Usage
- Acetylcysteine + Pyridoxamine dihydrochloride is prescribed for the management of chronic kidney disease (CKD), particularly in patients with diabetes and hypertension. It helps to slow the progression of CKD and protect kidney function. It also finds use as an antidote for paracetamol poisoning.
- Pharmacological Classification: This combination acts as a nutritional supplement and a nephroprotective agent.
- Mechanism of Action: Acetylcysteine functions as an antioxidant, scavenging free radicals and protecting kidney tissues from oxidative damage. Pyridoxamine dihydrochloride, a form of vitamin B6, inhibits the formation of advanced glycation end products (AGEs), which contribute to the progression of diabetic nephropathy. It also acts as a coenzyme in fat, carbohydrate, and protein metabolism, thus helping to maintain energy balance in CKD patients.
Alternate Names
- While “Acetylcysteine + Pyridoxamine dihydrochloride” is the generic name, there isn’t an internationally recognized alternate name.
- Brand Names: Nefrosave Forte, Renosave Forte, Stylecystin Forte.
How It Works
- Pharmacodynamics: Acetylcysteine’s antioxidant effect helps to protect kidney cells from damage. Pyridoxamine dihydrochloride, by inhibiting AGEs formation, reduces inflammation and fibrosis in the kidneys, thereby slowing disease progression. It also assists in nutrient metabolism.
- Pharmacokinetics:
- Absorption: Acetylcysteine is absorbed orally, while pyridoxamine dihydrochloride’s absorption varies.
- Metabolism: Acetylcysteine is extensively metabolized in the liver, forming cysteine, its active metabolite, and other metabolites like N,N-diacetylcysteine and N-acetylcysteine. Pyridoxamine is converted to pyridoxal phosphate, the active form of vitamin B6.
- Elimination: Acetylcysteine metabolites are primarily excreted in the urine.
- Mode of Action: At the cellular level, acetylcysteine increases glutathione levels, which plays a crucial role in cellular defense against oxidative stress. Pyridoxamine inhibits the formation of AGEs by trapping reactive carbonyl intermediates. The combination works synergistically to protect kidney function.
Dosage
Due to the limited information, providing detailed dosage guidelines for different clinical scenarios is not possible. Dosage should be individualized based on patient characteristics and clinical response.
Standard Dosage
Adults:
Consult the prescribing information for a particular brand, as there isn’t a globally standardized dosage. As per some sources, one tablet containing 300mg of Acetylcysteine and 50-75mg of Pyridoxamine Dihydrochloride once or twice daily. However, it’s crucial to consult your healthcare provider.
Children:
Limited information is available on pediatric dosing. Safety and efficacy have not been established in children younger than two years of age for CKD treatment. The dosage in children should be determined by a doctor.
Special Cases:
- Elderly Patients, Patients with Renal/Hepatic Impairment & Patients with Comorbid Conditions: Limited information is available on dosage adjustments for elderly patients or those with renal or hepatic impairment. Careful monitoring and individualised dosing are necessary in these populations.
Clinical Use Cases & Dosage Adjustments:
Specific dosage recommendations for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations aren’t established for this drug combination.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain, rash, itching, upset stomach, drowsiness.
Rare but Serious Side Effects:
Allergic reactions (difficulty breathing, chest tightness, swelling of face, lips, tongue), severe skin reactions.
Long-Term Effects & ADR:
Limited data exists on long-term adverse effects.
Contraindications
- Hypersensitivity to acetylcysteine or pyridoxamine dihydrochloride.
- Children under two years of age.
- Conditions where caution is necessary: Asthma, stomach ulcers, liver disease.
Drug Interactions
- Levodopa, isoniazid, activated charcoal, penicillamine, aminoglycoside antibiotics (gentamicin, streptomycin, tobramycin, amikacin), penicillin, tetracycline, glyceryl trinitrate.
- High potassium or phosphate intake.
Pregnancy and Breastfeeding
- Pregnancy: Caution is advised. Consult a physician if considering use during pregnancy.
- Breastfeeding: Caution is advised. Consult a physician before using while breastfeeding.
Drug Profile Summary
(See above for a summary of mechanism of action, side effects, contraindications, drug interactions, pregnancy and breastfeeding safety, and dosage.)
- Monitoring Parameters: Monitor kidney function tests (e.g., eGFR, creatinine), liver function tests, electrolytes.
Popular Combinations & Precautions:
No established or recommended combinations for this particular mix are known at the moment.
FAQs
Q1: What is the recommended dosage for Acetylcysteine + Pyridoxamine dihydrochloride?
A: The standard dosage isn’t universally established. Refer to brand-specific information or consult a doctor. Typically, one tablet (300 mg acetylcysteine + 50-75mg pyridoxamine dihydrochloride) once or twice daily.
Q2: How does this drug combination work in CKD?
A: Acetylcysteine provides antioxidant protection to kidney cells, while pyridoxamine dihydrochloride inhibits AGE formation and supports metabolic processes.
Q3: Is it safe to use this combination in pregnant or breastfeeding women?
A: Caution is advised. Consult a doctor before using it during pregnancy or while breastfeeding.
Q4: What are the common side effects?
A: Nausea, vomiting, diarrhea, and abdominal pain are among the reported side effects.
Q5: Are there any serious drug interactions?
A: Yes, potential interactions exist with various drugs like levodopa, isoniazid, and certain antibiotics. Consult a doctor for details regarding your specific medications.
Q6: Can this combination be used in children?
A: Its use is generally not recommended for children under two years of age for the treatment of CKD. Limited information is available on pediatric dosing for other uses.
Q7: What should patients be monitored for while on this medication?
A: Patients should be monitored for changes in kidney function, liver function, and electrolyte levels.
Q8: Is there a specific diet that patients should follow while taking this medication?
A: Patients with CKD are generally advised to follow a low-protein, isocaloric diet. Consult a dietician or healthcare professional for specific dietary recommendations.
Q9: What should a patient do if they miss a dose?
A: If a dose is missed, take it as soon as remembered. However, if it is close to the time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose.
