CLARITIN®
Description Each tablet contains micronized loratadine 10 mg and the inactive
ingredients cornstarch, lactose and magnesium stearate.
Each 5 mL of syrup contains micronized loratadine 5 mg and the
inactive ingredients propylene glycol, glycerin, citric acid monohydrate,
sodium benzoate 0.1% w/v (preservative), sugar, peach flavor and
purified water.
Indications Relief of symptoms associated with allergic
rhinitis, eg sneezing, nasal discharge (rhinorrhea) and itching,
as well as ocular itching and burning.
Nasal and ocular signs and symptoms are relieved rapidly after
oral administration.
Also indicated for relief of symptoms and signs of chronic urticaria
and other allergic dermatological disorders.
Dosage Adults and Children ?12 years: 10
mg (1 tab or two 5-mL tsp of syrup).
Children 2-12 years: Body weight >30 kg: 10 mg (1 tab or
two 5-mL tsp of syrup); ?30 kg: 5 mg (? tab or one 5-mL tsp
of syrup).
All doses to be given once daily.
Patients with severe liver impairment should be administered
a lower initial dose because they may have reduced clearance
of loratadine; an initial dose of 5 mg (? tab or one 5-mL tsp
of syrup) once daily, or 10 mg (1 tab or two 5-mL tsp of syrup)
every other day is recommended.
Overdosage To date, overdosage has not
occurred with loratadine. A single acute ingestion of 160 mg
produced no adverse effects. In the event of overdosage, treatment,
which should be started immediately, is symptomatic and supportive.
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. Loratadine is not cleared by hemodialysis to any appreciable
extent. After emergency treatment, the patient should continue
to be medically monitored.
Contraindications Patients
who have shown hypersensitivity or idiosyncrasy to any of the
components of Claritin.
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 can be completed.
Drug/Laboratory Test: Claritin should be discontinued approximately
48 hrs prior to skin testing procedures since antihistamines
may prevent or diminish otherwise positive reactions to dermal
reactivity indicators.
Storage Store between 2°C and 30°C.
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