Oxyla Special Precautions



PT Novell


Prosweal Healthcare
Full Prescribing Info
Special Precautions
Induction of labour: The induction of labor by means of oxytocin should be attempted only when strictly indicated for medical reasons rather than for convenience. Administration should only be under hospital conditions and qualified medical supervision.
Oxytocin (Oxyla) should not be used for prolonged periods in patients with oxytocin-resistant uterine inertia, severe pre-eclamptic toxemia or severe cardiovascular disoders.
Oxytocin (Oxyla) should not be given as I.V. bolus injection as it may cause an acute short-lasting hypotension accompanied with flushing and reflex tachycardia.
Cardiovascular disorders: Oxytocin (Oxyla) should be used with caution in patients who have pre-disposition to myocardial ischemia due to pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, vascular heart disease and/or ischemic heart disease including coronary artery vasospasm), to avoid significant changes in blood pressure and heart rate in these patients.
QT Syndrome: Oxytocin (Oxyla) should be given with caution to patients with known long QT syndrome or related symptoms and to patients taking drugs that are known to prolong the QT interval (see Interactions).
When oxytocin (Oxyla) is given for induction and enhancement of labor: It must only be administered as an I.V. infusion, and never by S.C., I.M or I.V. bolus injection.
Fetal distress and fetal death: Administration of oxytocin at excessive doses results in uterine overstimulation which may cause fetal distress, asphyxia and death, or may lead to hypertonicity, tetanic contractions or rupture of the uterus. Careful monitoring of fetal heart rate and uterine motility (frequency, strength and duration of contractions) is essential, so that the dosage may be adjusted to individual response.
Particular caution is required in the presence of borderline cephalopelvic disproportion, secondary uterine inertia, mild or moderate degrees of pregnancy-induced hypertension of cardiac disease and in patients above 35 years of age or with a history of lower-uterine-segment caesarean section.
Disseminated intravascular coagulation: In rare circumstances, the pharmacological induction of labor using uterotonic agents including oxytocin increases the risk of postpartum disseminated intravascular coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk. This risk is increased in particular if the woman has additional risk factors for DIC such as being 35 years of age or over, complications during the pregnancy and gestational age more than 40 weeks. In these women, oxytocin or any other alternative drug should be used with care, and the practitioner should be alerted by signs of DIC.
Intrauterine death: In the case of fetal death in utero, and/or in the presence of meconium-stained amniotic fluid, tumultuous labor must be avoided, as it may cause amniotic fluid embolism.
Water intoxication: Because oxytocin possesses slight antidiuretic activity, its prolonged I.V. administration at high doses in conjunction with large volumes of fluid, as may be the case in the treatment of inevitable or missed abortion, or in the management of postpartum hemorrhage, may cause water intoxication associated with hyponatremia. The combined antidiuretic effect of oxytocin and the I.V. fluid administration may cause fluid overload leading to a hemodynamic form of acute pulmonary edema without hyponatremia. To avoid these rare complications, the following precautions must be observed whenever high doses of oxytocin are administered over a long time; an electrolyte-containing diluent must be used (not dextrose); the volume of infused fluid should be kept low (by infusing oxytocin at a higher concentration than recommended for the induction or enhancement of labor at term); fluid intake by mouth must be restricted; a fluid balance chart should be kept and serum electrolytes should be measured when electrolyte imbalance is suspected.
Caution should be exercised in patients with severe renal impairment because of possible water retention and possible accumulation of oxytocin.
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