Lipo-B
Injections

Important Safety Information

Lipo-B

Important Safety Information Regarding Compounded Lipo-B ProductsPlease be aware that compounded drugs are not FDA-approved and do not undergo the same clinical studies as FDA-approved, commercially available products. Compounded products may still be legally prescribed, and your healthcare provider may issue you a prescription for compounded Lipo-B based on your medical consultation.What is Lipo-B?Lipo-B (sometimes called “B-Complex Lipotropic”) is an injectable formulation that typically contains a high-potency blend of B-vitamins—most commonly:

• Cyanocobalamin (Vitamin B12)
• Thiamine (Vitamin B1)
• Riboflavin (Vitamin B2)
• Niacinamide (Vitamin B3)
• Pyridoxine (Vitamin B6)
• Dexpanthenol (Vitamin B5)

Some pharmacies may include additional nutrients (e.g., L-carnitine or inositol). These components are intended to support energy metabolism, red-blood-cell formation, and overall nutritional status when combined with a balanced diet and regular physical activity.Speak with your healthcare provider to see if Lipo-B may be right for you.Lipo-B may cause serious side effects, including:• 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 hereditary eye disorders such as Leber’s optic neuropathy (high-dose B12 may precipitate optic atrophy).• Peripheral neuropathy with prolonged high-dose pyridoxine (B6).• Liver toxicity or significant flushing with large niacinamide doses.Who should not use Lipo-B:• Do not use Lipo-B if you are allergic to any B-vitamin or other component of the formulation.• Do not use Lipo-B if you have a history of Leber’s optic neuropathy.• Do not use Lipo-B if you have severe liver disease or active peptic ulcer disease without provider clearance.• Do not use Lipo-B if you are pregnant or breastfeeding unless your provider determines the benefits outweigh the risks.Before starting Lipo-B, tell your healthcare provider if you have any other medical conditions, including if you:• Have or have had liver or kidney problems.• Have cardiovascular disease, elevated homocysteine, or gout.• Have peripheral neuropathy or sensory disorders.• Are taking any prescription medications, over-the-counter medicines, vitamins, or herbal supplements. Specific drug interactions may include:

• Levodopa – efficacy may be reduced by high-dose pyridoxine unless combined with carbidopa.
• Phenytoin or phenobarbital – folate and other B-vitamins can alter serum levels; monitor as directed.
• Alcohol – chronic use can impair B-vitamin absorption and heighten liver risk.

Serious side effects can occur with Lipo-B. You or a caregiver should carefully monitor for these side effects, especially at the start of treatment and after dosage changes.The most common side effects of Lipo-B may include: injection-site redness, swelling, or soreness; mild flushing or warmth; nausea; headache; dizziness; fatigue; transient diarrhea or upset stomach.If you are experiencing a medical emergency, call 911 or seek immediate medical attention.You are encouraged to report negative side effects of prescription products:Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatchLipo-B administration. The medication is self-administered as a subcutaneous or intramuscular injection in the abdomen, thigh, or upper arm—typically once weekly, unless otherwise directed by your provider. Inject slowly over 20–30 seconds and rotate injection sites to minimize irritation. Maximum dose: 1 mL per injection unless instructed differently. Do not change your dosing regimen or stop taking Lipo-B without first discussing with your healthcare provider.This information is not comprehensive. Please discuss any questions or concerns with your healthcare provider.

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