Insulin aspart + Insulin aspart protamine


Concise Prescribing Info
Indications/Uses
Diabetes mellitus.
Dosage/Direction for Use
Adult : SC Each 100 U/mL contains insulin aspart 30% and insulin aspart protamine 70%: Patient with type 1 diabetes mellitus: 0.5-1 U/kg daily, may be titrated according to patient’s diet, physical activity or concomitant illness. Patient with type 2 diabetes mellitus: As monotherapy or in combination with oral antidiabetic agents or GLP-1 agonists: Initial: 6 U given in 2 divided doses daily or 12 U once daily, may be adjusted at 1 week interval until target HbA1c is achieved. Dosage is individualised and adjusted based on patient’s glycaemic response.
Dosage Details
Subcutaneous
Diabetes mellitus
Adult: Available preparation:
Each 100 U/mL susp contains insulin aspart 30% and insulin aspart protamine 70%.

Patient with type 1 diabetes mellitus: 0.5-1 U/kg daily, may be titrated according to patient’s diet, physical activity or concomitant illness. Patient with type 2 diabetes mellitus: As monotherapy or in combination with oral antidiabetic agents or glucagon-like peptide-1 (GLP-1) agonists: Initially, 6 U given in 2 divided doses daily or 12 U once daily. Dosage is individualised and adjusted based on patient’s glycaemic response.
Child: ≥10 years Same as adult dose.
Renal Impairment
Dosage adjustment may be needed.
Hepatic Impairment
Dosage adjustment may be needed.
Administration
Should be taken with food. Administer immediately before or soon after a meal.
Contraindications
Hypersensitivity. Episodes of hypoglycaemia.
Special Precautions
Patients with infections or feverish conditions, adrenal, pituitary or thyroid gland diseases. Not recommended for treatment of diabetic ketoacidosis. Renal and hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypoglycaemia.
Eye disorders: Refraction disorders, diabetic retinopathy.
Gastrointestinal disorders: Diarrhoea, dyspepsia.
General disorders and admin site conditions: Lipodystrophy, oedema, inj site reactions (e.g. pain, erythema, inflammation, pruritus, bruising), influenza-like symptoms.
Immune system disorders: Urticaria.
Investigations: Weight gain.
Metabolism and nutrition disorders: Peripheral oedema.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Headache. Rarely, painful peripheral neuropathy.
Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, pharyngitis, rhinitis.
Skin and subcutaneous tissue disorders: Rash, eruptions.
Potentially Fatal: Severe hypoglycaemia, hypokalaemia. Rarely, hypersensitivity reactions (e.g. anaphylaxis).
Patient Counseling Information
This drug may impair ability to concentrate and react due to hypoglycaemia, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor serum glucose, HbA1c, serum electrolytes, LFTs, renal function and weight at regular intervals during therapy. Assess for signs of hypoglycaemia and hypokalaemia.
Overdosage
Symptoms: Mild to severe hypoglycaemia, hypokalaemia. Management: For mild episodes of hypoglycaemia, may administer oral glucose or sugary products. For unconscious patient with severe hypoglycaemic episodes, may administer IM/SC glucagon (0.5-1 mg) or administer IV glucose if the patient does not respond to glucagon within 10-15 minutes. When the patient becomes conscious, administer oral carbohydrates to prevent relapse.
Drug Interactions
Increased risk of fluid retention and heart failure with PPAR-γ agonists including thiazolidinediones (e.g. pioglitazone). Increased risk of hypoglycaemia with oral antidiabetic agents, GLP-1 agonists, ACE inhibitors, MAOIs, salicylates, anabolic steroids, sulfonamides, disopyramide, propoxyphene, fibrates, fluoxetine. Hypoglycaemic effect may be decreased by danazol, isoniazid, niacin, oral contraceptives, thiazide diuretics, corticosteroids, atypical antipsychotics (e.g. olanzapine, clozapine), sympathomimetics (e.g. epinephrine, terbutaline, salbutamol), thyroid and growth hormones. ß-blockers, clonidine, guanethidine, reserpine may mask the symptoms of hypoglycaemia. Hypoglycaemia effect may either be potentiated or reduced by lithium salts, octreotide, lanreotide, pentamidine.
Food Interaction
Alcohol may either potentiate or reduce the hypoglycaemic effect of insulin aspart + insulin aspart protamine.
Action
Description: Insulin aspart + Insulin aspart protamine is a biphasic human insulin analogue. It lowers blood glucose by binding to specific membrane-bound receptors on skeletal muscles and fat cells thus stimulating glucose uptake and simultaneously inhibiting glucose production from the liver. It also inhibits lipolysis and proteolysis of fats in adipose tissues and enhances protein synthesis in skeletal muscles.
Onset: 10-20 minutes.
Duration: 18-24 hours.
Pharmacokinetics:
Absorption: Fairly rapidly absorbed from subcutaneous tissue upon inj. Time to peak plasma concentration: 1-1.5 hours.
Distribution: Plasma protein binding: ≤9%.
Metabolism: Rapidly metabolised mainly in the liver but also in kidneys and muscle tissues.
Excretion: Mainly via urine (small amounts as unchanged drug). Elimination half-life: Approx 8-9 hours.
Storage
Unopened vial/cartridge/pen: Store between 2-8°C. Do not freeze. Protect from heat and sunlight. Punctured (in use) vial/cartridge/pen: Store below 30°C. Do not freeze or refrigerate. Protect from sunlight.
ATC Classification
A10AD05 - insulin aspart ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.
References
Anon. Insulin Aspart Protamine and Insulin Aspart. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2019.

Anon. Insulin Aspart. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/06/2019.

Buckingham R (ed). Insulin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2019.

NovoLog Mix 70/30 (Novo Nordisk Inc.). U.S. FDA. https://www.fda.gov/. Accessed 06/06/2019.

Novolog Mix 70/30 Injection, Suspension (A-S Medication Solutions). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/06/2019.

Novolog Mix 70/30 Injection, Suspension (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/09/2017.

Disclaimer: This information is independently developed by MIMS based on Insulin aspart + Insulin aspart protamine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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