Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
NALOXONE 400 microgram/ml solution for injection or infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Naloxone hydrochloride dihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Naloxone is a drug used to counter the effects of opioid overdose, for example morphine overdose. Naloxone is used for reversal of unwanted effects of opioids for countering life-threatening depression of the central nervous system and respiratory system (breathing difficulties). Naloxone is also used to diagnose an acute opioid overdose or intoxication. 2.
What you need to know before you take it
e Naloxone
Do not use Naloxone if you are allergic to naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6). Take special care with Naloxone − if you are physically dependent to morphine or similar drugs or when you have received high doses of these drugs, you may develop withdrawal symptoms like high blood pressure, rapid heartbeat, serious respiratory problems or stop of the heartbeat. − if Naloxone must be administered to your newborn baby, as acute withdrawal symptoms can occur. − if you have cardiovascular complaints (because side effects like high and low blood pressure, rapid heartbeat or serious respiratory problems probably can occur sooner). − if you take the analgesic drug buprenorphine. In that case naloxone is effective to a limited extend (see also the paragraph ''Taking other medicines"). Please consult your doctor even if these statements were applicable to you at any time in the past. Other medicines and Naloxone Tell your doctor if you are taking, have recently taken or might take any other medicines, , including medicines obtained without a prescription.
2
Please note that these statements may also apply to products used some time ago or at some time in the future. − –
If you use analgesics, such as buprenorphine, the analgesic effects can be increased when you are treated with Naloxone. An administration of Naloxone in coma as a consequence of clonidine-overdose, serious high blood pressure has been reported. Clonidine is a medicine used in withdrawal symptoms occurring after stopping opioides. It is also administered in high blood pressure, migraine and menopausal flushes.
Naloxone with food and drink Please inform your doctor if you drank alcohol. In patients with multiple intoxication (with opioids and sedatives or alcohol) Naloxone onset of effect can be less rapid. Pregnancy and breast-feeding Pregnancy If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. There are no adequate data available on the use of Naloxone in pregnant women. During pregnancy, your doctor will outweigh the benefits of the use of Naloxone against the possible risks for the unborn baby. Naloxone can cause withdrawal symptoms in the baby (see paragraph Take special care with Naloxone). Ask your doctor or pharmacist for advice before taking any medicine. Breast-feeding It is not known whether Naloxone passes into breast milk and it has not been established whether infants who are breast-fed are affected by Naloxone. Therefore, breast-feeding is not recommended for 24 hours after treatment. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines After receiving Naloxone for the reversal of the effects of opioids you must not take part in road traffic, operate machinery or engage in any other physically or mentally demanding activity for at least 24 hours since the effects of opioids may possibly recur. Naloxone contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. 3.
How to take it
Naloxone
Dose Your doctor will determine the right dose. Adults
- i.v. injection: 0.1 to 0.2 mg naloxone hydrochloride, if necessary additional i.v. injections of 0.1 mg can be administered at 2 – 3 minute intervals. An additional injection can be necessary again within 1 to 2 hours. Children and adolescents
- Initially, i.v. injection of 0.01 – 0.02 mg naloxone hydrochloride per kg body weight, at intervals of 2 -3 minutes. Additional doses may be necessary at 1 to 2 hour intervals. The doses can be different due to local recommendations. Elderly
- In elderly patients with pre-existing heart disease or in those receiving potentially cardiotoxic drugs, naloxone hydrochloride should be used with caution. 3
Diagnosis of suspected acute opioid overdose or intoxication Adults
- Starting dose is 0.4 – 2 mg naloxone hydrochloride i.v. If needed, the dose can be repeated at 2-3 minute intervals. Children and adolescents
- Starting dose is 0.01 mg/kg body weight i.v. If a satisfactory response is not achieved, an increased additional dose of 0.1 mg/kg can be administered.
- The dose in children and adolescents can be different due to local recommendations. Neonates whose mothers have received opioids
- Usual dose is 0.01 mg/kg body weight i.v. If needed, the dose can be repeated at 2-3 minute intervals.
- The dose in neonates can be different due to local recommendations. Method of administration Nexodal can be injected into a vein (i.v.), into a muscle (i.m.) or can be given via intravenous infusion by a doctor or a nurse. The i.m. administration of naloxone hydrochloride should only be used in cases where an i.v. administration is not possible. It can be given as intravenous infusion after dilution with sodium chloride 0.9% or glucose 5%. Duration of treatment Your doctor will determine the duration of treatment. If you have the impression that the effect of Naloxone is too strong or too weak, talk to your doctor or pharmacist. If you use more Naloxone than you should If you may have received more Naloxone than you should, talk to your doctor or nurse immediately. He/she will take further measures, if necessary. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may appear: Very common (affects more than 1 user in 10): sickness, feeling of being sick Common (affects 1 to 10 users in 100): dizziness, headache, rapid heartbeat, low blood pressure, high blood pressure, vomiting, postoperative pain Uncommon (affects 1 to 10 users in 1,000): shiver, sweating, heart rhythm disturbance, slow heartbeat, diarrhoea, dry mouth, rapid and deep breathing (hyperventilation), irritation of vessel wall (after intravenous administration) 4
Rare (affects 1 to 10 users in 10,000): fits, tension Very rare (affects less than 1 user in 10,000): rapid and irregular heartbeat, stop of heartbeat, fluid accumulation in the lungs, allergic reactions (urticaria, rhinitis, respiratory difficulties, Quincke ́s oedema), anaphylactic shock, Erythema multiforme When Naloxone is administered to persons addicted to morphine or similar drugs, acute withdrawal symptoms can occur (for example high blood pressure and heart symptoms). This can also occur in babies of opioid-dependent mothers. If a too large dose is given after an operation, you may become excited and feel pain (because the painkilling effects of the medicines you were given will have been counteracted as well as the effects on your breathing). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Naloxone
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and ampoule after "exp". The expiry date refers to the last day of that month. Do not store above 25°C. Keep the ampoules in the outer carton in order to protect from light. After first opening the medicinal product must be used immediately. After dilution, the product 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 under controlled and validated aseptic conditions. This medicinal product is for single use only. Discard any unused solution. Do not use Naloxone if you notice a discolouration, cloudiness or particles in the solution. For i.v. infusion, Naloxone 0.4 mg/ml is diluted with sodium chloride 0.9% w/v or glucose 5% w/v. 5 ampoules of Naloxone 0.4 mg/ml (2 mg) diluted to 500 ml give a final concentration of 4 microgram/ml. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6.
Contents of the pack and other information
What Naloxone contains The active substance is naloxone hydrochloride. Each ampoule of 1 ml of solution for injection or solution contains 400 microgram/ml naloxone hydrochloride (as naloxone hydrochloride dihydrate). The other ingredients are sodium chloride, hydrochloric acid (diluted) and water for injections.
5
What Naloxone looks like and contents of the pack Naloxone is a clear and colourless solution for injection or solution. Naloxone is available in packs with 10 ampoules of 1 ml solution of injection or solution. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Orpha-Devel Handels und Vertriebs GmbH 3002 Purkersdorf, Austria Manufacturer AOP Orphan Pharmaceuticals GmbH A-1190 Vienna, Austria This medicinal product is authorised in the Member States of the EEA under the following names: Estonia, Nexodal 0,4 mg/ml süste-/infusioonilahus Finland, Nexodal 0,4 mg/ml injektio-/infuusioneste, liuos Hungary, Nexodal 0,4 mg/ml oldatos injekció vagy infúzió Ireland, Naloxone 400 microgram/ml solution for injection or infusion Netherlands, Naloxon Orpha 0,4 mg/ml oplossing voor injectie of infusie Romania, Nexodal 0,4 mg/ml soluţie injectabilă sau perfuzabilă Slovenia, Nexodal 0,4 mg/ml raztopina za injiciranje ali infundiranje United Kingdom, Naloxone 400 microgram/ml solution for injection or infusion This leaflet was last last revised in 12/2021
6
Frequently asked questions about NALOXONE 400 microgram/ml solution for injection or infusion
How do I take NALOXONE 400 microgram/ml solution for injection or infusion?
NALOXONE 400 microgram/ml solution for injection or infusion comes as injection containing 400microgram/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in NALOXONE 400 microgram/ml solution for injection or infusion?
The active substance in NALOXONE 400 microgram/ml solution for injection or infusion is naloxone hydrochloride dihydrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for NALOXONE 400 microgram/ml solution for injection or infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get NALOXONE 400 microgram/ml solution for injection or infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: naloxone hydrochloride dihydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Complete or partial reversal of CNS depressive effects, especially respiratory depression, caused by natural or synthetic opioids and partial agonist/antagonist opioids.
Diagnosis of suspected acute opioid overdose or intoxication.
4.2. Posology and method of administration
Method of administration
The medicinal product can be injected intravenously (i.v.), 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 hydrochloride 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 hydrochloride 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 action of some opioids is longer than that of naloxone hydrochloride, the patient must be constantly monitored and repeated doses must be administered, if necessary.
Posology
Complete or partial reversal of CNS depressive effects, especially respiratory depression, caused by natural or synthetic opioids and partial agonist/antagonist opioids.
Adults
Dosage is determined for each patient in order to obtain optimum respiratory response while maintaining adequate analgesia. An i.v. injection of 100 to 200 microgram naloxone hydrochloride is usually sufficient. If necessary, additional i.v. injections of 100 microgram can be administered at 2 - 3 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 microgram/ml can alternatively be administered as an i.v. infusion, if the duration of action for some opioids is longer than that of the naloxone hydrochloride i.v. bolus.
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 (see section 6.6).
Children and adolescents
Initially, 10-20 microgram 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.
The dose in children and adolescents can be different due to local recommendations.
Elderly
In elderly patients with pre-existing cardiovascular disease or in those receiving potentially cardiotoxic drugs, naloxone hydrochloride 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.
Diagnosis and treatment of suspected acute opioid overdose or intoxication
Adults
The usual starting dose for adults is 400-2000 microgram naloxone hydrochloride, administered intravenously. If the desired degree of reversal and improvement of the respiratory function are not attained directly after the i.v. injection, the injection can be repeated intravenously at 2-3 minute intervals. Naloxone hydrochloride can also be injected intramuscularly, if i.v. 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 than opioids.
Children and adolescents
The usual starting dose is 10 microgram naloxone hydrochloride/kg body weight i.v. If a satisfactory clinical response is not achieved, an increased additional dose of 100 microgramm/kg can be administered. Depending on the individual patient, an i.v. infusion may also be necessary. If i.v. administration is not possible, Naloxone 400 microgram/ml can also be injected i.m. (initial dose 10 microgram/kg), divided into several doses.
The dose in children and adolescents can be different due to local recommendations.
Neonates whose mothers have received opioids
The usual dosage is 10 microgram 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 microgram/ml can also be injected i.m. (initial dose 10 microgram/kg).
The dose in neonates can be different due to local recommendations.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Naloxone 400 microgram/ml should be given with caution to patients,who have received high doses of opioids or are physically dependent on opioides (including neonates born to women who are opioid dependent). In such cases a prompt and complete reversal of opioid effects by a too high dose of Naloxone may precipitate acute withdrawal symptoms. Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described. This also applies to newborn infants of such patients.
Patients who have responded satisfactorily to naloxone hydrochloride treatment must be carefully monitored. The effect of opioids can be longer than the effect of naloxone hydrochloride and new injections may be necessary.
Too large doses of naloxone hydrochloride in post-operative patients may result in a clear reversal in analgesia, excitement and an elevation in blood pressure. A reversal of opioid effects achieved too rapidly may induce nausea, vomiting, sweating or tachycardia.
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.
Naloxone should be used with caution in patients with pre-existing cardiovascular disease or in patients who are taking relatively cardiotoxic drugs (e.g. calcium channel blockers, beta-blockers, digoxin) (see section 4.8).
This medicine contains less than 1 mmol sodium (23 mg) per ampoule (1ml), that is to say essentially 'sodium-free'. Each ampoule of 1 ml solution contains 3.54 mg sodium.
4.5. Interaction with other medicinal products and other forms of interaction
The effect of naloxone is based on the interaction with opioids and opioid agonists. At the usual naloxone dose there is no interaction with barbiturates and tranquillizers. Data on the interaction with alcohol are not uniform. In patients with multiple intoxication with opioids and sedatives or alcohol, the result of naloxone administration may be delayed, dependent on the cause of intoxication.
In administration of naloxone to patients that had buprenorphine as analgesic, complete analgesia can be restored. It is assumed that this effect is caused by the arched form of the dose-response curve of buprenorphine with decreasing analgesia at (too) high doses. However, reversal of respiratory depression caused by buprenorphine is limited.
In administration of naloxone in coma caused by clonidine-overdosing, serious hypertension has been reported.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data available on the use of naloxone hydrochloride in pregnant women.
Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. The medicinal product should not be used during pregnancy unless clearly necessary.
Naloxone hydrochloride can cause withdrawal symptoms in the new-born infant (see section 4.4).
Breast-feeding
It is not known whether naloxone hydrochloride passes into breast milk and it has not been established whether infants who are breast-fed are affected by naloxone hydrochloride. Therefore, breast-feeding should be avoided for 24 hours after treatment.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Patients who have received naloxone hydrochloride to reverse the effect 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 exertation for at least 24 hours, since the effect of the opioids may return.
4.8. Undesirable effects
The following undesirable effects are ranked according to system organ class and to their frequency:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Very common (≥ 1/10)
Common (≥1/100 to < 1/10)
Uncommon (≥1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
Immune system disorders
Very rare:
Allergic reactions (urticaria, rhinitis, dyspnoea, Quincke's oedema), anaphylactic shock
Nervous system disorders
Common:
Dizziness, headache
Uncommon:
Tremor, sweating
Rare:
Seizures, tension
Seizures have occurred rarely following administration of naloxone hydrochloride; however, a causal relationship to the drug has not been established. Higher than recommended dosage in postoperative use can lead to tension.
Cardiac disorders
Common:
Tachycardia
Uncommon:
Arrhythmia, bradycardia
Very rare:
Fibrillation, cardiac arrest
Vascular disorders
Common:
Hypotension, hypertension
Hypotension, hypertension and cardiac arrhythmia (including ventricular tachycardia and fibrillation) have also occurred with the postoperative use of naloxone hydrochloride. Adverse cardiovascular effects have occurred most frequently in postoperative patients with a pre-existing cardiovascular disease or in those receiving other drugs that produce similar adverse cardiovascular effects.
Respiratory, thoracic and mediastinal disorders:
Very rare:
Pulmonary oedema
Pulmonary oedema has also occurred with the postoperative use of naloxone hydrochloride.
Gastrointestinal disorders
Very common:
Nausea
Common:
Vomiting
Uncommon:
Diarrhoea, dry mouth
Nausea and vomiting have been reported in postoperative patients who have received doses higher than recommended. However, a causal relationship has not been established, and the symptoms may be signs of too rapid antagonisation of the opioid effect.
Skin and subcutaneous tissue disorders:
Very rare:
Erythema multiforme
One case of erythema multiforme cleared promptly after naloxone hydrochloride was discontinued.
General disorders and administration site conditions
Common:
Postoperative pain
Uncommon:
Hyperventilation, irritation of vessel wall (after i.v. administration)
Higher than recommended dosage in postoperative use can lead to the return of pain. A fast reversal of opioid effect can induce hyperventilation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Regarding the indication and the wide therapeutic index, overdosing is not to be expected.
Single doses of 10 mg naloxone hydrochloride intravenously and cumulative doses up to 90 mg/day subcutaneously have been tolerated without undesirable effects or changes in laboratory parameters.
Thus far no cases of intoxication are known.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- FORVEL 0,4 mg/ml prescriptionNALOXONUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Naloxone AccordNaloxoni hydrochloridum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about NALOXONE 400 microgram/ml solution for injection or infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.