CLOPITORVA 40 Capsule 10’s

INTRODUCTION

CLOPITORVA 40 CAPSULE is a combination of Atorvastatin and Clopidogrel which belongs to theroup of medicines called HMG-CoA reductase inhibitors and Antiplatelet medicines respectively. CLOPITORVA 40 CAPSULE 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), angina (chest pain), heart failure including stroke (reduced blood supply to the brain leading to brain death) or revascularization procedures in adult patients with or without a clinically evident chronic heart disease.

Along with treatment with CLOPITORVA 40 CAPSULE, patient should follow an appropriate lipid-lowering diet as advised by their doctor to enhance recovery.

Before using CLOPITORVA 40 CAPSULE, inform your doctor if you have any liver or kidney disease. Patients with active liver disease should discontinue the use of CLOPITORVA 40 CAPSULE as it may cause serious side effects in them.

CLOPITORVA 40 CAPSULE is not recommended for use in pregnant or breastfeeding women and in patients with bleeding disorders. CLOPITORVA 40 CAPSULE is not suitable for use in children and adolescents (aged below 18 years).

Avoid consumption ofrapefruit juice or alcohol while taking CLOPITORVA 40 CAPSULE as it may lead to unwanted interactions. Consult your doctor for advice before taking this medicine.

The most common side effects of taking CLOPITORVA 40 CAPSULE are muscle pain, joint pain, diarrhoea, nausea, headache or stomach pain. Consult your doctor if any of the side effects worsen.

USES OF CLOPITORVA 40 CAPSULE
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), angina, heart failure including stroke or revascularization procedures in adult patients with or without clinically evident of chronic heart disease
HOW CLOPITORVA 40 CAPSULE WORKS

CLOPITORVA 40 CAPSULE 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 heart attack, cardiac failure or angina).

DIRECTIONS FOR USE

Take CLOPITORVA 40 CAPSULE as advised by your physician. Swallow CLOPITORVA 40 CAPSULE with alass 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 CLOPITORVA 40 CAPSULE
COMMON
Diarrhoea
Stomach pain
Indigestion or heartburn
Inflammation of nasal passages, pain in the throat, nosebleed
Allergic reactions
Headache
Nausea, constipation, flatulence, indigestion
Joint pain, muscle and back pain
UNCOMMON
Loss of appetite
Weightain
Decrease in blood sugar levels (in diabetic patients)
Nightmares, insomnia
Dizziness, numbness or tingling sensation in fingers 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
Cholestasis (yellowing of the skin and whites of the eyes)
Tendon injury
Vertigo, enlarged breasts in males

Stop taking CLOPITORVA 40 CAPSULE and contact your doctor immediately if you experience any of 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 discolouration 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,enitals and fever. Skin rash with red raised lumps on palms of hands or soles 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 more frequent meals. Avoid eating oily, spicy or fried foods. If the symptom does not improve, contact your doctor.

Diarrhoea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhoea. Consult your doctor if the symptom does 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 alcohol. Consult your doctor if the symptom does not improve.

Flatulence:

Eat smaller and more frequent meals. Eat and drink slowly and exercise regularly. Consult your doctor if the symptom does not improve.

Constipation: 

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

WARNING & PRECAUTIONS
PREGNANCY

CLOPITORVA 40 CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking CLOPITORVA 40 CAPSULE if you are pregnant or planning toet pregnant.

BREASTFEEDING

CLOPITORVA 40 CAPSULE 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 CLOPITORVA 40 CAPSULE.

ALCOHOL

Avoid consumption of alcohol while taking CLOPITORVA 40 CAPSULE.

KIDNEY

CLOPITORVA 40 CAPSULE should be used with caution in patients with kidney disease. Consult your doctor before taking CLOPITORVA 40 CAPSULE.

LIVER

CLOPITORVA 40 CAPSULE is not recommended for use in patients with active liver disease, including unexplained persistent elevations in hepatic transaminase levels. Consult your doctor before taking CLOPITORVA 40 CAPSULE.

ALLERGY

Do not take CLOPITORVA 40 CAPSULE if you are allergic to Atorvastatin or Clopidogrel.

LUNGS

CLOPITORVA 40 CAPSULE should be used with caution in patients with severe respiratory failure. Consult your doctor before taking CLOPITORVA 40 CAPSULE.

OTHERS

CLOPITORVA 40 CAPSULE is not recommended for use if you have:

Bleeding disorders (such as bleeding in theastrointestinal tract due to stomach ulcer or bleeding within the brain)

Before taking CLOPITORVA 40 CAPSULE, 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 haemorrhage
Allergy or reaction to any medicine used to treat your disease

Use in pediatrics:

CLOPITORVA 40 CAPSULE is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety and effectiveness. Consult your child’s doctor for advice.

Use ineriatrics:

CLOPITORVA 40 CAPSULE should be used with caution in elderly patients (65 years of age or above). During prolonged treatment with CLOPITORVA 40 CAPSULE, your doctor will monitor you regularly. Consult your doctor before taking CLOPITORVA 40 CAPSULE.

INTERACTIONS

A. Drug-Drug interactions:

Before taking CLOPITORVA 40 CAPSULE inform your doctor, if you are taking any of these medicines:

Other medicines used to control high blood cholesterol levels (Ex. cholestyramine, colestipol,emfibrozil, 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 preventraft rejection)
Telithromycin, clarithromycin, fusidic acid (used to treat bacterial infections)
HIV protease inhibitors (used to treat HIV infection) 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 certain 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 treatout)
Non-steroidal anti-inflammatory agents (NSAIDs) (used to treat pain) Ex. aspirin
Heparin and warfarin (used to prevent or treat blood clots)
St. john’s wort (used to treat mental illness)

B. Drug-Food interaction:

While taking CLOPITORVA 40 CAPSULE, avoid taking large quantities (not more than one or two smalllasses) ofrapefruit juice as it can alter the effects of this medicine resulting in undesired therapeutic outcomes.

Overdosage:

If you or anyone else accidentally take too much of CLOPITORVA 40 CAPSULE, contact your doctor immediately oro 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 fo heart diseases
Dosage Forms :   Tablet, Capsule
MORE INFORMATION
Keep CLOPITORVA 40 CAPSULE out of reach of children
Store at room temperature
FAQs ABOUT CLOPITORVA 40 CAPSULE

What foods should I avoid while taking CLOPITORVA 40 CAPSULE?

While taking CLOPITORVA 40 CAPSULE avoid eating foods high in fat or cholesterol such as fried or processed foods,rapefruit juice, dairy products and red meat which can lead to poor therapeutic outcomes to treat disease.

Can I drink alcohol while taking CLOPITORVA 40 CAPSULE?

No, avoid drinking alcohol while taking CLOPITORVA 40 CAPSULE as it may increase the risk of bleeding in the stomach or delay bleeding time. Drinking alcohol also worsens the condition of the patient resulting in an increased risk of heart attack or stroke.

Can I try toet pregnant while taking CLOPITORVA 40 CAPSULE?

No, CLOPITORVA 40 CAPSULE should be discontinued from use if you are trying toet pregnant because it may cause severe abnormalities to therowing fetus. Also, it is advised that women of childbearing potential should use a suitable contraceptive method to avoid pregnancy while taking CLOPITORVA 40 CAPSULE.

Can I continue to take CLOPITORVA 40 CAPSULE before any planned surgeries?

No, avoid taking CLOPITORVA 40 CAPSULE if you areoing 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 CLOPITORVA 40 CAPSULE for some time or may suggest an alternative therapy to improve your disease condition.

Can CLOPITORVA 40 CAPSULE be taken during periods?

CLOPITORVA 40 CAPSULEenerally can increase your tendency to bleed and if taken during periods, it may cause heavy menstrual bleeding. Consult your doctor before taking CLOPITORVA 40 CAPSULE. Your doctor might either ask you to discontinue the treatment with CLOPITORVA 40 CAPSULE 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.oodman &ilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 894-898.

3.erald. Briggs and Roger K. Freeman. A referenceuide 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 29th October 2022] https://clinicaltrials.gov/ct2/show/NCT01335048

5.oeng 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 29th October 2022]  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040400/

6. Cipla Ltd. Atorlip CV Capsules (Atorvastatin calcium + Clopidogrel). Ciplamed. [Revised in October 2016]. [Accessed on 29th October 2022] https://www.ciplamed.com/content/atorlip-cv-capsules

7. CP Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 29th October 2022] 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 29th October 2022] https://www.medicines.org.uk/emc/files/pil.5207.pdf

USEFUL DIAGNOSTIC TESTS
Kidney function test
Liver function test
Complete blood count
PRODUCT DETAILS
Country Of Origin
India