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  • Lantus
    (insulin glargine (rDNA origin))

    THERAPEUTIC CLASS

    Insulin

    DEA CLASS

    RX

    INDICATIONS

    To improve glycemic control in patients with type 1 diabetes mellitus (DM) and in adults with type 2 DM.

    ADULT DOSAGE

    Adults: Individualize dose. Inject SQ qd at same time every day. Type 1 DM: Initial: 1/3 of total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of daily insulin requirements. Type 2 DM not Currently Treated with Insulin: Initial: 10 U (or 0.2 U/kg) qd. Adjust according to blood glucose measurements. Switching from QD NPH Insulin: Initial: Same as NPH dose being discontinued. Switching from BID NPH Insulin: Initial: 80% of the total NPH dose being discontinued. Renal/Hepatic Impairment: May need to reduce dose. Elderly: Dose conservatively.

    PEDIATRIC DOSAGE

    Pediatrics: ≥6 Yrs: Individualize dose. Inject SQ qd at same time every day. Type 1 DM: Initial: 1/3 of total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of daily insulin requirements. Adjust according to blood glucose measurements. Switching from QD NPH Insulin: Initial: Same as NPH dose being discontinued. Switching from BID NPH Insulin: Initial: 80% of the total NPH dose being discontinued. Renal/Hepatic Impairment: May need to reduce dose.

    ADMINISTRATION

    SQ route. Rotate inj sites within the same region (abdomen, thigh, or deltoid) from one inj to the next. Do not mix or dilute with any other insulin or sol. Refer to PI for further preparation, handling, and administration instructions.

    HOW SUPPLIED

    Inj: 100 U/mL [3mL SoloStar, 10mL vial]

    WARNINGS/PRECAUTIONS

    Not recommended for the treatment of diabetic ketoacidosis. Must be used in regimens with short-acting insulin in patients with type 1 DM. Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in need for a change in insulin dose or adjustment in concomitant oral antidiabetic treatment. Not for IV use or via an insulin pump. Do not share disposable or reusable insulin devices or needles between patients; may carry a risk for transmission of blood-borne pathogens. Hypoglycemia may occur; caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (eg, pediatric population, patients who fast or have erratic food intake). Hypoglycemia may impair ability to concentrate and react. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Careful glucose monitoring and dose adjustments may be necessary with renal/hepatic impairment. Not recommended during periods of rapidly declining renal/hepatic function. Caution in elderly.

    ADVERSE REACTIONS

    Hypoglycemia, allergic reactions, upper respiratory tract infection, peripheral edema, HTN, influenza, sinusitis, cataract, bronchitis, arthralgia, infection, pain in extremities, back pain, cough, urinary tract infection.

    DRUG INTERACTIONS

    May require dose adjustment and close monitoring with drugs that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia (eg, oral antidiabetic drugs, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, propoxyphene, pentoxifylline, salicylates, somatostatin analogs, sulfonamide antibiotics), drugs that may decrease the blood-glucose-lowering effect (eg, corticosteroids, niacin, danazol, diuretics, sympathomimetics [eg, epinephrine, albuterol, terbutaline], glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens [eg, in oral contraceptives], protease inhibitors, atypical antipsychotics [eg, olanzapine, clozapine], or drugs that may either potentiate or weaken the blood-glucose-lowering effect (β-blockers, clonidine, lithium salts, alcohol). Pentamidine may cause hypoglycemia, sometimes followed by hyperglycemia. Signs of hypoglycemia may be reduced or absent with sympatholytics (eg, β-blockers, clonidine, guanethidine, reserpine). Fluid retention and heart failure (HF) can occur with concomitant use of thiazolidinediones; observe for signs/symptoms of HF and consider dose discontinuation/reduction of thiazolidinedione if HF develops.

    PREGNANCY AND LACTATION

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Insulin glargine (rDNA origin); regulates glucose metabolism. Lowers blood glucose by stimulating peripheral glucose uptake and by inhibiting hepatic glucose production. Inhibits lipolysis and proteolysis, and enhances protein synthesis.

    PHARMACOKINETICS

    Metabolism: M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin) (active metabolites).

    ASSESSMENT

    Assess for diabetic ketoacidosis, predisposition to hypoglycemia, hypersensitivity, renal/hepatic impairment, pregnancy/nursing status, and possible drug interactions. Obtain baseline blood glucose and HbA1c levels.

    MONITORING

    Monitor for signs/symptoms of hypoglycemia, allergic reactions, and other adverse reactions. Monitor blood glucose and HbA1c levels.

    PATIENT COUNSELING

    Inform about potential side effects (eg, lipodystrophy, weight gain, allergic reactions, hypoglycemia). Inform that hypoglycemia may impair ability to concentrate and react; advise to use caution when driving or operating machinery. Instruct to always check the label before each inj to avoid medication errors. Advise to use only if sol is clear and colorless with no particles visible. Advise not to share disposable or reusable insulin devices or needles with other patients. Instruct on self-management procedures, including glucose monitoring, proper inj technique, and management of hypoglycemia and hyperglycemia, and on handling of special situations, such as intercurrent conditions, inadequate or skipped dose, inadvertent administration of increased insulin dose, inadequate food intake, and skipped meals. Advise to inform physician if pregnant or contemplating pregnancy.

    STORAGE

    Do not freeze; discard if the vial has been frozen. Unopened: 2-8°C (36-46°F) until expiration date. Open (In-Use): 2-8°C (36-46°F) or ≤30°C (86°F) for vials and <30°C (86°F) for SoloStar. Discard after 28 days. Protect from direct heat and light. Do not refrigerate opened (in-use) SoloStar.