It is contraindicated in patients with known hypersensitivity to quinolone antibacterials or with known hypersensitivity to the medicine or to other nitroimidazole derivatives, children and adolescents, up to 18 years in the growth phase
in nursing mothers
patients in whom tendon disorders have arisen after using quinolones
ADVERSE DRUG REACTIONS (ADR)
Gastrointestinal effects like nausea vomiting, anorexia and metallic or bitter taste are observed. CNS effects like dizziness, vertigo, rigidity, tremor, coordination problems, convulsions, impairment of consciousness and signs of sensitive or mixed peripheral neuropathy has been observed (< 1%) Blood dyscrasias like medullar aplasia and neutropenia may be encounters occasionally. Other adverse effects like fatigue and headache may be reported
Tendinopathy and Tendon Rupture
Flouroquinolones are associated with an increased risk of tendinitis and tendon rupture in all ages. Tendon rupture can occur during or after completion of therapy cases occurring up to several month after completion of therapy have been reported. Mebatic infusion should be discontinued if patient experiences pain, selling, inflammation or rupture of tendon
Serious and occasionally fatal hypersensitivity and/or anaphylatic reactions have been reported in patients receiving therapy with fluoroquinolones including Mebatic Infusion. These reactions often occur following the first dose and may be accomplished by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction including (bronchospasm, shortness of breath, and acute respiratory distress) dyspnea, uticaria, itching, and other serious skin infections. Mebatic infusion should be discontinued immediately at first appearance of skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine, and other resuscitation including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated
Other Serious and Fatal Reactions
Other serious and sometimes fatal events due to hypersensitivity and some due to uncertain etiology may occur rarely in patients receiving this therapy .
The drug should be discontinued immediately at the first appearance of skin rash, jaundice, nephritis, anemia or any other sign of hypersensitivity and supportive measures should be instituted.
Hepatotoxicity may occur in patients of 65 years of age or older. Mebatic infusion should be discontinued immediately if patients develops signs and symptoms of hepatitis.
Central Nervous System Effects
Convulsions and toxic psychoses have been reported in patients receiving fluoroquinolones, mebatic infusion should be used with caution in patients with known or suspected CNS disorder that may predispose them to seizures
Rare cause of neuropathy including pain, burning, tingling, numbness or weakness if observed, the therapy should be discontinued if symptoms persists (< 18 years of age) Prolongation of the QT interval, musculoskeletal disorder in pediatrics patients, Blood glucose disturbance, may occur very rarely so appropriate precautions should be taken while instituting the therapy
Pregnancy and Lactation
Mebatic should be administered to pregnant and breast feeding women with caution. Mebatic passes the placenta barrier and attains a concentration in the amniotic fluid equal to approx. 30% of the maximum concentration measured in the maternal serum as per studies done in rat model
Effect on the ability to drive and use machines
Some undesirable effects (e.g. diziness/vertigo, drowsiness, visual disturbances) may impair the patients ability to concentrate and react and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating a machinery). This applies all the more if taken in combination with alcohol