Insulin Glargine Solostar 100 [iU]/mL

insulin glargine · INJECTION, SOLUTION · A-S Medication Solutions

No Recall HistoryCurrently in Shortage

Plain English

Insulin Glargine Solostar is a injection, solution containing insulin glargine at 100 [iU]/mL, taken subcutaneous. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name: Insulin Glargine Solostar
Generic Name: insulin glargine
NDC Code (Product): 50090-6178
Manufacturer: A-S Medication Solutions
Strength: 100 [iU]/mL
Dosage Form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Marketing Status
Application #: BLA021081
Drug Class: Insulin Analog [EPC]
Marketing Start: 05/02/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Insulin glargine is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Insulin glargine is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for treating diabetic ketoacidosis. ( 1 ) Limitations of Use Insulin glargine is not recommended for the treatment of diabetic ketoacidosis.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ( 2.1 , 2.3 , 2.4 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) Closely monitor glucose when changing to Insulin glargine and during initial weeks thereafter. ( 2.4 ) 2.1 Important Administration Instructions Administer Insulin glargine subcutaneously once daily at any time of day but at the same time every day. Prior to initiation of Insulin glargine, train patients on proper use and injection technique. Patient should follow the Instructions for Use to correctly administer Insulin glargine. Administer Insulin glargine subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystroph…

Contraindications

4 CONTRAINDICATIONS Insulin glargine is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions (5.3) ] in patients with hypersensitivity to Insulin glargine or one of its excipients [see Warnings and Precautions (5.5) ] During episodes of hypoglycemia ( 4 ) Hypersensitivity to Insulin glargine or one of its excipients ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 8 includes clinically significant drug interactions with Insulin glargine. Table 8: Clinically Significant Drug Interactions with Insulin Glargine 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 analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention : Dose reductions and increased frequency of glucose monitoring may be required when Insulin glargine is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of Insulin Glargine 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 increases and increased frequency of glucose monitoring may be required when Insulin glargine is coadministered with …

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions (5.3) ] Hypersensitivity and allergic reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions commonly associated with Insulin glargine include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. ( 6.1 ) 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 conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The data in Table 1 reflect the exposure of 2327 patients with type 1 diabetes to Insulin glargine or NPH. The type 1 diabetes population had the following characteristics: Mean age was 38.5 years. Fifty-four percent were male, 96.9% were Caucasian, 1.8% were Black or African American and 2.7% were Hispanic. The mean BMI was 25.1 k…

Frequently Asked Questions

What is Insulin Glargine Solostar used for?

Insulin Glargine Solostar contains insulin glargine. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is Insulin Glargine Solostar a controlled substance?

Insulin Glargine Solostar is not classified as a controlled substance by the DEA.

What is the generic name for Insulin Glargine Solostar?

The generic name for Insulin Glargine Solostar is insulin glargine. There are 12 other brand versions of insulin glargine.

What is the NDC code for Insulin Glargine Solostar 100 [iU]/mL?

The NDC (National Drug Code) for Insulin Glargine Solostar 100 [iU]/mL is 50090-6178, listed by A-S Medication Solutions.

Product NDC

50090-6178

Package NDC

50090-6178-0

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

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