STATIGA GOLD 20 Capsule 10's

INTRODUCTION

STATIGA GOLD 20 CAPSULE is a combination of Aspirin, Clopidogrel and Atorvastatin which belongs to the group of medicines called Antiplatelets and HMG-CoA reductase inhibitors respectively. STATIGA GOLD 20 CAPSULE is indicated in the treatment of patients with percutaneous coronary intervention (PCI) and myocardial infarction (also known as heart attack which occurs when blood flow to the heart muscle is blocked or interrupted).

Percutaneous coronary intervention (also known as angioplasty with stent) is a non-surgical procedure used among patients with heart problems (such as cardiogenic shock, acute severe heart failure or ischemic symptoms) to unclog blood vessels in the heart that have been narrowed by plaque buildup by placing a stent.

Along treatment with STATIGA GOLD 20 CAPSULE follow a healthy low-fat diet as advised by your doctor to achieve better results. Avoid drinking alcohol during treatment with STATIGA GOLD 20 CAPSULE, as it could increase the risk of bleeding in the gastrointestinal tract.

STATIGA GOLD 20 CAPSULE is not recommended for use in patients with severe liver or kidney disease, recent ischemic stroke, gout, active or recurrent peptic ulcer with or without gastrointestinal bleeding and bleeding disorders (such as bleeding in the brain or hemophilia).

STATIGA GOLD 20 CAPSULE is generally not recommended for use in pregnant or breastfeeding women and in children or adolescents (aged below 18 years). It should be used with caution in elderly patients (aged 70 years or above) because of increased risk of gastro-intestinal bleeding.

The most common side effects of taking STATIGA GOLD 20 CAPSULE are increased bleeding tendency, nausea, indigestion, diarrhea, stomach pain, constipation, muscle pain, dizziness and headache. Consult your doctor if any of these side effects worsen.

USES OF STATIGA GOLD 20 CAPSULE

• Treats patients with percutaneous coronary intervention (PCI) and myocardial infarction

HOW STATIGA GOLD 20 CAPSULE WORKS

STATIGA GOLD 20 CAPSULE 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 atorvastatin 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 STATIGA GOLD 20 CAPSULE as advised by your physician. Swallow STATIGA GOLD 20 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 upon your age, body weight and disease condition.

SIDE EFFECTS OF STATIGA GOLD 20 CAPSULE

HOW TO MANAGE SIDE EFFECTS

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.

Diarrhea

Drink lot 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 does not improve.

Dizziness Or Drowsiness

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 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 of alcohol. Consult your doctor if the symptom does not improve.

Nausea And Vomiting

Try to take STATIGA GOLD 20 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 does not improve.

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 does not improve.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

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

BREASTFEEDING

Contraindicated

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

DRIVING AND USING MACHINES

Use with Caution

STATIGA GOLD 20 CAPSULE does not impair your ability to drive or operate any machines. Consult your doctor before taking STATIGA GOLD 20 CAPSULE.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking STATIGA GOLD 20 CAPSULE as it may increase the risk of stomach bleeding and aggravate your existing condition. Consult your doctor before taking STATIGA GOLD 20 CAPSULE.

KIDNEY

Consult your doctor

STATIGA GOLD 20 CAPSULE is not recommended for use in patients having severe kidney disease and should be used with caution in patients with kidney impairment. Consult your doctor before taking STATIGA GOLD 20 CAPSULE.

LIVER

Consult your doctor

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

ALLERGY

Contraindicated

Do not take STATIGA GOLD 20 CAPSULE if you are allergic to Clopidogrel, Atorvastatin, Aspirin or Prostaglandin synthetase inhibitors (Ex. naproxen, ibuprofen, mefenamic acid and indomethacin).

LUNGS

Use with Caution

STATIGA GOLD 20 CAPSULE should be used with caution in patients with interstitial lung disease or other respiratory problems such as hay fever, asthma or chronic respiratory diseases due to increased risk of bronchospasm and asthma attacks. Consult your doctor before taking STATIGA GOLD 20 CAPSULE.

HEART DISEASE

Consult your doctor

STATIGA GOLD 20 CAPSULE is not recommended for use in patients with recent ischemic stroke and should be used with caution in patients with high blood pressure. Consult your doctor before taking STATIGA GOLD 20 CAPSULE.

INTERACTIONS

A. Drug-Drug interactions:

Before taking STATIGA GOLD 20 CAPSULE 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, colestipol)
• other non-steroidal anti-inflammatory drugs (Ex. ibuprofen, indomethacin)
• medicines used to treat HIV infection (Ex. glecaprevir/pibrentasvir, delavirdine, ritonavir with lopinavir and/or atazanavir or sofosbuvir with velpatasvir and voxilaprevir)
• st. john's wort (herbal medicine), 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)
• other medicines used during percutaneous coronary intervention (Ex. abciximab, eptifibatide and tirofiban)
• antibiotics (used to treat bacterial infections) such as macrolides (Ex. azithromycin, telithromycin, erythromycin, roxithromycin and clarithromycin) or fusidic acid
• medicines used to treat epilepsy (Ex. phenytoin, valproic acid, stiripentol)
• medicines used to treat diabetes (Ex. insulin, glipizide, glimepiride)
• ciclosporin or tacrolimus (used to prevent graft rejection or treat auto-immune disease)
• azole antifungal agents (used to treat fungal infection) Ex. clotrimazole, fluconazole
• methotrexate (used to treat cancer or other auto-immune diseases)
• lithium (used to treat mental illness)
• corticosteroids (used to treat pain and inflammation) Ex. prednisolone, dexamethasone
• acetazolamide (used to treat or prevent altitude sickness)
• mifepristone (used to prevent pregnancy)
• metoclopramide (used to treat vomiting)
• deferasirox (used to treat iron overload)
• zafirlukst (used to prevent asthmatic symptoms)
• digoxin, amiodarone and verapamil (used to treat abnormal heart rhythm)
• angiotensin-converting enzyme (ACE) inhibitors such as captopril, enalapril and diuretics such as hydrochlorothiazide (used to treat high blood pressure)
• rifampin (used to treat tuberculosis)
• colchicine, probenecid or sulfinpyrazone (used to treat gout)

B. Drug - Food interaction:

During treatment with STATIGA GOLD 20 CAPSULE, do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can alter the effects of this medicine.

Overdosage:

If you or anyone else accidentally take too much of STATIGA GOLD 20 CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of STATIGA GOLD 20 CAPSULE includes increased bleeding, confusion, disorientation, coma, convulsions, vomiting (sometimes with blood), increased body temperature, low blood sugar levels, tinnitus (ringing in the ears), vertigo (spinning sensation), sweating, warm extremities with bounding pulses, kidney failure, increased respiratory rate and hyperventilation.

SYNOPSIS

MORE INFORMATION

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

FAQs ABOUT STATIGA GOLD 20 CAPSULE

Q: Can I try to get pregnant while taking STATIGA GOLD 20 CAPSULE?

A: No, STATIGA GOLD 20 CAPSULE 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 STATIGA GOLD 20 CAPSULE.

Q: Can I consume alcohol while taking STATIGA GOLD 20 CAPSULE?

A: No, avoid consumption of alcohol while taking STATIGA GOLD 20 CAPSULE as it could aggravate your existing disease condition and increase the risk of bleeding. Before taking STATIGA GOLD 20 CAPSULE inform your doctor if you are alcoholic.

Q: Can STATIGA GOLD 20 CAPSULE cause dizziness?

A: Yes, STATIGA GOLD 20 CAPSULE may cause dizziness in some people. To manage this effect, 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 does not improve.

Q: What to do if I forget to take STATIGA GOLD 20 CAPSULE?

A: You should take STATIGA GOLD 20 CAPSULE immediately when you remember. If it is time for your next dose of STATIGA GOLD 20 CAPSULE skip the dose and follow your regular dose schedule. Do not double the dose of STATIGA GOLD 20 CAPSULE to match up your missed dose.

Q: Is STATIGA GOLD 20 CAPSULE safe to use in patients with liver disease?

A: STATIGA GOLD 20 CAPSULE is not recommended for use in patients with severe liver impairment and active liver disease (including persistent elevations of liver enzymes exceeding three times the upper limit) and should be used with caution in patients with liver impairment. Your doctor will regularly monitor your liver function tests during treatment with STATIGA GOLD 20 CAPSULE to prevent the risk of liver damage. 

Q: Can STATIGA GOLD 20 CAPSULE be used in elderly patients?

A: STATIGA GOLD 20 CAPSULE should be used with caution in elderly patients (aged 70 years and 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 STATIGA GOLD 20 CAPSULE.

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. 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 7th October 2021] https://clinicaltrials.gov/ct2/show/NCT01335048

4. Hospital do Coracao. Statins Evaluation in Coronary Procedures and Revascularization Trial (SECURE-PCI). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in June 2019] [Accessed on 7th October 2021] https://clinicaltrials.gov/ct2/show/NCT01448642

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 7th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040400/

6. Rolf P Kreutz, Jeffrey A Breall Anjan Sinha, Elisabeth von der Lohe, Richard J Kovacs and David A Flockhart. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. NCBI; PMC US National Library of Medicine, National Institute of Health. June 2016. [Accessed on 7th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4902146/

7. HamidReza Pourhosseini , Reza Lashkari, Arya Aminorroaya, Danesh Soltani, Arash Jalali, Masih Tajdini. Effects of high dose atorvastatin before elective percutaneous coronary intervention on highly sensitive troponin T and one year major cardiovascular events; a randomized clinical trial. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. January 2019 [Accessed on 7th October 2021] https://pubmed.ncbi.nlm.nih.gov/30671535/

8. Torrent Pharmaceuticals Ltd. Deplatt-CV. Torrentian.com. [Revised in July 2019]. [Accessed on 7th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2538.pdf

9. Torrent Pharmaceuticals Ltd. Deplatt-CV 20 Forte (Clopidogrel, Atorvastatin and Aspirin Capsules). Torrentian.com. [Revised in July 2019] [Accessed on 7th October 2021] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2741.pdf

USEFUL DIAGNOSTIC TESTS

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

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 28 Jan 2023 | 11:00 AM(IST)