Insulin Aspart-Szjj is a medicine sold in the U.S. under 2 brand and generic names, for type 1 diabetes mellitus, type 2 diabetes mellitus and hyperglycemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Merilog (application BLA761325). Other insulin aspart-szjj products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
See Full Prescribing Information for important preparation, administration, and dosage instructions ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ). Subcutaneous injection ( 2.2 ): Inject subcutaneously within 5–10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm. Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Should generally be used in regimens with an intermediate- or long-acting insulin. Individualize and adjust the dosage of MERILOG based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.3 ). Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness ( 2.3 ). 2.1 Important Preparation and Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4) ]. Inspect MERILOG visually before use. It should appear clear and colorless. Do not use MERILOG if particulate matter or coloration is seen. Use MERILOG SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose. 2.2 Preparation and Administration Instructions for the Approved Routes of Administration…
The following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions observed with insulin aspart products include: hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The safety of insulin aspart was evaluated in two treat-to-target trials of 6 months duration, conducted in patients with type 1 diabetes or type 2 diabetes [see Clinical Studies (14) ] . The data in Table 1 reflect the exposure of 596 patients with type 1 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks. The mean age was 39 years. Fifty-one percent were male, 94% were Caucasian, 2% were Black and 4% were other races. The…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Injectable | — | — | View → | |
| 2 | 70/100 | Prescription | Injectable | — | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
MERILOG is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.3) ]. In patients with hypersensitivity to insulin aspart products or any of the excipients in MERILOG [see Warnings and Precautions (5.5) ]. During episodes of hypoglycemia ( 4 ). Hypersensitivity to insulin aspart products or any of the excipients in MERILOG.( 4 ).
The table below presents clinically significant drug interactions with MERILOG. Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when MERILOG is concomitantly administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of MERILOG Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when MERILOG is concomitantly administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of MERILOG Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Pentamidine may cause hypoglycemia, which may sometimes be…