Friday, August 10, 2012

Tuberculin


Class: Tuberculosis
VA Class: DX300
Brands: Aplisol, Tubersol

Introduction

Skin-test antigen for diagnosis of Mycobacterium tuberculosis infection.a b c


Uses for Tuberculin


Diagnosis of Tuberculosis (TB) Infection



  • Aids in identifying Mycobacterium tuberculosis-infected individuals at high risk for developing active TB who may benefit from treatment of latent TB infection.b c d e




  • Treatment of latent TB infection previously referred to as “preventive therapy” or “chemoprophylaxis”.144 d e




  • ATS and CDC recommend tuberculin testing in high-risk groups and generally discourage such testing in those at low risk to maximize use of resources and minimize false-positive results.144




  • ATS, CDC, and IDSA recommend tuberculin testing in the following high-risk individuals or groups:144 f




  • Close contacts (i.e., those sharing same household or other closed environment) of known cases of clinical TB or individuals suspected of having TB144 b e f




  • HIV-infected individuals;107 117 121 132 144 145 146 b c e f consider annual testing in such individuals at high risk of continued exposure to TB, beginning at 3–12 months of age145 c e k




  • Other individuals with medical conditions or factors that increase risk of latent TB infection progressing to active TB, including diabetes mellitus,144 c e f chronic renal failure,144 c e f certain hematologic or reticuloendothelial disorders (e.g., leukemias, lymphomas),144 b certain other malignancies (e.g., head and neck or lung cancer),144 b f immunosuppression (e.g., organ transplant recipients, individuals receiving prolonged high-dose corticosteroid therapy, tumor necrosis factor, or other immunosuppressive agents),144 e f j silicosis,144 b f weight >10% below ideal body weight,144 f gastrectomy or jejunoileal bypass144 b f




  • Illicit-drug users and other locally identified high-risk substance users (e.g., crack cocaine users);144 b f required in all individuals enrolled in methadone detoxification or maintenance treatment program129 130 f




  • Residents and employees of high-risk congregate settings (e.g., correctional facilities, nursing homes, mental institutions, other long-term residential facilities [e.g., for HIV-infected patients], homeless shelters);144 146 b f routine (at least annual) testing recommendedc g




  • Foreign-born individuals (e.g., legal immigrants and refugees with class B1 and B2 TB notification status),f including children who recently arrived (≤5 years) from countries with high incidence or prevalence of TB and those adopted from outside US144 b e f




  • Certain medically underserved, low-income populations (e.g., migrant farm workers, homeless persons)121 b f




  • Individuals with pulmonary fibrotic lesions on chest radiographs (consistent with healed TB)144 b e f




  • Children <5 yearsf of age or infants, children, and adolescents exposed to adults in high-risk categories;121 e f annual testing recommended in high-risk pediatric patients (e.g., individuals from countries with high prevalence of TB, low-income groups, children infected with HIV, incarcerated adolescents)b e




  • All health-care workers (baseline and postexposure screening); ongoing periodic screening recommended according to riskc f h




  • History of BCG vaccination does not rule out use of tuberculin testing to aid diagnosis of TB infection.b c (See False-positive Reactions under Cautions.)



Tuberculin Dosage and Administration


General



  • Document test result in permanent medical record.c Include name of preparation, manufacturer and lot number, administration technique (i.e., Mantoux method), date and dose administered, date of test reading, and extent of induration in mm (including 0).c 121 Recording result only as “negative” or “positive” is not adequate.c



Administration


Intradermal Administration


Administer by intradermal injection using Mantoux method.b c Avoid administering by IV, IM, or sub-Q.b c Sub-Q injection lacks diagnostic value and may result in adverse reactions (e.g., general febrile reaction, acute inflammation around old tuberculous lesions) in highly sensitive individuals.c


Use tuberculin syringe with short (0.25–0.5 inch) 26- or 27-gauge needle.b c Use a separate sterile, single-use disposable syringe and needle for each individual patient to prevent transmission of infectious agents (e.g., HIV, hepatitis virus).b c To avoid contamination of vial content (and subsequent transmission of infectious agents to other individuals), never use the same needle and/or syringe to re-enter multidose vial, even when used for the same individual.c


To prepare dose, wipe vial stopper with suitable germicide (e.g., 70% alcohol) and use aseptic technique to draw exact dose into syringe, taking care to exclude air bubbles.a b c .


Prior to intradermal injection, cleanse administration site with 70% alcohol or other antiseptic and allow to dry.b c Usual injection site is volar (preferred) or dorsal surface of forearm, approximately 4 inches below elbow.b c 121 Avoid hairy areas, areas with lesions, areas near veins, swollen or red areas,b c 121 and areas without adequate subcutaneous tissue (e.g., concavities over tendon or bone).a


Potential for a drop of blood when needle withdrawn from injection site.c Remove any blood at injection site gently with gauze to avoid squeezing out tuberculin.c


Avoid recapping needle following use; properly dispose of used needles and syringes.c


Mantoux Method

With needle bevel pointing upward, insert needle into the most superficial layers of the skin and inject slowly.b c


A pale bleb about 6–10 mm in diameter should form at injection site.b c Bleb is absorbed within minutes; no dressing required.b c


If improperly administered (i.e., no bleb formed) or if dose leaks from injection site, repeat test immediately at another site at least 5 cm (2 inches) from original injection site; indicate site used for second test in patient’s record or by circling second site.b c 121


In individuals requiring routine periodic testing (e.g., health-care professionals, residents and workers in hospitals, nursing homes, mental institutions, prisons), perform 2-step testing method initially (using Mantoux method) to avoid misinterpreting a booster effect as a conversion.b c g h 121 (See Booster Effect and Two-Step Testing under Dosage and Administration.) If a small or negative reaction is observed after the first test, administer second test 1–4 weeks later.c g h 121


Examine test site 48–72 hours after administration.b c e 121 (See Interpretation of Tuberculin Reaction under Dosage and Administration.)


Interpretation of Tuberculin Reaction

Only trained health professionals should interpret tuberculin skin test; interpretation by untrained individuals or family member not reliable.c e


At 48–72 hours after administration, visually inspect and palpate test site to determine extent of induration.b c 121 Disregard finding of erythema (no diagnostic value); in absence of induration, an area of erythema with diameter >10 mm indicates too deep an injection and requires retesting.b c Note and record presence and extent of necrosis and edema, although these findings have no diagnostic value.b c


Measure diameter of palpable induration transversely to long axis of forearm.b c e Record in mm (including 0) and interpret reaction using guidelines from manufacturer, ATS, and CDC.b c 121 (See Table 1.)













Table 1. Guidelines for Interpreting Tuberculin Reactionbcei121144

Induration



Interpretation



≥5 mm



Positive in the following groups:



  • Individuals with fibrotic changes on chest radiographs consistent with prior TB




  • Recent contacts of individuals with active TB




  • Individuals with known or suspected HIV-infection




  • Other immunosuppressed patients (patients receiving ≥15 mg of prednisone, or its equivalent, daily for ≥1 month; organ or bone marrow transplant patients; patients taking tumor necrosis factor-alpha antagonists)b c e 121 144 i




≥10 mm



Positive in the following groups who do not meet above criteria:



  • IV drug users who are HIV-negative




  • Individuals with medical conditions that increase risk of progressing from latent TB infection to active TB (e.g., diabetes mellitus, chronic renal failure, malignancies [e.g., leukemias, lymphomas, head/neck/lung cancer], weight loss of ≥10% of ideal body weight, silicosis, gastrectomy, jejunoileal bypass)




  • Residents/employees of high-risk congregate settings (e.g., prisons, nursing homes, long-term care/health-care facilities, homeless shelters, residential facilities for AIDS patients)




  • Foreign-born persons arriving within the last 5 years from areas with high prevalence/incidence of TB (e.g., Asia, Africa, the Caribbean, Latin America)




  • Some medically underserved, low-income populations (e.g., migrant farm workers, homeless persons)




  • High-risk racial or ethnic minority populations, as defined locally




  • Personnel in mycobacteriology laboratories




  • Children <4 years of age




  • Children (including infants) and adolescents exposed to adults in high-risk categories




  • Children who travel to areas with high prevalence of TBb c e i 121 144




≥15 mm



Positive in individuals (including children ≥4 years of age) with no risk factors for TBb c e i 121 144



<15 mm



Negative in normal, healthy individuals with no risk factors for TB (lack of hypersensitivity to tuberculin);b c TB highly unlikelyb


When of diagnostic importance, accept negative reaction as proof that sensitivity is absent only after normal reactivity to nonspecific irritants has been demonstrated.b In individuals suspected of being TB positive who exhibit negative reaction to tuberculin testing, perform second test to exclude possibility of active TB.c Individuals with negative reaction to initial and second test may be considered tuberculin negative.c


To establish diagnosis of latent or active TB infection, rule out possible false-positive reaction (see False-positive Reactions under Cautions) and perform further medical and diagnostic evaluation (e.g., medical history, chest radiograph, sputum smear, culture examination).b c 144


A positive reaction may indicate latent infection, prior infection, and/or M. tuberculosis disease and may not indicate active TB;c d individuals with a positive reaction should be considered positive by current public health guidelines and referred for further medical evaluation.c d


A negative tuberculin skin test should not be used to exclude active TB in individuals with symptoms compatible with TB (see False-negative Reactions under Cautions).b e


Booster Effect and Two-Step Testing

If tuberculin sensitivity has waned (see Actions), initial testing will produce a small or negative reaction.b c 121 Repeated testing may boost size of reaction (booster effect), which can be misinterpreted as a conversion (i.e., positive reaction indicative of recent infection with M. tuberculosis).b c 121 144


Therefore, individuals requiring routine periodic testing (e.g., health-care professionals, residents and workers in hospitals, nursing homes, mental institutions, prisons) should initially receive 2-step testing (i.e., a repeat tuberculin test after an initial negative reaction)i to permanently document infectivity status (e.g., uninfected, previously infected).b c 121 If first test is negative, use result of second test performed 1–4 weeks later to determine TB status.121 c If reaction to second test is positive, individual is considered previously infected; if reaction is negative, individual is considered uninfected.c 121 In these uninfected individuals, a reaction size of ≥10 mm upon repeat testing within a 2-year period is considered a conversion.c 121 144


Individuals whose second test is negative, but whose reaction is positive after one year, are considered to have newly acquired TB infection and should be managed accordingly.c


Dosage


Each dose (0.1 mL) is bioequivalent to 5 US units (TU) of the US reference standard (PPD-S).b c


Pediatric Patients


Diagnosis of TB Infection

Intradermal

0.1 mL.b c


Adults


Diagnosis of TB Infection

Intradermal

0.1 mL.b c


Cautions for Tuberculin


Contraindications



  • Known hypersensitivity or previous severe reaction (e.g., anaphylaxis, vesiculation, ulceration, necrosis, blistering) to tuberculin or any ingredient in the formulation.b c




  • Individuals with previous positive reactions;c severe reactions (vesiculation, ulceration, necrosis) may occur in these patients.c




  • Individuals with documented active TB or a history of treatment for TB infection or disease.c




  • Individuals with extensive burns or eczema.c




  • Defer testing for patients with major viral infections or live-virus vaccination (e.g., measles, mumps, rubella, oral polio, yellow fever) in previous month;c common cold is not contraindication to test (see False-negative Reactions under Cautions).c



Warnings/Precautions


Warnings


Previous Severe Reaction

Risk of severe reaction at test site in individuals who previously experienced a severe reaction (e.g., vesiculation, ulceration, necrosis).b Use not recommended in such individuals.b (See Contraindications under Cautions.)


False-negative Reactions

Possible decreased ability to respond to test (resulting in false-negative reaction) in individuals with any condition that impairs or attenuates cell-mediated immunity, including viral infections (e.g., HIV, infectious mononucleosis, influenza, measles, mumps, rubella, varicella), overwhelming TB or tuberculous pleurisy, other bacterial infections (e.g., brucellosis, leprosy, pertussis, typhoid fever, typhus), fungal infections (e.g., blastomycosis), diseases affecting lymphoid organs (e.g., Hodgkin’s disease, chronic leukemia, lymphoma, sarcoidosis), or malignancy.a b c


Possible temporarily decreased ability to respond to test (resulting in false-negative reaction) caused by live virus vaccines (e.g., measles, mumps, rubella, oral polio, yellow fever).b c Administer skin test and vaccine at separate sites when tuberculin screening required at same time as live-virus vaccine.c Delay tuberculin skin test for ≥4–6 weeks after live virus vaccination if live virus vaccine recently administered.b c


Possible decreased ability to respond to test (resulting in false-negative reaction) in individuals with metabolic derangements (e.g., chronic renal failure), low protein states, malnutrition, stress (e.g., surgery, burns, mental illness, graft-versus-host reactions), or with immunosuppressive therapy.b c (See Interactions.)


Reactivity to test possibly depressed or suppressed for 5–6 weeks following viral infections, immunization with certain live virus vaccines, or discontinuance of corticosteroid or immunosuppressive therapy.b (See Interactions.)


Possible decreased ability to respond to test (resulting in false-negative reaction) in newborns and geriatric patients.b c (See Specific Populations under Cautions.)


In HIV-infected individuals, test becomes less reliable as CD4+ T-cell count declines; therefore, perform tuberculin testing as soon as possible after HIV infection develops.b c k


Possible false-negative reaction if performed too soon after infection with M. tuberculosis.a (See Actions.)


False-positive Reactions

Possible false-positive reaction in individuals infected with nontuberculous mycobacteria or in individuals previously vaccinated with BCG vaccine.b c 121 144


Cannot reliably distinguish between reactions caused by BCG vaccination and those caused by natural mycobacterial infections.c 144 In individuals with prior BCG vaccination, indurations ≥20 mm in diameter not likely caused by BCG vaccination.144


Test reaction of ≥10 mm probably attributable to M. tuberculosis infection in a BCG-vaccinated individual from a country with a high prevalence of TB or who is in close contact with another person with infectious TB (especially if contact has spread M. tuberculosis to others) or if individual continually exposed to groups with a high TB prevalence.c


Sensitivity gradually wanes with time (period of years) but may be boosted/prolonged by periodic tuberculin testing.b c 144 (See Booster Effect and Two-Step Testing under Dosage and Administration.)


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylactic/anaphylactoid reactions manifested by angioedema, upper respiratory stridor, dyspnea, rash, generalized rash and/or urticaria reported within 24 hours after injection; manifestations resolved following treatment with epinephrine, diphenhydramine, and/or corticosteroids.c Allergic reactions may occur in individuals with no prior history of hypersensitivity to tuberculin skin test components.c


Ensure immediate availability of epinephrine and other appropriate agents in case of anaphylactic/anaphylactoid or acute hypersensitivity reaction.b c


Major Toxicities


Strongly Positive Reactions

Possible vesiculation, ulceration, or necrosis in highly sensitive individuals; may result in scarring at test site.b c


ATS recommends using a dry dressing to prevent secondary infection.a


Some manufacturers recommend using cold packs or topical corticosteroid preparations for symptomatic relief of pain, pruritus, and discomfort at injection site.b However, topical 1% hydrocortisone ointment shown to be ineffective in reducing extent or rate of resolution of induration reaction.a


General Precautions


Improper Storage and Handling

Possible loss of potency and inaccurate test results if improperly stored or handled.b c (See Storage under Stability.)


Specific Populations


Pregnancy

Category C.b c Tuberculin skin testing considered valid and safe throughout pregnancy.b Weigh benefit against risk, particularly in high-risk groups.b


Pediatric Use

Due to an immature immune system, infants <6 weeks of age infected with M. tuberculosis may not react to test.b 105 In older infants and children, tuberculin sensitivity develops 2–12 weeks (median: 3–6 weeks) after initial infection.c e


Very young children infected with M. tuberculosis at increased risk for active tuberculosis.c During contact investigations, give high priority to skin testing and treatment in young children and infants exposed to individuals with active TB.c


Geriatric Use

Skin test sensitivity may wane with advancing age;b skin test reaction may develop slowly and not be maximal until >72 hours.b c


Common Adverse Effects


Erythema, pain, pruritus, discomfort at test site.b c (See Major Toxicities under Cautions.)


Occasionally, localized redness or rash (without induration) within 12 hours of skin test;c reaction does not indicate TB infection.c (See Major Toxicities under Cautions.)


Interactions for Tuberculin


Specific Drugs


















Drug



Interaction



Comments



Corticosteroids



Possible depressed or suppressed reactivity, persisting up to 5–6 weeks following discontinuance of corticosteroidb c



Immunosuppressive agents



Possible depressed or suppressed reactivity, persisting up to 5–6 weeks following discontinuance of immunosuppressive agentb c



Vaccine, BCG



Possible false-positive reactionc 144



Sensitivity in BCG-vaccinated individuals gradually wanes with time (over a period of years) or advancing age;b c unlikely to persist for ≥10 yearsa


Sensitivity may be boosted/prolonged by periodic tuberculin testingb c 144



Vaccines, live virus (oral polio, measles, mumps, rubella, smallpox, yellow fever, varicella)



Possible depressed reactivityb c



Administer test before or simultaneously with vaccine(s) (at separate sites) or postpone test for 4–6 weeksb c


Tuberculin Pharmacokinetics


Absorption


Onset


In sensitive individuals, delayed hypersensitivity reaction is evident within 5–6 hours and is maximal within 48–72 hours.b c


In geriatric individuals or first-time recipients, reaction develops more slowly and may not be maximal until after 72 hours.b c


Duration


In tuberculin-sensitive individuals, delayed hypersensitivity reaction subsides over a period of days.105 144 Positive reaction may persist for up to 1 week.144


Stability


Storage


Parenteral


Injection

2–8°C; do not freeze.b c Protect from light.b c Due to possible oxidation and degradation (which may affect potency), discard vials in use for ≥30 days.b c b c


ActionsActions



  • Purified protein fraction isolated from a human strain of M. tuberculosis.b c




  • Produces delayed hypersensitivity response (e.g., local vasodilation, edema, infiltration of leukocytes) in individuals with tuberculin sensitivity (e.g., those infected with M. tuberculosis or other mycobacteria, those with history of BCG vaccination).b c Test not specific for M. tuberculosis; other nontuberculous mycobacteria may cross-react.a b c




  • Delayed hypersensitivity develops 2–12 weeks (median: 3–4 weeks) following infection and manifests as palpable induration (and occasional vesiculation and necrosis) at injection site.a b c




  • Tuberculin sensitivity generally persists throughout life but may gradually diminish or disappear with time (over a period of years) or advancing age.b c 121 Upon initial testing after sensitivity has waned, reactivity may be small or absent.b c 121 (See Booster Effect and Two-Step Testing under Dosage and Administration.)



Advice to Patients



  • Risk of pain, pruritus, and discomfort at injection site.b c Importance of informing clinician if vesiculation, ulceration, or necrosis occurs.b c




  • Importance of patient returning to clinician 48–72 hours after skin test administration for interpretation of test.b c




  • Importance of maintaining personal immunization record.b c




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




  • Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.b c




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



Preparations


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


















Purified Protein Derivative

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Injection, for intradermal use only



5 TU/0.1 mL



Aplisol (with phenol)



Parkedale



Tubersol (with phenol)



Aventis Pasteur



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 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References


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



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129. US Food and Drug Administration Substance Abuse and Mental Health Services Administration. Methadone in maintenance treatment of narcotic addicts; joint revision of conditions for use; interim maintenance treatment; human immunodeficiency virus disease counseling. 21 CFR Part 291. Final rule. [Docket No. 88N-0444] Fed Regist. 1993; 48:495-9.



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a. AHFS drug information 2004. McEvoy GK, ed. Tuberculin Purified Protein Derivative. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2486-91.



b. Parkdale Pharmaceuticals. Aplisol (tuberculin purified protein derivative, diluted [stabilized solution]) diagnostic antigen prescribing information. Rochester, MI; 2002 May.



c. Aventis Pasteur. Tubersol (tuberculin purified protein derivative [Mautoux]) diagnostic antigen prescribing information. Swiftwater, PA; 2007 Jan.



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i. Centers for Disease Control and Prevention. Tuberculin skin testing fact sheet. 2007 May. From CDC website



Sectral


Generic Name: acebutolol (A se BUE toe lol)

Brand Names: Sectral


What is Sectral (acebutolol)?

Acebutolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).


Acebutolol is used to treat hypertension (high blood pressure) and heart rhythm disorders.


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


What is the most important information I should know about Sectral (acebutolol)?


Do not stop taking acebutolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need to have any type of surgery, you may need to temporarily stop using acebutolol. Be sure the surgeon knows ahead of time that you are using acebutolol.


Acebutolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking acebutolol.

Acebutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.


Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.


What should I discuss with my healthcare provider before taking Sectral (acebutolol)?


If you have any of these conditions, you may not be able to use acebutolol, or you may need a dosage adjustment or special tests during treatment:



  • asthma, bronchitis, emphysema;




  • diabetes;




  • low blood pressure;




  • a heart problem such as heart block, sick sinus syndrome, slow heart rate, or congestive heart failure;




  • depression;




  • liver or kidney disease;




  • a thyroid disorder;




  • myasthenia gravis;




  • pheochromocytoma; or




  • problems with circulation (such as Raynaud's syndrome).




FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Acebutolol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Sectral (acebutolol)?


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


Take this medication with a full glass of water.

Take acebutolol at the same time every day.


Do not skip doses or stop taking acebutolol without first talking to your doctor. Stopping suddenly may make your condition worse.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. It is important that you not miss any scheduled visits to your doctor.


If you need to have any type of surgery, tell the surgeon that you are using acebutolol. You may need to briefly stop using acebutolol before having surgery.


Acebutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.


Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.


Store acebutolol at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If your next dose is less than 4 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, or seizure (convulsions).


What should I avoid while taking Sectral (acebutolol)?


Acebutolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking acebutolol.

Sectral (acebutolol) side effects


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

  • slow or uneven heartbeats;




  • feeling light-headed, fainting;




  • feeling short of breath, even with mild exertion;




  • swelling of your ankles or feet;




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • depression; or




  • cold feeling in your hands and feet.



Less serious side effects may include:



  • decreased sex drive, impotence, or difficulty having an orgasm;




  • sleep problems (insomnia);




  • tired feeling; or




  • anxiety, nervousness.



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 Sectral (acebutolol)?


Before taking acebutolol, tell your doctor if you are using:



  • allergy treatments (or if you are undergoing allergy skin-testing);




  • clonidine (Catapres);




  • guanabenz (Wytensin);




  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam);




  • a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), or metformin (Glucophage);




  • a heart medication such as nifedipine (Procardia, Adalat), reserpine (Serpasil), verapamil (Calan, Verelan, Isoptin), diltiazem (Cartia, Cardizem);




  • medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair); or




  • cold medicines, stimulant medicines, or diet pills.



This list is not complete and there may be other drugs that can interact with acebutolol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Sectral resources


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


  • Sectral Prescribing Information (FDA)

  • Sectral MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sectral Monograph (AHFS DI)

  • Sectral Advanced Consumer (Micromedex) - Includes Dosage Information

  • Acebutolol Prescribing Information (FDA)



Compare Sectral with other medications


  • High Blood Pressure
  • Premature Ventricular Depolarizations
  • Ventricular Tachycardia


Where can I get more information?


  • Your pharmacist can provide more information about acebutolol.

See also: Sectral side effects (in more detail)



Symax FasTabs Orally Disintegrating Tablets


Pronunciation: HYE-oh-SYE-a-meen
Generic Name: Hyoscyamine
Brand Name: Examples include NuLev and Symax FasTabs


Symax FasTabs Orally Disintegrating Tablets are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is also used to control stomach secretions and cramps. It is also used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is also used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.


Symax FasTabs Orally Disintegrating Tablets are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.


Do NOT use Symax FasTabs Orally Disintegrating Tablets if:


  • you are allergic to any ingredient in Symax FasTabs Orally Disintegrating Tablets

  • you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)

  • you have glaucoma, myasthenia gravis, or certain severe heart problems (eg, decreased blood flow to the heart)

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



Before using Symax FasTabs Orally Disintegrating Tablets:


Some medical conditions may interact with Symax FasTabs Orally Disintegrating Tablets. 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or you are at risk for glaucoma

  • if you have diarrhea or fever, have been very ill, or are in poor health

  • if you have phenylketonuria

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


  • Amantadine, other anticholinergics (eg, scopolamine), antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Symax FasTabs Orally Disintegrating Tablets's side effects

  • Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Symax FasTabs Orally Disintegrating Tablets

  • Ketoconazole or metoclopramide because their effectiveness may be decreased by Symax FasTabs Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Symax FasTabs Orally Disintegrating Tablets 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 Symax FasTabs Orally Disintegrating Tablets:


Use Symax FasTabs Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Symax FasTabs Orally Disintegrating Tablets are usually taken 30 to 60 minutes before a meal. Follow your doctor's specific instructions for taking Symax FasTabs Orally Disintegrating Tablets.

  • Place the tablet on the tongue and allow it to dissolve and then swallow. Some brands of Symax FasTabs Orally Disintegrating Tablets may also be chewed. Ask your pharmacist if your brand may be chewed.

  • Symax FasTabs Orally Disintegrating Tablets may be taken with or without water.

  • If you also take antacids, take Symax FasTabs Orally Disintegrating Tablets before meals and the antacid after meals, unless directed otherwise by your doctor.

  • If you miss a dose of Symax FasTabs Orally Disintegrating Tablets, 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 Symax FasTabs Orally Disintegrating Tablets.



Important safety information:


  • Symax FasTabs Orally Disintegrating Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Symax FasTabs Orally Disintegrating Tablets 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 Symax FasTabs Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.

  • Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.

  • Proper dental care is important while you are taking Symax FasTabs Orally Disintegrating Tablets. Brush and floss your teeth and visit the dentist regularly.

  • Symax FasTabs Orally Disintegrating Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

  • Tell your doctor or dentist that you take Symax FasTabs Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.

  • Use Symax FasTabs Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.

  • Caution is advised when using Symax FasTabs Orally Disintegrating Tablets in CHILDREN; they may be more sensitive to its effects, including excitability.

  • Some of these products should not be used in CHILDREN younger than 6 years old. Ask your pharmacist if your brand may be used in children younger than 6 years old. Check with your doctor if you have questions about giving Symax FasTabs Orally Disintegrating Tablets to your child.

  • Symax FasTabs Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

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


Possible side effects of Symax FasTabs Orally Disintegrating Tablets:


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:



Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.



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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.



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: Symax FasTabs 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 disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.


Proper storage of Symax FasTabs Orally Disintegrating Tablets:

Store Symax FasTabs Orally Disintegrating Tablets 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 Symax FasTabs Orally Disintegrating Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Symax FasTabs Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Symax FasTabs Orally Disintegrating Tablets are 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 Symax FasTabs Orally Disintegrating Tablets. 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 Symax FasTabs resources


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


Compare Symax FasTabs with other medications


  • Anesthesia
  • Crohn's Disease
  • Endoscopy or Radiology Premedication
  • Irritable Bowel Syndrome
  • Urinary Incontinence


Saturday, August 4, 2012

Tamsulosin



tam-SOO-loe-sin hye-droe-KLOR-ide


Commonly used brand name(s)

In the U.S.


  • Flomax

Available Dosage Forms:


  • Capsule

Therapeutic Class: Benign Prostatic Hypertrophy Agent


Pharmacologic Class: Tamsulosin


Uses For tamsulosin


Tamsulosin is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.


Tamsulosin helps relax the muscles in the prostate and the opening of the bladder. This may help increase the flow of urine or decrease the symptoms. However, tamsulosin will not shrink the prostate. The prostate may continue to get larger. This may cause the symptoms to become worse over time. Therefore, even though tamsulosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future.


tamsulosin is available only with your doctor's prescription.


Before Using tamsulosin


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 tamsulosin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to tamsulosin 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


Tamsulosin is not indicated for use in the pediatric population.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tamsulosin in the elderly.


Pregnancy








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

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 taking tamsulosin, 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 tamsulosin 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.


  • Atazanavir

  • Clarithromycin

  • Indinavir

  • Itraconazole

  • Ketoconazole

  • Nefazodone

  • Nelfinavir

  • Ritonavir

  • Saquinavir

  • Tadalafil

  • Telithromycin

Using tamsulosin 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.


  • Acebutolol

  • Alprenolol

  • Atenolol

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bucindolol

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Cimetidine

  • Dilevalol

  • Esmolol

  • Labetalol

  • Levobunolol

  • Mepindolol

  • Metipranolol

  • Metoprolol

  • Nadolol

  • Nebivolol

  • Oxprenolol

  • Paroxetine

  • Penbutolol

  • Pindolol

  • Propranolol

  • Sildenafil

  • Sotalol

  • Talinolol

  • Tertatolol

  • Timolol

  • Vardenafil

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Other Medical Problems


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


  • Allergy to sulfa drugs (e.g., sulfamethoxazole, sulfasalazine, sulfasoxazole, Azulfidine®, Bactrim®, or Septra®)—Increased allergic reaction risk in patients with this condition.

  • Kidney disease or

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

  • Low blood pressure—Use with caution. May make this conditions worse.

Proper Use of tamsulosin


Take tamsulosin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


tamsulosin comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


Take the capsule approximately 30 minutes after the same meal each day. Swallow the capsule whole. Do not crush, chew, or open it.


Dosing


The dose of tamsulosin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tamsulosin. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (capsules):
    • For benign prostatic hyperplasia:
      • Adults—At first, 0.4 milligram (mg) once a day. Your doctor may increase your dose if needed.

      • Children—Use is not recommended.



Missed Dose


If you miss a dose of tamsulosin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using tamsulosin


It is very important that your doctor check your progress at regular visits to make sure that tamsulosin is working properly and to check for unwanted effects.


Women and children should not use tamsulosin.


Dizziness, lightheadedness, or fainting may occur after you take tamsulosin, especially when you get up from a lying or sitting position. Getting up slowly may help lessen this problem. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.


Because tamsulosin may cause some people to become dizzy or feel faint, make sure you know how you react to tamsulosin before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


This medication may rarely cause a severe allergic reaction (swelling of face, tongue, or throat; difficulty breathing; and blistering of the skin. Check with your doctor immediately if this occurs.


You should seek medical attention right away if you experience a prolonged erection while using tamsulosin. This is an extremely rare unwanted effect that must be treated right away to prevent permanent erectile damage (impotence).


If you plan to have cataract surgery, tell your eye doctor (ophthalmologist) that you are taking tamsulosin or that you used tamsulosin in the past 9 months. A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were taking tamsulosin or who had recently taken tamsulosin when they had cataract surgery.


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.


tamsulosin 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 immediately if any of the following side effects occur:


More common
  • Cough or hoarseness

  • fever or chills

  • lower back or side pain

  • painful or difficult urination

Less common
  • Chest pain

Rare
  • Dizziness or lightheadedness

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fainting

  • feeling of constant movement of self or surroundings

  • painful or prolonged erection of the penis

  • sensation of spinning

Incidence not known
  • Blistering, peeling, or loosening of the skin

  • blurred vision

  • confusion

  • diarrhea

  • difficult or labored breathing

  • fast, pounding, or irregular heartbeat or pulse

  • itching

  • joint or muscle pain

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

  • red skin lesions, often with a purple center

  • red, irritated eyes

  • shortness of breath or troubled breathing

  • sore throat

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

  • sweating

  • tightness of the chest or wheezing

  • 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:


More common
  • Abnormal ejaculation

  • back pain

  • body aches or pain

  • congestion

  • headache

  • lack or loss of strength

  • sneezing

  • stuffy or runny nose

  • tender, swollen glands in the neck

  • trouble with swallowing

  • voice changes

Less common
  • Decreased interest in sexual intercourse

  • decreased sexual drive or performance

  • drowsiness

  • inability to have or keep an erection

  • increased cough

  • loss in sexual ability, desire, drive, or performance

  • nausea

  • pain or tenderness around the eyes and cheekbones

  • sleepiness or unusual drowsiness

  • sleeplessness

  • tooth disorder

  • trouble with sleeping

  • unable to sleep

Incidence not known
  • Constipation

  • hives or welts

  • redness of the skin

  • skin rash

  • vomiting

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: tamsulosin 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 tamsulosin resources


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


  • Tamsulosin Prescribing Information (FDA)

  • Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Flomax Prescribing Information (FDA)

  • Flomax Monograph (AHFS DI)

  • Flomax Consumer Overview



Compare tamsulosin with other medications


  • Benign Prostatic Hyperplasia
  • Overactive Bladder
  • Urinary Tract Stones


Sunday, July 29, 2012

Sitzmarks oral and rectal


Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen


What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.


Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.


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


What is the most important information I should know about barium sulfate?


You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.


Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.


Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?


You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:



  • asthma, eczema, or allergies;




  • a blockage in your stomach or intestines;




  • cystic fibrosis;




  • a colostomy;




  • rectal cancer;




  • heart disease or high blood pressure;




  • Hirschsprung's disease (a disorder of the intestines);




  • a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);




  • a recent history of surgery on your esophagus, stomach, or intestines;




  • a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;




  • if you have recently had a rectal biopsy;




  • if you have ever choked on food by accidentally inhaling it into your lungs;




  • if you are allergic to simethicone (Gas-X, Phazyme, and others); or




  • if you are allergic to latex rubber.




It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?


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


Barium sulfate comes in tablets, paste, cream, or liquid forms.


In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.


You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.


If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.


Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.


If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked 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.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.


Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?


If you are using barium sulfate at home, call your doctor for instructions if you miss a 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 stomach pain, ongoing diarrhea, confusion, or weakness.


What should I avoid before or after using barium sulfate?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Barium sulfate side effects


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

  • severe stomach pain;




  • severe cramping, diarrhea, or constipation;




  • sweating;




  • ringing in your ears;




  • confusion, fast heart rate; or




  • pale skin, weakness.



Less serious side effects may include:



  • mild stomach cramps;




  • nausea, vomiting;




  • loose stools or mild constipation.



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 barium sulfate?


There may be other drugs that can interact with barium sulfate. 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 Sitzmarks resources


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


Compare Sitzmarks with other medications


  • Computed Tomography


Where can I get more information?


  • Your doctor or pharmacist can provide more information about barium sulfate.

See also: Sitzmarks side effects (in more detail)



Saturday, July 28, 2012

Sting-Kill


Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B


What is Sting-Kill (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.


Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.


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


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


What is the most important information I should know about Sting-Kill (benzocaine topical)?


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


Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.


Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.


If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.


What should I discuss with my health care provider before using Sting-Kill (benzocaine topical)?


Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

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



  • asthma, bronchitis, emphysema, or other breathing disorder;




  • heart disease;




  • a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or




  • if you smoke.




FDA pregnancy category C. It is not known whether benzocaine topical 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 benzocaine topical 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. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Sting-Kill (benzocaine topical)?


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.


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.


To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.


Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.


If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.


Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?


Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Sting-Kill (benzocaine topical)?


Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.


Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.


Sting-Kill (benzocaine topical) side effects


Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:



  • headache, tired feeling, confusion;




  • fast heart rate;




  • feeling light-headed or short of breath; and




  • pale, blue, or gray appearance of your skin, lips, or fingernails.




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 benzocaine topical and call your doctor at once if you have any of these other serious side effects:

  • headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);




  • severe burning, stinging, or sensitivity where the medicine is applied;




  • swelling, warmth, or redness; or




  • oozing, blistering, or any signs of infection.



Less serious side effects may include:



  • mild stinging, burning, or itching where the medicine is applied;




  • skin tenderness or redness; or




  • dry white flakes where the medicine was applied.



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 Sting-Kill (benzocaine topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. 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 Sting-Kill resources


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


  • Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

  • Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information

  • Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Sting-Kill with other medications


  • Pruritus


Where can I get more information?


  • Your pharmacist can provide more information about benzocaine topical.

See also: Sting-Kill side effects (in more detail)



Topcare Anti-Diarrheal




Generic Name: loperamide

Dosage Form: tablet
Topco Anti-Diarrheal Tablets Drug Facts

Active ingredient (in each caplet)


Loperamide HCl 2 mg



Purpose


Anti-diarrheal



Uses


controls symptoms of diarrhea, including Travelers’ Diarrhea



Warnings


Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl



Do not use


if you have bloody or black stool



Ask a doctor before use if you have


  • fever

  • mucus in the stool

  • a history of liver disease


Ask a doctor or pharmacist before use if you are


taking antibiotics



When using this product


  • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.


Stop use and ask a doctor if


  • symptoms get worse

  • diarrhea lasts for more than 2 days

  • you get abdominal swelling or bulging. These may be signs of a serious condition.


If pregnant or breast-feeding,


ask a health professional before use.



Keep out of reach of children.


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



Directions


  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

  • find right dose on chart. If possible, use weight to dose; otherwise, use age.










adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)ask a doctor

Other information


  • store between 20-25°C (68-77°F)

  • do not use if printed foil under cap is broken or missing (Bottle Only)

  • do not use if carton or blister unit is broken or torn (Blister Only)

  • see end panel for lot number and expiration date


Inactive ingredients


anhydrous lactose, carnauba wax, D&C yellow no. 10, FD&C blue no. 1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch



Questions or comments?


1-888-423-0139



Principal Display Panel


Easy to Swallow


Loperamide Hydrochloride Tablets, 2 mg


Anti-Diarrheal Tablets


Controls the Symptoms of Diarrhea, Including Travelers’ Diarrhea


Actual Size


Compare to Imodium® A-D active ingredient


Each Caplet (Capsule-Shaped Tablet) Contains 2 mg Loperamide Hydrochloride


Anti-Diarrheal Tablets Carton











TOPCARE ANTI DIARRHEAL 
loperamide hydrochloride  tablet










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-224
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE)LOPERAMIDE HYDROCHLORIDE2 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorGREENScore2 pieces
ShapeCAPSULESize10mm
FlavorImprint CodeL2
Contains      






































Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-224-911 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
16 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (36800-224-91)
236800-224-532 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
26 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (36800-224-53)
336800-224-624 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
36 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (36800-224-62)
436800-224-801 BOTTLE In 1 CARTONcontains a BOTTLE
496 TABLET In 1 BOTTLEThis package is contained within the CARTON (36800-224-80)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523202/26/2003


Labeler - Topco Associates LLC (006935977)
Revised: 08/2009Topco Associates LLC




More Topcare Anti-Diarrheal resources


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


Compare Topcare Anti-Diarrheal with other medications


  • Diarrhea
  • Diarrhea, Acute
  • Diarrhea, Chronic
  • Lymphocytic Colitis
  • Traveler's Diarrhea