Insulin Lispro + Insulin Lispro Protamine
Medicine Type :
Allopathy
Allopathy
Prescription Type:
Prescription Required
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Schedule H
Pharmacological Class:
Fast Acting Insulin, Long-Acting Insulin, Therapy Class:
Antidiabetic Agent, Approved Countries
The United States, Canada, the United Kingdom, Germany, France and Australia.
Insulin Lispro + Insulin Lispro Protamine is an anti-diabetic Agent belonging to the pharmacological class of fast-acting and long-acting insulins.
Insulin Lispro + Insulin Lispro Protamine is approved for treating adult-onset diabetes mellitus. It helps control blood sugar levels by simulating the body's normal insulin response to meals, preventing complications related to elevated blood sugar levels.
Following subcutaneous injection, insulin Lispro + insulin Lispro Protamine is absorbed. Insulin Lispro promotes glucose uptake by tissues, quickly lowering blood glucose levels. Because insulin Lispro Protamine absorbs more slowly, its effects last longer. The two components, Lispro and Lispro Protamine have different elimination half-lives, and the liver and kidneys are the primary sites of metabolism.
The common side effect of Insulin Lispro + Insulin Lispro Protamine is low blood sugar levels (hypoglycemia).
Insulin Lispro + Insulin Lispro Protamine is available as a suspension for an injectable solution.
Insulin Lispro + Insulin Lispro Protamine is available in the United States, Canada, the United Kingdom, Germany, France and Australia.
Insulin Lispro + Insulin Lispro Protamine is an anti-diabetic Agent belonging to the pharmacological class of fast-acting and long-acting insulins.
The regulation of glucose metabolism is the primary function of insulin, including Insulin Lispro + Insulin Lispro Protamine. Insulins reduce blood sugar levels by promoting glucose absorption by skeletal muscle and fat cells in the periphery and blocking the synthesis of glucose in the liver. Insulins promote protein synthesis and prevent lipolysis and proteolysis.
Synergistic Benefits: The dual-action insulin formulation of Insulin Lispro + Insulin Lispro Protamine results in a combination of synergistic benefits. To imitate the body's normal insulin response, the fast-acting insulin Lispro helps quickly lower blood sugar levels after meals. Intermittent blood sugar control is provided with insulin lispro protonate, which has an intermediate-acting profile. Combining their efforts, they provide a thorough covering that helps lower the risk of problems related to uncontrolled diabetes by managing both immediate and sustained glucose control.
Bioavailability: SC is well absorbed; it acts twice to three times faster than conventional insulin.
Onset: <15 min
Time of Peak Plasma: 30 to 90 min
Insulin Lispro + Insulin Lispro Protamine is a suspension for an injectable solution.
Prefilled pen: Insulin Lispro + Insulin Lispro Protamine is a suspension for an injectable solution. Prefilled pen, identify the injection site, disinfect it, attach a new needle, prepare the pen, dial the dose, inject, and cautiously dispose of it. For proper use, adhere to the doctor's recommendations and self-administration is not advisable.
The physician determines the exact dosage and timing based on the patient's needs and blood sugar levels.
For those with type 1 or type 2 diabetes, Insulin Lispro + Insulin Lispro Protamine is mainly used to control elevated blood sugar levels. It is specifically made to regulate blood sugar levels throughout mealtimes and the day, helping manage blood sugar levels in many types of diabetes-related diseases.
Insulin Lispro + Insulin Lispro Protamine belongs to the class of antidiabetic medications and is primarily utilized to improve blood sugar control in adults diagnosed with diabetes mellitus. It comprises a combination of Insulin Lispro and Insulin Lispro Protamine. These hormones function by decreasing glucose levels in the bloodstream. Insulin Lispro is a fast-acting insulin, while Insulin Lispro Protamine is an intermediate-acting insulin. This medication suppresses liver sugar production and aids the reuptake of sugar in fat and muscle cells, ensuring swift and consistent sugar control. Its usage mitigates the risk of severe diabetes complications like retinopathy, nephropathy, neuropathy, diabetic foot ulcers, and related ailments. Administered through injection, it initiates action within 10 minutes, peaks at 2 hours, and sustains effectiveness for up to 24 hours, effectively managing glucose levels throughout the day.
- Management of hyperglycemia in individuals with diabetes mellitus.
- Specifically indicated for mealtime glucose control both in fasting and postprandial conditions.
- It helps prevent complications associated with uncontrolled diabetes.
Insulin Lispro + Insulin Lispro Protamine is administered Parenterally.
Preparation
Before administration, check insulin labels. Resuspend the suspension at room temperature for Insulin Lispro Protamine and Insulin Lispro. Roll the Pen gently 10 times and invert it 10 times until a uniform white cloudy appearance. Visually inspect for discolouration or particles; do not use if present.
Administration
Administer Insulin Lispro Protamine and Insulin Lispro via subcutaneous injection into the abdomen, thigh, upper arm, or buttocks post-resuspension. Rotate the injection site within the same area to avoid lipodystrophy and cutaneous amyloidosis. Dial in 1 unit increments. Use caution in visually impaired patients relying on clicks for dosing. Avoid intravenous or continuous subcutaneous infusion. Do not mix with other insulins or diluents.
If a dose is missed, it should be taken with the following main meal and then continue the regular dosing schedule; taking an extra amount to compensate for the missed one is not recommended.
The dosage and duration of treatment should be as per the treating physician's clinical judgment.
Injectable solution (Prefilled pen): 75/25 units per mL and 50/50 units per mL
Insulin Lispro+ Insulin Lispro Protamine is an injectable solution (prefilled pen).
Dosage Adjustment for Adult Patients
Diabetes Mellitus
Patients' dose regimens vary according to their metabolic needs; the usual daily requirement for insulin is between 0.5 and 1 unit/kg.
Administer SC BID or before breakfast and dinner; each dose is intended to cover two meals or a full meal and a snack.
Insulin Lispro + Insulin Lispro Protamine should be used in treating diabetes mellitus, along with appropriate dietary restrictions.
While taking Insulin Lispro + Insulin Lispro Protamine, maintain an appropriate diet, primarily focusing on regulating carbohydrate intake and consuming a balanced and healthy meal plan.
Patients should limit high-carbohydrate foods like potatoes, rice, mangoes, and sugary items. opt for low-calorie alternatives to manage sugar levels.
Avoid drinking alcohol. It increases the risk of lactic acidosis, which occurs when the body produces too much lactic acid and affects several organs, and hypoglycemia, which is a fall in blood sugar that can be fatal in some circumstances.
While taking this combination, it is advised to stay hydrated, consume a rich-balanced diet low in saturated fats and cholesterol—and drink plenty of vegetables, whole grains, fruits, and lean proteins in meals.
The dietary restriction should be individualized as per patient requirements.
Insulin Lispro+ Insulin Lispro Protamine may be contraindicated in the following conditions: -
- During episodes of hypoglycemia,
- Documented hypersensitivity to Insulin Lispro + Insulin Lispro Protamine or one of its excipients.
Even if the needle is replaced, never share an insulin lispro + Insulin lispro protamine pen between patients.
When there are changes in the insulin regimen and hyper- or hypoglycemia, follow medical advice closely and check blood sugar levels more frequently.
Hypoglycemia: This condition could be fatal. Boost monitoring when adjusting insulin dosage, concurrent administration of drugs that drop blood sugar, meal schedule, physical activity, and in patients with hepatic or renal impairment or hypoglycemic unawareness.
Medication errors can result in hypoglycemia: Inadvertent confusion between different insulin products can happen. Tell patients to read the labels on their Insulin before injecting. To avoid overdosing and severe hypoglycemia, DO NOT put insulin lispro + Insulin lispro protamine into a syringe for administration.
Hypersensitivity reactions: Anaphylaxis and other severe, perhaps fatal generalized allergies can happen. End Insulin lispro + Insulin lispro protamine; if necessary, monitor and treat.
Hypokalemia: This condition could be fatal. Track the potassium content in individuals who may be hypokalemic and treat them if necessary.
Heart failure and fluid retention associated with concurrent usage of Thiazolidinediones (TZDs): Watch for heart failure symptoms and indicators; if it develops, consider lowering your dosage or stopping it altogether.
Alcohol Warning
It is unsafe to consume Insulin Lispro + Insulin Lispro Protamine with alcohol.
Breast Feeding Warning
Safe during breastfeeding, but caution is advised.
Pregnancy Warning
Generally considered safe to use during pregnancy.
Food Warning
Consume foods with a low glycemic index for more stable blood glucose levels.
The adverse reactions related to Insulin Lispro + Insulin Lispro Protamine can be categorized as:-
- Common Adverse Effects: Hypoglycemia, injection site reactions, weight gain, and lipodystrophy
- Less Common Adverse Effects: Nausea, headache, and diarrhoea
- Rare Adverse Effects: Severe allergic reactions, vision changes, and serious skin reactions.
The clinically relevant drug interactions of Insulin Lispro + Insulin Lispro Protamine are briefly summarized here:
- Drug-Drug Interactions: Insulin Lispro + Insulin Lispro Protamine may interact with thyroid hormones (e.g., levothyroxine), antidiabetics (e.g., pioglitazone), medicines that lower blood pressure (e.g., metoprolol, hydrochlorothiazide, irbesartan, candesartan), bronchodilators (e.g., metaproterenol), painkillers (e.g., aspirin), and antidepressants (e.g. sertraline).
- Drug-Food Interactions: Avoid alcohol since it may raise or lower your blood sugar levels when using Insulin Lispro + Insulin Lispro Protamine together.
- Drug-Disease Interactions: If one has or has ever had kidney disease, hepatic impairment or liver disease, hypoglycemia (low blood sugar), or hypokalaemia (low potassium level), inform the physician immediately before taking Insulin Lispro + Insulin Lispro Protamine.
The most common side effects of Insulin Lispro + Insulin Lispro Protamine include:
Weight gain
Low blood glucose, or hypoglycemia
Infusion site reaction
Edema (swelling)
Skin rash
Insulin Lispro+ Insulin Lispro Protamine should be prudent in the following particular population groups.
- Pregnancy
Category B pregnancy (FDA): Possibly acceptable. Research on animals has either not indicated any danger, but human studies have yet to be conducted, or research on animals has shown some risk but not human risk.
There are risks to mother and fetus associated with poorly controlled diabetes during pregnancy; published studies during pregnancy have not reported an association between drug and induction of significant congenital disabilities, miscarriage, or adverse maternal or fetal outcomes; and there is a lack of information regarding the limited data available in pregnant women regarding the risk of adverse developmental effects from drugs.
Maternal risks for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery problems are increased when diabetes is poorly controlled during pregnancy. Fetal risks for significant birth abnormalities, stillbirth, and morbidity associated with macrosomia are also increased.
Animal data
When pregnant rats and rabbits were exposed to the drug during organogenesis, the offspring of the rats were given a dose approximately three times the human subcutaneous dose of one unit of insulin lispro/kg/day. Similarly, the offspring of the rabbits were given a dose of up to approximately 0.24 times the human subcutaneous dose of one unit of insulin lispro/kg/day, and no adverse effects were observed on the development of the embryo or fetal tissue.
- Nursing Mothers
According to information currently available from published literature, human milk may contain exogenous human insulin products, such as insulin lispro.
There is a lack of information regarding the effects of exogenous human insulin products, such as insulin lispro, on milk supply, and no adverse reactions in breastfed infants have been documented in clinical studies.
Examine the advantages of nursing for the child's growth and well-being, the mother's clinical requirement for insulin, and any possible negative consequences the infant may experience from treatment or an underlying disease.
- Pediatric Use
As per FDA, safety and effectiveness in the pediatric population have yet to be established.
- Geriatric Use
There needed to be more participants 65 and older in the Insulin Lispro + Insulin Lispro Protamine clinical trials to ascertain whether their responses differed from those of younger patients. The greater likelihood of reduced renal, hepatic, or cardiac function, as well as the presence of concomitant diseases or other medication therapies, should be considered when choosing a dose for an aged patient.
Dose Adjustment in Kidney Impairment Patients:
Patients with renal impairment may need more frequent adjustments to the dosage of Insulin Lispro + Insulin Lispro Protamine and more regular blood glucose monitoring due to an increased risk of hypoglycemia.
Dose Adjustment in Hepatic Impairment Patients:
Patients with hepatic impairment may need more frequent adjustments to the dosage of Insulin Lispro + Insulin Lispro Protamine and more regular blood glucose testing due to their higher risk of hypoglycemia.
Signs and Symptoms
The physician should be vigilant about the knowledge pertaining to the identification and treatment of overdosage of Insulin Lispro + Insulin Lispro Protamine. Overconsumption of Insulin Aspart Protamine + Insulin aspart could lead to hypoglycemia with symptoms like hypoglycemia (low blood sugar), confusion, dizziness, shaking, sweating, rapid heartbeat, and fainting.
Management
There is no specific antidote or treatment for excessive Insulin Lispro + Insulin Lispro Protamine intake. However, immediate medical attention is essential. Insulin Lispro + Insulin Lispro Protamine should be terminated immediately when an overdose is In cases of overdose, close medical attention is crucial. Insulin Lispro + Insulin Lispro Protamine should be discontinued if an overdose is suspected or if unusual symptoms occur after ingestion.
If mild or moderate, consume a fast-acting carbohydrate like fruit juice or sugar cubes. If conscious, follow it with a snack containing protein and carbohydrates. For severe unconsciousness or inability to swallow, administer intravenous glucose or glucagon injection. Avoid further insulin administration until glucose levels stabilize.
In cases of allergic reactions, immediate medical attention is necessary, and alternative insulin therapy may need to be considered.
It's essential to regularly check blood glucose levels in order to modify insulin dosage as necessary. By rotating and applying appropriate injection techniques, injection site reactions can be controlled.
Pharmacodynamics
Following subcutaneous administration of Insulin Aspart Protamine and Insulin Aspart to 24 healthy participants, a euglycemic clamp study was conducted to evaluate glucose utilization. After a single subcutaneous injection of 0.3 units/kg of Insulin Aspart Protamine and Insulin Aspart, the effects take 10–20 minutes to manifest, with a mean ± SD time to peak activity of 2.7 hours ± 0.9 hours. The action might go on for up to 24 hours.
Pharmacokinetics
- Absorption: After injection, subcutaneous tissue absorbs the substance quite quickly. Peak plasma concentration takes one to one and a half hours.
- Distribution: ≤9% binding to plasma proteins.
- Metabolism: Muscle tissues, the kidneys, and the liver are the primary sites of rapid metabolism.
- Excretion: Mostly through urine (in small amounts as unaltered medication). Half-life of elimination: roughly 8 to 9 hours.
Therapeutic benefits of a combination of Insulin Lispro + Insulin Lispro Protamine
- Optimal Glycemic Control: Insulin Lispro with Insulin Lispro Protamine work together to provide an immediate response and a long-lasting impact that helps control blood sugar levels throughout the day long.
- Reduce Chance of Diabetes Complications: This combination reduces the chance of developing diabetic foot ulcers, retinopathy, nephropathy, and neuropathy by keeping blood sugar levels steady.
- Citro G, Lorusso B, et al. Insulin lispro protamine suspension in an intensive insulin treatment: an Italian observational study. Curr Med Res Opin. 2009 Sep;25(9):2259-65. doi: 10.1185/03007990903166474. PMID: 19630489.
- Marcus Hompesch, Scott M. Ocheltree, Eshetu T. Wondmagegnehu, Linda A. Morrow, Alexa P. Kollmeier, Barbara N. Campaign & Scott J. Jacober (2009) Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes, Current Medical Research and Opinion, 25:11, 2679-2687, DOI: 10.1185/03007990903223739
- Antonietta Colatrella, Natalia Visalli, Santina Abbruzzese, Sergio Leotta, Marzia Bongiovanni, Angela Napoli, "Comparison of Insulin Lispro Protamine Suspension with NPH Insulin in thePregnant Women with Type 2 and Gestational Diabetes Mellitus: Maternal and Perinatal Outcomes", International Journal of Endocrinology, vol. 2013, Article ID 151975, 8 pages, 2013. https://doi.org/10.1155/2013/151975
https://www.ema.europa.eu/en/medicines/human/EPAR/humalog
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021017s108lbl.pdf
https://pi.lilly.com/ca/humalog-ca-pm.pdf
https://www.ncbi.nlm.nih.gov/books/NBK507840/
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm
Published on: 15 Nov 2023 5:12 AM GMT