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XIFAXANTA 200 mg Film-coated Tablets

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

One film-coated tablet contains:

Rifaximin 200 mg

Excipients:

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet

Pink circular biconvex film-coated tablets, with “AW” printed on both sides.

4. Clinical Particulars

4.1 Therapeutic Indications

Xifaxanta 200mg film-coated tablets are indicated for the treatment of travellers' diarrhoea that is not associated with any of:

Fever

Bloody diarrhoea

Eight or more unformed stools in the previous 24 h

Occult blood or leucocytes in the stool.

Xifaxanta 200mg film-coated tablets may shorten the duration of diarrhoea when this is associated with non-invasive strains of E.coli (see sections 4.4 and 5.1).

4.2 Posology And Method Of Administration

Posology

200 mg every 8 hours for three days (total 9 doses).

Rifaximin must not be used for more than 3 days even if symptoms continue and a second course of treatment must not be taken (see section 4.4).

Rifaximin can be administered with or without food.

Paediatric population

The safety and efficacy of Xifaxanta 200 mg film-coated tablets in children (aged less than 18 years) have not been established.

A dosage adjustment for patients with hepatic or renal insufficiency is not necessary.

Method of administration

Orally with a glass of water.

4.3 Contraindications

Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Clinical data have shown that Rifaximin is not effective in the treatment of travellers' diarrhoea caused by invasive enteric pathogens such as Campylobacter, Salmonella and Shighella, which typically produce dysentery-like diarrhoea characterised by fever, blood in the stool and high stool frequency.

If symptoms worsen treatment with Rifaximin should be interrupted.

If symptoms have not resolved after 3 days of treatment, or recur shortly afterwards, a second course of Rifaximin should not be administered.

Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including Rifaximin. The potential association of Rifaximin treatment with CDAD and pseudomembranous colitis (PMC) cannot be ruled out.

Paediatric population

Xifaxanta 200 mg film-coated tablets are not recommended for use in children (<18 years old).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There is no experience regarding administration of rifaximin to subjects who are taking another rifamycin antibacterial agent to treat a systemic bacterial infection. Due to the lack of data and the potential for severe disruption of gut flora with unknown consequences rifaximin should not be administered concomitantly with other rifamycins.

Due to the negligible gastrointestinal absorption of orally administered Rifaximin (less than 1%), the systemic drug interaction potential is low.

In vitro data show that Rifaximin is a weak inducer of the CYP3A4 isoenzyme of the P450 cytochrome. Drug-drug interaction studies investigating the clinical interaction between Rifaximin and drugs metabolised by the human cytochrome P450 isoenzymes demonstrated that Rifaximin did not significantly affect the pharmacokinetics of midazolam or an oral contraceptive containing ethinyl estradiol and norgestimate. Therefore, clinical interactions with drugs metabolised by these isoenzymes are not expected.

The potential for drug-drug interactions to occur at the level of gut transporter systems has not been evaluated and cannot be ruled out.

No drug interaction studies investigating the concomitant intake of Rifaximin and other drugs that might be used during an episode of travellers' diarrhoea (e.g. loperamide, charcoal) are available. Patients should take Rifaximin at least 2 hours after the administration of charcoal.

4.6 Pregnancy And Lactation

For Rifaximin no clinical data on exposed pregnancies are available.

Animal studies have shown reproductive toxicity (see 5.3).

Rifaximin is not recommended during pregnancy and in women of childbearing potential not using contraception (see Section 5.3).

It is not known whether rifaximin is excreted in human milk. A decision should be taken whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

In clinical controlled trials dizziness has been reported but rifaximin has negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

In clinical studies in subjects who received Rifaximin for treatment of travellers' diarrhoea Adverse Reactions considered as being at least possibly related to Rifaximin have been categorised by organ system and frequency.

MedDRA System Organ Class (ver. 12.1)

Common

(

Uncommon

(

Infections and infestations

 

Candidiasis,

Herpes simplex,

Nasopharyngitis,

Pharyngitis,

Upper respiratory tract infection

Blood and lymphatic system disorder

 

Lymphocytosis,

Monocytosis,

Neutropenia

Metabolism and nutrition disorders

 

Decreased appetite,

Dehydration

Psychiatric Disorders

 

Abnormal dreams,

Depressed mood,

Insomnia,

Nervousness

Nervous system disorders

Dizziness,

Headache

Hypoesthesia,

Migraine,

Paraesthesia,

Sinus headache,

Somnolence

Eye disorders

 

Diplopia

Ear and labyrinth disorders

 

Ear pain,

Vertigo

Cardiac disorders

 

Palpitations

Vascular disorders

 

Blood pressure increased

Hot flush

Respiratory, thoracic, and mediastinal disorders

 

Cough,

Dry throat,

Dyspnoea,

Nasal congestion,

Oropharyngeal pain,

Rhinorrhea

Gastrointestinal disorders

Abdominal pain,

Constipation,

Defecation urgency,

Diarrhoea,

Flatulence, bloating and distension,

Nausea and vomiting symptoms,

Rectal tenesmus

Abdominal pain upper,

Dry lips,

Dyspepsia,

Gastrointestinal motility disorder,

Faeces hard,

Haematochezia,

Mucous stools,

Taste disorders

Hepatobiliary disorders

 

Aspartate aminotransferase increased

Skin and subcutaneous tissue disorders

 

Rashes, eruptions and exanthemas NEC

Sunburn

Musculoskeletal and connective tissue disorders

 

Back pain,

Muscle spasms,

Muscular weakness,

Myalgia

Neck pain

Renal and urinary disorders

 

Blood in urine present

Glycosuria,

Pollakiuria,

Polyuria

Proteinuria

Reproductive system and breast disorders

 

Polymenorrhoea

General disorders and administration site conditions

Pyrexia

Asthenic conditions,

Chills,

Cold sweat,

Hyperhidrosis,

Influenza like illness,

Oedema peripheral,

Pain and discomfort NEC

Post-marketing experience

During post-approval use of Rifaximin further undesirable effects have been reported.

The frequency of these reactions is not known (cannot be estimated from the available data).

MedDRA System Organ Class (ver. 12.1)

Frequency not known

Infections and infestations

Clostridial infections

Blood and lymphatic system disorder

Thrombocytopenia

Immune system disorders

Anaphylactic responses,

Angioedemas,

Hypersensitivity

Vascular disorders

Presyncope

Hepatobiliary disorders

Liver function tests abnormalities

Skin and subcutaneous tissue disorders

Dermatitis

Eczema

Erythemas

Pruritus NEC

Urticarias

Investigations

International normalised ratio abnormalities

4.9 Overdose

No case of overdose has been reported.

In clinical trials with patients suffering from travellers' diarrhoea doses of up to 1800 mg/day have been tolerated without any severe clinical signs.

In case of overdose gastric emptying and administration of appropriate supportive treatment are recommended.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: intestinal anti-infective agents, antibiotics. ATC code: A07AA11

Mode of action

Rifaximin is an antibacterial agent of the rifamycin class that binds irreversibly to the beta sub-unit of the bacterial enzyme DNA-dependent RNA polymerase and consequently inhibits bacterial RNA synthesis.

Mechanism of resistance

The main mechanism of acquiring resistance to rifaximin appears to involve: a mutation in the rpoB gene encoding the bacterial RNA polymerase.

Susceptibility

Rifaximin is a non-absorbed antibacterial agent.In vitro susceptibility testing cannot be used to reliably establish susceptibility or resistance of bacteria to Rifaximin. There are currently insufficient data available to support the setting of a clinical breakpoint for susceptibility testing.

5.2 Pharmacokinetic Properties

Absorption

Pharmacokinetic studies in rats, dogs and humans demonstrated that after oral administration Rifaximin in the polymorph ? form is virtually not absorbed (less than 1%). Following the administration of therapeutic doses of Rifaximin in healthy volunteers and patients with damaged intestinal mucosa (Inflammatory Bowel Disease), plasma levels are negligible (less than 10 ng/ml). Systemic absorption of Rifaximin is increased but not by a clinically relevant extent by administration within 30 minutes of a high-fat breakfast.

Elimination

The urinary recovery of Rifaximin does not exceed 0.4% of the administered dose.

Special Populations

No clinical data are available on the use of Rifaximin in patients with impaired renal function.

In patients with hepatic encephalopathy mean peak plasma concentrations of 13.5 ng/mL Rifaximin were detected after administration of 800 mg Rifaximin three times daily for 7 days. Less than 0.1% of the administered dose was recovered after 7 days. Because of the limited systemic absorption of Rifaximin, no specific dosing adjustments are recommended for patients with hepatic insufficiency.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity Morphological alterations have been observed in the foetuses of Rifaximin orally administered rats and rabbits.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Sodium starch glycolate type A

glycerol distearate

colloidal anhydrous silica

talc

microcrystalline cellulose

Tablet coating:

hypromellose,

titanium dioxide

disodium edetate

propylene glycol

red iron oxide E172.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Original packing: 3 years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

PVC/PE/PVDC -Aluminium blister pack containing 9 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Norgine Pharmaceuticals Limited

Moorhall Road

Harefield

Uxbridge

UB9 6NS

8. Marketing Authorisation Number(S)

PL 20011/0021

9. Date Of First Authorisation/Renewal Of The Authorisation

02/12/2010 / 01/12/2015

10. Date Of Revision Of The Text

01/06/2011





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