INTRODUCTION

WELMINIC LS DROPS contains Ambroxol, Levosalbutamol and Guaifenesin which belongs to the group of medicines known as Mucolytics, Bronchodilators, and Expectorants. It is indicated for the treatment of productive cough with mucous for children (1-12years of age) associated with bronchospasm (spasm of lung muscle causing breathing difficulty).

The conditions can be bronchitis (inflammation of bronchial tubes which carries air from and to the lungs), bronchial asthma (inflammatory airway disease), wheezing, chest congestion, cough, etc.

WELMINIC LS DROPS should be used with caution in children having liver, kidney or heart disease, high blood pressure, uncontrolled juvenile diabetes mellitus, hyperthyroidism (increased secretion of thyroid hormones), seizures or fits.

WELMINIC LS DROPS can be used in children aged 1-12years, however, consult your doctor for advice before giving [GBNKRYWORD] to your child. WELMINIC LS DROPS is not recommended for use in pregnant and breastfeeding women unless absolutely necessary. Consult with your doctor before taking.

The most common side effects of taking WELMINIC LS DROPS are increased heart rate, palpitations (sensation of fluttering heartbeat), indigestion, headache, vomiting, nausea (feel sick), sweating, muscle cramps. Contact your doctor if any of the symptoms does not improve or worsen.

USES OF WELMINIC LS DROPS

Used in pediatric patients (1-12years of age) for the treatment of productive cough associated with following conditions:

• bronchospasm
• bronchitis
• bronchial asthma
• tenacious or thickened mucus, wheezing
• chest congestion

HOW WELMINIC LS DROPS WORKS

Ambroxol is a mucolytic agent that promotes mucus clearance by decreasing its viscosity and increasing its volume. It facilitates expectoration and eases productive cough. Guaiphenesin is an expectorant which works by reducing the viscosity of lung secretions and aids in spitting out the mucous. Levosalbutamol is a beta agonist that activates the certain receptors called beta-2 adrenergic receptors in lungs which facilitates the smooth muscle relaxation and makes airways open for easy breathing and also acts as an anti-inflammatory agent. Together, they help the patients with congestion, breathe freely and deeply.

DIRECTIONS FOR USE

Give WELMINIC LS DROPS to your 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 WELMINIC LS DROPS

HOW TO MANAGE SIDE EFFECTS

Nausea And Vomiting

Give WELMINIC LS DROPS to the child with, or just after a meal or snack. Let the child stick to simple meals and avoiding oil rich or spicy foods. Consult your doctor if there is no improvement in symptoms.

Dry Mouth

Dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free hard candies to stimulate the flow of saliva. Make your child sip water at regular intervals of time. Consult your physician for advice.

Stomach Pain

Try and make your child to rest and relax. Make your child eat slowly or try to keep frequent and smaller meals. Keep a heat pad on your child’s stomach. If the symptom does not improve or worsens, contact your doctor.

Headache

Apply hot or cold-water bag on your child’s head. Let the child take enough rest and relax. Massage on scalp or head with mild pressure. Consult your doctor if there is no improvement in symptoms.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

WELMINIC LS DROPS is not recommended for use in pregnant women unless absolutely necessary. WELMINIC LS DROPS is intended for use only in children (1-12years). Consult your doctor before taking.

BREASTFEEDING

Monitoring required

WELMINIC LS DROPS is not recommended for use in breastfeeding women unless absolutely necessary. WELMINIC LS DROPS is intended for use only in children (1-12years). Consult your doctor before taking.

KIDNEY

Use with Caution

WELMINIC LS DROPS should be used with caution in children having kidney diseases such as kidney failure. Consult your doctor before administering.

LIVER

Use with Caution

WELMINIC LS DROPS should be used with caution in children having liver impairment. Consult your doctor before administering.

ALLERGY

Contraindicated

Do not administer WELMINIC LS DROPS if the child is allergic to Ambroxol, Levosalbutamol, Guaifenesin or any other ingredients of this medicine.

HEART DISEASE

Use with Caution

WELMINIC LS DROPS should be used with caution in children having heart diseases. Consult your doctor before administering WELMINIC LS DROPS.

USE IN PEDIATRICS

Consult your doctor

WELMINIC LS DROPS is recommended for use in children aged 1-12years, however, consult your doctor for advice before giving [GBNKRYWORD]. Your doctor will decide the correct dose and duration for your child depending upon the age, body weight and disease condition.

INTERACTIONS

A. Drug - Drug interactions:

Before giving WELMINIC LS DROPS to your child, inform your doctor if you are taking any of the following medicines:

• aminophylline (used to treat bronchospasm)
• corticosteroids such as prednisolone, hydrocortisone (used to treat inflammatory and autoimmune diseases)
• albuterol, levalbuterol (used to provide relief from breathlessness)
• epinephrine (medicine used for severe allergic reactions)
• diuretics such as furosemide, bumetanide, spironolactone (used to remove excess fluid or water from the body)
• digitalis (used to treat heart problems like congestive heart failure, angina, etc)
• monoamine oxidase inhibitors such as isocarboxazid, phenelzine, selegiline and tricyclic antidepressants such as amitriptyline, doxepin (used to treat depression)

Overdosage:

If the child or anyone else accidentally took too much of WELMINIC LS DROPS, consult your doctor immediately or visit any nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep WELMINIC LS DROPS out of reach of children
• Store WELMINIC LS DROPS at a temperature below 25°C

FAQs ABOUT WELMINIC LS DROPS

Q: What are the uses of WELMINIC LS DROPS?

A: WELMINIC LS DROPS is indicated for the treatment of productive cough with mucous for children (1-12years of age) associated with conditions like bronchospasm, bronchitis, bronchial asthma, tenacious or thickened mucus, wheezing, and chest congestion.

Q: How much WELMINIC LS DROPS should be given?

A: Your doctor will decide the correct dose and duration of WELMINIC LS DROPS for your child depending on the age, body weight and disease condition. Administer the correct dose of WELMINIC LS DROPS as per your child’s doctor instructions. Do not alter the dose on your own.

Q: When WELMINIC LS DROPS should be given with caution?

A: WELMINIC LS DROPS should be used with caution in children having a liver impairment, kidney failure, high blood pressure, heart disease, uncontrolled juvenile diabetes mellitus, hyperthyroidism (increased secretion of thyroid hormones), seizures or fits.

Q: Does WELMINIC LS DROPS cause nausea or vomiting?

A: Yes, it may cause nausea or vomiting in some children. 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.

Q: What should I do if I missed to administer a dose of WELMINIC LS DROPS to child?

A: If you have missed a dose by chance, try to administer the WELMINIC LS DROPS as soon as possible when you notice. However, if the time for the next dose is closer, skip the dosage and do not try to give the double dosage.

REFERENCES

1. KD. Tripathi. Drugs for Cough and Bronchial Asthma. Essentials of medical pharmacology. Eighth edition. 2013. Page – 238.

2. Helmut H. Albrecht, Peter V. Dicpinigaitis, and Eric P. Guenin, Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections. NIH National Library of Medicine, National centre for biotechnology information. PubMed Central. December 2017. [Accessed 22nd October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724298/

3. NIH National Library of Medicine, National center for biotechnology information. Pubchem. Ambroxol. [Accessed on 22nd October 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Ambroxol#section=Mechanism-of-Action

4. NIH National Library of Medicine, National center for biotechnology information. Pubchem. Levalbuterol. [Accessed on 22nd October 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Levalbuterol

5. Ahmad Kantar, Ludger Klimek, Dorotheea Cazan, Annette Sperl, Ulrike Sent, and Margarida Mesquita. An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children. NIH National Library of Medicine, National centre for biotechnology information. PubMed Central. January 2020. [Accessed 22nd October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137760/

6. Mukesh Kumar Gupta , Meenu Singh. Evidence based review on levosalbutamol. NIH National Library of Medicine, National centre for biotechnology information. PubMed.gov. February 2007. [Accessed 22nd October 2022] https://pubmed.ncbi.nlm.nih.gov/17337829/

7. Centaur Pharmaceuticals Pvt Ltd. Kofarest PD Drops 15ml. (Ambroxol + Levosalbutamol + Guaifenesin). [Accessed 22nd October 2022]. https://www.centaurpharma.com/downloads/2021/pediatrics/cough/KOfarest%20PD%20drops.pdf

8. Centaur Pharmaceuticals Pvt Ltd. KOFAREST LS JUNIOR Syrup 60ml. (Ambroxol + Levosalbutamol + Guaifenesin). [Revised on January 2021] [Accessed 22nd October 2022] https://www.centaurpharma.com/downloads/peadiatrics/cough/Kofarest%20LS%20Junior%20syrup.pdf

9. Innovative Pharmaceuticals Pvt Ltd. Broncolite – LS Drops (Ambroxol + Levosalbutamol + Guaifenesin). [Accessed 22nd October 2022] https://www.innovativepharma.in/product/broncolite-ls-drops/

10. Leeford Healthcare. Amrox – LX Drops. (Ambroxol + Levosalbutamol + Guaifenesin). [Accessed 22nd October 2022] https://www.leeford.in/product/239/amrox-ls-drops

USEFUL DIAGNOSTIC TESTS

• CT scan
• MRI
• Chest X-rays
• Blood test