Desloratadine

Registered South African indications:

• Symptomatic relief of seasonal types of allergy that present with symptoms such as rhinitis (fct, sol, syr, tab) 
• Symptomatic relief of chronic urticaria (fct, tab)

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (syr, fct, tab)
• Breastfeeding (syr, fct, tab)
• Cross-sensitivity to other antihistamines
• Porphyria (syr)

• Renal impairment
• Hepatic impairment
• Elderly
• Medical or familial history of seizures
• Phenotypic poor metabolisers of desloratadine
• Low sodium diet (syr)
• Fructose intolerance (syr)
• May impair ability to drive or operate machinery

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

South African registered indications and dosages

Symptomatic relief of seasonal types of allergy that present with symptoms such as rhinitis

• Oral (fct, tab, sol, syr): 5mg, once daily

Symptomatic relief of chronic urticaria

• Oral (fct, tab): 5mg, once daily

Can be taken with or without food

Safety and efficacy of desloratadine has not been established for treatment periods in excess of 4 weeks

Tablets: 5mg film-coated tablets has an effect within 1 to 2 hours after administration

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

South African registered indications and dosages

Symptomatic relief of seasonal types of allergy that present with symptoms such as rhinitis

Oral (sol, syr)

• <2 year: Not established for use
• Between 2-5 years: 1.25mg, once daily
• Between 6-11 years: 2.5mg, once daily
• ≥12 years: See adult dosage

Oral (fct, tab)

• <12 year: Not established for use
• ≥12 years: See adult dosage

Symptomatic relief of chronic urticaria

Oral (fct, tab)

• <12 year: Not established for use
• ≥12 years: See adult dosage

Can be taken with or without food

Safety and efficacy of desloratadine has not been established for treatment periods in excess of 4 weeks

Pregnancy

South African recommendations

Syrup, Tablets

• Contraindicated
• Desloratadine should not be used during pregnancy
• Safety and efficacy in pregnancy have not been established

Solution

• Caution; not recommended
• Desloratadine should not be used during pregnancy. Safety and efficacy in pregnancy have not been established

Breastfeeding

South African recommendations

Syrup, Tablets

• Contraindicated
• Desloratadine is distributed into breast milk therefore is not recommended for use during lactation
• Safety and efficacy in lactation have not been established

Solution

• Caution; not recommended
• Desloratadine and metabolites have been detected in breast milk
• Small amounts of desloratadine entering the breast milk may cause drowsiness or excitement in infants
• Desloratadine should not be used during lactation 
• Safety and efficacy in lactation have not been established

Fertility

South African recommendations

• There are no clinical data on fertility

South African recommendations

Solution, Tablets

• Caution; dose adjustment recommended
  Mild to moderate: Oral (sol): Initial: 5mg, on alternate days
  Severe: Use with caution (sol)
  Severe: Caution; no information available (fct, tab)

Syrup

• Caution; dose adjustment recommended
  Oral (syr): Initial: 5mg, on alternate days

South African recommendations

Solution, Tablets

• Caution; dose adjustment recommended
  Mild to moderate: Oral (sol): Initial: 5mg, on alternate days
  Severe: Use with caution (sol)
  Severe: Caution; no information available (fct, tab)

Syrup

• Caution; dose adjustment recommended
  Oral (syr): Initial: 5mg, on alternate days

South African recommendations

• Caution; no dosage adjustment recommended (sol, syr)
  In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal and cardiac function, and of concomitant disease or with concomitant medicines (sol, fct, tab)

Central Nervous System Disorders

• Hallucinations
• Abnormal behaviour
• Aggression
• Headache
• Somnolence
• Insomnia
• Dizziness
• Psychomotor hyperactivity
• Seizures
• Fatigue

Cardiovascular Disorders

• Tachycardia
• Palpitations
• QT prolongation
• Arrhythmia
• Bradicardia

Gastrointestinal Disorders

• Dry mouth
• Abdominal pain
• Nausea and vomiting
• Dyspepsia
• Diarrhoea

Hepatobiliary Disorders

• Elevations of liver enzymes
• Increased bilirubin
• Hepatitis
• Jaundice

Endocrine and Metabolic Disorders

• Increased appetite
• Increased weight

Musculoskeletal Disorders

• Myalgia

Skin and Subcutaneous Tissue Disorders

• Photosensitivity

Immune, Blood and Lymphatic System Disorders

• Fever
• Hypersensitivity reactions
  - Anaphylaxis
  - Angioedema
  - Dyspnoea
  - Pruritis
  - Rash
  - Urticaria

• Alcohol (see Additional Prescrbing Points) 

None routine 

Coadministration with alcohol

• In a clinical pharmacological trial, desloratadine taken concomitantly with alcohol did not potentiate the performance-impairing effects of alcohol. However, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, caution is recommended if alcohol is taken concomitantly

Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H-receptor antagonist activity. After oral administration, desloratadine selectively blocks peripheral histamine H-receptors because the substance is excluded from entry to the central nervous system.

Tablet 5mg

• Acuhist fct (Actavis)
• Aerzit (Camox)
• Clarex 5 (Unicorn)
• Dazit (Ranbaxy)
• Desaway  (Pharmacare)
• Deselex (Bayer) originator
• Desodene (Dr Reddy's)
• Desotab (Zydus)
• Loralex (Cipla)
• Neoclarityne  (Bayer) originator
• Neoloridin 5 (Zydus)
• Pollentyne ND (Abex Pharmaceutica)

Syrup (per 5ml) 2.5mg

• Adco-Desloratadine (Adcock Ingram)
• Dehrin (Abex)
• Deselex  (Bayer) originator
• Neoclarityne (Bayer) originator