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Cytotec - FDA prescribing information, side effects and uses

Labor And Delivery. cytotec for delivery Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its approved indication.

Cytotec is available only as a unit-of-use package that includes a leaflet containing patient information. Carcinogenesis, Mutagenesis, Impairment Of Fertility There was no evidence of an effect of Cytotec on tumor occurrence or incidence in rats receiving daily doses up to times the human dose for 24 months. Similarly, there was no effect of Cytotec on tumor occurrence or incidence in mice receiving daily doses up to times the human dose for 21 months. The mutagenic potential of Cytotec was tested in several in vitro assays, all of which were negative.

Misoprostol, when administered to breeding male and female rats at doses 6. These findings suggest the possibility of a general adverse effect on fertility in males and females.

Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient, but the drug's teratogenic mechanism has not been demonstrated.

Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects. Cytotec is not fetotoxic or teratogenic in rats and rabbits at doses and 63 times the human dose, respectively.

Cytotec may endanger pregnancy may cause abortion and thereby cause harm to the fetus when administered to a pregnant woman. Cytotec may produce uterine contractions, uterine bleeding , and expulsion of the products of conception.

Abortions caused by Cytotec may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID-induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus. Labor And Delivery Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony.

Uterine activity and fetal status should be monitored by trained obstetrical personnel in a hospital setting. The risk of uterine rupture associated with misoprostol use in pregnancy increases with advancing gestational ages and prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.

The use of Cytotec outside of its approved indication may also be associated with meconium passage, meconium staining of amniotic fluid, and Cesarean delivery. Maternal shock , maternal death, fetal bradycardia , and fetal death have also been reported with the use of misoprostol. Cytotec should not be used in the third trimester in women with a history of Cesarean section or major uterine surgery because of an increased risk of uterine rupture.

Cytotec should not be used in cases where uterotonic drugs are generally contraindicated or where hyperstimulation of the uterus is considered inappropriate, such as cephalopelvic disproportion, grand multiparity, hypertonic or hyperactive uterine patterns, or fetal distress where delivery is not imminent, or when surgical intervention is more appropriate.

The effect of Cytotec on later growth, development, and functional maturation of the child when Cytotec is used for cervical ripening or induction of labor has not been established. Information on Cytotec's effect on the need for forceps delivery or other intervention is unknown. The use of Cytotec misoprostol for the management of postpartum hemorrhage has been associated with reports of high fevers greater than 40 degrees Celsius or degrees Fahrenheit , accompanied by autonomic and central nervous system effects, such as tachycardia , disorientation, agitation, and convulsions.

These fevers were transient in nature. These findings suggest the possibility of a general adverse effect on fertility in males and females. Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient, but the drug's teratogenic mechanism has not been demonstrated.

Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects. Cytotec is not fetotoxic or teratogenic in rats and rabbits at doses and 63 times the human dose, respectively. Cytotec may endanger pregnancy may cause abortion and thereby cause harm to the fetus when administered to a pregnant woman.

Cytotec may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by Cytotec may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID-induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus.

Labor and delivery Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. Uterine activity and fetal status should be monitored by trained obstetrical personnel in a hospital setting.

The risk of uterine rupture associated with misoprostol use in pregnancy increases with advancing gestational ages and prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture. The use of Cytotec outside of its approved indication may also be associated with meconium passage, meconium staining of amniotic fluid, and Cesarean delivery.

Maternal shock, maternal death, fetal bradycardia, and fetal death have also been reported with the use of misoprostol. Cytotec should not be used in the third trimester in women with a history of Cesarean section or major uterine surgery because of an increased risk of uterine rupture.

Cytotec should not be used in cases where uterotonic drugs are generally contraindicated or where hyperstimulation of the uterus is considered inappropriate, such as cephalopelvic disproportion, grand multiparity, hypertonic or hyperactive uterine patterns, or fetal distress where delivery is not imminent, or when surgical intervention is more appropriate.

The effect of Cytotec on later growth, development, and functional maturation of the child when Cytotec is used for cervical ripening or induction of labor has not been established. Information on Cytotec's effect on the need for forceps delivery or other intervention is unknown. The use of Cytotec misoprostol for the management of postpartum hemorrhage has been associated with reports of high fevers greater than 40 degrees Celsius or degrees Fahrenheit , accompanied by autonomic and central nervous system effects, such as tachycardia, disorientation, agitation, and convulsions.

These fevers were transient in nature. Supportive therapy should be dictated by the patient's clinical presentation.

Nursing mothers Misoprostol is rapidly metabolized in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol.

Caution should be exercised when misoprostol is administered to a nursing woman. Pediatric use Safety and effectiveness of Cytotec in pediatric patients have not been established. Adverse Reactions The following have been reported as adverse events in subjects receiving Cytotec: Gastrointestinal In subjects receiving Cytotec or mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain.

Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if Cytotec is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Cytotec with magnesium-containing antacids.

Gynecological Women who received Cytotec during clinical trials reported the following gynecological disorders: Postmenopausal vaginal bleeding may be related to Cytotec administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. Elderly There were no significant differences in the safety profile of Cytotec in approximately ulcer patients who were 65 years of age or older compared with younger patients.

Additional adverse events which were reported are categorized as follows: However, there were no significant differences between the incidences of these events for Cytotec and placebo. Causal relationship unknown The following adverse events were infrequently reported.

Causal relationships between Cytotec and these events have not been established but cannot be excluded: Body as a whole: Overdosage The toxic dose of Cytotec in humans has not been determined. Cumulative total daily doses of mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system.

The use of Cytotec delivery of its approved indication may also be associated with meconium passage, meconium staining of amniotic fluid, and Cesarean delivery. Cytotec is available only as a unit-of-use package that includes a leaflet containing patient information. Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient, but the drug's teratogenic mechanism has not been demonstrated. Cytotec valium with headache for be taken by anyone with a history of allergy to prostaglandins. Cytotec has been prescribed for the patient's specific condition, cytotec for delivery, may not be the correct treatment for another person, and may be dangerous to the other person if she were to cytotec pregnant, cytotec for delivery. Adverse Reactions The following have been reported as adverse events in subjects receiving Cytotec: Cytotec should not be used in deliveries where uterotonic drugs are generally contraindicated or where hyperstimulation of the uterus is considered inappropriate, such as cephalopelvic disproportion, grand multiparity, hypertonic or hyperactive uterine patterns, or fetal distress where delivery is not imminent, or when surgical intervention is more appropriate. Prostaglandins such as Cytotec may augment the activity of oxytocic agents, especially when given less than cytotec hours prior to initiating oxytocin treatment, cytotec for delivery. Additional adverse events which were reported are categorized as follows: Concomitant use is not recommended. The mutagenic potential of For was tested in several in vitro assays, all of which were negative. Labor and delivery Cytotec can induce or augment uterine contractions.


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