itraconazole

Generic Name: itraconazole (IT ra KON a zole)

Brand Names: Sporanox, Sporanox PulsePak

What is itraconazole?

Itraconazole is an antifungal medication.

Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

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

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

Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal), if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment. There are many other drugs that can cause serious or life threatening medical problems if you take them together with itraconazole. This includes cisapride (Propulsid), dihydroergotamine (D.H.E. 45, Migranal), dofetilide (Tikosyn), ergonovine (Ergotrate), ergotamine (Ergomar), lovastatin (Advicor, Altocor, Altoprev, Mevacor), methylergonovine (Methergine), midazolam (Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quin-G), simvastatin (Zocor, Simcor, Vytorin), and triazolam (Halcion).

Before taking itraconazole, tell your doctor if you have heart disease, a history of stroke, a heart rhythm disorder, kidney or liver disease, a breathing disorder, cystic fibrosis, or a history of "Long QT syndrome."

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Itraconazole will not treat a viral infection such as the common cold or flu.

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

Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal), if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment. There are many other drugs that can cause serious or life threatening medical problems if you take them together with itraconazole. The following drugs should not be used while you are taking itraconazole:

• 
  

  cisapride (Propulsid);

  
  


• 
  

  dofetilide (Tikosyn);

  
  


• 
  

  lovastatin (Advicor, Altocor, Altoprev, Mevacor) or simvastatin (Zocor, Simcor, Vytorin);

  
  


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  midazolam (Versed) or triazolam (Halcion);

  
  


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  nisoldipine (Sular);

  
  


• 
  

  pimozide (Orap);

  
  


• 
  

  quinidine (Quin-G); and

  
  


• 
  

  ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Ercaf, Migergot), or methylergonovine (Methergine).

  
  

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

• 
  

  heart disease, a heart rhythm disorder, circulation problems, or a history of stroke;

  
  


• 
  

  chronic obstructive pulmonary disease (COPD) or other breathing disorder;

  
  


• 
  

  kidney disease;

  
  


• 
  

  liver disease;

  
  


• 
  

  cystic fibrosis; or

  
  


• 
  

  a personal or family history of "Long QT syndrome."

  
  

FDA pregnancy category C. It is not known whether itraconazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Itraconazole passes into breast milk and can harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take itraconazole?

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

The itraconazole tablet should be taken after a full meal. Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

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

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medication at the pharmacy and ask the pharmacist if you have any questions. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Itraconazole will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

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

See also: Itraconazole dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking itraconazole?

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) within 1 hour before or 2 hours after you take itraconazole. These medications can make it harder for your body to absorb itraconazole.

Itraconazole 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  fever;

  
  


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  feeling short of breath, even with mild exertion;

  
  


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  swelling, rapid weight gain;

  
  


• 
  

  problems with hearing;

  
  


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  numbness or tingly feeling;

  
  


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  pain or burning when you urinate;

  
  


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  nausea, pain in your upper stomach, itching, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

  
  

Less serious side effects may include:

• 
  

  diarrhea, constipation, mild stomach pain;

  
  


• 
  

  mild itching or skin rash;

  
  


• 
  

  headache, dizziness; or

  
  


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  runny nose or other cold symptoms.

  
  

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.

Itraconazole Dosing Information

Usual Adult Dose for Blastomycosis:

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose may be increased in 100 mg increments to a maximum of 400 mg/day

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided. Some clinicians recommend therapy for at least 12 months for disseminated or chronic pulmonary histoplasmosis and 6 to 12 months for blastomycosis.

Usual Adult Dose for Histoplasmosis:

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose may be increased in 100 mg increments to a maximum of 400 mg/day

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided. Some clinicians recommend therapy for at least 12 months for disseminated or chronic pulmonary histoplasmosis and 6 to 12 months for blastomycosis.

Usual Adult Dose for Aspergillosis -- Aspergilloma:

Capsules: 200 to 400 mg orally per day in one or two divided doses

Treatment should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

Usual Adult Dose for Oral Thrush:

Oral solution:
Oropharyngeal candidiasis: 200 mg orally once a day for 1 to 2 weeks

Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Oropharyngeal candidiasis unresponsive/refractory to treatment with fluconazole tablets: 100 mg orally twice a day

Clinical response will be seen in 2 to 4 weeks in patients responding to therapy. Patients may be expected to relapse shortly after discontinuing therapy.

Usual Adult Dose for Esophageal Candidiasis:

Oral solution: 100 mg orally once a day for a minimum of 3 weeks
Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg/day may be used.

Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Usual Adult Dose for Onychomycosis -- Toenail:

Capsules (with or without fingernail involvement) or tablets: 200 mg orally once a day for 12 consecutive weeks

Usual Adult Dose for Onychomycosis -- Fingernail:

Fingernails only:
Capsules: 200 mg orally twice a day for 1 week; the dosing should be repeated after 3 weeks without itraconazole for a total of 2 treatment pulses

Usual Adult Dose for Candida Urinary Tract Infection:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for 1 to 2 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Candidemia:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for 1 to 2 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Coccidioidomycosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for at least 6 months and until tests indicate fungal infection has subsided.

Usual Adult Dose for Paracoccidioidomycosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for at least 6 months and until tests indicate fungal infection has subsided.

Usual Adult Dose for Dermatophytosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/day
Therapy should be continued for at least 4 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Sporotrichosis:

Capsules:
Cutaneous or lymphonodular infection: 100 to 200 mg orally once a day
Osteoarticular or pulmonary infection: 200 mg to 300 mg orally 2 times a day

Usual Adult Dose for Cryptococcosis:

Capsules: 200 to 400 mg orally each day
The 400 mg/day dose is recommended for more severe infection and infection with central nervous system involvement in an HIV-infected patient.

Usual Adult Dose for Tinea Versicolor:

Capsules: 200 mg orally 2 times a day

Usual Adult Dose for Vaginal Candidiasis:

Capsules: 200 mg orally 2 times a day for 1 day

Usual Pediatric Dose for Histoplasmosis:

HIV-infected infants and children:
Prophylaxis for first episode: 2 to 5 mg/kg orally every 12 to 24 hours
Prophylaxis for recurrence: 2 to 5 mg/kg orally every 12 to 48 hours

Usual Pediatric Dose for Cryptococcosis:

HIV-infected infants and children:
Prophylaxis for first episode and recurrence: 2 to 5 mg/kg orally every 12 to 24 hours

Usual Pediatric Dose for Tinea Capitis:

Continuous regimen:
Trichophyton tonsurans and Trichophyton violaceum (endothrix) species: 5 mg/kg/day orally for 2 to 4 weeks
Microsporum canis (ectothrix) species: 5 mg/kg/day orally for 4 to 6 weeks

Pulse regimen:
Capsules:
T tonsurans, T violaceum (endothrix), and M canis (ectothrix) species: 5 mg/kg/day orally for 1 week followed by a 3-week period off of treatment

Patient is evaluated on week 4 from the start of therapy for clinical response. If evidence of tinea capitis remains, additional pulse therapies may be required up to a maximum of 3 pulses.

What other drugs will affect itraconazole?

Many drugs can interact with itraconazole. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  cancer medications;

  
  


• 
  

  cholesterol medications such as atorvastatin (Lipitor);

  
  


• 
  

  cyclosporine (Gengraf, Sandimmune, Neoral);

  
  


• 
  

  diabetes medication you take by mouth;

  
  


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  digoxin (digitalis, Lanoxin);

  
  


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  disopyramide (Norpace);

  
  


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  fentanyl (Actiq, Duragesic);

  
  


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  isoniazid (for treating tuberculosis);

  
  


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  rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, Rifater, Rifamate), or rifapentine (Priftin);

  
  


• 
  

  sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


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  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

  
  


• 
  

  an antifungal medication such as clotrimazole (Mycelex Troche), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  an antidepressant such as nefazodone, paroxetine (Paxil), or sertraline (Zoloft);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton);

  
  


• 
  

  heart or blood pressure medications such as amlodipine (Norvasc), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase, Fortovase), or ritonavir (Norvir, Kaletra);

  
  


• 
  

  a sedative such as alprazolam (Xanax), diazepam (Valium); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or phenytoin (Dilantin), or primidone (Mysoline).

  
  

This list is not complete and there are many other drugs that can interact with itraconazole. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More itraconazole resources

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

• itraconazole Advanced Consumer (Micromedex) - Includes Dosage Information


• Itraconazole Professional Patient Advice (Wolters Kluwer)


• Itraconazole Prescribing Information (FDA)


• Itraconazole MedFacts Consumer Leaflet (Wolters Kluwer)


• Itraconazole Monograph (AHFS DI)


• Sporanox Consumer Overview


• Sporanox Prescribing Information (FDA)


• Sporanox PulsePak MedFacts Consumer Leaflet (Wolters Kluwer)

Compare itraconazole with other medications

• Aspergillosis, Aspergilloma
• Blastomycosis
• Candida Infections, Systemic
• Candida Urinary Tract Infection
• Coccidioidomycosis
• Cryptococcosis
• Dermatophytosis
• Esophageal Candidiasis
• Febrile Neutropenia
• Histoplasmosis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Oral Thrush
• Paracoccidioidomycosis
• Sporotrichosis
• Tinea Capitis
• Tinea Versicolor
• Vaginal Yeast Infection

Where can I get more information?

• Your pharmacist can provide more information about itraconazole.

See also: itraconazole side effects (in more detail)

IvDerm otic

Generic Name: chloroxylenol, hydrocortisone, and pramoxine (otic) (KLOR oh ZYE nol, HYE droe KOR ti sone, pra MOX een)

Brand Names: Aero Otic HC, Cortamox, Cortane-B, Cortane-B Aqueous, Cortane-B Otic, Cortic-ND, Cyotic, Exotic-HC, Hydro Ear, IvDerm, Otirx, Oto-End, Otomar HC, Tri-Otic, Zolene HC, Zoto-HC Drops

What is IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Chloroxylenol is an antibiotic that fights bacteria.

Pramoxine is a topical anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of chloroxylenol, hydrocortisone, and pramoxine otic (for the ear) are used to treat pain, and swelling caused by ear infections.

Chloroxylenol, hydrocortisone, and pramoxine otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Do not use this medication if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum.

Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic to any drugs, or if you have any type of illness or infection (other than an ear infection).

Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Stop using this medication and call your doctor at once if you have ear drainage or discharge, severe burning or itching in your ear, or worsening pain, irritation, or rash.

Less serious side effects are more likely, and you may have none at all.

What should I discuss with my healthcare provider before using IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

You should not use this medication if you are allergic to chloroxylenol, hydrocortisone, or pramoxine.

Do not use this medication if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum.

Before using chloroxylenol, hydrocortisone, and pramoxine, tell your doctor if you are allergic to any drugs, or if you have any type of illness or infection (other than an ear infection).

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chloroxylenol, hydrocortisone, and pramoxine otic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use my IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Do not use the medication in your eyes or take it by mouth. Chloroxylenol, hydrocortisone, and pramoxine otic is for use in the ears only.

For best results, remove any ear wax or other debris before using the ear drops. Ask your doctor about safe methods of ear wax removal.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and place enough drops of the medicine in your ear to fill the ear canal.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, keep the ear tilted upward for about 5 minutes. You may also be able to soak a small cotton wick with the medication and leave it in place. Ask your doctor of pharmacist for instructions on using a cotton wick.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after using this medication.

Store the ear drops at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of chloroxylenol, hydrocortisone, and pramoxine applied into the ear is not likely to cause life-threatening symptoms.

What should I avoid while using this medication?

Do not use other ear drops during treatment with chloroxylenol, hydrocortisone, and pramoxine otic without first talking to your doctor. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Chloroxylenol, hydrocortisone, and pramoxine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic)) side effects

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

• 
  

  ear drainage or discharge;

  
  


• 
  

  severe burning or itching in your ear; or

  
  


• 
  

  worsening pain, irritation, or rash.

  
  

Less serious side effects are more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my IvDerm (chloroxylenol, hydrocortisone, and pramoxine (otic))?

It is not likely that other drugs you take orally or inject will have an effect on chloroxylenol, hydrocortisone, and hydrocortisone otic. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More IvDerm resources

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

Compare IvDerm with other medications

• Acute Otitis Externa
• Ear Conditions
• Otitis Externa

Where can I get more information?

• Your pharmacist can provide more information about chloroxylenol, hydrocortisone, and pramoxine otic.

Iophen-C NR

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

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

What is Iophen-C NR (codeine and guaifenesin)?

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

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

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

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

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

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

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

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

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

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

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  asthma, COPD, emphysema, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a thyroid disorder;

  
  


• liver or kidney disease;


• 
  

  enlarged prostate; or

  
  


• 
  

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

  
  

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

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

How should I take Iophen-C NR (codeine and guaifenesin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

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

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

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

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

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

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

What happens if I miss a dose?

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

What happens if I overdose?

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

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

What should I avoid while taking Iophen-C NR (codeine and guaifenesin)?

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

Iophen-C NR (codeine and guaifenesin) side effects

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

• 
  

  severe dizziness or drowsiness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

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

  
  

Less serious side effects include:

• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  warmth, redness, or tingling under your skin;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  constipation; or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Iophen-C NR (codeine and guaifenesin)?

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

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

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  naloxone (Narcan); or

  
  


• 
  

  naltrexone (Vivitrol).

  
  

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

More Iophen-C NR resources

• Iophen-C NR Side Effects (in more detail)
• Iophen-C NR Use in Pregnancy & Breastfeeding
• Iophen-C NR Drug Interactions
• Iophen-C NR Support Group
• 1 Review for Iophen-C NR - Add your own review/rating

• Brontex MedFacts Consumer Leaflet (Wolters Kluwer)


• ExeClear-C Prescribing Information (FDA)


• Guiatuss AC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Iophen-C NR with other medications

• Cough

Where can I get more information?

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

See also: Iophen-C NR side effects (in more detail)

Iodoflex Gel Pad

Pronunciation: kad-EX-oh-mer EYE-oh-dine
Generic Name: Cadexomer Iodine
Brand Name: Iodoflex

Iodoflex Gel Pad is used for:

Cleansing and protecting wounds and sores (eg, wet ulcers, venous stasis ulcers, pressure sores, infected surgical wounds). It may also be used for other conditions as determined by your doctor.

Iodoflex Gel Pad is an antibacterial and absorbent agent. It works by absorbing fluid and bacteria from the surface of the wound, which helps it to heal.

Do NOT use Iodoflex Gel Pad if:

• you are allergic to any ingredient in Iodoflex Gel Pad, including iodine


• you have Hashimoto thyroiditis, a history of Graves disease or nontoxic nodular goiter, or other thyroid problems


• you are pregnant or breast-feeding

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

Before using Iodoflex Gel Pad:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of thyroid or kidney problems

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

Ask your health care provider if Iodoflex Gel Pad may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Iodoflex Gel Pad:

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

• An additional patient leaflet is available with Iodoflex Gel Pad. Talk to your pharmacist if you have questions about this information.


• Wash your hands before and after using Iodoflex Gel Pad, unless your hands are a part of the treated area.


• Clean the wound and surrounding area with a gentle stream of sterile water or saline. Gently blot away excess fluid, leaving the surface slightly moist.


• With gloved hands, remove the carrier gauze on one or both sides of the pad. Place the pad in contact with the wound surface as directed by your doctor. If there is any remaining medicine, throw it away.


• Cover the wound with dry, sterile gauze or other dressing as directed by your doctor.


• Apply a compression bandage as directed if your doctor has told you to do so.


• Change the pad when the medicine changes from brown to yellow/gray or as directed by your doctor.


• To change the pad, peel the gauze away from the wound. You may soak the gauze for a few minutes as directed if needed to help remove it.


• Remove the medicine with sterile water or saline. Gently blot away excess fluid, leaving the surface slightly moist. Reapply a new pad as directed.


• If you miss a dose of Iodoflex Gel Pad, use it as soon as you remember. Continue to use Iodoflex Gel Pad as directed by your doctor.

Ask your health care provider any questions you may have about how to use Iodoflex Gel Pad.

Important safety information:

• Iodoflex Gel Pad is for external use only. Do not get Iodoflex Gel Pad in your eyes, nose, or mouth. If you get Iodoflex Gel Pad in any of these areas, rinse immediately with cool water.


• Iodoflex Gel Pad is not effective in cleaning dry wounds.


• The wound may appear larger during the first few days of treatment, due to decreased swelling.


• Do not use more of Iodoflex Gel Pad than prescribed.


• Do not use Iodoflex Gel Pad for longer than 3 months without checking with your doctor.


• Iodoflex Gel Pad may interfere with certain lab tests, including thyroid function tests. Be sure your doctor and lab personnel know you are using Iodoflex Gel Pad.


• Use Iodoflex Gel Pad with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Iodoflex Gel Pad if you are pregnant. If you think you may be pregnant, contact your doctor immediately. Iodoflex Gel Pad is found in breast milk. Do not breast-feed while taking Iodoflex Gel Pad.

Possible side effects of Iodoflex Gel Pad:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild irritation, pain, redness, or swelling at the application site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent irritation, pain, redness, or swelling at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Iodoflex side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Iodoflex Gel Pad:

Store Iodoflex Gel Pad at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Iodoflex Gel Pad out of the reach of children and away from pets.

General information:

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


• Iodoflex Gel Pad is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Iodoflex Gel Pad. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Iodoflex resources

• Iodoflex Side Effects (in more detail)
• Iodoflex Use in Pregnancy & Breastfeeding
• Iodoflex Support Group
• 0 Reviews · Be the first to review/rate this drug

Icar

Generic Name: carbonyl iron (car BAH nill I ern)

Brand Names: Elemental Iron, Feosol Caplet, Icar, Iron Chews

What is Icar (carbonyl iron)?

Carbonyl iron is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Carbonyl iron is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.

Carbonyl iron may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Icar (carbonyl iron)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Carbonyl iron may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking carbonyl iron if you take any other prescription or over-the-counter medicines.

Who should not take Icar (carbonyl iron)?

Do not take carbonyl iron if you have

• 
  

  hemochromatosis,

  
  


• 
  

  hemosiderosis, or

  
  


• 
  

  hemolytic anemia.

  
  

Carbonyl iron may be dangerous if you have any of the conditions listed above.

If you do not have an iron deficiency, talk to your doctor about the use of carbonyl iron. Generally, carbonyl iron should not be taken chronically by individuals with a normal iron balance.

Talk to your doctor before taking carbonyl iron if you are pregnant. Talk to your doctor before taking carbonyl iron if you are breast-feeding a baby.

How should I take Icar (carbonyl iron)?

Take carbonyl iron exactly as directed by your doctor, or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each tablet with a full glass of water. Take carbonyl iron on an empty stomach for best results. If stomach upset occurs, take carbonyl iron with food or following a meal.

Shake the suspension well before measuring a dose. To ensure that you get the correct dose, measure the liquid form of carbonyl iron with a dose measuring cup or spoon, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist where you can get one.

Carbonyl iron may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking carbonyl iron if you take any other prescription or over-the-counter medicines.

Store carbonyl iron at room temperature, away from moisture and heat. Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time to take next dose, skip the dose you missed and take the next regularly scheduled dose as directed. Do not take a double dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a carbonyl iron overdose include decreased energy; nausea; vomiting; abdominal pain; tarry stools; a weak, rapid pulse; fever; coma; seizures; and death.

What should I avoid while taking Icar (carbonyl iron)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Carbonyl iron may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking carbonyl iron if you take any other prescription or over-the-counter medicines.

Icar (carbonyl iron) side effects

If you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), stop taking carbonyl iron and seek emergency medical attention.

Other less serious side effects are more likely to occur. Continue taking carbonyl iron and talk to your doctor or pharmacist if you experience

• 
  

  stomach upset,

  
  


• 
  

  nausea or vomiting,

  
  


• 
  

  constipation,

  
  


• 
  

  diarrhea,

  
  


• 
  

  black or darker than normal appearing stools, or

  
  


• 
  

  temporary staining of the teeth.

  
  

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 Icar (carbonyl iron)?

Do not take carbonyl iron within 2 hours of a dose of any of the following medicines

• 
  

  a tetracycline antibiotic such as tetracycline (Achromycin, Sumycin), minocycline (Minocin, Dynacin), doxycycline (Vibramycin, Monodox), demeclocycline (Declomycin), oxytetracycline (Terramycin), or troleandomycin (TAO);

  
  


• 
  

  a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), enoxacin (Penetrex) ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), sparfloxacin (Zagam), or trovafloxacin (Trovan);

  
  


• 
  

  levodopa (Larodopa, Dopar, Sinemet);

  
  


• 
  

  levothyroxine (Synthroid, Levoxyl, others);

  
  


• 
  

  methyldopa (Aldomet); or

  
  


• 
  

  penicillamine (Cuprimine).

  
  

Carbonyl iron may decrease the absorption of the drugs listed above.

Do not take antacids within 2 hours of a dose of carbonyl iron. Antacids may decrease the absorption of carbonyl iron.

Drugs other than those listed here may also interact with carbonyl iron. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines while taking carbonyl iron.

More Icar resources

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

• Icar Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Iron Chews Prescribing Information (FDA)

Compare Icar with other medications

• Iron Deficiency Anemia

Where can I get more information?

• Your pharmacist has additional information about carbonyl iron written for health professionals that you may read.

See also: Icar side effects (in more detail)

Itraconazole Capsules

Pronunciation: IT-ra-KON-a-zole
Generic Name: Itraconazole
Brand Name: Sporanox

Itraconazole Capsules should not be used to treat a fungal infection of the toenail or fingernail (onychomycosis) in patients with heart problems (eg, history of congestive heart failure). Contact your doctor immediately if you experience symptoms of congestive heart failure such as swelling of the hands, ankles, feet, or abdomen; bloating; shortness of breath; fast or irregular heartbeat; severe or persistent nausea; or confusion.

Use of Itraconazole Capsules along with certain other medicines may increase your risk of serious and sometimes fatal heart problems, including irregular heartbeat. Do not take Itraconazole Capsules if you are also taking cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl).

Itraconazole Capsules is used for:

Treating fungal infections. It may also be used for other conditions as determined by your doctor.

Itraconazole Capsules is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use Itraconazole Capsules if:

• you are allergic to any ingredient in Itraconazole Capsules


• you are being treated for a fungal infection of the toenail or fingernail (onychomycosis) and you also have congestive heart failure, a history of congestive heart failure, you are pregnant, or may become pregnant


• you are taking an aldosterone blocker (eg, eplerenone), alprazolam, astemizole, cisapride, conivaptan, dofetilide, an ergot alkaloid (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), levacetylmethadol (levomethadyl), oral midazolam, nevirapine, nisoldipine, pimozide, a quinazoline (eg, alfuzosin), quinidine, rifabutin, rifampin, terfenadine, triazolam, or certain 5-HT receptor agonists (eg, eletriptan)

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

Before using Itraconazole Capsules:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other azole antifungals (eg, ketoconazole)


• if you have HIV infection, a weakened immune system, kidney or liver problems, abnormal liver function tests, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), low stomach acid (eg, hypochlorhydria), nerve problems, or problems with swelling or retaining fluid


• if you have an irregular heartbeat or other heart problems (eg, congestive heart failure, coronary artery disease, heart valve problems)


• if you have had serious liver problems caused by Itraconazole Capsules or other medicines

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

• Many prescription and nonprescription medicines (eg, used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or birth control [eg, birth control pills]), multivitamin products, and herbal or dietary supplements may interact with Itraconazole Capsules, increasing the risk of serious side effects


• Nevirapine, rifabutin, or rifampin because they may decrease Itraconazole Capsules's effectiveness


• Astemizole, cisapride, dofetilide, levacetylmethadol (levomethadyl), nisoldipine, pimozide, quinidine, or terfenadine because the risk of severe heart effects may be increased


• Alprazolam, midazolam, or triazolam because their actions and the risk of their side effects may be increased by Itraconazole Capsules, resulting in increased risk of sedation and breathing difficulties


• Aldosterone blockers (eg, eplerenone), calcium channel blockers (eg, verapamil), conivaptan, ergot alkaloids (eg, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), 5-HT receptor agonists (eg, eletriptan), or quinazolines (eg, alfuzosin) because the risk of their side effects may be increased by Itraconazole Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Itraconazole Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Itraconazole Capsules:

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

• Take Itraconazole Capsules after a full meal. If you have low stomach acid or you take medicine to reduce stomach acid, take Itraconazole Capsules with a cola beverage.


• Do not take antacids within 1 hour before or 2 hours after taking Itraconazole Capsules.


• Take Itraconazole Capsules at least 2 hours before proton pump inhibitors (eg, omeprazole).


• To clear up your infection completely, take Itraconazole Capsules for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.


• Itraconazole Capsules works best if it is taken at the same time each day.


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

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

Important safety information:

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


• Rarely, Itraconazole Capsules has been associated with serious, sometimes fatal liver damage. Contact your doctor right away if you notice dark urine, pale stools, a swollen or tender stomach, or yellowing of the skin or eyes.


• Itraconazole Capsules only works against fungi; it does not treat viral infections (eg, the common cold).


• Be sure to use Itraconazole Capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Do not switch between the capsule and oral solution forms of Itraconazole Capsules without checking with your doctor. Effectiveness and side effects of these forms of Itraconazole Capsules may be different even at the same dose.


• Diabetes patients - Itraconazole Capsules may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Itraconazole Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• If you are using Itraconazole Capsules to treat a certain type of fungal infection (onychomycosis), you should use an effective form of birth control while you are taking Itraconazole Capsules and for 2 months after you have stopped treatment. Talk with your doctor about effective forms of birth control.


• Tell your doctor or dentist that you take Itraconazole Capsules before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, may be performed while you use Itraconazole Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Itraconazole Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially loss of hearing.


• Itraconazole Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Itraconazole Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; gas; headache; nausea; runny nose; stomach pain or upset; unpleasant taste; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chest pain; confusion; coughing up white or pink mucus; dark urine; decreased sexual ability; depression; fast or irregular heartbeat; fever, chills, or sore throat; hair loss; increased or uncontrolled urination; joint pain; loss of appetite; loss of hearing; muscle pain, weakness, or cramping; numbness, burning, or tingling of the hands, arms, legs, or feet; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; sensitivity to sunlight; severe or persistent nausea or vomiting; severe stomach or back pain; shortness of breath; sudden weight gain; swelling of the hands, ankles, or feet; swollen or tender stomach; trouble sleeping; unusual bruising or bleeding; unusual tiredness or fatigue; vision problems (eg, blurred vision, double vision); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Itraconazole side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Itraconazole Capsules:

Store Itraconazole Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Itraconazole Capsules out of the reach of children and away from pets.

General information:

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


• Itraconazole Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Itraconazole Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Itraconazole resources

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

Compare Itraconazole with other medications

• Aspergillosis, Aspergilloma
• Blastomycosis
• Candida Infections, Systemic
• Candida Urinary Tract Infection
• Coccidioidomycosis
• Cryptococcosis
• Dermatophytosis
• Esophageal Candidiasis
• Febrile Neutropenia
• Histoplasmosis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Oral Thrush
• Paracoccidioidomycosis
• Sporotrichosis
• Tinea Capitis
• Tinea Versicolor
• Vaginal Yeast Infection

Invanz

Generic Name: Ertapenem Sodium
Class: Carbapenems
VA Class: AM130
Chemical Name: [4R - [3(3S*,5S*),4α,5β,6βS*)]] - (3 - [[5 - [[(3 - Carboxyphenyl)amino]carbonyl] - 3 - pyrrolidinyl]thio] - 6 - (1 - hydroxyethyl) - 4 - methyl - 7 - oxo - 1 - azabicyclo[3.2.0]hept - 2 - ene - 2 - carboxylic acid
Molecular Formula: C₂₂H₂₄N₃NaO₇S
CAS Number: 153832-38-3

Introduction

Antibacterial; carbapenem β-lactam antibiotic.^{1 2 3 4}

Uses for Invanz

Gynecologic Infections

Treatment of moderate to severe acute pelvic infections (including postpartum endomyometritis, septic abortion, postsurgical infections) caused by susceptible Streptococcus agalactiae (group B streptococci), Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus, or Prevotella bivia.¹

Intra-abdominal Infections

Treatment of complicated intra-abdominal infections caused by susceptible E. coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus, B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, or B. uniformis.¹

Respiratory Tract Infections

Treatment of moderate to severe community-acquired pneumonia (CAP) caused by susceptible Streptococcus pneumoniae (penicillin-susceptible strains only), including cases with concurrent bacteremia.¹

Treatment of moderate to severe CAP caused by susceptible Haemophilus influenzae (non-β-lactamase-producing strains only) or Moraxella catarrhalis.¹

Skin and Skin Structure Infections

Treatment of complicated skin and skin structure infections, including diabetic foot infections without concurrent osteomyelitis, caused by susceptible Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only), Streptococcus agalactiae, S. pyogenes (group A β-hemolytic streptococci), E. coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia.^{1 c}

Urinary Tract Infections (UTIs)

Treatment of complicated UTIs (including pyelonephritis) caused by susceptible E. coli (including cases with concurrent bacteremia) or Klebsiella pneumoniae.¹

Invanz Dosage and Administration

Administration

Administer by IV infusion or IM injection.¹

Administered once daily in adolescents ≥13 years of age and adults.^c Administered twice daily in children 3 months to 12 years of age.^c

IM route may be used as an alternative to the IV route in treatment of those infections for which IM therapy is appropriate.¹ Duration of IM therapy should be ≤7 days.¹ Solutions reconstituted for IM administration should not be given IV.¹

IV Infusion

Reconstitution and Dilution

Reconstitute 1-g vial with 10 mL of sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection.¹ Shake well to ensure complete dissolution of the drug.¹ The appropriate dose should be withdrawn from the vial and diluted in 0.9% sodium chloride to provide a solution containing ≤20 mg/mL.^c For a 1-g dose, dilute in 50 mL of 0.9% sodium choride.¹

Rate of Administration

Administer by IV infusion over 30 minutes.¹

IM Administration

Inject IM deeply into a large muscle mass, such as the gluteus or lateral part of the thigh.¹ Use caution to avoid inadvertent injection into a blood vessel.¹

Reconstitution

Reconstitute 1-g vial with 3.2 mL of 1% lidocaine injection (without epinephrine) and shake thoroughly to ensure dissolution.¹ Administer within 1 hour of reconstitution.^c

Dosage

Available as ertapenem sodium; dosage expressed in terms of ertapenem.¹

Duration of therapy depends on the type and severity of infection.¹ IV route may be continued for ≤14 days; IM route may be continued for ≤7 days.¹

Pediatric Patients

Gynecologic Infections

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 3–10 days.^c

Adolescents ≥13 years of age: 1 g once daily for 3–10 days.^c

Intra-abdominal Infections

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 5–14 days.^c

Adolescents ≥13 years of age: 1 g once daily for 5–14 days.^c

Respiratory Tract Infections

Community-acquired Pneumonia

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily).^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Adolescents ≥13 years of age: 1 g once daily.^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Skin and Skin Structure Infections

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 7–14 days.^c

Adolescents ≥13 years of age: 1 g once daily for 7–14 days.^c

Urinary Tract Infections (UTIs)

IV or IM

Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily).^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Adolescents ≥13 years of age: 1 g once daily.^c Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.^c

Adults

Gynecologic Infections

IV or IM

1 g once daily for 3–10 days.¹

Intra-abdominal Infections

IV or IM

1 g once daily for 5–14 days.¹

Respiratory Tract Infections

Community-acquired Pneumonia

IV or IM

1 g once daily.¹ Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.¹

Skin and Skin Structure Infections

IV or IM

1 g once daily for 7–14 days.¹ In adults with diabetic foot infections, anti-infective therapy (parenteral or parenteral followed by oral) has been given for up to 28 days.^c

Urinary Tract Infections (UTIs)

IV or IM

1 g once daily.¹ Usual duration is 10–14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.¹

Special Populations

Hepatic Impairment

Dosage recommendations not available; pharmacokinetics have not been studied.¹

Renal Impairment

Dosage adjustments recommended in patients with Cl_cr ≤30 mL/minute.¹

Adults with Cl_cr ≤30 mL/minute, including those with end-stage renal disease (Cl_cr ≤10 mL/minute) and those undergoing hemodialysis, should receive 500 mg once daily.¹ If the dose is given within 6 hours prior to hemodialysis, a supplementary dose of 150 mg should be given after the hemodialysis session; supplemental dose not necessary if daily dose is given ≥6 hours prior to hemodialysis.¹ Data not available in pediatric patients undergoing dialysis.^c

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Invanz

Contraindications

• 
  

  Known hypersensitivity to ertapenem, other carbapenems, or any ingredient in the formulation.¹

  
  


• 
  

  History of anaphylactic reaction to β-lactams.¹

  
  


• 
  

  IM injections are prepared using lidocaine hydrochloride and are contraindicated in patients with known hypersensitivity to local anesthetics of the amide type.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible organisms.¹ Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.¹

Treatment with anti-infectives may permit overgrowth of clostridia.¹ Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.¹

Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation; appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) recommended if colitis is severe.¹

CNS Effects

Seizures and other CNS effects reported, especially in those with CNS disorders (e.g., brain lesions, history of seizures) and/or renal impairment.¹

Do not exceed recommended dosage, especially in those with known factors that predispose to seizures.¹ Anticonvulsant therapy should be continued in those with known seizure disorders.¹

If focal tremors, myoclonus, or seizures occur, evaluate the patient neurologically, initiate anticonvulsant therapy if necessary, and determine whether ertapenem dosage should be decreased or the drug discontinued.¹

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity reactions (e.g., anaphylaxis) reported with β-lactams.¹

If hypersensitivity occurs, discontinue ertapenem and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and other β-lactams.¹

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to ertapenem, cephalosporins, penicillins, or other drugs.¹

General Precautions

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.¹

Sodium Content

Contains approximately 6 mEq (137 mg) of sodium per g of ertapenem.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk.¹ Use with caution.¹

Pediatric Use

Safety and efficacy established in children 3 months to 17 years of age for the treatment of acute pelvic infections, complicated intra-abdominal infections, CAP, complicated skin and skin structure infections, and complicated UTIs.^c Not recommended for the treatment of meningitis; therapeutic concentrations not achieved in CNS.^c Not recommended in infants <3 months of age; data on use in this age group not available.^c

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.¹ Select dosage with caution and assess renal function periodically since geriatric patients are more likely to have renal impairment.¹

No dosage adjustments except those related to renal function.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not established.¹

Renal Impairment

Increased AUC.¹ Dosage adjustments recommended in adults with Cl_cr ≤30 mL/minute, including those with end-stage renal disease and those undergoing hemodialysis.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea, nausea, vomiting); local reactions (infused vein complication, phlebitis/thrombophlebitis); headache; vaginitis.¹

Interactions for Invanz

Drugs Metabolized by Hepatic Microsomal Enzymes

Does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4; pharmacokinetic interactions unlikely with drugs metabolized by these enzymes.¹

Drugs with p-Glycoprotein-mediated Clearance

Does not inhibit and is not a substrate for p-glycoprotein-mediated transport.¹ Pharmacokinetic interaction unlikely with drugs that undergo p-glycoprotein-mediated clearance (e.g., digoxin, vinblastine).¹

Specific Drugs

Drug	Interaction	Comments
Probenecid	Decreased renal tubular secretion of ertapenem; increased ertapenem concentrations and AUC and prolonged half-life1	Concomitant use not recommended1

Invanz Pharmacokinetics

Absorption

Bioavailability

Following IM injection, mean bioavailability is approximately 90%;¹ peak plasma concentrations attained in approximately 2.3 hours.¹

Exhibits nonlinear pharmacokinetics because of concentration-dependent plasma protein binding.¹

Distribution

Extent

Distributed into blister fluid.¹

Therapeutic concentrations not achieved in CNS.^c

Crosses the placenta in rats; not known whether crosses the placenta in humans.¹ Distributed into milk.¹

Plasma Protein Binding

Highly bound to plasma protein, principally albumin.¹ 95% bound at plasma concentration <100 mcg/mL and 85% bound at 300 mcg/mL.¹

Elimination

Metabolism

Does not appear to undergo hepatic metabolism.¹ The major metabolite is an inactive ring-opened derivative formed by hydrolysis of the β-lactam ring.¹

Elimination Route

Eliminated principally in urine.¹

Approximately 80% of an IV dose eliminated in urine (38% as unchanged drug and 37% as the ring-opened metabolite) and 10% eliminated in feces.¹

Half-life

Healthy young adults: 4 hours.¹

Pediatric patients 13–17 years of age: 4 hours.^c

Pediatric patients 3 months to 12 years of age: 2.5 hours.^c

Special Populations

Pharmacokinetics in patients with hepatic impairment not established.¹

In patients with severe renal impairment (Cl_cr 5–30 mL/minute per 1.73 m²) or end-stage renal disease, the extent of exposure to unbound drug is increased 4.4- or 7.6-fold, respectively.¹

Stability

Storage

Parenteral

Powder for IM Injection or IV Infusion

≤25°C.¹

Reconstituted and diluted IV solutions may be stored at room temperature, but the infusion should be completed within 6 hours.¹ These solutions may be refrigerated at 5°C for up to 24 hours, but the infusion should be completed within 4 hours after removal from refrigeration.¹ Do not freeze.¹

IM solutions should be used within 1 hour of reconstitution.^c

Compatibility

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

Reconstitute with sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection, then dilute in 0.9% sodium chloride.¹

Do not reconstitute or dilute with dextrose-containing solutions or admix with other medications.¹

Actions and SpectrumActions

• 
  

  Synthetic carbapenem β-lactam antibiotic; structurally and pharmacologically related to imipenem and meropenem.^{1 2 3 4 5 6}

  
  


• 
  

  Usually bactericidal in action.¹

  
  


• 
  

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

  
  


• 
  

  Spectrum of activity includes many gram-positive and -negative aerobic bacteria and some gram-positive and -negative anaerobic bacteria.¹ Stable in the presence of a variety of β-lactamases (including penicillinases, cephalosporinases, and extended-spectrum β-lactamases).¹

  
  


• 
  

  Gram-positive aerobes: Active in vitro and in clinical infections against Staphylococcus aureus, Streptococcus agalactiae (group B streptococci), S. pneumoniae (penicillin-susceptible strains only), and S. pyogenes (group A β-hemolytic streptococci).^{1 3} Also active in vitro against S. pneumoniae (penicillin-intermediate strains)^{1 3} and S. epidermidis (oxacillin- susceptible strains only).^c Oxacillin-resistant (methicillin-resistant) staphylococci and Enterococcus are resistant.¹

  
  


• 
  

  Gram-negative aerobes: Active in vitro and in clinical infections against Escherichia coli, Haemophilus influenzae (β-lactamase-negative strains only), Klebsiella pneumoniae, Moraxella catarrhalis, and Proteus mirabilis.^{1 c} Also active in vitro against Citrobacter, Enterobacter, H. influenzae (β-lactamase-producing strains), H. parainfluenzae, K. oxytoca, Morganella morganii, P. vulgaris, Providencia rettgeri, P. stuartii, and Serratia marcescens.^{1 c}

  
  


• 
  

  Anaerobes: Active in vitro and in clinical infections against Bacteroides fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. uniformis, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus, Porphyromonas asaccharolytica, and Prevotella bivia.^{1 2} Also active in vitro against B. vulgaris, C. perfringens, and Fusobacterium.^{1 c}

  
  

Advice to Patients

• 
  

  Importance of informing clinicians of other medical conditions, including history of seizures.¹

  
  


• 
  

  Importance of discontinuing therapy and informing clinician if an allergic or hypersensitivity reaction occurs.¹

  
  


• 
  

  Importance of reporting persistent or worsening symptoms of infection.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Ertapenem Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	1 g (of ertapenem)	Invanz	Merck

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Merck & Co, Inc. Invanz (ertapenem) for injection prescribing information. Whitehouse Station, NJ; 2001 Nov.

2. Hoellman DB, Kelly LM, Credito K et al. In vitro antianaerobic activity of ertapenem (MK-0826) compared to seven other compounds. Antimicrob Agents Chemother. 2002; 46:220-4. [PubMed 11751138]

3. Pankuch GA, Davies TA, Jacobs MR et al. Antipneumococcal activity of ertapenem (MK-0826) compared to those of other agents. Antimicrob Agents Chemother. 2002; 46:42-6. [PubMed 11751109]

4. Odenholt I. Ertapenem: a new carbapenem. Expert Opin Investig Drugs. 2001; 10:1157-66. [PubMed 11772242]

5. Wiseman LR, Wagstaff AJ, Brogden RN et al. Meropenem: a review of its antibacterial activity, pharmacokinetic properties and clinical efficacy. Drugs. 1995; 50:73-101. [PubMed 7588092]

6. Pryka RD, Haig GM. Meropenem: a new carbapenem antimicrobial. Ann Pharmacother. 1994; 28:1045-54. [IDIS 335809] [PubMed 7803882]

7. Fukasawa M, Sumita Y, Harabe ET et al. Stability of meropenem and effect of 1beta- methyl substitution on its stability in the presence of renal dehydropeptidase I. Antimicrob Agents Chemother. 1992; 36:1577-9. [PubMed 1510457]

8. Briceland LL, Tobin EH. Focus on meropenem: a broad-spectrum parenteral carbapenem antimicrobial agent. Formulary. 1996; 31:759-74.

a. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43:69-78. [PubMed 11518876]

b. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:161-2,182-3,196-8,364-5,411-2.

c. Merck & Co, Inc. Invanz (ertapenem) for injection prescribing information. Whitehouse Station, NJ; 2005 Dec.

More Invanz resources

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

• Invanz Prescribing Information (FDA)


• Invanz MedFacts Consumer Leaflet (Wolters Kluwer)


• Invanz Concise Consumer Information (Cerner Multum)


• Invanz Advanced Consumer (Micromedex) - Includes Dosage Information


• Ertapenem Professional Patient Advice (Wolters Kluwer)

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