Pulmont5 mg

Pulmont is an FDA-approved leukotriene receptor antagonist with the following established indications:

• Prophylaxis and chronic treatment of asthma in adults and pediatric patients as young as 12 months of age (established, FDA-approved use).
• Prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (established, FDA-approved use).
• Relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older (established, FDA-approved use).
• Relief of symptoms of perennial allergic rhinitis in patients 6 months of age and older (established, FDA-approved use).

Because of its neuropsychiatric boxed warning, current prescribing guidance reserves Pulmont for allergic rhinitis only in patients who have an inadequate response to, or cannot tolerate, other allergy medicines. Pulmont is not indicated for the treatment of acute asthma attacks or acute bronchospasm, and it is not an antibiotic or antimicrobial agent.

Montelukast is available as the active ingredient (as montelukast sodium) in several oral dosage forms:

• Film-coated tablets: Montelukast 10 mg
• Chewable tablets: Montelukast 4 mg and 5 mg
• Oral granules: Montelukast 4 mg per sachet

Chewable tablet formulations may contain aspartame (a source of phenylalanine); patients with phenylketonuria should be counseled accordingly.

Pulmont is a selective leukotriene receptor antagonist (LTRA) used in the long-term management of asthma and for relief of allergic rhinitis symptoms. It works by blocking the action of cysteinyl leukotrienes, inflammatory mediators that contribute to airway edema, smooth muscle constriction, and inflammatory cell activity in asthma and allergic disease. Pulmont is taken orally and is not a bronchodilator or rescue medication for acute symptoms.

Pulmont belongs to the leukotriene receptor antagonist (LTRA) class of anti-asthmatic and anti-allergic agents.

Mechanism of Action

Montelukast selectively and competitively antagonizes the cysteinyl leukotriene receptor CysLT1 found on airway smooth muscle and other airway cells. By blocking this receptor, Montelukast inhibits the physiologic actions of leukotrienes C4, D4, and E4 - potent mediators released from mast cells and eosinophils that cause airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process of asthma and allergic rhinitis.

Pharmacokinetics

• Absorption: Rapidly absorbed after oral administration; the 10 mg tablet reaches peak plasma concentration in about 3-4 hours in adults (chewable tablets slightly faster).
• Bioavailability: Approximately 64% (10 mg tablet); food does not affect oral bioavailability of the tablet.
• Protein binding: Greater than 99% bound to plasma proteins.
• Metabolism: Extensively metabolized in the liver, principally via cytochrome P450 enzymes CYP3A4 and CYP2C9.
• Elimination half-life: Approximately 2.7 to 5.5 hours in healthy adults.
• Excretion: Predominantly via bile/feces, with negligible urinary excretion of unchanged drug.

Pulmont is taken by mouth, once daily, generally in the evening for asthma (timing is flexible for allergic rhinitis alone).

• Tablets: Swallow whole with water; may be taken with or without food.
• Chewable tablets: Chew thoroughly before swallowing.
• Oral granules: Administer directly on the tongue or mixed with a spoonful of soft food or milk immediately before use; consume within 15 minutes of opening the packet. Do not dissolve granules in liquid for drinking, and do not store a prepared dose for later use.

If a dose is missed, take it as soon as remembered, but do not double the dose to make up for a missed one. Pulmont should be continued regularly as prescribed and should not be stopped abruptly without medical advice, even when symptoms improve.

Pulmont has relatively few clinically significant drug interactions, but the following are well documented:

• Phenobarbital and rifampin (strong CYP metabolism inducers): Reduce plasma concentrations of Pulmont by inducing its hepatic metabolism; while no routine dose adjustment is mandated, clinical response should be monitored when these agents are co-administered.
• Gemfibrozil: Significantly increases Pulmont systemic exposure by inhibiting its metabolism; caution and clinical monitoring are advised with concurrent use.

No clinically significant interactions have been established with theophylline, warfarin, digoxin, oral contraceptives, or prednisone/prednisolone at recommended doses. Patients should inform their physician or pharmacist of all medicines and supplements they are taking before starting Pulmont.

Pulmont is generally well tolerated. Reported adverse effects include:

• Common: headache, abdominal pain, cough, dyspepsia, dizziness, fatigue, fever, and upper respiratory tract infection symptoms.
• Common in children: ear infection (otitis media), pharyngitis, sinusitis, diarrhea, rash, and influenza-like illness.
• Neuropsychiatric events (see boxed warning): agitation, aggressive behavior, anxiousness, abnormal dreams/hallucinations, insomnia, irritability, restlessness, depression, and rarely suicidal thinking and behavior (including completed suicide).
• Uncommon/rare: hypersensitivity reactions (rash, urticaria, angioedema, anaphylaxis), elevated liver enzymes, hepatitis, edema, palpitations, bruising/bleeding tendency, and, rarely, a systemic eosinophilic condition sometimes with vasculitic features consistent with Churg-Strauss syndrome (see Precautions and Warnings).

Patients or caregivers should seek prompt medical attention for any new or worsening mood or behavior change, or for signs of a serious allergic reaction.

Pregnancy

Published data from prospective and retrospective cohort studies have not established a clear drug-associated risk of major birth defects with Pulmont use in pregnancy. However, because uncontrolled asthma during pregnancy poses well-recognized risks to both mother and fetus (including pre-eclampsia and low birth weight), Pulmont should be used in pregnancy only if clearly needed, and treatment for asthma is generally continued during pregnancy when required, under a physician's guidance, since the risks of poorly controlled asthma typically outweigh the theoretical risks of continued therapy. A physician should always be consulted regarding use of Pulmont during pregnancy.

Lactation

Pulmont is present in human breast milk in small amounts. There is no evidence of harm to breastfed infants reported to date, but a physician should be consulted to weigh the benefits of breastfeeding and the mother's clinical need for Pulmont against any potential risk to the infant.

Boxed Warning: Neuropsychiatric Events

Pulmont has been associated with serious neuropsychiatric events, including agitation, aggression, anxiousness, abnormal dreams, hallucinations, depression, insomnia, irritability, restlessness, and suicidal thinking and behavior (including completed suicide). Patients and caregivers should be counseled to watch for and immediately report any new or worsening mood, behavior, or thinking changes; the risks and benefits of Pulmont, particularly for allergic rhinitis where alternative therapies exist, should be discussed with a physician before starting treatment.

Not for Acute Asthma Attacks

Pulmont is not a bronchodilator and is not indicated to treat acute asthma attacks. Patients should continue to use their prescribed rescue (short-acting bronchodilator) inhaler for acute symptoms and should have it available at all times. Continued use of Pulmont should not lead to abrupt discontinuation or reduction of other asthma medications (including corticosteroids) except under a physician's direction.

Eosinophilic Conditions (Churg-Strauss-type Vasculitis)

In rare cases, patients on Pulmont - particularly when oral corticosteroid doses are being reduced - have developed a systemic eosinophilic condition with features of vasculitis consistent with Churg-Strauss syndrome. A causal relationship has not been definitively established, but prescribers should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in such patients.

Phenylketonuria

Chewable tablet formulations of Pulmont may contain aspartame, a source of phenylalanine, which should be considered in patients with phenylketonuria.

Reported adverse events following Pulmont overdose have included abdominal pain, sleepiness, thirst, headache, vomiting, and psychomotor hyperactivity; serious adverse effects have generally not been reported at supratherapeutic doses, but data on very large overdoses are limited.

There is no specific antidote for Pulmont overdose. If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. Management consists of general supportive and symptomatic measures under medical supervision; it is not known whether Pulmont is removed by hemodialysis or peritoneal dialysis. Do not attempt to manage a suspected overdose with home remedies.

Store at room temperature (below 30°C), away from light and moisture. Keep the oral granules packet sealed until immediately before use. Keep out of reach of children.

• Pediatric use: Approved from 6 months of age for perennial allergic rhinitis, 12 months for asthma, 2 years for seasonal allergic rhinitis, and 6 years for exercise-induced bronchoconstriction, using age-appropriate formulations and doses. See Pediatric Uses for full detail.
• Geriatric use: Clinical studies have not identified overall differences in safety or effectiveness between elderly and younger adult patients; no dose adjustment based on age alone is required.
• Renal impairment: No dosage adjustment is required.
• Hepatic impairment: No dosage adjustment is required in mild-to-moderate hepatic impairment; Pulmont has not been studied in severe hepatic impairment, so caution is advised.
• Pregnancy and lactation: See Pregnancy and Lactation section.

Duration of Pulmont therapy depends on the indication:

• Chronic asthma and perennial allergic rhinitis: Used as long-term, continuous daily therapy as directed by a physician, with periodic reassessment of ongoing need and response.
• Seasonal allergic rhinitis: Typically used for the duration of the relevant pollen/allergen season, as advised by a physician.
• Exercise-induced bronchoconstriction: Used as a single dose before anticipated exercise; not intended for continuous daily dosing solely for this indication unless also treating chronic asthma.

Pulmont should not be stopped or its dose changed without consulting the prescribing physician, particularly when other asthma medicines are also being used.

Montelukast belongs to the leukotriene receptor antagonist (LTRA) drug class, used as an anti-asthmatic and anti-allergic agent.

Montelukast works by selectively blocking the cysteinyl leukotriene receptor (CysLT1) on cells in the airway. Cysteinyl leukotrienes are potent inflammatory mediators released by mast cells and eosinophils during allergic and asthmatic responses; when they bind to CysLT1 receptors, they cause bronchoconstriction, increased vascular permeability, mucus secretion, and recruitment of inflammatory cells. By occupying and blocking this receptor, Montelukast prevents these downstream effects, resulting in reduced airway inflammation, decreased bronchoconstriction, and relief of nasal allergy symptoms. Montelukast does not act as a bronchodilator and has no role in reversing acute bronchospasm.

B

Pulmont has several established pediatric indications, with approved age ranges and formulations as follows:

• 6 to 23 months: Oral granules (4 mg) approved for perennial allergic rhinitis.
• 12 to 23 months: Oral granules (4 mg) approved for asthma.
• 2 to 5 years: 4 mg chewable tablet or oral granules approved for asthma, seasonal allergic rhinitis, and perennial allergic rhinitis.
• 6 to 14 years: 5 mg chewable tablet approved for asthma, exercise-induced bronchoconstriction, seasonal allergic rhinitis, and perennial allergic rhinitis.
• 15 years and older: Adult 10 mg tablet dose applies to all indications.

Safety and efficacy of Pulmont have not been established below these respective age cutoffs for each indication (for example, exercise-induced bronchoconstriction has not been established in children under 6 years). Parents/caregivers of pediatric patients should be counseled specifically to monitor for and report behavior or mood changes, consistent with the boxed warning.