LEVOKAST 4/2.5MG SUSPENSION is a combination of Levocetirizine and Montelukast which belongs to the group of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. LEVOKAST 4/2.5MG SUSPENSION is indicated for the treatment and prevention of allergic rhinitis, chronic idiopathic urticaria (allergic skin reaction with red raised itchy bumps on skin) and bronchial asthma in children aged between 2-5 years.
Allergic rhinitis (also known as hay fever) is a heterogeneous disorder characterized by inflammation of the inner lining of nose accompanied by nasal decongestion, repeated sneezing, wheezing or red, watery and itchy eyes.
It is usually caused by allergens such as pollens, dust, mould or flakes of skin from certain animals and can occur seasonally or year-round. Bronchial asthma is a long-term medical condition in which the path of the airways becomes inflamed, narrow and swollen. Symptoms include coughing, wheezing and chest tightness.
LEVOKAST 4/2.5MG SUSPENSION is contraindicated for use in children with severe kidney impairment. Consult your pediatrician before using LEVOKAST 4/2.5MG SUSPENSION.
LEVOKAST 4/2.5MG SUSPENSION may cause certain unpleasant neuropsychiatric events (such as behaviour and mood-related changes: agitation including aggressive behaviour or hostility, depression) in some children and so parents or caregivers should immediately consult your child’s doctor if you notice any unusual behaviour in your child.
The most common side effects of taking LEVOKAST 4/2.5MG SUSPENSION are upper respiratory tract infection, fever, cough, inflammation of the pharynx, dryness of mouth, headache and sleepiness. Consult your child’s doctor if any of the side effects worsen.
USES OF LEVOKAST 4/2.5MG SUSPENSION
- Treats and prevents allergic rhinitis, chronic idiopathic urticaria and bronchial asthma in children aged between 2-5 years
HOW LEVOKAST 4/2.5MG SUSPENSION WORKS
LEVOKAST 4/2.5MG SUSPENSION provides relief from the symptoms of allergic rhinitis, asthma and urticaria where levocetirizine acts by blocking the actions of histamines (a substance that causes an allergic reaction), at the H1 receptors present on the surface of cells and montelukast acts by blocking the action of leukotrienes D4 (an inflammatory molecule causing narrowing and swelling of the airways) in the lungs, thus causing relaxation of smooth muscle, reduction in swelling and/or inflammation of the airways and a marked decrease in the onset of allergic reactions.
DIRECTIONS FOR USE
Give LEVOKAST 4/2.5MG SUSPENSION to your child as advised by the physician. Shake well before use. Use a measuring cup to properly measure the dose. Your child’s doctor will decide the correct dose and duration of LEVOKAST 4/2.5MG SUSPENSION for your child depending upon the child’s age, body weight and disease condition.
SIDE EFFECTS OF LEVOKAST 4/2.5MG SUSPENSION
- Sinusitis (inflammation of the nasal passage)
- Rhinorrhea (thin mucus discharge from nose)
- Upper respiratory infection
- Cough, cold, fever or flu-like symptoms
- Pharyngitis (inflammation of the pharynx)
- Headache and tiredness
- Dizziness, sleepiness
- Nausea, vomiting, dry mouth, thirst, stomach pain, diarrhoea, indigestion
- Otitis media (inflammation or infection of the ears)
- Skin rash, eczema, urticaria (itching)
- Myopia or conjunctivitis (eye problems)
- Varicella infection
- Bleeding from the nose
- Muscle pain, joint pain
- Behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
- Drowsiness, tingling, prickling and numbness sensation usually in hands or legs
- Bruising, itching, hives
- Muscle cramps
- Bedwetting in children
- Weakness, feeling unwell, swelling
- Behaviour and mood-related changes: disturbance in attention, memory impairment
- Uncontrolled muscle movements
Stop giving LEVOKAST 4/2.5MG SUSPENSION to your child and contact the doctor immediately if your child experiences any of the following side effects:
- Allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
- Behaviour and mood-related changes: agitation including aggressive behaviour or hostility, depression
- Increased bleeding tendency
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Follow a simple meal plan for your child while administering LEVOKAST 4/2.5MG SUSPENSION. Avoid giving foods that are oily, fried or spicy foods. Do not let your child to lie down or sleep immediately after eating. Consult the child’s doctor if the symptom does not improve.
Advise your child to drink plenty of water and stay hydrated. Avoid giving your child a high-fat diet or spicy foods. Try to avoid giving any medicine on your own to your child to treat diarrhoea. Consult the child’s doctor if the symptom gets worse.
Advise your child to rest and relax. Tell your child to eat and drink slowly or try to have lesser and more frequent meals. Keep a heating pad on the child’s stomach to relieve pain. Consult the child’s doctor if the symptom gets worse.
Apply a hot or cold-water bag on your child’s head. Advise your child to take a rest in a quiet room. Massage the child’s scalp or head with mild pressure for relieving effect. Consult the child’s doctor if the symptom does not improve.
Avoid hot showers because hot water can irritate your child’s skin further. Tell your child not to scratch the affected area. Use protective clothing for your child when going outdoors. Regularly moisturize your child’s skin. Consult your child’s doctor if the symptom did not improve.
WARNING & PRECAUTIONS
LEVOKAST 4/2.5MG SUSPENSION is not recommended for use in pregnant women as it is used only in children. Consult your doctor for advice.
LEVOKAST 4/2.5MG SUSPENSION is not recommended for use in breastfeeding women as it is used only in children. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not let your child drive their play cycle in outdoors or make them travel along with you for long hours, because this medicine may cause somnolence, sleepiness, tiredness or dizziness in them.
LEVOKAST 4/2.5MG SUSPENSION is not recommended for use in children with severe impairment of kidney function and should be used with caution in children with impaired kidney function. Consult your child’s doctor for advice before administration of LEVOKAST 4/2.5MG SUSPENSION to your child.
LEVOKAST 4/2.5MG SUSPENSION should be taken with caution in children with liver disease. Consult your child’s doctor for advice before administration of LEVOKAST 4/2.5MG SUSPENSION to your child.
Talk to your child’s doctor if your child is allergic to Montelukast, Levocetirizine or Cetirizine or other ingredients of LEVOKAST 4/2.5MG SUSPENSION.
LEVOKAST 4/2.5MG SUSPENSION is not recommended for use in children with acute asthma attacks including status asthmaticus. Consult your child’s doctor for advice before administration of LEVOKAST 4/2.5MG SUSPENSION to your child.
LEVOKAST 4/2.5MG SUSPENSION is not recommended for use if your child:
- Has galactose intolerance (an inherited condition in which the body cannot convert galactose to glucose)
- Has Lapp lactase deficiency (deficiency of the enzyme lactase in the body)
- Has glucose-galactose malabsorption
- Has phenylketonuria (release of phenylalanine in urine)
Before giving LEVOKAST 4/2.5MG SUSPENSION to your child, inform the child’s doctor if your child:
- Has epilepsy
- Has sensitivity to aspirin or other NSAIDs
- Has schedule for allergy skin tests
- Has any predisposing factors of urinary retention (Ex. spinal cord lesion, prostatic hyperplasia)
Use in pediatrics:
LEVOKAST 4/2.5MG SUSPENSION is strictly not recommended for use in children aged below 2 years of age. Consult your child’s doctor for advice.
Use in geriatrics:
LEVOKAST 4/2.5MG SUSPENSION is not recommended for use in elderly patients as it is used only in children. Consult your doctor for advice.
A. Drug-Drug interactions:
Before giving LEVOKAST 4/2.5MG SUSPENSION to your child, inform to child’s doctor if your child is taking or receiving any of the following medicines:
- Gemfibrozil (used to control high blood cholesterol levels)
- Phenytoin, phenobarbital (used to treat epilepsy)
- Rifampicin (used to treat tuberculosis)
- Ritonavir (a medicine used to treat viral infections)
- Theophylline (a medicine used to treat asthma)
- Alcohol-containing medicines (Ex. antitussives)
If your child or anyone else accidentally takes too much of LEVOKAST 4/2.5MG SUSPENSION, consult your child’s doctor immediately or visit the nearby hospital. Overdosage symptoms of LEVOKAST 4/2.5MG SUSPENSION might include stomach pain, thirst, sleepiness, headache, vomiting, psychomotor hyperactivity, agitation and restlessness.
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