Information about Sostendo XR
Composition
Each 500 mg Extended Release FilmCoated Tablet contains equivalent to 500 mg of Ciprofloxacin base.
Each 1000 mg Extended Release Film Coated Tablet.
Indications:
Sostendo XR is intended only totreat:
- Urinary tract infections and
- Acute uncomplicated pyelonephritis(also known as a kidney infection).
Contraindications:
Sostendo XR is contraindicated inpatients who have ever had a severe reaction to any of the group of antibiotics known as «quinolones».
Sostendo XR is not recommended for persons less than 18 years of age.
Side Effects:
- Most adverse events reported were described as mild to moderate in severity and required no treatment. The overall incidence, type and distribution of adverse events were similar in patients receiving both 500 mg and 1000 mg of Ciprofloxacin XR.
- In the control arm the most common reason for discontinuation was nausea/vomiting
- The most common side effects: nausea, headache, dyspepsia, dizziness, vaginal moniliasis yeast infection and diarrhea. (If diarrhea persists, the doctor should be called for help). Antibiotics of the quinolone class may also cause vomiting, rash, and abdominal pain/discomfort.
Only a few patientshad a history of hypersensitivity reactions
- Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
- Patients should avoid excessive sunlight or artificial ultraviolet light while receiving Ciprofloxacin XR and to discontinue therapy if phototoxicity occurs.
- Ciprofloxacin XR should not betaken with dairy products (like milk or yogurt) or calcium-fortified juices alone. It may be taken with a meal that contains these products.
Dosage and Administration
- Ciprofloxacin XR should be administered orally once daily with food or on an empty stomach (it should notbe taken with dairy products like milk or yogurt or calcium-fortified juices alone); as described in the following Dosage Guidelines table:
- Impaired Renal Function
No dosage adjustment is required for patients with uncomplicated urinary tract infections receiving 500 mg ciprofloxacin XR.
In patients with complicated urinary tract infections and acute uncomplicated pyelonephritis, who have a creatinine clearance of < 30 mL/min, the dose of CIPROFLOXACIN XR should be reduced from 1000 mg to 500 mg daily.
For patients onhemodialysis or peritoneal dialysis, administer CIPROFLOXACIN XR after the dialysis procedure is completed.
Impaired Hepatic Function
No dosage adjustment is required with CIPROFLOXACIN XR in patients with stable chronic cirrhosis.
Over-dosage:
In the event of acute excessive overdosage, the stomach should be emptied by inducing vomiting or bygastric Lavage.
The patients should be carefully observed and given supportive treatment including administration of Magnesium or Calcium containing antacids which can reduce the absorption of Ciprofloxacin.
Adequate Hydration must be maintained.
Only a small amount of Ciprofloxacin <10% is removed from the body after hemodialysis or peritoneal dialysis.
Storage:
Sostendo XR should be stored at a dry place at a temperature 15 -30°C.
It should be kept out of reach of children.
Packaging:
Pack of 10 film coated tablets of 500 mg.
Pack of 10 film coated tablets of 1000 mg.