Specification

INTRODUCTION
MONTE L TABLET is a combination of Levocetirizine and Montelukast which belongs to theroup of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. MONTE L 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.
MONTE L TABLET is contraindicated for use in patients having severe kidney impairment. Consult your doctor before use. Avoid consumption of alcohol while taking MONTE L TABLET as it could make you feel drowsier.
MONTE L 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 MONTE L TABLET.
The most common side effects of taking MONTE L 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 MONTE L TABLET

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

HOW MONTE L TABLET WORKS
MONTE L 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 MONTE L TABLET as advised by your physician. Swallow MONTE L TABLET with alass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of MONTE L TABLET for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF MONTE L 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, diarrhoea, indigestion

Otitis media (inflammation or infection of the ears)

Skin rash

Bleeding from the nose

Muscle pain, joint pain

UNCOMMON

Exhaustion

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)
Stopiving MONTE L 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 the 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 sleep, tremor, attention disturbance)

Thoughts of harming or killing yourself (suicidal ideation)

HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Try to take MONTE L 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.
Diarrhoea:
Drink lots of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own to treat diarrhoea. 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.
Dizziness:
Try to rest and relax.et 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.
Stomach pain:
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heating pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS

PREGNANCY
MONTE L TABLET should be used with caution during pregnancy only if considered clearly necessary. Consult your doctor before taking MONTE L TABLET.
BREASTFEEDING
MONTE L TABLET should be used with caution in breast-feeding. Consult your doctor before taking MONTE L TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience sleepiness/drowsiness, fatigue or physical weakness. Consult your doctor before taking MONTE L TABLET.
ALCOHOL
Avoid consumption of alcohol while taking MONTE L TABLET as it could cause a reduction in alertness and impairment of performance. Consult your doctor before taking MONTE L TABLET.
KIDNEY
MONTE L 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 MONTE L TABLET.
LUNGS
MONTE L TABLET is not recommended for use in patients with asthma attacks. Consult your doctor before taking MONTE L TABLET.
OTHERS
MONTE L TABLET is not recommended for use if you:
Havealactose intolerance (inherited condition in which the body cannot convertalactose tolucose)

Have Lapp lactase deficiency (deficiency of the enzyme lactase in the body)

Havelucose-galactose malabsorption

Have phenylketonuria (release of phenylalanine in urine)
Before taking MONTE L 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)
Use in pediatrics:
MONTE L TABLET is strictly not recommended for use in infants and children (aged below 15 years). Consult your child?s doctor for advice.
Use ineriatrics:
MONTE L 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 MONTE L TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking MONTE L 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 MONTE L TABLET, contact your doctor immediately oro to a hospital straight away. Overdosage symptoms of MONTE L 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, Dispersible Tablet, Oral Solution, Syrup, Suspension

MORE INFORMATION

Keep MONTE L TABLET out of reach of children

Store MONTE L TABLET at room temperature

FAQs ABOUT MONTE L TABLET
How long does it take for MONTE L TABLET to provide relief from symptoms?
Following oral administration with MONTE L 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.
Can MONTE L TABLET be used to treat acute asthma attacks?
No, MONTE L TABLET is used only to prevent asthma attacks. MONTE L TABLET should not be used on an asthma attack that has been started already. Contact your doctor oro to the nearby hospital to avoid exacerbation of the attack.
Can MONTE L TABLET be used in infants?
No, MONTE L TABLET is only meant to be used in adults and in adolescents (aged 15 years or above). MONTE L TABLET is strictly not recommended for use in children aged between 6 months to 11 years of age without consulting your doctor.
Can MONTE L TABLET make you feel sleepy?
Yes, MONTE L TABLET may make you feel sleepy or drowsy. Try to rest and relax.et 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.
Is MONTE L TABLET safe to use in patients with kidney problems?
MONTE L 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 MONTE L 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. Erdos. Histamine, Bradykinin, and their antagonists.oodman &ilman?s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page ? 918-923 & 1052-1054.
3.erald. Briggs and Roger K. Freeman. L & M. A referenceuide 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 Allergic Rhinitis-,Montelukast plus levocetirizine was well tolerated, with a safety profile,perennial allergic rhinitis and asthma.
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-Lipi?ska,?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.lenmark Pharmaceuticals s.r.o. Tillomed Laboratories Ltd. Andlenmark 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
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USEFUL DIAGNOSTIC TESTS

Complete Blood Count

VIDEOS

Levocetirizine Montelukast TABLET ? Drug Information
Levocetirizine Montelukast TABLET : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage
PRODUCT DETAILS

Net Qty

1 N

Item Weight

17.5

Ingredient

LEVOCETIRIZINE 5MG MONTELUKAST 10MG

Hsn Code

30049099

Show more

Additional information

Weight
17.5 g

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