Humulin N
Generic: INSULIN HUMAN
Basic Information
Manufacturer
Eli Lilly and Company
Product Type
HUMAN OTC DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
f6edd793-440b-40c2-96b5-c16133b7a921
Indications & Usage
1 INDICATIONS AND USAGE HUMULIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
HUMULIN ® N is an intermediate-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
( 1 )
HUMULIN ® N is an intermediate-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: 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 )] .
The following additional adverse reactions have been identified during post-approval use of HUMULIN N.
Because 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 observed with HUMULIN N include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain, and edema.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Allergic Reactions Some patients taking HUMULIN N have experienced erythema, local edema, and pruritus at the site of injection.
These conditions were usually self-limiting.
Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions ( 5.5 )] .
Peripheral Edema Some patients taking HUMULIN N have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy Administration of insulin subcutaneously, including HUMULIN N, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.2 )] in some patients.
Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Weight gain Weight gain has occurred with insulins, including HUMULIN N, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Immunogenicity Development of antibodies that react with human insulin have been observed with all insulins, including HUMULIN N.
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 )] .
The following additional adverse reactions have been identified during post-approval use of HUMULIN N.
Because 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 observed with HUMULIN N include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, weight gain, and edema.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Allergic Reactions Some patients taking HUMULIN N have experienced erythema, local edema, and pruritus at the site of injection.
These conditions were usually self-limiting.
Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions ( 5.5 )] .
Peripheral Edema Some patients taking HUMULIN N have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy Administration of insulin subcutaneously, including HUMULIN N, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.2 )] in some patients.
Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Weight gain Weight gain has occurred with insulins, including HUMULIN N, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Immunogenicity Development of antibodies that react with human insulin have been observed with all insulins, including HUMULIN N.