Lox Adverse Reactions

Gastrointestinal: Diarrhea, pseudomembranous colitis, indigestion, stomatitis, rarely gastritis, glossitis, black hairy tongue, and occasionally nausea, vomiting, loss of appetite, abdominal pain, abdominal distention, constipation, colonalgia, gastric hyperacidity, loose stools and dry mouth have been reported. Candidiasis and antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) has been reported rarely. It is less occurred after parenteral administration (in case of injections). Severe colitis along with bloody stool can be occurred, thus regular check-up or observation is necessary and if abdominal pain and frequent diarrhea occurred, stop the medication and take proper actions. Nausea, although uncommon, is more often associated with higher oral dosages. If gastrointestinal side effects occur with oral administration, they may be reduced by taking Co-amoxiclav tablet at the start of meals. As with other antibiotics the incidence of gastrointestinal side effects may be raised in children under two years. In clinical trials, however, only 4% of children under 2 years were withdrawn from treatment.
Liver: Moderate rises in AST, ALT, ALP, LDH, and serum bilirubin have been reported occasionally. Hepatitis and cholestatic jaundice have been reported rarely. These symptoms have been reported more frequently in this drug than other penicillin drugs and more commonly in adults, elderly patients (in particular, over 60), or males. Signs and symptoms of adverse reactions can be occurred during the treatment but can be reported later at 6 weeks after cessation of treatment. Hepatic reactions are usually reversible but very rare deaths have been reported. These deaths have been generally related to patients with prolonged serious illness or co-administration of other drugs. Abnormal hepatic reactions have been mainly reported in males and the elderly, which were increased in case of prolonged treatment of more than 14 days. Histologic observation on liver biopsy has shown cholestatic, hepatocellular, or combination of both changes. In particular, it has been reported in young children in rare cases. The period of drug administration should be properly examined depending on indications and should not be exceeded 14 days without examination.
Hypersensitivity: Rarely, itch and erythema multiforme exudativum, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, and acute generalized exanthematous pustulosis (AGEP) have been reported. These skin reactions can be controlled by antihistamines or systemic corticosteroids if necessary. If rashes are developed, stop the medication and follow the doctors' instruction. As with other β-lactam antibiotics, angioedema, anaphylaxis, serum sickness-like syndrome [serum sickness-like III type hypersensitivity (immune complex disease) is characterized by fever, rashes (particularly skin rash around the mouth, urticaria, urticaria rash), arthralgia, edema, and lymphadenopathy]. Hypersensitivity angitis, acute generalized exanthematous pustulosis (AGEP), dyspnea with bronchospasm, laryngeal edema, and decreased blood pressure that causes anaphylactic shock.
Hematology: As with other β-lactam antibiotics, reversible leucopenia (including neutropenia and agranulocytosis), reversible thrombocytopenia and haemolytic anemia, thrombocytopenic purpura, eosinophilia, leukemia, agranulocytosis and lymphocytopenia have been reported rarely. Slight thrombocytosis and myelosuppression have been rarely reported. Also, the extension of bleeding time and prothrombin time has been reported rarely.
Genitourinary: In addition to mucocutaneous candidiasis, vaginal itch, soreness, or discharge can be increased.
CNS: Adverse reactions to the CNS are very rare but possible. These reactions include dysesthesia, anxiety, behavioral changes, confusion, drowsiness, insomnia, reversible hyperactivity, dizziness, rarely headaches and convulsions. Convulsions may occur with impaired renal function or at high dose therapy doses.
Renal: Serious renal dysfunction such as acute renal failure, interstitial nephritis, and related hematuria can be rarely possible. Thus, close observation including regular check-up is necessary and if abnormality is recognized, stop the medication and take proper action.
Superinfection: Rare occurrence of stomatitis and candidiasis. When these symptoms occur, stop the medications and take proper actions.
Vitamin deficiencies: Vitamin K deficiencies (hypoprothrombinemia, bleeding tendency, etc.) and vitamin B complex deficiencies (glossitis, stomatitis, loss of appetite, neuritis, etc.) are rarely possible.
Others: Superficial tooth discoloration has been reported in young children and rarely in adults, mostly with the suspension. However, it can usually be removed by brushing and good oral hygiene can prevent the discoloration of teeth (in case of syrups). Also, dysgeusia and malaise have been rarely reported.