Adult: Dosage must be individualised and titrated based on the patient’s metabolic needs, blood glucose monitoring results, and goal in glycaemic control. In combination with oral antidiabetics and/or GLP-1 receptor agonists: Initially, 0.1-0.2 units/kg or 10 units once daily. When GLP-1 receptor agonists are added: Reduce dose by 20% to minimise the risk of hypoglycaemia. When used as part of basal-bolus insulin regimen: Give once or twice daily based on the patient's needs. Alternatively, in insulin-naive patients with type 2 cases inadequately controlled on oral antidiabetics or GLP-1 receptor agonists: Initially, 10 units or 0.1-0.2 units/kg once daily in the evening or twice daily. In insulin-naive patients with type 1 cases (must be used concurrently with rapid- or short-acting insulin): General insulin dosing recommendation: Initial total daily dose (TDD) is 0.2-0.4 units/kg daily. Dose adjustments may be necessary with changes in physical activity, meal patterns, renal or hepatic functions or during concomitant/acute illness. Treatment guidelines may vary among countries (refer to product-specific recommendations). Child: Dosage must be individualised and titrated based on the patient's metabolic needs, blood glucose monitoring results, and goal in glycaemic control. Treatment guidelines may vary among countries (refer to product-specific recommendations).
Dose adjustment may be needed.
Dose adjustment may be needed.
May be taken with or without food. For patients treated w/ once daily regimen, administer w/ evening meal or at bedtime. For patients who need twice daily dosing, the evening dose can be administered either w/ the evening meal or at bedtime or 12 hr after the morning dose.
Incompatible with other insulins or solutions, and infusion fluids. May cause degradation with products containing thiols or sulfites.
Chống chỉ định
Hypersensitivity. Episodes of hypoglycaemia.
Patient with risk factors for hypoglycaemia, including changes in meal pattern, level of physical activity, concurrent illness or drugs used; cardiac disease, risk factors for developing heart failure and hypokalaemia (e.g. use of loop diuretics); adrenal, pituitary, or thyroid gland diseases; severe hypoalbuminaemia. Not recommended for use in patients with diabetic ketoacidosis. Not to be administered via IV, IM, or insulin infusion pumps. Renal and hepatic impairment. Children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Hypoglycaemia, hypokalaemia; hyperglycaemia (inadequate dosing or treatment discontinuation in patients with type 1 cases); certain skin and SC tissue disorders (e.g. lipodystrophy, cutaneous amyloidosis), inj site reactions (e.g. redness, pain, inflammation, hives, bruising, swelling, itching). Eye disorders: Refraction disorders, diabetic retinopathy. Gastrointestinal disorders: Abdominal pain, gastroenteritis, nausea, vomiting. General disorders and administration site conditions: Influenza-like illness, fever, oedema. Infections and infestations: Viral infection. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache. Rarely, peripheral neuropathy. Respiratory, thoracic and mediastinal disorders: Pharyngitis, cough, upper respiratory tract infection, bronchitis, rhinitis. Potentially Fatal: Severe and prolonged episodes of hypoglycaemia resulting in unconsciousness, convulsion, or brain damage (temporary or permanent); untreated hypokalaemia leading to respiratory paralysis and ventricular arrhythmia; untreated hyperglycaemia leading to diabetic ketoacidosis (patients with type 1 cases); hypersensitivity reactions, including anaphylaxis.
This drug may impair the patient's ability to concentrate and react due to hypoglycaemia; if affected, do not drive or operate machinery.
Chỉ số theo dõi
Monitor blood glucose (closely monitor in patients with renal or hepatic impairment); electrolytes; HbA1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting treatment goals or treatment change); serum K in patients at risk of hypokalaemia; renal and hepatic function; weight.
Symptoms: Hypoglycaemia and hypokalaemia. Management: For mild hypoglycaemic episodes, give oral glucose or sugary products. For severe hypoglycaemia where the patient is unconscious, administer SC or IM 0.5-1 mg glucagon, or IV concentrated glucose if the patient does not respond to glucagon within 10-15 minutes. Once consciousness is regained, continue monitoring and give oral carbohydrates to prevent a relapse. Correct hypokalaemia as appropriately.
May cause dose-related fluid retention and exacerbate heart failure with peroxisome proliferator-activated receptor (PPAR)-γ agonists, including thiazolidinediones (e.g. pioglitazone). May increase risk of hypoglycaemia with other antidiabetic agents, GLP-1 receptor agonists, ACE inhibitors, β-blockers, angiotensin II receptor blockers, MAOIs, fibrates, salicylates, and sulfonamides. Hypoglycaemic symptoms may be masked by β-blockers, clonidine, guanethidine, reserpine. May reduce hypoglycaemic effects with glucagon, corticosteroids, thyroid hormones, atypical antipsychotics, thiazide diuretics, sympathomimetic agents (e.g. salbutamol, epinephrine, terbutaline), oral contraceptives, and danazol.
Tương tác với thức ăn
May increase or reduce the risk of hypoglycaemia with alcohol.
Description: Insulin detemir is a long-acting recombinant human insulin analogue. It reduces blood glucose by stimulating the uptake of peripheral glucose after the binding of insulin to receptors on skeletal muscle and fat cells, and by inhibiting the release of glucose from the liver. Onset: 3-4 hours. Duration: 6-24 hours (dose-dependent). Pharmacokinetics: Absorption: Absolute bioavailability: Approx 60%. Time to peak plasma concentration: 6-8 hours. Distribution: Volume of distribution: 0.1 L/kg. Plasma protein binding: >98%, mainly albumin. Excretion: Via urine. Terminal elimination half-life: 5-7 hours (dose-dependent).
Unopened pen/cartridge/vial: Store between 2-8°C. Do not freeze. Protect from heat and light. Opened (in-use) pen/cartridge: Store below 30°C for up to 42 days. Do not refrigerate or freeze. Opened (in-use) vial: May be stored between 2-8°C or below 30°C for up to 42 days. Protect from light. Storage recommendations may vary among countries (refer to specific product guidelines).
A10AE05 - insulin detemir ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Tài liệu tham khảo
Anon. Insulin Detemir. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/06/2021.Anon. Insulin Detemir. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/06/2021.Buckingham R (ed). Insulin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/06/2021.Joint Formulary Committee. Insulin Detemir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/06/2021.Levemir FlexPen 100 U/mL, Solution for Injection in Pre-filled Pen (Novo Nordisk Pharma [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/06/2021.Levemir FlexPen 100 units/mL Solution for Injection in Pre-filled Pen (Novo Nordisk A/S). MHRA. https://products.mhra.gov.uk. Accessed 07/06/2021.Levemir Injection, Solution (Novo Nordisk). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/06/2021.Levemir Penfill 100 units/mL Solution for Injection in Cartridge (Novo Nordisk A/S). MHRA. https://products.mhra.gov.uk. Accessed 07/06/2021.