INTRODUCTION

AROKAST L SYRUP is a combination of Levocetirizine and Montelukast which belongs to the group of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. AROKAST L SYRUP is indicated for the treatment and prevention of allergic rhinitis, chronic idiopathic urticaria (allergic skin reaction with red raised itchy bumps on the skin) and bronchial asthma in children aged between 6-14 years.           

Allergic rhinitis (also known as hay fever) is a heterogeneous disorder characterized by inflammation of the inner lining of the 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 skin flakes 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.    

AROKAST L SYRUP is contraindicated for use in children having severe kidney impairment. Consult your child’s doctor before using AROKAST L SYRUP.       

AROKAST L SYRUP may cause certain unpleasant neuropsychiatric events (such as behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression) in some children. Consult your child’s doctor immediately if your child experiences any such events during treatment with AROKAST L SYRUP.

The most common side effects of taking AROKAST L SYRUP 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 AROKAST L SYRUP

• Treats and prevents allergic rhinitis, chronic idiopathic urticaria and bronchial asthma in children aged between 6-14 years

HOW AROKAST L SYRUP WORKS

AROKAST L SYRUP provides relief from the symptoms of allergic rhinitis, asthma and urticaria where levocetirizine acts by blocking the actions of histamines (a substance that cause 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 AROKAST L SYRUP 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 AROKAST L SYRUP for your child depending upon child’s age, body weight and disease condition.

SIDE EFFECTS OF AROKAST L SYRUP

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Follow simple meal plan for your child while administering AROKAST L SYRUP. Avoid giving foods that are oily, fried or spicy foods. Do not let your child to lie down or sleep immediately after eating. Consult child’s doctor if the symptom does not improve.         

Diarrhea:

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 diarrhea. Consult child’s doctor if the symptom gets worse.    

Stomach pain:

Advice 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 heat pad on child’s stomach to relieve pain. Consult child’s doctor if the symptom gets worse. 

Headache:

Apply hot or cold-water bag on your child’s head. Advise your child to take rest in a quiet room. Massage child’s scalp or head with mild pressure for relieving effect. Consult child’s doctor if the symptom does not improve.       

Skin rash:

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

PREGNANCY

AROKAST L SYRUP is not recommended for use in pregnant women as it is used only in children. Consult your doctor for advice.   

BREASTFEEDING

AROKAST L SYRUP is not recommended for use in breast-feeding women as it is used only in children. Consult your doctor for advice.     

DRIVING AND USING MACHINES

Do not let your child ride bicycles or drive other vehicles or operate any tools if your child experiences dizziness, headache or somnolence. Consult your child’s doctor for advice before administration of AROKAST L SYRUP to your child.

KIDNEY

AROKAST L SYRUP 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 AROKAST L SYRUP to your child.       

LIVER

AROKAST L SYRUP should be taken with caution in children with liver disease. Consult your child’s doctor for advice before administration of AROKAST L SYRUP to your child.

ALLERGY

Talk to your child’s doctor if your child is allergic to Montelukast, Levocetirizine or Cetirizine or other ingredients of AROKAST L SYRUP.

LUNGS

AROKAST L SYRUP is not recommended for use in children with acute asthma attacks including status asthmaticus. Consult your child’s doctor for advice before administration of AROKAST L SYRUP to your child.

INTERACTIONS

A. Drug-Drug interactions:

Before giving AROKAST L SYRUP 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)

Overdosage:

If your child or anyone else accidentally takes too much of AROKAST L SYRUP, consult your child’s doctor immediately or visit the nearby hospital. Overdosage symptoms of AROKAST L SYRUP might include stomach pain, thirst, sleepiness, headache, vomiting, psychomotor hyperactivity, agitation and restlessness.

SYNOPSIS

MORE INFORMATION

• Keep AROKAST L SYRUP out of reach of children
• Store AROKAST L SYRUP at room temperature

FAQs ABOUT AROKAST L SYRUP

Can AROKAST L SYRUP be used to treat acute asthmatic attacks in children?   

No, AROKAST L SYRUP is used only to prevent asthma attacks. AROKAST L SYRUP should not be used on an asthma attack that has been started already. Contact child’s doctor or go to the nearby hospital to avoid exacerbation of the attack.           

Can AROKAST L SYRUP be used in infants?       

No, AROKAST L SYRUP is only meant to be used in children aged between 6-14 years. AROKAST L SYRUP is strictly not recommended for use in children aged below 6 years without consulting your child’s doctor.   

Can AROKAST L SYRUP make my child feel sleepy?   

Yes, AROKAST L SYRUP can cause sleepiness or drowsiness in some children, although not everybody gets them. This is quite normal and does not need to worry about it. Avoid unnecessary distractions in children and try to make them stay relaxed. Avoid taking them outdoors unnecessarily. Avoid giving them concomitant medicines that can make them drowsier like cough syrups or sedatives. If the symptom does not improve or worsens contact your child’s doctor.    

Can AROKAST L SYRUP make my child hyperactive?

Yes, AROKAST L SYRUP can cause certain neuropsychiatric events like behaviour and mood-related changes: agitation including aggressive behaviour or hostility, depression in some children, although not everybody gets them. Consult your child’s doctor immediately if you notice any unusual behaviour in your child during treatment with AROKAST L SYRUP. 

Is AROKAST L SYRUP safe to use in children with kidney problems?

AROKAST L SYRUP 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 AROKAST L SYRUP to your child.   

How to administer AROKAST L SYRUP to my child?

Give AROKAST L SYRUP 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 AROKAST L SYRUP for your child depending upon child’s age, body weight and disease condition.

REFERENCES

1. KD. Tripathi. Histamines and Antihistamines & Drugs for cough and bronchial asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page – 166-168 & 228-229.

2. Peter J. Barnes. Pulmonary pharmacology. Randal A. Skidgel, Allen P. Kaplan and Ervin G. Erdos. Histamine, Bradykinin, and their antagonists. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 918-923 & 1052-1054.

3. B Knorr, P Larson, H H Nguyen, S Holland, T F Reiss, P Chervinsky, K Blake, C H van Nispen, G Noonan, A Freeman, R Haesen, N Michiels, J D Rogers, R D Amin, J Zhao, X Xu, B C Seidenberg, B J Gertz, S Spielberg. Montelukast dose selection in 6- to 14-year-olds: comparison of single-dose pharmacokinetics in children and adults. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. August 1999. [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/10434229/

4. Gary M Doherty. Is montelukast effective and well tolerated in the management of asthma in young children? Part A: Evidence-based answer and summary. NCBI; PMC US National Library of Medicine, National Institute of Health. April 2007. [Accessed on 13th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528689/

5. Maciej Ciebiada, Malgorzata Gorska-Ciebiada, Lawrence M DuBuske, Pawel Gorski. Montelukast with desloratadine or levocetirizine for the treatment of persistent allergic rhinitis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 2006. [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/17165277/

6. A N Pampura, N G Papadopoulos, V Spicák, R Kurzawa. Evidence for clinical safety, efficacy, and parent and physician perceptions of levocetirizine for the treatment of children with allergic disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2011. [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/21346367/

7. F Estelle R Simons. Early Prevention of Asthma in Atopic Children (EPAAC) Study Group. Safety of levocetirizine treatment in young atopic children: an 18-month study. ResearchGate. October 2007. [Accessed on 13th October 2021] https://www.researchgate.net/publication/6274909_Early_Prevention_of_Asthma_in_Atopic_Children_EPAAC_Study_Group_Safety_of_levocetirizine_treatment_in_young_atopic_children_an_18-month_study

8. RND Laboratories. Laboratories division. Rnd Kast-L5 Syrup. [Accessed on 13th October 2021] http://www.rndlaboratories.com/laboratories_division.php

9. Cipla Ltd. Montair LC & Montair LC Kid DT / Syrup (Montelukast sodium + Levocetirizine dihydrochloride). Ciplamed.com. [Revised in December 2020]. [Accessed on 13th October 2021] https://www.ciplamed.com/content/montair-lc-montair-lc-kid-dt-syrup

10. Cipla Ltd. Rid-AR Tablets & Rid-AR Kid DT/Syrup (Montelukast sodium + Levocetirizine dihydrochloride). Ciplamed.com. [Revised in November 2013]. [Accessed on 13th October 2021] https://www.ciplamed.com/content/rid-ar-tablets-rid-ar-kid-dtsyrup

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 09 Dec 2022 | 09:35 AM(IST)