Usage
- This combination medication is primarily prescribed for age-related hearing loss (presbycusis). It is also used in the treatment of gastritis, gastric ulcers, peptic ulcers, gastroesophageal reflux disease (GERD), and other gastrointestinal conditions. It has shown efficacy in alleviating symptoms of dry eyes and mouth ulcers.
- Pharmacological Classification: Antioxidant, Mucolytic agent, Mucoprotective agent, Cytoprotective agent.
- Mechanism of Action: This combination leverages the antioxidant, mucoprotective, and cytoprotective properties of its individual components. Acetylcysteine and Alpha Lipoic Acid act as antioxidants, scavenging free radicals and protecting cells from oxidative damage. Rebamipide enhances mucus production in the gastrointestinal tract, protecting the mucosa and promoting ulcer healing.
Alternate Names
- Rebagen Otic
- Rebagen-Otic
How It Works
- Pharmacodynamics: Acetylcysteine replenishes glutathione, a vital cellular antioxidant. Alpha Lipoic Acid directly neutralizes free radicals and regenerates other antioxidants like vitamin C and vitamin E. Rebamipide increases prostaglandin E2 in the gastric mucosa, enhances mucus production and mucosal blood flow, reduces inflammation, and stimulates mucosal cell growth.
- Pharmacokinetics:
- Acetylcysteine: Rapidly absorbed orally. Metabolized in the liver. Excreted primarily in the urine.
- Alpha Lipoic Acid: Well-absorbed after oral administration. Metabolized through various pathways, including oxidation and conjugation. Excreted through the kidneys.
- Rebamipide: Peak plasma concentration reached in approximately 2 hours. Minimally metabolized in the liver. Primarily excreted in urine (about 10% as unchanged drug).
- Mode of Action: Acetylcysteine acts as a free radical scavenger. Alpha Lipoic Acid acts as an antioxidant by neutralizing free radicals. Rebamipide increases prostaglandin E2 in the gastric mucosa and elevates gastric mucous, gastric mucosal blood flow and secretion of gastric alkaline. Additionally, it stimulates gastric mucosal cell growth and decreases gastric mucosa injury.
- Receptor binding, enzyme inhibition, or neurotransmitter modulation: Rebamipide inhibits the production of inflammatory cytokines.
Dosage
Standard Dosage
Adults:
- One capsule (containing 100mg of each ingredient) taken twice daily, preferably 30 minutes before meals, or three times daily (morning, evening, and before bedtime). For eye drops: the recommended dose is 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution three to four times a day.
Children:
- Safety and efficacy not established. Use only under strict medical supervision if benefits outweigh risks.
Special Cases:
- Elderly Patients: Caution is advised due to age-related decline in organ function. Close monitoring is recommended. Dose adjustment may not be needed.
- Patients with Renal Impairment: Use with caution. Dosage adjustments may be necessary.
- Patients with Hepatic Dysfunction: Use with caution. Dosage adjustments may be necessary.
- Patients with Comorbid Conditions: Adjustments may be required based on the specific comorbid conditions.
Clinical Use Cases
Dosage recommendations for specific clinical use cases are not explicitly defined in the current literature.
Dosage Adjustments
Dose adjustments may be needed in patients with renal or hepatic impairment, based on individual patient characteristics and clinical response.
Side Effects
Common Side Effects
- Constipation
- Nausea
- Vomiting
- Stomach upset
- Bloating
- Diarrhea
- Dizziness
- Headache
- Rash
- Itching
- Anaphylactoid reactions (eczema, rash, itching, and hives)
Rare but Serious Side Effects
- Anaphylactoid reactions (severe cases)
- Hypoglycemia (low blood sugar)
- Severe vomiting, including blood or coffee-ground appearance
- Severe abdominal pain
- Jaundice
Long-Term Effects
Long-term effects are not well-established in the current medical literature.
Adverse Drug Reactions (ADR)
- Anaphylaxis
- Severe hypoglycemia
Contraindications
- Known hypersensitivity or allergy to any component of the medication
- Asthma
- Pregnancy (unless benefits clearly outweigh risks)
- Breastfeeding (unless benefits clearly outweigh risks)
Drug Interactions
- Antibiotics (e.g., erythromycin, rifampicin)
- Nitroglycerin
- Antimalarials (e.g., chloroquine)
- Antihypertensives (e.g., ACE inhibitors, ARBs, calcium channel blockers)
- Anticoagulants (e.g., warfarin, heparin)
- NSAIDs (e.g., ibuprofen, naproxen)
- Antidiabetic drugs (e.g., insulin)
- Levothyroxine
- Anticancer drugs (e.g., gemcitabine)
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C (Use with caution if benefits outweigh risks.)
- Limited data is available on the effects during pregnancy and breastfeeding. Consult with a physician to assess the risks and benefits.
Drug Profile Summary
- Mechanism of Action: Antioxidant, mucoprotective, cytoprotective.
- Side Effects: Constipation, nausea, vomiting, stomach upset, bloating, diarrhea, dizziness, headache, rash, itching. Rare but serious: anaphylaxis, hypoglycemia, severe vomiting, jaundice.
- Contraindications: Hypersensitivity, asthma, pregnancy (unless benefits outweigh risks), breastfeeding (unless benefits outweigh risks).
- Drug Interactions: Numerous drug interactions, including antibiotics, nitroglycerin, antihypertensives, anticoagulants, NSAIDs, antidiabetic drugs, levothyroxine, and anticancer drugs.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Adults: One capsule twice or three times daily. Dosage adjustments may be needed based on individual conditions. Pediatric use not established.
- Monitoring Parameters: Monitor for allergic reactions, gastrointestinal issues, liver function, kidney function, blood glucose, and signs of bleeding.
Popular Combinations
Combinations with other medications may be used based on specific clinical needs.
Precautions
- General Precautions: Pre-screening for allergies, asthma, liver disease, and kidney disease.
- Specific Populations: Use cautiously in pregnant or breastfeeding women, children, and the elderly.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Acetylcysteine + Alpha Lipoic Acid + Rebamipide?
A: The standard adult dosage is one capsule (containing 100mg of each ingredient) twice or three times daily, preferably 30 minutes before meals.
Q2: What are the common side effects?
A: Common side effects include constipation, nausea, vomiting, stomach upset, bloating, dizziness, and headache.
Q3: Can this combination be used in children?
A: The safety and efficacy in children have not been established. Use only if the benefits outweigh the potential risks and under strict medical supervision.
Q4: What are the serious side effects to watch for?
A: Serious side effects can include severe allergic reactions, hypoglycemia, severe vomiting, and jaundice.
Q5: What should patients with kidney or liver disease do?
A: Patients with renal or hepatic impairment should use this combination with caution. Dosage adjustments may be necessary. Consult a physician.
A: No, it does not cure age-related hearing loss. It helps manage symptoms by protecting ear cells from damage.
Q7: What are the drug interactions I should be aware of?
A: This combination interacts with a wide range of medications. Inform your physician about all medications you are currently taking, including over-the-counter drugs and supplements.
Q8: Can I take this medication if I am pregnant or breastfeeding?
A: It is generally recommended to avoid this medication during pregnancy and breastfeeding unless specifically advised by a physician. The potential benefits must clearly outweigh the risks.
Q9: How should this medication be taken?
A: Take the capsules orally with a glass of water, preferably 30 minutes before a meal. Do not crush or chew the capsules. For eye drops: instill 3 to 5 mL of the 20% solution or 6 to 10 mL of the 10% solution three to four times a day.
Q10: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose.
