INTRODUCTION

ADDTREX 50 TABLET contains Naltrexone which belongs to the group of medicines called Opiate antagonists. ADDTREX 50 TABLET is used as a part of treatment programme to help affected individuals from taking opiates (substances that provide relief from pain) and prevent them from opioid dependence and addiction.

ADDTREX 50 TABLET is not recommended for use in patients allergic to Naltrexone hydrochloride. It is also not recommended for use in patients who have opioid-addiction (without successful withdrawal), and/or experience acute symptoms of opioid withdrawal (such as paranoia, confusion, tremors, disorientation). The medicine is also not recommended for use in patients suffering from severe liver/kidney problems, and/or acute hepatitis (inflammation of liver).

Before taking ADDTREX 50 TABLET, inform your doctor if you have intolerance to certain sugars such as lactose.

ADDTREX 50 TABLET should be used with caution during pregnancy and in women planning for pregnancy only if it is clearly necessary. It is not recommended for use in breastfeeding women.

The medicine is also not recommended for use in children and adolescents (aged below 18 years) and is advised to be used with caution in elderly patients (aged 65years/above) after consulting the doctor.

The most common side effects of taking ADDTREX 50 TABLET are anxiety, nervousness, dizziness, abdominal pain, nausea, vomiting, diarrhea, and/or constipation. Consult your doctor if any of these symptoms worsen.

USES OF ADDTREX 50 TABLET

• Prevents opioid dependence and addiction
• Aids in the treatment programme to help affected individuals from taking opiates (substances that provide relief from pain)

HOW ADDTREX 50 TABLET WORKS

ADDTREX 50 TABLET works by binding to opioid receptors which leads to reduced opioid cravings and blockade of euphoric and sedative effects of opiates thus aiding the affected individuals from opioid dependence and addiction.

DIRECTIONS FOR USE

Take ADDTREX 50 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.

SIDE EFFECTS OF ADDTREX 50 TABLET

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.

Nausea and vomiting:

Take ADDTREX 50 TABLET with/just after a meal. Stick to simple meals. Avoid eating oil rich/spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, and drink slowly in between meals. Consult your doctor if the condition worsens.

Diarrhoea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult and inform your doctor if the symptom worsens.

Constipation:

Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink plenty of water. Involve in regular exercise (going for a daily walk or run) and if this does not help, consult and inform your doctor for receiving alternate treatments for constipation.

Headache:

If ADDTREX 50 TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking ADDTREX 50 TABLET. If it lasts more than a week or becomes severe, then consult and inform your doctor.

Thirst:

Try to drink plenty of cold water and sip on cold unsweetened drinks and use lip balm if your lips are dry. Brush your teeth twice a day and use mouthwash. Consult and inform your doctor if the symptom gets worse.

Rashes:

Do not scratch the affected area. Wear protective clothing while going outdoors. Regularly moisturize your skin. Consult and inform your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

PREGNANCY

ADDTREX 50 TABLET should be used with caution during pregnancy and in women planning for pregnancy only if it is clearly necessary. Consult your doctor before taking the medicine.

BREASTFEEDING

ADDTREX 50 TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking the medicine.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel less alert or drowsy after taking ADDTREX 50 TABLET.

KIDNEY

ADDTREX 50 TABLET is not recommended for use in patients with severe kidney problems. Consult your doctor before taking the medicine.

LIVER

ADDTREX 50 TABLET is not recommended to use in patients with severe liver problems or acute hepatitis (inflammation of liver). Consult your doctor before taking the medicine.

ALLERGY

Do not take ADDTREX 50 TABLET if you are allergic to Naltrexone hydrochloride, and/or any other ingredients of this medicine.

INTERACTIONS

A. Drug-Drug interactions:

Before taking ADDTREX 50 TABLET, inform your doctor if you are taking any of the following medicine:

• medicines used to treat cough (Ex. dextromethorphan, pholcodine)
• medicines used to treat diarrhea (Ex. loperamide, diphenoxylate)
• medicines used to treat pain (Ex. codeine, tramadol)

Overdosage:

If you or anyone else accidentally take too much of ADDTREX 50 TABLET, consult your doctor immediately or visit the nearby hospital to manage overdose symptoms.

SYNOPSIS

MORE INFORMATION

• Keep ADDTREX 50 TABLET out of reach of children
• Do not store ADDTREX 50 TABLET above 25°C

FAQs ABOUT ADDTREX 50 TABLET

What is ADDTREX 50 TABLET used for?

ADDTREX 50 TABLET is used in a part of treatment programme to help affected individuals from taking opiates (substances that provide relief from pain) and prevent them from opioid dependence and addiction.

How ADDTREX 50 TABLET works?

ADDTREX 50 TABLET works by binding to opioid receptors which leads to reduced opioid cravings and blockade of euphoric and sedative effects of opiates thus aiding the affected individuals from opioid dependence and addiction.

How ADDTREX 50 TABLET works?

ADDTREX 50 TABLET works by binding to opioid receptors which leads to reduced opioid cravings and blockade of euphoric and sedative effects of opiates thus aiding the affected individuals from opioid dependence and addiction.

What are the common side effects of taking ADDTREX 50 TABLET?

The most common side effects of taking ADDTREX 50 TABLET are anxiety, nervousness, dizziness, abdominal pain, nausea, vomiting, diarrhea, and/or constipation. Consult your doctor if any of these symptoms worsen.

How ADDTREX 50 TABLET should be taken?

Take ADDTREX 50 TABLET as advised by your physician. Swallow the medicines with a glass of water. Do not crush or chew the medicine. Your physician will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Can ADDTREX 50 TABLET be used in pregnant women?

Yes, ADDTREX 50 TABLET can be used but with caution during pregnancy and in women planning for pregnancy only if it is clearly necessary. Consult your doctor before taking the medicine.

REFERENCES

1. KD Tripathi. Opioid Analgesics and Antagonists. Essential of medical pharmacology. Seventh Edition. 2013. Page - 483.

2. Rajesh R Tampi, Aarti Chhatlani, Hajra Ahmad, Kripa Balaram, Joel Dey, Ricardo Escobar, Thejasvi Lingamchetty. Substance use disorders among older adults: A review of randomized controlled pharmacotherapy trials. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. September 2019. [Accessed on 22nd December 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6757194/

3. AOP Orphan Pharmaceuticals GmbH. Health Products Regulatory Authority (HPRA). [Revised in December 2021] [Accessed on 22nd December 2022] https://www.hpra.ie/img/uploaded/swedocuments/56b21611-8aaa-4155-ad7d-8b973c42df04.pdf

AUTHOR DETAILS

Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 23 Dec 2022 | 07:22 PM(IST)