INTRODUCTION

ADVASTAT CV 10MG CAPSULE is a combination of Clopidogrel and Rosuvastatin which belongs to the group of medicines called Antiplatelets and HMG-CoA reductase inhibitors respectively. ADVASTAT CV 10MG CAPSULE is indicated for the treatment and prevention of cardiovascular diseases such as acute coronary syndrome, myocardial infarction (also known as a heart attack), angina (chest pain due to inadequate blood supply to the heart) and stroke (reduced blood supply to the brain leading to brain death), among patients with elevated cholesterol and/or triglyceride levels along with a suitable diet, exercise and weight management regimen.

An acute coronary syndrome is a heart condition caused by plaque rupture or clot formation in the coronary arteries. Symptoms include heart attack, chest pressure or pain while at rest, shortness of breath and sweating.

During and prior to treatment with ADVASTAT CV 10MG CAPSULE, your doctor would recommend several blood tests to check your liver function.

ADVASTAT CV 10MG CAPSULE generally increases your tendency to bleed and so if you cut or injure yourself, it may take a little longer for the bleeding to stop. Bleeding for minor injuries like small cut or shaving is of no concern.

However, if you experience excessive bleeding for a prolonged period, contact your doctor. Before taking ADVASTAT CV 10MG CAPSULE inform your doctor if you have any liver, kidney or lung disease.

ADVASTAT CV 10MG CAPSULE is generally not suitable for use in pregnant or breastfeeding women and in children or adolescents (aged below 18 years). ADVASTAT CV 10MG CAPSULE should be used with caution in elderly patients (aged 65 years or above).

The most common side effects of taking ADVASTAT CV 10MG CAPSULE are headache, dizziness, nausea, stomach pain or increased bleeding tendency. Consult your doctor if any of the side effects worsen.

USES OF ADVASTAT CV 10MG CAPSULE

• Treats and prevents the risk of cardiovascular disease (such as acute coronary syndrome, myocardial infarction, angina including stroke among patients with elevated cholesterol and triglyceride levels)

HOW ADVASTAT CV 10MG CAPSULE WORKS

ADVASTAT CV 10MG CAPSULE reduces the risk of heart problems, where clopidogrel acts by irreversibly inhibiting the aggregation of platelet in the coronary arteries and rosuvastatin acts by inhibiting the action of an enzyme called HMG-CoA reductase which is responsible for catalyzing cholesterol biosynthesis in the body, thus reducing the chances of plaque formation/blood clots in the coronary arteries leading to the prevention of fatal cardiac outcomes.

DIRECTIONS FOR USE

Take ADVASTAT CV 10MG CAPSULE as advised by your physician. Swallow ADVASTAT CV 10MG CAPSULE with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

SIDE EFFECTS OF ADVASTAT CV 10MG CAPSULE

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take ADVASTAT CV 10MG CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating oil-rich or spicy foods. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Constipation :

Eat fibre-rich foods such as fresh fruits, vegetables, cereals and drink plenty of water. Try to exercise more regularly. Consult your doctor if the symptom did not improve on its own.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heating pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

Skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking ADVASTAT CV 10MG CAPSULE inform your doctor, if you are taking any of these medicines:

• ciclosporin (a medicine used to treat autoimmune disease or prevent graft rejection)
• warfarin (a medicine used to dissolve blood clots by thinning the blood)
• medicines used to control elevated blood cholesterol levels such as fibrates (Ex. gemfibrozil, fenofibrate) or ezetimibe
• medicines used to neutralize acid in the stomach such as antacids (Ex. aluminium hydroxide) or proton pump inhibitors (Ex. omeprazole and esomeprazole)
• antibiotics (used to treat bacterial infections) such as erythromycin, fusidic acid
• oral contraceptive (used to prevent pregnancy) Ex. mifepristone
• regorafenib (a medicine used to treat cancer)
• hormone replacement therapy (used to treat menstrual problems)
• medicines used to treat viral infections such as HIV or hepatitis C (Ex. ritonavir, lopinavir, ombitasvir, paritaprevir, dasabuvir, atazanavir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir)

Overdosage:

If you or anyone else accidentally take too much of ADVASTAT CV 10MG CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage of ADVASTAT CV 10MG CAPSULE may lead to  prolonged bleeding time and subsequent bleeding complications.

SYNOPSIS

MORE INFORMATION

• Keep ADVASTAT CV 10MG CAPSULE out of reach of children
• Store at room temperature

FAQs ABOUT ADVASTAT CV 10MG CAPSULE

Can I consume alcohol while taking [GBBNKEYWORD]?

No, avoid consumption of alcohol while taking ADVASTAT CV 10MG CAPSULE, as it could aggravate your existing disease condition. Follow the lifestyle modification suggested by your doctor such as quitting smoking or alcohol consumption during this therapy to achieve better results. Before taking ADVASTAT CV 10MG CAPSULE inform your doctor if you are an alcoholic.

Can ADVASTAT CV 10MG CAPSULE be taken during pregnancy?

No, ADVASTAT CV 10MG CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking this medicine. If you become pregnant while taking ADVASTAT CV 10MG CAPSULE, stop taking it and consult your doctor immediately. Women of childbearing potential should use a suitable contraceptive method to avoid pregnancy while taking ADVASTAT CV 10MG CAPSULE.

Can ADVASTAT CV 10MG CAPSULE cause diabetes?

Yes, ADVASTAT CV 10MG CAPSULE can cause your blood sugar levels to increase, which is highly predominant among individuals who already have any risk factors for developing diabetes (such as being obese or overweight, having high blood pressure or having pre-diabetes). While taking ADVASTAT CV 10MG CAPSULE follow a low-carb diet and avoid smoking or consuming alcohol. Manage your body weight by doing regular physical activity as instructed by your doctor.

Can I take aspirin along with ADVASTAT CV 10MG CAPSULE?

Although the combination of aspirin with clopidogrel and rosuvastatin is considered safe, consult your doctor before taking ADVASTAT CV 10MG CAPSULE. Try to avoid the concomitant administration of other antiplatelet medicine without consulting your doctor. Your doctor will decide the correct dosing regimen for you depending on your health condition.

Can ADVASTAT CV 10MG CAPSULE prevent a heart attack?

Yes, ADVASTAT CV 10MG CAPSULE can prevent the incidence of heart attack. It acts by blocking the aggregation of platelets and by reducing plaque or clot formation in the blood vessels which contributes to the prophylactic effects of heart attack. Before taking ADVASTAT CV 10MG CAPSULE inform your doctor if you have pre-existing heart problems.

Can ADVASTAT CV 10MG CAPSULE cause blood in stool?

ADVASTAT CV 10MG CAPSULE generally increases your tendency to bleed and can cause black or blood-stained stools due to increased bleeding in the gut. If you have any existing condition that can make you bleed more (such as presence of stomach ulcer) please inform your doctor before taking ADVASTAT CV 10MG CAPSULE.

What to do If I forget to take ADVASTAT CV 10MG CAPSULE?

You should take ADVASTAT CV 10MG CAPSULE immediately when you remember. If it is time for your next dose of ADVASTAT CV 10MG CAPSULE skip the dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

What is ADVASTAT CV 10MG CAPSULE used for?

ADVASTAT CV 10MG CAPSULE is used to treat and prevent the risk of cardiovascular diseases such as acute coronary syndrome, myocardial infarction, angina and stroke among patients with elevated cholesterol and triglyceride levels. Consult your doctor before taking ADVASTAT CV 10MG CAPSULE.

REFERENCES

1. KD. Tripathi. Drugs Affecting Coagulation, Bleeding and Thrombosis. Essentials of medical pharmacology. Seventh edition. 2013. Page – 630 & 632-633.

2. Jeffery I. Weitz. Blood Coagulation and Anticoagulant, Fibrinolytic and Antiplatelet drugs. Thomas P. Bersot. Drug therapy for hypercholesterolemia and Dyslipidemia. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 869 & 894-898.

3. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 888 & 3463.

4. Gregory G Schwartz , Michael A Bolognese, Benoit P Tremblay, Richard Caplan, Howard Hutchinson, Ali Raza, Michael Cressman. Efficacy and safety of rosuvastatin and atorvastatin in patients with hypercholesterolemia and a high risk of coronary heart disease: a randomized, controlled trial. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July 2004. [Accessed on 30th October 2021] https://pubmed.ncbi.nlm.nih.gov/15215813/

5. Ke An, Rong Huang, Sai Tian, Dan Guo, Jiaqi Wang, Hongyan Lin and Shaohua Wang. Statins significantly reduce mortality in patients receiving clopidogrel without affecting platelet activation and aggregation: a systematic review and meta-analysis. Lipids in Health and Disease. BioMed Central Ltd (BMC) – a part of Springer Nature. May 2019. [Accessed on 30th October 2021] https://lipidworld.biomedcentral.com/articles/10.1186/s12944-019-1053-0#citeas

6. Jun Pang, Qiang Wu, Zheng Zhang, Tong-Zhang Zheng, Qiuling Xiang, Ping Zhang, Xiaoqiao Liu, Changhai Zhang, Hongwen Tan, Jing Huang, Wei Liu, Fang Song, Hongwen Tan, Zongzhuang Li, Feng Yue, Zhi Jiang, Fang Wei, Kai Zhou, Feng Tang, Yongyao Yang, Xiangshu Long, Chunyan Kuang, Yueting Wu, Baolin Chen, Ye Tian. Efficacy and safety of clopidogrel only vs. clopidogrel added proton pump inhibitors in the treatment of patients with coronary heart disease after percutaneous coronary intervention: A systematic review and meta-analysis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 2019. [Accessed on 30th October 2021] https://pubmed.ncbi.nlm.nih.gov/31321282/

7. Torrent pharmaceuticals ltd. Rozuplatt. Torrentian.com. [Revised in August 2020] [Accessed on 30th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2984.pdf

8. Exmo Biogenics Pvt Ltd. Roscad-CV 5/10. [Accessed on 30th October 2021] http://www.exmobiogenics.com/ROSCAD-CV.php

9. Llyod Healthcare. Rosloy CV. [Accessed on 30th October 2021] https://www.lloydhealthcare.org/rosloy-cv.php

USEFUL DIAGNOSTIC TESTS

• Liver function tests