|Indication & Dosage
Allergic rhinitis, Cold andÂ flu
Adult:Â 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
Child:Â 6-12 yr: As syrup containing loratadine 5 mg and pseudoephedrine 60 mg (per 5 ml): â‰¤30 kg: 2.5 ml bid;
>30 kg: 5 ml bid.Â
Hepatic impairment:Â Severe: Initial dose of 1 tab (containing loratadine 5 mg and pseudoephedrine
sulfate 120 mg) daily or Â½ the usual syrup dose.
||May be taken with or without food.
||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.
Narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism. Patients on MAOI therapy or within 14 days
of discontinuing MAOI.
||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
||Insomnia, dry mouth, headache, nervousness, epistaxis,
pharyngitis, dizziness, fatigue, tachycardia, postural hypotension, transient abnormal hepatic function, urinary retention, CNS stimulation,
||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
Potentially Fatal:Â 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.Â Please consult detailed drug
interactions before prescribing.
||Reactions to skin testing procedures may be reduced, antihistamines should be discontinued 48 hr before
||Oral:Â Store below
||Loratadine is a long-acting, non-sedating
antihistamine with little antimuscarinic activity. Pseudoephedrine, a vasoconstrictor, acts on the Î±-receptors and produces a decongestant effect by
shrinking congested mucosa in the upper respiratory areas.
Onset:Â Nasal decongestion: 30 minutes.
Duration:Â Nasal decongestion: 8 hr (60 mg pseudoephedrine) and 12 hr (120 mg pseudoephedrine in extended release preparations).
Absorption:Â 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:Â 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:Â 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:Â 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
||R01BA02 - pseudoephedrine ; Belongs to the class of systemic
sympathomimetic preparations used as nasal decongestants.Â
R06AX13 - loratadine ; Belongs to the class of other agents used as systemic