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What are the side effects of levolukast kid tablets?

4 min read

Up to 15% of children taking montelukast, a key component of Levolukast, have experienced neuropsychiatric side effects such as sleep disturbances and agitation during clinical studies. Understanding what are the side effects of levolukast kid tablets is crucial for parents and caregivers to ensure safe and effective treatment for their child's allergies.

Quick Summary

Levolukast kid tablets combine montelukast and levocetirizine, potentially causing side effects ranging from mild drowsiness and headache to more serious mood and behavioral changes. Parents should monitor for these reactions and seek medical advice for persistent symptoms.

Key Points

  • Combination Drug Effects: Levolukast contains both levocetirizine and montelukast, causing a combined set of potential side effects.

  • Drowsiness is Common: Sleepiness or fatigue is a frequent side effect, primarily due to the levocetirizine, and can affect a child's daily activities.

  • Monitor Neuropsychiatric Symptoms: Parents should watch for mood and behavioral changes such as agitation, aggression, anxiety, or sleep disturbances, linked to the montelukast component.

  • Gastrointestinal Issues: Stomach pain, nausea, vomiting, or diarrhea are common, especially in younger children, but often resolve over time.

  • Do Not Stop Abruptly: Stopping the medication suddenly can cause symptoms to rebound or worsen, so always consult a doctor before making changes to the treatment plan.

  • Seek Immediate Medical Help for Severe Reactions: Serious side effects like severe allergic reactions (swelling, hives, trouble breathing), jaundice, or urinary retention require prompt medical attention.

  • Age-Specific Side Effects: The incidence of specific side effects, such as fever or diarrhea, can vary depending on the child's age.

In This Article

Levolukast is a brand name for a combination medication containing levocetirizine and montelukast, prescribed to children to manage allergic conditions and asthma. Levocetirizine is a second-generation antihistamine that blocks histamine, a chemical responsible for allergy symptoms like sneezing, runny nose, and itching. Montelukast is a leukotriene receptor antagonist, which blocks another chemical messenger (leukotriene) to reduce inflammation in the airways and nasal passages. While effective, the combination can cause a range of side effects that parents should be aware of. These side effects can vary in severity and depend on the child's age and overall health.

Common Side Effects

Most children tolerate Levolukast well, and many common side effects are temporary, resolving as the child’s body adjusts to the medication. It is important to monitor your child for these reactions and consult a doctor if they persist or cause significant discomfort.

  • Drowsiness or Sleepiness: Levocetirizine, the antihistamine component, is known to cause drowsiness. This is one of the most frequently reported side effects and can affect a child's energy levels and alertness. Some children may feel more tired or weak than usual.
  • Gastrointestinal Issues: Stomach pain, nausea, vomiting, diarrhea, or constipation are common, particularly in younger children. These symptoms are typically mild but should be managed with proper hydration and diet.
  • Headache: Mild to moderate headaches can occur. If your child complains of persistent headaches, consult a doctor.
  • Cold-like Symptoms: Nasopharyngitis (inflammation of the nose and throat), cough, and fever are reported, especially in children between 6 and 11 years old.
  • Dry Mouth: The antihistamine component can cause dryness in the mouth.

Serious and Less Common Side Effects

Although less common, some side effects are more serious and require immediate medical attention. The montelukast component is particularly associated with neuropsychiatric effects.

Neuropsychiatric Changes

Parents and caregivers should closely observe for any changes in their child's mood or behavior. Studies have noted that neuropsychiatric reactions may be more prevalent than typically reported.

  • Agitation and Irritability: Unexplained restlessness, anxiety, or aggression should be reported to a doctor immediately.
  • Sleep Disturbances: Some children experience changes in their sleep patterns, including sleep difficulties, interrupted sleep, and nightmares.
  • Mood Changes: Cases of depression, anxiety, and in very rare instances, suicidal thoughts have been associated with montelukast.
  • Hyperactivity: Increased energy levels and hyperactivity have also been reported in some children.

Other Significant Reactions

  • Severe Allergic Reactions: Anaphylaxis is a rare but life-threatening allergic reaction. Symptoms include a widespread rash, swelling of the face, tongue, or throat, and difficulty breathing. Seek immediate emergency help if these occur.
  • Liver Problems: While rare, signs of liver issues, such as yellowing of the skin or eyes (jaundice), should be reported to a healthcare provider.
  • Urinary Issues: Some children, especially those with pre-existing conditions, may experience painful or difficult urination.

Side Effects by Age Group

Different age groups may experience different side effects.

  • Ages 1 to 5: Common side effects include fever, diarrhea, and vomiting. Some children in this group may also experience otitis media (middle ear infection).
  • Ages 6 to 11: Common side effects include cough, fever, and sleepiness. Nosebleeds are also reported.
  • Older Children: The side effects are similar to those in adults, with sleepiness and headache being most common.

Comparison of Levolukast Components' Side Effects

The side effect profile of Levolukast reflects the combined effects of its two active ingredients. The table below compares the common side effects associated with each component individually.

Side Effect Levocetirizine (Antihistamine) Montelukast (Leukotriene Antagonist)
Drowsiness/Sleepiness Very Common Less Common, but can contribute
Headache Common Common
Gastrointestinal Issues Diarrhea, vomiting Abdominal pain, nausea
Fever Common in children Common
Mood/Behavior Changes Less frequent, but reported Significant risk, including agitation, anxiety, and depression
Allergic Reactions Severe reactions possible Severe reactions possible

Managing Levolukast Side Effects

For minor side effects, specific strategies can help manage the symptoms.

  • For Nausea and Upset Stomach: Giving the tablet with food can help alleviate stomach discomfort.
  • For Diarrhea: Ensure your child drinks plenty of fluids, such as water or squash, to prevent dehydration.
  • For Headaches: Encourage your child to rest and stay hydrated. A pharmacist or doctor can recommend appropriate painkillers if needed.
  • For Sleepiness: Avoid activities that require alertness, like cycling or sports, until you know how the medication affects your child. Discuss the timing of doses with your doctor.
  • For Mood and Behavior Changes: Immediately report any significant or unusual changes to your child's pediatrician. Do not stop the medication suddenly without medical guidance.

When to Seek Medical Attention

It is important to contact a healthcare provider if side effects are concerning or severe. Seek immediate medical help if your child experiences any of the following:

  • Signs of a severe allergic reaction, including swelling of the face, lips, or tongue; hives; or trouble breathing.
  • Worsening mood or behavior, such as agitation, aggression, or depression.
  • Difficulty or pain during urination.
  • Yellowing of the skin or eyes (jaundice).

Conclusion

Levolukast kid tablets provide effective relief for pediatric allergies and asthma, but they carry potential side effects, with some notable risks associated with the montelukast component. While common side effects are often mild and temporary, parents and caregivers must remain vigilant for more serious neuropsychiatric symptoms and severe allergic reactions. Adhering to the prescribed dosage, monitoring for any adverse reactions, and maintaining open communication with your child's pediatrician are the best ways to ensure a positive and safe treatment outcome. Never alter the dose or stop the medication abruptly without professional medical advice.

A note on research

While Levolukast is a brand name for a combination drug, research on its individual components, montelukast and levocetirizine, provides a thorough understanding of potential side effects. A study published in the National Institutes of Health journal (PMC) highlighted a higher prevalence of neuropsychiatric adverse drug reactions associated with montelukast than previously reported in children.

Adverse Drug Reactions (ADRs) of Montelukast in Children

Frequently Asked Questions

Levolukast kid tablets are a combination medication prescribed for children to treat and prevent symptoms of allergic conditions, such as allergic rhinitis (hay fever) and asthma.

Yes, sleepiness and fatigue are common side effects of Levolukast, mainly caused by the levocetirizine component. It is important to monitor how your child reacts before engaging in activities that require alertness.

Yes, the montelukast component of Levolukast has been linked to neuropsychiatric side effects, including mood changes, anxiety, agitation, irritability, and sleep disturbances. Parents should closely monitor for these changes and consult a doctor if they occur.

For mild side effects like nausea or diarrhea, simple remedies like giving the medication with food or ensuring hydration may help. For persistent or severe side effects, or any signs of an allergic reaction, contact your doctor immediately.

No, you should never stop giving Levolukast abruptly without consulting a doctor. Stopping treatment too early can cause symptoms to return or worsen. Follow the full course of treatment as prescribed.

The most serious side effects include severe allergic reactions (swelling of the face/throat, difficulty breathing), significant behavioral changes (agitation, depression), and liver problems (jaundice). Seek immediate medical attention for these issues.

Levolukast should be used with caution in children with kidney problems, especially severe impairment, as dose adjustments may be needed. It is essential to inform your doctor of your child's complete medical history before starting treatment.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.