Humalog Mix75/25 100 [iU]/mL

Insulin lispro · INJECTION, SUSPENSION · Eli Lilly and Company

No Recall HistoryCurrently in Shortage

Plain English

Humalog Mix75/25 is a injection, suspension containing insulin lispro at 100 [iU]/mL, taken subcutaneous. Manufactured by Eli Lilly and Company.

Key Facts

Brand Name: Humalog Mix75/25
Generic Name: Insulin lispro
NDC Code (Product): 0002-7511
Manufacturer: Eli Lilly and Company
Strength: 100 [iU]/mL
Dosage Form: INJECTION, SUSPENSION
Route: SUBCUTANEOUS
Marketing Status
Application #: BLA021017
Drug Class: Insulin Analog [EPC]
Marketing Start: 12/22/1999

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood glucose increased36,702 reports

incorrect dose administered8,608 reports

blood glucose decreased8,544 reports

drug ineffective7,839 reports

visual impairment5,218 reports

nausea4,754 reports

malaise3,898 reports

hypoglycaemia3,776 reports

fatigue3,696 reports

drug dose omission3,674 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE HUMALOG Mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. HUMALOG ® Mix75/25™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. ( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. ( 1 ) Limitations of Use : The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important preparation and administration instructions. ( 2.1 ) Inject HUMALOG Mix75/25 subcutaneously (within 15 minutes before a meal) in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 , 2.2 ) Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) Do not administer HUMALOG Mix75/25 intravenously or by a continuous subcutaneous insulin infusion pump. ( 2.1 ) HUMALOG Mix75/25 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). ( 2.2 ) 2.1 Important Preparation and Administration Instructions Preparation Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . HUMALOG Mix75/25 is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature. To resuspend the: vial, carefully invert the vial at least 10 times until the suspension appears uniformly white and cloudy. KwikPen, gently roll the …

Contraindications

4 CONTRAINDICATIONS HUMALOG Mix75/25 is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] in patients who have had hypersensitivity reactions to HUMALOG Mix75/25 or to any of its excipients. [see Warnings and Precautions ( 5.5 )] Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to HUMALOG Mix75/25 or any of its excipients. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 1 below presents clinically significant drug interactions with HUMALOG Mix75/25. Table 1: Clinically Significant Drug Interactions with HUMALOG Mix75/25 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 Mix75/25 is co-administered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of HUMALOG Mix75/25 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 Mix75/25 is co-administered w…

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 )] Adverse reactions observed with HUMALOG Mix75/25 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, edema, pruritus, and rash. ( 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. Adverse Reactions from Clinical Studies or Postmarketing Reports The following adverse reactions have been identified during post-marketing use of HUMALOG Mix75/25. 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 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 a…

Frequently Asked Questions

What is Humalog Mix75/25 used for?

Humalog Mix75/25 contains Insulin lispro. It is a injection, suspension taken subcutaneous. Consult your doctor for specific uses.

Is Humalog Mix75/25 a controlled substance?

Humalog Mix75/25 is not classified as a controlled substance by the DEA.

What is the generic name for Humalog Mix75/25?

The generic name for Humalog Mix75/25 is Insulin lispro. There are 12 other brand versions of Insulin lispro.

What is the NDC code for Humalog Mix75/25 100 [iU]/mL?

The NDC (National Drug Code) for Humalog Mix75/25 100 [iU]/mL is 0002-7511, listed by Eli Lilly and Company.

Product NDC

0002-7511

Package NDC

0002-7511-01

Other Insulin Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)