Singulair 10 mg oral tablet: Singulair Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Singulair Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Warnings:
This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts). Talk to your doctor about the risks and benefits of this medication.
Warnings:
This medication may rarely cause serious mental/mood changes. These effects may occur even after the medication has been stopped. Tell your doctor right away if you or a caregiver/family member notice symptoms such as agitation, anxiety, abnormal dreams, depression, memory/attention problems, hallucinations, trouble sleeping, or changes in behavior (such as aggression, hostility, restlessness, sleepwalking, suicidal thoughts/attempts).
Talk to your doctor about the risks and benefits of this medication.
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Uses
Montelukast is used to control and prevent symptoms caused by asthma (such as wheezing and shortness of breath). It is also used before exercise to prevent breathing problems during exercise (bronchospasm). This medication can help decrease the number of times you need to use your quick relief inhaler.Montelukast is also used to relieve symptoms of hay fever and allergic rhinitis (such as sneezing, stuffy/runny/itchy nose). Since there are other allergy medications that may be safer (see also Warning section), this medication should be used for this condition only when you cannot take other allergy medications or they do not work well.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.
This drug works by blocking certain natural substances (leukotrienes) that may cause or worsen asthma and allergies. It helps make breathing easier by reducing swelling (inflammation) in the airways.
How to use Singulair oral
Read the Medication Guide provided by your pharmacist before you start taking montelukast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your age and medical condition.
If you are using the chewable tablets, chew them thoroughly before swallowing. If your child cannot safely chew and swallow them, consult the doctor or pharmacist for advice.
Take this medication at the same time each day. If you are taking this medication for asthma or for both asthma and allergies, take your dose in the evening. If you are taking montelukast to prevent only allergies, take your dose either in the morning or the evening.
If you are taking this medication to prevent breathing problems during exercise, take your dose at least 2 hours before exercise. Do not take more than one dose in 24 hours. Do not take a dose before exercise if you are already taking this medication daily for asthma or allergies. Doing so may increase the risk of side effects.
Do not increase or decrease your dose or stop using this medication without consulting your doctor. Continue to use this medication regularly to keep your asthma under control, even during sudden asthma attacks or periods when you have no asthma symptoms. Continue to also take other medications for asthma as directed by your doctor. This medication works over time and is not meant to relieve sudden attacks of asthma. If an asthma attack or other breathing problem occurs, use your quick-relief inhaler as prescribed. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.
Get medical help right away if your asthma symptoms worsen and your quick-relief inhaler is not helping.
Tell your doctor promptly if asthma symptoms, breathing problems, allergy symptoms, number of times you use your rescue inhaler last or get worse.
Side Effects
See also Warning section.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: numbness/tingling/shooting pain in the arms or legs, sinus pain/swelling, muscle weakness, uncontrolled muscle movements, stuttering.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before taking montelukast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this drug, tell your doctor or pharmacist your medical history, especially of: liver disease, mental/mood problems (such as anxiety, depression, thoughts of suicide).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
The chewable tablets may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Does Singulair oral interact with other drugs you are taking?
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Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.
Canada residents can call a provincial poison control center. Symptoms of overdose may include: thirst, drowsiness, inability to keep still, vomiting, or severe stomach pain.
Do not share this medication with others.
Lab and/or medical tests (such as lung function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Do not take more than 1 dose in 24 hours.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Images
Singulair 5 mg chewable tablet
Color: pinkShape: roundImprint: MSD 275 SINGULAIR
This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.
Singulair 10 mg tablet
Color: beigeShape: square (rounded corners)Imprint: MSD 117 SINGULAIR
This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.
Singulair 5 mg chewable tablet
Color: pinkShape: roundImprint: SINGULAIR MRK 275
This medicine is a pink, round, cherry, chewable tablet imprinted with “MSD 275” and “SINGULAIR”.
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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals.
The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Singulair (Montelukast) – Side Effects, Interactions, Uses, Dosage, Warnings
uses
What is Singulair (Montelukast) used for?
- Allergic Rhinitis
- Asthma — Maintenance
- Bronchospasm Prophylaxis
warnings
What is the most important information I should know about Singulair (Montelukast)?
You should not use montelukast if you are allergic to it.
Tell your doctor if you have ever had:
- mental illness or psychosis; or
- asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin or another NSAID.
The chewable tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).
Tell your doctor if you are pregnant or breastfeeding.
Do not give this medicine to a child without a doctor’s advice.
User Reviews & Rating
Overall rating for Singulair (Montelukast)
2.9
out of 5
Side Effects
Easy to Use
Effectiveness
Read Singulair (Montelukast) Reviews
Side Effects
What are the side effects of Singulair (Montelukast)?
Get emergency medical help if you have signs of an allergic reaction: hives, blisters, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have signs of blood vessel inflammation: flu-like symptoms, severe sinus pain, a skin rash, numbness or a “pins and needles” feeling in your arms or legs.
Some people using montelukast have had new or worsening mental problems.
Stop taking this medicine and call your doctor right away if you have unusual changes in mood or behavior, such as:
- agitation, aggression, feeling restless or irritable;
- anxiety, depression, confusion, problems with memory or attention;
- stuttering, tremors, uncontrolled muscle movements;
- suicidal thoughts or actions;
- hallucinations, sleep problems, vivid, dreams, sleep-walking; or
- compulsive or repetitive behaviors.
Common side effects may include:
- stomach pain, diarrhea;
- fever or other flu symptoms;
- ear pain or full feeling, trouble hearing;
- headache; or
- cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Singulair (Montelukast) if I’m pregnant or breastfeeding?
Tell your doctor if you are pregnant or breastfeeding.
Interactions
What drugs and food should I avoid while taking Singulair (Montelukast)?
Avoid situations or activities that may trigger an asthma attack.
If your asthma symptoms get worse when you take aspirin, avoid taking aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
Dosage Guidelines & Tips
How to take Singulair (Montelukast)?
Use Singulair (Montelukast) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
What should I do if I missed a dose of Singulair (Montelukast)?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Singulair (Montelukast)?
If you think you or someone else may have overdosed on: Singulair (Montelukast), call your doctor or the Poison Control center
(800) 222-1222
If someone collapses or isn’t breathing after taking Singulair (Montelukast), call 911
911
What to Expect
Montelukast starts to lower leukotriene levels in your body right away, but it may take about a week before you notice the full benefits.
You can safely use this medicine for a long period of time. It will only work while you’re taking it.
Secondary Uses
Singulair is sometimes prescribed “off-label” to treat other medical conditions, such as hives or chronic obstructive pulmonary disorder (COPD).
Images
SINGULAIR, MSD 117
Color: brown
Shape: square
Imprint: SINGULAIR, MSD 117
54 157
Color: brown
Shape: round
Imprint: 54 157
54 144
Color: pink
Shape: oval
Imprint: 54 144
Singular 10 mg n14 tablets
Indications
Prevention and long-term treatment of bronchial asthma in adults and children aged 6 years and older, including:
– prevention of daytime and nighttime symptoms of the disease;
– treatment of bronchial asthma in patients with hypersensitivity to acetylsalicylic acid;
– prevention of exercise-induced bronchospasm.
Relief of day and night symptoms of seasonal allergic rhinitis (in adults and children aged 6 years and over) and persistent allergic rhinitis (in adults and children aged 6 years and over).
Pharmacological action
Leukotriene receptor antagonist. Montelukast inhibits cysteinyl leukotriene receptors in the epithelium of the respiratory tract, while simultaneously showing the ability to inhibit bronchospasm caused by inhalation of cysteinyl leukotriene LTD 4 in patients with bronchial asthma. Doses of 5 mg are sufficient to relieve bronchospasm induced by LTD 4 . The use of montelukast in doses exceeding 10 mg / day. 1 time / day, does not increase the effectiveness of the drug.
Montelukast causes bronchodilation within 2 hours of oral administration and may supplement bronchodilation induced by beta 2 beta-agonists.
Pharmacokinetics
Absorption
After oral administration, montelukast is rapidly and almost completely absorbed from the gastrointestinal tract.
Regular meals do not affect plasma C max and the bioavailability of coated tablets and chewable tablets. In adults, when taken on an empty stomach, film-coated tablets at a dose of 10 mg C max in plasma is achieved after 3 hours. Bioavailability when taken orally is 64%.
After oral administration on an empty stomach, the drug in the form of chewable tablets at a dose of 5 mg C max in adults is achieved after 2 hours. Bioavailability is 73%.
Distribution
Binding of montelukast to plasma proteins is more than 99%. V d averages 8-11 liters.
With a single dose of the drug in the form of coated tablets, at a dose of 10 mg 1 time / day. there is a moderate (about 14%) accumulation of the active substance in plasma.
Metabolism
Montelukast is extensively metabolized in the liver. When used in therapeutic doses, the concentration of montelukast metabolites in plasma in an equilibrium state in adults and children is not determined.
It is assumed that cytochrome P450 isoenzymes (3A4 and 2C9) are involved in the metabolism of montelukast, while at therapeutic concentrations montelukast does not inhibit cytochrome P450 isoenzymes: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.
Elimination of
T 1/2 montelukast in young healthy adults ranges from 2.7 to 5.5 hours. Montelukast clearance in healthy adults averages 45 ml/min. After oral administration of montelukast, 86% is excreted in the feces within 5 days and less than 0.2% in the urine, which confirms that montelukast and its metabolites are excreted almost exclusively in the bile.
Pharmacokinetics in special clinical situations
The pharmacokinetics of montelukast remains almost linear after oral administration of more than 50 mg.
When taking montelukast in the morning and evening, no differences in pharmacokinetics are observed.
Pharmacokinetics of montelukast in women and men is similar.
When taken orally coated tablets at a dose of 10 mg 1 time / day. pharmacokinetic profile and bioavailability are similar in elderly and young patients.
In patients with mild to moderate hepatic insufficiency and clinical manifestations of liver cirrhosis, a slowdown in the metabolism of montelukast was noted, accompanied by an increase in AUC of approximately 41% after a single dose of the drug at a dose of 10 mg. The excretion of montelukast in these patients is slightly increased compared with healthy subjects (T 1/2 averages 7.4 hours). Dose modification of montelukast is not required in patients with mild to moderate hepatic impairment. There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).
Since montelukast and its metabolites are not excreted in the urine, the pharmacokinetics of montelukast have not been evaluated in patients with renal insufficiency.
Dose adjustment in this category of patients is not required.
There were no differences in clinically significant pharmacokinetic effects in patients depending on race.
Instructions for use / dosage
The drug is taken orally 1 time per day. regardless of food intake. For treatment of bronchial asthma Singular should be taken in the evening. When treatment of allergic rhinitis the drug can be taken at any time of the day.
Adults and adolescents aged 15 years and older the drug is prescribed at a dose of 10 mg (1 coated tablet) per day.
For children aged 6 to 14 years, is prescribed at a dose of 5 mg (1 chewable tablet) per day. No dose adjustment is required for this age group.
The therapeutic effect of Singulair on indicators reflecting the course of bronchial asthma develops during the first day.
The patient should continue to take Singular both during the period of achieving control of asthma symptoms and during the period of exacerbation of the disease.
For elderly patients, patients with renal insufficiency , patients with mild or moderate hepatic impairment , and also depending on gender, no special dose adjustment is required.
Singular can be added to treatment with bronchodilators and inhaled corticosteroids.
Side effects
Allergic reactions: anaphylaxis, angioedema, rash, itching, urticaria; very rarely – eosinophilic infiltrates of the liver.
From the side of the central nervous system: unusual vivid dreams, hallucinations, drowsiness, irritability, agitation, including aggressive behavior, fatigue, insomnia, paresthesia / hypoesthesia, headache; very rarely – convulsive seizures.
From the digestive system: nausea, vomiting, dyspepsia, diarrhea, abdominal pain.
From the musculoskeletal system: arthralgia, myalgia, including muscle cramps.
Other: tendency to increase bleeding, formation of subcutaneous hemorrhages, palpitations, edema.
In general, Singulair is well tolerated. Side effects are usually mild and usually do not require discontinuation of treatment. Overall frequency of side effects reported with Singulara comparable to placebo.
Contraindications
– hypersensitivity to the components of the drug. Use during pregnancy and lactation The benefit to the mother outweighs the potential risk to the fetus or baby.
Use in hepatic impairment
For patients with mild or moderate hepatic impairment, no special dose adjustment is required.
There are no data on the nature of the pharmacokinetics of montelukast in patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale).
Use for impaired renal function
No special dose adjustment is required for patients with renal insufficiency.
Special instructions
Singular is not recommended for the treatment of acute attacks of bronchial asthma. In the acute course of bronchial asthma, patients should be prescribed medications for therapy that stops and prevents attacks of the disease.
The dose of inhaled GCS used simultaneously with Singular can be gradually reduced under the supervision of a physician. Should not be abruptly replaced Singular therapy with inhaled or oral corticosteroids.
Reducing the systemic dose of corticosteroids in patients receiving anti-asthma drugs, including leukotriene receptor antagonists, was accompanied in rare cases by the appearance of one or more of the following phenomena: eosinophilia, vascular rash, worsening of pulmonary symptoms, cardiac complications and / or neuropathy, sometimes diagnosed as Churg-Ostrich syndrome – systemic eosinophilic vasculitis.
Although a causal relationship of these adverse events with therapy with leukotriene receptor antagonists has not been established, with a decrease in the systemic dose of GCS in patients taking Singulair , caution should be exercised and appropriate clinical monitoring should be carried out.
Age differences in the efficacy and safety profile Singulara were not found.
Influence on the ability to drive vehicles and work with mechanisms
Facts indicating that the reception of Singulara affects the ability to drive a car or moving mechanisms have not been identified.
Overdose
Symptoms of overdose Singulara in patients with chronic bronchial asthma when used at a dose exceeding 200 mg / day for 22 weeks and at a dose of 900 mg / day. – within 1 week, not detected.
There are reports of acute overdose of montelukast in children (at a dose of at least 150 mg / day). Clinical and laboratory data at the same time indicate compliance with the safety profile of Singulara in children safety profile in adults and elderly patients. The most common adverse events were thirst, drowsiness, mydriasis, hyperkinesis and abdominal pain.
Treatment: symptomatic therapy.
There are no data on the possibility of excretion of montelukast by peritoneal dialysis or hemodialysis.
Drug interaction
Singular may be given with other medicines traditionally used for the prevention and long-term treatment of asthma. Montelukast at the recommended clinical dose did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (ethinyl estradiol / norethindrone 35/1), terfenadine, digoxin and warfarin.
In patients who simultaneously received phenobarbital, the AUC of montelukast decreased by approximately 40%. Dose selection Singulara is not required for this category of patients.
If bronchodilators are ineffective as monotherapy for bronchial asthma, Singulair can be added to the treatment. When a therapeutic effect is achieved (usually after the first dose) during therapy with Singular , the dose of bronchodilators can be gradually reduced.
Treatment Singular provides an additional therapeutic effect in patients receiving inhaled corticosteroids. Upon reaching stabilization of the patient’s condition, it is possible to reduce the dose of corticosteroids. The dose of corticosteroids should be reduced gradually, under the supervision of a physician.