Thursday, October 13, 2016

Medent-LDI


Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA


What is Medent-LDI (guaifenesin and pseudoephedrine)?

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


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.


Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Medent-LDI (guaifenesin and pseudoephedrine)?


Do not give this medication to a child younger than 4 years old. Alwayss 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. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

What should I discuss with my healthcare provider before taking Medent-LDI (guaifenesin and pseudoephedrine)?


You should not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:



  • heart disease or high blood pressure;




  • diabetes; or




  • a thyroid disorder.




It is not known whether guaifenesin and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take Medent-LDI (guaifenesin and pseudoephedrine)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and 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. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

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


Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take with food if this medicine upsets your stomach. Do not take guaifenesin and pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.


Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?


Since cough or cold 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.

Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.


What should I avoid while taking Medent-LDI (guaifenesin and pseudoephedrine)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

Medent-LDI (guaifenesin and pseudoephedrine) side effects


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

  • fast, pounding, or uneven heartbeat;




  • severe dizziness, anxiety, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).



Less serious side effects may include:



  • dizziness or headache;




  • feeling restless or excited;




  • sleep problems (insomnia);




  • mild nausea, vomiting, or stomach upset;




  • mild loss of appetite;




  • warmth, redness, or tingly feeling under your skin; 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 Medent-LDI (guaifenesin and pseudoephedrine)?


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



  • methyldopa (Aldomet);




  • blood pressure medications;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or




  • an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.



This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. 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 Medent-LDI resources


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


  • Congestac MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mucinex D Prescribing Information (FDA)

  • Mucinex D Consumer Overview

  • Pseudovent Consumer Overview

  • Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Medent-LDI with other medications


  • Cough and Nasal Congestion


Where can I get more information?


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

See also: Medent-LDI side effects (in more detail)


Medrox-Rx Ointment




Generic Name: methyl salicylate, menthol, capsaicin

Dosage Form: ointment
Medrox-Rx

methyl salicylate 20.00 % topical analgesic


menthol 7.00 % topical analgesic


capsaicin 0.050 % external analgesic



acrylates copolymer, aloe barbadensis leaf (aloe vera gel) juice, aqua (deionized water), cetyl alcohol, ethylhexylglycerin, glycerin, isopropyl myristate, peg-150 disterate, phenoxyethanol, polysorbate-20, sodium lauryl sulfate, triethanolamine



keep out of reach of children. if swallowed, consult physician.



apply directly to affected area. do not use more than four times per day.



for temporary relief of minor aches and pains of the muscles and joints associated with simple arthritis, sprains, bruises and simple backache.


for temporary relief of minor aches and pains of the muscles and joints associated with simple arthritis, sprains, bruises and simple backache.

for external use only


avoid contact with eyes


do not bandage or wrap tightly


do not apply to wounds or damages skin


if symptoms persist for more than seven days, discontinue use and consult physician


keep out of reach of children. if swallowed consult physician.




                    Rx Only


Medrox-Rx


(medroxcin)     Pain relief ointment


effecive, soothing, long lasting, paraben-free









MEDROX-RX 
methyl salicylate, menthol, capsaicin  ointment










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)45861-005
Route of AdministrationTOPICALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
methyl salicylate (methyl salicylate)methyl salicylate24 g  in 120 g
menthol (menthol)menthol8.4 g  in 120 g
capsaicin (capsaicin)capsaicin0.6 g  in 120 g
































Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A 
ALOE VERA LEAF 
WATER 
CETYL ALCOHOL 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
PEG-150 DISTEARATE 
PHENOXYETHANOL 
POLYSORBATE 20 
SODIUM LAURYL SULFATE 
TROLAMINE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
145861-005-01120 g In 1 TUBENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34810/27/2011


Labeler - Pharmaceutica North America, Inc. (962739699)

Registrant - Pharmaceutica North America, Inc. (962739699)









Establishment
NameAddressID/FEIOperations
Pure Source969241041manufacture
Revised: 10/2011Pharmaceutica North America, Inc.



Mediplast


Generic Name: salicylic acid topical (SAL i SIL ik AS id TOP ik al)

Brand Names: Compound W, DermalZone, Dermarest Psoriasis Skin Treatment, Dr Scholl's Callus Removers, Dr Scholl's Clear Away Wart Remover, Dr Scholl's Corn Removers, Duofilm, Freezone Corn Remover, Hydrisalic, Keralyt, Mediplast, Oxy Face Scrub, Propa P.H., Salac, Salex, Scalpicin Scalp Relief, Sebucare, Stri-Dex, Wart-Off Treatment


What is Mediplast (salicylic acid topical)?

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.


Salicylic acid topical is used in the treatment of acne, dandruff, corns, and warts.


Salicylic acid topical may also be used for purposes other than those listed here.


What is the most important information I should know about Mediplast (salicylic acid topical)?


Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

What should I discuss with my healthcare provider before using Mediplast (salicylic acid topical)?


Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

Before using salicylic topical, talk to your doctor if you


  • have kidney disease;

  • have liver disease;


  • have diabetes;




  • have poor circulation; or




  • are treating a child.



You may not be able to use salicylic acid topical, or you may require a dosage adjustment or special monitoring during treatment.


It is not known whether salicylic acid topical will be harmful to an unborn baby. Do not use salicylic acid topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. Salicylic acid topical may pass into breast milk and affect a nursing baby. Do not use salicylic acid topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Mediplast (salicylic acid topical)?


Use salicylic acid topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


Gently clean and dry the affected area. For the treatment of warts and calluses, gentle removal of loose skin with a soft brush, wash cloth, or emery board may be recommended before application of the medication.


Shake the lotion gently before application.

Apply a thin film of the medication to the affected area(s) as directed.


Use the soap and shampoo as directed on the package.


Apply the salicylic acid topical adhesive pads as directed on the package.


It is important to use salicylic acid topical regularly to get the most benefit. Do not stop using the medication if you do not see results immediately. Use the medication for the full amount of time directed.

Talk to your doctor if you experience excessive burning, dryness, or irritation of the skin, or changes in the color of the skin.


Store salicylic acid topical at room temperature away from moisture and heat. Some forms of salicylic acid topical may be flammable, keep away from heat and flame.

What happens if I miss a dose?


Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose.


Do not apply a double dose of the medication.


What happens if I overdose?


An overdose of salicylic acid topical is unlikely to occur. If you do suspect an overdose, or if the medication has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Mediplast (salicylic acid topical)?


Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.


Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.


Mediplast (salicylic acid topical) side effects


Serious side effects are not likely to occur with the use of salicylic acid topical. If you do experience any of the following rare serious side effects, stop using salicylic acid topical and seek emergency medical attention or contact your doctor:

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives); or




  • severe skin irritation.



Other, less serious side effects are more likely to occur. Continue to use salicylic acid topical and talk to your doctor if you experience skin burning; stinging; itching; dryness; redness; peeling; or irritation.


Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Mediplast (salicylic acid topical)?


Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.


Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.


Drugs other than those listed here may also interact with salicylic acid topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More Mediplast resources


  • Mediplast Use in Pregnancy & Breastfeeding
  • Mediplast Drug Interactions
  • Mediplast Support Group
  • 0 Reviews for Mediplast - Add your own review/rating


  • Mediplast Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Duofilm Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Duoplant Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Durasal Prescribing Information (FDA)

  • Freezone Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hydrisalic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ionil Plus Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)

  • Keralyt Prescribing Information (FDA)

  • Keralyt Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Keralyt Scalp Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)

  • Salacyn Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Salex Prescribing Information (FDA)

  • Salex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Salkera Foam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Salvax Prescribing Information (FDA)

  • Virasal Prescribing Information (FDA)

  • Virasal Film-Forming Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Mediplast with other medications


  • Acne
  • Warts


Where can I get more information?


  • Your pharmacist has additional information about salicylic acid topical written for health professionals that you may read.


Medi-Tabs


Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap


What is acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.


Acetaminophen is a pain reliever and a fever reducer.


Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.


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


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


There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are taking.


Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

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


You should not take acetaminophen if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:


  • liver disease; or


  • a history of alcoholism.




Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?


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


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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


If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.


Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.


To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.


Stop taking acetaminophen and call your doctor if:

  • you still have a fever after 3 days of use;




  • you still have pain after 7 days of use (or 5 days if treating a child);




  • you have a skin rash, ongoing headache, or any redness or swelling; or




  • if your symptoms get worse, or if you have any new symptoms.



This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.


Store at room temperature away from heat and moisture.

What happens if I miss a dose?


Since acetaminophen is taken as 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 acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


What should I avoid while taking acetaminophen?


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Acetaminophen 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 a serious side effect such as:

  • nausea, upper stomach pain, itching, loss of appetite;




  • dark urine, clay-colored stools; or




  • jaundice (yellowing of the skin or eyes).



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 acetaminophen?


Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:



  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;




  • birth control pills or hormone replacement therapy;




  • blood pressure medication;




  • cancer medications;




  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;




  • gout or arthritis medications (including gold injections);




  • HIV/AIDS medications;




  • medicines to treat psychiatric disorders;




  • an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or




  • seizure medications.



This list is not complete and there may be other drugs that can interact with acetaminophen. 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 Medi-Tabs resources


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


  • acetaminophen Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Acetaminophen MedFacts Consumer Leaflet (Wolters Kluwer)

  • Acetaminophen Monograph (AHFS DI)

  • Acetazolamide Monograph (AHFS DI)

  • Apra Advanced Consumer (Micromedex) - Includes Dosage Information

  • Apraclonidine Hydrochloride Monograph (AHFS DI)

  • Genapap Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mapap Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ofirmev Consumer Overview

  • Ofirmev Injection MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ofirmev Prescribing Information (FDA)

  • Paracetamol Consumer Overview

  • Tempra 1 Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tylenol Consumer Overview

  • Tylenol MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Medi-Tabs with other medications


  • Fever
  • Muscle Pain
  • Pain
  • Sciatica


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen.

See also: Medi-Tabs side effects (in more detail)


Mefoxin



cefoxitin sodium

Dosage Form: injection, solution
Mefoxin®

(CEFOXITIN INJECTION)

PREMIXED INTRAVENOUS SOLUTION


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Mefoxin1 and other antibacterial drugs, Mefoxin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.



1


Mefoxin is a registered trademark of Bioniche Teoranta.




Mefoxin Description


Cefoxitin sodium is a semi-synthetic, broad-spectrum cepha antibiotic for intravenous administration. It is derived from cephamycin C, which is produced by Streptomyces lactamdurans. Its chemical name is sodium (6R,7S) - 3 - (hydroxymethyl) - 7 - methoxy - 8 - oxo - 7 - [2 - (2 - thienyl)acetamido] - 5 - thia - 1 - azabicyclo[4.2.0]oct - 2 - ene - 2 - carboxylate carbamate (ester). The empirical formula is C16H16N3NaO7S2, and the molecular weight is 449.44. The structural formula is:



Cefoxitin sodium contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity.


Premixed Intravenous Solution Mefoxin (Cefoxitin Injection) is supplied as a sterile, nonpyrogenic, frozen iso-osmotic solution of cefoxitin sodium. Each 50 mL contains Cefoxitin Sodium, USP equivalent to either 1 gram or 2 grams cefoxitin. Dextrose Hydrous, USP has been added to the above dosages to adjust osmolality (approximately 2 grams and 1.1 grams to 1 gram and 2 gram dosages, respectively). The pH is adjusted with sodium bicarbonate and may have been adjusted with hydrochloric acid. The pH is approximately 6.5. After thawing, the solution is intended for intravenous use only. Solutions of Mefoxin range from colorless to light amber.


The plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.



Mefoxin - Clinical Pharmacology



Clinical Pharmacology


Following an intravenous dose of 1 gram of cefoxitin, serum concentrations were 110 mcg/mL at 5 minutes, declining to less than 1 mcg/mL at 4 hours. The half-life after an intravenous dose is 41 to 59 minutes. Approximately 85 percent of cefoxitin is excreted unchanged by the kidneys over a 6-hour period, resulting in high urinary concentrations. Probenecid slows tubular excretion and produces higher serum levels and increases the duration of measurable serum concentrations.


Cefoxitin passes into pleural and joint fluids and is detectable in antibacterial concentrations in bile.


In a published study of geriatric patients ranging in age from 64 to 88 years with normal renal function for their age (creatinine clearance ranging from 31.5 to 174.0 mL/min), the half-life for cefoxitin ranged from 51 to 90 minutes, resulting in higher plasma concentrations than in younger adults. These changes were attributed to decreased renal function associated with the aging process.



Microbiology


The bactericidal action of cefoxitin results from inhibition of cell wall synthesis. Cefoxitin has in vitro activity against a wide range of gram-positive and gram-negative organisms. The methoxy group in the 7α position provides cefoxitin with a high degree of stability in the presence of beta-lactamases, both penicillinases and cephalosporinases, of gram-negative bacteria.


Cefoxitin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.


Aerobic gram-positive microorganisms
 

Staphylococcus aureus2 (including penicillinase-producing strains)

 

Staphylococcus epidermidis2 

 

Streptococcus agalactiae

 

Streptococcus pneumoniae

 

Streptococcus pyogenes

Most strains of enterococci, e.g., Enterococcus faecalis, are resistant.



2


Staphylococci resistant to methicillin/oxacillin should be considered resistant to cefoxitin.



Aerobic gram-negative microorganisms
 

Escherichia coli

 

Haemophilus influenzae

 

Klebsiella spp. (including K. pneumoniae)

 

Morganella morganii

 

Neisseria gonorrhoeae (including penicillinase-producing strains)

 

Proteus mirabilis

 

Proteus vulgaris

 

Providencia spp. (including Providencia rettgeri)

Anaerobic gram-positive microorganisms
 

Clostridium spp.

 

Peptococcus niger

 

Peptostreptococcus spp.

Anaerobic gram-negative microorganisms
 

Bacteroides distasonis

 

Bacteroides fragilis

 

Bacteroides ovatus

 

Bacteroides thetaiotaomicron

 

Bacteroides spp.

The following in vitro data are available, but their clinical significance is unknown.


Cefoxitin exhibits in vitro minimum inhibitory concentrations (MIC's) of 8 µg/mL or less for aerobic microorganisms and 16 µg/mL or less for anaerobic microorganisms against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of cefoxitin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.


Aerobic gram-negative microorganisms
 

Eikenella corrodens [non-β-lactamase producers]

 

Klebsiella oxytoca

Anaerobic gram-positive microorganisms
 

Clostridium perfringens

Anaerobic gram-negative microorganisms
 

Prevotella bivia (formerly Bacteroides bivius)

Cefoxitin is inactive in vitro against most strains of Pseudomonas aeruginosa and enterococci and many strains of Enterobacter cloacae.


Susceptibility Tests

Dilution Techniques


Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's). These MIC's provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC's should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cefoxitin powder. The MIC values should be interpreted according to the following criteria:



For testing aerobic microorganisms3,4,5 other than Neisseria gonorrhoeae:











MIC (µg/mL)Interpretation
≤ 8Susceptible (S)
16Intermediate (I)
≥ 32Resistant (R)

3


Staphylococci exhibiting resistance to methicillin/oxacillin should be reported as also resistant to cefoxitin despite apparent in vitro susceptibility.



4


For testing Haemophilus influenzae these interpretative criteria applicable only to tests performed by broth microdilution method using Haemophilus Test Medium (HTM)1.



5


For testing streptococci these interpretative criteria applicable only to tests performed by broth microdilution method using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood1.




For testing Neisseria gonorrhoeae6:











MIC (µg/mL)Interpretation
≤ 2Susceptible (S)
4Intermediate (I)
≥ 8Resistant (R)

6


Interpretative criteria applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement and incubated in 5% CO21. A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.




Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard cefoxitin powder should provide the following MIC values:
















MicroorganismMIC (µg/mL)

*

Interpretative criteria applicable only to tests performed by agar dilution method using GC agar base with 1% defined growth supplement and incubated in 5% CO21.

Escherichia coliATCC 259221-4
Neisseria gonorrhoeae*ATCC 492260.5-2
Staphylococcus aureusATCC 292131-4

Diffusion Techniques


Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30-μg cefoxitin to test the susceptibility of microorganisms to cefoxitin.


Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-μg cefoxitin disk should be interpreted according to the following criteria:



For testing aerobic microorganisms7,8,9 other than Neisseria gonorrhoeae:











Zone Diameter (mm)Interpretation
≥ 18Susceptible (S)
15-17Intermediate (I)
≤ 14Resistant (R)

7


Staphylococci exhibiting resistance to methicillin/oxacillin should be reported as also resistant to cefoxitin despite apparent in vitro susceptibility.



8


For testing Haemophilus influenzae these interpretative criteria applicable only to tests performed by disk diffusion method using Haemophilus Test Medium (HTM)1.



9


For testing streptococci these interpretative criteria applicable only to tests performed by disk diffusion method using Mueller-Hinton agar with 5% defibrinated sheep blood and incubated in 5% CO22.




For testing Neisseria gonorrhoeae10:











Zone Diameter (mm)Interpretation
≥ 28Susceptible (S)
24-27Intermediate (I)
≤ 23Resistant (R)

10


Interpretative criteria applicable only to tests performed by disk diffusion method using GC agar base with 1% defined growth supplement and incubated in 5% CO22.




Interpretation should be as stated above for results using dilution techniques.


Interpretation involves correlation of the diameter obtained in the disk test with the MIC for cefoxitin.


As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30-µg cefoxitin disk should provide the following zone diameters in these laboratory test quality control strains:
















MicroorganismZone Diameter (mm)

*

Interpretative criteria applicable only to tests performed by disk diffusion method using GC agar base with 1% defined growth supplement and incubated in 5% CO22.

Escherichia coliATCC 2592223-29
Neisseria gonorrhoeae*ATCC 4922633-41
Staphylococcus aureusATCC 2592323-29

Anaerobic Techniques


For anaerobic bacteria, the susceptibility to cefoxitin as MIC's can be determined by standardized test methods3. The MIC values obtained should be interpreted according to the following criteria:











MIC (µg/mL)Interpretation
≤ 16Susceptible (S)
32Intermediate (I)
≥ 64Resistant (R)

Interpretation is identical to that stated above for results using dilution techniques.



As with other susceptibility techniques, the use of laboratory control microorganisms is required to control the technical aspects of the laboratory standardized procedures. Standard cefoxitin powder should provide the following MIC values:














Using either an Agar Dilution Method* or Using a Broth Microdilution Method:
MicroorganismMIC (µg/mL)

*

Range applicable only to tests performed using either Brucella blood or Wilkins-Chalgren agar.


Range applicable only to tests performed in the broth formulation of Wilkins-Chalgren agar3.

Bacteroides fragilisATCC 252854-16
Bacteroides thetaiotaomicronATCC 297418-32

Indications and Usage for Mefoxin


Mefoxin, supplied as a premixed solution in plastic containers, is intended for intravenous use only.



Treatment


Mefoxin is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.


  • (1) Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae, other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, Haemophilus influenzae, and Bacteroides species.

  • (2) Urinary tract infections caused by Escherichia coli, Klebsiella species, Proteus mirabilis, Morganella morganii, Proteus vulgaris and Providencia species (including P. rettgeri).

  • (3) Intra-abdominal infections, including peritonitis and intra-abdominal abscess, caused by Escherichia coli, Klebsiella species, Bacteroides species including Bacteroides fragilis, and Clostridium species.

  • (4) Gynecological infections, including endometritis, pelvic cellulitis, and pelvic inflammatory disease caused by Escherichia coli, Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, Peptostreptococcus species, and Streptococcus agalactiae. Mefoxin, like cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when Mefoxin is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.

  • (5) Septicemia caused by Streptococcus pneumoniae, Staphylococcus aureus (including penicillinase-producing strains), Escherichia coli, Klebsiella species, and Bacteroides species including B. fragilis.

  • (6) Bone and joint infections caused by Staphylococcus aureus (including penicillinase-producing strains).

  • (7) Skin and skin structure infections caused by Staphylococcus aureus (including penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes and other streptococci (excluding enterococci e.g., Enterococcus faecalis [formerly Streptococcus faecalis]), Escherichia coli, Proteus mirabilis, Klebsiella species, Bacteroides species including B. fragilis, Clostridium species, Peptococcus niger, and Peptostreptococcus species.

Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organisms to Mefoxin. Therapy may be started while awaiting the results of these studies.


In randomized comparative studies, cefoxitin and cephalothin were comparably safe and effective in the management of infections caused by gram-positive cocci and gram-negative rods susceptible to the cephalosporins. Mefoxin has a high degree of stability in the presence of bacterial beta-lactamases, both penicillinases and cephalosporinases.


Many infections caused by aerobic and anaerobic gram-negative bacteria resistant to some cephalosporins respond to Mefoxin. Similarly, many infections caused by aerobic and anaerobic bacteria resistant to some penicillin antibiotics (ampicillin, carbenicillin, penicillin G) respond to treatment with Mefoxin. Many infections caused by mixtures of susceptible aerobic and anaerobic bacteria respond to treatment with Mefoxin.



Prevention


Mefoxin is indicated for the prophylaxis of infection in patients undergoing uncontaminated gastrointestinal surgery, vaginal hysterectomy, abdominal hysterectomy, or cesarean section.


If there are signs of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate treatment may be instituted.


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Mefoxin and other antibacterial drugs, Mefoxin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.



Contraindications


Mefoxin is contraindicated in patients who have shown hypersensitivity to cefoxitin and the cephalosporin group of antibiotics.



Warnings


BEFORE THERAPY WITH 'Mefoxin' IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFOXITIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO 'Mefoxin' OCCURS, DISCONTINUE THE DRUG. SERIOUS HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES.


Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including Mefoxin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.


C. difficile produces toxins A and B which contribute to the development of CDAD.


Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.


If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.



Precautions



General


The total daily dose should be reduced when Mefoxin is administered to patients with transient or persistent reduction of urinary output due to renal insufficiency (see DOSAGE AND ADMINISTRATION, TREATMENT), because high and prolonged serum antibiotic concentrations can occur in such individuals from usual doses.


Antibiotics (including cephalosporins) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.


As with other antibiotics, prolonged use of Mefoxin may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.


Do not use unless solution is clear and seal is intact.


Prescribing Mefoxin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.



Information for Patients


Patients should be counseled that antibacterial drugs including Mefoxin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Mefoxin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Mefoxin or other antibacterial drugs in the future.


Diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.



Laboratory Tests


As with any potent antibacterial agent, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.



Drug Interactions


Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.



Drug/Laboratory Test Interactions


As with cephalothin, high concentrations of cefoxitin (>100 micrograms/mL) may interfere with measurement of serum and urine creatinine levels by the Jaffé reaction, and produce false increases of modest degree in the levels of creatinine reported. Serum samples from patients treated with cefoxitin should not be analyzed for creatinine if withdrawn within 2 hours of drug administration.


High concentrations of cefoxitin in the urine may interfere with measurement of urinary 17–hydroxy-corticosteroids by the Porter-Silber reaction, and produce false increases of modest degree in the levels reported.


A false-positive reaction for glucose in the urine may occur. This has been observed with CLINITEST11 reagent tablets.



11


Clinitest is a trademark of Siemens Healthcare Diagnostics Inc.




Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term studies in animals have not been performed with cefoxitin to evaluate carcinogenic or mutagenic potential. Studies in rats treated intravenously with 400 mg/kg of cefoxitin (approximately three times the maximum recommended human dose) revealed no effects on fertility or mating ability.



Pregnancy


Pregnancy Category B

Reproduction studies performed in rats and mice at parenteral doses of approximately one to seven and one-half times the maximum recommended human dose did not reveal teratogenic or fetal toxic effects, although a slight decrease in fetal weight was observed.


There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.


In the rabbit, cefoxitin was associated with a high incidence of abortion and maternal death. This was not considered to be a teratogenic effect but an expected consequence of the rabbit's unusual sensitivity to antibiotic-induced changes in the population of the microflora of the intestine.



Nursing Mothers


Cefoxitin is excreted in human milk in low concentrations. Caution should be exercised when Mefoxin is administered to a nursing woman.



Pediatric Use


Safety and efficacy in pediatric patients from birth to three months of age have not yet been established. In pediatric patients three months of age and older, higher doses of cefoxitin have been associated with an increased incidence of eosinophilia and elevated SGOT.


The potential for toxic effects in pediatric patients from chemicals that may leach from the single-dose I.V. preparation in plastic has not been determined.



Geriatric Use


Of the 1,775 subjects who received cefoxitin in clinical studies, 424 (24%) were 65 and over, while 124 (7%) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see CLINICAL PHARMACOLOGY).


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. 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 (see DOSAGE AND ADMINISTRATION and PRECAUTIONS).



Adverse Reactions


Cefoxitin is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently.



Local Reactions


Thrombophlebitis has occurred with intravenous administration.



Allergic Reactions


Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted.



Cardiovascular


Hypotension.



Gastrointestinal


Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely.



Neuromuscular


Possible exacerbation of myasthenia gravis.



Blood


Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia, including hemolytic anemia, thrombocytopenia, and bone marrow depression. A positive direct Coombs test may develop in some individuals, especially those with azotemia.



Liver Function


Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported.



Renal Function


Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely. The role of Mefoxin in changes in renal function tests is difficult to assess, since factors predisposing to prerenal azotemia or to impaired renal function usually have been present.


In addition to the adverse reactions listed above which have been observed in patients treated with Mefoxin, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:


Urticaria, erythema multiforme, Stevens-Johnson syndrome, serum sickness-like reactions, abdominal pain, colitis, renal dysfunction, toxic nephropathy, false-positive test for urinary glucose, hepatic dysfunction including cholestasis, elevated bilirubin, aplastic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis, superinfection, vaginitis including vaginal candidiasis.


Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.



Overdosage


The acute intravenous LD50 in the adult female mouse and rabbit was about 8.0 g/kg and greater than 1.0 g/kg, respectively. The acute intraperitoneal LD50 in the adult rat was greater than 10.0 g/kg.



Mefoxin Dosage and Administration


NOTE: Mefoxin® in Galaxy12 container is for intravenous infusion only.



12


Galaxy® is a registered trademark of Baxter International Inc.




TREATMENT


Adults

The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).


If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoxitin sodium has no activity against this organism.


Mefoxin may be used in patients with reduced renal function with the following dosage adjustments:


In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.


When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.









Males:Weight (kg) × (140-age)
72 × serum creatinine (mg/100 mL)


Females:


0.85 × male value

In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.


Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.


Pediatric Patients

The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.


At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).


In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).



PREVENTION


Effective prophylactic use depends on the time of administration. Mefoxin usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.


For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:


Adults

2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.


Pediatric Patients (3 months and older)

30 to 40 mg/kg doses may be given at the times designated above.


Cesarean section patients

For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

















Table 1 - Guidelines for Dosage of Mefoxin
Type of InfectionDaily DosageFrequency and Route

*

Including patients in whom bacteremia is absent or unlikely.

Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection3-4 grams1 gram every 6-8 hours IV
Moderately severe or severe infections6-8 grams1 gram every 4 hours

or

2 grams every 6-8 hours IV
Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)12 grams2 grams every 4 hours

or

3 grams every 6 hours IV













Table 2 - Maintenance Dosage of Mefoxin in Adults with Reduced Renal Function
Renal FunctionCreatinine Clearance

(mL/min)
Dose (grams)Frequency
Mild impairment50-301-2every 8-12 hours
Moderate impairment29-101-2

Mefoxin


Generic Name: cefoxitin (Intravenous route)

sef-OX-i-tin

Commonly used brand name(s)

In the U.S.


  • Mefoxin

Available Dosage Forms:


  • Powder for Solution

  • Solution

Therapeutic Class: Antibiotic


Pharmacologic Class: 2nd Generation Cephalosporin


Uses For Mefoxin


Cefoxitin injection is used to treat bacterial infections in many different parts of the body. This medicine is also given before certain types of surgery to prevent infections.


Cefoxitin injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.


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


Before Using Mefoxin


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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefoxitin injection in children. However, safety and efficacy have not been established in children younger than 3 months old.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefoxitin injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefoxitin injection.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Colitis (inflammation in gut), history of or

  • Diarrhea, severe, history of or

  • Seizures—Use with caution. May make these conditions worse.

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

Proper Use of Mefoxin


A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.


Precautions While Using Mefoxin


If your symptoms or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.


Cefoxitin injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.


Before you or your child have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.


Mefoxin 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 or nurse immediately if any of the following side effects occur:


More common
  • Changes in skin color

  • pain

  • swelling of the foot or leg

  • tenderness

Rare
  • Agitation

  • coma

  • confusion

  • decreased urine output

  • depression

  • dizziness

  • headache

  • hostility

  • irritability

  • lethargy

  • muscle twitching

  • nausea

  • rapid weight gain

  • seizures

  • stupor

  • swelling of the face, ankles, or hands

  • unusual tiredness or weakness

Incidence not known
  • Abdominal or stomach cramps or tenderness

  • back, leg, or stomach pains

  • bleeding and bruising

  • bleeding gums

  • blistering, peeling, or loosening of the skin

  • bloating

  • bloody or cloudy urine

  • bloody, black, or tarry stools

  • chest pain

  • chills

  • clay-colored stools

  • cloudy urine

  • cough

  • coughing up blood

  • cracks in the skin

  • dark urine

  • decrease in urine output or decrease in urine-concentrating ability

  • diarrhea

  • diarrhea, watery and severe, which may also be bloody

  • difficult or labored breathing

  • difficult or painful urination

  • difficulty with breathing, chewing, swallowing, or talking

  • dizziness

  • double vision

  • drooping eyelids

  • fast heartbeat

  • feeling of discomfort

  • fever

  • general body swelling

  • greatly decreased frequency of urination or amount of urine

  • headache

  • high fever

  • hives

  • increased menstrual flow or vaginal bleeding

  • increased thirst

  • inflammation of the joints

  • itching

  • itching of the vagina or genital area

  • joint or muscle pain

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • loss of appetite

  • loss of heat from the body

  • muscle aches

  • muscle weakness

  • nosebleeds

  • pain during sexual intercourse

  • pale skin

  • paralysis

  • prolonged bleeding from cuts

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • rash

  • red or black, tarry stools

  • red or dark brown urine

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • red, swollen skin

  • scaly skin

  • severe tiredness

  • shortness of breath

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • sudden decrease in the amount of urine

  • swelling of the feet or lower legs

  • swollen lymph glands

  • swollen or painful glands

  • thick, white vaginal discharge with no odor or with a mild odor

  • tightness in the chest

  • troubled breathing with exertion

  • unexplained bleeding or bruising

  • unpleasant breath odor

  • unusual bleeding or bruising

  • unusual weight loss

  • vomiting

  • vomiting of blood

  • wheezing

  • yellowing of the eyes or skin

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
  • Red streaks on the skin

  • swelling, tenderness, or pain at the injection site

Incidence not known
  • Hives or welts

  • redness of the skin

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: Mefoxin side effects (in more detail)



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More Mefoxin resources


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


  • Mefoxin Prescribing Information (FDA)

  • Mefoxin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mefoxin Concise Consumer Information (Cerner Multum)

  • Mefoxin Monograph (AHFS DI)

  • Cefoxitin Prescribing Information (FDA)



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