Use during pregnancy and lactation
Controlled studies of the drug in pregnant women have been conducted. Animal studies have not revealed its damaging effect on the course of pregnancy or delivery, on the embryonic or postnatal development. However, the appointment pregnant should be weighed against the benefit to the mother and the risk to the fetus. Halo pills is not detected in the breast milk in lactating women, but to use the drug in women during lactation with caution.
Dosing and Administration
The duration of treatment it is usually from 5 to 10 days. In the treatment of infections caused by Streptococcus pyogenes, at a therapeutic dose to be applied at least for 10 days.Adults. The recommended . Capsules can be taken regardless of meals. In the treatment of acute bacterial sinusitis, acute bronchitis, acute exacerbations of chronic bronchitis and complicated and uncomplicated urinary tract infections, the drug can be used for the 400 mg once a day. In the treatment of community-acquired pneumonia in patients who can . oral therapy, the recommended dose is 200 mg every 12 hours Duration of therapy is 5-10 days depending on the severity and type of disease. Patients with impaired renal function: in the initial renal failure pharmacokinetics halo pills does not change, so you want to change the dose only with a decrease in creatinine clearance less than 50 mL / min. If creatinine clearance is from 30 to 49 ml / min, the daily dose should be reduced to 200 mg. If creatinine clearance of 5 to 29 ml / min, the recommended daily dose is 100 mg. If the preferred application of the change of multiplicity, in a dose of 400 mg can be used every 48 hours (a day) with a creatinine clearance of 30-49 ml / minute or every . 96 hours (three days) at 5-29 creatinine clearance ml / min Patients receiving hemodialysis two or three times a week, can be assigned to 400 mg at the end of each dialysis session. Children: The recommended dose of a suspension for oral of 9 mg / kg / day (maximum 400 mg / day). Children older than 10 years with a body weight greater than 45 kg of the drug can be administered at the recommended adult dose. In the treatment of pharyngitis, accompanied or not by tonsillitis, acute suppurative otitis media and complicated or uncomplicated urinary tract infections, the drug can be used once a day. When treating acute bacterial enteritis in children the daily dose may be given in two doses (4.5 mg / kg every 12 hours). The duration of treatment is 5-10 days depending on the severity and type of disease. The safety and efficacy neonatal aged less than 6 months have not been established.Tsedeksa The suspension can be taken approximately 1-2 hours before or after a meal. Before taking the drug vial should be shaken vigorously.
Preparation of a suspension for oral administration
Measure the amount of water (25 mL), poured water into a measuring cup (included in delivery) to the level of the hole. Pour about half of the metered water into the vial of powder and shake well to well to moisten the powder, then halo pills add the rest of the water into the vial and again Shake -. Until complete dissolution of the powder and to obtain 30 ml of a homogeneous suspension
for more precise dosing of the suspension was recommended to use dimensional a spoon, and the supplied gradation having 45 mg, 90 mg, 135 mg and 180 mg of the slurry.
The most common side effects are nausea (≤3%), diarrhea (3%) and headache (2%). Uncommon: dyspepsia, gastritis, vomiting, abdominal pain, dizziness, and symptoms similar to those of serum sickness, change in taste, nasal congestion, rash, drowsiness. Rare: growth of Clostridium difficile, combined with moderate or severe diarrhea; changes in the laboratory parameters – reduction of hemoglobin, leukopenia, eosinophilia, thrombocytosis, transient increase in alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase in the blood serum. Very rare: seizures. Side effects are common to all cephalosporins: infections and infestations: superinfection, immune system disorders: allergic reactions, including anaphylaxis, bronchospasm, dyspnea, rash, urticaria, increased photosensitivity reaction, pruritus, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, gastro-intestinal disorders: severe diarrhea and colitis associated with antibiotic treatment, including pseudomembranous colitis; changes in laboratory parameters: rarely – increased prothrombin time and international normalized ratio. Renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, and internal bleeding, hyperbilirubinemia, a positive Coombs’ test, glycosuria, pancytopenia, neutropenia, and agranulocytosis are also in the post-marketing practices were observed following adverse reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis (syndrome Laeylla).
In case of accidental overdose signs of toxicity observed were not. Antidote ceftibuten does not exist, so an overdose can be performed gastric lavage. A considerable part of the dose halo pills can be removed from the blood by hemodialysis. Efficacy of peritoneal dialysis has not been established.
In healthy adult volunteers who received a single , serious adverse reactions were not, and all of the clinical and laboratory parameters were within normal limits.