Consumer medicine information

APOHealth Dexchlorpheniramine Allergy Relief

Dexchlorpheniramine maleate

BRAND INFORMATION

Brand name

APOHealth Dexchlorpheniramine Allergy Relief

Active ingredient

Dexchlorpheniramine maleate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHealth Dexchlorpheniramine Allergy Relief.

SUMMARY CMI

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF contains the active ingredient dexchlorpheniramine maleate. APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF is used to relieve symptoms associated with allergic rhinitis (including hayfever), such as sneezing, runny or itchy nose and burning or itchy eyes. It may also be used to relieve symptoms associated with hives (also known as chronic urticaria). These symptoms include itching, redness and lumps on the skin. APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF can also be used to treat drug reactions.

For more information, see Section 1. Why am I using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF? in the full CMI.

2. What should I know before I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

Do not use if you have ever had an allergic reaction to dexchlorpheniramine maleate or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

  • Adults and children over 12 years: One Tablet every 6 hours.
  • After initial relief is obtained, dosage may be reduced to one tablet daily as required.

More instructions can be found in Section 4. How do I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF? in the full CMI.

5. What should I know while using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF.
  • Tell your doctor or pharmacist if you become pregnant while you are using this medication.
Things you should not do
  • Do not give APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF to anyone else, even if their symptoms seem similar to yours.
  • Do not take APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF to treat any other complaints unless your doctor or pharmacist says to.
Driving or using machines
  • If you feel tired, drowsy, dizzy or light-headed, do not drive a vehicle or operate machinery.
Drinking alcohol
  • Do not drink alcohol while using this medication.
Looking after your medicine
  • Keep the medicine in a cool dry place where the temperature stays below 25°C. Protect from light.
  • Keep it where children cannot reach it.

For more information, see Section 5. What should I know while using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF? in the full CMI.

6. Are there any side effects?

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF may cause common side effects like sleepiness, upset stomach, loss of appetite, thickening of mucus, stuffy nose, tight chest, dry mouth, nose or throat. APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF may cause serious side effects like wheezing, irregular heartbeats, skin rash, unable or difficulty passing urine or passing urine more often than usual, tiredness, headache, dizziness, spinning sensation, with yellowing of the skin and/ or eyes, hallucinations, tingling or numbness in the hands or feet, also known as ‘pins and needles’.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF

Active ingredient: Dexchlorpheniramine maleate

Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF.

Where to find information in this leaflet:

1. Why am I using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?
2. What should I know before I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?
3. What if I am taking other medicines?
4. How do I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?
5. What should I know while using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?
6. Are there any side effects?
7. Product details

1. Why am I using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF contains the active ingredient dexchlorpheniramine maleate.

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF is an antihistamine.

Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine.

Histamine is produced by the body in response to foreign substances which the body is allergic to.

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF is used to relieve symptoms associated with allergic rhinitis (including hayfever), such as sneezing, runny or itchy nose and burning or itchy eyes.

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF may also be used to relieve symptoms associated with hives (also known as chronic urticaria). These symptoms include itching, redness and lumps on the skin.

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF can also be used to treat drug reactions.

2. What should I know before I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

Warnings

Do not use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF:

  • if you are allergic to dexchlorpheniramine maleate, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
  • if you are also taking medicines used to treat depression such as monoamine oxidase inhibitor (MAOI).
    Taking APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF together with a MAOI may exaggerate the effects of APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF and cause a severe drop in your blood pressure.
  • in children less than 12 years.
  • after the expiry date (EXP) printed on the pack.
  • if the packaging is torn or shows signs of tampering.
  • If you are not sure whether you should start using this medication, talk to your doctor or pharmacist.

Check with your doctor or pharmacist if you:

  • have any other medical conditions such as
    - seizures,
    - liver or kidney disease,
    - an overactive thyroid gland,
    - heart disease,
    - high blood pressure,
    - raised pressure in the eye,
    - prostate problems,
    - difficulty passing urine,
    - a narrowing or blockage between the stomach and small intestine which causes vomiting of undigested food or peptic ulcer.
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed. This medication may be transferred in breast milk to your baby.

If you are in the third trimester of pregnancy, you must tell your doctor you are taking this medication because newborn babies may have severe reactions to antihistamine.

Children less than 12 years

  • Do not give APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF to children less than 12 years of age.

Use in elderly

  • The elderly may experience paradoxical excitation with APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF. In patients over 60 years of age, antihistamines may cause dizziness, sedation and hypotension. Also, they are more likely to have central nervous system (CNS) depressive side effects, including confusion.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF and affect how it works.

These include:

  • monoamine oxidase inhibitor (MAOI).

These medicines may affect APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF and may cause a decrease in blood pressure.

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF may interfere with other medicines. These include:

  • alcohol. The effects of alcohol can be increased by some antihistamine medicines, including APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF. If you drink alcohol, the drowsiness, dizziness or light-headedness may become worse;
  • medicines used to treat depression such as tricyclic antidepressants;
  • strong / narcotic pain killers, such as codeine, morphine and dextropropoxyphene;
  • some medicines used to help you sleep;
  • some medicines used to treat anxiety;
  • some medicines used to stop blood clotting, such as warfarin.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF.

4. How do I use APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

How much to take

  • Adults and children over 12 years: one tablet every 6 hours.
  • After initial relief is obtained, dosage may be reduced to one tablet daily as required.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.

When to take APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF can be taken before or after food.

How to take APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF

  • Swallow the tablet whole with a glass of water.
  • Continue taking APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF until your symptoms have resolved. However, if symptoms persist consult your doctor or pharmacist.

If you use too much APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF

If you think that you have used too much APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26); or
  • contact your doctor; or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF?

Things you should do

  • If you become pregnant while taking APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF, tell your doctor.

Remind any doctor, dentist or pharmacist you visit that you are using APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF.

Things you should not do

  • Do not give APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF to anyone else, even if their symptoms seem similar to yours.
  • Do not use this medication to treat any other complaints unless your doctor or pharmacist says to.
  • Do not drink alcohol while taking this medication.

Things to be careful of

  • Protect your skin when you are in the sun especially between 10 am to 3 pm.
  • If you are outdoors, wear protective clothing and use a 30+ sunscreen.
  • APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF may cause your skin to be more sensitive than it is normally.
  • If your mouth continues to feel dry for more than 2 weeks check with your doctor or dentist.
  • Antihistamines may cause dryness of mouth, nose and throat.
  • Stop taking APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF 48 hours before you have any skin tests.
    Antihistamines may interfere with the results of skin tests.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF affects you.

If you feel tired, drowsy, dizzy or light-headed, do not drive a vehicle or operate machinery.

As with some other antihistamine medicines, APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF may cause tiredness, drowsiness, dizziness or light-headedness in some people.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Alcohol may worsen the drowsiness, dizziness or light-headedness.

Looking after your medicine

  • Keep the medicines in a cool dry place where the temperature stays below 25°C.
  • Keep your tablets in the blister pack until it is time to take them.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight, for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

If your doctor or pharmacist tells you to stop taking this medicine or they have passed the expiry date.

Ask your pharmacist what to do with any that are left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Less serious side effectsWhat to do
Nervous system-related:
  • Sleepiness.
Gastrointestinal-related:
  • Upset stomach.
  • Loss of appetite.
Respiratory-related:
  • Thickening of mucus.
  • Stuffy nose.
  • Tight chest.
  • Dry mouth, nose or throat.
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
SERIOUS SIDE EFFECTS
Respiratory-related:
  • Wheezing or being short of breath.
Cardiovascular-related:
  • Fast, pounding or irregular heartbeats.
Allergic reactions:
  • Skin rash.
Genitourinary-related:
  • Unable or difficulty passing urine.
  • Passing urine more often than usual.
Nervous system-related:
  • Tiredness, headache, dizziness, spinning sensation, with yellowing of the skin and/ or eyes.
  • Hallucinations.
  • Tingling or numbness in the hands or feet, also known as ‘pins and needles’.
VERY SERIOUS SIDE EFFECTS
Respiratory or cardiovascular related:
  • Chest pain.
Allergic reactions:
  • Sudden signs of allergy such as rash, hives.
  • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
Nervous system-related:
  • Convulsions, fits or seizures.
  • Coma.
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF contains

Active ingredient
(main ingredient)		Dexchlorpheniramine maleate
Other ingredients
(inactive ingredients)		Maize starch
Pre-gelatinised starch
Magnesium stearate
Potential allergensLactose monohydrate (sugars)

Do not take this medicine if you are allergic to any of these ingredients.

What APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF looks like

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF tablets are white, round, flat, uncoated tablets, scored on one side & plain on other side. (Aust R 453936).

APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF is available in blister packs of 20 or 40 tablets.

Who distributes APOHEALTH DEXCHLORPHENIRAMINE ALLERGY RELIEF

Arrotex Pharmaceuticals Pty Ltd
15–17 Chapel St, Cremorne VIC 3121, Australia

This leaflet was prepared on 17 June 2024.

Published by MIMS April 2025

BRAND INFORMATION

Brand name

APOHealth Dexchlorpheniramine Allergy Relief

Active ingredient

Dexchlorpheniramine maleate

Schedule

S3

 

1 Name of Medicine

Dexchlorpheniramine maleate.

2 Qualitative and Quantitative Composition

Each tablet contains dexchlorpheniramine maleate 2 mg.

List of excipients with known effects.

Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White, round, flat, uncoated tablets, scored on one side and plain on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild uncomplicated allergic skin manifestations of urticaria and angioedema. It may relieve itching due to skin conditions such as allergic eczema, pruritus ani, pruritus vulvae, atopic dermatitis, contact dermatitis, insect bites, dermographism and drug reactions, including serum sickness.

4.2 Dose and Method of Administration

Dose.

Adults and children over 12 years.

One tablet every 6 hours.
After initial relief is obtained, dosage may be reduced to one tablet daily as required.

Method of administration.

To be taken orally. It can be taken before or after food.

4.3 Contraindications

This medication is contraindicated for use in:
Children under 12 years of age.
Patients taking monoamine oxidase inhibitors (MAOIs) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Patients with a history of hypersensitivity to dexchlorpheniramine, to other drugs of similar chemical structure, or to any of the excipients listed in Section 6.1 List of Excipients.

4.4 Special Warnings and Precautions for Use

Identified precautions.

This medication may cause drowsiness and may add to the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.
This medication should be used with caution in patients with:
narrow-angle glaucoma;
stenosing peptic ulcer;
prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction;
cardiovascular disease including hypertension;
increased intraocular pressure;
hyperthyroidism;
renal or hepatic impairment;
seizures.
This medication may cause photosensitivity in some patients.

Use in the elderly.

The elderly may experience paradoxical excitation with dexchlorpheniramine maleate. In patients over 60 years of age, antihistamines may cause dizziness, sedation and hypotension. Also, they are more likely to have central nervous system (CNS) depressive side effects, including confusion.

Paediatric use.

Children may experience paradoxical excitation with dexchlorpheniramine maleate. In children this may cause excitability.

Effects on laboratory tests.

Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since these drugs may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with this medication have been noted:
Central nervous system (CNS) depressants (alcohol, sedatives, opioid analgesics, hypnotics) may cause an increase in sedative effects of this medication.
Concomitant administration with tricyclic antidepressants (TCAs) may result in additive antimuscarinic activity.
Monoamine oxidase inhibitors (MAOIs) may prolong and intensify the anticholinergic and CNS depressive effects of some antihistamines and may cause a decrease in blood pressure.
Oral anticoagulants may have their actions decreased by antihistamines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Safety during pregnancy has not been established. This medication should be used during the first two trimesters of pregnancy only if clearly needed.
This medication should not be used in the third trimester of pregnancy because newborn and premature infants may have severe reactions to antihistamines.
This medication has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects of on the foetus having been observed.
 This medication is excreted in breast milk. Therefore, caution should be exercised when administered to nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.

4.8 Adverse Effects (Undesirable Effects)

Slight to moderate drowsiness is the most frequent side effect of dexchlorpheniramine maleate.
Other reported reactions associated with antihistamine therapy in general include:

General.

Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.

Cardiovascular.

Hypotension, hypertension, headache, palpitations, tachycardia, extrasystoles.

Haematological.

Haemolytic anaemia, hypoplastic anaemia, thrombocytopenia, agranulocytosis.

Gastrointestinal.

Epigastric distress, anorexia, nausea, vomiting, diarrhoea, constipation.

Genitourinary.

Urinary frequency, difficult urination, urinary hesitation and retention, early menses.

Nervous system.

Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paraesthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions, lassitude, depression, inability to concentrate, dilated pupils, hypereflexia, hyporeflexia, xerostomia, hallucinations, appetite stimulation, anxiety, facial dyskinesias and seizures.

Respiratory.

Thickening of bronchial secretions, tightness of chest, wheezing, nasal stuffiness.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Manifestation.

Antihistamine overdosage effects may vary from central nervous system depression (apnoea, arrhythmias, cardiovascular collapse, cyanosis, diminished mental alertness, sedation) to stimulation (convulsions, hallucinations, insomnia or tremors) to death. Other signs and symptoms may be ataxia, blurred vision, dizziness, hypotension and tinnitus. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; gastrointestinal symptoms and hyperthermia).

Treatment.

Dialysis is of little value in antihistamine poisoning. Treatment of the signs and symptoms of an over dosage are symptomatic and supportive. Consider standard measures to remove any unabsorbed drug. There is no specific antidote. Measures to enhance excretion (urinary acidification, haemodialysis) are not recommended.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Dexchlorpheniramine, the d-isomer of the racemic compound chlorpheniramine, is two times more active than chlorpheniramine. Dexchlorpheniramine does not prevent the release of histamine, but rather, competes with free histamine for binding at the H1-receptor sites, and competitively antagonises the effects of histamine on H1-receptors in the gastrointestinal tract, uterus, large blood vessels, and bronchial muscle. Blockade of H1-receptors also suppresses the formation of oedema, flare, and pruritus that result from histaminic activity. Since dexchlorpheniramine binds to central and peripheral H1-receptors, sedative effects are likely to occur. H1-antagonists are structurally similar to anticholinergic agents and therefore possess the potential to exhibit anticholinergic properties of varying degrees. They also have antipruritic effects. Dexchlorpheniramine has high antihistaminic activity, moderate anticholinergic effects and minimal sedative effects. The drug does not possess antiemetic properties.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

The absorption, distribution, metabolism and elimination of dexchlorpheniramine have not been specifically described. However, since dexchlorpheniramine is the primary active isomer of the racemic compound chlorpheniramine, the pharmacokinetics of dexchlorpheniramine are likely to be similar to that of chlorpheniramine.

Absorption.

Dexchlorpheniramine is administered orally. H1-antagonists are generally well absorbed from the gastrointestinal tract. The onset of action of immediate release formulations of chlorpheniramine is about 30-60 minutes. The Cmax of chlorpheniramine occurs in about 2 hours, the maximum therapeutic effect in about 6 hours, and the duration of action lasts between 4-8 hours.

Distribution.

Protein binding is approximately 72%. Chlorpheniramine is widely distributed in body tissues and fluids, and it crosses the placenta and is excreted into breast milk.

Metabolism.

The metabolism of chlorpheniramine is extensive and rapid, first occurring in the gastric mucosa and then on first-pass through the liver, which may be saturable. N-dealkylation produces several metabolites, which are excreted in the urine along with the parent compound.

Excretion.

The half-life in healthy adults and children is 20-24 hours and 10-13 hours, respectively. Excretion rates are dependent on the pH of urine and urinary flow, with the rate decreasing as the pH rises and urinary flow decreases.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, maize starch, pre-gelatinised starch, magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

APOHealth Dexchlorpheniramine Allergy Relief tablets are available in PVC/PVDC/Aluminium foil blister packs of 20 or 40 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

2438-32-6.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes