Loratadine

Registered South African indications:

• Symptomatic relief of seasonal allergic rhinitis and chronic urticaria

Registered South African contraindications

Syrup

• Hypersensitivity to the active ingredient or any of its excipients
• Safety in the elderly has not been established
• Safety in children under 2 years of age has not been established

Tablet

• Hypersensitivity to the active ingredient or any of its excipients 
• Cross sensitivity to other antihistamines
• Porphyria

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients

• Pregnancy
• Breastfeeding
• Renal impairment (South African recommendations)
• Hepatic impairment
• Elderly (tab) (South African recommendations)
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: syr, tab

South African registered indications and dosages

Symptomatic relief of seasonal allergic rhinitis and chronic urticariaa

• Oral (syr, tab): 10mg, dly

Use of loratadine should be limited to 14 days

Loratadine syrup can be taken with or without meal

Paed. forms avail. in SA and covered in this monograph: syr

South African registered indications and dosages

Symptomatic relief of allergic rhinitis such as sneezing, rhinorrhoea, and itching of nose and throat
Relief of chronic idiopathic urticaria and other allergic dermatoses

Oral (syr)

• Younger than 2 years: Contraindicated
• Between 2-5 years: 5mg, dly
• Between 6-12 years: 10mg, dly
• Older than 12 years: See adult dosage

Use of loratadine should be limited to 14 days

Loratadine syrup can be taken with or without meal

Pregnancy

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; not recommended
• Safety in pregnancy has not been established
• A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity of loratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
• As a precautionary measure, it is preferable to avoid the use of loratadine tablet during pregnancy

Breastfeeding

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; not recommended
• Safety in breastfeeding has not been established
• Loratadine is excreted in breast milk, therefore its use is not recommended in breastfeeding women

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• There are no data available on male and female fertility

South African recommendations

Syrup

• Caution; no information available

Tablet

• CrCl≥30ml/min: Caution; no dose adjustment recommended
• CrCl<30ml/min: Caution; dose adjustment recommended
  A lower starting dose should be used

Recommendations in other jurisdictions

• No dose adjustment recommended

South African recommendations

Syrup

• Caution; dose adjustment recommended
  Reduced doses should be administered in patients with hepatic impairment as they may have decreased clearance of loratadine
  An initial dose of 5mg once daily OR 10mg on alternate days is recommended 

Tablet

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Caution; dose adjustment recommended
  As reduced clearance of loratadine may occur, dosage adjustment may be needed

Recommendations in other jurisdictions

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Caution; dose adjustment recommended
  >30kg: Initial: 10mg every 48hrs
  ≤30kg: Initial: 5mg (5ml) every 48hrs

South African recommendations

Syrup

• Contraindicated
  Safety in the elderly has not been established

Tablet

• Caution; no dose adjustment recommended
  Safety in the elderly has not been established

Recommendations in other jurisdictions

• No dose adjustment recommended

Central Nervous System Disorders

• Dizziness
• Convulsion
• Fatigue

Cardiovascular Disorders

• Tachycardia
• Palpitation

Gastrointestinal Disorders

• Nausea
• Dry mouth
• Gastritis

Hepatobiliary Disorders

• Abnormal hepatic function

Skin and Subcutaneous Tissue Disorders

• Rash
• Alopecia

Immune System Disorders

• Hypersensitivity reaction
• Anaphylaxis

• CYP3A4 inhibitors
• CYP2D6 inhibitors

None routine

Loratadine is a second generation histamine-receptor antagonist. It competes with free histamine and has specific, selective peripheral H1 antagonistic activity. This blocks the action of endogenous histamine, which leads to temporary relief of the negative symptoms caused by histamine.

Syrup (per 5ml) 5mg

• Allergex Non-Drowsy (Adcock) originator
• AP Loratadine (Pharmacare)
• Clarinese (Pharmacare)
• Clarityne (Bayer) originator
• Pollentyme S (Abex Pharmaceutica)

Tablet 10mg

• Allergex Non-Drowsy (Adcock) originator
• AP Loratadine (Pharmacare)
• Apex-Loratadine (Camox)
• Austell Loratadne (Camox)
• Cipla-Loratadine (Cipla Medpro)
• Clarinese (Pharmacare)
• Clarityne (Bayer) originator
• Laura 10 (Ranbaxy)
• Lorano (Sandoz)
• Loratadine 10 Biotech (Biotech)
• Lorfast (Ranbaxy)
• Lorhay (Ranbaxy)
• Lormeg (Gulf Drug)
• Pollentyme (Abex Pharmaceutica)
• Rhinigine (Xixia)
• Sandoz Loratadine (Sandoz)
• Simayla Loratadine (Ranbaxy)

COMBINATION PREPARATIONS

Loratadine/ Pseudoephedrine

Tablet 5mg/120mg

• Demazin NS Repetabs (Bayer)