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.
Chlorphenamine Maleate 10mg/ml Solution for Injection
⚠ 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 Chlorphenamine maleate 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 Chlorphenamine 10mg/ml Solution for Injection contains the active ingredient chlorphenamine maleate which is an antihistamine. These medicines inhibit the release of histamine into the body that occurs during an allergic reaction. This product relieves some of the main symptoms of a severe allergic reaction. This injection is usually given to you by your doctor or someone else trained to give it to you.
What you need to know before you take it
Chlorphenamine You MUST NOT be given Chlorphenamine if you:
- are allergic to chlorphenamine or any of the other ingredients of this medicine (listed in section 6)
- are in a pre-coma state
- have had monoamine oxidase inhibitor (MAOI) antidepressive treatment within the past 14 days. Warnings and precautions Talk to your doctor before you are given Chlorphenamine if you:
- are being treated for an overactive thyroid or enlarged prostate gland
- have epilepsy, glaucoma, very high blood pressure, heart, liver, asthma or chest diseases.
Other medicines and Chlorphenamine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following affect the way Chlorphenamine works:
- MAOIs – these must not be given with Chlorphenamine. Chlorphenamine may increase the effects of the following:
- drugs that treat anxiety or help you to sleep
- alcohol
- psychotropic drugs (that change perception or behaviour)
- atropine
- phenytoin, for epilepsy. Pregnancy and breast-feeding Tell your doctor before using any medicine. Chlorphenamine must not be given during pregnancy or breastfeeding unless your doctor believes it is essential. Driving and using machines Chlorphenamine may cause drowsiness and make you sleepy. Do not drive or operate machinery until you know how this product affects you. Chlorphenamine contains sodium This medicinal product contains less than 1mmol sodium (23mg) per dose of up to 4ml, i.e. it is essentially "sodium-free".
How to take it
This injection is usually given to you by your doctor or someone else trained to give it to you. You will be given the injection beneath your skin, or into a muscle, or directly into a vein. Adults: the usual dose is 10mg – 20mg (1 or 2 ampoules), up to a maximum of 40mg (4 ampoules) in 24 hours. Use in children and adolescents: the dose will be calculated by the doctor, according to the child's age or body weight: Age
Dose
1 month to 1 year 1 to 5 years 6 to 12 years 12 to 18 years
0.25mg/kg 2.5mg to 5mg
OR 0.20mg/kg
5mg to 10mg
OR 0.20mg/kg
10mg to 20mg OR 0.20mg/kg
The doctor may dilute Chlorphenamine with sodium chloride 0.9% to make it easier to measure and inject the small amounts required for children. When administered into a vein, the injection should be given slowly over a period of one minute to avoid a fall in blood pressure (hypotension) or central nervous system stimulation.
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
giddiness or hypotension which may follow is usually transitory.
Chlorphenamine 10mg/ml Solution for Injection Please refer to the Summary of Product Characteristics (SmPC) for further details on this product.
In the event of a blood transfusion reaction, a dose of 10mg to 20mg of chlorphenamine injection should be given by the subcutaneous route. This can be repeated to a total of 40mg within a 24-hour period, or oral forms of chlorphenamine may be given until the symptoms subside.
Qualitative and Quantitative Composition Each 1ml of solution contains 10mg of chlorphenamine maleate. Excipient with known effect: Each 1ml of solution contains 0.13mmol (3.1mg) of sodium. Pharmaceutical Form Solution for injection Clear, colourless sterile solution for injection. The pH of the solution is 4.0 – 5.2 and the osmolality is 261 – 319 mOsm/Kg. Therapeutic Indications Chlorphenamine injection is indicated for acute urticaria, control of allergic reactions to insect bites and stings, angioneurotic oedema, drug and serum reactions, desensitisation reactions, hayfever, vasomotor rhinitis, severe pruritus of non-specific origin. Posology and method of administration Adults: The usual dose of chlorphenamine injection for adults is 10mg to 20mg, but not more than 40mg should be given within a 24-hour period. The injection may be given by the subcutaneous, intramuscular or intravenous route. When a rapid effect is desired, as in anaphylactic reactions, the intravenous route is recommended in addition to emergency therapy with adrenaline (epinephrine), corticosteroids, oxygen and supportive therapy as required. In this case chlorphenamine injection should be injected slowly over a period of one minute, using the smallest adequate syringe. Any drowsiness,
Chlorphenamine injection may be helpful in the prevention of delayed reactions to penicillin and other drugs when given separately by intramuscular injection immediately prior to administration of the other drug. The usual dose is 10mg. Chlorphenamine injection cannot, however, be relied on to prevent anaphylactic reactions in patients known to be allergic to a particular drug. Paediatric population: The dose for children should be calculated, based on either the child's age or their body weight, using the following table: Age
Dose
1 month to 1 year
0.25mg/kg
1 to 5 years
2.5mg to 5mg OR 0.20mg/kg
6 to 12 years
5mg to 10mg
12 to 18 years
10mg to 20mg OR 0.20mg/kg
OR 0.20mg/kg
Extra care should be taken when preparing the injection for children under 1 year due to the small volumes that are required. Dilution of chlorphenamine injection with sodium chloride intravenous infusion (0.9% w/v) should facilitate preparation. For example, diluting 0.2ml chlorphenamine injection to 2ml with sodium chloride 0.9% injection produces a solution containing chlorphenamine 1mg/ml.
pg1/2 ARTWORK CHECK BOX PRODUCT : COMPONENT : CUSTOMER : FP CODE : DIMENSIONS : PHARMACODE : MIN. FONT SIZE : FILE NAME : SOFTWARE : TYPEFACES : REQUEST RECEIVED ON : PROOF REVISION :
Chlorphenamine 10mg/ml Solution for injection
- 5 ampoules Leaflet Wockhardt UK – (w)150mm x (h)460mm 256 9 pt. Chlorphenamine Injection_Leaflet_107937-4.ai Adobe Illustrator CS5 Myriad Pro Regular / Bold 30th May, 2022
- 1st PDF submitted on
- 31ST MAY 2022
- 2nd PDF submitted on – 7TH JUNE 2022
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Changes in detail: • New regulatory text
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Non-Regulatory
If you are given more Chlorphenamine than you should This product will be given to you under medical supervision. It is therefore unlikely that you will be given too much. However, if you feel unwell, you should tell your doctor immediately. Symptoms of overdose include sedation, seizures, stopping of breathing (apnoea), convulsions, abnormal and sustained muscle contractions (dystonic reactions) and heart failure (cardiovascular collapse). If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effect is sedation, which can range from slight drowsiness to deep sleep. The following side effects have been reported:
- a stinging or burning feeling at the site of injection
- giddiness or drowsiness if the drug is injected too quickly into a vein (this usually passes)
- nausea, vomiting, or diarrhoea
- feeling dizzy, weak, tired, unable to concentrate
- rapid or irregular heart beat, chest tightness, fall in blood pressure
- dryness of the mouth, headache, anorexia, indigestion, abdominal pain, liver problems including jaundice, difficulty passing urine
- muscular incoordination, ringing in the ears, blurred vision, irritability, depression, nightmares
- allergic reactions (skin reactions, itching of raised bumps on the skin, sensitivity to light)
- blood abnormalities. Elderly people may become confused and children may become excitable. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system listed below: United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
- After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 5°C in polypropylene syringes. From a microbiological point of view, 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
- This medicine should not be used after the expiry date which is stated on the carton and inner label after 'EXP'. The expiry date refers to the last day of that month
- Medicines should not be thrown away via wastewater or household waste. Your doctor or nurse will dispose of medicines no longer required. These measures will help protect the environment.
How to store it
Chlorphenamine
- Keep out of the sight and reach of children
- This medicinal product does not require any special storage conditions
- This medicine should be used immediately after opening. Once opened, any unused contents should be discarded
For instruction on dilution of the product before administration, see "Special precautions for disposal". For shelf-life and storage conditions after dilution of the medicinal product, see "Shelf life" and "Special precautions for storage". Pharmaceutical Particulars List of excipients Sodium chloride Water for Injections Incompatibilities In the absence of incompatibility studies, this product must not be mixed with other medicinal products. Shelf life Unopened: 36 months The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 5°C in polypropylene syringes. From a microbiological point of view, 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 in controlled and validated aseptic conditions. Special precautions for storage This medicinal product does not require any special storage conditions. For storage conditions after dilution of the medicinal product, see "Shelf life". Nature and contents of container Chlorphenamine injection is presented in 1ml clear, neutral glass (Type I) ampoules. It is supplied in boxes of 5 ampoules.
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Special precautions for disposal and other handling Use in the paediatric population Due to the small volumes that are required for children under one year of age, chlorphenamine injection may be diluted with sodium chloride 0.9% injection to produce a solution containing chlorphenamine 1mg/ml. For example, 0.2ml chlorphenamine injection may be diluted to 2ml with sodium chloride 0.9% injection immediately prior to administration. See the information under "Posology and method of administration" for details of paediatric dosing. The diluted solution should be inspected visually for particulate matter and discoloration prior to administration. In the event of either being observed, discard the medicinal product. Only clear solution should be used. See the information under "Shelf-life" for details regarding the shelf-life of the diluted solution. This medicinal product is for single use only. If the entire reconstituted content of the ampoule is not required, any unused solution should be discarded in accordance with local requirements. Marketing Authorisation Holder in UK: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom Marketing Authorisation Number(s) PL 29831/0585 Date of Revision of the Text 06/2022
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Contents of the pack and other information
What Chlorphenamine contains The active substance is: chlorphenamine maleate (also known as chlorpheniramine maleate). Each 1ml of solution contains 10mg chlorphenamine maleate. The other ingredients are: sodium chloride and water (see end of section 2). What Chlorphenamine looks like and contents of the pack Chlorphenamine is a clear, colourless sterile solution for injection, supplied in 1ml clear, neutral glass (Type I) ampoules. It is available in packs of five ampoules. Marketing Authorisation Holder in UK: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom Manufacturer CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom Other sources of information To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). This medicinal product is authorised in the Member States of the EEA under the following name: United Kingdom: Chlorphenamine 10mg/ml Solution for Injection This leaflet was last revised 06/2022
Frequently asked questions about Chlorphenamine Maleate 10mg/ml Solution for Injection
How do I take Chlorphenamine Maleate 10mg/ml Solution for Injection?
Chlorphenamine Maleate 10mg/ml Solution for Injection comes as injection containing 10mg/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 Chlorphenamine Maleate 10mg/ml Solution for Injection?
The active substance in Chlorphenamine Maleate 10mg/ml Solution for Injection is chlorphenamine maleate.
Are there equivalent medicines to Chlorphenamine Maleate 10mg/ml Solution for Injection?
Medicines with the same active substance, strength and form include: Chlorphenamine 10 mg/ml Solution for injection, Chlorphenamine 10mg/ml Solution for Injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Chlorphenamine Maleate 10mg/ml Solution for Injection, 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 Chlorphenamine Maleate 10mg/ml Solution for Injection 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: chlorphenamine maleate
- 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
Chlorphenamine injection is indicated for acute urticaria, control of allergic reactions to insect bites and stings, angioneurotic oedema, drug and serum reactions, desensitisation reactions, hayfever, vasomotor rhinitis, severe pruritus of non-specific origin.
4.2. Posology and method of administration
Adults:
The usual dose of chlorphenamine injection for adults is 10mg to 20mg, but not more than 40mg should be given within a 24-hour period. The injection may be given by the subcutaneous, intramuscular or intravenous route.When a rapid effect is desired, as in anaphylactic reactions, the intravenous route is recommended in addition to emergency therapy with adrenaline (epinephrine), corticosteroids, oxygen and supportive therapy as required. In this case chlorphenamine injection should be injected slowly over a period of one minute, using the smallest adequate syringe. Any drowsiness, giddiness or hypotension which may follow is usually transitory.In the event of a blood transfusion reaction, a dose of 10mg to 20mg of chlorphenamine injection should be given by the subcutaneous route. This can be repeated to a total of 40mg within a 24-hour period, or oral forms of chlorphenamine may be given until the symptoms subside.Chlorphenamine injection may be helpful in the prevention of delayed reactions to penicillin and other drugs when given separately by intramuscular injection immediately prior to administration of the other drug. The usual dose is 10mg.Chlorphenamine injection cannot, however, be relied on to prevent anaphylactic reactions in patients known to be allergic to a particular drug. Paediatric population:
The dose for children should be calculated, based on either the child's age or their body weight, using the following table: Age Dose
1 month to 1 year 0.25mg/kg
1 to 5 years 2.5mg to 5mg OR 0.20mg/kg
6 to 12 years 5mg to 10mg OR 0.20mg/kg
12 to 18 years 10mg to 20mg OR 0.20mg/kg
Extra care should be taken when preparing the injection for children under 1 year due to the small volumes that are required. Dilution of chlorphenamine injection with sodium chloride intravenous infusion (0.9% w/v) should facilitate preparation. For example, diluting 0.2ml chlorphenamine injection to 2ml with sodium chloride 0.9% injection produces a solution containing chlorphenamine 1mg/ml. For instruction on dilution of the product before administration, see section 6.6. For shelf-life and storage conditions after dilution of the medicinal product, see sections 6.3 and 6.4.
4.3. Contraindications
Hypersensitivity to the active substance, antihistamines or to any of the excipients listed in section 6.1.Use in pre-coma states.The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorphenamine injection is therefore contraindicated in patients who have been treated with MAOIs within the last fourteen days.
4.4. Special warnings and precautions for use
Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis; bronchiectasis and asthma; hepatic disease and thyrotoxicosis. Children and the elderly are more likely to experience the neurological anticholinergic effects.This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 4ml, i.e. it is essentially 'sodium- free'.
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may potentiate drowsiness. Concurrent use of alcohol may have a similar effect.Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.The anticholinergic effects of chlorphenamine are intensified by MAOIs (see section 4.3).
4.6. Fertility, pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Chlorphenamine injection should only be used during pregnancy when clearly needed and when the potential benefits outweigh the potential unknown risks to the foetus. Use during the third trimester may result in reactions in neonates.It is reasonable to assume that chlorphenamine may inhibit lactation and may be secreted in breast milk. The use of chlorphenamine injection in mothers breast-feeding their babies requires that the therapeutic benefits of the drug should be weighed against the potential hazards to the mother and baby.
4.7. Effects on ability to drive and use machines
The anticholinergic properties of chlorphenamine may cause drowsiness, blurred vision and psychomotor impairment, which can seriously hamper the patient's ability to drive and use machinery.
4.8. Undesirable effects
The most common side-effect is sedation varying from slight drowsiness to deep sleep. The following may also occasionally occur: inability to concentrate; lassitude; blurred vision; gastro-intestinal disturbances such as nausea, vomiting and diarrhoea.Urinary retention; headaches; dry mouth; dizziness; palpitation; painful dyspepsia; anorexia; hepatitis including jaundice; thickening of bronchial secretions; haemolytic anaemia and other blood dyscrasias; allergic reactions including exfoliative dermatitis, photosensitivity, skin reactions and urticaria; twitching, muscular weakness and incoordination; tinnitus; depression; irritability and nightmares infrequently occur.Paradoxical excitation in children and confusional psychosis in the elderly can occur.Some patients have reported a stinging or burning sensation at the site of injection. Rapid intravenous injection may cause transitory hypotension or CNS stimulation. 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
The estimated lethal dose of chlorphenamine is 25mg to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical stimulation of the CNS, toxic psychosis, seizures, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions, and fluid and electrolytic balance. If overdosage is by the oral route, treatment should include gastric lavage or induced emesis using syrup of ipecacuanha. Following these measures activated charcoal and cathartics may be administered to minimise absorption.Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with iv diazepam. Haemoperfusion may be used in severe cases.
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Ask anything about Chlorphenamine Maleate 10mg/ml Solution for Injection. 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.