Montelukast Oral Granules

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Granules may be taken by mouth or mixed with applesauce, baby formula, breast milk, carrots, rice, or ice cream. Do not mix granules in other liquids.
• After mixing, take your dose right away. Do not store for future use.
• Take even during sign-free periods.
• If working out or playing sports causes signs, use at least 2 hours before doing it.
• If this medicine (montelukast oral granules) is for asthma, take in the evening.
• To gain the most benefit, do not miss doses.
• Take this medicine at the same time of day.
• Keep taking this medicine (montelukast oral granules) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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.
• Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine (a component of aspartame).

Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

Revised: 03/2017

Patient Information

Montelukast Sodium (mon te loo' kast soe' dee um) Tablets, USP 

Montelukast Sodium (mon te loo' kast soe' dee um) Chewable Tablets, USP 

Montelukast Sodium (mon te loo' kast soe' dee um) Oral Granules, USP 

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 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 tablets, chewable tablets or oral granules are 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.

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 phenylketonuria. Montelukast sodium chewable tablets contain aspartame, a source of phenylalanine
• 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.

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. See the information below in the section "How should I give montelukast sodium oral granules to my child?" for information about what foods and liquids can be taken with montelukast sodium oral granules.
• 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 tablets or chewable tablets 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.

How should I give montelukast sodium oral granules to my child?

Give montelukast sodium oral granules to your child exactly as instructed by your healthcare provider.

Do not open the sachet until ready to use.

Montelukast sodium 4-mg oral granules can be given:

• right in the mouth; or
• dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk; or
• mixed with 1 spoonful of one of the following soft foods at cold or room temperature: applesauce, mashed carrots, rice, or ice cream.

Give the child all of the mixture right away, within 15 minutes.

Do not store any leftover montelukast sodium mixture (oral granules mixed with food, baby formula, or breast milk) for use at a later time. Throw away any unused portion.

Do not mix montelukast sodium oral granules with any liquid drink other than baby formula or breast milk. Your child may drink other liquids after swallowing the mixture.

What is the dose of montelukast sodium?

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

• 6 to 23 months: one sachet of 4-mg oral granules.
• 2 to 5 years: one 4-mg chewable tablet or one sachet of 4-mg oral granules.
• 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:

• 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 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 tablets, chewable tablets or oral granules for a condition for which it was not prescribed. Do not give montelukast sodium tablets, chewable tablets or oral granules 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.

What are the ingredients in montelukast sodium?

Active ingredient: montelukast sodium

Inactive ingredients:

• 4-mg oral granules: mannitol, hydroxypropyl cellulose, and magnesium stearate.
• 4-mg and 5-mg chewable tablets: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, ferric oxide red, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.
  People with Phenylketonuria: Montelukast sodium 4-mg chewable tablets contain 0.449 mg of phenylalanine, and montelukast sodium 5-mg chewable tablets contain 0.561 mg of phenylalanine.
• 10-mg tablet: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The film coating contains: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, ferric oxide red, and ferric oxide yellow.

Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

Revised:  03/2017

NDC 27241 016 03

30 Tablets

Montelukast Sodium Chewable Tablets

4 mg*

For Pediatric Patients 2-5 Years of Age

Phenylketonurics : contains phenylalanine (a component of aspartame) 0.449 mg per 4mg chewable tablet.

*Each tablet contains 4.2 mg Montelukast Sodium USP equivalent to 4 mg Montelukast.

Rx only

P19498

Code  No. MH/DRUGS/AD/018

Dosage: See accompanying product literature.

Storage:

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Keep out of the reach of children.

Marketed by:

Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

NDC 27241 016 09

90 Tablets

Montelukast Sodium Chewable Tablets

4 mg*

For Pediatric Patients 2-5 Years of Age

Phenylketonurics : contains phenylalanine (a component of aspartame) 0.449 mg per 4mg chewable tablet.

*Each tablet contains 4.2 mg Montelukast Sodium USP equivalent to 4 mg Montelukast.

Rx only

P19499

Code  No. MH/DRUGS/AD/018

Dosage: See accompanying product literature.

Storage:

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Keep out of the reach of children.

Marketed by:

Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.

More Common Side Effects

The more common side effects that can occur with use of montelukast include:

• upper respiratory infection (infection in the nose or throat)

• fever

• headache

• sore throat

• cough

• stomach pain

• diarrhea

• earache or ear infection

• flu

• runny nose

• sinus infection

• bed-wetting in children

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Behavior and mood changes. Symptoms can include:

  • feeling anxious
  • bad or vivid dreams
  • confusion
  • agitation
  • restlessness
  • tremor
  • trouble sleeping

• Increase in eosinophils (white blood cells)

• Systemic vasculitis (inflamed blood vessels). Symptoms can include:

  • feeling of “pins and needles” or numbness in the arms or legs
  • flu-like symptoms such as fever, muscle aches, or cold sweats
  • severe pain and swelling of the sinuses

• Increased bleeding. Symptoms can include:

  • bleeding under the skin
  • longer bleeding from cuts
  • blood in the urine or feces

• Stevens-Johnson syndrome. This is a medical emergency. Symptoms can include:

  • swelling of the face or tongue
  • hives
  • skin pain
  • a purple or red rash

• Uncontrolled muscle movements. Symptoms can include:

  • tics (muscle spasms)