Saturday, October 6, 2012

Equate Sleep Aid



doxylamine succinate

Dosage Form: tablet
Wal-Mart Sleep Aid Tablets Drug Facts

Active ingredient (in each tablet)


Doxylamine succinate 25 mg



Purpose


Nighttime sleep-aid



Uses


  • helps to reduce difficulty in falling asleep


Warnings


Ask a doctor before use if you have


  • a breathing problem such as asthma, emphysema or chronic bronchitis

  • glaucoma

  • trouble urinating due to an enlarged prostate gland


Do not give


to children under 12 years of age



Ask a doctor or pharmacist before use if you are


taking any other drugs



When using this product


  • avoid alcoholic beverages

  • take only at bedtime


Stop use and ask a doctor if


  • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.


If pregnant or breast-feeding,


ask a health professional before use.



Keep out of reach of children.


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



Directions


  • adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor

  • children under 12 years of age: do not use


Other information


  • store at 68°-77°F (20°-25°C)

  • retain in carton until time of use

  • see carton end panel for lot number and expiration date


Inactive ingredients


dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate



Questions or comments?


1-800-996-5358



Principal Display Panel


Compare to Unisom® SleepTabs® active ingredient


Just One Tablet Per Dose


Sleep Aid Tablets


Doxylamine Succinate Tablets, 25 mg


Night Time Sleep Aid


Fall Asleep Fast


Proven Effective


Actual Size


Sleep Aid Tablets Carton










Equate Sleep Aid 
doxylamine succinate  tablet










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)49035-441
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE)DOXYLAMINE SUCCINATE25 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint CodeL441
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
149035-441-642 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
116 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (49035-441-64)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016702/25/1997


Labeler - Wal-Mart Stores Inc (051957769)
Revised: 06/2009Wal-Mart Stores Inc




More Equate Sleep Aid resources


  • Equate Sleep Aid Dosage
  • Equate Sleep Aid Use in Pregnancy & Breastfeeding
  • Equate Sleep Aid Drug Interactions
  • 0 Reviews for Equate Sleep Aid - Add your own review/rating


Compare Equate Sleep Aid with other medications


  • Allergies
  • Conjunctivitis, Allergic
  • Hay Fever
  • Insomnia
  • Nasal Congestion
  • Rhinorrhea
  • Upper Respiratory Tract Infection

Exenatide


Pronunciation: ex-EN-a-tide
Generic Name: Exenatide
Brand Name: Byetta


Exenatide is used for:

Treating type 2 diabetes.


Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It lowers blood sugar by increasing the release of insulin from the pancreas. It also mimics the actions of certain hormones that lower blood sugar levels.


Do NOT use Exenatide if:


  • you are allergic to any ingredient in Exenatide

  • you have type 1 diabetes

  • you have a buildup of ketones in the blood or urine caused by diabetes (diabetic ketoacidosis)

  • you have severe kidney problems or severe stomach or bowel problems

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



Before using Exenatide:


Some medical conditions may interact with Exenatide. 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 stomach or bowel problems, gallbladder problems (eg, gallstones), inflammation of the pancreas (pancreatitis), high blood triglyceride levels, alcohol abuse, kidney problems or kidney transplant, or if you receive dialysis

  • if you are also using insulin

  • if you are taking lovastatin

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


  • Insulin, meglitinides (eg, repaglinide), sulfonylureas (eg, glipizide), or thiazolidinediones (eg, pioglitazone) because the risk of low blood sugar may be increased

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril), diuretics (eg, furosemide, hydrochlorothiazide), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or other medicines that may affect kidney function (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; cyclosporine; tacrolimus; vancomycin) because the risk of kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might affect kidney function

  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Exenatide

Ask your health care provider if Exenatide 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 Exenatide:


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


  • Exenatide comes with an extra patient information sheet called a Medication Guide and a user manual for the pen. Read them carefully. Read them again each time you get Exenatide refilled.

  • Use Exenatide within 1 hour before your morning and evening meals (or before the 2 main meals of the day), unless your doctor tells you otherwise. Do NOT use it after a meal. Your doses of Exenatide should be about 6 hours or more apart.

  • If you will be using Exenatide at home, a health care provider will teach you how to use it. Be sure you understand how to use Exenatide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Do not mix Exenatide with insulin. Do not transfer Exenatide from the pen into a syringe or vial.

  • Inject Exenatide into your upper leg (thigh), stomach area (abdomen), or upper arm as directed by your doctor or other health care provider.

  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.

  • Do not use Exenatide if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • If you are taking certain medicines by mouth (eg, antibiotics, birth control pills), you may need to take them at least 1 hour before you use Exenatide. Ask your doctor, pharmacist, or other health care provider if you need to take any of your medicines at a different time than Exenatide.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Exenatide, 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 Exenatide.



Important safety information:


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

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

  • Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Exenatide exactly as prescribed, tell your doctor.

  • Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Exenatide.

  • The risk of low blood sugar may be increased when Exenatide is used with certain other diabetes medicines (eg, insulin, meglitinides, sulfonylureas, thiazolidinediones). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

  • Exenatide may decrease your appetite, the amount of food you eat, and your weight. This is normal. Do not change your dose of Exenatide without checking with your doctor.

  • Patients taking Exenatide have developed a severe and sometimes fatal pancreas problem (pancreatitis). Contact your doctor right away if you develop severe or persistent stomach pain that may radiate to the back (with or without nausea or vomiting).

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

  • Do not store the pen with the needle attached. If the needle is left on, the medicine may leak from the pen or air bubbles may form in the cartridge.

  • Lab tests, including hemoglobin A1c levels, blood sugar levels, and kidney function, may be performed while you use Exenatide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

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


Possible side effects of Exenatide:


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:



Constipation; decreased appetite; diarrhea; dizziness; feeling jittery; headache; indigestion; nausea; vomiting; weakness; weight loss.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; fainting; fast heartbeat; severe dizziness; severe or persistent headache, diarrhea, nausea, or vomiting; severe or persistent stomach pain that may radiate to the back (with or without nausea or vomiting); symptoms of kidney problems (eg, change in the amount of urine produced, unusual or persistent pain in the mid to lower back, unexplained swelling); symptoms of low blood sugar (eg, chills, confusion, drowsiness, increased hunger, increased sweating, irritability, nervousness, tremor, blurred vision, 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: Exenatide 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 dizziness; severe nausea or vomiting; symptoms of low blood sugar (eg, chills, confusion, drowsiness, fainting, fast heartbeat, increased hunger, increased sweating, irritability, nervousness, severe dizziness, tremor, blurred vision, weakness).


Proper storage of Exenatide:

Store unused (unopened) pens in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use Exenatide if it has been frozen. Store used (open) pens below 77 degrees F (25 degrees C). Protect from light. Do not store with the needle attached to the pen. Throw away a used pen 30 days after first use, even if some medicine remains in the pen. Do not use past the expiration date. Keep Exenatide out of the reach of children and away from pets.


General information:


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

  • Exenatide 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 Exenatide. 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 Exenatide resources


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


  • Exenatide Professional Patient Advice (Wolters Kluwer)

  • Exenatide Monograph (AHFS DI)

  • exenatide Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • exenatide Concise Consumer Information (Cerner Multum)



Compare Exenatide with other medications


  • Diabetes, Type 2

Friday, October 5, 2012

Adoport 1 mg Capsules, hard





1. Name Of The Medicinal Product



Adoport 1 mg Capsules, hard


2. Qualitative And Quantitative Composition



Each capsule contains 1 mg tacrolimus (as tacrolimus monohydrate).



Excipient(s):



Each capsule contains 47.4 mg lactose monohydrate.



For a full list of excipients, see section 6.1.



3. Pharmaceutical Form



Capsules, hard



Opaque white and light brown hard gelatin capsules containing white to off- white powder.



4. Clinical Particulars



4.1 Therapeutic Indications



Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.



Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal



products.



4.2 Posology And Method Of Administration



Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.



The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.



Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of side effects, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8). Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.



General considerations



The recommended initial dosages presented below are intended to act solely as a guideline. Tacrolimus dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations). If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.



Tacrolimus can be administered intravenously or orally. In general, dosing may commence orally; if necessary, by administering the capsule contents suspended in water, via nasogastric tubing. Tacrolimus is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period. The tacrolimus dose may vary depending upon the immunosuppressive regimen chosen.



Method of administration



It is recommended that the oral daily dose be administered in two divided doses (e.g. morning and evening). Capsules should be taken immediately following removal from the blister. The capsules should be swallowed with fluid (preferably water).



Capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).



Duration of dosing



To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.



Dosage recommendations – Liver transplantation



Prophylaxis of transplant rejection - adults



Oral tacrolimus therapy should commence at 0.10-0.20 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence approximately 12 hours after the completion of surgery.



If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01-0.05 mg/kg/day should be initiated as a continuous 24 hour infusion.



Prophylaxis of transplant rejection - children



An initial oral dose of 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening). If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day should be administered as a continuous 24-hour infusion.



Dose adjustment during post-transplant period in adults and children



Tacrolimus doses are usually reduced in the post-transplant period. It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus monotherapy.



Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.



Rejection therapy – adults and children



Increased tacrolimus doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity are noted (e.g. pronounced adverse reactions - see section 4.8) the dose of tacrolimus may need to be reduced.



For conversion to tacrolimus, treatment should begin with the initial oral dose recommended for primary immunosuppression.



For information on conversion from ciclosporin to tacrolimus, see below under “Dose adjustments in specific patient populations”.



Dosage recommendations - Kidney transplantation



Prophylaxis of transplant rejection – adults



Oral tacrolimus therapy should commence at 0.20-0.30 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence within 24 hours after the completion of surgery.



If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05-0.10 mg/kg/day should be initiated as a continuous 24 hour infusion.



Prophylaxis of transplant rejection – children



An initial oral dose of 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening). If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.075–0.100 mg/kg/day should be administered as a continuous 24 hour infusion.



Dose adjustment during post-transplant period in adults and children



Tacrolimus doses are usually reduced in the post-transplant period. It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus-based dual-therapy.



Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.



Rejection therapy – adults and children



Increased tacrolimus doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity are noted (e.g. pronounced adverse reactions - see section 4.8) the dose of tacrolimus may need to be reduced.



For conversion to tacrolimus, treatment should begin with the initial oral dose recommended for primary immunosuppression.



For information on conversion from ciclosporin to tacrolimus, see below under “Dose adjustments in specific patient populations”.



Dosage recommendations - Heart transplantation



Prophylaxis of transplant rejection – adults



Tacrolimus can be used with antibody induction (allowing for delayed start of tacrolimus therapy) or alternatively in clinically stable patients without antibody induction.



Following antibody induction, oral Tacrolimus therapy should commence at a dose of 0.075 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised. If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 to 0.02 mg/kg/day should be initiated as a continuous 24 hour infusion.



An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation. This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction). In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.



Prophylaxis of transplant rejection – children



Tacrolimus has been used with or without antibody induction in paediatric heart transplantation.



In patients without antibody induction, if tacrolimus therapy is initiated intravenously, the recommended starting dose is 0.03-0.05 mg/kg/day as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15-25 ng/ml. Patients should be converted to oral therapy as soon as clinically practicable. The first dose of oral therapy should be 0.30 mg/kg/day starting 8 to 12 hours after discontinuing intravenous therapy.



Following antibody induction, if tacrolimus therapy is initiated orally, the recommended starting dose is 0.10-0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).



Dose adjustment during post-transplant period in adults and children



Tacrolimus doses are usually reduced in the post-transplant period. Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.



Rejection therapy – adults and children



Increased tacrolimus doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.



In adult patients converted to tacrolimus , an initial oral dose of 0.15 mg/kg/day should be administered in two divided doses (e.g. morning and evening).



In paediatric patients converted to tacrolimus , an initial oral dose of 0.20-0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening).



For information on conversion from ciclosporin to tacrolimus , see below under “Dose adjustments in specific patient populations”.



Dosage recommendations - Rejection therapy, other allografts



The dose recommendations for lung, pancreas and intestinal transplantation are based on limited prospective clinical trial data. In lung-transplanted patients tacrolimus has been used at an initial oral dose of 0.10-0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.



Dosage adjustments in specific patient populations



Patients with liver impairment



Dose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.



Patients with kidney impairment



As the pharmacokinetics of tacrolimus are unaffected by renal function, no dose adjustment should be required. However, owing to the nephrotoxic potential of tacrolimus careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance and monitoring of urine output).



Paediatric patients



In general, paediatric patients require doses 1½ - 2 times higher than the adult doses to achieve similar blood levels.



Elderly patients



There is no evidence currently available to indicate that dosing should be adjusted in elderly patients.



Conversion from ciclosporin



Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5). Tacrolimus therapy should be initiated after considering ciclosporin blood concentrations and the clinical condition of the patient. Dosing should be delayed in the presence of elevated ciclosporin blood levels. In practice, tacrolimus therapy has been initiated 12-24 hours after discontinuation of ciclosporin. Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.



Target whole blood trough concentration recommendations



Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient.



As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood including a semi-automated microparticle enzyme immunoassay (MEIA). Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed. In current clinical practice, whole blood levels are monitored using immunoassay methods.



Blood trough levels of tacrolimus should be monitored during the post-transplantation period. When dosed orally, blood trough levels should be drawn approximately 12 hours post-dosing, just prior to the next dose. The frequency of blood level monitoring should be based on clinical needs. As tacrolimus is a medicinal product with low clearance, adjustments to the dosage regimen may take several days before changes in blood levels are apparent. Blood trough levels should be monitored approximately twice weekly during the early post-transplant period and then periodically during maintenance therapy. Blood trough levels of tacrolimus should also be monitored following dose adjustment, changes in the immunosuppressive regimen, or following co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).



Clinical study analysis suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml. It is necessary to consider the clinical condition of the patient when interpreting whole blood levels.



In clinical practice, whole blood trough levels have generally been in the range 5-20 ng/ml in liver transplant recipients and 10-20 ng/ml in kidney and heart transplant patients in the early post-transplant period. Subsequently, during maintenance therapy, blood concentrations have generally been in the range of 5-15 ng/ml in liver, kidney and heart transplant recipients.



4.3 Contraindications



Hypersensitivity to tacrolimus or other macrolides.



Hypersensitivity to any of the excipients.



4.4 Special Warnings And Precautions For Use



During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations. If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.



Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed. This has led to serious adverse events, including graft rejection, or other side effects which could be a consequence of either under- or over-exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).



Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking tacrolimus due to the risk of interactions that lead to decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus (see section 4.5).



Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.



The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.5).



Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions. Most cases have been reversible, occurring primarily in children with tacrolimus blood trough concentrations much higher than the recommended maximum levels. Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema. Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at three months and then at 9-12 months). If abnormalities develop, dose reduction of tacrolimus therapy, or change of treatment to another immunosuppressive agent should be considered. Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes. Caution should be exercised in patients with diagnosed or suspected Congenital Long QT Syndrome.



Patients treated with tacrolimus have been reported to develop EBV-associated lymphoproliferative disorders. Patients switched to tacrolimus therapy should not receive anti-lymphocyte treatment concomitantly. Very young (< 2 years), EBV-VCA-negative children have been reported to have an increased risk of developing lymphoproliferative disorders. Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with tacrolimus. During treatment, careful monitoring with EBV-PCR is recommended. Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.



Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES). If patients taking tacrolimus present with symptoms indicating PRES such as headache, altered mental status, seizures, and visual disturbances, a radiological procedure (e.g. MRI) should be performed. If PRES is diagnosed, adequate blood pressure control and immediate discontinuation of systemic tacrolimus is advised. Most patients completely recover after appropriate measures are taken.



Patients treated with immunosuppressants, including tacrolimus are at increased risk of opportunistic infections (bacterial, fungal, viral and protozoal). Among these conditions are BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML). These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in patients with deteriorating renal function or neurological symptoms.



As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.



As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).



As Adoport contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Metabolic interactions



Systemically available tacrolimus is metabolised by hepatic CYP3A4. There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall. Concomitant use of medicinal products or herbal remedies known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels. It is therefore recommended to monitor tacrolimus blood levels whenever substances which have the potential to alter CYP3A metabolism are used concomitantly and to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).



Inhibitors of metabolism



Clinically the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole and voriconazole, the macrolide antibiotic erythromycin or HIV protease inhibitors (e.g. ritonavir). Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.



Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole and nefazodone.



In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin.



Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.



Inducers of metabolism



Clinically the following substances have been shown to decrease tacrolimus blood levels:



Strong interactions have been observed with rifampicin, phenytoin or St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients. Clinically significant interactions have also been observed with phenobarbital. Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.



High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease tacrolimus blood levels.



Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.



Effect of tacrolimus on the metabolism of other medicinal products



Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products. The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly. In addition, synergistic/additive nephrotoxic effects can occur. For these reasons, the combined administration of ciclosporin and tacrolimus is not recommended and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.4). Tacrolimus has been shown to increase the blood level of phenytoin.



As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.



Limited knowledge of interactions between tacrolimus and statins is available. Available data suggests that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.



Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and phenazone.



Other interactions which have led to clinically detrimental effects



Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g. aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).



Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.



As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene or spironolactone) should be avoided.



Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective. The use of live attenuated vaccines should be avoided.



Protein binding considerations



Tacrolimus is extensively bound to plasma proteins. Possible interactions with other medicinal products known to have high affinity for plasma proteins should be considered (e.g. NSAIDs, oral anticoagulants, or oral anti-diabetics).



4.6 Pregnancy And Lactation



Human data show that tacrolimus crosses the placenta. Limited data from organ transplant recipients show no evidence of an increased risk of adverse effects on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products. To date, no other relevant epidemiological data are available. Tacrolimus treatment can be considered in pregnant women when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus. In case of in utero exposure, monitoring of the newborn for the potential adverse effects of tacrolimus is recommended (in particular the effects on the kidneys). There is a risk for premature delivery (<37 week) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2%), which, however, normalizes spontaneously.



In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3). Tacrolimus affected male fertility in rats (see section 5.3).



Lactation



Human data demonstrate that tacrolimus is excreted into breast milk. As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Tacrolimus.



4.7 Effects On Ability To Drive And Use Machines



Tacrolimus may cause visual and neurological disturbances. This effect may be enhanced if tacrolimus is administered in association with alcohol.



4.8 Undesirable Effects



The adverse drug reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medications.



Many of the adverse drug reactions stated below are reversible and/or respond to dose reduction. Oral administration appears to be associated with a lower incidence of adverse drug reactions compared with intravenous use. Adverse drug reactions are listed below in descending order by frequency of occurrence: very common (



Infections and infestations



As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal). The course of pre-existing infections may be aggravated. Both generalised and localised infections can occur.



Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including tacrolimus.



Neoplasms benign, malignant and unspecified (including cysts and polyps)Patients receiving immunosuppressive therapy are at increased risk of developing malignancies. Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.


























































































































































Blood and lymphatic system disorders:


 


common:




anaemia, leukopenia, thrombocytopenia, leukocytosis, red blood cell analyses abnormal




uncommon:




coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia




rare:




thrombotic thrombocytopenic purpura, hypo-prothrombinaemia




Immune system disorders:


 


Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).


 


Endocrine disorders:


 


rare:




hirsutism




Metabolism and nutrition disorders:


 


very common:




hyperglycaemic conditions, diabetes mellitus, hyperkalaemia




common:




hypomagnesaemia, hypophosphataemia, hypokalaemia, hypocalcaemia, hyponatraemia, fluid overload, hyperuricaemia, appetite decreased, anorexia, metabolic acidoses, hyperlipidaemia, hypercholesterolaemia, hypertriglyceridaemia, other electrolyte abnormalities




uncommon:




dehydration, hypoproteinaemia, hyperphosphataemia, hypoglycaemia




Psychiatric disorders:


 


very common:




insomnia




common:




anxiety symptoms, confusion and disorientation, depression, depressed mood, mood disorders and disturbances, nightmare, hallucination, mental disorders




uncommon:




psychotic disorder




Nervous system disorders:


 


very common:




tremor, headache




common:




seizures, disturbances in consciousness, paraesthesias and dysaesthesias, peripheral neuropathies, dizziness, writing impaired, nervous system disorders




uncommon:




coma, central nervous system haemorrhages and cerebrovascular accidents, paralysis and paresis, encephalopathy, speech and language abnormalities, amnesia




rare:




hypertonia




very rare:




myasthenia




Eye disorders:


 


common:




vision blurred, photophobia, eye disorders




uncommon:




cataract




rare:




blindness




Ear and labyrinth disorders:


 


common:




tinnitus




uncommon:




hypoacusis




rare:




deafness neurosensory




very rare:




hearing impaired




Cardiac disorders:


 


common:




ischaemic coronary artery disorders, tachycardia




uncommon:




ventricular arrhythmias and cardiac arrest, heart failures, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations, ECG investigations abnormal, heart rate and pulse investigations abnormal




rare:




pericardial effusion




very rare:




echocardiogram abnormal




Vascular disorders:


 


very common:




hypertension




common:




haemorrhage, thrombembolic and ischaemic events, peripheral vascular disorders, vascular hypotensive disorders




uncommon:




infarction, venous thrombosis deep limb, shock




Respiratory, thoracic and mediastinal disorders:


 


common:




dyspnoea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion and inflammations




uncommon:




respiratory failures, respiratory tract disorders, asthma




rare:




acute respiratory distress syndrome




Gastrointestinal disorders:


 


very common:




diarrhoea, nausea




common:




gastrointestinal inflammatory conditions, gastrointestinal ulceration and perforation, gastrointestinal haemorrhages, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pains, dyspeptic signs and symptoms, constipation, flatulence, bloating and distension, loose stools, gastrointestinal signs and symptoms




uncommon:




ileus paralytic, peritonitis, acute and chronic pancreatitis, blood amylase increased, gastrooesophageal reflux disease, impaired gastric emptying




rare:




subileus, pancreatic pseudocyst




Hepatobiliary disorders:


 


common:




hepatic enzymes and function abnormalities, cholestasis and jaundice, hepatocellular damage and hepatitis, cholangitis




rare:




hepatitic artery thrombosis, venoocclusive liver disease




very rare:




hepatic failure, bile duct stenosis




Skin and subcutaneous tissue disorders:


 


common:




pruritus, rash, alopecias, acne, sweating increased




uncommon:




dermatitis, photosensitivity




rare:




toxic epidermal necrolysis (Lyell's syndrome)




very rare:




Stevens Johnson syndrome




Musculoskeletal and connective tissue disorders:


 


common:




arthralgia, muscle cramps, pain in limb, back pain




uncommon:




joint disorders




Renal and urinary disorders:


 


very common:




renal impairment




common:




renal failure, renal failure acute, oliguria, renal tubular necrosis, nephropathy toxic, urinary abnormalities, bladder and urethral symptoms




uncommon:




anuria, haemolytic uraemic syndrome




very rare:




nephropathy, cystitis haemorrhagic




Reproductive system and breast disorders:


 


uncommon:




dysmenorrhoea and uterine bleeding




General disorders and administration site conditions:


 


common:




asthenic conditions, febrile disorders, oedema, pain and discomfort, blood alkaline phosphatase increased, weight increased, body temperature perception disturbed




uncommon:




multi-organ failure, influenza like illness, temperature intolerance, chest pressure sensation, feeling jittery, feeling abnormal, blood lactate dehydrogenase increased, weight decreased




rare:




thirst, fall, chest tightness, mobility decreased, ulcer




very rare:




fat tissue increased




Injury, poisoning and procedural complications:


 


common:




primary graft dysfunction



Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed. A number of associated cases of transplant rejection have been reported (frequency cannot be estimated from available data).



4.9 Overdose



Experience with over dosage is limited. Several cases of accidental over dosage have been reported; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy, increased blood urea nitrogen and elevated serum creatinine concentrations, and increase in alanine aminotransferase levels.



No specific antidote to tacrolimus therapy is available. If over dosage occurs, general supportive measures and symptomatic treatment should be conducted. Based on its high molecul

Thursday, October 4, 2012

Radionuclide Myocardial Perfusion Study Medications


Drugs associated with Radionuclide Myocardial Perfusion Study

The following drugs and medications are in some way related to, or used in the treatment of Radionuclide Myocardial Perfusion Study. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.





Drug List:

Tuesday, October 2, 2012

Naropin


Generic Name: ropivacaine (roe PIV a kane)

Brand Names: Naropin, Naropin Polyamp, Naropin SDV


What is Naropin (ropivacaine)?

Ropivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to your brain.


Ropivacaine is used as a local (in only one area) anesthesia for a spinal block, also called an epidural. The medication is used to provide anesthesia during a surgery or C-section, or to ease labor pains.


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


What is the most important information I should know about Naropin (ropivacaine)?


You should not receive ropivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving ropivacaine, tell your doctor if you are allergic to any drugs, or if you have liver disease, heart disease, or kidney disease.


Tell your caregivers at once if you have a serious side effect such as: confusion, feeling like you might pass out, problems with speech or vision, ringing in your ears, numbness or tingling around your mouth, seizure, weak or shallow breathing, fast or slow heart rate, weak pulse, gasping, or feeling unusually hot.

This medication can cause numbness over a large portion of your body. Take care to avoid injury before the feeling has returned completely.


Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from ropivacaine.


What should I discuss with my health care provider before receiving Naropin (ropivacaine)?


You should not receive ropivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving ropivacaine, tell your doctor if you are allergic to any drugs, or if you have:



  • liver disease;




  • heart disease; or




  • kidney disease.



If you have any of these conditions, you may need a dose adjustment or special tests to safely receive ropivacaine.


FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. It is not known whether ropivacaine can pass into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is ropivacaine given?


Ropivacaine is given as an injection through a needle placed into an area of your middle or lower back near your spine. You will receive this injection in a clinic or hospital setting.


Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving ropivacaine.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from ropivacaine.


What happens if I miss a dose?


Since ropivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.


What happens if I overdose?


Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include extreme drowsiness, ringing in your ears, blurred vision, fainting, seizure (convulsions), weak or shallow breathing, or breathing that stops.


What should I avoid after receiving Naropin (ropivacaine)?


This medication can cause numbness over a large portion of your body. Take care to avoid injury before the feeling has returned completely.


Naropin (ropivacaine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives or red skin rash; dizziness; sneezing; difficulty breathing; nausea or vomiting; sweating; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

  • feeling anxious, restless, confused, or like you might pass out;




  • problems with speech or vision;




  • ringing in the ears, metallic taste, vision problems, numbness or tingling around your mouth, or tremors;




  • seizure (convulsions);




  • weak or shallow breathing;




  • slow heart rate, weak pulse; or




  • fast heart rate, gasping, feeling unusually hot.



Less serious side effects include:



  • nausea, vomiting;




  • headache, back pain;




  • fever;




  • itching;




  • numbness or tingly feeling; or




  • problems with urination or sexual function.



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 Naropin (ropivacaine)?


Many drugs can interact with ropivacaine. Below is just a partial list. Tell your doctor if you are using:



  • birth control pills or other hormones;




  • cimetidine (Tagamet);




  • cyclobenzaprine (Flexeril);




  • interferon (Actimmune, Roferon, Intron, Rebetron, and others);




  • ondansetron (Zofran);




  • propranolol (Inderal);




  • theophylline (Elixophyllin, Respbid, Slo-Bid, Theobid, Theo-Dur);




  • verapamil (Calan, Covera, Isoptin, Verelan);




  • warfarin (Coumadin);




  • a heart rhythm medication such as amiodarone (Cordarone, Pacerone), bretylium (Bretylan, Tosylate), dofetilide (Tikosyn), ibutilide (Corvert), mexiletine (Mexitil), or sotalol (Betapace);




  • antidepressants such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), fluvoxamine (Luvox), imipramine (Janimine, Tofranil); or




  • medicines to treat psychiatric disorders, such as clozapine (Clozaril, Fazaclo), haloperidol (Haldol), olanzapine (Zyprexa, Zydis).



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



More Naropin resources


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


  • Naropin Prescribing Information (FDA)

  • Naropin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Naropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ropivacaine Professional Patient Advice (Wolters Kluwer)



Compare Naropin with other medications


  • Cesarean Section
  • Labor Pain
  • Local Anesthesia


Where can I get more information?


  • Your doctor or pharmacist can provide more information about ropivacaine.

See also: Naropin side effects (in more detail)


Sunday, September 30, 2012

Ankylosing Spondylitis Medications


Definition of Ankylosing Spondylitis: Spondylitis involves inflammation of one or more vertebrae. Ankylosing spondylitis is a chronic inflammatory disease that affects the joints between the vertebrae of the spine, and the joints between the spine and the pelvis. It eventually causes the affected vertebrae to fuse or grow together.

Drugs associated with Ankylosing Spondylitis

The following drugs and medications are in some way related to, or used in the treatment of Ankylosing Spondylitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Ankylosing Spondylitis





Drug List:

Nitrofurazone Soluble Dressing





Dosage Form: FOR ANIMAL USE ONLY
EQUI-PHAR NITROZONE SOLUBLE DRESSINNG

INDICATIONS:


For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers.



ADMINISTRATION:


Apply directly on the lesion with a spatula, or first place on a piece of gauze. Application of a bandage is optional.

This preparation should be in contact with the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period.



PRECAUTION:


In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use, reconsult veterinarian. Avoid exposure to alkaline material and fluorescent lighting.


KEEP AWAY FROM EXCESSIVE HEAT OR DIRECT SUNLIGHT.

CONTENTS:


0.2% Nitrofurazone in a Water-soluble base of Polyethylene Glycols.



HUMAN WARNINGS:


CARCINOGENESIS: NITROFURAZONE, THE ACTIVE INGREDIENT OF Nitrofurazone Soluble Dressing, HAS BEEN SHOWN TO PROOUCE MAMMARY TUMORS IN RATS AND OVARIAN TUMORS IN MICE.

SOME PEOPLE MAY BE HYPERSENSITIVE TO THIS PRODUCT. EITHER WEAR GLOVES WHEN APPLYING, OR WASH HANDS AFTERWARDS.



STORAGE:


Store at controlled room temperature between 15°-30°C (59°-86°F).  Keep container tightly closed when not In use.



DISPLAY PANEL


For Use In Horses Only


An Antibacterial Preparation for Topical Application


CAUTION: FEDERAL LAW PROHIBITS THE USE OF THIS PRODUCT IN FOOD-PRODUCING ANIMALS.


FOR ANIMAL USE ONLY


KEEP OUT OF REACH OF CHILDREN


Distributed By:  VEDCO, INC., St. Joseph, MO 64507


Iss. 09 - 09                             



NET CONTENTS:


1 lb (453.6 g)



IMAGE OF LABEL











NITROFURAZONE  SOLUBLE DRESSING
nitrofurazone  ointment










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)50989-165
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROFURAZONE (NITROFURAZONE)NITROFURAZONE0.2 g  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Coloryellow (YELLOW)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
150989-165-2612 JAR In 1 CASEcontains a JAR
1453.6 g In 1 JARThis package is contained within the CASE (50989-165-26)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20042509/01/2009


Labeler - VEDCO INCORPORATED (021634266)
Revised: 09/2009VEDCO INCORPORATED