Mifoxin (Ciprofloxacin): A Guide to Uses, Dosage, and Serious Safety Warnings

Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice. Do not self-medicate or stop prescribed treatment without consulting your physician or pharmacist.

Mifoxin® (Ciprofloxacin)

Summary

Mifoxin®, with the active ingredient Ciprofloxacin, is a potent fluoroquinolone antibiotic used to treat a wide range of serious bacterial infections. Due to significant safety concerns, including the risk of disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system, its use is generally reserved for infections where other antibiotic options are not suitable. It works by inhibiting essential bacterial enzymes, leading to cell death.

Manufacturer

MISR Company for Pharmaceutical Industries (MISR PHARM IND S.A.E.), Egypt.

Category & Active Ingredient

• Category: Antibiotic (Fluoroquinolone).
• Active Ingredient: Ciprofloxacin (as Hydrochloride Monohydrate).

Available Forms & Strengths in Egypt

Mifoxin is available in the following forms:

• Film-coated tablets: 250 mg.
• Film-coated tablets: 500 mg.

Properties and Mechanism of Action

Ciprofloxacin is a bactericidal antibiotic belonging to the fluoroquinolone class. It functions by inhibiting two essential bacterial enzymes: DNA gyrase (topoisomerase II) and topoisomerase IV. These enzymes are crucial for bacterial DNA replication, transcription, repair, and recombination. By blocking these processes, ciprofloxacin prevents bacterial cell division and ultimately causes cell death.

Pharmacokinetics

• Absorption: Oral bioavailability is approximately 70%. Peak serum concentrations are reached within 1-2 hours.
• Distribution: Widely distributed throughout the body, penetrating well into tissues and fluids.
• Metabolism: Partially metabolized in the liver (around 15% of the dose).
• Excretion: Primarily excreted unchanged in the urine. The elimination half-life is about 4 hours in individuals with normal renal function.

Indications

Ciprofloxacin is indicated for the treatment of various bacterial infections. Important: Due to safety risks, it should be reserved for use in patients who have no alternative treatment options for the following conditions: Acute Bacterial Sinusitis, Acute Bacterial Exacerbation of Chronic Bronchitis, and Uncomplicated Urinary Tract Infections.

It is also used for more serious infections, including:

• Lower respiratory tract infections (e.g., pneumonia).
• Complicated urinary tract infections and pyelonephritis.
• Infectious diarrhea and typhoid fever.
• Bone and joint infections.
• Complicated intra-abdominal infections.
• Skin and soft tissue infections.
• Prostatitis and certain genital infections like gonorrhea.

Dosage and Administration

Dosage and duration vary depending on the type and severity of the infection. Always follow the physician's prescription.

• Adults (Oral): Doses typically range from 250 mg to 750 mg twice daily.
  • UTIs: 250-500 mg twice daily.
  • Respiratory/Bone/Skin infections: 500-750 mg twice daily.
  • Infectious Diarrhea: 500 mg twice daily for 5-7 days.
  • Uncomplicated Gonorrhea: A single dose of 250-500 mg.
• Renal Impairment: Dose adjustment is necessary for patients with impaired kidney function. The dose and/or frequency will be reduced based on creatinine clearance.

Contraindications

Ciprofloxacin should not be used in:

• Patients with a history of hypersensitivity to ciprofloxacin or any other quinolone antibiotic.
• Patients with a history of tendon disorders related to fluoroquinolone use.
• Concomitant administration with tizanidine.
• It is generally contraindicated in children and adolescents (under 18 years), during pregnancy, and while breastfeeding due to the risk of cartilage damage.

Warnings & Precautions

BLACK BOX WARNING: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions. Discontinue immediately and avoid use in patients with these reactions.

• Tendinitis and Tendon Rupture: Increased risk, especially in the elderly, patients taking corticosteroids, and in transplant recipients. Can occur within hours or days of starting or even months after completion.
• Peripheral Neuropathy: Risk of sensory or sensorimotor axonal polyneuropathy. Symptoms can occur soon after initiation and may be permanent.
• Central Nervous System Effects: Increased risk of seizures, increased intracranial pressure, dizziness, confusion, tremors, hallucinations, and suicidal thoughts or acts.
• Aortic Aneurysm and Dissection: Increased risk. Avoid use in patients with a known history or risk factors for aortic aneurysm.
• Photosensitivity/Phototoxicity: Moderate to severe reactions can occur. Avoid excessive exposure to sunlight or UV light.
• Crystalluria: Ensure adequate hydration to prevent the formation of highly concentrated urine.

Drug Interactions

• Absorption Interactions: Antacids, sucralfate, or products containing magnesium, aluminum, iron, or calcium can significantly reduce the absorption of ciprofloxacin. Administer ciprofloxacin at least 2 hours before or 6 hours after these products.
• Theophylline & Caffeine: Ciprofloxacin can increase the levels of these drugs, leading to toxicity.
• Warfarin: May enhance the anticoagulant effect. INR should be monitored closely.
• NSAIDs: Concomitant use may increase the risk of CNS stimulation and seizures.
• Diabetes Medications: May cause significant disturbances in blood glucose (hypoglycemia or hyperglycemia).

Side Effects

Common side effects include nausea, diarrhea, and vomiting. Other significant side effects are listed under "Warnings & Precautions."

• Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain.
• Central Nervous System: Dizziness, headache, restlessness.
• Skin: Rash, pruritus, photosensitivity.
• Musculoskeletal: Tendinitis, tendon rupture, arthralgia (joint pain).
• Hypersensitivity: Allergic reactions, including anaphylaxis.

Use in Pregnancy & Lactation

• Pregnancy: Contraindicated. Based on animal studies, fluoroquinolones may cause damage to cartilage in the developing fetus.
• Lactation: Ciprofloxacin is excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Overdose

• Symptoms: May include GI distress, CNS effects, and acute renal impairment.
• Management: Symptomatic and supportive. Gastric emptying via lavage may be performed. Maintain adequate hydration. Hemodialysis or peritoneal dialysis removes only a small amount of the drug.

Storage

• Store below 30°C in a dry place, protected from direct sunlight.
• Keep out of reach of children.

Presentation / Package

• Box containing 10 film-coated tablets (250 mg or 500 mg).

Frequently Asked Questions (FAQ)

Q1: Can Mifoxin be used for a cold or the flu?

A: No. Ciprofloxacin is an antibiotic and is completely ineffective against viral infections like the common cold or influenza.

Q2: Why is Mifoxin not recommended for children?

A: Studies have shown that fluoroquinolones can cause damage to weight-bearing joints and cartilage in developing animals, so it is generally avoided in patients under 18.

Q3: Should I avoid any foods while taking Mifoxin?

A: Yes. Avoid taking ciprofloxacin with dairy products (like milk, yogurt) or calcium-fortified juices alone, as they can decrease its absorption. However, you may take it with a meal that contains these products.

Q4: What should I do if I feel pain in my heel or shoulder while taking Mifoxin?

A: Stop taking the medication immediately, avoid exercise, and contact your doctor. This could be a sign of tendinitis or tendon rupture, a serious side effect.

References

1. U.S. Food and Drug Administration (FDA). Ciprofloxacin Prescribing Information (including Black Box Warning).
2. British National Formulary (BNF), "Ciprofloxacin".
3. Martindale: The Complete Drug Reference.
4. MISR Company for Pharmaceutical Industries, Product Leaflet.