Loratadine + Pseudoephedrine


Concise Prescribing Info
Indications/Uses
Allergic rhinitis and common cold.
Dosage/Direction for Use
Adult : PO Extended release Per tab contains loratadine 5 mg and pseudoephedrine sulfate 120 mg: 1 tab twice daily. Per tab contains loratadine 10 mg and pseudoephedrine sulfate 120 mg: 1 tab once daily.
Dosage Details
Oral
Allergic rhinitis, Cold and flu
Adult: As extended release preparation containing loratadine 5 mg and pseudoephedrine sulfate 120 mg: 1 tablet bid. As extended release preparation containing loratadine 10 mg and pseudoephedrine sulfate 120 mg: 1 tab once daily.
Child: 6-12 yr: As syrup containing loratadine 5 mg and pseudoephedrine 60 mg (per 5 ml): ≤30 kg: 2.5 ml bid; >30 kg: 5 ml bid.
Hepatic Impairment
Severe: Initial dose of 1 tab (containing loratadine 5 mg and pseudoephedrine sulfate 120 mg) daily or ½ the usual syrup dose.
Administration
Extended-Release: May be taken with or without food. Swallow whole, do not break, chew or dissolve.
Contraindications
Lactation. Narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism. Patients on MAOI therapy or within 14 days of discontinuing MAOI.
Special Precautions
Glaucoma, increased intraocular pressure, stenosing peptic ulcer and pyloroduodenal obstruction, prostatic hypertrophy, bladder neck obstruction, CV disease, DM, severe liver impairment. Not recommended for use in pregnancy. Elderly. Tablets to be swallowed whole and patients should be instructed not to break, chew, or dissolve such tablets.
Adverse Reactions
Insomnia, dry mouth, headache, nervousness, epistaxis, pharyngitis, dizziness, fatigue, tachycardia, postural hypotension, transient abnormal hepatic function, urinary retention, CNS stimulation, excitability.
Overdosage
Symptoms: CNS depression (sedation, apnoea, decreased mental alertness, cyanosis, coma, CV collapse), CNS stimulation (insomnia, hallucination, convulsions) and even death. Management: Induce emesis, followed by supportive and symptomatic treatment.
Drug Interactions
Loratadine: Increased loratadine levels with ritonavir, amprenavir; increased loratadine levels with erythromycin, cimetidine and ketoconazole without evidence of clinical significance or toxicity; may block effects of betahistine. Pseudoephedrine: Increased adverse effects (e.g. somnolence, agitation) with atomoxetine; increased BP or heart rate with sibutramine.
Potentially Fatal: Pseudoephedrine: Increased risk of psychosis with bromocriptine; increased risk of fatal hypertensive crisis with MAOI, avoid concurrent use during and for 2 wk after stopping the MAOI; increased BP with linezolid and selegiline.
Lab Interference
Reactions to skin testing procedures may be reduced, antihistamines should be discontinued 48 hr before procedure.
Action
Description: Loratadine is a long-acting, non-sedating antihistamine with little antimuscarinic activity. Pseudoephedrine, a vasoconstrictor, acts on the α-receptors and produces a decongestant effect by shrinking congested mucosa in the upper respiratory areas.
Onset: Nasal decongestion: 30 minutes.
Duration: Nasal decongestion: 8 hr (60 mg pseudoephedrine) and 12 hr (120 mg pseudoephedrine in extended release preparations).
Pharmacokinetics:
Absorption: Loratadine: Absorbed rapidly from GI tract, peak plasma concentrations reached in about 1 hr, bioavailability increased and time to peak plasma concentrations delayed when taken with food.
Distribution: Loratadine: 98% bound to plasma proteins; desloratadine 73-76% bound to plasma proteins; loratadine and its metabolites enters into breast milk, but do not to cross the blood-brain barrier significantly. Pseudoephedrine: May distribute into milk, crosses placenta and into CSF.
Metabolism: Loratadine: Undergoes extensive metabolism by cytochrome P450 isoenzymes CYP3A4 and CYP2D6; its major metabolite desloratadine has potent antihistaminic activity; elimination half-lives 8.4 hr (loratadine), 28 hr (desloratadine).
Excretion: Loratadine: Excreted equally in the urine and faeces, mainly in the form of metabolites. Pseudoephedrine: Undergoes incomplete metabolism in the liver by N-demethylation to inactive metabolite; excreted in urine with 55-75% of dose excreted unchanged.
Storage
Store below 25°C.
Disclaimer: This information is independently developed by MIMS based on Loratadine + Pseudoephedrine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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