including multiple daily doses of insulin – tried and unsuccessful† Insulin glargine is classified as FDA Pregnancy Category C and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus *Less strong recommendation, very high quality evidence †Less strong recommendation, low quality evidence ‡Less strong recommendation, moderate quality evidence §Strong recommendation, moderate quality evidence Noninsulin therapy Glyburide May be used as alternative to insulin in women with GDM who do not achieve sufficient glycemic control after 1-week trial of medical nutrition therapy and exercise* Exceptions, in which case insulin is preferred therapy:* Diagnosis of GDM before 25 weeks FPG >110 mg/dL (6.1 mmol/L) Metformin Use only for wo Continue reading >>
Insulin For Gestational Diabetes - What It Is And How It Works
Where blood sugar levels cannot be lowered and stabilised enough through dietary and lifestyle changes, or through using medication such as Metformin, some ladies will be required to use insulin for gestational diabetes. Insulin is a hormone in the body produced by the pancreas. Your body uses insulin to move the sugar (glucose) obtained from food and drink from the bloodstream into cells throughout the body. The cells are then able to use the sugar for energy. Here are the most commonly asked Q&A on insulin for gestational diabetes from our Facebook support group Why do I need to take insulin for gestational diabetes? If lower blood sugar levels cannot be reached through diet, exercise and medication such as Metformin, then many will be required insulin for gestational diabetes. If blood sugar levels remain high, then the diabetes is not controlled and can cause major complications with the pregnancy and baby. If your levels are rising out of target range, your own insulin production may need to be topped up at the meal time. You may need to take insulin at one or all of your meals. Sometimes the insulin you produce in-between your meals and overnight may also require a top up. This may mean that you require an extra slower-release insulin at bedtime and/or in the morning. Some consultants will prescribe insulin on diagnosis of gestational diabetes on the basis of your GTT results or following other complications relating to gestational diabetes. For the majority, you will be given some time to try diet and exercise changes and then medication such as Metformin before insulin is introduced as a way to help lower and control your levels. NICE guidelines for timing and use of insulin for gestational diabetes 1.2.19 Offer a trial of changes in diet and exercise to women w Continue reading >>
Insulin Glargine Safety In Pregnancy
Erika K. Pollex, BMSC; Denice S. Feig, MD; Angelika Lubetsky; Paul M. Yip, PhD; Gideon Koren, MD ObjectiveInsulin glargine (Lantus) is an extended-action insulin analog with greater stability and duration of action than regular human insulin. The long duration of action and decreased incidence of hypoglycemia provide potential advantages for its use in pregnancy. However, the placental pharmacokinetics of insulin glargine have not been studied. Therefore, the objective of this study was to determine whether insulin glargine crosses the human placenta using the human perfused placental lobule technique. Research design and methodsPlacentae were obtained with informed consent after elective cesarean section delivery of noncomplicated term pregnancies. Insulin glargine, at a therapeutic concentration of 150 pmol/l (20 U/ml) was added to the maternal circulation. Additional experiments were carried out at insulin glargine concentrations 1,000-fold higher than therapeutic levels (150, 225, and 300 nmol/l). A subsequent perfusion for which the maternal circuit remained open and insulin glargine was continuously infused at 150 pmol/l was completed for further confirmation of findings. The appearance of insulin glargine in the fetal circulation was analyzed by a chemiluminescence immunoassay. ResultsResults from perfusions carried out at therapeutic concentrations (150 pmol/l) of insulin glargine showed no detectable insulin glargine in the fetal circuit. After perfusion with very high insulin glargine concentrations of 150, 225, and 300 nmol/l, the rate of transfer remained low at 0.079 0.01, 0.14, and 0.064 pmol min1 g tissue1, respectively. ConclusionsInsulin glargine, when used at therapeutic concentrations, is not likely to cross the placenta. Several new long-acting insu Continue reading >>
Lantus (insulin Glargine)
What is it used for? How does it work? Lantus vials, Lantus SoloStar pre-filled pens and Lantus penfill cartridges (for use with ClikSTAR or Autopen 24 pens) contain the active ingredient insulin glargine. They are used to treat diabetes. People with diabetes have a deficiency or absence of a hormone manufactured by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar (glucose) in the blood. People with type one diabetes need to have injections of insulin to control the amount of glucose in their bloodstream. Insulin injections act as a replacement for natural insulin and allow people with diabetes to achieve normal blood glucose levels. Insulin injections work in the same way as natural insulin, by binding to insulin receptors on cells in the body. Insulin causes cells in the liver, muscle and fat tissue to increase their uptake of glucose from the bloodstream. It also decreases the production of glucose by the liver, and has various other effects that lower the amount of glucose in the blood. Lantus contains a type of insulin called insulin glargine. This is known as a long-acting insulin. When injected under the skin it starts working within two to three hours and produces a steady effect for 25 hours. It is used to help provide background control of blood glucose throughout the day. Insulin glargine is normally used in combination with a short-acting insulin, which is given before meals to control the increasing blood glucose levels after eating. It is important to monitor your blood glucose regularly and adjust your insulin dose as required. Your doctor or diabetic team will explain how to do this. Keeping your blood glucose level as close to normal as possible, and not too high or too low, significantly reduces the risk of Continue reading >>
High-alert Medications - Lantus (insulin Glargine)
The leaflets are FREELY available for download and can be reproduced for free distribution to consumers. Or, if you are a facility or organization, you can order professional pre-printed leaflets shipped directly to you. Extra care is needed because Lantus is a high-alert medicine. High-alert medicines have been proven to be safe and effective. But these medicines can cause serious injury if a mistake happens while taking them. This means that it is very important for you to know about this medicine and take it exactly as directed. Top 10 List of Safety Tips for Lantus When taking your medicine 1. Know your insulin. Lantus is a long-acting insulin that should be injected below the skin once daily as directed by your doctor. On rare occasions, your physician may direct you to take Lantus two times daily. Take Lantus the same time every day. 2. Prepare your insulin. A rapid- or short-acting insulin is often prescribed with Lantus. However, Lantus should never be mixed in the same syringe with other insulins before injection. Do not vigorously shake insulin before use. 3. Don't reuse or recycle. Dispose of used syringes/needles, pens, and lancets in a sealable hard plastic or metal container (e.g., empty detergent bottle, sharps container from your pharmacy). When the container is full, seal the lid before placing it in the trash. Do not reuse or recycle syringes/needles or lancets. 4. Don't share. Even if you change the needle, sharing an insulin pen or syringe may spread diseases carried in the blood, including hepatitis and HIV. To avoid serious side effects 5. Avoid mix-ups. List If you use more than one type of insulin, make sure each vial or pen looks different to avoid mix-ups. Lantus is a long-acting insulin that may look like a rapid- or short-acting insulin. For Continue reading >>
Meta-analysis Of Maternal And Neonatal Outcomes Associated With The Use Of Insulin Glargine Versus Nph Insulin During Pregnancy
Copyright © 2012 Jacques Lepercq et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract As glargine, an analog of human insulin, is increasingly used during pregnancy, a meta-analysis assessed its safety in this population. A systematic literature search identified studies of gestational or pregestational diabetes comparing use of insulin glargine with human NPH insulin, with at least 15 women in both arms. Data was extracted for maternal outcomes (weight at delivery, weight gain, 1st/3rd trimester , severe hypoglycemia, gestation/new-onset hypertension, preeclampsia, and cesarean section) and neonatal outcomes (congenital malformations, gestational age at delivery, birth weight, macrosomia, LGA, 5 minute Apgar score 7, NICU admissions, respiratory distress syndrome, neonatal hypoglycemia, and hyperbilirubinemia). Relative risk ratios and weighted mean differences were determined using a random effect model. Eight studies of women using glargine (331) or NPH (371) were analyzed. No significant differences in the efficacy and safety-related outcomes were found between glargine and NPH use during pregnancy. 1. Introduction An estimated 4% of pregnancies in the United States are complicated by diabetes [1]. Whether due to preexisting type 1 or type 2 diabetes mellitus (pregestational) or diabetes that developed during pregnancy (gestational), hyperglycemia during pregnancy is associated with increased risk of various maternal and fetal complications. Subclinical increases in fasting blood glucose levels as little as 6.9 mg/dL and elevated postprandial plasma glucose levels have been associated with Continue reading >>
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How To Use The Lantus® Solostar® Pen
Please check the leaflet for the insulin for complete instructions on how to store SoloSTAR®. If your SoloSTAR® is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject. Keep SoloSTAR® out of the reach and sight of children. Keep your SoloSTAR® in cool storage (36°F–46°F [2°C–8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack. Once you take your SoloSTAR® out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SoloSTAR® in use must not be stored in a refrigerator. Do not use SoloSTAR® after the expiration date printed on the label of the pen or on the carton. Protect SoloSTAR® from light. Discard your used SoloSTAR® as required by your local authorities. Protect your SoloSTAR® from dust and dirt. You can clean the outside of your SoloSTAR® by wiping it with a damp cloth. Do not soak, wash, or lubricate the pen as this may damage it. Your SoloSTAR® is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloSTAR® might be damaged. If you are concerned that your SoloSTAR® may be damaged, use a new one. Continue reading >>
Insulin Glargine Safety In Pregnancy
Abstract OBJECTIVE Insulin glargine (Lantus) is an extended-action insulin analog with greater stability and duration of action than regular human insulin. The long duration of action and decreased incidence of hypoglycemia provide potential advantages for its use in pregnancy. However, the placental pharmacokinetics of insulin glargine have not been studied. Therefore, the objective of this study was to determine whether insulin glargine crosses the human placenta using the human perfused placental lobule technique. RESEARCH DESIGN AND METHODS Placentae were obtained with informed consent after elective cesarean section delivery of noncomplicated term pregnancies. Insulin glargine, at a therapeutic concentration of 150 pmol/l (20 μU/ml) was added to the maternal circulation. Additional experiments were carried out at insulin glargine concentrations 1,000-fold higher than therapeutic levels (150, 225, and 300 nmol/l). A subsequent perfusion for which the maternal circuit remained open and insulin glargine was continuously infused at 150 pmol/l was completed for further confirmation of findings. The appearance of insulin glargine in the fetal circulation was analyzed by a chemiluminescence immunoassay. RESULTS Results from perfusions carried out at therapeutic concentrations (150 pmol/l) of insulin glargine showed no detectable insulin glargine in the fetal circuit. After perfusion with very high insulin glargine concentrations of 150, 225, and 300 nmol/l, the rate of transfer remained low at 0.079 ± 0.01, 0.14, and 0.064 pmol · min−1 · g tissue−1, respectively. CONCLUSIONS Insulin glargine, when used at therapeutic concentrations, is not likely to cross the placenta. Several new long-acting insulin analogs, such as glargine and detemir, are currently available f Continue reading >>
Lantus (insulin Glargine) Dose, Indications, Adverse Effects, Interactions... From Pdr.net
Hormone secreted by pancreatic beta-cells of the islets of Langerhans and essential for the metabolism and homeostasis of carbohydrate, fat, and protein. Insulin glargine is a once-daily basal insulin analog without pronounced peaks. BASAGLAR, Lantus, Lantus SoloStar, Toujeo SoloStar BASAGLAR/Lantus/Lantus SoloStar/Toujeo SoloStar Subcutaneous Inj Sol: 1mL, 100U, 300U For the treatment of type 1 diabetes mellitus and type 2 diabetes mellitus. For the treatment of type 1 diabetes mellitus. Subcutaneous dosage (100 units/mL, i.e., Lantus, Basaglar) Initially, administer one-third of the total daily insulin requirements/dose subcutaneously once daily. Titrate dosage to achieve blood glucose control and A1C goals in conjunction with a short-acting insulin. Give the dose at the same time every day, at any time. Administration in the morning may avoid nocturnal hypoglycemia. When transferring from once daily NPH insulin, the dose is usually not changed. However, when transferring from twice-daily NPH insulin to insulin glargine, the total daily dose of NPH insulin (or other twice daily basal insulin) should be reduced by 20% and administered as single dose once daily. When transferring from once-daily Toujeo to once-daily Lantus or Basaglar, the recommended initial Lantus or Basaglar dose is 80% of the Toujeo dose that is being discontinued. Thereafter, the dosage of insulin glargine should be adjusted to response. Children and Adolescents 6 years and older Insulin requirements are highly variable and must be individualized based on patient-specific factors and type of insulin regimen. During partial remission phase, total combined daily insulin requirement is often less than 0.5 units/kg/day. Prepubertal children (outside the partial remission phase) usually require 0.7 to Continue reading >>
