Tuesday, May 8, 2012

Soliris


Generic Name: Eculizumab
Class: Complement Inhibitors
ATC Class: L04AA25
VA Class: BL500
Chemical Name: Disulfide with human-mouse monoclonal 5G.1.1 light chain anti-(human complement C5 α-chain) (human-mouse monoclonal 5G1.1 heavy chain) immunoglobulin dimer
CAS Number: 219685-50-4



  • Risk of serious meningococcal infection.1 10




  • Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to first dose of eculizumab; revaccinate according to current vaccination guidelines.1 5 (See Meningococcal Vaccination under Dosage and Administration and also see Infectious Complications under Cautions.)




  • Monitor patients during therapy for early manifestations of meningococcal infection.1 Evaluate suspected infections immediately and initiate appropriate antibiotic treatment if indicated.1



REMS:


FDA approved a REMS for eculizumab to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of eculizumab and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Terminal complement inhibitor; a recombinant humanized immunoglobulin IgG2/4 kappa monoclonal antibody.1 3 4 10 16 17 19


Uses for Soliris


Paroxysmal Nocturnal Hemoglobinuria


Treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis (designated an orphan drug by FDA for this use).1 2 3 4 10 16 17


Improves symptoms of PNH by reducing hemolysis, stabilizing hemoglobin concentrations, and reducing transfusion requirements.1 3 4 6 10 16 17 Reduced fatigue and improved quality of life also reported.1 3 6 Only curative treatment of PNH to date is stem cell transplantation.8 10 20


Soliris Dosage and Administration


General



  • Distribute medication guide to every patient prior to first dose and before each subsequent infusion.1 21



Meningococcal Vaccination



  • Assess vaccination status prior to initiating therapy.1 Ensure patients are vaccinated against Neisseria meningitidis at least 2 weeks before first dose of eculizumab and revaccinated thereafter based on current immunization guidelines. 1 6 (See Infectious Complications under Cautions.)




  • CDC recommends vaccination with meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4) for adults ≤55 years of age, and meningococcal polysaccharide combined vaccine (MPSV4) for adults >55 years of age.5 Use of a conjugated quadrivalent vaccine strongly recommended by the manufacturer.1 6



Risk Minimization Plan



  • A risk minimization plan has been developed to monitor adverse events associated with eculizumab, including meningococcal infections.6 11 12 13 (See Boxed Warning and also see Infectious Complications under Cautions.)




  • Patients being treated with eculizumab will automatically be enrolled in a registry (Soliris Safety Registry) established to monitor long-term safety of the drug.6 12 13 Enrollment in a separate Global PNH Patient Registry that monitors the natural history and management of PNH is optional.6 10 14 For additional information, consult registry website at .14




  • Eculizumab is available through a flexible distribution program.6 7 Drug can be obtained through the Soliris OneSource Program, a manufacturer-sponsored support service that facilitates access to therapy; patient education, reimbursement support, and coordination of care also provided.7 Information about the Soliris OneSource Program available at 888-SOLIRIS (888-765-4747) or at .7



Administration


IV Administration


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


Administer by IV infusion using gravity flow or a controlled-infusion device (e.g., infusion pump or syringe pump).1 Do not administer by rapid IV injection such as IV push or bolus.1


Allow solution to warm to room temperature before administering to patient.1 Do not heat (e.g., in a microwave).1


Monitor patients for hypersensitivity or infusion-related reactions during and for 1 hour following each infusion.1 Slow infusion rate or discontinue therapy if adverse reaction occurs.1 (See Hypersensitivity Reactions under Cautions.)


Dilution

Must dilute eculizumab concentrate for injection prior to administration.1


Withdraw appropriate dose of eculizumab from vial, add to infusion bag, and dilute with 5% dextrose, 0.9% sodium chloride, 0.45% sodium chloride, or Ringer's injection to provide a final concentration of 5 mg/mL.1 6


To prepare a 600-mg dose, withdraw 60 mL of the concentrate for injection (containing 10 mg/mL) and add to 60 mL of diluent in an infusion bag to achieve a final admixture volume of 120 mL (i.e., 5 mg of eculizumab per mL).1 6 To prepare a 900-mg dose, withdraw 90 mL of the concentrate for injection (containing 10 mg/mL) and add to 90 mL of diluent in an infusion bag to achieve a final admixture volume of 180 mL (i.e., 5 mg of eculizumab per mL).1 6


Gently invert diluted solution to mix completely; do not shake.1


Vials are for single use only.1 Discard any unused portion after preparing dose.1


Rate of Administration

Administer by IV infusion over 35 minutes; if infusion must be slowed due to adverse effects, do not exceed 2 hours total infusion time.1


Dosage


Adults


Paroxysmal Nocturnal Hemoglobinuria

IV

Initially, 600 mg every 7 days for 4 weeks, followed by one dose of 900 mg 7 days later (week 5), then 900 mg every 14 days thereafter.1 6


Doses should be administered at the recommended time points, or within 2 days of each time point, to achieve maximum benefit.1 16 17 A few patients have required a decrease in the recommended dosage interval (i.e., from 14 to 12 days) to achieve optimal reduction in hemolysis (as determined by reduction in LDH levels).1


Prescribing Limits


Adults


Paroxysmal Nocturnal Hemoglobinuria

IV

Total infusion time beyond 2 hours not recommended.1


Cautions for Soliris


Contraindications


Active, severe N. meningitidis infection.1


Patients not currently vaccinated against N. meningitidis.1


Warnings/Precautions


Warnings


Infectious Complications

Eculizumab increases susceptibility to infections caused by encapsulated bacteria, particularly meningococcal infections.1 10 Serious infections (e.g., meningococcal sepsis) reported in some patients receiving eculizumab.1 6 Do not initiate therapy in patients with active meningococcal infections or in those not immunized against N. meningitidis.1 (See Boxed Warning.) Use caution in patients with other systemic infections.1


Patients must be vaccinated against N. meningitidis at least 2 weeks prior to the first dose of eculizumab and revaccinated thereafter according to current vaccination guidelines.1 5 6 Vaccination may not prevent meningococcal infection; cases of meningococcal septicemia reported in patients treated with eculizumab despite immunization.1 6 10


Monitor for manifestations of infection during therapy; strongly consider discontinuance in patients who develop serious infection, and initiate appropriate antibiotic treatment.1


Hemolysis

Possible risk of serious hemolysis following treatment discontinuance due to eculizumab-induced increase in PNH erythrocytes.1 6 10


Monitor patients ≥8 weeks after discontinuing therapy for manifestations of serious hemolysis, consisting of elevated serum LDH concentrations with any of the following: >25% absolute decrease in PNH clone size (in the absence of transfusional dilution) in ≤1 week; hemoglobin concentration <5 g/dL or decrease in hemoglobin of >4 g/dL in ≤1 week; angina; altered mental status; 50% increase in Scr; or thrombosis.1


Treatment of serious hemolysis may consist of packed RBCs transfusion, exchange transfusion (if PNH erythrocytes are >50% of total RBCs by flow cytometry), anticoagulation, corticosteroids, or reinitiation of eculizumab.1 6 9


Hypersensitivity Reactions

Infusion reactions requiring discontinuance of eculizumab not observed during clinical trials, but hypersensitivity or anaphylaxis possible with all protein products.1 6


Monitor for infusion-related reactions during treatment; if hypersensitivity or other serious reaction develops, interrupt eculizumab infusion and initiate appropriate treatment.1


General Precautions


Thrombosis Prevention and Management

High risk of venous thrombosis (potentially life-threatening or fatal) in patients with PNH.4 8 18 20 Effects of withdrawing anticoagulant therapy in patients receiving eculizumab not established.1 Treatment with eculizumab should not affect concomitant anticoagulant management.1


Immunogenicity

Low titers of antibodies to eculizumab reported infrequently; relationship between development of antibodies and clinical response not observed.1 3 6


Laboratory Monitoring

Serum LDH concentrations and flow cytometry may be used to monitor response to therapy (e.g., hemolysis, PNH erythrocytes).1 10 In a few patients in clinical studies, a reduction in LDH levels was maintained only after a decrease in the eculizumab dosage interval from 14 to 12 days.1 6


Following withdrawal of therapy, monitor serum LDH concentrations and other parameters to detect serious hemolysis.1 6 (See Hemolysis under Cautions.)


Specific Populations


Pregnancy

Category C.1


Lactation

Not known whether eculizumab is distributed into human milk.1 (See Extent under Pharmacokinetics.) Caution if used in nursing women.1


Pediatric Use

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


Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1


Common Adverse Effects


Headache,1 3 4 21 nasopharyngitis,1 3 4 back pain,1 3 21 nausea,1 3 4 21 fatigue,1 cough,1 herpes simplex infections,1 sinusitis,1 respiratory tract infection,1 constipation,1 myalgia,1 pain in extremity,1 influenza-like illness.1


Interactions for Soliris


No formal drug interaction studies to date.1


Soliris Pharmacokinetics


Absorption


Plasma Concentrations


Plasma concentrations ≥35 mcg/mL required to block complement.16 17


Duration

Complement activity inhibited for ≤2 weeks following single dose.19


Reduction of hemolysis (as determined by reduction in LDH concentrations) maintained at least 52 weeks in open-label study.1 17


Distribution


Extent


Human IgG crosses placenta and is distributed into milk.1 Potential exists for eculizumab to cross placenta and distribute into milk.1


Elimination


Metabolism


Metabolic fate of immunoglobulins not well characterized; catabolized in various tissues via diffuse cellular processes.15


Elimination Route


Minimal excretion in urine expected due to large molecular size.1 15 Small quantities of immunoglobulin found in bile.15


Half-life


Approximately 272 hours.1


Stability


Storage


Parenteral


Injection

2–8°C.1 Do not freeze or shake.1 Store in manufacturer's carton and protect from light.1


Following dilution, stable for 24 hours at 2–8°C or at room temperature.1


Single-use vials do not contain preservative.1 Discard unused portions.1


Compatibility


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


Parenteral


Solution Compatibility1






Compatible



Dextrose 5% in water



Sodium chloride 0.45 or 0.9%



Ringer's injection


Actions



  • IgG2/4 kappa immunoglobulin containing human framework (i.e., variable and constant regions) and murine complementarity-determining regions.1




  • Hemolysis in PNH results from a genetic deficiency of glycosylphosphatidylinositol (GPI)-linked complement inhibitor CD-59 on the surface of RBCs (PNH erythrocytes), which renders such erythrocytes sensitive to persistent terminal complement-mediated destruction.1 4 8 9 10 18 20




  • Eculizumab prevents destruction of PNH erythrocytes that lack complement protection with CD-59 by binding specifically and with high affinity to complement protein C5, preventing activation of terminal complement components (cleavage to C5a and C5b and subsequent formation of C5b–C9 terminal complement complex).1 3 10 19



Advice to Patients



  • Importance of patients fully understanding risks and benefits of therapy prior to initiation.1 21




  • Risk of serious meningococcal infections and other systemic infections.1 21 Importance of immunization against meningococcal infections at least 2 weeks prior to first dose and revaccination as recommended while on therapy.1 6 21 Advise patients that vaccination may not prevent infection; importance of informing clinician immediately if manifestations of meningococcal infection (moderate to severe headache with nausea, vomiting, fever, stiff neck or back; temperature ≥103°F; fever with rash; confusion; severe muscle aches with flu-like symptoms; light sensitivity) develop.1 21




  • Notify clinician immediately if a dose is missed.1 21 Discontinuance of therapy may cause sudden hemolysis; importance of monitoring for hemolysis for ≥8 weeks following treatment discontinuance.1 21




  • Importance of reading medication guide provided by manufacturer before each infusion.1 21 Advise patients to carry patient safety card (describing symptoms requiring immediate medical attention) at all times.1 21




  • Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1 21




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1 21




  • Importance of informing patients of other important precautionary information.1 21 (See Cautions.)



Preparations


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













Eculizumab

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection, concentrate, for IV infusion only



10 mg/mL (300 mg)



Soliris (preservative-free)



Alexion



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




References



1. Alexion Pharmaceuticals, Inc. Soliris (eculizumab) concentrated solution for intravenous infusion prescribing information. Chesire, CT; 2007 June.



2. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97 414). Rockville, MD. From FDA web site (). Accessed 2007 Jul 11.



3. Hillmen P, Young NS, Schubert J et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006; 355:1233-43. [PubMed 16990386]



4. Young NS, Antonioli E, Rotoli B et al. Safety and efficacy of the terminal complement inhibitor eculizumab in patients with paroxysmal nocturnal hemoglobinuria: SHEPHERD phase III clincial study results. Paper presented at American Society of Hematology Annual Meeting. Orlando, FL: 2006 Dec 9.



5. Centers for Disease Control and Prevention. Prevention and control of meningococcal disease recommendations of the advisory committee on immunization practices (ACIP). MMWR. 2005;54 (No. RR-7):1-21.



6. Alexion Pharmaceuticals, Cheshire, CT: Personal communication.



7. The Soliris (eculizumab) OneSource Program for Healthcare Professionals and Patients. Soliris website. Available at: . Accessed 2007 July 25.



8. Hillmen P, Lewis SM, Bessler M et al. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995; 333:1253-8. [PubMed 7566002]



9. Parker C, Omine M, Richards S et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005; 106:3699-709. [PubMed 16051736]



10. Hill A, Richards SJ, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal hemoglobinuria. Br J Haematol. 2007; 137:181-92. [PubMed 17408457]



11. US Food and Drug Administration. FDA approves first-of-its-kind drug to treat rare blood disorder. FDA News. P07-47. 2007 Mar 16. Available at: . Accessed 2007 Jul 5.



12. Pazdur R. Approval letter for eculizumab (application number 125166). Rockville, MD: US Food and Drug Administration; 2007 Mar 16. From FDA website ().



13. Alexion Pharmaceuticals. FDA approves Alexion's Soliris for all patients with PNH: first therapy approved for this rare and life-threatening blood disease. Cheshire, CT; 2007 Mar 16. Press release from website ().



14. PNH Source. PNHSource website. Available at: . Accessed 2007 Aug 15.



15. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004; 93:2645-68. [PubMed 15389672]



16. Hillmen P, Hall C, Marsh JCW et al. Effect of eculizumab on hemolysis and transfusion requirements in patients with paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2004; 350:552-59. [PubMed 14762182]



17. Hill A, Hillmen P, Richards SJ et al. Sustained response and long-term safety of eculizumab in paroxysmal nocturnal hemoglobinuria. Blood. 2005; 106:2559-65. [PubMed 15985537]



18. In: Lee RG, Bithell TC, Foerster J et al, eds. Winthrobe's clinical hematology. 9th ed. Malver, PA: Lea and Febiger; 1993:1232-44.



19. Anon. Eculizumab: 5G1.1, h5G1.1, long-acting anti-C5 monoclonal antibody 5G1-1, long-acting anti-C5 monoclonal antibody 5G1.1. Drugs R D. 2007; 8:61-8.



20. Socie G, Jean-Yves M, de Gramont A et al. Paroxysmal nocturnal haemoglobinuria: long term follow-up and prognostic factors. Lancet. 1996; 348:573-77. [PubMed 8774569]



21. Alexion Pharmaceuticals, Inc. Soliris (eculizumab) medication guide. Chesire, CT; 2007 Jun.



More Soliris resources


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


  • Soliris Prescribing Information (FDA)

  • Soliris Consumer Overview

  • Soliris Advanced Consumer (Micromedex) - Includes Dosage Information

  • Soliris MedFacts Consumer Leaflet (Wolters Kluwer)

  • Eculizumab Professional Patient Advice (Wolters Kluwer)



Compare Soliris with other medications


  • Hemolytic Uremic Syndrome
  • Myasthenia Gravis
  • Paroxysmal Nocturnal Hemoglobinuria


Tobrex


Generic Name: tobramycin (Ophthalmic route)

toe-bra-MYE-sin

Commonly used brand name(s)

In the U.S.


  • AKTob

  • Tobrasol

  • Tobrex

In Canada


  • Apo-Tobramycin

  • Sab-Tobramycin

  • Tomycine

Available Dosage Forms:


  • Ointment

  • Solution

Therapeutic Class: Antibiotic


Chemical Class: Aminoglycoside


Uses For Tobrex


Ophthalmic tobramycin is used in the eye to treat bacterial infections of the eye. Tobramycin works by killing bacteria.


Ophthalmic tobramycin may be used alone or with other medicines for eye infections. Either the drops or the ointment form of this medicine may be used alone during the day. In addition, both forms may be used together, with the drops being used during the day and the ointment at night.


Tobramycin ophthalmic preparations are available only with your doctor's prescription.


Before Using Tobrex


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


This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.


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 or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic tobramycin in the elderly with use in other age groups.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alcuronium

  • Atracurium

  • Cidofovir

  • Cisatracurium

  • Colistimethate Sodium

  • Decamethonium

  • Doxacurium

  • Ethacrynic Acid

  • Fazadinium

  • Furosemide

  • Gallamine

  • Hexafluorenium

  • Lysine

  • Metocurine

  • Mivacurium

  • Pancuronium

  • Pipecuronium

  • Rapacuronium

  • Rocuronium

  • Succinylcholine

  • Tacrolimus

  • Tubocurarine

  • Vancomycin

  • Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Cisplatin

  • Cyclosporine

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 tobramycin

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


For patients using tobramycin ophthalmic solution (eye drops):


  • The bottle is only partially full to provide proper drop control.

  • To use:
    • First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection.

    • If you think you did not get the drop of medicine into your eye properly, use another drop.

    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.


  • If your doctor ordered two different ophthalmic solutions to be used together, wait at least 5 minutes between the times you apply the medicines. This will help to keep the second medicine from ``washing out'' the first one.

For patients using tobramycin ophthalmic ointment (eye ointment):


  • To use:
    • First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1.25-cm (approximately ½-inch) strip of ointment usually is enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes and keep them closed for 1 or 2 minutes, to allow the medicine to come into contact with the infection.

    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using tobramycin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.


To help clear up your eye infection completely, keep using tobramycin for the full time of treatment, even if your symptoms have disappeared. 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 ophthalmic ointment dosage forms:
    • For mild to moderate infections:
      • Adults and children—Use every eight to twelve hours.


    • For severe infections:
      • Adults and children—Use every three to four hours until improvement occurs.



  • For ophthalmic solution (eye drops) dosage forms:
    • For mild to moderate infections:
      • Adults and children—One drop every four hours.


    • For severe infections:
      • Adults and children—One drop every hour until improvement occurs.



Missed Dose


If you miss a dose of this medicine, take 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. Do not double doses.


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 Tobrex


If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.


Tobrex 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 immediately if any of the following side effects occur:


Less common
  • Itching, redness, swelling, or other sign of eye or eyelid irritation not present before use of this medicine

Symptoms of overdose
  • Increased watering of the eyes

  • itching, redness, or swelling of the eyes or eyelids

  • painful irritation of the clear front part of the eye

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
  • Burning or stinging of the eyes

Eye ointments usually cause your vision to blur for a few minutes after application.


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: Tobrex side effects (in more detail)



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More Tobrex resources


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


  • Tobrex Prescribing Information (FDA)

  • Tobrex Concise Consumer Information (Cerner Multum)

  • Tobrex Drops MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Tobrex with other medications


  • Conjunctivitis, Bacterial


Sunday, May 6, 2012

Synagis


Pronunciation: pal-i-VIZ-u-mab
Generic Name: Palivizumab
Brand Name: Synagis


Synagis is used for:

Preventing serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.


Synagis is a monoclonal antibody. It works by preventing RSV from reproducing.


Do NOT use Synagis if:


  • you are allergic to any ingredient in Synagis

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



Before using Synagis:


Some medical conditions may interact with Synagis. 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 a bleeding or blood clotting disorder or low blood platelet levels

  • if you are having heart surgery (cardiopulmonary bypass)

  • if you are taking a blood thinner (eg, warfarin)

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


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


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


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

  • Synagis is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Synagis at home, a health care provider will teach you how to use it. Be sure you understand how to use Synagis. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Do not use Synagis if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Continue to use Synagis even if you feel well. Do not miss any doses.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Synagis, contact your doctor right away.

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



Important safety information:


  • Children, including those who develop RSV, should continue to receive monthly doses of Synagis throughout the RSV season (generally November through April in the Northern Hemisphere). The first dose should be given before the RSV season begins.

  • PREGNANCY and BREAST-FEEDING: Synagis is not for use in adults. It is not known if Synagis can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Synagis while you are pregnant. Synagis is not indicated for use in breast-feeding mothers. Do not breast-feed while taking Synagis.


Possible side effects of Synagis:


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:



Cough; diarrhea; mild fever; minor pain, redness, swelling, or warmth at the injection site; runny or stuffy nose; upset stomach; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; muscle weakness or limpness); blue lips or skin (including under the fingernails); ear pain or discharge; fever; irregular heartbeat; stomach pain; unusual bruising or bleeding; wheezing.



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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .


See also: Synagis 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 Synagis:

Synagis is usually handled and stored by a health care provider. If you are using Synagis at home, store Synagis as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Synagis out of the reach of children and away from pets.


General information:


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

  • Synagis 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 Synagis. 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 Synagis resources


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


  • Synagis Prescribing Information (FDA)

  • Synagis Consumer Overview

  • Synagis Monograph (AHFS DI)

  • Synagis Advanced Consumer (Micromedex) - Includes Dosage Information

  • Palivizumab Professional Patient Advice (Wolters Kluwer)



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Tussi-Organidin NR


Generic Name: codeine and guaifenesin (KOE deen and gwye FEN a sin)

Brand Names: Allfen CD, Allfen CDX, Brontex, Cheracol with Codeine, Cheratussin AC, Dex-Tuss, Diabetic Tussin C, Duraganidin NR, ExeClear-C, Guaiatussin AC, Guaifen-C, Guiatuss AC, Guiatussin with Codeine, Iophen-C NR, M-Clear WC, Mar-cof CG, Mytussin AC, Robafen AC, Robitussin-AC, Tussi-Organidin NR, Tussi-Organidin-S NR, Tussiden C, Tusso-C


What is Tussi-Organidin NR (codeine and guaifenesin)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.


Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.


The combination of codeine and guaifenesin is used to treat cough and to reduce chest congestion caused by upper respiratory infections or the common cold.


Codeine and guaifenesin will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Tussi-Organidin NR (codeine and guaifenesin)?


Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains an guaifenesin, or an expectorant. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

What should I discuss with my healthcare provider before taking Tussi-Organidin NR (codeine and guaifenesin)?


You should not take this medication if you are allergic to codeine or guaifenesin.

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



  • heart disease, heart rhythm disorder;




  • asthma, COPD, emphysema, or other breathing disorders;




  • a history of head injury or brain tumor;




  • epilepsy or other seizure disorder;




  • a stomach or intestinal disorder;




  • Addison's disease or other adrenal gland disorders;




  • curvature of the spine;




  • a thyroid disorder;



  • liver or kidney disease;


  • enlarged prostate; or




  • a history of depression, mental illness, or drug addiction;




FDA pregnancy category C. It is not known whether codeine and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Codeine may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Liquid forms of this medication may contain sugar or artificial sweetener (phenylalanine). Talk to your doctor before using this form of codeine and guaifenesin if you have diabetes or phenylketonuria (PKU).


How should I take Tussi-Organidin NR (codeine and guaifenesin)?


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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take codeine and guaifenesin with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

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


Call your doctor if your symptoms do not improve after 7 days of treatment, or if you also have a fever, headache, or skin rash.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using codeine and guaifenesin.


Do not stop using this medication suddenly after long-term use or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medication. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.


What happens if I miss a dose?


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


What happens if I overdose?


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

Overdose symptoms may include extreme dizziness or drowsiness, nausea, vomiting, sweating, confusion, hallucinations, cold and clammy skin, blue-colored lips or fingernails, weak or limp muscles, pinpoint pupils, weak pulse, slow breathing, fainting, or seizures (convulsions).


What should I avoid while taking Tussi-Organidin NR (codeine and guaifenesin)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains an guaifenesin, or an expectorant. Drinking alcohol can increase certain side effects of codeine and guaifenesin.

Tussi-Organidin NR (codeine and guaifenesin) 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 this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness or drowsiness;




  • confusion, hallucinations, unusual thoughts or behavior;




  • urinating less than usual or not at all; or




  • slow heart rate, weak pulse, fainting, weak or shallow breathing.



Less serious side effects include:



  • dizziness, drowsiness, headache;




  • warmth, redness, or tingling under your skin;




  • nausea, vomiting, upset stomach;




  • constipation; or




  • skin rash or itching.



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 Tussi-Organidin NR (codeine and guaifenesin)?


Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine and guaifenesin.

Also tell your doctor if you are using any of the following drugs:



  • cimetidine (Tagamet);




  • quinidine (Quin-G);




  • naloxone (Narcan); or




  • naltrexone (Vivitrol).



This list is not complete and other drugs may interact with codeine and guaifenesin. 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 Tussi-Organidin NR resources


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


  • Tussi-Organidin NR Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Brontex MedFacts Consumer Leaflet (Wolters Kluwer)

  • ExeClear-C Prescribing Information (FDA)



Compare Tussi-Organidin NR with other medications


  • Cough


Where can I get more information?


  • Your pharmacist can provide more information about codeine and guaifenesin.

See also: Tussi-Organidin NR side effects (in more detail)



Thursday, May 3, 2012

Sumadan Wash



sulfacetamide sodium and sulfur

Dosage Form: cream
Sumadan™

(Sodium Sulfacetamide 9% & Sulfur 4.5%)

WASH

Rx Only


In a Moisturizing

Novasome® Vehicle



Sumadan Wash Description


Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:



Each mL of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.



Sumadan Wash - Clinical Pharmacology



The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.



INDICATIONS


Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.



Contraindications


Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is not to be used by patients with kidney disease.



Warnings


Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.


FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.



Precautions



General


If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.



Information for Patients


Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.



Carcinogenesis, Mutagenesis and Impairment of Fertility


Long-term studies in animals have not been performed to evaluate carcinogenic potential.



PREGNANCY


Category C

Animal reproduction studies have not been conducted with Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash. It is also not known whether Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash should be given to a pregnant woman only if clearly needed.



NURSING MOTHERS


It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is administered to a nursing woman.



PEDIATRIC USE


Safety and effectiveness in children under the age of 12 have not been established.



ADVERSE REACTIONS:


Although rare, sodium sulfacetamide may cause local irritation.



Sumadan Wash Dosage and Administration


Apply Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash sooner or using less often.



How is Sumadan Wash Supplied


Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is available in a 16 fl. oz. (473 mL) bottle, NDC 43538-190-16.



Store at controlled room temperature 15°- 30° C (59°-86° F). Protect from freezing.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.



Manufactured for:


MEDIMETRIKS

PHARMACEUTICALS, INC


363 Route 46 West

Fairfield, NJ 07004-2402 USA


www.medimetriks.com


IP022

Iss. 5/11



PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton


NDC 43538-190-16


Rx Only

Sumadan™

(Sodium Sulfacetamide 9% & Sulfur 4.5%)

WASH

In a moisturizing

Novasome® vehicle


Net Wt. 16 oz. (454 g)


MEDIMETRIKS

PHARMACEUTICALS, INC.




PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton


NDC 43538-191-16


Rx Only

Sumadan™

(Sodium Sulfacetamide 9% & Sulfur 4.5%)

KIT


CONTENTS:

1 - Sumadan™ (Sodium Sulfacetamide 9% & Sulfur 4.5%) Wash (Net Wt. 16 oz.)

1- Rehyla™ Wash Moisturizing Daily Wash (16 fl. oz.)


MEDIMETRIKS

PHARMACEUTICALS, INC.










Sumadan Wash 
sulfacetamide sodium and sulfur  cream










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)43538-190
Route of AdministrationTOPICALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfacetamide sodium (sulfacetamide)sulfacetamide sodium90 mg  in 1 g
sulfur (sulfur)sulfur45 mg  in 1 g
























































Inactive Ingredients
Ingredient NameStrength
butylated hydroxytoluene 
Alkyl (C12-15) Benzoate 
caprylyl glycol 
cetyl alcohol 
cholesterol 
dimethicone 
edetate disodium 
glyceryl monostearate 
hexylene glycol 
lemon oil 
magnesium aluminum silicate 
magnesium chloride 
magnesium nitrate 
methylchloroisothiazolinone 
methylisothiazolinone 
niacinamide 
nonoxynol-20 
octoxynol-5 
water 
PEG-100 stearate 
phenoxyethanol 
propylene glycol 
sodium methyl cocoyl taurate 
sodium thiosulfate 
stearyl alcohol 
xanthan gum 


















Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
143538-190-161 BOTTLE In 1 CARTONcontains a BOTTLE, PUMP
1454 g In 1 BOTTLE, PUMPThis package is contained within the CARTON (43538-190-16)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER07/10/2011





















SUMADAN 
sulfacetamide sodium and sulfur  kit






Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)43538-191










Packaging
#NDCPackage DescriptionMultilevel Packaging
143538-191-161 KIT In 1 CARTONNone











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP  454 g
Part 21 BOTTLE, PUMP  454 g



Part 1 of 2
Sumadan Wash 
sulfacetamide sodium and sulfur  cream










Product Information
   
Route of AdministrationTOPICALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfacetamide Sodium (Sulfacetamide)Sulfacetamide90 mg  in 1 g
Sulfur (Sulfur)Sulfur45 mg  in 1 g


























































Inactive Ingredients
Ingredient NameStrength
butylated hydroxytoluene 
Alkyl (C12-15) Benzoate 
caprylyl glycol 
cetyl alcohol 
cholesterol 
dimethicone 
disodium oleamido mipa-sulfosuccinate 
edetate disodium 
glyceryl monostearate 
hexylene glycol 
lemon oil 
magnesium aluminum silicate 
magnesium chloride 
magnesium nitrate 
methylchloroisothiazolinone 
methylisothiazolinone 
niacinamide 
nonoxynol-20 
octoxynol-5 
water 
PEG-100 stearate 
phenoxyethanol 
propylene glycol 
sodium methyl cocoyl taurate 
sodium thiosulfate 
stearyl alcohol 
xanthan gum 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
11 BOTTLE In 1 CARTONcontains a BOTTLE, PUMP
1454 g In 1 BOTTLE, PUMPThis package is contained within the CARTON










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/01/2011




Part 2 of 2
REHYLA WASH 
inert  cream










Product Information
   
Route of AdministrationTOPICALDEA Schedule    






Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
No Active Ingredients Found
















































Inactive Ingredients
Ingredient NameStrength
water 
glyceryl monostearate 
glycerin 
cetyl alcohol 
disodium oleamido mipa-sulfosuccinate 
cholesterol 
disodium laureth sulfosuccinate 
helianthus annuus seed wax 
caprylyl glycol 
propylene glycol 
phenoxyethanol 
sodium cocoyl isethionate 
cocamidopropyl betaine 
sodium methyl cocoyl taurate 
C13-14 isoparaffin 
sodium chloride 
niacinamide 
edetate disodium 
hexylene glycol 
laureth-7 
chamaemelum nobile flower 
hyaluronate sodium 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
11 BOTTLE In 1 CARTONcontains a BOTTLE, PUMP
1454 g In 1 BOTTLE, PUMPThis package is contained within the CARTON










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/01/2011











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/01/2011


Labeler - Medimetriks Pharmaceuticals Inc. (019903816)









Establishment
NameAddressID/FEIOperations
IGI Laboratories011036910MANUFACTURE
Revised: 11/2011Medimetriks Pharmaceuticals Inc.




More Sumadan Wash resources


  • Sumadan Wash Side Effects (in more detail)
  • Sumadan Wash Use in Pregnancy & Breastfeeding
  • Sumadan Wash Drug Interactions
  • Sumadan Wash Support Group
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  • Acne
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Monday, April 30, 2012

Nia-Chrom


Generic Name: chromium supplement (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Amino-CR

  • Chromacaps

  • Chromate

  • Chromax

  • M2 Chromium

  • Nia-Chrom

Available Dosage Forms:


  • Tablet

  • Capsule

  • Capsule, Liquid Filled

Uses For Nia-Chrom


Chromium supplements are used to prevent or treat chromium deficiency.


The body needs chromium for normal growth and health. For patients who are unable to get enough chromium in their regular diet or who have a need for more chromium, chromium supplements may be necessary. They are generally taken by mouth but some patients may have to receive them by injection. Chromium helps your body use sugar properly. It is also needed for the breakdown of proteins and fats.


Lack of chromium may lead to nerve problems and may decrease the body's ability to use sugar properly.


There is not enough evidence to show that taking chromium supplements improves the way your body uses sugar (glucose tolerance).


Injectable chromium is given by or under the supervision of a health care professional. Other forms are available without a prescription.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


Chromium is found in various foods, including brewer's yeast, calf liver, American cheese, and wheat germ.


The daily amount of chromium needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Because a lack of chromium is rare, there is no RDA or RNI for it. Normal daily recommended intakes for chromium are generally defined as follows:


  • Infants and children—
    • Birth to 3 years of age—10 to 80 micrograms (mcg) a day.

    • 4 to 6 years of age—30 to 120 mcg a day.

    • 7 to 10 years of age—50 to 200 mcg a day.


  • Adolescents and adults—50 to 200 mcg a day.

Before Using Nia-Chrom


If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Problems in children have not been reported with intake of normal daily recommended amounts.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts.


Pregnancy


It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement during pregnancy may be harmful to the mother and/or fetus and should be avoided.


Breast Feeding


It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.


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.


Other Medical Problems


The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Type 2 diabetes mellitus—Taking chromium supplements when you have a chromium deficiency may cause a change in the amount of insulin you need.

Proper Use of chromium supplement

This section provides information on the proper use of a number of products that contain chromium supplement. It may not be specific to Nia-Chrom. Please read with care.


Dosing


The dose medicines in this class 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 these medicines. 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 oral dosage forms (capsules and tablets):
    • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
      • Adults and teenagers—50 to 200 micrograms (mcg) per day.

      • Children 7 to 10 years age—50 to 200 mcg per day.

      • Children 4 to 6 years of age—30 to 120 mcg per day.

      • Children birth to 3 years of age—10 to 80 mcg per day.


    • To treat deficiency:
      • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.



Missed Dose


If you miss a dose of this medicine, take 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. Do not double doses.


If you miss taking chromium supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in chromium. However, if your health care professional has recommended that you take chromium, try to remember to take it as directed every day.


Storage


Keep out of the reach of children.


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


Do not keep outdated medicine or medicine no longer needed.


Nia-Chrom Side Effects


No side effects or overdoses have been reported for chromium. However, check with your health care professional if you notice any unusual effects while you are taking it.



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 Nia-Chrom resources


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


Compare Nia-Chrom with other medications


  • Diabetes, Type 2
  • Vitamin/Mineral Supplementation and Deficiency


Saturday, April 28, 2012

Stadol NS Nasal


Generic Name: butorphanol (Nasal route)

bue-TOR-fa-nol

Commonly used brand name(s)

In the U.S.


  • Stadol NS

Available Dosage Forms:


  • Spray

Therapeutic Class: Analgesic


Pharmacologic Class: Opioid Agonist/Antagonist


Chemical Class: Opioid


Uses For Stadol NS


Butorphanol nasal spray is used to relieve pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Butorphanol acts on the central nervous system (CNS) to relieve pain.


When butorphanol is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.


This medicine is available only with your doctor's prescription.


Before Using Stadol NS


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


Appropriate studies have not been performed on the relationship of age to the effects of butorphanol nasal spray in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butorphanol nasal spray in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butorphanol nasal spray.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alfentanil

  • Alphaprodine

  • Codeine

  • Dihydrocodeine

  • Fentanyl

  • Fospropofol

  • Hydrocodone

  • Hydromorphone

  • Levorphanol

  • Meperidine

  • Methadone

  • Morphine

  • Morphine Sulfate Liposome

  • Oxycodone

  • Oxymorphone

  • Propoxyphene

  • Sufentanil

  • Tapentadol

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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse, history of or

  • Breathing problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or

  • CNS diseases or

  • Drug dependence, especially narcotic abuse or dependence, or history of—Use with caution. May increase risk for more serious side effects.

  • Brain tumor or

  • Head injuries or

  • Increased pressure in the head—Some of the side effects of butorphanol nasal spray can cause serious problems in people who have these medical problems.

  • Heart attack or

  • Heart or blood vessel problems or

  • Hypertension (high blood pressure) or

  • Hypotension (low blood pressure) or

  • Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make these conditions worse.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Stadol NS


This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.


This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.


If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release eight test sprays into the air away from the face, or pump the bottle until some of the medicine sprays out. Now it is ready to use. Prime the spray if it has not been used for more than 48 hours or longer. Shake the medicine well before each use.


Before using this medicine, gently blow your nose to clear the nostrils.


After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.


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 nasal dosage form (spray):
    • For pain:
      • Adults—1 milligram (mg) or 1 spray in one nostril. A second spray may be taken 60 to 90 minutes after the first dose if needed. This may be repeated every 3 to 4 hours as needed.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take 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. Do not double doses.


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.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Stadol NS


It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.


Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.


This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.


Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.


For pregnant women: Do not use this medicine during labor and delivery of your child.


Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


Stadol NS 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 immediately if any of the following side effects occur:


Less common
  • Bloody nose

  • body aches or pain

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • chills

  • cough

  • cough producing mucus

  • difficult or labored breathing

  • difficulty with breathing

  • ear congestion

  • fast, irregular, pounding, or racing heartbeat or pulse

  • feeling faint, dizzy, or lightheaded

  • feeling of warmth or heat

  • fever

  • flushing or redness of the skin, especially on the face and neck

  • headache

  • loss of voice

  • runny nose

  • shakiness in the legs, arms, hands, or feet

  • shortness of breath

  • sneezing

  • sore throat

  • stuffy nose

  • sweating

  • tightness in the chest

  • trembling or shaking of the hands or feet

  • unusual tiredness or weakness

  • wheezing

Rare
  • Blurred vision

  • chest pain

  • confusion

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fainting

  • shallow breathing

Incidence not known
  • Bluish lips or skin

  • convulsion

  • not breathing

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Change in consciousness

  • extremely shallow or slow breathing

  • loss of consciousness

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:


More common
  • Nausea

  • sleepiness or unusual drowsiness

  • sleeplessness

  • trouble sleeping

  • unable to sleep

  • vomiting

Less common
  • Bad or unusual or unpleasant (after) taste

  • continuing ringing or buzzing or other unexplained noise in the ears

  • difficulty having a bowel movement (stool)

  • dry mouth

  • ear pain

  • false or unusual sense of well-being

  • fear or nervousness

  • floating feeling

  • hearing loss

  • lack or loss of strength

  • loss of appetite

  • pain or tenderness around the eyes and cheekbones

  • sneezing

  • stomach pain

  • tender, swollen glands in the neck

  • trouble with swallowing

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

  • voice changes

  • weight loss

Incidence not known
  • Dizziness or lightheadedness

  • false beliefs that cannot be changed by facts

  • feeling of constant movement of self or surroundings

  • sensation of spinning

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: Stadol NS Nasal 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 Stadol NS Nasal resources


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


Compare Stadol NS Nasal with other medications


  • Anesthesia
  • Anesthetic Adjunct
  • Labor Pain
  • Pain