Trilock 4 mg/3.5 gm (Oral Granules)

Title and Categories

• Trilock 4 mg/3.5 gm Granules
• Medicine
• Leukotriene Receptor Antagonist

Indications

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis

Pharmacology

• Leukotriene receptor antagonist
• Selective and orally active
• Inhibits cysteinyl leukotriene receptor (CysLT1)
• Correlated with the pathophysiology of asthma and allergic rhinitis

Dosage and Administration

• Dosage for adults and adolescents 15 years of age and older: Montelukast 10 mg tablet once daily
• Dosage for pediatric patients 6 to 14 years of age: Montelukast 5 mg tablet once daily
• Dosage for pediatric patients 2 years to 5 years of age: Montelukast 4 mg tablet once daily
• Dosage for pediatric patients 6 months to 5 years of age: Montelukast 4 mg oral granules once daily
• No dosage adjustment for mild-to-moderate hepatic insufficiency
• No dosage adjustment for renal insufficiency
• Similar pharmacokinetic profile in elderly adults

Interaction

• No clinically important effects on the pharmacokinetics of certain drugs
• Used concomitantly with a wide range of commonly prescribed drugs without evidence of clinical adverse interactions
• Phenobarbital decreased the AUC of Trilock approximately 40%
• Appropriate clinical monitoring when potent cytochrome P450 enzyme inducers are co-administered

Contraindications

• Hypersensitivity 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

• Crosses the placenta in rats and rabbits
• Use during pregnancy only if clearly needed
• Caution should be exercised when given to a nursing mother

Precautions & Warnings

• Not indicated for use in the reversal of bronchospasm in acute asthma attacks
• Appropriate rescue medication should be available
• Therapy can be continued during acute exacerbations of asthma
• Should not be abruptly substituted for inhaled or oral corticosteroids
• Not to be used as monotherapy for the treatment and management of exercise induced bronchospasm
• Avoidance of aspirin or non-steroidal anti-inflammatory agents in patients with known aspirin sensitivity
• No evidence of truncating bronchoconstrictor response to aspirin and other non-steroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients

Overdose Effects

• No adverse experiences in the majority of reports
• Usual supportive measures recommended in the event of overdose

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: (Image of chemical structure)

Common Questions

• What is Trilock 4 mg/3.5 gm Granules?
• What is Trilock 4 mg/3.5 gm Granules used for?
• How soon can the effect be observed?
• How long does the effect last?
• Should it be taken empty stomach?
• What if a dose is missed?
• Are there any pregnancy warnings?
• General Instructions

Usability Instructions

• Take Trilock 4 mg/3.5 gm Granules exactly as prescribed by your doctor
• Do not change dose or stop using asthma medication without doctor's advice
• Not a fast-acting rescue medicine for asthma attacks
• Avoid situations or activities that may trigger an asthma attack
• Talk to your doctor before using if pregnant or breastfeeding

Advice for Missed Dose

• Take as soon as possible if missed
• Do not double up on doses

Adverse Interaction with Other Drugs

• No clinically important effects with several commonly prescribed drugs
• Appropriate clinical monitoring when potent cytochrome P450 enzyme inducers are co-administered

Effect Duration

• Lasts for an average duration of 24 hours

Special Effect Time

• Effect can be observed after 1-3 hours of administration

Dosage Information for Different Age Groups

• Dosage for adults and adolescents 15 years of age and older
• Dosage for pediatric patients 6 to 14 years of age
• Dosage for pediatric patients 2 years to 5 years of age
• Dosage for pediatric patients 6 months to 5 years of age

Dosage Adjustment for Specific Conditions

• No adjustment for mild-to-moderate hepatic insufficiency
• No adjustment for renal insufficiency

Pharmacokinetic Profile for Elderly

• Similar to younger adults
• Slightly longer plasma half-life in the elderly

Medication Storage

• Store in cool & dry place below 30°C
• Protect from light & moisture
• Keep out of reach of children

Pregnancy Usage Caution

• Use during pregnancy only if clearly needed

Nursing Mother Caution

• Caution should be exercised when given to a nursing mother

Side Effect Frequency

• Common
• Uncommon
• Rare

Side Effect Duration

• May occur for a temporary duration

Medication Composition

• Active ingredient: Montelukast

Chemical Formula

• C35H36ClNO3S

Engagement with Clinical Monitoring

• Appropriate clinical monitoring when potent cytochrome P450 enzyme inducers are co-administered

Adequate and Well-controlled Studies

• Safety and efficacy established in pediatric patients with asthma 6 months to 14 years of age

Clinical Monitoring for Potent Enzyme Inducers

• Employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers are co-administered

Appearance of the Medication

• Granules form for pediatric patients
• Tablet form for adults and adolescents

Drug Class Information

• Belongs to the class of leukotriene receptor antagonists

Elderly Usage

• Similar oral bioavailability to younger adults
• Slightly longer plasma half-life in the elderly

Therapy Continuation during Exacerbation

• Therapy can be continued during acute exacerbations of asthma

Substitution Cautions

• Should not be abruptly substituted for inhaled or oral corticosteroids

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