Indications
Trilock is indicated for:
Prophylaxis and chronic treatment of asthma
Acute prevention of Exercise-Induced Bronchoconstriction
(EIB)
Relief of symptoms of Allergic Rhinitis (AR): Seasonal &
Perennial Allergic Rhinitis
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Pharmacology
Montelukast is a selective and orally active leukotriene
receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1).
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid
metabolism and are released from various cells, including mast cells and
eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have
been correlated with the pathophysiology of asthma & allergic rhinitis,
including airway edema, smooth muscle contraction, and altered cellular
activity associated with the inflammatory process, which contribute to the
signs and symptoms of asthma.
Dosage & Administration
Adults and adolescents with asthma or seasonal allergic
rhinitis:
The dosage for adults and adolescents 15 years of age and
older: Montelukast 10 mg tablet once daily.
Pediatric patients with asthma or seasonal allergic
rhinitis:
The dosage for pediatric patients 6 to 14 years of age:
Montelukast 5 mg tablet once daily.
The dosage for pediatric patients 2 years to 5 years of age:
Montelukast 4 mg tablet once daily.
The dosage for pediatric patients 6 months to 5 years of
age: Montelukast 4 mg oral granules once daily. This can be administered either
directly in the mouth, or mixed with a spoonful of cold water or soft food at
room temperature
Use in the pediatric patient: The safety and efficacy of
Montelukast have been established in adequate and well-controlled studies in
pediatric patients with asthma 6 months to 14 years of age. Safety and efficacy
profiles in this age group are similar to those seen in adults.
Hepatic Insufficiency: No dosage adjustment is required in
patients with mild-to-moderate hepatic insufficiency.
Renal Insufficiency: No dosage adjustment is recommended in
patients with renal insufficiency.
Elderly use: The pharmacokinetic profile and the oral
bioavailability of a single 10-mg oral dose of montelukast are similar in
elderly and younger adults. The plasma half-life of montelukast is slightly
longer in the elderly. No dosage adjustment in the elderly is required.
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Interaction
Trilock has been administered with other therapies routinely
used in the prophylaxis and chronic treatment of asthma with no apparent
increase in adverse reactions. In drug interaction studies, the recommended
clinical dose of Trilock did not have clinically important effects on the pharmacokinetics
of the following drugs: theophylline, prednisone, prednisolone, oral
contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), terfenadine,
digoxin, and warfarin. Although additional specific interaction studies were
not performed, Trilock was used concomitantly with a wide range of commonly
prescribed drugs in clinical studies without evidence of clinical adverse
interactions. These medications included thyroid hormones, sedative hypnotics,
non-steroidal anti-inflammatory agents, benzodiazepines and decongestants.
Phenobarbital, which induces hepatic metabolism, decreased the AUC of Trilock
approximately 40% following a single 10mg dose of Trilock. No dosage adjustment
for Trilock is recommended. It is reasonable to employ appropriate clinical
monitoring when potent cytochrome P450 enzyme inducers, such as phenobarbital
or rifampin, are co-administered with Trilock.
Contraindications
Montelukast is contraindicated in patients who are
hypersensitive to any component of this product.
Side Effects
Common: Diarrhoea, fever, gastrointestinal discomfort,
headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal
behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage,
irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation,
sleep disorders.
Rare: Angioedema, concentration impaired, disorientation,
eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination,
hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal
tendencies, tremor.
Pregnancy & Lactation
Montelukast crosses the placenta following oral dosing in
rats and rabbits. There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always
predictive of human response, Montelukast should be used during pregnancy only
if clearly needed. Because many drugs are excreted in human milk, caution
should be exercised when Montelukast is
given to a nursing mother.
Precautions & Warnings
Trilock is not indicated for use in the reversal of
bronchospasm in acute asthma attacks, including status asthmaticus. Patients
should be advised to have appropriate rescue medication available. Therapy with
Trilock can be continued during acute exacerbations of asthma. While the dose
of inhaled corticosteroid may be reduced gradually under medical supervision,
Trilock should not be abruptly substituted for inhaled or oral corticosteroids.
Trilock should not be used as monotherapy for the treatment and management of
exercise induced bronchospasm. Patients with known aspirin sensitivity should
continue avoidance of aspirin or non-steroidal anti-inflammatory agents while
taking Trilock. Although Trilock is effective in improving airway function in
asthmatics with documented aspirin sensitivity, it has not been shown to
truncate bronchoconstrictor response to aspirin and other non-steroidal
anti-inflammatory drugs in aspirin-sensitive asthmatic patients.
Overdose Effects
There were no adverse experiences in the majority of
overdosage reports. The most frequently occurring adverse experiences were
consistent with the safety profile of Trilock and included abdominal pain,
somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the
event of overdose, it is reasonable to employ the usual supportive measures;
e.g., remove unabsorbed material from the gastrointestinal tract, employ
clinical monitoring, and institute supportive therapy, if required.
Therapeutic Class
Leukotriene receptor antagonists
Storage Conditions
Store in cool & dry place below 30°C, protect from light
& moisture. Keep out of reach of children.
Chemical Structure
Molecular Formula : C35H36ClNO3S
Chemical Structure : Chemical
Structure of Montelukast Sodium
Common Questions about Trilock 4 mg/3.5 gm Oral Granules
What is Trilock 4 mg/3.5 gm Granules?
Trilock 4 mg/3.5 gm Granules is a selective and orally
active leukotriene receptor antagonist.
What is Trilock 4 mg/3.5 gm Granules used for?
Trilock 4 mg/3.5 gm Granules is commonly used to treat
asthma or allergic rhinitis. It helps keep airways open and easy breathing by
blocking leukotrienes.
How soon can the effect of Trilock 4 mg/3.5 gm Granules be
observed?
The effect of Trilock 4 mg/3.5 gm Granules can be observed
after 1-3 hours of administration. Trilock 4 mg/3.5 gm Granules is not a
fast-acting rescue medicine for asthma attacks and needs to be taken daily to
work properly.
How long does the effect of Trilock 4 mg/3.5 gm Granules
last?
The effect of Trilock 4 mg/3.5 gm Granules lasts for an
average duration of 24 hours.
Should I use Trilock 4 mg/3.5 gm Granules empty stomach?
Trilock 4 mg/3.5 gm Granules may be taken with or without
food as prescribed by your doctor.
What if I miss a dose of Trilock 4 mg/3.5 gm Granules?
If you miss a dose, you may take it as soon as possible. But
if it is almost time for your next dose, just skip that dose. Do not double up
on doses.
Are there any pregnancy warnings for Trilock 4 mg/3.5 gm
Granules?
Use of Trilock 4 mg/3.5 gm Granules in pregnant women should
be avoided unless clearly needed.
General Instructions
Take Trilock 4 mg/3.5 gm Granules exactly as prescribed by
your doctor.
Do not change your Trilock 4 mg/3.5 gm Granules dose or stop
using asthma medication without your doctor's advice.
Trilock 4 mg/3.5 gm Granules is not a fast-acting rescue
medicine for asthma attacks. Seek medical attention if your breathing problems
get worse quickly, or if you think your medications are not working.
Avoid situations or activities that may trigger an asthma
attack.
Talk to your doctor before using Trilock 4 mg/3.5 gm
Granules if you're pregnant or breastfeeding. They can help you decide if it's
the right choice for you.
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