Furocot

Generic Name: furosemide (Oral route)

fure-OH-se-mide

Oral route(Tablet)

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs .

Commonly used brand name(s)

In the U.S.

• Furocot


• Lasix

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic, Loop

Uses For Furocot

Furosemide belongs to a group of medicines called loop diuretics (also known as water pills). Furosemide is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine.

Furosemide is also used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

This medicine is available only with your doctor's prescription.

Before Using Furocot

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of furosemide in children. However, premature babies are more likely to have unwanted effects on the kidney, which may require caution in patients receiving furosemide.

Geriatric

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

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amikacin


• Arsenic Trioxide


• Bepridil


• Chloral Hydrate


• Cisplatin


• Digitoxin


• Dofetilide


• Droperidol


• Ethacrynic Acid


• Gentamicin


• Kanamycin


• Ketanserin


• Levomethadyl


• Lithium


• Metolazone


• Neomycin


• Netilmicin


• Sotalol


• Streptomycin


• Tobramycin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bromfenac


• Captopril


• Celecoxib


• Cephaloridine


• Cholestyramine


• Cilazapril


• Clofibrate


• Colestipol


• Cyclosporine


• Delapril


• Dibekacin


• Diclofenac


• Diflunisal


• Digoxin


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Fludrocortisone


• Flurbiprofen


• Fosinopril


• Germanium


• Ginseng


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pancuronium


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Trandolapril


• Tubocurarine


• Vecuronium


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Anuria (not able to pass urine)—Should not be used in patients with this condition. .

• Anemia or


• Bladder problem with urinating or


• Dehydration or


• Diabetes mellitus or


• Gout or


• Hearing problems or


• Hyperuricemia (high uric acid in the blood) or


• Hypocalcemia (low calcium in the blood) or


• Hypochloremic alkalosis (low chlorine in the blood) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Hyponatremia (low sodium in the blood) or


• Hypotension (low blood pressure) or


• Hypovolemia (low blood volume) or


• Liver disease, severe (e.g., cirrhosis) or


• Systemic lupus erythematosus (SLE) or


• Tinnitus (ringing in the ears) or


• Trouble urinating—Use with caution. May make these conditions worse.

• Hypoproteinemia (low protein in the blood) from a kidney problem or


• Radiocontrast nephropathy (kidney problem), history of—May cause side effects to become worse.

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

Proper Use of furosemide

This section provides information on the proper use of a number of products that contain furosemide. It may not be specific to Furocot. Please read with care.

Take this medicine exactly as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Many patients who have high blood pressure will not notice any symptoms of the condition. In fact, most patients feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

In addition to using this medicine, treatment of your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt) or potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

This medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

If you are taking sucralfate (Carafate®), take this medicine 2 hours before or 2 hours after taking furosemide. It may keep furosemide from working properly.

Dosing

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

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

• For oral dosage forms (oral solution or tablets):
  
  • For edema:
    
    • Adults—At first, 20 to 80 milligrams (mg) once a day as a single dose or divided and given twice per day. Your doctor may adjust your dose as needed.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 2 milligrams (mg) per kilogram (kg) of body weight per day as a single dose. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per kg of body weight per day.
    
    
  
  
  • For high blood pressure:
    
    • Adults—At first, 40 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Furocot

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood or urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant may cause your unborn baby to be bigger than normal. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause you or your child to lose more potassium from your body than normal (hypokalemia). This is more likely to occur if you have liver disease (e.g., cirrhosis), or if you are using this medicine together with steroids (cortisone-like medicines), adrenocorticotropic hormone (ACTH), large amounts of licorice, or laxatives for a long time. Tell your doctor if you become sick with severe or continuing nausea, vomiting, or diarrhea, and drink fluids to prevent getting dehydrated. Check with your doctor right away if you have one or more of these symptoms: dry mouth; increased thirst; muscle cramps; or nausea or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Stop using this medicine and check with your doctor right away if you or your child have a sudden decrease in hearing or loss of hearing. You may also have dizziness or ringing in the ears with the hearing problem. Tell your doctor if you have dizziness or lightheadedness; a feeling of constant movement of self or surroundings; or a sensation of spinning.

This medicine may cause an increase in blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen, hat, and protective clothing when you are outdoors. Avoid sunlamps and tanning beds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Furocot Side Effects

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

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

Rare

• Chest pain


• chills


• cough or hoarseness


• fever


• general feeling of tiredness or weakness


• headache


• lower back or side pain


• painful or difficult urination


• shortness of breath


• sore throat


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


• swollen or painful glands


• tightness in the chest


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Incidence not known

• Back or leg pains


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine or stools


• blurred vision


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


• changes in skin color, pain, tenderness, or swelling of the foot or leg


• clay-colored stools


• cloudy urine


• cold sweats


• confusion


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• coughing up blood


• cracks in the skin


• darkened urine


• diarrhea


• difficulty breathing


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


• dry mouth


• fast heartbeat


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• greatly decreased frequency of urination or amount of urine


• hearing loss


• increased hunger


• increased thirst


• increased urination


• indigestion


• itching


• joint stiffness or swelling


• loss of appetite


• loss of heat from the body


• nausea or vomiting


• nosebleeds


• pain in the joints or muscles


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


• red, irritated eyes


• red, swollen skin


• scaly skin


• severe abdominal or stomach pain


• skin rash


• stomach cramps


• sugar in the urine


• sweating


• swelling of the feet or lower legs


• troubled breathing with exertion


• unpleasant breath odor


• unusual weight loss


• vomiting of blood


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Decreased urination


• drowsiness


• increase in heart rate


• irregular heartbeat


• irritability


• mood changes


• muscle cramps


• numbness, tingling, pain, or weakness in the hands, feet, or lips


• rapid breathing


• seizures


• sunken eyes


• thirst


• trembling


• weak pulse


• weakness and heaviness of the legs


• wrinkled skin

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:

Incidence not known

• Feeling of constant movement of self or surroundings


• hives or welts


• increased sensitivity of the skin to sunlight


• muscle spasm


• redness or other discoloration of the skin


• restlessness


• sensation of spinning


• severe sunburn


• weakness

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: Furocot 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.

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More Furocot resources

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

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Niacor

Pronunciation: NYE-a-sin
Generic Name: Niacin
Brand Name: Niacor

Niacor is used for:

Improving cholesterol levels, reducing the risk for a second heart attack, slowing or treating hardening of the arteries, and lowering very high serum triglyceride levels. It is used in combination with diet. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Niacor is an antihyperlipidemic. It works by reducing low-density lipoprotein ("bad") cholesterol and triglycerides and increasing high-density lipoprotein ("good") cholesterol.

Do NOT use Niacor if:

• you are allergic to any ingredient in Niacor


• you have severe or unexplained liver problems, an active peptic ulcer, or a history of arterial bleeding

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

Before using Niacor:

Some medical conditions may interact with Niacor. 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 chest pain, diabetes, gallbladder problems, glaucoma, gout, heart problems or a recent heart attack, kidney or liver problems, low blood pressure, low phosphate levels, muscle problems (eg, rhabdomyolysis), stomach problems (eg, peptic ulcers), or thyroid problems


• if you have a history of bleeding problems or are taking anticoagulants (eg, warfarin)


• if you consume large amounts of alcohol

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

• Anticoagulants (eg, warfarin) because side effects such as bleeding may occur


• Fibrates (eg, gemfibrozil, fenofibrate) or HMG-CoA reductase inhibitors ("statins") (eg, simvastatin) because side effects, such as serious muscle aches and weakness that may be a symptom of a serious medical condition called rhabdomyolysis, may occur


• Medicine for high blood pressure (eg, diltiazem) or angina (eg, nitroglycerin) because side effects, such as dizziness upon standing and very low blood pressure, may be increased by Niacor


• Alcohol because toxic effects, such as delirium or lactic acidosis, may occur

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

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

• To minimize flushing and upset stomach, take Niacor at bedtime after a low-fat snack (eg, low-fat yogurt, banana, crackers with a glass of milk) unless your doctor directs otherwise. Do not take Niacor with alcohol, a hot drink, or spicy foods.


• Do not take bile acid sequestrants (eg, colestipol, cholestyramine) within 4 to 6 hours of taking Niacor.


• If you miss a dose of Niacor, 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 Niacor.

Important safety information:

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


• Niacor may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.


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


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


• Do not substitute Niacor for any other type of niacin without talking with your doctor. Severe liver damage can occur.


• If you stop taking Niacor for an extended period, contact your doctor before you start taking it again. Your dose may need to be adjusted.


• Flushing occurs with Niacor and may last for several hours. Talk with your doctor if flushing becomes bothersome.


• Take Niacor at bedtime so that flushing will occur during sleep. If you are awakened by flushing at night, get up slowly, especially if you feel dizzy or faint or if you are taking blood thinners. Take aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen) 30 minutes before taking Niacor to lessen flushing.


• Diabetes patients - Niacor may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Do not take large doses of vitamins while you use Niacor unless your doctor tells you to.


• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.


• Niacor may interfere with certain lab tests, including plasma or urinary catecholamine tests or urine glucose tests. Be sure your doctor and lab personnel know you are taking Niacor.


• Lab tests, including liver function tests, blood glucose, and serum creatine kinase tests, may be performed while you use Niacor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Niacor 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 Niacor while you are pregnant. It is not known if Niacor is found in breast milk. Do not breast-feed while taking Niacor.

Possible side effects of Niacor:

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:

Diarrhea; dizziness; headache; heartburn; increased cough, indigestion, or upset stomach; nausea; temporary skin redness, itching, tingling, or feelings of warmth (flushing); 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; unusual hoarseness); black, tarry, or bloody stools; changes in vision (eg, cloudy or blurred vision); decrease in urine or dark-colored urine; fainting; fast or irregular heartbeat; flu-like symptoms (eg, chills, fever, persistent sore throat); increased sweating; loss of appetite; muscle pain, tenderness, swelling, or weakness (with or without fever and fatigue); numbness or persistent tingling of the skin; severe dizziness or headache; severe or persistent diarrhea, nausea, or vomiting; shortness of breath; stomach pain; swelling of the hands, legs, or feet; unusual bruising or bleeding; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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

See also: Niacor 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 flushing.

Proper storage of Niacor:

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

General information:

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


• Niacor 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 Niacor. 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 Niacor resources

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

• Niacor nicotinic acid Concise Consumer Information (Cerner Multum)


• Niacor Advanced Consumer (Micromedex) - Includes Dosage Information


• Niacor Prescribing Information (FDA)


• Niacin Monograph (AHFS DI)

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Magnesium Sulfate

Dosage Form: injection
Magnesium Sulfate INJECTION, USP 50%

Rx Only

2.03 mM/mL of Magnesium Sulfate Heptahydrate

Osmolarity 4.06 mOsmol/mL

MUST BE DILUTED PRIOR TO IV ADMINISTRATION

DESCRIPTION

Magnesium Sulfate Injection, USP (50%) for IV and IM use is a sterile concentrated solution of Magnesium Sulfate USP. Each mL contains: Magnesium Sulfate (Heptahydrate) 500 mg, which provides 4.06 mEq each of Magnesium (Mg++) and Sulfate (SO4=), Water for Injection q.s.  The pH (5.5 - 7.0) is adjusted with Sulfuric Acid and/or Sodium Hydroxide. The solution contains no bacteriostatic agent or other preservatives. The molecular formula is MgSO4 • 7H2O and the molecular weight is 246.47.

CLINICAL PHARMACOLOGY

Magnesium is the second most plentiful cation of the intracellular fluids. It is essential for the activity of many enzyme systems and plays an important role with regard to neurochemical transmission and muscular excitability. Deficits are accompanied by a variety of structural and functional disturbances.

INDICATIONS AND USAGE

Magnesium Sulfate is indicated in the following conditions:

Convulsions (treatment) - Intravenous Magnesium Sulfate is indicated for immediate control of life-threatening convulsions in the treatment of severe toxemias (pre-eclampsia and eclampsia) of pregnancy and in the treatment of acute nephritis in children.

Hypomagnesemia (prophylaxis and treatment) - Magnesium Sulfate is indicated for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those of hypocalcemia.

Magnesium Sulfate is also used to prevent or treat magnesium deficiency in patients receiving total parenteral nutrition.

Tetany, uterine (treatment) - Magnesium Sulfate is indicated in uterine tetany as a myometrial relaxant.

CONTRAINDICATIONS

Magnesium Sulfate should not be administered parenterally in patients with heart block or myocardial damage.

WARNINGS

Magnesium Sulfate should be given very cautiously in the presence of serious impairment of renal function since it is excreted almost entirely by the kidneys.

The principle hazard in parenteral magnesium therapy is the production of abnormally high levels of magnesium in the plasma. Such high levels may cause flushing, sweating, hypotension, circulatory collapse and depression of cardiac and central nervous system function. The most immediate danger to life is respiratory depression.

During the period of parenteral therapy with magnesium salts, the patient should be watched carefully. A preparation of calcium, such as the gluconate or gluceptate should be at hand for intravenous administration as an antidote.

In the presence of severe renal insufficiency, no more than 20 grams of magnesium should be given within a forty-eight hour period. In eclampsia, however, renal function is not seriously impaired and magnesium may be more rapidly excreted.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

When barbiturates, narcotics, or other hypnotics (or systemic anesthetics) are to be given in conjunction with magnesium, their dosage should be adjusted with caution because of the additive central depressive effects of magnesium.

Pregnancy

Teratogenic Effects

Pregnancy category C. Animal reproduction studies have not been conducted with Magnesium Sulfate Injection, USP 50%. It is also not known whether Magnesium Sulfate Injection, USP 50% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Magnesium Sulfate Injection, USP 50% should be given to a pregnant woman only if clearly needed.

ADVERSE REACTIONS

Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately, respiratory depression. Hypocalcemia with signs of tetany secondary to Magnesium Sulfate therapy for eclampsia has been reported.

DOSAGE AND ADMINISTRATION

Intramuscular: Adults and older children: For severe hypomagnesemia, 1 to 5 g (2 to 10 mL of 50% solution) daily in divided doses; administration is repeated daily until serum levels have returned to normal. If deficiency is not severe, 1 g (2 mL of 50% solution) can be given once or twice daily.Serum magnesium levels should serve as a guide to continued dosage.

Intravenous: 1 to 4 g Magnesium Sulfate may be given intravenously in 10% to 20% solution, but only with great caution; the rate should not exceed 1.5 mL of 10% solution or equivalent per minute until relaxation is obtained.

Intravenous Infusion: 4 g in 250 mL of 5% Dextrose Injection at a rate not exceeding 3 mL per minute.

Usual Dose Range: 1 to 40 g daily.

Electrolyte Replenisher: Intramuscular 1 to 2 g in 50% solution four times a day until serum magnesium is within normal limits.

Usual Pediatric Dose: Intramuscular 20 to 40 mg per kg of body weight in a 20% solution repeated as necessary.

For Eclampsia: Initially 1 to 2 g in 25% or 50% solution is given intramuscularly. Subsequently, 1 g is given every 30 minutes until relief is obtained. The blood pressure should be monitored after each injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Product No.	Vial Sizes
NDC 0517-2602-25	2 mL Single Dose Vial	Boxes of 25
NDC 0517-2610-25	10 mL Single Dose Vial	Boxes of 25
NDC 0517-2650-25	50 mL Single Dose Vial	Boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Discard unused portion.

IN0291

Rev. 7/11

MG #7879

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 2 mL Container

NDC 0517-2602-25

Magnesium Sulfate INJECTION, USP

50% (0.5 g/mL)

1 gram/2 mL

(4.06 mEq/mL Magnesium)

2 mL SINGLE DOSE VIAL

FOR IM USE.

FOR IV USE AFTER DILUTION.

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL – 10 mL Container

NDC 0517-2610-25

Magnesium Sulfate INJECTION, USP

50% (0.5 g/mL)

5 grams/10 mL

(4.06 mEq/mL Magnesium)

10 mL SINGLE DOSE VIAL

FOR IM USE

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL – 50 mL Container

NDC 0517-2650-25

Magnesium Sulfate INJECTION, USP

50% (0.5 g/mL)

25 grams/50 mL

(4.06 mEq/mL Magnesium)

50 mL SINGLE DOSE VIAL

FOR IM USE

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 2/08

Magnesium Sulfate  Magnesium Sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-2602 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Magnesium Sulfate HEPTAHYDRATE (MAGNESIUM CATION) Magnesium Sulfate HEPTAHYDRATE 500 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SULFURIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-2602-25 25 VIAL In 1 TRAY contains a VIAL, SINGLE-DOSE 1 2 mL In 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-2602-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/30/1990

Magnesium Sulfate  Magnesium Sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-2610 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Magnesium Sulfate HEPTAHYDRATE (MAGNESIUM CATION) Magnesium Sulfate HEPTAHYDRATE 500 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SULFURIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-2610-25 25 VIAL In 1 TRAY contains a VIAL, SINGLE-DOSE 1 10 mL In 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-2610-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/30/1990

Magnesium Sulfate  Magnesium Sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-2650 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Magnesium Sulfate HEPTAHYDRATE (MAGNESIUM CATION) Magnesium Sulfate HEPTAHYDRATE 500 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SULFURIC ACID   SODIUM HYDROXIDE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-2650-25 25 VIAL In 1 TRAY contains a VIAL, SINGLE-DOSE 1 50 mL In 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-2650-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/30/1990

Labeler - American Regent, Inc. (622781813)

Revised: 12/2011American Regent, Inc.