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INTRODUCTION
ROZAT CV CAPSULE is a combination of Clopidogrel and Rosuvastatin which belongs to the group of medicines called Antiplatelets and HMG-CoA reductase inhibitors respectively. ROZAT CV 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 ROZAT CV CAPSULE, your doctor would recommend several blood tests to check your liver function.
ROZAT CV 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 ROZAT CV CAPSULE inform your doctor if you have any liver, kidney or lung disease.
ROZAT CV CAPSULE is generally not suitable for use in pregnant or breastfeeding women and in children or adolescents (aged below 18 years). ROZAT CV CAPSULE should be used with caution in elderly patients (aged 65 years or above).
The most common side effects of taking ROZAT CV CAPSULE are headache, dizziness, nausea, stomach pain or increased bleeding tendency. Consult your doctor if any of the side effects worsen.
USES OF ROZAT CV 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 ROZAT CV CAPSULE WORKS
ROZAT CV 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 ROZAT CV CAPSULE as advised by your physician. Swallow ROZAT CV 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 ROZAT CV CAPSULE
COMMON
- headache, dizziness
- general weakness
- nausea, stomach pain, constipation
- muscle pain
- diabetes (high blood glucose level)
- bleeding problems (such as blood in the urine, bleeding in the stomach or bowels, bleeding in the nose, eyes, head, lungs or joints or bleeding under the skin)
UNCOMMON
- skin rash, itching or other skin reactions
- vomiting, flatulence
- stomach ulcer and duodenal ulcer
- sensation of tingling and numbness
RARE
- severe stomach pain (caused by inflammation in the pancreas)
- vertigo (spinning sensation)
- breast enlargement in men
- hepatitis (inflammation of the liver)
- joint pain
- memory loss
- cough, difficulty in breathing
- symptoms of generalized allergic reaction (sensation of heat or warmth all over the body with sudden general discomfort and fainting)
- oral sores or swelling
- decrease in blood pressure
- confusion, hallucinations
- changes in taste
Stop taking ROZAT CV CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- severe allergic reactions (such as skin rash, severe itching of the skin with raised lumps, blisters in the skin, swelling of the face, lips, tongue and/or throat with difficulty in breathing or swallowing)
- fever, signs of infection or extreme tiredness
- signs of liver problems (such as jaundice (yellowing of the skin and the whites of the eyes) with or without bleeding that can appear as red pinpoint dots under the skin and/or confusion)
- rhabdomyolysis (prolonged unusual muscle weakness, tenderness or pain associated with general weakness or fever)
- thrombotic thrombocytopenic purpura (a blood disorder causing blood clots forming in capillaries which may lead to high fever, severe bleeding under the skin resembling red pinpoint dots, with or without unexplained extreme tiredness, confusion or jaundice)
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Try to take ROZAT CV 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
PREGNANCY
ROZAT CV CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking this medicine. If you became pregnant while taking ROZAT CV CAPSULE, stop taking it and consult your doctor immediately. Women of child-bearing potential should use a suitable contraceptive method to avoid pregnancy while taking ROZAT CV CAPSULE.
BREASTFEEDING
ROZAT CV CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking ROZAT CV CAPSULE.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you experience dizziness after taking ROZAT CV CAPSULE.
ALCOHOL
Avoid consumption of alcohol while taking ROZAT CV CAPSULE, as it could aggravate your existing disease condition.
KIDNEY
ROZAT CV CAPSULE is not recommended for use in patients with severe kidney disease and should be used with caution in patients with kidney problems. Consult your doctor before taking ROZAT CV CAPSULE.
LIVER
ROZAT CV CAPSULE is not recommended for use in patients with liver disease. Consult your doctor before taking ROZAT CV CAPSULE.
ALLERGY
Do not take ROZAT CV CAPSULE if you are allergic to Clopidogrel or Rosuvastatin.
LUNGS
ROZAT CV CAPSULE should be taken with caution in patients with severe respiratory failure. Consult your doctor before taking ROZAT CV CAPSULE.
OTHERS
ROZAT CV CAPSULE is not recommended for use if you:
- have or had repeated or unexplained muscle aches or pains in the past
- have a family history of muscle problems
- have a previous history of muscle problems while taking other cholesterol-lowering medicines
- have problems in the thyroid gland
- are alcoholic
- have any condition that can increase the risk of bleeding (such as the presence of stomach ulcer, blood disorders, ischemic stroke (a blood clot in an artery supplying your brain), recent serious injury or have any upcoming surgery (including dental) or recently had one)
Before taking ROZAT CV CAPSULE, inform your physician if you:
- are of asian origin
- have diabetes or at risk of developing diabetes (Ex. being overweight, having high levels of glucose in the blood or high blood pressure)
Use in pediatrics:
ROZAT CV CAPSULE is not suitable for use in children and adolescents (aged below 18 years) due to risk of bleeding (such as stomach ulcer, blood disorders leading to bleeding into tissues, organs or joints of the body, recent serious injury, recent surgery (including dental), ischemic stroke (occurred within last 7 days), planned surgery (in next 7 days). It is strictly not recommended for use in children aged below 6 years. Consult your child’s doctor for advice.
Use in geriatrics:
ROZAT CV CAPSULE should be used with caution in elderly patients (aged 65 years or above). Proper dose adjustments and careful monitoring are required in such patients. Consult your doctor before taking ROZAT CV CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ROZAT CV 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 ROZAT CV CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage of ROZAT CV CAPSULE may lead to prolonged bleeding time and subsequent bleeding complications.
SYNOPSIS
| Drug | : | Clopidogrel, Rosuvastatin |
| Pharmacological Category | : | Antiplatelets, HMG-CoA reductase inhibitors |
| Therapeutic Indication | : | Myocardial infarction, Angina, Acute coronary Syndrome and stroke |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep ROZAT CV CAPSULE out of reach of children
- Store at room temperature
FAQs ABOUT ROZAT CV CAPSULE
Can I consume alcohol while taking [GBBNKEYWORD]?
No, avoid consumption of alcohol while taking ROZAT CV 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 ROZAT CV CAPSULE inform your doctor if you are an alcoholic.
Can ROZAT CV CAPSULE be taken during pregnancy?
No, ROZAT CV CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking this medicine. If you become pregnant while taking ROZAT CV CAPSULE, stop taking it and consult your doctor immediately. Women of childbearing potential should use a suitable contraceptive method to avoid pregnancy while taking ROZAT CV CAPSULE.
Can ROZAT CV CAPSULE cause diabetes?
Yes, ROZAT CV 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 ROZAT CV 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 ROZAT CV CAPSULE?
Although the combination of aspirin with clopidogrel and rosuvastatin is considered safe, consult your doctor before taking ROZAT CV 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 ROZAT CV CAPSULE prevent a heart attack?
Yes, ROZAT CV 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 ROZAT CV CAPSULE inform your doctor if you have pre-existing heart problems.
Can ROZAT CV CAPSULE cause blood in stool?
ROZAT CV 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 ROZAT CV CAPSULE.
What to do If I forget to take ROZAT CV CAPSULE?
You should take ROZAT CV CAPSULE immediately when you remember. If it is time for your next dose of ROZAT CV CAPSULE skip the dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
What is ROZAT CV CAPSULE used for?
ROZAT CV 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 ROZAT CV 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
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 02 Dec 2022 | 12:47 PM(IST)
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