Thursday, May 31, 2012

Tylenol w/ Codeine


Pronunciation: a-seet-a-MIN-oh-fen/KOE-deen
Generic Name: Acetaminophen/Codeine
Brand Name: Examples include Aceta w/ Codeine and Tylenol w/ Codeine

Tylenol w/ Codeine contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.





Tylenol w/ Codeine is used for:

Relieving mild to moderate pain. It may also be used for other conditions as determined by your doctor.


Tylenol w/ Codeine is an analgesic combination. It works in certain areas of the brain and nervous system to decrease pain. The combination may provide better pain relief than either medicine alone.


Do NOT use Tylenol w/ Codeine if:


  • you are allergic to any ingredient in Tylenol w/ Codeine or any other codeine- or morphine-related medicine (eg, oxycodone)

  • you have severe diarrhea due to taking an antibiotic

  • you are taking naltrexone, quinidine, or sodium oxybate (GHB)

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



Before using Tylenol w/ Codeine:


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


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

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

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

  • if you have a history of alcoholism or substance abuse, or you consume more than 3 alcoholic drinks per day

  • if you have considered or attempted suicide

  • if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, or an infection of the brain or nervous system

  • if you have asthma, other lung or breathing problems, epilepsy, or seizures

  • if you have a history of stomach or intestinal problems, chronic inflammation or ulceration of the bowel, or gallbladder problems (eg, gallstones), or you have had recent abdominal surgery

  • if you have Addison disease, heart problems, liver problems (eg, hepatitis), an underactive thyroid, prostate problems, severe kidney problems, or urinary problems

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


  • Naltrexone because it may decrease the effectiveness of Tylenol w/ Codeine and withdrawal symptoms may occur if you are physically dependent on opioids. You must not take naltrexone until you have stopped taking Tylenol w/ Codeine for 7 to 10 days and after a naloxone challenge test is negative.

  • Quinidine because it may decrease the effectiveness of Tylenol w/ Codeine

  • Cimetidine, ethanol, HIV protease inhibitors (eg, ritonavir), isoniazid, medicine for mental or mood disorders (eg, olanzapine, haloperidol), medicine for anxiety (eg, diazepam), other narcotic pain medicine (eg, oxycodone), or sodium oxybate (GHB) because side effects such as excessive drowsiness, disorientation, trouble breathing, or seizures may occur

  • Anticoagulants (eg, warfarin) because the risk of side effects such as bleeding may be increased by Tylenol w/ Codeine

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


Use Tylenol w/ Codeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Tylenol w/ Codeine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation..

  • If you miss a dose of Tylenol w/ Codeine and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol w/ Codeine.



Important safety information:


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

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

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

  • Tylenol w/ Codeine may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol w/ Codeine. Talk to your doctor before you take Tylenol w/ Codeine or other fever reducers if you drink more than 3 drinks with alcohol per day.

  • Do not take more than the recommended dose or use Tylenol w/ Codeine for longer than prescribed without checking with your doctor. Do not suddenly stop taking Tylenol w/ Codeine without first checking with your doctor.

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

  • Tylenol w/ Codeine has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Tylenol w/ Codeine may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while taking Tylenol w/ Codeine, talk with your doctor or pharmacist. A stool softener or fiber laxative may be required.

  • If nausea occurs, consult your doctor or pharmacist about alternatives for decreasing nausea (eg, taking antihistamines, lying down for 1 to 2 hours with minimal head movement).

  • Use Tylenol w/ Codeine with caution in the ELDERLY; they may be more sensitive to its effect, especially drowsiness and trouble breathing.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol w/ Codeine while you are pregnant. Tylenol w/ Codeine is found in breast milk. If you are or will be breast-feeding while you use Tylenol w/ Codeine, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Tylenol w/ Codeine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tylenol w/ Codeine stops working well. Do not take more than prescribed.


Some people who use Tylenol w/ Codeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Tylenol w/ Codeine, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.



Possible side effects of Tylenol w/ Codeine:


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:



Blurred vision; constipation; dizziness; drowsiness; exaggerated sense of well-being; feeling unwell or unhappy; flushing; lightheadedness; mental/mood changes; nausea; stomach pain; vision changes; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine; dark urine; difficulty breathing; slow/irregular breathing; slow/irregular heartbeat; stomach pain; yellowing of the skin or eyes.



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


See also: Tylenol w/ Codeine 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 cold, clammy skin; extreme drowsiness; fatigue; loss of consciousness; persistent nausea/vomiting; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; unusual sweating; weakness; yellowing of the skin or eyes.


Proper storage of Tylenol w/ Codeine:

Store Tylenol w/ Codeine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol w/ Codeine out of the reach of children and away from pets.


General information:


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

  • Tylenol w/ Codeine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

This information is a summary only. It does not contain all information about Tylenol w/ Codeine. 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 Tylenol w/ Codeine resources


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


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Tuesday, May 29, 2012

Sufenta


Pronunciation: soo-FEN-ta-nil
Generic Name: Sufentanil
Brand Name: Sufenta


Sufenta is used for:

Producing anesthesia for surgery. It may also be used with other medicines as part of epidural anesthesia during labor and delivery to decrease pain.


Sufenta is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.


Do NOT use Sufenta if:


  • you are allergic to any ingredient in Sufenta or any related medicine (eg, sufentanil)

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



Before using Sufenta:


Some medical conditions may interact with Sufenta. 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 diabetes, asthma or other breathing problems, fever, increased pressure or unusual growths in the brain, heart problems, liver or kidney disease, pancreatitis, or a recent head injury

  • if you have a history of slow or irregular heartbeat or blood pressure problems

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


  • Naltrexone because the effectiveness of Sufenta may be decreased

  • Amiodarone, azole antifungals (eg, fluconazole), beta-blockers (eg, propranolol), benzodiazepines (eg, alprazolam), calcium channel blockers (eg, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, chlorpromazine), sibutramine, or sodium oxybate (GHB) because the risk of side effects may be increased

  • Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), sibutramine, or sodium oxybate (GHB) because actions and side effects of these medicines may be increased

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


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


  • Sufenta is usually administered as an injection at your doctor's office, hospital, or clinic.

  • If Sufenta contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

  • If you miss a dose of Sufenta, contact your doctor immediately.

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



Important safety information:


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

  • Avoid drinking alcohol while taking Sufenta.

  • Use Sufenta with caution in the ELDERLY because they may be more sensitive to its effects.

  • Use Sufenta with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Sufenta during pregnancy. Sufenta is excreted in breast milk. If you are or will be breast-feeding while you are using Sufenta, check with your doctor to discuss the risk to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Sufenta. This is known as DEPENDENCE or "addiction."



Possible side effects of Sufenta:


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:



Anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); hallucinations; muscle rigidity; seizures; slow or irregular heartbeat; slowed breathing; trouble breathing; weakness.



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: Sufenta side effects (in more detail)


If OVERDOSE is suspected:


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


Proper storage of Sufenta:

Sufenta is usually handled and stored by a health care provider. If you are using Sufenta at home, store Sufenta as directed by your pharmacist or health care provider. Keep Sufenta out of the reach of children and away from pets.


General information:


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

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

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

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

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


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


  • Sufenta Monograph (AHFS DI)

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Monday, May 28, 2012

Tinidazole


Class: Antiprotozoals, Miscellaneous
VA Class: AP109
Chemical Name: 1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitro-1H-imidazole
Molecular Formula: C8H13N3O4S
CAS Number: 19387-91-8
Brands: Tindamax



  • Metronidazole (a nitroimidazole anti-infective chemically similar to tinidazole) is carcinogenic in mice and rats.1 31




  • Carcinogenic potential of tinidazole not evaluated in animal studies to date.1




  • Avoid unnecessary use; reserve for use in approved indications.1 (See Uses.)




Introduction

Antiprotozoal and antibacterial; 1 58 59 63 64 65 68 nitroimidazole derivative.1 58 59 63 64 65 68


Uses for Tinidazole


Amebiasis


Treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in adults and children >3 years of age.1 18 25 26 27 28 29 30 34 43 47 48 49 50 51 52 53 54 69 Designated an orphan drug by FDA for treatment of amebiasis.2


Oral tinidazole or oral metronidazole followed by a luminal amebicide (iodoquinol, paromomycin) is the regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.18 24 25 26 27 34 47


Not recommended for treatment of asymptomatic cyst passers;1 18 47 these patients should be treated with a luminal amebicide such as iodoquinol, paromomycin, or diloxanide furoate (not commercially available in the US).18 25 26 27


Giardiasis


Treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis) in adults and children >3 years of age.1 18 20 21 22 23 24 34 40 41 43 44 45 46 56 57 Designated an orphan drug by FDA for use in this condition.2


Drugs of choice are metronidazole,17 18 20 tinidazole,17 18 20 or nitazoxanide;17 18 alternatives are paromomycin (especially in pregnant women),17 18 20 furazolidone (not commercially available in the US),17 18 20 or quinacrine (not commercially available in the US).17 18


Treatment of asymptomatic carriers of giardiasis not recommended, except possibly to prevent transmission from carriers in households of patients with hypogammaglobulinemia or cystic fibrosis or pregnant women with toddlers.18


Trichomoniasis


Treatment of symptomatic and asymptomatic trichomoniasis in men and women in whom Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).1 3 4 5 9 11 13 14 15 16 18 35 36 38 39 67 68


Drug of choice is metronidazole or tinidazole.9 17 18 Tinidazole may be effective in some patients who do not respond to metronidazole,3 62 but some T. vaginalis isolates with reduced susceptibility to metronidazole may also have reduced susceptibility to tinidazole.1 61 62


Goal of treatment is to provide symptomatic relief, achieve microbiologic cure, and reduce transmission.1 7 8 9 15 To achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated simultaneously;1 7 8 9 15 treat sexual contacts presumptively even if they are asymptomatic and/or T. vaginalis has not been demonstrated.67


Bacterial Vaginosis


Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in nonpregnant women.1 72 73 Rule out other pathogens commonly associated with vulvovaginitis (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, herpes simplex viruses).1


CDC recommends treatment of bacterial vaginosis in all symptomatic nonpregnant women.9 Routine treatment of sex partners not recommended.9


Nongonococcal Urethritis


Treatment of recurrent and persistent urethritis in patients with nongonococcal urethritis who have already been treated with a recommended regimen.9


For treatment of nongonococcal urethritis in adults, CDC recommends a single oral dose of azithromycin or a 7-day regimen of doxycycline; alternative regimens are a 7-day regimen of oral erythromycin base or ethylsuccinate or a 7-day regimen of oral ofloxacin or oral levofloxacin.9 Patients are instructed to abstain from sexual intercourse until 7 days after initiation of treatment and to return for evaluation if symptoms persist or recur after completion of therapy; symptoms alone (without documentation of signs or laboratory evidence of urethral inflammation) are not sufficient basis for retreatment.9


Patients with persistent or recurrent urethritis who were not compliant with the treatment regimen or were reexposed to untreated sexual partner(s) should be retreated with the initial regimen.9 If patient with recurrent and persistent urethritis was compliant with the regimen and reexposure can be excluded, CDC recommends a single oral dose of metronidazole or tinidazole given in conjunction with a single oral dose of azithromycin (if azithromycin was not used in the initial regimen).9


Tinidazole Dosage and Administration


Administration


Oral Administration


Administer orally once daily with food.1


Administration with meals may reduce incidence of adverse GI effects.1


Do not consume alcohol during or for 3 days after completion of tinidazole therapy.1


For children and other patients unable to swallow tablets, an oral suspension may be prepared extemporaneously using the tablets.1


Extemporaneous Oral Suspension

To prepare an oral suspension containing 66.7 mg/mL, grind 2 g (four 500-mg tablets) to a fine powder with a mortar and pestle.1 Add approximately 10 mL of cherry syrup to the powder and mix until smooth.1 Transfer suspension to a graduated amber container;1 use several small rinses of the cherry syrup to transfer any remaining drug in the mortar to provide a suspension with a final volume of 30 mL.1


Shake suspension well prior to administration of each dose.1


Dosage


Pediatric Patients


Amebiasis

Entamoeba histolytica Infections

Oral

Children >3 years of age (intestinal amebiasis): 50 mg/kg (up to 2 g) once daily given for 3 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47


Children >3 years of age (amebic liver abscess): 50 mg/kg (up to 2 g) once daily given for 3–5 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47


Giardiasis

Oral

Children >3 years of age: 50 mg/kg (up to 2 g) given as a single dose.1 17


Trichomoniasis

Oral

Children >3 years of age: 50 mg/kg (up to 2 g) given as a single dose.17


Adults


Amebiasis

Entamoeba histolytic Infections

Oral

Intestinal amebiasis: 2 g once daily given for 3 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47


Amebic liver abscess: 2 g once daily for 3–5 days;1 17 follow-up with an oral luminal amebicide (e.g., iodoquinol, paromomycin).1 18 25 47


Giardiasis

Oral

2 g given as a single dose.1 17


Trichomoniasis

Oral

2 g given as a single dose.1 9 17


Treat sexual partners of the patient simultaneously using the same dosage.1 9 67


For treatment failure following a metronidazole regimen (e.g., single 2-g dose of metronidazole), CDC recommends retreatment with a single 2-g dose of tinidazole; if retreatment fails, CDC recommends tinidazole 2 g once daily for 5 days.9 If multiple-dose regimen fails, consult a specialist.9


Bacterial Vaginosis

Nonpregnant Women

Oral

2 g once daily for 2 days or 1 g once daily for 5 days.1


Nongonococcal Urethritis

Oral

CDC recommends a single 2-g dose of tinidazole in conjunction with a single1-g dose of oral azithromycin (if azithromycin not used in the initial regimen) for treatment of recurrent and persistent urethritis in patients who previously received a recommended regimen. (See Nongonococcal Urethritis under Uses.)9


Prescribing Limits


Pediatric Patients


Oral

Children >3 years of age: Maximum 50 mg/kg (up to 2 g) daily or as a single dose.1 17


Special Populations


Hepatic Impairment


Data insufficient to make specific dosage recommendations.1 Use usual dosage with caution.1 (See Hepatic Impairment under Cautions.)


Renal Impairment


Dosage adjustments not needed, unless patient is undergoing hemodialysis.1 60


If given on a day that hemodialysis is performed, administer an additional dose (equivalent to 50% of the recommended dose) after the dialysis session.1 60


Geriatric Patients


Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1


Cautions for Tinidazole


Contraindications



  • History of hypersensitivity reaction to tinidazole or other nitroimidazole derivatives.1




  • First trimester of pregnancy.1




  • Breast-feeding.1 (See Lactation under Cautions.)



Warnings/Precautions


Warnings


Carcinogenicity

Carcinogenic effects reported in mice and rats following chronic oral administration of metronidazole (a chemically related nitroimidazole anti-infective).1 31 (See Boxed Warning). Similar animal studies using tinidazole have not been reported to date.1


Because of potential risks, tinidazole should be reserved for approved indications only and unnecessary use avoided.1


Nervous System Effects

Convulsive seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with tinidazole and other nitroimidazoles (e.g., metronidazole).1 31


If abnormal neurologic signs develop, promptly discontinue drug.1


Sensitivity Reactions


Hypersensitivity Reactions

Hypersensitivity reactions (e.g., urticaria, pruritus, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema, bronchospasm, dyspnea, Stevens-Johnson syndrome, erythema multiforme) reported.1 55


General Precautions


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of tinidazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1


History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasia.1 58


As with other nitroimidazoles (e.g., metronidazole), transient leukopenia and neutropenia may occur; persistent hematologic abnormalities not reported to date.1 31 58


If retreatment is necessary, perform total and differential leukocyte counts.1


Candidiasis

Vaginal candidiasis reported; treat with an appropriate antifungal.1


Specific Populations


Pregnancy

Category C (second and third trimesters).1


Contraindicated during first trimester.1


Not evaluated for treatment of bacterial vaginosis in pregnant women.1


Lactation

Distributed into milk in concentrations similar to serum concentrations.1 66 Interrupt breast-feeding during therapy and for 72 hours following the last dose.1 66


Pediatric Use

Safety and efficacy not established in pediatric patients ≤3 years of age.1 Some data available regarding safety and efficacy for treatment of giardiasis in pediatric patients <3 years of age.18 23 32 42 43 44 57


Safety and efficacy in pediatric patients >3 years of age established only for treatment of amebiasis or giardiasis.1 18


Monitor pediatric patients closely if duration of therapy is >3 days (e.g., for treatment of amebic liver abscess)1 since only limited data available.1 32 69


Adverse effects reported in pediatric patients generally similar in nature and frequency to those reported in adults.1


Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.1


Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1


Hepatic Impairment

Use with caution;1 pharmacokinetics not evaluated.1


Studies using metronidazole (a chemically similar nitroimidazole) indicate reduced elimination and increased plasma concentrations in severe hepatic dysfunction.1 31


Renal Impairment

Dosage adjustment may be needed in patients undergoing hemodialysis.1 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


GI effects (metallic/bitter taste, nausea, anorexia, dyspepsia/cramps/epigastric discomfort, vomiting, constipation), nervous system effects (weakness/fatigue/malaise, dizziness, headache).1


Interactions for Tinidazole


Metabolized principally by CYP3A4.1


Does not inhibit CYP1A2, 2B6, 2C9, 2D6, 2E1, or 3A4 in vitro.1


Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes


Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma tinidazole concentrations).1


Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma tinidazole concentrations).1


Specific Drugs and Laboratory Tests


No formal drug interaction studies performed with tinidazole to date; interactions reported with metronidazole (a chemically similar nitroimidazole) may occur with tinidazole.1
















































Drug or Test



Interaction



Comments



Alcohol



Alcoholic beverages or preparations containing alcohol or propylene glycol may cause abdominal cramps, nausea, vomiting, headaches, and flushing 1



Avoid alcoholic beverages and preparations containing alcohol or propylene glycol during or for 3 days following completion of tinidazole therapy1



Anticoagulants, oral (warfarin)



Possible increased PT and enhanced anticoagulant effects1



Monitor PT and warfarin dosage carefully during concomitant use and for up to 8 days after the last tinidazole dose1 32



Antifungal agents (ketoconazole)



Possible prolonged half-life, decreased clearance, and increased plasma concentrations of tinidazole1



Cholestyramine



Studies using metronidazole indicate cholestyramine decreases oral bioavailability of the nitroimidazole by 21%1



Give tinidazole and cholestyramine doses at separate times1



Cimetidine



Possible prolonged half-life, decreased clearance, and increased plasma concentrations of tinidazole1



Disulfiram



Experience with metronidazole and disulfiram indicates psychotic reactions can occur; such reactions not reported to date with tinidazole 1 31



Do not use concomitantly; do not initiate tinidazole until 2 weeks after disulfiram is discontinued1



Fluorouracil



Experience with metronidazole and fluorouracil indicates decreased fluorouracil clearance, increased fluorouracil-associated adverse effects, no increased therapeutic benefit1



If concomitant use of tinidazole and fluorouracil is unavoidable, monitor for fluorouracil toxicity1



Immunosuppressive agents (cyclosporine, tacrolimus)



Experience with metronidazole indicates increased plasma concentrations of cyclosporine or tacrolimus1



Monitor for cyclosporine or tacrolimus toxicity if tinidazole used concomitantly with one of these drugs1



Lithium



Experience with metronidazole and lithium indicates increased lithium concentrations;1 not reported to date with tinidazole1



Measure serum lithium and creatinine concentrations after several days of concomitant lithium and tinidazole therapy to detect potential lithium intoxication1



Phenobarbital



Possible increased elimination and decreased plasma concentrations of tinidazole1



Phenytoin or fosphenytoin



Experience with oral metronidazole and IV phenytoin indicates prolonged phenytoin half-life and reduced phenytoin clearance;1 not reported with oral phenytoin and oral metronidazole1


Possible increased elimination and decreased plasma concentrations of tinidazole1



Rifampin



Possible increased elimination and decreased plasma concentrations of tinidazole1



Tests based on ultraviolet (UV) absorbance



Falsely decreased serum concentrations (including undetectable concentrations) of AST, ALT, LDH, triglycerides, or hexokinase glucose may be reported during tinidazole therapy if results are based on decreases in UV absorbance that occur during oxidation-reduction of NADH/NAD1


UV absorbance peaks of NADH and tinidazole are similar1



Use caution when interpreting test results based on UV absorbance during tinidazole therapy1



Tetracyclines



Experience with metronidazole indicates oxytetracycline (no longer commercially available in the US) may inhibit therapeutic effects of the nitroimidazole1


Tinidazole Pharmacokinetics


Absorption


Bioavailability


Estimated oral bioavailability >90%.63


Rapidly absorbed following oral administration; peak plasma concentrations usually attained within about 2 hours.1 32 63 68


Pharmacokinetic parameters reported with extemporaneous oral suspension containing 66.7 mg/mL (prepared using crushed 500-mg tablets and cherry syrup) in healthy individuals after an overnight fast similar to those reported with tablets swallowed whole under fasted conditions.1 32


Food


Administration with food delays time to peak plasma concentrations by approximately 2 hours and decreases peak plasma concentrations by 10%,1 32 but does not affect AUC or elimination half-life.1 32


Distribution


Extent


Distributed into virtually all body tissues and body fluids.1 32 63


Crosses blood-brain barrier.1 32 63


Crosses placenta and is distributed into breast milk.1


Plasma Protein Binding


12%.1 32 63


Elimination


Metabolism


Extensively metabolized prior to elimination.1 63 1


Partially metabolized via oxidation, hydroxylation, and conjugation.1 63 Metabolized principally by CYP3A4.1


Present in plasma principally as unchanged drug with small amounts of the 2-hydroxymethyl metabolite.1 32 63


Elimination Route


Eliminated by the liver and kidneys.1


Excreted in urine as unchanged drug (20–25%) and in feces (12%).1 32 63 68


Removed by hemodialysis.1 60


Not known whether removed by CAPD.1


Half-life


Approximately 12–14 hours.1 32 58 63 68


Special Populations


Hepatic impairment: Pharmacokinetics not evaluated.1 Studies using metronidazole (a chemically similar nitroimidazole) indicate reduced elimination and increased plasma concentrations in severe hepatic impairment.1 31


Severe renal impairment: Pharmacokinetics not affected by severe impairment (Clcr <22 mL/min).1


Hemodialysis patients: Clearance increased and elimination half-life decreased (from 12 hours to 4.9 hours).1 60 (See Renal Impairment under Dosage and Administration.)


Stability


Storage


Oral


Tablets

20–25°C (may be exposed to 15–30°C);1 protect from light.1


Extemporaneous Oral Suspension

Suspension containing 66.7 mg/mL: Stable for 7 days at room temperature.1 (See Extemporaneous Oral Suspension under Dosage and Administration.)


Actions and SpectrumActions



  • Amebicidal, trichomonacidal, and bactericidal.1 32 58 59 63 64 65 68




  • Cell extracts of Trichomonas appear to reduce the nitroimidazole group of tinidazole and generate the free nitro radical, which may be responsible for the drug’s anti-infective activity.1 32 59 65 Mechanism of activity against Giardia and Entamoeba histolytica not known.1




  • Protozoa: Active in vitro and in clinical infections against Trichomonas vaginalis, G. duodenalis (also known as G. lamblia or G. intestinalis), and E. histolytica.1 58 59 65




  • Anaerobes: Active in vitro against many anaerobic bacteria including some Bacteroides58 64 (e.g., B. fragilis,32 59 63 64 65 68 B. melaninogenicus63 ), some Clostridium32 59 63 (e.g., C. difficile,32 C. perfringens63 64 ), Prevotella,32 Fusobacterium,63 64 68 Peptococcus,32 58 59 63 and Peptostreptococcus.32 58 59 63




  • Other organisms: Active against Helicobacter pylori 32 and Gardnerella vaginalis.32 59 65 Inactive against most Lactobacillus normally resident in vagina.1 32




  • Potential for development of resistance in Giardia, E. histolytica, or bacteria associated with bacterial vaginosis not evaluated.1




  • Although clinical importance unclear,61 some T. vaginalis with reduced susceptibility to metronidazole also have reduced susceptibility to tinidazole in vitro.1 61 62 61



Advice to Patients



  • Importance of taking with food to reduce the incidence of adverse GI effects (e.g., epigastric discomfort).1




  • Advise patients to avoid alcoholic beverages and preparations containing alcohol or propylene glycol during and for at least 3 days after receiving tinidazole.1




  • Advise patients to promptly discontinue tinidazole and contact clinician if abnormal neurologic signs occur.1




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




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




  • Importance of advising patients of other important precautionary information.1 (See Cautions.)



Preparations


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


















Tinidazole

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



250 mg



Tindamax (scored)



Mission



500 mg



Tindamax (scored)



Mission


Comparative Pricing


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


Tindamax 500MG Tablets (MISSION): 20/$195.88 or 60/$556.36



Disclaimer

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


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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2009. 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



1. Mission Pharmacal. Tindamax (tinidazole tablets) prescribing information. San Antonio, TX; 2007 Jul.



2. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website (). Accessed 2004 Aug.



3. Hager WD. Treatment of metronidazole-resistant Trichomonas vaginalis with tinidazole: case reports of three patients. Sex Transm Dis. 2004; 31:343-5. [PubMed 15167642]



4. Gulmezoglu AM, Garner P. Trichomoniasis treatment in women: a systematic review. Trop Med Int Health. 1998; 3:553-8. [IDIS 412104] [PubMed 9705189]



5. O-Prasertsawat P, Jetsawangsri T. Split-dose metronidazole or single-dose tinidazole for the treatment of vaginal trichomoniasis. Sex Transm Dis. 1992; 19:295-7. [IDIS 521309] [PubMed 1411848]



7. Lossick JG. Treatment of sexually transmitted vaginosis/vaginitis. Rev Infect Dis. 1990; 12(Suppl 6):S665-81. [IDIS 300932] [PubMed 2201078]



8. Heine P, McGregor JA. Trichomonas vaginalis: a reemerging pathogen. Clin Obstet Gynecol. 1993; 36:137-44. [PubMed 8435938]



9. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006; 55(RR-11):1-95.



10. Lossick JG. Treatment of Trichomonas vaginalis infections. Rev Infect Dis. 1982; 4(Suppl):S801-18.



11. Lossick JG, Kent HL. Trichomoniasis: trends in diagnosis and management. Am J Obstet Gynecol. 1991; 165:1217-22. [IDIS 290714] [PubMed 1951578]



13. Anjaeyulu R, Gupte SA, Desai DB. Single-dose treatment of trichomonal vaginitis: a comparison of tinidazole and metronidazole. J Int Med Res. 1977; 5:438-41. [PubMed 590601]



14. Bloch B, Smyth E. The treatment of Trichomonas vaginalis vaginitis: an open controlled prospective study comparing a single dose of metronidazole tablets, benzoyl metronidazole suspension and tinidazole tablets. S Afr Med J. 1985; 67:455-7. [IDIS 200360] [PubMed 3885425]



15. Lyng J, Christensen J. A double-blind study of the value of treatment with a single dose tinidazole of partners to females with trichomoniasis. Acta Obstet Gynecol Scand. 1981; 60:199-201. [PubMed 7018164]



16. Chaudhuri P, Drogendijk AC. A double-blind controlled clinical trial of carnidazole and tinidazole in the treatment of vaginal trichomoniasis. Eur J Obstet Gynecol Reprod Biol. 1980; 10:325-8. [PubMed 6995193]



17. Anon. Drugs for parasitic infections. From the Medical Letter web site (). Aug 2008.



18. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.



19. Hill DR. Giardiasis: issues in diagnosis and management. Infect Dis Clin North Am. 1993; 7:503-25. [PubMed 8254157]



20. Ortega YR, Adam RD. Giardia: overview and update. Clin Infect Dis. 1997; 25:545-50. [IDIS 393721] [PubMed 9314441]



21. Nigam P, Kapoor KK, Kumar AJ et al. Clinical profile of giardiasis and comparison of its therapeutic response to metronidazole and tinidazole. J Assoc Physicians India. 1991; 39:613-5. [PubMed 1814877]



22. Gupta JP, Jain AK, Nanivadekar AS. Efficacy of tinidazole (Fasigyn) in giardiasis by parasitologic, biochemical, and gut transit studies. Indian J Gastroenterol. 1989; 8:103-4. [PubMed 2707840]



23. Cervetto JL, Ramonet M, Nahmod LH et al. Giardiasis. Functional, immunological and histological study of the small bowel: therapeutic trial with a single dose of tinidazole. Arg Gastroenterol. 1987; 24:102-12.



24. Speelman P. Single-dose tinidazole for the treatment of giardiasis. Antimicrob Agents Chemother. 1985; 27:227-9. [IDIS 196181] [PubMed 3985604]



25. Ravdin JI. Amebiasis. Clin Infect Dis. 1995; 20:1453-66. [IDIS 349015] [PubMed 7548493]



26. Aucott JN, Ravdin JI. Amebiasis and “nonpathogenic” intestinal protozoa. Infect Dis Clin North Am. 1993; 7:467-85. [PubMed 8254155]



27. Reed SL. Amebiasis: an update. Clin Infect Dis. 1992; 14:385-93. [IDIS 292053] [PubMed 1554822]



28. Lim JK. Clinical trial of tinidazole (Fasigyn) in acute and chronic intestinal Amoebiasis. Kisaengchunghak Chapchi. 1974; 12:135-140. [PubMed 12913475]



29. Salles JM, Bechara C, Tavares AM et al. Comparative study of the efficacy and tolerability of secnidazole suspension (single dose) and tinidazole suspension (two days dosage) in the treatment of amebiasis in children. Braz J Infect Dis. 1999; 3:80-88. [PubMed 11098194]



30. Boonyapisit S, Chinapak O, Plengvanit U. Amoebic liver abscess in Thailand, clinical analysis of 418 cases. J Med Assoc Thai. 1993;76:243-6.



31. G.D. Searle. Flagyl (metronidazole tablets) prescribing information. Chicago, IL; 2003 Aug.



32. Presutti Laboratories, Arlington Heights, IL: personal communication.



34. Centers for Disease Control and Prevention. Health information for international travel, 2005–2006. Atlanta, GA: US Department of Health and Human Services; 2005. Updates available from CDC website ().



35. Forna F, Gulmezoglu AM. Interventions for treating Trichomoniasis in women (Cochrane review). In: The Cochrane Library. Issue 2. Oxford, United Kingdom: update software 2004.



36. Gabriel G, Robertson E, Thin RN. Single dose treatment of trichomoniasis. J Int Med Res. 1982;10:129-30.



37. Rees PH, McGlashan HE, Mwega V. Single-dose treatment of vaginal trichomoniasis with tinidazole. East Afr Med J. 1974;51:782-5.



38. Mati JK, Wallace RJ. The treatment of trichomonal vaginitis using a single dose of tinidazole by mouth. East Afr Med J. 1974;51:883-8.



39. Sobel JD. Vaginitis. N Engl J Med.1997;337:1896-903.



40. Zaat JO, Mank T, Assendelft WJ. Drugs for treating giardiasis (Cochrane Database). In: The Cochrane Library. Issue 3. Oxford, United Kingdom: update software 2004.



41. Jokipii L, Jokipii AMM. Single-dose metronidazole and tinidazole as therapy for giardiasis: success rates, side effects, and drug absorption and elimination. J Infect Dis. 1979;140:984-88.



42. Danzig S, Hatchuel WLF. Single-dose treatment of giardiasis with tinidazole. S Afr Med J. 1974; 52:708.



43. Bakshi JS, Ghiara JM, Nanivadekar AS. How does tinidazole compare with metronidazole? Drugs. 1978;4315:33-42.



44. Gazder AJ & Banerjee M: Single-dose treatment of giardiasis in children: a comparison of tinidazole and metronidazole. Curr Med Res Opin. 1977; 5:164-68.



45. Centers for Disease Control and Prevention. CDC surveillance summaries: giardiasis surveillance United States, 1992–1997. MMWR CDC Surveill Summ. 2000;49:1-13.



46. Kyronseppa H, Pettersson T. Treatment of giardiasis: relative efficacy of metronidazole as compared with tinidazole. Scand J Inf Dis. .1981; 13:311-12.



47. Haque R, Huston CD, Hughes M, et al. Amebiasis. N Engl J Med. 2003;348:1565-73.



48. Mabadadeje AF, Oredugba. Single-dose tinidazole treatment of amebic dysentery. Curr Ther Res. 1977;21:685-8.



49. Swami B, Lavakusulu D, Devi CS. Tinidazole and metronidazole in the treatment of intestinal amoebiasis. Curr Med Res Opin. 1977;5:152-6.



50. Ahmed T, Ali F, Sarwar SG. Clinical evaluation of tinidazole in amoebiasis in children. Arch Dis Childhood. 1976;51:388-89.



51. Singh G, Kumar S. Short course of single daily dosage treatment with tinidazole and metronidazole in intestinal amoebiasis: a comparative study. Curr Med Res Opin. 1977;5:157-60.



52. Islam N, Hasan K. Tinidazole and metronidazole


Sunday, May 27, 2012

Sulfacetamide Ointment


Generic Name: Sulfacetamide (sul-fa-SEE-ta-mide)
Brand Name: Generic only. No brands available.


Sulfacetamide Ointment is used for:

Treating eye infections caused by certain bacteria.


Sulfacetamide Ointment is a sulfonamide. It works by restricting the production of folic acid, which bacteria need for growth. This kills the bacteria.


Do NOT use Sulfacetamide Ointment if:


  • you are allergic to any ingredient in Sulfacetamide Ointment

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

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



Before using Sulfacetamide Ointment:


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


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

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

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

  • if you have a discharge from your eye.

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


  • Silver-containing products because they may decrease Sulfacetamide Ointment's effectiveness

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


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


  • Sulfacetamide Ointment may be used around the eye or in the eye. To use Sulfacetamide Ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Sulfacetamide Ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.

  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

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

  • Sulfacetamide Ointment works best if it is taken at the same time each day.

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

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

Ask your health care provider any questions you may have about how to use Sulfacetamide Ointment.



Important safety information:


  • Sulfacetamide Ointment only works against bacteria; it does not treat viral infections

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

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

  • Sulfacetamide Ointment should be used with extreme caution in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sulfacetamide Ointment while you are pregnant. It is not known if Sulfacetamide Ointment is found in breast milk after use in the eye. Do not breast-feed while using Sulfacetamide Ointment.


Possible side effects of Sulfacetamide Ointment:


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



Mild irritation, stinging, or burning.



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); fever, chills, or persistent sore throat; new or worsening eye discharge, inflammation, or pain; joint pain; red, swollen, or blistered skin; vision changes; yellowing of the eyes or skin.



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



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. Sulfacetamide Ointment may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.


Proper storage of Sulfacetamide Ointment:

Store Sulfacetamide Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Sulfacetamide Ointment out of the reach of children and away from pets.


General information:


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

  • Sulfacetamide Ointment 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.

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


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


Compare Sulfacetamide with other medications


  • Conjunctivitis
  • Trachoma


Sulfalax Calcium


Generic Name: docusate (DOK ue sate)

Brand Names: Calcium Stool Softener, Colace, Correctol Softgel Extra Gentle, D-S Caps, Diocto, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docusoft S, DocuSol, DOK, DOS, DSS, Dulcolax Stool Softener, Enemeez Mini, Fleet Sof-Lax, Kao-Tin, Kaopectate Stool Softener, Kasof, Phillips Stool Softener, Silace, Sur-Q-Lax


What is Sulfalax Calcium (docusate)?

Docusate is a stool softener. It makes bowel movements softer and easier to pass.


Docusate is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements.


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


What is the most important information I should know about Sulfalax Calcium (docusate)?


You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist before using docusate if you are on a low-salt diet, if you are pregnant or breast-feeding, or if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.


What should I discuss with my healthcare provider before using Sulfalax Calcium (docusate)?


You should not use docusate if you are allergic to it, or if you have a blockage in your intestines. Do not use docusate while you are sick with nausea, vomiting, or stomach pain. Do not take mineral oil while using docusate, unless your doctor tells you to.

Ask a doctor or pharmacist if it is safe for you to take docusate:



  • if you are on a low-salt diet; or




  • if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.




It is not known whether docusate 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 docusate 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 give this medication to a child younger than 2 years old without the advice of a doctor.

How should I use Sulfalax Calcium (docusate)?


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.


Take docusate tablets or capsules with a full glass of water. Drink plenty of liquids while you are taking docusate. Do not crush, chew, or break a docusate capsule. Swallow it whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.


Do not take docusate rectal enema by mouth. It is for use only in your rectum. Wash your hands before and after using docusate rectal enema.

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


Twist off the applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it.


After using docusate, you should have a bowel movement within 12 to 72 hours. Call your doctor if you have not had a bowel movement within 1 to 3 days.


Do not use docusate for longer than 7 days unless your doctor has told you to. Overuse of a stool softener can lead to serious medical problems. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since docusate 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.

Overdose symptoms may include nausea, vomiting or stomach pain.


What should I avoid while using Sulfalax Calcium (docusate)?


Avoid using laxatives or other stool softeners unless your doctor has told you to.

Avoid using the bathroom just after using docusate enema.


Sulfalax Calcium (docusate) 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 docusate and call your doctor at once if you have a serious side effect such as:

  • rectal bleeding or irritation;




  • numbness or a rash around your rectum;




  • severe diarrhea or stomach cramps; or




  • continued constipation.



Less serious side effects may include:



  • mild diarrhea; or




  • mild nausea.



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 Sulfalax Calcium (docusate)?


There may be other drugs that can interact with docusate. 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 Sulfalax Calcium resources


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


  • Docusate Professional Patient Advice (Wolters Kluwer)

  • Colace MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diocto Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Docusate Salts Monograph (AHFS DI)

  • Dostinex Monograph (AHFS DI)

  • Enemeez Mini Enema MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Sulfalax Calcium with other medications


  • Constipation


Where can I get more information?


  • Your pharmacist can provide more information about docusate.

See also: Sulfalax Calcium side effects (in more detail)



Friday, May 25, 2012

Trexall


Pronunciation: METH-oh-TREX-ate
Generic Name: Methotrexate
Brand Name: Examples include Rheumatrex and Trexall

Trexall may cause severe and sometimes fatal side effects. These may include bone marrow, blood, liver, lung, kidney, or skin problems. For this reason, Trexall is only used to treat certain patients who have life-threatening cancer or who have severe psoriasis or rheumatoid arthritis that is not relieved by other treatments. Your doctor will perform lab tests to check for side effects while you take Trexall. Keep all doctor and laboratory appointments. Talk with your doctor and be sure you understand the risks and benefits of using Trexall.


Trexall may cause birth defects or fetal death. Do not use Trexall to treat psoriasis or rheumatoid arthritis if you are pregnant. Tell your doctor before you take Trexall if you are pregnant or think you may be pregnant. Do not become pregnant or father a child while using Trexall. Talk to your doctor about using an effective form of birth control.


Certain medicines and conditions may increase your risk for side effects. Tell your doctor if you take a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib) or salicylate (eg, aspirin), or if you receive radiation therapy. Tell your doctor if you have excess fluid in your stomach or around your lungs, or if you have any liver, kidney, lung, blood, bone marrow, stomach, bowel, or immune system problems. Tell your doctor right away if you develop any new or worsening symptoms, including black, tarry stools; dry, nonproductive cough; mouth sores; red, swollen, blistered, or peeling skin; severe or persistent diarrhea or vomiting; shortness of breath or trouble breathing; signs of infection (eg, fever, chills, persistent sore throat); stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; or yellowing of the skin or eyes.


Trexall may cause a serious and possibly fatal condition called tumor lysis syndrome (TLS) in certain patients with cancer. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.


Trexall may increase the risk of developing a certain type of cancer (lymphoma). Discuss any questions or concerns with your doctor.





Trexall is used for:

Treating certain types of cancer. It is also used to control severe psoriasis and severe rheumatoid arthritis in certain patients. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.


Trexall is an antimetabolite. It works to treat cancer and psoriasis by slowing the growth of cancer cells and abnormal skin cells. Exactly how Trexall works to treat rheumatoid arthritis is unknown. It reduces symptoms of inflammation (eg, pain, swelling, stiffness) caused by rheumatoid arthritis.


Do NOT use Trexall if:


  • you are allergic to any ingredient in Trexall

  • you are breast-feeding

  • you are treating psoriasis or rheumatoid arthritis and any of the following apply to you:
    • you are pregnant

    • you have alcoholism, liver problems caused by alcohol, or chronic liver problems

    • you have a weakened immune system or certain blood problems (eg, anemia, bone marrow depression, low white blood cell count, low blood platelet count)


  • you are taking acitretin

  • you have taken or will be taking palifermin within 24 hours of taking Trexall

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



Before using Trexall:


Some medical conditions may interact with Trexall. 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 breastfeeding

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

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

  • if you are able to become pregnant or father a child

  • if you have a history of lung problems, immune system problems, nervous system problems (eg, seizures), liver problems (eg, hepatitis), kidney problems, diabetes, or blood problems (eg, anemia, low white blood cell levels, low blood platelet levels)

  • if you have an active infection, severe vomiting or diarrhea, or dehydration

  • if you have mouth sores, excess fluid in your stomach or around your lungs, stomach or bowel ulcers, bowel inflammation (eg, ulcerative colitis), or a blockage of your stomach or bowel

  • if you have a folic acid deficiency, are in very poor health or are very overweight, or have a history of alcohol abuse

  • if you are receiving chemotherapy or radiation

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


  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer

  • Medicines that may harm the kidney (eg, amphotericin B; tacrolimus; aminoglycoside antibiotics such as gentamicin) or the liver (eg, azathioprine; retinoids such as acitretin or isotretinoin; acetaminophen; ketoconazole; isoniazid; certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver

  • Chloramphenicol, ciprofloxacin, corticosteroids (eg, prednisone), cyclosporine, dantrolene, hydantoins (eg, phenytoin), hydroxychloroquine, leflunomide, NSAIDs (eg, ibuprofen, celecoxib, ketorolac), penicillamine, penicillin antibiotics (eg, amoxicillin), phenylbutazone, pristinamycin, probenecid, proton pump inhibitors (PPIs) (eg, omeprazole), salicylates (eg, aspirin), sulfonamide medicines (eg, sulfamethoxazole, sulfasalazine), tetracycline antibiotics (eg, doxycycline), trimethoprim, or vancomycin because they may increase the risk of Trexall's side effects

  • Folic acid because it may decrease Trexall's effectiveness

  • Digoxin because its effectiveness may be decreased by Trexall

  • Mercaptopurine, oral anticoagulants (eg, warfarin), or theophylline because the risk of their side effects may be increased by Trexall

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


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


  • Take Trexall by mouth with or without food. However, you should take it the same way each time in relation to food.

  • Drinking extra fluids while you are taking Trexall is recommended. Check with your doctor for instructions.

  • The dose of Trexall and how often you use it are based on your medical condition and response to treatment. It is very important that you follow your doctor's instructions carefully. Taking too much of Trexall may cause serious and sometimes fatal side effects. Be sure you understand exactly how much of Trexall to take and how often you should take it. Ask your doctor or pharmacist if you have any questions.

  • It may take several weeks for the full benefit of Trexall to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop taking Trexall without checking with your doctor.

  • Trexall works best if each dose is taken at the scheduled time.

  • Continue to take Trexall even if you feel well. Do not miss any doses.

  • If you miss a dose of Trexall, contact your doctor right away. Do not take 2 doses at once.

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



Important safety information:


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

  • Check with your doctor before you drink alcohol while you are taking Trexall.

  • Nausea, vomiting, and loss of appetite are common with Trexall. Ask your doctor or pharmacist for ways to decrease these effects if they occur.

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

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

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

  • Trexall 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.

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Trexall. Talk with your doctor before you receive any vaccine.

  • Trexall may affect your ability to become pregnant or to father a child. Discuss any questions or concerns with your doctor.

  • Men who take Trexall should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Trexall and for 3 months after you stop taking it.

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

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

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

  • Trexall 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: Trexall may cause birth defects and fetal or newborn death if you take it while you are pregnant. Do not become pregnant while you are using it. Use an effective form of birth control while you take Trexall and for at least 1 ovulatory cycle after you stop taking it. If you think you may be pregnant, contact your doctor right away. Trexall is found in breast milk. Do not breast-feed while taking Trexall.


Possible side effects of Trexall:


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:



Dizziness; drowsiness; general body discomfort; headache; loss of appetite; mild hair loss; mild stomach pain; nausea; tiredness.



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); black, tarry stools; blood in the urine; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; coughing up blood; diarrhea or vomiting; difficult or painful urination; dry cough; enlargement of the breasts (in males); fainting; fever, chills, or persistent sore throat; menstrual changes; mental or mood changes; mouth or tongue sores or swelling; muscle weakness; night sweats; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or light-headedness; shortness of breath; speech changes; swollen glands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach pain with or without nausea or vomiting); unexplained weight loss; unusual bleeding or bruising; unusual pain and discoloration of the skin; unusual tiredness or weakness; vaginal discharge; vision loss or other vision changes (eg, blurred vision); vomit that looks like coffee grounds.



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: Trexall 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 black or bloody stools; change in the amount of urine produced; seizures; severe headache, nausea, vomiting, or stomach pain; swelling or soreness of the mouth or tongue; unusual bruising or bleeding; unusual tiredness or weakness; vomit that looks like coffee grounds.


Proper storage of Trexall:

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


General information:


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

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

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

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

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


  • Trexall Side Effects (in more detail)
  • Trexall Dosage
  • Trexall Use in Pregnancy & Breastfeeding
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  • Trexall Drug Interactions
  • Trexall Support Group
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  • Methotrexate Monograph (AHFS DI)

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