Montelukast Sodium (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Montelukast Sodium Tablets, 10 mg (base), are light tan, round, film-coated tablets with product identification “54 157″ on one side and plain on the other. They are supplied as follows:

NDC 0054-0259-13 Bottle of 30

NDC 0054-0259-22 Bottle of 90

NDC 0054-0259-31 Bottle of 1,000

Montelukast Sodium Chewable Tablets, 4 mg (base), are pink speckled, oval tablets with product identification “54 144″ on one side and plain on the other side. They are supplied as follows:

NDC 0054-0288-13 Bottle of 30

NDC 0054-0288-22 Bottle of 90

NDC 0054-0288-29 Bottle of 500

Montelukast Sodium Chewable Tablets, 5 mg (base), are pink speckled, round tablets with product identification “54 741″ on one side and plain on the other side. They are supplied as follows:

NDC 0054-0289-13 Bottle of 30

NDC 0054-0289-22 Bottle of 90

NDC 0054-0289-29 Bottle of 500

Storage

Store montelukast sodium 4 mg chewable tablets, 5 mg chewable tablets and 10 mg film‑coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Storage for Bulk Bottles

Store bottles of 1000 montelukast sodium tablets and 500 montelukast sodium chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well‑closed, light‑resistant container.

17 PATIENT COUNSELING INFORMATION

[See FDA-Approved Patient Labeling (Patient Information).]

Information for Patients

Patients should be advised to take montelukast sodium daily as prescribed, even when they are asymptomatic, as well as during periods of worsening asthma, and to contact their physicians if their asthma is not well controlled.
Patients should be advised that oral montelukast sodium is not for the treatment of acute asthma attacks. They should have appropriate short-acting inhaled β-agonist medication available to treat asthma exacerbations. Patients who have exacerbations of asthma after exercise should be instructed to have available for rescue a short-acting inhaled β-agonist. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Patients should be advised that, while using montelukast sodium, medical attention should be sought if short-acting inhaled bronchodilators are needed more often than usual, or if more than the maximum number of inhalations of short-acting bronchodilator treatment prescribed for a 24-hour period are needed.
Patients receiving montelukast sodium should be instructed not to decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician.
Patients should be instructed to notify their physician if neuropsychiatric events occur while using montelukast sodium.
Patients with known aspirin sensitivity should be advised to continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast sodium.

Roxane Laboratories, Inc., Columbus, Ohio 43216

10006150/02 Revised January 2013

© RLI, 2013

PATIENT INFORMATION

MONTELUKAST SODIUM TABLETS

MONTELUKAST SODIUM CHEWABLE TABLETS

Read the Patient Information Leaflet that comes with montelukast sodium before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is montelukast sodium?

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 2 years 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 15 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 2 years and older.

Who should not take montelukast sodium?

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.

What should I tell my healthcare provider before taking 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. If you are pregnant or plan to become pregnant, 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.

How should I take montelukast sodium?

For anyone who takes montelukast sodium:

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 Poison Control Center right away.

For adults and children 2 years 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 15 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 2 years of age and older with perennial allergic rhinitis:

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

What is the dose of montelukast sodium?

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.

What should I avoid while taking montelukast sodium?

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.

What are the possible side effects of 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
bad or vivid dreams
depression
disorientation (confusion)
feeling anxious
hallucinations (seeing or hearing things that are not really there)
irritability
restlessness
sleep walking
suicidal thoughts and actions (including suicide)
tremor
trouble sleeping
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 usually, but not always, 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
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
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 FDA at 1-800-FDA-1088.

How should I store montelukast sodium?

Store montelukast sodium at 59°F to 86°F (15°C to 30°C).
Keep montelukast sodium in the container it comes in.
Keep montelukast sodium in a dry place and away from light.

General Information about the safe and effective use of montelukast sodium

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, go to www.roxane.com or call 1-800-962-8364.

What are the ingredients in montelukast sodium?

Active ingredient: montelukast sodium, USP

Inactive ingredients:

10 mg tablet: lactose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, microcrystalline cellulose, Opadry II Yellow, polyvinyl alcohol, sodium starch glycolate, talc, and titanium dioxide.
4 mg and 5 mg chewable tablets: copovidone, iron oxide (red), magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, sucralose, and wild cherry flavor.

Pediatric use information for patients ages 6 to 14 years of age for prevention of exercise-induced asthma is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Roxane Laboratories, Inc., Columbus, Ohio 43216

10006150/02 Revised January 2013

© RLI, 2013

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