Clopidogrel

Add Info

Clopidogrel Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Add Info

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

Add Info

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Add Info

Uses

1.1 Acute Coronary Syndrome (ACS) • For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel bisulfate has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. • For patients with ST-elevation myocardial infarction (STEMI), clopidogrel bisulfate has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.

The optimal duration of clopidogrel bisulfate therapy in ACS is unknown.

1.2 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, clopidogrel bisulfate 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.

Add Info

History

There is currently no drug history available for this drug.

Add Info

Other Information

Clopidogrel bisulfate 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. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2S•H2SO4 and its molecular weight is 419.9.

The structural formula is as follows:

Clopidogrel bisulfate 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 sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°.

Clopidogrel tablets, USP 75 mg for oral administration are provided as pink, round, biconvex, film coated tablets, engraved “APO” on one side, “CL” over “75” on the other side. The tablets contain 97.875 mg of clopidogrel bisulfate, which is the molar equivalent of 75 mg of clopidogrel base.

Each tablet contains anhydrous lactose, colloidal silicon dioxide, crospovidone, methylcellulose and zinc stearate as inactive ingredients. The pink film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol, red ferric oxide and titanium dioxide.

Sources

Clopidogrel Manufacturers

Cardinal Health

Clopidogrel | Cardinal Health

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].
• For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. • For patients with STEMI, the recommended dose of clopidogrel is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Remedyrepack Inc.

Clopidogrel | Remedyrepack Inc.

• Acute coronary syndrome (2.1)
     - UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in combination with aspirin
      (75 to 325 mg once daily)
      - STEMI: 75 mg once daily, in combination with aspirin (75 to 325 mg once daily), with or without a loading dose
• Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily (2.2)

Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)] For patients with STEMI, the recommended dose of clopidogrel tablets is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)].

The recommended daily dose of clopidogrel tablets is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.

Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Remedyrepack Inc.

Clopidogrel | Remedyrepack Inc.

• Acute coronary syndrome (2.1)
     - UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in combination with aspirin
      (75 to 325 mg once daily)
      - STEMI: 75 mg once daily, in combination with aspirin (75 to 325 mg once daily), with or without a loading dose
• Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily (2.2)

Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)] For patients with STEMI, the recommended dose of clopidogrel tablets is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)].

The recommended daily dose of clopidogrel tablets is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.

Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Major Pharmaceuticals

Clopidogrel | Aloe Vera Industries Pty Ltd

Directions

Edge is a topical gel. Apply a very small amount

of Edge onto the tip of your finger.

Gently massage the gel onto the head

(glans) of your penis and leave to air dry for

a few minutes.

You should start to feel a tingling sensation in about

30 to 40 minutes and the product should be fully effective

in about an hour.

Its potency will last several hours which means Edge can be

applied long before any sexual contact. This also means that

you and your partner can enjoy uninterrupted sex without

spoiling the moment.

No Recall
Direct Rx

Clopidogrel | American Sales Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle. • pull yellow part of syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance
Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

*or as directed by a doctor

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
Other information • store at 20-25°C (68-77°F) • do not use if printed neckband is broken or missing

No Recall
State Of Florida Doh Central Pharmacy

Clopidogrel | State Of Florida Doh Central Pharmacy

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)]
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel bisulfate with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel bisulfate [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel bisulfate is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel bisulfate may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel bisulfate is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel bisulfate. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel bisulfate. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
State Of Florida Doh Central Pharmacy

Clopidogrel | State Of Florida Doh Central Pharmacy

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets USP [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets USP may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use With Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Remedyrepack Inc.

Clopidogrel | Remedyrepack Inc.

Acute coronary syndrome. (2.1)
-    UA/NSTEMI: 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75 to 325 mg once daily).

-    STEMI: 75 mg once daily, in combination with aspirin (75 to 325 mg once daily), with or without a loading dose


Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily. (2.2)

Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)].

The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.

Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Vensun Pharmaceuticals, Inc.

Clopidogrel | Vensun Pharmaceuticals, Inc.

2.1 Acute Coronary Syndrome
Clopidogrel can be administered with or without food [see Clinical Pharmacology (12.3)].
• For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel [see Clinical Studies (14.1)]. • For patients with STEMI, the recommended dose of clopidogrel is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite[see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
American Health Packaging

Clopidogrel | American Health Packaging

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)]
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets 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 clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets is 75 mg once daily orally, administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Legacy Pharmaceutical Packaging

Clopidogrel | Legacy Pharmaceutical Packaging

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets USP [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets USP may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use With Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Wockhardt Usa Llc.

Clopidogrel | Wockhardt Usa Llc.

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)]
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets 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 clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Wockhardt Limited

Clopidogrel | Wockhardt Limited

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)]
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets 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 clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
American Health Packaging

Clopidogrel | American Health Packaging

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)]
• For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets 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 clopidogrel tablets [see Clinical Studies (14.1)]. • For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75-325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Unit Dose Services

Clopidogrel | Unit Dose Services

2.1 Acute Coronary SyndromeClopidogrel tablets can be administered with or without food .
[see ] Clinical Pharmacology (12.3)
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets . [see ] Clinical Studies (14.1) For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose . [see ] Clinical Studies (14.1) 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial DiseaseThe recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food .
[see ] Clinical Pharmacology (12.3) 2.3 CYP2C19 Poor MetabolizersCYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response , an appropriate dose regimen for this patient population has not been established.
[see ] Clinical Pharmacology (12.5) 2.4 Use with Proton Pump Inhibitors (PPI)Avoid using omeprazole esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite .
or [see , and ] Warnings and Precautions (5.1)Drug Interactions (7.1)Clinical Pharmacology (12.3)

No Recall
Remedyrepack Inc.

Clopidogrel | Remedyrepack Inc.

Acute coronary syndrome. (2.1)
- Non-ST-segment elevation ACS (UA/NSTEMI): 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75 to 325 mg once daily).

- STEMI: 75 mg once daily, in combination with aspirin (75 to 325 mg once daily), with or without a loading dose and with or without thrombolytics.
Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily. (2.2)

Clopidogrel tablets can be administered with or without food

[see Clinical Pharmacology (12.3)]

.

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)].

The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food

[see Clinical Pharmacology (12.3)]

.

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response

[see Clinical Pharmacology (12.5)]

, an appropriate dose regimen for this patient population has not been established.

Avoid using omeprazole

or

esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite

[see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)]

.

No Recall
Remedyrepack Inc.

Clopidogrel | Remedyrepack Inc.

Acute coronary syndrome. (2.1)
- Non-ST-segment elevation ACS (UA/NSTEMI): 300 mg loading dose followed by 75 mg once daily, in combination with aspirin (75 to 325 mg once daily).

- STEMI: 75 mg once daily, in combination with aspirin (75 to 325 mg once daily), with or without a loading dose and with or without thrombolytics.
Recent MI, recent stroke, or established peripheral arterial disease: 75 mg once daily. (2.2)

Clopidogrel tablets can be administered with or without food

[see Clinical Pharmacology (12.3)]

.

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)].

The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food

[see Clinical Pharmacology (12.3)]

.

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response

[see Clinical Pharmacology (12.5)]

, an appropriate dose regimen for this patient population has not been established.

Avoid using omeprazole

or

esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite

[see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)]

.

No Recall
Medvantx, Inc.

Clopidogrel | Medvantx, Inc.

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)].
• For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets USP [ see Clinical Studies (14.1)]. • For patients with STEMI, the recommended dose of clopidogrel tablets USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets USP may be initiated with or without a loading dose [ see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use With Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Aidarex Pharmaceuticals Llc

Clopidogrel | Aidarex Pharmaceuticals Llc

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Teva Pharmaceuticals Usa Inc

Clopidogrel | Osborn

To provide 2 g/gal: Dissolve contents in 250 gallons of water. For proportioners, dissolve contents of 1/2 package in 1 gallon of water. Meter at 1 oz/gal.

To provide 1 g/gal: Dissolve contents in 500 gallons of water. For proportioners, dissolve contents of 1/2 package in 2 gallons of water. Meter at 1 oz/gal.

To provide 1/2 g/gal: Dissolve contents of 1/2 package in 500 gallons of water. For proportioners, dissolve contents of 1/2 package in 4 gallons of water. Meter at one (1) oz/gal.

No Recall
Aurobindo Pharma Limited

Clopidogrel | Aurobindo Pharma Limited

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Macleods Pharmaceuticals Limited

Clopidogrel | Epic Pharma, Llc

Hypertension
The recommended initial dosage of trandolapril tablets for patients not receiving a diuretic is 1 mg once daily in non-black patients and 2 mg in black patients. Dosage should be adjusted according to the blood pressure response. Generally, dosage adjustments should be made at intervals of at least 1 week. Most patients have required dosages of 2 to 4 mg once daily. There is little clinical experience with doses above 8 mg.

Patients inadequately treated with once-daily dosing at 4 mg may be treated with twice-daily dosing. If blood pressure is not adequately controlled with trandolapril tablets monotherapy, a diuretic may be added.

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of trandolapril tablets. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with trandolapril tablets. (see WARNINGS.) Then, if blood pressure is not controlled with trandolapril tablets alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 0.5 mg trandolapril tablets should be used with careful medical supervision for several hours until blood pressure has stabilized. The dosage should subsequently be titrated (as described above) to the optimal response. (see WARNINGS, PRECAUTIONS and DRUG INTERACTIONS.)

Concomitant administration of trandolapril tablets with potassium supplements, potassium salt substitutes, or potassium sparing diuretics can lead to increases of serum potassium. (see PRECAUTIONS.)
Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction
The recommended starting dose is 1 mg, once daily. Following the initial dose, all patients should be titrated (as tolerated) toward a target dose of 4 mg, once daily. If a 4 mg dose is not tolerated, patients can continue therapy with the greatest tolerated dose.
Dosage Adjustment in Renal Impairment or Hepatic Cirrhosis
For patients with a creatinine clearance < 30 mL/min. or with hepatic cirrhosis, the recommended starting dose, based on clinical and pharmacokinetic data, is 0.5 mg daily. Patients should subsequently have their dosage titrated (as described above) to the optimal response.

No Recall
American Health Packaging

Clopidogrel | Gurwitch Products, L.l.c.

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor

No Recall
Accord Healthcare Inc.

Clopidogrel | Accord Healthcare Inc.

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)]
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel bisulfate with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel bisulfate [see Clinical Studies (14.1)] . For patients with STEMI, the recommended dose of clopidogrel bisulfate is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel bisulfate may be initiated with or without a loading dose [see Clinical Studies (14.1)] . 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel bisulfate is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)] .
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)] , an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel bisulfate. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel bisulfate. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
State Of Florida Doh Central Pharmacy

Clopidogrel | State Of Florida Doh Central Pharmacy

2.1 Acute Coronary Syndrome

Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers

CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)

Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Legacy Pharmaceutical Packaging

Clopidogrel | Legacy Pharmaceutical Packaging

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets USP [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets USP may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use With Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Amneal Pharmaceuticals Of New York, Llc

Clopidogrel | Amneal Pharmaceuticals Of New York, Llc

2.1 Acute Coronary Syndrome
Clopidogrel tablets, USP can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets, USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets, USP [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets, USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets, USP may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets, USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets, USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets, USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Readymeds

Clopidogrel | Readymeds

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].

For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Bryant Ranch Prepack

Clopidogrel | Bryant Ranch Prepack

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets USP [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets USP may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use With Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Clopidogrel | Deseret Biologicals, Inc.

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

No Recall
International Labs, Inc.

Clopidogrel | Walgreen Co.

do not take more than directed
(see overdose warning) adults and children 12 years and over take 2 gelcaps every 4 hours do not take more than 12 gelcaps in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Clinical Solutions Wholesale

Clopidogrel | Clinical Solutions Wholesale

2.1 Acute Coronary Syndrome
Clopidogrel tablets can be administered with or without food [see Clinical Pharmacology (12.3)].
• For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets [see Clinical Studies (14.1)]. • For patients with STEMI, the recommended dose of clopidogrel tablet is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablet is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use with Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall
Apotex Corp.

Clopidogrel | Par Pharmaceutical Companies, Inc.

2.1 General Dosing Considerations
Rash

There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of lamotrigine with valproate, (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors [see BOXED WARNING]. Therefore, it is important that the dosing recommendations be followed closely.

The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation for lamotrigine is exceeded and in patients with a history of allergy or rash to other AEDs.

Lamotrigine ODT Patient Titration Kits provide lamotrigine at doses consistent with the recommended titration schedule for the first 5 weeks of treatment, based upon concomitant medications, for patients with epilepsy (older than 12 years) and bipolar I disorder (adults) and are intended to help reduce the potential for rash. The use of lamotrigine ODT Patient Titration Kits is recommended for appropriate patients who are starting or restarting lamotrigine [see HOW SUPPLIED/STORAGE AND HANDLING (16)].

It is recommended that lamotrigine not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued lamotrigine, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed. The half-life of lamotrigine is affected by other concomitant medications [see Clinical Pharmacology (12.3)].

Lamotrigine Added to Drugs Known to Induce or Inhibit Glucuronidation

Because lamotrigine is metabolized predominantly by glucuronic acid conjugation, drugs that are known to induce or inhibit glucuronidation may affect the apparent clearance of lamotrigine. Drugs that induce glucuronidation include carbamazepine, phenytoin, phenobarbital, primidone, rifampin, estrogen-containing oral contraceptives, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Valproate inhibits glucuronidation. For dosing considerations for lamotrigine in patients on estrogen-containing contraceptives and atazanavir/ritonavir, see below and Table 13. For dosing considerations for lamotrigine in patients on other drugs known to induce or inhibit glucuronidation, see Tables1, 2, 5 to 6, and 13.

Target Plasma Levels for Patients with Epilepsy or Bipolar Disorder

A therapeutic plasma concentration range has not been established for lamotrigine. Dosing of lamotrigine should be based on therapeutic response [see Clinical Pharmacology (12.3)].

Women Taking Estrogen-Containing Oral Contraceptives

Starting lamotrigine in Women Taking Estrogen-Containing Oral Contraceptives: Although estrogen-containing oral contraceptives have been shown to increase the clearance of lamotrigine [see Clinical Pharmacology (12.3)], no adjustments to the recommended dose-escalation guidelines for lamotrigine should be necessary solely based on the use of estrogen-containing oral contraceptives. Therefore, dose escalation should follow the recommended guidelines for initiating adjunctive therapy with lamotrigine based on the concomitant AED or other concomitant medications (see Tables1, 5, and 7). See below for adjustments to maintenance doses of lamotrigine in women taking estrogen-containing oral contraceptives.

Adjustments to the Maintenance Dose of lamotrigine in Women Taking Estrogen-Containing Oral Contraceptives:

(1) Taking Estrogen-Containing Oral Contraceptives: In women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)], the maintenance dose of lamotrigine will in most cases need to be increased by as much as 2-fold over the recommended target maintenance dose to maintain a consistent lamotrigine plasma level.

(2) Starting Estrogen-Containing Oral Contraceptives: In women taking a stable dose of lamotrigine and not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)], the maintenance dose will in most cases need to be increased by as much as 2-fold to maintain a consistent lamotrigine plasma level. The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week. Dose increases should not exceed the recommended rate (see Tables1 and 5) unless lamotrigine plasma levels or clinical response support larger increases. Gradual transient increases in lamotrigine plasma levels may occur during the week of inactive hormonal preparation (pill-free week), and these increases will be greater if dose increases are made in the days before or during the week of inactive hormonal preparation. Increased lamotrigine plasma levels could result in additional adverse reactions, such as dizziness, ataxia, and diplopia. If adverse reactions attributable to lamotrigine consistently occur during the pill-free week, dose adjustments to the overall maintenance dose may be necessary. Dose adjustments limited to the pill-free week are not recommended. For women taking lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)], no adjustment to the dose of lamotrigine should be necessary.

(3) Stopping Estrogen-Containing Oral Contraceptives: In women not taking carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)], the maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% in order to maintain a consistent lamotrigine plasma level. The decrease in dose of lamotrigine should not exceed 25% of the total daily dose per week over a 2-week period, unless clinical response or lamotrigine plasma levels indicate otherwise [see Clinical Pharmacology (12.3)]. In women taking lamotrigine in addition to carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)], no adjustment to the dose of lamotrigine should be necessary.

Women and Other Hormonal Contraceptive Preparations or Hormone Replacement Therapy

The effect of other hormonal contraceptive preparations or hormone replacement therapy on the pharmacokinetics of lamotrigine has not been systematically evaluated. It has been reported that ethinylestradiol, not progestogens, increased the clearance of lamotrigine up to 2-fold, and the progestin-only pills had no effect on lamotrigine plasma levels. Therefore, adjustments to the dosage of lamotrigine in the presence of progestogens alone will likely not be needed.

Patients Taking Atazanavir/Ritonavir

While atazanavir/ritonavir does reduce the lamotrigine plasma concentration, no adjustments to the recommended dose-escalation guidelines for lamotrigine should be necessary solely based on the use of atazanavir/ritonavir. Dose escalation should follow the recommended guidelines for initiating adjunctive therapy with lamotrigine based on concomitant AED or other concomitant medications (see Tables 1, 2, and 5). In patients already taking maintenance doses of lamotrigine and not taking glucuronidation inducers, the dose of lamotrigine may need to be increased if atazanavir/ritonavir is added, or decreased if atazanavir/ritonavir is discontinued [see Clinical Pharmacology (12.3)].

Patients with Hepatic Impairment

Experience in patients with hepatic impairment is limited. Based on a clinical pharmacology study in 24 subjects with mild, moderate, and severe liver impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)], the following general recommendations can be made. No dosage adjustment is needed in patients with mild liver impairment. Initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. Escalation and maintenance doses may be adjusted according to clinical response.

Patients with Renal Impairment

Initial doses of lamotrigine should be based on patients’ concomitant medications (see Tables 1 to 3 and 5); reduced maintenance doses may be effective for patients with significant renal impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)]. Few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. Because there is inadequate experience in this population, lamotrigine should be used with caution in these patients.

Discontinuation Strategy

Epilepsy: For patients receiving lamotrigine in combination with other AEDs, a re-evaluation of all AEDs in the regimen should be considered if a change in seizure control or an appearance or worsening of adverse reactions is observed.

If a decision is made to discontinue therapy with lamotrigine, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.8)].

Discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation should prolong the half-life of lamotrigine; discontinuing valproate should shorten the half-life of lamotrigine.

Bipolar Disorder: In the controlled clinical trials, there was no increase in the incidence, type, or severity of adverse reactions following abrupt termination of lamotrigine. In the clinical trials in patients with bipolar disorder, 2 patients experienced seizures shortly after abrupt withdrawal of lamotrigine. Discontinuation of lamotrigine should involve a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.8)].
2.2 Epilepsy Adjunctive Therapy
This section provides specific dosing recommendations for patients older than 12 years and patients aged 2 to 12 years. Within each of these age-groups, specific dosing recommendations are provided depending upon the concomitant AEDs or other concomitant medications (see Table 1 for patients older than 12 years and Table 2 for patients aged 2 to 12 years). A weight-based dosing guide for patients aged 2 to 12 years on concomitant valproate is provided in Table 3.

Patients Older than 12 Years

Recommended dosing guidelines are summarized in Table 1.

Table 1. Escalation Regimen for Lamotrigine in Patients Older than 12 Years with Epilepsy

In Patients TAKING Valproatea

In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone,b or Valproatea
In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2
25 mg every otherday
25 mg every day
50 mg/day
Weeks 3 and 4
25 mg every day
50 mg/day
100 mg/day
(in 2 divided doses)
Week 5 onward to maintenance
Increase by 25 to 50 mg/day every 1 to 2 weeks.
Increase by 50 mg/day every 1 to 2 weeks.
Increase by 100 mg/day every 1 to 2 weeks.
Usual maintenance dose
100 to 200 mg/day with valproate alone
100 to 400 mg/day with valproate and other drugs that induce glucuronidation
(in 1 or 2 divided doses)
225 to 375 mg/day
(in 2 divided doses)
300 to 500 mg/day
(in 2 divided doses)

a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)].

b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), DRUG INTERACTIONS (7), and Clinical Pharmacology (12.3)].

Patients Aged 2 to 12 Years

Recommended dosing guidelines are summarized in Table 2.

Lower starting doses and slower dose escalations than those used in clinical trials are recommended because of the suggestion that the risk of rash may be decreased by lower starting doses and slower dose escalations. Therefore, maintenance doses will take longer to reach in clinical practice than in clinical trials. It may take several weeks to months to achieve an individualized maintenance dose. Maintenance doses in patients weighing less than 30 kg, regardless of age or concomitant AED, may need to be increased as much as 50%, based on clinical response.

Table 2. Escalation Regimen for Lamotrigine in Patients Aged 2 to 12 Years with Epilepsy

In Patients TAKING Valproatea
In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone,b or Valproatea
In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2
0.15 mg/kg/day
in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 for weight-based dosing guide)
0.3 mg/kg/day
in 1 or 2 divided doses, rounded down to the nearest whole tablet
0.6 mg/kg/day
in 2 divided doses, rounded down to the nearest whole tablet
Weeks 3 and 4
0.3 mg/kg/day
in 1 or 2 divided doses, rounded down to the nearest whole tablet (see Table 3 for weight-based dosing guide)
0.6 mg/kg/day
in 2 divided doses, rounded down to the nearest whole tablet
1.2 mg/kg/day
in 2 divided doses, rounded down to the nearest whole tablet
Week 5 onward to maintenance
The dose should be increased every 1 to 2 weeks as follows: calculate 0.3 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose.
The dose should be increased every 1 to 2 weeks as follows: calculate 0.6 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose.
The dose should be increased every 1 to 2 weeks as follows: calculate 1.2 mg/kg/day, round this amount down to the nearest whole tablet, and add this amount to the previously administered daily dose.
Usual maintenance dose
1 to 5 mg/kg/day (maximum 200 mg/day in 1 or 2 divided doses)
1 to 3 mg/kg/day
with valproate alone
4.5 to 7.5 mg/kg/day
(maximum 300 mg/day in 2 divided doses)
5 to 15 mg/kg/day
(maximum 400 mg/day in 2 divided doses)
Maintenance dose in patients less than 30 kg
May need to be increased by as much as 50%, based on clinical response.
May need to be increased by as much as 50%, based on clinical response.
May need to be increased by as much as 50%, based on clinical response.

Note: Only whole tablets should be used for dosing.

a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)].

b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), DRUG INTERACTIONS (7), and Clinical Pharmacology (12.3)].

Table 3. The Initial Weight-Based Dosing Guide for Patients Aged 2 to 12 Years Taking Valproate (Weeks 1 to 4) with Epilepsy
If the patient’s weight is
Give this daily dose, using the most appropriate combination of lamotrigine 2- and 5-mg tablets
Greater than
And less than
Weeks 1 and 2
Weeks 3 and 4
6.7 kg
14 kg
2 mg every other day
2 mg every day
14.1 kg
27 kg
2 mg every day
4 mg every day
27.1 kg
34 kg
4 mg every day
8 mg every day
34.1 kg
40 kg
5 mg every day
10 mg every day

Usual Adjunctive Maintenance Dose for Epilepsy

The usual maintenance doses identified in Tables 1 and 2are derived from dosing regimens employed in the placebo-controlled adjunctive trials in which the efficacy of lamotrigine was established. In patients receiving multidrug regimens employing carbamazepine, phenytoin, phenobarbital, or primidone without valproate, maintenance doses of adjunctive lamotrigine as high as 700 mg/day have been used. In patients receiving valproate alone, maintenance doses of adjunctive lamotrigine as high as 200 mg/day have been used. The advantage of using doses above those recommended in Tables 1 to 4 has not been established in controlled trials.
2.3 Epilepsy Conversion From Adjunctive Therapy to Monotherapy
The goal of the transition regimen is to attempt to maintain seizure control while mitigating the risk of serious rash associated with the rapid titration of lamotrigine.

The recommended maintenance dose of lamotrigine as monotherapy is 500 mg/day given in 2 divided doses.

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations for lamotrigine should not be exceeded [see BOXED WARNING].

Conversion from Adjunctive Therapy with Carbamazepine, Phenytoin, Phenobarbital, or Primidone to Monotherapy with Lamotrigine

After achieving a dose of 500 mg/day of lamotrigine using the guidelines in Table 1, the concomitant enzyme-inducing AED should be withdrawn by 20% decrements each week over a 4-week period. The regimen for the withdrawal of the concomitant AED is based on experience gained in the controlled monotherapy clinical trial.

Conversion from Adjunctive Therapy with Valproate to Monotherapy with Lamotrigine

The conversion regimen involves the 4 steps outlined in Table 4.

Table 4. Conversion from Adjunctive Therapy with Valproate to Monotherapy with Lamotrigine in Patients Aged 16 Years and Older with Epilepsy

Lamotrigine
Valproate
Step 1
Achieve a dose of 200 mg/day according to guidelines in Table 1.
Maintain established stable dose.
Step 2
Maintain at 200 mg/day.
Decrease dose by decrements no greater than 500 mg/day/week to 500 mg/day and then maintain for 1 week.
Step 3
Increase to 300 mg/day and maintain for 1 week.
Simultaneously decrease to 250 mg/day and maintain for 1 week.
Step 4
Increase by 100 mg/day every week to achieve maintenance dose of 500 mg/day.
Discontinue.

Conversion from Adjunctive Therapy with Antiepileptic Drugs other than Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate to Monotherapy with Lamotrigine

No specific dosing guidelines can be provided for conversion to monotherapy with lamotrigine with AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate.
2.4 Bipolar Disorder
The goal of maintenance treatment with lamotrigine is to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see INDICATIONS AND USAGE (1)].

Patients taking lamotrigine for more than 16 weeks should be periodically reassessed to determine the need for maintenance treatment.

Adults

The target dose of lamotrigine is 200 mg/day (100 mg/day in patients taking valproate, which decreases the apparent clearance of lamotrigine, and 400 mg/day in patients not taking valproate and taking either carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitor lopinavir/ritonavir that increase the apparent clearance of lamotrigine). In the clinical trials, doses up to 400 mg/day as monotherapy were evaluated; however, no additional benefit was seen at 400 mg/day compared with 200 mg/day [see Clinical Studies (14.2)]. Accordingly, doses above 200 mg/day are not recommended.

Treatment with lamotrigine is introduced, based on concurrent medications, according to the regimen outlined in Table 5. If other psychotropic medications are withdrawn following stabilization, the dose of lamotrigine should be adjusted. In patients discontinuing valproate, the dose of lamotrigine should be doubled over a 2-week period in equal weekly increments (see Table 6). In patients discontinuing carbamazepine, phenytoin, phenobarbital, primidone, or other drugs such as rifampin and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir that induce lamotrigine glucuronidation, the dose of lamotrigine should remain constant for the first week and then should be decreased by half over a 2-week period in equal weekly decrements (see Table 6). The dose of lamotrigine may then be further adjusted to the target dose (200 mg) as clinically indicated.

If other drugs are subsequently introduced, the dose of lamotrigine may need to be adjusted. In particular, the introduction of valproate requires reduction in the dose of lamotrigine [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)].

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations of lamotrigine should not be exceeded [see BOXED WARNING].

Table 5. Escalation Regimen for Lamotrigine in Adultswith Bipolar Disorder

In Patients TAKING Valproatea
In Patients NOT TAKING Carbamazepine, Phenytoin, Phenobarbital, Primidone,b or Valproatea
In Patients TAKING Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb and NOT TAKING Valproatea
Weeks 1 and 2
25 mg every other day
25 mg daily
50 mg daily
Weeks 3 and 4
25 mg daily
50 mg daily
100 mg daily, in divided doses
Week 5
50 mg daily
100 mg daily
200 mg daily, in divided doses
Week 6
100 mg daily
200 mg daily
300 mg daily, in divided doses
Week 7
100 mg daily
200 mg daily
up to 400 mg daily, in divided doses

a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)].

b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), DRUG INTERACTIONS (7), and Clinical Pharmacology (12.3)].

Table 6. Dosage Adjustments to Lamotrigine in Adultswith Bipolar Disorder Following Discontinuation of Psychotropic Medications

Discontinuation of Psychotropic Drugs (excluding Valproate,a Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb)
After Discontinuation of Valproatea
After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb
Current Dose of lamotrigine (mg/day)
100
Current Dose of lamotrigine (mg/day)
400
Week 1
Maintain current dose of lamotrigine
150
400
Week 2
Maintain current dose of lamotrigine
200
300
Week 3 onward
Maintain current dose of lamotrigine
200
200

a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see DRUG INTERACTIONS (7), Clinical Pharmacology (12.3)].

b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), DRUG INTERACTIONS (7), and Clinical Pharmacology (12.3)].
2.6 Administration of Lamotrigine Orally Disintegrating Tablets
Lamotrigine orally disintegrating tablets should be placed onto the tongue and moved around in the mouth. The tablet will disintegrate rapidly, can be swallowed with or without water, and can be taken with or without food.

No Recall
St Marys Medical Park Pharmacy

Clopidogrel | St Marys Medical Park Pharmacy

2.1 Acute Coronary Syndrome
Clopidogrel tablets USP can be administered with or without food [see Clinical Pharmacology (12.3)].
For patients with non-ST-elevation ACS (UA/NSTEMI), initiate clopidogrel tablets USP with a single 300 mg oral loading dose and then continue at 75 mg once daily. Initiate aspirin (75 to 325 mg once daily) and continue in combination with clopidogrel tablets USP [see Clinical Studies (14.1)]. For patients with STEMI, the recommended dose of clopidogrel tablets USP is 75 mg once daily orally, administered in combination with aspirin (75 to 325 mg once daily), with or without thrombolytics. Clopidogrel tablets USP may be initiated with or without a loading dose [see Clinical Studies (14.1)]. 2.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
The recommended daily dose of clopidogrel tablets USP is 75 mg once daily orally, with or without food [see Clinical Pharmacology (12.3)].
2.3 CYP2C19 Poor Metabolizers
CYP2C19 poor metabolizer status is associated with diminished antiplatelet response to clopidogrel. Although a higher dose regimen in poor metabolizers increases antiplatelet response [see Clinical Pharmacology (12.5)], an appropriate dose regimen for this patient population has not been established.
2.4 Use With Proton Pump Inhibitors (PPI)
Avoid using omeprazole or esomeprazole with clopidogrel tablets USP. Omeprazole and esomeprazole significantly reduce the antiplatelet activity of clopidogrel tablets USP. 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 clopidogrel active metabolite [see Warnings and Precautions (5.1), Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

No Recall