Usage
Roxithromycin + Serratiopeptidase is prescribed for bacterial infections, especially those affecting the respiratory tract (bronchitis, pneumonia, sinusitis, tonsillitis), skin and soft tissue, dental infections (e.g., periodontitis), and otitis media (middle ear infection). It may also be used off-label for chronic inflammatory airway conditions like COPD.
Pharmacological Classification:
- Roxithromycin: Macrolide antibiotic
- Serratiopeptidase: Proteolytic enzyme
Mechanism of Action:
Roxithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, which prevents bacterial growth and multiplication. Serratiopeptidase breaks down proteins that cause inflammation and fluid buildup, reducing swelling, pain, and mucus secretion.
Alternate Names
While Roxithromycin + Serratiopeptidase is a common generic name, some alternative names include Roxithromycin and Serratiopeptidase. Some brand names it is marketed under include Roxidase, Roksri SP, Roxid S, Curox S, and Satrox SP. More brand names may exist internationally.
How It Works
Pharmacodynamics: Roxithromycin exerts its antibacterial effect by inhibiting bacterial protein synthesis. Serratiopeptidase reduces inflammation by breaking down proteins causing swelling and fluid accumulation.
Pharmacokinetics:
- Roxithromycin: Absorbed orally, achieving peak plasma concentrations within 2 hours. Metabolized in the liver and excreted primarily in bile and feces, with a small amount in urine.
- Serratiopeptidase: Absorbed orally, it forms a complex with alpha-2-macroglobulin in the blood, masking its antigenicity while retaining some enzymatic activity. It is then transported to the target sites where it exerts its anti-inflammatory effect. Eliminated via renal/hepatic routes.
Mode of Action: Roxithromycin binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis. Serratiopeptidase acts as a proteolytic enzyme, cleaving peptide bonds in proteins involved in inflammation.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Roxithromycin targets bacterial ribosomes. Serratiopeptidase inhibits inflammatory mediators.
Dosage
Standard Dosage
Adults:
150 mg Roxithromycin + 10 mg Serratiopeptidase twice daily or 300 mg Roxithromycin + 20 mg Serratiopeptidase once daily.
Children:
- 6-40 kg: 5-8 mg/kg Roxithromycin daily, divided into two doses.
- ≥40 kg: Same as adult dose.
Not recommended for children under 6 years of age.
Special Cases:
- Elderly Patients: No specific dose adjustments, but caution is advised in those with comorbidities.
- Patients with Renal Impairment: Careful monitoring is recommended, particularly in severe renal dysfunction. Dose adjustment is usually not necessary.
- Patients with Hepatic Dysfunction: Patients with severe hepatic impairment (e.g., cirrhosis) should have their roxithromycin dose reduced, typically to 150 mg once daily.
- Patients with Comorbid Conditions: Dosage adjustments may be necessary. Careful assessment is required.
Clinical Use Cases
The dosage for clinical use cases such as intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined on a case-by-case basis considering the specific circumstances and patient condition. Typically follows standard dosage guidelines.
Dosage Adjustments
Dose modifications may be necessary based on individual patient factors (e.g., renal/hepatic dysfunction, metabolic disorders, drug interactions).
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, stomach pain, headache, rash, loss of appetite.
Rare but Serious Side Effects:
Acute pancreatitis, allergic reactions (rash, itching, swelling, shortness of breath), Clostridium difficile associated diarrhea, Stevens-Johnson Syndrome, hepatic dysfunction, QT prolongation.
Long-Term Effects:
Potential for Candida overgrowth with prolonged use.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis, angioedema), severe skin reactions, hepatotoxicity.
Contraindications
Hypersensitivity to roxithromycin, serratiopeptidase, or macrolide antibiotics; Severe hepatic impairment; Concomitant use with vasoconstrictive ergot alkaloids; Co-administration with drugs that prolong the QT interval and are metabolized by CYP3A4 (e.g., terfenadine, astemizole, cisapride). Myasthenia gravis.
Drug Interactions
Roxithromycin can interact with theophylline, warfarin, ergot alkaloids, digoxin, midazolam, triazolam, some antiarrhythmics (e.g., disopyramide, amiodarone, quinidine), cyclosporine, tacrolimus. Serratiopeptidase can interact with anticoagulants (e.g., warfarin, clopidogrel) and antiplatelet medications.
Pregnancy and Breastfeeding
Roxithromycin is classified as Pregnancy Category B. It is not recommended unless clearly needed. Roxithromycin is excreted in breast milk, so caution is advised during breastfeeding. The effects of serratiopeptidase during pregnancy and breastfeeding aren’t well-established.
Drug Profile Summary
- Mechanism of Action: Roxithromycin: Inhibits bacterial protein synthesis. Serratiopeptidase: Reduces inflammation.
- Side Effects: Nausea, vomiting, diarrhea, allergic reactions, QT prolongation, hepatotoxicity.
- Contraindications: Hypersensitivity, severe hepatic impairment, concomitant use with ergot alkaloids and some CYP3A4 substrates.
- Drug Interactions: Theophylline, warfarin, ergot alkaloids, cyclosporine, and anticoagulants.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Adults: 150 mg Roxithromycin + 10 mg Serratiopeptidase twice daily or 300 mg Roxithromycin + 20 mg Serratiopeptidase once daily. Children: Weight based dosing.
- Monitoring Parameters: Liver function tests, ECG (for QT prolongation), signs of superinfection.
Popular Combinations
Roxithromycin is sometimes combined with ambroxol. There is no information about serratiopeptidase’s popular combination with other medications besides Roxithromycin.
Precautions
Assess for allergies, hepatic/renal function, and cardiac conditions before initiating therapy. Monitor for adverse drug reactions. *Caution in patients with myasthenia gravis. * Avoid alcohol due to increased drowsiness. * May impair ability to drive.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Roxithromycin + Serratiopeptidase?
A: Adults: 150 mg Roxithromycin + 10 mg Serratiopeptidase twice daily or 300 mg Roxithromycin + 20 mg Serratiopeptidase once daily. Children: 5-8 mg/kg Roxithromycin daily in two divided doses (6-40kg), same as adult dose if over 40kg.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, abdominal pain, and headache.
Q3: What are the serious side effects?
A: Allergic reactions, liver dysfunction, QT prolongation.
Q4: What are the contraindications?
A: Hypersensitivity to roxithromycin, serratiopeptidase, or macrolides; severe hepatic impairment; concomitant use of ergot alkaloids, astemizole, cisapride.
Q5: Can it be used in pregnancy?
A: Use with caution only if the benefits outweigh the risks. Consult a specialist.
Q6: Can it be used during breastfeeding?
A: Roxithromycin passes into breast milk. Consult a specialist for risk/benefit assessment.
Q7: What if a dose is missed?
A: Take the missed dose as soon as remembered unless it is close to the next dose. Do not double the dose.
Q8: Does it interact with other medications?
A: Yes. It can interact with theophylline, warfarin, and certain other medications. Inform your doctor about all other medications being taken.
Q9: Can it cause diarrhea?
A: Yes, diarrhea is a possible side effect. If diarrhea becomes severe or persistent, consult a doctor.
Q10: Should the medication be stopped as soon as I feel better?
A: No, complete the entire prescribed course even if symptoms improve to prevent recurrence and antibiotic resistance.
