Apidra (insulin glulisine) - Sanofi Canada

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Post-Market Adverse Drug Reactions Other: Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine. DRUG INTERACTIONS Overview Drug-Drug Interactions The following are examples of potential drug-drug interactions that may occur with APIDRA treatment: Page 16 of 61
Table 5- Established or Potential Drug-Drug Interactions Proper name Ref Effect Clinical comment Oral antidiabetic agents Theoretical May enhance May require close monitoring of blood ACE inhibitors the blood- glucose level and dose adjustment Disopyramide glucose (reduction) of APIDRA Fibrates lowering effect Fluoxetine and increase MAO inhibitors susceptibility to Pentoxifylline Propoxyphene Salicylates Sulfonamide antibiotics hypoglycemia Corticosteroids Theoretical May reduce the May require close monitoring of blood Danazol blood-glucose- glucose level and dose adjustment Diazoxide Diuretics Glucagon Isoniazid Estrogens and progestogens (e.g. in oral contraceptives) Phenothiazine derivatives Somatropin Sympathomimetic agents (e.g. epinephrine, salbutamol, terbutaline) Protease inhibitors Atypical antipsychotic medications (e.g. olanzapine and clozapine) lowering effect. (increase or decrease) of APIDRA Somatostatin analogs Theoretical May enhance May require close monitoring of blood Thyroid hormones or decrease the glucose level and dose adjustment insulin requirements (increase or decrease) of APIDRA Alcohol Theoretical May either May require close monitoring of blood Beta-blockers potentiate or glucose level and dose adjustment Clonidine weaken the (increase or decrease) of APIDRA Lithium salts blood-glucoselowering effect of insulin Pentamidine Theoretical May cause May require close monitoring of blood hypoglycemia, glucose level and dose adjustment which may sometimes be followed by hyperglycemia (increase or decrease) of APIDRA Page 17 of 61
Page 1 and 2: PRODUCT MONOGRAPH APIDRA ® insulin
Page 3 and 4: PRODUCT MONOGRAPH APIDRA ® insulin
Page 5 and 6: PHARMACOLOGY). APIDRA given by subc
Page 7 and 8: Hyperglycemia: The use of too low i
Page 9 and 10: and reduced insulin metabolism, sim
Page 11 and 12: Occupational Hazards The patient’
Page 13 and 14: Table 2 - Number (percentage) of pe
Page 15: Table 4 - Common (≥1%) Adverse Dr
Page 19 and 20: APIDRA should be administered by su
Page 21 and 22: ACTION AND CLINICAL PHARMACOLOGY Ph
Page 23 and 24: Table 7. Pharmacokinetic and Pharma
Page 25 and 26: gender did not show differences in
Page 27 and 28: Opened APIDRA SoloSTAR should not b
Page 29 and 30: glargine followed by randomization.
Page 31 and 32: treatment regimens. No differences
Page 33 and 34: TOXICOLOGY Single and Repeated Dose
Page 35 and 36: Table 14: Reproductive & Developmen
Page 37 and 38: Table 15: Reproductive & Developmen
Page 39 and 40: PART III: CONSUMER INFORMATION APID
Page 41 and 42: INTERACTIONS WITH THIS MEDICATION O
Page 43 and 44: 12. Make sure the tip of the needle
Page 45 and 46: Hyperglycemia Hyperglycemia (too mu
Page 47 and 48: MORE INFORMATION Your physician, ph
Page 49 and 50: APIDRA should be given within 15 mi
Page 51 and 52: Do not take a double dose to make u
Page 53 and 54: history of diabetes, or in patients
Page 55 and 56: MORE INFORMATION Your physician, ph
Page 57 and 58: efore or within 20 minutes after st
Page 59 and 60: Preparing the Dose 1. To avoid medi
Page 61: • redness, itching, swelling, or

Apidra (insulin glulisine) - Sanofi Canada

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