Naloxone 400 Micrograms/Ml Solution For Injection
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NALOXONE 400 MICROGRAMS/ML SOLUTION FOR INJECTION OR INFUSION
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same
_as yours.>_
The name of your product is Naloxone 400 micrograms/ml solution for injection or infusion. In the rest of this leaflet it is called Naloxone Injection.
In this leaflet:
1. What Naloxone Injection is and what it is used for
2. Before you are given Naloxone Injection
3. How Naloxone Injection is given
4. Possible side effects
5. Storing Naloxone Injection
Naloxone 400 micrograms/ml Injection
- The active substance is naloxone hydrochloride (dihydrate) 440 micrograms. Equivalent to 400 micrograms/ml of naloxone hydrochloride.
- The other ingredients are sodium chloride, water for injections, sodium hydroxide and hydrochloric acid.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, UK.
1. WHAT NALOXONE IS AND WHAT IT IS USED FOR
Naloxone belongs to a group of medicines known as opioid antagonists.
It is used to treat very shallow breathing caused by opioid pain killers. It may also be used to diagnose opioid overdose.
2. BEFORE YOU ARE GIVEN NALOXONE 400 MICROGRAMS/ML INJECTION
You should not be given Naloxone Injection:
if you are hypersensitive (allergic) to Naloxone or any of the other ingredients of Naloxone Injection just before delivery if you are pregnant
You should let your doctor know if you are dependent on opioid painkillers such as diamorphine (heroin), even if you are being treated with methadone, as naloxone may cause withdrawal symptoms.
Care should also be taken if you have problems with your heart or circulation, if you are on medicines which depress the function of the heart, if you have recently been given a large dose of an opioid painkiller, or of you have been given an opioid for pain after an operation.
Pregnancy
Inform your doctor if you are pregnant Breast-feeding
Inform your doctor if you are breast feeding Taking other medicines:
Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
Naloxone may interfere with the actions of other medicines. These include:
• Opioid or opioid-like painkillers, such as pentazocine and fentanyl
Driving and operating machinery
Naloxone has no known effect on your ability to drive or operate machinery.
3. HOW NALOXONE 400 MICROGRAMS/ML INJECTION IS GIVEN
The nurse or doctor will give you an injection.
Your doctor will decide the dose that is best for you. The dose administered will be dependent on what is wrong with you and where the injection is given.
The injection may be given into the muscle, vein or skin.
Patients treated with Naloxone must be kept under observation as repeated doses may be needed.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Naloxone can cause side effects in some patients particularly when treatment is first started. Common side-effects include feeling sick and being sick.
Other effects which some patients have had with naloxone include: disturbances of the heart rhythm, low or high blood pressure, heart failure, heart stoppage, difficulty in breathing, shortness of breath, large amounts of fluid in the lungs, tingling hands and feet, trembling, fits, changes in behaviour including violent behaviour, nervousness, restlessness, excitement and irritability.
Opioid withdrawal syndrome (symptoms of which include but are not limited to diarrhoea; feeling sick and being sick; abdominal and muscle cramps; muscle trembling; weakness; hair standing on end; sweating; anxiety; irritability; restlessness; raised blood pressure; faster heart beat; yawning; “runny” nose; sneezing; fever) has also been reported in patients physically dependent on opioids and in patients who have had large doses of opioids.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or nurse.
5. STORING NALOXONE 400 MICROGRAMS/ML INJECTION
Keep out of the reach and sight of children Do not store above 25°C.
Store in the original package
Keep the container in the outer carton in order to protect from light Do not use after the expiry date stated on the ampoule
This leaflet was last revised: May 2008 -------------------------------------------------V----
1 NAME OF THE MEDICINAL PRODUCT
Naloxone 400 micrograms/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml contains naloxone hydrochloride (dihydrate) 0.44mg This is equivalent to 0.40mg/ml of anhydrous naloxone hydrochloride
For excipients, see 6.1
3 PHARMACEUTICAL FORM Solution for injection or Infusion
A clear, colourless solution free from particulate matter.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Naloxone is indicated for the treatment of respiratory depression induced by natural and synthetic opioids. It may also be used for the diagnosis of suspected acute opioid overdosage.
4.2 Posology and method of administration
Naloxone injection is for intravenous (iv), intramuscular (im) or subcutaneous (sc) injection.
Opioid overdosage (known or suspected)
Adults:
An initial dose of 400 micrograms to 2mg of naloxone may be administered intravenously. If the desired degree of counteraction and improvement in respiratory function is not obtained it may be repeated at two to three minute intervals. If no response is observed after 10mg of naloxone being administered the diagnosis of opioid-induced or partial opioid induced toxicity should be questioned. Intramuscular or subcutaneous administration may be necessary if dosing by the intravenous route is not feasible.
Post-operative Use:
When naloxone is used post-operatively, the dose should be titrated for each patient in order to obtain respiratory response while maintaining analgesia. An intravenous dose of 1.5 - 3.0 micrograms/kg body weight is usually sufficient, but a full two minutes should be allowed between each 100 microgram increment of naloxone administered. Further intramuscular doses may be needed within one to two hours, depending on the interval since the last opioid administration and the amount and type (i.e. long or short acting) of drug used. Alternatively, naloxone may be administered as an intravenous infusion (see below).
Children:
The usual initial dose in children is 5-10 micrograms per kg body-weight given intravenously. If this does not result in the desired degree of clinical improvement, a subsequent dose of 100 micrograms per body weight may be administered. Naloxone may be administered intramuscularly or subcutaneously in divided doses.
Intravenous Infusion (iv)
In situations where one of the longer acting opioids is known or suspected to be the cause of the symptoms, IV infusion of naloxone is recommended to produce sustained antagonism to the opioid (without antagonism of pain relief) rather than repeated injection.
Naloxone may be diluted for intravenous infusion in normal saline (0.9%) or 5% dextrose in water or saline.
Mixtures should be used within 24 hours. Any remaining unused solution must then be discarded. The rate of administration should be titrated in accordance with the patient's response.
4.3 Contraindications
Naloxone should not be given to patients who are known to be hypersensitive to it.
4.4 Special warnings and precautions for use
Patients who have responded satisfactorily to naloxone should be kept under observation. Repeated doses may be necessary since the duration of action of some opioids may exceed that of naloxone.
Naloxone is not effective against respiratory depression caused by nonopioid drugs.
Cautions: cardiovascular disease or concomitant cardiotoxic drugs as serious adverse cardiovascular effects have been reported (see section 4.8 Undesirable effects); physical dependence on opioids (including patients being treated with methadone), or after large doses of opioids, as naloxone may precipitate acute withdrawal syndrome (see section 4.8 Undesirable effects).
Naloxone may antagonise the analgesic effects of the opioids in the control of postoperative pain.
4.5 Interaction with other medicinal products and other forms of interaction
Naloxone should be used with caution in patients who are opioid dependent (including patients being treated with methadone), as it may precipitate an acute withdrawal syndrome.
Naloxone reverses the analgesic effects of opioid analgesics (e.g. nalbupine, pentazocine) and opioid agonist analgesics (e.g. alfentanil, fentanyl, remifentanil).
4.6 Pregnancy and lactation
Naloxone crosses the placenta; adequate and well-controlled studies in humans have not been done, therefore naloxone, like all drugs, should be used with caution during pregnancy. Risk-benefit must be considered before naloxone is administered to a pregnant woman who is known or suspected to be opioid dependent because naloxone may precipitate withdrawal in the foetus as well as the mother.
It is not generally advisable to give naloxone just prior to delivery as blocking endogenous endorphins may affect the ability of the foetus to withstand the stress of delivery.
It is not known if naloxone is distributed into breast milk. Problems in humans have not been documented.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Cardiac disorders: atrial and ventricular dysrhythmias, including atrial premature contractures, ventricular tachycardia and fibrillation, asystole, hypotension, hypertension, left ventricular failure and cardiac arrest.
Gastrointestinal disorders: Nausea and vomiting.
General disorders and administration site conditions: Opioid withdrawal symptoms- sweating, yawning, rhinorrhoea, sneezing, muscle tremor, weakness, anxiety, irritability, restlessness, nausea, vomiting, diarrhoea, abdominal and muscle cramps, piloerection, increases in heart rate (tachycardia), blood pressure and temperature (fever). Acute withdrawal syndrome may include, but is not limited to the above listed signs and symptoms. Acute withdrawal effects after naloxone have only been reported in individuals physically dependent on opioids or after large doses of opioids.
Nervous system disorders: tingling/numbness of the extremities, trembling and generalised convulsions.
Psychiatric disorders: behavioural changes, including violent behaviour, nervousness, restlessness, excitement, irritability.
Respiratory, thoracic and mediastinal disorders: Pulmonary oedema and dyspnoea.
4.9 Overdose
No documented reports of acute overdosage, either accidental or nonaccidental, are available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Naloxone is a specific narcotic antagonist and finds particular use in the off-set of respiratory depression caused by opioids.
5.2 Pharmacokinetic proporties
Naloxone acts within two minutes of intravenous injection and usually within three to five minutes of subcutaneous or intramuscular injection. The plasma half life is approximately one to two hours.
5.3 Preclinical safety data
Animal toxicity and reproductive studies have not revealed any mutagenic, carcinogenic, teratogenic or embryotoxic effects, nor impaired fertility.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride Water for injections Sodium hydroxide Hydrochloric acid
6.2 Incompatibilities
Naloxone is stable in the range pH 2.5-5.0, but should not be added to infusion solutions with an alkaline pH. It is not compatible with solutions containing bisulphate, sulphites, or long chain/high molecular weight anions.
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 25°C Store in the original container
6.5 Nature and contents of container
1ml clear glass ampoules Type 1 (Ph.Eur)
Packs of 3, 10 or 50 ampoules
6.6 Special precautions for disposal
None
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK.
8. MARKETING AUTHORISATION NUMBER(S)
PL 29831/0148
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15 June 2007
10 DATE OF REVISION OF THE TEXT
May 2008