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Soliqua 100/33

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Overview

What is Soliqua 100/33?

SOLIQUA 100/33 (insulin glargine and lixisenatide injection), for subcutaneous use, is a combination of a long-acting basal insulin analog, insulin glargine, and a GLP-1 receptor agonist, lixisenatide.

Each SOLIQUA 100/33 prefilled single-patient disposable pen contains 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL of solution contains 100 units insulin glargine and 33 mcg lixisenatide.

SOLIQUA 100/33 contains the following inactive ingredients (per mL): 3 mg of methionine, 2.7 mg of metacresol, 20 mg of glycerol, 30 mcg of zinc, hydrochloric acid, sodium hydroxide and water for injection.



What does Soliqua 100/33 look like?



What are the available doses of Soliqua 100/33?

Injection: 100 units of insulin glargine per mL and 33 mcg of lixisenatide per mL in a 3 mL single-patient use pen. ()

What should I talk to my health care provider before I take Soliqua 100/33?

How should I use Soliqua 100/33?

SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide.

Limitations of Use:

The following are important dosing information for SOLIQUA 100/33, a combination of insulin glargine and lixisenatide:

Table 1 presents the units insulin glargine and the micrograms of lixisenatide in each dosage of SOLIQUA 100/33.


What interacts with Soliqua 100/33?

Sorry No Records found


What are the warnings of Soliqua 100/33?

Sorry No Records found


What are the precautions of Soliqua 100/33?

Sorry No Records found


What are the side effects of Soliqua 100/33?

Sorry No records found


What should I look out for while using Soliqua 100/33?

SOLIQUA 100/33 is contraindicated:


What might happen if I take too much Soliqua 100/33?


How should I store and handle Soliqua 100/33?

Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Protect from light. Discard after the expiration date printed on the label. SOLIQUA 100/33 should not be stored in the freezer and should not be allowed to freeze. Discard SOLIQUA 100/33 if it has been frozen.After first use, store at room temperature below 77°F (25°C). Replace the pen cap after each use to protect from light.Discard pen 28 days after first use.Always remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached. This prevents contamination and/or infection, or leakage of the SOLIQUA 100/33 pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Protect from light. Discard after the expiration date printed on the label. SOLIQUA 100/33 should not be stored in the freezer and should not be allowed to freeze. Discard SOLIQUA 100/33 if it has been frozen.After first use, store at room temperature below 77°F (25°C). Replace the pen cap after each use to protect from light.Discard pen 28 days after first use.Always remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached. This prevents contamination and/or infection, or leakage of the SOLIQUA 100/33 pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Protect from light. Discard after the expiration date printed on the label. SOLIQUA 100/33 should not be stored in the freezer and should not be allowed to freeze. Discard SOLIQUA 100/33 if it has been frozen.After first use, store at room temperature below 77°F (25°C). Replace the pen cap after each use to protect from light.Discard pen 28 days after first use.Always remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached. This prevents contamination and/or infection, or leakage of the SOLIQUA 100/33 pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Protect from light. Discard after the expiration date printed on the label. SOLIQUA 100/33 should not be stored in the freezer and should not be allowed to freeze. Discard SOLIQUA 100/33 if it has been frozen.After first use, store at room temperature below 77°F (25°C). Replace the pen cap after each use to protect from light.Discard pen 28 days after first use.Always remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached. This prevents contamination and/or infection, or leakage of the SOLIQUA 100/33 pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Protect from light. Discard after the expiration date printed on the label. SOLIQUA 100/33 should not be stored in the freezer and should not be allowed to freeze. Discard SOLIQUA 100/33 if it has been frozen.After first use, store at room temperature below 77°F (25°C). Replace the pen cap after each use to protect from light.Discard pen 28 days after first use.Always remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached. This prevents contamination and/or infection, or leakage of the SOLIQUA 100/33 pen, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612Potassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted “001” on the cap and body, packaged as follows:Unit dose packages of 100 (10 x 10) NDC 68084-419-01Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] PACKAGING INFORMATIONAmerican Health Packaging unit dose blisters (see How Supplied section) contain drug product fromZydus Pharmaceuticals (USA) Inc. as follows:[750 mg (10 mEq) / 100 UD] NDC 68084-419-01 packaged from NDC 68382-701Packaged and Distributed by:American Health PackagingColumbus, OH 432178241901/0612


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
SOLIQUA 100/33 is contraindicated:

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see ).

In clinical trials of lixisenatide, a component of SOLIQUA 100/33, there have been cases of anaphylaxis (frequency of 0.1% or 10 cases per 10,000 patient-years) and other serious hypersensitivity reactions including angioedema. Severe, life-threatening, generalized allergic reactions, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock can occur with insulins, including insulin glargine, a component of SOLIQUA 100/33 .

Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis with lixisenatide. SOLIQUA 100/33 is contraindicated in patients with known hypersensitivity to lixisenatide or insulin glargine . If a hypersensitivity reaction occurs, the patient should discontinue SOLIQUA 100/33 and promptly seek medical attention.

The following adverse reactions are discussed elsewhere:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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