Insulin human, isophane


Generic Medicine Info
Indications and Dosage
Subcutaneous
Diabetes mellitus
Adult: Dosage is individualised and adjusted according to metabolic needs, blood glucose monitoring results and glycaemic control goals. Dosage adjustments may be necessary when switching from another insulin, during acute illness, or with changes in physical activity, meal patterns, renal or hepatic function, or concurrent medications. Refer to specific product or local treatment guidelines for further information.
Child: Treatment recommendations may vary among individual products and countries (refer to specific product or local treatment guidelines).
Renal Impairment
Dosage adjustment may be required.
Hepatic Impairment
Dosage adjustment may be required.
Contraindications
Hypersensitivity. Episodes of hypoglycaemia.
Special Precautions
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.
Adverse Reactions
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
Patient Counseling Information
This drug may cause hypoglycaemia which may reduce your ability to concentrate and react; if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor plasma glucose (typically before meals and snacks and at bedtime; additional monitoring if needed); electrolytes, HbA1c (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.
Overdosage
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.
Drug Interactions
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.
Food Interaction
Increased or decreased blood glucose lowering effect with alcohol.
Action
Description: 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.
Storage
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).
MIMS Class
Insulin Preparations
ATC Classification
A10AC01 - insulin (human) ; Belongs to the class of intermediate-acting insulins and analogues. Used in the treatment of diabetes.
References
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.

Disclaimer: This information is independently developed by MIMS based on Insulin human, isophane 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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