INTRODUCTION
ATREST 12.5MG TABLET contains Tetrabenazine which belongs to the group of medicines called Vesicular monoamine transporter 2 inhibitors. ATREST 12.5MG TABLET is used to treat diseases that cause hyperkinetic motor disorders?(such as?jerky, irregular, uncontrollable movements) associated with Huntington?s chorea (an inherited neurodegenerative disease) in affected individuals.
ATREST 12.5MG TABLET is not recommended for use in patients allergic to Tetrabenazine. It is also not recommended for use in patients suffering from Parkinson-like symptoms, depression, active suicidal thoughts, pheochromocytoma (tumor of the adrenal gland), and/or kidney disorders.
Before taking ATREST 12.5MG TABLET, inform your doctor if you are intolerant to certain sugars (such as lactose), and/or have heart problems (such as long QT syndrome, heart rhythm disorders), liver problems (such as mild, moderate/severe hepatic disorders).
ATREST 12.5MG 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 not recommended for use in children and adolescents (aged below 18 years) and is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.
The most common side effects of taking ATREST 12.5MG TABLET are confusion, anxiety, sleeplessness, low blood pressure, nausea, vomiting, diarrhea, and/or constipation. Consult your doctor if any these symptoms worsen.

USES OF ATREST 12.5MG TABLET

Treats diseases that cause hyperkinetic motor disorders (such as jerky, irregular, uncontrollable movements) associated with Huntington?s chorea (an inherited neurodegenerative disease) in affected individuals

HOW ATREST 12.5MG TABLET WORKS
ATREST 12.5MG TABLET works by inhibiting the absorption of certain chemicals (dopamine, serotonin) in brain which results in improved movements thus treating hyperkinetic motor disorders associated with Huntington?s chorea in affected individuals.

DIRECTIONS FOR USE
Take ATREST 12.5MG TABLET as advised by your physician. Swallow the medicine with 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 ATREST 12.5MG TABLET

COMMON

Drowsiness (with higher dosages)
Parkinson-like symptoms (such as uncontrollable movements of the head, legs, hands, arms)
Confusion, anxiety
Sleeplessness
Low blood pressure
Dysphagia (difficulty in swallowing)
Nausea, vomiting, diarrhea, constipation
Sweating

UNCOMMON

Mental changes (such as confusion, hallucinations)
Stiffness in your muscles
Fever

RARE

Signs of Neuroleptic malignant syndrome (life threatening reaction to antipsychotic drug) such as mental changes (confusion, hallucinations), stiffness in muscles, and/or temperature

Stop taking ATREST 12.5MG TABLET and contact your doctor immediately if you experience any of the following side effects:

Feeling sad/depressed
Suicidal thoughts
Have/plan to hurt yourself intentionally

HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take ATREST 12.5MG 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.

WARNING & PRECAUTIONS

PREGNANCY
ATREST 12.5MG 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
ATREST 12.5MG TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking the medicine.

DRIVING AND USING MACHINES
Do not drive/operate machines if you feel drowsy after taking ATREST 12.5MG TABLET.

ALCOHOL
Avoid consumption of alcohol while taking ATREST 12.5MG TABLET since the medicine may make you feel abnormally sleepy.

KIDNEY
ATREST 12.5MG TABLET is not recommended for use in patients with kidney disorders. Consult your doctor before taking ATREST 12.5MG TABLET.

LIVER
ATREST 12.5MG TABLET should be used with caution in patients with liver problems such as mild, moderate, and/or severe hepatic disorders. Consult your doctor before taking ATREST 12.5MG TABLET.

ALLERGY
Do not take ATREST 12.5MG TABLET if you are allergic to Tetrabenazine, and/or any other ingredients of this medicine.

HEART DISEASE
ATREST 12.5MG TABLET should be used with caution in patients with heart problems such as long QT syndrome, and/or problems associated with heart rhythm. Consult your doctor before taking ATREST 12.5MG TABLET.

OTHERS
ATREST 12.5MG TABLET is not recommended for use if you:

Suffer from Parkinson-like symptoms
Are diagnosed with depression which has not been treated or difficult to treat
Have active suicidal thoughts
Have pheochromocytoma (tumor of the adrenal gland)
Have prolactin-dependent tumors such as pituitary/ breast cancer

Before taking ATREST 12.5MG TABLET, inform your doctor if you:

Are a slow/intermediate metabolizer of an enzyme called CYP2D6 (enzyme responsible for metabolism of medicines)
Are intolerant to certain sugars such as lactose

Use in Pediatrics:
ATREST 12.5MG TABLET is not recommended for use in children and adolescents (aged below 18 years). ?Consult your doctor before taking ATREST 12.5MG TABLET.
Use in Geriatrics:
ATREST 12.5MG TABLET should be used with caution in elderly patients (aged 65 years/above).? Consult your doctor before taking ATREST 12.5MG TABLET.

INTERACTIONS
A. Drug-Drug interactions:
Before taking ATREST 12.5MG TABLET, inform your doctor if you are taking any of the following medicine:

Reserpine (used to control high blood pressure and treat psychosis)
Antidepressants (used to treat depression) such as MAO inhibitors (Ex. phenelzine, selegiline)
Levodopa (used to treat Parkinson?s disease)
Opioids (used to control pain) Ex. oxycodone, hydrocodone
Antihypertensive drugs (used to treat high blood pressure) Ex. telmisartan, chlorthalidone
Beta blockers (used to treat heart problems) Ex. acebutolol, atenolol
Medicines used to treat psychotic disorders such as hypnotics (Ex. ambien, belsomra), neuroleptics (Ex. butaperazine)
CYP2D6 inhibitors (medicines used to reduce the metabolism of certain medicines) Ex. fluoxetine, paroxetine, terbinafine, moclobemide, quinidine
Medicines that prolong the QTc interval in the ECG (Ex. haloperidol, droperidol)
Certain antibiotics (used to treat bacterial infections) Ex. gatifloxacin, moxifloxacin
Medicines used to treat heart rhythm conditions (Ex. quinidine, procainamide, amiodarone, sotalol)

Overdosage:
If you or anyone else accidentally take too much of ATREST 12.5MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are uncontrollable muscle spasms (affecting eyes, head, neck and body), uncontrolled rolling of eyes, excessive blinking of eye, nausea, vomiting, diarrhea, sweating, dizziness, feeling cold, confusion, hallucinations, drowsiness, redness/inflammation, and/or tremor.

SYNOPSIS

Drug
:
Tetrabenazine

Pharmacological Category
:
Vesicular monoamine transporter 2 inhibitor

Therapeutic Indication
:
Hyperkinetic motor disorders?associated with Huntington?s chorea

Dosage Forms
:
Tablet

MORE INFORMATION

Keep ATREST 12.5MG TABLET out of reach of children
Store ATREST 12.5MG TABLET at room temperature

FAQs ABOUT ATREST 12.5MG TABLET
What is ATREST 12.5MG TABLET used for?
ATREST 12.5MG TABLET is used to treat diseases that cause hyperkinetic motor disorders (such as jerky, irregular, uncontrollable movements) associated with Huntington?s chorea (an inherited neurodegenerative disease) in affected individuals.
What are the common side effects of taking ATREST 12.5MG TABLET?
The most common side effects of taking ATREST 12.5MG TABLET are confusion, anxiety, sleeplessness, low blood pressure, nausea, vomiting, diarrhea, and/or constipation. Consult your doctor if any these symptoms worsen.
How ATREST 12.5MG TABLET works?
ATREST 12.5MG TABLET works by inhibiting the absorption of certain chemicals (dopamine, serotonin) in brain which results in improved movements thus treating hyperkinetic motor disorders associated with Huntington?s chorea in affected individuals.
How ATREST 12.5MG TABLET should be taken?
Take ATREST 12.5MG 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 ATREST 12.5MG TABLET be used in pregnant and breastfeeding women?
Yes, ATREST 12.5MG TABLET can be used but with caution during pregnancy and in women planning for pregnancy only if it is clearly necessary. The medicine is not recommended for use in breastfeeding women. Consult your doctor before taking the medicine.

REFERENCES
1. Goodman Gilmans. Treatment of central nervous system degenerative disorders. The Pharmacological Basis of Therapeutics. Twelfth Edition. 2011. Page : 436, 624.
2. Tatiana Yero, Jose A. Rey. Tetrabenazine (Xenazine), An FDA-Approved Treatment Option for Huntington?s Disease?Related Chorea. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. December 2008. [Accessed on 1st June 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730806/
3. Joseph M. Ferrara, Giovanni Mostile, Christine Hunter, Octavian R. Adam, Joseph Jankovic. Effect of Tetrabenazine on Motor Function in Patients with Huntington Disease. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. December 2012. [Accessed on 1st June 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4389035/
4. Sun Pharmaceutical Industries Europe B.V. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 1st June 2022]?https://www.medicines.org.uk/emc/files/pil.2668.pdf
5.?Sun Pharmaceutical Industries Europe B.V. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 1st June 2022]?https://www.medicines.org.uk/emc/product/2668/smpc

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