Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Naloxone hydrochloride must be given with caution to patients who have received high doses of opioids or are physically dependent on opioids. Too rapid reversal of the opioid effect can cause an acute withdrawal syndrome in such patients. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described. This also applies to newborn infants of such patients.

Patients who respond satisfactorily to naloxone hydrochloride must be closely monitored. The effect of opioids can be longer than the effect of naloxone hydrochloride and new injections may be necessary.

Naloxone hydrochloride is not effective in central depression caused by agents other than opioids.
Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs respiration should be mechanically assisted.

Following the use of opioids during surgery, excessive dosage of naloxone hydrochloride should be avoided, because it may cause excitement, increase in blood pressure and clinically important reversal of analgesia. A reversal of opioid effects achieved too rapidly may induce nausea, vomiting, sweating or tachycardia.

Naloxone hydrochloride has been reported to induce hypotension, hypertension, ventricular tachycardia, fibrillation and pulmonary oedema. These adverse effects have been observed postoperatively most often in patients who have cardiovascular diseases or who have used medicines with similar cardiovascular adverse effects. Although no direct causative relations have been shown, caution should be used in administering naloxone hydrochloride to patients with heart diseases or to patients who are taking relatively cardiotoxic drugs causing ventricular tachycardia, fibrillation and cardiac arrest (e.g.
cocaine, methamphetamine, cyclic antidepressants, calcium channel blockers, beta-blockers, digoxin).
See section 4.8.

This medicinal product contains less than 1 mmol sodium (23 mg) per 1ml, i.e. essentially ‘sodium- free’.

Effects on Driving

4.7   Effects on ability to drive and use machines

Patients who have received naloxone hydrochloride to reverse the effects of opioids should be warned not to take part in road traffic, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.