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Lox

Lox Special Precautions

amoxicillin + clavulanic acid

Manufacturer:

Chong Kun Dang

Distributor:

D & G Pharma
Full Prescribing Info
Special Precautions
Patients with severe hepatic dysfunction (the hepatic dysfunction may be aggravated).
Patients with moderate or severe renal disorder (to be used with proper intervals because the blood concentrations is maintained longer than patients without renal disorder).
Patients who or whose patients or siblings is/are susceptible to such allergic symptoms as bronchial asthma, rashes, urticaria, etc.
Patients with poor oral intakes, parenteral nutrition, elderly, or poor general condition (possible vitamin K deficiency).
Patients with gastro-intestinal diseases with vomiting or diarrhea (no guarantee to sufficient drug absorption) (in case of oral medication).
Because this drug contains potassium, patients who have to restrict potassium should consider its contents.
Also, patients who have to restrict sodium should consider its content if high-dose parenteral administration is required (in case of injections).
General Precautions: It is desirable to use this drug for the minimum period of time that is required for the treatment by confirming the sensitivity to prevent the expression of drug-resistant bacteria.
Serious and occasionally hypersensitivity (anaphylactic) reactions and angioedema have been reported in patients on penicillin therapy. These reactions are more likely to occur in patients with the history of hypersensitivity to penicillins or multiple allergens. It occurs more often in parenteral therapy but it also occurs in oral therapy.
Treatment should be directed to the careful monitoring and the maintenance of sedate condition, because anaphylactic shock can occur although it is rare. After the administration, the patient should be maintained with stable condition and carefully observed. When serious anaphylactic reaction occurs, emergency treatment such as epinephrine should be quickly performed. Perform treatments as instructed by doctors such as catheterization, oxygen supply, intravenous injection of corticoids, and securing the airway.
Almost all antibiotics including this drug have been reported as causing moderate to severe pseudomembranous colitis. Thus, it is important to observe and diagnose patients with continuous diarrhea among patients who have received antibiotics including this drug. The intestinal flora can be changed due to the use of antibiotics and causes the overgrowth of clostridia. According to some studies, toxins produced by Clostridium difficile is the major cause of antibiotic-associated colitis. If diagnosed as having pseudomembranous colitis, the treatment should be initiated. Mild pseudomembranous colitis can be recovered by stopping the drug. Moderate to severe cases should be treated with fluids, electrolytes, and protein supplementation, and then treated with clinically effective antibiotics against Clostridium difficile.
Sometimes the excessive proliferation of insusceptible bacteria can be observed with prolonged drug use. Thus it should be carefully observed when used more than 14 days.
Changes in liver function tests have been observed in some patients receiving this drug. The clinical significance of these changes is uncertain but Co-amoxiclav should be used with caution in patients with signs of hepatic dysfunction. Cholestatic jaundice which may be severe but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for 6 weeks after the treatment has ceased.
Because most of this drug is excreted through the kidney, the dosage of this drug should be controlled in patients with more than medium degree of renal dysfunction (see Dosage & Administration for recommended dosing for patients with impaired renal function).
Because erythematous eruption is related to infectious mononucleosis that is developed due to the use of amoxicillin, the use of this drug should be avoided when infectious mononucleosis is concerned.
When symptoms such as urticaria, skin rash, and serum diseases occur, stop the medication and consult the medication and take proper actions.
This drug has low toxicity among penicillins antibiotics, but regular observations on renal function, hepatic function, and hematopoiesis are necessary in case of prolonged administration.
An inquiry is necessary to confirm the medical history of hypersensitivity reactions to penicillins, cephalosporins, or other allergens before starting the treatment with this drug.
Store reconstituted suspension under refrigeration and use within 7 days (in case of dry syrup products).
Use in Children: Administration to Infants (In Case of Oral Medication): The safety for premature babies and infants (less than 2 months of age) has not been established (in case of syrup preparation). The safety or young children has not been established (few experiences) (in case of tablets).
Use in Elderly: Take precautions when administer to the elderly by checking the condition of patients and the dosage and intervals.
Adverse reactions can be easily developed due to decreased physiological functions.
Hemorrhage can be occurred due to vitamin K deficiency.
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