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(B) Dose-related histopathologic changes in peripheral white blood cells associated with an allergic type reaction after exposure to floxacin as described in (S)
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Adult Dosing Recommendations
For most adults, the lowest effective dosage should be used. In patients with moderate to severe renal impairment, the use of a higher dose (i.e., 100 mg plus) may be appropriate. For patients with impaired hepatic function or other adverse reactions associated with increased renal function, the higher dosage may be appropriate.
AUTHORIZED USERS: For additional information on adult medication use, see Guide for Adults, Geriatric Care, and OLDER ADULTS.
APPROVED USERS: For additional information on APPROVED USERS, including additional patient-specific information, see Medication Guide for Approved Users.
IMPORTANT INFORMATION: Adult and pediatric patients, including those receiving adjunctive therapy for rheumatoid arthritis, should be cautioned about the potential for drug interactions when concomitant therapy is initiated with cetirizin olibanum. This relationship is due to different mechanisms of action by which cetirizin and olibanum exert their anti-inflammatory effects. This includes mechanisms which may differ by patient.
CETIRIZIN AND OLDER ADULTS: can cause hepatotoxicity that includes liver failure, hepatitis, and more rarely, death. Cetirizin has been causally linked to a number of severe and life-threatening liver disorders including acute failure, inflammation and adenomas, hepatic necrosis, other signs and symptoms of bacterial infection (e.g., fever, malaise, weakness, loss of appetite, diarrhea).
In addition, cetirizin has demonstrated an increased incidence of abnormal liver enzyme findings in patients with mild liver disease (pre-existing cirrhosis) and even when taking the higher dose (i.e., 100 mg plus), and this should be kept in mind when administering concomitant therapy with cetirizin olibanum.
It is important to be alert the signs of ocular side effects. Examples possible effects include iritis, an inflammation of the conjunctiva and eyelids (common in patients with inflammatory conjunctivitis); macules, small lesions of the cornea arising in morning or late afternoon (rare in patients with corneal neovascularisation, an inflammatory condition of the cornea which may be associated with infection); and visual disturbances such as blurred vision and flaring of the cornea as a result of drug interaction. It is important to be alert the signs of ocular side effects.
The use of corticosteroids should be evaluated for their safety in patients with severe rheumatoid arthritis that is resistant to previous treatment.
The recommended dose of cetirizin is 100 mg.
Patenting the anti-inflammatory action of olibanum (Cetirizin, olibanum) in patients with rheumatoid arthritis may contribute to the treatment of severe or refractory symptoms by suppressing inflammation over a prolonged period as compared with other conventional therapies (i.e., corticosteroids). There is now evidence that olibanum improves the clinical condition of patients with inflammation-related rheumatoid arthritis.
Patenting the anti-inflammatory action of olibanum (Cetirizin, olibanum) in patients with rheumatoid arthritis may contribute to the treatment of severe or refractory symptoms by suppressing inflammation over a prolonged period as compared with other conventional therapies (i.e., corticosteroids). There is now evidence that olibanum improves the clinical condition of patients with inflammation-related rheumatoid arthritis. NITPED: Studies have demonstrated that olibanum (Olibanum, Olinea) may potentiate the anti-acne effects of fluoxetine in patients with moderate to severe acne who had failed fluoxetine. Therefore, the use of both drugs may be considered in patients with severe acne who are not responding adequately to fluoxetine.
See Full Prescribing Information for Olibanum (Olinea)
Studies have not been conducted with this drug in pregnant or lactating women; therefore, it should not be used during pregnancy.
Cetirizin and olibanum are metabolized by the same enzyme in liver, which has been demonstrated to be very closely related in size,.
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