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LORINE
®
Tablets and Syrup
Brand of loratadine Long-Acting, Non-Sedating Antihistamine
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COMPOSITION
Each
LORINE Tablet contains 10 mg micronized loratadine and the inactive
ingredients corn starch, lactose and magnesium stearate. Each 5
ml of LORINE Syrup contains 5 mg of micronized loratadine and the
inactive ingredients propylene glycol, glycerin, citric acid monohydrate,
sodium benzoate, sugar, peach flavor and purified water.
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ACTIONS
Loratadine
is a potent long-acting tricyclic antihistamine with selective peripheral
H1-receptor antagonistic activity.
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INDICATIONS
AND USAGE
LORINE
Products are indicated for the relief of symptoms associated with
allergic rhinitis, such as 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.
LORINE Products are also indicated for relief of symptoms and signs
of chronic urticaria and other allergic dermatologic disorders.
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DOSAGE
AND ADMINISTRATION
Adults and Children
12 years of age and over:
LORINE Tablet:
One Tablet [10 mg] once daily;
LORINE Syrup:
Two teaspoonsful [10 ml] once daily.
Children 2 to 12 years of age:
Body Weight > 30 kg - 10 ml [10 mg], (two teaspoonsful), LORINE
Syrup once daily.
Body Weight < 30 kg - 5 ml [5 mg], (one teaspoonful), LORINE Syrup
once daily.
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DRUG
INTERACTIONS
When administered
concomitantly with alcohol, loratadine has no potentiating effects
as measured by psychomotor performance studies.
LORINE can be administered independently of the meals. Increases
in plasma concentrations of loratadine has 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 coadministered
with caution until definitive interaction studies can be completed.
Drug/Laboratory Test Interactions:
LORINE Products should be discontinued approximately 48 hours prior
to skin testing procedures since antihistamines may prevent or diminish
otherwise positive reactions to dermal reactivity indicators.
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ADVERSE
REACTIONS
LORINE has no clinically significant sedative
properties at the daily recommended dose of 10 mg. Most commonly
reported side effects include fatigue, headache, somnolence, dry
mouth, gastrointestinal disorders such as nausea, gastritis, and
also allergic symptoms like rash.
During the marketing of loratadine tablets, alopecia, anaphylaxis,
and abnormal hepatic function have been reported rarely. Similarly,
the incidence of adverse effects associated with LORINE Syrup has
been comparable to that of placebo.
In controlled pediatric clinical trials, the incidence of treatment-related
headache, sedation and nervousness, which were rarely reported events,
was similar to that of placebo.
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CONTRAINDICATIONS
LORINE Products are contraindicated
in patients who have shown hypersensitivity or idiosyncrasy to their
components.
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PRECAUTIONS
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 or 5 ml once daily,
or 10 mg or 10 ml every other day is recommended.
Safety and efficacy of LORINE Products in children younger than
two years of age have not yet been established.
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USAGE
DURING PREGNANCY AND IN NURSING MOTHERS
Safe use of LORINE Products during pregnancy
and lactation has not been established; therefore, use only if potential
benefit justifies potential risk to fetus.
Since loratadine is excreted in breast milk and because of the increased
risk of antihistamines for infants, particularly newborns and premature
infants, a decision should be made whether to discontinue nursing
or discontinue the drug.
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OVERDOSAGE
INFORMATION
Somnolence, tachycardia
and headache have been reported with overdoses. 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.
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 to 360 milliliters of water. If emesis
does not occur within 15 minutes, 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 of
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.
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PRESENTATIONS
AND STORAGE
LORINE Tablets
are available in packages of 10 and 20 tablets.
LORINE Syrup 1 mg / ml in bottles of 100 ml.
STORAGE:
Store between 2° and 30°C.
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