Singulair (montelukast sodium)

Dosage of montelukast sodium is expressed in terms of montelukast.

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.

No dosing information is available for this tab.

No dosing information is available for this tab.

Montelukast has been used concomitantly in clinical studies with other drugs used routinely for the prevention and long-term symptomatic management of asthma without an apparent increase in adverse effects. In addition, montelukast has been used concomitantly with benzodiazepines, decongestants, nonsteroidal anti-inflammatory agents (NSAIAs), sedative-hypnotics, or thyroid hormones without evidence of an increase in adverse effects.

In drug-interaction studies, usual dosages of montelukast did not have clinically important effects on the pharmacokinetics of theophylline, warfarin, terfenadine (no longer commercially available in the US), digoxin, oral contraceptives (ethinyl estradiol with norethindrone), prednisone, or prednisolone.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

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.

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.

No enhanced messaging available.