Clarityn-D 12Hour Repetabs

Clarityn-D 12Hour Repetabs

loratadine + pseudoephedrine

Manufacturer:

Bayer

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Loratadine, pseudoephedrine sulfate.
Description
Each repetab contains loratadine 5 mg in the tablet coating and pseudoephedrine sulfate 120 mg equally distributed between the tablet coating and the barrier-coated core. The 2 active components in the coating are quickly liberated; release of the decongestant in the core is delayed for several hours. It also contains the following inactive ingredients: Acacia, calcium sulfate, carnauba wax, gum rosin, microcrystalline cellulose, oleic acid, medicinal soap, sucrose, talc, titanium dioxide, white wax, zein, anhydrous lactose, cornstarch, povidone, magnesium stearate and purified water.
Action
Pharmacotherapeutic Group: Long-acting, nonsedating antihistamine/decongestant.
Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
Pseudoephedrine sulfate, 1 of the naturally occurring alkaloids of the Ephedra and an orally administered vasoconstrictor, produces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in upper respiratory areas. The mucous membrane of the respiratory tract is decongested through the action of the sympathetic nerves.
Indications/Uses
Clarityn-D 12Hour Repetabs is indicated for relief of symptoms associated with allergic rhinitis and the common cold including nasal congestion, sneezing, rhinorrhea, pruritus and lacrimation.
Clarityn-D 12Hour Repetabs is recommended when both the antihistaminic properties of loratadine and the decongestant effect of pseudoephedrine sulfate are desired.
Dosage/Direction for Use
Adults and Children ≥12 years: 1 repetab twice daily.
Overdosage
Symptoms: In the event of overdosage, general symptomatic and supportive treatment should be started immediately and maintained for as long as necessary.
Manifestation: They may vary from central nervous system depression (sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to stimulation (insomnia, hallucination, tremors or convulsions) to death. Other signs and symptoms may be euphoria, excitement, tachycardia, palpitations, thirst, perspiration, nausea, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia and gastrointestinal symptoms).
In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.
The oral LD50 values for this combination product were >525 mg/kg and 1839 mg/kg in mice and rats, respectively.
Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologically-induced vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 240-360 mL of water. If emesis does not occur within 15 min, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in children.
Following emesis, absorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Physiologic saline solution is the lavage solution of choice, particularly in children. In adults, tap water can be used; however, as much as possible, the amount administered should be removed before the next instillation. Saline cathartics draw water into the bowel by osmosis and therefore may be valuable for their action in rapid dilution of bowel content. It is not known whether Clarityn-D 12Hour Repetabs is dialyzable. After emergency treatment, the patient should continue to be medically monitored.
Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermic blanket. Apnea is treated with ventilatory support.
Contraindications
Hypersensitivity or idiosyncrasy to loratadine, pseudoephedrine sulfate or to any components of Clarityn-D 12Hour Repetabs, to adrenergic agents or to other drugs of similar chemical structure; patients receiving monoamine oxidase inhibitor (MAOI) therapy or within 14 days of discontinuing such treatment; patients with narrow-angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.
Special 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.
Acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, may occur with pseudoephedrine-containing products in isolated cases. If signs and symptoms such as fever, erythem or small (generalized) pustules are observed, patients should discontinue the drug and consult their physician.
Patients with severe liver impairment should be administered with a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 1 tablet daily is recommended.
Patients who have a history of difficulty in swallowing tablet; or have had upper GI narrowing or abnormal esophageal peristalsis should not use this product.
Drug Abuse and Dependence: There are no data available to indicate that abuse or dependency occurs with loratadine.
Pseudoephedrine sulfate, like other CNS stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, decreased appetite and a sense of increased physical energy, mental capacity and alertness. Anxiety, irritability and loquacity also have been experienced. With continued use, tolerance develops; the user increases the dose and ultimately toxicity occurs. Depression may follow rapid withdrawal.
Use in pregnancy & lactation: Safe use of Clarityn-D 12Hour Repetabs during pregnancy has not been established. Therefore, it should be used only if the potential benefit justifies the potential risk to the fetus.
Since loratadine and pseudoephedrine sulfate are excreted in breast milk, a decision should be made whether to discontinue nursing or to discontinue the use of Clarityn-D 12Hour Repetabs.
Use in children: Safety and efficacy of Clarityn-D 12Hour Repetabs in children <12 years have not yet been established.
Use in the elderly: In patients ≥60 years, sympathomimetics are also more likely to cause adverse reactions eg, confusion, hallucination, convulsions, CNS depression and death. Consequently, caution should be exercised when administering a repeat-action formulation to elderly patients.
Use In Pregnancy & Lactation
Safe use of Clarityn-D 12Hour Repetabs during pregnancy has not been established. Therefore, it should be used only if the potential benefit justifies the potential risk to the fetus.
Since loratadine and pseudoephedrine sulfate are excreted in breast milk, a decision should be made whether to discontinue nursing or to discontinue the use of Clarityn-D 12Hour Repetabs.
Adverse Reactions
During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with Clarityn-D 12Hour Repetabs was comparable to that of placebo, with the exception of insomnia and dry mouth, both of which were commonly reported. Other reported adverse reactions associated with both Clarityn-D 12Hour Repetabs and placebo included headache and somnolence.
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, paraesthesia, tremor, vertigo, flushing, postural hypotension, increased sweating, weight and appetite; eye disorders, earache, tinnitus, taste abnormality, agitation, apathy, depression, euphoria, paroneiria, change in bowel habits, dyspepsia, eructation, hemorrhoids, tongue discolouration and disorder; vomiting, transient abnormal hepatic function, dehydration, hypertension, palpitation, migraine, bronchospasm, coughing, dyspnea, epistaxis, sneezing, nasal congestion and irritation, dysuria, micturition disorder, nocturia, polyuria, urinary retention, asthenia, back pain, leg cramps, malaise and rigors.
During the marketing of loratadine, alopecia, anaphylaxis and abnormal hepatic functions have been reported rarely.
Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Increase in plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other drugs known to inhibit hepatic metabolism should be co-administered with caution until definitive interaction studies can be completed.
When sympathomimetics are given to patients receiving monoamine oxidase inhibitors (MAOIs), hypertensive reactions, including hypertensive crises may occur. The antihypertensive effects of methyldopa, mecamylamine, reserpine and veratum alkaloids may be reduced by sympathomimetics. Beta-adrenergic-blocking agents may also interact with sympathomimetics. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Antacids increase the rate of pseudoephedrine absorption; kaolin decreases it.
Drug/Laboratory Test Interactions: Antihistamines should be discontinued approximately 48 hrs prior to skin testing procedures since these may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
The in vitro addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatinine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over 6 hrs.
Storage
Store at or below 25°C. Protect blister packs from excessive moisture.
ATC Classification
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Presentation/Packing
Repetab (cartons) 2 x 7's, 5 x 10's.
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