Pseudoephedrine Sulphate/ Loratadine

Registered South African indications:

• Relief of nasal and ocular symptoms of upper respiratory mucosal congestion, as in allergic and vasomotor rhinitis

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
  - Sensitivity or idiosyncrasy to either of its active components
• Sensitivity or idiosyncrasy to adrenergic agents or drugs of similar chemical structure
• Patients receiving monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment
• Relative contraindications
  - Narrow-angle glaucoma
  - Urinary retention
  - Severe hypertension
  - Coronary artery disease
  - Hyperthyroidism
• Children under 12 years
• Pregnancy
• Breastfeeding mothers
• Elderly

South African recommendations

Caution in the following patient groups

• Renal impairment
• Mild to moderate hepatic impairment

Severe hepatic impairment

• In patients with severe liver impairment, a lower initial dose is advised due to potentially reduced clearance of loratadine. For such patients, starting with one tablet daily is recommended

Sugar content

• Patients with rare hereditary conditions like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not use this combination product due to its sugar content

Patients 60 years and older

• In patients aged 60 or older, sympathomimetics are more likely to cause serious adverse reactions, including confusion, hallucinations, seizures, CNS depression, and even death
• Extra caution is necessary when prescribing repeat-action formulations to elderly individuals

Cautious use of sympathomimetics in patients with

• Glaucoma
• Stenosing peptic ulcer
• Pyloroduodenal obstruction
• Prostatic hypertrophy
• Urinary tract obstruction
• Cardiovascular disease
• Increased intraocular pressure
• Diabetes mellitus

Pseudoephedrine Sulphate

Abuse potential

• Pseudoephedrine sulphate can be abused, especially at high doses. Common effects of abuse include mood elevation, decreased appetite, and a feeling of increased energy, mental capacity, and alertness
• Users may also experience anxiety, irritability, and excessive talkativeness
• Tolerance can develop with continued use, leading to increased dosages and potential toxicity
• Depression may occur following rapid withdrawal from the substance

Risk of Acute Generalised Exanthematous Pustulosis (AGEP)

• AGEP, a form of severe skin reaction, may occur with pseudoephedrine-containing products in isolated cases
• Symptoms to watch for include fever, erythema, or small (generalised) pustules
• If these signs appear, patients should immediately stop using the drug and consult a healthcare professional

Loratadine

Effects on ability to drive and use machinery

• Generally, loratadine does not cause significant sedation
• However, a minority of users may experience drowsiness
• Patients are advised to assess their individual response to loratadine before engaging in activities like driving or operating complex machinery
• The sedative effect of loratadine can be intensified if taken alongside alcohol or other central nervous system depressants

Forms avail. in SA and covered in this monograph: srt

South African registered indications and dosages

Relief of nasal and ocular symptoms of upper respiratory mucosal congestion, as in allergic and vasomotor rhinitis

Pseudoephedrine Sulphate/ Loratadine
120/5 (mg)

• Oral (srt): 1 tab, twice daily without chewing tablet; Max duration: 14 days

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The duration of symptoms should determine the treatment duration and should not exceed 14 days

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

South African registered indications and dosages

Relief of nasal and ocular symptoms of upper respiratory mucosal congestion, as in allergic and vasomotor rhinitis

Pseudoephedrine Sulphate/ Loratadine
120/5 (mg)

• Younger than 12 years: Contraindicated
• Older than 12 years: See adult dosage

Pregnancy

South African recommendations

• Contraindicated
• Safe use has not been established in pregnancy

Breastfeeding

South African recommendations

• Contraindicated
• Safe use has not been established in lactating mothers

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no information available

South African recommendations

• Mild to moderate: Caution; no dose adjustment recommended
• Severe: Caution; dose adjustment recommended
  Patients with severe liver impairment should be administered a lower initial dose due to reduced clearance of loratadine. An initial dose of 1 tablet daily is recommended

South African recommendations

• Contraindicated
  Safety in the elderly has not been established

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Immune System Disorders

Frequency unknown

• Hypersensitivity reactions, including:
  • Bronchospasm
  • Angioedema
  • Anaphylaxis

Psychiatric Disorders

Frequency unknown

• Depression
• Confusion
• Decreased libido
• Hyperkinesia
• Agitation
• Apathy
• Euphoria
• Insomnia

Nervous System Disorders

Frequency unknown

• Nervousness
• Dizziness
• Thirst
• Hypoesthesia
• Paraesthesia
• Tremor
• Increased sweating
• Migraine
• Malaise
• Central nervous system stimulation
• Excitability
• Convulsions
• Rigors
• Anxiety
• Paroniria
• Taste abnormality

Eye Disorders

Frequency unknown

• Various unspecified eye disorders

Ear and Labyrinth Disorders

Frequency unknown

• Vertigo
• Earache
• Tinnitus

Cardiac Disorders

Frequency unknown

• Tachycardia
• Postural hypotension
• Palpitation
• Hypertension
• Supraventricular tachyarrhythmias
• Cardiovascular collapse

Vascular Disorders

Frequency unknown

• Flushing
• Hypertension

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Pharyngitis
• Rhinitis
• Bronchospasm
• Coughing
• Dyspnoea
• Nasal congestion
• Sneezing
• Nasal irritation
• Epistaxis

Gastrointestinal Disorders

Frequency unknown

• Nausea and vomiting
• Abdominal distress
• Changes in bowel habits
• Dyspepsia
• Haemorrhoids
• Taste abnormality
• Tongue discoloration
• Tongue disorder
• Eructation
• Dehydration

Hepatobiliary Disorders

Frequency unknown

• Transient abnormal hepatic function
• Abnormal hepatic function

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Pruritus
• Rash
• Urticaria
• Acne
• Alopecia

Musculoskeletal and Connective Tissue Disorders

Frequency unknown

• Arthralgia
• Back pain
• Leg cramps
• Asthenia

Renal and Urinary Disorders

Frequency unknown

• Dysuria
• Micturition disorder
• Nocturia
• Polyuria
• Urinary retention

General Disorders and Administration Site Conditions

Frequency unknown

• Dysphonia
• Increased appetite
• Anorexia
• Increased weight
• Epistaxis
• Asthenia
• Malaise
• Fatigue
• Rigors
• Excitability

Post-marketing experience - Pseudoephedrine-containing products

Isolated cases

• Acute generalised exanthematous pustulosis (AGEP)

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Pseudoephedrine Sulphate

• Monoamine oxidase inhibitors
• Methyldopa
• Mecamylamine
• Reserpine
• Veratrum alkaloids
• Digitalis
• Beta-adrenergic blockers
• Antacids
• Kaolin

Loratadine

• Medicines known to inhibit hepatic metabolism

Other interactions

• Skin testing procedures (See additional prescribing points)

None routine

Skin testing procedures interaction

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

Pseudoephedrine Sulphate
Pseudoephedrine sulphate is an orally active vasoconstrictor which produces sustained shrinkage of congested upper respiratory mucosa through a sympathomimetic action.

Loratadine
Loratadine is a long-acting, tricyclic antihistamine with selective peripheral H1-receptor antagonist activity.

COMBINATION PREPARATIONS

Pseudoephedrine Sulphate/ Loratadine

Tablet 120mg/5mg

• Demazin ND (iNova Pharmaceuticals) originator