Friday, 13 July 2012

tolterodine


Generic Name: tolterodine (tol TER oh deen)

Brand Names: Detrol, Detrol LA


What is tolterodine?

Tolterodine reduces spasms of the bladder muscles.


Tolterodine is used to treat overactive bladder with symptoms of urinary frequency, urgency, and incontinence.


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


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


You should not take this medication if you are allergic to tolterodine or fesoterodine (Toviaz), if you have untreated or uncontrolled narrow-angle glaucoma, or if you have a blockage of the urinary tract, stomach, or intestines.

Before you take tolterodine, tell your doctor if you have kidney or liver disease, glaucoma, myasthenia gravis, or a personal or family history of "Long QT syndrome."


Do not crush, chew, break, or open a controlled-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Tolterodine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase some of the side effects of tolterodine. There are many other drugs that can interact with tolterodine. 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.

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


You should not use this medication if you are allergic to tolterodine or fesoterodine (Toviaz), or if you have:

  • a blockage of the urinary tract (difficulty urinating);




  • a blockage in your stomach or intestines; or




  • untreated or uncontrolled narrow-angle glaucoma.



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


  • liver disease;

  • kidney disease;


  • myasthenia gravis;




  • glaucoma; or




  • a personal or family history of Long QT syndrome.




FDA pregnancy category C. It is not known whether tolterodine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether tolterodine 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 take tolterodine?


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


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


Take this medication with water. Do not crush, chew, break, or open a controlled-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Store at room temperature away from moisture and heat.

See also: Tolterodine 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.

Overdose symptoms may include dry mouth, blurred vision, and fast heartbeat.


What should I avoid while taking tolterodine?


Tolterodine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase some of the side effects of tolterodine.

Tolterodine 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 tolterodine and call your doctor at once if you have any of these serious side effects:

  • chest pain, fast or uneven heart rate;




  • confusion, hallucinations;




  • urinating less than usual or not at all; or




  • painful or difficult urination.



Less serious side effects may include:



  • dry mouth, dry eyes;




  • blurred vision;




  • dizziness, drowsiness;




  • constipation or diarrhea;




  • stomach pain or upset;




  • joint pain; or




  • headache.



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.


Tolterodine Dosing Information


Usual Adult Dose for Urinary Incontinence:

Initial dose:
Tablets: 2 mg orally twice a day
Extended release capsules: 4 mg orally once a day

Maintenance dose:
Tablets: 1 to 2 mg orally twice a day, depending on the patient's response and tolerability
Extended release capsules: 2 to 4 mg orally once a day, depending on the patient's response and tolerability

Usual Adult Dose for Urinary Frequency:

Initial dose:
Tablets: 2 mg orally twice a day
Extended release capsules: 4 mg orally once a day

Maintenance dose:
Tablets: 1 to 2 mg orally twice a day, depending on the patient's response and tolerability
Extended release capsules: 2 to 4 mg orally once a day, depending on the patient's response and tolerability


What other drugs will affect tolterodine?


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



  • arsenic trioxide (Trisenox);




  • chloroquine (Arelan) or halofantrine (Halfan);




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • droperidol (Inapsine);




  • narcotic medication such as levomethadyl (Orlaam) or methadone (Dolophine, Methadose);




  • pentamidine (NebuPent, Pentam);




  • vinblastine (Velban);




  • antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), pentamidine (NebuPent, Pentam), or telithromycin (Ketek);




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil) pimozide (Orap), or thioridazine (Mellaril); or




  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan, Pronestyl), quinidine (Quin-G), or sotalol (Betapace).



This list is not complete and there are many other drugs that can interact with tolterodine. 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 tolterodine resources


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


  • tolterodine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Tolterodine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Detrol Prescribing Information (FDA)

  • Detrol Monograph (AHFS DI)

  • Detrol Consumer Overview

  • Detrol LA Prescribing Information (FDA)

  • Detrol LA Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare tolterodine with other medications


  • Overactive Bladder
  • Urinary Incontinence


Where can I get more information?


  • Your pharmacist can provide more information about tolterodine.

See also: tolterodine side effects (in more detail)


Thursday, 12 July 2012

Triaminic-D Multi-Symptom Cold


Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)

Brand Names: AccuHist PDX Drops, Atuss DS, Children's NyQuil, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Dicel DM, Dicel DM Chewables, Entre-S, Esocor P, Kidcare Cough and Cold, M-End DM, Mesehist DM, Neutrahist PDX Drops, Nyquil Child Cough and Cold, Pediatric Cough & Cold Medicine, Rescon-DM, Robitussin Pediatric Night Relief, Robitussin PM Cough & Cold, Triaminic Cold and Cough, Triaminic Multi-Sympton, Triaminic Night Time, Triaminic Softchew Cold and Cough, Triaminic-D Multi-Symptom Cold, Vicks 44M Pediatric, Vicks Pediatric Formula 44M


What is Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


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


The combination of chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?


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 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 taking this medicine if you have heart disease, high blood pressure, kidney disease, diabetes, glaucoma, a thyroid disorder, emphysema or bronchitis, an enlarged prostate, or urination problems.


Do not use cold or cough medicine without your doctor's advice if you are pregnant or breast-feeding. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, 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 an antihistamine, cough suppressant, or decongestant. Do not take this medicine 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.

What should I discuss with my healthcare provider before taking Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?


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;




  • kidney disease;




  • diabetes;




  • glaucoma;




  • a thyroid disorder;




  • emphysema or chronic bronchitis;




  • an enlarged prostate; or




  • problems with urination.




FDA pregnancy category C. It is not known whether chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. Chlorpheniramine, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use cold or cough medicine without medical advice 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 Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, 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 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.

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.


The chewable tablet should be chewed before you swallow it.


Shake the oral suspension well just before you measure a dose. Do not take this medicine 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.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


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 and heat.

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 severe forms of some of the side effects listed in this medication guide.


What should I avoid while taking Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?


This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.


Drinking alcohol can increase certain side effects of this medication.

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. Chlorpheniramine, dextromethorphan, 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 an antihistamine, cough suppressant, or decongestant.

Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, 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 medicine and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeats;




  • slow, shallow breathing;




  • confusion, hallucinations, unusual thoughts or behavior;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • urinating less than usual or not at all;




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




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • dry mouth, nose, or throat;




  • mild stomach pain, constipation;




  • blurred vision;




  • dizziness, drowsiness, mild headache;




  • sleep problems (insomnia);




  • feeling restless or excited (especially in children);




  • problems with memory or concentration; or




  • flushing (warmth, redness, or tingly feeling).



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 Triaminic-D Multi-Symptom Cold (chlorpheniramine, dextromethorphan, and pseudoephedrine)?


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

Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, dextromethorphan, and pseudoephedrine if you are also using any of the following drugs:



  • glycopyrrolate (Robinul);




  • mepenzolate (Cantil);




  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);




  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);




  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);




  • a diuretic (water pill), or blood pressure medicine;




  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or




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



This list is not complete and other drugs may interact with chlorpheniramine, dextromethorphan, 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 Triaminic-D Multi-Symptom Cold resources


  • Triaminic-D Multi-Symptom Cold Side Effects (in more detail)
  • Triaminic-D Multi-Symptom Cold Use in Pregnancy & Breastfeeding
  • Triaminic-D Multi-Symptom Cold Drug Interactions
  • 0 Reviews for Triaminic-D Multi-Symptom Cold - Add your own review/rating


  • AccuHist PDX Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • AccuHist PDX Drops Prescribing Information (FDA)

  • Dicel DM Chewables Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entre-S Prescribing Information (FDA)



Compare Triaminic-D Multi-Symptom Cold with other medications


  • Cough and Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Triaminic-D Multi-Symptom Cold side effects (in more detail)


Tuesday, 10 July 2012

Chloromycetin Sodium Succinate


Generic Name: Chloramphenicol
Class: Chloramphenicol
VA Class: AM150
CAS Number: 56-75-7



  • Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia) can occur after short-term or prolonged therapy.a Chloramphenicol-associated aplastic anemia (terminating in leukemia) has been reported.a (See Hematologic Effects under Cautions.)




  • Use only when other potentially less hazardous anti-infectives cannot be used or would be ineffective.a Do not use for trivial infections or when not indicated (e.g., for colds, influenza, throat infections, prophylaxis).a




  • It is essential that adequate blood studies be performed during chloramphenicol treatment.a While such studies may detect early peripheral blood changes (e.g., leukopenia, reticulocytopenia, granulocytopenia) before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia.a




  • To facilitate appropriate blood studies and observation, patient should be hospitalized while receiving chloramphenicol.a




Introduction

Antibacterial; broad-spectrum antibiotic used only in serious infections caused by susceptible bacteria when less hazardous anti-infectives are ineffective or contraindicated.132 a


Uses for Chloromycetin Sodium Succinate


Meningitis


Treatment of meningitis caused by susceptible bacteria, including Neisseria meningitidis, Haemophilus influenzae, or Streptococcus pneumoniae.106 112 132 144 149 a Generally used only when penicillins and cephalosporins are contraindicated or ineffective.101 102 104 105 106 132 149 A regimen of ampicillin and chloramphenicol may be used as an alternative to cefotaxime or ceftriaxone for treatment of H. influenzae meningitis.132


Do not use for treatment of meningitis caused by penicillin-resistant S. pneumoniae132 149 unless the chloramphenicol minimum bactericidal concentration (MBC) is ≤4 mcg/mL.132 149


Do not use for treatment of meningitis caused by Listeria monocytogenes144 or gram-negative bacilli.147


Anthrax


Alternative for treatment of anthrax†,165 166 170 especially anthrax meningoencephalitis.165 166


Component of multiple-drug parenteral regimens recommended for treatment of inhalational anthrax that occurs as the result of exposure to B. anthracis spores in the context of biologic warfare or bioterrorism.164 167 Initiate treatment with IV ciprofloxacin or doxycycline and 1 or 2 other anti-infective agents predicted to be effective (e.g., chloramphenicol, clindamycin, rifampin, vancomycin, clarithromycin, imipenem, penicillin, ampicillin);164 167 if meningitis is established or suspected, use IV ciprofloxacin (rather than doxycycline) and chloramphenicol, rifampin, or penicillin.164


Brucellosis


Treatment of brucellosis†; used with or without streptomycin as an alternative to a tetracycline regimen.106


Burkholderia Infections


Treatment of infections caused by Burkholderia cepacia† (e.g., in cystic fibrosis patients, immunocompromised patients).106 Co-trimoxazole considered drug of choice; chloramphenicol, ceftazidime, or imipenem are alternatives.106


Treatment of glanders† caused by B. mallei; used in conjunction with streptomycin as an alternative to tetracycline and streptomycin.106


Treatment of melioidosis† caused by B. pseudomallei; used in a multiple-drug regimen with doxycycline and co-trimoxazole.106 154 Ceftazidime or imipenem monotherapy may be preferred.106 152 153 154 156 B. pseudomallei is difficult to eradicate and relapse of melioidosis is common.152 153 154 156


Chlamydial Infections


Treatment of psittacosis† (ornithosis) caused by Chlamydia psittaci.106 132 Alternative to tetracyclines.106


Clostridium Infections


Alternative to penicillin G or clindamycin for treatment of infections caused by Clostridium perfringens†.106 132


Ehrlichiosis


Treatment of ehrlichiosis† caused by Ehrlichia chaffeensis.106 159 160 Recommended as an alternative to tetracyclines,106 but efficacy has not been established.132 159


Plague


Alternative for treatment of plague† caused by Yersinia pestis, including naturally occurring or endemic plague or pneumonic plague that occurs following exposure to Y. pestisin the context of biologic warfare or bioterrorism.106 132 133 168 Regimen of choice is streptomycin (or gentamicin) with or without doxycycline.106 132 168 170 Alternatives include doxycycline (or tetracycline), chloramphenicol, co-trimoxazole (may be less effective than other alternatives), or ciprofloxacin (or another fluoroquinolone).132 168 170


Treatment of plague meningitis; drug of choice.132 170


Rat-bite Fever


Alternative to penicillin G for treatment of rat-bite fever† caused by Streptobacillus moniliformis or Spirillum minus.132


Rickettsial Infections


Alternative to tetracyclines for treatment of Rocky Mountain spotted fever and other rickettsial infections.102 104 105 106 132 135


Tularemia


Alternative to streptomycin (or gentamicin) for treatment of tularemia† caused by Francisella tularensis,106 132 133 169 including naturally occurring or endemic tularemia or tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism.169 170


Typhoid Fever


Treatment of typhoid fever caused by susceptible Salmonella typhi.106 132 134 136 139 140 a Drugs of choice are third generation cephalosporins (e.g., ceftriaxone, cefotaxime) or fluoroquinolones (e.g., ciprofloxacin, ofloxacin); chloramphenicol is an alternative.106 132 139 150 151


Do not use to treat S. typhi carriers.101 104 110 112 a


Vibrio Infections


Treatment of cholera† caused by Vibrio cholerae.106 123 128 129 130 Alternative to tetracyclines;123 128 129 130 132 used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.106 132


Chloromycetin Sodium Succinate Dosage and Administration


General


Because differences between therapeutic and toxic plasma concentrations of chloramphenicol are narrow and because of interindividual differences in metabolism and elimination of the drug, most clinicians recommend that plasma concentrations of chloramphenicol be monitored in all patients.101 102 104 105 107 108 109 114 115 Some experts suggest chloramphenicol dosage be adjusted to maintain plasma concentrations at 5–20 mcg/mL.101 102 104 105 107 108


Administration


Chloramphenicol is administered IV.a Do not administer IM since this route may be ineffective.a


Administer IV chloramphenicol no longer than necessary; change to an oral regimen of another appropriate anti-infective as soon as practical.a


Repeated courses of chloramphenicol should be avoided if at all possible.a


IV Administration


Reconstitution

Reconstitute vial containing 1 g of chloramphenicol by adding 10 mL of an aqueous diluent (e.g., sterile water for injection, 5% dextrose injection) to provide a solution containing 100 mg/mL.a


Rate of Administration

Inject calculated dose IV over a period of ≥1 minute.a


Dosage


Available as chloramphenicol sodium succinate; dosage expressed in terms of chloramphenicol.a


Pediatric Patients


General Dosage for Neonates

IV

25 mg/kg daily given in 4 equally divided doses every 6 hours during the first 2 weeks of life.102 112 a Full-term neonates >2 weeks of age may receive 50 mg/kg daily given in 4 equally divided doses every 6 hours.a


General Dosage for Children >1 Month of Age

IV

50 mg/kg daily given in equally divided doses every 6 hours.102 112 132 a


Up to 100 mg/kg daily may be required in infections caused by less susceptible organisms or if necessary to achieve adequate CSF concentrations.112 132 a However, because of concern that toxic chloramphenicol concentrations may occur with this high dosage, some clinicians suggest that 75 mg/kg daily be used initially in the treatment of these infections.102 105 Dosage should be reduced to 50 mg/kg daily as soon as possible.112 a


General Dosage for Pediatric Patients with Immature Metabolic Processes

IV

25 mg/kg daily will usually produce therapeutic blood concentrations in young infants and other pediatric patients in whom immature metabolic functions are suspected.a


Monitoring chloramphenicol plasma concentrations is particularly important in these patients.a


Anthrax†

Treatment of Anthrax (Inhalational, GI, Meningeal, Septicemia)†

IV

50–75 mg/kg daily given in 4 divided doses.165


Meningoencephalitis caused by B. anthracis may require 1 g every 4 hours.166


Used in multiple-drug regimens that initially include IV ciprofloxacin or IV doxycycline and 1 or 2 other anti-infectives predicted to be effective.164 167


Duration of treatment is 60 days if anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.164 167


Plague†

IV

25 mg/kg 4 times daily for 10 days for treatment of pneumonic plague† that occurs as the result of exposure to Y. pestis in the context of biologic warfare or bioterrorism.168


Initial loading dose of 25 mg/kg followed by 15 mg/kg 4 times daily for 10–14 days for treatment of plague meningitis.170


Tularemia†

IV

15 mg/kg 4 times daily given for 14–21 days for treatment of tularemia† that occurs as the result of exposure to F. tularensis in the context of biologic warfare or bioterrorism.169


Typhoid Fever

IV

50 mg/kg daily in equally divided doses every 6 hours given for 14–15 days.134 139 140


Adults


General Adult Dosage

IV

50 mg/kg daily given in equally divided doses every 6 hours.102 112 a


In infections caused by less susceptible organisms or if necessary to achieve adequate CSF concentrations, up to 100 mg/kg daily may be required.112 c However, because of concern that toxic plasma chloramphenicol concentrations may occur with this high dosage, some clinicians suggest that 75 mg/kg daily be used initially in the treatment of these infections.102 105 Dosage should be reduced to 50 mg/kg daily as soon as possible.112 c


Anthrax†

Treatment of Anthrax (Inhalational, GI, Meningeal, Septicemia)†

IV

50–100 mg/kg daily in 4 divided doses.165


Meningoencephalitis caused by B. anthracis may require 1 g every 4 hours.166


Used in multiple-drug regimens that initially include IV ciprofloxacin or IV doxycycline and 1 or 2 other anti-infectives predicted to be effective.164 167


Duration of treatment is 60 days if anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.164 167


Plague†

IV

25 mg/kg 4 times daily given for 10 days for treatment of pneumonic plague† that occurs as the result of exposure to Y. pestis in the context of biologic warfare or bioterrorism.168


Initial loading dose of 25 mg/kg followed by 15 mg/kg 4 times daily given for 10–14 days for treatment of plague meningitis.170


Tularemia†

IV

15 mg/kg 4 times daily given for 14–21 days for treatment of tularemia† that occurs as the result of exposure to F. tularensis in the context of biologic warfare or bioterrorism.169


Typhoid Fever

IV

50 mg/kg daily in equally divided doses every 6 hours given for 14–15 days.134 139 140


Prescribing Limits


Pediatric Patients


Maximum 25 mg/kg daily in 4 divided doses in neonates <2 weeks of age.a Higher dosage in these neonates should be used only to maintain blood concentrations within a therapeutically effective range.a


Special Populations


Hepatic Impairment


Reduce dosage in proportion to the degree of impairment.a Closely monitor plasma chloramphenicol concentrations, especially in pediatric patients.a


Renal Impairment


Reduce dosage in proportion to the degree of impairment.a Closely monitor plasma chloramphenicol concentrations, especially in pediatric patients.a


Cautions for Chloromycetin Sodium Succinate


Contraindications



  • Known hypersensitivity to chloramphenicol.a




  • History of previous toxic reaction to chloramphenicol.a




  • Trivial infections or when not indicated (e.g., colds, influenza, throat infections, prophylaxis).a



Warnings/Precautions


Warnings


Hematologic Effects

Serious and potentially fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, granulocytopenia) reported with both short-term and prolonged use.a An irreversible type of bone marrow depression leading to aplastic anemia with a high mortality rate has occurred.a


Dose-related, reversible bone marrow depression may occur.a This type of bone marrow depression is characterized by vacuolization of erythroid cells, reduction in reticulocytes and leukopenia, and usually responds promptly to discontinuance of chloramphenicol.a


Hematologic function should be evaluated prior to and approximately every 2 days during chloramphenicol therapy.a Consider that such studies do not exclude the possible later appearance of the irreversible type of bone marrow depression.a


Discontinue chloramphenicol if reticulocytopenia, leukopenia, thrombocytopenia, anemia, or any other blood study findings attributable to the drug occur.a


Sensitivity Reactions


Hypersensitivity Reactions

Fever, macular and vesicular rash, angioedema, urticaria, and anaphylaxis may occur.a


General Precautions


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of chloramphenicol and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.a


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.a


Chloramphenicol may be initiated pending results of in vitro susceptibility testing, but should be discontinued if the causative organism is found to be susceptible to potentially less hazardous anti-infectives.a A decision to continue use of chloramphenicol rather than switching to a less hazardous anti-infective should be based on severity of the infection, susceptibility of the causative organism to the other anti-infectives, and efficacy of the various drugs in the specific infection type.a


Repeated courses of chloramphenicol should be avoided if at all possible.a Treatment should not be continued longer than required to produce a cure with little or no risk or relapse.a


Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.a Discontinue drug and institute appropriate therapy if superinfection occurs.a


CNS Effects

Headache, mild depression, metal confusion, and delirium have been reported.a


Optic and peripheral neuritis reported, usually following long-term therapy.a Promptly discontinue chloramphenicol if this occurs.a


Sodium Content

Contains approximately 52 mg (2.25 mEq) of sodium per g of chloramphenicol sodium succinate.a


Specific Populations


Pregnancy

Category C.a


Lactation

Distributed into milk; discontinue nursing or the drug.a


Pediatric Use

Use with caution in premature and full-term neonates and infants because of potential for gray syndrome toxicity.a


Gray syndrome can be fatal within a few hours of symptom onset; symptoms include abdominal distension (with or without emesis), progressive pallid cyanosis, and vasomotor collapse (frequently accompanied by irregular respiration).a Syndrome may be reversible if drug discontinued at early evidence of symptoms.a


Immature metabolic processes in neonates and infants may result in excessive chloramphenicol concentrations.a Adjust dosage accordingly and monitor blood concentrations at appropriate intervals.a


Hepatic Impairment

Excessive chloramphenicol concentration may occur in patients with impaired hepatic function.a Decrease dosage accordingly.a Determine chloramphenicol concentrations at appropriate intervals.a


Renal Impairment

Excessive chloramphenicol concentrations may occur in patients with impaired renal function.a Decrease dosage accordingly.a Determine chloramphenicol concentrations at appropriate intervals.a


Common Adverse Effects


Hematologic effects (blood dyscrasias, bone marrow depression); GI effects (nausea, vomiting, glossitis, stomatitis, diarrhea, enterocolitis).a


Interactions for Chloromycetin Sodium Succinate


Specific Drugs
























Drug



Interaction



Comments



Antianemia agents



Possible delayed response to iron preparations, vitamin B12, or folic acidc



Concomitant use of iron preparations, vitamin B12, or folic acid should be avoided if possiblec



Anticoagulants, oral



Possible increased anticoagulant effect;c chloramphenicol may impair utilization of prothrombin or decrease vitamin K production by intestinal bacteriac



β-Lactam antibiotics



In vitro evidence of antagonism with penicillins or cephalosporinsc



Concomitant use with penicillins or cephalosporins not recommendedc



Myelosuppressive agents



Potential additive bone marrow depressiona c



Avoid concomitant use with other drugs that may cause bone marrow depressiona c



Phenobarbital



Possible decreased chloramphenicol concentrationsc



Monitor chloramphenicol concentrations in patients receiving concomitant phenobarbitalc



Rifampin



Possible decreased chloramphenicol concentrations103


Chloromycetin Sodium Succinate Pharmacokinetics


Absorption


Bioavailability


Inactive until chloramphenicol sodium succinate is hydrolyzed in vivo to active chloramphenicol, presumably by esterases in liver, kidneys, and lungs.102 107


Bioavailability following IV administration varies; there is considerable interindividual variation in plasma chloramphenicol concentrations.101 102 107 109 114


Distribution


Extent


Widely distributed into most body tissues and fluids, including saliva, ascitic fluid, pleural fluid, synovial fluid, and aqueous and vitreous humor.c Highest concentrations attained in liver and kidneys.c


CSF concentrations may be 21–50% of concurrent plasma concentrations in patients with uninflamed meninges and 45–89% of concurrent plasma concentrations in patients with inflamed meninges.c


Crosses the placenta and is distributed into milk.a


Plasma Protein Binding


Approximately 60%.c


Elimination


Metabolism


Chloramphenicol sodium succinate hydrolyzed to active chloramphenicol, presumably by esterases in liver, kidneys, and lungs.102 107 Rate and extent of hydrolysis is highly variable.101 102 107 109 114


Chloramphenicol inactivated principally in the liver by glucuronyl transferase.c


Elimination Route


Eliminated in urine by glomerular filtration or active tubular secretion.c Approximately 30% of an IV dose excreted unchanged in urine, but fraction excreted in urine varies considerably and may range from 6–80% in neonates and children.102 107 109


Half-life


Adults with normal renal and hepatic function: plasma half-life 1.5–4.1 hours.101 104 107


Neonates and infants: plasma half-life ≥24 hours in neonates 1–2 days of age and approximately 10 hours in those 10–16 days of age.c Premature infants and neonates have immature mechanisms for glucuronide conjugation and excretion which results in higher and more prolonged chloramphenicol concentrations.c


Special Populations


Patients with impaired hepatic function: plasma half-life prolonged.c


Patients with impaired renal function: plasma half-life not substantially prolonged, but half-lives of the inactive conjugated metabolites may be prolonged.c


Stability


Storage


Parenteral


Powder for Injection

15–25°C.a


Compatibility


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


Parenteral


Solution CompatibilityHID
























Compatible



Dextran 40,000



Dextran 6% in dextrose 5%



Dextran 6% in sodium chloride 0.9%



Dextrose–Ringer’s injection combinations



Dextrose–Ringer’s injection, lactated, combinations



Dextrose 5% in Ringer’s injection, lactated



Dextrose–saline combinations



Dextrose 5% in sodium chloride 0.9%



Dextrose 2½, 5, or 10% in water



Fat emulsion 10%, intravenous



Fructose 10% in sodium chloride 0.9%



Fructose 10% in water



Invert sugar 5 and 10% in sodium chloride 0.9%



Invert sugar 5 and 10% in water



Ionosol products



Normosol M in dextrose 5% in water



Normosol R



Ringer’s injection



Ringer's injection, lactated



Sodium chloride 0.45 or 0.9%



Sodium lactate (1/6) M


Drug Compatibility

















































Admixture CompatibilityHID

Compatible



Amikacin sulfate



Aminophylline



Ascorbic acid injection



Calcium chloride



Calcium gluconate



Colistimethate sodium



Cyanocobalamin



Dimenhydrinate



Dopamine HCl



Ephedrine sulfate



Heparin sodium



Hydrocortisone sodium succinate



Kanamycin



Lidocaine HCl



Magnesium sulfate



Metaraminol bitartrate



Methyldopate HCl



Methylprednisolone sodium succinate



Metronidazole



Metronidazole HCl with sodium bicarbonate



Nafcillin sodium



Oxacillin sodium



Oxytocin



Penicillin G potassium



Penicillin G sodium



Pentobarbial sodium



Phenylephrine HCl



Phenlephrine HCl with sodium bicarbonate



Phytonadione



Plasma protein fraction



Potassium chloride



Promazine HCl



Ranitidine HCl



Sodium bicarbonate



Sodium bicarbonate with phenylephrine HCl



Thiopental sodium



Verapamil HCl



Vitamin B complex with C



Incompatible



Chlorpromazine HCl



Hydroxyzine HCl



Polymyxin B sulfate



Prochlorperazine edisylate



Prochlorperazine mesylate



Promethazine HCl



Vancomycin



















Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Cyclophosphamide



Enalaprilat



Esmolol HCl



Foscarnet sodium



Hydromorphone HCl



Labetalol HCl



Magnesium sulfate



Meperidine HCl



Morphine sulfate



Nicardipine HCl



Perphenazine



Tacrolimus



Incompatible



Fluconazole


Actions and SpectrumActions



  • Usually bacteriostatic in action, but may be bactericidal in high concentrations or against highly susceptible organisms.c




  • Inhibits protein synthesis in susceptible organisms by binding to 50S ribosomal subunits.c Also inhibits protein synthesis in rapidly proliferating mammalian cells; reversible bone marrow depression reported during chloramphenicol therapy may occur because of inhibition of protein synthesis in mitochondria of bone marrow cells.c




  • Inactive until chloramphenicol sodium succinate is hydrolyzed in vivo to active chloramphenicol.102 107




  • Spectrum of activity includes many gram-positive and -negative aerobic bacteria, many anaerobic bacteria, and some other organisms (e.g., Rickettsia, Chlamydia, and Mycoplasma).c Inactive against fungi and viruses.c




  • Gram-positive aerobes: active against Streptococcus pneumoniae and other streptococci.104 110 c Also active in vitro against Bacillus anthracis.161 167




  • Gram-negative aerobes: active against some strains of Brucella, Burkholderia mallei, B. cepacia, Francisella tularensis, Haemophilus influenzae, Neisseria meningitidis, Proteus mirabilis, Salmonella, and Shigella,104 110 Vibrio cholerae, and Yersinia pestis,171 172




  • Anaerobes: active against Bacteroides fragilis, Clostridium, Fusobacterium, Prevotella melaninogenica, and Veillonella.104 110




  • Resistance has been reported in staphylococci, S. pneumoniae,126 131 Escherichia coli, H. influenzae,104 110 125 Neisseria meningitidis, Salmonella, and Shigella.142



Advice to Patients



  • Advise patients that antibacterials (including chloramphenicol) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).a




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




  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.a




  • Importance of advising patients of other important precautionary information.a (See Cautions.)



Preparations


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


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name


















Chloramphenicol Sodium Succinate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection



1 g (of chloramphenicol)*



Chloramphenicol Sodium Succinate Sterile



American Pharmaceutical Partners



Chloromycetin Sodium Succinate



Monarch



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 August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References


Only references cited for selected revisions after 1984 are available electronically.



100. Freundlich M, Cynamon H, Tamer A et al. Management of chloramphenicol intoxication in infancy by charcoal hemoperfusion. J Pediatr. 1983; 103:485-7. [IDIS 175139] [PubMed 6886919]



101. Bartlett JG. Chloramphenicol. Med Clin North Am. 1982; 66:91-102. [PubMed 7038343]



102. Shalit I, Marks MI. Chloramphenicol in the 1980s. Drugs. 1984; 28:281-91. [IDIS 193569] [PubMed 6386425]



103. Prober CG, Jadavji T, Soldin SJ. Effect of rifampin on chloramphenicol levels. N Engl J Med. 1985; 312:788-9. [IDIS 198165] [PubMed 3974656]



104. Standiford HC. Tetracyclines and chloramphenicol. In: Mandell GL, Douglas RG Jr, Bennett JE, eds. Principles and practice of infectious diseases. 2nd ed. New York; John Wiley & Sons; 1985:206-16.



105. Marks MI, LaFerriere C. Chloramphenicol: recent developments and clinical indications. Clin Pharm. 1982; 1:315-20. [IDIS 154494] [PubMed 6764390]



106. Anon. The choice of antibacterial drugs. Med Lett Drugs Ther. 2001; 43: 69-78.



107. Ambrose PJ. Clinical pharmacokinetics of chloramphenicol and chloramphenicol succinate. Clin Pharmacokinet. 1984; 9:222-38. [IDIS 186221] [PubMed 6375931]



108. Mulhall A, de Louvois J, Hurley R. Chloramphenicol toxicity in neonates: its incidence and prevention. BMJ. 1983; 287:1424-7. [IDIS 178991] [PubMed 6416440]



109. Kauffman RE, Miceli JN, Strebel L et al. Pharmacokinetics of chloramphenicol and chloramphenicol succinate in infants and children. J Pediatr. 1981; 98:315-20. [IDIS 137940] [PubMed 7463235]



110. Kucers A, Bennett NM. The use of antibiotics. 3rd ed. London: William Heineman Medical Books Ltd; 1979:420-56.



112. Parke-Davis. Chloromycetin sodium succinate (sterile chloramphenicol sodium succinate) for intravenous administration prescribing information (dated 1996 Aug). In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998:2081-2.



113. Shann F, Linnemann V, Mackenzie A et al. Absorption of chloramphenicol sodium succinate after intramuscular administration in children. N Engl J Med. 1985; 313:410-4. [IDIS 203367] [PubMed 4022068]



114. Sack CM, Koup JR, Smith AL. Chloramphenicol pharmacokinetics in infants and young children. Pediatrics. 1980; 66:579-84. [IDIS 123431] [PubMed 7432844]



115. Nahata MC, Powell DA. Chloramphenicol serum concentration falls during chloramphenicol succinate dosing. Clin Pharmacol Ther. 1983; 33:308-13. [IDIS 168659] [PubMed 6825386]



116. Brown TH, Alford HR. Antagonism by chloramphenicol of broad-spectrum β-lactam antibiotics against Klebsiella pneumoniae. Antimicrob Agents Chemother. 1984; 25:405-7. [IDIS 184272] [PubMed 6375551]



117. Centers for Disease Control. Rocky mountain spotted fever—United States, 1988. MMWR Morb Mortal Wkly Rep. 1989; 38:513-5. [PubMed 2501644]



118. Fishbein DB. Treatment of Rocky Mountain spotted fever. JAMA. 1988; 260:3192.



119. Asmar BI, Prainito M, Dajani AS. Antagonistic effect of chloramphenicol in combination with cefotaxime of ceftriaxone. Antimicrob Agents Chemother. 1988; 32:1375-8. [IDIS 248089] [PubMed 3195999]



120. Dance DA, Wuthiekanun V, Chaowagul W et al. Interactions in vitro between agents used to treat melioidosis. J Antimicrob Chemother. 1989; 24:311-6. [PubMed 2681117]



121. French GL, Ling TKW, Davies DP et al. Antagonism of ceftazidime by chloramphenicol in vitro and in vivo during treatment of gram negative meningitis. BMJ. 1985; 291:636-7. [IDIS 205179] [PubMed 3928061]



122. Cephalosporins interactions: chloramphenicol. In: Hansten PD, Horn JR. Drug interactions: clinical significance of drug-drug interactions. 6th ed. Philadelphia: Lea & Febiger; 1989:213-4.



123. Swerdlow DL, Ries AA. Cholera in the Americas: guidelines for the clinician. JAMA. 1992; 267:1495-9. [PubMed 1371570]



124. Flegg P, Cheong I, Welsby PD. Chloramphenicol: are concerns about aplastic anemia justified? Drug Safety. 1992; 7:167-9.



125. Jorgensen JH. Update on mechanisms and prevalence of antimicrobial resistance in Haemophilus influenzae. Clin Infect Dis. 1992; 14:1119-23. [PubMed 1600014]



126. Friedland IR, Klugman KP. Failure of chloramphenicol therapy in penicillin-resistant pneumococcal meningitis. Lancet. 1992; 339:405-8. [IDIS 291433] [PubMed 1346668]



127. Islam A, Butler T, Nath SK et al. Randomized treatment of patients with typhoid fever by using ceftriaxone or chloramphenicol. J Infect Dis. 1988; 158:742-7. [IDIS 263618] [PubMed 3171225]



128. Saraswathi K, Deodhar LP. A study of V. cholerae strains isolated in Bombay. J Postgrad Med. 1990; 36:128-30. [PubMed 2102910]



129. Willke A, Arman D, Tolunay C. [Susceptibility of Vibrio cholerae El-Tor strains to various antibiotics]. Mikrobiyol Bul. 1988; 22:101-4. [PubMed 3273600]



130. Khan MM, Ara F, Yousuf MO et al. Outbreak of gastroenteritis in different areas of Pakistan. J Pak Med Assoc. 1989; 39:151-4. [PubMed 2504955]



131. Syrogiannopoulos GA, Grivea IN, Beratis NG et al. Resistance patterns of Streptococcus pneumoniae from carriers attendng day-dare centers in Southwestern Greece. Clin Infect Dis. 1997; 25:188-94. [IDIS 392202] [PubMed 9332508]



132. 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; 2000:192-3,234-6,262-72,396-401,450-60,473-5,489-93,501-6,618-20,656.



133. Centers for Disease Control and Prevention. Human plague—India, 1994. MMWR Morb Mortal Wkly Rep. 1994; 43:689-91. [PubMed 8084331]



134. Islam A, Butler T, Kabir I et al. Treatment of typhoid fever with ceftriaxone for 5 days or chloramphenicol for 14 days: a randomized clinical trial. Antimicrob Agents Chemother. 1993; 37:1572-5. [IDIS 318762] [PubMed 8215265]



135. Walker DH. Rocky mountain spotted fever: a seasonal alert. Clin Infect Dis. 1995; 20:1111

Sunday, 8 July 2012

Seb-Prev Lotion


Pronunciation: sul-fa-SEE-ta-mide
Generic Name: Sulfacetamide
Brand Name: Seb-Prev and Sebizon


Seb-Prev Lotion is used for:

Treating bacterial infections of the skin, including dandruff. It may also be used for other conditions as determined by your doctor.


Seb-Prev Lotion is a sulfonamide. It works by restricting the production of folic acid, which bacteria need for growth. This kills the bacteria.


Do NOT use Seb-Prev Lotion if:


  • you are allergic to any ingredient in Seb-Prev Lotion

  • you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

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



Before using Seb-Prev Lotion:


Some medical conditions may interact with Seb-Prev Lotion. 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 asthma

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


  • Silver-containing products (eg, silver sulfadiazine) because they may decrease Seb-Prev Lotion's effectiveness

  • Methenamine because it may increase the risk of Seb-Prev Lotion's side effects

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


Use Seb-Prev Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Seb-Prev Lotion is for use on the skin only.

  • Shake well before each use.

  • Wash your hands before and after using Seb-Prev Lotion.

  • Apply enough medicine to cover the affected area. Rub in gently.

  • If your skin becomes too dry, apply less medicine to the affected area.

  • To clear up your infection completely, use Seb-Prev Lotion for the full course of treatment. Keep using it even if you feel better in a few days.

  • Seb-Prev Lotion works best if it is used at the same time each day.

  • Continue to use Seb-Prev Lotion even if you feel well. Do not miss any doses.

  • If you miss a dose of Seb-Prev Lotion, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Seb-Prev Lotion.



Important safety information:


  • Avoid getting Seb-Prev Lotion in your eyes, nose, or mouth.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • Do not apply Seb-Prev Lotion over large areas of the body or to open wounds or scraped, infected, or burned skin without first checking with your doctor.

  • Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

  • Seb-Prev Lotion only works against bacteria; it does not treat viral infections.

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

  • Long-term or repeated use of Seb-Prev Lotion may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.

  • Large amounts of Seb-Prev Lotion may stain skin or white fabrics. This stain may be removed from fabric by ordinary laundering without bleach.

  • Seb-Prev Lotion should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

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


Possible side effects of Seb-Prev Lotion:


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.



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); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; severe or persistent irritation; sores in the mouth; stomach cramps/pain.



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: Seb-Prev 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. Seb-Prev Lotion may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.


Proper storage of Seb-Prev Lotion:

Store Seb-Prev Lotion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Seb-Prev Lotion out of the reach of children and away from pets.


General information:


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

  • Seb-Prev Lotion 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 Seb-Prev Lotion. 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 Seb-Prev resources


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


Compare Seb-Prev with other medications


  • Seborrheic Dermatitis
  • Secondary Cutaneous Bacterial Infections

Stalevo


Pronunciation: KAR-bi-DOE-pa/LEE-voe-DOE-pa/en-TAK-a-pone
Generic Name: Carbidopa/Levodopa/Entacapone
Brand Name: Stalevo


Stalevo is used for:

Treating symptoms of Parkinson disease.


Stalevo is an antidyskinetic combination of dopamine-enhancing medicines. It works by increasing the amount of dopamine in the brain. By increasing the amount of dopamine in the brain, the chemicals of the brain become more balanced and the symptoms of this disease are lessened.


Do NOT use Stalevo if:


  • you are allergic to any ingredient in Stalevo

  • you have narrow-angle glaucoma, skin growths of unknown cause, skin cancer, or a history of skin cancer

  • you have taken furazolidone or certain monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) within the last 14 days

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



Before using Stalevo:


Some medical conditions may interact with Stalevo. 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 heart problems (eg, irregular heartbeat) or a heart attack, blood pressure problems, endocrine problems, fainting, lung problems (eg, asthma), kidney or liver problems, neuroleptic malignant syndrome (NMS), a severe muscle problem called rhabdomyolysis, glaucoma or increased pressure in the eye, or mood or mental problems (eg, depression)

  • if you have stomach or intestinal problems (eg, ulcers), or biliary or gallbladder problems

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


  • Furazolidone, MAOIs (eg, phenelzine), selegiline, or tricyclic antidepressants (eg, amitriptyline) because serious side effects (eg, headache, very high blood pressure, abnormal heartbeat) may occur

  • Ampicillin, chloramphenicol, cholestyramine, erythromycin, metoclopramide, probenecid, rifampin, or sympathomimetics (eg, phenylephrine) because they may increase the risk of Stalevo's side effects

  • Apomorphine, butyrophenones (eg, haloperidol), hydantoins (eg, phenytoin), isoniazid, metoclopramide, papaverine, phenothiazines (eg, chlorpromazine), or risperidone because they may decrease Stalevo's effectiveness

  • Medicines for blood pressure because the risk of their side effects may be increased by Stalevo

  • Digoxin and iron salts (eg, ferrous sulfate) because their effectiveness may be decreased by Stalevo

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


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


  • Take Stalevo by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Swallow Stalevo whole. Do not break, crush, or chew before swallowing.

  • Take Stalevo at least 4 hours before or after taking iron salts (eg, ferrous sulfate).

  • Diets that are high in protein may decrease your body's ability to absorb Stalevo. Discuss any questions or concerns with your doctor. Tell your doctor if you have a diet that is high in protein, or if you will be changing your diet to include more protein.

  • Do not suddenly stop taking Stalevo without checking with your doctor. Side effects may occur. They may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating.

  • If you miss a dose of Stalevo, 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 Stalevo.



Important safety information:


  • Stalevo may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Stalevo with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Stalevo; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Stalevo may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Diets high in protein may prevent your body's ability to absorb Stalevo. Dietary protein should be eaten evenly throughout the day.

  • Gradually increase physical activity as your symptoms improve.

  • A "wearing-off" effect may occur before you need to take your next dose of Stalevo. If this effect becomes bothersome, contact your doctor.

  • Stalevo may cause diarrhea. It typically begins within 4 to 12 weeks of starting Stalevo, but may occur during the first week or many months after starting it. Rare cases of prolonged diarrhea caused by colitis (inflammation of the large intestine) have occurred in patients taking Stalevo. Contact your doctor if you have severe, persistent, or watery diarrhea.

  • If diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • Stalevo may discolor the saliva, urine, or sweat a dark color (red, brown, or black). This is normal and not a cause for concern.

  • Stalevo may cause nausea, especially when you first start to take it. Check with your doctor if nausea persists or is severe.

  • Stalevo may cause mental or mood changes. Contact your doctor at once if any new or worsening symptoms such as depressed mood; anxious, restless, or irritable behavior; or unusual changes in mood or behavior occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.

  • You may experience an increase in involuntary movements while taking Stalevo. Check with your doctor if this occurs.

  • NMS is a possibly fatal syndrome that can be caused by Stalevo. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.

  • Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Stalevo. Tell your doctor right away if you notice such effects.

  • Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Stalevo also increases the risk of melanoma. You may need to have skin exams while you are using Stalevo. Discuss any questions or concerns with your doctor.

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

  • Diabetes patients - Stalevo may cause the results of some tests for urine glucose or urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.

  • Stalevo may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Stalevo.

  • Lab tests, including complete blood cell counts and heart, liver, and kidney function, may be performed while you use Stalevo. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Stalevo with extreme caution in the ELDERLY; they may be more sensitive to its effects.

  • Stalevo should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

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


Possible side effects of Stalevo:


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:



Change in taste; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; upset stomach.



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); chest pain; confusion; dark urine; depression with thoughts of suicide; fainting; fast or irregular heartbeat; fever; hallucinations; lack of response to environment; mental or mood changes; muscle pain, stiffness, or rigidity; new or increased involuntary movements; paranoia; seizures; severe or persistent dizziness; severe, persistent, or watery diarrhea; shortness of breath; stomach pain; trouble sleeping; unusual or painful movements of the face, eyelids, mouth, tongue, arms, hands, or legs; unusual skin growths or change in the appearance of a mole; unusual sweating; vomiting; 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: Stalevo side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; confusion; dark urine or trouble urinating; fast or irregular heartbeat; high blood pressure; insomnia; muscle spasms; restlessness.


Proper storage of Stalevo:

Store Stalevo at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, moisture, and light. Keep in a tight, light-resistant container. Do not store in the bathroom. Keep Stalevo out of the reach of children and away from pets.


General information:


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

  • Stalevo 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 Stalevo. 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.

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