INTRODUCTION

VITARESP FX SUSPENSION is a combination of Fexofenadine and Montelukast which belongs to the group of medicines called Histamine H1 receptor blockers and Leukotriene receptor antagonists respectively. VITARESP FX SUSPENSION is indicated for the treatment of allergic rhinitis in children (aged between 2-11 years).

Allergic rhinitis is a heterogeneous disorder caused by allergens such as pollens, dusts, mold or flakes of skin from certain animals. It can occur seasonally or year-round and characterized by inflammation of the inner lining of nose accompanied by nasal decongestion, repeated sneezing, or a red, watery and itchy eyes.

VITARESP FX SUSPENSION is also used to treat asthma (narrowing of airways causing difficulty in breathing) and uncomplicated skin reactions of chronic idiopathic urticaria (an allergic reaction with itchy raised bumps on skin) in children aged between 6 months to 11 years of age.

VITARESP FX SUSPENSION is not recommended for use in infants (aged less than 6 months) due to lack of safety and effectiveness. It should not be used as an alternative to treat acute asthma attacks.

Before administering VITARESP FX SUSPENSION to your child, inform child’s doctor if your child has any lung, heart, liver or kidney problems.

The most common side effects of VITARESP FX SUSPENSION are dizziness, drowsiness, headache, nausea, vomiting and diarrhea. Consult your child’s doctor if any of the side effects worsens.

USES OF VITARESP FX SUSPENSION

Treats allergic rhinitis in children (aged between 2-11 years)
Treats asthma in children (aged between 6 months to 11 years)
Treats chronic idiopathic urticaria (hives) in children (aged between 6 months to 11 years)

HOW VITARESP FX SUSPENSION WORKS

VITARESP FX SUSPENSION reduces the unpleasant symptoms of allergic rhinitis, asthma and hives where fexofenadine acts by antagonizing the effects of histamine (a substance that cause allergic reaction) on the surface of cells and montelukast acts by blocking the leukotriene receptor, thus leading to bronchodilatation, decrease in swelling and inflammation of airways and a marked reduction in allergic skin reactions.

DIRECTIONS FOR USE

Give VITARESP FX 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 VITARESP FX SUSPENSION for your child depending upon the age, body weight and disease condition.

SIDE EFFECTS OF VITARESP FX SUSPENSION

COMMON

headache
drowsiness or dizziness
nausea and vomiting
diarrhea
infections of upper respiratory tract
skin rashes
fever

UNCOMMON

tiredness or sleepiness
behavior and mood related changes (irritability, dream abnormalities, including nightmares, trouble sleeping, sleepwalking, anxious, restlessness)
tingling, prickling or numbness sensation
nosebleed
indigestion, dry mouth
bruising, itching
muscle cramps, joint or muscle pain
bedwetting in children
weakness, feeling unwell, swelling

RARE

bleeding
attention disturbance and memory impairment

Stop giving VITARESP FX SUSPENSION to your child and contact child’s doctor immediately if your child experiences any of the following side effects:

severe allergic reactions (such as swelling of the face, lips, tongue and/or throat, difficulty in breathing or swallowing, mood changes, agitation, aggressive behavior or hostility, depression, seizure)
increased bleeding tendency, tremor (shaking), palpitations (fast heartrate)
flu-like symptoms, numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss Syndrome)
decreased blood platelet count (signs include easy bleeding or bruising)
inflammation (swelling) of the lungs
neuropsychiatric changes (such as disorientation, hallucinations)
thoughts of harming or killing yourself (suicidal ideation)
erythema multiforme (a severe skin reactions)

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

In case of nausea or vomiting, give VITARESP FX SUSPENSION with or just after meals to your child. Avoid giving them rich-spicy foods and make them eat only simple meals. Consult your pediatrician if the symptom did not improve.

Diarrhoea:

Keep your child stay hydrated by giving them lot of fluids such as water, fruit juices or electrolytes. Avoid using any medicine on your own to treat diarrhea. Consult your pediatrician if the symptom did not improve.

Skin rash:

Avoid hot showers because hot water can irritate your child’s skin further. Tell your child not scratch the affected area. Use protective clothing when going outdoors. Consult your pediatrician if the symptom did not improve.

Dizziness or Drowsiness:

Make your child sleep or lie down until dizziness or drowsiness passes away, then make your child move slowly and carefully. Consult your pediatrician if the symptom did not improve.

WARNING & PRECAUTIONS

PREGNANCY

VITARESP FX SUSPENSION is intended for use only in pediatrics and therefore not recommended for use in pregnant women.

BREASTFEEDING

VITARESP FX SUSPENSION is intended for use only in pediatrics and therefore not recommended for use in breastfeeding women.

KIDNEY

VITARESP FX SUSPENSION should be used with caution in children with decreased kidney function. Treatment will be initiated at the lowest effective dose depending upon kidney function. Consult pediatrician for advice before giving VITARESP FX SUSPENSION to your child.

LIVER

VITARESP FX SUSPENSION should be used with caution in children with liver problems. Consult pediatrician for advice before giving VITARESP FX SUSPENSION to your child.

ALLERGY

Talk to your child’s doctor if your child is allergic to Fexofenadine or Montelukast.

LUNGS

VITARESP FX SUSPENSION should not be used as a substitute to treat acute asthma attacks. It should also be used with caution in children having other respiratory diseases. Consult pediatrician for advice before giving VITARESP FX SUSPENSION to your child.

HEART DISEASE

VITARESP FX SUSPENSION should be used with caution in children with history or recent heart disease since it may increase the risk of fast or irregular heartbeat. Consult pediatrician for advice before giving VITARESP FX SUSPENSION to your child.

OTHERS

Use in pediatrics:

VITARESP FX SUSPENSION is not recommended for use in infants less than 6 months of age due to lack of safety and effectiveness. Consult your child’s doctor for advice.

Use in geriatrics:

VITARESP FX SUSPENSION is intended for use only in pediatrics and therefore not recommended for use in elderly patients.

INTERACTIONS

A. Drug-Drug interactions:

Before giving VITARESP FX SUSPENSION to your child, inform to child’s doctor if your child is taking or receiving any of these medicines:

antacids (used to reduce stomach acids) e.g., aluminium or magnesium hydroxide
phenytoin or phenobarbital (used to control seizure)
rifampicin (used to treat tuberculosis)
ketoconazole (used to treat fungal infections)
erythromycin (used to treat bacterial infections)

B. Drug-Food interactions:

While giving VITARESP FX SUSPENSION to your child avoid giving it together with fruit juices such as grapefruit, orange and apple as it may reduce the bioavailability and decrease the effect of this medicine.

Overdosage:

If your child or anyone else accidentally takes too much of VITARESP FX SUSPENSION, consult your child’s doctor or visit the nearby hospital immediately. Overdosage may cause undesirable effects such as dizziness, drowsiness and dry mouth.

SYNOPSIS

Drug	:	Fexofenadine, Montelukast
Pharmacological Category	:	Histamine H1 receptor blocker, Leukotriene receptor antagonists
Therapeutic Indication	:	Allergic rhinitis, Asthma, Chronic idiopathic urticaria
Dosage Forms	:	Tablet, Dispersible tablet, Chewable tablet, Syrup, Suspension

MORE INFORMATION

Keep VITARESP FX SUSPENSION out of reach of children
Store at room temperature

FAQs ABOUT VITARESP FX SUSPENSION

What is VITARESP FX SUSPENSION used to treat?

VITARESP FX SUSPENSION is indicated for the treatment of allergic rhinitis in children (aged between 2-11 years). Also, it is used to treat asthma (narrowing of airways causing difficulty in breathing) and uncomplicated skin reactions of chronic idiopathic urticaria (an allergic reaction with itchy raised bumps on skin) in children aged between 6 months to 11 years of age.

What are the symptoms of overdose of VITARESP FX SUSPENSION?

Always give the dose to your child that is prescribed by the doctor. However, if your child accidently takes too much of VITARESP FX SUSPENSION, consult pediatrician or seek immediate medical attention. Symptoms of overdose can include dizziness, drowsiness and dry mouth.

Can VITARESP FX SUSPENSION make your child feel sleepy?

Yes, VITARESP FX SUSPENSION may make your child feel sleepy or drowsy. Let your child gets enough sleep. If it impairs ability of your child to concentrate in daily essential activities. Consult pediatrician immediately for advice.

Can VITARESP FX SUSPENSION be given together with phenytoin to your child?

No, avoid concomitant use of VITARESP FX SUSPENSION with antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital because it may increase the risk of side effects. Consult pediatrician for advice before giving VITARESP FX SUSPENSION to your child.

Is VITARESP FX SUSPENSION safe to use in children with kidney problems?

VITARESP FX SUSPENSION should be used with caution in children with decreased kidney function. Usually, treatment will be initiated at the lowest effective dose depending upon kidney function. Consult pediatrician for advice before giving VITARESP FX SUSPENSION to your child.

REFERENCES

1. KD. Tripathi. Autocoids and related drugs & Drugs for Cough and Bronchial Asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page – 166-169 & 228-229.

2. 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 – 920-924.

3. Merck Sharp & Dohme Corp. Montelukast in Pediatric Allergic Asthma (0476-336) (COMPLETED). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2016] [Accessed on 24th August 2021] https://clinicaltrials.gov/ct2/show/NCT00289874

4. Nathan Segal, Robert E Grubbe, Arden L Levy, Michael J Maloney, Anjuli S Nayak, Barbara Kittner, Javier T Quesada. Pharmacokinetics, safety and tolerability of an oral suspension of fexofenadine for children with allergic rhinitis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July – August 2008. [Accessed on 24th August 2021] https://pubmed.ncbi.nlm.nih.gov/18702885/

5. Ozge Yilmaz, Derya Altintas, Carmen Rondon, Cemal Cingi, Fatih Oghan. Effectiveness of montelukast in pediatric patients with allergic rhinitis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. December 2013. [Accessed on 24th August 2021] https://pubmed.ncbi.nlm.nih.gov/24210867/

6. H S Nelson, R Reynolds, J Mason. Fexofenadine HCl is safe and effective for treatment of chronic idiopathic urticaria. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. May 2000. [Accessed on 24th August 2021] https://pubmed.ncbi.nlm.nih.gov/10831005/

7. Sanofi India Limited. Sanofi.in. [Revised on May 2020] [Accessed on 24th August 2021] https://www.sanofi.in/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-IN/Home/science-and-innovation/for-healthcare-professionals/product-information/Allegra-PI.pdf?la=en

8. Sanofi-aventis U.S. LLC. U.S. Food & Drug Administration. [Accessed on 24th August 2021] https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021963lbl.pdf

9. Cipla Ltd. Fexigra Oral Suspension (Fexofenadine hydrochloride). Ciplamed. [Revised in January 2020] [Accessed on 24th August 2021] https://ciplamed.com/content/fexigra-oral-suspension

10. Merck Sharp & Dohme BV. Electronic Medicines Compendium (EMC). [Revised in May 2020] [Accessed on 24th August 2021] https://www.medicines.org.uk/emc/files/pil.45.pdf

USEFUL DIAGNOSTIC TESTS

Complete blood count

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 05 Nov 2022 | 03:10 PM(IST)