Naloxone 400 Micrograms/Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Naloxone 400 micrograms/ml Solution for Injection or Infusion Naloxone Hydrochloride (dihydrate)
Read all of this leaflet carefully before you start using
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. See section 4.
The name of your medicine 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 should be given
4. Possible side effects
5. How to store Naloxone Injection
6. Contents of the pack and other information
1. WHAT NALOXONE INJECTION IS AND WHAT IT IS USED FOR
The active ingredient in Naloxone Injection is naloxone hydrochloride which belongs to a group of medicines called opioid antagonists. These drugs reverse the actions of opioids. Opioids are used as pain killers (e.g. codeine, morphine). However some of them are abused by drug addicts (e.g. heroin).
Nalaxone Injection is used to treat very shallow breathing caused by opioid use. It may also be used to diagnose opioid use.
2. BEFORE YOU ARE GIVEN NALOXONE INJECTION
You should not be given Naloxone Injection:
• if you are allergic to naloxone hydrochloride or any
of the other ingredients contained in Naloxone Injection (see list under heading ‘What Naloxone Injection contains' in section 6)
If the above statement applies to you, you should tell your doctor or nurse
Speak to your doctor before you are given Naloxone Injection if you:
• have problems with your heart or blood vessels
• are taking medicines that can affect the normal functioning of the heart (e.g. cyclic antidepressants
- used to treat depression, bipolar disorder, anxiety, and other mood disorders, calcium channel blockers
- used to treat high blood pressure, angina, Raynaud's phenomenon and abnormal heart rhythms, beta-blockers - used to treat angina, heart failure and high blood pressure, digoxin - used to treat heart failure).
• are dependent on opioids
• are being treated with methadone
• have recently taken a large dose of an opioid
• have recently been given an opioid for pain (e.g. during or after an operation)
Taking other medicines
Taking another medicine while you are being given Naloxone Injection can affect how it or the other medicine works.
Please inform your doctor or nurse if you are taking or have recently taken any other medicines or drugs, including those you may have bought yourself without a prescription.
Please check with your doctor if you are taking or have been given any of the following (or any other medication):
• opioid or opioid-like pain killers, such as pentazocine, nalbupine, fentanyl, alfentanil or remifentanil
• opioids for any other reason (e.g. heroin)
• methadone
If you have any doubts about whether you should be given this medicine then discuss matters with your doctor.
Pregnancy and breast-feeding
You should speak to your doctor before being given Naloxone Injection if you are pregnant or wish to become pregnant. Pregnant women who are opioid dependent must consult their doctor before being given Naloxone Injection as there is a chance that the newborn child could experience withdrawal symptoms as well as the mother.
You should not generally receive Naloxone Injection just before delivery of your baby.
You should speak to your doctor if you are breast-feeding or wish to breast-feed whilst being given Naloxone Injection.
Driving and using machines
Naloxone Injection does not affect the ability to drive or operate machinery.
Naloxone Injection contains sodium chloride
This medicinal product contains less than 1 mmol sodium (23mg) per ampoule, i.e. it is essentially ‘sodium-free'.
3. HOW NALOXONE INJECTION SHOULD BE GIVEN
Your nurse or doctor will give you your injection. Your injection may be given into a muscle, vein or just under the skin.
Alternatively, under certain circumstances Naloxone Injection may be given over a period of time as an infusion into a vein via a drip. Your doctor or nurse will dilute Naloxone Injection in water or a salt solution prior to giving you an infusion.
Patients treated with Naloxone Injection must be kept under observation as repeated doses may be needed.
To diagnose or treat an opioid overdose Adults
An initial dose of 400 micrograms to 2mg of Naloxone Injection may be given into a vein. This may be repeated at two to three minute intervals until your breathing improves. If it does not improve after 10mg Naloxone Injection has been given you may not have an opioid overdose.
After an operation Adults
The usual dose is 1.5 - 3.0 micrograms per kg body weight given into a vein. Additional doses may be given every two minutes until your breathing is under control but you are still free of pain. Further doses into the muscle 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.
Use in children
The usual initial dose in children is 5-10 micrograms per kg body-weight given into a vein.
A subsequent dose of 100 micrograms per kg body weight may be administered.
Naloxone Injection may be administered into a muscle or under the skin in divided doses.
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The following information is intended for healthcare professionals only:
SUMMARY OF PRODUCT CHARACTERISTICS
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 full list of excipients, see section 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 non-opioid drugs.
Cautions: cardiovascular disease or concomitant cardio toxic 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).
If you are given more Naloxone Injection than you should
5. HOW TO STORE NALOXONE INJECTION
Keep this medicine out of the sight and reach of children.
A doctor or nurse will give you this medicine. If you think that you have been given too much, inform your doctor or nurse.
If you think you have missed a dose of Naloxone Injection
A doctor or nurse will give you this medicine. If you think you have missed a dose, inform your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
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Product name |
Reference number |
|
Naloxone 400 micrograms/ml Solution for Injection or Infusion |
29831/0148 |
Like all medicines, this medicine can cause side effects, although not everybody gets them.
if you experience any of the following symptoms, contact your doctor or nurse IMMEDIATELY:
Opioid withdrawal syndrome. This can occur in patients who are physically dependent on opioids (including patients being treated with methadone) and in patients who have had large doses of opioids. Symptoms include:
• diarrhoea
• feeling sick
• 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
Heart problems
• disturbances of the rhythm of your heart e.g. a faster or slower heartbeat than usual or an irregular heartbeat
• low blood pressure - symptoms include dizziness, light headedness, fainting, confusion, palpitations, nausea
• high blood pressure - symptoms include persistent headache, blurred or double vision, nosebleeds
• heart failure - symptoms include breathlessness, extreme tiredness, swollen ankles which may extend up the legs
• heart stoppage - symptoms include breathing difficulties and unconsciousness
Other symptoms include:
Lack of pain control
• Naloxone Injection might prevent your opioid pain killer from working properly
Breathing problems
• difficulty in breathing
• shortness of breath
• fluid in your lungs - symptoms include wheezing or gasping for breath, feelings of suffocating,
or a cough that produces frothy sputum that may be tinged with blood.
Problems with your nervous system
• tingling hands and feet
• trembling
• fits
Psychiatric disorders
• changes in behaviour including violent behaviour
• nervousness
• restlessness
• excitement
• irritability
Problems with your digestive tract
• feeling sick
• being sick
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or nurse immediately.
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 non-accidental, 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.
This medicine should not be used if the expiry date on the ampoule has passed. The expiry date refers to the last day of that month.
This medicine should not be stored above 25°C.
Store the ampoule in the outer carton in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Naloxone Injection contains
The active ingredient in Naloxone Injection is naloxone hydrochloride. Each 1ml contains 0.44mg naloxone hydrochloride (dihydrate), equivalent to 0.4 mg/ml of anhydrous naloxone hydrochloride.
The other ingredients are sodium chloride, water for injections, sodium hydroxide and hydrochloric acid.
What Naloxone Injection looks like and contents of the pack
The injection is a clear, colourless solution in a 1ml clear glass ampoule.
The ampoules are available is packs of 3, 10 or 50 ampoules.
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
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This leaflet was last revised in September 2015.
103077/3
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5.2 Pharmacokinetic properties
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 United Kingdom.
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
WOCKHARDT'