Loratadine/Pseudoephedrine

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[edit] BRAND NAMES

[edit] STRUCTURE

[edit] MECHANISM OF ACTION

Loratadine is long-acting tricyclic second generation (non-sedating) antihistamine. It acts as an antagonist at peripheral histamine (H1) receptors. Histamine is a substance that causes allergic symptoms. When histamine (H1) receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy. As with other second-generation antihistamines, the low incidence of sedation can be attributed to reduced penetration into the CNS

Pseudoephedrine, one of the naturally occurring alkaloids of Ephedra and an orally administered vasoconstrictor, is a sympathomimetic drug that produces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in upper respiratory areas.

[edit] INDICATIONS

Relief of symptoms of seasonal allergic rhinitis when both the antihistaminic properties and the nasal decongestant activity are desired

[edit] DOSAGE

Adults and Children 12 years of age and over: One Loratadine/Pseudoephedrine tablet (loratadine 5mg/Pseudoephedrine 120 mg) every 12 hours; not more than 2 tablets in 24 hours

[edit] CONTRAINDICATIONS

  • Hypersensitivity to Loratadine or to Pseudoephedrine .
  • Patients receiving MAO inhibitor therapy or within fourteen days of discontinuing such treatment
  • Patients with narrow-angle glaucoma
  • Urinary retention
  • Severe hypertension
  • Severe coronary artery disease
  • Hyperthyroidism.

[edit] PRECAUTIONS

Sympathomimetics should be used with caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitus.

Sympathomimetics should be used with caution in patients receiving digitalis.

Sympathomimetics may cause central nervous system (CNS) stimulation, excitability, convulsions, and/or cardiovascular collapse with accompanying hypotension.

In patients 60 years of age or older, sympathomimetics are also more likely to cause adverse reactions such as confusion, hallucination, convulsions, CNS depression and death. Consequently, caution should be exercised when administering a repeat-action formulation to this patient group.

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of one tablet daily is recommended.

[edit] INTERACTIONS

  • Monoamine Oxidase (MAO) Inhibitors: Do not use. May potentiate the effect of pseudoephedrine on vascular system; hypertensive reactions, including hypertensive crises, may occur.

[edit] PREGNANCY AND LACTATION

  • Safety during pregnancy has not been established. Therefore, the product should be used only if the potential benefit justifies the potential risk to the fetus.
  • Since loratadine and pseudoephedrine are excreted in breast milk, a decision should be made whether to discontinue nursing or to discontinue the use of this product.

[edit] SIDE EFFECTS

Most common adverse reactions: insomnia/somnolence and dry mouth.

Rare adverse reactions in decreasing order of frequency included nervousness, dizziness, fatigue, nausea, abdominal distress, anorexia, thirst, tachycardia, pharyngitis, rhinitis, acne, pruritus, rash, urticaria, arthralgia, confusion, dysphonia, hyperkinesia, hypoesthesia, decreased libido, paresthesia, tremor, vertigo, flushing, postural hypotension, increased sweating, eye disorders, earache, tinnitus, taste abnormality, agitation, apathy, depression, euphoria, paroneiria, increased appetite, change in bowel habits, dyspepsia, eructation, hemorrhoids, tongue discoloration, tongue disorder, vomiting, transient abnormal hepatic function, dehydration, increased weight, hypertension, palpitation, migraine, bronchospasm, coughing, dyspnea, epistaxis, nasal congestion, sneezing, nasal irritation, dysuria, micturition disorder, nocturia, polyuria, urinary retention, asthenia, back pain, leg cramps, malaise and rigors.

During the marketing of Loratadine/Pseudoephedrine, alopecia, anaphylaxis, tachycardia, palpitations and abnormal hepatic function have been reported rarely.

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