Chlorphenamine for Injection 10mg/ml Taj Pharma

  1. Name of the medicinal product

Chlorphenamine 10mg/ml Solution for Injection.

  1. Qualitative and quantitative composition

Each 1 ml of solution contains:
Chlorphenamine Maleate             10mg.
Excipient                                       q.s

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Solution for Injection (Injection).

  1. Clinical particulars

4.1 Therapeutic indications

Chlorphenamine is indicated in adults, and children (aged 1 month to 18 years) 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

Posology

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.

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 0.2 ml chlorphenamine injection to 2 ml with sodium chloride 0.9% injection produces a solution containing chlorphenamine 1mg/ml. The diluted product should be used immediately.

Method of Administration

Intramuscular

Subcutaneous

Intravenous

When administered intravenously the injection should be given slowly over a period of one minute in order to avoid hypotension or central nervous system stimulation.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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 medicine contains less than 1 mmol sodium (23mg) per 1 ml, that is to say 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 Contraindications).

4.6 Fertility, pregnancy and lactation

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Chlorphenamine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Chlorphenamine during pregnancy. Use during the third trimester may result in reactions in neonates.

Small amounts of antihistamines are excreted in breast milk. Use by nursing mothers is not recommended because of the risks of adverse effects in the infants. Antihistamines may inhibit lactation.

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 following effects have been reported and are listed below by system organ class:

System Organ Class (SOC) Frequency Adverse Event
Blood and lymphatic system disorders Not known* Haemolytic anaemia and other blood dyscrasias
Cardiac disorders Not known* Palpitations
Ear and labyrinth disorders Not known* Tinnitus
Eye disorders Not known* Blurred vision
Gastrointestinal disorders Not known* Nausea, vomiting, diarrhoea, dry mouth, painful dyspepsia
General disorders and administration site conditions Not known* Irritability, lassitude, stinging or burning sensation at the site of injection
Hepatobiliary disorders Not known* Hepatitis including jaundice
Immune system disorders Not known* Hypersensitivity, anaphylactic reaction
Metabolism and nutrition disorders Not known* Anorexia
Musculoskeletal and connective tissue disorders Not known* Twitching, muscular weakness,

incoordination

Nervous system disorders Not known* Headaches, dizziness, inability to concentrate, sedation (most common side effect varying from slight drowsiness to deep sleep), CNS stimulation (as a result of rapid intravenous injection)
Psychiatric disorders Not known* Depression, nightmares, paradoxical excitation in children, confusional psychosis in the elderly
Renal and urinary disorders Not known* Urinary retention
Respiratory, thoracic and mediastinal disorders Not known* Thickening of bronchial secretions
Skin and subcutaneous tissue disorders Not known* Exfoliative dermatitis, photosensitivity, skin reactions, urticaria
Vascular disorders Not known* Transitory hypotension (as a result of rapid intravenous injection)

* cannot be estimated from the available data

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.

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. 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.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Antihistamines for systemic use, substituted alkylamines.

Antihistamines, including chlorphenamine, used in the treatment of allergy act by competing with histamine for H1-receptor sites on cells and tissues. Chlorphenamine also has anticholinergic activity.

The mechanism by which chlorphenamine exerts its anti-emetic, anti- motion sickness and anti-vertigo effects is not precisely known but may be related to its central actions. Further, most antihistamines, including chlorphenamine, cross the blood-brain barrier and probably produce sedation largely by occupying H1-receptors in the brain.

5.2 Pharmacokinetic properties

Following iv administration, the apparent steady-state volume of distribution of chlorphenamine is approximately 3 L/kg in adults and 3.8 L/kg in children.

Chlorphenamine is approximately 70% bound to plasma proteins.

In adults with normal renal and hepatic function, the terminal elimination half-life of chlorphenamine reportedly ranges from 12 to 43 hours.

The systemic exposure permg dose is lower in children than adults and the elimination half-life may be shorter.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

  1. Pharmaceutical particulars

6.1 List of excipients

Sodium chloride, Water for Injections.

6.2 Incompatibilities

In the absence of incompatibility studies, this product must not be mixed with other medicinal products.

6.3 Shelf life

3 years unopened.

The product should be administered immediately after opening ampoule.

6.4 Special precautions for storage

Do not store above 25°C. Keep the container in the outer carton in order to protect from light.

6.5 Nature and contents of container

Chlorphenamine injection is presented in 1 ml neutral glass ampoules. It is supplied in boxes of 5 or 100 ampoules. Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

  1. MANUFACTURED IN INDIA BY:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

Chlorphenamine for Injection 10mg/ml Taj Pharma

 Package leaflet: Information for the patient

Chlorphenamine 10 mg/ml Solution for Injection

(Chlorphenamine Maleate)

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor or
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section

 

What is in this leaflet:
  1. What Chlorphenamine is and what it is used for
  2. What you need to know before Chlorphenamine is given
  3. How Chlorphenamine is given
  4. Possible side effects
  5. How to store Chlorphenamine
  6. Contents of the pack and other information

 

 

1.              What Chlorphenamine is and what it is used for

 

Chlorphenamine 10 mg/ml Solution for Injection contains the active ingredient chlorphenamine maleate which is an antihistamine.

Chlorphenamine is indicated in adults and children (aged 1 month to 18 years) for the treatment of acute allergic reactions.

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.

  1. What you need to know before Chlorphenamine is given You MUST NOT be given Chlorphenamine:
  • if you are allergic to chlorphenamine maleate or any of the other ingredients of this medicine (listed in section 6)
  • if you have had monoamine oxidase inhibitor (MAOI) antidepressive treatment within the past 14

 

Warnings and precautions

Talk to your doctor or nurse before you are given this medicine if you:

  • are being treated for an overactive thyroid or enlarged prostate gland
  • have epilepsy, raised blood pressure within the eye or glaucoma, very high blood pressure, heart, liver, asthma or other chest diseases.

 

Children and the elderly are more likely to experience certain side effects (see section 4).

 

Other medicines and Chlorphenamine

Tell your doctor 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 may increase the effects of the following:

  • drugs that treat anxiety or help you to sleep
  • psychotropic drugs (that change perception or behaviour)
  • atropine (used as eye drops to dilate the pupils, or given as an injection to treat low heart rate in emergencies)
  • phenytoin (used to treat epilepsy).

 

Chlorphenamine with alcohol

Do not consume alcohol whilst being treated with Chlorphenamine. It may cause the effects of the medicine to be increased, making you more drowsy. It may also cause the effect of the alcohol to be increased.

 

Pregnancy and breast-feeding

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 you are given this 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 medicine contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially ‘sodium-free’.

 

 

3.              How Chlorphenamine is given

 

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, into a muscle, or directly into a vein.

 

Adults: the usual dose is 10 mg – 20 mg (1 or 2 ampoules), up to a maximum of 40 mg (4 ampoules) in 24 hours.

 

Children: the dose will be calculated by the doctor, according to the child’s age or body weight:

 

Age Dose
1 month to 1 year 0.25 mg/kg
1 to 5 years 2.5 mg to 5 mg OR 0.20 mg/kg
6 to 12 years 5 mg to 10 mg OR 0.20 mg/kg
12 to 18 years 10 mg to 20 mg OR 0.20 mg/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 (giddiness).

 

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 nurse.

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:

 

Frequency Not Known (cannot be estimated from the available data)

  • allergic reactions (skin reactions, including redness and scaling of the skin, itching of raised bumps on the skin, sensitivity to light)
  • 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
  • fall in blood pressure
  • dryness of the mouth, thickening of the phlegm in the airways (this may make it more difficult to cough up phlegm), headache, loss of appetite, indigestion, liver problems including jaundice (this can cause yellowing of the skin and whites of the eyes), difficulty passing urine
  • muscular twitching, weakness and incoordination, ringing in the ears, blurred vision, irritability, depression, nightmares
  • blood

 

Children and the elderly are more likely to experience the side effects which relate to the nervous system (these may affect the mind, nerves, muscles, and the senses). Elderly people may become confused and children may become agitated or excitable.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.

By reporting side effects you can help provide more information on the safety of this medicine.

 

5.              How to store Chlorphenamine

 

Keep this medicine out of the sight and reach of children.

Store below 25ºC. Keep the ampoules in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the ampoule label and carton after ‘EXP’.

Once opened this medicine should be used immediately.

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 protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION What Chlorphenamine contains

The active substance is: chlorphenamine maleate (also known as chlorpheniramine maleate). Each 1 ml ampoule contains 10 mg of chlorphenamine maleate.

The other ingredients are: sodium chloride and water for injections (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 glass ampoules.

Contents: 5 or 100 glass ampoules per box. Not all pack sizes may be marketed.

  1. MANUFACTURED IN INDIA BY:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com