Pheniramine Maleate Injection 22.75mg Taj Pharma

 

  1. Name of the medicinal product

Pheniramine Maleate Injection 22.75mg Taj Pharma

  1. Qualitative and quantitative composition

Each 1ml of solution contains
Pheniramine Maleate   22.75mg
Excipients                    q.s

For the full list of excipients, see section 6.1.

  1. 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.

  1. Clinical particulars

4.1 Therapeutic indications

Pheniramine Maleate 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 Pheniramine Maleate injection for adults is 22.75mg 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 Pheniramine Maleate 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 22.75mg to 20mg of Pheniramine Maleate 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 Pheniramine Maleate may be given until the symptoms subside.

Pheniramine Maleate 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 22.75mg.

Pheniramine Maleate 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:

AgeDose
1 month to 1 year0.25mg/kg
1 to 5 years2.5mg to 5mgOR0.20mg/kg
6 to 12 years5mg to 22.75mgOR0.20mg/kg
12 to 18 years22.75mg to 20mgOR0.20mg/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 Pheniramine Maleate injection with sodium chloride intravenous infusion (0.9% w/v) should facilitate preparation. For example, diluting 0.2ml Pheniramine Maleate injection to 2ml with sodium chloride 0.9% injection produces a solution containing Pheniramine Maleate 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 Pheniramine Maleate are intensified by monoamine oxidase inhibitors (MAOIs). Pheniramine Maleate 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

Pheniramine Maleate, 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 Pheniramine Maleate and hypnotics or anxiolytics may potentiate drowsiness. Concurrent use of alcohol may have a similar effect.

Pheniramine Maleate inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of Pheniramine Maleate are intensified by MAOIs (see section 4.3).

4.6 Fertility, pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Pheniramine Maleate 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 Pheniramine Maleate may inhibit lactation and may be secreted in breast milk. The use of Pheniramine Maleate 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 Pheniramine Maleate 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.

4.9 Overdose

The estimated lethal dose of Pheniramine Maleate 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.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use

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

The mechanism by which Pheniramine Maleate 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 Pheniramine Maleate, 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 Pheniramine Maleate is approximately 3L/kg in adults and 3.8L/kg in children.

Pheniramine Maleate is approximately 70% bound to plasma proteins.

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

The systemic exposure per mg 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

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.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Pheniramine Maleate injection is presented in 1ml clear, neutral glass (Type I, PhEur) ampoules. It is supplied in boxes of 5 ampoules.

6.6 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, Pheniramine Maleate injection may be diluted with sodium chloride 0.9% injection to produce a solution containing Pheniramine Maleate 1mg/ml. For example, 0.2ml Pheniramine Maleate injection may be diluted to 2ml with sodium chloride 0.9% injection immediately prior to administration. See section 4.2 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 section 6.3 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.

  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

 

Pheniramine Maleate Injection 22.75mg Taj Pharma

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pheniramine Maleate 22.75mg Solution for Injection Pheniramine 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 again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet:

  1. What Pheniramine Maleate is and what it is used for
  2. What you need to know before you are given Pheniramine Maleate
  3. How Pheniramine Maleate is given
  4. Possible side effects
  5. How to store Pheniramine Maleate
  6. Contents of the pack and other information

 

 

  1. WHAT PHENIRAMINE MALEATE IS AND WHAT IT IS USED FOR

Pheniramine Maleate 22.75mg Solution for Injection contains the active ingredient pheniramine 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.

 

  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENIRAMINE MALEATE

You MUST NOT be given Pheniramine Maleate 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 Pheniramine Maleate 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  Pheniramine Maleate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following auect the way Pheniramine Maleate works:

  • MAOIs – these must not be given with Pheniramine Maleate.

Pheniramine Maleate 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. Pheniramine Maleate must not be given during pregnancy or breastfeeding unless your doctor believes it is essential.

 

Driving and using machines

Pheniramine Maleate may cause drowsiness and make you sleepy. Do not drive or operate machinery until you know how this product affects you.

 

Pheniramine Maleate contains sodium

This medicinal product contains less than 1mmol sodium (23mg) per dose of up to 4ml, i.e. it is essentially “sodium-free”.

 

  1. HOW PHENIRAMINE MALEATE 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, or into a muscle, or directly into a vein.

 

Adults: the usual dose is 22.75mg – 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:

 

AgeDose
1 month to 1 year  0.25mg/kg
1 to 5 years2.5mg to 5mgOR0.20mg/kg
6 to 12 years5mg to 22.75mgOR0.20mg/kg
12 to 18 years22.75mg to 20mg 

OR

 

0.20mg/kg

 

The doctor may dilute Pheniramine Maleate 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.

 

If you are given more Pheniramine Maleate 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.

 

 

  1. 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 or pharmacist. 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.

 

  1. HOW TO STORE PHENIRAMINE MALEATE
  • 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.
  • 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.

 

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pheniramine Maleate contains

The active substance is: pheniramine maleate (also known as pheniramine maleate). Each 1ml of solution contains 22.75mg pheniramine maleate.

The other ingredients are: sodium chloride and water (see end of section 2).

 

What Pheniramine Maleate looks like and contents of the pack Pheniramine Maleate 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.

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