Montelukast Sodium Tablets

Montelukast sodium is a prescription medicine that blocks substances in the body called leukotrienes. This may help to improve symptoms of asthma and allergic rhinitis. Montelukast sodium does not contain a steroid.

Montelukast sodium is used to:

1. Prevent asthma attacks and for the long-term treatment of asthma in adults and children ages 12 months and older. Do not take montelukast sodium if you need relief right away for a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.

2. Prevent exercise-induced asthma in people 6 years of age and older.

3. Help control the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose). Montelukast sodium is used to treat outdoor allergies that happen part of the year(seasonal allergic rhinitis) in adults and children ages 2 years and older, and indoor allergies that happen all year (perennial allergic rhinitis) in adults and children ages 6 months and older.

Do not take montelukast sodium if you are allergic to any of its ingredients.

See the end of this leaflet for a complete list of the ingredients in montelukast sodium.

Before taking Montelukast Sodium, tell your healthcare provider if you:

· are allergic to aspirin

· have any other medical conditions

· are pregnant or plan to become pregnant. Talk to your doctor if you are pregnant or plan to become pregnant, as montelukast sodium may not be right for you.

· are breast-feeding or plan to breast-feed. It is not known if montelukast sodium passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking montelukast sodium.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how montelukast sodium works, or montelukast sodium may affect how your other medicines work.

· Take montelukast sodium exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much montelukast sodium to take, and when to take it.

· Do not stop taking montelukast sodium or change when you take it without talking with your healthcare provider.

· You can take montelukast sodium with food or without food.

· If you or your child misses a dose of montelukast sodium, just take the next dose at your regular time. Do not take 2 doses at the same time.

· If you take too much montelukast sodium, call your healthcare provider or a Poison Control Center right away.

For adults and children 12 months of age and older with asthma:

· Take montelukast sodium 1 time each day, in the evening. Continue to take montelukast sodium every day for as long as your healthcare provider prescribes it, even if you have no asthma symptoms.

· Tell your healthcare provider right away if your asthma symptoms get worse, or if you need to use your rescue inhaler medicine more often for asthma attacks.

· Do not take montelukast sodium if you need relief right away from a sudden asthma attack. If you get an asthma attack, you should follow the instructions your healthcare provider gave you for treating asthma attacks.

· Always have your rescue inhaler medicine with you for asthma attacks.

· Do not stop taking or lower the dose of your other asthma medicines unless your healthcare provider tells you to.

For patients 6 years of age and older for the prevention of exercise-induced asthma:

· Take montelukast sodium at least 2 hours before exercise.

· Always have your rescue inhaler medicine with you for asthma attacks.

· If you take montelukast sodium every day for chronic asthma or allergic rhinitis, do not take another dose to prevent exercise-induced asthma. Talk to your healthcare provider about your treatment for exercise-induced asthma.

· Do not take 2 doses of montelukast sodium within 24 hours (1 day).

For adults and children 2 years of age and older with seasonal allergic rhinitis, or for adults and children 6 months of age and older with perennial allergic rhinitis:

· Take montelukast sodium 1 time each day, at about the same time each day.

The dose of montelukast sodium prescribed for your or your child’s condition is based on age:

· 2 to 5 years: one 4-mg chewable tablet.

· 6 to 14 years: one 5-mg chewable tablet.

· 15 years and older: one 10-mg tablet.

If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking montelukast sodium.

Montelukast sodium may cause serious side effects.

· Behavior and mood-related changes. Tell your healthcare provider right away if you or your child have any of these symptoms while taking montelukast sodium:

· agitation including aggressive behavior or hostility
· attention problems
· bad or vivid dreams
· depression
· disorientation (confusion)
· feeling anxious
· hallucinations (seeing or hearing things that are not really there)
· irritability
· memory problems
· obsessive-compulsive symptoms
· restlessness
· sleepwalking
· suicidal thoughts and actions (including suicide)
· tremor
· trouble sleeping
· uncontrolled muscle movements

· Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body(systemic vasculitis). Rarely, this can happen in people with asthma who take montelukast sodium. This sometimes happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered.

Tell your healthcare provider right away if you get one or more of these symptoms:

· a feeling of pins and needles or numbness of arms or legs
· a flu-like illness
· rash
· severe inflammation (pain and swelling) of the sinuses (sinusitis)

The most common side effects with montelukast sodium include:

· upper respiratory infection
· fever
· headache
· sore throat
· cough
· stomach pain
· diarrhea
· earache or ear infection
· flu
· runny nose
· sinus infection

Other side effects with montelukast sodium include:

· increased bleeding tendency, low blood platelet count
· allergic reactions [including swelling of the face, lips, tongue, and/or throat (which may cause · · trouble breathing or swallowing), hives and itching
· dizziness, drowsiness, pins and needles/numbness, seizures (convulsions or fits)
· palpitations
· nose bleed, stuffy nose, swelling (inflammation) of the lungs
· heartburn, indigestion, inflammation of the pancreas, nausea, stomach or intestinal upset, vomiting
· hepatitis
· bruising, rash, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis) that may occur without warning
· joint pain, muscle aches and muscle cramps
· bedwetting in children
· tiredness, swelling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of montelukast sodium. For more information ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088.

· Store montelukast sodium at 59°F to 86°F (15°Cto30°C).
· Keep montelukast sodium in the container it comes in.
· Keep montelukast sodium in a dry place and away from light.

Medicines are sometimes prescribed for purposes other than those mentioned in Patient Information Leaflets. Do not use montelukast sodium for a condition for which it was not prescribed. Do not give montelukast sodium to other people even if they have the same symptoms you have. It may harm them. Keep montelukast sodium and all medicines out of the reach of children.

This leaflet summarizes information about montelukast sodium. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about montelukast sodium that is written for health professionals. For more information, call 1-844-834-0530.

Active ingredient: montelukast sodium

Inactive ingredients:

4-mg and 5-mg chewable tablets: butylated hydroxyanisole, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, mannitol, microcrystalline cellulose, natural and artificial orange flavor, red ferric oxide, sodium stearyl fumarate and sucralose.

10-mg tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium stearyl fumarate, talc and titanium dioxide.

Rx only

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136