MONTELUKAST SODIUM- montelukast sodium tablet, chewable
MONTELUKAST SODIUM- montelukast sodium tablet
MONTELUKAST SODIUM- montelukast sodium granule
Torrent Pharmaceuticals Limited
What is the most important information I should know about Montelukast Sodium?
• agitation, including aggressive behavior or hostility• attention problems
• bad or vivid dreams
• disorientation (confusion)
• feeling anxious
• hallucinations (seeing or hearing things that are not really there)
• memory problems
• obsessive-compulsive symptoms
• sleep walking
• suicidal thoughts and actions(including suicide)
• trouble sleeping
• uncontrolled muscle movements
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 inflammation of the lining of the nose (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 have 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 such as sneezing, stuffy nose, runny nose, and itching of the nose. Montelukast sodium is used to treat the following in people who have already taken other medicines that did not work well enough or in people who could not tolerate other medicines:
Do not take montelukast sodium if you are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in Montelukast sodium.
Before taking montelukast sodium, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over the counter 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:
For adults and children 12 months of age and older with asthma:
For people 6 years of age and older for the prevention of exercise-induced asthma:
For anyone 2 years of age and older with seasonal allergic rhinitis, or for anyone 6 months of age and older with perennial allergic rhinitis:
What should I avoid while takingmontelukast 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 ofmontelukast sodium?
Montelukast sodium may cause serious side effects, including:
• a feeling of pins and needles or numbness of arms or legs
• a flu-like illness
• severe inflammation (pain and swelling) of the sinuses (sinusitis)
The most common side effects of montelukast sodium include:
• upper respiratory infection
• sore throat
• stomach pain
• earache or ear infection
• runny nose
• sinus infection
These are not all the possible side effects of montelukast sodium. Call your doctor 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 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
• Keep montelukast sodium in the package it comes in.
• Keep montelukast sodium in a dry place and keep it away from light.
• Keep montelukast sodium and all medicines out of the reach of children.
General information about the safe and effective use of montelukast sodium.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. 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.
You can ask your pharmacist or healthcare provider for information about montelukast sodium that is written for health professionals.
For more information, call Torrent Pharma Inc. at 1-800-912-9561.
What are the ingredients in montelukast sodium?
Active ingredient: Montelukast Sodium USP
People with Phenylketonuria: Montelukast sodium 4-mg chewable tablets contain 0.168 mg of phenylalanine, and montelukast sodium 5-mg chewable tablets contain 0.210 mg of phenylalanine.
TORRENT PHARMACEUTICALS LTD., INDIA.
TORRENT PHARMA INC., Basking Ridge, NJ 07920.
8093932 Revised: August 2023
This Medication Guide has been approved by U.S. Food and Drug Administration.