Insulin Recombinant Human is a medicine sold in the U.S. under 2 brand and generic names. 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 Novolin R (application BLA019938). Other insulin recombinant human products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
See Full Prescribing Information for important administration instructions. ( 2.1 ) • Subcutaneous injection: inject subcutaneously 30 minutes before a meal into the abdominal area, buttocks, thigh or the upper arm. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) • Intravenous use: administer intravenously ONLY under medical supervision at concentrations from 0.05 unit/mL to 1 unit/mL in infusion systems using polypropylene infusion bags. ( 2.2 ) • Individualize dose based on route of administration, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) • NOVOLIN R given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin. ( 2.3 ) • Can be mixed with NOVOLIN N. ( 2.5 ) 2.1 Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. • Inspect NOVOLIN R visually before use. It should appear clear and colorless. Do not use NOVOLIN R if particulate matter or coloration is seen. • Use of NOVOLIN R in insulin pumps is not recommended because of the risk of precipitation. 2.2 Route of Administration Subcutaneous Administration • Inject NOVOLIN R subcutaneously approximately 30 minutes prior to the start of a meal into the abdominal area, buttocks,…
The following adverse reactions are also discussed elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • 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 from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLIN R. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Adverse reactions associated with insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypersensitivity reactions Severe, life-threatening, generalized allergy, including anaphylaxis. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in NOVOLIN R. Hypokalemia NOVOLIN R can cause a shift in potassium from 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 | Over-the-counter | Injectable | — | — | View → | |
| 2 |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
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.
NOVOLIN R is contraindicated: • During episodes of hypoglycemia • In patients with hypersensitivity to NOVOLIN R or any of its excipients • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to NOVOLIN R or any of its excipients ( 4 )
Table 1: Clinically Significant Drug Interactions with NOVOLIN R 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 NOVOLIN R is co-administered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of NOVOLIN R 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 NOVOLIN R is co-administered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLIN R Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be…
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