DRUGS AND SUPPLEMENTS

Montelukast

March 21, 2017

Montelukast Sodium Chewable tablet

What is this medicine?

MONTELUKAST (mon te LOO kast) is used to prevent and treat the symptoms of asthma. It is also used to treat allergies. Do not use for an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • liver disease

  • phenylketonuria

  • an unusual or allergic reaction to montelukast, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Chew it completely before swallowing. Follow the directions on the prescription label. If you have asthma, take this medicine once a day in the evening. If you have allergies, take this medicine once a day, at about the same time each day. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

  • carbamazepine

  • paclitaxel

  • phenobarbital

  • phenytoin

  • repaglinide

  • rifabutin

  • rifampin

  • rosiglitazone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your allergy or asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.

If you have asthma, talk to your doctor about what to do in an acute asthma attack. Always have your inhaled rescue medicine for asthma attacks with you.

Patients and their families should watch for new or worsening thoughts of suicide or depression. Also watch for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. Any worsening of mood or thoughts of suicide or dying should be reported to your health care professional right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash or hives, or swelling of the face, lips, or tongue

  • breathing problems

  • confusion

  • dark urine

  • fever or infection

  • flu-like symptoms

  • hallucinations

  • painful lumps under the skin

  • pain, tingling, numbness in the hands or feet

  • sinus pain or swelling

  • suicidal thoughts or other mood changes

  • trouble sleeping

  • unusual bleeding or bruising

  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • cough

  • dizziness

  • drowsiness

  • headache

  • nightmares

  • stomach upset

  • stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at a room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep this medicine in the original bottle. Throw away any unused medicine after the expiration date.

Montelukast Sodium Oral granules

What is this medicine?

MONTELUKAST (mon te LOO kast) is used to prevent and treat the symptoms of asthma. It is also used to treat allergies. Do not use for an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • liver disease

  • an unusual or allergic reaction to montelukast, medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. This medicine may be taken with or without food. For asthma, take this medicine once a day in the evening. For allergies, take this medicine once a day, at about the same time each day. Do not stop taking your medicine unless your doctor tells you to.

Do not open the packet until ready to use. After opening the packet, the dose must be given within 15 minutes. The granules can be placed directly into the mouth. Or, the granules can be mixed in one teaspoonful of baby formula or breast milk or in one teaspoon of applesauce, carrots, rice, or ice cream. Do not mix with any liquids except formula or breast milk. Discard any unused medicine and mixture.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in children as young as 12 months of age to control asthma and as young as 6 months of age to control allergies.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for the next dose, skip the missed dose. Do not use double or extra doses.

What may interact with this medicine?

  • carbamazepine

  • paclitaxel

  • phenobarbital

  • phenytoin

  • repaglinide

  • rifabutin

  • rifampin

  • rosiglitazone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your allergy or asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.

If you have asthma, talk to your doctor about what to do in an acute asthma attack. Always have your inhaled rescue medicine for asthma attacks with you.

Patients and their families should watch for new or worsening thoughts of suicide or depression. Also watch for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. Any worsening of mood or thoughts of suicide or dying should be reported to your health care professional right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash or hives, or swelling of the face, lips, or tongue

  • breathing problems

  • confusion

  • dark urine

  • fever or infection

  • flu-like symptoms

  • hallucinations

  • painful lumps under the skin

  • pain, tingling, numbness in the hands or feet

  • sinus pain or swelling

  • suicidal thoughts or other mood changes

  • trouble sleeping

  • unusual bleeding or bruising

  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • cough

  • dizziness

  • drowsiness

  • headache

  • nightmares

  • stomach upset

  • stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at a room temperature of 59 to 86 degrees F (15 to 30 degrees C). Protect from light and moisture. Keep in the original package. Throw away any unused medicine after the expiration date.

Montelukast Sodium Oral tablet

What is this medicine?

MONTELUKAST (mon te LOO kast) is used to prevent and treat the symptoms of asthma. It is also used to treat allergies. Do not use for an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • liver disease

  • an unusual or allergic reaction to montelukast, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine should be given by mouth. Follow the directions on the prescription label. Take this medicine at the same time every day. You may take this medicine with or without meals. Do not chew the tablets. Do not stop taking your medicine unless your doctor tells you to.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 15 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

  • anti-infectives like rifampin and rifabutin

  • medicines for diabetes like rosiglitazone and repaglinide

  • medicines for seizures like phenytoin, phenobarbital, and carbamazepine

  • paclitaxel

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or health care professional if your allergy or asthma symptoms do not improve. Take your medicine even when you do not have symptoms. Do not stop taking any of your medicine(s) unless your doctor tells you to.

If you have asthma, talk to your doctor about what to do in an acute asthma attack. Always have your inhaled rescue medicine for asthma attacks with you.

Patients and their families should watch for new or worsening thoughts of suicide or depression. Also watch for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. Any worsening of mood or thoughts of suicide or dying should be reported to your health care professional right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash or hives, or swelling of the face, lips, or tongue

  • breathing problems

  • confusion

  • dark urine

  • fever or infection

  • flu-like symptoms

  • hallucinations

  • painful lumps under the skin

  • pain, tingling, numbness in the hands or feet

  • sinus pain or swelling

  • suicidal thoughts or other mood changes

  • trouble sleeping

  • unusual bleeding or bruising

  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • cough

  • dizziness

  • drowsiness

  • headache

  • nightmares

  • stomach upset

  • stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Keep this medicine in the original bottle. Throw away any unused medicine after the expiration date.

Updated:  

March 21, 2017

Sources:  

U.S. FDA-approved Package Insert