by ALBENDAZOLE TABLET USE
WARNINGS Included as part of the "PRECAUTIONS" Section PRECAUTIONS Bone Marrow Suppression Fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia. ALBENZA may cause bone marrow suppression, aplastic anemia, and agranulocytosis.
Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with ALBENZA in all patients.
Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue ALBENZA if clinically significant decreases in blood cell counts occur. Embryo-Fetal Toxicity Based on findings from animal reproduction studies, ALBENZA may cause fetal harm when administered to a pregnant woman. Embryotoxicity and skeletal malformations were reported in rats and rabbits when treated during the period of organogenesis (at oral doses approximately 0.1 to 0.6 times the recommended human dose normalized for total body surface area). Advise pregnant women of the potential risk to a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating ALBENZA .
Advise females of reproductive potential to use an effective method of contraception during treatment with ALBENZA and for 3 days after the final dose . Risk Of Neurologic Symptoms In Neurocysticercosis Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain. Risk Of Retinal Damage In Patients With Retinal Neurocysticercosis Cysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by ALBENZA-induced death of the parasite. Hepatic Effects In clinical trials, treatment with ALBENZA has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis . Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks during treatment.
If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing ALBENZA therapy based on individual patient circumstances. Restarting ALBENZA treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further ALBENZA usage. Perform laboratory tests frequently if ALBENZA treatment is restarted. Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression . Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur. Unmasking Of Neurocysticercosis In Hydatid Patients Undiagnosed neurocysticercosis may be uncovered in patients treated with ALBENZA for other conditions.
Patients with epidemiologic factors who are at risk for neurocysticercosis should be evaluated prior to initiation of therapy. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term carcinogenicity studies were conducted in mice and rats. No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis).
In genotoxicity tests, albendazole was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, albendazole produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation. Albendazole did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m2). Use In Specific Populations Pregnancy Risk Summary Based on findings from animal reproduction studies, ALBENZA may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2) and pregnant rabbits (at doses of 0.60 times the maximum recommended human dose based on body surface area in mg/m2). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m2) (see Data). Advise a pregnant woman of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2, respectively) during organogenesis (gestation days 6 to 15) and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the maximum recommended human dose based on body surface area in mg/m2) administered during organogenesis (gestation days 7 to 19). In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m2), administered during gestation days 6 to 15.
Lactation Risk Summary Concentrations of albendazole and the active metabolite, albendazole sulfoxide, have been reported to be low in human breast milk. There are no reports of adverse effects on the breastfed infant and no information on the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALBENZA and any potential adverse effects on the breastfed infant from ALBENZA or from the underlying maternal condition. Females And Males Of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating ALBENZA. Contraception Females ALBENZA may cause fetal harm when administered to a pregnant woman . Advise females of reproductive potential to use effective contraception during treatment with ALBENZA and for 3 days after the final dose. Pediatric Use Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of ALBENZA in children appears to be similar to that in adults. Geriatric Use In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of ALBENZA is different from that of younger patients. Patients With Impaired Renal Function The pharmacokinetics of ALBENZA in patients with impaired renal function has not been studied. Patients With Extra-Hepatic Obstruction In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of albendazole sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of albendazole sulfoxide appeared to be prolonged with mean Tmax and serum elimination half-life values of 10 hours and 31.7 hours, respectively.
Plasma concentrations of parent ALBENZA were measurable in only 1 of 5 patients.
Albendazole sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebrospinal fluid (CSF). Concentrations in plasma were 3-fold to 10-fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively.
Albendazole binds to the colchicine‑sensitive site of β‑tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites decreases their absorptive function, especially the uptake of glucose by the adult and larval forms of the parasites, and also depletes glycogen storage. Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate (ATP) and the parasite eventually dies.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time.
Do not double the dose to catch up.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Notes Do not share this medication with others.This medication has been prescribed for your current condition only.
Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as liver function tests, complete blood counts) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. Missed Dose If you miss a dose, take it as soon as you remember.
If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Storage Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
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