Hepaximin

Hepaximin

rifaximin

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Rifaximin.
Description
Each film coated tablet contains Rifaximin BP 550 mg.
Action
Pharmacology: Rifaximin is a non-aminoglycoside, semi-synthetic, antibacterial derived from Rifamycin. Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis.
Indications/Uses
Hepatic encephalopathy (HE).
Dosage/Direction for Use
Hepatic Encephalopathy (HE): 550 mg twice daily.
Contraindications
Hepaximin is contraindicated in patients with a hypersensitivity to Rifaximin, or any of the Rifamycin antimicrobial agents, or any of the components of Hepaximin.
Special Precautions
Use in Renal Insufficient Patients: The pharmacokinetics of Rifaximin in patients with impaired renal function has not been studied.
Use in Hepatic Insufficient Patients: No dosage adjustment with Rifaximin is necessary due to its limited systemic absorption. Nonetheless, caution should be exercised when Rifaximin is administered to patients with severe hepatic impairment.
Use in Children: The safety and effectiveness of Hepaximin 550 mg for hepatic encephalopathy have not been established in patients <18 years of age.
Geriatric Use: Clinical studies of Hepaximin tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Hepaximin should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Use in Lactation: It is not known whether Rifaximin is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Hepaximin, 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.
Side Effects
Common side effects are nausea, vomiting, abdominal pain, flatulence, headache and dizziness.
Drug Interactions
Although in vitro studies demonstrated the potential of Rifaximin to interact with cytochrome P450 (CYP3A4), a clinical drug-drug interaction study demonstrated that Rifaximin did not significantly affect the pharmacokinetics of midazolam. An additional clinical drug-drug interaction study showed no effect of Rifaximin on the presystemic metabolism of an oral contraceptive containing ethinyl estradiol and norgestimate.
Therefore, clinical interactions with drugs metabolized by human cytochrome P450 isozymes are not expected.
Storage
Store in a cool & dry place, protect from light.
MIMS Class
ATC Classification
A07AA11 - rifaximin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.
Presentation/Packing
FC tab 550 mg x 10's.
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