Trubiotic-500

Trubiotic-500

Category:Tablets
Classification:Antibiotic
Product English Name:Trubiotic
Product Arabic Name:تروبيوتيك
Scientific Name English:Ciprofloxacin
Scientific Name Arabic:سيبروفلوكساسين
Product Unit: 10 Tablets
Product Strength:500mg

Categories: ,

Description

Clinical Pharmacology

Mechanism of Action:
Ciprofloxacin is a broad-spectrum bactericidal drug that inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, repair, transcription, and recombination. This inhibition prevents bacterial cell division, leading to cell death.

Spectrum of activity:
Ciprofloxacin is active against most isolates of both gram-positive and gram-negative bacteria.

Additional information

Composition

Each Film-Coated Tablet Contains:
Ciprofloxacin hydrochloride equivalent to
Ciprofloxacin 500 mg, 750 mg.
Drug Class: Fluoroquinolone, Antibiotic.
Pharmacokinetics

Absorption:
Ciprofloxacin is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of approximately 70%. Peak plasma concentrations are typically reached within 1 to 2 hours following oral administration.

Distribution:
The drug is widely distributed throughout body tissues and fluids, including the lung, skin, bone, and urogenital tissues.

Metabolism:
Ciprofloxacin undergoes partial hepatic metabolism to four metabolites, which possess antimicrobial activity. These metabolites account for approximately 15% of the administered dose.

Excretion:
Approximately 40-50% of an oral dose is excreted unchanged in the urine. The plasma elimination half-life in patients with normal renal function is approximately 4 hours.
Indications and Usage

• Skin and Skin Structure Infections.
• Bone and Joint Infections.
• Complicated Intra-Abdominal Infections.
• Infectious Diarrhea.
• Typhoid Fever (Enteric Fever).
• Uncomplicated Cervical and Urethral Gonorrhea.
• Inhalational Anthrax (Post-Exposure).
• Plague.
• Chronic Bacterial Prostatitis.
• Lower Respiratory Tract Infections.
• Urinary Tract Infections.
Administration and Dosage

Indication: Skin and Skin Structure Infections
Dose: 500-750 mg every 12 h
Duration: 7-14 days

Indication: Bone and Joint Infections
Dose: 500-750 mg every 12 h
Duration: 4-8 weeks

Indication: Complicated Intra-Abdominal Infections
Dose: 500 mg every 12 h
Duration: 7-14 days

Indication: Infectious Diarrhea
Dose: 500 mg every 12 h
Duration: 5-7 days

Indication: Typhoid Fever
Dose: 500 mg every 12 h
Duration: 10 days

Indication: Uncomplicated Gonorrhea
Dose: 250 mg single dose
Duration: Single dose

Indication: Inhalational Anthrax (post-exposure)
Dose: 500 mg every 12 h
Duration: 60 days

Indication: Plague
Dose: 500-750 mg every 12 h
Duration: 14 days

Indication: Chronic Bacterial Prostatitis
Dose: 500 mg every 12 h
Duration: 28 days

Indication: Lower Respiratory Tract Infections/AECB
Dose: 500-750 mg every 12 h
Duration: 7-14 days

Indication: Urinary Tract Infections
Dose: 250-500 mg every 12 h
Duration: 7-14 days

Indication: Acute Uncomplicated Cystitis
Dose: 250 mg every 12 h
Duration: 3 days
Administration Guide

• Take Trubiotic at least 2 hours before or 6 hours after products containing magnesium, aluminum, calcium, iron, or zinc (e.g., antacids, sucralfate, multivitamins, or dairy products).
• Ensure adequate hydration to prevent crystalluria.
• If a dose is missed, it should be taken as soon as remembered unless it is within 6 hours of the next dose.
Contraindications

• Known hypersensitivity to ciprofloxacin or other fluoroquinolones.
• Concomitant use with tizanidine.
Warnings and Precautions

Tendinitis and Tendon Rupture: Increased risk in patients over 60 years and those on corticosteroids. Avoid use in patients with a history of tendon disorders.

Peripheral Neuropathy: Symptoms such as pain, burning, tingling, or numbness may be rapid in onset and irreversible. Discontinue immediately if symptoms occur.

Central Nervous System Effects: Includes psychiatric symptoms and neurological events. Use with caution in patients with seizure disorders or CNS conditions.

Exacerbation of Myasthenia Gravis: Fluoroquinolones may worsen muscle weakness in myasthenia gravis and have been associated with serious outcomes. Avoid in such patients.

Severe Hypersensitivity and Other Reactions: Life-threatening reactions may occur. Discontinue immediately if signs of hypersensitivity develop.

Hepatotoxicity: Severe and sometimes fatal liver injury has been reported. Discontinue treatment if signs of hepatic dysfunction appear.

Aortic Aneurysm and Dissection: Use with caution in patients with existing aneurysms or risk factors. Limit use to situations where no alternatives exist.

Clostridioides difficile–Associated Diarrhea (CDAD): May occur during or after treatment and can be severe. Evaluate patients with persistent diarrhea accordingly.

QT Prolongation: May lead to arrhythmias, including torsades de pointes. Avoid in patients with known QT prolongation or those taking medications that prolong the QT interval.

Musculoskeletal Disorders in Pediatrics: Use in children is limited to specific indications due to the risk of joint-related adverse effects. Animal studies show permanent cartilage damage.

Photosensitivity: Exaggerated sunburn reactions may occur. Advise patients to avoid excessive sunlight or UV exposure.

Blood Glucose Disturbances: Both hypo- and hyperglycemia have been reported, particularly in diabetic patients. Monitor glucose levels closely.

Crystalluria: Ciprofloxacin may rarely form crystals in human urine, particularly if urine is alkaline. To minimize risk, ensure adequate hydration and avoid urinary alkalinization during treatment.
Use in Specific Populations

Patients with Renal Impairment:
Ciprofloxacin is mainly eliminated by the renal. Dose adjustment is recommended for patients with severe renal impairment.

Patients with Hepatic Impairment:
Preliminary studies in patients with stable chronic liver cirrhosis show no significant changes in ciprofloxacin pharmacokinetics. However, the effects of acute hepatic insufficiency on ciprofloxacin pharmacokinetics have not been studied.

Pregnancy:
Data from published studies and clinical experience over decades have not shown an increased risk of birth defects, miscarriage, or adverse pregnancy outcomes with ciprofloxacin use during pregnancy. Ciprofloxacin should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:
Ciprofloxacin is excreted in human milk following oral and intravenous administration. Due to the potential risk of serious adverse effects in breastfed infants, such as arthropathy, breastfeeding is not recommended during treatment and for two days after the last dose.

Pediatric Use:
Ciprofloxacin is associated with a higher incidence of adverse reactions in pediatric patients compared to adults, particularly joint-related effects. Therefore, its use in pediatrics should be limited to situations where the expected benefit justifies the potential risk.

Geriatric Use:
Ciprofloxacin should be used with caution in the elderly after taking into account the severity of the illness and the creatinine clearance.
Side Effects/Adverse Reactions

• Gastrointestinal: Nausea, diarrhea, vomiting, abdominal pain, liver enzyme abnormalities.
• Central Nervous System: Dizziness, headache, tremors, insomnia, hallucinations, seizures (rare).
• Musculoskeletal: Arthralgia, myalgia, tendonitis, tendon rupture.
• Dermatologic: Rash, pruritus, photosensitivity, Stevens-Johnson syndrome (rare).
Drug Interactions

• Sucralfate, Multivitamins, and Antacids (magnesium hydroxide, aluminum hydroxide): May reduce ciprofloxacin bioavailability by up to 90%. Avoid simultaneous use or separate administration by several hours.
• Tizanidine: Concomitant use is contraindicated due to increased tizanidine exposure, causing enhanced hypotensive and sedative effects.
• Ropinirole: Ciprofloxacin increases ropinirole exposure. Monitor for adverse effects and adjust the ropinirole dose as needed.
• Clozapine: Ciprofloxacin increases serum clozapine and its metabolite levels by ~30%. Monitor for toxicity and adjust the clozapine dose accordingly.
• Sildenafil: Co-administration doubles sildenafil exposure. Use sildenafil cautiously with ciprofloxacin.
• Duloxetine: The concomitant use may increase duloxetine plasma levels by up to fivefold; therefore, caution is advised.
• Lidocaine: Ciprofloxacin increases lidocaine exposure. Potential for increased adverse reactions.
Storage Conditions

Store in a dry place below 30°C.

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