Indications and Usage for Basaglar
The sugar that the amylases produce serves as food for the fermenting yeast and also makes for better-tasting, better-toasting bread. The awkward case of 'his or her'. I gave her Citrical and D3, but it hurts my heart to realize that this poor thing is walking with a cane at only age 53! Do you think that there was maybe an underlying condition even back when she was 2, that caused her to prefer sitting to standing and walking and running around? Another Insulin Glargine Product Bedtime.
Pieces of chocolate, in various flavours, are sometimes added to breakfast cereals and ice cream. Food and Drug Administration FDA to change the legal definition of chocolate to allow the substitution of "safe and suitable vegetable fats and oils" including partially hydrogenated vegetable oils for cocoa butter in addition to using "any sweetening agent" including artificial sweeteners and milk substitutes. The use of cocoa butter substitutes in Canada is not permitted.
Chocolate sold in Canada cannot contain vegetable fats or oils. The only sweetening agents permitted in chocolate in Canada are listed in Division 18 of the Food and Drug Regulations. Products manufactured or imported into Canada that contain non-permitted ingredients vegetable fats or oils, artificial sweeteners cannot legally be called "chocolate" when sold in Canada.
A non-standardized name such as "candy" must be used. In Japan, 'chocolate products' are classified on a complex scale q. Chocolate is a product based on cocoa solid or cocoa fat or both.
The amount and types of cocoa solids and fat that the term implies is a matter of controversy. Manufacturers have an incentive to use the term for variations that are cheaper to produce, containing less cocoa and more cocoa substitutes. There has been disagreement in the EU about the definition of chocolate; this dispute covers several ingredients, including the types of fat used and the quantity of cocoa.
A recent workaround has been to reduce the amount of cocoa butter in candy bars without using vegetable fats by adding polyglycerol polyricinoleate PGPR , which is an artificial castor oil-derived emulsifier that simulates the mouthfeel of fat. Cacao beans can be tested for their quality as a certain variety using DNA tests, especially by testing single-nucleotide polymorphisms that act as markers. From Wikipedia, the free encyclopedia.
Candy making Chocolate bar List of bean-to-bar chocolate manufacturers List of desserts. Archived from the original on 2 January Retrieved 5 December The New York Times. Archived from the original on 14 May Retrieved 1 January Archived from the original on 5 December Archived from the original on 11 June Retrieved 30 May The Art and Soul of Baking. Archived from the original on 23 March Retrieved 3 March Archived from the original on 11 November Title 21 — Food and Drugs.
Archived from the original on 10 March Retrieved 1 May Archived from the original on 26 January Archived from the original PDF on 2 December The effect of hepatic impairment on the pharmacokinetics of Basaglar has not been studied. However, as with all insulin products, more frequent glucose monitoring and dose adjustment may be necessary for Basaglar in patients with hepatic impairment [see Warnings and Precautions 5.
Excess insulin administration relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions 5. Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.
Hypokalemia must be corrected appropriately. Basaglar insulin glargine injection is a long-acting insulin for subcutaneous use. Insulin glargine is a recombinant human insulin analog [see Clinical Pharmacology 12 ]. Basaglar 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.
Insulin glargine has the following structural formula:. Basaglar is a clear, colorless, sterile aqueous solution of insulin glargine. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. Basaglar has a pH of approximately 4. The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Insulin and its analog lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis. The pharmacodynamic profile for Basaglar was determined after subcutaneous administration of a single 0.
The median time to maximum effect of Basaglar measured by the peak rate of glucose infusion was approximately The pharmacodynamic profile of Basaglar following subcutaneous injection demonstrated sustained glucose lowering activity over 24 hours with no pronounced peak.
A euglycemic clamp study in 20 patients with type 1 diabetes showed a similar pharmacodynamic profile with a sustained glucose lowering activity over 24 hours following a single 0. After subcutaneous injection of 0. The time course of action of insulins, including insulin glargine, may vary between individuals and within the same individual. The pharmacokinetic profile for Basaglar was determined after subcutaneous administration of a single 0.
The median time to maximum serum insulin concentration was 12 hours after injection. On average, serum insulin concentrations declined to baseline by approximately 24 hours.
The in vitro activity of M1 and M2 were similar to that of insulin. Age, Race, and Gender: Effect of age, race, and gender on the pharmacokinetics of Basaglar has not been evaluated. Effect of BMI on the pharmacokinetics of Basaglar has not been evaluated.
In mice and rats, standard two-year carcinogenicity studies with another insulin glargine product were performed at doses up to 0. The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats statistically significant and male mice not statistically significant in acid vehicle containing groups.
These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown. Another insulin glargine product was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells Ames- and HGPRT-test and in tests for detection of chromosomal aberrations cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters.
In a combined fertility and prenatal and postnatal study of another insulin glargine product in male and female rats at subcutaneous doses up to 0. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.
In general, the reduction in glycated hemoglobin HbA 1c with this other insulin glargine product was similar to that with NPH insulin.
Randomized were adults with type 1 diabetes. Mean age was The mean BMI was approximately Observed HbA 1c data at 24 weeks were available from Regular human insulin was administered before each meal.
This other insulin glargine product was administered at bedtime. NPH insulin was administered once daily at bedtime or in the morning and at bedtime when used twice daily.
In Study A, the average age was The mean duration of diabetes was In Study B, the average age was The majority of patients were Caucasian Insulin lispro was used before each meal.
This other insulin glargine product was administered once daily at bedtime and NPH insulin was administered once or twice daily. The average age was Type 1 Diabetes — Pediatric see Table 9. Patients were randomized to either this other insulin glargine product administered once daily at bedtime or NPH insulin administered once or twice daily.
The mean duration of diabetes was 4. Similar effects on HbA 1c see Table 9 were observed in both treatment groups. A total of patients were randomized. Three patients randomized to Basaglar did not receive study drug and were not included in efficacy analysis.
The average age was approximately 59 years. This other insulin glargine product administered once daily at bedtime was as effective as NPH insulin administered once daily at bedtime in reducing HbA 1c and fasting glucose see Table The rate of hypoglycemia was similar in this other insulin glargine product and NPH insulin treated patients [see Adverse Reactions 6. Regular human insulin was used before meals, as needed. This other insulin glargine product had similar effectiveness as either once- or twice daily NPH insulin in reducing HbA 1c and fasting glucose see Table 11 with a similar incidence of hypoglycemia [see Adverse Reactions 6.
The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the ETDRS scale. HbA 1c change from baseline was a secondary endpoint. Similar glycemic control in the 2 treatment groups was desired in order to not confound the interpretation of the retinal data. After this other insulin glargine product or NPH insulin dose was adjusted, other anti-diabetic agents, including pre-meal insulin were to be adjusted or added.
This other insulin glargine product group had a smaller mean reduction from baseline in HbA 1c compared to the NPH insulin group, which may be explained by the lower daily basal insulin doses in this other insulin glargine product group see Table Both treatment groups had a similar incidence of reported symptomatic hypoglycemia.
Patients were also treated with insulin lispro at mealtime. This other insulin glargine product administered at different times of the day resulted in similar reductions in HbA 1c compared to that with bedtime administration see Table In these patients, data are available from 8-point home glucose monitoring. The maximum mean blood glucose was observed just prior to injection of this other insulin glargine product regardless of time of administration. No patients in the other two arms discontinued for this reason.
This other insulin glargine product given before breakfast was at least as effective in lowering HbA 1c as this other insulin glargine product given at bedtime or NPH insulin given at bedtime see Table Five-year Trial Evaluating the Progression of Retinopathy. The numbers of retinal adverse events reported for this other insulin glargine product and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes. Mean baseline HbA 1c was 8. Patients with pre-specified post-baseline eye procedures pan-retinal photocoagulation for proliferative or severe nonproliferative diabetic retinopathy, local photocoagulation for new vessels, and vitrectomy for diabetic retinopathy were also considered as 3-step progressions regardless of actual change in ETDRS score from baseline.
Retinopathy graders were blinded to treatment group assignment. The results for the primary endpoint are shown in Table 13 for both the per-protocol and Intent-to-Treat populations, and indicate similarity of this other insulin glargine product to NPH in the progression of diabetic retinopathy as assessed by this outcome.
The objective of the trial was to demonstrate that use of this other insulin glargine product could significantly lower the risk of major cardiovascular outcomes compared to standard care. The first co-primary endpoint was the time to first occurrence of a major adverse cardiovascular event defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke. The second co-primary endpoint was the time to the first occurrence of CV death or nonfatal myocardial infarction or nonfatal stroke or revascularization procedure or hospitalization for heart failure.
Anthropometric and disease characteristics were balanced at baseline. The mean HbA 1c SD at baseline was 6. Vital status was available for The median duration of follow-up was 6. The mean HbA 1c SD at the end of the trial was 6.
The median dose of this other insulin glargine product at end of trial was 0. Eighty-one percent of patients randomized to this other insulin glargine product were using this other insulin glargine product at end of the study. The mean change in body weight from baseline to the last treatment visit was 2.
Overall, the incidence of major adverse cardiovascular outcomes was similar between groups see Table All-cause mortality was also similar between groups. Advise patients that they must never share a Basaglar KwikPen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions 5.
Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery. Advise patients that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions 5.
Inform patients to always check the insulin label before each injection [see Warnings and Precautions 5. Basaglar must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that Basaglar must NOT be diluted or mixed with any other insulin or solution [see Dosage and Administration 2. Management of Hypoglycemia and Handling of Special Situations.
Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions illness, stress, or emotional disturbances , an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals [see Warnings and Precautions 5.
Advise patients to inform their health care professional if they are pregnant or are contemplating pregnancy. This Patient Information has been approved by the U. Food and Drug Administration. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Do not share your Basaglar KwikPen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. One pen contains multiple doses of medicine. This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen. If you have any questions or problems with your Basaglar KwikPen, contact Lilly at LillyRx or call your healthcare provider for help.
For more information on Basaglar KwikPen and insulin, go to www. Lantus , Toujeo SoloStar. By clicking Subscribe, I agree to the Drugs. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to receive email notifications whenever new articles are published.
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Dose reductions and increased frequency of glucose monitoring may be required when Basaglar is co-administered with these drugs. Dose increases and increased frequency of glucose monitoring may be required when Basaglar is co-administered with these drugs. Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when Basaglar is co-administered with these drugs.
Increased frequency of glucose monitoring may be required when Basaglar is co-administered with these drugs. Basaglar is a long-acting man made insulin used to control high blood sugar in adults and children with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Basaglar is not for use to treat diabetic ketoacidosis.
It is not known if Basaglar is safe and effective in children less than 6 years of age with type 1 diabetes mellitus or in children with type 2 diabetes mellitus. Who should not use Basaglar? Do not use Basaglar if you: See the end of this Patient Information leaflet for a complete list of ingredients in Basaglar. What should I tell my healthcare provider before using Basaglar? Before using Basaglar, tell your healthcare provider about all your medical conditions, including if you: If you have heart failure, it may get worse while you take TZDs with Basaglar.
It is not known if Basaglar may harm your unborn or breastfeeding baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Before you start using Basaglar, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use Basaglar? Read the detailed Instructions for Use that come with your Basaglar. Use Basaglar exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Basaglar to use and when to use it.
Know the amount of Basaglar you use. Do not change the amount of Basaglar you use unless your healthcare provider tells you to. Check your insulin label each time you give your injection to make sure you are using the correct insulin.
Basaglar may be used at any time during the day, but Basaglar should be used at the same time each day. Only use Basaglar that is clear and colorless. If your Basaglar is cloudy or slightly colored, return it to your pharmacy for a replacement.
Basaglar is injected under your skin subcutaneously. Do not use Basaglar in an insulin pump or inject Basaglar into your vein intravenously. Change rotate your injection sites within the area you chose with each dose. Do not use the exact spot for each injection. Do not mix Basaglar with any other type of insulin. Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels. Keep Basaglar and all medicines out of the reach of children.
Your dose of Basaglar may need to change because of: What should I avoid while using Basaglar? While using Basaglar do not: What are the possible side effects of Basaglar? Basaglar may cause serious side effects that can lead to death, including: Signs and symptoms that may indicate low blood sugar include: Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction: This can happen even if you have never had heart failure or heart problems before.
If you already have heart failure it may get worse while you take TZDs with Basaglar. Your healthcare provider should monitor you closely while you are taking TZDs with Basaglar. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: