Granisetron-Actavis may be available in the countries listed below.
Granisetron hydrochloride (a derivative of Granisetron) is reported as an ingredient of Granisetron-Actavis in the following countries:
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In the US, Bactrim Pediatric is a member of the following drug classes: miscellaneous antibiotics, sulfonamides and is used to treat Bacterial Infection, Bacterial Skin Infection, Bronchitis, Diverticulitis, Epiglottitis, Granuloma Inguinale, Infection Prophylaxis, Kidney Infections, Melioidosis, Meningitis, Nocardiosis, Otitis Media, Pneumocystis Pneumonia, Pneumocystis Pneumonia Prophylaxis, Pneumonia, Prevention of Bladder infection, Prostatitis, Shigellosis, Sinusitis, Toxoplasmosis, Toxoplasmosis - Prophylaxis, Traveler's Diarrhea, Upper Respiratory Tract Infection and Urinary Tract Infection.
Sulfamethoxazole is reported as an ingredient of Bactrim Pediatric in the following countries:
Trimethoprim is reported as an ingredient of Bactrim Pediatric in the following countries:
International Drug Name Search
Metrovax may be available in the countries listed below.
Metronidazole is reported as an ingredient of Metrovax in the following countries:
International Drug Name Search
Class: Other Miscellaneous Therapeutic Agents
Chemical Name: Drotrecogin Alfa (Activated) for Injection
CAS Number: 42617-41-4
Brands: Xigris
Special Alerts:
[Posted 10/25/2011] ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of drotrecogin alfa (activated) [Xigris]. In a recently completed clinical trial (PROWESS-SHOCK trial), drotrecogin alfa (activated) failed to show a survival benefit for patients with severe sepsis and septic shock.
BACKGROUND: Drotrecogin alfa (activated) is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.
RECOMMENDATION: For more information visit the FDA website at: and .
Biosynthetic (recombinant DNA origin) form of human activated protein C with antithrombotic, anti-inflammatory, and profibrinolytic properties.1 2 5 6
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Used for mortality reduction in adults with severe sepsis and a high risk of death (e.g., as determined by an Acute Physiology and Chronic Health Evaluation [APACHE II] score of ≥25).1 2 4 7 9 International guidelines for the management of severe sepsis and septic shock suggest use in patients who generally have multiple organ failure and an APACHE score of ≥25.21
Efficacy not established and use not recommended in patients with a lower risk of death (e.g., APACHE II score <25) or in pediatric patients.1 2 11 16 18 21 22
Accurate diagnosis of severe sepsis and assessment of risk of death are critical when considering patients for therapy.1 11
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Discontinue therapy 2 hours prior to an invasive surgical procedure or procedures with an inherent risk of bleeding.1 9 Once adequate hemostasis is achieved, reconsider reinitiating therapy at initial recommended doses 12 hours after major invasive procedures or surgery or immediately following uncomplicated, less invasive procedures.1
Immediately discontinue therapy in patients with clinically important bleeding.1
Administer by continuous IV infusion using a controlled infusion device (i.e., infusion pump or syringe pump).1 9
For solution and drug compatibility information, see Compatibility under Stability.
Do not admix or infuse concomitantly with other drugs.1 (See Compatibility under Stability.)
Determine appropriate number of vials to reconstitute by calculating the amount of drug required for a particular infusion period based on patient's actual body weight (in kg) and duration of infusion (in hours); round total amount to nearest 5-mg increment to avoid wastage.1 A maximum infusion period of 12 hours is recommended for each infusion bag or syringe; multiple infusions are required to cover recommended 96-hour duration of therapy.1
Reconstitute vial containing 5 or 20 mg of drotrecogin alfa (activated) with 2.5 or 10 mL of sterile water for injection, respectively, to provide solutions containing 2 mg/mL.1
Swirl vial gently to ensure dissolution; do not invert or shake vial.1 Must be diluted further before IV administration.1
Reconstituted solutions contain no preservatives; solutions preferably should be diluted immediately after reconstitution.1 If not used immediately, solution may be stored at 20–25°C, but must be used within 3 hours.1
Dilute reconstituted solution with 0.9% sodium chloride injection in an IV infusion bag or syringe compatible with a syringe pump according to the manufacturer's directions to yield a concentration of 100–200 mcg/mL.1
Administer at room temperature within 12 hours of dilution; if not used immediately, store at 2–8°C for up to 12 hours.1 Total in-use time, including dilution, refrigeration, and administration, should not exceed 24 hours.1 4 10
Administer by IV infusion at 24 mcg/kg per hour for a total of 96 hours.1 9 If infusion is interrupted for >1 hour, extend infusion time to account for interruptions (i.e., allow for a total infusion duration of 96 hours) unless the interruption lasts for ≥36 hours.4
When administering the drug at low flow rates (< approximately 5 mL/hr), prime syringe pump for approximately 15 minutes at a flow rate of approximately 5 mL/hour.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Dosage escalation or loading doses are not recommended.1
Dosage adjustment based on clinical or laboratory parameters is not recommended.1
24 mcg/kg per hour for a total of 96 hours.1 9
Dosage adjustment not required in patients with renal impairment undergoing hemodialysis or peritoneal dialysis.1
Dosage adjustment not required.1
Dosage adjustment not required.1
Active internal bleeding.1 7 9
Recent (within 3 months) hemorrhagic stroke.1 7 9
Recent (within 2 months) intracranial or intraspinal surgery or severe head trauma.1 7 9
Trauma with an increased risk of life-threatening bleeding.1 7 9
Presence of an epidural catheter.1 7 9
Intracranial neoplasm or mass lesion, or evidence of cerebral herniation.1 7 9
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Serious bleeding events, including intracranial hemorrhage, have occurred in patients receiving drotrecogin alfa (activated) therapy.1 2 14 16 19 20 Possible increased risk of bleeding in patients with one or more of the following conditions: concurrent heparin therapy to treat an active thrombotic or embolic event; platelet counts <30,000/mm3 (even if the platelet count is increased after transfusions); PT-INR >3; recent (within 6 weeks) GI bleeding; recent (within 3 days) thrombolytic therapy; recent (within 7 days) administration of oral anticoagulants, platelet glycoprotein (GP IIb/IIIa) inhibitors or other platelet-aggregation inhibitors (e.g., > 650 mg of aspirin daily); recent (within 3 months) ischemic stroke (see Contraindications under Cautions); intracranial arteriovenous malformation or aneurysm; known bleeding diathesis; chronic severe hepatic disease; or any other condition in which bleeding constitutes a substantial hazard or would be particularly difficult to manage because of its location.1
In a retrospective study of patients who received drotrecogin alfa (activated) for sepsis, serious bleeding events and deaths occurred in substantially more patients with baseline bleeding risk factors than those without such risk factors.13 14 15 FDA is currently investigating these preliminary findings and is working with the manufacturer to further evaluate the risk of serious bleeding and mortality in patients receiving drotrecogin alfa (activated).13 Pending completion of the safety review, FDA states that clinicians should carefully weigh the anticipated benefits of drotrecogin alfa (activated) against the risk of bleeding in any patient being considered for therapy.1 13
Some clinicians suggest avoiding use in patients with baseline bleeding risk factors.14 15 If clinically important bleeding occurs, immediately discontinue therapy.1 22 Also evaluate continued use of other agents affecting the coagulation system.1 (See Specific Drugs under Interactions.) Manufacturer states that resumption of therapy may be considered once adequate hemostasis has been achieved;1 however, some clinicians recommend against reinitiation of therapy in patients who develop severe bleeding during the infusion.22 (See General under Dosage and Administration.)
Higher mortality reported in placebo-controlled clinical studies within a small subset of patients receiving drotrecogin alfa (activated) therapy who had single-organ dysfunction and recent surgery (i.e., within 30 days prior to treatment).1 2 11 16 Some of these patients had a lower risk of death (e.g., APACHE II score <25 or sepsis-induced single-organ failure at any APACHE II score) than that of the indicated population for this drug.1 11 16 22
Patients with single-organ dysfunction and recent surgery may not be at high risk of death (regardless of APACHE II score); drotrocegin alfa (activated) therapy is not recommended in such patients.1 11 21 22
Higher rates of mortality demonstrated in patients receiving drotrecogin alfa (activated) who discontinue prophylactic enoxaparin or unfractionated heparin therapy.1 20 Consider continuing low molecular weight heparin for prophylaxis of venous thromboembolism in patients receiving drotrecogin alfa (activated) unless discontinuance is medically necessary.1 20
May interfere with one-stage coagulation assays (e.g., factor VIII, IX, XI assays) based on aPTT; minimal effect on PT.1
Discontinue drug prior to any invasive procedure (e.g., surgery) associated with an inherent risk of bleeding.1 9 (See General under Dosage and Administration.)
Minimize invasive procedures, including arterial and venous punctures, during drotrecogin alfa (activated) therapy; avoid establishing IV access at noncompressible sites (e.g., subclavian or jugular veins).1 (See Hematologic Effects under Cautions.)
Do not use aPTT to monitor degree of coagulopathy; may use PT instead.1
Antibodies to drotrecogin alfa (activated) reported in 1.5% of patients in clinical trials; a few patients tested positive for neutralizing antibodies.1 No apparent correlation between presence of antibodies and adverse effects.1
Limited experience with readministration (i.e., >1 course of therapy) of drotrecogin alfa (activated) in patients with severe sepsis;1 no hypersensitivity reactions or evidence of antibody development reported.1 4
Category C.1
Not known whether drotrecogin alfa (activated) is distributed into milk.1 Discontinue nursing or the drug, taking into account the importance of the drug to the mother.1
Safety and efficacy not demonstrated in children <18 years of age;1 18 not indicated for use in pediatric patients with severe sepsis.1 21 22
Interim analysis of a randomized, double-blind study evaluating safety and efficacy in pediatric patients with severe sepsis showed that treatment with drotrecogin alfa (activated) was highly unlikely to result in improvement in the primary end point (composite time to complete organ failure resolution over a 14-day period) compared with placebo; as a result, the study was discontinued before completion.1 18 In addition, the rate of CNS bleeding was numerically greater in the drotrecogin alfa (activated) group than in the placebo group.1 18 Of patients with intracranial hemorrhage, the majority were <60 days of age.18 The incidence of 28-day all-cause mortality, fatal CNS bleeding, serious adverse events, overall serious bleeding events, and major amputations appeared to be similar between the groups.1 18
No overall differences in safety and efficacy relative to younger adults.1
Bleeding (e.g., ecchymoses, GI bleeding, intracranial hemorrhage).1
Drug | Interaction | Comments |
|---|---|---|
Antiplatelet agents (e.g., aspirin, GP IIb/IIIa-receptor inhibitors) | Potential increased risk of bleeding1 | Use with caution1 |
Anticoagulants, oral | Potential increased risk of bleeding1 | Use with caution1 |
Heparin | Concomitant use of enoxaparin 40 mg every 24 hours or sub-Q unfractionated heparin sodium 5000 units every 12 hours did not increase risk of serious bleeding, but increased incidence of nonserious bleeding;1 clearance and steady-state plasma concentrations of drotrecogin alfa (activated) not altered1 | No dosage adjustment necessary1 |
NSAIAs | Potential increased risk of bleeding1 | Use with caution1 |
Thrombolytic agents | Potential increased risk of bleeding1 | Use with caution1 |
Steady-state plasma drotrecogin alfa (activated) concentrations are rapidly attained (e.g., within 2 hours) after the start of infusion and rapidly decrease after the end of infusion.1
Drotrecogin alfa (activated) and endogenous activated protein C are inactivated by endogenous plasma protease inhibitors.1
Plasma clearance of the drug in patients with severe sepsis is approximately 50% higher than that in healthy individuals.1
In patients without sepsis undergoing peritoneal dialysis or hemodialysis, clearance of drotrecogin alfa (activated) was similar to that observed in healthy individuals.1
2–8°C.1 Do not freeze; protect from light.1
If the reconstituted solution is not used immediately, store at 20–25°C and use within 3 hours.1
Administer within 12 hours if stored at 20–25°C.1
Alternatively, store at 2–8°C for a maximum of 12 hours prior to administration.1 4 10 If refrigerated, total in-use time, including dilution, preparation, refrigeration, and administration, should not exceed 24 hours.1
For information on systemic interactions resulting from concomitant use, see Interactions.
Compatible with glass infusion bottles or infusion bags and syringes made of polyvinyl chloride, polyethylene, polypropylene, or polyolefin.1
Compatible |
|---|
Sodium chloride 0.9% |
Compatible |
|---|
Dextrose 5% |
Dextrose and sodium chloride injections |
Lactated Ringer’s injection |
Sodium chloride 0.9% |
A serine protease structurally similar to endogenous human plasma-derived activated protein C that has antithrombotic, anti-inflammatory, and profibrinolytic properties but does not exhibit direct antimicrobial activity.1 2 5 6
Produces the same biologic effects as endogenous activated protein C.4
Produces dose-dependent decreases in D-dimer (a breakdown product of cross-linked fibrin) and interleukin-6, which are markers of coagulopathy and inflammation, respectively; however precise mechanism of action is not known.1 2 3 4 5 6
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of informing patients of potential risks and benefits associated with therapy, including risk of severe bleeding.1 (See Hematologic Effects under Cautions.)
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 4
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for IV infusion | 5 mg | Xigris | Lilly |
20 mg | Xigris | Lilly |
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 October 26, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Eli Lilly and Company. Xigris (drotrecogin alfa [activated]) injection prescribing information. Indianapolis, IN; 2008 Oct.
2. Bernard GR, Vincet JL, Laterre PF et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001; 344:699-709. [IDIS 461713] [PubMed 11236773]
3. Matthay MA. Severe sepsis—a new treatment with both anticoagulant and antiinflammatory properties. N Engl J Med. 2001; 344:759-62. [IDIS 461714] [PubMed 11236781]
4. Eli Lilly and Company. Indianapolis, IN: Personal communication.
5. Mann HJ. Recombinant human activated protein C in severe sepsis. Am J Health-Syst Pharm. 2002; 59(Suppl 1):S19-23. [IDIS 478158] [PubMed 11885409]
6. Kinasewitz GT,, Margolis B, Freebairn C et al. Changes in markers of coagulation and inflammation in patients with severe sepsis treated with recombinant human activated protein C. Crit Care Med. 2000; 28(Suppl 12):A68.
7. Anon. FDA approves first biologic treatment for sepsis. Rockville, MD: Food and Drug Administration; 2001 Nov 21. From FDA web site.
8. Anti-infective Drugs Advisory Committee. Gaithersburg, MD: Food and Drug Administration; 2001 Oct 16. From FDA web site.
9. Anon. Activated protein C (Xigris) for severe sepsis. Med Lett Drugs Ther. 2002; 44:17-18. [PubMed 11856952]
10. Vanscoy G. Addendum. Am J Health-Syst Pharm. 2002; 59(Suppl):S28-9.
11. Eisenberg P. Dear healthcare professional letter regarding important drug warning for Xigris. Indianapolis, IN: Eli Lilly and Company; 2005 Feb 4.
12. Food and Drug Administration. Xigris (drotrecogin alfa [activated]) [Apr 21, 2005: Eli Lilly]. Medwatch 2005 safety alert. Rockville, MD; April 2005. From FDA website.
13. Food and Drug Administration. Early communication about an ongoing safety review of Xigris (drotrecogin alfa [activated]). Rockville, MD; 2009 June 18. From FDA website.
14. Gentry CA, Gross KB, Sud B et al. Adverse outcomes associated with the use of drotrecogin alfa (activated) in patients with severe sepsis and baseline bleeding precautions. Crit Care Med. 2009; 37:19-25. [PubMed 19050637]
15. Sweeney DA, Natanson C, Eichacker PQ. Recombinant human activated protein C, package labeling, and hemorrhage risks. Crit Care Med. 2009; 37:327-9. [PubMed 19112285]
16. Abraham E, Laterre PF, Garg R et al. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med. 2005; 353:1332-41. [PubMed 16192478]
17. Angus DC, Laterre PF, Helterbrand J et al. The effect of drotrecogin alfa (activated) on long-term survival after severe sepsis. Crit Care Med. 2004; 32:2199-206. [PubMed 15640631]
18. Nadel S, Goldstein B, Williams MD et al. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007; 369:836-43. [PubMed 17350452]
19. Vincent JL, Bernard GR, Beale R et al. Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: further evidence for survival and safety and implications for early treatment. Crit Care Med. 2005; 33:2266-77. [PubMed 16215381]
20. Levy M, Levi M, Williams MD et al. Comprehensive safety analysis of concomitant drotrecogin alfa (activated) and prophylactic heparin use in patients with severe sepsis. Intensive Care Med. 2009; 35:1196-203. [PubMed 19367397]
21. Dellinger RP, Levy MM, Carlet JM et al, for the International Surviving Sepsis Campaign Guidelines Committee. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008; 36:296-327. [PubMed 18158437]
22. Toussaint S, Gerlach H. Activated Protein C for sepsis. New Engl J Med 2009; 361:2646-52. [PubMed 20042756]
Enalapril HCT Actavis may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enalapril HCT Actavis in the following countries:
Hydrochlorothiazide is reported as an ingredient of Enalapril HCT Actavis in the following countries:
International Drug Name Search
Apo-Amitriptyline may be available in the countries listed below.
Amitriptyline is reported as an ingredient of Apo-Amitriptyline in the following countries:
Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Apo-Amitriptyline in the following countries:
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Treating symptoms of benign prostatic hyperplasia (BPH) or enlargement of the prostate gland. It also helps to reduce the risk of urinary blockage and the need for prostate surgery. It may also be used along with other medicines (eg, tamsulosin).
Dutasteride is a 5 alpha-reductase enzyme inhibitor. It works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dutasteride. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Dutasteride. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dutasteride 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.
Use Dutasteride as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dutasteride.
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:
Breast enlargement and/or tenderness; decreased sex drive; decreased volume of ejaculate; inability to have an erection.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness).
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: Dutasteride side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Dutasteride at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dutasteride out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dutasteride. 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.
Definition of Glucagonoma: Glucagonoma is a tumor of the islet cells of the pancreas, which secrete the hormones insulin and glucagon.
The following drugs and medications are in some way related to, or used in the treatment of Glucagonoma. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Medical Encyclopedia:
Gentamicin Uphace may be available in the countries listed below.
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamicin Uphace in the following countries:
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Recoveron may be available in the countries listed below.
Acexamic Acid calcium salt (a derivative of Acexamic Acid) is reported as an ingredient of Recoveron in the following countries:
Acexamic Acid sodium salt (a derivative of Acexamic Acid) is reported as an ingredient of Recoveron in the following countries:
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Levalbuterol Tartrate may be available in the countries listed below.
Levalbuterol Tartrate (USAN) is also known as Levosalbutamol (Rec.INN)
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Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Corifeo may be available in the countries listed below.
Lercanidipine hydrochloride (a derivative of Lercanidipine) is reported as an ingredient of Corifeo in the following countries:
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Acemetacina may be available in the countries listed below.
Acemetacina (DCIT) is also known as Acemetacin (Rec.INN)
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Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Endoxana may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Cyclophosphamide is reported as an ingredient of Endoxana in the following countries:
Cyclophosphamide monohydrate (a derivative of Cyclophosphamide) is reported as an ingredient of Endoxana in the following countries:
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Doxorubicin Sandoz may be available in the countries listed below.
Doxorubicin hydrochloride (a derivative of Doxorubicin) is reported as an ingredient of Doxorubicin Sandoz in the following countries:
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