loratadine + pseudoephedrine




Four Star
Full Prescribing Info
Loratadine, pseudoephedrine.
Each CLARINASE REPETABS Tablet contains 5 mg loratadine in the tablet coating and 120 mg pseudoephedrine sulfate equally distributed between the tablet coating and the barrier-coated core. The two active components in the coating are quickly liberated; release of the decongestant in the core is delayed for several hours.
Each ER tab contains loratadine 10 mg in the tablet coating and pseudoephedrine sulfate 240 mg in the tablet core. The loratadine component is released immediately, whereas the pseudoephedrine component is released slowly from the core allowing for once-daily administration.
Excipients/Inactive Ingredients: Repetab: lactose monohydrate, maize starch, povidone, magnesium stearate, acacia, sucrose, calcium sulfate dihydrate, calcium sulfate anhydrous, colophonium, zein, oleic acid, soap powder, talc, microcrystalline cellulose, titanium dioxide, white beeswax, carnauba wax, purified water and ethanol 96%.
ER Tab: Core: Hydroxypropyl methylcellulose, ethylcellulose, dibasic calcium phosphate dihydrate, povidone, silicone dioxide and magnesium stearate.
Film-Coat: Polyethylene glycol, dye opaspray white, sugar, carnauba wax and white wax.
Pharmacotherapeutic Group: Long-Acting, Non-sedating Antihistamine/Decongestant.
Pharmacology: Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
Pseudoephedrine sulfate, one of the naturally occurring alkaloids of 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 on the sympathetic nerves.
The combination of loratadine and pseudoephedrine sulfate controls histamine-mediated symptoms and relieves nasal congestion associated with allergic rhinitis and the common cold.
Relief of symptoms associated with allergic rhinitis and the common cold including nasal congestion, sneezing, rhinorrhoea, pruritus and lacrimation.
Clarinase is recommended when both the antihistaminic properties of loratadine and the decongestant effect of pseudoephedrine sulfate are desired.
Dosage/Direction for Use
Repetab: Adults and Children 12 years of age and over: One CLARINASE REPETABS Tablet twice a day.
ER Tab: Adults and Children ≥12 years:
1 tab once daily taken whole with a glass of water. Clarinase may be taken without regard to mealtime.
Patients who have a history of difficulty in swallowing tablets or who have known upper GI narrowing or abnormal oesophageal peristalsis should not take Clarinase (see Precautions and Adverse Reactions).
In the event of overdosage, general symptomatic and supportive treatment should be started immediately and maintained for as long as necessary.
Manifestations: They may vary from CNS depression (sedation, apnoea, 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 greater than 525 and 1839 mg/kg in mice and rats, respectively.
Treatment: Consider standard measures to remove any unabsorbed drug in the stomach, such as adsorption by the administration of activated charcoal as a slurry with water. The administration of gastric lavage should be considered. 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, adsorption 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 this product 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.
CLARINASE REPETABS/Clarinase ER tab is contraindicated in those who have shown sensitivity or idiosyncrasy to their components, to adrenergic agents or to other drugs of similar chemical structure. CLARINASE REPETABS/Clarinase ER tab is also contraindicated in patients receiving MAO inhibitor therapy or within fourteen days of discontinuing such treatment and in 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.
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 elderly patients.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; for ER tablet, initial dose of 1 tablet every other day is recommended. For repetab, initial dose of one tablet daily is recommended.
Patients who have a history of difficulty in swallowing tablets or who have known upper GI narrowing or abnormal oesophageal peristalsis should not use Clarinase tablets.
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 use increases the doses and ultimately toxicity occurs. Depression may follow rapid withdrawal.
Use in Children: Safety and efficacy of CLARINASE REPETABS/Clarinase ER tab in children younger than 12 years of age have not yet been established.
Use In Pregnancy & Lactation
Safe use of CLARINASE REPETABS/Clarinase ER tab 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 sulfate are excreted in breast milk, a decision should be made whether to discontinue nursing or to discontinue the use of this product.
Adverse Reactions
Repetab: During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with CLARINASE REPETABS Tablets 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 CLARINASE REPETABS Tablets 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, 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, alopecia, anaphylaxis, tachycardia, palpitations, abnormal hepatic function, and dizziness have been reported rarely.
ER Tab: In clinical studies, the most frequently reported adverse events associated with Clarinase were headache and dry mouth. Less commonly reported events were somnolence and insomnia, which were reported also at a comparable rate with placebo and other new generation antihistamine controls.
Rarely reported events in decreasing order of frequency included dizziness, fatigue, anorexia, nervousness, nausea, epistaxis, hyperkinesia, constipation, dyspepsia, palpitation, tachycardia, thirst, agitation, irritability, coughing, dyspnoea, nasal irritation and pharyngitis.
With the exception of headache, which was occasionally severe, most of the adverse events associated with Clarinase were mild to moderate in severity.
During the marketing of loratadine, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.
There were rare post-marketing reports of mechanical upper GI tract obstruction in patients taking the original round tablet formulation of Clarinase. In many of these cases, patients have had a history of difficulty in swallowing tablets, or had known upper GI narrowing or abnormal oesophageal peristalsis.
Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effect 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 (MAO) inhibitors, hypertensive reactions, including hypertensive crises may occur. The antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum 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 hours prior to skin testing procedures since these drugs 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 six hours.
ER Tab: Store below 25°C.
Protect from excessive moisture.
ATC Classification
R01BA52 - pseudoephedrine, combinations ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
Repetab: 2 x 7's. ER tab: 7's.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in