Oxyla Adverse Reactions



PT Novell


Prosweal Healthcare
Full Prescribing Info
Adverse Reactions
When oxytocin is used by I.V. infusion for the induction or enhancement of labor, administration 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.
Rapid I.V. bolus injection of oxytocin at doses amounting to several IU may result in acute short-lasting hypotension accompanied with flushing and reflex tachycardia (see Precautions). These rapid hemodynamic changes may result in myocardial ischemia, particularly in patients with pre-existing cardiovascular disease. Rapid I.V. bolus injection of oxytocin at doses amounting to several IU may also lead to QTc prolongation.
In rare circumstances (i.e. incidence rate <0.0006), the pharmacological induction of labor using uterotonic agents, including oxytocin, increases the risk of postpartum disseminated intravascular coagulation (see Precautions).
Water Intoxication: Water intoxication associated with maternal and neonatal hyponatraemia has been reported in cases where high doses of oxytocin have been administered together with large amounts of electrolyte-free fluid over a prolonged period of time (see Precautions).
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 hyponatraemia (see Precautions).
The following adverse drug reactions have been reported regardless of the mode of administration.
Adverse reactions (Tables 1 and 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliable estimate their frequency which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness. (See Tables 1 and 2).

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