Usage
Ofloxacin + Serratiopeptidase is prescribed for bacterial infections accompanied by inflammation. This includes conditions like respiratory tract infections (e.g., pneumonia, bronchitis), urinary tract infections, skin and soft tissue infections, and post-surgical inflammation.
- Pharmacological Classification: Antibiotic (Ofloxacin) and proteolytic enzyme (Serratiopeptidase)
- Mechanism of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication and repair, ultimately leading to bacterial cell death. Serratiopeptidase breaks down proteins at the inflammation site, reducing swelling and pain.
Alternate Names
This combination drug does not have an International Nonproprietary Name (INN). It is known by various brand names such as Aviflox ST, Floxzen ST, and others, which vary based on the region and manufacturer.
How It Works
- Pharmacodynamics: Ofloxacin kills bacteria by inhibiting their DNA replication. Serratiopeptidase reduces inflammation by breaking down proteins like bradykinin, fibrin, and histamine, which contribute to inflammation.
- Pharmacokinetics:
- Ofloxacin: Well-absorbed orally, reaching therapeutic levels in various tissues and fluids. It is metabolized minimally in the liver and excreted primarily through the kidneys.
- Serratiopeptidase: Absorbed in the intestines and distributed systemically. Its metabolic pathways are not fully understood.
- Mode of Action:
- Ofloxacin: Binds to DNA gyrase and topoisomerase IV, disrupting DNA replication and transcription, leading to bacterial cell death.
- Serratiopeptidase: Enzymatically cleaves peptide bonds in inflammatory proteins, thereby resolving the inflammatory response.
- Elimination Pathways:
- Ofloxacin: Primarily renal excretion, with some hepatic metabolism.
- Serratiopeptidase: Unknown.
Dosage
Standard Dosage
Adults:
The usual dose is 200mg Ofloxacin + 15mg Serratiopeptidase every 12 hours. The duration of treatment varies depending on the infection, generally from 3-14 days, but can extend up to 6 weeks for prostatitis.
Children:
This combination is contraindicated in children and growing adolescents due to the risk of cartilage damage from Ofloxacin, and a lack of clear safety and efficacy data for Serratiopeptidase.
Special Cases:
- Elderly Patients: Dose adjustment is often necessary based on renal and hepatic function. Close monitoring is required due to an increased risk of side effects.
- Patients with Renal Impairment: Dose reduction is required based on creatinine clearance.
- Patients with Hepatic Dysfunction: Dose adjustments may be necessary, and liver function tests should be monitored.
- Patients with Comorbid Conditions: Caution is advised in patients with conditions like diabetes, cardiovascular disease, seizures, and myasthenia gravis, as Ofloxacin can exacerbate these.
Clinical Use Cases
Dosage for the combination remains consistent across clinical settings and is primarily guided by the severity and type of infection being treated. Specific clinical adjustments are not routinely recommended for use in intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dosage modifications are necessary for patients with renal or hepatic impairment. Consult current clinical guidelines for specific recommendations.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness. Skin reactions, such as rash or itching, may also occur.
Rare but Serious Side Effects
Tendon rupture (Ofloxacin), severe allergic reactions (anaphylaxis), peripheral neuropathy (Ofloxacin), seizures (Ofloxacin), Clostridium difficile-associated diarrhea.
Long-Term Effects
Potential for cartilage damage with prolonged Ofloxacin use, especially in children. Long-term effects of Serratiopeptidase are largely unknown due to lack of long-term study data.
Adverse Drug Reactions (ADR)
Tendonitis or tendon rupture, especially in elderly patients or those taking corticosteroids, requires immediate discontinuation of the drug. Severe skin reactions (e.g., Stevens-Johnson syndrome), anaphylaxis, and Clostridium difficile infection represent potentially life-threatening ADRs.
Contraindications
Hypersensitivity to Ofloxacin, Serratiopeptidase, or any quinolone antibiotic. History of tendon disorders related to quinolone use, myasthenia gravis, pregnancy, breastfeeding, and in children and growing adolescents.
Drug Interactions
Antacids, sucralfate, iron supplements, multivitamins, and dairy products can reduce Ofloxacin absorption. Ofloxacin can interact with warfarin, theophylline, NSAIDs, and some antiarrhythmic drugs. Serratiopeptidase may increase the risk of bleeding, especially when taken with anticoagulants.
Pregnancy and Breastfeeding
Ofloxacin is contraindicated during pregnancy and breastfeeding due to potential risks to the fetus and infant. Serratiopeptidase’s safety during pregnancy and breastfeeding is not established.
Drug Profile Summary
- Mechanism of Action: Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV. Serratiopeptidase: Breaks down inflammatory proteins.
- Side Effects: Nausea, vomiting, diarrhea, tendon rupture (Ofloxacin), skin reactions (Serratiopeptidase).
- Contraindications: Hypersensitivity, tendon disorders related to quinolones, myasthenia gravis, pregnancy, breastfeeding, children.
- Drug Interactions: Antacids, iron, warfarin, theophylline, NSAIDs.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: 200mg Ofloxacin + 15mg Serratiopeptidase every 12 hours. Children: Contraindicated.
- Monitoring Parameters: Renal and hepatic function, signs of tendonitis, hypersensitivity reactions.
Popular Combinations
There are no established popular fixed-dose combinations that specifically include Ofloxacin and Serratiopeptidase together with other drugs. In clinical practice, the combined formulation is usually prescribed by itself, with adjunctive medications prescribed separately as needed.
Precautions
- General Precautions: Evaluate renal and hepatic function. Assess for history of tendon disorders. Monitor for hypersensitivity reactions. Avoid prolonged sun exposure due to Ofloxacin’s photosensitizing potential.
- Specific Populations: Pregnant and breastfeeding women: Contraindicated. Children and elderly: Use with caution and adjust dose as needed.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ofloxacin + Serratiopeptidase?
A: Adults: 200mg Ofloxacin + 15mg Serratiopeptidase every 12 hours. Children: Contraindicated. Dose adjustment may be needed for elderly patients and those with renal or hepatic dysfunction.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, and skin reactions are common side effects.
Q3: Can this combination be used during pregnancy or breastfeeding?
A: No, it’s contraindicated in both pregnancy and breastfeeding due to potential risks to the fetus/infant.
Q4: What are the serious side effects to watch out for?
A: Tendon rupture, severe allergic reactions, peripheral neuropathy, and seizures are rare but serious side effects.
Q5: What are the contraindications to using this medication?
A: Hypersensitivity, history of tendon disorders with quinolones, myasthenia gravis, pregnancy, breastfeeding, and childhood are contraindications.
Q6: What drugs interact with Ofloxacin + Serratiopeptidase?
A: Antacids, iron, warfarin, theophylline, NSAIDs, and some antiarrhythmic medications can interact with this combination.
Q7: What are the long-term safety concerns?
A: Cartilage damage with prolonged Ofloxacin use, especially in children, is a concern. Long-term effects of Serratiopeptidase are not well-studied.
Q8: What precautions should be taken while prescribing this combination?
A: Evaluate renal and hepatic function, assess for tendon disorders, monitor for hypersensitivity, avoid prolonged sun exposure, and counsel about drug interactions.
Q9: How does Serratiopeptidase affect Ofloxacin’s action?
A: Serratiopeptidase can synergistically enhance Ofloxacin’s antibacterial action by reducing biofilm formation and improving tissue penetration of the antibiotic in some infections.
Q10: What is the role of Serratiopeptidase in this combination?
A: Serratiopeptidase primarily adds anti-inflammatory and anti-edema effects, helping reduce swelling and pain associated with infection.
