Simclovix is used alone or together with aspirin to lessen the chance of a heart attack or stroke. It is given to patients who have already had a heart attack, severe chest pain, or a stroke, or to patients with other circulation problems that could cause a stroke or heart attack.
A heart attack or stroke may occur when a blood vessel is blocked by a blood clot. Simclovix is a platelet inhibitor. It reduces the chance that a harmful blood clot will form by preventing platelets from clumping together in the blood. Simclovix may also increase the chance of serious bleeding in some people.
Simclovix is available only with your doctor's prescription.
Simclovix indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Prevention of atherothrombotic events in: Recent MI, Recent Stroke or Established Peripheral Arterial Disease: For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Simclovix has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
Acute Coronary Syndrome: For patients with non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or coronary artery bypass graft (CABG), Simclovix has been shown to decrease the rate of a combined endpoint of cardiovascular death, MI or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke or refractory ischemia.
For patients with ST-segment elevation acute MI, Simclovix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, reinfarction or stroke.
Atrial Fibrillation: In patients with atrial fibrillation (AF) at increased risk of vascular events who can take vitamin K antagonist (VKA) therapy, VKA has been shown to be associated with a better clinical benefit than acetylsalicylic acid (aspirin) alone or the combination of Simclovix and aspirin for the reduction of stroke.
In patients with atrial fibrillation who have at least 1 risk factor for vascular events and who cannot take VKA therapy [eg, specific risk of bleeding, physician assessment that patient is unable to comply with international normalized ratio (INR) monitoring or that VKA use is inappropriate], Simclovix is indicated in combination with aspirin for the prevention of atherothrombotic and thromboembolic events, including stroke. Simclovix in combination with aspirin has been shown to reduce the rate of the combined endpoint of stroke, myocardial infarction (MI), non-CNS systemic embolism, or vascular death, largely through a reduction in stroke.
How should I use Simclovix?
Use Simclovix as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Simclovix by mouth with or without food.
Take Simclovix on a regular schedule to get the most benefit from it.
Do not stop taking Simclovix without talking to your doctor. This may increase the risk of heart problems.
If you miss a dose of Simclovix, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Simclovix.
Uses of Simclovix in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Acute coronary syndrome:
ST-segment elevation myocardial infarction: To reduce the rate of myocardial infarction (MI) and stroke in conjunction with aspirin in patients with acute ST-elevation MI who are to be managed medically.
Non-ST-segment elevation acute coronary syndromes: To decrease the rate of MI and stroke in conjunction with aspirin in patients with non-ST-segment elevation acute coronary syndromes (unstable angina/non-ST-elevation MI), including patients who are to be managed medically and those who are to be managed with coronary revascularization.
Myocardial infarction, ischemic stroke, or peripheral atherosclerotic disease: To reduce the rate of MI and stroke in patients with a history of recent MI, recent stroke, or established peripheral atherosclerotic disease.
Off Label Uses
Carotid artery atherosclerosis, symptomatic
Based on the American College of Chest Physicians guidelines for antithrombotic therapy in peripheral artery disease, Simclovix is effective and recommended for patients with symptomatic carotid artery atherosclerosis.
Carotid artery stenting
A randomized, controlled trial with blinded end point adjudication evaluated carotid artery stenting versus carotid endarterectomy in patients with carotid artery stenosis. In this trial, aspirin in combination with Simclovix was used for patients who underwent carotid artery stenting, which suggests that this antiplatelet combination is effective.
Simclovix description
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Each film-coated tablet contains Clopidogrel hydrogen sulphate 97.875 mg (molar equivalent of Simclovix base 75 mg) or Simclovix hydrogen sulphate 391.5 mg (molar equivalent of Simclovix base 300 mg).
Simclovix also contains the following excipients: Hydrogenated castor oil, hydroxypropyl cellulose, mannitol E421, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredient. The pink film coating contains ferric oxide E172, hypromellose 2910, lactose, titanium dioxide and triacetin. The tablets are polished with carnauba wax.
Simclovix hydrogen sulfate is methyl(+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). It has an empirical formula of C16H16CINO2S·H2SO4 and a molecular weight of 419.9.
Simclovix hydrogen sulfate is an inhibitor of ADP-induced platelet aggregation acting by direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex.
Simclovix hydrogen sulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves slightly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°.
Simclovix dosage
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Simclovix Dosage
Generic name: Simclovix bisulfate 75mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Acute Coronary Syndrome
Simclovix can be administered with or without food.
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate Simclovix with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75–325 mg once daily) and continue in combination with Simclovix.
For patients with STEMI, the recommended dose of Simclovix is 75 mg once daily orally, administered in combination with aspirin (75–325 mg once daily), with or without thrombolytics. Simclovix may be initiated with or without a loading dose.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of Simclovix is 75 mg once daily orally, with or without food.
CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to Simclovix. Although a higher dose regimen in poor metabolizers increases antiplatelet response, an appropriate dose regimen for this patient population has not been established.
Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with Simclovix. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of Simclovix. When concomitant administration of a PPI is required, consider using another acid-reducing agent with minimal or no CYP2C19 inhibitory effect on the formation of Simclovix active metabolite.
Because of the increased risk of bleeding, the concomitant administration of warfarin with Simclovix should be undertaken with caution.
Glycoprotein IIb/IIIa Inhibitors: As a pharmacodynamic interaction between Simclovix and glycoprotein IIb/IIIa inhibitors is possible, concomitant use should be undertaken with caution.
Acetylsalicylic Acid: Acetylsalicylic acid did not modify the Simclovix-mediated inhibition of ADP-induced platelet aggregation, but Simclovix potentiated the effect of ASA on collagen-induced platelet aggregation. However, concomitant administration of ASA 500 mg twice daily for 1 day did not significantly increase the prolongation of bleeding time induced by Simclovix intake. As a pharmacodynamic interaction between Simclovix and ASA is possible, leading to increased risk of bleeding. Therefore, concomitant use should be undertaken with caution. However, Simclovix and ASA have been administered together for up to 1 year.
Injectable Anticoagulants: In a clinical study conducted in healthy subjects, Simclovix did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation. Co-administration of heparin had no effect on the IPA induced by Simclovix. As a pharmacodynamic interaction between Simclovix and heparin is possible, concomitant use should be undertaken with caution.
Thrombolytics: The safety of the concomitant administration of Simclovix, thrombolytic agents and heparins was assessed in patients with acute MI. The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparins are co-administered with ASA.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): In a clinical study conducted in healthy volunteers, the concomitant administration of Simclovix and naproxen increased occult gastrointestinal blood loss. However, due to the lack of interaction studies with other NSAIDs, it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs. Consequently, NSAIDs including COX-2 inhibitors and Simclovix should be co-administered with caution.
Selective Serotonin Reuptake Inhibitors (SSRIs): Since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with Simclovix should be undertaken with caution.
Other Concomitant Therapy: Since Simclovix is metabolised to its active metabolite partly by CYP2C19, use of drugs that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of Simclovix. The clinical relevance of this interaction is uncertain. Concomitant use of strong or moderate CYP2C19 inhibitors (eg, omeprazole) should be discouraged. If a proton-pump inhibitor is to be used concomitantly with Simclovix, consider using one with less CYP2C19 inhibitory activity eg, pantoprazole.
Proton-Pump Inhibitors (PPI): In a crossover clinical study, Simclovix (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as Simclovix) were administered for 5 days. The exposure to the active metabolite of Simclovix was decreased by 45% (day 1) and 40% (day 5) when Simclovix and omeprazole were administered together. Mean IPA with 5 mM ADP was diminished by 39% (24 hrs) and 21% (day 5) when Simclovix and omeprazole were administered together.
In a 2nd interaction study with omeprazole 80 mg administered 12 hrs apart from the Simclovix standard regimen, the results were similar, indicating that administering Simclovix and omeprazole at different times does not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19.
In a 3rd interaction study with omeprazole 80 mg administered with a higher dose regimen of Simclovix (600-mg loading dose followed by 150 mg/day), a degree of interaction was observed similar to that noted in the other omeprazole interaction studies. However, active metabolite formation and platelet aggregation were at the same level as Simclovix administered alone at the standard dose regimen.
In a crossover clinical study, healthy subjects were administered Simclovix (300-mg loading dose followed by 75 mg/day) alone and with pantoprazole (80 mg at the same time as Simclovix) for 5 days. The exposure to the active metabolite of Simclovix was decreased by 20% (day 1) and 14% (day 5) when Simclovix and pantoprazole were administered together. Mean IPA was diminished by 15% (24 hrs) and 11% (day 5) when Simclovix and pantoprazole were administered together. These results indicate that Simclovix can be administered with pantoprazole.
The CURRENT trial compared 2 dosing regimens of Simclovix (600-mg loading dose, then 150 mg/day for 6 days followed by 75 mg/day up to 30 days vs 300-mg loading dose followed by 75 mg/day up to 30 days). A subanalysis (n=18,432) correlated PPI use (mainly omeprazole and pantoprazole) at randomization and hospital discharge and demonstrated no interaction between Simclovix and PPI use for the primary endpoint (CV death, MI or stroke) or any secondary endpoints, including stent thrombosis.
A number of other clinical studies have been conducted with Simclovix and other concomitant medications to investigate the potential for pharmacodynamic and pharmacokinetic interactions. No clinically significant pharmacodynamic interactions were observed when Simclovix was co-administered with atenolol, nifedipine or both atenolol and nifedipine. Furthermore, the pharmacodynamic activity of Simclovix was not significantly influenced by the co-administration of phenobarbital, or oestrogen.
The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of Simclovix. Antacids did not modify the extent of Simclovix absorption.
Although the administration of Simclovix 75 mg/day did not modify the pharmacokinetics of S-warfarin (a CYP2C9 substrate) or INR in patients receiving long-term warfarin therapy, co-administration of Simclovix with warfarin increases the risk of bleeding because of independent effects on hemostasis. However, at high concentrations in vitro, Simclovix inhibits CYP2C9. It is unlikely that Simclovix may interfere with the metabolism of drugs eg, phenytoin and tolbutamide and the NSAIDs, which are metabolised by cytochrome P-450 2C9. Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with Simclovix.
Apart from the specific drug interaction information described previously, interaction studies with Simclovix and some drugs commonly administered in patients with atherothrombotic disease have not been performed. However, patients entered into clinical trials with Simclovix received a variety of concomitant medications including diuretics, β-blockers, ACE inhibitors, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, hormone replacement therapy and GP IIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Simclovix has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including >12,000 patients treated for ≥1 year. Overall, Simclovix 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race. The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed as follows. In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the 1st month of treatment.
In CAPRIE, in patients treated with either Simclovix or ASA, the overall incidence of any bleeding was 9.3%. The incidence of severe cases was similar for Simclovix and ASA.
In CURE, there was no excess in major bleeds with Simclovix + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy >5 days prior to surgery. In patients who remained on therapy within 5 days of bypass graft surgery, the event rate was 9.6% for Simclovix + ASA, and 6.3% for placebo + ASA.
In CLARITY, there was an overall increase in bleeding in the Simclovix + ASA group versus the placebo + ASA group. The incidence of major bleeding was similar between groups. This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
In ACTIVE-A, the rate of major bleeding was greater in the Simclovix + ASA group than in the placebo + ASA group (6.7% vs 4.3%). Major bleeding was mostly of extracranial origin in both groups (5.3% in the Simclovix + ASA group; 3.5% in the placebo + ASA group), mainly from the gastrointestinal tract (3.5% vs 1.8%). There was an excess of intracranial bleeding in the Simclovix + ASA treatment group compared to the placebo + ASA group (1.4% vs 0.8%, respectively). There was no statistically significant difference in the rates of fatal bleeding (1.1% in the Simclovix + ASA group and 0.7% in the placebo + ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in Table 2. Their frequency is defined using the following conventions: Common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000). Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Simclovix should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Simclovix is contraindicated in patients with pheochro-mocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phen-tolamine.
Simclovix is contraindicated in patients with known sensitivity or intolerance to the drug.
Simclovix should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.
DTP/NCI. "clopidogrel: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
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