Insulin lispro + Insulin lispro protamine

Subcutaneous
Diabetes mellitus

Dose reduction may be required.

Dose reduction may be required.

Should be taken with food. Administer w/in 15 min before or after meals.

Hypersensitivity. Episodes of hypoglycaemia.

Patient with ongoing illness, emotional disturbances; changes in levels of physical activity, meal patterns or concurrent medications; risk factors for hypokalaemia (e.g. receiving loop diuretics). Not indicated for treatment of diabetic ketoacidosis. Early warning symptoms of hypoglycaemia may be different or less pronounced in patients with long-standing diabetes, intensified insulin therapy, diabetic nerve disease, and those receiving β-blockers or those who switched from animal-source insulin to human insulin. Patient concurrently receiving PPAR-γ agonists including thiazolidinediones (e.g. pioglitazone). Renal and hepatic impairment. Pregnancy and lactation.

Significant: Hypoglycaemia; lipodystrophy (including lipoatrophy or lipohypertrophy) and localised cutaneous amyloidosis at the inj site.
Investigations: Weight gain.
Metabolism and nutrition disorders: Oedema.
General disorders and administration site conditions: Redness, swelling or itching at the inj site.
Potentially Fatal: Severe hypersensitivity reactions (including anaphylaxis); prolonged and severe hypoglycaemia; hypokalaemia.

Parenteral: B

This drug may cause an impaired ability to concentrate and react due to hypoglycaemia, if affected, do not drive or operate machinery. Continuously rotate inj sites within the same body region to lower the risk of inj site reactions.

Monitor blood glucose; HbA_1c (at least twice a year in patients with stable glycaemic control and are meeting treatment goals; quarterly in patients who have not met treatment goals or with change in therapy); renal and hepatic function, electrolytes and weight. Assess for signs and symptoms of hypoglycaemia.

Symptoms: Hypoglycaemia (may be associated with headache, listlessness, confusion, sweating, palpitations, and vomiting) and hypokalaemia. Management: Administer oral glucose or sugar products to treat mild hypoglycaemia. For moderately severe hypoglycaemia, administer IM or SC glucagon and then give oral carbohydrate once the patient has sufficiently recovered. IV glucose solution may be given if the patient fails to respond to glucagon or if glucagon is not available. After clinical recovery, sustained carbohydrate intake and observation may be needed. Provide appropriate correction of hypokalaemia.

May cause dose-related fluid retention that may result in or exacerbate cardiac failure with PPAR-γ agonists including thiazolidinediones (e.g. pioglitazone). May reduce blood glucose lowering effect with oral contraceptives, corticosteroids, thyroid hormones, isoniazid, phenothiazines, danazol, and β₂ stimulants (e.g. ritodrine, salbutamol, terbutaline). Increased risk of hypoglycaemia with oral hypoglycaemic agents, salicylates (e.g. aspirin), sulfonamide antibiotics, certain antidepressants (e.g. MAOIs, SSRIs), pramlintide, certain ACE inhibitors (e.g. captopril, enalapril), ARBs, β-blockers, and octreotide.

Increased risk of hypoglycaemia with alcohol.

Description:
Mechanism of Action: Insulin lispro and insulin lispro protamine is a fixed combination of a rapid-acting insulin analogue (insulin lispro) and an intermediate-acting insulin analogue (insulin lispro protamine) which primarily regulates the metabolism of glucose. It stimulates the peripheral glucose uptake by the skeletal muscle and fat and inhibits the hepatic glucose production, thus lowering blood glucose levels. Additionally, it prevents lipolysis and proteolysis and enhances the synthesis of protein.
Synonym(s): Biphasic insulin lispro.
Onset: 0.25-0.5 hours.
Duration: 14-24 hours.
Pharmacokinetics:
Absorption: Undergoes 2 phases of absorption: Rapid onset of insulin lispro (early phase); prolonged absorption of insulin lispro protamine (late phase). Time to peak plasma concentration: 0.75-13.5 hours (50% insulin lispro/50% insulin lispro protamine); 0.5-4 hours (25% insulin lispro/75% insulin lispro protamine).

Unopened vial/pen/cartridge: Store between 2-8°C. Do not freeze. Protect from excessive heat and direct light. Opened (in-use) pen/cartridge: Store below 30°C for up to 28 days. Do not refrigerate or freeze. Opened (in-use) vial: Store between 2-8°C or below 30°C for up to 28 days. Do not freeze. Protect from excessive heat and direct light. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Insulin Preparations

A10AD04 - insulin lispro ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.

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Anon. Insulin Lispro. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/04/2024.

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Humalog Mix 25 100 units/mL KwikPen Suspension for Injection in a Pre-filled Pen (Eli Lilly Nederland B.V.). MHRA. https://products.mhra.gov.uk. Accessed 29/02/2024.

Humalog Mix 25 and Mix 50 KwikPen Injection (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 29/02/2024.

Humalog Mix 50/50 Injection, Suspension; Humalog Mix 50/50 KwikPen Injection, Suspension (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/02/2024.

Insulin Lispro; Insulin Lispro Protamine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 16/04/2024.

Joint Formulary Committee. Biphasic Insulin Lispro. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/02/2024.