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

Indications

Alpha-Lipogamma 600 mg solution is indicated for:

• Treatment of diabetic polyneuropathy with symptoms such as burning, tingling, or pain in the limbs
• Supportive therapy in chronic liver conditions, such as hepatitis and fatty liver disease
• Reduction of oxidative stress in neurological disorders
• Adjunct therapy in metabolic syndrome and insulin resistance

Dosage and Administration

• Route of administration: Intravenous infusion
• Recommended dose: 1 ampoule (600 mg) daily
• Dilution: Must be diluted in 250 ml of 0.9% sodium chloride solution before use
• Infusion time: Minimum 30 minutes to reduce the risk of adverse reactions
• Course duration: Typically 2 to 4 weeks, followed by oral maintenance therapy

Contraindications

• Hypersensitivity to alpha-lipoic acid or any excipients
• Pediatric use (under 18 years old)
• Pregnancy and breastfeeding unless directed by a physician

Precautions and Warnings

• Use cautiously in diabetic patients due to risk of hypoglycemia
• Alcohol consumption reduces the efficacy of treatment and should be avoided
• Monitor glucose levels regularly in diabetic patients
• Use in severe renal or hepatic impairment requires close monitoring
• Administer only by qualified medical personnel

Adverse Effects

• Local: Pain, redness, or swelling at injection site
• Neurological: Metallic taste, headache, dizziness
• Gastrointestinal: Nausea, vomiting (rare)
• Allergic reactions: Rash, urticaria, very rarely anaphylaxis
• Metabolic: Hypoglycemia in patients on antidiabetic medications

Drug Interactions

• May enhance the effects of insulin and oral antidiabetic agents
• Should not be taken simultaneously with metal-containing supplements (e.g., iron, magnesium)
• Inform your doctor of all medications and supplements being used

Pregnancy and Lactation

Use only if clearly needed and prescribed by a healthcare provider. Safety during pregnancy and lactation has not been firmly established.

Overdose

Signs of overdose may include:

• Nausea, vomiting, dizziness
• Severe cases: Lactic acidosis, hypoglycemia, seizures

Immediate medical attention is necessary. Hospitalization and supportive care may be required.

Storage

• Store at 15–25°C (59–77°F)
• Protect from light and do not freeze
• Keep in original packaging
• Keep out of reach of children

Scientific References

• Alpha-lipoic acid in the treatment of diabetic neuropathy – PubMed
• Pharmacological effects of alpha-lipoic acid – NCBI

Patient Information

Alpha-Lipogamma 600 mg injection should only be used under medical supervision as part of a prescribed treatment plan. Do not self-administer. Follow all instructions provided by healthcare professionals and report any unusual symptoms or side effects immediately. Regular monitoring and follow-up are recommended during therapy.