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Composition |
Each mint flavored
dispersible tablet contains Loratadine 10 mg.
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Description |
Awayke™ MD is an
anti-allergic medication intended to provide relief from
various symptoms of allergy and common cold.
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Clinical Pharmacology |
General
Loratadine belongs to second-generation antihistamines (nonsedating)
which selectively blocks peripheral H1 receptors
(histamine receptor) and therefore less liable to cause
side effects.
Mechanism of action
Loratadine is a potent histamine antagonist
(antihistamine) acting specifically on H1 receptors. It
competes with histamine for the receptor site and
reversibly inhibits interaction of histamine with H1
receptors. It starts exhibiting its effect within 1 to 3
hour, reaching a maximum at 8 to 12 hours and lasting
for about 24 hours.
Pharmacokinetics
Loratadine is rapidly absorbed from gastrointestinal
tract. Following oral administration of Loratadine 10 mg
daily for 10 days, mean peak plasma concentration was
attained at 1.3 hours and 2.3 hours (Tmax) for
Loratadine and its major active metabolite
descarboethoxyloratadine, respectively. Food delayed
Tmax of Loratadine and descarboethoxyloratadine by 2.4
and 3.7 hours. However, peak concentration (Cmax) of the
parent compound and its metabolite were not altered by
administration of food. Following oral administration,
Loratadine is metabolized in the liver by the hepatic
microsomal P450 system and excreted primarily in the
urine.
Special population
- Renal Insufficiency:
Both AUC and Cmax of Loratadine increased in chronic
renal impairment (creatinine clearance less than 30
ml/min.) Hemodialysis also does not have any effect on
pharmacokinetics of loratadine in chronic renal
impairment.
- Hepatic Insufficiency:
The AUC, Cmax and elimination half-lives of loratadine
were increased in patients with hepatic insufficiency.
- Geriatric Population:
The AUC, Cmax and mean elimination half-lives of
loratadine and its metabolite were increased in
geriatric subject.
- Pediatric Population:
Pharmacokinetics profile in 6 to 12 year age group is
similar to that of adults.
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Indications |
Awayke™ MD
tablets are indicated for relief from symptoms of
seasonal allergic rhinitis and other allergic disorders,
common cold and chronic idiopathic urticaria.
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Dosage |
Adults and children above 12
years of age: One tablet (Loratadine 10 mg) daily.
Children aged 2 to 12 years: Consult your physician
Children below 2 years of age: Not recommended
Do not exceed the recommended doses.
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Directions for use |
Place the tablet on the
tongue, it disperses in few seconds. No water is
required while taking the tablet.
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Precautions |
General
Awayke™ MD should be used with caution
in patients with liver disorder, kidney diseases and in
elderly population. Patients with liver impairment or
renal insufficiency (GFR<30 mL/min) should be given a
lower initial dose (10 mg every other day).
Pregnancy
- Teratogenic effects:
There was no evidence of teratogenicity in animal
studies at oral doses 75 to 150 times the maximum
recommended daily human dose. However, safety of
Loratadine has not been clearly established during
pregnancy in humans.
- Nursing mothers:
Loratadine and its metabolite,
descarboethoxyloratadine, pass easily into breast milk
and thereofore, it is to be avoided during lactation.
Pediatric use
Safety and efficacy of Loratadine has not been
established in children below 2 years of age.
Geriatric use
A peak plasma level of Loratadine has been found much
greater than those observed in young individuals.
Therefore, it is to be used with caution in geriatric
population.
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Adverse effects |
The side effects include
fatigue, headache, dry mouth, nose and throat,
drowsiness, nausea, nervousness, coughing and
sensitivity to sunlight. Pharyngitis, anorexia and
dysmenorrhea have also been rarely reported. Sometimes,
discolored urine may be noticed which is harmless.
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Overdosage |
In adults overdosage (more
than 10 mg) has been reported to cause tachycardia and
drowsiness.
In case of overdosage consult your physician. General
symptomatic and supportive measure should be carefully
instituted in such cases. Vomiting or emesis may be
induced or gastric lavage may be performed with normal
saline. Loratadine is not eliminated by hemodialysis or
peritoneal dialysis.
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Drug interactions |
Awayke™ MD should
not be administered with macrolide antibiotics
(Erythromycin), ketoconazole, cimetidine, ranitidine,
theophylline, CNS depressants and alcohol.
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Storage |
Store at temperature between
200 C and 250 C in a dry place, away from light and
moisture.
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Supply |
Awayke™ MD
tablets are supplied in a blister pack of 10
tablets.
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