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LELIPEL — Montelukast Sodium 4 mg, 5 mg & 10 mg — Leukotriene Receptor Antagonist
1- Disclaimer
This monograph is intended for general educational and professional informational purposes. It does not replace the locally approved prescribing information, the advice of a qualified healthcare professional, or individualized clinical assessment. Product-specific indications, age limits, excipients, packaging, and administration instructions may vary between countries and formulations.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
For LELIPEL marketed in Egypt, the current Egyptian-approved package leaflet/SmPC and Egyptian Drug Authority information should take precedence where they differ from international reference labeling.
2- Summary
LELIPEL contains montelukast sodium, an orally active selective cysteinyl leukotriene type-1 (CysLT1) receptor antagonist. Montelukast reduces leukotriene-mediated bronchoconstriction, airway edema and inflammatory activity and is used primarily in asthma and exercise-related bronchoconstriction; certain regulatory jurisdictions also authorize it for allergic rhinitis.
Current Globe product listings identify LELIPEL as being available in 4 mg oral granules, 5 mg chewable tablets and 10 mg film-coated tablets.
Montelukast is not a rescue bronchodilator and must not be used to treat an acute asthma attack. An important contemporary safety issue is the risk of serious neuropsychiatric reactions, including behavioral changes, depression and suicidal thoughts or behavior.
3- Brand Name
LELIPEL
4- Category
Pharmacotherapeutic class: Leukotriene receptor antagonist (LTRA); systemic drug for obstructive airway disease.
ATC Code: R03DC03 — Montelukast.
5- Active Ingredient
Montelukast sodium
The supplied LELIPEL information states:
LELIPEL 10 mg film-coated tablet:
Each tablet contains montelukast sodium 10.4 mg, equivalent to 10 mg montelukast.
LELIPEL 4 mg oral granules:
Each sachet contains montelukast sodium 4.2 mg, equivalent to 4 mg montelukast.
LELIPEL 5 mg chewable tablet:
Contains montelukast sodium equivalent to 5 mg montelukast. The precise amount of the sodium salt and the complete current excipient list should be confirmed from the current Egyptian-approved product information.
6- Pharmaceutical Form & Strength
Available/currently listed LELIPEL presentations include:
LELIPEL 10 mg: Film-coated tablets, for adults and adolescents for whom the 10 mg dose is appropriate.
LELIPEL 5 mg: Chewable tablets, primarily for pediatric patients requiring the 5 mg dose.
LELIPEL 4 mg: Oral granules in sachets, primarily for younger pediatric patients.
The manufacturer currently lists all three LELIPEL strengths on its HCP product pages.
The supplied leaflet describes inactive ingredients for the 10 mg film-coated tablet as microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hypromellose and magnesium stearate, with a film coat containing hypromellose, polyethylene glycol, titanium dioxide, talc and iron oxide red. It describes the 4 mg granules as containing mannitol, hydroxypropyl cellulose and magnesium stearate.
Excipients can change between formulations or manufacturing versions; the current pack leaflet should be checked, particularly where an excipient has clinical importance.
7- Manufacturer & Marketing Authorization Holder
According to the supplied Egyptian product information:
Produced by:
Egyptian Group for Pharmaceutical Industries (EGPI)
For:
Globe International Pharmaceuticals.
Current public Globe webpages continue to list LELIPEL under the Globe brand.
The exact current legal Marketing Authorization Holder designation should be verified against the latest Egyptian-approved pack or Egyptian Drug Authority record.
8- Mechanism of Action
Cysteinyl leukotrienes LTC4, LTD4 and LTE4 are inflammatory mediators released from cells including mast cells and eosinophils.
They bind to CysLT receptors, particularly CysLT1 receptors, which are found in airway smooth muscle and several inflammatory cell populations.
In asthma, cysteinyl leukotrienes contribute to:
- Bronchoconstriction.
- Airway edema.
- Mucus-related and inflammatory airway changes.
- Recruitment and activation of inflammatory cells.
Montelukast binds selectively and with high affinity to the CysLT1 receptor and inhibits the physiological effects of LTD4 without agonist activity.
9- Spectrum of Activity
A conventional antimicrobial “spectrum of activity” does not apply to montelukast because it is not an antibacterial, antiviral, antifungal or antiparasitic drug.
Its pharmacological activity is directed against CysLT1 receptor-mediated leukotriene signaling.
By blocking this pathway, montelukast reduces leukotriene-mediated bronchoconstriction and inflammatory airway effects associated with asthma and allergic airway disease.
10- Pharmacokinetics
Absorption
Montelukast is rapidly absorbed after oral administration.
After a fasting 10 mg film-coated tablet in adults, mean peak plasma concentration is reached in approximately 3–4 hours, and mean oral bioavailability is approximately 64%.
For the 5 mg chewable tablet, mean peak concentration is reached in approximately 2–2.5 hours in fasting adults.
The 4 mg oral-granule formulation has demonstrated bioequivalence to the 4 mg chewable formulation under studied fasting conditions.
Distribution
Montelukast is more than 99% bound to plasma proteins.
The average steady-state apparent volume of distribution is approximately 8–11 L.
Metabolism
Montelukast is extensively metabolized. CYP enzymes involved include CYP2C8, CYP2C9 and CYP3A4, with CYP2C8 playing an important role at clinically relevant concentrations.
Elimination
Montelukast and its metabolites are eliminated predominantly through the biliary/fecal route. Following radiolabeled dosing, approximately 86% of radioactivity was recovered in feces and less than 0.2% in urine.
Mean plasma elimination half-life in healthy young adults is approximately 2.7–5.5 hours.
Renal impairment
No dosage adjustment is generally required because montelukast and its metabolites are not meaningfully eliminated through the urine.
Hepatic impairment
Mild-to-moderate hepatic impairment can increase systemic exposure and modestly prolong elimination, but routine dosage adjustment is not generally required. Pharmacokinetics in severe hepatic impairment have not been adequately evaluated.
11- Indications
The exact authorized indications and minimum ages should follow the current Egyptian-approved LELIPEL labeling, because regulatory indications for montelukast are not completely identical internationally.
Asthma
Montelukast is used as controller therapy, particularly as an add-on treatment in patients whose persistent asthma is not adequately controlled by appropriate inhaled therapy.
Current product information for 4 mg montelukast granules in European-style labeling permits add-on treatment in children 6 months to 5 years with mild-to-moderate persistent asthma inadequately controlled with inhaled corticosteroids and as-needed short-acting β-agonists. Public Globe product pages confirm the marketed LELIPEL presentations, but their indication wording should not be used alone to establish age-specific prescribing because the wording is not consistent across the current product pages.
For selected children 2–5 years with mild persistent asthma who cannot appropriately use inhaled corticosteroids and who have no recent history of severe attacks requiring systemic corticosteroids, montelukast may be considered as an alternative under relevant SmPCs. It is not generally considered an equivalent substitute for inhaled corticosteroids in patients who can use effective ICS treatment.
Exercise-Induced Bronchoconstriction
Montelukast can help prevent bronchoconstriction associated with exercise.
Age authorization and the regulatory framing of this use differ between systems. European-style pediatric SmPCs authorize montelukast from 2 years of age for prophylaxis of asthma in which exercise-induced bronchoconstriction is the predominant component. Current U.S. labeling separately authorizes prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years and older, including a specific pre-exercise dosing regimen. These uses should not be treated as identical regulatory indications.
Allergic Rhinitis
Montelukast can relieve symptoms of allergic rhinitis under regulatory labeling where this indication is approved.
Current U.S. prescribing information includes seasonal allergic rhinitis in patients 2 years and older and perennial allergic rhinitis in patients 6 months and older. However, because of the risk of serious neuropsychiatric reactions, it recommends reserving montelukast for allergic rhinitis when other therapies have produced an inadequate response or are not tolerated.
By contrast, contemporary European/UK 10 mg SmPCs describe symptomatic relief of seasonal allergic rhinitis in patients with asthma for whom montelukast is already indicated for asthma, rather than the broader independent allergic-rhinitis indication used in U.S. labeling.
These international allergic-rhinitis indications and age thresholds should not be attributed to current Egyptian LELIPEL labeling unless confirmed by the current Egyptian-approved product information.
12- Administration
Asthma
Montelukast is generally given once daily in the evening.
Typical age-based montelukast doses are:
6 months–5 years: 4 mg where the relevant indication is locally authorized.
6–14 years: 5 mg once daily.
15 years and older: 10 mg once daily.
The exact minimum age depends on the indication and locally approved labeling.
5 mg chewable tablet
The tablet should be chewed before swallowing.
Many contemporary European SmPCs recommend taking the chewable tablet 1 hour before or 2 hours after food.
10 mg film-coated tablet
Swallow orally with water. Montelukast 10 mg can generally be administered with or without food.
Allergic rhinitis
Where authorized, once-daily administration may be individualized according to patient needs.
Exercise-induced bronchoconstriction
Under current U.S. labeling for prevention of EIB, a single age-appropriate dose is administered at least 2 hours before exercise. An additional dose should not be taken within 24 hours, and a patient already taking daily montelukast should not take an extra dose specifically for exercise. A short-acting inhaled β2-agonist should remain available for rescue treatment.
This U.S. pre-exercise regimen should be distinguished from European-style SmPC wording in which montelukast is used as ongoing prophylaxis of asthma when exercise-induced bronchoconstriction is the predominant component.
13- Method of Preparation
LELIPEL 4 mg Oral Granules
Do not open a sachet until immediately before administration.
According to the supplied LELIPEL instructions, the granules may be:
- Administered directly into the mouth.
- Mixed with a small spoonful of suitable cold or room-temperature soft food.
- Administered according to the specific current LELIPEL leaflet instructions regarding breast milk or infant formula.
Once a sachet has been opened and prepared, administer the entire dose within 15 minutes and discard any unused portion. Do not store a prepared dose for later administration.
Administration instructions for montelukast granules differ slightly among internationally marketed products: for example, some European SmPCs instruct that granules should not be dissolved in liquid, whereas U.S.-style instructions allow certain infant formula or breast-milk administration methods. Therefore, the current LELIPEL package leaflet should be followed rather than transferring mixing instructions from another montelukast brand.
14- Contraindications
Hypersensitivity to montelukast or to any component of the specific formulation.
No other universal absolute contraindication is established in major contemporary montelukast labeling.
15- Warnings & Precautions
Serious Neuropsychiatric Events
Serious neuropsychiatric reactions have been reported with montelukast in adults and children, including:
- Agitation or aggression.
- Anxiety.
- Depression.
- Abnormal dreams or nightmares.
- Insomnia or sleep disturbance.
- Hallucinations.
- Irritability.
- Attention or memory disturbances.
- Somnambulism.
- Obsessive-compulsive symptoms.
- Tics or tremor.
- Suicidal thoughts or behavior, including completed suicide.
Events have occurred in patients with and without previous psychiatric illness and may occur during treatment or, in some reports, after discontinuation.
Patients and caregivers should be informed of this risk. If new behavioral changes, neuropsychiatric symptoms, suicidal thoughts or suicidal behavior develop, contemporary labeling advises stopping montelukast and contacting a healthcare professional promptly.
Because of this risk, FDA recommends reserving montelukast for allergic rhinitis for patients who have not responded adequately to or cannot tolerate alternative therapies.
Acute Asthma
Montelukast is not indicated for reversal of acute bronchospasm or status asthmaticus.
Patients with asthma should have an appropriate rapid-acting rescue inhaler available.
Corticosteroid Therapy
Montelukast must not be abruptly substituted for inhaled or systemic corticosteroids.
Any reduction in corticosteroid treatment should be medically supervised.
Eosinophilic Conditions
Rarely, systemic eosinophilia and clinical features of eosinophilic granulomatosis with polyangiitis (EGPA; historically called Churg-Strauss syndrome) have been observed, sometimes around reductions in systemic corticosteroid treatment.
Clinicians should be alert for eosinophilia, vasculitic rash, worsening pulmonary symptoms, neuropathy or cardiac complications.
Aspirin-Sensitive Asthma
Patients with aspirin-sensitive asthma should continue to avoid aspirin and other triggering NSAIDs even while receiving montelukast.
Severe Hepatic Impairment
Adequate pharmacokinetic data are lacking; use requires appropriate clinical judgment.
Excipients
The complete excipient list of the current LELIPEL strength being used should be checked for clinically relevant components. In particular, some montelukast chewable formulations contain aspartame/phenylalanine, but this warning should not be attributed to LELIPEL 5 mg without confirmation from its current approved formulation.
16- Drug Interactions
Montelukast has generally shown a low potential for clinically significant drug interactions at recommended doses.
No clinically important dose adjustment is generally required when montelukast is administered with medicines including theophylline, prednisone, prednisolone, certain oral contraceptives, fexofenadine, digoxin or warfarin.
Enzyme Inducers
Phenobarbital can reduce montelukast exposure by approximately 40%. Other potent metabolic enzyme inducers such as rifampicin may also reduce exposure, so appropriate clinical monitoring is reasonable.
Gemfibrozil
Gemfibrozil, an inhibitor of CYP2C8 and CYP2C9, can increase systemic montelukast exposure approximately 4.4-fold. Routine dose adjustment is not generally required according to established labeling, but clinicians should be aware of the possibility of increased adverse effects.
Itraconazole
Itraconazole alone has not produced a clinically significant increase in montelukast exposure in interaction studies.
Montelukast inhibits CYP2C8 in vitro but has not demonstrated clinically important CYP2C8 inhibition in vivo at therapeutic exposure.
17- Side Effects
Adverse effects vary with age, indication and study population.
Frequently reported events in clinical studies have included:
- Headache.
- Abdominal pain.
- Fever.
- Upper respiratory tract infection.
- Pharyngitis.
- Cough.
- Diarrhea.
- Rhinorrhea.
- Sinusitis.
- Otitis-related events.
Not all events observed during clinical trials were necessarily caused by montelukast.
Important Post-Marketing Adverse Reactions
Psychiatric: agitation, aggression, anxiety, depression, sleep and dream abnormalities, hallucinations, disorientation, attention or memory disturbance, somnambulism, obsessive-compulsive symptoms, suicidal thinking and behavior, tic and related neuropsychiatric reactions.
Neurologic: drowsiness, paraesthesia/hypoesthesia and seizures.
Hypersensitivity: anaphylaxis, angioedema and other hypersensitivity reactions.
Hepatic: elevated transaminases and rare cholestatic, hepatocellular or mixed-pattern liver injury.
Skin: rash, urticaria, pruritus, erythema nodosum, erythema multiforme and rare severe reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis in post-marketing reports.
Hematologic: increased bleeding tendency and thrombocytopenia.
Musculoskeletal: arthralgia, myalgia and muscle cramps.
Other: palpitations, epistaxis, edema and enuresis in children have been reported.
Post-marketing reporting does not always permit reliable determination of frequency or a definite causal relationship.
18- Use in Special Populations
Pregnancy
Available human observational data over several decades have not established a drug-associated increase in major congenital malformations.
Asthma itself can create important maternal and fetal risks when inadequately controlled; treatment decisions during pregnancy should therefore consider both the need for asthma control and medication-related considerations.
Breastfeeding
Montelukast has been detected in human milk.
Available contemporary U.S. labeling states that published clinical lactation data do not suggest a significant risk of adverse reactions in breastfed infants, although effects on milk production are unknown. The benefits of breastfeeding, the mother's clinical need for treatment and potential infant effects should all be considered.
Some current European/UK SmPCs still state that it is unknown whether montelukast is excreted in human milk and recommend use during breastfeeding only when considered clearly essential. This is a regulatory-labeling difference; the statement above that montelukast has been detected in human milk reflects published human lactation data cited in current U.S. labeling.
Pediatric Use
Age eligibility depends on indication, formulation and local authorization.
Contemporary international references include:
- 4 mg granules for young pediatric populations.
- 5 mg chewable tablets for ages 6–14 years.
- 10 mg film-coated tablets for ages 15 years and older.
The lower age limit for asthma and exercise-related indications differs between regulatory jurisdictions; the approved Egyptian LELIPEL information should therefore be followed.
Elderly
No routine dosage adjustment is required solely because of age. Clinical trials have not demonstrated major overall differences in safety or effectiveness compared with younger adults, although increased sensitivity in some elderly individuals cannot be excluded.
Renal Impairment
No dosage adjustment is generally required.
Hepatic Impairment
No dosage adjustment is generally required in mild-to-moderate hepatic impairment. Pharmacokinetics in severe hepatic impairment have not been adequately evaluated.
19- Storage Conditions
For LELIPEL, the supplied product information specifies storage at a temperature not exceeding 30°C in a dry place and keeping the medicine out of reach of children.
Keep sachets sealed until immediately before use.
Protect the medicine from inappropriate heat and moisture according to the package instructions.
20- Additional Sections
Place in Asthma Therapy
Montelukast is a controller medication, not a rescue medication.
Current international asthma-management strategy continues to place inhaled corticosteroid-containing therapy at the center of asthma treatment. Leukotriene receptor antagonists such as montelukast are generally less effective than inhaled corticosteroids, particularly for preventing exacerbations, and the potential neuropsychiatric adverse effects of montelukast should be considered when selecting therapy.
Onset of Pharmacological Effect
An effect on parameters of asthma control can occur within approximately one day of starting regular treatment, but this does not make montelukast suitable for emergency relief of an acute attack.
Overdose
There is no specific antidote for montelukast overdose.
Management is primarily supportive and symptomatic, with appropriate clinical monitoring.
Reported overdose symptoms have included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity.
It is not known whether montelukast is effectively removed by hemodialysis or peritoneal dialysis.
Packaging
The supplied LELIPEL information describes:
LELIPEL 10 mg: film-coated tablets supplied in blister packaging.
LELIPEL 4 mg: oral granules supplied as 14 child-resistant foil sachets.
Current Egyptian market and manufacturer listings also confirm a 5 mg chewable-tablet presentation. Exact currently marketed pack sizes should be checked from the actual Egyptian pack at the time of dispensing.
21- Frequently Asked Questions (FAQ)
What is LELIPEL used for?
LELIPEL contains montelukast, which is used principally for long-term management of asthma and prevention of exercise-related bronchoconstriction. Allergic-rhinitis use depends on the locally authorized indication.
Can LELIPEL be used during an asthma attack?
No. Montelukast does not act rapidly enough to replace a rescue bronchodilator. Patients should use their prescribed rapid-acting rescue treatment for acute bronchospasm.
When should LELIPEL be taken?
For regular asthma treatment, montelukast is commonly taken once daily in the evening. Timing for other indications can differ.
Can inhaled corticosteroids be stopped after starting LELIPEL?
They should not be stopped or abruptly replaced with montelukast without medical supervision.
What should be done if unusual mood, sleep or behavioral symptoms occur?
The patient or caregiver should take new neuropsychiatric symptoms seriously. Current prescribing information advises stopping montelukast if neuropsychiatric symptoms develop and contacting the healthcare professional promptly for assessment.
Is montelukast preferred for simple allergic rhinitis?
Not necessarily. Because of the potential for serious neuropsychiatric adverse effects, FDA recommends that montelukast be reserved for allergic rhinitis when alternative treatments have been ineffective or are not tolerated.
Can LELIPEL oral granules be prepared in advance?
No. An opened/prepared sachet should be administered promptly according to the product instructions, and unused prepared material should not be stored for a later dose.
Can two doses be taken if one is missed?
No. Under contemporary montelukast labeling, the next dose should be taken at the usual scheduled time rather than taking two doses together.
22- References
- LELIPEL Egyptian product information supplied with this monograph — Montelukast sodium film-coated tablets and oral granules; Egyptian Group for Pharmaceutical Industries (EGPI) / Globe International Pharmaceuticals.
- Globe International Pharmaceuticals — LELIPEL product/HCP information, including currently listed LELIPEL 4 mg, 5 mg and 10 mg presentations.
- DailyMed — Montelukast Sodium tablets, chewable tablets and oral granules, Full Prescribing Information, contemporary U.S. prescribing information, including the boxed warning for serious neuropsychiatric events.
- U.S. Food and Drug Administration (FDA) — Drug Safety Communication: Boxed Warning regarding serious mental-health adverse effects with montelukast and restriction of use for allergic rhinitis.
- Electronic Medicines Compendium (emc) — Montelukast Summary of Product Characteristics, including 4 mg oral granules, 5 mg chewable tablets and 10 mg film-coated tablets.
- Global Initiative for Asthma (GINA), Global Strategy for Asthma Management and Prevention, 2026, for the contemporary therapeutic position of leukotriene receptor antagonists in asthma management.