Usage
This combination medication is prescribed for various bacterial infections, including:
- Respiratory tract infections (pneumonia, bronchitis)
- Sexually transmitted infections (gonorrhea, chlamydia, syphilis)
- Urinary tract infections
- Skin and soft tissue infections (cellulitis, acne)
- Gum disease (periodontitis)
- Certain parasitic infections (amebiasis, giardiasis, trichomoniasis)
Pharmacological Classification: Antibiotic
Mechanism of Action: This drug combines three active ingredients:
- Doxycycline: A tetracycline antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thus halting bacterial growth.
- Ornidazole: A nitroimidazole antibiotic that damages bacterial DNA by forming reactive intermediates, leading to bacterial death. It is particularly effective against anaerobic bacteria and certain parasites.
- Beta-Cyclodextrin: A complexing agent that enhances the solubility and absorption of doxycycline and ornidazole, increasing their bioavailability and effectiveness.
Alternate Names
- Dox-M-OZ
- Doxycycline + Ornidazole + Beta-Cyclodextrin
How It Works
Pharmacodynamics:
- Doxycycline: Inhibits bacterial protein synthesis.
- Ornidazole: Disrupts bacterial DNA structure and function.
Pharmacokinetics:
- Absorption: Both doxycycline and ornidazole are well-absorbed orally. Beta-cyclodextrin enhances their absorption.
- Metabolism: Doxycycline is primarily excreted unchanged. Ornidazole is metabolized in the liver.
- Elimination: Doxycycline is eliminated through urine and feces. Ornidazole metabolites are excreted in the urine.
Mode of Action:
- Doxycycline: Binds to the 30S ribosomal subunit, inhibiting bacterial protein synthesis.
- Ornidazole: Forms reactive intermediates that interact with and damage bacterial DNA.
Elimination Pathways:
- Doxycycline: Renal and fecal excretion.
- Ornidazole: Hepatic metabolism followed by renal excretion of metabolites.
Dosage
Dosage and duration are determined by the infection’s type and severity and should be adjusted based on individual patient factors.
Standard Dosage
Adults:
- One tablet (Doxycycline 100mg + Ornidazole 500mg + Beta-Cyclodextrin 50mg) once or twice daily.
- Treatment duration: 5 to 14 days.
Children:
- Dosage is determined by weight or age, and the infection’s type and severity.
- Tetracyclines like doxycycline should be used cautiously in children younger than 8 years old due to the risk of permanent tooth discoloration.
Special Cases:
- Elderly Patients: Adjustments may be necessary based on kidney and liver function.
- Patients with Renal Impairment: Dosage adjustment may be required in severe renal impairment.
- Patients with Hepatic Dysfunction: Dosage adjustment may be necessary in severe liver disease.
- Patients with Comorbid Conditions: Consider adjustments for conditions affecting drug metabolism or clearance (e.g., diabetes, cardiovascular disease).
Clinical Use Cases
Dosage recommendations for specific clinical settings (intubation, surgical procedures, mechanical ventilation, ICU use, emergency situations) are not specifically defined for this fixed-dose combination. Dosage is adjusted based on the infection, patient condition, and other clinical factors.
Dosage Adjustments
Dose modifications might be necessary based on patient-specific factors such as renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms affecting drug metabolism.
Side Effects
Common Side Effects
- Headache
- Nausea
- Vomiting
- Diarrhea
- Stomach pain
- Photosensitivity
- Loss of appetite
Rare but Serious Side Effects
- Severe allergic reactions (rash, itching, swelling, shortness of breath)
- Blood disorders (bruising, bleeding, sore throat, fever, fatigue)
- Severe diarrhea (watery or bloody stools)
- Liver dysfunction
- Kidney damage
Long-Term Effects
- Permanent tooth discoloration (especially in children)
Adverse Drug Reactions (ADR)
Clinically significant ADRs requiring immediate intervention include severe allergic reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Contraindications
- Hypersensitivity to tetracyclines or nitroimidazoles
- Pregnancy (especially second and third trimesters)
- Children under 8 years old (except for severe or life-threatening infections)
Drug Interactions
- Antacids, iron supplements, calcium supplements, and multivalent cations reduce doxycycline absorption.
- Alcohol can cause a disulfiram-like reaction with ornidazole.
- Doxycycline may potentiate the effects of anticoagulants (warfarin).
- This medication may alter the metabolism of antiepileptic drugs.
Pregnancy and Breastfeeding
- Pregnancy: Contraindicated, particularly in the second and third trimesters, due to fetal harm risk (tooth discoloration and skeletal development issues).
- Breastfeeding: Safety not established. Use with caution.
Drug Profile Summary
- Mechanism of Action: Doxycycline inhibits bacterial protein synthesis; ornidazole damages bacterial DNA; beta-cyclodextrin enhances absorption.
- Side Effects: Nausea, vomiting, diarrhea, photosensitivity (common); severe allergic reactions, blood disorders (rare but serious).
- Contraindications: Pregnancy, children under 8, hypersensitivity to components.
- Drug Interactions: Antacids, iron/calcium supplements, alcohol, anticoagulants, antiepileptic drugs.
- Pregnancy & Breastfeeding: Contraindicated in pregnancy; caution during breastfeeding.
- Dosage: Adults: one tablet once or twice daily; pediatric: weight/age-based.
- Monitoring Parameters: Infection resolution, adverse reactions, liver/kidney function.
Popular Combinations
This drug is a combination product. Combining it with additional antibiotics is generally avoided unless specifically indicated and monitored for drug interactions.
Precautions
- General: Pre-screening for allergies, metabolic disorders, organ dysfunction.
- Pregnant Women: Avoid use.
- Breastfeeding Mothers: Use with caution.
- Children & Elderly: Age-specific dosing and monitoring.
- Lifestyle: Avoid alcohol during ornidazole treatment; avoid prolonged sun exposure; use sunscreen.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Beta-Cyclodextrin + Doxycycline + Ornidazole?
A: Adults: Typically one tablet once or twice daily. Pediatric dosing is weight/age-based. Adjustments needed for renal/hepatic impairment.
Q2: What infections does this combination treat?
A: Bacterial infections including respiratory, urinary tract, sexually transmitted, skin, and specific parasitic infections.
Q3: Can this drug be used during pregnancy or breastfeeding?
A: Contraindicated in pregnancy, especially the second and third trimesters. Use cautiously during breastfeeding.
Q4: Are there any major drug interactions to be aware of?
A: Yes, with antacids, iron/calcium supplements, alcohol, anticoagulants, and antiepileptic medications.
Q5: What are the common side effects?
A: Nausea, vomiting, diarrhea, stomach upset, and photosensitivity.
Q6: What are signs of a serious adverse reaction?
A: Severe allergic reaction, blood disorders (unusual bruising/bleeding), severe diarrhea, liver/kidney problems.
Q7: Can children take this medication?
A: Use with caution in children under 8 due to tooth discoloration risk. Pediatric dosages are weight/age-based.
Q8: Should this medication be taken with food?
A: Can be taken with or without food but preferably at the same time each day. Taking it with food can reduce gastrointestinal upset.
Q9: What should a patient do if they miss a dose?
A: Take the missed dose as soon as remembered, unless it’s almost time for the next dose. Do not double the dose.
Q10: How should this medication be stored?
A: Store at room temperature (10-30°C) away from light and moisture. Keep out of reach of children and pets.
