Usage
Ciprofloxacin + Ornidazole is a combination antibiotic used to treat bacterial and parasitic infections. It combines a fluoroquinolone antibiotic (ciprofloxacin) with a nitroimidazole antibiotic (ornidazole). This combination is particularly effective against mixed infections where both bacteria and anaerobic organisms or parasites (like amoeba) are involved. It is commonly prescribed for:
- Infectious diarrhea
- Amoebiasis (infection with amoeba)
- Giardiasis (infection with Giardia lamblia)
- Vaginal infections (bacterial or parasitic)
- Intra-abdominal infections
- Pelvic inflammatory disease
- Dental infections
- Post-surgical infections
- Certain urinary tract infections
- Typhoid fever
Pharmacological Classification:
- Ciprofloxacin: Fluoroquinolone antibiotic
- Ornidazole: Nitroimidazole antibiotic (antiprotozoal, antibacterial against anaerobes)
Mechanism of Action:
Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, thus leading to bacterial cell death. Ornidazole is metabolized within the bacterial/parasitic cell to reactive intermediates, which damage DNA and cause cell death. The two antibiotics have different mechanisms, providing a broad spectrum of coverage.
Alternate Names
There isn’t a single official international non-proprietary name (INN) for the combination, but it is often referred to simply as “ciprofloxacin and ornidazole.” Brand names vary by region. Some examples include:
- Ciplox-OZ
- Cifran OZ
- Orcipyx
- Cipromac OZ
How It Works
Pharmacodynamics:
Ciprofloxacin exerts bactericidal effects primarily by inhibiting bacterial DNA gyrase and topoisomerase IV. Ornidazole has bactericidal and antiprotozoal activity, targeting anaerobic bacteria and some parasites.
Pharmacokinetics:
- Absorption: Both drugs are well-absorbed orally. Food may slightly delay but not reduce the absorption of ciprofloxacin. Milk and dairy products can decrease absorption of ciprofloxacin significantly.
- Metabolism: Ciprofloxacin is minimally metabolized. Ornidazole is metabolized in the liver, primarily by oxidation and glucuronidation.
- Elimination: Ciprofloxacin is primarily excreted renally (through kidneys). Ornidazole is excreted in urine and feces, with renal excretion being the major route.
Mode of Action:
Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, essential for bacterial DNA replication, transcription, repair, and recombination. Ornidazole’s metabolites interact with microbial DNA, forming adducts and causing strand breakage, leading to cell death.
Receptor Binding/Enzyme Inhibition:
- Ciprofloxacin targets DNA gyrase and topoisomerase IV.
- Ornidazole: intracellular reduction in anaerobic organisms generates reactive metabolites.
Elimination Pathways:
- Ciprofloxacin: Primarily renal excretion.
- Ornidazole: Renal and hepatic excretion.
Dosage
Standard Dosage
Adults: Usual dose is 500 mg of ciprofloxacin and 500 mg of ornidazole every 12 hours, usually for 5 to 10 days depending on the infection.
Children: Use is generally avoided in children under 18. In certain serious infections where benefits outweigh risks, it can be prescribed under specialist supervision. Dosage calculations are based on weight, but information on exact pediatric dosing is not included in the provided sources.
Special Cases:
- Elderly Patients: Dose adjustments may be needed based on renal function.
- Patients with Renal Impairment: The dose should be reduced according to creatinine clearance.
- Patients with Hepatic Dysfunction: Usually, no dose adjustment is required for ornidazole, but caution is advised. Dose adjustments for ciprofloxacin may be necessary in severe cases.
- Patients with Comorbid Conditions: Caution is warranted in patients with a history of seizures, myasthenia gravis, and QT interval prolongation.
Clinical Use Cases
Dosing for specific clinical situations like intubation, surgical procedures, mechanical ventilation, or ICU use needs to be determined based on the specific infection and the patient’s status, which is not detailed in the provided sources. Dosages provided in the sources refer to general indications only and should be confirmed with a qualified doctor.
Dosage Adjustments
Dose modification may be required in renal impairment, severe hepatic dysfunction, or in patients with certain comorbid conditions. Specific recommendations are provided in the ‘Special Cases’ section.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain/discomfort
- Headache
- Dizziness
- Metallic taste
- Dry mouth
Rare but Serious Side Effects:
- Tendinitis/tendon rupture
- Peripheral neuropathy
- Seizures
- QT interval prolongation (heart rhythm problems)
- Hepatic dysfunction (cholestatic jaundice)
- Clostridium difficile associated diarrhea
- Severe allergic reactions
Long-Term Effects:
Long-term use can increase the risk of tendinitis/tendon rupture, peripheral neuropathy and Clostridium difficile infection.
Adverse Drug Reactions (ADR):
Severe hypersensitivity, anaphylaxis, QT interval prolongation, Clostridium difficile associated diarrhea, hepatic dysfunction, seizures, tendinitis/tendon rupture.
Contraindications
- Hypersensitivity to ciprofloxacin, ornidazole, or any other quinolone or nitroimidazole antibiotic.
- History of seizures, epilepsy.
- Myasthenia gravis.
- QT interval prolongation.
Drug Interactions
- Antacids, iron supplements, multivitamins with zinc or calcium: reduce the absorption of ciprofloxacin.
- Warfarin: ciprofloxacin may increase the anticoagulant effect.
- Theophylline: ciprofloxacin increases plasma theophylline levels.
- Tizanidine: avoid concomitant use due to increased risk of hypotension.
- Methotrexate: ciprofloxacin can increase methotrexate levels.
Pregnancy and Breastfeeding
- Pregnancy: Use is generally avoided during pregnancy unless the benefits clearly outweigh the risks. It is classified as pregnancy Category C.
- Breastfeeding: Ciprofloxacin and ornidazole are present in breast milk. While short-term use is generally considered safe, long-term use should be avoided.
Drug Profile Summary
- Mechanism of Action: Ciprofloxacin inhibits bacterial DNA gyrase/topoisomerase IV. Ornidazole disrupts microbial DNA through its metabolites.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, metallic taste. Serious: tendinitis, seizures, QT prolongation.
- Contraindications: Hypersensitivity, epilepsy, myasthenia gravis, QT prolongation.
- Drug Interactions: Antacids, iron supplements, warfarin, theophylline.
- Pregnancy & Breastfeeding: Avoid in pregnancy if possible. Caution in breastfeeding.
- Dosage: Adults: 500mg ciprofloxacin/500mg ornidazole 12 hourly. Adjust for renal dysfunction.
- Monitoring Parameters: Renal function, LFTs, signs of tendinitis, QT interval, signs of CNS toxicity (seizures, altered mental status).
Popular Combinations
The combination of ciprofloxacin and ornidazole itself is a popular combination. There isn’t sufficient evidence to recommend other combinations involving these two drugs mentioned in the provided sources.
Precautions
- Assess renal and hepatic function.
- Monitor for QT interval prolongation.
- Caution in patients with myasthenia gravis and seizure disorders.
- Avoid concomitant use with medications that prolong the QT interval.
- Advise patients to avoid dairy products and calcium-fortified beverages around the time of ciprofloxacin administration.
- Educate on potential for tendinitis/tendon rupture.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ciprofloxacin + Ornidazole?
A: The standard adult dose is 500 mg of ciprofloxacin and 500 mg of ornidazole administered every 12 hours. Dose adjustments may be necessary in renal impairment and other conditions.
Q2: What are the most common side effects?
A: Common side effects include nausea, vomiting, diarrhea, headache, dizziness, metallic taste, and dry mouth.
Q3: Can Ciprofloxacin + Ornidazole be used in pregnant or breastfeeding women?
A: Its use during pregnancy is generally avoided. While considered safe for short-term use during breastfeeding, long-term use should be avoided.
Q4: What are the major drug interactions to be aware of?
A: Significant interactions include antacids, metal ions (calcium, iron, magnesium, zinc), warfarin, theophylline, tizanidine.
Q5: Are there any serious side effects?
A: Yes. Rare but serious effects can include tendinitis, tendon rupture, peripheral neuropathy, seizures, and QT prolongation.
Q6: What conditions are contraindicated with Ciprofloxacin + Ornidazole?
A: It is contraindicated in patients with hypersensitivity to either drug, epilepsy, myasthenia gravis, and QT interval prolongation.
Q7: How does renal impairment affect the dosing?
A: Dose reduction is necessary in moderate to severe renal impairment. Specific recommendations are provided in the dosage section.
Q8: What advice should be given to patients regarding diet?
A: Patients should avoid consuming dairy products or calcium-fortified beverages within two hours before or six hours after taking Ciprofloxacin + Ornidazole, as these can reduce ciprofloxacin’s absorption.
Q9: Should the drug be taken with or without food?
A: The drug can be taken either with or without food. However, see above about its interaction with dairy products and calcium-fortified products.
