NALOXONE Solution for injection/infusion Ref.[7005] Active ingredients: Naloxone

Posology

Complete or partial reversal of CNS and especially respiratory depression, caused by natural or synthetic opioids

Adults

Dosage is determined for each patient in order to obtain optimum respiratory response while maintaining adequate analgesia. An i.v. injection of 0.1 to 0.2 mg naloxone hydrochloride (approx. 1.5-3 µg/kg) is usually sufficient. If necessary, additional i.v. injections of 0.1 mg can be administered at 2 minute intervals until satisfactory respiration and consciousness are obtained. An additional injection can again be necessary within 1 to 2 hours, depending on the type of active substance to be antagonised (short-term effect or slow release), the amount administered and time and mode of administration. Naloxone 400 micrograms/ml can alternatively be administered as an i.v. infusion.

Infusion: The duration of action for some opioids is longer than that of the naloxone hydrochloride i.v. bolus. Therefore, in situations where depression is known to be induced by such substances or there is a reason to suspect this, naloxone hydrochloride should be administered as a continuous infusion. The infusion rate is determined according to the individual patient, depending on the response of the patient to the i.v. bolus and on the reaction of the patient to the i.v. infusion. The use of the continuous intravenous infusion should be carefully considered and respiratory assistance should be applied if necessary.

Children

Initially, 0.01-0.02 mg naloxone hydrochloride per kg i.v. at intervals of 2-3 minutes until satisfactory respiration and consciousness are obtained. Additional doses may be necessary at 1- to 2-hours intervals depending on the response of the patient and the dosage and duration of action of the opiate administered.

Diagnosis and treatment of suspected acute opioid overdose or intoxication

Adults

The initial dose is usually 0.4-2 mg naloxone hydrochloride i.v. If the desired improvement in the respiratory depression is not obtained immediately after i.v. administration, the injections can be repeated at intervals of 2-3 minutes. Naloxone 400 micrograms/ml can also be injected intramuscularly (initial dose usually 0.4-2 mg) if intravenous administration is not possible. If 10 mg naloxone hydrochloride does not produce a significant improvement, this suggests that the depression is wholly or partially caused by other pathological conditions or active substances other than opioids.

Children

The usual starting dose is 0.01 mg naloxone hydrochloride per kg i.v. If the satisfactory clinical response is not achieved, the dose can be increased in the next injection to 0.1 mg/kg. Depending on the individual patient, an i.v. infusion may also be necessary. If i.v. administration is not possible, Naloxone 400 micrograms/ml can also be injected i.m. (initial dose 0.01 mg/kg), divided into several doses.

Reversal of respiratory and other CNS depression in the neonate whose mothers have received opioids

The usual dosage is 0.01 mg naloxone hydrochloride per kg i.v. If the respiratory function is not reversed to a satisfactory level with this dosage, the injection can be repeated at 2 to 3 minute intervals. If i.v. administration is not possible, Naloxone 400 micrograms/ml can also be injected i.m. (initial dose 0.01 mg/kg).

Elderly

In elderly patients with pre-existing cardiovascular disease or in those receiving potentially cardiotoxic drugs, Naloxone 400 micrograms/ml should be used with caution since serious adverse cardiovascular effects such as ventricular tachycardia and fibrillation have occurred in postoperative patients following administration of naloxone hydrochloride.

Method of administration

The medicinal product can be injected intravenously (i.v.) or intramuscularly (i.m.) or can be given via intravenous infusion.

For incompatibilities and instructions on dilution of the product before administration, see sections 6.2 and 6.6.

The i.m. administration of Naloxone 400 micrograms/ml should only be used in cases where an i.v. administration is not possible.

The most rapid effect is obtained by means of i.v. administration, which is why this method of administration is recommended in acute cases.

When Naloxone 400 micrograms/ml is administered i.m., it is necessary to remember that the onset of action is slower than following i.v. injection; however, i.m. administration has a longer action than i.v. administration. The duration of action is dependent upon the dose and route of administration of naloxone hydrochloride, varying between 45 minutes and 4 hours.

Furthermore, it has to be considered that necessary i.m. dosages are generally higher than i.v. dosages and that dosage has to be adapted to the individual patient.

As it is possible that the duration of effect of some opioids (e.g. dextropropoxyphene, dihydrocodeine, methadone) is longer than that of naloxone hydrochloride, the patients must be kept under continuous supervision, and repeated doses must be given if necessary.

In view of the indication and the broad therapeutic margin overdose is not to be expected. Single doses of 10 mg naloxone hydrochloride i.v. have been tolerated without any adverse effects or changes in laboratory values. Higher than recommended dosage in postoperative use can lead to the return of pain and tension.

3 years.

Shelf-life after first opening: After first opening the medicinal product should be used immediately.

Shelf-life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours below 25°C.

From the microbiological point of view, the dilutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Keep the ampoules in the outer carton in order to protect from light.

Store below 25°C.

Store diluted solutions below 25°C.

Type I clear, colourless glass ampoules.

Packs of 5 or 10 ampoules of 1 ml.

Not all pack sizes may be marketed.

For i.v. infusion Naloxone 400 micrograms/ml is diluted with sodium chloride 0.9% or glucose 5%. 5 ampoules of Naloxone 400 micrograms/ml (2 mg) per 500 ml give 4 µg/ml.

This medicinal product is for single use only.

Please inspect the medicinal product visually prior to use (also after dilution). Use only clear and colourless solutions practically free from particles.