RIFOCIN ® Rifamycin

RIFOCIN ® is a drug based on rifamycin sodium

THERAPEUTIC GROUP: Antimycobacterial - Antibiotics for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications RIFOCIN ® Rifamycin

RIFOCIN ® for systemic use is indicated in the treatment of infections caused by micro-organisms susceptible to Rifamycin such as osteomyelitis, bronchopulmonary infections, skin and soft tissue infections.

RIFOCIN ® can also be used for topical use in the treatment of dermatitis, sores, ulcers, abscesses, pyoderma and infected wounds.

Mechanism of action RIFOCIN ® Rifamycin

RIFOCIN ® is a drug based on Rifamycin, a semi-synthetic antibiotic belonging to the pharmaceutical category of antimicrobial chemotherapeutics, known for its broad spectrum of action, extended not only to Gram positive and Gram negative microorganisms but also to mycobacteria.

Effective both systemically and topically, this active ingredient is able to selectively inhibit the enzyme RNA bacterial DNA-dependent RNA polymerase, thus exerting a bactericidal action against microorganisms in active multiplication and bacteriostatic against those at low growth rate.

The chemical variations made to the classic structure of Rifamycin S, obtained naturally through specific bacterial fermentation processes, give semisynthetic Rifamycin, like the one present in RIFOCIN ®, a decidedly more intense therapeutic efficacy than that of its predecessors.

Administered for systemic use, both intramuscular and intravenous, after intense hepatic metabolism, rifamycin is eliminated mainly via the bile and to a minimal extent via the kidney.

Studies carried out and clinical efficacy

THE EFFECTIVENESS OF THERAPY WITH HIGH DOSAGES WITH REFINEMENT

Recent pharmacokinetic work demonstrating how high doses of Rifamycin may be more effective than the low in Tuberculosis therapy, given the ability to induce more intense blood peaks.

MECHANISMS OF RESISTANCE TO THE REFINEMENT

Study that focuses on the onset of rifamicin resistance mechanisms in mycobacteria and E. coli. In most cases, in addition to mutations in the binding site, the main cause of resistance appears to be linked to the great expression of efflux pumps.

NEW RELEASE SYSTEMS FOR THE RIFAMICINA

Work that focuses on the various possibilities that today's technology offers to significantly improve the therapeutic efficacy of the drug. In this case the efficacy of release systems characterized by micro-particles able to release antibiotics such as Rifamycin directly on site is evaluated, thus optimizing the drug's biodistribution and limiting the appearance of side effects.

Method of use and dosage

RIFOCIN ®

Solution for injection of 250 mg of rifamycin per ml of solution.

Solvent for solution for intralesional or cutaneous use of 90 mg of rifamycin per 18 ml of concentrate.

The dosing schedule for the use of RIFOCIN ® both injectable and topical or intralesional should be defined by the specialist in the treatment of infectious diseases.

An adjustment of the doses to be used would be necessary in patients suffering from hepatic and renal pathologies due to the impairment of metabolic and excretory capacities.

Warnings RIFOCIN ® Rifamycin

The use of RIFOCIN ® must necessarily be preceded and supervised by specialist medical personnel in order to guarantee maximum efficacy and contain the potential side effects at the same time.

The use of this antibiotic should be limited both in duration and in dosages in order to reduce the development of microbial strains resistant to drug therapy based on Rifamycins.

It is important to remember that RIFOCIN ® for systemic use has excipients such as potassium and sodium metabisulphite potentially responsible for hypersensitivity reactions especially in atopic patients.

PREGNANCY AND BREASTFEEDING

Given the absence of clinical trials able to fully characterize the safety profile of the drug for fetal health, it would be appropriate to limit the use of RIFOCIN ® exclusively to cases of real need and necessarily always under strict supervision medical.

Interactions

The pharmacokinetic properties of Rifamycin expose the patient on RIFOCIN ® therapy to potential drug interactions.

For this reason throughout the treatment it would be necessary to avoid the simultaneous intake of oral anticoagulants, psychotropic drugs, oral contraceptives, methadone, antihypertensives, anticonvulsants, glucocorticoids, anesthetics, probenecid, and all the other active ingredients metabolized by the cytochromial enzyme system.

Contraindications RIFOCIN ® Rifamycin

The use of RIFOCIN ® is contraindicated in patients suffering from liver disease and in patients hypersensitive to the active substance or to one of its excipients.

If RIFOCIN ® additionally presents lidocaine, it would be advisable to extend the contraindications to intravenous use of the drug or in patients with serious heart conditions.

Undesirable effects - Side effects

RIFOCIN ® therapy could expose the patient to the onset of:

• Itching, skin rash and different hypersensitivity reactions;
• Gastrointestinal disorders such as nausea, abdominal pain, anorexia and hepatitis;
• Immunological disorders with eosinophilia, leukopenia, thrombocytopathies and myopathies;
• Increased blood concentrations of transaminases and bilirubin and liver function disorders;
• Asthenia.

Note

RIFOCIN ® is a prescription-only drug.