Sunday, September 30, 2012

Thioridazine


Pronunciation: THYE-oh-RID-a-zeen
Generic Name: Thioridazine
Brand Name: Generic only. No brands available.

Thioridazine may increase your risk of severe and possibly fatal irregular heartbeat. Thioridazine should only be used in patients who have not shown improvement with or are unable to take other medicines.


Thioridazine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Thioridazine is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.





Thioridazine is used for:

Treating schizophrenia in patients who have not shown improvement with or are unable to take other medicines. It may also be used for other conditions as determined by your doctor.


Thioridazine is a phenothiazine. It is not known exactly how it works.


Do NOT use Thioridazine if:


  • you are allergic to any ingredient in Thioridazine or to other phenothiazines (eg, chlorpromazine)

  • you have a certain type of irregular heartbeat (congenital long QT syndrome, prolonged QT interval) or a history of other types of irregular heartbeat

  • you have severe drowsiness, severe high or low blood pressure, or low levels of potassium in the blood

  • you have recently taken large amounts of alcohol or medicines that may cause drowsiness, such as barbiturates (eg, phenobarbital) or narcotic pain medicines (eg, codeine)

  • you are taking certain antiarrhythmics (eg, amiodarone, bretylium, quinidine, sotalol), astemizole, cabergoline, cisapride, dofetilide, metoclopramide, pergolide, pindolol, propranolol, certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine, fluvoxamine), terfenadine, tramadol, or any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Ask your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

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



Before using Thioridazine:


Some medical conditions may interact with Thioridazine. 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 developed severe side effects (eg, blood problems, yellowing of the skin or eyes) while taking another phenothiazine (eg, chlorpromazine)

  • if you have a history of heart problems (eg, angina, mitral valve problems, slow heartbeat), high or low blood pressure, blood problems (eg, anemia, porphyria), bone marrow problems (eg, low white blood cell count), diabetes, liver problems (eg, cirrhosis), kidney problems, neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), an enlarged prostate gland, seizures, trouble urinating, mental or mood problems (eg, depression), or an adrenal gland tumor (pheochromocytoma)

  • if you have asthma, a lung infection, or other lung or breathing problems (eg, emphysema); or increased pressure in the eyes or glaucoma or if you are at risk of glaucoma

  • if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome

  • if you have had high blood prolactin levels, a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer

  • if you are in poor health or are regularly exposed to extreme heat or certain insecticides (organophosphorus insecticides)

  • if you have a history of alcohol abuse, drink alcohol, or are in alcohol withdrawal

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


  • Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, irregular heartbeat, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach or bowel problems, overactive bladder), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Thioridazine. Ask your doctor if you are unsure if any of your medicines may interact with Thioridazine

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


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


  • Thioridazine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Continue to use Thioridazine even if you feel well. Do not miss any doses.

  • If you miss a dose of Thioridazine, 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 Thioridazine.



Important safety information:


  • Thioridazine may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Thioridazine. Using Thioridazine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

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

  • Do NOT take more than the recommended dose without checking with your doctor.

  • Do not drink alcohol while you are using Thioridazine.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Thioridazine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

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

  • Thioridazine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how your react to Thioridazine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Thioridazine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Some patients who take Thioridazine may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Thioridazine in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Thioridazine.

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

  • Thioridazine may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.

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

  • Diabetes patients - Thioridazine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Thioridazine may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have any questions or concerns about your pregnancy test results.

  • Thioridazine may interfere with certain lab tests. Make sure your doctor and laboratory personnel know you are using Thioridazine.

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

  • Use Thioridazine with caution in the ELDERLY because they may be more sensitive to its effects, especially confusion; constipation; dizziness or light-headedness, especially upon standing; drowsiness; fainting; trouble urinating; and uncontrolled muscle movements.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Thioridazine during pregnancy. Using Thioridazine during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Thioridazine is excreted in breast milk. Do not breast-feed while taking Thioridazine.

If you suddenly stop taking Thioridazine, you may experience WITHDRAWAL symptoms, including nausea, vomiting, dizziness, stomach upset, and tremors.



Possible side effects of Thioridazine:


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:



Agitation; constipation; diarrhea; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose; 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 or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); chest pain; confusion; decreased coordination; drooling; fainting; fast, slow, or irregular heartbeat; mask-like face; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood problems; numbness of an arm or leg; prolonged or painful erection; restlessness; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; sleeplessness; stiff or rigid muscles; sudden shortness of breath or vomiting; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); tremor; trouble urinating; twisting or twitching movements; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs; trouble speaking, breathing, or swallowing); unusual bruising or bleeding; unusual eye movements or inability to move eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).



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: Thioridazine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; coma; confusion; difficulty breathing; fainting; fast, slow, or irregular heartbeat; loss of consciousness; muscle spasms or uncontrolled muscle movements; restlessness; seizures; severe constipation or stomach pain; severe drowsiness or dizziness; tremors; or trouble urinating.


Proper storage of Thioridazine:

Store Thioridazine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Thioridazine out of the reach of children and away from pets.


General information:


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

  • Thioridazine 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.

  • If using Thioridazine for an extended period of time, obtain refills before your supply runs out.

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

This information is a summary only. It does not contain all information about Thioridazine. 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 Thioridazine resources


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Saturday, September 29, 2012

Seromycin


Generic Name: cycloserine (sye kloe SER een)

Brand Names: Seromycin


What is Seromycin (cycloserine)?

Cycloserine is an antibiotic. It prevents tuberculous bacteria from growing in your body.


Cycloserine is used to treat tuberculosis (TB).


Cycloserine is also sometimes used to treat urinary tract and other types of infections that have not responded to other treatments.


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


What is the most important information I should know about Seromycin (cycloserine)?


Take all of the cycloserine that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Avoid alcohol while taking cycloserine. Alcohol will increase your risk of having a seizure during cycloserine treatment. Alcohol will also increase dizziness and drowsiness. Use caution when driving, operating machinery, or performing other hazardous activities. Cycloserine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Call your doctor immediately if you experience a skin rash, mental confusion, dizziness, headache, or tremors (shaking).


Who should not take Seromycin (cycloserine)?


You cannot take cycloserine if you



  • have epilepsy,




  • suffer from depression,




  • have an anxiety disorder,




  • have a psychotic or psychiatric disorder,




  • have kidney disease, or




  • drink alcohol on a daily basis.




Cycloserine is in the FDA pregnancy category C. This means that it is not known whether cycloserine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant Cycloserine passes into breast milk, and it is not known whether cycloserine will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Seromycin (cycloserine)?


Take cycloserine exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass (8 ounces) of water.

Cycloserine is usually taken twice a day. Follow your doctor's instructions.


Take all of the cycloserine that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Cycloserine is usually combined with one or more other tuberculosis medicines.


Your doctor may also want you to take a supplemental vitamin B6 (pyridoxine) tablet daily during treatment to lessen side effects.


Store this medication at room temperature away from moisture and heat.

See also: Seromycin dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a cycloserine overdose include drowsiness, confusion, headache, dizziness, irritability, numbness and tingling, difficulty speaking, paralysis, abnormal behavior, seizures, and unconsciousness.


What should I avoid while taking Seromycin (cycloserine)?


Avoid alcohol while taking cycloserine. Alcohol will increase your risk of having a seizure during treatment with this medication. Also, alcohol will increase dizziness and drowsiness. Use caution when driving, operating machinery, or performing other hazardous activities. Cycloserine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Seromycin (cycloserine) side effects


If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • seizures;




  • numbness or tingling in your hands or feet;




  • a skin rash;




  • confusion or abnormal behavior;




  • tremors (shaking);




  • headache;




  • drowsiness;




  • dizziness;




  • difficulty speaking; or




  • irritability.



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


What other drugs will affect Seromycin (cycloserine)?


Before taking cycloserine, tell your doctor if you are taking



  • ethionamide (Trecator-SC), or




  • isoniazid (Nydrazid).



You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.


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



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  • Cycloserine

  • Cycloserine Professional Patient Advice (Wolters Kluwer)



Compare Seromycin with other medications


  • Tuberculosis, Active
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Where can I get more information?


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

See also: Seromycin side effects (in more detail)



Monday, September 24, 2012

Terra-Cortril





Dosage Form: Ophthalmic Suspension

Terra-Cortril Description


Terra-Cortril suspension combines the antibiotic, oxytetracycline HCl (C22H24N2O9•HCl) and the adrenocorticoid, hydrocortisone acetate (C23H32O6). Each ml of Terra-Cortril contains Terramycin (oxytetracycline HCl) equivalent to 5 mg of oxytetracycline, and 15 mg of Cortril (hydrocortisone acetate) incorporated in mineral oil with aluminum tristearate.


For Ophthalmic Use Only.



Terra-Cortril - Clinical Pharmacology


Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.


The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.


Terramycin is considered active against the following microorganisms:


  • Rickettsiae (Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers),

  • Mycoplasma pneumoniae (PPLO, Eaton Agent),

  • Agents of psittacosis and ornithosis,

  • Agents of lymphogranuloma venereum and granuloma inguinale,

  • The spirochetal agent of relapsing fever (Borrelia recurrentis).

The following gram-negative microorganisms:


  • Haemophilus ducreyi (chancroid),

  • Pasteurella pestis and Pasteurella tularensis,

  • Bartonella bacilliformis,

  • Bacteroides species,

  • Vibrio comma and Vibrio fetus,

  • Brucella species (in conjunction with streptomycin).

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended.


Oxytetracycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:


  • Escherichia coli,

  • Enterobacter aerogenes (formerly Aerobacter aerogenes),

  • Shigella species,

  • Mima species and Herellea species,

  • Haemophilus influenzae (respiratory infections),

  • Klebsiella species (respiratory and urinary infections).

Oxytetracycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:



Streptococcus species:


Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive.


For upper respiratory infections due to Group A beta-hemolytic streptococci, pencillin is the usual drug of choice, including prophylaxis of rheumatic fever.


Diplococcus pneumoniae,


Staphylococcus aureus, skin and soft tissue infections. Oxytetracycline is not the drug of choice in the treatment of any type of staphylococcal infections.


When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections due to:


  • Neisseria gonorrhoeae,

  • Treponema pallidum and Treponema pertenue (syphilis and yaws),

  • Listeria monocytogenes,

  • Clostridium species,

  • Bacillus anthracis,

  • Fusobacterium fusiforme (Vincent's infection),

  • Actinomyces species.

Tetracyclines are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.


Inclusion conjunctivitis may be treated with oral tetracyclines or with a combination of oral and topical agents.


When a decision to administer both a corticoid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drug are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.


The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.



Indications and Usage for Terra-Cortril


For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.


Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation, thermal burns, or penetration of foreign bodies.


The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.


The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:


  • Staphylococcus aureus

  • Streptococci, including Streptococcus pneumoniae

  • Escherichia coli

  • Neisseria species

The product does not provide adequate coverage against:


  • Haemophilus influenzae

  • Klebsiella/Enterobacter species

  • Pseudomonas aeruginosa

  • Serratia marcescens


Contraindications


Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)


The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.



Warnings


Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.


Employment of steroid medication in the treatment of herpes simplex requires great caution.



Precautions


The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.


The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.



Adverse Reactions


Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.


Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.



Secondary Infection


The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.


Secondary bacterial ocular infection following suppression of host responses also occurs.



Terra-Cortril Dosage and Administration


Instill 1 or 2 drops of Terra-Cortril Ophthalmic Suspension into the affected eye three times daily.


Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in "Precautions" above.



How is Terra-Cortril Supplied


Terra-Cortril Ophthalmic Suspension (NDC 0049-0670-48) is supplied in 5 ml vials with separate sterile dropper.




LAB-0194-2.0








TERRA-CORTRIL 
oxytetracycline hydrochloride and hydrocortisone acetate  suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0049-0670
Route of AdministrationOPHTHALMICDEA Schedule    

















INGREDIENTS
Name (Active Moiety)TypeStrength
oxytetracycline hydrochloride (oxytetracycline)Active5 MILLIGRAM  In 1 MILLILITER
hydrocortisone acetate (hydrocortisone)Active15 MILLIGRAM  In 1 MILLILITER
mineral oilInactive 
aluminum tristearateInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10049-0670-485 mL (MILLILITER) In 1 VIALNone

Revised: 04/2006Roerig

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Neutrogena T-Scalp


Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort


What is Neutrogena T-Scalp (hydrocortisone topical)?

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


Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.


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


What is the most important information I should know about Neutrogena T-Scalp (hydrocortisone topical)?


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


Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.


Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.


Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.


Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Neutrogena T-Scalp (hydrocortisone topical)?


Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.


FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone 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 medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Neutrogena T-Scalp (hydrocortisone topical)?


Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.


Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.


Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.


Apply a small amount to the affected area and rub it gently into the skin.


Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.


Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?


Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Neutrogena T-Scalp (hydrocortisone topical)?


Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.


Neutrogena T-Scalp (hydrocortisone topical) side effects


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

  • blurred vision, or seeing halos around lights;




  • uneven heartbeats;




  • sleep problems (insomnia);




  • weight gain, puffiness in your face; or




  • feeling tired.



Less serious side effects may include:



  • skin redness, burning, itching, or peeling;




  • thinning of your skin;




  • blistering skin; or




  • stretch marks.



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 Neutrogena T-Scalp (hydrocortisone topical)?


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



More Neutrogena T-Scalp resources


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


  • Ala-Cort Advanced Consumer (Micromedex) - Includes Dosage Information

  • Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Carmol HC Prescribing Information (FDA)

  • Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hydrocortisone Acetate Monograph (AHFS DI)

  • Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hytone Prescribing Information (FDA)

  • Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Locoid Lipocream Prescribing Information (FDA)

  • Locoid Lotion Prescribing Information (FDA)

  • Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pandel Prescribing Information (FDA)

  • Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Proctocort Prescribing Information (FDA)

  • Texacort Prescribing Information (FDA)

  • U-cort Prescribing Information (FDA)

  • Westcort Prescribing Information (FDA)



Compare Neutrogena T-Scalp with other medications


  • Anal Itching
  • Aphthous Stomatitis, Recurrent
  • Atopic Dermatitis
  • Dermatitis
  • Eczema
  • Gingivitis
  • Proctitis
  • Pruritus
  • Psoriasis
  • Seborrheic Dermatitis
  • Skin Rash
  • Ulcerative Colitis, Active


Where can I get more information?


  • Your pharmacist can provide more information about hydrocortisone topical.

See also: Neutrogena T-Scalp side effects (in more detail)



Wednesday, September 19, 2012

Strongstart


Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN


What are Strongstart (prenatal multivitamins)?

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


Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.


Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.


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


What is the most important information I should know about prenatal vitamins?


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


Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?


Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.


You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?


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.


Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.


The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.


Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


What should I avoid while taking prenatal vitamins?


Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:



  • upset stomach;




  • headache; or




  • unusual or unpleasant taste in your mouth.



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 prenatal vitamins?


Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:



  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




  • trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.



This list is not complete and other drugs may interact with prenatal vitamins. 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 Strongstart resources


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


  • Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

  • CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • CitraNatal Assure Prescribing Information (FDA)

  • CitraNatal Harmony Prescribing Information (FDA)

  • Concept DHA Prescribing Information (FDA)

  • Docosavit Prescribing Information (FDA)

  • Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folcal DHA Prescribing Information (FDA)

  • Folcaps Care One Prescribing Information (FDA)

  • Gesticare DHA Prescribing Information (FDA)

  • Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • Inatal Advance Prescribing Information (FDA)

  • Inatal Ultra Prescribing Information (FDA)

  • Multi-Nate DHA Prescribing Information (FDA)

  • Multi-Nate DHA Extra Prescribing Information (FDA)

  • MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

  • Natelle One Prescribing Information (FDA)

  • Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Paire OB Plus DHA Prescribing Information (FDA)

  • PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

  • PreNexa Prescribing Information (FDA)

  • PreferaOB Prescribing Information (FDA)

  • Prenatal Plus Prescribing Information (FDA)

  • Prenatal Plus Iron Prescribing Information (FDA)

  • Prenate Elite Prescribing Information (FDA)

  • Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prenate Elite tablets

  • Prenate Essential Prescribing Information (FDA)

  • PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

  • PrimaCare ONE capsules

  • PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Renate DHA Prescribing Information (FDA)

  • Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Se-Natal 19 Prescribing Information (FDA)

  • Tandem DHA Prescribing Information (FDA)

  • Tandem OB Prescribing Information (FDA)

  • TriAdvance Prescribing Information (FDA)

  • Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Triveen-PRx RNF Prescribing Information (FDA)

  • UltimateCare ONE NF Prescribing Information (FDA)

  • Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vinate AZ Prescribing Information (FDA)

  • Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zatean-CH Prescribing Information (FDA)



Compare Strongstart with other medications


  • Vitamin/Mineral Supplementation during Pregnancy/Lactation


Where can I get more information?


  • Your pharmacist can provide more information about prenatal vitamins.



Sulfinpyrazone


Class: Uricosuric Agents
VA Class: MS400
CAS Number: 57-96-5
Brands: Anturane

Introduction

Uricosuric agent,a b platelet aggregation inhibitor. a


Uses for Sulfinpyrazone


Hyperuricemia Associated with Gout


Treatment of chronic or intermittent gouty arthritis and tophaceous gout.a b


Used in patients with frequent disabling attacks of gout.a b


Used when tophi are visible or serum urate concentrations are >8.5–9 mg/dL in patients with family history of tophi or low uric acid excretion.a


Not recommended for management of asymptomatic hyperuricemia; however, some clinicians initiate therapy when serum urate concentrations are >9 mg/dL (by colorimetric method) because such concentrations often are associated with increased joint changes and renal complications.a b


Goal of therapy is to lower serum urate concentrations to about 6 mg/dL. a


Alternative to probenecid, which generally is better tolerated.a May be used with allopurinol for additive effect, especially in the presence of tophaceous deposits.a May be used with probenecid if the uricosuric response to one drug is insufficient at maximum therapeutic dosage.a


Not effective in patients with moderate to severe chronic renal insufficiency.a (See Renal Impairment under Cautions.)


Of no value in the treatment of acute gout attacks.a b (See Actions and also see Acute Gout under Cautions.)


Hyperuricemia Secondary to Other Causes


Has been used effectively and is commonly employed to promote uric acid excretion in hyperuricemia secondary to administration of thiazide and related diuretics, furosemide, ethacrynic acid, pyrazinamide, or ethambutol.a


Do not use to treat hyperuricemia secondary to cancer chemotherapy, radiation, or myeloproliferative neoplastic diseases; may increase risk of uric acid nephropathy.a


Platelet Aggregation Inhibition


Has been used to decrease platelet aggregation and increase platelet survival time in cardiovascular disorders, including angina, MI, TIAs, amaurosis fugax, peripheral arterial atherosclerosis, DVT and recurrent venous thrombosis, and in patients with arteriovenous dialysis shunts and prosthetic mitral valves. a


Not associated with benefit in patients with unstable angina or non-ST-segment elevation MI; not recommended by ACC/AHA as antiplatelet therapy in such patients.201


Has been used to maintain graft patency in patients undergoing CABG surgery; however, not consistently effective and not recommended by the American College of Chest Physicians (ACCP) for this use.200


Sulfinpyrazone Dosage and Administration


General



  • All patients should maintain daily urine output at ≥2–3 L; alkalinization of urine desirable.a



Administration


Oral Administration


Take with meals, milk, or antacids to minimize adverse GI effects.a b


Dosage


Adjust dosage according to the response and tolerance of the patient.a


Use low dosages initially to reduce possibility of acute gout attacks and prevent massive uricosuria.a


Adults


Hyperuricemia Associated with Gout

Oral

Initially, 100–200 mg twice daily during the first week of therapy, then increase as needed to full maintenance dosage of 200–400 mg twice daily.a b Serum urate concentrations usually fall to minimum levels within a few days; once controlled, may attempt to reduce dosage to 200 mg daily in divided doses.a b


Patients previously controlled with other uricosuric therapy may begin sulfinpyrazone at full maintenance dosage.a b


Uricosuric therapy should be continued indefinitely and without interruption; irregular dosage schedules may result in increased serum urate concentrations.a b


Inhibition of Platelet Aggregation

Oral

600–800 mg daily has been used.a


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.a


Renal Impairment


No specific dosage recommendations at this time.a (See Renal Impairment under Cautions.)


Geriatric Patients


No specific dosage recommendations at this time.a


Cautions for Sulfinpyrazone


Contraindications



  • Active peptic ulcer or symptoms of GI inflammation or ulceration.b




  • Known hypersensitivity to sulfinpyrazone or any ingredient in the formulation, or to other pyrazolone derivatives such as phenylbutazone.a b




  • Past or present blood dyscrasias.b (See Hematologic Effects.)



Warnings/Precautions


Sensitivity Reactions


Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.a


General Precautions


Hematologic Effects

Pyrazole compound; closely monitor patients and perform periodic blood counts.a b


Acute Gout

Of no value in treatment of acute gout attacks; will prolong and exacerbate inflammation during the acute phase.a b May increase frequency of acute attacks during the first 6–12 months of therapy despite maintenance of normal or subnormal serum urate concentrations.a b Therefore, administer prophylactic doses of colchicine concurrently during first 3–6 months of therapy.a


Acute attacks usually become less severe and of briefer duration after several months; during acute attacks, continue sulfinpyrazone and give full therapeutic doses of colchicine or other anti-inflammatory agents.a


Urolithiasis

May promote development of uric acid stones; may cause renal colic and hematuria, especially early in therapy.a Advise patient to ingest large amounts of fluids to maintain large volumes of alkaline urine to reduce risk of stone formation.a Allopurinol preferred in patients with urinary uric acid excretion >900 mg/day or with gouty nephropathy, urinary tract stones or obstruction, or azotemia.a


GI Effects

May reactivate or aggravate peptic ulcers.a b May use with caution in patients with history of healed peptic ulcer.a b


Specific Populations


Pregnancy

No reports of congenital malformation.a Use caution in pregnant women, weighing possible risks against potential benefits.a


Pediatric Use

Safety and efficacy not established.b


Renal Impairment

Use caution in patients with mild renal impairment; avoid when Clcr <50 mL/minute.a Assess renal function periodically in patients with impaired renal function.a


Common Adverse Effects


Nausea,a dyspepsia,a GI pain and blood loss,a reactivation or aggravation of peptic ulcer,a b rash,a b dizziness,a vertigo,a tinnitus,a edema.a


Interactions for Sulfinpyrazone


Weak Organic Acids


Competitively inhibits renal tubular secretion of many weak organic acids, possibly potentiating their effects by elevating plasma concentrations.a Substantially increases plasma concentrations of acidic drugs eliminated principally by renal secretion, but increases plasma concentrations only slightly if the drug is eliminated mainly by glomerular filtration.a Drugs for which high urinary concentrations are desired (i.e. nitrofurantoin) may be less effective due to blocked renal secretion.a


Protein-bound Drugs


Because of high protein binding, could interact with other protein-bound drugs; observe for signs of toxicity if such drugs used concurrently.a c


Drugs that Increase Serum Uric Acid


Increase in sulfinpyrazone dosage may be necessary.a Avoid uricosurics in patients receiving cancer chemotherapy due to risk of uric acid nephropathy.a


Specific Drugs and Laboratory Testsa b c





































































Drug



Interaction



Comments



Alcohol



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Allopurinol



Additive uricosuric effects



Used to therapeutic advantage



Aminohippuric acid test



Sulfinpyrazone decreases urinary excretion



Evaluate test results accordingly



Aminosalicylic acid



Increased plasma aminosalicylic acid concentration



Importance unknown



Antineoplastic agents



Increased serum urate concentration, risk of uric acid nephropathy



Avoid concurrent use



Cholestyramine



Binds and delays absorption of sulfinpyrazone



Give sulfinpyrazone >1 hour before or 4–6 hours after cholestyramine



Colchicine



Risk of acute myeloblastic leukemia and multiple myeloma



Careful hematologic examinations recommended if used concurrently



Diazoxide



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Diuretics



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Insulin



Increased plasma insulin concentration



Use with caution



Mecamylamine



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Nitrofurantoin



Reduced nitrofurantoin efficacy and possible toxicity



Avoid concurrent use



Penicillins



Increased plasma penicillin concentration



Not clinically important or useful



Phenolsulfonphthalein test



Sulfinpyrazone decreases urinary excretion



Evaluate test results accordingly



Probenecid



Inhibits secretion of sulfinpyrazone and active metabolite



No clinically important interaction; may be used concurrently



Pyrazinamide



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Salicylates



Antagonize uricosuric action of sulfinpyrazone



Concurrent use contraindicated; acetaminophen may be used



Sulfonamides



Increased plasma sulfonamide concentration



Not clinically important or useful



Sulfonylureas



Increased plasma sulfonylurea concentration



Theoretical risk of hypoglycemia; use with caution



Thrombolytics



GI bleeding, decreased platelet aggregation



Avoid concurrent use



Warfarin



Enhanced hypoprothrombinemic effect



Use with caution and close monitoring; consider different uricosuric agent


Sulfinpyrazone Pharmacokinetics


Absorption


Bioavailability


Rapidly and completely absorbed from GI tract.a Peak plasma concentrations reached 1–2 hours after single oral dose.a


Duration


Usually 4–6 hours (up to 10 hours).a


Distribution


Plasma Protein Binding


Approximately 98% bound to plasma proteins.a


Elimination


Metabolism


Rapidly metabolized in liver to glucuronide conjugate and three oxidation products: a sulfone, a 4-hydroxy, and a p-hydroxy compound, which possesses uricosuric activity. a


Elimination Route


Small amounts of sulfinpyrazone filtered at glomeruli; most actively secreted at proximal tubule.a Minimal amounts then reabsorbed by kidney tubule.a After 2 days, approximately 45% of a single oral 200-mg dose is excreted in urine as unchanged drug, 25% as sulfinpyrazone glucuronide, and 10% as the other 3 metabolites.a Approximately 5% of dose excreted in feces.a


Half-life


3 hours (range 1–9 hours). a


Stability


Storage


Oral


Capsules and Tablets

15–30°C in tight containers.a b


ActionsActions



  • Pyrazolone-derivative renal tubular blocking agent; competitively inhibits active reabsorption of uric acid at proximal convoluted tubule, promoting urinary excretion of uric acid and resorption of tophi and reducing serum urate concentrations.a b


    May reduce plasma protein binding of urate and, in subtherapeutic doses, may inhibit renal secretion of uric acid.a Has no effect on glomerular filtration rate or tubular reabsorption of normal urinary constituents such as sodium, potassium, and water in healthy patients.a




  • Exerts no clinically apparent analgesic or anti-inflammatory activity.a b (See Acute Gout under Cautions.)




  • Inhibits release of adenosine monophosphate, diphosphate, and triphosphate and 5-hydroxytryptamine (5-HT); inhibition of adenosine diphosphate and 5-HT results in decreased platelet adhesiveness and increases platelet survival time.a No effect on plasma prothrombin or thromboplastin levels but may increase platelet count.a Blood clotting time not altered.a




  • A small but significant lowering of serum cholesterol has been demonstrated in gouty patients receiving sulfinpyrazone.a



Advice to Patients



  • Importance of informing patient that sulfinpyrazone is not intended for relief of an acute gout attack. a b




  • Importance of drinking plenty of fluids and maintaining alkaline urine.a




  • Importance of taking with meals, milk, or antacids to minimize adverse GI effects.a b




  • Importance of informing patient that acute gout attacks may increase in frequency during the first 6–12 months of therapy, then diminish.a b Continue sulfinpyrazone during attacks; other drugs for acute gout attack may be prescribed by clinician.a b




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




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




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



Preparations


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


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


















Sulfinpyrazone

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



200 mg*



Anturane (with sodium bisulfite)



Novartis



Tablets



100 mg*



Anturane (scored)



Novartis



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


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




References


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



200. Stein PD, Schunemann HJ, Dalen JE et al. Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126:600S–608S.



201. Braunwald E, Antman E, Beasley JW et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). 2002. Available at



a. AHFS Drug Information 2008. McEvoy GK, ed. Sulfinpyrazone. Bethesda, MD: American Society of Health-System Pharmacists; 2008:[page 2795-6].



b. Ciba-Geigy. Anturane (sulfinpyrazone) tablets and capsules prescribing information. Summit, NJ; 2006. (). Dated 1996 Apr. Accessed 9/21/07.



c. Jack Ansell J, Hirsh J, Poller L et al. The pharmacology and management of the vitamin K antagonists. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 204S-33S.



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Sani-Supp rectal


Generic Name: glycerin (rectal) (GLISS er in)

Brand Names: Colace Glycerin Suppositories, Fleet Babylax, Fleet Glycerin Suppositories Adult, Fleet Glycerin Suppositories Pediatric, Glycerin Suppositories Maximum Strength, Pedia-Lax Liquid, Sani-Supp


What is Sani-Supp (glycerin (rectal))?

Glycerin rectal is used as a laxative. It works by causing the intestines to hold more water, which softens the stool.


Glycerin rectal is used to treat constipation or to cleanse the bowel before a rectal exam or other intestinal procedure.


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


What is the most important information I should know about Sani-Supp (glycerin (rectal))?


Before using glycerin rectal, tell your doctor if you have nausea, vomiting, stomach pain, rectal bleeding, a change in bowel habits that has lasted for 2 weeks or longer, toxic megacolon, or if you have used another laxative for longer than 1 week.


Do not take glycerin rectal by mouth. It is for use only in your rectum. Call your doctor if this medication does not cause you to have a bowel movement within 1 hour after use. Do not use glycerin rectal more than once in a 24-hour period. Do not use other laxatives in combination with glycerin rectal unless your doctor has told you to. Stop using glycerin rectal and call your doctor at once if you have severe stomach pain or cramping, bloody diarrhea, or severe rectal pain, bleeding, or irritation.

What should I discuss with my health care provider before using Sani-Supp (glycerin (rectal))?


You should not use this medication if you are allergic to glycerin.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using glycerin rectal, tell your doctor if you have:



  • nausea, vomiting, and stomach pain;




  • rectal bleeding;




  • a change in bowel habits that has lasted for 2 weeks or longer;




  • intestinal blockage;




  • ulcerative colitis, toxic megacolon; or




  • if you have used another laxative for longer than 1 week.




It is not known whether glycerin rectal is harmful to an unborn baby when used during pregnancy. Before using this medication, tell your doctor if you are pregnant. Do not use this medication in a child younger than 2 years old. Seek your doctor's advice when using glycerin rectal in a child who is 2 to 5 years old.

How should I use Sani-Supp (glycerin (rectal))?


Do not take glycerin rectal by mouth. It is for use only in your rectum.

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


Do not use glycerin rectal more than once in a 24-hour period.

This medication comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Try to empty your bowel and bladder just before using the glycerin suppository or enema.


Remove the outer wrapper from the rectal suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.


You may wet the suppository first with a small amount of water to make it easier to insert. Gently insert the suppository into the rectum, pointed tip first. The suppository will begin to melt once inserted and you should feel little or no discomfort while holding it in.


You should have a bowel movement within 15 to 60 minutes after using the suppository.


To use the rectal enema or liquid suppository, remove the protective cap and gently insert the tip of the applicator or bulb syringe into the rectum. Do not force the applicator into the rectum or injury could result. Slowly squeeze the bottle to place the medicine into the rectum. You do not need to empty the bottle completely and there may be a small amount of liquid left in the bottle after use.


For best results after using glycerin rectal, stay lying down until you feel the urge to have a bowel movement.


Call your doctor if this medication does not cause you to have a bowel movement within 1 hour after use. Store the rectal enema at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate them unless directed on the medicine label.

What happens if I miss a dose?


Since this medication is usually given only once as needed, you will not be on a dosing schedule. Do not use glycerin rectal more than once in a 24-hour period.


What happens if I overdose?


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

If you use glycerin rectal as directed on the medicine label, an overdose is not likely to occur.


What should I avoid while using Sani-Supp (glycerin (rectal))?


Avoid using other laxatives in combination with glycerin rectal unless your doctor has told you to.

Sani-Supp (glycerin (rectal)) side effects


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

  • severe stomach pain or cramping




  • bloody diarrhea; or




  • severe rectal pain, bleeding, or irritation.



Less serious side effects may include:



  • diarrhea;




  • nausea or stomach discomfort; or




  • mild rectal pain or burning.



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


What other drugs will affect Sani-Supp (glycerin (rectal))?


There may be other drugs that can interact with glycerin rectal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



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Where can I get more information?


  • Your pharmacist can provide more information about glycerin rectal.

See also: Sani-Supp side effects (in more detail)