Platless Dosage

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Dosage of Platless in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet,

Oral:

Platless: 75 mg, 300 mg [DSC]

Generic: 75 mg, 300 mg

Dosing: Adult

Acute coronary syndrome:

Note: Routine platelet-function testing or genetic testing for CYP2C19 polymorphisms is not recommended (ACC/AHA [Levine 2016]; Scott 2013; Sibbing 2019).

ST-segment elevation myocardial infarction: Note: Regardless of the reperfusion strategy, administer Platless in combination with a parenteral anticoagulant and aspirin (ACCF/AHA [O'Gara 2013]).

If using fibrinolytic therapy for reperfusion:

Age ≤75 years:

Oral: Initial loading dose: 300 mg once at the time of diagnosis; followed by 75 mg once daily (ACCF/AHA [O'Gara 2013]; Sabatine 2005a).

Age >75 years:

Oral: 75 mg once daily (ACCF/AHA [O'Gara 2013]).

Patient requires percutaneous coronary intervention following fibrinolytic therapy:

Fibrinolytic administered with a loading dose of Platless:

Oral: Continue 75 mg once daily (do not administer an additional loading dose) (ACCF/AHA [O'Gara 2013]).

Fibrinolytic administered ≤24 hours ago without a loading dose of Platless:

Oral: Initial: 300 mg once prior to percutaneous coronary intervention (PCI); followed by 75 mg once daily after PCI (ACCF/AHA [O'Gara 2013]).

Fibrinolytic administered >24 hours ago without a loading dose of Platless:

Oral: Initial: 600 mg once prior to PCI; followed by 75 mg once daily after PCI (ACCF/AHA [O'Gara 2013]).

If using percutaneous coronary intervention for reperfusion (alternative agent) (off-label use): Note: Some experts prefer ticagrelor or prasugrel over Platless unless there is high risk for bleeding (Lincoff 2019; Wallentin 2009; Wiviott 2007).

Oral: Initial: 600 mg once as early as possible before PCI; followed by 75 mg once daily after PCI (ACCF/AHA [O'Gara 2013]; Dangas 2009; Mehta 2010).

If no planned reperfusion strategy (alternative agent): Note: Some experts prefer ticagrelor over Platless (Lincoff 2019).

Oral: Initial: 300 mg once at the time of diagnosis; followed by 75 mg once daily (Lincoff 2019).

Duration of therapy: Platless plus aspirin (dual antiplatelet therapy [DAPT]) should be continued for ≥12 months unless bleeding is a concern. If there have been no major bleeding complications after 12 months, continuation of DAPT may be considered. Reevaluate the need for DAPT at regular intervals based on bleeding and thrombotic risks. When DAPT is complete, discontinue Platless and continue aspirin indefinitely (ACC/AHA [Levine 2016]; ACCF/AHA [O'Gara 2013]; Lincoff 2019; Mauri 2014).

Non-ST-segment elevation acute coronary syndromes: Note: Regardless of the management strategy, administer Platless in combination with a parenteral anticoagulant and aspirin (ACC/AHA [Amsterdam 2014]).

If using an ischemia-guided approach (medical management) (alternative agent): Note: Some experts prefer ticagrelor over Platless (Cutlip 2019a).

Oral: Initial: 300 or 600 mg once at the time of diagnosis; followed by 75 mg once daily (ACC/AHA [Amsterdam 2014]). Some experts prefer an initial dose of 600 mg unless there is high risk for bleeding, in which case, an initial dose of 300 mg is also appropriate (Cutlip 2019a).

If using an invasive approach (reperfusion using percutaneous coronary intervention) (alternative agent): Note: Some experts prefer ticagrelor or prasugrel over Platless unless there is high risk for bleeding (Cutlip 2019a; Wallentin 2009; Wiviott 2007).

Oral: Initial: 600 mg once as early as possible before PCI; followed by 75 mg once daily after PCI (ACC/AHA [Amsterdam 2014]).

Duration of therapy: Platless plus aspirin (DAPT) should be continued for ≥12 months unless bleeding is a concern. If there have been no major bleeding complications after 12 months, continuation of DAPT may be considered. Reevaluate the need for DAPT at regular intervals based on bleeding and thrombotic risks. When DAPT is complete, discontinue Platless and continue aspirin indefinitely (ACC/AHA [Amsterdam 2014]; ACC/AHA [Levine 2016]; Cutlip 2019a; Mauri 2014; Mehta 2001; Yusuf 2001).

Percutaneous coronary intervention for stable ischemic heart disease (off-label use): Note: Administer Platless in combination with a parenteral anticoagulant and aspirin for patients who undergo PCI with stenting (ACCF/AHA/SCAI [Levine 2011]).

Oral: Initial: 600 mg once, administered ≥2 hours before PCI, ideally ≥24 hours before PCI; followed by 75 mg once daily (ACCF/AHA/SCAI [Levine 2011]; Cutlip 2020).

Duration of therapy: Upon completion of the recommended duration of DAPT (Platless plus aspirin), discontinue Platless and continue aspirin indefinitely (ACC/AHA [Levine 2016]; Cutlip 2019c):

• Bare metal stent implantation: DAPT for a minimum of 1 month (ACC/AHA [Levine 2016]). Some experts recommend at least 6 months and up to 12 months; in patients at high bleeding risk, shorter duration may be considered. After 6 to 12 months, assess bleeding and ischemic risks to determine if patient should receive longer therapy (eg, for an additional 18 to 24 months) (Cutlip 2019c).

• Drug eluting stent implantation: DAPT for at least 6 months and up to 12 months; if bleeding occurs or patient is at high risk of bleeding, may stop after 3 months (ACC/AHA [Levine 2016]). After 6 to 12 months, assess bleeding and ischemic risks to determine if patient should receive longer therapy (eg, for an additional 18 to 24 months) (Cutlip 2019c).

Carotid artery atherosclerosis, symptomatic (alternative agent) (off-label use): Note: For patients who are intolerant of aspirin.

Oral: 75 mg once daily (ACCP [Alonso-Coello 2012]; Cucchiara 2019).

Carotid artery stenting (off-label use):

Initial:

Initiation ≥48 hours before procedure:

Oral: 75 mg

twice daily in combination with aspirin (Brott 2010; Fairman 2019).

Initiation <48 hours of procedure:

Oral: 450 mg once ≥4 hours before procedure in combination with aspirin (Brott 2010; Fairman 2019).

Maintenance:

Oral: 75 mg

once daily in combination with aspirin for ≥6 weeks; after 6 weeks of DAPT with Platless and aspirin, assess bleeding and ischemic risks to determine total duration of therapy; upon completion of DAPT, discontinue Platless and continue aspirin indefinitely. In patients with history of neck irradiation, some experts recommend continuing Platless plus aspirin indefinitely (Brott 2010; Fairman 2019).

Coronary artery bypass graft surgery (off-label use):

Aspirin-allergic or aspirin-intolerant patients:

Oral: 75 mg once daily; continue indefinitely (AHA [Kulik 2015]).

Following off-pump coronary artery bypass graft surgery:

Oral: 75 mg once daily in combination with aspirin for 1 year, then discontinue Platless and continue aspirin indefinitely (AHA [Kulik 2015]; Deo 2013; Mannacio 2012).

Patients with acute coronary syndrome followed by coronary artery bypass graft surgery:

Oral: 75 mg once daily in combination with aspirin for 1 year, then discontinue Platless and continue aspirin indefinitely (AHA [Kulik 2015]). Some experts do not use Platless postoperatively in these patients (Aranki 2020).

Peripheral atherosclerotic disease (upper or lower extremity; with or without revascularization):

Oral: 75 mg once daily (ACCP [Alonso-Coello 2012]; AHA/ACC [Gerhard-Herman 2017]; CAPRIE 1996).

Stable ischemic heart disease (alternative agent) (off-label use): Note: Aspirin is preferred; Platless is an alternative for patients who have a history of GI bleeding or are allergic to aspirin (ACCF/AHA [Fihn 2012]).

Oral: 75 mg once daily (ACCF/AHA [Fihn 2012]; ACCP [Vandvik 2012]; CAPRIE 1996).

Stroke/Transient ischemic attack:

Intracranial atherosclerosis (50% to 99% stenosis of a major intracranial artery), secondary prevention: Note: Aspirin is recommended for all patients; may consider Platless (in combination with aspirin) for short-term use in patients with recent stroke or transient ischemic attack (within 30 days) (AHA/ASA [Kernan 2014]; Ehtisham 2019). For long-term stroke prevention, indefinite use of Platless monotherapy is an alternative to aspirin (AHA/ASA [Kernan 2014]).

Oral: 75 mg once daily in combination with aspirin; duration of Platless depends on degree of stenosis.

Stenosis of 50% to 69%: Platless may be added to aspirin for 21 days; after 21 days, discontinue Platless and continue aspirin indefinitely (Ehtisham 2019).

Stenosis of 70% to 99%: Platless may be added to aspirin for 90 days; after 90 days, discontinue Platless and continue aspirin indefinitely (AHA/ASA [Kernan 2014]; Derdeyn 2014; Ehtisham 2019).

Ischemic stroke or transient ischemic attack, noncardioembolic, secondary prevention:

Oral: 75 mg once daily.

Minor ischemic stroke (NIHSS score ≤3) or high-risk transient ischemic attack (ABCD score ≥4): Note: Short-term use of Platless in combination with aspirin may be considered for initiation as soon as possible and within 24 hours of stroke onset. If an IV thrombolytic was administered, delay starting antiplatelet therapy for ≥24 hours but administer as soon as possible thereafter (AHA/ASA [Kernan 2014]; AHA/ASA [Powers 2018]; Johnston 2018; Wang 2013).

Oral: Initial: 300 to 600 mg in combination with aspirin; followed by 75 mg once daily for 21 days; after 21 days, discontinue Platless and continue aspirin indefinitely (AHA/ASA [Kernan 2014]; AHA/ASA [Powers 2018]; Johnston 2018; Wang 2013).

Transcatheter aortic valve replacement (thromboprophylaxis) (off-label use):

Oral: 300 mg once prior to valve implantation in combination with aspirin; followed by 75 mg once daily for 3 to 6 months depending on the type of valve implanted; after completion of Platless, continue aspirin indefinitely (ACC [Otto 2017]; AHA/ACC [Nishimura 2014], AHA/ACC [Nishimura 2017]; Kalich 2018). To minimize risk of bleeding complications, may give aspirin or Platless alone and reserve dual antiplatelet therapy during the first 3 to 6 months for patients at high risk of a thrombotic event; for either strategy, continue aspirin indefinitely (Kuno 2019).

Transitioning between P2Y inhibitor to Platless:

Transitioning from prasugrel:

Patient received prasugrel for ≤5 days: Give a Platless 300 mg loading dose 24 hours after the last dose of prasugrel, followed by 75 mg once daily; some experts do not administer a loading dose (Lincoff 2019).

Patient received prasugrel for >5 days: Give Platless 75 mg once daily, starting 24 hours after the last dose of prasugrel (Kerneis 2013; Lincoff 2019).

Transitioning from ticagrelor: Give a Platless 600 mg loading dose 12 hours after the last dose of ticagrelor, followed by 75 mg once daily (Franchi 2018).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Antiplatelet effect: Limited data available:

Infants and Children ≤24 months: In the PICOLO trial, a dose of 0.2 mg/kg/dose once daily was found to achieve a mean inhibition of platelet aggregation similar to adults receiving the recommended dose; Note: This study included pediatric patients with a systemic-to-pulmonary artery shunt, intracardiac or intravascular stent, Kawasaki disease, or arterial graft; 79% of patients received concomitant aspirin (Li 2008).

Children >2 years and Adolescents: Initial dose: 1 mg/kg once daily; titrate to response; in general, do not exceed adult dose (Finkelstein 2005; Soman 2006).

CYP2C19 poor metabolizers (ie, CYP2C19*2 or *3 carriers): Specific pediatric recommendations are lacking; based on experience in adult patients, routine genetic testing is not recommended in patients treated with Platless undergoing PCI, testing may be considered to identify poor metabolizers who would be at risk for poor outcomes while receiving Platless; if identified, these patients may be considered for an alternative P2Y12 inhibitor (Levine 2011).

What other drugs will affect Platless?

Certain other medicines may increase your risk of bleeding. Tell your doctor if you take aspirin, especially if you have had a stroke. Talk to your doctor about whether you should take aspirin with Platless. Ask a doctor or pharmacist before taking an NSAID (nonsteroidal anti-inflammatory drug), including ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Tell your doctor about all other medicines you use to prevent blood clots, such as:

Tell your doctor about all other medicines you use, and those you start or stop using during your treatment with Platless, especially:

This list is not complete. Other drugs may interact with Platless, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Platless interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Platless, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Oral Anticoagulants:

Because of the increased risk of bleeding, the concomitant administration of warfarin with Platless should be undertaken with caution.

Glycoprotein IIb/IIIa Inhibitors: As a pharmacodynamic interaction between Platless and glycoprotein IIb/IIIa inhibitors is possible, concomitant use should be undertaken with caution.

Acetylsalicylic Acid: Acetylsalicylic acid did not modify the Platless-mediated inhibition of ADP-induced platelet aggregation, but Platless 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 Platless intake. As a pharmacodynamic interaction between Platless and ASA is possible, leading to increased risk of bleeding. Therefore, concomitant use should be undertaken with caution. However, Platless and ASA have been administered together for up to 1 year.

Injectable Anticoagulants: In a clinical study conducted in healthy subjects, Platless 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 Platless. As a pharmacodynamic interaction between Platless and heparin is possible, concomitant use should be undertaken with caution.

Thrombolytics: The safety of the concomitant administration of Platless, 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 Platless 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 Platless 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 Platless should be undertaken with caution.

Other Concomitant Therapy: Since Platless 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 Platless. 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 Platless, consider using one with less CYP2C19 inhibitory activity eg, pantoprazole.

Proton-Pump Inhibitors (PPI): In a crossover clinical study, Platless (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as Platless) were administered for 5 days. The exposure to the active metabolite of Platless was decreased by 45% (day 1) and 40% (day 5) when Platless and omeprazole were administered together. Mean IPA with 5 mM ADP was diminished by 39% (24 hrs) and 21% (day 5) when Platless and omeprazole were administered together.

In a 2nd interaction study with omeprazole 80 mg administered 12 hrs apart from the Platless standard regimen, the results were similar, indicating that administering Platless 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 Platless (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 Platless administered alone at the standard dose regimen.

In a crossover clinical study, healthy subjects were administered Platless (300-mg loading dose followed by 75 mg/day) alone and with pantoprazole (80 mg at the same time as Platless) for 5 days. The exposure to the active metabolite of Platless was decreased by 20% (day 1) and 14% (day 5) when Platless and pantoprazole were administered together. Mean IPA was diminished by 15% (24 hrs) and 11% (day 5) when Platless and pantoprazole were administered together. These results indicate that Platless can be administered with pantoprazole.

The CURRENT trial compared 2 dosing regimens of Platless (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 Platless 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 Platless and other concomitant medications to investigate the potential for pharmacodynamic and pharmacokinetic interactions. No clinically significant pharmacodynamic interactions were observed when Platless was co-administered with atenolol, nifedipine or both atenolol and nifedipine. Furthermore, the pharmacodynamic activity of Platless 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 Platless. Antacids did not modify the extent of Platless absorption.

Although the administration of Platless 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 Platless with warfarin increases the risk of bleeding because of independent effects on hemostasis. However, at high concentrations in vitro, Platless inhibits CYP2C9. It is unlikely that Platless 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 Platless.

Apart from the specific drug interaction information described previously, interaction studies with Platless and some drugs commonly administered in patients with atherothrombotic disease have not been performed. However, patients entered into clinical trials with Platless 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.

Incompatibilities: Not applicable.


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References

  1. FDA/SPL Indexing Data. "A74586SNO7: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  2. MeSH. "Purinergic P2Y Receptor Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Thieno[3,2-c]pyridine-5(4H)-acetic acid, α-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (αS)-: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Platless are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Platless. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported frequency of use

No survey data has been collected yet


1 consumer reported doses

What doses of Platless drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Platless drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Users%
51-100mg1
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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