seysara

Important safety information

The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. ( 5.2 ) Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. ( 5.3 ) SEYSARA may cause intracranial hypertension. Discontinue SEYSARA if symptoms occur. ( 5.4 ) Photosensitivity can occur with SEYSARA. Patients should minimize or avoid exposure to natural or artificial sunlight. ( 5.5 ) 5.1 Teratogenic Effects SEYSARA, like other tetracyclines, can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately. The use of drugs of the tetracycline-class during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of these drugs, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated with SEYSARA during pregnancy in association with maternal toxicity [see Use in Specific Populations ( 8.1 )] . 5.2 Clostridium difficile Associated Diarrhea (Antibiotic Associated Colitis) Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to potential overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile should be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.3 Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. 5.4 Intracranial Hypertension Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and papilledema. Although signs and symptoms of intracranial hypertension resolve after discontinuation of treatment, the possibility for sequelae such as visual loss that may be permanent or severe exists. Women of childbearing age who are overweight have a greater risk for developing intracranial hypertension. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension [see Drug Interactions ( 7.1 )] . If visual disturbance occurs during treatment, patients should be checked for papilledema. 5.5 Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA. If patients need to be outdoors while using SEYSARA, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. 5.6 Development of Drug Resistant Bacteria Bacterial resistance to tetracyclines may develop in patients using SEYSARA. Because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, it should only be used as indicated. 5.7 Superinfection/Potential for Microbial Overgrowth As with other antibiotic preparations, use of SEYSARA may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted.