INTRODUCTION

COSTEAD contains Ursodeoxycholic acid (also known as Ursodiol) which is a Gallstone dissolving agent. It is used to dissolve gall bladder stones (made up of cholesterol) and prevents them from forming back. It can also be used to manage a type of liver disease called primary biliary cholangitis. Primary biliary cholangitis (also known as primary biliary cirrhosis) is a long-term liver disease in which the tubes carrying a digestive fluid called bile (bile ducts) are injured, inflamed, and permanently damaged. As a result, it can cause yellow or white bumps under the skin or eyes, dark urine, and abnormally swollen stomach with pain with frequent nausea, weight loss and tiredness. COSTEAD can also be used to manage liver and biliary diseases caused due to cystic fibrosis (an inherited disorder that affects major organs) in children aged between 6-18 years.

COSTEAD is a liver protectant medication. It works by reducing cholesterol levels in the blood which is dissolving the gall bladder stones made up of cholesterol. It also improves liver functions by protecting the liver cells against the injury caused by toxic bile acid.

Before taking COSTEAD inform your doctor, if you have any other liver problems apart from gall stones and biliary cirrhosis. While taking COSTEAD, your doctor would regularly monitor your liver function to access how you respond to the management. COSTEAD is not recommended for use in pregnant women. Women of childbearing age should use a suitable non-hormonal contraceptive method like condemn or copper-IUD to avoid getting pregnant. The most common side effect of COSTEAD is pasty stools. Consult your doctor if it bothers you.

USES OF COSTEAD

• Manages primary biliary cholangitis
• Manages and prevents gall bladder stones
• Manages liver and biliary diseases caused due to cystic fibrosis in children aged between 6-18 years

HOW COSTEAD WORKS

COSTEAD is a liver protectant medication. It works by reducing cholesterol levels in the blood by decreasing its production in the liver and by inhibiting its absorption in the intestines. As a result, it slowly breaks down the gall bladder stones made up of cholesterol. It also improves liver functions by protecting the liver cells against the injury caused by toxic bile acid, thereby improving liver health in diseased patients.

DIRECTIONS FOR USE

COSTEAD should only be used under medical supervision. Swallow COSTEAD with a glass of water and do not crush or chew it. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition. You can take COSTEAD after a meal with a glass of milk or a small snack.

SIDE EFFECTS OF COSTEAD

HOW TO MANAGE SIDE EFFECTS

Pasty stools or diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Take plenty of rest. Do not take any medicines without speaking to a doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Before taking COSTEAD, inform your doctor, if you are taking any of the following medicine:

• medicines that can bind to cholesterol and inactive them (Ex. bile acid sequestrants (such as colestipol, colestyramine))
• medicines used to neutralize stomach acid (such as antacids containing aluminium hydroxide or smectite)
• ciprofloxacin (used to manage bacterial infection)
• dapsone (used to manage leprosy)
• nitrendipine (a medicine used to manage high blood pressure)
• ciclosporin (used to suppress immune function and prevent graft rejection)
• oral contraceptives (birth control pills) Ex. norethindrone
• oestrogens (used to manage menopause, PMS, and other hormonal conditions in females) Ex. Estradiol

Overdosage:

If you or anyone else accidentally take excess of COSTEAD, consult your doctor immediately or visit the nearby hospital. Symptom of overdose can be prolonged diarrhea.

SYNOPSIS

MORE INFORMATION

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

FAQs ABOUT COSTEAD

Can COSTEAD cause constipation?

There is no proper information regarding incidence of constipation while taking COSTEAD. If you feel constipated, try to include fiber rich diet in your meals and drink plenty of water. Try to perform a brisk walk at least for 30 minutes regularly after consulting your doctor. If the symptom bothers you, contact your physician.

How to take COSTEAD?

COSTEAD is preferably taken after meals along with a glass of milk or a small snack. Swallow COSTEAD with a glass of water and do not crush or chew it. Your doctor will decide the correct dose for you depending upon your age, body weight and disease condition.

How COSTEAD works on my body?

COSTEAD works by reducing cholesterol levels in the blood which eventually causes break down of the gall bladder stones. It also improves liver functions by protecting the liver cells against the injury caused by toxic bile acid, thereby improving liver health in diseased patients.

Is COSTEAD safe to use in children?

Yes. COSTEAD can be used to manage liver disease associated with cystic fibrosis in children aged between 6-18 years. However, consult your doctor for the correct dose and duration that suits your child.

How long should I use COSTEAD to dissolve gall stones?

Your doctor will advise you to use COSTEAD based on your condition. Generally, the duration of the management ranges between 3-4 months but may further get extended depending on the size of the gallstone that need to be dissolved. Make sure that you receive an uninterrupted therapy during this period and your doctor might suggest having a periodic X-ray or an ultrasound to access whether the stones were completely dissolved or not. Even after dissolution of gall stones, your doctor might still prescribe you COSTEAD to avoid its recurrence.

What precaution I need to follow while taking COSTEAD?

COSTEAD must be used only under medical supervision. Do not stop taking COSTEAD once your symptoms subside, without consulting your doctor, because it may lead to recurrence of gallbladder stones. Avoid alcohol consumption as it could further aggravate your liver disease and make sure to have regular check-ups of liver function as instructed by your doctor without fail to access your improvement.

REFERENCES

1. KD. Tripathi. Antiemetic, Prokinetic and Digestant drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 671.

2. Keith A. Sharkey and John L. Wallace. Management of disorders of bowel motility and water flux; Antiemetics; Agents used in biliary and pancreatic disease. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1347.

3. Mitsubishi Tanabe Pharma Corporation. Efficacy and Safety Study of Ursodeoxycholic Acid to Manage Chronic Hepatitis C. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on March 2012] [Accessed on 24th March 2022] https://clinicaltrials.gov/ct2/show/NCT00200343

4. Keith D. Lindor, Kris V. Kowdley, Velimir A. C. Luketic, M. Edwyn Harrison, Timothy McCashland, Alex S. Befeler, Denise Harnois, Roberta Jorgensen, Jan Petz, Jill Keach, Jody Mooney, Carol Sargeant, Julie Braaten, Tamara Bernard, Debra King, Ellen Miceli, Jeff Schmoll, Tanya Hoskin, Prabin Thapa and Felicity Enders. High Dose Ursodeoxycholic Acid for the Management of Primary Sclerosing Cholangitis. NCBI; PMC US National Library of Medicine, National Institute of Health. September 2010. [Accessed on 24th March 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2758780/

5. G Dinler,  N Koçak, A Yüce, F Gürakan, H Ozen. Ursodeoxycholic acid therapy in children with cholestatic liver disease. NIH. National Library of Medicine. National Center for Biotechnology Information. Pubmed.gov. January-March 1999. [Accessed on 24th March 2022] https://pubmed.ncbi.nlm.nih.gov/10770681/

6. Glenmark Pharmaceuticals Europe Limited. Electronic Medicines Compendium (EMC). [Revised on March 2019] [Accessed on 24th March 2022] https://www.medicines.org.uk/emc/files/pil.10064.pdf

USEFUL DIAGNOSTIC TESTS

• Liver function test
• Abdominal ultrasound