Friday, September 30, 2016

Pennchlor




In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Pennchlor



Bacitracin

Bacitracin methylene disalicylate (a derivative of Bacitracin) is reported as an ingredient of Pennchlor in the following countries:


  • United States

Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Pennchlor in the following countries:


  • United States

Chlortetracycline

Chlortetracycline is reported as an ingredient of Pennchlor in the following countries:


  • United States

Chlortetracycline calcium salt (a derivative of Chlortetracycline) is reported as an ingredient of Pennchlor in the following countries:


  • United States

Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of Pennchlor in the following countries:


  • United States

Decoquinate

Decoquinate is reported as an ingredient of Pennchlor in the following countries:


  • United States

Monensin

Monensin sodium salt (a derivative of Monensin) is reported as an ingredient of Pennchlor in the following countries:


  • United States

Salinomycin

Salinomycin sodium salt (a derivative of Salinomycin) is reported as an ingredient of Pennchlor in the following countries:


  • United States

Sulfadimidine

Sulfadimidine is reported as an ingredient of Pennchlor in the following countries:


  • United States

Tiamulin

Tiamulin fumarate (a derivative of Tiamulin) is reported as an ingredient of Pennchlor in the following countries:


  • United States

International Drug Name Search

Up and Up All Day Allergy Relief D



cetirizine hydrochloride and pseudoephedrine hydrochloride

Dosage Form: tablet, extended release
Target Corp. All Day Allergy Relief-D Drug Facts

Active ingredient (in each extended release tablet)


Cetirizine HCl 5 mg


Pseudoephedrine HCl 120 mg



Purpose


Antihistamine


Nasal Decongestant



Uses


  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose

  • sneezing

  • itchy, watery eyes

  • itching of the nose or throat

  • nasal congestion

  • reduces swelling of nasal passages

  • temporarily relieves sinus congestion and pressure

  • temporarily restores freer breathing through the nose


Warnings



Do not use


  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


Ask a doctor before use if you have


  • heart disease

  • thyroid disease

  • diabetes

  • glaucoma

  • high blood pressure

  • trouble urinating due to an enlarged prostate gland

  • liver or kidney disease. Your doctor should determine if you need a different dose.


Ask a doctor or pharmacist before use if you are


taking tranquilizers or sedatives.



When using this product


  • do not use more than directed

  • drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when driving a motor vehicle or operating machinery


Stop use and ask a doctor if


  • an allergic reaction to this product occurs. Seek medical help right away.

  • you get nervous, dizzy, or sleepless

  • symptoms do not improve within 7 days or are accompanied by fever


If pregnant or breast-feeding:


  • if breast-feeding: not recommended

  • if pregnant: ask a health professional before use.


Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away.




Directions


  • do not break or chew tablet; swallow tablet whole










adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and overask a doctor
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information


  • store between 20° to 25°C (68° to 77°F) 


Inactive ingredients


colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide



Questions?


Call 1-800-910-6874



Principal Display Panel


All Day Allergy Relief-D


Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5 mg/120 mg


antihistamine/nasal decongestant


Compare to Active Ingredients in Zyrtec-D®


Original Prescription Strength


Indoor and Outdoor Allergies


12 Hour Relief of: Sneezing/Runny Nose/Sinus Pressure/Itchy, Watery Eyes/Itchy Throat or Nose/Nasal Congestion


Allergy and Congestion


12 Hour Relief


# Tablets


Shown Actual Size Above


All Day Allergy Relief-D Carton










Up and Up All Day Allergy Relief D 
cetirizine hcl, pseudoephedrine hcl  tablet, extended release










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)11673-176
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)PSEUDOEPHEDRINE HYDROCHLORIDE120 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (one side white one side light yellow)Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code5029;5;120
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
111673-176-532 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
16 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (11673-176-53)
211673-176-624 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
26 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (11673-176-62)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07717007/28/2009


Labeler - Target Corporation (006961700)
Revised: 06/2009Target Corporation




More Up and Up All Day Allergy Relief D resources


  • Up and Up All Day Allergy Relief D Side Effects (in more detail)
  • Up and Up All Day Allergy Relief D Dosage
  • Up and Up All Day Allergy Relief D Use in Pregnancy & Breastfeeding
  • Up and Up All Day Allergy Relief D Drug Interactions
  • 0 Reviews for Up and Up All Day Allergy Relief D - Add your own review/rating


Compare Up and Up All Day Allergy Relief D with other medications


  • Hay Fever

Hydrocortisone Suppository




Dosage Form: rectal suppository
Hydrocortisone Acetate Suppositories 25 mg For Rectal Administration Rx Only

Hydrocortisone Suppository Description


Each Hydrocortisone Acetate 25 mg Suppository contains 25 mg hydrocortisone acetate in a hydrogenated vegetable oil base.  Hydrocortisone acetate is a corticosteroid.  Chemically, hydrocortisone acetate is a pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17- dihydroxy (11β)- with the following structural formula:




C23H32O6


MW 404.50



Hydrocortisone Suppository - Clinical Pharmacology


In normal subjects, about 26 percent of hydrocortisone acetate is absorbed when the hydrocortisone acetate suppository is applied to the rectum.  Absorption of hydrocortisone acetate may vary across abraded or inflamed surfaces.


Topical steroids are primarily effective because of their anti-inflammatory, anti-pruritic and vasoconstrictive action.



Indications and Usage for Hydrocortisone Suppository


For use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum and pruritis ani.



Contraindications


Hydrocortisone Acetate Suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components.



Precautions


Do not use unless adequate proctologic examination is made.  If irritation develops, the product should be discontinued and appropriate therapy instituted.


In the presence of an infection, the use of an appropriate antifungal or antibacterial agent should be instituted.  If a favorable response does not occur promptly, the hydrocortisone acetate should be discontinued until the infection has been adequately controlled.


No long-term studies in animals have been performed to evaluate the carcinogenic potential of corticosteroid suppositories.



INFORMATION FOR PATIENTS


Staining of fabric may occur with use of the suppository.  Precautionary measures are recommended.



PREGNANCY CATEGORY C



In laboratory animals, topical steroids have been associated with an increase in the incidence of fetal abnormalities when gestating females have been exposed to rather low dosage levels.  There are no adequate and well-controlled studies in pregnant women.


Hydrocortisone Acetate Suppositories should only be used during pregnancy if the potential benefit justifies the risk to the fetus.  Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.


It is not known whether this drug is excreted in human milk, and because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Hydrocortisone Acetate Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Adverse Reactions


The following local adverse reactions have been reported with corticosteroid suppositories:  burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis and secondary infection.



Drug Abuse and Dependence


Drug abuse and dependence have not been reported in patients treated with Hydrocortisone Acetate Suppositories.



Overdosage


If signs and symptoms of systemic overdosage occur, discontinue use.



Hydrocortisone Suppository Dosage and Administration


Usual dosage:  One suppository in the rectum morning and night for two weeks, in nonspecific proctitis.  In more severe cases, one suppository three times daily; or two suppositories twice daily.  In factitial proctitis, recommended therapy is six to eight weeks or less, according to response.



OPENING INSTRUCTIONS


Avoid excessive handling of the suppository, it is designed to melt at body temperature.


  1. Separate tabs at top opening and pull downward

  2. Continue pulling downward to almost the full length of the suppository

  3. Gently remove the suppository from the package

  4. Insert suppository into the rectum, pointed end first, with gentle pressure


How is Hydrocortisone Suppository Supplied




Hydrocortisone Acetate Suppositories are white, torpedo shaped, with one end tapered.  Package of 12 suppositories NDC 43199-021-12 and package of 24 suppositories NDC 43199-021-24.


Store at 20o-25o C (68o-77o F).  See USP controlled room temperature.  Store away from heat.  Protect from freezing.


Rx Only.


Distributed by:

County Line Pharmaceuticals, LLC

Brookfield, WI  53005



For Inquiries Call:

1-866-207-5636


PI-CLP021A

7/10

PRINCIPAL DISPLAY PANEL - CARTON



NDC 43199-021-12


12 Suppositories


For Rectal Administration


Rx Only


Hydrocortisone Acetate


Suppositories 25 mg



Hydrocortisone Acetate Suppositories 25 mg


12 Suppositories


TAMPER EVIDENT:  DO NOT USE IF FILM IS TORN OR BROKEN



PRINCIPAL DISPLAY PANEL - DOSE PACK



HYDROCORTISONE ACETATE


25 mg SUPPOSITORY


Mfd for:  County Line Pharmaceuticals, LLC


Brookfield, WI  53005









HYDROCORTISONE ACETATE 
hydrocortisone acetate  suppository










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)43199-021
Route of AdministrationRECTALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE)HYDROCORTISONE ACETATE25 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
143199-021-1212 DOSE PACK In 1 CARTONcontains a DOSE PACK
11 SUPPOSITORY In 1 DOSE PACKThis package is contained within the CARTON (43199-021-12)
243199-021-2424 DOSE PACK In 1 CARTONcontains a DOSE PACK
21 SUPPOSITORY In 1 DOSE PACKThis package is contained within the CARTON (43199-021-24)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/29/2010


Labeler - County Line Pharmaceuticals, LLC (015585278)

Registrant - County Line Pharmaceuticals, LLC (015585278)









Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546manufacture
Revised: 11/2010County Line Pharmaceuticals, LLC

More Hydrocortisone Suppository resources


  • Hydrocortisone Suppository Use in Pregnancy & Breastfeeding
  • Hydrocortisone Suppository Drug Interactions
  • Hydrocortisone Suppository Support Group
  • 15 Reviews for Hydrocortisone - Add your own review/rating


Compare Hydrocortisone Suppository with other medications


  • Anal Itching
  • Aphthous Stomatitis, Recurrent
  • Atopic Dermatitis
  • Dermatitis
  • Eczema
  • Gingivitis
  • Hemorrhoids
  • Proctitis
  • Pruritus
  • Psoriasis
  • Seborrheic Dermatitis
  • Skin Rash
  • Ulcerative Colitis, Active

Sinapol




Sinapol may be available in the countries listed below.


Ingredient matches for Sinapol



Paracetamol

Paracetamol is reported as an ingredient of Sinapol in the following countries:


  • Bangladesh

International Drug Name Search

Thursday, September 29, 2016

Aciclovir Pensa




Aciclovir Pensa may be available in the countries listed below.


Ingredient matches for Aciclovir Pensa



Acyclovir

Aciclovir is reported as an ingredient of Aciclovir Pensa in the following countries:


  • Italy

  • Spain

International Drug Name Search

Lozapine




Lozapine may be available in the countries listed below.


Ingredient matches for Lozapine



Clozapine

Clozapine is reported as an ingredient of Lozapine in the following countries:


  • Israel

International Drug Name Search

Vancocin


Generic Name: Vancomycin Hydrochloride
Class: Glycopeptides
VA Class: AM900
CAS Number: 1404-93-9

Introduction

Antibacterial; tricyclic glycopeptide antibiotic.266 267


Uses for Vancocin


Endocarditis


Treatment of native valve or prosthetic valve endocarditis caused by susceptible Staphylococcus aureus or S. epidermidis, including oxacillin-resistant (methicillin-resistant) strains.155 265 266 267 AHA and IDSA recommend vancomycin as drug of choice for treatment of endocarditis caused by oxacillin-resistant staphylococci.265 Also recommended as alternative to nafcillin (or oxacillin) or cefazolin for treatment of endocarditis caused by oxacillin-susceptible staphylococci in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.265 May be used alone for native valve endocarditis caused by oxacillin-susceptible staphylococci; used in conjunction with rifampin and gentamicin for endocarditis caused by oxacillin-resistant staphylococci and for prosthetic valve staphylococcal endocarditis.265


Treatment of native valve or prosthetic valve endocarditis caused by viridans streptococci or Streptococcus bovis.155 265 266 267 Recommended by AHA and IDSA as an alternative to penicillin G or ceftriaxone for treatment of streptococcal endocarditis in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.265


Treatment of native valve or prosthetic valve enterococcal endocarditis; used in conjunction with gentamicin or streptomycin.155 265 266 267 Recommended by AHA and IDSA as an alternative to penicillin G or ampicillin for treatment of enterococcal endocarditis in patients with immediate-type (anaphylactoid) hypersensitivity to β-lactams.265


Empiric treatment of culture-negative endocarditis.265 For culture-negative native valve endocarditis, regimen of ampicillin-sulbactam and gentamicin recommended by AHA and IDSA; regimen of vancomycin, gentamicin, and ciprofloxacin recommended for those unable to tolerate penicillin.265 For culture-negative prosthetic valve endocarditis occurring ≤1 year after valve replacement, regimen of vancomycin, gentamicin, and rifampin recommended; this regimen also should include cefepime if onset of infection is within 2 months of valve replacement.265 Selection of the most appropriate anti-infective regimen is difficult and should be guided by epidemiologic features and clinical course of the infection.265 Consultation with an infectious diseases specialist is recommended.265


Treatment of early-onset prosthetic valve endocarditis caused by Corynebacterium jeikeium (JK group);149 266 267 c used in conjunction with rifampin and/or an aminoglycoside.c


Prevention of bacterial endocarditis in patients undergoing certain genitourinary and GI (except esophageal) procedures who have cardiac conditions that put them at moderate or high risk.145 AHA recommends ampicillin as a drug of choice; vancomycin recommended in those hypersensitive to penicillins.145 Used alone in penicillin-allergic individuals at moderate risk or in conjunction with gentamicin in those at high risk.145 Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.145


Meningitis


Treatment of meningitis caused by S. pneumoniae that are highly resistant to penicillins.122 149 235 236 237 .122 149 203 204 205 206 235 236 237 For empiric treatment, usually used in conjunction with a third generation cephalosporin (ceftriaxone, cefotaxime) with or without rifampin;122 203 204 205 206 235 236 237 vancomycin should be discontinued if the causative organism is found to be susceptible to the cephalosporin.235 236 237


Should not be used alone for treatment of meningitis since effective CSF concentrations may not be attained.122 148 235 237


Osteomyelitis


Treatment of osteomyelitis caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.266 267


Respiratory Tract Infections


Treatment of pneumonia caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.266 267


Treatment of pneumonia caused by S. pneumonia highly resistant to penicillins.122 149 235 236 237 266 267 Used alone or in conjunction with a third generation cephalosporin (ceftriaxone, cefotaxime) with or without rifampin.122 149 235 236 237


Septicemia


Treatment of septicemia caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.149 155 266 267 Used alone or in conjunction with gentamicin and/or rifampin.149


Skin and Skin Structure Infections


Treatment of skin and skin structure infections caused by S. aureus or S. epidermidis, including oxacillin-resistant strains.155 266 267


Bacillus Infections


Treatment of infections caused by Bacillus cereus or B. subtilis.149 Drug of choice.149


Capnocytophaga Infections


Treatment of infections caused by Capnocytophaga.149


Optimum regimens for treatment of infections caused by Capnocytophaga not identified; some clinicians recommend use of penicillin G or, alternatively, a third generation cephalosporin (cefotaxime, ceftizoxime, ceftriaxone), a carbapenem (imipenem or meropenem), vancomycin, a fluoroquinolone, or clindamycin.149


Clostridium difficile-associated Diarrhea andColitis


Treatment of Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis, and pseudomembranous colitis) in seriously ill patients (i.e., with severe or potentially life-threatening colitis) or those who cannot tolerate or do not respond to oral metronidazole.122 149 197 198 199 200 211 212 213 214 215 266 267


Oral metronidazole appears to be as effective as oral vancomycin for treatment of Clostridium difficile-associated diarrhea and colitis.172 178 179 180 181 182 183 184 185 193 211 212 213 214 215


Because of cost considerations122 172 178 179 180 181 182 183 184 185 211 212 213 214 215 and concerns about increasing resistance to vancomycin in enterococci and other bacteria (e.g., staphylococci) and the risk of selection of such strains secondary to widespread and/or injudicious use of the drug,115 122 169 172 173 174 175 176 189 190 191 192 200 most experts state that oral metronidazole is preferred (unless a resistant strain of C. difficile is suspected or therapy with metronidazole is contraindicated or not tolerated) when anti-infective therapy is indicated for most cases of Clostridium difficile-associated diarrhea and colitis.122 149 172 178 179 180 181 182 183 184 185 198 200 211 212 213 214 215


Oral vancomycin is the drug of choice when anti-infective therapy is indicated for critically ill patients or those who cannot tolerate or do not respond to oral metronidazole.122 149 180 181 182 184 193 198 199 200 211 212 213 214 215 (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)


Has been used to prevent nosocomial outbreaks of Clostridium difficile-associated diarrhea and colitis in institutionalized patients who asymptomatically harbor the organism.186 187 188 194 However, current evidence suggests that the risks of such prophylaxis (e.g., in selecting potentially resistant organisms such as enterococci) outweigh any possible benefit.172 177 181 186 188 189 190 192 194 Most experts currently recommend that appropriate enteric and barrier precautions (e.g., isolation of patients, private bathroom facilities, strict hygiene) rather than prophylactic anti-infective therapy be implemented to prevent nosocomial transmission of the organisms.177 180 187 188 190 192 193 194 212 213


Rhodococcus Infections


Treatment of infections caused by Rhodococcus equi.149 240 241 242 243 Optimum regimens not identified; combination regimens usually recommended, including vancomycin given with a fluoroquinolone, rifampin, a carbapenem (imipenem or meropenem), or amikacin.149 240 241 242 243


Staphylococcal Enterocolitis


Treatment of enterocolitis caused by S. aureus (including oxacillin-resistant strains).199 Considered the drug of choice for staphylococcal enterocolitis because it does not affect the normal coliform bacteria present in the GI tract.c


Prevention of Perinatal Group B Streptococcal (GBS) Infection


Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease in penicillin-allergic pregnant women at risk for anaphylaxis with a β-lactam anti-infective when clindamycin or erythromycin cannot be used.158 159


Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.158 159


Penicillin G is the regimen of choice and ampicillin is the preferred alternative.158 159 Cefazolin can be used in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity, but clindamycin or erythromycin are the drugs of choice in penicillin-allergic women at high risk for anaphylaxis.158


Because S. agalactiae (group B streptococci) with in vitro resistance to clindamycin and erythromycin has been reported with increasing frequency,158 in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening is necessary.158 If in vitro susceptibility testing is not possible, results are unknown, or isolates are found to be resistant to erythromycin or clindamycin, vancomycin should be used for intrapartum prophylaxis in penicillin-allergic women at high risk for anaphylaxis with β-lactams.158


Perioperative Prophylaxis


Perioperative prophylaxis to reduce the risk of infection in patients undergoing cardiac surgery (e.g., placement of electrophysiologic devices, ventricular assist devices, ventriculoatrial shunts, arterial patches), neurosurgery (e.g., craniotomy, spinal surgery), orthopedic surgery (e.g., joint replacement, internal fixation of compound or open fractures with nails, plates, screws, or wires), noncardiac thoracic surgery (pulmonary resection, closed-tube thoracostomy for chest trauma with hemothorax or pneumothorax), or vascular surgery (arterial reconstructive surgery involving the abdominal aorta, leg procedures that include a groin incision, lower extremity amputation for ischemia) at institutions where oxacillin-resistant S. epidermidis are frequent causes of postoperative wound infection.208 Also used in these procedures when drugs of first choice (cefazolin, cefuroxime) cannot be used because patient is hypersensitive to β-lactams.208


Routine use of vancomycin for perioperative prophylaxis is not recommended since such use may promote emergence of vancomycin-resistant enterococci or staphylococci.200 208 224 (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)


Empiric Therapy in Febrile Neutropenic Patients


Has been used in conjunction with 1 or 2 other anti-infectives for empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients.256


Some clinicians suggest that it may be prudent to include vancomycin in an initial empiric regimen in selected patients with clinically suspected serious catheter-related infections (e.g., bacteremia, cellulitis); known colonization with penicillin- and cephalosporin-resistant S. pneumoniae or oxacillin-resistant (methicillin-resistant) S. aureus; initial blood culture results indicating presence of gram-positive bacteria; or hypotension or other evidence of cardiovascular impairment.256


If vancomycin is included in an initial empiric regimen, it should be discontinued within 24–48 hours if results of cultures do not identify gram-positive bacteria susceptible to the drug.256 (See Vancomycin-resistant Enterococci and Staphylococci under Cautions.)


Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.256 Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.256


Vancocin Dosage and Administration


Administration


Administer orally197 or by slow IV infusion.155 266 267 Should not be given IM;266 267 safety and efficacy of intrathecal (intralumbar or intraventricular) or intraperitoneal administration have not been determined.266 267


Given orally as capsules for treatment Clostridium difficile-associated diarrhea and colitis or for treatment of staphylococcal enterocolitis;197 if necessary, the parenteral formulation (500-mg single-use vial) may be diluted and administered orally or by NG tube for treatment of these infections.267


Oral vancomycin is not effective for treatment of systemic infections197 266 267


Oral Administration


Administer orally as capsules.197 Alternatively, an oral solution prepared using the IV preparation of the drug can be given orally or via NG tube.267


Reconstitution

When necessary, an oral solution can be prepared by diluting the appropriate dose of vancomycin powder for IV infusion in 30 mL of water.267 The 500-mg single-use vial should be used to prepare these oral solutions;267 ADD-Vantage vials should not be used.266


IV Infusion


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


Usually administered by intermittent IV infusion.266 267 Has been administered by continuous IV infusion when intermittent infusions were not feasible.c


Reconstitution and Dilution

Reconstitute powder for IV infusion by adding 10 or 20 mL of sterile water for injection to a vial containing 500 mg or 1 g of vancomycin.267 Further dilute reconstituted solutions containing 500 mg or 1 g with at least 100 mL or at least 200 mL, respectively, of a compatible IV solution.267


Alternatively, ADD-Vantage vials containing 500 mg or 1 g of vancomycin may be reconstituted according to the manufacturer’s directions using 5% dextrose injection or 0.9% sodium chloride injection.266 ADD-Vantage vials should be used only when actual doses of 500 mg or 1 g are appropriate and should not be used in neonates, infants, or young children who require doses <500 mg.266


The pharmacy bulk package is not intended for direct IV infusion; doses of the drug from the reconstituted bulk package must be further diluted in a compatible IV infusion solution prior to administration.157


Thaw the commercially available injection (frozen) at room temperature or in a refrigerator; do not force thaw by immersion in a water bath or by exposure to microwave radiation.155 A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature.155 Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact.155


The thawed injection should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.155


Rate of Administration

Administer by IV infusion over ≥1 hour.266 267


Rapid IV infusion should be avoided and patients monitored closely to detect a hypotensive reaction if it occurs.266 267


Adverse effects may be minimized if infusion rate is ≤10 mg/minute,266 267 but consider that adverse effects associated with vancomycin infusions could occur with any infusion rate.155 247 266 267 (See Infusion Reactions under Cautions.)


If intermittent IV infusion is not feasible, 1–2 g of reconstituted vancomycin may be added to a sufficient volume of 0.9% sodium chloride or 5% dextrose injection to permit administration of the desired daily dosage over a 24-hour period.c


Dosage


Available as vancomycin hydrochloride; dosage expressed in terms of vancomycin.197 266 267


Pediatric Patients


General Dosage for Neonates

Systemic Infections

IV

AAP states optimal dosage in neonates should be based on serum vancomycin concentrations, especially in those with low birthweight (i.e., <1.5 kg).122


Manufacturer recommends 15 mg/kg initially, followed by 10 mg/kg every 12 hours in neonates <1 week of age and 10 mg/kg every 8 hours in neonates 1 week to 1 month of age.266 267


Neonates <1 week of age: AAP recommends 15 mg/kg every 24 hours in those weighing <1.2 kg, 10–15 mg/kg every 12–18 hours in those weighing 1.2–2 kg, or 10–15 mg/kg every 8–12 hours for those weighing > 2 kg.122


Neonates ≥1 week of age: AAP recommends 15 mg/kg every 24 hours in those weighing <1.2 kg, 10–15 mg/kg every 8–12 hours in those weighing 1.2–2 kg, or 10–15 mg/kg every 6–8 hours in those weighing >2 kg.122


General Pediatric Dosage

Systemic Infections

IV

10 mg/kg every 6 hours.266 267


Children ≥1 month of age: AAP recommends 40 mg/kg daily given in 3–4 divided doses for mild to moderate infections or 40–60 mg/kg daily given in 4 divided doses for severe infections.122


Endocarditis

Treatment of Endocarditis Caused by Staphylococci (Including Oxacillin-resistant Staphylococci)

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265


Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for ≥6 weeks.265 Given in conjunction with oral or IV rifampin (20 mg/kg daily given in 3 equally divided doses for ≥6 weeks) and IM or IV gentamicin (3 mg/kg daily given in 3 divided doses during first 2 weeks of treatment).265


Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 4 weeks.265


Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265


Treatment of Enterococcal Endocarditis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265 Used in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (20–30 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Prosthetic valve or other prosthetic material: 40 mg/kg daily given in 2 or 3 equally divided doses for 6 weeks.265 Used in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (20–30 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Culture-negative Endocarditis

IV

Native valve: 40 mg/kg daily given in 2 or 3 equally divided doses in conjunction with oral or IV ciprofloxacin (20–30 mg/kg daily given in 2 equally divided doses) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses).265 All 3 drugs should be given for 4–6 weeks.265


Prosthetic valve (≤1 year after valve replacement): 40 mg/kg daily given in 2 or 3 equally divided doses in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses) and oral or IV rifampin (20 mg/kg daily given in 3 equally divided doses).265 Cefepime (150 mg/kg daily given IV in 3 equally divided doses) also may be included.265 Vancomycin, rifampin, and cefepime should be given for 6 weeks; gentamicin should be given only during first 2 weeks of treatment.265


Prevention of Bacterial Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures

IV

For moderate-risk patients, 20 mg/kg given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure.145


For high-risk patients, 20 mg/kg given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure; given in conjunction with IV or IM gentamicin (1.5 mg/kg given within 30 minutes prior to start of the procedure).145


Meningitis

IV

Children ≥1 month of age: AAP and other clinicians recommend 60 mg/kg daily given in 4 divided doses.122 235 236 237


Clostridium difficile-associated Diarrhea and Colitis

Oral

40 mg/kg given in 3 or 4 divided doses for 7–10 days.122 156 197


Staphylococcal Enterocolitis

Oral

40 mg/kg given in 3 or 4 divided doses for 7–10 days.122 156 197


Adults


General Adult Dosage

Treatment of Life-threatening Systemic Infections

IV

500 mg every 6 hours or 1 g every 12 hours.266 267


Endocarditis

Treatment of Endocarditis Caused by Staphylococci (Including Oxacillin-resistant Staphylococci)

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265


Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for ≥6 weeks.265 Given in conjunction with oral or IV rifampin (900 mg daily given in 3 equally divided doses every 8 hours for ≥6 weeks) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses during first 2 weeks of treatment).265


Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 4 weeks.265


Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265


Treatment of Enterococcal Endocarditis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265 Given in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (15 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Prosthetic valve or other prosthetic material: 30 mg/kg daily given in 2 equally divided doses for 6 weeks.265 Given in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses for 6 weeks); substitute IM or IV streptomycin (15 mg/kg daily given in 2 equally divided doses for 6 weeks) for gentamicin-resistant strains.265


Culture-negative Endocarditis

IV

Native valve: 30 mg/kg daily given in 2 equally divided doses in conjunction with ciprofloxacin (1 g daily given orally in 2 equally divided doses or 800 mg daily given IV in 2 equally divided doses) and IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses).265 All 3 drugs should be given for 4–6 weeks.265


Prosthetic valve (≤1 year after valve replacement): 30 mg/kg daily given in 2 equally divided doses in conjunction with IM or IV gentamicin (3 mg/kg daily given in 3 equally divided doses) and oral or IV rifampin (900 mg daily given in 3 equally divided doses).265 Cefepime (6 g daily given IV in 3 equally divided doses) also may be included.265 Vancomycin, rifampin, and cefepime should be given for 6 weeks; gentamicin should be given only during first 2 weeks of treatment.265


Prevention of Bacterial Endocarditis in Patients Undergoing Certain GU or GI (except Esophageal) Procedures

IV

For moderate-risk patients, 1 g given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure.145


For high-risk patients, 1 g given IV over 1–2 hours with the infusion completed within 30 minutes prior to start of the procedure; given in conjunction with IV or IM gentamicin (1.5 mg/kg given within 30 minutes prior to start of the procedure).145


Meningitis

IV

500 mg every 6 hours or 1 g every 12 hours.266


Osteomyelitis

IV

500 mg every 6 hours or 1 g every 12 hours.266


Respiratory Tract Infections

IV

500 mg every 6 hours or 1 g every 12 hours.266


Septicemia

IV

500 mg every 6 hours or 1 g every 12 hours.266


Skin and Skin Structure Infections

IV

500 mg every 6 hours or 1 g every 12 hours.266


Clostridium difficile-associated Diarrhea and Colitis

Oral

0.5–2 g daily given in 3 or 4 divided doses for 7–10 days.156 197 Many clinicians recommend 125 mg 4 times daily for 7–10 days.212 215 c


Staphylococcal Enterocolitis

Oral

0.5–2 g daily given in 3 or 4 divided doses for 7–10 days.156 197


Prevention of Perinatal Group B Streptococcal (GBS) Infection

IV

1 g every 12 hours beginning at time of labor or rupture of membranes and continued until delivery.158


Perioperative Prophylaxis

Cardiac, Neurosurgical, Orthopedic, Thoracic (Noncardiac), or Vascular Surgery

IV

A single 1-g dose given just prior to the procedure.208


Start infusion 1–2 hours prior to incision to minimize risk of adverse reaction occurring at time of induction of anesthesia and to ensure adequate tissue concentrations at time of incision.208 If surgery is prolonged (>4 hours), additional intraoperative doses may be given every 6–12 hours for duration of the procedure; additional doses also are advisable if substantial blood loss occurs.208 Postoperative doses generally unnecessary and should not be used.208


Prescribing Limits


Pediatric Patients


Maximum 2 g daily.122 235 197 236 237


For treatment of endocarditis, AHA and IDSA state pediatric dosage should not exceed recommended adult dosage.265


Adults


Maximum 2 g daily.265


For treatment of endocarditis, AHA and IDSA recommend maximum 2 g daily unless serum concentrations are inappropriately low.265 These experts recommend dosage be adjusted to obtain peak serum concentrations (1 hour after completion of IV infusion) of 30–45 mcg/mL and trough concentrations of 10–15 mcg/mL.265


Special Populations


Hepatic Impairment


Limited data suggest dosage adjustments not necessary.264


Renal Impairment


Treatment of Systemic Infections

IV

Doses and/or frequency of administration must be modified in response to the degree of renal impairment.266 267 c


Various methods of calculating vancomycin dosage for patients with impaired renal function have been proposed and specialized references should be consulted.c


If possible, dosage should be based on serum vancomycin concentrations, especially in seriously ill patients with changing renal function.105 106 266 267 Peak serum concentrations of 30–40 mg/L and trough concentrations <10–20 mg/L generally have been recommended.264 To ensure efficacy and avoid toxicity, trough serum concentrations may be more useful than peak serum concentrations.264


Some clinicians have recommended that 1 g of vancomycin be administered at 12-hour intervals in patients with Scr of <1.5 mg/dL, at 3- to 6-day intervals in patients with Scr of 1.5–5 mg/dL, and at 10- to 14-day intervals in patients with Scr >5 mg/dL.c


Others have recommended that the usual individual dose be administered every 3–10 days in patients with GFR 10–50 mL/minute and every 10 days in patients with GFR <10 mL/minute.116


Geriatric Patients


Cautious dosage selection (usually starting at the low end of the dosing range) because of age-related decreases in renal function.197 266 267 (See Renal Impairment under Dosage and Administration.)


Cautions for Vancocin


Contraindications



  • Hypersensitivity to vancomycin.197 266 267




  • Commercially available frozen vancomycin hydrochloride injection in 5% dextrose may be contraindicated in patients with known allergy to corn or corn products.155



Warnings/Precautions


Warnings


Ototoxicity

Ototoxicity, including damage to the auditory branch of the eighth cranial nerve and permanent deafness, vertigo, dizziness, and tinnitus, has been reported.132 134 266 267


Most cases involved patients with renal impairment, patients receiving high dose or prolonged IV therapy, patients with preexisting hearing loss, or those receiving other ototoxic drugs concomitantly.266 267


Ototoxicity usually has been associated with serum or blood vancomycin concentrations of 80–100 mcg/mL, but has occurred with concentrations as low as 25 mcg/mL.132


Ototoxicity may be transient or permanent;155 266 267 deafness may progress despite cessation of therapy.c


Not recommended in patients with previous hearing loss; if use in these patients is considered necessary, reduce dosage.c


Auditory function testing may minimize risk of ototoxicity during vancomycin therapy.155 266 267 In addition, regular determinations of serum or blood vancomycin concentrations is recommended in patients with borderline renal function and in those >60 years of age.c


If tinnitus occurs, discontinue vancomycin.c


Nephrotoxicity

Nephrotoxicity has been reported, including increased BUN or Scr concentrations, presence of hyaline and granular casts and albumin in urine, fatal uremia, and acute interstitial nephritis.132 133 134


Reported most frequently in patients with renal impairment, patients receiving high dose or prolonged IV therapy, or those receiving other nephrotoxic drugs concomitantly.256


Nephrotoxicity usually is associated with serum or blood vancomycin concentrations of 80–100 mcg/mL, but has occurred with concentrations as low as 25 mcg/mL.132


Use with caution in patients with impaired renal function.266 267 Perform urinalysis and renal function tests periodically during therapy.266 267


Infusion Reactions

Rapid IV administration may result in a potentially serious hypotensive reaction.112 118 119 120 136 137 138 139 143 238 244 247


These infusion reactions usually involve a sudden and possibly severe decrease in blood pressure and may be accompanied by flushing and/or a maculopapular or erythematous rash on the face, neck, chest, and upper extremities (“red-man syndrome” or “red-neck syndrome”).112 118 119 120 135 136 137 142 143 Latter manifestations may occur in the absence of hypotension.120 135 136 142 238 244 247 Wheezing, dyspnea, angioedema, urticaria, pruritus, and, rarely, cardiac arrest or seizures may also occur.139 121 138


The reaction usually begin a few minutes after infusion is started, but may not occur until after its completion and usually resolves spontaneously over 1 to several hours after discontinuance.118 120 135 136 143 238 If the hypotensive reaction is severe, antihistamines, corticosteroids, or IV fluids are recommended.118 120 136


To minimize risk of an infusion reaction, administer IV over a period of ≥1 hour using a rate ≤10 mg/minute and monitor patient’s blood pressure.118 119 120 136 155 266 267 Avoid rapid IV administration (e.g., over several minutes).155


Pretreatment with antihistamines may attenuate but not eliminate the risk of infusion reactions.244 136 141 144


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylaxis, urticaria, exfoliative dermatitis, macular rashes, exfoliative dermatitis, and Stevens-Johnson syndrome have been reported.131 266 267


Rapid IV administration may result in anaphylactoid reaction involving hypotension, wheezing, dyspnea, urticaria, or pruritus.266 267 (See Infusion Reactions under Cautions.)


General Precautions


Hematologic Effects

Neutropenia, eosinophilia, and thrombocytopenia have been reported rarely.155 266 267 c Neutropenia may occur ≥7 days after initiation of therapy or after a total dose o

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Drug List:

Hydrocodone Bitartrate and Acetaminophen Oral Solution




Dosage Form: oral solution

Warning




HEPATOTOXICITY


ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.



Hydrocodone Bitartrate and Acetaminophen Oral Solution Description

Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration.


WARNING: May be habit-forming (see PRECAUTIONS, Information for Patients/Caregivers, and DRUG ABUSE AND DEPENDENCE).


Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α- epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:


C18H21NO3 • C4H6O6 • 2½ H2O M.W. 494.490



Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:


C8H9NO2 MW = 151.16



       


Hydrocodone Bitartrate and Acetaminophen Oral Solution contains:




















Per


5 mL



Per


15 mL


Hydrocodone Bitartrate..........................2.5 mg7.5 mg
Acetaminophen..........................108.0 mg325.0 mg
Alcohol..........................7 %7 %

In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.



Hydrocodone Bitartrate and Acetaminophen Oral Solution - Clinical Pharmacology


Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.


The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.



Pharmacokinetics


The behavior of the individual components is described below.


Hydrocodone


Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites.


See OVERDOSAGE for toxicity information.


Acetaminophen


Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.


See OVERDOSAGE for toxicity information.



Indications and Usage for Hydrocodone Bitartrate and Acetaminophen Oral Solution


Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the relief of moderate to moderately severe pain.



Contraindications


This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product.


Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.



Warnings



Hepatotoxicity


Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.


The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.


Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.



Hypersensitivity/anaphylaxis


There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Oral Solution for patients with acetaminophen allergy.



Respiratory Depression


At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.


Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS, Pediatric Use). If use of Hydrocodone Bitartrate and Acetaminophen Oral Solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring.



Head Injury and Increased Intracranial Pressure


The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.



Acute Abdominal Conditions


The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.



Misuse, Abuse, and Diversion of Opioids


Hydrocodone Bitartrate and Acetaminophen Oral Solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.


Hydrocodone Bitartrate and Acetaminophen Oral Solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Hydrocodone Bitartrate and Acetaminophen Oral Solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).



Precautions



General


Special Risk Patients


As with any narcotic analgesic agent, Hydrocodone Bitartrate and Acetaminophen Oral Solution should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.


Cough Reflex


Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Hydrocodone Bitartrate and Acetaminophen Oral Solution is used postoperatively and in patients with pulmonary disease.



Information for Patients/Caregivers


  • Do not take Hydrocodone Bitartrate and Acetaminophen Oral Solutiont if you are allergic to any of its ingredients.

  • If you develop signs of allergy such as a rash or difficulty breathing, stop taking Hydrocodone Bitartrate and Acetaminophen Oral Solution and contact your healthcare provider immediately.

  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.


Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.


Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.


Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling.



Laboratory Tests


In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.



Drug Interactions


Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Hydrocodone Bitartrate and Acetaminophen Oral Solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.


The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.



Drug/Laboratory Test Interactions


Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.



Carcinogenesis, Mutagenesis, Impairment of Fertility


No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility.


Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.


No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility.


Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.



Pregnancy


Teratogenic Effects

Pregnancy Category C


There are no adequate and well-controlled studies in pregnant women. Hydrocodone Bitartrate and Acetaminophen Oral Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Nonteratogenic Effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.



Labor and Delivery


Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown.



Nursing Mothers


Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of Hydrocodone Bitartrate and Acetaminophen Oral Solution in the pediatric population is supported by the evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults with additional data which support the development of metabolic pathways in children two years of age and over (see DOSAGE AND ADMINISTRATION for pediatric dosage information).



Geriatric Use


Clinical studies of Hydrocodone Bitartrate and Acetaminophen Oral Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Hydrocodone Bitartrate and Acetaminophen Oral Solution and observed closely.



Adverse Reactions


To request medical information or to report SUSPECTED ADVERSE REACTIONS, contact Talec Pharma, L.L.C. at (855) 206-7812 or FDA at 1-800-FDA 1088 or www.fda.gov/medwatch.


Potential effects of high dosage are also listed in the OVERDOSAGE section.


Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.


Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.


Endocrine: Hypoglycemic coma.


Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting.


Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.


Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.


Hypersensitivity: Allergic reactions.


Musculoskeletal: Skeletal muscle flaccidity.


Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE), shortness of breath.


Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.


Skin: Cold and clammy skin, diaphoresis, pruritus, rash.



Drug Abuse and Dependence



Misuse, Abuse, and Diversion of Opioids


Hydrocodone Bitartrate and Acetaminophen Oral Solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Hydrocodone Bitartrate and Acetaminophen Oral Solution, and other opioids, used in analgesia can be abused and are subject to criminal diversion.


Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.


“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.


Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Hydrocodone Bitartrate and Acetaminophen Oral Solution, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.


Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.



Overdosage


Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.



Signs and Symptoms


Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.


Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.



Treatment


A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.


For hydrocodone overdose, primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.


Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.


Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.



Hydrocodone Bitartrate and Acetaminophen Oral Solution Dosage and Administration


Dosage should be adjusted according to severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.


The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls.


The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Hydrocodone Bitartrate and Acetaminophen Oral Solution (providing 0.135 mg/kg of hydrocodone bitartrate and 5.85 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.




























BODY WEIGHT



APPROXIMATE AGE



DOSE


every 4 to 6 hours



MAXIMUM TOTAL DAILY DOSE


(6 doses per day)

12 to 15 kg


27 to 34 lbs.
2 to 3 years

¾ teaspoonful


= 3.75 mL

4½ teaspoonfuls


=22.5 mL

16 to 22 kg


35 to 50 lbs.
4 to 6 years

1 teaspoonful


= 5 mL

6 teaspoonfuls


= 30 mL

23 to 31 kg


51 to 69 lbs.
7 to 9 years

1½ teaspoonfuls


= 7.5 mL

9 teaspoonfuls


= 45 mL

32 to 45 kg


70 to 100 lbs.
10 to 13 years

2 teaspoonfuls


= 10 mL

12 teaspoonfuls


= 60 mL

46 kg and up


101 lbs. and up
14 years to adult

1 Tablespoonful


= 15 mL

6 Tablespoonfuls


= 90 mL

The total daily dosage for children should not exceed 6 doses per day.


It is of utmost importance that the dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.



How is Hydrocodone Bitartrate and Acetaminophen Oral Solution Supplied


Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL is a red-colored, tropical fruit punch flavored liquid containing hydrocodone bitartrate (WARNING: may be habit-forming) 7.5 mg and acetaminophen 325 mg per 15 mL, with 7% alcohol. It is supplied in containers of one pint (473 mL).


NDC 76181-001-25.



STORAGE


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure.


A Schedule CIII Narcotic.


Distributed by:


Talec Pharma, L.L.C.


699 Trade Center Blvd., Suite A


Chesterfield, MO 63005


To request medical information or to report SUSPECTED ADVERSE REACTIONS, contact Talec Pharma, L.L.C. at (855) 206-7812.



PATIENT INFORMATION LEAFLET


Hydrocodone Bitartrate and Acetaminophen Oral Solution


7.5 mg/325 mg per 15 mL




Summary


Hydrocodone Bitartrate and Acetaminophen Oral Solution is used to relieve moderate to moderately severe pain. You should not take Hydrocodone Bitartrate and Acetaminophen Oral Solution if you are allergic to hydrocodone or acetaminophen. The most common side effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.




Uses


Hydrocodone Bitartrate and Acetaminophen Oral Solution is an analgesic used to relieve moderate to moderately severe pain. Hydrocodone Bitartrate and Acetaminophen Oral Solution is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist.


General Cautions


  • Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to Hydrocodone Bitartrate and Acetaminophen Oral Solution.

  • This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product.

  • This medicine may not be right for you. Check with your doctor or pharmacist, if you:
    • are pregnant.

    • are nursing.

    • are taking other medications: narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol.

    • have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison’s disease, enlarged prostate or difficulty urinating.


Proper Use


Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist.


Dosing


The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. If your dose is different, do not change doses unless your doctor tells you to do so.




























BODY WEIGHT



APPROXIMATE AGE



DOSE


every 4 to 6 hours

MAXIMUM TOTAL DAILY DOSE


(6 doses per day)

12 to 15 kg


27 to 34 lbs.
2 to 3 years

¾ teaspoonful


= 3.75 mL

4½ teaspoonfuls


=22.5 mL

16 to 22 kg


35 to 50 lbs.
4 to 6 years

1 teaspoonful


= 5 mL

6 teaspoonfuls


= 30 mL

23 to 31 kg


51 to 69 lbs.
7 to 9 years

1½ teaspoonfuls


= 7.5 mL

9 teaspoonfuls


= 45 mL

32 to 45 kg


70 to 100 lbs.
10 to 13 years

2 teaspoonfuls


= 10 mL

12 teaspoonfuls


= 60 mL

46 kg and up


101 lbs. and up
14 years to adult

1 Tablespoonful


= 15 mL

6 Tablespoonfuls


= 90 mL

It is very important that Hydrocodone Bitartrate and Acetaminophen Oral Solution be dosed accurately. A household teaspoon or tablespoon is not an accurate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured.


Since a household teaspoon is not accurate and can be mixed-up with a tablespoon (which can cause overdosage), it is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper.


Missed Dose


  • To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don’t take doses at intervals less than 4 hours apart.

  • If you miss taking a dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose.

  • If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled.

  • Do not double the prescribed dose.

Possible Side Effects


Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting.


Call your doctor if these effects continue or are bothersome.


Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor.


Storage


  • Keep out of reach of children.

  • Store at room temperature (protect from heat, do not refrigerate).

  • Keep in original labeled bottle.

  • Discard medicines that are old or no longer needed.

  • Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

  • This leaflet provides a summary of information about Hydrocodone Bitartrate and Acetaminophen Oral Solution. If you have any questions or concerns, or want more information about Hydrocodone Bitartrate and Acetaminophen Oral Solution, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Hydrocodone Bitartrate and Acetaminophen Oral Solution that is written for health professionals that you can ask to read.

Distributed by:


Talec Pharma, L.L.C.


699 Trade Center Blvd., Suite A


Chesterfield, MO 63005


To request medical information or to report SUSPECTED ADVERSE REACTIONS, contact Talec Pharma, L.L.C. at (855) 206-7812.


Code 866F00


Rev. 07/11


PRINCIPAL DISPLAY PANEL








HYDROCODONE BITARTRATE AND ACETAMINOPHEN 
hydrocodone bitartrate and acetaminophen  syrup










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)76181-001
Route of AdministrationORALDEA ScheduleCIII    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCODONE BITARTRATE (HYDROCODONE)HYDROCODONE BITARTRATE7.5 mg  in 15 mL
ACETAMINOPHEN (ACETAMINOPHEN)ACETAMINOPHEN325 mg  in 15 mL




























Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
ETHYL MALTOL 
FD&C RED NO. 40 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SACCHARIN SODIUM 
SORBITOL 
SUCROSE 
WATER 


















Product Characteristics
ColorREDScore    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
176181-001-25473 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04048208/01/2011


Labeler - Talec Pharma, LLC (968039946)

Registrant - Mikart, Inc. (030034847)









Establishment
NameAddressID/FEIOperations
Mikart, Inc.030034847MANUFACTURE









Establishment
NameAddressID/FEIOperations
Mikart, Inc.013322387MANUFACTURE
Revised: 08/2011Talec Pharma, LLC

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