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04 Mar WHAT IS THE DIFFERENCE BETWEEN ALLERGEX NON-DROWSY SYRUP AND TABLETS?

Posted at 10:47h in January by
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Both Allergex Non-Drowsy syrup and tablets are indicated for the relief of symptoms associated with allergic rhinitis, rhinorrhoea (runny nose), itching of the nose and throat, chronic idiopathic urticaria (hives) and other allergic dermatoses (allergic skin reactions). ¹ 1

The differences lie in the format, composition, dosage and usage by children and adults. Join us as we place these differences under a microscope.

Dosage

Allergex Non-Drowsy Syrup can be prescribed to both adults and children of two years and over, but the tablets can only be used by adults. The dosage indicated for children and adults also vary. ¹,² 1

See the dosage summary below:

  • Children from two to five years old: 5 ml (1 medicine measure) once daily¹
  • Children from six to twelve years old: 10 ml (2 medicine measures) once daily¹
  • Adults and children of twelve years and older: 10 ml (2 medicine measures)
  • One Allergex Non-Drowsy tablet daily 2 1

Composition and classification

Both Allergex Non-Drowsy syrup and tablets are pharmacologically classified as antihistaminics that contain Loratadine, a long lasting antihistamine.¹,² 2, 3

The difference lies in the composition. Each Allergex Non-Drowsy tablet contains 10 mgs of Loratadine which is micronized and 75 mgs of lactose monohydrate.² 2

Each 5 ml of Allergex Non-Drowsy syrup on the other hand, only contains 5 mgs of micronised Loratadine, as well as 0, 1% m/v sodium benzoate as a preservative, as well as 1,000 mgs of sucrose. ¹ 3

Format

Naturally the format of Allergex Non-Drowsy tablets and syrup are also different. Allergex Non-Drowsy tablets are available in easy-to-carry-around packs of ten or thirty tablets and the syrup is available in 150 ml bottles. ¹,² 1

Availability

Both Allergex Non-Drowsy tablets and syrup are available over-the-counter at most leading pharmacies. 1

As there are a multitude of factors that can influence its usage and efficacy, such as chronic medicine you may be using or other medical conditions you may have, it is always best to consult with your pharmacist or GP first.

References:

  1. Allergex® Non Drowsy Tablets packaging insert approved 6 February 2004
  2. Allergex Non Drowsy Syrup packaging insert approved on 24 January 2003

S1 Allergex® Non Drowsy Tablets. Each tablet contains loratadine 10 mg. Reg. No. 36/5.7.1/0286

S1 Allergex® Non Drowsy Syrup. Each 5 ml contains loratadine 5 mg. Reg. No. 36/5.7.1/0008

For full prescribing information, refer to the package insert approved by the medicines regulatory authority. 2018112810111291

Adcock Ingrams Limited. Reg. No. 1949/03485/06. Private Bag X69, Bryanston, 2021, South Africa.

Tel. +27 11 635 0000, www.adcock.com.

BIBLIOGRAPHY AND SOURCES

  1. Adcock Ingram. Allergex Non-Drowsy. Accessed on 16 November 2018. Available at: adcockingram.co.za/products 

Allergex Non-Drowsy is used for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea (runny nose), and itching of the nose and throat. Is also indicated for the relief of chronic idiopathic urticaria (hives) and other allergic dermatoses (allergic skin reactions). 1

  • Allergex Non-Drowsy contains Loratadine.
  • Loratadine is a long acting antihistamine, that only needs to be taken once daily

Dosage:

  • Children 2 to 5 years of age:5 ml (1 medicine measure) once daily
  • Children 6 to 12 years of age:10 ml (2 medicine measures) once daily
  • Adults and children over 12 years of age:10 ml (2 medicine measures) or 1 tablet once daily 1

Available in the following packs and formats:

  • Allergex ND Syrup 150ml
  • Allergex ND Tablets 10s
  • Allergex ND Tablets 30s

Available at most leading pharmacies 1

  1. Allergex® Non-Drowsy Tablets packaging insert approved 6 February 2004

 

Pharma Code 93 llllll 19380

 

SCHEDULING STATUS:         S2

PROPRIETARY NAME:           ALLERGEX® NON-DROWSY TABLETS

(AND DOSAGE FORM)           (TABLET)

COMPOSITION:

Each tablet contains:

Loratadine (micronised)          10 mg

Contains sugar:

Lactose monohydrate 75 mg

PHARMACOLOGICAL CLASSIFICATION:

A: 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:

Loratadine is a long acting piperidine antihistamine. 2

It is a selective H1 receptor antagonist which is a reversible, competitive inhibitor of histamine at H1 receptor sites.

Loratadine is a second generation H1 antagonist.

It does not readily cross the blood brain barrier.

 Pharmacokinetics:

Peak plasma levels are reached within 1,5 hours and the clinical effect is achieved within 2 hours.

Excretion occurs equally via the faeces and the urine.

INDICATIONS:

The relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria.

CONTRAINDICATIONS:

ALLERGEX NON DROWSY TABLETS is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Safety in pregnancy and lactation has not been established.

The safe use of ALLERGEX NON DROWSY TABLETS in the elderly has not been established.

DOSAGE AND DIRECTIONS FOR USE:

One tablet to be taken once daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Most commonly reported side effects include fatigue, headache, somnolence and dry mouth.

Gastrointestinal side effects including nausea, vomiting, diarrhoea, gastritis or epigastric pain may occur.

Allergic symptoms like rashes and hypersensitivity reactions may occur.

Abnormal hepatic function, alopecia and anaphylaxis have also been reported.

Precautions:

ALLERGEX NON-DROWSY TABLETS lack significant sedative properties. However, patients should be advised that a small number of individuals may experience sedation. Therefore, the effect of the medicine on a particular patient should be ascertained before they drive or operate machinery. This effect can be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

A lower dose should be administered to patients with hepatic impairment as they may have decreased clearance of loratadine; i.e. an initial dose of 5 mg once daily or 10 mg on alternate days.

Medicine/laboratory test interactions:

The use of ALLERGEX NON DROWSY TABLETS should be stopped several days before skin testing as antihistamines may suppress the positive skin response to allergen extracts.

Medicines known to inhibit the hepatic metabolism of loratadine include cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine. These medicines should therefore not be administered concomitantly with loratadine as they may raise the plasma concentrations of loratadine.

However, no clinically significant consequences have been observed when these medicines are administered concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

See “SIDE EFFECTS AND SPECIAL PRECAUTIONS”.

Cardiac effects such as tachycardia have been reported.

Headache and somnolence have also been reported with overdoses.

In the event of overdosage, treatment should be started immediately.

Treatment is symptomatic and supportive. Haemodialysis is not an effective means of removing loratadine or its metabolite from the body.

IDENTIFICATION:

White, 8 mm, round, flat tablets, with a breakline.

PRESENTATION:

Glass-clear, rigid, glossy, PVC film and aluminium foil blister packs of 7, 10, 14, 21 and 30 tablets.

STORAGE INSTRUCTIONS:

Store below 25 ºC.

Protect from light.

Do not remove the blister pack from the outer carton until required for use.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:

36/ 5.7.1/0286

NAME AND ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:

Adcock Ingram Limited

1 New Road

Erand Gardens

Midrand, 1685

Private Bag X69

Bryanston, 2021

www.adcock.com

 

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

  • February 2004
  1. Allergex Non Drowsy Syrup packaging insert approved on 24 January 2003
Pharma Code: 120 Llllll
Size:                   150 mm x ??? mm

Folded to:             150 mm x 35 mm

SCHEDULING STATUS:         S2

PROPRIETARY NAME:                       ALLERGEX® NON DROWSY SYRUP

(AND DOSAGE FORM)                       (SYRUP)

COMPOSITION:

Each 5 ml of ALLERGEX NON DROWSY SYRUP contains:

Loratadine (micronised)          5 mg

Preservative:

Sodium benzoate        0,1 % m/v

Contains sugar:

Sucrose          1 000 mg

PHARMACOLOGICAL CLASSIFICATION:

A: 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:

Loratadine is a long acting piperidine antihistamine. 3

It is a selective H1-receptor antagonist which is a reversible, competitive inhibitor of histamine at H1-receptor sites.

Loratadine is a second generation (non-sedating) H1-receptor antagonist.

Following oral administration, peak plasma concentrations are achieved in 2 to 3 hours. Loratadine is metabolised in the liver to active metabolites by the hepatic microsomal P450 system.

It does not cross the blood brain barrier.

INDICATIONS:

The relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhoea, and itching of nose and throat.

ALLERGEX NON DROWSY SYRUP is also indicated for the relief of chronic idiopathic urticaria and other allergic dermatoses.

CONTRAINDICATIONS:

ALLERGEX NON DROWSY SYRUP is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Safety in pregnancy and lactation has not been established.

The safe use of ALLERGEX NON DROWSY SYRUP in children under 2 years of age and in the elderly has not been established.

DOSAGE AND DIRECTIONS FOR USE:

Children 2 to 5 years of age: 5 ml (1 medicine measure) once daily.

Children 6 to 12 years of age: 10 ml (2 medicine measures) once daily.

Adults and children 12 years of age and over: 10 ml (2 medicine measures) once daily.

The use of ALLERGEX NON DROWSY SYRUP should be limited to 14 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Side effects:

Gastrointestinal side effects including nausea, vomiting, diarrhoea or epigastric pain have been reported. Fatigue, headache, somnolence and dry mouth have also been reported.

Allergic symptoms like rashes and hypersensitivity reactions may occur.

Sedation and nervousness have been reported.

Abnormal hepatic function has also been reported less frequently.

Palpitations and arrhythmias have been reported.

Blood disorders including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia, although less frequent, have been reported.

Convulsions, sweating, myalgia, paraesthesia, extrapyramidal effects, tremor, sleep disturbances, depression, tinnitus, hypotension, and hair loss have been reported.

Photosensitivity may occur.

Precautions:

ALLERGEX NON DROWSY SYRUP lacks significant sedative properties. However, patients should be advised that a small number of individuals may experience sedation. Therefore, the effect of the medicine on a particular patient should be ascertained before they can drive or operate machinery.

Patients with hepatic impairment should be administered  a reduced dose as they may have decreased clearance of loratadine; an initial dose of 5 ml once daily or 10 ml on alternate days is recommended.

Use with caution in patients with epilepsy due to less frequent reports of convulsions.

Cross sensitivity to related drugs may occur.

Drug/laboratory test interactions:

The use of ALLERGEX NON DROWSY SYRUP should be stopped approximately 48 hours before skin testing as antihistamines may suppress the positive skin response to allergen extracts.

Drugs known to inhibit the hepatic metabolism of loratadine include cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine. These drugs should therefore not be administered concomitantly with loratadine as they may raise the plasma concentrations of loratadine. However, no clinically significant consequences have been observed when these drugs are administered concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

See “SIDE EFFECTS AND SPECIAL PRECAUTIONS”.

Cardiac effects such as tachycardia have been reported.

Headache and somnolence have also been reported with overdoses.

In the event of overdosage, treatment should be started immediately.

Treatment is symptomatic and supportive.

Haemodialysis is not an effective means of removing loratadine or its metabolites from the body.

IDENTIFICATION:

ALLERGEX NON DROWSY SYRUP is a clear, colourless syrup having a characteristic peach odour and taste.

PRESENTATION:

Amber glass bottles of 100 ml and 150 ml syrup.

STORAGE INSTRUCTIONS:

Store in a well-closed container below 25 ºC. Protect from light.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:

36/5.7.1/0008

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION

Adcock Ingram Limited

1 New Road

Erand Gardens

Midrand, 1685

Private Bag X69

Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

24 January 2003