INTRODUCTION
ECOPRIL AT is a combination of Atorvastatin and Clopidogrel which belongs to the group of medicines called HMG-CoA reductase inhibitors and Antiplatelet medicines respectively. ECOPRIL AT is used to reduce elevated cholesterol and triglyceride levels in patients when a low-fat diet and lifestyle changes alone have failed. It can also be used to reduce the risk of heart problems such as myocardial infarction (heart attack), stroke (reduced blood supply to brain leading to brain death), angina (chest pain), heart failure or revascularization procedures in adult patients with or without a clinically evident chronic heart disease.
Atorvastatin reduces the production of bad cholesterol and clopidogrel blocks the aggregation of platelets in the blood vessels, leading to prevention of heart problems. Along with the treatment, the patient should follow an appropriate lipid-lowering diet as advised by their doctor to enhance recovery.
ECOPRIL AT is not suitable for use in children aged below 18 years. Before using ECOPRIL AT, inform your doctor if you have any liver or kidney disease. Patients with an active liver disease should discontinue the use of ECOPRIL AT as it may cause serious side effects in them. ECOPRIL AT is not recommended for use in pregnant or breast-feeding women and in patients with bleeding disorders.
Avoid consumption of grapefruit juice or alcohol while taking ECOPRIL AT as it may lead to unwanted interactions. Consult your doctor for advice before taking. The most common side effects of taking ECOPRIL AT are muscle pain, joint pain, diarrhea, nausea, headache, or stomach pain. Consult your doctor if any of the symptoms worsen.
USES OF ECOPRIL AT
- To reduce elevated cholesterol and triglyceride levels in patients when a low-fat diet and lifestyle changes alone have failed
- To reduce the risk of heart problems such as myocardial infarction (MI), stroke, angina, heart failure or revascularization procedures in adult patients with or without a clinically evident chronic heart disease
HOW ECOPRIL AT WORKS
ECOPRIL AT reduces elevated cholesterol and risk of heart disease, where atorvastatin acts by inhibiting the action of an enzyme called HMG-CoA reductase, which is required to catalyze the formation of cholesterol and clopidogrel acts by inhibiting platelet aggregation, which is believed to be an important factor resulting in heart problems (such as MI, stroke, cardiac failure, or angina).
DIRECTIONS FOR USE
Take ECOPRIL AT as advised by your physician. Swallow ECOPRIL AT 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 ECOPRIL AT
COMMON
- diarrhoea
- stomach pain
- indigestion or heartburn
- inflammation of nasal passages, pain in throat, nosebleed
- allergic reactions
- headache
- nausea, constipation, flatulence, indigestion
- joint pain, muscle and back pain
UNCOMMON
- loss of appetite
- weight gain
- decrease in blood sugar levels (in diabetic patients)
- nightmares, insomnia
- dizziness, numbness or tingling sensation in finger or toes
- reduction of sensation to pain or touch, change in sense of taste
- loss of memory, blurred vision
- ringing in the ears or head
- vomiting, belching, upper and lower abdominal pain
- inflammation of pancreas (leading to stomach pain)
- inflammation of liver
- stomach ulcer
- skin rash and itching
- hair loss
- neck pain, muscle tiredness
- feeling unwell, tiredness, weakness, or chest pain
- swelling especially in the ankles (oedema), raised temperature
RARE
- visual disturbance
- unexpected bleeding or bruising
- cholestasis (yellowing of the skin and whites of the eyes)
- tendon injury
- vertigo, enlarged breasts in males
Stop taking ECOPRIL AT and contact your doctor immediately if you experience the following side effects:
- severe allergic reactions (such as swelling of the face, lips, tongue, and/or throat which can lead to difficulty in breathing or swallowing)
- rhabdomyolysis (abnormal muscle breakdown causing muscle weakness, pain, tenderness, red-brown discoloration of urine, weakness and raised body temperature)
- lupus-like disease syndrome (such as joint disorders, rash and altered count of blood cells)
- unexpected or unusual bleeding or bruising, hematoma
- severe skin reactions (such as peeling and swelling of the skin, blistering of skin around mouth, eyes, genitals, and fever. Skin rash with red raised lumps on palms of hands or sole of the feet)
- signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether associated with bleeding which appears under the skin as red pinpoint dots
- signs of infection or extreme tiredness (due to decrease of some blood cells)
HOW TO MANAGE SIDE EFFECTS
Stomach pain:
Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Avoid eating oily, spicy or fried foods. If the symptom does not improve, contact your doctor.
Diarrhoea:
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.
Flatulence:
Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. 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.
WARNING & PRECAUTIONS
PREGNANCY
ECOPRIL AT is not recommended for use in pregnant women. Consult your doctor before taking ECOPRIL AT if you are pregnant or planning to get pregnant.
BREASTFEEDING
ECOPRIL AT is not recommended for use in breast-feeding women. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or operate any machines if your ability is affected after taking ECOPRIL AT.
ALCOHOL
Avoid consumption of alcohol while taking ECOPRIL AT.
KIDNEY
ECOPRIL AT should be used with caution in patients with kidney disease. Consult your doctor before taking ECOPRIL AT.
LIVER
ECOPRIL AT is not recommended for use in patients with active liver disease including unexplained persistent elevations in hepatic transaminase levels. Consult your doctor before taking ECOPRIL AT.
ALLERGY
Do not take ECOPRIL AT if you are allergic to Atorvastatin or Clopidogrel.
LUNGS
ECOPRIL AT should be used with caution in patients with severe respiratory failure. Consult your doctor before taking ECOPRIL AT.
OTHERS
ECOPRIL AT is not recommended for use if you have:
- bleeding disorders (such as bleeding in gastro-intestinal tract due to stomach ulcer or bleeding within the brain)
Before taking ECOPRIL AT, inform your physician if you have:
- hypothyroidism, diabetes
- repeated or unexplained muscle aches or pains
- personal history or family history of muscle problems
- previous muscular problems during treatment with other lipid-lowering medicines (such as rosuvastatin or fenofibrate)
- blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs, or joints of your body)
- recent serious injury
- recent surgery (including dental surgery)
- any planned surgeries
- ischemic stroke which occurred within the last seven days.
- past medical history of non-traumatic brain hemorrhage
- allergy or reaction to any medicine used to treat your disease.
Use in pediatrics:
ECOPRIL AT is not recommended for use in children and adolescents (below 18 years) due to lack of safety and effectiveness. Consult child’s doctor for advice.
Use in geriatrics:
ECOPRIL AT should be used with caution in elderly patients (65 years of age or above). During prolonged treatment with ECOPRIL AT your doctor will monitor you regularly. Consult your doctor before taking ECOPRIL AT.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ECOPRIL AT inform to your doctor, if you are taking any of these medicines:
- other medicines used to control high blood cholesterol levels (Ex. cholestyramine, colestipol, gemfibrozil, ezetimibe)
- ticlopidine (used to prevent stroke)
- medicines used to treat depression (Ex. fluoxetine, fluvoxamine, citalopram, sertraline, venlafaxine, duloxetine, desvenlafaxine)
- niacin (a vitamin supplement)
- cyclosporin (an immunosuppressant used to prevent graft rejection)
- telithromycin, clarithromycin, fusidic acid (used to treat bacterial infections)
- HIV protease inhibitors (used to treat HIV infections) such as ritonavir or lopinavir
- itraconazole (used to treat fungal infections)
- proton pump inhibitors (used to treat stomach ulcers) Ex. omeprazole and esomeprazole
- repaglinide (used to treat diabetes)
- paclitaxel (used to treat some forms of cancer)
- rifampin (used to treat tuberculosis)
- digoxin (used to treat abnormal heart rate)
- oral contraceptives (Ex. norethindrone and ethinyl estradiol) (used to prevent pregnancy)
- colchicine (used to treat gout)
- non-steroidal anti-inflammatory agents (NSAIDs) (used to treat pain) Ex. aspirin
- heparin and warfarin (used to reduce blood clotting)
- St. john’s wort (used to mental illness)
B. Drug-Food interaction:
While taking ECOPRIL AT, avoid taking large quantities (not more than one or two small glasses) of grapefruit juice as it can alter the effects of this medicine resulting in undesired therapeutic outcome.
Overdosage:
If you or anyone else take too much of ECOPRIL AT, contact your doctor immediately or go to a hospital straight away because of increased risk of bleeding.
SYNOPSIS
| Drug | : | Atorvastatin, Clopidogrel |
| Pharmacological Category | : | HMG-CoA reductase inhibitors, Anti-platelet medication |
| Therapeutic Indication | : | Controls blood cholesterol levels, Reduces the risk of heart diseases |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep ECOPRIL AT out of reach of children
- Store at room temperature
FAQs ABOUT ECOPRIL AT
What foods should I avoid while taking ECOPRIL AT?
While taking ECOPRIL AT avoid eating foods high in fat or cholesterols such as fried or processed foods, grapefruit juice, dairy products, and red meat which can lead to poor therapeutic outcome to treat disease.
Can I drink alcohol while taking ECOPRIL AT?
No, avoid drinking alcohol while taking ECOPRIL AT as it may increase the risk of bleeding in stomach or delays bleeding time. Drinking alcohol also worsens the condition of the patient resulting in increased risk of heart attack or stroke.
Can I try to get pregnant while taking ECOPRIL AT?
No, ECOPRIL AT 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 ECOPRIL AT.
Can I continue to take ECOPRIL AT before any planned surgeries?
No, avoid taking ECOPRIL AT 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 ECOPRIL AT for some time or may suggest an alternative therapy to improve your disease condition.
Can ECOPRIL AT be taken during periods?
ECOPRIL AT generally can increase your tendency to bleed and if taken during periods, it may cause heavy menstrual bleeding. Consult your doctor before taking ECOPRIL AT. Your doctor might either ask you to discontinue the treatment with ECOPRIL AT for some time or may suggest an alternative therapy to improve your disease condition.
REFERENCES
1. KD. Tripathi. Hypolipidemic Drugs and Plasma Expanders & Drugs Affecting Coagulation, Bleeding and Thrombosis. Essentials of medical pharmacology. Seventh edition. 2013. Page – 636 & 630.
2. 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 – 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 – 321-2775.
4. Ospedale Misericordia e Dolce. Atorvastatin and Clopidogrel High Dose in Stable Patients with Residual High Platelet Activity (ACHIDO). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in January 2012] [Accessed on 18th August 2021] https://clinicaltrials.gov/ct2/show/NCT01335048
5. Goeng Bae Kim, Jeong Kyung Kim, Sul Park, Jae Jin Jeong, Hyung Sik Yoon, Sang Hun Ko, Jae Ee Ko, Soo Jin Park, Seon Woo Nam, Jae Hwan Lee, and Min Soo Hyon. Effect of Atorvastatin and Clopidogrel Co-Administration After Coronary Stenting in Korean Patients with Stable Angina. NCBI; PMC US National Library of Medicine, National Institute of Health. January 2011. [Accessed on 18th August 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040400/
6. Cipla Ltd. ATORLIP CV Capsules (Atorvastatin calcium + Clopidogrel). Ciplamed. [Revised in October 2016]. [Accessed 18th August 2021] https://www.ciplamed.com/content/atorlip-cv-capsules
7. CP Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 18th August 2021] https://www.medicines.org.uk/emc/files/pil.2346.pdf
8. APL Swift Services (Malta) Limited or Milpharm Limited. Electronic Medicines Compendium (EMC). [Revised in March 2021] [Accessed on 18th August 2021] https://www.medicines.org.uk/emc/files/pil.5207.pdf
USEFUL DIAGNOSTIC TESTS
- Kidney function test
- Liver function test
- Complete blood count
VIDEOS
Atorvastatin+Clopidogrel Tablet - Drug Information
Atorvastatin+Clopidogrel Tablet : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage
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