Drugplain

Humalog 100 [iU]/mL

Insulin lispro · INJECTION, SOLUTION · Eli Lilly and Company

No Recall HistoryCurrently in Shortage
Plain English

Humalog is a injection, solution containing insulin lispro at 100 [iU]/mL, taken intravenous. Manufactured by Eli Lilly and Company.

Key Facts

Brand Name
Humalog
Generic Name
Insulin lispro
NDC Code (Product)
0002-7510
Manufacturer
Eli Lilly and Company
Strength
100 [iU]/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS, SUBCUTANEOUS
Marketing Status
Application #
BLA020563
Drug Class
Insulin Analog [EPC]
Marketing Start
06/14/1996

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 , 2.3 , 2.4 ) Subcutaneous injection ( 2.2 ): Administer HUMALOG ® U-100 or U-200 by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if HUMALOG can be used. Use in accordance with the insulin pump instructions for use. Administer HUMALOG U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. DO NOT administer HUMALOG U-200 by continuous subcutaneous infusion. Intravenous Infusion ( 2.2 ): Administer HUMALOG U-100 by intravenous infusion ONLY after dilution and under medical supervision. DO NOT administer HUMALOG U-200 by intravenous infusion. The dosage of HUMALOG must be individualized based on the route of ad…

Contraindications

4 CONTRAINDICATIONS HUMALOG is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . in patients who are hypersensitive to insulin lispro or to any of the excipients in HUMALOG [see Warnings and Precautions ( 5.5 )] . Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to insulin lispro or any of the excipients in HUMALOG. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS The table below includes clinically significant drug interactions with HUMALOG. 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 HUMALOG is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of HUMALOG 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 HUMALOG is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of HUMALOG Drugs: A…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are 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 associated with HUMALOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) 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. 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 with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% of patients treated with insulin lispro or regular human insulin. The frequencies of adverse reactions during HUMALOG clinical trials in patients with type 1 diabet…

Frequently Asked Questions

What is Humalog used for?

Humalog contains Insulin lispro. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Humalog a controlled substance?

Humalog is not classified as a controlled substance by the DEA.

What is the generic name for Humalog?

The generic name for Humalog is Insulin lispro. There are 10 other brand versions of Insulin lispro.

What is the NDC code for Humalog 100 [iU]/mL?

The NDC (National Drug Code) for Humalog 100 [iU]/mL is 0002-7510, listed by Eli Lilly and Company.

Product NDC

0002-7510

Package NDC

0002-7510-01

Other Humalog Dosages

Other Insulin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)