Indications
Trilock OFT 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 OFT 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 OFT 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 OFT 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 OFT approximately 40% following a
single 10mg dose of Trilock OFT. No dosage adjustment for Trilock OFT 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 OFT.
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 OFT 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 OFT can be continued during acute exacerbations of asthma. While the
dose of inhaled corticosteroid may be reduced gradually under medical
supervision, Trilock OFT should not be abruptly substituted for inhaled or oral
corticosteroids. Trilock OFT 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 OFT. Although Trilock OFT 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 OFT 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 OFT 4 mg Flash Tablet
What is Trilock OFT 4 mg Flash Tablet?
Trilock OFT 4 mg Flash Tablet is a selective and orally
active leukotriene receptor antagonist.
What is Trilock OFT 4 mg Flash Tablet used for?
Trilock OFT 4 mg Flash Tablet 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 OFT 4 mg Flash Tablet be
observed?
The effect of Trilock OFT 4 mg Flash Tablet can be observed
after 1-3 hours of administration. Trilock OFT 4 mg Flash Tablet 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 OFT 4 mg Flash Tablet
last?
The effect of Trilock OFT 4 mg Flash Tablet lasts for an
average duration of 24 hours.
Should I use Trilock OFT 4 mg Flash Tablet empty stomach?
Trilock OFT 4 mg Flash Tablet may be taken with or without
food as prescribed by your doctor.
What if I miss a dose of Trilock OFT 4 mg Flash Tablet?
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 OFT 4 mg Flash
Tablet?
Use of Trilock OFT 4 mg Flash Tablet in pregnant women
should be avoided unless clearly needed.
General Instructions
Take Trilock OFT 4 mg Flash Tablet exactly as prescribed by
your doctor.
Do not change your Trilock OFT 4 mg Flash Tablet dose or
stop using asthma medication without your doctor's advice.
Trilock OFT 4 mg Flash Tablet 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 OFT 4 mg Flash
Tablet if you're pregnant or breastfeeding. They can help you decide if it's
the right choice for you.
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