nfusion should be used in pregnant women or in women of child bearing potential only if the potential benefit justifies the potential risk to the foetus. When Rifadin is administered during the last few weeks of pregnancy it may cause post-natal haemorrhages in the mother and infant for which treatment with Vitamin K1 may be indicated.
Lactation
Rifampicin is excreted in breast milk and infants should not be breast fed by a patient receiving rifampicin unless in the physician's judgement the potential benefit to the patient outweighs the potential risk to the infant.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
The following CIOMS frequency rating is used, when applicable:
Very common ≥ 10 %; Common ≥ 1 and <10%; Uncommon ≥ 0.1 and <1%;
Rare ≥ 0.01 and <0.1%; Very rare <0.01%, Unknown (cannot be estimated from available data).
Rifadin for Infusion is generally well tolerated and accepted by patients, although hypersensitivity reactions have been described and occasionally patients have experienced fever, skin rashes and nausea/vomiting.
Occasional instances of phlebitis and pain at the infusion site have been reported.
Reactions occurring with either daily or intermittent dosage regimens include:
Infections and infestations
Unknown: Pseudomembranous colitis, influenza consisting of episodes of pyrexia, chills, headache, dizziness
Blood and lymphatic system disorders
Common: Thrombocytopenia with or without purpura, usually associated with intermittent therapy, but is reversible if drug is discontinued as soon as purpura occurs.
Uncommon: leukopenia
Unknown: Disseminated intravascular coagulation,eosinophilia, agranulocytosis, hemolytic anemia
Immune system disorders
Unknown: anaphylactic reaction
Endocrine disorders
Unknown: adrenal insufficiency in patients with compromised adrenal function have been observed.
Metabolism and nutritional disorders
Unknown: decreased appetite
Psychiatric disorders
Unknown: Psychotic disorder
Nervous system disorders
Unknown: Cerebral hemorrhage and fatalities have been reported when rifampicin administration has been continued or resumed after the appearance of purpura.
Eye disorders
Unknown: Tear discoloration
Vascular disorders
Unknown: Shock, flushing, vasculitis
Respiratory, thoracic and mediastinal disorders
Unknown: Dyspnoea, wheezing, sputum discoloured
Gastrointestinal disorders
Common: Nausea, vomiting
Uncommon: Diarrhea
Unknown: Gastrointestinal disorder, abdominal discomfort
Hepatobiliary disorders
Unknown: Hepatitis, hyperbilirubinaemia (see section 4.4: Special warnings and precautions for use)
Skin and subcutaneous tissue disorders
Unknown: Erythema multiforme including Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome (See section 4.4), skin reaction, pruritus, rash pruritic, urticaria, dermatitis allergic, pemphigoid, sweat discoloration.
Musculoskeletal and connective tissue disorders
Unknown: Muscle weakness, myopathy, bone pain
Renal and urinary disorders
Unknown: acute kidney injury usually due to renal tubular necrosis or tubulointerstitial neph
