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DRUG IMAGES
SINGULAIR 10 MG TABLET
SINGULAIR 5 MG TABLET CHEW
The following indications for SINGULAIR (montelukast sodium) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for SINGULAIR (montelukast sodium):
Dosage of montelukast sodium is expressed in terms of montelukast.
For the prevention and long-term symptomatic control of asthma with or without allergic rhinitis, the usual dosage of montelukast for adults and adolescents 15 years of age or older is 10 mg once daily as film-coated tablets. The pharmacokinetic profile of montelukast in geriatric adults generally is similar to that in younger adults, and the manufacturer states that dosage of the drug in geriatric patients does not need to be modified based solely on age.
Adolescents 15 years of age or older may receive the usual adult dosage of montelukast of 10 mg once daily as film-coated tablets.
For the prevention and long-term symptomatic control of asthma with or without allergic rhinitis, the usual dosage of montelukast for children 6-14 years of age is 5 mg once daily as chewable tablets. The usual dosage of montelukast for the prevention and long-term symptomatic control of asthma with or without allergic rhinitis in children 2-5 years of age is 4 mg once daily as chewable tablets or oral granules. The usual dosage of montelukast for the prevention and long-term symptomatic control of asthma with or without allergic rhinitis in pediatric patients 12-23 months of age is 4 mg once daily as oral granules.
For the prevention of exercise-induced bronchospasm, the usual dosage of montelukast for adults and adolescents 15 years of age or older not already taking the drug for another indication is 10 mg as a film-coated tablet administered at least 2 hours prior to exercise; an additional dose should not be taken within 24 hours of the previous dose. The pharmacokinetic profile of montelukast in geriatric adults generally is similar to that in younger adults, and the manufacturer states that dosage of the drug in geriatric patients does not need to be modified based solely on age.
For prevention of exercise-induced bronchospasm in children 6-14 years of age not already taking the drug for another indication, the usual dosage is 5 mg as a chewable tablet administered at least 2 hours prior to exercise; an additional dose should not be taken within 24 hours of the previous dose. Safety and efficacy of montelukast for exercise-induced bronchospasm in patients younger than 6 years of age have not been established.
For symptomatic control of seasonal or perennial allergic rhinitis with or without asthma, the usual dosage of montelukast is 10 mg once daily as film-coated tablets.
Adolescents 15 years of age or older with allergic rhinitis with or without asthma may be given 10 mg once daily as film-coated tablets.
For the symptomatic control of seasonal or perennial allergic rhinitis with or without asthma, the usual dosage of montelukast for children 6-14 years of age is 5 mg once daily as chewable tablets. In children 2-5 years of age with seasonal or perennial allergic rhinitis with or without asthma, the usual dosage is 4 mg once daily as chewable tablets or oral granules. In infants and children 12-23 months of age or older with allergic rhinitis and asthma, the usual dosage of montelukast is 4 mg once daily as oral granules.
The usual dosage of montelukast in pediatric patients 6-23 months of age with perennial allergic rhinitis is 4 mg once daily as oral granules.
Limited evidence in patients with mild to moderate hepatic impairment and clinical evidence of cirrhosis indicate that area under the plasma concentration-time curve (AUC) of montelukast is increased 41% and plasma montelukast elimination half-life is prolonged in these patients relative to patients with normal hepatic function. However, the manufacturer makes no specific recommendations for adjustment of montelukast dosage in patients with mild to moderate hepatic impairment. The pharmacokinetics of montelukast in patients with severe hepatic impairment or with hepatitis have not been evaluated.
The manufacturer makes no specific recommendations for dosage adjustment in patients with renal impairment. The drug is extensively metabolized and excreted principally in feces.
For the prevention and long-term symptomatic control of asthma with or without allergic rhinitis, the usual dosage of montelukast for adults and adolescents 15 years of age or older is 10 mg once daily as film-coated tablets. The pharmacokinetic profile of montelukast in geriatric adults generally is similar to that in younger adults, and the manufacturer states that dosage of the drug in geriatric patients does not need to be modified based solely on age.
Adolescents 15 years of age or older may receive the usual adult dosage of montelukast of 10 mg once daily as film-coated tablets.
For the prevention and long-term symptomatic control of asthma with or without allergic rhinitis, the usual dosage of montelukast for children 6-14 years of age is 5 mg once daily as chewable tablets. The usual dosage of montelukast for the prevention and long-term symptomatic control of asthma with or without allergic rhinitis in children 2-5 years of age is 4 mg once daily as chewable tablets or oral granules. The usual dosage of montelukast for the prevention and long-term symptomatic control of asthma with or without allergic rhinitis in pediatric patients 12-23 months of age is 4 mg once daily as oral granules.
For the prevention of exercise-induced bronchospasm, the usual dosage of montelukast for adults and adolescents 15 years of age or older not already taking the drug for another indication is 10 mg as a film-coated tablet administered at least 2 hours prior to exercise; an additional dose should not be taken within 24 hours of the previous dose. The pharmacokinetic profile of montelukast in geriatric adults generally is similar to that in younger adults, and the manufacturer states that dosage of the drug in geriatric patients does not need to be modified based solely on age.
For prevention of exercise-induced bronchospasm in children 6-14 years of age not already taking the drug for another indication, the usual dosage is 5 mg as a chewable tablet administered at least 2 hours prior to exercise; an additional dose should not be taken within 24 hours of the previous dose. Safety and efficacy of montelukast for exercise-induced bronchospasm in patients younger than 6 years of age have not been established.
For symptomatic control of seasonal or perennial allergic rhinitis with or without asthma, the usual dosage of montelukast is 10 mg once daily as film-coated tablets.
Adolescents 15 years of age or older with allergic rhinitis with or without asthma may be given 10 mg once daily as film-coated tablets.
For the symptomatic control of seasonal or perennial allergic rhinitis with or without asthma, the usual dosage of montelukast for children 6-14 years of age is 5 mg once daily as chewable tablets. In children 2-5 years of age with seasonal or perennial allergic rhinitis with or without asthma, the usual dosage is 4 mg once daily as chewable tablets or oral granules. In infants and children 12-23 months of age or older with allergic rhinitis and asthma, the usual dosage of montelukast is 4 mg once daily as oral granules.
The usual dosage of montelukast in pediatric patients 6-23 months of age with perennial allergic rhinitis is 4 mg once daily as oral granules.
Limited evidence in patients with mild to moderate hepatic impairment and clinical evidence of cirrhosis indicate that area under the plasma concentration-time curve (AUC) of montelukast is increased 41% and plasma montelukast elimination half-life is prolonged in these patients relative to patients with normal hepatic function. However, the manufacturer makes no specific recommendations for adjustment of montelukast dosage in patients with mild to moderate hepatic impairment. The pharmacokinetics of montelukast in patients with severe hepatic impairment or with hepatitis have not been evaluated.
The manufacturer makes no specific recommendations for dosage adjustment in patients with renal impairment. The drug is extensively metabolized and excreted principally in feces.
In patients with asthma with or without coexisting allergic rhinitis, montelukast is administered orally as a single daily dose in the evening. Safety and efficacy of montelukast in the management of asthma were established in clinical trials in which the drug was administered in the evening without regard to meals in adults, adolescents, and children 2-14 years of age. Evening dosing has been employed so that achievement of peak plasma concentrations of the drug might coincide with peak airway reactivity in the morning.
In patients with allergic rhinitis, the time of administration may be individualized to suit patient needs. Efficacy was demonstrated in patients with seasonal allergic rhinitis when montelukast was administered in the morning or evening without regard to food intake. Pharmacokinetic and clinical data support use of the 10-mg film-coated tablet of montelukast in adults and adolescents 15 years of age or older, use of the 5-mg chewable tablet in children 6-14 years of age, use of the 4-mg chewable tablet or 4-mg oral granules formulation in children 2-5 years of age, and use of the 4-mg oral granules formulation in infants and children 12-23 months of age for the treatment of asthma and in infants and children 6-23 months of age for the treatment of perennial allergic rhinitis.
Oral granules may be administered orally alone (directly in the mouth) or mixed with 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or a spoonful of cold or room temperature soft food (applesauce, carrots, rice, or ice cream only); the stability of the drug when mixed with other foods has not been determined. Oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk prior to administration. However, liquids may be taken subsequent to administration, and oral granules can be administered without regard to meals.
The packet should not be opened until ready to use. After opening the packet of granules, patients should receive the full dose within 15 minutes; do not store the opened packet or mixtures of the drug with food, breast milk, or baby formula. Any unused portions should be discarded.
In patients with allergic rhinitis, the time of administration may be individualized to suit patient needs. Efficacy was demonstrated in patients with seasonal allergic rhinitis when montelukast was administered in the morning or evening without regard to food intake. Pharmacokinetic and clinical data support use of the 10-mg film-coated tablet of montelukast in adults and adolescents 15 years of age or older, use of the 5-mg chewable tablet in children 6-14 years of age, use of the 4-mg chewable tablet or 4-mg oral granules formulation in children 2-5 years of age, and use of the 4-mg oral granules formulation in infants and children 12-23 months of age for the treatment of asthma and in infants and children 6-23 months of age for the treatment of perennial allergic rhinitis.
Oral granules may be administered orally alone (directly in the mouth) or mixed with 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or a spoonful of cold or room temperature soft food (applesauce, carrots, rice, or ice cream only); the stability of the drug when mixed with other foods has not been determined. Oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk prior to administration. However, liquids may be taken subsequent to administration, and oral granules can be administered without regard to meals.
The packet should not be opened until ready to use. After opening the packet of granules, patients should receive the full dose within 15 minutes; do not store the opened packet or mixtures of the drug with food, breast milk, or baby formula. Any unused portions should be discarded.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for SINGULAIR (montelukast sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for SINGULAIR (montelukast sodium):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for SINGULAIR (montelukast sodium):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 0 less severe adverse reactions.
The following precautions are available for SINGULAIR (montelukast sodium):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Montelukast crosses the placenta following oral dosing in rats and rabbits. Reproduction studies in rats using oral dosages up to 400 mg/kg daily (estimated exposure approximately 100 times the AUC for adults at the maximum recommended daily oral dose) and in rabbits using oral dosages up to 300 mg/kg daily (estimated exposure approximately 110 times the AUC for adults at the maximum recommended daily oral dose) have not revealed evidence of harm to the fetus. There are no adequate and well-controlled studies to date using montelukast in pregnant women, and the manufacturer states that montelukast should be used during pregnancy only when clearly needed.
The American College of Obstetricians and Gynecologists (ACOG) generally recommends use of leukotriene modifiers as an alternative to a long-acting beta2-agonist in pregnant women with moderate persistent asthma who are inadequately controlled with low to medium dosages of an inhaled corticosteroid. (See Uses: Asthma.) During postmarketing experience with montelukast, congenital limb defects have been reported rarely in the children of women treated with the drug; however, most of these women were receiving other antiasthmatic agents during their pregnancies. A causal relationship between montelukast use and the development of these congenital anomalies has not been established.
The manufacturer maintains a registry to monitor pregnancy outcomes in women exposed to montelukast during pregnancy. Patients may be enrolled by calling 800-986-8999.
The American College of Obstetricians and Gynecologists (ACOG) generally recommends use of leukotriene modifiers as an alternative to a long-acting beta2-agonist in pregnant women with moderate persistent asthma who are inadequately controlled with low to medium dosages of an inhaled corticosteroid. (See Uses: Asthma.) During postmarketing experience with montelukast, congenital limb defects have been reported rarely in the children of women treated with the drug; however, most of these women were receiving other antiasthmatic agents during their pregnancies. A causal relationship between montelukast use and the development of these congenital anomalies has not been established.
The manufacturer maintains a registry to monitor pregnancy outcomes in women exposed to montelukast during pregnancy. Patients may be enrolled by calling 800-986-8999.
Montelukast is distributed into milk in rats. Since it is not known whether montelukast is distributed in human milk, the drug should be used with caution in nursing women.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Montelukast | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Data suggest low excretion with no known adv infant effects |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for SINGULAIR (montelukast sodium):
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.
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.
The following icd codes are available for SINGULAIR (montelukast sodium)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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