Insulin human, isophane

Dosage adjustment may be required.

Dosage adjustment may be required.

Hypersensitivity. Episodes of hypoglycaemia.

Patient with adrenal, pituitary or thyroid disease; ongoing illness, emotional disturbance, or those who have changes in their physical activity or usual diet. Early warning symptoms of hypoglycaemia may be different or less pronounced in patients with long-standing diabetes, intensified insulin therapy, diabetic nerve disease, or in those who switched from animal-source insulin to human insulin. Renal and hepatic impairment. Children. Pregnancy and lactation.

Significant: Lipoatrophy or lipohypertrophy, localised cutaneous amyloidosis at the inj site, development of antibodies.
General disorders and administration site conditions: Redness, swelling, and itching at inj site.
Investigations: Weight gain.
Metabolism and nutrition disorders: Na retention, oedema.
Potentially Fatal: Hypersensitivity reactions (including anaphylaxis); hypoglycaemia, hypokalaemia.

IM/Parenteral/SC: B

This drug may cause hypoglycaemia which may reduce your ability to concentrate and react; if affected, do not drive or operate machinery.

Monitor plasma glucose (typically before meals and snacks and at bedtime; additional monitoring if needed); electrolytes, HbA_1c (at least twice yearly in patients who have stable glycaemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with change in therapy); renal and hepatic function, weight; signs and symptoms of hypoglycaemia or hypokalaemia. Monitor serum K and supplement K if needed.

Symptoms: Hypoglycaemia (may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting), hypokalaemia. Management: Oral administration of glucose or sugar products in case of mild hypoglycaemia. Correction of moderately severe hypoglycaemic episodes can be achieved by IM or SC administration of glucagon, followed by oral carbohydrate upon patient recovery. IV glucose solution may be given to patients who fail to respond to glucagon. For a comatose patient, administer IM or SC glucagon; if glucagon is not available or if the patient fails to respond to glucagon, an IV glucose solution must be given. After clinical recovery, sustained carbohydrate intake and observation may be needed. Treat hypokalaemia appropriately.

Concomitant use with peroxisome proliferator-activated receptor (PPAR)-γ agonists (e.g. thiazolidinediones) may result in dose-related fluid retention leading to heart failure. Increased risk of hypoglycaemia with other antidiabetic agents, salicylates, sulfonamide antibiotics, MAOIs, fluoxetine, disopyramide, fibrates, pentoxifylline, ACE inhibitors, angiotensin II receptor blockers, somatostatin analogues (e.g. octreotide). Reduced blood glucose lowering effects with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g. epinephrine, salbutamol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, thyroid hormones. Increased or decreased blood glucose lowering effect with β-blockers, clonidine and lithium salts. β-blockers, clonidine, guanethidine and reserpine may blunt the signs and symptoms of hypoglycaemia.

Increased or decreased blood glucose lowering effect with alcohol.

Description:
Mechanism of Action: Insulin human, isophane is an intermediate-acting, sterile suspension of zinc insulin crystals and protamine sulfate. It acts by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production thereby lowering blood glucose levels. It also inhibits lipolysis and proteolysis, and enhances protein synthesis.
Synonym: neutral protamine Hagedorn (NPH) insulin.
Onset: 1-2 hours.
Duration: 14-24 hours.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 6-10 hours.
Distribution: Enters breast milk.
Metabolism: Metabolised mainly in the liver, kidney, muscle, and adipocytes.
Excretion: Via urine.

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

Insulin

A10AC01 - insulin (human) ; Belongs to the class of intermediate-acting insulins and analogues. Used in the treatment of diabetes.

Anon. Insulin Human. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 29/10/2021.

Anon. Insulin Isophane [Insulin NPH]. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/10/2021.

Buckingham R (ed). Insulin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/10/2021.

Eli Lilly and Company (NZ) Limited. Humulin R (Regular), 100 IU/mL, Solution for Injection; Humulin NPH, 100 IU/mL, Suspension for Injection; Humulin 30/70, 100 IU/mL, Suspension for Injection data sheet 30 October 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 29/10/2021.

Humulin I (Isophane) 100 IU/mL Suspension for Injection in Cartridge (Eli Lilly Nederland B.V.). MHRA. https://products.mhra.gov.uk. Accessed 29/10/2021.

Humulin I (Isophane) 100 IU/mL Suspension for Injection in Vial (Eli Lilly and Company Limited). MHRA. https://products.mhra.gov.uk. Accessed 29/10/2021.

Humulin N Cartridge (Eli Lilly Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 29/10/2021.

Humulin N Injection, Suspension (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/10/2021.

Joint Formulary Committee. Isophane Insulin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/10/2021.

Novolin N Injection, Suspension (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/10/2021.