Lipo-C injection

Important Safety Information

Lipo-C

Please be aware that compounded drugs are not FDA-approved and do not undergo clinical studies to evaluate safety and efficacy, similar to FDA-approved commercially available products. Compounded products may still be legally prescribed, and your healthcare provider may issue you a prescription for compounded Lipo-C based on your medical consultation.

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Lipo-C (sometimes called “MIC + B-Complex”) is a lipotropic injection that typically contains methionine, inositol, choline, and pyridoxine (B6). It is intended to support fat metabolism, energy production, and overall metabolic health when combined with a reduced-calorie diet and increased physical activity.

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Speak with your healthcare provider to see if Lipo-C may be right for you.

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Lipo-C may cause serious side effects, including:

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• Severe allergic reactions (anaphylaxis). Seek emergency care if you develop swelling of the face, lips, tongue, or throat; difficulty breathing; rash; or rapid heartbeat.

• Optic nerve damage in people with certain hereditary eye disorders (e.g., Leber’s optic neuropathy).

• Worsening of gout or high uric acid levels.

• Elevated homocysteine levels, which may increase cardiovascular risk in susceptible individuals.

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Who should not use Lipo-C:

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• Do not use Lipo-C if you are allergic to methionine, inositol, choline, any B-vitamin, or any other component of the formulation.

• Do not use Lipo-C if you have severe liver disease, chronic kidney disease, active peptic ulcer disease, or a history of Leber’s optic neuropathy.

• Do not use Lipo-C if you are pregnant or breastfeeding.

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Before starting Lipo-C, tell your healthcare provider if you have any other medical conditions, including if you:

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• Have or have had problems with your liver or kidneys.

• Have cardiovascular disease, high cholesterol, or elevated homocysteine levels.

• Have gout, hyperuricemia, or a history of kidney stones.

• Have pernicious anemia or folate deficiency.

• Are taking prescription medications, over-the-counter medicines, vitamins, or herbal supplements.

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Serious side effects can occur with Lipo-C. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dosage changes. Lipo-C may cause serious side effects, including those listed above under “Lipo-C may cause serious side effects.”

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The most common side effects of Lipo-C may include: injection-site redness, swelling, or soreness; mild nausea or upset stomach; headache; dizziness; body odor or “fishy” breath (from choline); fatigue.

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If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

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You are encouraged to report negative side effects of prescription products:

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Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

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Lipo-C administration. The medication is self-administered as a subcutaneous or intramuscular injection in the stomach, thigh, or upper arm, typically 1–2 times per week on the same day(s) every week, unless otherwise directed by your provider. Inject slowly over 20–30 seconds and rotate injection sites to reduce irritation. Maximum dose: 1 mL per injection. Do not change your dosing regimen or stop taking Lipo-C as prescribed without first discussing with your healthcare provider.

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This information is not comprehensive. Please discuss with your healthcare provider any questions or concerns you have regarding Lipo-C.

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