Fleet Phospho Soda

Generic Name: sodium biphosphate and sodium phosphate ( SOE dee um bye FOS foe nate and SOE dee um FOS fate)

Brand Names: Fleet Enema, Fleet Enema for Children, OsmoPrep, Visicol

What is Fleet Phospho Soda (sodium biphosphate and sodium phosphate)?

Sodium biphosphate and sodium phosphate are forms of phosphorus, which is a naturally occurring substance that is important in every cell in the body.

Sodium biphosphate and sodium phosphate is used to treat constipation and to clean the bowel before surgery, x-rays, endoscopy, or other intestinal procedures. Sodium biphosphate and sodium phosphate enemas are also used for general care after surgery and to help relieve impacted bowels.

Sodium biphosphate and sodium phosphate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Fleet Phospho Soda (sodium biphosphate and sodium phosphate)?

You should not use this medication if you have used it within the past 7 days, or if you have kidney disease, dehydration, or an electrolyte imbalance (such as high or low levels of potassium, sodium, phosphorous, or magnesium in your blood).

If you have any these conditions, you could have dangerous or life-threatening side effects on your kidneys from taking sodium biphosphate and sodium phosphate.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before using sodium biphosphate and sodium phosphate, tell your doctor about all of your medical conditions, especially heart disease, liver disease, recent stomach surgery, a bowel perforation or obstruction, colitis or inflammatory bowel disease, seizures, if you are older than 56 years, if you are on a low-salt diet, or if you have recently had a heart attack or recovered from drug or alcohol addiction.

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

When using this medication in a child, use only the forms that are specially made for children.

What should I discuss with my healthcare provider before using Fleet Phospho Soda (sodium biphosphate and sodium phosphate)?

You should not use this medication if you have used it within the past 7 days, or if you have:

• kidney disease (or if you are on dialysis);


• 
  

  dehydration; or

  
  


• 
  

  an electrolyte imbalance (such as high or low levels of potassium, sodium, phosphorous, or magnesium in your blood).

  
  

If you have any these conditions, you could have dangerous or life-threatening side effects on your kidneys from taking sodium biphosphate and sodium phosphate.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

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

• 
  

  congestive heart failure;

  
  


• liver problems such as cirrhosis, or ascites (fluid around your liver);


• 
  

  unstable angina (chest pain);

  
  


• 
  

  a heart rhythm disorder (such as "Long-QT syndrome");

  
  


• 
  

  a history of recent heart attack, heart surgery, or bypass surgery;

  
  


• 
  

  a history of gastric bypass surgery or stomach stapling;

  
  


• 
  

  a bowel obstruction or severe constipation;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  a perforated bowel;

  
  


• 
  

  inflammatory bowel disease, colitis or toxic megacolon;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a recent history of drug or alcohol addiction withdrawal.

  
  


• 
  

  if you have ongoing vomiting or diarrhea, or if you are sweating more than usual;

  
  


• 
  

  if you are older than 56 years; or

  
  


• 
  

  if you are on a low-salt diet.

  
  

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using sodium biphosphate and sodium phosphate, tell your doctor if you are pregnant. It is not known whether sodium biphosphate and sodium phosphate 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.

How should I use Fleet Phospho Soda (sodium biphosphate and sodium phosphate)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Never use the medication in larger amounts, or use it for longer than recommended.

To keep from getting dehydrated, drink a full glass (8 ounces) of water or other clear liquid each time you use this medication. You may be instructed not to drink or eat anything before your medical test. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours after using this medicine.

If you take the tablet form of this medicine, you will most likely start taking it the evening before your colonoscopy, and finish taking it on the day of your colonoscopy.

For best results, take the oral liquid on an empty stomach when you first get out of bed, at least 30 minutes before eating. You may also take the medicine at bedtime. In most cases, it will work overnight.

Measure the oral liquid and mix it with one-half glass (4 oz) of cool water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

When using this medication in a child, use only the forms that are specially made for children.

• 
  

  Fleet Enema For Children can be used in children from 2 to 11 years old.

  
  


• 
  

  Never use an adult-strength sodium biphosphate and sodium phosphate enema in a child younger than 12 years old.

  
  


• 
  

  Do not use the enema to treat a child younger than 2 years of age without the advice of a doctor.

  
  


• 
  

  Fleet Phospho-Soda oral liquid can be given to children who are at least 5 years old.

  
  


• 
  

  Do not give the oral solution to a child younger than 5 years of age without the advice of a doctor.

  
  


• 
  

  Do not give the oral tablet (Visicol) to a child younger than 18 years old.

  
  

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

To use the enema, lie down on your left side with your knees bent.

Remove the cap from the applicator tip and gently insert the tip into your rectum. Slowly squeeze the bottle to empty the contents into the rectum.

For best results, stay lying down until you feel the urge to have a bowel movement. This should occur within 2 to 15 minutes in most cases.

If you do not get any results after using sodium biphosphate and sodium phosphate, call your doctor before using another dose. Using too much of this medication in 24 hours can be harmful. Do not use sodium biphosphate and sodium phosphate for longer than 1 week unless your doctor has told you to. Store sodium biphosphate and sodium phosphate at room temperature away from moisture and heat. Throw away any leftover medicine after your treatment ends.

To be sure this medication has not caused harmful effects, your doctor may want to test your blood and check your kidney function in the days after your colonoscopy. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose or do not finish all doses required before your colonoscopy.

Do not use more than the recommended dose of this medication in any 24-hour period.

What happens if I overdose?

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

Overdose may cause dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, or fainting.

What should I avoid while using Fleet Phospho Soda (sodium biphosphate and sodium phosphate)?

Do not use other laxatives while using sodium biphosphate and sodium phosphate unless your doctor has told you to.

Fleet Phospho Soda (sodium biphosphate and sodium phosphate) 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 this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  rectal bleeding;

  
  


• 
  

  no bowel movement after use;

  
  


• 
  

  sores or ulcers around your rectum;

  
  


• 
  

  seizure (black-out or convulsions);

  
  


• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting; or

  
  


• 
  

  swelling, weight gain, feeling short of breath.

  
  

Less serious side effects may include:

• 
  

  bloating, stomach pain;

  
  


• 
  

  nausea, vomiting, tightness in your throat;

  
  


• 
  

  dizziness; or

  
  


• 
  

  headache.

  
  

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 Fleet Phospho Soda (sodium biphosphate and sodium phosphate)?

Tell your doctor about all other medications you use, especially:

• 
  

  arsenic trioxide (Trisenox);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  droperidol (Inapsine);

  
  


• 
  

  narcotic medication such as fentanyl (Actiq, Duragesic, Ionsys), hydrocodone (Vicodin), hydromorphone (Dilaudid), levomethadyl (Orlaam), methadone (Dolophine, Methadose) methadone (Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Percocet), propoxyphene (Darvocet, Darvon), and others;

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

  
  


• 
  

  an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);

  
  


• 
  

  anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

  
  


• 
  

  medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);

  
  


• 
  

  migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig);

  
  


• 
  

  heart or blood pressure medication such as benazepril (Lotensin), candesartan (Atacand), captopril (Capoten), eprosartan (Teveten), fosinopril (Monopril), enalapril (Vasotec), irbesartan (Avapro, Avalide), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar); quinapril (Accupril), telmisartan (Micardis), valsartan (Diovan), and others; or

  
  


• 
  

  heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan, Pronestyl), quinidine (Cardioquin, Quinaglute), or sotalol (Betapace).

  
  

This list is not complete and there may be other drugs that can interact with sodium biphosphate and sodium phosphate. 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 Fleet Phospho Soda resources

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

• OsmoPrep Prescribing Information (FDA)


• OsmoPrep Consumer Overview


• OsmoPrep Advanced Consumer (Micromedex) - Includes Dosage Information


• OsmoPrep MedFacts Consumer Leaflet (Wolters Kluwer)


• Visicol Prescribing Information (FDA)

Compare Fleet Phospho Soda with other medications

• Bowel Preparation
• Constipation

Where can I get more information?

• Your pharmacist can provide more information about sodium biphosphate and sodium phosphate.

See also: Fleet Phospho Soda side effects (in more detail)

Notuss-NX Liquid

Pronunciation: klor-SYE-klih-zeen/KOE-deen
Generic Name: Chlorcyclizine/Codeine
Brand Name: Notuss-NX

Notuss-NX Liquid is used for:

Relieving runny nose; sneezing; itching of the nose or throat; itching, watery eyes; and cough caused by colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Notuss-NX Liquid is an antihistamine and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Notuss-NX Liquid if:

• you are allergic to any ingredient in Notuss-NX Liquid or any other codeine- or morphine-related medicine (eg, oxycodone)


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Notuss-NX Liquid:

Some medical conditions may interact with Notuss-NX Liquid. 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 heart blood vessel problems, irregular heartbeat, or any other heart problems (eg, cor pulmonale)


• if you have a history of high blood pressure, diabetes, liver or kidney problems, low blood volume, a stroke, glaucoma or increased pressure in the eye, or thyroid problems


• if you have shortness of breath; a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic obstructive pulmonary disease (COPD); or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, recent head or brain injury, brain tumor or lesions, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation, ulceration of the bowel, diarrhea caused by antibiotic use), or gallbladder problems (eg, gallstones); a blockage of your bladder, stomach, or bowel; trouble urinating; an enlarged prostate or other prostate problems; or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol abuse, drug abuse, mental or mood problems (eg, depression), or suicidal thoughts or behavior, or if you are in poor health or are very overweight


• if you are taking medicine for high blood pressure or depression

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

• Anticholinergics (eg, scopolamine) because a serious bowel problem (paralytic ileus) may occur


• Cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Notuss-NX Liquid's side effects


• Buprenorphine, naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Notuss-NX Liquid's effectiveness


• Narcotic pain medicines (eg, hydrocodone) because the risk of their side effects may be increased by Notuss-NX Liquid

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

Use Notuss-NX Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Notuss-NX Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Notuss-NX Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Notuss-NX Liquid.

Important safety information:

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


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


• Notuss-NX Liquid 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 use Notuss-NX Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Before you start any new medicine, check the label to see if it has an antihistamine or a cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


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


• If your cough or other symptoms do not get better within 1 week; if they come back; or if you also have a fever, rash, or persistent headache, check with your doctor.


• Notuss-NX Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Notuss-NX Liquid for a few days before the tests.


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


• Tell your doctor or dentist that you take Notuss-NX Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Notuss-NX Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.


• Caution is advised when using Notuss-NX Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Notuss-NX Liquid should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; 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 Notuss-NX Liquid while you are pregnant. It is not known if Notuss-NX Liquid is found in breast milk. Do not breast-feed while taking Notuss-NX Liquid.

When used for long periods of time or at high doses, Notuss-NX Liquid 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 Notuss-NX Liquid stops working as well. Do not take more than prescribed.

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

If you suddenly stop taking Notuss-NX Liquid, 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 Notuss-NX Liquid:

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; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; upset stomach; 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); blurred vision, double vision, or other vision changes; confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; loss of coordination; mood or mental changes; nervousness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual weakness or tiredness.

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: Notuss-NX 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include blurred vision; chest pain; cold or clammy skin; confusion; difficult or very slow breathing; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Notuss-NX Liquid:

Store Notuss-NX Liquid 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 Notuss-NX Liquid out of the reach of children and away from pets.

General information:

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


• Notuss-NX Liquid 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 Notuss-NX Liquid. 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 Notuss-NX resources

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

Compare Notuss-NX with other medications

• Cold Symptoms
• Hay Fever

gadofosveset Injection

gad-oh-FOS-ve-set

Injection route(Solution)

Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) in patients with impaired elimination of the drugs (ie, chronic, severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute kidney injury. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age greater than 60 years, hypertension, or diabetes), perform lab testing to estimate the GFR. For patients with the highest NSF risk, do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Commonly used brand name(s)

In the U.S.

• Ablavar

Available Dosage Forms:

• Solution

Uses For gadofosveset

Gadofosveset is a contrast agent. It is used in magnetic resonance angiography (MRA) to help create a clear picture of the blood vessels (arteries). The MRA scan is a special kind of diagnostic procedure. It uses magnets and computers to create images or “pictures” of the blood vessels in certain areas of the body. Gadofosveset is a gadolinium-based contrast agent (GBCA).

Gadofosveset is given by injection before MRA to help diagnose problems in the blood vessels (e.g., blockage of the arteries).

gadofosveset is to be used only by or under the direct supervision of a doctor.

Before Using gadofosveset

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of gadofosveset in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Asthma or allergies, history of or


• Heart disease, history of or


• Heart rhythm problems (e.g., QT prolongation) or


• Kidney problems, severe (recent or long-term)—Use with caution. May cause side effects to become worse.

• Diabetes or


• Hypertension (high blood pressure)—Use with caution. May increase risk for kidney problems.

Proper Use of gadofosveset

A doctor or other trained health professional will give you gadofosveset. gadofosveset is given through a needle placed in one of your veins just before you have an MRA scan.

Precautions While Using gadofosveset

Check with your doctor right away if you have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

gadofosveset may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have cold, clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.

gadofosveset can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Tell your doctor right away if you have mild, burning pain; feeling of warmth or coldness; or redness at the injection site.

gadofosveset Side Effects

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

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

More common

• Cough


• difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Less common

• Blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• headache


• nervousness


• pounding in the ears


• slow or fast heartbeat


• sweating

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

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• change in taste


• feeling cold


• loss of taste


• nausea

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

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

See also: gadofosveset Injection side effects (in more detail)

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

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

More gadofosveset Injection resources

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

Compare gadofosveset Injection with other medications

• Magnetic Resonance Angiography

Se-Natal 19

Dosage Form: tablet
Se-Natal 19 Tablets

Vitamins & Minerals with Folic Acid

Rx Only

Se-Natal 19 Description

Se-Natal 19 provides oil soluble vitamins, water-soluble vitamins and minerals.

Each tablet contains:
Vitamin A (as beta carotene)	1000 IU
Vitamin C (ascorbic acid)	100 mg
Vitamin D (as cholecalciferol)	400 IU
Vitamin E (as dl-alpha tocopheryl acetate)	30 IU
Thiamine Mononitrate (Vitamin B1)	3mg
Riboflavin (Vitamin B2)	3 mg
Niacin (as niacinamide)	15 mg
Vitamin B6 (as pyridoxine HCI)	20 mg
Folate (folic acid)	1 mg
Vitamin B12 (as cyanocobalamin)	12 mcg
Pantothenic Acid (as calcium pantothenate)	7 mg
Calcium (as calcium carbonate)	200 mg
Iron (as ferrous fumarate)	29 mg
Zinc (as zinc oxide)	20 mg
Docusate Sodium	25 mg

OTHER INGREDIENTS

Carnauba Wax, Corn Starch, Dicalcium Phosphate, Fumed Silica, Gum Arabic, Hydroxy Propyl Methyl Cellulose, Maltodextrin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Sodium Benzoate, Stearic Acid, Talc, and Titanium Dioxide.

INDICATIONS

Se-Natal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 tablets are also useful in improving the nutritional status of women prior to conception.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestation remain progressive.

Se-Natal 19 Dosage and Administration

One tablet daily, or as directed by a physician.

How is Se-Natal 19 Supplied

Se-Natal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019," packaged in bottles of 100 tablets.

NDC 13925-116-01.

STORAGE

Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.

PHARMACIST

Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.

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

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.

Reserved for Professional Recommendation.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Manufactured For:

Seton Pharmaceuticals

Manasquan, NJ 08736

1-800-510-3401

Rev.11.07.2011

SETON PHARMACEUTICALS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13925-116-01

Se-Natal 19

Tablets

Vitamins and Minerals with Folic Acid

100 Tablets

Rx Only

SETON

PHARMACEUTICALS

Se-Natal 19  vitamins,minerals and folic acid  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13925-116 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 1000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE 3 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg CALCIUM CARBONATE (CALCIUM) CALCIUM 200 mg FERROUS FUMARATE (IRON) IRON 29 mg ZINC OXIDE (ZINC) ZINC 20 mg DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 mg

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX   STARCH, CORN   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   SILICON DIOXIDE   ACACIA   HYPROMELLOSES   MALTODEXTRIN   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   PROPYLENE GLYCOL   SODIUM BENZOATE   STEARIC ACID   TALC   TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code TL019 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13925-116-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2009

Labeler - Seton Pharmaceuticals (828898002)

Establishment
Name	Address	ID/FEI	Operations
Cispharma, Inc.		833171445	MANUFACTURE

Revised: 07/2011Seton Pharmaceuticals

Remegel Summer Fruit

1. Name Of The Medicinal Product

Remegel Summer Fruit.

2. Qualitative And Quantitative Composition

Each tablet contains 800mg Calcium Carbonate USP.

3. Pharmaceutical Form

Soft, pink, raspberry-flavoured, chewable square tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Remegel Summer Fruit are indicated for the relief of acid indigestion, heartburn and associated stomach upsets (dyspepsia).

4.2 Posology And Method Of Administration

Route of administration: oral

Adults and children 12 years and over: One or two tablets of Remegel Summer Fruit to be chewed as symptoms occur. Repeat hourly as necessary. Maximum dose: 12 tablets in 24 hours.

Children under 12 years of age: Not recommended

The elderly: As for adults, see above

Hepatic Dysfunction: There is no specific information relating to the use of Remegel Summer Fruit in hepatic impairment. Normal adult dosage is appropriate.

Renal Dysfunction: Remegel Summer Fruit should be used with caution in subjects with moderate to severe renal impairment. Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia.

4.3 Contraindications

Hypersensitivity to any of the components. Hypercalcaemia.

4.4 Special Warnings And Precautions For Use

This product should be taken with care by subjects on a low phosphate diet (e.g. the malnourished), as it may lead to a phosphate depletion syndrome, (see Undesirable Effects).

This product should be used with caution in renal dysfunction, (see Posology and Method of Administration).

This product contains sucrose and glucose syrup and as such, care is required in patients with diabetes mellitus.

If symptoms persist, a pharmacist or doctor should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other antacids, calcium carbonate may form complexes with certain drugs such as tetracyclines and digoxin, leading to their reduced absorption. This should be taken into account when concomitant administration is considered.

4.6 Pregnancy And Lactation

There is no information relating to the use of Remegel Summer Fruit in pregnancy.

Calcium carbonate antacids have been used during pregnancy for many years without apparent ill consequence, although as with other antacids, this product should be administered with care in the first trimester.

There is no information relating to the excretion of Remegel Summer Fruit in breast milk. However, no problems would be anticipated from the use of this product during lactation.

4.7 Effects On Ability To Drive And Use Machines

No special comment – unlikely to produce an effect.

4.8 Undesirable Effects

Calcium carbonate may cause constipation. Eructation (due to carbon dioxide production in the stomach) may occur in come patients.

4.9 Overdose

Excessive ingestion of calcium carbonate can lead to hypercalcaemia (characterised by gastro-intestinal pain, nausea and vomiting), metabolic alkalosis and reversible renal failure, sometimes presenting as the milk-alkali syndrome. Treatment should be symptomatic and supportive. Haemodialysis and other therapeutic measures, such as saline diuresis, have been used to successfully treat excessive ingestion of calcium carbonate antacid.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Calcium carbonate is a potent antacid, neutralising gastric acid when taken orally.

Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn.

5.2 Pharmacokinetic Properties

Absorption: Calcium carbonate is converted to calcium chloride by gastric acid (hydrochloric acid) in the stomach, with the resulting formation of carbon dioxide and water. Some of the calcium is absorbed from the intestines but the majority is reconverted into insoluble calcium salts such as carbonate and stearate, which is excreted in the faeces.

Distribution, Metabolism and Elimination: Once absorbed from the stomach, physiological concentrations of calcium are tightly controlled, principally through the effects of parathyroid hormone, vitamin D and its metabolites, and calcitonin. These control mechanisms are well documented in standard texts.

5.3 Preclinical Safety Data

Pre-clinical safety data does not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sugar solution; Glucose syrup (41^o baume); Purified water; Hyfoama DS (hydrolysed milk protein); Gelatin 200 Bloom; Cornflour Starch; Sorbitol (crystalline); Glycerol; Titanium dioxide (E171); Allure Red (E129); Paramount C (hydrogenated vegetable fat); Amerfond Fondant Sugar; Raspberry flavour; Butylated hydroxyanisole; Talc

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Each tablet in stickpacks is wrapped in printed silicone paper and overwrapped in hermetically sealed aluminium foil stickpack. 8 piece stickpack

6.6 Special Precautions For Disposal And Other Handling

None applicable.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0131.

9. Date Of First Authorisation/Renewal Of The Authorisation

03/01/2006

10. Date Of Revision Of The Text

03/01/2006

Erythromycin

Pronunciation: e-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: PCE

Erythromycin is used for:

Treating infections caused by certain bacteria. It is also used to prevent attacks of rheumatic fever in certain patients. It may also be used for other conditions as determined by your doctor.

Erythromycin is a macrolide antibiotic. It works by killing or slowing the growth of sensitive bacteria.

Do NOT use Erythromycin if:

• you are allergic to any ingredient in Erythromycin


• you are taking astemizole, cisapride, diltiazem, dofetilide, dronedarone, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, tolvaptan, toremifene, vandetanib, or verapamil

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

Before using Erythromycin:

Some medical conditions may interact with Erythromycin. 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 diarrhea


• if you have a history of kidney or liver disease, heart problems, a fast or irregular heartbeat, myasthenia gravis, or the blood disease porphyria


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

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

• Astemizole, cisapride, diltiazem, dofetilide, dronedarone, halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, toremifene, vandetanib, or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur. Check with your doctor if you have questions about which medicines may affect your heartbeat


• Eletriptan, ergot alkaloids (eg, dihydroergotamine, ergotamine), or tolvaptan because the risk of their side effects may be increased by Erythromycin


• Many prescription and nonprescription medicines (eg, used for aches and pains, allergies, blood thinning, breathing problems, cancer, diabetes, erection problems, gout, irregular heartbeat or other heart problems, high blood calcium levels, high blood pressure, high cholesterol, HIV infection, inflammation, infections, low blood sodium levels, migraine, mood or mental problems, nausea and vomiting, overactive bladder, Parkinson disease, prevention of organ transplant rejection, seizures, stomach problems, trouble sleeping), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with Erythromycin. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Erythromycin

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

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

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


• Swallow Erythromycin whole. Do not break, crush, or chew before swallowing.


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


• Erythromycin works best if taken at the same times each day.


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


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

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

Important safety information:

• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


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


• Be sure to use Erythromycin 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 Erythromycin 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.


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


• Rarely, patients taking Erythromycin have developed reversible hearing loss. The risk is greater if you have kidney problems or you take high doses of Erythromycin. Contact your doctor if you develop decreased hearing or hearing loss.


• Erythromycin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Erythromycin.


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


• Use Erythromycin with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval).


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

Possible side effects of Erythromycin:

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:

Loss of appetite; mild diarrhea; nausea; stomach pain; 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); bloody stools; changes in the amount of urine produced; decreased hearing or hearing loss; irregular heartbeat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain; stomach cramps; symptoms of liver problems (eg, yellowing of the skin or eyes; pale stools; severe or persistent nausea, vomiting, or loss of appetite; dark urine).

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 ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Erythromycin:

Store Erythromycin at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Erythromycin out of the reach of children and away from pets.

General information:

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


• Erythromycin 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 Erythromycin. 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 Erythromycin resources

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

• Erythromycin Professional Patient Advice (Wolters Kluwer)


• Erythromycin Monograph (AHFS DI)


• erythromycin Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information


• E.E.S. Granules Advanced Consumer (Micromedex) - Includes Dosage Information


• E.E.S. granules


• Ery-Tab Consumer Overview


• Ery-Tab Prescribing Information (FDA)


• EryPed Prescribing Information (FDA)


• Eryc Prescribing Information (FDA)

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• Bartonellosis
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• Campylobacter Gastroenteritis
• Chancroid
• Chlamydia Infection
• Dental Abscess
• Legionella Pneumonia
• Lyme Disease
• Lymphogranuloma Venereum
• Mycoplasma Pneumonia
• Nongonococcal Urethritis
• Ocular Rosacea
• Otitis Media
• Pemphigoid
• Pertussis
• Pharyngitis
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• Rheumatic Fever Prophylaxis
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• Upper Respiratory Tract Infection

Sytron

1. Name Of The Medicinal Product

Sytron

2. Qualitative And Quantitative Composition

Sodium feredetate 190mg (equivalent to 27.5mg of iron/5ml)

3. Pharmaceutical Form

Oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

Iron deficiency anaemia, notably in paediatrics.

In pregnancy when other forms of oral iron may not be well tolerated.

Anaemias secondary to rheumatoid arthritis.

4.2 Posology And Method Of Administration

For oral administration:

Adults: 5ml increasing gradually to 10ml three times daily.

Elderly (over 65 years): As for adults.

Infants (including premature infants) up to 1 year: 2.5ml twice daily; somewhat smaller doses should be used initially.

1 to 5 years: 2.5ml three times daily.

6 to 12 years: 5ml three times daily.

4.3 Contraindications

None known

4.4 Special Warnings And Precautions For Use

None known

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No adverse effects have been reported.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Patients have occasionally complained of nausea or mild diarrhoea in the early stages of treatment. In such cases it has been found that if treatment is withdrawn for a short time, these symptoms quickly disappear and subsequently the patient will tolerate further doses, which should be on a somewhat reduced scale. Normal individuals have taken Sytron at twice the recommended dosage and some of these have experienced mild diarrhoea. This should be taken into account if dosage is increased much higher than the recommended scale.

4.9 Overdose

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur.

Treatment of overdosage

1. Administer an emetic.

2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). Desferrioxamine 5g in 50ml to 100ml water should be introduced into the stomach following gastric emptying.

3. Keep the patient under constant surveillance to detect possible aspiration of vomitus. Maintain suction apparatus and standby emergency oxygen in case of need.

4. In adults, a drink of mannitol or sorbitol should be given to induce small bowel emptying. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children.

5. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (adults >142µmol/l, children >90µmol/l), immediate supportive measures should be introduced. Desferrioxamine should be given by slow iv infusion (adults 5mg/kg/h, children 15mg/kg/h). The maximum dose is 80mg/kg/24h. Warning: hypotension may occur if the infusion rate is too rapid.

6. Less severe poisoning: im desferrioxamine should be administered (adults 50mg/kg to a maximum of 4g, children 1g 4 to 6 hourly).

7. Serum iron levels should be monitored throughout.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Iron preparations

ATC classification: B03A

After absorption, elemental iron is available for haemoglobin regeneration and reversal of anaemia associated with iron-deficient states.

5.2 Pharmacokinetic Properties

Sodium feredetate is not an iron salt as it contains iron in an un-ionised form. In this compound the iron is “insulated” or “sequestered” with the sodium salt of ethylenediamine tetra-acetic acid (EDTA) to form a chelate. This accounts for the fact that Sytron is not astringent and does not discolour teeth. Studies using radioactive tracers have shown that the iron chelate is split within the gastro-intestinal tract, releasing elemental iron which is absorbed and rendered available for haemoglobin regeneration.

Iron absorption is enhanced in iron-deficiency states. Post-absorption distribution of elemental iron is as follows: 60% to 70% is incorporated into haemoglobin and most of the remainder is present in storage forms, either as ferritin or haemosiderin, in the reticulo-endothelial system and to a lesser extent, hepatocytes. A further 4% is present in myoglobin and haeme-containing enzymes, or bound to transferrin in plasma. Excretion is mainly in the faeces.

EDTA passes through the body unchanged. The compound is poorly absorbed, and that which reaches the bloodstream is eliminated by both glomerular filtration and tubular excretion.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Citric acid monohydrate

Saccharin sodium

Glycerol

Sorbitol solution

Ethanol 96%

Black cherry flavour 51-779A

Ponceau 4R (E124)

Potable water

6.2 Incompatibilities

None known

6.3 Shelf Life

Unopened: 60 months

Opened: 3 months from date of opening

If this product has been diluted with water use within 14 days of preparation.

6.4 Special Precautions For Storage

Store below 30°C

6.5 Nature And Contents Of Container

Sytron is supplied in round amber glass bottles with a CRC cap. Each bottle contains either 125ml or 500ml or 2250ml of Sytron.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Water is the recommended diluent for this product.

7. Marketing Authorisation Holder

Archimedes Pharma Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

PL 12406/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

13 October 1993/11 November 1998

10. Date Of Revision Of The Text

November 2007

® Sytron is a registered trade mark

SYTL500-SPC06

Systemic Mastocytosis Medications

Definition of Systemic Mastocytosis: A disease that produces skin lesions, intense itching, and hive formation at the site of the lesion upon rubbing.

Drugs associated with Systemic Mastocytosis

The following drugs and medications are in some way related to, or used in the treatment of Systemic Mastocytosis. 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:

Gastrocrom-Concentrate

Gleevec

Prevacid

Prevacid-I-V

Prevacid-Otc

Prevacid-Solutab-Orally-Disintegrating-Tablets

Prilosec