Cedax

Pronunciation: sef-TYE-byoo-ten
Generic Name: Ceftibuten
Brand Name: Cedax

Cedax is used for:

Treating mild to moderate infections caused by certain bacteria.

Cedax is a cephalosporin antibiotic. It works by killing sensitive bacteria.

Do NOT use Cedax if:

• you are allergic to any ingredient in Cedax or any other cephalosporin antibiotic (eg, cephalexin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cedax:

Some medical conditions may interact with Cedax. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin (eg, amoxicillin) or other beta-lactam antibiotic (eg, imipenem)


• if you have a blood clotting disorder, kidney problems, or stomach or bowel problems (eg, inflammation)

Some MEDICINES MAY INTERACT with Cedax. However, no specific interactions with Cedax are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cedax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cedax:

Use Cedax as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cedax may be taken with or without food.


• To clear up your infection completely, continue using Cedax for the full course of treatment even if you feel better in a few days.


• If you miss a dose of Cedax, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cedax.

Important safety information:

• Cedax is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold)


• It is important to use Cedax for the full course of treatment. Failure to do so may decrease the effectiveness of Cedax and may increase the risk that the bacteria will no longer be sensitive to Cedax and will not be able to be treated by this or certain other antibiotics in the future.


• Long-term or repeated use of Cedax may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.


• If severe diarrhea, stomach pain or cramps, or bloody stools occur, contact your doctor immediately. This could be a symptom of a serious side effect requiring immediate medical attention. Do not treat diarrhea without consulting your doctor.


• Diabetes patients - Cedax may cause incorrect test results with some urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.


• Cedax may interfere with certain lab test results. Make sure your doctor and lab personnel know you are using Cedax.


• Use Cedax with caution in the ELDERLY because they may be more sensitive to its effects.


• Use Cedax with extreme caution in CHILDREN younger than 6 months of age. Safety and effectiveness in this age group have not been confirmed.


• Use Cedax with extreme caution in CHILDREN younger than 10 years of age who have diarrhea or a stomach or bowel infection.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cedax, discuss with your doctor the benefits and risks of using Cedax during pregnancy. It is unknown if Cedax is excreted in breast milk. If you are or will be breast-feeding while you are using Cedax, check with your doctor of pharmacist to discuss the risk to your baby.

Possible side effects of Cedax:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; indigestion; loose stools; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; dark urine; decreased urination; fever, chills, or sore throat; joint pain; mental or mood changes; red, swollen, or blistered skin; seizures; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cedax side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include muscle spasms; seizures.

Proper storage of Cedax:

Store Cedax at room temperature, between 36 and 77 degrees F (2 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cedax out of the reach of children and away from pets.

General information:

• If you have any questions about Cedax, please talk with your doctor, pharmacist, or other health care provider.


• Cedax is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cedax. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cedax resources

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

• Cedax Prescribing Information (FDA)


• Cedax Advanced Consumer (Micromedex) - Includes Dosage Information


• Cedax Concise Consumer Information (Cerner Multum)


• Cedax Monograph (AHFS DI)


• Ceftibuten Professional Patient Advice (Wolters Kluwer)

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Quinidine Gluconate

Class: Class Ia Antiarrhythmics
Note: This monograph also contains information on Quinidine Sulfate
VA Class: CV300
CAS Number: 7054-25-3

• Mortality


• 
  

  In many antiarrhythmic drug trials for non-life-threatening arrhythmias, active antiarrhythmic drug therapy was associated with increased mortality.^{163 167 168 169 170}

  
  


• 
  

  Risk associated with antiarrhythmic drug therapy probably is greatest in patients with structural heart disease.^{163 167 168 169 170}

  
  


• 
  

  A meta-analysis of data from several randomized, controlled studies in patients with atrial flutter and fibrillation indicates that quinidine therapy may be associated with a mortality rate >3 times higher than that associated with placebo.^{163 167 168 169 170}

  
  


• 
  

  A meta-analysis in patients with various non-life-threatening ventricular arrhythmias showed mortality associated with quinidine was consistently greater than that associated with various other antiarrhythmic agents (i.e., flecainide, mexiletine, propafenone, tocainide).^{163 167 168 169 170}

  
  

Introduction

Antiarrhythmic agent (class IA); antimalarial.^{119 161 163 167 168 169 170}

Uses for Quinidine Gluconate

Comparably effective to procainamide for atrial or ventricular arrhythmias; choice based on pharmacokinetics and adverse effect profile.^b

Supraventricular Tachyarrhythmias

Used principally for prophylactic therapy to maintain normal sinus rhythm after conversion of atrial fibrillation and/or flutter by other means.^b

Abnormal ventricular rate and CHF should first be controlled by administration of digoxin.^b Electrical cardioversion usually is considered the treatment of choice for conversion of atrial fibrillation or flutter.^b

Prevention of recurrence of atrial fibrillation or flutter is controversial because mortality may increase despite recurrence suppression.^b

May maintain normal sinus rhythm for long periods in recent onset of atrial fibrillation or flutter without CHF, atrial enlargement, or left ventricular hypertrophy, but long-standing atrial fibrillation is likely to recur even with quinidine maintenance therapy.^b

Generally, quinidine should not be used prophylactically for atrial fibrillation if the ventricular rate is adequately controlled by digoxin and the patient is asymptomatic.^b

Treatment of paroxysmal atrial tachycardia or paroxysmal AV junctional rhythm.^b

Atrial Premature Complexes

Treatment of atrial premature complexes; however, these arrhythmias usually are treated with digoxin.^b

Ventricular Premature Complexes (VPCs)

Treatment of VPCs; however, parenteral lidocaine is considered the drug of choice because quinidine can decrease myocardial contractility.^b

Like other antiarrhythmic drugs, not shown to decrease mortality rate in VPCs associated with AMI.^b

Avoid in treatment of asymptomatic VPCs.^b

Not for treatment of cardiac glycoside-induced ventricular arrhythmias.^b

VT

Treatment of paroxysmal VT that is not associated with complete heart block; however, treatment with cardioversion or lidocaine usually is preferred.^b

Suppression and prevention of recurrent ventricular arrhythmias (e.g., sustained VT) that in the judgment of the clinician are life-threatening.^b

Because of arrhythmogenic potential and the lack of evidence for improved survival for class I antiarrhythmic agents,^{146 147} not recommended for less severe VTs; avoid treatment in asymptomatic VPCs.^b

Malaria

Treatment of severe, life-threatening malaria caused by Plasmodium falciparum.^{101 102 104 105 119 122 124 126 142 153 158 162} Drug of choice for initial treatment of severe malaria.^{101 126 142 153 154 158 162}

Severe malaria usually is caused by P. falciparum and requires initial aggressive treatment with a parenteral antimalarial regimen initiated as soon as possible after diagnosis.^{158 162} Exchange transfusions can be considered if parasitemia is >10% or patient has cerebral malaria, altered mental status, non-volume-overload pulmonary edema, or renal complications.^{158 162}

For initial treatment of severe malaria in adults or children, CDC recommends a regimen of IV quinidine gluconate in conjunction with doxycycline, tetracycline, or clindamycin (oral or IV as tolerated).^{158 162} After at least 24 hours and when parasitemia is reduced to <1% and an oral regimen can be tolerated, IV quinidine gluconate can be discontinued and oral quinine sulfate initiated to complete 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (3 days if malaria acquired in Africa or South America or 7 days if acquired in Southeast Asia).^{158 162}

Because of potentially fatal consequences of delays in initiating treatment of severe malaria, institutional pharmacy services should be aware of the essential role of ready availability of IV quinidine gluconate.^{142 143 153 158} (See Availability for Use in Treatment of Severe Malaria under Cautions.)

When IV quinidine gluconate is unavailable or cannot be used because of intolerance or contraindications, parasitemia is high or has not responded to quinidine gluconate therapy, and a parenteral regimen is indicated, IV artesunate is available from CDC under an investigational new drug (IND) protocol for the treatment of severe malaria.^{158 162 171 172} WHO and other clinicians recommend artesunate as a drug of choice for the treatment of severe malaria.^{101 173}

Although oral quinidine sulfate has been used for the treatment of malaria,^{167 170} including uncomplicated malaria† caused by multidrug-resistant P. falciparum,^{102 104 108 109 110 112} oral quinine sulfate is not included in CDC recommendations for treatment of uncomplicated or severe P. falciparum malaria.^{158 162}

Assistance with diagnosis or treatment of malaria and assistance obtaining IV quinidine gluconate or IV artesunate for treatment of severe malaria is available by contacting the CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.^{158 162 171 172}

Quinidine Gluconate Dosage and Administration

General

Arrhythmias

• 
  

  Initiate quinidine or adjust quinidine dosage in a setting where facilities and personnel for patient monitoring and resuscitation are continuously available, especially if used in patients with known structural heart disease or other risk factors for toxicity.^{163 167 168 169 170}

  
  


• 
  

  ECG monitoring of cardiac function and determination of plasma concentrations are recommended, especially when given IV or when >2 g is administered orally daily, and in patients with an increased risk of adverse reactions to quinidine (e.g., severe heart disease, hypotension, hepatic or renal disease).^b

  
  


• 
  

  Use for conversion of atrial fibrillation/flutter only after alternative measures (e.g., use of other drugs to control ventricular rate) have been inadequate.^{163 167 168 169 170} Discontinue quinidine if sinus rhythm is not restored within a reasonable amount of time.^{119 163 167 168 169 170}

  
  


• 
  

  Discontinue quinidine and consider other means of conversion if QRS complex widens to 130% of its pretreatment duration, QT_c interval widens to 130% of its pretreatment duration and is >500 milliseconds, P waves disappear, or patient develops clinically important tachycardia, symptomatic bradycardia, or hypotension.^{119 163 167 168 169 170}

  
  

Malaria

• 
  

  Initiate IV quinidine gluconate regimen as soon as possible after severe P. falciparum malaria is diagnosed.^{158 162} CDC recommends the regimen be initiated in patients with strong clinical evidence of severe malaria, even if initial blood smears do not demonstrate parasitemia or indicate P. vivax, P. ovale, or P. malariae infection.¹⁵⁸

  
  


• 
  

  CDC and others recommend the IV quinidine gluconate regimen be administered in an intensive care facility with close monitoring.^{101 111 122 123 124 125 126 141 153 158}

  
  


• 
  

  Monitor BP, plasma quinidine concentrations, and ECG closely and monitor blood glucose periodically in patients receiving quinidine for treatment of malaria; adjust dosage accordingly.^{101 102 104 111 141 158 162}

  
  


• 
  

  Because most deaths from severe malaria occur within the first 24–48 hours of illness, an initial loading dose is used to attain therapeutic plasma concentrations rapidly during this critical period of elevated parasitemia.¹⁵⁸ A loading dose should not be used if patient received >40 mg/kg of quinine in the previous 48 hours or received mefloquine in the previous 12 hours.¹⁵⁸

  
  


• 
  

  Calculate loading dose and infusion rate carefully to prevent acute cardiac events.¹⁵³ Consider that the risk of serious ventricular arrhythmias associated with quinidine is increased by bradycardia, hypokalemia, hypomagnesemia, and concomitant use of drugs that can prolong QT interval (e.g., halofantrine [an antimalarial drug not commercially available in the US], mefloquine, quinine).^{101 153 158}

  
  


• 
  

  CDC recommends consultation with a cardiologist and a clinician with experience in treating malaria.^{153 158 162} A cardiologist may be helpful if attempting to resume IV infusion of quinidine gluconate in patients who develop prolongation of QT interval or hypotension during treatment.¹⁵³

  
  

Administration

Administer quinidine sulfate orally.^{163 167} Administer quinidine gluconate orally^{168 169} or by IV infusion.¹¹⁹

IM administration of quinidine gluconate is not recommended because absorption may vary depending on the patient’s peripheral perfusion.¹¹⁹

Oral Administration

Administer quinidine sulfate orally as conventional^{167 170} or extended-release tablets.¹⁶³

Administer quinidine gluconate orally as extended-release tablets.^{168 169}

May be administered with food or antacids to decrease adverse GI effects.^b Avoid grapefruit juice.^{156 163 168 169} (See Specific Drugs and Foods under Interactions.)

To determine possible idiosyncrasy to quinidine, administer a test dose of 200 mg of quinidine sulfate orally several hours before initiating full dosage.^b For children, the test dose for idiosyncrasy is 2 mg/kg (up to 200 mg) of quinidine sulfate orally.^{164 b}

Extended-release Tablets

Used principally for maintenance therapy in the management of arrhythmias.^b

Quinidine gluconate extended-release tablets may be broken in half in order to titrate dosage; however, do not chew or crush.^{168 169}

IV Administration

Arrhythmias: Administer by IV infusion.¹¹⁹

Malaria: Administer by continuous or intermittent IV infusion.^{101 102 104 111 119 122 123 124 125 158 162}

Dilution

Arrhythmias: Dilute contents of multiple-dose vial containing 800 mg of quinidine gluconate (10 mL of 80-mg/mL injection) in 40 mL of 5% dextrose injection to provide solution containing 16 mg/mL.¹¹⁹

Malaria (continuous IV infusion regimen): Dilute loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate)^{101 119 141 153 158} in approximately 5 mL/kg of 0.9% sodium chloride injection.¹¹⁹

Malaria (intermittent IV infusion regimen): Dilute loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate)^{119 153 158} in 250 mL of 0.9% sodium chloride injection.¹¹⁹

Rate of Administration

Minimize length of IV tubing because of quinidine adsorption to PVC tubing.¹¹⁹ (See Compatibility under Stability.)

Overly rapid IV administration can cause potentially severe cardiovascular effects.¹¹⁹ (See IV Administration under Cautions.)

Arrhythmias: Up to 0.25 mg/kg per minute (i.e., about 1 mL/kg per hour of 16-mg/mL dilution).¹¹⁹

Malaria (continuous IV infusion regimen): Give loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate) by IV infusion over 1–2 hours, followed by continuous IV infusions given at a rate of 12.5 mcg/kg of quinidine per minute (20 mcg/kg of quinidine gluconate per minute) for at least 24 hours.^{101 119 153 158} Administer infusion at a rate that maintains a plasma quinidine concentration of 3–8 mcg/mL.¹⁵⁸ Decrease infusion rate or interrupt flow if corrected QT interval is >0.6 seconds, corrected QT interval exceeds baseline by >25%, QRS widening is >50% of baseline, or clinically important hypotension unresponsive to fluid expansion develops.^{111 124 128 158}

Malaria (intermittent IV infusion regimen): Give loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate) by IV infusion over 4 hours, followed 4 hours later (i.e., 8 hours after the beginning of the loading-dose infusion) by maintenance doses of 7.5 mg/kg of quinidine (12 mg/kg of quinidine gluconate) given by IV infusion over 4 hours at 8-hour intervals.^{119 153 158} Administer infusion at a rate that maintains a plasma quinidine concentration of 3–8 mcg/mL.¹⁵⁸ Decrease infusion rate or interrupt flow if corrected QT interval is >0.6 seconds, corrected QT interval exceeds baseline by >25%, QRS widening exceeds baseline by >50%, or clinically important hypotension unresponsive to fluid expansion develops.¹⁵⁸

Dosage

Available as quinidine sulfate^{163 167 170} and quinidine gluconate.^{119 168 169} Dosage for treatment of arrhythmias usually expressed in terms of the salt;^{119 163 167 168 169 170} dosage for treatment of malaria expressed in terms of the base or salt.^{119 158 162}

On a molar basis, approximately 267 mg of quinidine gluconate is equivalent to 200 mg of quinidine sulfate.^b

Each 100 mg of quinidine gluconate contains 62.5 mg of quinidine.¹¹⁹

Pediatric Patients

Quinidine Sulfate

Arrhythmias†

Oral

15–60 mg/kg of quinidine sulfate daily given in divided doses every 6 hours has been recommended by some clinicians.^{164 165} Others recommend 30 mg/kg daily or 900 mg/m² daily, given in 5 divided doses.^b

Quinidine Gluconate

Arrhythmias†

Oral

20–60 mg/kg of quinidine gluconate daily given in divided doses every 8 hours has been recommended by some clinicians.¹⁶⁵

IV

30 mg/kg daily or 900 mg/m² daily of quinidine gluconate, given in 5 divided doses, is recommended by some clinicians.^b

Severe Malaria

IV

Continuous IV infusion regimen: Initial loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate) given by IV infusion over 1–2 hours,^{101 119 158 162} followed by a maintenance infusion of 12.5 mcg/kg of quinidine per minute (20 mcg/kg of quinidine gluconate per minute) continued for ≥24 hours and until parasitemia is reduced to <1% and oral quinine sulfate can be substituted.^{101 111 119 122 123 124 125 141 158 162} Some clinicians state initial loading dose should not exceed 375 mg of quinidine (600 mg of quinidine gluconate).¹⁰¹

Intermittent IV infusion regimen: Initial loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate) given by IV infusion over 4 hours, followed 4 hours later (i.e., 8 hours after the beginning of the loading-dose infusion) by maintenance doses of 7.5 mg/kg of quinidine (12 mg/kg of quinidine gluconate) given by IV infusion over 4 hours at 8-hour intervals until 3 maintenance doses have been administered and parasitemia is reduced to <1% and oral quinine sulfate can be substituted.^{119 153 158 162}

After ≥24 hours of quinidine gluconate and when clinically indicated, switch to oral quinine sulfate therapy to complete a total of 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (3 days if malaria was acquired in Africa or South America or 7 days if acquired in Southeast Asia).^{122 123 141 158 162}

The IV quinidine gluconate regimen followed by oral quinine sulfate is used in conjunction with a 7-day regimen of doxycycline, tetracycline, or clindamycin (given IV or orally as tolerated).¹⁵⁸

Adults

Quinidine Sulfate

Arrhythmias

Oral

Conversion of atrial fibrillation/flutter (conventional tablets): Manufacturers recommend 400 mg of quinidine sulfate (332 mg of quinidine) every 6 hours initially; dose may be cautiously increased if conversion is not attained after 4 or 5 doses.^{167 170}

Conversion of atrial fibrillation/flutter (extended-release tablets): Manufacturer recommends 300 mg of quinidine sulfate (249 mg of quinidine) every 8–12 hours initially; dose may be cautiously increased if conversion not attained, quinidine serum concentrations are within the therapeutic range, and the drug is well tolerated.¹⁶³

If successful conversion of atrial fibrillation does not occur when quinidine serum concentrations are in the therapeutic range, further dosage increases generally are unsuccessful and increase the possibility of toxicity.^b

Reduction in frequency of relapse into atrial fibrillation/flutter (conventional tablets): Manufacturers recommend 200 mg of quinidine sulfate (166 mg of quinidine) every 6 hours initially.^{167 170} Dose may be cautiously increased if well tolerated, serum quinidine concentrations are within therapeutic range, and average time between arrhythmic episodes has not been satisfactorily increased.^{167 170} Use such prophylaxis only if alternative measures have been inadequate and if potential benefits outweigh risks;^{167 170} consider mortality risk.^{167 170}

Reduction in frequency of relapse into atrial fibrillation/flutter (extended-release tablets): Manufacturer recommends 300 mg of quinidine sulfate (249 mg of quinidine) every 8–12 hours initially.¹⁶³ Dose may be cautiously increased if well tolerated, serum quinidine concentrations are within therapeutic range, and average time between arrhythmic episodes has not been satisfactorily increased.¹⁶³ Use such prophylaxis only if alternative measures have been inadequate and if potential benefits outweigh risks;¹⁶³ consider mortality risk.¹⁶³

Manufacturers state that dosage regimens for suppression of life-threatening ventricular arrhythmias have not been adequately studied, but regimens similar to those used in the management of atrial fibrillation/flutter have been described.^{163 167 170} Whenever possible, such therapy should be guided by results of programmed electrical stimulation and/or Holter monitoring with exercise.^{163 167 170}

Malaria

Oral

300–600 mg or 10 mg/kg of quinidine sulfate every 8 hours for 5–7 days has been used for the treatment of uncomplicated P. falciparum malaria.^{102 103 108 109 110}

Not included in CDC recommendations for treatment of uncomplicated or severe malaria.^{158 162} (See Malaria under Uses.)

Quinidine Gluconate

Arrhythmias

Oral

Conversion of atrial fibrillation/flutter (extended-release tablets): Manufacturers recommend 648 mg of quinidine gluconate (403 mg of quinidine) every 8 hours initially; dose may be cautiously increased if conversion is not attained after 3 or 4 doses.^{168 169} Alternatively, manufacturers state that a regimen of 324 mg of quinidine gluconate (202 mg of quinidine) may be given every 8 hours for 2 days, then 648 mg of quinidine gluconate (403 mg of quinidine) every 12 hours for 2 days, and then 648 mg of quinidine gluconate (403 mg of quinidine) every 8 hours for up to 4 days.^{168 169} If the 648-mg dose is not tolerated, the lower dosage can be continued for the last 4 days.^{168 169}

Reduction in frequency of relapse into atrial fibrillation/flutter (extended-release tablets): Manufacturers recommend 324 mg of quinidine gluconate (202 mg of quinidine) every 8 or 12 hours initially.^{168 169} Dose may be cautiously increased if well tolerated, serum quinidine concentrations are within therapeutic range, and average time between arrhythmic episodes has not been satisfactorily increased.^{168 169} Use such prophylaxis only if alternative measures have been inadequate and if potential benefits outweigh risks;^{168 169} consider mortality risk.^{168 169}

Manufacturers state that dosage regimens for suppression of life-threatening ventricular arrhythmias have not been adequately studied, but regimens similar to those used in the management of atrial fibrillation/flutter have been described.^{168 169} Whenever possible, such therapy should be guided by results of programmed electrical stimulation and/or Holter monitoring with exercise.^{168 169}

IV

Treatment of symptomatic atrial fibrillation/flutter: Initially, up to 0.25 mg/kg of quinidine gluconate per minute (i.e., up to 1 mL/kg per hour) of 16-mg/mL dilution.¹¹⁹ Discontinue IV infusion as soon as sinus rhythm is restored.¹¹⁹

Most arrhythmias responsive to IV quinidine respond to a total IV dosage <5 mg/kg, although 10 mg/kg may be required in some patients.¹¹⁹ If conversion to sinus rhythm has not occurred after infusion of quinidine gluconate 10 mg/kg, discontinue the infusion and consider other means of cardioversion.¹¹⁹

Although dosing regimens for the management of life-threatening ventricular arrhythmias have not been systematically evaluated, regimens similar to that used in the management of atrial fibrillation/flutter have been described.¹¹⁹

Severe Malaria

IV

Continuous IV infusion regimen: Initial loading dose of 6.25 mg/kg of quinidine (10 mg/kg of quinidine gluconate) given by IV infusion over 1–2 hours,^{101 119 141 158 162} followed by a maintenance infusion of 12.5 mcg/kg of quinidine per minute (20 mcg/kg of quinidine gluconate per minute) continued for ≥24 hours and until parasitemia is reduced to <1% and oral quinine sulfate can be substituted.^{101 111 119 122 123 124 125 141 158 162} Some clinicians state initial loading dose should not exceed 375 mg of quinidine (600 mg of quinidine gluconate).¹⁰¹

Intermittent IV infusion regimen: Initial loading dose of 15 mg/kg of quinidine (24 mg/kg of quinidine gluconate) given by IV infusion over 4 hours, followed 4 hours later (i.e., 8 hours after the beginning of the loading-dose infusion) by maintenance doses of 7.5 mg/kg of quinidine (12 mg/kg of quinidine gluconate) given by IV infusion over 4 hours at 8-hour intervals until 3 maintenance doses have been administered and parasitemia is reduced to <1% and oral quinine sulfate can be substituted.^{119 153 158 162}

After ≥24 hours of quinidine gluconate and when clinically indicated, switch to oral quinine sulfate therapy to complete a total of 3 or 7 days of total quinidine and quinine therapy as determined by the geographic origin of the infecting parasite (3 days if malaria was acquired in Africa or South America or 7 days if acquired in Southeast Asia).^{122 123 141 158}

The IV quinidine gluconate regimen followed by oral quinine sulfate is used in conjunction with a 7-day regimen of doxycycline, tetracycline, or clindamycin (given IV or orally as tolerated).^{158 162}

Prescribing Limits

Pediatric Patients

Arrhythmias†

Quinidine Gluconate or Quinidine Sulfate

Oral

2.4 g of quinidine sulfate or quinidine gluconate daily.¹⁶⁵

Severe Malaria

Quinidine Gluconate

IV

Continuous IV infusion regimen: Maximum initial loading dose of 375 mg of quinidine (600 mg of quinidine gluconate).¹⁰¹

Adults

Severe Malaria

Quinidine Gluconate

IV

Continuous IV infusion regimen: Maximum initial loading dose of 375 mg of quinidine (600 mg of quinidine gluconate).¹⁰¹

Special Populations

Hepatic Impairment

Dosage reduction may be necessary to avoid toxicity.^{119 163 167 168 169 170}

Renal Impairment

Dosage reduction may be necessary to avoid toxicity.^{119 163 167 168 169 170}

In patients with severe malaria receiving IV quinidine gluconate, CDC states that initial (including loading) doses do not need to be reduced in those with renal failure.¹⁵⁸ If renal failure persists or clinical improvement does not occur in such patients, CDC recommends reducing maintenance IV infusion rate by one-third to one-half on the third day of treatment.¹⁵⁸

CHF

Dosage reduction may be necessary to avoid toxicity.^{119 163 167 168 169 170}

Geriatric Patients

Select dosage with caution, usually starting at the low end of the dosage range, and consider age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹¹⁹

Cautions for Quinidine Gluconate

Contraindications

• 
  

  Patients with AV junctional or idioventricular pacemaker, including those in complete AV block.^{119 163 167 168 169 170}

  
  


• 
  

  History of quinidine- or quinine-associated thrombocytopenic purpura.^{119 163 167 168 169 170}

  
  


• 
  

  Myasthenia gravis or other conditions that might be adversely affected by anticholinergic effects.^{119 163 167 168 169 170}

  
  


• 
  

  Known hypersensitivity to quinidine.^{119 163 167 168 169 170}

  
  

Warnings/Precautions

Warnings

Mortality

Pooled analysis of data from several randomized, controlled studies in patients with ventricular arrhythmias indicates that mortality rate associated with quinidine therapy is at least as high as that associated with other antiarrhythmic agents (e.g., flecainide, mexiletine, propafenone, tocainide).^b

Use quinidine only for life-threatening arrhythmias.¹⁴⁵ Avoid use for less severe ventricular arrhythmias and treatment of asymptomatic VPCs.¹⁴⁵

Additionally, pooled analysis of data from several randomized, controlled studies in patients with atrial flutter and fibrillation indicates that quinidine therapy may be associated with a mortality rate more than 3 times higher than that associated with placebo;^{163 167 168 169 170} consider the increased risk of death when initiating quinidine therapy.¹⁴⁴

Use with extreme caution, if at all, in patients with incomplete AV nodal block, since complete heart block and asystole may result.^b Parenteral administration is especially hazardous in the presence of AV block, in the absence of atrial activity, and in patients with extensive myocardial injury.^b

Proarrhythmic Effects

The possibility that potentially serious cardiac arrhythmias, including torsades de pointes, could occur if used concomitantly with other drugs that prolong the QT_c interval should be considered and such combined use should be avoided.¹⁵¹

Hypokalemia, hypoxia, and disorders of acid-base balance must be eliminated as potentiating factors in patients who require large doses of antiarrhythmic agents to control ventricular arrhythmias.^b

Paradoxical Increase in Ventricular Rate in Atrial Flutter/Fibrillation

Paradoxically, an extremely rapid ventricular rate may occur when used in the treatment of atrial flutter or fibrillation, due to a reduction in the degree of AV nodal block to a 1:1 ratio.^b The anticholinergic action on the AV node also may increase the heart rate.^b

This tachycardia may be prevented by prior digitalization.^b

If cessation of atrial fibrillation or flutter is accompanied by depression of the normal pacemaker, an idioventricular rhythm (including ventricular tachycardia and fibrillation) may result.^b

Exacerbated Bradycardia in Sick Sinus Syndrome

Possible marked sinus node depression and bradycardia.^b

IV Administration

Overly rapid IV administration may cause peripheral vascular collapse and hypotension.¹¹⁹

Sensitivity Reactions

Hypersensitivity Reactions

Idiosyncratic and hypersensitivity reactions to quinidine may occur, and the reaction to a test dose or the first dose of the drug should be observed carefully.^b (See Oral Administration under Dosage and Administration.)

Observe for hypersensitivity for the first weeks of therapy.^b

Symptoms of cinchonism such as tinnitus, headache, vertigo, fever, dizziness, lightheadedness, tremor, nausea, and disturbed vision may occur in sensitive patients after a single dose.^b

Decrease dosage if signs of cinchonism appear.^b

General Precautions

Cardiovascular Effects

Possible syncope, probably due to ventricular tachycardia or fibrillation in usual doses.^b May subside spontaneously, but occasionally are fatal.^b If quinidine-induced syncope occurs, discontinue the drug.^b Also may cause bradycardia.^b

Severe hypotension may occur following IV administration or oral overdosage.^b Vascular collapse, respiratory distress, and respiratory arrest may occur.^b Reportedly related to the dose and rate of administration of the drug.^{102 107 119} Rapid IV injection of as little as 200 mg reportedly may cause a decrease in blood pressure of 40–50 mm Hg.¹¹⁹ Norepinephrine or metaraminol may be used if necessary to treat vascular collapse; artificial respiration and other supportive measures may be required.^b

While substantial cardiovascular toxicity generally has not occurred, ECG changes, including prolonged QT interval, widened QRS complex, and flattened T waves (without dysrhythmia), have occurred frequently and hypotension and ventricular tachycardia have occurred occasionally in patients receiving IV quinidine gluconate for the treatment of Plasmodium falciparum malaria.^{102 104 108 124}

Use with caution in patients without implanted pacemakers at high risk of complete atrioventricular block (e.g., digitalis intoxication, second-degree atrioventricular block, severe intraventricular conduction defects).^{163 167 168 169 170}

Availability for Use in Treatment of Severe Malaria

Because of potentially fatal consequences of delays in initiating treatment of severe malaria, institutional pharmacy services should be aware of the essential role of ready availability of IV quinidine gluconate.^{b 142 143 153 158}

If IV quinidine gluconate is not readily available for a patient with severe P. falciparum malaria (e.g., in hospitals where the drug is not maintained on formulary or otherwise available), health-care professionals should contact a nearby healthcare facility that stocks the drug.¹⁵⁸ If a local source cannot be found, contact the local or regional distributor of the drug.¹⁵⁸

If IV quinidine gluconate is unavailable, cannot be used because of intolerance or contraindications, or parasitemia is high or has not responded to quinidine gluconate therapy, IV artesunate is available from the CDC under an IND protocol for treatment of severe malaria.^{158 162 171} (See Malaria under Uses.)

Specific Populations

Pregnancy

Category C.^{119 163 166 167 168 169 170}

Generally considered relatively safe at usual dosages, but may exhibit oxytocic effect (possible abortion) at high dosages.¹⁶⁶

Lactation

Distributed into milk.^{119 163 166 167 168 169 170} Avoid, if possible, in nursing women.^{119 163 167 168 169 170}

Pediatric Use

Safety and efficacy as an antiarrhythmic agent in children not established.^{119 163 167 168 169 170} Has been used in children with arrhythmias†.^{165 b}

Study and experience in children with malaria suggest that safety and efficacy of IV quinidine gluconate are similar to those in adults.¹¹⁹

Geriatric Use

Safety and efficacy not systematically studied in geriatric patients.^{119 167 168 169 170} Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently than younger adults;¹¹⁹ other reported clinical experience has not identified differences in responses between geriatric adults and younger patients.¹¹⁹

When used in geriatric patients, select dosage with caution, usually initiating therapy at the low end of dosage range, and consider the greater frequency of decreased hepatic, renal, and/or cardiac function and concomitant disease and drug therapy in this age group.¹¹⁹

Hepatic Impairment

Decreased clearance;^{119 163 167 168}

TheraTears Nutrition

Generic Name: omega-3 polyunsaturated fatty acids (oh MAY ga 3 POL ee un SAT yoo ray ted FAT ee AS ids)

Brand Names: Animi-3, Animi-3 with Vitamin D, Divista, EPA Fish Oil, Fish Oil, Fish Oil Ultra, Icar Prenatal Essential Omega-3, Lovaza, Marine Lipid Concentrate, MaxEPA, MaxiTears Dry Eye Formula, MaxiVision Omega-3 Formula, Mi-Omega NF, Omega-500, Sea-Omega, Sea-Omega 30, TheraTears Nutrition, TherOmega

What is TheraTears Nutrition (omega-3 polyunsaturated fatty acids)?

Omega-3 polyunsaturated fatty acids are found in oil from certain types of fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet. Omega-3 polyunsaturated fatty acids work by lowering the body's production of triglycerides. High levels of triglycerides can lead to coronary artery disease, heart disease, and stroke.

Omega-3 polyunsaturated fatty acids are used together with diet and exercise to help lower triglyceride levels in the blood.

Omega-3 polyunsaturated fatty acids may also be used for purposes not listed in this medication guide.

What is the most important information I should know about TheraTears Nutrition (omega-3 polyunsaturated fatty acids)?

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.

Swallow the omega-3 polyunsaturated capsule whole. Do not puncture or open the capsule.

This medication is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

There may be other drugs that can interact with omega-3 polyunsaturated fatty acids. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What should I discuss with my health care provider before taking TheraTears Nutrition (omega-3 polyunsaturated fatty acids)?

Do not use this medication if you are allergic to fish or soybeans.

Ask a doctor or pharmacist about using this medicine if you have:

• 
  

  diabetes;

  
  


• 
  

  liver disease;

  
  


• 
  

  a pancreas disorder;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  if you drink more than 2 alcoholic beverages per day.

  
  

FDA pregnancy category C. It is not known whether omega-3 polyunsaturated fatty acids will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether omega-3 polyunsaturated fatty acids pass into breast milk or if this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old.

How should I take TheraTears Nutrition (omega-3 polyunsaturated fatty acids)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Swallow the omega-3 polyunsaturated capsule whole. Do not puncture or open the capsule. This medication works best if you take it with food.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

This medication is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking TheraTears Nutrition (omega-3 polyunsaturated fatty acids)?

Avoid eating foods that are high in fat or cholesterol. This medication will not be as effective in lowering your triglycerides if you do not follow the diet plan recommended by your doctor.

Avoid drinking alcohol. It can increase triglycerides and may make your condition worse.

TheraTears Nutrition (omega-3 polyunsaturated fatty acids) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  chest pain; or

  
  


• 
  

  uneven heartbeats.

  
  

Less serious side effects may include:

• 
  

  back pain;

  
  


• 
  

  unusual or unpleasant taste in your mouth;

  
  


• 
  

  upset stomach, belching; or

  
  


• 
  

  mild skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect TheraTears Nutrition (omega-3 polyunsaturated fatty acids)?

Tell your doctor about all other medicines you use, especially:

• 
  

  estrogens (birth control pills or hormone replacement);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HydroDIURIL, Microzide), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

  
  

This list is not complete and other drugs may interact with omega-3 polyunsaturated fatty acids. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More TheraTears Nutrition resources

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

• Animi-3 MedFacts Consumer Leaflet (Wolters Kluwer)


• Animi-3 with Vitamin D Prescribing Information (FDA)


• Divista Prescribing Information (FDA)


• Divista MedFacts Consumer Leaflet (Wolters Kluwer)


• Fish Oil Consumer Overview


• Lovaza Prescribing Information (FDA)


• Lovaza Advanced Consumer (Micromedex) - Includes Dosage Information


• Lovaza MedFacts Consumer Leaflet (Wolters Kluwer)


• Mi-Omega NF Prescribing Information (FDA)


• Omacor Prescribing Information (FDA)


• Omacor Consumer Overview


• Omacor Monograph (AHFS DI)

Compare TheraTears Nutrition with other medications

• ADHD
• Dietary Supplementation
• Hypertriglyceridemia

Where can I get more information?

• Your pharmacist can provide more information about omega-3 polyunsaturated fatty acids.

See also: TheraTears Nutrition side effects (in more detail)

Tylenol Extra Strength PM

Generic Name: acetaminophen and diphenhydramine (a SEET a MIN oh fen and DYE fen HYE dra meen)

Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief

What is Tylenol Extra Strength PM (acetaminophen and diphenhydramine)?

Acetaminophen is a pain reliever and fever reducer.

Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of acetaminophen and diphenhydramine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen and diphenhydramine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tylenol Extra Strength PM (acetaminophen and diphenhydramine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen and can increase certain side effects of diphenhydramine. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking Tylenol Extra Strength PM (acetaminophen and diphenhydramine)?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• 
  

  kidney disease;

  
  


• 
  

  cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  low blood pressure; or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

How should I take Tylenol Extra Strength PM (acetaminophen and diphenhydramine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Tylenol Extra Strength PM (acetaminophen and diphenhydramine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of diphenhydramine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Tylenol Extra Strength PM (acetaminophen and diphenhydramine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, rapid pulse, fast or uneven heart rate;

  
  


• 
  

  confusion, hallucinations, severe nervousness;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  mild headache;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  feeling nervous; or

  
  


• 
  

  sleep problems (insomnia);

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tylenol Extra Strength PM (acetaminophen and diphenhydramine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by diphenhydramine.

Tell your doctor about all other medicines you use, especially:

• 
  

  leflunomide (Arava);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  diphenhydramine (Benadryl) applied to the skin;

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  bladder or urinary medications;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a bronchodilator;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with acetaminophen and diphenhydramine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Tylenol Extra Strength PM resources

• Tylenol Extra Strength PM Side Effects (in more detail)
• Tylenol Extra Strength PM Use in Pregnancy & Breastfeeding
• Drug Images
• Tylenol Extra Strength PM Drug Interactions
• Tylenol Extra Strength PM Support Group
• 6 Reviews for Tylenol Extra Strength PM - Add your own review/rating

Compare Tylenol Extra Strength PM with other medications

• Headache
• Insomnia
• Pain

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and diphenhydramine.

See also: Tylenol Extra Strength PM side effects (in more detail)

Salactol Collodion

1. Name Of The Medicinal Product

SALACTOL™ COLLODION

2. Qualitative And Quantitative Composition

Salicylic Acid 16.7% w/w; Lactic Acid 16.7% w/w.

3. Pharmaceutical Form

Colourless or pale yellow/brown evaporative collodion paint.

4. Clinical Particulars

4.1 Therapeutic Indications

For the topical treatment of warts, verrucas, corns and calluses.

4.2 Posology And Method Of Administration

For adults, children and the elderly. Salactol should be applied once daily usually at night. It can take up to twelve (12) weeks for resistant lesions to disappear, and it is necessary to persevere with the treatment. Soak the affected site in warm water and pat dry. Gently rub the surface of the wart, verruca, corn or callus with a pumice stone or manicure emery board to remove any hard skin. Using the applicator provided, carefully apply a few drops of Salactol to the lesion, allowing each drop to dry before applying the next one. Take care to localise the application to the affected area. Plantar warts should be covered with an adhesive plaster. Leave for 24 hours. Repeat the procedure daily, after first removing any plaster.

4.3 Contraindications

Not to be used on or near the face, intertriginous or anogenital regions or by diabetics or individuals with impaired peripheral blood circulation. Not to be used on moles, birthmarks, hairy warts or on any other skin lesions for which Salactol is not indicated. Not to be used in cases of sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep away from the eyes and mucous membranes. The gel should be applied carefully to the wart, verruca, corn or callus only, to avoid possible irritation of surrounding normal skin. Some mild, transient irritation may be expected, but in cases of more severe or persistent pain/irritation, the treatment should be suspended and/or discontinued. See also Section 4.8. Extremely flammable. Avoid spillage. Avoid inhaling vapour. Replace cap tightly after use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Salactol may be irritant in certain patients, which in rare instances may appear as a temporary blemish on the skin. See also Section 4.4.

4.9 Overdose

Any excessive use of Salactol could cause irritation of the skin. If this occurs, Salactol should be used more sparingly or applied less frequently. Accidental oral ingestion should be treated immediately by gastric lavage with a 2 to 5% aqueous sodium bicarbonate solution. Fluid and electrolyte balance should be monitored and appropriate supportive measures should be provided. Symptoms include headache, nausea, vomiting, diarrhoea and respiratory depression.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of salicylic acid and lactic acid in flexible collodion has been shown to be particularly efficacious in treating warts, verrucas, corns and calluses.

Salicylic acid has bacteriostatic and fungicidal actions as well as keratolytic properties. Its effectiveness for topical treatment of hyperkeratotic skin lesions is based on mild keratolytic action which produces slow and painless destruction of the epithelium. In the treatment of warts, a mild irritant reaction, which may render the virus more prone to immunologic stimulation or response, may add to the mechanical removal of infected cells. Apart from its antiseptic and caustic properties, lactic acid enhances the availability of salicylic acid from the dried collodion.

5.2 Pharmacokinetic Properties

Salactol contains 16.7% salicylic acid and 16.7% lactic acid in flexible collodion. The bioavailability of salicylic acid is reduced as the collodion film dries on the skin due to entrapment of the drug which inhibits release. The addition of lactic acid to salicylic acid collodion provides more efficient release of the salicylic acid, since the non-volatile lactic acid remains in the film, thus permitting continued release of the keratolytic which may otherwise be entrapped within the dried collodion film. Systemic absorption of salicylic acid or lactic acid after application to small circumscribed areas is exceedingly unlikely.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pyroxylin; Colophony; Castor Oil; IMS; Ether.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

10 ml amber glass bottle with plastic cap, incorporating a specially designed spatula for ease of application. This is supplied as an original pack (OP).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/5006R.

9. Date Of First Authorisation/Renewal Of The Authorisation

2 May 2006.

10. Date Of Revision Of The Text

June 2011.

Antithrombin III (Human)

Class: Anticoagulants, Miscellaneous
VA Class: BL500
CAS Number: 52014-67-2
Brands: Thrombate III

Introduction

Anticoagulant; naturally occurring plasma thrombin inhibitor.^{1 4 6 9 14 16 17 18}

Uses for Antithrombin III (Human)

Congenital Antithrombin III Deficiency

Short-term replacement therapy for prevention or treatment of thromboembolism in selected patients with congenital antithrombin III deficiency at high risk for thromboembolism (i.e., those undergoing surgical or obstetrical procedures) or those with thromboembolism.^{1 3 4 5 6 9} Has been designated an orphan drug by FDA for this use.²

Confirm congenital antithrombin III deficiency based on clear family history of venous thrombosis and decreased endogenous plasma antithrombin III concentrations;^{1 6} exclude acquired antithrombin III deficiency.¹

Thromboprophylaxis (e.g., with unfractionated heparin, low molecular weight heparin) throughout pregnancy recommended by the American College of Chest Physicians (ACCP) and other clinicians in women with congenital antithrombin III deficiency.^{4 8 10 12 14 17} ACCP and other clinicians recommend discontinuance of heparin or low molecular weight heparin thromboprophylaxis prior to labor followed by postpartum anticoagulation with warfarin.^{4 8 10 14 17} Follow-up replacement therapy with antithrombin III in women with congenital deficiency suggested by some clinicians, initiated prior to or on day of delivery and continued postpartum.^{4 6 9 10 14 19} Has been used in combination with unfractionated heparin after delivery in such patients.⁵

Management of venous thromboembolism in patients with congenital antithrombin III deficiency generally similar to that in other patients (i.e., conventional anticoagulation with unfractionated heparin, low molecular weight heparin, or fondaparinux followed by warfarin).^{6 7 9 10 12 13 14 17 18 19} Short-term therapy with antithrombin III suggested by some clinicians when unacceptable risks of bleeding exist with conventional anticoagulation.^{12 14}

Role of antithrombin III as adjunctive therapy to unfractionated heparin in patients with congenital antithrombin III deficiency and thromboembolism not clearly defined.¹² (See Interactions.) Used to overcome unfractionated heparin resistance (e.g., IV heparin dosage >35,000–40,000 units daily required to achieve aPTT ≥1.5 times control value)⁵ in such patients.^{1 3 4 5 9 12 14 18 19 21} Use of antithrombin III also suggested by some clinicians in patients with severe thrombosis or breakthrough thrombosis despite anticoagulation.^{3 12 14}

Has been used in a limited number of neonates† with congenital antithrombin III deficiency.⁵ (See Pediatric Use under Cautions.)

Antithrombin III (Human) Dosage and Administration

General

• 
  

  Monitor antithrombin III concentrations periodically to individualize dosage and assess response to therapy.¹ (See Laboratory Monitoring under Cautions.)

  
  


• 
  

  Suggested dosage recommendations are general guidelines.¹

  
  


• 
  

  Individualize dosage and duration of therapy based on clinical situation (e.g., indication for treatment, patient's clinical condition and past history, type and extent of surgery or obstetrical procedure), clinical judgment, response to therapy, actual antithrombin III plasma concentrations achieved, and desired plasma concentrations.¹

  
  

Administration

IV Administration

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

Prior to administration, allow reconstituted solution to warm to room temperature.¹

Administer by IV infusion over 10–20 minutes.¹

Reconstitution

Prior to reconstitution, allow manufacturer-supplied diluent to warm to room temperature.¹

Reconstitute lyophilized powder with diluent provided by manufacturer.¹ Use strict aseptic technique since drug contains no preservative.¹

Reconstitute single-use vials of lyophilized powder by adding 10 or 20 mL of sterile water for injection without preservatives to vial containing approximately 500 or 1000 units of drug, respectively, using transfer needle provided by manufacturer.¹ Direct stream of diluent at 45-degree angle against side of vial to minimize foaming.¹

Gently swirl to avoid foam formation and dissolve powder completely.¹

Withdraw reconstituted solution from vial(s) using filter needle provided by manufacturer.¹ Before administration, remove filter needle and attach injection or butterfly needle.¹

Rate of Administration

Individualize infusion rates based on patient response.¹ Administration of entire dose in 10–20 minutes usually well tolerated.¹

Dosage

Potency expressed in international units (units) as tested against activity of WHO reference standard.¹ One unit approximately equivalent to amount of antithrombin III (mg) in 1 mL of pooled human plasma from healthy donors.^{12 16 23} Specific activity of antithrombin III is 6.9–9 units of antithrombin III per mg of protein.²³

Number of units of antithrombin III indicated on label of each vial.^{1 23}

Use clinical response and laboratory tests to guide dosage calculations.¹ (See Laboratory Monitoring under Cautions.)

Determine preinfusion (baseline) antithrombin III concentration and calculate initial (loading) dosage using following formula:^{1 4}

Initial Dose (units) = (desired antithrombin III concentration - baseline antithrombin III concentration [% of normal] × wt (in kg) ÷ 1.4

Formula based on expected incremental in vivo recovery (increase) of antithrombin III concentrations above baseline values of 1.4% for each unit/kg administered (functional activity).¹

For example, to increase antithrombin III plasma concentrations to 120% of normal from a baseline antithrombin III plasma concentration of 57% of normal, the total initial dose of antithrombin III for a 70-kg adult would be 3150 units.¹

Following initial dose, subsequent dose based on recovery (increase) of antithrombin III plasma concentrations resulting from initial dose.¹ Base adjustments of maintenance dosage and/or dosage interval on actual antithrombin III plasma concentrations achieved.¹

Adults

Antithrombin III Deficiency

IV Infusion

Initial (loading) dose: Administer appropriate dose to increase plasma antithrombin III concentration to a suggested level of 120% of normal using above formula.¹

Following initial dose, determine plasma antithrombin III concentrations 20 minutes postinfusion (peak concentration), 12 hours after administration, and before next infusion (trough concentration) to ensure plasma antithrombin III concentrations >80% of normal.^{1 4} If plasma antithrombin III concentration at 12 hours <80% of normal, administer additional antithrombin III (using the same formula used to calculate the initial dose)²³ to achieve plasma concentration >80% of normal.^{4 23}

Maintenance dosage: Determine preinfusion (trough) and peak postinfusion antithrombin III concentrations and administer additional doses of antithrombin III at appropriate intervals (e.g., every 24 hours) until peak and trough concentrations are maintained within therapeutic range (i.e., steady state), generally 80–120% of normal.^{1 4}

In general, approximately 60% of initial loading dose every 24 hours required to maintain steady-state plasma antithrombin III concentrations within 80–120% of normal.^{1 4} (See Laboratory Monitoring under Cautions.)

Continue therapy for 2–8 days following thromboembolism or surgical or obstetric procedure, depending on clinical situation.^{1 4} (See General under Dosage and Administration.)

Special Populations

Increased clearance with certain conditions or concurrent therapy (e.g., hemorrhage, acute thrombosis, surgery, pregnancy, concurrent IV heparin therapy); more frequent administration may be required.^{1 4 6 18}

Cautions for Antithrombin III (Human)

Contraindications

• 
  

  None known.¹

  
  

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Potential vehicle for transmission of human viruses (e.g., hepatitis C virus [HCV], hepatitis B virus [HBV], HIV) or other infectious agents.^{1 5 9}

Despite application of a number of viral elimination/reduction steps (e.g., heat treatment in solution, Cohn cold ethanol precipitation, screening for certain viruses) to prevent transmission of infectious agents, risk of transmission still remains.^{1 5}

Weigh risk of viral infection against benefits of therapy.^{1 5}

Report all infections thought possibly to have been transmitted by antithrombin III preparation to manufacturer at 800-520-2807.¹

Risk of Creutzfeldt-Jakob Disease

May carry a risk of transmitting causative agent of Creutzfeldt-Jakob disease (CJD).¹

Fractionation procedure decreases infectivity of intentionally added, experimental agent of transmissible spongiform encephalopathy (TSE), a model for CJD and variant CJD (vCJD) agents.¹ Provides reasonable assurance of removal of low concentrations of CJD or vCJD agents during manufacturing process.¹

Potentiation of Anticoagulant Effect

Enhanced anticoagulant effect with concurrent heparin; reduced heparin dosage recommended during concurrent therapy.¹ (See Interactions.)

General Precautions

Laboratory Monitoring

Prior to therapy, confirm congenital antithrombin III deficiency based on clear family history of venous thrombosis and decreased endogenous plasma antithrombin III concentrations determined by amidolytic assays with chromogenic substrates, clotting assays, or immunoassays (e.g., crossed immunoelectrophoresis).^{1 9 10 17} Immunoassays may not detect all congenital antithrombin III deficiencies.^{1 12}

Investigations to determine possible thrombophilia should not be performed after a recent thromboembolic event or during anticoagulant therapy since antithrombin III concentrations are reduced in these circumstances.⁶ (See Special Populations under Pharmacokinetics.)

Monitoring of antithrombin III concentrations critical for adjusting dosage and ensuring adequate therapeutic response.^{1 18} (See Antithrombin III Deficiency under Dosage and Administration.)

More frequent monitoring necessary in patients with increased clearance of antithrombin III (e.g., hemorrhage, acute thrombosis, concurrent IV heparin therapy, surgery).^{1 5} (See Special Populations under Pharmacokinetics.)

Determination of antithrombin III concentrations immediately after birth recommended in neonates of parents with congenital antithrombin III deficiency.¹ (See Pediatric Use under Cautions.)

Specific Populations

Pregnancy

Category B.¹

Pediatric Use

Safety and efficacy of antithrombin III not established in pediatric patients younger than 16 years of age.^{1 23}

Fatal thromboembolism (e.g., aortic thrombi) reported in neonates born to women with congenital antithrombin III deficiency.^{1 5} Determine antithrombin III concentrations immediately after birth in neonates of parents with congenital antithrombin III deficiency.¹

Plasma antithrombin III concentrations in healthy full-term neonates or healthy premature neonates average approximately 60 or 35%, respectively, of those in healthy adults.^{1 5 23} Low antithrombin III plasma concentrations, especially in premature neonates, do not necessarily indicate congenital deficiency.¹

Manufacturer and some clinicians recommend consultation with an expert on coagulation disorders regarding testing and treatment of neonates with suspected congenital antithrombin III deficiency.¹

Common Adverse Effects

Dizziness,^{1 4} chest tightness,^{1 4} nausea,¹ foul taste,^{1 4} chills,¹ cramps,^{1 4} shortness of breath,^{1 4} chest pain,¹ film over eye,¹ lightheadedness,^{1 3 4} bowel fullness,¹ hives,^{1 4} fever,^{1 4} oozing,¹ hematoma formation.¹

Interactions for Antithrombin III (Human)

Specific Drugs

Drug	Interaction	Comments
Heparin	Enhanced anticoagulant effect; increased risk of bleeding complications1 5 Decreases half-life of antithrombin III1 5 9 16 18	Reduce heparin dosage during concurrent treatment1 4

Antithrombin III (Human) Pharmacokinetics

Absorption

Plasma Concentrations

Therapeutic target plasma concentrations in patients with congenital antithrombin III deficiency range from 80–120% of values in healthy adults.^{1 18 23} (See Dosage under Dosage and Administration.) At plasma concentrations ≤70% of normal, increased thrombin generation.⁴ Supraphysiologic plasma concentrations (e.g., 150–200% of normal) have increased bleeding risk in patients with sepsis and disseminated intravascular coagulation†;¹¹ not known whether supraphysiologic concentrations increase bleeding risk in patients with congenital antithrombin III deficiency.^{11 23}

Distribution

Extent

Distributed into plasma (39%), extravascular space (49%), and vascular endothelial cells (11%).^{9 11 16}

Elimination

Metabolism

<5% metabolized to low molecular weight breakdown products.¹⁶

Elimination Route

Complexes of antithrombin III with thrombin or other proteinases cleared principally by liver^{6 9} and excreted in urine.^{15 16}

Half-life

Biphasic; terminal half-life is approximately 2.5–4.8 days.^{1 3 4 5 9 11 16 18}

Special Populations

Decreased half-life associated with hemorrhage, acute thrombosis, pregnancy, surgery, or concurrent IV heparin therapy.^{1 4 5 9 16 18} (See Special Populations under Dosage and Administration.)

Stability

Storage

Parenteral

Powder for Injection

2–8°C; protect from freezing as diluent vial may break.¹

Reconstituted solutions contain no preservative; use ≤3 hours after reconstitution and do not refrigerate.¹

Compatibility

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

Parenteral

Once reconstituted, do not mix with other agents or diluents.¹

ActionsActions

• 
  

  Neutralizes serine proteinases such as thrombin, plasmin, and activated coagulation factors IX, X, XI, and XII.^{1 4 5 6 9 10 14 16 17 18}

  
  


• 
  

  Principally neutralizes thrombin and activated coagulation factor X (X_a).¹⁴ Neutralization of factor X_a prevents thrombin generation (e.g., decreased formation of prothrombin fragment 1.2 [F1 and F2]).^{4 9 22} Neutralization of thrombin prevents conversion of fibrinogen to fibrin.^{9 22}

  
  


• 
  

  Slowly and irreversibly complexes stoichiometrically with these coagulation factors; such reactions are rapid in presence of endogenous heparin-like proteoglycans or exogenous heparin.^{1 4 5 9 10 14 16 17 18}

  
  


• 
  

  Inhibits thrombus formation^{1 3 4 9} and may prevent extension of existing thrombi.^{4 9}

  
  

Advice to Patients

• 
  

  Importance of informing patients with congenital antithrombin III deficiency about inheritance of disease.^{1 12 17}

  
  


• 
  

  Risk of thrombosis associated with pregnancy and surgery in patients with congenital antithrombin III deficiency.^{1 12 17}

  
  


• 
  

  Importance of patients understanding potential risks of therapy, including possible transmission of infectious agents.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 17}

  
  


• 
  

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

Antithrombin III

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	number of units indicated on label	Thrombate III (heat-treated, wet method; cold ethanol precipitation; with sterile water for injection diluent, double-ended transfer needle, filter needle)	Talecris Biotherapeutics

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 June 2008. 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. Talecris Biotherapeutics. Thrombate III (antithrombin III) injection prescribing information. Research Triangle Park, NC; 2006 Dec.

2. Food and Drug Administration. List of orphan designations and approvals. Rockville, MD; 2007 Oct 4. From FDA website (http: / / www.fda.gov / ForIndustry / DevelopingProductsforRareDiseasesConditions / HowtoapplyforOrphanProductDesignation / default.htm). Accessed 2007 Oct 15.

3. Menache D, O'Malley JP, Schorr JB et al. Evaluation of the safety, recovery, half-life, and clinical efficacy of antithrombin III (human) in patients with hereditary antithrombin III deficiency. Blood. 1990; 75:33-9. [PubMed 2403821]

4. Schwartz RS, Bauer KA, Rosenberg RD et al. Clinical experience with antithrombin III concentrate in treatment of congenital and acquired deficiency of antithrombin. Am J Med. 1989; 87:53-60S.

5. Lechner K, Kyrle PA. Antithrombin III concentrates — Are they clinically useful? Thromb Haemost. 1995; 73:340-8.

6. Cavenagh JD, Colvin BT. Guidelines for the management of thrombophilia. Postgrad Med J. 1996; 72:87-94. [PubMed 8871458]

7. Buller HR, Agnelli G, Hull RD et al. Antithrombotic therapy for venous thromboembolic disease: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126 (Suppl):401S-28S. [IDIS 523841] [PubMed 15383479]

8. Bates SM, Greer I, Hirsch J. Use of antithrombotic agents during pregnancy: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126 (Suppl):627S-44S. [IDIS 523850] [PubMed 15383488]

9. Menache D, Grossman BJ, Jackson CM. Antithrombin III: physiology, deficiency, and replacement therapy. Transfusion. 1992; 32:580-8. [PubMed 1502714]

10. Nicolaides AN, Breddin HK, Carpenter P et al. Thrombophilia and venous thromboembolism. International consensus statement. Guidelines according to scientific evidence. Int Angiol. 2005; 24:1-26. [PubMed 15876995]

11. Aibiki M, Fukuoka N, Nishiyama T et al. Differences in antithrombin III activities by administration method in critical patients with disseminated intravascular coagulation: a pharmacokinetic study. Shock. 2007; 28:141-7. [PubMed 17515857]

12. Lane DA, ManNucci PM, Bauer KA et al. Inherited thrombophilia: Part 2. Thromb Haemost. 1996; 76:824-34. [PubMed 8971998]

13. Geerts W, Pineo GF, Heit JA et al. Prevention of venous thromboembolism. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126 (Suppl):338S-400S. [IDIS 523840] [PubMed 15383478]

14. Maclean PS, Tait RC. Hereditary and acquired antithrombin III deficiency: epidemiology, pathogenesis and treatment options. Drugs. 2007; 67:1429-40. [PubMed 17600391]

15. Chan V, Yeung CK, Chan TK. Antithrombin III and fibrinogen degradation product (fragment E) in diabetic nephropathy. J Clin Pathol. 1982; 82:35:661-6.

16. Collen D, De Cock F, Holmer E et al. Metabolism of antithrombin III (heparin cofactor) in man: effects of venous thrombosis and of heparin administration. Eur J Clin Invest. 1977; 7:27–35.

17. Walker ID, Greaves M, Preston FE. Guideline: investigation and management of heritable thrombophilia. Br J Haematol. 2001; 114:512-28. [PubMed 11552975]

18. Kohler M. Antithrombin (AT) substitution: sense or nonsense? Anaesthesia. 1998; 53 (Suppl 2):52-4.

19. Schulman S, Tengborn L. Treatment of venous thromboembolism in patients with congenital deficiency of antithrombin III. Thromb Haemost. 1992; 68:634-6. [PubMed 1287876]

20. AHFS drug information 2007. McEvoy GK, ed. Heparin. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1458-71.

21. Hirsh J, Raschke R. Heparin and low-molecular weight heparin: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126:188S-203S. [IDIS 523834] [PubMed 15383472]

22. Brummel-Ziedins K, Orfeo T, Jenny NS et al. Blood coagulation and fibrinolysis. In: Greer JP, Rodgers GM, Foerster J et al, eds. Wintrobe's clinical hematology. 11th ed. Philadelphia: Lippincott Williams & Wilkins; 2004:677-774.

23. Talecris Biotherapeutics, Research Triangle Park, NC: Personal communication.

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