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INTRODUCTION

ROSLOY GOLD 20 is a combination of Aspirin, Clopidogrel and Rosuvastatin which belongs to the group of medicines called Non-Steroidal Anti-Inflammatory Drugs, Antiplatelets and HMG-CoA reductase inhibitors respectively. ROSLOY GOLD 20 is indicated for the treatment of acute coronary syndrome, myocardial infarction (heart attack), angina (chest pain), or stroke (reduced blood supply to brain leading to brain death) that were caused due to clot or plaque formation in the blood vessels supplying the heart. 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.  

Clopidogrel is an antiplatelet medicine that blocks the aggregation of platelets (cells that form blood clots) in the blood vessels and aspirin is a non-steroidal anti-inflammatory drug that irreversibly inhibits the activity of certain enzymes involved in the production of platelets. Rosuvastatin is an HMG-CoA reductase inhibitor that helps in reducing the production of bad cholesterol. Collectively they reduce the risk of clot or plaque formation in the blood vessels suppling the heart, leading to an improved cardiac function.  Along treatment with ROSLOY GOLD 20 follow a healthy low-fat diet as advised by doctor to achieve better results.

Avoid drinking alcohol during the therapy, as it could increase the risk of bleeding in the gastrointestinal tract. ROSLOY GOLD 20 is not recommended for use in patients having severe liver, kidney, or heart disease. Consult your doctor before taking. ROSLOY GOLD 20 is generally not recommended for use in pregnant or breastfeeding women and in children (below 18 years). Consult your doctor for an alternative therapy. The most common side effects of taking ROSLOY GOLD 20 are increased bleeding tendency, nausea, indigestion, diarrhea, stomach pain, constipation, muscle pain, dizziness, and headache. Contact your doctor if any of these symptoms worsen.

USES OF ROSLOY GOLD 20

  • Treats acute coronary syndrome  
  • Treats myocardial infarction
  • Treats angina
  • Treats stroke

HOW ROSLOY GOLD 20 WORKS

ROSLOY GOLD 20 effectively improves cardiac function and reduces the risk of heart problems, where clopidogrel acts by inhibiting platelet aggregation in the coronary arteries, aspirin acts by blocking the actions of an enzyme called cyclo-oxygenase 1 which is believed to be responsible for catalyzing the synthesis of platelets and rosuvastatin acts by inhibiting the action of an enzyme called HMG-CoA reductase, which is required to catalyze the formation of cholesterol, thus preventing clot or plaque formation in the coronary arteries leading to an uninterrupted supply of oxygen and blood to the heart.

DIRECTIONS FOR USE

Take ROSLOY GOLD 20 as advised by your physician. Swallow ROSLOY GOLD 20 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 ROSLOY GOLD 20

COMMON

  • increased bleeding or bruising
  • indigestion, diarrhea, stomach pain, nausea, constipation
  • bleeding in the gut
  • diabetes (high blood glucose)
  • dizziness and headache
  • muscle cramps or pain
  • weakness or lack of energy
  • epistaxis (bleeding from the nose)

UNCOMMON

  • runny nose
  • skin rash, itching, or skin reactions
  • breathing difficulty
  • stomach ulcer, vomiting
  • excessive gas in stomach or intestine
  • tingling or numbness sensation

RARE

  • signs of decreased platelet count (easy bleeding or bruising)
  • enlarged breasts in men (gynecomastia)
  • vertigo (spinning sensation)
  • lupus-like disease syndrome (including rash, joint disorders, and effects on blood cells)
  • aplastic anemia
  • intracranial hemorrhage (bleeding in the brain)

Stop taking ROSLOY GOLD 20 and contact your doctor immediately if you experience any of the following side effects:

  • severe allergic reactions (such as skin rash, itching, swelling of the face, lips, throat and neck, difficulty in breathing or swallowing)
  • Thrombotic Thrombocytopenic Purpura (a blood disorder that causes blood clots in capillaries throughout the body)
  • severe skin disorders with fever (Ex. Lyell’s syndrome, Steven-Johnsons syndrome, erythema nodosum, erythema multiforme)
  • symptoms of pancreatitis (such as moderate to severe abdominal pain, nausea, vomiting, fever, rapid heart rate)
  • jaundice (yellowing of eyes, skin, and urine with fever)
  • rhabdomyolysis (muscle rupture)
  • unusual bleeding (such as blood in vomit or urine, coughing up blood, black stools, purple spots under the skin)
  • flu-like symptoms (fever, cough, sore throat, headache and extreme tiredness)
  • breathing difficulties (Ex. bronchospasm, asthma attack)
  • hemorrhagic vasculitis (inflammation of the blood vessels with bleeding)
  • abnormal heavy or prolonged menstrual periods

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take ROSLOY GOLD 20 with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Diarrhea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. 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 head 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 fiber rich foods such as fresh fruits, vegetables and 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 heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

WARNING & PRECAUTIONS

PREGNANCY

ROSLOY GOLD 20 is not recommended for use in pregnant women. However, consult your doctor before taking ROSLOY GOLD 20. Women of child-bearing potential should use suitable contraceptive method to avoid pregnancy while taking ROSLOY GOLD 20.

BREASTFEEDING

ROSLOY GOLD 20 is not recommended for use in breastfeeding women. Consult your doctor before taking ROSLOY GOLD 20.

DRIVING AND USING MACHINES

ROSLOY GOLD 20 does not affect your ability to drive or operate machines. However, if you experience dizziness during treatment with ROSLOY GOLD 20, do not drive or operate any machines. Consult your doctor before taking ROSLOY GOLD 20.

ALCOHOL

Avoid consumption of alcohol while taking ROSLOY GOLD 20 as it may increase the risk of stomach bleeding and aggravate your existing condition.

KIDNEY

ROSLOY GOLD 20 is not recommended for use in patients having moderate-to-severe kidney disease and ROSLOY GOLD 20 should be used with caution in patients with kidney problems. Consult your doctor before taking ROSLOY GOLD 20.

LIVER

ROSLOY GOLD 20 is not recommended for use in patients having severe liver disease and active liver disease (including persistent elevations of serum transaminases exceeding three times the upper limit) and ROSLOY GOLD 20 should be used with caution in patients with history of liver disease. Consult your doctor before taking ROSLOY GOLD 20.

ALLERGY

Do not take ROSLOY GOLD 20 if you are allergic to Clopidogrel, Rosuvastatin, Aspirin or prostaglandin synthetase inhibitors (Ex. naproxen, ibuprofen, mefenamic acid, and indomethacin).

LUNGS

ROSLOY GOLD 20 should be used with caution in patients with interstitial lung disease or severe respiratory failure. Consult your doctor before taking ROSLOY GOLD 20.

HEART DISEASE

ROSLOY GOLD 20 is not recommended for use in patients with recent ischemic stroke. Consult your doctor before taking ROSLOY GOLD 20.

OTHERS

ROSLOY GOLD 20 is not recommended for use if you:

  • have or had any repeated or unexplained muscle pains
  • have family history of hereditary muscular disorders
  • have family history of muscle problems following treatment with cholesterol-lowering medicines
  • have an underactive thyroid gland
  • have gastrointestinal problems (such as peptic ulcer, or bleeding in the gut)
  • have bleeding disorders (Ex. bleeding in the brain, hemophilia, or others)
  • have thrombocytopenia (decreased platelet count)
  • have gout
  • have lactose intolerance
  • have diabetes
  • have dehydration
  • have menorrhagia (abnormally heavy bleeding during menstruation)
  • are alcoholic

Before taking ROSLOY GOLD 20, inform your doctor if you have:

  • upcoming planned surgery (including dental surgery)

Use in pediatrics:

ROSLOY GOLD 20 is strictly not recommended for use in children under 6 years of age and generally not recommended for use in children and adolescents (under 18 years of age) unless prescribed by your physician due to increased risk of bleeding. Consult your doctor before taking ROSLOY GOLD 20.

Use in geriatrics:

ROSLOY GOLD 20 should be used with caution in elderly patients (aged 70 years or above) because of increased risk of gastro-intestinal bleeding and perforation when used for prolonged duration (if prolonged therapy is essential, patients should be reviewed regularly). Consult your doctor before taking ROSLOY GOLD 20.

INTERACTIONS

A. Drug-Drug interactions:

Before taking ROSLOY GOLD 20 inform to your doctor, if you are taking any of these medicines:

  • other anticoagulants (used for blood thinning) Ex. warfarin, coumarin, heparin, phenindione
  • other cholesterol-lowering medicines (Ex. clofibrate, gemfibrozil, fenofibrate, ezetimibe)
  • other non-steroidal anti-inflammatory drugs (Ex. ibuprofen, paracetamol)
  • medicines used to treat HIV infection (Ex. ritonavir with lopinavir and/or atazanavir or sofosbuvir with velpatasvir and voxilaprevir)
  • selective serotonin reuptake inhibitors (used to treat depression) Ex. fluoxetine, sertraline, paroxetine, or fluvoxamine 
  • medicines used to treat stomach ulcers such as antacids (Ex. aluminium hydroxide, magnesium hydroxide) and proton-pump inhibitors (Ex. omeprazole or esomeprazole)
  • medicines used during percutaneous coronary intervention (Ex. abciximab, eptifibatide, and tirofiban)
  • antibiotics (used to treat bacterial infections) such as macrolides (Ex. azithromycin, erythromycin, roxithromycin, and clarithromycin) or fusidic acid
  • medicines used to treat epilepsy (Ex. phenytoin, valproic acid)
  • medicines used to treat diabetes (Ex. insulin, glipizide, glimepiride)
  • ciclosporin or tacrolimus (used to prevent graft rejection or treat auto-immune disease)
  • nicotinic acid (used to treat vitamin b3 deficiency)
  • azole antifungal agents (used to treat fungal infection) Ex. clotrimazole, fluconazole
  • methotrexate (used to treat cancer or other auto-immune diseases)
  • digoxin (used to treat abnormal heart rate)
  • darolutamide (used to treat prostate cancer)
  • regorafenib (used to treat colon or rectal cancer)
  • probenecid or sulfinpyrazone (used to treat gout)
  • dipyridamole (an antiplatelet medicine)
  • lithium (used to treat metal illness)
  • corticosteroids (used to treat pain and inflammation) Ex. prednisolone, dexamethasone
  • acetazolamide (used to treat or prevent altitude sickness)
  • mifepristone (abortion pill)
  • metoclopramide (used to treat vomiting)

Overdosage:

If you or anyone else take too much of ROSLOY GOLD 20, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of ROSLOY GOLD 20 might include increased bleeding, confusion, disorientation, coma, convulsions, vomiting, tinnitus (ringing in the ears), vertigo (spinning sensation), sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation.

SYNOPSIS

Drug :   Aspirin, Clopidogrel, Rosuvastatin
Pharmacological Category :   Non-Steroidal Anti-inflammatory Drugs, Antiplatelets, HMG-CoA reductase inhibitors
Therapeutic Indication :   Acute coronary syndrome, Myocardial infarction, Angina, Stroke
Dosage Forms :   Tablet, Capsule

MORE INFORMATION

  • Keep ROSLOY GOLD 20 out of reach of children
  • Store at room temperature

FAQs ABOUT ROSLOY GOLD 20

Can ROSLOY GOLD 20 make me bleed more?

Yes. ROSLOY GOLD 20 can increase your tendency to bleed and therefore it should be used with caution in patients having bleeding disorders like hemophilia, bleeding in the gut, brain or under the skin or others. While taking ROSLOY GOLD 20 if you experience any symptoms like blood in vomit or urine, coughing up blood, black stools, or purple spots under the skin, contact your doctor immediately as it could be a sign of severe internal bleeding.

Can ROSLOY GOLD 20 be taken during periods?

ROSLOY GOLD 20 generally can increase your tendency to bleed and if taken during periods, it may cause heavy menstrual bleeding. Consult your doctor before taking ROSLOY GOLD 20. Your doctor might either ask you to discontinue the treatment with ROSLOY GOLD 20 for some time or may suggest an alternative therapy to improve your disease condition. 

Can I continue to take ROSLOY GOLD 20 before any planned surgeries?

No. Avoid taking ROSLOY GOLD 20 if you are going to undergo any surgery (including dental surgery) because this medicine can make you bleed more than usual. Your doctor might either ask you to discontinue the treatment with ROSLOY GOLD 20 for some time or may suggest an alternative therapy to improve your disease condition.

Can ROSLOY GOLD 20 be used in children?

No. ROSLOY GOLD 20 is not recommended for use in children and adolescents (under 18 years) unless prescribed by your physician. ROSLOY GOLD 20 is strictly not recommended for use in children aged less than 6 years due to risk of increased side effects. Consult your doctor before taking ROSLOY GOLD 20.

Can I try to get pregnant while taking ROSLOY GOLD 20?

No. ROSLOY GOLD 20 should be discontinued from use if you are trying to get pregnant because, it may cause severe abnormalities to the growing fetus. Also, it is advised that women of child-bearing potential should use suitable contraceptive method to avoid pregnancy while taking ROSLOY GOLD 20. 

Can I consume alcohol while taking ROSLOY GOLD 20?

No. Avoid consumption of alcohol while taking ROSLOY GOLD 20 as it could aggravate your existing disease condition and increase the risk of bleeding. Before taking ROSLOY GOLD 20 inform your doctor if you are alcoholic or have history of alcohol abuse.

REFERENCES

1. KD. Tripathi. Drugs Affecting Coagulation, Bleeding and Thrombosis and Hypolipidemic Drugs and Plasma Expanders. Essentials of medical pharmacology. Seventh edition. 2013. Page – 629-633 & 636-638.

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 – 868-870 & 892-898.

3. Gerald G. Briggs and Roger K. Freeman. A. C. & R. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 888-891, 288-298 & 3463-3465.

4. Susan Smyth. Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in March 2017] [Accessed on 7th October 2021] https://www.clinicaltrials.gov/ct2/show/study/NCT01241903

5. Michael J. Lim, Frederick A. Spencer, Joel M. Gore, Omar H. Dabbous, Giancarlo Agnelli, Eva M. Kline-Rogers, Donna DiBenedetto, Kim A. Eagle, Rajendra H. Mehta. Impact of combined pharmacologic treatment with clopidogrel and a statin on outcomes of patients with non-ST-segment elevation acute coronary syndromes: perspectives from a large multinational registry. European Heart Journal. Oxford Academic. February 2005. [Accessed on 7th October 2021] https://academic.oup.com/eurheartj/article/26/11/1063/560931

6. Charles H Hennekens, Danielle Hollar, Arthur S Agatston. Aspirin and Statins to Decrease Risks of Cardiovascular Disease – The Need for Wider Utilization. US Cardiology reviews. 2004. [Accessed on 7th October 2021] https://www.uscjournal.com/articles/aspirin-and-statins-decrease-risks-cardiovascular-disease-need-wider-utilization-0

7. Travis R. Sexton, Eric L. Wallace, Tracy E. Macaulay, Richard J. Charnigo, Virgilio Evangelista, Charles L. Campbell, Alison L. Bailey and Susan S. Smyth. The effect of rosuvastatin on thromboinflammation in the setting of acute coronary syndrome. NCBI; PMC US National Library of Medicine, National Institute of Health. October 2014. [Accessed on 7th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4320305/

8. 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. NCBI; PMC US National Library of Medicine, National Institute of Health. May 2019. [Accessed on 7th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6533696/

9. P. Maggi, G. V. De Socio, S. Cicalini, M. D’Abbraccio, G. Dettorre, A. Di Biagio, C. Martinelli, G. Nunnari, S. Rusconi, L. Sighinolfi, V. Spagnuolo, and N. Squillace. Statins and aspirin in the prevention of cardiovascular disease among HIV-positive patients between controversies and unmet needs: review of the literature and suggestions for a friendly use. NCBI; PMC US National Library of Medicine, National Institute of Health. May 2019. [Accessed on 7th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534832/

10. TORRENT PHARMACEUTICALS LTD. UNISTAR GOLD / ROZUCOR GOLD. Torrentian.com. [Revised in March 2021]. [Accessed on 7th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2934.pdf

11. Cipla Ltd. ROSULIP GOLD Capsules (Rosuvastatin calcium + Clopidogrel + Aspirin). Ciplamed.com. [Revised in January 2019] [Accessed on 7th October 2021] https://ciplamed.com/content/rosulip-gold-capsules

USEFUL DIAGNOSTIC TESTS

  • Electrocardiogram
  • Kidney function test
  • Liver function test
  • Complete blood count

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ROSLOY GOLD 20 Capsule 15's

ROSLOY GOLD 20 Capsule 15's Mkt: Lloyd Healthcare Pvt Ltd

M.R.P.: Rs.361.04
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