Adult: Dosage is individualised based on patient metabolic needs, blood glucose monitoring results, and goal in glycaemic control. Administer dose once daily at the same time each day. In insulin-naive patients with type 2 diabetes mellitus: Initially, 0.2 units/kg once daily followed by individual dose adjustments. Switching from insulin glargine 300 units/mL to 100 units/mL: Reduce dose by approx 20%. Switching from insulin glargine 100 units/mL to 300 units/mL: May be done on a unit-unit basis but a higher 300 units/mL dose (approx 10-18%) may be necessary. Switching from other basal insulins: May be done on a unit-unit basis based on the previous basal insulin dose (once-daily basal insulin) or initiate insulin glargine at 80% of the total daily dose of basal insulin (twice-daily basal insulin). Dosage recommendations may vary among countries and individual products (refer to detailed product guideline). Child: ≥2 years Treatment recommendations may vary among countries and individual products (refer to detailed product or local treatment guidelines).
Dose reduction may be necessary.
Dose reduction may be necessary.
Hypersensitivity. Episodes of hypoglycaemia.
Patient with risk factors for hypoglycaemia (e.g. changes in inj area, level of physical activity, pattern of meal times, or concomitant medications), significant stenosis of coronary arteries or blood vessels supplying the brain, proliferative retinopathy (particularly if untreated with photocoagulation), intercurrent illness. Symptoms of hypoglycaemia may be less pronounced in patients in whom glycaemic control is markedly improved or with recurrent hypoglycaemia, diabetic nerve disease, long history of diabetes, or suffering from psychiatric illness; who switched from animal insulin to human insulin; receiving sympathetic nervous system blockers (e.g. β-blockers). Insulin glargine 100 units/mL and 300 units/mL are not bioequivalent and are not directly interchangeable. Not indicated for the treatment of diabetic ketoacidosis. Renal and hepatic impairment. Not to be administered via IV, IM, or insulin infusion pump. Concomitant use with peroxisome proliferator-activated receptor (PPAR)-γ agonists (including thiazolidinediones). Children and elderly. Pregnancy and lactation.
Significant: Hypoglycaemia, hypokalaemia, insulin antibody development, cutaneous amyloidosis at the inj site. Eye disorders: Rarely, visual impairment, retinopathy, cataract. Gastrointestinal disorders: Diarrhoea. General disorders and administration site conditions: Inj site reactions (e.g. itching, inflammation, hives, pain, redness). Rarely, oedema. Infections and infestations: Infection, influenza. Musculoskeletal and connective tissue disorders: Arthralgia, back pain, limb pain. Nervous system disorders: Headache. Psychiatric disorders: Depression. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, bronchitis, cough, sinusitis, nasopharyngitis. Skin and subcutaneous tissue disorders: Lipohypertrophy, lipoatrophy. Vascular disorders: Hypertension. Potentially Fatal: Prolonged or severe hypoglycaemic episodes, severe allergic reactions (e.g. anaphylaxis).
Patient Counseling Information
This drug may impair the ability to concentrate and react due to hypoglycaemia; if affected, do not drive or operate machinery.
Monitor serum glucose (usually before meals and snacks then at bedtime; additional monitoring may be necessary), HbA1c (at least twice annually in patients with stable glycaemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with treatment change); renal function, LFTs, weight; electrolytes, particularly serum K (in patients at risk for hypokalaemia). Monitor for signs and symptoms of hypoglycaemia at regular intervals during treatment.
Symptoms: Severe and occasionally long-term and potentially fatal hypoglycaemia (e.g. coma, seizure, neurologic impairment); hypokalaemia. Management: Treat mild hypoglycaemic episodes with oral carbohydrates; adjustments in dose, meal patterns, or physical activity may be necessary. In case of severe episodes, administer IM or SC glucagon or concentrated IV glucose. Continuous observation and carbohydrate intake may be needed following clinical recovery from hypoglycaemia. Correct hypokalaemia appropriately.
Concomitant use with PPAR-γ agonists (e.g. pioglitazone) may result in dose-related fluid retention and lead to or exacerbate cardiac failure. May enhance the therapeutic effect and increase the risk of hypoglycaemia with other antihyperglycaemic agents, ACE inhibitors, angiotensin II receptor blockers, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates, somatostatin analogues (e.g. octreotide), and sulfonamide antibiotics. May reduce the therapeutic effect with atypical antipsychotics (e.g. clozapine, olanzapine), corticosteroids, danazol, diuretics, glucagon, nicotinic acid, isoniazid, oral contraceptives (e.g. estrogens and progestogens), phenothiazines, somatropin, sympathomimetic agents (e.g. epinephrine, salbutamol, terbutaline), thyroid hormones, and protease inhibitors. May either enhance or diminish the therapeutic effect with β-blockers, clonidine, lithium salts, pentamidine. Sympatholytic agents (e.g. β-blockers, clonidine, guanethidine, reserpine) may reduce or mask the signs of hypoglycaemia.
May either enhance or diminish the therapeutic effect with alcohol.
Description: Insulin glargine, a long-acting insulin analogue, stimulates peripheral glucose uptake (particularly by skeletal muscle and fat) and inhibits hepatic glucose production, thus reducing blood glucose levels. It prevents lipolysis in the adipocyte, inhibits proteolysis, and increases protein synthesis. Duration: 24 hours (range: 10.8->24 hours). Pharmacokinetics: Absorption: Slowly absorbed. Metabolism: Rapidly and partially metabolised at the carboxyl terminus of the β chain to form 2 active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin), with the M1 metabolite being the principal circulating compound. Excretion: Via urine.
Unopened pen/cartridge/vial: Store between 2-8°C, or below 30°C for 28 days (for pens and vials only). Do not freeze. Protect from light. Opened (in-use) pen/cartridge: Store below 30°C for 28 days. Do not freeze or refrigerate. Protect from heat and light. Opened (in-use) vial: Store between 2-8°C or below 30°C for 28 days. Protect from direct light or heat. Storage recommendations may vary among individual products. Refer to detailed product guideline.
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
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