"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
Patients should also be instructed that ocular preparations, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated preparations (see PRECAUTIONS , General ). If redness, irritation, swelling, or pain persists or becomes aggravated, the patient should be advised to consult a physician.
Patients should also be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
Patients should be advised that norfloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
ADDITIONAL CAUTIONARY INFORMATION
Norfloxacin is available as an oral dosage form in addition to the ophthalmic dosage form. The following adverse effects, while they have not been reported with the ophthalmic dosage form, have been reported with the oral dosage form. However, it should be noted that the usual dosage of oral norfloxacin (800 mg/day) contains 6,666 times the amount in one drop of CHIBROXIN (norfloxacin) Ophthalmic Solution 0.3% (0.12 mg).
Convulsions have been reported in patients receiving oral norfloxacin. Convulsions, increased intracranial pressure, and toxic psychoses have been reported with other drugs in this class. Orally administered quinolones may also cause central nervous system (CNS) stimulation which may lead to tremors, restlessness, lightheadedness, confusion and hallucinations. If these reactions occur in patients receiving norfloxacin, the drug should be discontinued and appropriate measures instituted.
The effects of norfloxacin on brain function or on the electrical activity of the brain have not been tested. Therefore, as with the oral formulation, norfloxacin should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors which predispose to seizures.
The following adverse effects have been reported with Tablets NOROXON* (norfloxacin tablets).
Hypersensitivity Reactions: Hypersensitivity reactions including anaphylactoid reactions, angioedema, arthralgia, arthritis, dyspnea, myalgia, urticaria, vasculitis; Gastrointestinal: Hepatitis, jaundice, including cholestatic jaundice, pancreatitis, pseudomembranous colitis; Hematologic: Hemolytic anemia, sometimes associated with glucose-6-phosphate dehydrogenase deficiency, leukopenia, neutropenia, thrombocytopenia; Musculoskeletal: Possible exacerbation of myasthenia gravis, tendinitis, tendon rupture; Nervous System/Psychiatric: Ataxia, CNS effects characterized as generalized seizures and myoclonus, Guillain-Barr© syndrome, paresthesia, peripheral neuropathy, psychic disturbances including confusion, depression, psychotic reactions; Renal: Interstitial nephritis, renal failure; Skin: Erythema multiforme and Stevens-Johnson syndrome, exfoliative dermatitis, photosensitivity, rash, toxic epidermal necrolysis; Special Senses: Diplopia, tinnitus, transient hearing loss.
Please consult the package circular for Tablets NOROXIN (norfloxacin tablets) for additional information concerning these and other adverse effects and other cautionary information.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Chibroxin Information
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