Emend

Generic Name: Aprepitant/Fosaprepitant Dimeglumine
Class: Antiemetics, Miscellaneous
VA Class: GA605
Chemical Name: 5-[[(2R,3S)-2-[(1R)-1-[3,5,bis (trifluoromethyl)phenyl]ethoxy] - 3 - (4 - fluorophenyl) - 4 - morpholinyl]methyl] - 1,2, - dihydro - 3H - 1,2,4, - triazol - 3 - one
Molecular Formula: C₂₃H₂₁F₇N₄O₃C₂₃H₂₂F₇N₄O₆P•2C₇H₁₇NO₅
CAS Number: 170729-80-3

Introduction

Antiemetic; aprepitant is a selective, high-affinity antagonist at substance P/neurokinin-1 (NK₁) receptors; fosaprepitant dimeglumine is a lyophilized prodrug of aprepitant.^{1 2 3 4 7 8 9 11 12 16}

Uses for Emend

Cancer Chemotherapy-induced Nausea and Vomiting

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin therapy.^{1 4 7 8 9 12 16} Used in combination with other antiemetic agents.^{1 4 7 8 9 12 16}

Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.^{1 11 12 16} Used in combination with other antiemetic agents.^{1 11 12 16}

For prevention of nausea and vomiting associated with chemotherapy with a high emetic risk (>90% incidence of emesis without antiemetics) and for combination anthracycline and cyclophosphamide chemotherapy, ASCO recommends a 3-drug antiemetic regimen consisting of aprepitant, a type 3 serotonin (5-HT₃) receptor antagonist (e.g., dolasetron, granisetron, ondansetron, palonosetron), and dexamethasone.⁷ For chemotherapy regimens of moderate emetic risk (>30% and ≤90% incidence of emesis without antiemetics), ASCO prefers a 2-drug antiemetic regimen consisting of a 5-HT₃ receptor antagonist and dexamethasone.⁷ For chemotherapy with a low emetic risk (>10% and ≤30% incidence of emesis without antiemetics), ASCO recommends dexamethasone alone on the first day of chemotherapy.⁷

For prevention of delayed emesis in patients receiving cisplatin or other chemotherapy associated with a highemetic risk, ASCO recommends a 2-drug combination of aprepitant and dexamethasone.⁷

Safety and efficacy for chronic use or for treatment of established nausea and vomiting not established.^{1 2 12}

Postoperative Nausea and Vomiting

Prevention of postoperative nausea and vomiting.^{1 2 6 14 15}

Safety and efficacy for chronic use or for treatment of established nausea and vomiting not established.^{1 2}

Emend Dosage and Administration

Administration

Dispensing and Administration Precautions

Because of similarities in spelling and/or pronunciation between Emend (the trade name for aprepitant) and Amen (a former trade name for medroxyprogesterone acetate; no longer commercially available under this trade name in the US) or Vfend (the trade name for voriconazole), exercise extra care in ensuring the accuracy of prescriptions for these drugs.⁵ (See Possible Prescribing and Dispensing Errors under Cautions.)

Oral Administration

Administer aprepitant orally without regard to meals.^{1 2 4}

IV Administration

Administer fosaprepitant dimeglumine by IV infusion.¹²

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

Reconstitution and Dilution

Reconstitute powder for injection with 5 mL of 0.9% sodium chloride for injection; avoid jetting saline into the vial.¹² Gently swirl solution; do not shake.¹²

Withdraw entire volume from vial and transfer into infusion bag containing 110 mL of 0.9% sodium chloride, yielding a total volume of 115 mL (1 mg/mL).¹² Mix solutions by gentle inversion of the bag 2–3 times.¹²

Rate of Administration

Infuse over 15 minutes.¹²

Dosage

Dosage of fosaprepitant dimeglumine is expressed in terms of fosaprepitant.¹²

Adults

Cancer Chemotherapy-induced Nausea and Vomiting

Administer as part of a regimen that includes a 5-HT₃ receptor antagonist and a corticosteroid.^{1 2 4 12}

Highly Emetogenic Cancer Chemotherapy

Oral

Administer 125 mg of aprepitant 1 hour before chemotherapy on day 1, and follow with 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.^{1 2 4 7}

In clinical studies, aprepitant was administered with IV ondansetron (32 mg 30 minutes before chemotherapy on day 1) and oral dexamethasone (12 mg 30 minutes before chemotherapy on day 1, followed by 8 mg once daily in the morning on days 2–4).^{1 4}

IV

Administer 115 mg of fosaprepitant over 15 minutes, 30 minutes prior to chemotherapy as an alternative to oral aprepitant (125-mg) on day 1 only of 3-day regimen.^{1 12} Follow fosaprepitant with oral aprepitant 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.¹²

Moderately Emetogenic Cancer Chemotherapy

Oral

Administer 125 mg of aprepitant 1 hour before chemotherapy on day 1, and follow with 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.^{1 7}

In a clinical study, aprepitant was administered with oral ondansetron (8 mg 30–60 minutes before chemotherapy on day 1, followed by 8 mg 8 hours after the first dose) and oral dexamethasone (12 mg 30 minutes before chemotherapy on day 1).¹

IV

Administer 115 mg of fosaprepitant over 15 minutes, 30 minutes prior to chemotherapy as an alternative to oral aprepitant (125-mg) on day 1 only of 3-day regimen.^{1 12} Follow fosaprepitant with oral aprepitant 80 mg once daily in the morning on days 2 and 3 of the treatment regimen.¹²

Postoperative Nausea and Vomiting

Oral

Administer 40 mg of aprepitant within 3 hours before induction of anesthesia.¹

Special Populations

Hepatic Impairment

No dosage adjustment necessary in patients with mild to moderate hepatic impairment.¹ Not adequately studied in patients with severe hepatic impairment (Child-Pugh score >9).¹

Renal Impairment

No dosage adjustment necessary in patients with renal impairment or end-stage renal disease requiring hemodialysis.^{1 4}

Geriatric Patients

No dosage adjustment necessary.^{1 4}

Cautions for Emend

Contraindications

• 
  

  Concomitant use with astemizole (no longer commercially available in the US), cisapride (currently commercially available in the US only under a limited-access protocol), pimozide, or terfenadine (no longer commercially available in the US).^{1 2 4 12}

  
  


• 
  

  Known hypersensitivity to fosaprepitant, aprepitant, polysorbate 80, or any ingredient in the formulations.^{1 2 4 12}

  
  

Warnings/Precautions

Sensitivity Reactions

Stevens-Johnson syndrome reported in 1 patient receiving aprepitant with antineoplastic agents.^{1 4} Hypersensitivity reactions, including anaphylaxis, hives, rash, itching, and urticaria reported in patients receiving aprepitant or fosaprepitant; may be serious and can cause difficulty in breathing or swallowing.^{1 2 12 17} Angioedema reported in 1 patient.^{1 4}

General Precautions

Drug Interaction Potential

Drug-interaction potential could be altered with chronic use (see Interactions); safety of chronic use not established.¹

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling and/or pronunciation of Emend (trade name for aprepitant) and Amen (former trade name for medroxyprogesterone acetate) or Vfend (trade name for voriconazole) may result in errors.⁵

Specific Populations

Pregnancy

Category B.^{1 2 4 12}

Lactation

Aprepitant is distributed into milk in rats; not known whether distributed into human milk.^{1 2} Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy of fosaprepitant and aprepitant not established in children <18 years of age.^{1 4 6 12}

Geriatric Use

No substantial differences in safety, efficacy, or pharmacokinetics of oral aprepitant relative to younger adults, but increased sensitivity cannot be ruled out.^{1 4}

Hepatic Impairment

Oral aprepitant has not been adequately studied in patients with severe hepatic impairment (Child-Pugh score >9); caution advised in these patients.^{1 4 12}

Fosaprepitant metabolized by extrahepatic tissue; hepatic insufficiency not expected to alter conversion of fosaprepitant to aprepitant.¹²

Common Adverse Effects

Aprepitant capsules: Asthenia and/or fatigue, dizziness, hypoesthesia, nausea, anorexia, diarrhea, constipation, heartburn, abdominal pain, epigastric discomfort, dyspepsia, gastritis, stomatitis, pharyngolaryngeal pain, hiccups, perforating duodenal ulcer, enterocolitis, neutropenia, dehydration, hot flush, pruritus, hypotension, hypertension, sinus tachycardia, neutropenic sepsis, pneumonia, alopecia, bradycardia.^{1 2}

Fosaprepitant injection: Infusion site reactions (e.g., pain, induration), headache.^{12 13 16} Since fosaprepitant dimeglumine for injection is converted into aprepitant, adverse effects associated with aprepitant also may be expected to occur with the injection.¹²

Interactions for Emend

Drug interactions following fosaprepitant administration likely to occur with agents that interact with aprepitant.¹²

Aprepitant is extensively metabolized, principally by CYP3A4 and to a lesser extent by CYP1A2 and CYP2C19.^{1 12 16} The drug is a weak-to-moderate, dose-dependent inhibitor and an inducer of CYP3A4;^{1 4 12} also an inducer of CYP2C9.^{1 4 12}

Drugs Metabolized by Hepatic Microsomal Enzymes

CYP3A4 substrates: Possible altered metabolism of CYP3A4 substrates.^{1 4} Aprepitant may inhibit or induce CYP3A4.^{1 4} Inhibition of CYP3A4 is dose-dependent and moderate with the 125-mg/80-mg aprepitant regimen and weak with the single-dose, 40-mg regimen.¹ Possible increased plasma concentrations of concomitantly administered drugs, especially possible with higher aprepitant dosages (i.e., in a regimen consisting of 125 mg on day 1 followed by 80 mg on days 2 and 3) or with repeat administration at any aprepitant dose.^{1 4 6 16} Aprepitant (at a dosage level of 125 mg on day 1 followed by 80 mg on days 2 and 3) may increase plasma concentrations of a CYP3A4 substrate to lesser extent when the substrate is given IV rather than orally.^{1 6 18} Use with caution; dosage adjustment of the CYP3A4 substrate may be necessary.^{1 4 12}

CYP2C9 substrates: Possible increased metabolism and decreased plasma concentrations of the CYP2C9 substrate.^{1 4 6 12}

Drugs Affecting Hepatic Microsomal Enzymes

CYP3A4 inhibitors: Possible decreased aprepitant metabolism, resulting in increased plasma aprepitant concentrations.^{1 4 12} Use with caution.^{1 4 12 16}

CYP3A4 inducers: Possible increased aprepitant metabolism.^{1 4} Potential for decreased aprepitant efficacy with strong CYP3A4 inducers.^{1 4 12}

Specific Drugs

Drug	Interaction	Comments
Antiemetics, 5-HT3 receptor antagonists (e.g., dolasetron, granisetron, ondansetron)	No clinically important effects on 5-HT3 receptor antagonist pharmacokinetics1 12 16
Antifungals, azoles (e.g., itraconazole, ketoconazole)	Possible increased plasma aprepitant concentrations1 4	Use with caution1 4
Antineoplastic agents (e.g., etoposide, ifosfamide, imatinib, irinotecan, paclitaxel, vinblastine, vincristine)	Possible increased plasma concentrations of antineoplastic agents metabolized by CYP3A41 4	Use caution; careful monitoring required1 4
Astemizole (no longer commercially available in US)	Increased plasma astemizole concentrations;1 4 potential for serious or life-threatening reaction1 2 4	Concomitant use contraindicated1 4
Benzodiazepines (e.g., alprazolam, midazolam, triazolam)	Possible increased plasma concentrations of benzodiazepines metabolized by CYP3A41 4	Consider potential effect of increased plasma benzodiazepine concentrations1 4 12 16 IV midazolam: Dosage adjustment may be necessary when concurrently administered with oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 31 Interaction not clinically important when midazolam administered with single dose of fosaprepitant 100 mg or single 40-mg dose of aprepitant 1 6 12
Carbamazepine	Possible decreased plasma concentrations and decreased efficacy of aprepitant1 4
Cisapride (commercially available in US only under limited-access protocol)	Increased plasma cisapride concentrations;1 4 potential for serious or life-threatening reaction1 2 4	Concomitant use contraindicated1 4
Contraceptives, oral	Possible decreased plasma steroid concentrations and reduced contraceptive efficacy1 4	Use alternative or additional contraceptive methods during fosaprepitant or aprepitant treatment and for 1 month after last dose1 4 6 12 16
Corticosteroids (e.g., dexamethasone, methylprednisolone)	Possible increased plasma concentrations of corticosteroids metabolized by CYP3A4, particularly when given oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 31 4 12	Decrease dosage of oral and IV corticosteroids if necessary.1 4 12 Decrease dosage of oral dexamethasone and methylprednisolone by 50% and IV methylprednisolone by 25% in patients receiving oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 3;1 6 12 16 dosage adjustment not recommended in patients receiving the single-dose, 40-mg regimen6
Digoxin	Pharmacokinetic interaction unlikely1 4 12 16
Diltiazem	Possible increased plasma aprepitant and diltiazem concentrations; no clinically important changes in ECG, heart rate, or BP observed1 4 16 Small, but clinically meaningful, decrease in DBP, and possibly SBP, reported with concomitant fosaprepitant therapy; no clinically important changes in heart rate or PR interval observed12	Use with caution1 4 12
Docetaxel	No effects on docetaxel pharmacokinetics with oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 31 6
HIV protease inhibitors (nelfinavir, ritonavir)	Possible increased plasma aprepitant concentrations1 4	Use with caution1 4
Macrolide antibiotics (e.g., clarithromycin, troleandomycin)	Possible increased plasma aprepitant concentrations1 4	Use with caution1 4
Nefazodone	Possible increased plasma aprepitant concentrations1 4	Use with caution1 4
Paroxetine	Possible decreased plasma aprepitant and paroxetine concentrations1 4
Phenytoin	Possible decreased plasma concentrations and decreased efficacy of aprepitant; possible decreased plasma phenytoin concentrations1 4
Pimozide	Increased plasma pimozide concentrations;1 4 potential for serious or life-threatening reaction1 2 4	Concomitant use contraindicated1 4
Rifampin	Possible decreased plasma concentrations and decreased efficacy of aprepitant1 4
Terfenadine (no longer commercially available the US)	Increased plasma terfenadine concentrations;1 4 potential for serious or life-threatening reaction1 2 4	Concomitant use contraindicated1 4
Tolbutamide	Possible decreased plasma tolbutamide concentrations1 4
Vinorelbine	No effects on vinorelbine pharmacokinetics with oral aprepitant regimen of 125 mg on day 1 followed by 80 mg on days 2 and 31
Warfarin	Possible decreased plasma S-warfarin concentrations and decreased PT1 4	Monitor PT closely for 2 weeks (particularly 7–10 days) after initiation of fosaprepitant followed by aprepitant, the 3-day oral aprepitant regimen or administration of the single-dose aprepitant regimen1 4 6 12 16

Emend Pharmacokinetics

Absorption

Bioavailability

Absolute mean oral bioavailability at doses of 80–125 mg is approximately 60–65%.^{1 16} Absolute oral bioavailability of 40-mg dose not established.¹

Peak plasma concentrations achieved approximately 3–4 hours after oral administration.^{1 16}

Fosaprepitant undergoes hepatic and extrahepatic metabolism to aprepitant (the active moiety).¹²

Plasma concentrations of fosaprepitant were below limits of quantification within 30 minutes following infusion completion.¹²

Mean aprepitant plasma concentration 24 hours postdose similar between oral aprepitant (125-mg) dose and IV fosaprepitant (115-mg) dose.¹²

Food

Standard breakfast does not appreciably alter bioavailability.^{1 16}

Special Populations

In patients with mild to moderate hepatic impairment, no clinically meaningful changes in systemic exposure relative to healthy individuals.¹ Not studied in patients with severe hepatic impairment (Child-Pugh score >9).¹

In patients with severe renal impairment or end-stage renal disease requiring hemodialysis, total (protein bound and unbound) aprepitant AUCs and peak plasma concentrations are decreased, but AUC of active unbound drug is unaffected.¹

In geriatric patients, no clinically meaningful changes in systemic exposure relative to younger adults.¹

Distribution

Extent

Crosses the placenta in animals; crosses the blood-brain barrier in humans.¹

Plasma Protein Binding

>95%.¹

Elimination

Metabolism

Fosaprepitant rapidly metabolized to aprepitant in liver by CYP3A4 and to lesser extent by CYP1A2 and 2C19; also metabolized in extrahepatic tissues.^{12 16}

Aprepitant extensively metabolized to weakly active metabolites, principally by CYP3A4 and to a lesser extent by CYP1A2 and CYP2C19.¹

Elimination Route

Eliminated principally by metabolism; not renally excreted.¹

Following a single IV dose of radiolabeled fosaprepitant in healthy individuals, 57 and 45% of radioactivity recovered in urine and feces, respectively.¹⁶

Half-life

Terminal half-life is approximately 9–13 hours.^{1 16}

Special Populations

Not removed by hemodialysis.^{1 4}

Stability

Storage

Oral

Capsules

20–25°C.¹ Desiccant should remain in original bottle.¹

Parenteral

Injection

2–8°C.¹²

Following reconstitution and dilution to final concentration of 1 mg/mL in 0.9% sodium chloride injection, store at room temperature (≤25°C); use within 24 hours.¹²

Compatibility

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

Parenteral

Do not mix or reconstitute with solutions containing divalent cations (e.g., lactated Ringer’s solution, Hartmann’s solution).¹²

Solution Compatibility

Incompatible
Ringer’s injection, Lactated12
Hartmann’s solution12

ActionsActions

• 
  

  Fosaprepitant is a prodrug; pharmacologically active once metabolized to aprepitant.^{12 16}

  
  


• 
  

  Aprepitant occupies NK₁ receptors in the brain.^{1 3 4} Acts in the CNS to inhibit cancer chemotherapy-induced nausea and vomiting (including both acute and delayed emesis induced by cisplatin) and postoperative nausea and vomiting.^{1 3 4}

  
  


• 
  

  Augments the antiemetic activity of ondansetron and dexamethasone.^{1 3 4}

  
  

Advice to Patients

• 
  

  Importance of reading the fosaprepitant and aprepitant patient information provided by the manufacturer before beginning therapy and rereading each time the prescription is renewed.^{1 2 12}

  
  


• 
  

  Importance of using fosaprepitant and aprepitant only as directed by the clinician.^{1 2 12}

  
  


• 
  

  Importance of taking first oral aprepitant (125-mg) dose 1 hour before initiation of antineoplastic chemotherapy.^{1 2}

  
  


• 
  

  Advise patients that aprepitant may be taken with or without food.^{2 12 17}

  
  


• 
  

  Importance of taking aprepitant (40-mg) dose within 3 hours prior to induction of anesthesia for prevention of postoperative nausea and vomiting.¹

  
  


• 
  

  Importance of discontinuing aprepitant and promptly contacting a clinician if symptoms of an allergic reaction occur.^{2 12 17}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 2} Importance of women using alternative or additional contraceptive methods during fosaprepitant or aprepitant use (and for 1 month after last dose) if oral contraceptives are being taken.^{1 2 12}

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products.^{1 2 12} Importance of closely monitoring prothrombin time in patients receiving chronic warfarin therapy during the 2 weeks (particularly 7–10 days) after initiation of fosaprepitant followed by aprepitant, or the 3-day oral aprepitant regimen for each antineoplastic chemotherapy cycle, or administration of aprepitant for prevention of postoperative emesis.^{1 2 12}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 2} (See Cautions.)

  
  

Preparations

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

Aprepitant

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	40 mg	Emend	Merck
		80 mg	Emend	Merck
		125 mg	Emend	Merck

Fosaprepitant Dimeglumine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For IV infusion only	115 mg (of fosaprepitant)	Emend	Merck

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Emend 125MG Capsules (MERCK SHARP &amp; DOHME): 6/$920.99 or 18/$2638.97

Emend 40MG Capsules (MERCK SHARP &amp; DOHME): 5/$269.45 or 15/$763.43

Emend 80MG Capsules (MERCK SHARP &amp; DOHME): 2/$211.33 or 6/$608.57

Emend 80MG Capsules (MERCK SHARP &amp; DOHME): 6/$617.99 or 18/$1735.98

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 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Merck. Emend (aprepitant) capsules prescribing information. Whitehouse Station, NJ; 2008 Feb.

2. Merck. Emend (aprepitant) capsules patient information. Whitehouse Station, NJ; 2008 Apr.

3. Sorbera LA, Castaner J, Bayes M at al. Aprepitant and L-758298. Drugs Fut. 2002; 27:211-22.

4. Merck. Emend (aprepitant) product information form for the American Hospital Formulary Service. 2003.

5. Merck. Dear pharmacist letter regarding Emend (aprepitant). 2003 Apr.

6. Merck, Whitehouse Station, NJ: Personal communication.

7. Kris MG, Hesketh PJ, Somerfield MR et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006; 24:2932-2947. [PubMed 16717289]

8. Hesketh PJ, Grunberg SM, Gralla RJ et al. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin—the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003; 21:4112-9. [PubMed 14559886]

9. Poli-Bigelli S, Rodrigues-Pereira J, Carides AD et al. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting: results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer. 2003; 97:3090-8. [PubMed 12784346]

11. Warr DG, Hesketh PJ, Gralla RJ. et al. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005; 23:2822-30. [PubMed 15837996]

12. Merck. Emend (fosaprepitant dimeglumine) for injection prescribing information. Whitehouse Station, NJ; 2008 Feb.

13. Lasseter KC, Gambale J, Jin B et al. Tolerability of fosaprepitant and bioequivalency to aprepitant in healthy subjects. J Clin Pharmacol. 2007; 47:834-40. [PubMed 17525168]

14. Diemunsch P, Gan TJ, Philip BK et al. Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind Phase III trial in patients undergoing open abdominal surgery. Br J Anesth. 2007; 99:202-11.

15. Gan TJ, Apfel CC, Kovac A et al. A randomized, double-blind comparison of the NK₁ antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Anal. 2007; 104:1082-9.

16. Navari RM. Fosaprepitant (MK-0517): a neurokinin-1 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting. Expert Opin. Investig. Drugs. 2007; 16:1977-85.

17. Merck. Emend (fosaprepitant dimeglumine) for injection patient information. Whitehouse Station, NJ; 2009 Feb.

18. Merck. Whitehouse Station, NJ: Personal communication.

More Emend resources

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

• Emend Prescribing Information (FDA)


• Emend Consumer Overview


• Emend Advanced Consumer (Micromedex) - Includes Dosage Information


• Emend MedFacts Consumer Leaflet (Wolters Kluwer)


• Aprepitant Professional Patient Advice (Wolters Kluwer)

Compare Emend with other medications

• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative

Monomax XL 60mg Prolonged Release Tablets

Monomax XL 60 mg Tablets

isosorbide mononitrate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 
  1. What Monomax is and what it is used for
  


• 
  2. Before you take Monomax
  


• 
  3. How to take Monomax
  


• 
  4. Possible side effects
  


• 
  5. How to store Monomax
  


• 
  6. Further information
  

What Monomax is and what it is used for

Monomax XL Prolonged-release Tablets contain isosorbide mononitrate which belongs to a group of medicines called nitrates that act on the cardiovascular system (the heart and blood vessels). Monomax has been given to you by your doctor or pharmacist to reduce the frequency of your anginal attacks (chest pains). They are called prolonged-release tablets because they are manufactured in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours.

In angina, isosorbide mononitrate works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occurring when extra strain is placed upon the heart.

Before you take Monomax

Do not take Monomax:

• 
  if you are taking the drug, sildenafil, for the treatment of male erectile dysfunction (see also: Section 2 - Taking other medicines)


• if you are allergic to isosorbide mononitrate, other nitrates (e.g glyceryl trinitrate or isosorbide dinitrate) or any of the other ingredients in Monomax


• if you have suffered a stroke or have any other condition which may affect the blood supply to your brain


• if you suffer from low blood pressure


• if you have been told that you have a problem with your heart. Ask your doctor if you are not sure if this applies to you


• if you suffer from a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness


• to treat an angina attack as it occurs. Your doctor will probably have given you another tablet to take for sudden attacks.

Take special care with Monomax and always tell your doctor or pharmacist if:

• you suffer from increased pressure in your eyes


• you suffer from an underactive thyroid gland


• you suffer from an abnormally low body temperature


• you suffer from poor health caused by a poor diet


• you suffer from severe liver or kidney disease


• you have suffered from a head injury or bleeding in the brain


• if you have recently had a heart attack.

Taking other medicines

Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you have to go to a doctor, dentist or hospital for any reason, tell them that you are taking Monomax.

In particular, tell your doctor or pharmacist if you are taking:

• medicines for the treatment of high blood pressure, such as hydralazine or minoxidil


• water tablets, such as frusemide

Taking these types of medicines with Monomax can increase the risk of low blood pressure occurring, especially if you are elderly.

Do not take sildenafil, used for the treatment of erectile dysfunction at the same time as Monomax. If taken at the same time it could cause a severe fall in blood pressure resulting in collapse, unconciousness and may be fatal.

Taking Monomax with food and drink

If you drink alcohol while you are taking Monomax it can increase the risk of low blood pressure occurring, especially if you are elderly.

Pregnancy and breast-feeding:

Do not take Monomax if you are pregnant, trying to become pregnant or are breast-feeding.

Driving and using machines:

If you feel faint, dizzy or light headed when you stand up or move suddenly after taking Monomax, then do not drive or operate machinery.

Important information about some of the ingredients of Monomax:

Monomax contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Monomax

Always take Monomax exactly as your doctor or pharmacist has told you to. You should check with your doctor or pharmacist if you are not sure.

The label on the carton will tell you how many tablets you should take and when. It is very important that you take your tablets regularly. Do not stop treatment even if you feel better unless told to do so by your doctor.

Monomax is formulated so that you only have to take your tablets once a day. It is important that you take your tablets at the same time each day, preferably in the morning. Your tablet must be swallowed whole with a glass of water. Do not break or chew your tablets.

Adults and the elderly: the usual dose is 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 120 mg of Monomax once a day.

If you are elderly and suffer from low blood pressure, liver or kidney disease, your doctor may prescribe a lower dose for you to take.

Do not stop taking your medicine until your doctor tells you.

Children must not take this medicine.

If you take more Monomax than you should

If you accidentally take more Monomax than you should, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

If you forget to take Monomax

Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Monomax can cause side effects, although not everyone gets them.

If you experience a headache when you first start taking your tablets, contact your doctor or pharmacist immediately. Your doctor or pharmacist may need to adjust your dose.

The following side effects do not usually last long and are most likely to occur when you first start to take your medicine or if your dose has been increased. If they continue or if you are worried, contact your doctor or pharmacist immediately:

• light headedness when you stand up or move suddenly


• faintness

Also, some people experience:

• flushing


• dry skin rashes


• dizziness


• feeling sick


• itchy skin


• pains in the muscles

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Monomax

• Keep out of the reach and sight of children.


• Do not store above 25°C. Store in the original packaging.


• Do not use Monomax after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Further information

What Monomax contains:

• The active substance in your tablets is isosorbide mononitrate. Each tablet contains 60 mg of isosorbide mononitrate.


• The other ingredients are lactose monohydrate, hypromellose (E464), glyceryl palmitostearate, maize starch and magnesium stearate.

What Monomax looks like and the contents of the pack:

Monomax XL 60 mg Prolonged Release Tablets are white, oval and convex in shape with a break line between “SL” and “60”, which are embossed on one side. They are available in blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation holder and manufacturer is

Chiesi Limited

Cheadle Royal Business Park

Highfield

Cheadle

SK8 3GY

UK

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.

This leaflet was last approved in 06/2009

00108 V4/CP0027/2

Electrolyte Freezer-Pops

Pronunciation: e-LECK-troe-lite
Generic Name: Electrolyte
Brand Name: Examples include Pedialyte Freezer Pops and ReVital Freezer Pops

Electrolyte Freezer-Pops are used for:

Treating or preventing dehydration caused by vomiting or diarrhea. It may also be used for other conditions as determined by your doctor.

Electrolyte Freezer-Pops are a carbohydrate and electrolyte combination. It works by replacing electrolytes and carbohydrates in the body to prevent dehydration.

Do NOT use Electrolyte Freezer-Pops if:

• you are allergic to any ingredient in Electrolyte Freezer-Pops


• you have high blood potassium levels

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

Before using Electrolyte Freezer-Pops:

Some medical conditions may interact with Electrolyte Freezer-Pops. 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 heart failure, fluid retention (eg, swelling of the hands, ankles, or feet), intestinal holes or punctures, difficulty urinating, kidney problems, or unexplained rectal bleeding


• if you have severe or persistent vomiting, severe diarrhea, or if you are dehydrated


• if you are unable to properly absorb glucose from food

Some MEDICINES MAY INTERACT with Electrolyte Freezer-Pops. However, no specific interactions with Electrolyte Freezer-Pops are known at this time.

Ask your health care provider if Electrolyte Freezer-Pops 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 Electrolyte Freezer-Pops:

Use Electrolyte Freezer-Pops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Electrolyte Freezer-Pops by mouth with or without food.


• Do not mix Electrolyte Freezer-Pops with water or any other liquid.


• Do not heat Electrolyte Freezer-Pops.


• Electrolyte Freezer-Pops may be eaten frozen or the contents of one unfrozen sleeve may be poured into a cup or glass to drink. Immediately throw away any unused portion of the opened medicine.


• Do not reuse the container.


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

Ask your health care provider any questions you may have about how to use Electrolyte Freezer-Pops.

Important safety information:

• If vomiting, fever, or stomach pain or bloating occurs, or diarrhea continues for longer than 24 hours, check with your doctor.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Do not use Electrolyte Freezer-Pops in CHILDREN younger than 1 year old without first checking with your doctor.


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

Possible side effects of Electrolyte Freezer-Pops:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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: Electrolyte 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 Electrolyte Freezer-Pops:

Electrolyte Freezer-Pops may be stored frozen or at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Electrolyte Freezer-Pops out of the reach of children and away from pets.

General information:

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


• Electrolyte Freezer-Pops are 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 Electrolyte Freezer-Pops. 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 Electrolyte resources

• Electrolyte Side Effects (in more detail)
• Electrolyte Support Group
• 0 Reviews · Be the first to review/rate this drug

Loprox Topical

Generic Name: ciclopirox (Topical route)

sye-kloe-PIR-ox

Commonly used brand name(s)

In the U.S.

• CNL8


• Loprox


• Loprox TS


• Penlac

Available Dosage Forms:

• Lotion


• Gel/Jelly


• Cream


• Suspension


• Shampoo


• Solution


• Powder

Therapeutic Class: Antifungal

Uses For Loprox

Ciclopirox is used to treat infections caused by fungus. It works by killing the fungus or preventing its growth.

Ciclopirox cream, gel, or lotion are applied to the skin to treat:

• ringworm of the body (tinea corporis);


• ringworm of the foot (tinea pedis; athlete's foot);


• ringworm of the groin (tinea cruris; jock itch);


• “sun fungus” (tinea versicolor; pityriasis versicolor); and


• certain other fungus infections, such as Candida (Monilia) infections.

Ciclopirox gel or shampoo may also be applied to the scalp to treat seborrheic dermatitis.

Ciclopirox topical solution (nail lacquer) is applied to the nails to treat ringworm of the nails (tinea unguium).

Ciclopirox is available only with your doctor's prescription.

Before Using Loprox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ciclopirox in children under the age of 10 with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ciclopirox in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of ciclopirox

This section provides information on the proper use of a number of products that contain ciclopirox. It may not be specific to Loprox. Please read with care.

For patients using the cream, gel, or lotion form of this medicine:

• Keep this medicine away from the eyes.


• Apply enough ciclopirox to cover the affected and surrounding skin or scalp areas and rub in gently.

For patients using the shampoo form of this medicine:

• Keep this medicine away from the eyes.


• Apply shampoo to wet hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Rinse off.

For patients using the topical solution form of this medicine:

• Keep this medicine away from the eyes and mucous membranes


• This medicine comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use this medicine, be sure to ask your health care professional.


• In addition to daily application of this medicine, you will need to trim your nails as directed, and visit your healthcare professional at regular intervals to have the unattached infected nails removed.


• Do not use nail polish or other nail cosmetic products on the treated nails.


• Do not use near heat or open flame.

When ciclopirox is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may irritate the skin. Do not apply an airtight covering over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, it is very important that you keep using ciclopirox for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical cream and lotion dosage forms:
  
  • Fungus infections (treatment):
    
    • Adults and children 10 years of age and over—Apply two times a day, morning and evening.
    
    
    • Children up to 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  
  For topical gel dosage form:
  
  • Fungus infections (treatment) or seborrheic dermatitis (treatment):
    
    • Adults and children 16 years of age and over—Apply two times a day, morning and evening.
    
    
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  
  For shampoo dosage form:
  
  • Seborrheic dermatitis (treatment):
    
    • Adults and children 16 years of age and over—Apply 1 teaspoon (or up to 2 teaspoons for long hair) two times a week for four weeks with at least three days between each application.
    
    
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  
  For topical solution dosage form:
  
  • Fungus infections (treatment):
    
    • Adults —Apply once daily, preferably at bedtime or eight hours before washing.
    
    
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Loprox

If your skin problem does not improve within 2 to 4 weeks, or if it becomes worse, check with your doctor.

Inform your doctor right away if the area where you applied the medicine shows signs of increased irritation (e.g., redness, itching, burning, blistering, swelling, or oozing) because it could be an allergic reaction.

Nail problems treated with the topical solution form of this medicine may take up to 6 months to start improving.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required. The following measures will help reduce chafing and irritation and will also help keep the area cool and dry.

• For patients using ciclopirox for ringworm of the groin (tinea cruris):
  
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) on the skin. It is best to use the powder between applications of ciclopirox.
  
  


• For patients using ciclopirox for ringworm of the foot (tinea pedis):
  
  • Carefully dry the feet, especially between the toes, after bathing.
  
  
  • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if the feet sweat freely.
  
  
  • Wear sandals or well-ventilated shoes (for example, shoes with holes on top or on the side).
  
  
  • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) between the toes, on the feet, and in socks and shoes freely once or twice a day. It is best to use the powder between applications of ciclopirox.
  
  

If you have any questions about these measures, check with your health care professional.

Loprox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common - with ciclopirox shampoo

• Fainting


• fast, pounding, or irregular heartbeat or pulse


• palpitations

Rare

• Burning, itching, redness, swelling, or other signs of irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common - with ciclopirox shampoo

• Dandruff


• headache


• itching skin or scalp


• oily skin


• rash


• skin disorder

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Loprox Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Loprox Topical resources

• Loprox Topical Side Effects (in more detail)
• Loprox Topical Use in Pregnancy & Breastfeeding
• Loprox Topical Support Group
• 2 Reviews for Loprox Topical - Add your own review/rating

Compare Loprox Topical with other medications

• Cutaneous Candidiasis
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

ElixSure Cough Gel Syrup

Pronunciation: DEX-troe-meth-OR-fan
Generic Name: Dextromethorphan
Brand Name: ElixSure Cough

ElixSure Cough Gel Syrup is used for:

Temporarily relieving cough due to the common cold, hay fever, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

ElixSure Cough Gel Syrup is a cough suppressant. It works in the cough center of the brain to reduce a dry or nonproductive cough.

Do NOT use ElixSure Cough Gel Syrup if:

• you are allergic to any ingredient in ElixSure Cough Gel Syrup


• you are taking or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using ElixSure Cough Gel Syrup:

Some medical conditions may interact with ElixSure Cough Gel Syrup. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 chronic cough, chronic bronchitis, asthma, emphysema, chronic obstructive pulmonary disease (COPD), or if cough occurs with a large amount of mucus

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

• Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of toxic side effects may be increased by ElixSure Cough Gel Syrup

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

Use ElixSure Cough Gel Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• ElixSure Cough Gel Syrup may be taken with or without food. Take with food if stomach upset occurs.


• Shake well before using.


• Use the teaspoon provided with ElixSure Cough Gel Syrup to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


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

Ask your health care provider any questions you may have about how to use ElixSure Cough Gel Syrup.

Important safety information:

• ElixSure Cough Gel Syrup may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to ElixSure Cough Gel Syrup. Using ElixSure Cough Gel Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition.


• ElixSure Cough Gel Syrup contains dextromethorphan. Before you being taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains dextromethorphan. If it does or if you are not sure, contact your health care provider or pharmacist.


• Diabetes patients - Some brands of ElixSure Cough Gel Syrup may contain sugar and affect your blood sugar level. Read the label carefully before using ElixSure Cough Gel Syrup.


• ElixSure Cough Gel Syrup is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if ElixSure Cough Gel Syrup can cause harm to the fetus. If you become pregnant while taking ElixSure Cough Gel Syrup, discuss with your doctor the benefits and risks of using ElixSure Cough Gel Syrup during pregnancy. It is unknown if ElixSure Cough Gel Syrup is excreted in breast milk. Do not breast-feed while taking ElixSure Cough Gel Syrup.

Possible side effects of ElixSure Cough Gel Syrup:

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:

Dizziness; drowsiness; stomach upset.

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

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

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: ElixSure Cough side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Proper storage of ElixSure Cough Gel Syrup:

Store ElixSure Cough Gel Syrup between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep ElixSure Cough Gel Syrup out of the reach of children and away from pets.

General information:

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


• ElixSure Cough Gel Syrup 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 ElixSure Cough Gel Syrup. 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 ElixSure Cough resources

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

Compare ElixSure Cough with other medications

• Cough

liotrix

Generic Name: liotrix (LYE oh trix)

Brand Names: Thyrolar-1, Thyrolar-1/2, Thyrolar-1/4, Thyrolar-2, Thyrolar-3

What is liotrix?

Liotrix is a man-made form of a hormone that is normally produced by your thyroid gland to regulate the body's energy and metabolism. Liotrix is given when the thyroid does not produce enough of this hormone on its own.

Liotrix treats hypothyroidism (low thyroid hormone). Liotrix is also used to treat or prevent goiter (enlarged thyroid gland), and is also given as part of a medical tests for thyroid disorders.

Liotrix should not be used to treat obesity or weight problems.

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

What is the most important information I should know about liotrix?

Since thyroid hormone occurs naturally in the body, almost anyone can take liotrix. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

Before taking liotrix, tell your doctor if you have heart disease, angina (chest pain), coronary artery disease, congestive heart failure, diabetes, or problems with your pituitary or adrenal glands.

Tell your doctor if you are pregnant or breast-feeding.

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

Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.

Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.

What should I discuss with my healthcare provider before taking liotrix?

Since thyroid hormone occurs naturally in the body, almost anyone can take liotrix. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

To make sure you can safely take liotrix, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, angina (chest pain);

  
  


• 
  

  coronary artery disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  any type of diabetes; or

  
  


• 
  

  problems with your pituitary or adrenal gland.

  
  

FDA pregnancy category A. Liotrix is not expected to harm an unborn baby. However, tell your doctor if you become pregnant, since your dose needs may be different during pregnancy. Small amounts of liotrix can pass into breast milk, but this is not expected to harm a nursing baby. However, do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take liotrix?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

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

Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.

Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual. If you need surgery, tell the surgeon ahead of time that you are using liotrix. You may need to stop using the medicine for a short time. Store liotrix tablets in a tightly closed container in the refrigerator. Protect the medicine from light and do not allow it to freeze.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include headache, sweating, diarrhea, irregular menstrual periods, confusion, weakness, swelling in your hands or feet, fast heart rate, chest pain, feeling short of breath, fainting, or feeling nervous, restless, or irritable.

What should I avoid while taking liotrix?

Do not change brands or change to a generic drug product without first asking your doctor. Different brands of liotrix may not work the same. If you get a prescription refill and your new pills look different, talk with your pharmacist or doctor.

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking these medications within 4 hours before or after you take liotrix.

Liotrix side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  nausea;

  
  


• 
  

  depression, anxiety, feeling weak or tired;

  
  


• 
  

  weight gain;

  
  


• 
  

  dry or itchy skin;

  
  


• 
  

  joint or muscle pain; or

  
  


• 
  

  temporary hair loss (especially in children).

  
  

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 liotrix?

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

• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  epinephrine (EpiPen) or norepinephrine (Levophed);

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  medications that contain iodine (such as I-131);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

  
  


• 
  

  salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;

  
  


• 
  

  steroids such as prednisone and others.

  
  

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

More liotrix resources

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

• liotrix Advanced Consumer (Micromedex) - Includes Dosage Information


• Liotrix Professional Patient Advice (Wolters Kluwer)


• Liotrix Monograph (AHFS DI)


• Liotrix MedFacts Consumer Leaflet (Wolters Kluwer)

Compare liotrix with other medications

• Underactive Thyroid

Where can I get more information?

• Your pharmacist can provide more information about liotrix.

See also: liotrix side effects (in more detail)

Nortrel 1/35

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Nortrel 1/35 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Nortrel 1/35 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Nortrel 1/35 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Nortrel 1/35 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Nortrel 1/35 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Nortrel 1/35 (ethinyl estradiol and norethindrone) side effects

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

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Nortrel 1/35 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

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

More Nortrel 1/35 resources

• Nortrel 1/35 Side Effects (in more detail)
• Nortrel 1/35 Use in Pregnancy & Breastfeeding
• Drug Images
• Nortrel 1/35 Drug Interactions
• Nortrel 1/35 Support Group
• 2 Reviews for Nortrel/35 - Add your own review/rating

• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Nortrel 1/35 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Nortrel/35 side effects (in more detail)