Patient leaflet - Diazepam 5 mg/ml solution for injection
1. What Diazepam Injection is and what it is used for
The name of your medicine is Diazepam Injection; the active ingredient is diazepam. This medicine belongs to a group of medicines called benzodiazepines. Diazepam Injection is used:
- to treat anxiety and agitation
- as a sedative on minor surgical ad dental procedures
- as an anticonvulsant (medicine to control fits)
- as a muscle relaxant
2. Before you take Diazepam Injection
You should NOT be given Diazepam Injection if you:
are allergic (hypersensitivity) to diazepam, any other benzodiazepines or to any of the other
ingredients in Diazepam Injection (see section 6, Further information)
- are suffering from phobias (irrational fears) or obsessions
- have breathing problems
- suffer from obstructive sleep apnoea ( a condition where you stop breathing during sleep)
- have severe liver disease
- have suffered recent loss or bereavement as diazepam can cause memory loss
suffer from depression, anxiety or other long standing mental illness, for which you are not being
treated.
Diazepam Injection should not be used in premature or newborn babies.
Talk to your doctor before being given Diazepam Injection if you:
- have a kidney or liver disease
- suffer from lung disease
- suffer from porphyria (a disease of blood proteins affecting the skin, gut and nervous system)
- suffer from myasthenia gravis ( a disease of the nervous system causing muscle weakness)
- have a history of alcohol and/or drug abuse
- suffer from brain disease (particularly diseases affecting the blood circulation of the brain)
- if you take any medicines which affect the central nervous system.
Caution should be taken when giving Diazepam Injection to the elderly and comatose patients.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. The following medicines can affect or be affected treatment with Diazepam Injection:
- medicines used to treat bacterial infections (e.g. erythromycin, isoniazid and rifampicin)
- medicines used to treat depression (e.g. mirtazapine, fluvoxamine and fluoxetine)
- medicines used to treat fits (e.g. carbamazepine, phenobarbital, phenytoin and sodium valproate)
medicines used in surgery (general anaesthetics) and strong pain killers (narcotic analgesics e.g.
fentanyl)
- medicines used to treat allergies, including hay fever and insect bites (antihistamines)
- medicines used to treat high blood pressure
medicines used to treat psychosis, schizophrenia and other mental illnesses (e.g. onlanzapine,
clozapine and zotepine)
- medicines used to treat HIV infection (e.g. amprenavir, saquinavir and ritonavir)
- medicines used to treat anxiety and sleep disturbance
- digoxin (used to treat abnormal heart rhythms and heart failure)
- disulfiram (used to treat alcoholism)
- levodopa (used to treat Parkinson’s Disease)
- lofexidine (used to reduce symptoms of heroin withdrawal)
- baclofen and tizanidine (muscle relaxants)
- nabilone (used to treat nausea and nerve pain)
- oral contraceptives (“The Pill”)
- theophylline and aminophylline (used in asthma and lung diseases)
- cimetidine, esomeprazole and omeprazole (used to treat excess stomach acid and ulcers)
- diuretics (water tablets)
- nitrates, used in the treatment of angina
sodium oxybate, used to prevent episodes of sudden onset of sleep (narcolepsy) with muscle
weakness.
Taking Diazepam Injection with food and drink
You should avoid smoking and drinking alcohol whilst taking this medicine. Some of the ingredients of coffee (caffeine) will affect the way Diazepam Injection work.
Pregnancy and breast-feeding
You should not use this medicine if you are pregnant or breast feeding (unless your doctor decides it is essential). Tell your doctor straight away if you think you may be pregnant or intend to start a pregnancy.
Driving and using machinery
This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you.
It may be an offence to drive if your ability to drive safely is affected.
There is further information for patients who are intending to drive in Great Britain – go to http://www.gov.uk/drug-driving-law
Important information about some of the ingredients in Diazepam Injection
This medicine contains
12.5 vol % ethanol (alcohol) i.e. 100mg per ml, equivalent to 10ml beer, 4ml wine per dose. It is
therefore harmful to those suffering from alcoholism. This should also be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy.
15mg/ml of benzyl alcohol and so must not be given to premature or newborn babies. It may cause
toxic and/or allergic reactions in infants and children up to three years.
sodium benzoate (E211) and benzoic acid (E210) which may increase the risk of jaundice in
newborn babies.
- 0.34mmol/ml of sodium. This should be considered in patients on a controlled sodium diet.
3. How to take Diazepam Injection
Your doctor will decide the right dose for you. The dosage depends on the condition being treated, weight and age. If you do not understand what you are being given then ask your doctor or nurse. The usual doses are as follows:
Adults
In severe anxiety or acute muscle spasm:
- 10mg given into a vein or into a muscle
- This may be repeated after 4 hours, if necessary
In tetanus (lockjaw):
- 0.1 – 0.3mg per kg bodyweight given into a vein every one to four hours or
3 – 10mg per kg bodyweight given continuously over 24 hours through a nasoduodenal tube (a
tube passed through the nose into the gut)
In epileptic fits:
- 0.15 – 0.25mg per kg bodyweight given slowly into a vein
- this may be repeated if needed after 30-60 minutes.
Sedation prior to minor surgical or dental procedures:
0.1 – 0.2mg per kg bodyweight by injection in the vein or muscle, and adjusted according to
response.
Doses in the elderly and in those with kidney or liver problems should be reduced accordingly.
Children
Control of epileptic fits or febrile convulsions:
- 0.2 – 0.3mg per kg bodyweight (or 1mg for each year of age) given into a vein
- doses can be repeated, if needed after 30-60 minutes.
Sedation or as a muscle relaxant:
- up to 0.2mg per kg bodyweight as an injection.
If you take more Diazepam Injection than you should
This medicine is administered by your doctor and so you are unlikely to be given too much.
If you stop taking Diazepam Injection
Dependence on diazepam and other benzodiazepines can occur when used over a long time and is more common in patients with a history of drug or alcohol abuse. The risk of dependence is low in small doses given over short periods. If you have needed treatment with diazepam over a long period, your doctor will not stop treatment immediately but will gradually reduce your dose over time to stop withdrawal symptoms such as anxiety, depression, stomach cramps, nausea and sweating.
4. Possible side effects
Like all medicines, Diazepam Injection can cause side effects, especially the elderly, although not everybody gets them.
As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, tell your doctor immediately:
rash, itching, swelling of the face and eyes, difficulty breathing, serious illness with blistering of
the skin, mouth, eyes and genitals. The side effects of diazepam are usually mild and infrequent. Side effects that have been reported are:
Possible side effects are listed below under the parts of the body that might be affected.
Blood
- changes to blood cells
Psychiatric disorders
- hallucinations (seeing or hearing things that are not there)
- sleep problems and nightmare
- feeling excited or over anxious
- aggression
- restlessness and agitation
- depression
- numbed emotions
Nervous System
- headaches
- confusion
- tremor
- drowsiness
- reduced alertness
- slurred speech
- fatigue and a hangover effect
- clumsiness
- memory loss
- dizziness
- unusual movements of muscle of face
- fits
Eyes
- visual disturbances
Ears
- vertigo
Heart
- low blood pressure
- slow heartbeat
- stoppage of heart
- chest pain
Circulatory system
- inflammation of veins
- blood clots in veins (venous thrombosis)
Respiratory system
- breathing problems
Digestive system
- stomach and gut problems
- nausea
- dry mouth or increased production of saliva
Liver
- raised liver enzymes
- jaundice (yellowing of the skin)
Skin
- itchiness and rashes
Muscles
- muscle weakness
- muscle aches or cramps
Kidneys
- inability to pass water
- urinary incontinence
Reproductive system
- increase in breast tissue in men
- change in sex drive (libido)
- inhibition of female orgasm
- production of milk from breast
- increased testosterone in men
Other parts of your body
- pain at injection site
- poor blood supply and tissue damage (if drug injected into artery)
There may be a slight increase in abnormalities, particularly hare lip, in babies born to mothers given benzodiazepines during the first three months of pregnancy. Babies exposed to benzodiazepines during pregnancy may be slow developers.
If a mother has received diazepam towards the end of pregnancy or during labour, the baby may be affected, with feeling cold, floppiness, difficulty breathing and suckling, or withdrawal symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Diazepam Injection
Keep out of reach and sight of children.
Diazepam Injection should not be stored above 25ºC. Store in the original container to protect
from light; do not transfer to another container.
Diazepam Injection should not be taken after expiry date on the label; the expiry date
refers to the last day of the month, your doctor will check this.
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. Further information
What Diazepam Injection contains
The active ingredient is: diazepam 5mg/ml
The other ingredients are: benzoic acid (E210), ethanol, propylene glycol. Sodium benzoate (E211), benzyl alcohol and water for injections.
What Diazepam Injection looks like and the content of the pack
Diazepam Injection is a clear colourless to yellow solution. The medicine is supplied in 2ml or 4 ml amber glass ampoules in a cardboard outer carton.
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0800 198 5000 (UK only)
Please be ready to give the following information:
| Product name | Reference number |
|---|---|
| Diazepam 5mg/ml solution for injection | PL 55539/0013 |
This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder: SNIGD (UK Limited), Office Gold, Building 3 Chiswick Park, 566 Chiswick High Road, London, England, W4 5YA
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK