Description and Composition of Cledibact
Cledibact contains levofloxacin hemihydrate as its active pharmaceutical ingredient and other excipients or inactive pharmaceutical ingredients.. Excipients used in drugs formulation vary across brands and this is what usually differentiate a particular brand from the other.
Pharmacology and Mechanism of Action of Cledibact
Cledibact is a broad-spectrum antibiotic active against both Gram positive and Gram-negative bacteria.
It functions by inhibiting DNA gyrase, a type II topoisomerase, and topoisomerase IV, enzymes necessary to separate bacterial DNA, thereby inhibiting cell division.
Pharmacokinetics of Cledibact
Cledibact oral tablet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 99% with no substantial loss by first pass metabolism. The peak serum time is between 1 to 2 hours.
Indications and Uses of Cledibact
Antibiotics usage including cledibact should be guided by Microscopy, Culture and Sensitivity test result or standard treatment guidelines of a particular country or region where MCS test is not possible. Levofloxacin is used in the treatment of susceptible bacterial infections including:
- Acute bacterial sinusitis
- Acute bacterial exacerbations of chronic bronchitis
- Urinary tract infections
- Bacterial Gastroenteritis
- Bone and soft tissue infections
- Gynaecological and wound infections
- Respiratory infections (nosocomial or Community acquired pneumonia)
- Acute pyelonephritis
- Chronic bacterial prostatitis
- Gram negative septicaemia
- Meningitis Prophylaxis and Conjunctivitis
- Skin and skin structure infections
Contraindications of Cledibact
Cledibact is contraindicated in persons with a history of hypersensitivity to Levofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.
Dosage of Cledibact
Cledibact should be administered as per the directions given by the physician. Levofloxacin tablet should be swallowed without crushing and with sufficient amount of liquid. The tablets can be taken with or without food.
Acute bacterial sinusitis
Adult: 500mg daily for 10 to 14 or 750mg daily for 5 days.
Acute bacterial exacerbation of chronic bronchitis
Adult: 500 mg daily for 5 days
Urinary tract infections
Complicated or acute pyelonephritis: 750 mg daily for 5 days
Uncomplicated: 250 mg daily for 10 days
Uncomplicated: 250 mg daily for 3 days
750 mg daily for 7 to 10 days
Community acquired pneumonia
750 mg daily for 5 days
500 mg daily 7 to 10 days
Skin and skin structure infections
Complicated: 750 mg daily for 7 to 10 days
Uncomplicated: 500 mg daily for 7 to 10 days
Chronic bacterial prostatitis
500 mg daily for a month (28 days)
Adult and Children weighing 50 kg and above: 500 mg daily for 10 to 14 days
Children: (30 kg to 50 kg): 250 mg 12 hourly for 10 to 14 days
Post exposure therapy for inhalational anthrax
Adult and Children weighing up to 50 kg: 500 mg daily for 2 months (60 days)
Paediatric patients: 30 kg to 50 kg: 250 mg 12 hourly for 60 days
Acne vulgaris (Off label)
100 mg PO tds for a month (28 days)
Epididymitis (off label)
500 mg PO daily for 10 days
Overdosage of Cledibact
In the event of acute overdosage of cledibact, reversible renal toxicity has been reported in some cases. The stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids, which can reduce the absorption of Levofloxacin. Adequate hydration must be maintained.
Side Effects of Cledibact
Side effects associated with the use of cledibact may include:
- Diarrhoea or constipation
- Stomach upset
Drug Interactions with Cledibact
Cledibact is known to interact with other drugs and should not be co-administered or caution observed when doing so. Some are entirely contraindicated (C), have serious interaction, and minor. This list is not exhaustive and you’re advised to confirm with your Pharmacist or doctor for a comprehensive list.
- BCG vaccine live,
- Typhoid vaccine live
- Strontium ranelate
- Aluminium hydroxide
- Cholera vaccine
- Cyclosporin A
- Multivitamins with minerals
- Phenytoin Na
- Warfarin Na.
Cledibact Disease Interactions
Cledibact interacts with the following disease conditions
- CNS disorders
- Myasthenia gravis
- Peripheral neuropathy
- Renal dysfunction
- QT interval prolongation
Use of Cledibact in Pregnancy and Lactation
Cledibact is in Pregnancy category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans but potential benefits may warrant use of the drug in pregnant women despite potential risks. Lactation Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience. The drug is contraindicated in breastfeeding mothers
Storage of Cledibact
Store below 30°C in a cool & dry place. Keep all medicines out of reach of children.