- Approval Id
- 23a0c56b40970e23
- Drug Name
- XIFAXAN Film-coated Tablet 550mg
- Product Name
- XIFAXAN Film-coated Tablet 550mg
- Approval Number
- SIN14761P
- Approval Date
- 2015-03-23
- Registrant
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Licence Holder
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
Posology
Recommended dose: 550 mg twice a day. The clinical benefit was established from a controlled study in which subjects were treated for 6 months. Treatment beyond 6 months should take into consideration the individual balance between benefits and risks, including those associated with the progression of hepatic dysfunction (see sections 4.4, 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
XIFAXAN can be administered with or without food.
_Paediatric population_
The safety and efficacy of XIFAXAN in paediatric patients (aged less than 18 years) have not been established.
_Elderly_
No dosage adjustment is necessary as the safety and efficacy data of XIFAXAN showed no differences between the elderly and the younger patients.
_Hepatic impairment_
No dosage adjustment is necessary for patients with hepatic insufficiency (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Renal impairment_
Although dosing change is not anticipated, caution should be used in patients with impaired renal function (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Method of administration
Orally with a glass of water.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
XIFAXAN is indicated for the reduction in recurrence of episodes of overt hepatic encephalopathy in patients ≥ 18 years of age (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
In the pivotal study, 91% of the patients were using concomitant lactulose.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Contraindications
- **4.3 Contraindications**
- Hypersensitivity to rifaximin, rifamycin-derivatives or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Cases of intestinal obstruction.
- Atc Code
- A07AA11
- Atc Item Name
- rifaximin
- Pharma Manufacturer Name
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Company Detail Path
- /organization/united-italian-trading-corporation-private-limited
