Usage
Ofloxacin + Tinidazole is a combination antibiotic used to treat various bacterial and protozoal infections, including:
- Bacterial infections: Urinary tract infections, lower respiratory tract infections (including pneumonia and bronchitis), gonorrhea, and certain skin infections.
- Protozoal Infections: Amebiasis (including amebic dysentery and liver abscess), giardiasis, trichomoniasis, and bacterial vaginosis.
Pharmacological Classification: Antibiotic (fluoroquinolone and nitroimidazole combination).
Mechanism of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair. Tinidazole interferes with protozoal DNA synthesis and causes DNA strand breakage, leading to cell death.
Alternate Names
This combination is not widely known by a specific international nonproprietary name (INN). It is usually identified by the names of its components (Ofloxacin and Tinidazole).
Brand Names: Tiniflox, StayHappi Ofloxacin+Tinidazole, and numerous other regional brand names.
How It Works
Pharmacodynamics: Ofloxacin acts primarily on bacterial DNA replication, leading to bacterial cell death. Tinidazole disrupts protozoal DNA and is also effective against some anaerobic bacteria.
Pharmacokinetics:
- Absorption: Both drugs are well-absorbed orally. Food may slightly delay the absorption of Ofloxacin but does not significantly affect its bioavailability.
- Metabolism: Ofloxacin is partially metabolized in the liver. Tinidazole is primarily metabolized in the liver through oxidation and glucuronidation.
- Elimination: Ofloxacin is excreted primarily through the kidneys. Tinidazole is excreted primarily in the urine, with small amounts excreted in feces.
- Elimination pathways: Ofloxacin - Renal excretion; Tinidazole - Hepatic metabolism, renal excretion.
Dosage
Standard Dosage
Adults:
The usual adult dose is one tablet of Ofloxacin 200 mg + Tinidazole 600 mg twice daily for varying durations, depending on the infection being treated. Treatment durations can range from a single dose for certain infections like giardiasis or trichomoniasis to up to several weeks for prostatitis.
Children:
Ofloxacin is generally avoided in children and adolescents due to the risk of cartilage damage. Tinidazole dosing in children is weight-based and should be determined by a physician. For giardiasis, a typical pediatric dose of tinidazole is 50 mg/kg (up to 2 g) once daily for 3 days.
Special Cases:
- Elderly Patients: Dosage adjustment may be necessary based on renal function.
- Patients with Renal Impairment: Dosage adjustments are required based on creatinine clearance.
- Patients with Hepatic Dysfunction: Dosage adjustments may be required for Ofloxacin in cases of severe hepatic impairment.
- Patients with Comorbid Conditions: Close monitoring and dose adjustments are required in those with epilepsy, QT prolongation risk, or other conditions that may affect drug metabolism.
Clinical Use Cases
Dosing for these specific clinical scenarios should be tailored according to the individual patient’s condition and the specific infection being treated. Consult authoritative clinical guidelines for appropriate dosing recommendations in these cases.
- Intubation: Not specifically indicated.
- Surgical Procedures: Not routinely used for surgical prophylaxis.
- Mechanical Ventilation: Not specifically indicated.
- Intensive Care Unit (ICU) Use: Dosing will be dependent upon the specific infection and patient characteristics.
- Emergency Situations: The combination is not typically used for emergency situations.
Dosage Adjustments
Dose modifications are required for patients with renal impairment. In patients with hepatic dysfunction, Ofloxacin dose adjustments may be necessary.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, abdominal pain, dizziness, headache, metallic taste, and loss of appetite.
Rare but Serious Side Effects
Peripheral neuropathy, seizures, tendon rupture (especially Achilles tendon), severe allergic reactions (including anaphylaxis), Clostridium difficile-associated diarrhea, and hepatotoxicity. Psychiatric effects such as hallucinations, paranoia, and depression have been reported with fluoroquinolones.
Long-Term Effects
Peripheral neuropathy can be a long-term effect of fluoroquinolone use.
Adverse Drug Reactions (ADR)
Severe hypersensitivity reactions, Clostridium difficile-associated diarrhea, QT interval prolongation, and hepatic dysfunction.
Contraindications
Hypersensitivity to Ofloxacin, Tinidazole, or other fluoroquinolones or nitroimidazoles. Patients with a history of tendon disorders related to fluoroquinolone use, epilepsy, or CNS disorders with a lowered seizure threshold. First trimester of pregnancy and breastfeeding. Myasthenia Gravis.
Drug Interactions
Antacids, iron supplements, multivitamins containing zinc, sucralfate, warfarin, theophylline, and some antidiabetic medications. Alcohol should be avoided while taking Tinidazole and for a few days after discontinuation due to the possibility of a disulfiram-like reaction.
Pregnancy and Breastfeeding
Ofloxacin + Tinidazole is contraindicated during pregnancy (especially the first trimester) and breastfeeding. Ofloxacin is associated with cartilage damage in animal studies and its use is not recommended during pregnancy or breastfeeding. Tinidazole is excreted in breast milk and can cause potential adverse effects in the nursing infant.
Drug Profile Summary
- Mechanism of Action: Ofloxacin inhibits bacterial DNA replication. Tinidazole disrupts protozoal DNA.
- Side Effects: Nausea, vomiting, diarrhea, dizziness, headache. Rarely: tendon rupture, seizures, peripheral neuropathy.
- Contraindications: Hypersensitivity, history of tendon disorders with fluoroquinolones, epilepsy, pregnancy, breastfeeding.
- Drug Interactions: Antacids, metal ions, warfarin, theophylline.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: Ofloxacin 200 mg + Tinidazole 600 mg twice daily; adjust based on indication and patient factors. Pediatric dosing of Tinidazole is weight-based and must be determined by a physician. Ofloxacin use should be avoided in children.
- Monitoring Parameters: Renal function, liver function tests, signs of tendon inflammation, and neurological status.
Popular Combinations
Ofloxacin and Tinidazole are often used together because they cover a broad spectrum of bacterial and protozoal pathogens, making them effective in mixed infections.
Precautions
Screen for allergies, pre-existing medical conditions (especially renal/hepatic dysfunction, epilepsy), and concomitant medications. Monitor for tendon pain or inflammation. Advise patients about potential CNS side effects and avoid driving or operating machinery if these occur.
FAQs
Q1: What is the recommended dosage for Ofloxacin + Tinidazole?
A: The usual adult dose is Ofloxacin 200 mg + Tinidazole 600 mg twice daily. However, this can vary based on the infection, patient-specific factors, and clinical judgment. Pediatric dosing (Tinidazole only) should be weight-based and determined by a physician.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, abdominal pain, dizziness, headache, and metallic taste.
Q3: Can Ofloxacin + Tinidazole be used in pregnant women?
A: No, it is contraindicated during pregnancy, especially in the first trimester.
Q4: Can it be used during breastfeeding?
A: No, it is contraindicated. Both Ofloxacin and Tinidazole can be excreted in breast milk and pose a risk to the infant.
Q5: What are the serious side effects I should watch out for?
A: Tendon rupture, seizures, peripheral neuropathy, and severe allergic reactions. Report any unusual symptoms immediately.
Q6: What are the drug interactions I should be aware of?
A: Interactions can occur with antacids, iron supplements, warfarin, and theophylline, among others. Consult a comprehensive drug interaction resource for details.
Q7: Should alcohol be avoided with this medication?
A: Yes, alcohol should be avoided during Tinidazole therapy and for a few days after due to a potential disulfiram-like reaction.
Q8: What if a patient misses a dose?
A: Take the missed dose as soon as possible. If it’s almost time for the next dose, skip the missed dose and continue the regular schedule. Do not double the dose.
Q9: What are the monitoring parameters for this drug?
A: Monitor for renal function, liver function, signs of tendonitis, and any neurological or psychiatric symptoms.
Q10: Can this combination treat giardiasis?
A: Yes, Ofloxacin + Tinidazole is effective in treating giardiasis, although other options may be preferred. A single 2 g dose of Tinidazole is typically effective for giardiasis.
