Alpha-Lipogamma 600 mg

Description

Alpha-Lipogamma 600 mg Solution for Injection

Manufacturer

• Produced by: Wörwag Pharma GmbH & Co. KG.
• Country of Origin: Germany
• Distributed by: Authorized distributors worldwide.

Composition

• Each 24 ml ampoule contains:
  • Active ingredient: Alpha-lipoic acid – 600 mg.
  • Other ingredients: Trometamol, water for injection, and other excipients for stability.

Indications

Alpha-Lipogamma 600 mg solution is an antioxidant therapy for various conditions associated with oxidative stress and nerve damage. Indications include:

• Treatment of diabetic polyneuropathy, especially with symptoms such as pain, burning, and numbness in the extremities.
• Management of chronic liver diseases, including hepatitis and fatty liver.
• Supportive therapy in neurological conditions where oxidative stress contributes to disease progression.
• Adjunct therapy for conditions involving impaired glucose metabolism or metabolic syndrome.

Dosage and Administration

• Administration route: Intravenous (IV).
• Recommended dosage:
  • 1 ampoule (600 mg) once daily, administered as a slow intravenous infusion.
  • The solution must be diluted with 250 ml of compatible infusion solution (e.g., 0.9% sodium chloride) before administration.
  • Infusion duration should be at least 30 minutes to avoid adverse reactions.
• Duration of therapy: Typically 2-4 weeks of intravenous treatment, followed by oral alpha-lipoic acid therapy for maintenance.

Contraindications

Alpha-Lipogamma is contraindicated in the following cases:

• Known hypersensitivity to alpha-lipoic acid or any other ingredients in the formulation.
• Pediatric use, as safety and efficacy in children under 18 years have not been established.
• Pregnancy and lactation without prior consultation with a healthcare provider.

Precautions and Warnings

• Use with caution in diabetic patients, as alpha-lipoic acid may enhance insulin sensitivity, leading to hypoglycemia. Regular monitoring of blood glucose levels is recommended.
• Avoid alcohol consumption during treatment, as it reduces the efficacy of the therapy.
• Patients with severe renal or hepatic impairment should use this medication under strict medical supervision.
• Intravenous administration should be performed by qualified healthcare professionals to minimize the risk of local reactions or rapid infusion-related side effects.

Adverse Effects

Alpha-Lipogamma is generally well-tolerated. However, some patients may experience mild side effects, including:

• Local reactions: Redness, pain, or swelling at the injection site.
• Neurological effects: Dizziness, headache, or a metallic taste in the mouth.
• Gastrointestinal effects: Nausea or vomiting (rare).
• Allergic reactions: Rash, itching, or anaphylactic reactions (very rare).
• Hypoglycemia: Symptoms like sweating, shakiness, or confusion, particularly in diabetic patients.

Drug Interactions

• Alpha-lipoic acid may enhance the effects of insulin or oral antidiabetic medications, increasing the risk of hypoglycemia. Monitor blood sugar levels closely.
• Avoid simultaneous administration with metal-containing supplements (e.g., iron, magnesium), as alpha-lipoic acid may chelate these ions and reduce their absorption.
• No significant interactions with other medications have been reported, but inform your healthcare provider about all other medications you are taking.

Pregnancy and Lactation

Alpha-Lipogamma should only be used during pregnancy or lactation if the potential benefits outweigh the risks. Consult your healthcare provider for individual recommendations.

Overdose

Symptoms of overdose may include nausea, vomiting, dizziness, or hypoglycemia. Severe cases may lead to lactic acidosis or seizures. Supportive treatment and monitoring in a medical setting are required in case of overdose.

Storage

• Store at a temperature of 15-25°C (59-77°F).
• Protect from light and keep in the original packaging.
• Do not freeze.
• Keep out of reach of children.

Patient Information

Alpha-Lipogamma is intended for use as part of a comprehensive treatment plan under medical supervision. Patients should follow the prescribed dosage and infusion schedule and report any unusual symptoms to their healthcare provider immediately. Do not self-administer this medication.