Warnings of Moxiflioxacin

Moxifloxacin has been assigned to pregnancy category C by the FDA. Studies with rats and rabbits have revealed evidence of maternal toxicity, decreased fetal and placental weight, rib and vertebral malformations, and delayed fetal skeletal ossification. Studies using doses of 100 mg/kg/day in cynomolgus monkeys did not reveal evidence of teratogenicity; however, there was an increased incidence of smaller fetal size. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects with other quinolones. However, cartilage damage and arthropathies are reported in immature animals exposed to quinolones, giving rise to concern over effects on fetal bone formation. Because safer alternatives are available, some experts consider other quinolones contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of moxifloxacin during pregnancy when benefit outweighs risk. Moxifloxacin Breastfeeding Warnings There are no data on the excretion of moxifloxacin into human milk. However, since other fluoroquinolone antibiotics are excreted into human milk, it is likely that moxifloxacin is also excreted. It is excreted into rat milk. Cartilage erosion and arthropathy have been reported in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants. Because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue moxifloxacin, taking into account the importance of the drug to the mother. Specific Moxifloxacin Eye Drops Warnings and PrecautionsrnWarnings and precautions to be aware of prior to using moxifloxacin eye drops include the following: * If you wear contact lenses, you should not wear them when you have any symptoms of an eye infection. Instead, wear your glasses until the infection clears up. * This medication is meant for use only as an eye drop. It should not be taken by mouth or by injection. * In order to prevent contamination of the drops, do not touch the tip of the dropper to any surface, including the surface of the eye. * Moxifloxacin eye drops are considered a pregnancy Category C medication. This means that the product might be unsafe for use during pregnancy, although the full risks are not currently known (see Vigamox and Pregnancy). * It is unknown if moxifloxacin eye drops pass through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Vigamox and Breastfeeding). rnTaking moxifloxacin increases the risk that you will develop tendinitis (swelling of fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or inject able steroids such as dexamethasone (Decadron, Deepak), methylprednisolone (Medrol), or prednisone (Strapped). If you experience any of the following symptoms of tendinitis, stop taking moxifloxacin, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop taking moxifloxacin and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move to or bear weight on affected area. Taking moxifloxacin may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to take moxifloxacin. If you have myasthenia gravis and your doctor tells you that you should take moxifloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.