Lodin Plus

Approved Indications:

• Seasonal Allergic Rhinitis (Hay Fever): Relief of symptoms such as nasal congestion, sneezing, rhinorrhea, and itchy/watery eyes.
• Perennial Allergic Rhinitis: Management of year-round allergic symptoms with associated nasal congestion.
• Sinus Congestion and Pressure: Particularly useful in patients with upper respiratory allergies presenting with sinus blockage and facial pressure.
• Common Cold (Symptomatic Treatment): Relief of nasal congestion and rhinorrhea.

Clinically Accepted Off-label Use:

• Vasomotor Rhinitis (Non-allergic Rhinitis): Used for symptomatic relief in non-IgE mediated rhinitis with nasal congestion.

Adults and Adolescents (≥12 years):

• Extended-Release Tablets (Loratadine 5 mg + Pseudoephedrine 120 mg):
• One tablet orally every 12 hours.
• Maximum: 2 tablets (240 mg pseudoephedrine) in 24 hours.

Children (6–12 years):

• Loratadine 5 mg + Pseudoephedrine 60 mg (every 12-hour formulation):
• One tablet every 12 hours.
• Not recommended for children under 30 kg body weight.

Children (<6 years):

• Not recommended due to insufficient safety and efficacy data.

Geriatric Patients:

• Start at the lower end of the dosing range.
• Monitor closely for cardiovascular and CNS side effects.

Hepatic Impairment:

• Consider reducing the frequency due to prolonged loratadine half-life.
• Use with caution.

Renal Impairment:

• No specific dose adjustment is required, but monitor closely due to pseudoephedrine renal excretion.

Route of Administration: Oral
Instructions: Swallow extended-release tablets whole with water. Do not crush or chew. May be taken with or without food.

Loratadine is a long-acting, selective H1-receptor antagonist that blocks peripheral histamine-1 receptors, thereby preventing histamine-mediated allergic symptoms such as sneezing, nasal discharge, and itching. It has minimal central nervous system penetration, leading to reduced sedation. Pseudoephedrine is a sympathomimetic amine that acts on alpha-adrenergic receptors in the nasal mucosa to produce vasoconstriction, resulting in decreased nasal congestion. The combination addresses both the inflammatory and vascular components of allergic rhinitis.

Loratadine:

• Absorption: Rapid; peak plasma concentration within 1–1.5 hours.
• Bioavailability: Approximately 40%.
• Distribution: Highly protein-bound (≈97%).
• Metabolism: Hepatic via CYP3A4 and CYP2D6 to active metabolite desloratadine.
• Half-life: Loratadine: ~8 hours; Desloratadine: ~27 hours.
• Elimination: Excreted in urine (~42%) and feces (~40%).

Pseudoephedrine:

• Absorption: Rapid and complete.
• Bioavailability: High (~90%).
• Distribution: Widely distributed; crosses the blood-brain barrier.
• Metabolism: Partially hepatic.
• Half-life: 5–8 hours (longer in renal impairment).
• Elimination: Primarily via kidneys in unchanged form.

Pregnancy:

• Loratadine: Considered safe; formerly categorized as FDA Pregnancy Category B.
• Pseudoephedrine: May cause vasoconstriction of uterine blood vessels, especially in the first trimester. Use only if benefits outweigh risks.

Lactation:

• Loratadine: Present in small amounts in breast milk; generally considered safe.
• Pseudoephedrine: Excreted in breast milk and may reduce milk production; use with caution.

Recommendation: Use only if clearly needed under medical supervision during pregnancy or breastfeeding.

• Therapeutic Class: Combination Antihistamine and Nasal Decongestant.
• Subclasses:
• Loratadine: Second-generation, non-sedating H1-antihistamine.
• Pseudoephedrine: Systemic nasal decongestant (alpha-adrenergic agonist).

• Known hypersensitivity to loratadine, pseudoephedrine, or any component of the formulation.
• Severe hypertension or significant coronary artery disease.
• Concurrent or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs).
• Narrow-angle glaucoma.
• Severe renal or hepatic impairment.
• Urinary retention or prostatic hypertrophy.

• Cardiovascular Disease: Use with caution in patients with hypertension, arrhythmias, or ischemic heart disease.
• CNS Effects: May cause agitation, restlessness, or insomnia, especially in children and older adults.
• Hepatic Dysfunction: Loratadine clearance may be delayed.
• Renal Dysfunction: Prolonged half-life of pseudoephedrine may lead to accumulation.
• Prostatic Hypertrophy: Risk of urinary retention.
• Phenylketonuria (PKU): Some formulations may contain phenylalanine.

Common Side Effects:

• Central Nervous System: Headache, insomnia, nervousness, dizziness.
• Gastrointestinal: Dry mouth, nausea.
• Respiratory: Cough, epistaxis, sore throat.

Less Common:

• Palpitations, tachycardia.
• Restlessness, anxiety.
• Blurred vision.

Serious/Rare:

• Cardiac arrhythmias.
• Hypertensive crisis (especially with MAOIs).
• Allergic reactions, including rash and anaphylaxis (rare).

Onset: Symptoms generally begin improving within 1–2 hours.
Dose-Dependent: CNS stimulation and cardiovascular side effects may increase with higher doses.

• MAO Inhibitors: Risk of hypertensive crisis—contraindicated.
• Beta-Blockers: May enhance pressor effects of pseudoephedrine.
• CYP3A4 Inhibitors (e.g., ketoconazole, erythromycin): May increase loratadine serum concentrations.
• Alcohol: May potentiate CNS side effects such as dizziness or drowsiness.
• Other Decongestants: Risk of additive sympathomimetic effects.

Enzyme Systems Involved:

• Loratadine: Metabolized by CYP3A4 and CYP2D6.
• Pseudoephedrine: Minimally metabolized, mostly renal excretion.

• EMA issued safety warnings regarding rare risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine-containing products.
• No changes to dosing or indications by the FDA, WHO, or NICE as of the latest guidelines.
• Caution emphasized in hypertensive and elderly patients using pseudoephedrine-containing medications.

• Temperature: Store below 25°C (77°F).
• Humidity: Protect from moisture.
• Light: Store in a dry place away from direct light.
• Handling: Do not crush or split extended-release tablets.
• Packaging: Keep in original container or blister pack until use.