Loestrin 21 1 / 20

See also: Generic Loestrin 21 1.5/30, Generic Loestrin 24 Fe, Generic Loestrin Fe 1.5/30, Generic Loestrin Fe 1/20

Loestrin 21 1/20 is a brand name of ethinyl estradiol/norethindrone, approved by the FDA in the following formulation(s):

LOESTRIN 21 1/20 (ethinyl estradiol; norethindrone acetate - tablet; oral-21)

• 
  Manufacturer: WARNER CHILCOTT
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): 0.02MG;1MG ^[AB]

Has a generic version of Loestrin 21 1/20 been approved?

Yes. The following products are equivalent to Loestrin 21 1/20:

JUNEL 1/20 (ethinyl estradiol; norethindrone acetate tablet; oral-21)

• 
  Manufacturer: BARR
  
  Approval date: May 30, 2003
  
  Strength(s): 0.02MG;1MG ^[AB]

MICROGESTIN 1/20 (ethinyl estradiol; norethindrone acetate tablet; oral-21)

• 
  Manufacturer: WATSON LABS
  
  Approval date: July 30, 2003
  
  Strength(s): 0.02MG;1MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Loestrin 21 1/20. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Loestrin 21 1/20.

See also...

• Loestrin 21 1/20 Consumer Information (Cerner Multum)
• Ortho-Novum Consumer Information (Drugs.com)
• Norethindrone/Ethinyl Estradiol Consumer Information (Wolters Kluwer)
• Norethindrone/Ethinyl Estradiol (HRT) Consumer Information (Wolters Kluwer)
• Norethindrone/Ethinyl Estradiol Chewable Tablets Consumer Information (Wolters Kluwer)
• Norethindrone/Ethinyl Estradiol Tablets Consumer Information (Wolters Kluwer)
• Ethinyl estradiol and norethindrone Consumer Information (Cerner Multum)
• Ethinyl estradiol and norethindrone HRT Consumer Information (Cerner Multum)
• Norethindrone, ethinyl estradiol, and ferrous fumarate Advanced Consumer Information (Micromedex)

Zidin

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EpiPen Jr

In the US, EpiPen Jr (epinephrine systemic) is a member of the following drug classes: adrenergic bronchodilators, catecholamines, vasopressors and is used to treat Adams-Stokes Syndrome, Allergic Reactions, Asthma - acute, Asystole, AV Heart Block, COPD - Acute, Electromechanical Dissociation and Shock.

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Pirbuterol

In the US, Pirbuterol (pirbuterol systemic) is a member of the drug class adrenergic bronchodilators and is used to treat Asthma - acute, Asthma - Maintenance, COPD - Acute and COPD - Maintenance.

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Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

R03AC08,R03CC07

CAS registry number (Chemical Abstracts Service)

0038677-81-5

Chemical Formula

C12-H20-N2-O3

Molecular Weight

240

Therapeutic Category

Bronchodilator

Chemical Name

2,6-Pyridinedimethanol, α6-[[(1,1-dimethylethyl)amino]methyl]-3-hydroxy-

Foreign Names

• Pirbuterolum (Latin)
• Pirbuterol (German)
• Pirbutérol (French)
• Pirbuterol (Spanish)

Generic Names

• Pirbuterol (OS: BAN)
• Pirbutérol (OS: DCF)
• CP 24315-1 (IS)
• Pyrbuterol (IS)
• Pirbuterol Acetate (OS: USAN, BANM)
• CO 24314-14 (IS: Pfizer)

Brand Names

• Maxair
  Graceway, United States



• Spirolair
  3M, Luxembourg

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

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Halothane

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Mitotane

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Bivalirudin

Class: Direct Thrombin Inhibitors
Chemical Name: d - Phenylalanyl - l - prolyl - l - arginyl - l - prolylglycylglycylglycylglycyl - l - asparaginylglycyl - l - α - aspartyl - l - phenylalanyl - l - α - glutamyl - l - α - glutamyl - l - isoleucyl - l - prolyl - l - α - glutamyl - l - α - glutamyl - l - tyrosyl - l - leucine
CAS Number: 128270-60-0
Brands: Angiomax

Special Alerts:

The Editors of AHFS Drug Information (AHFS DI) and AHFS DI Essentials wish to inform you of an error in the monographs for bivalirudin 20:12.04.12 that resulted from an error in one of the cited references, the American College of Chest Physicians (ACCP) guideline on treatment and prevention of heparin-induced thrombocytopenia (Warkentin TE, Greinacher A, Koster A et al. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl):340S-80S).^{10 25}

The error appears under the subhead Heparin-induced Thrombocytopenia in Patients Undergoing Cardiac Surgery, in Dosage and Administration. In the second sentence under this subhead, the statement should read:

“During cardiopulmonary bypass, initially, 1 mg/kg by direct IV injection followed by 2.5 mg/kg per hour by continuous IV infusion has been used;^{10 24} if needed, additional direct IV doses of 0.1–0.5 mg/kg have been given to maintain a 2.5-fold or greater prolongation of the baseline ACT.²⁴ ”

The originally stated dosage of 0.1–0.5 mg for additional direct IV doses of bivalirudin is incorrect.²⁵

The following reflects the corrected version of this information, incorporating the change noted above.

Introduction

Anticoagulant; synthetic peptide analog of hirudin, an anticoagulant polypeptide found in the saliva of the medicinal leech (Hirudo medicinalis).^{1 2 3 4 5 6}

Uses for Bivalirudin

Acute Ischemic Complications of Percutaneous Coronary Intervention

Used with aspirin to reduce the risk of acute ischemic complications (e.g., death, MI, need for urgent revascularization procedures) in patients with unstable angina or non-ST-segment-elevation MI (i.e., non-ST-segment-elevation acute coronary syndromes) undergoing PCI, including percutaneous transluminal coronary angioplasty (PTCA).^{1 8 9 11 15 17}

American College of Chest Physicians (ACCP) recommends anticoagulant therapy (e.g., heparin, low molecular weight heparin, bivalirudin, fondaparinux) for all patients presenting with non-ST-segment-elevation acute coronary syndromes.¹⁷ ACCP suggests the use of bivalirudin in combination with clopidogrel over heparin for initial antithrombotic therapy in patients at moderate to high risk for an ischemic event and who are scheduled for very early coronary angiography (within <6 hours).¹⁷

Efficacy in patients with non-ST-segment-elevation acute coronary syndromes undergoing PCI similar to that of high-dose heparin.^{1 5}

Used with aspirin and “provisional” treatment with a GP IIb/IIIa-receptor inhibitor in selected patients undergoing PCI who have complications (i.e., prolonged ischemia, decreased perfusion [TIMI grade 0–2 flow] or slow reflow, dissection with decreased perfusion, new or suspected thrombus, persistent residual stenosis, distal embolism, unplanned or suboptimal stenting, side branch closure, abrupt closure, or other clinical instability).^{1 8 11 14 17} Efficacy in such patients similar to that of heparin and routine treatment with a GP IIb/IIIa-receptor inhibitor.^{1 8 9 11 14 16 17}

ACC, AHA, and the Society for Cardiovascular Angiography and Interventions (SCAI) suggest bivalirudin as an alternative to heparin and a GP IIb/IIIa-receptor inhibitor in patients undergoing PCI who are at low risk for ischemic complications.¹⁵

ACCP recommends either bivalirudin and provisional treatment with a GP IIb/IIIa-receptor inhibitor or heparin and routine treatment with a GP IIb/IIIa-receptor inhibitor in patients with non-ST-segment-elevation acute coronary syndromes undergoing PCI who are at low to moderate risk for ischemic complications.¹⁷

Safety and efficacy not established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.¹

Heparin-induced Thrombocytopenia in Patients Undergoing PCI

Used with aspirin in patients undergoing PCI who have, or are at risk for, heparin-induced thrombocytopenia (HIT).^{1 10 15}

ACC/AHA/SCAI recommend bivalirudin or argatroban and ACCP recommends bivalirudin, argatroban, or lepirudin as a substitute for unfractionated heparin or low molecular weight heparin in patients with HIT undergoing PCI.^{10 15}

ACCP suggests use of a nonheparin anticoagulant over continued therapy with unfractionated or low molecular weight heparin in patients with a history of HIT (antibody negative) who require cardiac catheterization or PCI.¹⁰

Heparin-induced Thrombocytopenia in Patients Undergoing Cardiac Surgery

Recommended as a substitute for heparin in patients with acute HIT (thrombocytopenic and HIT-antibody positive) who require cardiac surgery† (e.g., coronary artery bypass grafting [CABG]).^{10 24} ACCP recommends delaying surgery (if possible) until HIT antibodies are no longer detected or use of bivalirudin for intraoperative anticoagulation during cardiopulmonary bypass or “off-pump” cardiac surgery, provided special precautions to prevent blood stasis are followed.^{10 24 26} (See Patients with HIT Undergoing Cardiac Surgery under Cautions.)

Acute ST-Segment-Elevation MI

Used as an alternative to heparin in patients with acute ST-segment-elevation MI†.^{20 21 22} May be used in patients who have been pretreated with heparin and who are to undergo PCI; may also be used as an alternative to heparin in patients who have received fondaparinux in conjunction with a thrombolytic agent prior to PCI.²⁰

Bivalirudin Dosage and Administration

General

• 
  

  Manufacturer states that bivalirudin is intended for use concomitantly with aspirin 300–325 mg daily.¹ However, ACC/AHA/SCAI and ACCP recommend lower maintenance dosages of aspirin (e.g., 75–162 mg daily).^{15 17 18 19 20 21 23}

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by direct IV injection followed by IV infusion.¹ Do not administer IM.¹

Reconstitution

Reconstitute vial containing 250 mg of lyophilized bivalirudin with 5 mL of sterile water for injection (swirl gently) to provide a solution containing 50 mg/mL.¹

Discard any unused reconstituted solution.¹

Dilution

Dilute reconstituted solution in 50 mL of 5% dextrose or 0.9% sodium chloride injection to a final concentration of 5 mg/mL for direct IV injection and infusion.¹

For low-rate infusion, further dilute the 5-mg/mL solution in 500 mL of 5% dextrose or 0.9% sodium chloride injection to a final concentration of 0.5 mg/mL.^{1 7}

Dosage

Adults

Acute Ischemic Complications of PCI

IV

0.75 mg/kg (5-mg/mL solution) by direct IV injection immediately before PCI, followed by 1.75 mg/kg per hour (5-mg/mL solution) by continuous IV infusion for the duration of the procedure.¹ Obtain an activated clotting time (ACT) (as measured by a Hemochron device) 5 minutes after initial loading dose and administer an additional direct IV dose of 0.3 mg/kg if needed (e.g., if the ACT is <225 seconds).^{1 8}

May continue infusion for up to 4 hours after the procedure if necessary.¹ If needed, administer an additional IV infusion (0.5-mg/mL solution) at 0.2 mg/kg per hour for up to 20 hours.¹

Heparin-induced Thrombocytopenia in Patients Undergoing PCI

IV

0.75 mg/kg (5-mg/mL solution) by direct IV injection immediately before PCI, followed by 1.75 mg/kg per hour (5-mg/mL solution) by continuous IV infusion for the duration of the procedure.¹

May continue infusion for up to 4 hours after the procedure if necessary.¹ If needed, administer an additional IV infusion (0.5-mg/mL solution) at 0.2 mg/kg per hour for up to 20 hours.¹

Heparin-induced Thrombocytopenia in Patients Undergoing Cardiac Surgery†

IV

During “off-pump” cardiac surgery (i.e., without cardiopulmonary bypass), 0.75 mg/kg by direct IV injection, followed by 1.75 mg/kg per hour by continuous IV infusion to maintain an ACT >300 seconds has been used.^{10 26}

During cardiopulmonary bypass, initially, 1 mg/kg by direct IV injection followed by 2.5 mg/kg per hour by continuous IV infusion has been used;^{10 24} if needed, additional direct IV doses of 0.1–0.5 mg/kg have been given to maintain a 2.5-fold or greater prolongation of the baseline ACT.²⁴ In addition, 50 mg of bivalirudin is added to the recirculating priming fluid of the cardiopulmonary bypass circuit.^{10 24}

Acute ST-Segment-Elevation MI†

IV

0.25 mg/kg by direct IV injection followed by 0.5 mg/kg per hour by continuous IV infusion for the first 12 hours, then 0.25 mg/kg per hour for the subsequent 36 hours, has been used.^{21 22} Obtain aPTT 12 and 24 hours after the initial dosage; adjust dosage if needed.²¹

Special Populations

Renal Impairment

Reduction of the initial loading dose not necessary in patients with moderate to severe renal impairment.^{1 7} Closely monitor activated clotting time (ACT) in patients with renal impairment.¹ Reduce infusion rate to 1 mg/kg per hour in patients with severe renal impairment (Cl_cr <30 mL/minute).¹ In dialysis-dependent patients, reduce off-dialysis infusion rate to 0.25 mg/kg per hour.¹

Cautions for Bivalirudin

Contraindications

• 
  

  Active major bleeding.¹

  
  


• 
  

  Known hypersensitivity to bivalirudin or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Hematologic Effects

Possible bleeding, especially at site of arterial puncture.^{1 7} Unexplained decreases in hematocrit, hemoglobin, or BP may indicate hemorrhage.¹

Discontinue if severe hemorrhage occurs.¹ Use with caution in patients with an increased risk of hemorrhage.^{1 7}

Increased risk of potentially fatal thrombosis during vascular brachytherapy procedures; use caution.¹ Assess catheter function frequently by attempting to aspirate blood, and ensure patency by repeated flushing.¹ Minimize conditions promoting stasis within the catheter or circulatory system.^{1 10}

Sensitivity Reactions

Hypersensitivity

Positive bivalirudin antibody tests found rarely in clinical studies; however, no allergic or anaphylactic reactions reported.^{1 7}

General Precautions

Factors Increasing Risk of Hemorrhage

Increased risk of major bleeding events with concomitant heparin, warfarin, thrombolytic, or GP IIb/IIIa-receptor inhibitor therapy in clinical trials.¹ (See Common Adverse Effects and see Specific Drugs under Interactions.) No experience with concomitant administration of plasma expanders such as dextran.¹

Use with caution in patients with disease states associated with increased risk of hemorrhage.¹

Brachytherapy Procedures

Use with caution during vascular brachytherapy procedures because of an increased risk of potentially fatal thrombosis.¹

Patients with HIT Undergoing Cardiac Surgery

Possible formation of clots due to degradation of bivalirudin in areas of blood stasis; special maneuvers needed to avoid stasis within the cardiopulmonary bypass circuit during and after cardiac surgery.^{10 24 26} Avoid use of cardiotomy suction; also avoid use of patient blood to test graft patency or for cardioplegia solutions.^{10 24 26}

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether bivalirudin is distributed into milk.¹ Use with caution.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults.^{1 7}

Renal Impairment

Dosage reduction recommended in patients with moderate to severe renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Major hemorrhagic events less frequent with bivalirudin with or without provisional GP IIb/IIIa-receptor inhibitor therapy (2.3%) compared with unfractionated heparin and routine GP IIb/IIIa-receptor inhibitor therapy (4%).¹

Nonhemorrhagic effects in patients with unstable angina undergoing PTCA: Back pain,¹ pain (unspecified),¹ nausea,¹ headache,¹ hypotension,¹ injection site pain,¹ insomnia,¹ hypertension,¹ vomiting,¹ pelvic pain,¹ anxiety,¹ bradycardia,¹ dyspepsia,¹ abdominal pain,¹ fever,¹ nervousness,¹ urinary retention.¹

Nonhemorrhagic effects in patients undergoing PCI and receiving provisional therapy with a GP IIb/IIIa-receptor inhibitor: Back pain, angina pectoris,¹ pain (unspecified),¹ hypotension,¹ nausea,¹ injection site pain,¹ headache,¹ chest pain.¹

Interactions for Bivalirudin

Specific Drugs

Drug	Interaction	Comments
Aspirin	Increased risk of hemorrhage13
GP IIb/IIIa-receptor inhibitors	Increased risk of hemorrhage1
Heparin	Increased risk of hemorrhage1
Heparin, low molecular weight	No apparent pharmacodynamic interaction13	Limited data; safety and efficacy of combination therapy not established13
Plasma-volume expanders (e.g., dextran)	No experience with concomitant therapy1
Thrombolytic agents	Increased risk of hemorrhage1
Ticlopidine	No apparent pharmacodynamic interaction13	Limited data; safety and efficacy of combination therapy not established13
Warfarin	Increased risk of hemorrhage1

Bivalirudin Pharmacokinetics

Absorption

Onset

Immediate anticoagulant effect.¹

Duration

Effects are dose- and concentration-dependent and reversible; thrombin slowly cleaves the bivalirudin-Arg₃-Pro₄ bond, which results in recovery of the thrombin active site function.^{1 3 4} Coagulation times return to normal approximately 1–2 hours after cessation of infusion.^{1 7}

Distribution

Extent

Not known whether the drug is distributed into human milk.¹

Plasma Protein Binding

Does not bind to plasma proteins (other than thrombin).¹

Elimination

Metabolism

Cleared from the plasma by a combination of renal mechanisms and intracellular proteolysis.^{1 b}

Elimination Route

Approximately 20% of unchanged bivalirudin is cleared renally, and the remainder presumably undergoes intracellular proteolysis.^b

Half-life

22 minutes.¹

Special Populations

In patients with mild renal impairment (GFR of 60–89 mL/minute), half-life is 25 minutes.¹

In patients with moderate renal impairment (GFR of 30–59 mL/minute), half-life is 34 minutes.¹

In patients with severe renal impairment (GFR of 10–29 mL/minute), half-life is 57 minutes.¹

In dialysis-dependent patients, off-dialysis half-life is 3.5 hours.¹

Total body clearance reduced by about 20% in patients with moderate to severe renal impairment and by 80% in dialysis-dependent patients.¹

Approximately 25% of drug removed by hemodialysis.¹

Stability

Storage

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).¹

Reconstituted solution (50 mg/mL) may be stored at 2–8°C for up to 24 hours.¹

Diluted IV solutions (0.5–5 mg/mL) are stable at room temperature for up to 24 hours.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility¹

Compatible
Dextrose 5% in water
Sodium chloride 0.9%

Drug Compatibility^HID

Y-Site CompatibilityHID

Compatible
Abciximab
Alfentanil HCl
Amikacin sulfate
Aminophylline
Ampicillin sodium
Ampicillin sodium-sulbactam sodium
Azithromycin
Aztreonam
Bretylium tosylate
Bumetanide
Butorphanol tartrate
Calcium gluconate
Cefazolin sodium
Cefepime HCl
Cefotaxime sodium
Cefoxitin sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Cimetidine HCl
Ciprofloxacin
Clindamycin phosphate
Co-trimoxazole
Dexamethasone sodium phosphate
Digoxin
Diltiazem HCl
Diphenhydramine HCl
Dobutamine HCl
Dopamine HCl
Doxycycline hyclate
Droperidol
Enalaprilat
Ephedrine sulfate
Epinephrine HCl
Epoprostenol sodium
Eptifibatide
Erythromycin lactobionate
Esmolol HCl
Famotidine
Fentanyl citrate
Fluconazole
Furosemide
Gentamicin sulfate
Haloperidol lactate
Heparin sodium
Hydrocortisone sodium succinate
Hydromorphone HCl
Isoproterenol HCl
Labetalol HCl
Levofloxacin
Lidocaine HCl
Lorazepam
Magnesium sulfate
Mannitol
Meperidine HCl
Methylprednisolone sodium succinate
Metoclopramide HCl
Metronidazole
Midazolam HCl
Milrinone lactate
Morphine sulfate
Nalbuphine HCl
Nitroglycerin
Norepinephrine bitartrate
Phenylephrine HCl
Piperacillin sodium-tazobactam
Potassium chloride
Procainamide HCl
Promethazine HCL
Ranitidine HCl
Sodium bicarbonate
Sodium nitroprusside
Sufentanil citrate
Theophylline
Thiopental sodium
Ticarcillin disodium-clavulanate potassium
Tirofiban HCl
Tobramycin sulfate
Verapamil HCl
Warfarin sodium
Incompatible
Alteplase
Amiodarone HCl
Amphotericin B
Chlorpromazine HCl
Diazepam
Prochlorperazine edisylate
Reteplase
Vancomycin HCl

ActionsActions

• 
  

  Specific and reversible direct thrombin inhibitor that binds to circulating and clot-bound thrombin.^{1 2 3 4}

  
  


• 
  

  Inhibition of thrombin prevents various steps in the coagulation process (e.g., activation of factors V, VIII, and XIII; conversion of fibrinogen to fibrin; platelet activation and aggregation).^{1 2 3 4}

  
  


• 
  

  Prolongs activated clotting time (ACT), aPTT, thrombin time (TT), and PT.^{1 7}

  
  

Advice to Patients

• 
  

  Importance of patients reporting any signs of bleeding (e.g., bruising, petechiae, hematuria) to clinicians immediately.¹

  
  


• 
  

  Importance of patients informing clinicians of history of bleeding disorders or impaired renal function.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant diseases.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Bivalirudin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	250 mg	Angiomax	Medicines Company

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 25, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. The Medicines Company. Angiomax (bivalirudin) for injection prescribing information. Cambridge, MA; 2005 Dec 6.

2. Haines ST, Bussey HI. Thrombosis and the pharmacology of antithrombotic agents. Ann Pharmacother. 1995; 29:892-905. [IDIS 353388] [PubMed 8547739]

3. Stringer KA, Lindenfeld J. Hirudins: antithrombin anticoagulants. Ann Pharmacother. 1992; 26:1535-40. [IDIS 306624] [PubMed 1482812]

4. Bates SM, Weitz JI. Direct thrombin inhibitors for treatment of arterial thrombosis: potential differences between bivalirudin and hirudin. Am J Cardiol. 1998; 82:12-8P.

5. Bittl JA, Strony J, Brinker JA et al for the Hirulog Angioplasty Study investigators. Treatment with bivalirudin (hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina. N Engl J Med. 1995; 333:764-9. [IDIS 353197] [PubMed 7643883]

6. Bittl JA, Feit F for Hirulog Angioplasty Study investigators. A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for postinfarction angina. Am J Cardiol. 1998; 82:43-9P. [PubMed 9671007]

7. The Medicines Company, Cambridge, MA: Personal communication.

8. Lincoff AM, Bittl JA, Harrington RA et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003; 289:853-63. [IDIS 493155] [PubMed 12588269]

9. Saw J, Lincoff M, DeSmet W et al. Lack of clopidogrel pretreatment effect on the relative efficacy of bivalirudin with provisional glycoprotein IIb/IIIa blockade compared to heparin with routine glycoprotein IIb/IIIa blockade: a REPLACE-2 substudy. J Am Coll Cardiol. 2004; 44:1194-9. [IDIS 524399] [PubMed 15364319]

10. Warkentin TE, Greinacher A, Koster A et al. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed) Chest. 2008; 133 (Suppl):340S-80S

11. Popma JJ, Berger P, Ohman EM et al. Antithrombotic therapy in patients undergoing percutaneous coronary intervention. Chest. 2001; 119(Suppl):321S-36S.

12. Harrington RA, Becker RC, Ezekowitz M et al. Antithrombotic therapy in coronary artery disease. Chest. 2004; 126:513S-48S. [IDIS 523845] [PubMed 15383483]

13. The Medicines Company. Angiomax (bivalirudin) for injection prescribing information. Cambridge, MA; 2002 Jun 18.

14. Lincoff, AM, Kleiman NS, Kereiakes DJ et al. Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial. JAMA. 2004; 292:696-703.

15. Smith SC, Feldman TE, Hirschfeld JW et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Revise the 2001 Guidelines for Percutaneous Coronary Intervention). 2005. Available at the American College of Cardiology web site.

16. Lansky AJ, Hochman JS, Ward PA et al. Percutaneous coronary intervention and adjunctive pharmacotherapy in women: a statement for healthcare professionals from the American Heart Association. Circulation. 2005; 111:940-5. [PubMed 15687113]

17. Harrington RA, Becker RC, Cannon CP et al. Antithrombotic therapy for non-ST-segment elevation acute coronary syndromes.American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133:670S-707S. [PubMed 18574276]

18. King SB, Smith SC, Hirshfeld JW et al. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008; 51:172-9. [PubMed 18191745]

19. Becker RC, Meade TW, Berger PB et al. The primary and secondary prevention of coronary artery disease: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl): 776S-814S. [PubMed 18574278]

20. Antman EM, Hand M, Armstrong PW et al. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction. J Am Coll Cardiol. 2008; 51:210-47. [PubMed 18191746]

21. Goodman SG, Menon V, Cannon CP et al. Acute ST-segment elevation myocardial infarction: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl):708S-75S. [PubMed 18574277]

22. Schulman S, Beyth RJ, Kearon C et al. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians evidenced-based clinical practice guidelines (8th ed). Chest. 2008; 133 (Suppl):257S-98S. [PubMed 18574268]

23. Anderson JL, Adams CD, Antman EM et al. ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction). Available at ACC website. Accessed 2008 Oct 15.

24. Koster A, Dyke CM, Aldea G et al. Bivalirudin during cardiopulmonary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON trial. Ann Thorac Surg. 2007; 83:572-7.

25. Lewis SZ (American College of Chest Physicians, Northbrook, IL): Personal communication. 2011 Mar 15.

26. Dyke CM, Aldea G, Koster A et al. Off-pump coronary artery bypass with bivalirudin for patients with heparin-induced thrombocytopenia or antiplatelet factor four/heparin antibodies. Ann Thorac Surg. 2007; 84:836-40.

b. Robson R, White H, Aylward P et al. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002; 71:433-39. [PubMed 12087346]

HID. Trissel LA. Handbook on injectable drugs. 14th ed; Bethesda, MD: American Society of Health-System Pharmacists; 2007:207-13.

More Bivalirudin resources

• Bivalirudin Side Effects (in more detail)
• Bivalirudin Use in Pregnancy & Breastfeeding
• Bivalirudin Drug Interactions
• Bivalirudin Support Group
• 0 Reviews for Bivalirudin - Add your own review/rating

• Bivalirudin Professional Patient Advice (Wolters Kluwer)


• Bivalirudin MedFacts Consumer Leaflet (Wolters Kluwer)


• bivalirudin Concise Consumer Information (Cerner Multum)


• bivalirudin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Angiomax Prescribing Information (FDA)

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Pataday

Pataday is a brand name of olopatadine ophthalmic, approved by the FDA in the following formulation(s):

PATADAY (olopatadine hydrochloride - solution/drops; ophthalmic)

• 
  Manufacturer: ALCON PHARMS LTD
  
  Approval date: December 22, 2004
  
  Strength(s): EQ 0.2% BASE ^[RLD]

Has a generic version of Pataday been approved?

No. There is currently no therapeutically equivalent version of Pataday available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pataday. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Topical ophthalmic formulations for treating allergic eye diseases
  Patent 5,641,805
  Issued: June 24, 1997
  Inventor(s): Hayakawa; Eiji & Nakakura; Masashi & Robertson; Stella M. & Yanni; John Michael
  Assignee(s): Alcon Laboratories, Inc.
  Kyowa Hakko Kogyo Co. Ltd.
  Topical ophthalmic formulations of the invention contain as an active ingredient 11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid or a pharmaceutically acceptable salt thereof. The formulations are useful for treating allergic eye diseases such as allergic conjunctivitis, vernal conjunctivitis, vernal keratoconjunctivitis, and giant papillary conjunctivitis.
  
  Patent expiration dates:
  
  
  • June 6, 2015
    
    ✓ 
    Patent use: METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
  
  
  
  • December 6, 2015
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Olopatadine formulations for topical administration
  Patent 6,995,186
  Issued: February 7, 2006
  Inventor(s): Castillo; Ernesto J. & Han; Wesley Wehsin & Zhang; Huixiang & Bhagat; Haresh G. & Singh; Onkar N. & Bullock; Joseph Paul & Dixit; Suresh C.
  Assignee(s): Alcon, Inc.
  Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. The aqueous formulations contain approximately 0.17-0.62% (w/v) of olopatadine and an amount of polyvinylpyrrolidone or polystyrene sulfonic acid sufficient to enhance the physical stability of the formulations.
  
  Patent expiration dates:
  
  
  • November 12, 2023
    
    ✓ 
    Patent use: METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
    ✓ 
    Drug product
  
  
  
  • May 12, 2024
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Olopatadine formulations for topical administration
  Patent 7,402,609
  Issued: July 22, 2008
  Inventor(s): Castillo; Ernesto J. & Han; Wesley Wehsin & Zhang; Huixiang & Bhagat; Haresh G. & Singh; Onkar N. & Bullock; Joseph Paul & Dixit; Suresh C.
  Assignee(s): Alcon, Inc.
  Topical formulations of olopatadine for treatment of allergic or inflammatory disorders of the eye and nose are disclosed. The aqueous formulations contain approximately 0.17-0.62% (w/v) of olopatadine and an amount of polyvinylpyrrolidone or polystyrene sulfonic acid sufficient to enhance the physical stability of the formulations.
  
  Patent expiration dates:
  
  
  • June 19, 2022
    
    ✓ 
    Drug product
  
  
  
  • December 19, 2022
    
    ✓ 
    Pediatric exclusivity
  
  

See also...

• Pataday Drops Consumer Information (Wolters Kluwer)
• Pataday Consumer Information (Cerner Multum)
• Pataday Advanced Consumer Information (Micromedex)
• Olopatadine Drops Consumer Information (Wolters Kluwer)
• Olopatadine ophthalmic Consumer Information (Cerner Multum)
• Olopatadine Ophthalmic Advanced Consumer Information (Micromedex)
• Olopatadine Hydrochloride AHFS DI Monographs (ASHP)

Zilversulfadiazine ratiopharm

Zilversulfadiazine ratiopharm may be available in the countries listed below.

Ingredient matches for Zilversulfadiazine ratiopharm

Sulfadiazine

Sulfadiazine silver (a derivative of Sulfadiazine) is reported as an ingredient of Zilversulfadiazine ratiopharm in the following countries:

• Netherlands

International Drug Name Search

Tramamed

Tramamed may be available in the countries listed below.

Ingredient matches for Tramamed

Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramamed in the following countries:

• Luxembourg

International Drug Name Search

Zeloram

Zeloram may be available in the countries listed below.

Ingredient matches for Zeloram

Lorazepam

Lorazepam is reported as an ingredient of Zeloram in the following countries:

• Italy

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Nor Sartan

Nor Sartan may be available in the countries listed below.

Ingredient matches for Nor Sartan

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Nor Sartan in the following countries:

• Dominican Republic


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama

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Ciprofloxacin Aurus

Ciprofloxacin Aurus may be available in the countries listed below.

Ingredient matches for Ciprofloxacin Aurus

Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprofloxacin Aurus in the following countries:

• Germany

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Prosek

Prosek may be available in the countries listed below.

Ingredient matches for Prosek

Omeprazole

Omeprazole is reported as an ingredient of Prosek in the following countries:

• Turkey

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Artelac Advanced MDO

Artelac Advanced MDO may be available in the countries listed below.

Ingredient matches for Artelac Advanced MDO

Hyaluronic Acid

Hyaluronic Acid is reported as an ingredient of Artelac Advanced MDO in the following countries:

• Germany

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Fludocel

Fludocel may be available in the countries listed below.

Ingredient matches for Fludocel

Fluconazole

Fluconazole is reported as an ingredient of Fludocel in the following countries:

• Portugal

International Drug Name Search

Zelapar

In the US, Zelapar (selegiline systemic) is a member of the following drug classes: dopaminergic antiparkinsonism agents, monoamine oxidase inhibitors and is used to treat ADHD, Depression and Parkinson's Disease.

US matches:

• Zelapar


• Zelapar Orally Disintegrating Tablets

UK matches:

• Zelapar
• Zelapar (Cephalon Limited) (SPC)

Ingredient matches for Zelapar

Selegiline

Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Zelapar in the following countries:

• Argentina


• United Kingdom


• United States

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Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Zesger

Zesger may be available in the countries listed below.

Ingredient matches for Zesger

Lisinopril

Lisinopril is reported as an ingredient of Zesger in the following countries:

• Ireland

International Drug Name Search

Enalapril Torlan

Enalapril Torlan may be available in the countries listed below.

Ingredient matches for Enalapril Torlan

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril Torlan in the following countries:

• France

International Drug Name Search

Vital CST-222

Vital CST-222 may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Vital CST-222

Chlortetracycline

Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of Vital CST-222 in the following countries:

• Switzerland

Sulfadimidine

Sulfadimidine is reported as an ingredient of Vital CST-222 in the following countries:

• Switzerland

Tylosin

Tylosin phosphate (a derivative of Tylosin) is reported as an ingredient of Vital CST-222 in the following countries:

• Switzerland

International Drug Name Search

Clemastine

In some countries, this medicine may only be approved for veterinary use.

In the US, Clemastine (clemastine systemic) is a member of the drug class antihistamines and is used to treat Allergic Reactions, Hay Fever and Urticaria.

US matches:

• Clemastine


• Clemastine Syrup


• Clemastine and phenylpropanolamine


• Clemastine y phenylpropanolamine


• Clemastine Fumarate

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

D04AA14,R06AA04

CAS registry number (Chemical Abstracts Service)

0015686-51-8

Chemical Formula

C21-H26-Cl-N-O

Molecular Weight

343

Therapeutic Categories

Antiallergic agent

Histamine, H₁-receptor antagonist

Chemical Name

Pyrrolidine, 2-[2-[1-(4-chlorophenyl)-1-phenylethoxy]ethyl]-1-methyl-, [R-(R*,R*)]-

Foreign Names

• Clemastinum (Latin)
• Clemastin (German)
• Clémastine (French)
• Clemastina (Spanish)

Generic Names

• Clemastina (OS: DCIT)
• Clemastine (OS: BAN, USAN)
• Clémastine (OS: DCF)
• HS 592 (IS)
• HS 834 (IS)
• Mecloprodin (IS)
• Meclopyrolin (IS)
• Clemastine Fumarate (OS: BANM, USAN)
• Clémastine (fumarate de) (PH: Ph. Eur. 6)
• Clemastine Fumarate (PH: BP 2010, JP XV, USP 32, Ph. Eur. 6)
• Clemastinfumarat (PH: Ph. Eur. 6)
• Clemastini fumaras (PH: Ph. Eur. 6)

Brand Names

• Clemastin
  Terapia, Romania



• Clemastine
  Polfa Warshavskiy, Russian Federation



• Clemastinum
  Hasco, Poland; Polfa Warszawa, Lithuania; Polfa Warszawa, Lithuania



• Dexa Tavegil (Clemastine and Dexamethasone)
  Novartis Consumer Health, Spain



• Tavegyl
  Novartis, Colombia; Novartis, Iceland; Novartis, Romania; Novartis Consumer Health, South Africa



• Agasten
  Novartis, Brazil



• Allehist-1
  Family Pharmacy, United States; Leader, United States; Medicine Shoppe, United States



• Benanzyl
  Isei, Japan



• Clamist
  Wander, India



• Cle Mamallet
  Showa Yakuhin Kako, Japan



• Clemanil
  Sandoz, Japan



• Clemastin Actavis
  Balkanpharma, Bulgaria



• Clemastin
  Actavis, Georgia



• Clemastine Fumarate
  Actavis, United States; Morton Grove, United States; Novex, United States; Perrigo, United States; Sandoz, United States; Silarx, United States; Teva USA, United States



• Clemastinum
  Aflofarm, Poland; Polfa Warszawa, Poland



• Dayhist-1
  Drug Emporium, United States; Kroger, United States; Longs, United States; Major, United States; Perrigo, United States



• Fuluminol
  Tatsumi Kagaku, Japan



• Hinews
  Kyorin Rimedio, Japan



• Inbestan
  Nichi-Iko PharmaceuticalJMA, Japan



• Kinotomin
  Toa Eiyo, Japan



• Magotin
  Tsuruhara Seiyaku, Japan



• Mallermin F
  Taiyo Pharmaceutical, Japan



• Marsthine
  Towa Yakuhin, Japan



• Masletine
  Sioe SeiyakuShioe, Japan



• Piloral
  Nippon Kayaku, Japan



• Tavegil
  Dr. Fisher, Netherlands; Euro, Netherlands; Novartis, United Arab Emirates; Novartis, Bahrain; Novartis, Egypt; Novartis, Georgia; Novartis, Guyana; Novartis, Iraq; Novartis, Iran; Novartis, Jordan; Novartis, Kuwait; Novartis, Lebanon; Novartis, Oman; Novartis, Qatar; Novartis, Saudi Arabia; Novartis, Syria; Novartis, Yemen; Novartis Consumer Health, Germany; Novartis Consumer Health, Spain; Novartis Consumer Health, United Kingdom; Novartis Consumer Health, Netherlands



• Tavegil (veterinary use)
  Novartis Animal Health, United Kingdom



• Tavegyl
  Medis, Slovenia; Novartis, United Arab Emirates; Novartis, Bulgaria; Novartis, Bahrain; Novartis, Czech Republic; Novartis, Denmark; Novartis, Estonia; Novartis, Ghana; Novartis, Indonesia; Novartis, Iraq; Novartis, Jordan; Novartis, Japan; Novartis, Kenya; Novartis, Kuwait; Novartis, Lebanon; Novartis, Lithuania; Novartis, Latvia; Novartis, Libya; Novartis, Nigeria; Novartis, Philippines; Novartis, Portugal; Novartis, Qatar; Novartis, Russian Federation; Novartis, Saudi Arabia; Novartis, Sudan; Novartis, Sweden; Novartis, Slovakia; Novartis, Turkey; Novartis, Tanzania; Novartis, Yemen; Novartis Consumer Health, Switzerland; Novartis Consumer Health, Egypt



• Tavist
  Novartis, India; Novartis, United States



• Telgin G
  Takata Seiyaku, Japan



• Xolamin
  Yoshindo, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Drontal Plus

Dosage Form: FOR ANIMAL USE ONLY
Drontal Plus

(praziquantel/pyrantel pamoate/febantel)

Taste Tabs®

Broad Spectrum Chewable Anthelmintic Tablets for Dogs

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Drontal® Plus Taste Tabs® (praziquantel/pyrantel pamoate/febantel) Broad Spectrum Chewable Anthelmintic Tablets for Dogs are available in three tablet sizes. Each size is scored for convenient oral administration.

Each Drontal Plus Taste Tabs Tablet for Puppies and Small Dogs contains 22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate and 113.4 mg febantel.

Each Drontal Plus Taste Tabs Tablet for Medium Sized Dogs contains 68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate and 340.2 mg febantel.

Each Drontal Plus Taste Tabs Tablet for Large Dogs contains 136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate, and 680.4 mg febantel.

ACTION:

Drontal® Plus Taste Tabs® Tablets contain three active ingredients having different modes of action and spectra of activity. Praziquantel is active against cestodes (tapeworms). Praziquantel is absorbed, metabolized in the liver and excreted in the bile. Upon entering the digestive tract from the bile, cestocidal activity is exhibited.1 Following exposure to praziquantel, the tapeworm loses its ability to resist digestion by the mammalian host. Because of this, whole tapeworms, including the scolices, are very rarely passed after administration of praziquantel. In many instances only disintegrated and partially digested pieces of tapeworms will be seen in the stool. The majority of tapeworms are digested and are not found in the feces.

Pyrantel pamoate is active against hookworms and ascarids. Pyrantel pamoate acts on the cholinergic receptors of the nematode resulting in spastic paralysis. Peristaltic action of the intestinal tract then eliminates the parasite.2

Febantel is active against nematode parasites including whipworms. Febantel is rapidly absorbed and metabolized in the animal. Available information suggests that the parasite’s energy metabolism is blocked, leading to energy exchange breakdown and inhibited glucose uptake.

Laboratory efficacy and clinical studies conducted with Drontal Plus Anthelmintic Tablets demonstrate that each of the three active ingredients act independently without interference. The combined tablet formulation provides a wide spectrum of activity against the indicated species of intestinal helminths.

INDICATIONS:

Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Taste Tabs® Broad Spectrum Chewable Anthelmintic Tablets are indicated for removal of Tapeworms ( Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus,and removal and control of Echinococcus multilocularis) and for removal of Hookworms ( Ancylostoma caninum, Uncinaria stenocephala), Ascarids ( Toxocara canis, Toxascaris leonina), and Whipworms ( Trichuris vulpis) in dogs.

CONTRAINDICATIONS:

DO NOT USE IN PREGNANT ANIMALS. Dogs treated with elevated levels (6 consecutive days with 3 times the labeled dosage rate) of the combination of febantel and praziquantel in early pregnancy demonstrated an increased incidence of abortion and fetal abnormalities.8 The effects of Drontal® Plus Anthelmintic Tablets on pregnant animals have not been determined.

There are no known contraindications against the use of praziquantel or pyrantel pamoate in dogs.

WARNINGS:

KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS:

Strict hygienic precautions should be taken when handling dogs or feces suspected of harboring E. multilocularis. Infected dogs treated for the first time with Drontal® Plus Taste Tabs® Tablets and dogs treated at intervals greater than 28 days may shed eggs in the feces after treatment. The animal should be held in the clinic during this interval and all feces should be incinerated or autoclaved. If these procedures are not possible, the eggs can be destroyed by soaking the feces in a sodium hypochlorite (bleach) solution of 3.75% or greater.7 All areas where the animal was maintained or in contact with should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

USE DIRECTIONS

DOSAGE: The presence of parasites should be confirmed by laboratory fecal examination. Weigh the animal before treatment. Administer the proper dosage as specified in the following table as a single oral treatment.

DRONTAL® PLUS TASTE TABS® TABLETS DOSAGE CHARTS

* NOT FOR USE IN PUPPIES LESS THAN 3 WEEKS OF AGE OR DOGS WEIGHING LESS THAN 2 LBS.
for Puppies and Small Dogs* (2 - 25 lbs.)		for Medium Sized Dogs (26 - 60 lbs.)		for Large Dogs (45 lbs. and greater)
Body Wt. (lbs.)	No. of Tablets	Body Wt. (lbs.)	No. of Tablets	Body Wt. (lbs.)	No. of Tablets
2 – 4	0.5	26 – 30	1.0	45 – 60	1.0
5 – 7	1.0	31 – 44	1.5	61 – 90	1.5
8 – 12	1.5	45 – 60	2.0	91 – 120	2.0
13 – 18	2.0
19 – 25	2.5

ADMINISTRATION:

Most dogs find Drontal® Plus Taste Tabs® Tablets palatable. The tablets may be offered to the dog by hand. Alternatively tablets may be given directly by mouth or offered in a small amount of food. Fasting is neither necessary nor recommended prior to or after treatment.

RETREATMENT:

For those animals living where reinfections are likely to occur, clients should be instructed in the steps to optimize prevention; otherwise, retreatment may be necessary. This is true in cases of Dipylidium caninum where reinfection is almost certain to occur if fleas are not removed from the animal and its environment. In addition, for control of Echinococcus multilocularis, a program of regular treatment every 21 to 26 days may be indicated (see E. multilocularis section below).

ECHINOCOCCUS MULTILOCULARIS:

Echinococcus multilocularisis a tapeworm species usually found in wild canids, including foxes, coyotes and wolves. The parasite has also been identified in domestic dogs and cats and is potentially a serious public health concern because it may infect humans.

The life cycle of the parasite is based on a predator-prey relationship as depicted.

The adult tapeworm is small (1-4mm) and resides in the intestinal tract of the definitive host (wild or domestic canids). Eggs from the adult tapeworm are shed in the feces. Rodents such as mice and voles serve as the intermediate host. Eggs ingested by rodents develop in the liver, lungs and other organs to form multilocular cysts. The life cycle is completed after a canid consumes a rodent infected with cysts. Larvae within the cyst develop into adult tapeworms in the intestinal tract of the canid. Eggs may be passed in the feces of the canid approximately 28 days later.

This parasite poses a serious public health problem because of the possibility for human involvement in the life cycle. If eggs shed by an infected canid are accidentally ingested, a highly pathogenic condition (Alveolar Hydatid Disease) results from development of the cyst stage in humans.

The original geographic distribution of E. multiloculariswas primarily confined to northern areas of North America. Current evidence indicates migration of the parasite well into the continental United States.3,4

Domestic dogs living in E. multilocularisendemic areas that roam freely with the opportunity to catch wild rodents are at risk of infection. Pet owners should be advised on how to minimize this risk. Proper restraint of dogs should be encouraged, along with regular treatment with Drontal® Plus Taste Tabs® Tablets, following the dosing schedule aforementioned and precautions indicated below.

Additional information on the life cycle and epidemiology of this parasite is available in veterinary parasitology texts.5,6

DIAGNOSIS:

Diagnosis of E. multilocularis in canids is difficult. The adult tapeworm produces no clinical signs of infection. Tapeworm segments (proglottids) are usually not observed in the feces. E. multilocularis eggs, observed using microscopic fecal examination procedures, are similar in appearance to those of common species such as Taenia pisiformis. Assistance in the diagnosis of E. multilocularismay be available from a state veterinary diagnostic laboratory. Additional information regarding areas where E. multilocularisis suspected or has been confirmed may be obtained from area veterinary schools or the Centers for Disease Control in Atlanta, GA.

TREATMENT:

Dogs infected with E. multilocularis should be treated to prevent exposure of humans to infective eggs and to break the parasite’s life cycle.

The dosage of Drontal® Plus Taste Tabs® Tablets for removal of E. multilocularis is the same as that indicated for the removal of the other tapeworm species listed on the label. Laboratory efficacy studies conducted with Drontal Plus tablets have demonstrated the recommended dosage is 100% effective.

Under condition of continual exposure to wild rodents, retreatment of the dog at 21-26 day intervals is recommended to prevent the shedding of infectious eggs.

EFFICACY:

A total of 176 dogs and puppies with naturally acquired or experimental parasite infections were included in 4 well-controlled laboratory studies to establish the efficacy of Drontal® Plus Anthelmintic Tablets. In addition, 103 dogs and puppies were included in clinical field studies conducted in 5 veterinary clinics at different geographic locations throughout the United States to further evaluate safety and efficacy. These studies included dogs of various sizes, ages and breeds. Data from these studies demonstrated Drontal Plus Anthelmintic Tablets are safe and efficacious for the removal of the parasite species indicated on the label when used as directed. Results obtained in the laboratory and clinical studies indicate small numbers of hookworm or roundworm eggs may be passed in the feces for up to 7 days after treatment although the worms themselves were eliminated. A follow-up fecal examination should be conducted 2 to 4 weeks after treatment to determine the need for retreatment.

Palatability:

Palatability studies with Drontal® Plus Taste Tabs® Tablets were conducted at 3 different veterinary clinics in the United States. These studies included a total of 151 dogs (65 males / 86 females) representing 34 different breeds with body weights ranging from 3.8 – 190 lbs. The tablets were offered free-choice to the dogs by their owners and over 89% of the dogs willingly consumed the tablets.

ADVERSE REACTIONS:

None of the 103 dogs treated with Drontal® Plus Anthelmintic Tablets in the clinical field studies exhibited drug-related side effects. Of the 40 dogs treated with Drontal Plus Taste Tabs® Tablets in laboratory studies, two dogs exhibited vomiting, one puppy exhibited bloody/mucoid stool and one puppy exhibited watery/profuse stool.

For customer service or to obtain product information, including Material Safety Data Sheet, call 1-800-633-3796. For medical emergencies or to report adverse reactions, call 1-800-422-9874.

ANIMAL SAFETY:

Controlled safety evaluations have been conducted in dogs with Drontal® Plus (praziquantel/pyrantel pamoate/febantel) Anthelmintic Tablets. Dogs receiving up to 5 times the label dosage (35 mg praziquantel, 35 mg pyrantel pamoate and 179 mg febantel per kg of body weight) for 3 consecutive days (3 times the label duration) showed clinical signs of vomition and non-formed stools. One dog receiving a 3 times labeled dose had elevated SGPT, SGOT, CPK and GGT readings (outside of normal range) at 6 days post-treatment. No additional findings were noted in hematology/clinical chemistry parameters nor were there any treatment-related histological lesions. Vomition was the only side effect observed when dogs received a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate and 305 mg febantel/kg with one dog having an elevated SGPT reading (outside of normal range) at 24 hours post-treatment which had returned to normal by 7 days.

STORAGE CONDITIONS:

Drontal® Plus Taste Tabs® Tablets should be stored at or below 77 °F (25 °C).

Un-blistered whole or partial tablets should be stored in a tightly sealed container.

How is Drontal Plus Supplied

Drontal® Plus Taste Tabs® Tablets are available in three tablet sizes:

Code    08758428: 40 tabs/box for Puppies and Small Dogs

Code    08892051: 40 tabs/box for Medium Sized Dogs

Code    08892078: 30 tabs /box for Large Dogs

REFERENCES:

1 Andrews P. 1976. Pharmacokinetic Studies with DRONCIT® in Animals Using a Biological Assay. Veterinary Medical Review. 2:154-165.

2 Campbell WC. 1986. The Chemotherapy of Parasitic Infections. J. Parasit. 72(1):45-61.

3 Hildreth MB Johnson MD and Kazacos KR. 1991. A Zoonosis of Increasing Concern in the United States. Compendium for Cont. Ed. 13(5): 727-740.

4 PD Carney WP and Woods CE. 1970. Studies on Sylvatic Echinococcosis, Ill. Host Occurrence and Geographic Distribution of Echinococcus multilocularisin the North Central United States. J. Parasit. 56(6): 1141-1150.

5 Georgi JR and Georgi ME. 1990. Parasitology for Veterinarians. W.B. Saunders Co. 118-138.

6 Soulsby EJL. 1982. Helminths, Arthropods and Protozoa of Domesticated Animals. 7th Edition. Lea & Febiger. 118-138.

7 Craig PS and McPharson CNL. 1988. Sodium Hypochlorite as an Ovicide for Echinococcus. Ann Trop Med. and Parasit. 82(2): 211-213.

8 Freedom of Information Summary (FOI) NADA 133-953 Vercom Paste (febantel and praziquantel).

 

Bayer HealthCare LLC

Animal Health Division

Shawnee Mission, Kansas 66201 USA

NADA 141-007, Approved by FDA

January, 2006 ©2006 Bayer HealthCare LLC

R.0 Bayer, the Bayer Cross, Drontal, and Taste

12894 Tabs are registered trademarks of Bayer

Principal Display Panels

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Drontal Plus TASTE TABS  praziquantel/pyrantel pamoate/febantel  tablet, chewable

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0859-2168 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 22.7 mg PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 22.7 mg FEBANTEL (FEBANTEL) FEBANTEL 113.4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score 2 pieces Shape FREEFORM (Bone) Size 20mm Flavor MEAT (Artificial Beef) Imprint Code D10 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0859-2168-01 4 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the BOX (0859-2168-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141007	01/12/2006	12/28/2010

Drontal Plus TASTE TABS  praziquantel/pyrantel pamoate/febantel  tablet, chewable

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0859-2169 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 68 mg PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 68 mg FEBANTEL (FEBANTEL) FEBANTEL 340.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score 2 pieces Shape FREEFORM (Bone) Size 25mm Flavor MEAT (Artificial Beef) Imprint Code DP30 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0859-2169-01 4 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the BOX (0859-2169-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141007	01/12/2006	12/28/2010

Drontal Plus TASTE TABS  praziquantel/pyrantel pamoate/febantel  tablet, chewable

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0859-2182 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 136 mg PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 136 mg FEBANTEL (FEBANTEL) FEBANTEL 680.4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score 2 pieces Shape FREEFORM (Bone) Size 32mm Flavor MEAT (Artificial Beef) Imprint Code DP60 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0859-2182-01 3 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the BOX (0859-2182-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141007	01/12/2006

Drontal Plus TASTE TABS  praziquantel/pyrantel pamoate/febantel  tablet, chewable

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0859-2180 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 22.7 mg PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 22.7 mg FEBANTEL (FEBANTEL) FEBANTEL 113.4 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score 2 pieces Shape FREEFORM (Bone) Size 20mm Flavor MEAT (Artificial Beef) Imprint Code D10 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0859-2180-01 4 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the BOX (0859-2180-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141007	01/12/2006

Drontal Plus TASTE TABS  praziquantel/pyrantel pamoate/febantel  tablet, chewable

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0859-2181 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 68 mg PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 68 mg FEBANTEL (FEBANTEL) FEBANTEL 340.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score 2 pieces Shape FREEFORM (Bone) Size 25mm Flavor MEAT (Artificial Beef) Imprint Code DP30 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0859-2181-01 4 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the BOX (0859-2181-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141007	01/12/2006	12/28/2010

Labeler - Bayer HealthCare LLC Animal Health Division (152266193)

Revised: 05/2009Bayer HealthCare LLC Animal Health Division