Lantus XR

Lantus XR

insulin glargine

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Insulin glargine
Indications/Uses
DM in adults, adolescents & childn ≥6 yr.
Dosage/Direction for Use
SC Individualized dosage. Once daily at any time of the day, preferably at the same time every day. Patient w/ type 2 DM Initially 0.2 U/kg followed by individual adjustments.
Contraindications
Special Precautions
Not for IV administration. Not the insulin of choice for the treatment of diabetic ketoacidosis. Hyper- or hypoglycaemic episodes. Perform continuous inj site rotation to reduce the risk of developing lipodystrophy & cutaneous amyloidosis. Intensify blood glucose & metabolic monitoring. Caution in patients in whom hypoglycaemic episodes might be of clinical relevance (eg, patients w/ significant stenoses of the coronary arteries or of the blood vessels supplying the brain as well as in patients w/ proliferative retinopathy, particularly if not treated w/ photocoagulation; patients w/ diminished warning symptoms of hypoglycaemia (eg, patients in whom glycaemic control is markedly improved, in whom hypoglycaemia develops gradually, elderly, after transfer from animal to human insulin, in whom an autonomic neuropathy is present, w/ a long history of DM, suffering from a psychiatric illness, receiving concurrent certain medications). Prolonged effect may delay recovery from hypoglycaemia. Increased susceptibility to hypoglycaemia in case of change in inj area; improved insulin sensitivity; unaccustomed, increased or prolonged physical activity; intercurrent illness; inadequate food intake; missed meals; alcohol consumption; certain uncompensated endocrine disorders; concomitant treatment w/ certain other medicinal products. Switching between insulin glargine & other insulins w/ Lantus XR requires strict medical supervision. Intercurrent illness. May cause insulin Abs to form. Prolonged effect may delay recovery from hypoglycaemia.Reports of cardiac failure w/ pioglitazone, especially in patients w/ risk factors for development of cardiac heart failure; if the combination is used, patients should be observed for signs & symptoms of heart failre, wt gain & oedema. Discontinue concomitant use w/ pioglitazone if any deterioration in cardiac symptoms occur. Insulin label must always be checked before each inj to avoid medication errors. May impair ability to concentrate & react when driving or using machines. Hepatic & renal impairment. Maintain good metabolic control during pregnancy in women w/ preexisting or gestational diabetes. Decrease insulin requirements during 1st trimester & generally increase during 2nd & 3rd trimesters. Lactation. Childn <6 yr. Elderly ≥65 yr.
Adverse Reactions
Hypoglycaemia. Lipohypertrophy; inj site reactions.
Drug Interactions
Enhanced blood-glucose-lowering effect & increased susceptibility to hypoglycaemia w/ anti-hyperglycaemics, ACE inhibitors, disopyramides, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates & sulfonamide antibiotics. Reduced blood-glucose-lowering effect w/ corticosteroids, danazol, diazoxide, diuretics, glucagon, INH, oestrogens & progestogens, phenothiazine derivatives, somatropin, sympathomimetics (eg, epinephrine, salbutamol, terbutaline), thyroid hormones, atypical antipsychotics (eg, clozapine, olanzapine), PIs. Potentiated or weakened blood-glucose-lowering effect w/ β-blockers, clonidine, lithium salts or alcohol. Hypoglycemia may sometimes followed by hyperglycemia w/ pentamidine. Reduced or absent signs of adrenergic counter-regulation w/ sympatholytics eg, β-blockers, clonidine, guanethidine, reserpine.
MIMS Class
Insulin Preparations
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Form
Lantus XR soln for inj 300 U/mL
Packing/Price
(pre-filled pen) 1.5 mL x 5 × 1's (Rp2,014,900/boks)
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