Ceftaroline Fosamil

Class: Fifth Generation Cephalosporins
VA Class: AM119
Chemical Name: 4 - [2 - [[(6R,7R) - 2 - Carboxy - 7 - [[(2Z) - (ethoxyimino)[5 - (phosphonoamino) - 1,2,4 - thiadiazol - 3 - yl]acetyl]amino] - 8 - oxo - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - en - 3 - yl]thio] - 4 - thiazolyl] - 1 - methyl - pyridinium, inner salt, monoacetate, monohydrate
Molecular Formula: C₂₂H₂₁N₈O₈PS₄.C₂H₄O₂.H₂O
CAS Number: 866021-48-9
Brands: Teflaro

Introduction

Antibacterial; β-lactam antibiotic;^{1 5 6 7} fifth generation cephalosporin.^{5 6 7 8 27}

Uses for Ceftaroline Fosamil

Community-acquired Pneumonia

Treatment of community-acquired bacterial pneumonia (CABP, CAP) caused by susceptible Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible [oxacillin-susceptible] strains only), Haemophilus influenzae, Klebsiella pneumoniae, K. oxytoca, or Escherichia coli.^{1 3}

Skin and Skin Structure Infections

Treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible S. aureus (including methicillin-resistant S. aureus [MRSA; also known as oxacillin-resistant S. aureus, ORSA], S. pyogenes (group A β-hemolytic streptococci), S. agalactiae (group B streptococci), E. coli, K. pneumoniae, or K. oxytoca.^{1 2}

Ceftaroline Fosamil Dosage and Administration

Administration

Administer by IV infusion.¹

IV Administration

Do not admix with or add to solutions containing other drugs.¹

Reconstitution and Dilution

Reconstitute 400- or 600-mg single-use vials of ceftaroline fosamil by adding 20 mL of sterile water for injection to provide solution containing approximately 20 or 30 mg/mL, respectively.¹ Mix vial gently to ensure complete dissolution;¹ reconstitution should take <2 minutes.¹

Dilute appropriate dose of reconstituted solution in 250 mL of compatible IV solution (see Solution Compatibility under Stability).¹ Reconstituted and diluted solutions appear clear and light to dark yellow.¹ Final solution in IV infusion bag should be used within 6 hours when stored at room temperature or within 24 hours when stored in refrigerator at 2–8°C.¹

Rate of Administration

Administer by IV infusion over approximately 1 hour.¹

Dosage

Available as ceftaroline fosamil monoacetate monohydrate; dosage expressed in terms of anhydrous ceftaroline fosamil.¹

Adults

Community-acquired Pneumonia

IV

600 mg every 12 hours for 5–7 days.¹

Duration depends on site and severity of infection and patient’s clinical and bacteriologic progress.¹

Skin and Skin Structure Infections

IV

600 mg every 12 hours for 5–14 days.¹

Duration depends on site and severity of infection and patient’s clinical and bacteriologic progress.¹

Special Populations

Hepatic Impairment

Manufacturer makes no specific dosage recommendations;¹ hepatic impairment not expected to have a clinically important effect on systemic clearance of the drug.¹

Renal Impairment

Adjust dosage in adults with Cl_cr ≤50 mL/minute, including those undergoing hemodialysis.¹ (See Table 1.)

Table 1. Dosage for Adults with Renal Impairment1

Clcr (mL/min)	Recommended Dosage
31–50	400 mg every 12 h
15–30	300 mg every 12 h
<15 or receiving hemodialysis	200 mg every 12 h; on hemodialysis days, give dose after hemodialysis

Geriatric Patients

Dosage adjustment not required based on age; may be required based on age-related changes in renal function.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Ceftaroline Fosamil

Contraindications

• 
  

  Known hypersensitivity to ceftaroline or other cephalosporins.¹ (See Sensitivity Reactions under Cautions.)

  
  

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Serious, sometimes fatal, anaphylactic reactions and serious skin reactions reported in patients receiving β-lactam antibiotics.¹ Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.¹

Discontinue drug if hypersensitivity occurs.¹ Serious acute hypersensitivity (e.g., anaphylaxis) reactions require emergency treatment (e.g., epinephrine, airway management, oxygen, IV fluids, antihistamines, corticosteroids, vasopressors) as clinically indicated.¹

Cross-hypersensitivity

Partial cross-sensitivity occurs among β-lactam antibiotics.^{1 27}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to ceftaroline, other cephalosporins, penicillins, or carbapenems.¹ Contraindicated in patients hypersensitive to the drug or other cephalosporins; use with caution in those allergic to penicillin or other β-lactams.¹

Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.^{1 12 13 14 15 16}

C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) have been reported with nearly all systemic anti-infectives, including ceftaroline, and may range in severity from mild diarrhea to fatal colitis.^{1 12 13 14 15 16} C. difficile produces toxins A and B which contribute to development of CDAD;^{1 13 12} hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.¹

Consider CDAD if diarrhea develops during or after anti-infective therapy and manage accordingly.^{1 12 13 14 15 16} Obtain a careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.¹

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.^{1 12 14 15 16} Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.^{1 12 13 14 15 16}

Hematologic Effects

Seroconversion from negative to positive direct antiglobulin (Coombs’) tests reported in approximately 11% of patients receiving ceftaroline in phase 3 clinical trials; no evidence of hemolytic anemia in these patients.¹

Consider drug-induced hemolytic anemia in patients who develop anemia during or after ceftaroline treatment; perform diagnostic studies, including direct antiglobulin test.¹ If drug-induced hemolytic anemia is suspected, consider discontinuing ceftaroline and administer supportive treatment (e.g., transfusion) as clinically indicated.¹

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of ceftaroline and other antibacterials, use only for treatment of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy not established in patients <18 years of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Substantially eliminated by kidneys; consider age-related decreases in renal function, select dosage with caution, and consider monitoring renal function.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not established; systemic clearance not expected to be altered by hepatic impairment.¹

Renal Impairment

Dosage adjustments necessary in adults with Cl_cr ≤50 mL/minute, including those undergoing hemodialysis.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea,^{1 25} nausea,^{1 25} vomiting,¹ constipation¹ ), headache,²⁵ rash,^{1 25} pruritus,²⁵ hypokalemia,¹ increased transaminases,^{1 25} phlebitis.¹

Interactions for Ceftaroline Fosamil

Does not inhibit CYP1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4 in vitro; does not induce CYP1A2, 2B6, 2C8, 2C9, 2C19, or 3A4/5.¹ Pharmacokinetic interactions with drugs metabolized by these isoenzymes unlikely.¹

No formal drug interaction studies to date.¹

Specific Drugs

Drug	Interaction
Aminoglycosides	Amikacin: In vitro evidence of synergistic antibacterial effects against E. coli and K. pneumoniae that produce extended-spectrum β-lactamases (ESBL-producing), AmpC-derepressed Enterobacter cloacae, and Pseudomonas aeruginosa;22 no evidence of antagonism1 22
Aztreonam	In vitro evidence of indifferent antibacterial effects against ESBL-producing E. coli and K. pneumoniae, AmpC-derepressed E. cloacae, and Ps. aeruginosa;22 no evidence of synergism22 or antagonism1 22
Carbapenems	Meropenem: In vitro evidence of synergistic antibacterial effects against ESBL-producing E. coli and indifferent antibacterial effects against ESBL-producing K. pneumoniae, AmpC-derepressed E. cloacae, and Ps. aeruginosa;22 no evidence of antagonism1 22
Other anti-infectives	No in vitro evidence of antagonism between ceftaroline and azithromycin, daptomycin, levofloxacin, linezolid, tigecycline, or vancomycin1

Ceftaroline Fosamil Pharmacokinetics

Absorption

Ceftaroline is administered as ceftaroline fosamil, a prodrug that is inactive until converted in vivo to ceftaroline by a plasma phosphatase.^{1 4}

Plasma Concentrations

In healthy adults, peak plasma concentrations and AUC increase approximately in proportion to dose following single IV doses of 50–1000 mg of ceftaroline fosamil.¹

No appreciable accumulation reported when 600-mg doses are given by IV infusion over 1 hour every 12 hours for up to 14 days in adults with normal renal function.¹

Special Populations

In healthy adolescents 12–17 years of age†, peak plasma concentrations and AUC after a single 8-mg/kg IV dose (600 mg in those weighing >75 kg) are 10 and 23% lower, respectively, compared with healthy adults who received a single 600-mg IV dose.¹

Distribution

Extent

Limited data available regarding tissue distribution; animal data indicate ceftaroline is distributed into kidneys, skin, and lungs.^{4 9}

Not known whether distributed into milk.¹

Plasma Protein Binding

Approximately 20%;¹ decreases slightly with increasing concentrations >1–50 mcg/mL.¹

Elimination

Metabolism

Ceftaroline fosamil is rapidly converted in vivo to ceftaroline by a plasma phosphatase, principally during IV infusion.^{1 4} In addition, the β-lactam ring of ceftaroline is hydrolyzed to an inactive, open-ring metabolite (ceftaroline M-1).¹

Ceftaroline is not a substrate of CYP isoenzymes.¹

Elimination Route

Ceftaroline and its metabolites principally eliminated in urine by glomerular filtration.¹ Following a single 600-mg IV dose of ceftaroline fosamil, approximately 88% is eliminated in urine (approximately 64% as unchanged drug, and 2% as ceftaroline M-1) and 6% is eliminated in feces within 48 hours.¹

Removed by hemodialysis.¹

Half-life

Adults: 2.7 hours.¹

Special Populations

Pharmacokinetics in patients with hepatic impairment not established.¹

AUC and half-life increased in patients with renal impairment.^{1 4}

Stability

Storage

Parenteral

Powder for IV Infusion

2–8°C.¹ May be stored at room temperature (≤25°C) for ≤7 days.¹

Following reconstitution and dilution, may be stored in IV infusion bag for up to 6 hours at room temperature or up to 24 hours when refrigerated at 2–8°C.¹

Compatibility

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

Parenteral

Solution Compatibility¹

Compatible
Dextrose 2.5 or 5% in water
Ringer’s injection, lactated
Sodium chloride 0.45 or 0.9%

Actions and Spectrum

• 
  

  Based on spectrum of activity, classified as a fifth generation cephalosporin.^{5 6 7 8 27}

  
  


• 
  

  Like third and fourth generation cephalosporins, ceftaroline has an expanded spectrum of activity that includes both gram-positive and gram-negative bacteria.^{4 5 6 7 17 21 27} Unlike first, second, third, and fourth generation cephalosporins, ceftaroline has activity against methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant Staphylococcus aureus, ORSA).^{4 5 6 7 17 27}

  
  


• 
  

  Usually bactericidal.^{1 4 17 22}

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.¹

  
  


• 
  

  Spectrum of activity includes many gram-positive and gram-negative aerobic bacteria^{1 4 17 18 19 20 21 24 27} and some anaerobic bacteria.²³

  
  


• 
  

  Gram-positive aerobes: Active in vitro against S. aureus (including MRSA, vancomycin-resistant S. aureus [VRSA], and daptomycin-nonsusceptible S. aureus),^{1 4 17 21 24 27} coagulase-negative staphylococci (including methicillin-resistant [oxacillin-resistant] strains),^{4 21 27} Streptococcus pneumoniae (including penicillin- or cefotaxime-resistant S. pneumoniae or multidrug-resistant S. pneumoniae [MDRSP]),^{1 4 18 19 20 21 24 27} S. pyogenes (group A β-hemolytic streptococci),^{1 4 21 27} S. agalactiae (group B streptococci),^{1 4 21 27} viridans streptococci,^{4 21 27} and S. dysgalactiae.¹ Has only limited activity against Enterococcus faecalis; E. faecium are resistant.^{4 21}

  
  


• 
  

  Gram-negative aerobes: Active in vitro against Escherichia coli,^{1 21 27} Klebsiella pneumoniae,^{1 21 27} K. oxytoca,¹ and Haemophilus influenzae (including β-lactamase-producing strains).^{1 4 21 27} Also active in vitro against Citrobacter koseri,¹ C. freundii,^{1 21 27} Enterobacter cloacae,^{1 21 27} E. aerogenes,^{1 27} Moraxella catarrhalis (including β-lactamase-producing strains),^{1 4 21 27} Morganella morganii,^{1 21} Pasteurella multocida,²¹ Proteus mirabilis,^{1 21 27} and H. parainfluenzae.¹ Inactive against Pseudomonas aeruginosa^{4 27} .

  
  


• 
  

  Gram-negative bacteria that produce extended-spectrum β-lactamases (ESBLs) from the TEM, SHV or CTX-M families, AmpC cephalosporinases, class B metallo-β-lactamases, or serine carbapenemases are resistant.^{1 4 21 27}

  
  


• 
  

  Although cross-resistance may occur between ceftaroline and other cephalosporins, some bacteria resistant to other cephalosporins may be susceptible to ceftaroline.¹

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including ceftaroline) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).¹

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.¹

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ceftaroline or other antibacterials in the future.¹

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually resolves when the drug is discontinued.¹ Importance of contacting a clinician if watery or bloody diarrhea occurs.¹

  
  


• 
  

  Importance of informing clinicians of prior hypersensitivity reactions to ceftaroline, other cephalosporins, other β-lactam antibiotics, or other allergens.¹ Importance of discontinuing the drug and immediately informing clinician if an allergic or hypersensitivity reaction occurs.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.¹

  
  


• 
  

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

Ceftaroline Fosamil

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	400 mg	Teflaro	Forest
		600 mg	Teflaro	Forest

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 July 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

1. Forest Pharmaceuticals, Inc. Teflaro (ceftaroline fosamil) for injection prescribing information. St. Louis, MO; 2011 Jan.

2. Corey GR, Wilcox M, Talbot GH et al. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010; 51:641-50. [IDIS 642215] [PubMed 20695801]

3. File TM, Low DE, Eckburg PB et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. Clin Infect Dis. 2010; 51:1395-405. [IDIS 647043] [PubMed 21067350]

4. Zhanel GG, Sniezek G, Schweizer F et al. Ceftaroline: a novel broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus. Drugs. 2009; 69:809-31. [PubMed 19441869]

5. Kollef MH. New antimicrobial agents for methicillin-resistant Staphylococcus aureus. Crit Care Resusc. 2009; 11:282-6. [PubMed 20001879]

6. Skrupky LP, Micek ST, Kollef MH. Bench-to-bedside review: Understanding the impact of resistance and virulence factors on methicillin-resistant Staphylococcus aureus infections in the intensive care unit. Crit Care. 2009; 13:222. [PubMed 19889197]

7. Ritchie DJ, Alexander BT, Finnegan PM. New antimicrobial agents for use in the intensive care unit. Infect Dis Clin North Am. 2009; 23:665-81. [PubMed 19665089]

8. Schirmer PL, Deresinski SC. Ceftobiprole: a new cephalosporin for the treatment of skin and skin structure infections. Expert Rev Anti Infect Ther. 2009; 7:777-91. [PubMed 19735220]

9. US Food and Drug Administration, Center for Drug Evaluation and Research. Pharmacology review(s) NDA application number 200327. From FDA website.

12. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55. [PubMed 20307191]

13. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]

14. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

15. Bauer MP, Kuijper EJ, van Dissel JT et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect. 2009; 15:1067-79. [PubMed 19929973]

16. Jaber MR, Olafsson S, Fung WL et al. Clinical review of the management of fulminant Clostridium difficile infection. Am J Gastroenterol. 2008; 103:3195-203; quiz 3204. [PubMed 18853982]

17. Saravolatz L, Pawlak J, Johnson L. In vitro activity of ceftaroline against community-associated methicillin-resistant, vancomycin-intermediate, vancomycin-resistant, and daptomycin-nonsusceptible Staphylococcus aureus isolates. Antimicrob Agents Chemother. 2010; 54:3027-30. [PubMed 20404122]

18. Jacobs MR, Good CE, Windau AR et al. Activity of ceftaroline against recent emerging serotypes of Streptococcus pneumoniae in the United States. Antimicrob Agents Chemother. 2010; 54:2716-9. [PubMed 20308374]

19. McGee L, Biek D, Ge Y et al. In vitro evaluation of the antimicrobial activity of ceftaroline against cephalosporin-resistant isolates of Streptococcus pneumoniae. Antimicrob Agents Chemother. 2009; 53:552-6. [PubMed 19015339]

20. Fenoll A, Aguilar L, Robledo O et al. In vitro activity of ceftaroline against Streptococcus pneumoniae isolates exhibiting resistance to penicillin, amoxicillin, and cefotaxime. Antimicrob Agents Chemother. 2008; 52:4209-10. [PubMed 18725443]

21. Ge Y, Biek D, Talbot GH et al. In vitro profiling of ceftaroline against a collection of recent bacterial clinical isolates from across the United States. Antimicrob Agents Chemother. 2008; 52:3398-407. [PubMed 18625769]

22. Vidaillac C, Leonard SN, Sader HS et al. In vitro activity of ceftaroline alone and in combination against clinical isolates of resistant gram-negative pathogens, including beta-lactamase-producing Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2009; 53:2360-6. [PubMed 19349512]

23. Citron DM, Tyrrell KL, Merriam CV et al. In vitro activity of ceftaroline against 623 diverse strains of anaerobic bacteria. Antimicrob Agents Chemother. 2010; 54:1627-32. [PubMed 20100877]

24. Kosowska-Shick K, McGhee PL, Appelbaum PC. Affinity of ceftaroline and other beta-lactams for penicillin-binding proteins from Staphylococcus aureus and Streptococcus pneumoniae. Antimicrob Agents Chemother. 2010; 54:1670-7. [PubMed 20194704]

25. Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010; 65 Suppl 4:iv67-iv71. [PubMed 21115456]

26. Moisan H, Pruneau M, Malouin F. Binding of ceftaroline to penicillin-binding proteins of Staphylococcus aureus and Streptococcus pneumoniae. J Antimicrob Chemother. 2010; 65:713-6. [PubMed 20097788]

27. Andes DR, Craig WA. Cephalosporins. In: Mandell GL, Bennett JE, Dolin R eds. Mandell, Douglas and Bennett’s principles and practices of infectious disease. 7th ed. New York: Churchill Livingstone; 2010:323-36.

More Ceftaroline Fosamil resources

• Ceftaroline Fosamil Side Effects (in more detail)
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Garlic

Pronunciation: Not applicable.
Generic Name: Garlic
Brand Name: Generics only. No brands available.

Garlic is used for:

High cholesterol levels, for blood clots, and to lower blood pressure. It has also been promoted for colds, bronchitis, and other uses. Check with your pharmacist for more details regarding the particular brand you use.

Garlic is an herbal product. It is unknown exactly how it works.

Do NOT use Garlic if:

• you are allergic to any ingredient in Garlic


• you are pregnant

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

Before using Garlic:

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

• if you are 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 diabetes, stomach or bowel problems, or a blood disease

Some MEDICINES MAY INTERACT with Garlic. Tell your health care provider if you are taking any other medicines, especially any of the following:

• HIV protease inhibitors (eg, saquinavir) because effectiveness may be decreased by Garlic

This may not be a complete list of all interactions that may occur. Ask your health care provider if Garlic 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 Garlic:

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

• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• The smell of garlic may be noticeable on the breath and skin. If this is bothersome, use an enteric-coated garlic product.


• It may take several weeks for garlic to lower cholesterol and up to 6 months to lower blood pressure.


• If you miss taking a dose of Garlic for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information:

• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• If you are taking warfarin and your doctor has approved the use of a garlic product, notify your doctor if you experience any signs of bleeding.


• Diabetes patients - If you have diabetes, garlic may lower your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• PREGNANCY and BREAST-FEEDING: Do not use garlic supplements if you are pregnant. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using garlic supplements during pregnancy. Do not breast-feed while taking this product.

Possible side effects of Garlic:

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:

Burning of the mouth, stomach, and throat; changes in the menstrual cycle; lightheadedness; nausea; sweating.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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: Garlic 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.

Proper storage of Garlic:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Garlic out of the reach of children and away from pets.

General information:

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


• Garlic 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 Garlic. 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.

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• Garlic Side Effects (in more detail)
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Fluocinolone Acetonide Implant

Pronunciation: floo-oh-SIN-oh-lone
Generic Name: Fluocinolone Acetonide
Brand Name: Retisert

Fluocinolone Acetonide Implant is used for:

Treating a certain type of inflammation of the eye (chronic noninfectious uveitis).

Fluocinolone Acetonide Implant is a corticosteroid. Exactly how it works is unknown. It may decrease the production of certain substances that cause inflammation. Fluocinolone Acetonide Implant releases slowly over 30 months through a surgical implant in the eye.

Do NOT use Fluocinolone Acetonide Implant if:

• you are allergic to any ingredient in Fluocinolone Acetonide Implant or other corticosteroids (eg, prednisone)


• you have certain viral, bacterial, or fungal eye infections (eg, herpes simplex, mycobacterial infection)


• you have chickenpox or a certain infection due to smallpox vaccination (vaccinia)

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

Before using Fluocinolone Acetonide Implant:

Some medical conditions may interact with Fluocinolone Acetonide Implant. 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 other eye problems (eg, glaucoma, increased pressure in the eyes)

Some MEDICINES MAY INTERACT with Fluocinolone Acetonide Implant. Because little, if any, of Fluocinolone Acetonide Implant is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinolone Acetonide Implant 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 Fluocinolone Acetonide Implant:

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

• Fluocinolone Acetonide Implant will be surgically implanted into the eye at your doctor's office, hospital, or clinic.


• If you miss a dose of Fluocinolone Acetonide Implant, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fluocinolone Acetonide Implant.

Important safety information:

• After implantation of Fluocinolone Acetonide Implant, follow-up eye exams will be required. Be sure to keep all doctor and lab appointments.


• Most patients experience an immediate and temporary decrease in vision in the implanted eye for about 1 to 4 weeks after surgery. Do not drive or perform other possibly unsafe tasks until you know how you react to Fluocinolone Acetonide Implant. Contact your doctor if your vision does not return to normal after 4 weeks.


• Fluocinolone Acetonide Implant treats inflammation in the eye, but it may not treat the disease that caused the inflammation. You may need to use other medicines along with this one. Carefully follow your doctor's instructions for other eye medicines.


• Fluocinolone Acetonide Implant may increase pressure in your eyes. You may need to use medicines or have procedures to control the pressure in your eyes. Carefully follow your doctor's instructions for other eye medicines.


• Fluocinolone Acetonide Implant may cause cataracts. It may also decrease the ability of your eyes to heal after cataract surgery. Discuss any concerns with your doctor.


• Fluocinolone Acetonide Implant may increase the severity of eye infections and mask symptoms of eye infections. Contact your doctor if you suspect you have an eye infection.


• Lab tests, including eye exams, may be performed while you use Fluocinolone Acetonide Implant. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Fluocinolone Acetonide Implant should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Acetonide Implant while you are pregnant. It is not known if Fluocinolone Acetonide Implant is found in breast milk. If you are or will be breast-feeding while you use Fluocinolone Acetonide Implant, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone Acetonide Implant:

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:

Abnormal sensation in the eye; back or limb pain; blurred vision; cough; dizziness; drooping eyelids; dry eye; eye irritation, itching, or redness; eye pain; fever; flu-like symptoms; headache; increased tearing; joint pain; nausea; nose and throat irritation; reduced vision; sinus inflammation; swelling of the eye or eyelid; upper respiratory tract infection; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye; eye discharge; eye infection; eye pain; implant problems; vision changes.

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Fluocinolone Acetonide Implant:

Fluocinolone Acetonide Implant is usually handled and stored by a health care provider. If you are using Fluocinolone Acetonide Implant at home, store Fluocinolone Acetonide Implant as directed by your pharmacist or health care provider. Keep Fluocinolone Acetonide Implant out of the reach of children and away from pets.

General information:

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


• Fluocinolone Acetonide Implant 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 Fluocinolone Acetonide Implant. 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 Fluocinolone Acetonide resources

• Fluocinolone Acetonide Use in Pregnancy & Breastfeeding
• Fluocinolone Acetonide Drug Interactions
• Fluocinolone Acetonide Support Group
• 3 Reviews for Fluocinolone Acetonide - Add your own review/rating

Compare Fluocinolone Acetonide with other medications

• Uveitis

Period Pain Reliever 250mg Gastro-resistant Tablets

1. Name Of The Medicinal Product

Naproxen 250mg Gastro-resistant Tablets

Period Pain Reliever 250mg Gastro-resistant Tablets

2. Qualitative And Quantitative Composition

Each tablet contains: 250mg Naproxen

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Gastro-resistant tablets.

White, round, biconvex enteric-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated for the treatment of primary dysmenorrhoea in women aged 15 to 50 years.

4.2 Posology And Method Of Administration

For oral administration.

To be taken preferably with or after food swallowed whole with water.

Adolescents (post puberty) and adult females between the ages of 15 and 50:

On the first day 2 tablets (500 mg) should be taken initially and then one tablet (250 mg) after 6 to 8 hours if needed.

On the second and third day, if needed, one tablet (250mg) should be taken every 6 to 8 hours. Not more than 3 tablets to be taken per day. The maximum duration of continuous treatment in any one cycle (period) is 3 days.

Undesirable effects may be minimised by using the lowest effective dose the shortest duration necessary to control symptoms (see section 4.4).

4.3 Contraindications

Hypersensitivity to naproxen, naproxen sodium formulations or any of the other excipients.

Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

History of gastrointestinal bleeding or perforation, related to previous NSAIDs.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

Severe heart failure, renal failure or hepatic failure (see section 4.4).

Use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

Concomitant use of anticoagulants and antiplatelets (see section 4.5).

Pregnancy and breast-feeding (see section 4.6).

4.4 Special Warnings And Precautions For Use

Period Pain Reliever 250mg Gastro-resistant Tablets should not be taken, except on the advice of a doctor, by women who first experience period pain more than a year after starting menstruation.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI, cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small risk of arterial thrombotic events (for example myocardial infarction or stroke). Although data suggests that the use of naproxen (1000mg daily) may be associated with a lower risk, some risk cannot be excluded. There are insufficient data regarding the effects of low dose naproxen 250mg – 750mg daily to draw firm conclusions on possible thrombotic risks.

Gastrointestinal

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

Although naproxen is usually well tolerated, there have been reported incidences of gastro-intestinal bleeding. Therefore, patients with a history of gastro-intestinal disease should not take naproxen without being closely monitored by their doctor (see section 4.3)

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving naproxen, the treatment should be withdrawn.

The risk of GI bleeding, ulceration or perforation is higher

- with increasing NSAID doses

- in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3)

- in the elderly (see section 4.2)

- when used with alcohol

- in smoking

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

Respiratory disorders:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease

Renal:

Renal impairment, as the use of NSAIDs may result in further deterioration of renal function (see sections 4.3 and 4.8)

Patients with renal or cardiac impairment should only use naproxen with great caution and under their doctor's supervision who will monitor serum creatinine and/or creatinine clearance. When the baseline creatinine is less than 20 ml/min naproxen is not recommended.

When renal blood flow is compromised, patients should have renal function assessed before and during naproxen therapy. A reduction in daily dosage should be considered to avoid the possibility of excessive accumulation of naproxen metabolites in these patients.

Hepatic:

Patients with impaired liver function should only take naproxen under the supervision of their doctor (see sections 4.3 and 4.8). When liver function is impaired, the plasma concentration of unbound naproxen is increased. The significance of this is unknown but caution is advised when high doses are required (see sections 4.3 and 4.8).

Haematological:

Patients who have coagulation disorders or patients who are receiving drug therapy that interferes with haemostasis should be carefully observed if naproxen-containing products are administered.

Naproxen decreases platelet aggregation and prolongs bleeding time. Patients at high risk of bleeding or those on full anti-coagulation therapy (e.g. dicoumarol derivatives) can be at increased risk of bleeding if given naproxen-containing products.

Anaphylactic (anaphylactoid) reactions:

In susceptible individuals hypersensitivity reactions may occur (see section 4.3) Anaphylactic (anaphylactoid) reactions may occur both in patients with and without a history of hypersensitivity or exposure to aspirin, other non-steroidal anti-inflammatory drugs or naproxen-containing products. They may also occur in individuals with a history of angioedema, bronchospastic reactivity (e.g. asthma), rhinitis and nasal polyps.

Anaphylactic (anaphylactoid) reactions may have a fatal outcome.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease there may be increased risk of aseptic meningitis (see section 4.8)

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: onset of the reaction occurring in the majority of cases within the first month of treatment. Naproxen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Ocular effects:

Studies have not shown any changes in the eye attributable to naproxen administration. Rarely, adverse ocular disorders including papillitis, retrobulbar optic neuritis and papilledema, have been reported in users of NSAIDs including naproxen, although a cause-and-effect relationship cannot be established; accordingly, patients who develop visual disturbances during treatment with naproxen-containing products should have an ophthalmological examination.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

The anti-inflammatory and antipyretic activities of naproxen may reduce fever and inflammation, thereby diminishing their utility as diagnostic signs.

Steroids:

Patients taking steroids should not take naproxen except under the supervision of their doctor. If steroid dosage is eliminated or reduced during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

Interference in tests:

Naproxen therapy should be temporarily withdrawn 48 hours before adrenal function tests are performed as it may artifactually interfere with some tests for 17-ketogenic steroids. Similarly, naproxen may interfere with some assays of urinary 5-hydroxyindoleacetic acid.

Sporadic abnormalities in laboratory tests (e.g. liver function test) have occurred in patients on naproxen therapy, but no definite trend was seen in any test indicating toxicity.

This product contains potassium sorbate, caution should be used in treating patients on a low potassium diet. High blood levels of potassium can cause stomach upsets and diarrhoea.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Label will include:

Read the enclosed leaflet before taking this product.

Do not take if you:

• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

• are allergic to naproxen or any other ingredients of the product, aspirin or other related painkillers

• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg

• are taking medicines that thin the blood

• are pregnant or breastfeeding.

Speak to a pharmacist or your doctor before taking if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Naproxen should be avoided in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4).

Other NSAIDs including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.3).

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.3).

Naproxen should be used with caution in combination with:

Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Naproxen and other non-steriodal anti-inflammatory drugs may increase the risk of renal impairment associated with the use of ACE-inhibitors or angiotensin II receptor antagonists. Diuretics can increase the risk on nephrotoxity of NSAIDs.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increase risk of gastrointestinal bleeding (see section 4.4).

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Lithium: There is evidence for potential increases in plasma levels of lithium, due to decreased elimination of lithium.

Methotrexate: There is a potential for an increase in plasma methotrexate, due to decreased elimination of methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Probencid: may increase plasma levels and extend the half-life of some NSAIDs.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone,

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthoroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Bisphosphonates: concomitant use of bisphosphonates and NSAIDs may increase the risk of gastric mucosal damage.

Colestyramine: colestyramine delays the absorption of naproxen. Naproxen should be taken at least one hour before or four to six hours after colestyramine.

Naproxen is highly protein-bound to plasma proteins and if anti-coagulants, or hydantoins e.g. phenytoin are given simultaneously, overdosage of these drugs may result.

4.6 Pregnancy And Lactation

Naproxen should not be used during pregnancy or breast-feeding except on the advice of a doctor.

Whilst no teratogenic effects have been demonstrated in animal toxicology studies, the use of naproxen during pregnancy should if possible be avoided. Congenital abnormalities have been reported in association with naproxen administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (a closure of ductus arteriosus), use in pregnancy should be avoided. In the limited studies so far available, naproxen appears in the breast milk in very low concentrations and is unlikely to adversely affect the breast-fed infant. However, the use of naproxen should be avoided in patients who are breast feeding.

See section 4.4 Special warnings and precautions for use, regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low dose and short duration of treatment. However dizziness, drowsiness, vertigo, insomnia, depression or visual disturbances are possible undesirable effects after taking NSAIDs. If affected, patients should not drive or operate machinery.

4.8 Undesirable Effects

Gastro-intestinal: the most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (See section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis exacerbation of colitis and Crohn's disease (See section 4.4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs.

These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme.

Cardiovascular: Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Other adverse events reported less commonly include:

Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic: Abnormal liver function, hepatitis and jaundice.

Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation ( see section 4.4), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.

Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Eosinophilic pneumonitis, hyperkalaemia, have also been reported rarely with some NSAIDs.

Dermatological: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare). Photosensitivity reactions, alopecia.

4.9 Overdose

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central neverous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time / INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents with 1 hour of ingestion of a potentially toxic amount. If frequent of prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Naproxen is a non-steroidal anti-inflammatory agent.

Naproxen reduces the synthesis of prostaglandins primarily by inhibiting the enzyme cyclo-oxygenase. Naproxen has been shown to have anti-inflammatory activity in a number of experimental models. Naproxen inhibits prostaglandin E₂ synthesis in vitro by human rheumatoid synovial microsomes. It also inhibits prostaglandin E₂ production by phytohaemagglutin-stimulated peripheral blood mononuclear cells. At 10^-4 M (23mg.1^-1) naproxen inhibits neutral protease activity derived from human polymorphonuclear leucocytes. Naproxen also inhibits in vitro the activity of cathepsin-β and other hydrolytic enzymes derived from lysosomes. Naproxen is a potent in inhibitor of leucocyte migration and produces effects comparable to those of colchicine.

5.2 Pharmacokinetic Properties

Naproxen is readily absorbed from the gastrointestinal tract. Peak plasma concentrations are attained 2-4 hours after ingestion. Plasma concentrations of naproxen increase proportionally with dose up to about 500mg daily; at higher doses there is an increase in clearance caused by saturation of plasma proteins. At therapeutic concentrations naproxen is more than 99% bound to plasma proteins and has a plasma half-life of about 13 hours. Approximately 95% of a dose is excreted in urine as naproxen and 6-O-desmethylnaproxen and their conjugates. Less than 3% of a dose has been recovered in the faeces. Naproxen crosses the placenta and is excreted in breast milk.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methacrylic acid-ethylacrylate copolymer (1:1)

Lactose

Magnesium stearate

Maize starch

Crospovidone

Propylene glycol

Sodium hydroxide

Triethyl citrate

Titanium dioxide (E171)

Potassium sorbate (E202)

Sodium citrate (E331)

Xanthan gum (E415)

Hydroxypropyl cellulose (E463)

Purified talc (E553)

Beeswax

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Shelf-life

36 months from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original package.

6.5 Nature And Contents Of Container

PVC/PVdC/Aluminium blister. Pack sizes of 3,6,8,9 tablets.

(Not all pack sizes will be marketed).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0226

9. Date Of First Authorisation/Renewal Of The Authorisation

23^rd August 2010

10. Date Of Revision Of The Text

07.06.2011

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)

Aleve Easy Open Arthritis

Generic Name: naproxen (na PROX en)

Brand Names: Aleve, Aleve Caplet, Aleve Easy Open Arthritis, Aleve Gelcap, Anaprox, Anaprox-DS, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan 375, Naprelan 500, Naprelan 750, Naprosyn

What is Aleve Easy Open Arthritis (naproxen)?

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Naproxen may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Aleve Easy Open Arthritis (naproxen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use naproxen. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking naproxen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result.

What should I discuss with my healthcare provider before taking Aleve Easy Open Arthritis (naproxen)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to naproxen, or if you have a history of allergic reaction to aspirin or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use naproxen:

• 
  

  a history of heart attack, stroke, or blood clot;

  
  


• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  a history of stomach ulcers or bleeding;

  
  


• liver or kidney disease;


• 
  

  asthma;

  
  


• 
  

  polyps in your nose;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. Before using naproxen, tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take naproxen during pregnancy unless your doctor has told you to. Naproxen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

How should I take Aleve Easy Open Arthritis (naproxen)?

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

EC-Naprosyn is a slower-acting form of naproxen and this brand should be used only for treating arthritis or ankylosing spondylitis. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release or enteric-coated tablet. Swallow the pill whole. The extended-release pill is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked 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.

If you take naproxen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store naproxen at room temperature away from moisture and heat.

What happens if I miss a dose?

Since naproxen is sometimes taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, confusion, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Aleve Easy Open Arthritis (naproxen)?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

Aleve Easy Open Arthritis (naproxen) 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 taking naproxen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  swelling or rapid weight gain;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  bruising, severe tingling, numbness, pain, muscle weakness; or

  
  


• 
  

  fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

  
  


• 
  

  bloating, gas;

  
  


• 
  

  dizziness, headache, nervousness;

  
  


• 
  

  skin itching or rash;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  ringing in your ears.

  
  

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 Aleve Easy Open Arthritis (naproxen)?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with naproxen may cause you to bruise or bleed easily.

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

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  diuretics (water pills) such as furosemide (Lasix);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others; or

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

  
  

This list is not complete and there may be other drugs that can interact with naproxen. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Aleve Easy Open Arthritis resources

• Aleve Easy Open Arthritis Side Effects (in more detail)
• Aleve Easy Open Arthritis Use in Pregnancy & Breastfeeding
• Aleve Easy Open Arthritis Drug Interactions
• Aleve Easy Open Arthritis Support Group
• 33 Reviews for Aleve Easy Open Arthritis - Add your own review/rating

• Naproxen Professional Patient Advice (Wolters Kluwer)


• Naproxen Monograph (AHFS DI)


• Naproxen Prescribing Information (FDA)


• Aflaxen Advanced Consumer (Micromedex) - Includes Dosage Information


• Aleve MedFacts Consumer Leaflet (Wolters Kluwer)


• Aleve Consumer Overview


• Anaprox MedFacts Consumer Leaflet (Wolters Kluwer)


• EC-Naprosyn Enteric-Coated Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Naprosyn Consumer Overview


• Naprosyn Prescribing Information (FDA)

Compare Aleve Easy Open Arthritis with other medications

• Ankylosing Spondylitis
• Aseptic Necrosis
• Back Pain
• Bursitis
• Costochondritis
• Diffuse Idiopathic Skeletal Hyperostosis
• Dysautonomia
• Fever
• Frozen Shoulder
• Gout, Acute
• Headache
• Juvenile Rheumatoid Arthritis
• Muscle Pain
• Osteoarthritis
• Pain
• Period Pain
• Rheumatoid Arthritis
• Sciatica
• Spondylolisthesis
• Tendonitis

Where can I get more information?

• Your pharmacist can provide more information about naproxen.

See also: Aleve Easy Open Arthritis side effects (in more detail)

Vagifem

Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Vagifem

Vagifem should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Vagifem. Talk with your doctor if you have questions about the benefits and risks of using Vagifem.

Vagifem should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Vagifem.

Vagifem is used for:

Treating itching, burning, and dryness in or around the vaginal area in women past menopause.

Vagifem is a vaginal estrogen tablet. It works by increasing the amount of estrogen in the body in certain women who do not produce enough on their own.

Do NOT use Vagifem if:

• you are allergic to any ingredient in Vagifem


• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding


• you have unexplained, abnormal vaginal bleeding; known or suspected cancer of the breast or uterus; or estrogen-dependent tumors


• you have a history of breast cancer, blood clots (eg, deep vein thrombosis, pulmonary embolism), or liver problems


• you have had a heart attack or stroke within the last year

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

Before using Vagifem:

Some medical conditions may interact with Vagifem. 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 or a family member has a history of lumps in the breast, an abnormal mammogram, or breast cancer


• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)


• if you have uterine problems (eg, uterine fibroids/endometriosis) or vaginal conditions (eg, abnormal vaginal bleeding, recurring vaginal infections, prolapse, stenosis)


• if you have abnormal calcium levels in the blood, asthma, cancer, a certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver problems, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures (eg, epilepsy), vision problems, or yellowing of the skin or eyes


• if you smoke, will be having surgery, or will be on bed rest

Some MEDICINES MAY INTERACT with Vagifem. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Vagifem's side effects


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Vagifem's effectiveness


• Blood thinners (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Vagifem

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vagifem 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 Vagifem:

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

• An extra patient leaflet is available with Vagifem. Talk to your pharmacist if you have questions about this information.


• To use, tear off a single applicator, separate the plastic wrap, and remove the applicator from the plastic wrap.


• Select the position for vaginal insertion that is most comfortable for you (lying on the bed, squatting, or standing with one leg on a stool).


• Use the finger of one hand to press the applicator plunger. Use the other hand to gently and comfortably guide the applicator into the vagina. If the tablet falls out of the applicator before inserting the filled applicator, use a new applicator with a fresh tablet.


• Insert the tablet as far into the vagina as it can comfortably go without force.


• After inserting the filled applicator, gently press the plunger until you hear a click and the plunger is fully depressed. This will eject the tablet inside your vagina. The tablet will dissolve slowly over several hours.


• After depressing the plunger, gently remove the applicator and throw it away. Do not reuse the applicator.


• You may insert the tablet-filled applicator any time of day. You should use the applicator at the same time each day.


• Grapefruit and grapefruit juice may increase the risk of Vagifem's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vagifem.


• If you miss a dose of Vagifem, use 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 use 2 doses at once.

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

Important safety information:

• Vagifem may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vagifem with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Limit alcoholic beverages while you are using Vagifem.


• Vagifem may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.


• Vagifem may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).


• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.


• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vagifem.


• Follow your doctor's instructions for examining your breasts, and report any lumps immediately.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Vagifem.


• Vagifem may increase the risk of breast and endometrial cancer. Your doctor may prescribe another hormone (progestin) to decrease this risk.


• Your doctor should reevaluate you every 3 to 6 months to determine whether you need to continue taking Vagifem.


• Diabetes patients - Vagifem may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Vagifem may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vagifem.


• Lab tests, including hormone levels, physical exams, and blood pressure, may be performed while you use Vagifem. These tests may be used to monitor your condition or check for side effects. You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.


• Use Vagifem with caution in the ELDERLY; they may be more sensitive to its effects, including an increased risk of heart problems, stroke, breast or uterine cancer, and certain mental problems (eg, dementia).


• Vagifem should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Vagifem if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vagifem is found in breast milk. Do not breast-feed while taking Vagifem.

Possible side effects of Vagifem:

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 pain or tenderness; diarrhea; hair loss; headache; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; dizziness; fainting; fever; memory problems; mental or mood changes (eg, depression); muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe or persistent stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of the hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; unusual weight changes; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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.

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 excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Vagifem:

Store Vagifem 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 Vagifem out of the reach of children and away from pets.

General information:

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


• Vagifem 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 Vagifem. 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.