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INTRODUCTION
PRULASTIN M SUSPENSION contains Bilastine and Montelukast which belongs to the group of medicines called Histamine antagonists and Leukotriene antagonists, respectively. PRULASTIN M SUSPENSION is used to treat allergic rhinitis (inflammation of nose due to allergens) in children aged 6 to 11 years (weighing at least 20 kg).
PRULASTIN M SUSPENSION is not recommended for use in child allergic to bilastine, and montelukast.
Before administering PRULASTIN M SUSPENSION, inform your doctor if your child has mental health problems, kidney problems (such as moderate/severe renal impairment), and liver problems (such as mild to moderate hepatic insufficiency).
PRULASTIN M SUSPENSION is not recommended for use in pregnant and breastfeeding women since it is used only in children (aged 6 to 11 years). It is also not recommended for use in elderly patients.
The most common side effects of administering PRULASTIN M SUSPENSION are headache, allergic conjunctivitis (eye irritation), stuffy nose, stomach pain, scaly & itchy skin, rash, and/or thirst. Consult your doctor if any of these symptoms becomes worse in the child.
USES OF PRULASTIN M SUSPENSION
Used in pediatric patients:
- To treat allergic rhinitis in children aged 6 to 11 years
HOW PRULASTIN M SUSPENSION WORKS
PRULASTIN M SUSPENSION provides relief from allergic rhinitis where bilastine works by blocking histamine (chemical messenger responsible for allergy) thus preventing the occurrence of allergic symptoms and montelukast works by inhibiting the action of leukotrienes (chemical responsible for inflammatory reaction) thus preventing its occurrence and providing relief from associated symptoms of allergic rhinitis in affected children.
DIRECTIONS FOR USE
Administer PRULASTIN M SUSPENSION in child as directed by your physician. Shake well before use. Your doctor will decide the correct dose and duration for your child depending upon the age, body weight and disease condition.
SIDE EFFECTS OF PRULASTIN M SUSPENSION
COMMON
- headache
- allergic conjunctivitis (eye irritation)
- stuffy nose
- stomach pain
- hyperactivity
- scaly and itchy skin, rash
- thirst
UNCOMMON
- dizziness, tiredness, loss of consciousness
- diarrhoea, nausea, lip swelling
- skin inflammation, red itchy welts
- signs of allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing
- behaviour- and mood-related changes such as agitation, aggressive behaviour/hostility, depression
- seizure
RARE
Stop administering PRULASTIN M SUSPENSION and contact your doctor immediately if your child experiences any of the following:
- signs of allergic reactions such as swelling of the face, lips, tongue/throat, difficulty in breathing, dizziness, loss of consciousness, and/or redness of the skin
- change in behaviour/suicidal thoughts
HOW TO MANAGE SIDE EFFECTS
Headache:
If PRULASTIN M SUSPENSION causes headache in child, then ask the child to take rest and drink plenty of fluids. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking PRULASTIN M SUSPENSION. If it lasts more than a week or severe, inform your doctor.
Dizziness:
Ask your child to take rest and get enough sleep. Provide the child with a glass of fruit juice or water to improve dizziness. Consult your doctor if the symptom does not improve or becomes worse.
Diarrhoea:
Ask the child to drink lots of fluids such as water or fruit juices so that the child is sufficiently hydrated. Do not administer any medicine to treat the condition. Consult your doctor if the symptom does not improve or becomes worse.
Nausea:
Have the child take this medicine with or just after a meal or a snack. Let the child stick to simple meals and avoid having rich or spicy food.
WARNING & PRECAUTIONS
PREGNANCY
PRULASTIN M SUSPENSION is not recommended to take during pregnancy as it is intended to be used only in children.
BREASTFEEDING
PRULASTIN M SUSPENSION is not recommended for use in breast feeding women as it is intended to be used only in children.
KIDNEY
PRULASTIN M SUSPENSION should be used with caution in children with kidney problems (such as renal impairment) since safety and efficacy of the medicine is not established. Consult your doctor before administering the medicine to the child.
LIVER
PRULASTIN M SUSPENSION should be used with caution in children with liver problems (such as hepatic impairment) since safety and efficacy of the medicine is not established. Consult your doctor before administering the medicine to the child.
ALLERGY
Do not administer PRULASTIN M SUSPENSION if the child is allergic to Bilastine, Montelukast, and/or any other ingredients of this medicine.
LUNGS
PRULASTIN M SUSPENSION is not recommended for use in patients with lung problems such as acute asthma attacks. Consult your doctor before administering the medicine to the child.
OTHERS
Before administering PRULASTIN M SUSPENSION, inform your doctor if the child has:
- mental health problems
Use in Paediatrics:
PRULASTIN M SUSPENSION is not recommended to use in children below 6 years of age. Consult your doctor before administering the medicine to the child.
Use in Geriatrics:
PRULASTIN M SUSPENSION is not recommended for use in elderly patients as it is intended to be used only in children.
INTERACTIONS
A. Drug–drug interactions:
Before giving PRULASTIN M SUSPENSION to your child, inform your doctor if your child is taking any of the following medicines
- ketoconazole (medicine used to treat fungal infection)
- erythromycin (medicine used to treat bacterial infection)
- diltiazem (medicine used to treat heart diseases)
- lorazepam (medicine used to treat anxiety)
- cyclosporine (medicine used to treat transplanted organ rejection or reduce immune system activity)
- ritonavir (medicine used to treat HIV)
- phenobarbital, phenytoin (medicine used to treat epilepsy)
- rifampicin (medicine used to treat tuberculosis)
- gemfibrozil (medicine used to treat high levels of plasma lipid levels)
- terfenadine (medicine used to treat allergies)
- digoxin (medicine used to treat heart failure)
- warfarin (medicine used to prevent blood clotting)
- paclitaxel (used to treat breast cancer, ovarian cancer, non-small cell lung cancer)
- rosiglitazone, repaglinide (medicines used to treat type 2 diabetes mellitus)
- trimethoprim (medicine used to treat bladder infections)
- non-steroidal anti-inflammatory drugs (medicines used to treat pain and inflammation) Ex. aspirin
B. Drug–Food interactions:
Do not provide grapefruit juice/other fruit juices to your child while administering PRULASTIN M SUSPENSION since it may reduce the effect of the medicine.
Overdosage:
If child is administered too much of PRULASTIN M SUSPENSION, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are dizziness, headache, nausea, abdominal pain, excess sleepiness, thirst, vomiting, and mood disorders.
SYNOPSIS
| Drug | : | Bilastine, Montelukast |
| Pharmacological Category | : | Histamine antagonist, Leukotriene antagonist |
| Therapeutic Indication | : | Allergic rhinitis in children (aged 6-11 years) |
| Dosage Forms | : | Tablet, Suspension |
MORE INFORMATION
- Keep PRULASTIN M SUSPENSION out of reach of children.
- Do not store PRULASTIN M SUSPENSION above 30°C
FAQs ABOUT PRULASTIN M SUSPENSION
What is PRULASTIN M SUSPENSION used for?
PRULASTIN M SUSPENSION is used to treat allergic rhinitis in children aged 6 to 11 years which is an allergic response that occurs due to contact with an allergen such as pollen, pet hair, and/or insects. It is generally characterized by symptoms such as runny nose, sneezing, watery eyes, and/or itching in eyes.
How PRULASTIN M SUSPENSION works?
PRULASTIN M SUSPENSION provides relief from allergic rhinitis where bilastine works by blocking histamine (chemical messenger responsible for allergy) thus preventing the occurrence of allergic symptoms and montelukast works by inhibiting the action of leukotrienes (chemical responsible for inflammatory reaction) thus preventing its occurrence and providing relief from associated symptoms of allergic rhinitis in affected children.
How to administer PRULASTIN M SUSPENSION in child?
Administer PRULASTIN M SUSPENSION in child as directed by your physician. Shake well before use. Your doctor will decide the correct dose and duration for your child depending upon the age, body weight and disease condition.
What are the side effects of PRULASTIN M SUSPENSION?
The most common side effects of administering PRULASTIN M SUSPENSION are headache, allergic conjunctivitis (eye irritation), stuffy nose, stomach pain, scaly & itchy skin, rash, and/or thirst. Consult your doctor if any of these symptoms becomes worse in the child.
What happens to the child if a high dose of [ GBNKEYWORD] is administered?
If child is administered too much of PRULASTIN M SUSPENSION, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are dizziness, headache, nausea, abdominal pain, excess sleepiness, thirst, vomiting, and mood disorders.
REFERENCES
1. Sidhartha D. Ray. Antihistamines (H1 receptor antagonists). Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions: Volume 43. First edition. 2021. Page 190.
2. KD. Tripathi. Drugs For Cough and Bronchial Asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page 228.
3. Ciplamed. BILAFAV M Suspension. [Revised in March 2022] [Accessed on 1st November 2022] https://ciplamed.com/content/bilafav-m-suspension
USEFUL DIAGNOSTIC TESTS
- Skin prick test
- Immunoglobulin E (IgE) antibody test
AUTHOR DETAILS
Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 07 Nov 2022 | 01:56 PM(IST)
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