Wednesday, September 14, 2016

Lincomycin Hydrochloride


Class: Lincomycins
VA Class: AM350
CAS Number: 7179-49-9
Brands: Lincocin


  • Diarrhea and Colitis


  • Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including lincomycin, and may range in severity from mild to life-threatening.100 Anti-infectives alter normal flora of the colon and may permit overgrowth of C. difficile.100




  • Because lincomycin has been associated with severe colitis (potentially fatal), it should be reserved for treatment of serious infections when less toxic anti-infectives are inappropriate.100 (See Uses.)




  • C. difficile produces toxins A and B which contribute to development of CDAD.100 Hypertoxin-producing strains cause increased morbidity and mortality since they may be refractory to anti-infectives and may require colectomy.100 CDAD must be considered in all patients who present with diarrhea following anti-infective use.100 Careful medical history is necessary since CDAD has been reported to occur 2 months or longer after administration of anti-infectives.100




  • If CDAD is suspected or confirmed, ongoing anti-infective use not directed against C. difficile may need to be discontinued.100 Institute appropriate fluid and electrolyte management, protein supplementation, anti-infective treatment of C. difficile, and surgical evaluation as clinically indicated.100 (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis [CDAD] under Cautions.)




Introduction

Antibacterial; structurally related to clindamycin.a


Uses for Lincomycin Hydrochloride


Staphylococcal and Streptococcal Infections


Treatment of serious infections caused by susceptible staphylococci, Streptococcus pneumoniae, and other streptococci.100


Not considered drug of choice in infections caused by gram-positive cocci;111 reserve use for penicillin-allergic patients or other patients for whom less toxic alternatives (e.g., penicillins, cephalosporins, macrolides) are contraindicated.100


Do not use in the treatment of meningitis because of poor CNS penetration following parenteral administration.100


Do not use for treatment of minor bacterial infections or for nonbacterial infections.100


Certain infections may require incision and drainage or other indicated surgical procedures in addition to anti-infective therapy.100


Lincomycin Hydrochloride Dosage and Administration


Administration


Administer by IM injection or slow IV infusion.100 Also has been administered by subconjunctival injection.100 Has been administered orally, but an oral preparation is not commercially available in the US.a


Do not administer by rapid IV injection.100


IV Infusion


Prior to IV infusion, lincomycin injection must be diluted with a compatible IV solution.100


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


Dilution

Dilute each gram of lincomycin in ≥100 mL of compatible IV solution.100


Rate of Administration

IV infusions should be given over ≥1 hour.100


The manufacturer recommends that 600-mg or 1-g doses be given over 1 hour, 2-g doses be given over 2 hours, 3-g doses be given over 3 hours, and 4-g doses be given over 4 hours.100


Dosage


Available as lincomycin hydrochloride;100 dosage expressed in terms of lincomycin.100


Dosage depends on severity of infection.100


Pediatric Patients


Staphylococcal and Streptococcal Infections

IM

Infants and children >1 month of age: 10 mg/kg once every 24 hours for serious infections or 10 mg/kg every 12 hours (or more frequently) for more severe infections.100


IV

Infants and children >1 month of age: 10–20 mg/kg daily (depending on severity of infection) administered in 2 or 3 equally divided doses.100


Adults


Staphylococcal and Streptococcal Infections

IM

600 mg once every 24 hours for serious infections or 600 mg every 12 hours (or more frequently) for more severe infections.100


IV

600 mg to 1 g every 8–12 hours for serious infections;100 more severe infections may require increased dosage.100 Up to 8 g daily has been used in life-threatening infections.100


Subconjunctival

75-mg dose results in ocular fluid concentrations that last ≥5 hours and are sufficient for most susceptible bacteria.100


Prescribing Limits


Adults


IV

Maximum 8 g daily.100


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.100 Use with caution; monitor serum lincomycin concentrations during high-dose therapy.100


Renal Impairment


Severe renal impairment: 25–30% of usual dose.100 Use with caution; monitor serum lincomycin concentrations during high-dose therapy.100


Geriatric Patients


No specific dosage recommendations at this time.100


Cautions for Lincomycin Hydrochloride


Contraindications



  • Hypersensitivity to clindamycin or lincomycin.100



Warnings/Precautions


Warnings


Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms, particularly yeasts.100 Institute appropriate therapy if superinfection occurs.100


Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.100 101 102 103 104 105 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including lincomycin, and may range in severity from mild diarrhea to fatal colitis.100 101 102 103 104 105 Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.100


Consider CDAD if diarrhea develops during or after therapy and manage accordingly.100 101 102 103 104 105 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.100


If CDAD is suspected or confirmed, lincomycin may need to be discontinued.100 101 102 103 104 105 Some mild cases of CDAD may respond to discontinuance alone.101 102 103 104 105 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, appropriate anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.100 101 102 103 104 105


Patients with Meningitis

Do not use for treatment of meningitis; lincomycin diffusion into CSF is inadequate for these infections.100


Sensitivity Reactions


Angioneurotic edema, serum sickness, and anaphylaxis or anaphylactoid reactions have been reported.100 Erythema multiforme, sometimes resembling Stevens-Johnson syndrome, reported rarely.100


Rash,100 urticaria,100 pruritus,a and, rarely, exfoliative and vesiculobullous dermatitis,100 have occurred.


Use with caution in patients with history of asthma or significant allergies.100


If anaphylactoid reactions or other hypersensitivity reactions occur, discontinue lincomycin and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).100


General Precautions


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of lincomycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.100


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.100 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.100


Certain infections may require incision and drainage or other indicated surgical procedures in addition to anti-infective therapy.100


History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.100 (See Superinfection/Clostridium difficile-associated Colitis [CDAD] under Cautions.)


Cardiovascular Effects

Rapid IV administration has caused hypotension,100 syncope,a and rarely cardiopulmonary arrest.100


Severe cardiopulmonary reactions have occurred when lincomycin was administered in concentrations and at rates of administration higher than recommended.100


Hematologic Effects

Leukopenia, 100 neutropenia,100 eosinophilia,a agranulocytosis,100 and thrombocytopenic purpura100 reported. Rare reports of plastic anemia and pancytopenia.100


Monitor blood counts periodically during prolonged therapy.100


Hepatic Effects

Transient increases in serum bilirubin, alkaline phosphatase, and AST concentrations and jaundice reported;100 relationship to lincomycin not known.100


Monitor liver function tests periodically during prolonged therapy.100


Renal Effects

Azotemia, oliguria, and proteinuria reported rarely;100 relationship to lincomycin not known.100


Monitor renal function tests periodically during prolonged therapy.100


Specific Populations


Pregnancy

Category C.100


Lactation

Distributed into milk;100 discontinue nursing or the drug.100


Pediatric Use

Safety and efficacy not established in infants <1 month of age.100


Large amounts of benzyl alcohol (i.e., 100–400 mg/kg daily) have been associated with toxicity (fatal “gasping syndrome”) in neonates;100 106 107 108 109 110 each mL of lincomycin injection contains 9.45 mg of benzyl alcohol.100


Geriatric Use

Some geriatric patients with associated severe illness may tolerate diarrhea less well than younger individuals;100 carefully monitor for change in bowel frequency.100


Hepatic Impairment

Use with caution; monitor serum lincomycin concentrations during high-dose therapy.100


Renal Impairment

Use with caution in those with severe renal impairment; monitor serum lincomycin concentrations during high-dose therapy.100


Common Adverse Effects


GI effects (nausea,100 vomiting,100 diarrhea,100 colitis,100 abdominal pain,a tenesmus,a glossitis,100 stomatitis,100 pruritus ani100 ), rash,100 urticaria,100 pruritus,a vaginitis,100 headache,a myalgia,a tinnitus,100 dizziness,a vertigo.100


Interactions for Lincomycin Hydrochloride


Specific Drugs















Drug



Interaction



Comments



Erythromycin



In vitro evidence of antagonistic antibacterial effects100



Avoid concomitant use100



Kaolin



GI absorption of lincomycin reduced by up to 90%a



If concomitant use necessary, give kaolin ≥2 hours before lincomycina



Neuromuscular blocking agents (pancuronium, tubocurarine [not commercially available in US])



Potential for enhanced neuromuscular blocking action100



Use with caution in patients receiving neuromuscular blocking agents100


Lincomycin Hydrochloride Pharmacokinetics


Absorption


Bioavailability


Following IM administration of 600 mg in healthy adults, peak plasma concentrations of 9.3–18.5 mcg/mL occur in 30 minutes,a concentrations are 1.3–3.2 mcg/mL at 12 hours, and detectable concentrations may persist for up to 24 hours.a


Following IV infusion of 600 mg over 2 hours, postinfusion plasma concentrations average 15.9–20.9 mcg/mL.a


Distribution


Extent


Distributed into many body tissues and fluids, including peritoneal fluid,a pleural fluid,a synovial fluid,a bone,a bile,100 a and aqueous humor.a


Only low concentrations diffuse into CSF;100 in patients with inflamed meninges, CSF concentrations may be 18% of concurrent plasma concentration.a


Readily crosses the placenta; cord blood concentrations are 25% of concurrent maternal blood concentrations.a


Distributed into milk;100 lincomycin concentrations of 0.5–2.4 mcg/mL have been reported in human milk.100


Plasma Protein Binding


72% at plasma concentration of 5 mcg/mL; 57% at concentration of 1 mcg/mL.a


Elimination


Metabolism


Partially metabolized in the liver.a


Elimination Route


Unchanged drug and metabolites excreted in urine (1.8–30.3%), bile, and feces (4–14%).a


Not removed to an appreciable extent by hemodialysis100 or peritoneal dialysis.100


Half-life


4–6.4 hours.a


Special Populations


Half-life increased in proportion to degree of renal or hepatic impairment.100 May be up to 3 times normal in patients with severe renal impairment.a May be 2 times normal in patients with hepatic impairment.100


Stability


Storage


Parenteral


Injection

20–25°C;100 avoid freezing.a


Compatibility


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


Parenteral


Solution Compatibility100 HID









Compatible



Dextran 6% in sodium chloride 0.9%



Dextrose 5% or 10% in water



Dextrose 5% or 10% in sodium chloride 0.9%



Ringer’s injection



Sodium lactate (1/6)M



Sodium chloride 0.9%


Drug Compatibility

















Admixture Compatibility

Compatible



Amikacin sulfate



Chloramphenicol sodium succinate



Cimetidine HCL



Cytarabine



Heparin sodium



Polymyxin B sulfate



Ranitidine HCl



Vitamin B complex with C



Incompatible



Kanamycin sulfate



Phenytoin sodium



Variable



Penicillin G potassium



Penicillin G sodium


ActionsActions



  • May be bacteriostatic or bactericidal in action, depending on concentration attained at site of infection and susceptibility of the infecting organism.a




  • Inhibits protein synthesis in susceptible organisms by binding to 50S ribosomal subunits.a




  • Spectrum of activity is similar to that of clindamycin, but lincomycin generally is less active against susceptible organisms than clindamycin.a




  • Active in vitro against many gram-positive aerobic bacteria and some gram-positive and -negative anaerobic bacteria.a Inactive against fungi and viruses.a




  • Gram-positive aerobes: Active against Staphylococcus aureus (including penicillinase-producing strains),100 Streptococcus pneumoniae,100 viridans streptococci,100 and other streptococci (except Enterococcus faecalis).a Also active in vitro against Corynebacterium diphtheriae.100




  • Anaerobes: Active against Actinomyces,a Bacteroides,a Eubacterium,a Fusobacterium,a Propionibacterium acnes,100 microaerophilic streptococci,a Peptococcus,a Peptostreptococcus,a and Veillonella.a Clostridium perfringens,100 C. tetani,100 and Mycoplasmaa also are inhibited.




  • Inactive against Haemophilus,100 Neisseria,100 Enterobacteriaceae,a Plasmodium,a and most strains of C. difficile.a




  • Resistance to lincomycin has been reported in Staphylococcus.100 Resistance also has been reported in some strains of streptococci and Bacteroides fragilis.a




  • Complete cross-resistance occurs between lincomycin and clindamycin;100 a partial cross-resistance occurs between lincomycin and macrolides (erythromycin).100 a



Advice to Patients



  • Advise patients that antibacterials (including lincomycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).100




  • Importance of completing full course of therapy, even if feeling better after a few days.100




  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with lincomycin or other antibacterials in the future.100




  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.100 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.100




  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses.100




  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.100




  • Importance of advising patients of other important precautionary information.100 (See Cautions.)



Preparations


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













Lincomycin Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Injection



300 mg (of lincomycin) per mL



Lincocin



Pfizer



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 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



100. Pharmacia & Upjohn Company. Lincocin (lincomycin) injection USP prescribing information. New York, NY; 2007 Jun.



101. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of American. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]



102. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50 (IDIS 386628) [IDIS 386628] [PubMed 9149180]



103. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]



104. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]



105. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]



106. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]



107. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12(2):10-11. [PubMed 7188569]



108. Centers for Disease Control. Neonatal deaths associated with use of benzyl alcohol. MMWR Morb Mortal Wkly Rep. 1982; 31:290-1. [IDIS 150868] [PubMed 6810084]



109. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]



110. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]



111. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2007; 5:33-50.



a. AHFS Drug Information. McEvoy GK, ed. Lincomycin hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2007:472-4.



HID. Trissel LA. Handbook on injectable drugs. 15th ed. Bethesda, MD. American Society of Health-System Pharmacists; 2009:975-7.



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Compare Lincomycin Hydrochloride with other medications


  • Bacterial Infection
  • Conjunctivitis, Bacterial

Tuesday, September 13, 2016

Linezolid Tablets


Pronunciation: lin-AYZ-oh-lid
Generic Name: Linezolid
Brand Name: Zyvox


Linezolid is used for:

Treating adults with certain serious bacterial infections that are often resistant to other antibiotics.


Linezolid is an oxazolidinone antibiotic. It works by interfering with the production of proteins needed by bacteria to grow.


Do NOT use Linezolid if:


  • you are allergic to any ingredient in Linezolid

  • you are taking an amphetamine (eg, dextroamphetamine), an anorexiant (eg, phentermine), a catechol-O-methyltransferase (COMT) inhibitor (eg, entacapone), cyclobenzaprine, fentanyl, levodopa, meperidine, sibutramine, a sympathomimetic (eg, albuterol, pseudoephedrine), tetrabenazine, or a triptan (eg, sumatriptan)

  • you are taking or have taken apraclonidine, bupropion, buspirone, dextromethorphan, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), nefazodone, a norepinephrine reuptake inhibitor (eg, atomoxetine), a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, duloxetine, venlafaxine), a selective serotonin reuptake inhibitor (SSRI) (eg, paroxetine), a tetracyclic antidepressant (eg, maprotiline, mirtazapine), trazodone, a tricyclic antidepressant (eg, amitriptyline, doxepin), or vilazodone within the past 14 days

  • you are taking or have taken fluoxetine within the past 5 weeks

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



Before using Linezolid:


Some medical conditions may interact with Linezolid. 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 high blood pressure, kidney problems, eye or vision problems, bone marrow problems, low blood cell or platelet levels, an adrenal gland tumor (pheochromocytoma), carcinoid syndrome, severe liver problems, seizures, or an overactive thyroid

  • if you have a prolonged infection that has been previously treated with another antibiotic medicine

  • if you are taking any medicine for depression

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


  • Amphetamines (eg, dextroamphetamine), anorexiants (eg, phentermine), apraclonidine, bupropion, buspirone, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), cyclobenzaprine, dextromethorphan, epinephrine, fentanyl, ginseng, levodopa, meperidine, methylphenidate, MAOIs (eg, phenelzine, selegiline), nefazodone, norepinephrine reuptake inhibitors (eg, atomoxetine), propoxyphene, SNRIs (eg, duloxetine, venlafaxine ), SSRIs (eg, fluoxetine, paroxetine), sibutramine, sympathomimetics (eg, albuterol, pseudoephedrine), tetrabenazine, tetracyclic antidepressants (eg, maprotiline, mirtazapine), trazodone, tricyclic antidepressants (eg, amitriptyline, doxepin), triptans (eg, sumatriptan), tryptophan, or vilazodone because severe side effects, including severe headache, fever, high blood pressure, or mental or mood changes, may occur

  • Tramadol because the risk of seizures may be increased

  • Carbamazepine, barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifamycins (eg, rifampin) because they may decrease Linezolid's effectiveness

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


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


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

  • To clear up your infection completely, take Linezolid for the full course of treatment. Keep taking it even if you feel better in a few days.

  • If you miss a dose of Linezolid, 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 Linezolid.



Important safety information:


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

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

  • Be sure to use Linezolid 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 Linezolid 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.

  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. 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.

  • Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. This could occur for up to 2 weeks after you stop taking an MAOI. Do not eat foods high in tyramine while you take Linezolid. Ask your health care provider for a complete list of foods you should avoid. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.

  • Linezolid may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Linezolid only works against bacteria; it does not treat viral infections (eg, the common cold).

  • Lactic acidosis has occurred with the use of Linezolid. Contact your doctor if you have severe, persistent nausea, vomiting, stomach pain, or unusual tiredness or weakness.

  • Serious eye problems (eg, peripheral and optic neuropathy) have occurred with the use of Linezolid. Contact your doctor if you experience vision changes (eg, decreased or blurred vision, changes in color vision, loss of vision).

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

  • Linezolid should be used with extreme caution 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 Linezolid while you are pregnant. It is not known if Linezolid is found in breast milk. If you are or will be breast-feeding while you use Linezolid, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Linezolid:


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:



Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; trouble sleeping; 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; unusual hoarseness); agitation; bloody stools; bloody vomit; chills, fever, or sore throat; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; red, swollen, peeling, or blistered skin; seizures; severe or continuing diarrhea; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of the hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes (including decreased or blurred vision, changes in color vision, loss of vision); white patches in the mouth.



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: Linezolid 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 Linezolid:

Store Linezolid at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep bottle tightly closed. Keep Linezolid out of the reach of children and away from pets.


General information:


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

  • Linezolid 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 Linezolid. 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 Linezolid resources


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


Compare Linezolid with other medications


  • Bacteremia
  • Methicillin-Resistant Staphylococcus Aureus Infection
  • Nosocomial Pneumonia
  • Pneumonia
  • Skin and Structure Infection

Lanthanum Carbonate


Class: Phosphate-removing Agents
VA Class: GU900
Chemical Name: Lanthanum Carbonate
Molecular Formula: La2(CO3)3 xH2O
Brands: Fosrenol

Introduction

Phosphate binder used to reduce the intestinal absorption of phosphates.1 2 3


Uses for Lanthanum Carbonate


Hyperphosphatemia


Reduction of serum phosphorus in patients with end-stage renal disease (ESRD).1 2 3 Reductions in serum phosphorus concentrations are similar to those achieved with alternative phosphate binders (e.g., calcium salts, sevelamer).1 2 8 10


Risk of hypercalcemia apparently is less than with calcium (e.g., calcium carbonate) salts.1 5 8 9 10 11


Lanthanum Carbonate Dosage and Administration


Administration


Oral Administration


Administer orally in divided doses with or immediately after meals (in order to bind dietary phosphates efficiently).1 2


Chew tablets completely before swallowing; do not swallow intact tablets.1


Dosage


Available as lanthanum carbonate; dosage expressed in terms of lanthanum.1 2


Adults


Hyperphosphatemia

ESRD

Oral

Initially, 750 mg–1.5 g daily.1


Adjust dosage at 2- to 3-week intervals until serum phosphorus concentration is acceptable; generally titrated in increments of 750 mg daily in clinical studies.1 2


Dosage of 1.5–3 g daily usually is required to reduce serum phosphorus concentrations to <6 mg/dL;1 2 dosages up to 3.75 g daily have been studied.1


Monitor serum phosphorus concentrations as needed during titration and regularly thereafter.1


Cautions for Lanthanum Carbonate


Contraindications



  • No known contraindications.1



Warnings/Precautions


General Precautions


GI Disease

Safety and efficacy not established in active peptic ulcer disease, ulcerative colitis, Crohn’s disease, or bowel obstruction; use with caution in patients with these disorders.1


Radiographic Examinations

Abdominal radiographs performed in patients taking lanthanum may have the typical radiopaque appearance of a radiograph performed using an imaging agent.1


Chronic Use

No differences in fracture or mortality rates were observed between patients receiving lanthanum and those receiving alternative therapy for up to 3 years in clinical studies; however, data are insufficient to conclude lanthanum has no effect on fracture or mortality rates beyond 3 years of use.1


Specific Populations


Pregnancy

Category C.1


Lactation

Not known whether lanthanum is distributed into milk.1 Caution if used in nursing women.1


Pediatric Use

Safety and efficacy not established in children <18 years of age.1 12


Deposited in developing bone (including the growth plate) of animals in long-term studies;1 although growth abnormalities in animals were not observed, the consequences of deposition in developing bone of pediatric patients are unknown.1


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1


Common Adverse Effects


Nausea,1 2 3 4 vomiting,1 2 3 4 dialysis graft occlusion,1 2 abdominal pain.1 3 5


Interactions for Lanthanum Carbonate


Not a substrate for CYP isoenzymes.1 5 Does not inhibit CYP isoenzymes 1A2, 2C9/10, 2C19, 2D6, or 3A4/5.1


Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes


Pharmacokinetic interaction unlikely.1 5


Drugs Known to Interact with Antacids


Possible formation of insoluble complexes; do not administer such drugs within 2 hours of lanthanum dose.1 5


Specific Drugs



















Drug



Interaction



Citrate salts



Lanthanum absorption not altered1 5



Digoxin



No formation of insoluble complexes in vitro; digoxin absorption not altered1 2 5



Enalapril



No formation of insoluble complexes in vitro1 5



Furosemide



No formation of insoluble complexes in vitro1 5



Metoprolol



No formation of insoluble complexes in vitro; metoprolol absorption not altered1 2 5



Phenytoin



No formation of insoluble complexes in vitro1 5



Warfarin



No formation of insoluble complexes in vitro; warfarin absorption not altered1 2 5


Lanthanum Carbonate Pharmacokinetics


Absorption


Information regarding the mass balance of lanthanum in humans after oral administration is not available.1


Bioavailability


Minimally absorbed from the GI tract; bioavailability <0.002%.1 2 3 4 5


Food

Minimal effect on systemic lanthanum concentrations.1


Plasma Concentrations

Mean plasma concentrations of the drug remain low (≤1.1 ng/mL) for up to 2 years of use.1 2 3 Plasma concentrations increase minimally with increasing dosages in the recommended range.1


Distribution


Extent


Distributed into bone; bone lanthanum concentrations increase over time (e.g., 4.5 years of administration).1


Does not appear to cross the blood-brain barrier in animals.1 2 5


Plasma Protein Binding


>99%.1


Elimination


Metabolism


Not metabolized.1


Elimination Route


In animals, excreted principally in the feces (94–99%), mainly as unabsorbed drug; systemically absorbed lanthanum is eliminated in the feces, principally via biliary excretion.1 2 5


Minimally excreted in urine in healthy individuals (renal clearance of IV lanthanum chloride [not commercially available in the US] is <2% of total plasma clearance).1 5


Half-life


Plasma: 53 hours.1


Bone: 2–3.6 years.1


Special Populations


In lanthanum-treated patients with ESRD, no quantifiable amounts were present in the dialysate.1


Stability


Storage


Oral


Chewable Tablets

25°C (may be exposed to 15–30°C).1 Protect from moisture.1


ActionsActions



  • Dissociates in the acidic environment of the upper GI tract to release trivalent lanthanum ions, which bind dietary phosphate released during digestion, thereby forming highly insoluble lanthanum phosphate complexes that are excreted fecally.1 2 5




  • Lanthanum ions have a high affinity for phosphate; the drug binds about 97% of available phosphates in vitro at pH 3–5 (corresponding to that of gastric fluid) when in twofold molar excess to phosphates.1 2




  • Reduces phosphate absorption, serum phosphorus concentrations, and serum calcium times phosphorus product (Ca × P).1 2 3



Advice to Patients



  • Importance of adhering to instructions about diet.1




  • Importance of taking lanthanum with or immediately after meals.1 12




  • Importance of chewing tablets completely before swallowing, and not swallowing intact tablets.1




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




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




























Lanthanum Carbonate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, chewable



250 mg (of lanthanum)



Fosrenol



Shire



500 mg (of lanthanum)



Fosrenol



Shire



750 mg (of lanthanum)



Fosrenol



Shire



1 g (of lanthanum)



Fosrenol



Shire


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Fosrenol 1000MG Chewable Tablets (SHIRE US INC.): 30/$217.27 or 90/$622.87


Fosrenol 500MG Chewable Tablets (SHIRE US INC.): 45/$318.69 or 135/$927.13



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 May 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Shire US Inc. Fosrenol (lanthanum carbonate) chewable tablets prescribing information. Wayne, PA; 2005 Nov.



2. Harrison TS, Scott LJ. Lanthanum carbonate. Drugs. 2004; 69:985-96.



3. Joy MS, Finn WF, for the LAM-302 Study Group. Randomized, double-blind, placeo-controlled, dose-titration, phase III study assessing the efficacy and tolerability of lanthanum carbonate: a new phosphate binder for the treatment of hyperphosphatemia. Am J Kidney Dis. 2003; 42:96-107. [IDIS 501884] [PubMed 12830461]



4. Finn WS, Joy MS, Hladik G and the Lanthanum Study Group. Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialysis. Clin Nephrol. 2004; 62:193-201. [IDIS 523632] [PubMed 15481851]



5. Albaaj F, Hutchison AJ. Lanthanum carbonate for the treatment of hyperphosphatemia in renal failure and dialysis patients. Expert Opin Pharmacother. 2005; 6:319-28. [PubMed 15757427]



6. National Institutes of Health Consensus Development Conference Panel. Morbidity and mortality of renal dialysis: an NIH consensus conference statement. Ann Intern Med. 1994; 121:62-70. [PubMed 8198352]



7. Braintree Laboratories. PhosLo (calcium acetate) tablets prescribing information (dated May 1992). In: Physicians’ desk reference. 52nd ed. Montvale, NJ; 1998:733-4.



8. D’Haese PC, Spasovski GB, Sikole A et al. A multicenter study on the effects of lanthanum carbonate (Fosrenol) and calcium carbonate on renal bone disease in dialysis patients. Kidney Int. 2003; 85(Suppl 1):S73-8.



9. Loghman-Adham M. Safety of new phosphate binders for chronic renal failure. Drug Saf. 2003; 26:1093-115. [PubMed 14640773]



10. DeBroe ME, D’Haese PC for the Lanthanum Study Group. Improving outcomes in hyperphosphataemia. Nephrol Dial Transplant. 2004; 19(Suppl 1):i14-8.



11. Torres A, DeBroe ME, D’Haese PC et al. SU-PO1041. One-year, randomized, open-label study comparing the safety and efficacy of lanthanum carbonate (Fosrenol) and calcium carbonate in dialysis patients. J Am Soc Nephrol. 2003; 85:764A.



12. Shire, Wayne, PA: Personal communication.



More Lanthanum Carbonate resources


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


  • Lanthanum Carbonate MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lanthanum Carbonate Professional Patient Advice (Wolters Kluwer)

  • lanthanum carbonate Advanced Consumer (Micromedex) - Includes Dosage Information

  • Fosrenol Prescribing Information (FDA)

  • Fosrenol Consumer Overview



Compare Lanthanum Carbonate with other medications


  • Hyperphosphatemia of Renal Failure

Lanoxin Pediatric Intravenous



Generic Name: digoxin (Intravenous route)

di-JOX-in

Commonly used brand name(s)

In the U.S.


  • Lanoxin

  • Lanoxin Pediatric

Available Dosage Forms:


  • Solution

  • Injectable

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Cardiac Glycoside


Chemical Class: Digitalis Glycoside


Uses For Lanoxin Pediatric


Digoxin injection is used in combination with a diuretic ("water pill") and an angiotensin-converting enzyme (ACE) inhibitor to treat congestive heart failure and a heart rhythm problem called atrial fibrillation.


Digoxin injection belongs to the class of medicines called digitalis glycosides. It is used to improve the strength and efficiency of the heart, or to control the rate and rhythm of the heartbeat. This leads to better blood circulation and reduced swelling of the hands and ankles in patients with heart problems.


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


Before Using Lanoxin Pediatric


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of digoxin injection in children. However, infants are more likely to be very sensitive to the effects of digoxin injection which may require an individual dose for infants receiving digoxin injection.


Geriatric


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


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


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


  • Alprazolam

  • Amiodarone

  • Bemetizide

  • Bendroflumethiazide

  • Benzthiazide

  • Boceprevir

  • Buthiazide

  • Calcium

  • Chan Su

  • Chlorothiazide

  • Chlorthalidone

  • Clopamide

  • Conivaptan

  • Cyclopenthiazide

  • Cyclothiazide

  • Demeclocycline

  • Diphenoxylate

  • Doxycycline

  • Dronedarone

  • Erythromycin

  • Ezogabine

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Indapamide

  • Indomethacin

  • Itraconazole

  • Kyushin

  • Lapatinib

  • Lily of the Valley

  • Methyclothiazide

  • Metolazone

  • Minocycline

  • Oleander

  • Oxytetracycline

  • Pheasant's Eye

  • Polythiazide

  • Propafenone

  • Propantheline

  • Quercetin

  • Quinethazone

  • Quinidine

  • Ritonavir

  • Saquinavir

  • Spironolactone

  • Squill

  • Succinylcholine

  • Telaprevir

  • Tetracycline

  • Trichlormethiazide

  • Verapamil

  • Xipamide

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


  • Acarbose

  • Acebutolol

  • Alprenolol

  • Arbutamine

  • Atenolol

  • Atorvastatin

  • Azithromycin

  • Azosemide

  • Bepridil

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bucindolol

  • Canrenoate

  • Carteolol

  • Carvedilol

  • Cascara Sagrada

  • Celiprolol

  • Colchicine

  • Cyclosporine

  • Darunavir

  • Dilevalol

  • Diltiazem

  • Disopyramide

  • Epoprostenol

  • Esmolol

  • Etravirine

  • Flecainide

  • Fluoxetine

  • Furosemide

  • Gatifloxacin

  • Hydroxychloroquine

  • Indecainide

  • Labetalol

  • Lenalidomide

  • Lornoxicam

  • Lurasidone

  • Mepindolol

  • Metipranolol

  • Metoclopramide

  • Metoprolol

  • Mibefradil

  • Nadolol

  • Nebivolol

  • Nefazodone

  • Nilvadipine

  • Nisoldipine

  • Nitrendipine

  • Omeprazole

  • Oxprenolol

  • Pancuronium

  • Paromomycin

  • Penbutolol

  • Pindolol

  • Piretanide

  • Posaconazole

  • Propranolol

  • Quinine

  • Rabeprazole

  • Ranolazine

  • Rifampin

  • Rifapentine

  • Roxithromycin

  • Simvastatin

  • Sotalol

  • Sulfasalazine

  • Talinolol

  • Telithromycin

  • Telmisartan

  • Tertatolol

  • Ticagrelor

  • Timolol

  • Torsemide

  • Tramadol

  • Trazodone

  • Trimethoprim

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


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


  • Blood vessel disease (e.g., arteriovenous shunt) or

  • Hypocalcemia (low calcium in the blood) or

  • Hypoxia (low oxygen in the blood) or

  • Thyroid disease—Use with caution. Patients with these conditions may be less sensitive or resistant to the effects of digoxin injection.

  • Electrical cardioversion (a medical procedure)—Dose of digoxin injection may be reduced 1 to 2 days prior to electrical cardioversion of atrial fibrillation to avoid worsening of the condition.

  • Heart disease (e.g., amyloid heart disease, AV block, constrictive pericarditis, cor pulmonale, heart attack, hypertrophic cardiomyopathy, restrictive cardiomyopathy, sick sinus syndrome, Wolff-parkinson-white syndrome) or

  • Hypercalcemia (high calcium in the blood) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May make these conditions worse.

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

  • Ventricular fibrillation (heart rhythm problem)—Should not be used in patients with this condition.

Proper Use of digoxin

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


A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given usually through a needle placed in one of your veins or sometimes as a shot deep into your muscles.


Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.


Precautions While Using Lanoxin Pediatric


It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.


Do not stop taking this medicine without first checking with your doctor. Stopping suddenly may cause a serious change in heart function.


Watch for signs and symptoms of overdose while you are taking this medicine. Follow your doctor's directions carefully. The amount of this medicine needed to help most people is very close to the amount that could cause serious problems from overdose. Some early warning signs of overdose are loss of appetite, nausea, vomiting, diarrhea, or problems in seeing. Other signs of overdose are changes in the rate or rhythm of the heartbeat (becoming irregular or slow), palpitations (feeling of pounding in the chest), or fainting. In infants and small children, the earliest signs of overdose are changes in the rate and rhythm of the heartbeat. Children may not show the other symptoms as soon as adults.


Your doctor may want you to carry a medical identification card or bracelet stating that you are receiving this medicine.


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


Before having any tests, tell your doctor that you are using this medicine. This medicine may affect the results of certain medical tests.


Lanoxin Pediatric Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor or nurse immediately if any of the following side effects occur:


More common
  • Dizziness

  • fainting

  • fast, pounding, or irregular heartbeat or pulse

  • slow heartbeat

Rare
  • Black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • bloody vomit

  • pinpoint red spots on the skin

  • rash with flat lesions or small raised lesions on the skin

  • severe stomach pain

  • unusual bleeding or bruising

Incidence not known
  • Chest pain or discomfort

  • nausea

  • shortness of breath

  • sweating

  • swelling of the feet and lower legs

  • troubled breathing

  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Agitation or combativeness

  • anxiety

  • confusion

  • depression

  • diarrhea

  • expressed fear of impending death

  • hallucinations

  • rash

  • vomiting

Rare
  • Abdominal or stomach pain

Incidence not known
  • Blurred or loss of vision

  • disturbed color perception

  • double vision

  • halos around lights

  • headache

  • lack of feeling or emotion

  • loss of appetite

  • night blindness

  • overbright appearance of lights

  • swelling of the breasts or breast soreness in both females and males

  • tunnel vision

  • uncaring

  • weakness

  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lanoxin Pediatric Intravenous side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Lanoxin Pediatric Intravenous resources


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


Compare Lanoxin Pediatric Intravenous with other medications


  • Atrial Fibrillation
  • Heart Failure

Lapatinib


Pronunciation: la-PA-ti-nib
Generic Name: Lapatinib
Brand Name: Tykerb

Severe and sometimes fatal liver problems may occur with the use of Lapatinib. These problems may develop within days or several months after you start using it. Tell your doctor if you have a history of liver problems. Your doctor may need to check your liver function before you start Lapatinib and while you are taking it. Be sure to keep all doctor and lab appointments. Contact your doctor right away if you develop dark urine, pale stools, severe stomach pain, severe tiredness or weakness, unusual itching, or yellowing of the eyes or skin.





Lapatinib is used for:

Treating certain types of advanced or metastatic breast cancer. It is used in combination with another medicine (capecitabine or letrozole). It may also be used for other conditions as determined by your doctor.


Lapatinib is a protein-tyrosine kinase inhibitor. It works by preventing the growth of cancer cells.


Do NOT use Lapatinib if:


  • you are allergic to any ingredient in Lapatinib

  • you have developed liver problems from taking Lapatinib in the past

  • you have uncorrected low blood potassium or magnesium levels

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



Before using Lapatinib:


Some medical conditions may interact with Lapatinib. 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 able to become pregnant

  • 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 bone marrow problems, low white blood cell counts, or low blood platelets

  • if you have a history of liver problems, lung problems, heart problems (eg, heart failure), or an irregular heartbeat (eg, QT prolongation)

  • if you have low blood potassium or magnesium levels

  • if you are taking a calcium channel blocker (eg, diltiazem, verapamil, nifedipine) or you take medicine for depression or stomach ulcers

  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

  • if you have received an anthracycline (eg, doxorubicin) in the past

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


  • Antiarrhythmics (eg, amiodarone, quinidine), arsenic, astemizole, bepridil, chloroquine, cisapride, dofetilide, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), romidepsin, tacrolimus, terfenadine, toremifene, certain tricyclic antidepressants (eg, doxepin, nortriptyline), vandetanib, or ziprasidone because the risk of a certain type of irregular heartbeat (QT prolongation) may be increased

  • Atazanavir, azole antifungals (eg, itraconazole, ketoconazole, posaconazole), nefazodone, protease inhibitors (eg, boceprevir, indinavir, ritonavir), or voriconazole because they may increase the risk of Lapatinib's side effects

  • Carbamazepine, dexamethasone, hydantoins (eg, phenytoin), nevirapine, phenobarbital, primidone, rifamycins (eg, rifampin) or St. John's wort because they may decrease Lapatinib's effectiveness

  • Digoxin, midazolam, or paclitaxel because the risk of their side effects may be increased by Lapatinib

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


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


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

  • Take Lapatinib by mouth at least 1 hour before or 1 hour after eating.

  • Do not eat grapefruit or drink grapefruit juice while you use Lapatinib.

  • If you miss a dose of Lapatinib, 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 Lapatinib.



Important safety information:


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

  • Diarrhea is a common side effect of Lapatinib. If diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • If you may become pregnant, you must use an effective form of birth control while you take Lapatinib. If you have questions about effective birth control, talk with your doctor.

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

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

  • PREGNANCY and BREAST-FEEDING: Lapatinib may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lapatinib while you are pregnant. It is not known if Lapatinib is found in breast milk. Do not breast-feed while taking Lapatinib.


Possible side effects of Lapatinib:


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:



Back pain; diarrhea; dry skin; fingernail or toenail changes; headache; indigestion; loss of appetite; mild hair loss or thinning; mouth sores; nausea; nosebleed; redness and tingling of the hands and feet; tiredness; trouble sleeping; 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); chest pain; dark urine; dizziness or light-headedness; fast or irregular heartbeat; pale stools; persistent loss of appetite; severe or persistent cough; severe pain, redness, or swelling of the hands or feet; severe stomach pain or diarrhea; severe tiredness or weakness; shortness of breath; unusual bruising or bleeding; unusual itching; yellowing of the eyes or skin.



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: Lapatinib 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 fast heartbeat; sore scalp; swelling or soreness of the mouth.


Proper storage of Lapatinib:

Store Lapatinib between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lapatinib out of the reach of children and away from pets.


General information:


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

  • Lapatinib 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 Lapatinib. 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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  • Lapatinib Drug Interactions
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  • Lapatinib Professional Patient Advice (Wolters Kluwer)

  • lapatinib Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lapatinib Ditosylate Monograph (AHFS DI)

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Lamisil AT Cream



terbinafine hydrochloride

Dosage Form: cream
Drug Facts

Active ingredient


Terbinafine hydrochloride



Purpose


Antifungal



Uses


  • cures most athlete’s foot (tinea pedis)

  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)

  • relieves itching, burning, cracking and scaling which accompany these conditions


Warnings


For external use only



Do Not Use


  • on nails or scalp

  • in or near the mouth or eyes

  • for vaginal yeast infections


When using this product


do not get into eyes. If eye contact occurs, rinse thoroughly with water.



Stop use and ask doctor


if too much irritation occurs or gets worse



Keep out of reach of children


If swallowed, get medical help or contact a poison control center right away.



Directions


• adults and children 12 years and over:


    • use the tip of the cap to break the seal and open the tube


    • wash the affected skin with soap and water and dry completely before applying


    • for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily


        • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor


1 week between the toes



        • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor


2 weeks on the bottom or sides of the foot



    • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor


    • wash hands after each use


• children under 12 years: ask a doctor



Other information


  • do not use if seal on tube is broken or is not visible

  • store at controlled room temperature 20-25°C (68-77°F)


Inactive ingredients


benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.



Questions


call 1-800-452-0051


Novartis Consumer Health, Inc.


Parsippany, NJ 07054-0622 ©2008



Principal display panel


Lamisil AT Cream










LAMISIL  AT
terbinafine hydrochloride  cream










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0067-3998
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TERBINAFINE HYDROCHLORIDE (TERBINAFINE)TERBINAFINE HYDROCHLORIDE10 mg  in 1 g






















Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
CETYL PALMITATE 
ISOPROPYL MYRISTATE 
POLYSORBATE 60 
WATER 
SODIUM HYDROXIDE 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


































































Packaging
#NDCPackage DescriptionMultilevel Packaging
10067-3998-851 TUBE In 1 CARTONcontains a TUBE
124 g In 1 TUBEThis package is contained within the CARTON (0067-3998-85)
20067-3998-421 TUBE In 1 CARTONcontains a TUBE
212 g In 1 TUBEThis package is contained within the CARTON (0067-3998-42)
30067-3998-151 TUBE In 1 CARTONcontains a TUBE
315 g In 1 TUBEThis package is contained within the CARTON (0067-3998-15)
40067-3998-281 TUBE In 1 CARTONcontains a TUBE
428 g In 1 TUBEThis package is contained within the CARTON (0067-3998-28)
50067-3998-301 TUBE In 1 CARTONcontains a TUBE
530 g In 1 TUBEThis package is contained within the CARTON (0067-3998-30)
60067-3998-401 TUBE In 1 CARTONcontains a TUBE
640 g In 1 TUBEThis package is contained within the CARTON (0067-3998-40)
70067-3998-3636 g In 1 TUBENone
80067-3998-4342 g In 1 TUBENone
90067-3998-5454 g In 1 TUBENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02098008/10/2005


Labeler - Novartis Consumer Health, Inc. (879821635)
Revised: 01/2010Novartis Consumer Health, Inc.




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  • Tinea Corporis
  • Tinea Cruris
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