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INTRODUCTION

SETIKAST LC TABLET is a combination of Levocetirizine and Montelukast which belongs to the group of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. SETIKAST LC TABLET 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 adults and in adolescents (aged 15 years or above).

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 a red, watery and itchy eyes.

It is usually caused by allergens such as pollens, dusts, 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.

SETIKAST LC TABLET is contraindicated for use in patients having severe kidney impairment. Consult your doctor before use. Avoid consumption of alcohol while taking SETIKAST LC TABLET as it could make you feel drowsier.  

SETIKAST LC TABLET may cause certain unpleasant neuropsychiatric events (such as anxiety, depression, nightmares, hallucinations or even suicidal thoughts) in some individuals. Contact your doctor immediately if you or anyone else experience such events during treatment with SETIKAST LC TABLET.  

The most common side effects of taking SETIKAST LC TABLET are upper respiratory tract infection, fever, cough, inflammation of the pharynx, dryness of mouth, headache and sleepiness. Consult your doctor if any of the side effects worsen.

USES OF SETIKAST LC TABLET

  • Treats and prevents allergic rhinitis, chronic idiopathic urticaria and bronchial asthma in adults and in adolescents (aged 15 years or above)

HOW SETIKAST LC TABLET WORKS

SETIKAST LC TABLET 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

Take SETIKAST LC TABLET as advised by your physician. Swallow SETIKAST LC TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of SETIKAST LC TABLET for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF SETIKAST LC TABLET

COMMON

  • 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, diarrhea, indigestion
  • otitis media (inflammation or infection of the ears)
  • skin rash
  • bleeding from the nose
  • muscle pain, joint pain

UNCOMMON

  • exhausation
  • behaviour and mood related changes
  • agitation including aggressive behaviour or hostility
  • seizures
  • dream abnormalities
  • restlessness
  • drowsiness
  • bruising, itching, hives
  • muscle pain, muscle cramps, weakness
  • feeling unwell, swelling

RARE

  • increased bleeding tendency
  • uncontrolled muscle movements
  • angioedema (swelling underneath the skin)
  • palpitations (fast heartbeat)

Stop giving SETIKAST LC TABLET to your child and contact doctor immediately if your child experiences any of the following side effects:  

  • severe allergic reactions (such as skin rash, itching, swelling of the face, eyelids, mouth, throat and neck and difficulty in breathing or swallowing)
  • systemic eosinophilia (increased levels of WBC in blood)
  • vasculitis or Churg-Strauss syndrome (inflammation of the blood vessels)
  • neuropsychiatric disorders (such as agitation, anxiety, depression, disorientation, hyperactivity, nightmares, hallucinations, insomnia, memory impairment, walking in the sleep, tremor, attention disturbance)
  • thoughts of harming or killing yourself (suicidal ideation)

HOW TO MANAGE SIDE EFFECTS

Diarrhea

Drink lots of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Nausea And Vomiting

Try to take SETIKAST LC TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Stomach Pain

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

PREGNANCY
Use with Caution

SETIKAST LC TABLET should be used with caution during pregnancy only if considered clearly necessary. Consult your doctor before taking SETIKAST LC TABLET.    

BREASTFEEDING
Use with Caution

SETIKAST LC TABLET should be used with caution in breast-feeding. Consult your doctor before taking SETIKAST LC TABLET.   

DRIVING AND USING MACHINES
Use with Caution

Do not drive or operate any machines if you experience sleepiness/drowsiness, fatigue or physical weakness. Consult your doctor before taking SETIKAST LC TABLET.   

ALCOHOL
Consult your doctor

Avoid consumption of alcohol while taking SETIKAST LC TABLET as it could cause reduction in alertness and impairment of performance. Consult your doctor before taking SETIKAST LC TABLET.  

KIDNEY
Consult your doctor

SETIKAST LC TABLET is not recommended for use in patients with severe kidney impairment. It should be taken with extreme caution in patients with kidney disease. Consult your doctor before taking SETIKAST LC TABLET.  

LIVER
Use with Caution

SETIKAST LC TABLET should be taken with caution in patients with liver disease. Consult your doctor before taking SETIKAST LC TABLET.  

ALLERGY
Contraindicated

Do not take SETIKAST LC TABLET if you are allergic to Montelukast or Levocetirizine. Consult your doctor before taking SETIKAST LC TABLET.  

LUNGS
Contraindicated

SETIKAST LC TABLET is not recommended for use in patients with asthma attacks. Consult your doctor before taking SETIKAST LC TABLET. 

USE IN PEDIATRICS
Contraindicated

SETIKAST LC TABLET is strictly not recommended for use in infants and children (aged below 15 years). Consult your child’s doctor for advice.

USE IN GERIATRICS
Use with Caution

SETIKAST LC TABLET should be used with caution in elderly patients (aged 65 years or above). Proper dose titrations and careful monitoring of kidney functions are required in such patients. Consult your doctor before taking SETIKAST LC TABLET.

OTHERS

SETIKAST LC TABLET is not recommended for use if you:

  • have galactose intolerance (inherited condition in which the body cannot convert galactose to glucose)
  • have Lapp lactase deficiency (deficiency of the enzyme lactase in the body)
  • have glucose-galactose malabsorption
  • have phenylketonuria (release of phenylalanine in urine)

Before taking SETIKAST LC TABLET, inform your physician if you:

  • have or at risk of having epilepsy
  • have scheduled allergy skin tests
  • have sensitivity to aspirin or other NSAIDs
  • have any predisposing factors of urinary retention (Ex. spinal cord lesion, prostatic hyperplasia)

INTERACTIONS

A. Drug-Drug interactions:

Before taking SETIKAST LC TABLET, inform your doctor, if you are taking any of the following medicines:

  • gemfibrozil (used to control high blood cholesterol levels)
  • CNS depressants (Ex. phenobarbital), phenytoin (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 you or anyone else take too much of SETIKAST LC TABLET, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of SETIKAST LC TABLET might include stomach pain, thirst, sleepiness, headache, vomiting, hyperactivity, agitation, excitation and restlessness.  

SYNOPSIS

Drug :   Levocetirizine, Montelukast
Pharmacological Category :   H1 receptor antagonist, Leukotriene receptor antagonist
Therapeutic Indication :   Allergic rhinitis, Bronchial asthma, Chronic idiopathic urticaria
Dosage Forms :   Tablet, Capsule, Softgel capsule, Dispersible tablet, Syrup, Suspension

MORE INFORMATION

  • Keep SETIKAST LC TABLET out of reach of children
  • Store SETIKAST LC TABLET at room temperature

FAQs ABOUT SETIKAST LC TABLET

Q: How long does it take for SETIKAST LC TABLET to provide relief from symptoms?

A: Following oral administration with SETIKAST LC TABLET, it is believed to provide relief from the symptoms of allergy and asthma within 30 minutes to an hour. Please note that the onset of action varies from product to product and consult your doctor if you have any queries.

Q: Can SETIKAST LC TABLET be used to treat acute asthma attacks?

A: No, SETIKAST LC TABLET is used only to prevent asthma attacks. SETIKAST LC TABLET should not be used on an asthma attack that has been started already. Contact your doctor or go to the nearby hospital to avoid exacerbation of the attack.   

Q: Can SETIKAST LC TABLET be used in infants?

A: No, SETIKAST LC TABLET is only meant to be used in adults and in adolescents (aged 15 years or above). SETIKAST LC TABLET is strictly not recommended for use in children aged between 6 months to 11 years of age without consulting your doctor.  

Q: Can SETIKAST LC TABLET make you feel sleepy?

A: Yes, SETIKAST LC TABLET may make you feel sleepy or drowsy. Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling sleepy. Avoid alcohol intake, as it could aggravate your existing condition. Consult your doctor if the symptom did not improve.

Q: Is SETIKAST LC TABLET safe to use in patients with kidney problems?

A: SETIKAST LC TABLET is not recommended for use in patients with severe kidney impairment. It should be taken with extreme caution in patients with kidney disease. Consult your doctor before taking SETIKAST LC TABLET.  

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. Gerald G. Briggs and Roger K. Freeman. L & M. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 2219-2220 & 2629-2632.

4. Sheila Jacobs. Montelukast Plus Levocetirizine vs Monotherapy in Asthma, Allergic Rhinitis. Pulmonology adviser. [Revised in October 2018]. [Accessed on 13th October 2021] https://www.pulmonologyadvisor.com/home/meetings/chest-2018/montelukast-plus-levocetirizine-vs-monotherapy-in-asthma-allergic-rhinitis/#:~:text=Perennial%20Allergic%20Rhinitis-,Montelukast%20plus%20levocetirizine%20was%20well%20tolerated%2C%20with%20a%20safety%20profile,perennial%20allergic%20rhinitis%20and%20asthma.

5. S M Adsule, D Misra. Long term treatment with montelukast and levocetirizine combination in persistent allergic rhinitis: review of recent evidence. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. [Revised in June 2010] [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/21121394/

6. Mi-Kyeong Kim, Sook Young Lee, Hae-Sim Park, Ho Joo Yoon, Sang-Ha Kim, Young Joo Cho, Kwang-Ha Yoo, Soo-Keol Lee, Hee-Kyoo Kim, Jung-Won Park, Heung-Woo Park, Jin-Hong Chung, Byoung Whui Choi, Byung-Jae Lee, Yoon-Seok Chang, Eun-Jung Jo, Sang-Yeub Lee, You Sook Cho, Young-Koo Jee, Jong-Myung Lee, Jina Jung, Choon-Sik Park. A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. [Revised in July 2018] [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/29945738/

7. E Nettis, G F Calogiuri, E Di Leo, F Cardinale, L Macchia, A Ferrannini, and A Vacca. Once daily levocetirizine for the treatment of allergic rhinitis and chronic idiopathic urticaria. NCBI; PMC US National Library of Medicine, National Institute of Health. 2009. [Accessed on 13th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3048603/

8. TusharKanti Sarkar. Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial. ResearchGate. Indian Journal of Dermatology, Venereology and Leprology. June 2017. [Accessed on 13th October 2021] https://www.researchgate.net/publication/317945813_Effectiveness_and_safety_of_levocetirizine_10_mg_versus_a_combination_of_levocetirizine_5_mg_and_montelukast_10_mg_in_chronic_urticaria_resistant_to_levocetirizine_5_mg_A_double-blind_randomized_contr

9. Paulina Korczynska-Krawczyk, Iabela Kuprys-Lipiñska, Maciej Kupczyk, Malgorzata Wagrowska-Danilewicz, Janusz Szemraj, Wojciech Bienias, Joanna Narbutt, Janusz Smigielski, and Piotr Kuna. The effect of levocetirizine and montelukast on clinical symptoms, serum level and skin expression of COX-1 and COX-2 enzymes in patients suffering from chronic autoimmune urticaria – a pilot study. NCBI; PMC US National Library of Medicine, National Institute of Health. [Revised in February 2020]. [Accessed on 13th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247068/

10. 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

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

12. Torrent pharmaceuticals Ltd. Lezyncet-M. Torrentian.com. April 2020. [Accessed on 13th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2916.pdf

13. RND Laboratories. Laboratories division. Rnd Kast-L10 Tablets. [Accessed on 13th October 2021] http://www.rndlaboratories.com/laboratories_division.php

14. Viilbery Healthcare Pvt Ltd. Anti-allergic. Alocet M tablet. [Accessed on 13th October 2021] https://viilbery.com/products/anti-allergic/alocet-m-tablet.html#parentVerticalTab2

15. Glenmark Pharmaceuticals s.r.o. Tillomed Laboratories Ltd. And Glenmark Pharmaceuticals Europe Limited. Electronic Medicines Compendium (EMC). [Revised in November 2019] [Accessed on 13th October 2021] https://www.medicines.org.uk/emc/files/pil.9917.pdf

16. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 13th October 2021] https://www.medicines.org.uk/emc/files/pil.1243.pdf

USEFUL DIAGNOSTIC TESTS

  • Complete Blood Count

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 24 Feb 2023 | 10:19 AM(IST)

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PRODUCT DETAILS
    Net Qty
    1 N
    Shelf Life
    720
    Item Weight
    17.5 g
    Ingredient
    Levocetirizine 5 mg+Montelukast 10 mg
    Hsn Code
    30049099
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