Dosing & Uses
Dosage Forms & Strengths
tablet
- 10mg
tablet, chewable
- 4mg
- 5mg
oral granules
- 4mg/packet
Asthma
Indicated for prophylaxis and chronic treatment of asthma
10 mg (single 10-mg tablet) PO qPM
Exercise-Induced Bronchospasm
Indicated for prevention of exercise-induced bronchoconstriction (EIB)
10 mg PO 2 hr before exercise; do not take additional dose within 24 hours
If taking montelukast for another indication, do not take additional dose to prevent exercise-induced bronchospasm (EIB)
Allergic or Perennial Rhinitis
Indicated for symptomatic relief of seasonal or perennial allergic rhinitis
10 mg (single 10-mg tablet) PO qDay
Dosage Modifications
Renal impairment
- Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast were not evaluated
- No dosage adjustment recommended in patients with renal insufficiency
Hepatic impairment
- Mild-to-moderate: No dosage adjustment necessary
- Severe: Not evaluated
Dosage Forms & Strengths
tablet
- 10mg
tablet, chewable
- 4mg
- 5mg
oral granules
- 4mg/packet
Asthma
Prophylaxis and maintenance treatment in patients aged ≥12 months
<12 months: Safety and efficacy not established
12-24 months: 4 mg (granules) PO once daily in evening
2-6 years: 4 mg (chewable tablet or granules) PO once daily in evening
6-15 years: 5 mg (chewable tablet) PO once daily in evening
>15 years: 10 mg (conventional tablet) PO once daily in evening
Exercise-Induced Bronchospasm
Prophylaxis
6-15 years: 5 mg (chewable tablet) PO 2 hours before exercise; do not take additional dose within 24 hours
>15 years: 10 mg PO 2 hours before exercise; do not take additional dose within 24 hours
If taking drug for another indication, do not take additional dose to prevent EIB
Perennial Allergic Rhinitis
<6 months: Safety and efficacy not established
6-24 months: 4 mg (granules) PO once daily
2-6 years: 4 mg (chewable tablet or granules) PO once daily
6-15 years: 5 mg (chewable tablet) PO once daily
>15 years: 10 mg (conventional tablet) PO once daily
Seasonal Allergic Rhinitis
<2 years: Safety and efficacy not established
2-6 years: 5 mg (chewable tablet) or 4 mg (granules) PO once daily
6-15 years: 5 mg (chewable tablet) PO once daily
>15 years: 10 mg (conventional tablet) PO once daily
Dosage Modifications
Renal impairment
- Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast were not evaluated
- No dosage adjustment recommended in patients with renal insufficiency
Hepatic impairment
- Mild-to-moderate: No dosage adjustment necessary
- Severe: Not evaluated
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- apalutamide
apalutamide will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- fexinidazole
fexinidazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- idelalisib
idelalisib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- ivosidenib
ivosidenib will decrease the level or effect of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2C9 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
- tucatinib
tucatinib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- voxelotor
voxelotor will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (38)
- alpelisib
alpelisib will decrease the level or effect of montelukast by pharmacodynamic synergism. Modify Therapy/Monitor Closely.
- apalutamide
apalutamide will decrease the level or effect of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Coadministration of apalutamide, a weak CYP2C9 inducer, with drugs that are CYP2C9 substrates can result in lower exposure to these medications. Evaluate for loss of therapeutic effect if medication must be coadministered.
- cannabidiol
cannabidiol will increase the level or effect of montelukast by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C9 activity. Consider reducing the dose when concomitantly using CYP2C9 substrates.
- carbamazepine
carbamazepine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- chloramphenicol
chloramphenicol will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- clarithromycin
clarithromycin will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- crofelemer
crofelemer increases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.
- dabrafenib
dabrafenib will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- deferasirox
deferasirox will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- elagolix
elagolix decreases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.
elvitegravir/cobicistat/emtricitabine/tenofovir DF decreases levels of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Elvitegravir is a moderate CYP2C9 inducer. - enzalutamide
enzalutamide will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin base
erythromycin base will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- erythromycin stearate
erythromycin stearate will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- gemfibrozil
gemfibrozil will increase the level or effect of montelukast by decreasing metabolism. Use Caution/Monitor.
- iloperidone
iloperidone increases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.
- istradefylline
istradefylline will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- itraconazole
itraconazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- ketoconazole
ketoconazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lenacapavir
lenacapavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- letermovir
letermovir increases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- levoketoconazole
levoketoconazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor, montelukast. affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. In vitro studies suggest that lumacaftor may induce and ivacaftor may inhibit CYP2C9 substrates. .
lumacaftor/ivacaftor decreases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. No dose adjustment for montelukast is recommended. - mitotane
mitotane decreases levels of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- nefazodone
nefazodone will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- nitisinone
nitisinone will increase the level or effect of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Nitisinone inhibits CYP2C9. Caution if CYP2C9 substrate coadministered, particularly those with a narrow therapeutic index.
- peginterferon alfa 2b
peginterferon alfa 2b decreases levels of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. When patients are administered peginterferon alpha-2b with CYP2C9 substrates, the therapeutic effect of these drugs may be altered. .
- rifabutin
rifabutin will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifampin
rifampin will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- sparsentan
sparsentan will decrease the level or effect of montelukast by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Sparsentan (a CYP2C9 inducer) decreases exposure of CYP2C9 substrates and reduces efficacy related to these substrates.
- St John's Wort
St John's Wort will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- stiripentol
stiripentol, montelukast. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- tazemetostat
tazemetostat will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
Minor (62)
- acetazolamide
acetazolamide will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- amobarbital
amobarbital will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- aprepitant
aprepitant will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- armodafinil
armodafinil will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- artemether/lumefantrine
artemether/lumefantrine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- atazanavir
atazanavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- bosentan
bosentan will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- budesonide
budesonide will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- butabarbital
butabarbital will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- butalbital
butalbital will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- conivaptan
conivaptan will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cortisone
cortisone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclosporine
cyclosporine will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- darifenacin
darifenacin will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- darunavir
darunavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dasatinib
dasatinib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dexamethasone
dexamethasone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- DHEA, herbal
DHEA, herbal will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- dronedarone
dronedarone will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- efavirenz
efavirenz will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- etravirine
etravirine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fluconazole
fluconazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fludrocortisone
fludrocortisone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosamprenavir
fosamprenavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosaprepitant
fosaprepitant will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- fosphenytoin
fosphenytoin will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- grapefruit
grapefruit will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- griseofulvin
griseofulvin will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- hydrocortisone
hydrocortisone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- indinavir
indinavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- isoniazid
isoniazid will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- lapatinib
lapatinib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- lumefantrine
lumefantrine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- marijuana
marijuana will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- methylprednisolone
methylprednisolone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- metronidazole
metronidazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- miconazole vaginal
miconazole vaginal will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nelfinavir
nelfinavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nevirapine
nevirapine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nifedipine
nifedipine will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- nilotinib
nilotinib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- pentobarbital
pentobarbital will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- phenobarbital
phenobarbital will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- phenytoin
phenytoin will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- posaconazole
posaconazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- prednisone
prednisone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- primidone
primidone will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- quinupristin/dalfopristin
quinupristin/dalfopristin will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ribociclib
ribociclib will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- rifapentine
rifapentine will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- ritonavir
ritonavir will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- rufinamide
rufinamide will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- secobarbital
secobarbital will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- topiramate
topiramate will decrease the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- verapamil
verapamil will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- voriconazole
voriconazole will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- zafirlukast
zafirlukast will increase the level or effect of montelukast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
Some adverse drug reactions vary by age group
>10%
Headache (18.4%; similar to placebo)
1-10%
Abdominal pain (≥2%)
Eczema (≥2%)
Influenza (≥2%)
Laryngitis (≥2%)
Pharyngitis (≥2%)
Viral infection (≥2%)
Wheezing (≥2%)
Dental pain (2%)
Dizziness (2%)
Dyspepsia (2%)
Elevated liver function tests (2%)
Fever (2%)
Gastroenteritis (2%)
Nasal congestion (2%)
Otitis (2%)
Rash (2%)
Urticaria (2%)
Bronchitis (≥1%)
Cough (≥1%)
Sinusitis (≥1%)
Upper respiratory tract infection (≥1%)
<1%
Allergic granulomatous angiitis (Churg-Strauss syndrome; rare)
Cholestatic hepatitis (rare)
Aggressive behavior, altered behavior, suicidal thoughts
Postmarketing Reports
Hematologic: Increased bleeding tendency, thrombocytopenia
Immunologic: Hypersensitivity reactions (eg, anaphylaxis, hepatic eosinophilic infiltration)
Psychiatric: Agitation, including aggressive behavior or hostility, anxiousness, depression, disorientation, dream abnormalities, hallucinations, insomnia, tic, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tremor, obsessive compulsive disorders
Neurologic: Drowsiness, paresthesia or hypesthesia, seizures, dysphemia (stuttering)
Cardiac: Palpitations
Respiratory, thoracic, mediastinal: Epistaxis, pulmonary eosinophilia
Gastrointestinal: Diarrhea, dyspepsia, nausea, pancreatitis, vomiting
Hepatobiliary: Cases of cholestatic hepatitis, hepatocellular liver injury, and mixed-pattern liver injury have been reported, mostly occurring in combination with other confounding factors (eg, use of other medications, administration to patients who had underlying potential for liver disease [eg, alcohol use or other forms of hepatitis])
Dermatologic: Angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, urticaria
Musculoskeletal: Arthralgia, myalgia (including muscle cramps)
General: Edema
Warnings
Black Box Warnings
FDA announcement March 4, 2020
- Serious neuropsychiatric events that may include suicidal thoughts or actions have been reported in patients taking montelukast
- Only use montelukast for allergic rhinitis in patients who have an inadequate response or intolerance to alternative therapies
- Consider risks and benefits when prescribing or continuing treatment
- Advise all patients of the risk of neuropsychiatric events when prescribing
- Discontinue and contact a health care professional immediately if changes in behavior or new neuropsychiatric symptoms, suicidal thoughts, or behavior occur
- Monitor for neuropsychiatric symptoms
- Events have occurred in patients with and without pre-existing psychiatric disease
Contraindications
Hypersensitivity
Cautions
Not to be given for acute asthma attacks, including status asthmaticus
Advise patients to have appropriate rescue medication available
Inhaled corticosteroid may be reduced gradually; do not abruptly substitute montelukast for inhaled or oral corticosteroids
Patients with known aspirin sensitivity should continue to avoid aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) while taking montelukast; not to be given for treatment of bronchoconstriction resulting from aspirin or NSAID intake
Neuropsychiatric events reported, including agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tic, and tremor; prescribers should carefully evaluate the risks and benefits of continuing treatment if such events occur
Systemic eosinophilia reported, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome; these events are usually (but not always) associated with tapering of PO corticosteroid therapy
Use with caution in phenylketonuria; 4-mg and 5-mg chewable tablets contain phenylalanine; before prescribing to a patient with PKU, consider combined daily amount of phenylalanine from all sources, including amount in drug
Pregnancy & Lactation
Pregnancy
Available data from published prospective and retrospective cohort studies over decades in pregnant women have not established a drug-associated risk of major birth defects
Animal data
- In animal reproduction studies, no adverse developmental effects were observed with oral administration to pregnant rats and rabbits during organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) based on AUCs
- Poorly or moderately controlled asthma in pregnancy increases maternal risk of perinatal adverse outcomes such as preeclampsia and infant prematurity, low birth weight, and small for gestational age
Lactation
A published clinical lactation study reports presence of montelukast in human milk; data available on effects of drug on infants, either directly or through breast milk, do not suggest a significant risk of adverse events from exposure; effects of drug on milk production are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Blocks binding of leukotriene D4 to its receptor; alters pathophysiology associated with inflammatory process that contributes to signs and symptoms of asthma
Absorption
Bioavailability: 64% (mean)
Peak plasma time: Tablet, 3-4 hr; chewable tablet, 2-2.5 hr; granules, 1-3 hr
Distribution
Protein bound: >99%
Vd: 8-11 L
Metabolism
Metabolized by CYP3A4 and CYP2C9
Elimination
Half-life: 2.7-5.5 hr
Clearance: 45 mL/min
Excretion: Feces (86%), urine (0.2%)
Administration
Oral Administration
Take with or without food
Patients with both asthma and allergic rhinitis should take only 1 dose qPM
Asthma or EIB: Administer in the evening
Allergic rhinitis: Individualize administration time to suit patient’s needs
Oral granules
- Administer either directly in the mouth, dissolve in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mix with a spoonful of cold or room temperature soft foods
- Based on stability studies, only applesauce, carrots, rice, or ice cream should be used
- Do not open packet until ready to use
- After opening, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 min
- If mixed with baby formula, breast milk, or food, do not store oral granules for future use; discard any unused portion
- Oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration; however, liquids may be taken subsequent to administration
Storage
All formulations: Store at 25ºC (77°ºF), excursions permitted to 15-30ºC (59-86ºF)
Protect from moisture and light
Store in original package
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Singulair oral - | 5 mg chewable tablet |  | |
| Singulair oral - | 10 mg tablet |  | |
| Singulair oral - | 5 mg chewable tablet |  | |
| Singulair oral - | 4 mg package |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 4 mg package |  | |
| montelukast oral - | 4 mg package |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 4 mg package |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 4 mg package |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 10 mg tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 5 mg chewable tablet |  | |
| montelukast oral - | 4 mg package |  | |
| montelukast oral - | 4 mg chewable tablet |  | |
| montelukast oral - | 4 mg package |  | |
| montelukast oral - | 5 mg chewable tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
montelukast oral
MONTELUKAST - ORAL
(mon-teh-LEW-kast)
COMMON BRAND NAME(S): Singulair
WARNING: This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.
USES: Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler.Montelukast is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose). Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking montelukast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your age and medical condition.If you are using the chewable tablets, chew them thoroughly before swallowing. If your child cannot safely chew and swallow them, consult the doctor or pharmacist for advice.Take this medication at the same time each day. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. If you are taking montelukast to prevent only allergies, take your dose either in the morning or the evening.If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Do not take more than one dose in 24 hours. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Doing so may increase the risk of side effects.Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use this medication regularly to keep your asthma under control, even during sudden asthma attacks or periods when you have no asthma symptoms. Continue to also take other medications for asthma as directed by your doctor. This medication works over time and is not meant to relieve sudden attacks of asthma. If an asthma attack or other breathing problem occurs, use your quick-relief inhaler as prescribed. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.Get medical help right away if your asthma symptoms worsen and your quick-relief inhaler is not helping. Tell your doctor promptly if asthma symptoms, breathing problems, allergy symptoms, number of times you use your rescue inhaler last or get worse.
SIDE EFFECTS: See also Warning section.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: numbness/tingling/shooting pain in the arms or legs, sinus pain/swelling, muscle weakness, uncontrolled muscle movements, stuttering.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking montelukast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this drug, tell your doctor or pharmacist your medical history, especially of: liver disease, mental/mood problems (such as anxiety, depression, thoughts of suicide).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).The chewable tablets may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: thirst, drowsiness, inability to keep still, vomiting, or severe stomach pain.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as lung function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Do not take more than 1 dose in 24 hours.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
