ibuprofen lysine Intravenous

eye-bue-PROE-fen LYE-seen

Commonly used brand name(s)

In the U.S.

• Neoprofen

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Ibuprofen

Chemical Class: Ibuprofen

Uses For ibuprofen lysine

Ibuprofen lysine is used to treat patent ductus arteriosus (PDA) in premature infants (babies born too early) who weigh between 1.1 and 3.3 pounds. PDA is a heart problem where a blood vessel, the ductus arteriosus, fails to close normally after birth. This blood vessel is only used before birth, and is no longer needed after the baby is born. Ibuprofen lysine works by causing the PDA to constrict, and this closes the blood vessel .

ibuprofen lysine is available only with your doctor's prescription .

Before Using ibuprofen lysine

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 ibuprofen lysine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ibuprofen lysine 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 pediatrics-specific problems that would limit the usefulness of ibuprofen lysine in premature babies .

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	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.
2nd Trimester	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.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 receiving ibuprofen lysine, 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 ibuprofen lysine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using ibuprofen lysine 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.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using ibuprofen lysine 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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amikacin


• Amiloride


• Arotinolol


• Aspirin


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desipramine


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenytoin


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Tacrine


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Voriconazole


• Xipamide


• 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. 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 ibuprofen lysine. Make sure you tell your doctor if you have any other medical problems, especially:

• Active bleeding (brain or intestine) or


• Blood clotting problem (thrombocytopenia) or


• Congenital heart disease or


• Infection, untreated or


• Kidney problem or


• Necrotizing enterocolitis, known or suspected (an inflamed intestine)—ibuprofen lysine should not be used in babies with these conditions .

• Hyperbilirubinemia (high bilirubin in the blood)—May cause this condition to get worse .

Precautions While Using ibuprofen lysine

Ibuprofen lysine may change how the body reacts during an infection. Tell your baby's doctor if you notice any fever, chills, or other unusual behavior in your baby while ibuprofen lysine is being used .

ibuprofen lysine may affect the action of platelets, which are necessary for clotting the blood. This may increase the chance of bleeding for your baby. Call your baby's doctor right away if you notice any unusual bleeding or bruising, any dark-colored urine or stools, or other signs of bleeding in your baby .

ibuprofen lysine 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:

More common

• Abdominal cramps


• abdominal pain or swelling


• anxiety


• black, tarry stools


• bladder pain


• blood in eyes


• bloody or cloudy urine


• blue lips, fingernails, or skin


• bruising or purple areas on skin


• bumps on skin


• burning, itching, redness, or stinging of skin


• chills


• cold sweats


• coma


• cool, pale skin


• cough


• coughing up blood


• darkening of skin


• decreased alertness


• decreased frequency or amount of urine


• diarrhea


• difficulty in breathing


• fast heartbeat


• fever


• high blood pressure


• increased blood pressure


• increased hunger


• increased thirst


• indigestion


• irregular, fast or slow, or shallow breathing


• irregular heartbeats


• irritability


• joint pain or swelling


• loss of appetite


• muscle cramps in hands, arms, feet, legs, or face


• muscle twitching


• nausea or vomiting


• nervousness


• nosebleeds


• passing of gas


• rapid, shallow breathing


• rash on skin


• restlessness


• seizures


• shakiness


• shortness of breath


• sneezing


• stomach pain, fullness, or discomfort


• swelling of face, fingers, feet or lower legs


• tremor


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Bleeding, blistering, coldness, discoloration of skin, hives, infection, inflammation, itching, lumps, pain, rash, redness, scarring, soreness, swelling, tenderness, ulceration, or warmth at injection site


• bleeding gums


• blood in stools


• chest pain or discomfort


• clay-colored stools


• dark urine


• dilated neck veins


• dry mouth


• extreme fatigue


• fast, pounding, or irregular heartbeat or pulse


• flushed, dry skin


• fruit-like breath odor


• pinpoint red spots on skin


• severe constipation


• severe vomiting


• stomach upset


• sweating


• swelling of abdominal or stomach area


• tenderness in stomach area


• ulcers, sores, or white spots in mouth


• unexplained weight loss


• unpleasant breath odor


• vomiting of blood


• weight gain


• wheezing


• yellow eyes or skin

Symptoms of overdose

• Agitation


• change in consciousness


• drowsiness


• lethargy


• loss of consciousness


• rapid weight gain


• stupor


• swelling of face, ankles, or hands

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: ibuprofen lysine Intravenous side effects (in more detail)

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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 ibuprofen lysine Intravenous resources

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

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Isosorbide Mononitrate Sustained-Release Tablets

Pronunciation: EYE-soe-SOR-bide MON-oh-NYE-trate
Generic Name: Isosorbide Mononitrate
Brand Name: Imdur

Isosorbide Mononitrate Sustained-Release Tablets are used for:

Preventing angina (chest pain) caused by heart disease.

Isosorbide Mononitrate Sustained-Release Tablets are a nitrate vasodilator. It works by widening the blood vessels in the body. This reduces the workload of the heart and helps to relieve chest pain.

Do NOT use Isosorbide Mononitrate Sustained-Release Tablets if:

• you are allergic to any ingredient in Isosorbide Mononitrate Sustained-Release Tablets or to other nitrate medicines


• you are also taking a phosphodiesterase type 5 inhibitor (eg, sildenafil, tadalafil, vardenafil)

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

Before using Isosorbide Mononitrate Sustained-Release Tablets:

Some medical conditions may interact with Isosorbide Mononitrate Sustained-Release Tablets. 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 problems (eg, heart failure, heart attack, hypertrophic cardiomyopathy), low blood pressure, blood problems (eg, anemia), dehydration, bleeding in the brain, an overactive thyroid, or have had a recent head injury

Some MEDICINES MAY INTERACT with Isosorbide Mononitrate Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Calcium channel blockers (eg, diltiazem, verapamil) or phosphodiesterase type 5 inhibitors (eg, sildenafil, tadalafil, vardenafil) because the risk of severe low blood pressure may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Isosorbide Mononitrate Sustained-Release Tablets 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 Isosorbide Mononitrate Sustained-Release Tablets:

Use Isosorbide Mononitrate Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Isosorbide Mononitrate Sustained-Release Tablets by mouth with or without food.


• Swallow Isosorbide Mononitrate Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some strengths of Isosorbide Mononitrate Sustained-Release Tablets may be broken in half. If you have difficulty swallowing the tablet whole, ask your pharmacist if your strength of medicine may be broken in half.


• Take Isosorbide Mononitrate Sustained-Release Tablets with one-half glass of water or other liquid.


• Do not suddenly stop taking Isosorbide Mononitrate Sustained-Release Tablets. You may have an increased risk of side effects (eg, an angina attack). If you need to stop Isosorbide Mononitrate Sustained-Release Tablets or add a new medicine, your doctor will gradually lower your dose.


• If you miss a dose of Isosorbide Mononitrate Sustained-Release Tablets, take it as soon as possible. If it is late in the day, 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 Isosorbide Mononitrate Sustained-Release Tablets.

Important safety information:

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


• Isosorbide Mononitrate Sustained-Release Tablets may cause dizziness or lightheadedness; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not drink alcohol while you are taking Isosorbide Mononitrate Sustained-Release Tablets.


• When you begin taking Isosorbide Mononitrate Sustained-Release Tablets, headaches are likely to occur. Ask your doctor for instructions on ways to reduce this side effect.


• Isosorbide Mononitrate Sustained-Release Tablets should not be used to stop an attack of angina; it is intended only for prevention of an attack.


• Isosorbide Mononitrate Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Isosorbide Mononitrate Sustained-Release Tablets.


• Isosorbide Mononitrate Sustained-Release Tablets should not be used 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 Isosorbide Mononitrate Sustained-Release Tablets while you are pregnant. It is not known if Isosorbide Mononitrate Sustained-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Isosorbide Mononitrate Sustained-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Isosorbide Mononitrate Sustained-Release Tablets:

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

Dizziness; headache; nausea.

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); changes in vision; fainting; numbness of an arm or leg; severe stomach pain; sharp or crushing chest pain; sudden leg pain; sudden, severe headache; sudden shortness of breath; vomiting.

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: Isosorbide Mononitrate 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 breathing problems; confusion; dizziness; fainting; fever; flushing; headache; increased pressure in the head; irregular heartbeat; loss of appetite; nausea; paralysis; sweating; visual disturbances; vomiting.

Proper storage of Isosorbide Mononitrate Sustained-Release Tablets:

Store Isosorbide Mononitrate Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isosorbide Mononitrate Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Isosorbide Mononitrate Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Isosorbide Mononitrate Sustained-Release Tablets are 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 Isosorbide Mononitrate Sustained-Release Tablets. 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 Isosorbide Mononitrate resources

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

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Iopidine

Generic Name: apraclonidine ophthalmic (a pra KLAH ni deen)

Brand Names: Iopidine

What is Iopidine (apraclonidine ophthalmic)?

Apraclonidine reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Apraclonidine ophthalmic is used to treat or prevent high pressure inside the eye caused by certain types of eye surgery or procedures.

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

What is the most important information I should know about Iopidine (apraclonidine ophthalmic)?

Do not use apraclonidine ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before using apraclonidine ophthalmic, tell your doctor if you have kidney or liver disease, heart disease, high blood pressure, or a history of fainting or low blood pressure. Also tell your doctor if you are using any medications to treat high blood pressure or a heart rhythm disorder.

What should I discuss with my healthcare provider before using Iopidine (apraclonidine ophthalmic)?

You should not use this medication if you are allergic to apraclonidine or to clonidine (Catapres).

Do not use apraclonidine ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before using apraclonidine ophthalmic, tell your doctor if you have:

• kidney disease;


• liver disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a history of fainting or low blood pressure.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely use apraclonidine ophthalmic.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether apraclonidine ophthalmic 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 Iopidine (apraclonidine ophthalmic)?

This medication is usually given one hour before eye surgery and again right after surgery. Your doctor, nurse, or other healthcare professional will most likely give you this medication.

If you use apraclonidine ophthalmic at home, use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using the eye drops. Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using apraclonidine before putting your contact lenses in.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Keep the eye drop pouches in their foil overwrap until you are ready to us the medication. Store at room temperature away from heat and moisture. Use each single-dose applicator only one time.

What happens if I miss a dose?

Since apraclonidine ophthalmic is usually given as needed by a healthcare professional, it is not likely that you will miss a dose.

If you are on a dosing schedule and you forget to use your medication, apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of apraclonidine ophthalmic used in the eyes is not likely to produce life-threatening side effects, but overdose symptoms may include drowsiness, slow heart rate, and decreased body temperature.

What should I avoid while using Iopidine (apraclonidine ophthalmic)?

Avoid using other medications in your eyes during treatment with apraclonidine unless your doctor has told you to.

Iopidine (apraclonidine ophthalmic) 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  slow or uneven heart rate;

  
  


• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  shallow breathing, feeling like you might pass out;

  
  


• 
  

  severe swelling, redness, or discomfort in or around your eye;

  
  


• 
  

  eye pain or increased watering; or

  
  


• 
  

  numbness or tingly feeling in your hands or feet.

  
  

Less serious side effects may include:

• 
  

  burning, itching, or dryness of your eyes;

  
  


• 
  

  feeling like something is in your eye;

  
  


• 
  

  blurred or dimmed vision;

  
  


• 
  

  redness of the eye or eyelid;

  
  


• 
  

  mildly swollen or puffy eyes;

  
  


• 
  

  nausea, stomach pain, diarrhea;

  
  


• 
  

  headache, sleep problems (insomnia);

  
  


• 
  

  dry or stuffy nose, burning in your nose;

  
  


• 
  

  a dry mouth; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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

What other drugs will affect Iopidine (apraclonidine ophthalmic)?

Before using apraclonidine ophthalmic, tell your doctor if you are using any of the following medications:

• 
  

  blood pressure medications; or

  
  


• 
  

  heart rhythm medication.

  
  

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

More Iopidine resources

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

• Iopidine Prescribing Information (FDA)


• Iopidine Monograph (AHFS DI)


• Iopidine Advanced Consumer (Micromedex) - Includes Dosage Information


• Iopidine Drops MedFacts Consumer Leaflet (Wolters Kluwer)

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• Postoperative Increased Intraocular Pressure

Where can I get more information?

• Your pharmacist can provide more information about apraclonidine ophthalmic.

See also: Iopidine side effects (in more detail)

Vinblastine PCH

Vinblastine PCH may be available in the countries listed below.

Ingredient matches for Vinblastine PCH

Vinblastine

Vinblastine sulfate (a derivative of Vinblastine) is reported as an ingredient of Vinblastine PCH in the following countries:

• Indonesia


• South Africa

International Drug Name Search

H.G. Bromhexina

H.G. Bromhexina may be available in the countries listed below.

Ingredient matches for H.G. Bromhexina

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of H.G. Bromhexina in the following countries:

• Ecuador

International Drug Name Search

iodine Topical

EYE-oh-dine

Commonly used brand name(s)

In the U.S.

• Aplicare One Tincture Of Iodine


• Iodex


• Iodoflex


• Iodosorb

Available Dosage Forms:

• Swab


• Ointment


• Tincture


• Dressing


• Gel/Jelly

Therapeutic Class: Antibacterial

Uses For iodine

Topical iodine is used to prevent and treat infections that may occur in minor scrapes and cuts. It works by killing bacteria that can cause infections.

Before Using iodine

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 iodine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to iodine 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

Use of topical iodine is not recommended for newborn infants because it may cause skin and thyroid problems.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical iodine in the elderly with use in other age groups, iodine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 iodine. Make sure you tell your doctor if you have any other medical problems, especially:

• Animal bites or


• Deep wounds or


• Serious burns—The chance of side effects may be increased

Proper Use of iodine

Use iodine only as directed.

iodine is for external use only. Do not swallow it.

Keep iodine away from the eyes because it may cause irritation. If you should accidentally get some in your eyes, wash it away with water immediately.

Do not use topical iodine on deep, puncture wounds, animal bites, or serious burns. To do so may increase the chance of side effects.

Do not cover the wound to which you have applied topical iodine with a tight dressing or bandage since this may increase the chance of side effects.

Dosing

The dose of iodine 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 iodine. 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 topical dosage form (tincture):
  
  • For minor bacterial skin infections:
    
    • Adults and children 1 month of age and over—Use when necessary, according to the directions on the label or your doctor's instructions. Do not use for more than ten days.
    
    
    • Infants and children under 1 month of age—Use is not recommended.
    
    
  
  

To help clear up your infection completely, it is very important that you keep using topical iodine for the full time of treatment. Do not miss any doses.

Missed Dose

If you miss a dose of iodine, apply 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.

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.

Precautions While Using iodine

Check with your doctor if the skin problem for which you are using topical iodine becomes worse, or if you develop a constant irritation such as itching or burning that was not present before you started using iodine.

iodine can stain your skin and clothing. Alcohol may be used to remove iodine stain on the skin. Stains on clothing can be removed by washing and rinsing them in ammonia diluted with water. Stains on starched linens can be removed by washing them in soap and water.

iodine 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 as soon as possible if any of the following side effects occur:

Rare

• Blistering, crusting, irritation, itching, or reddening of skin

Symptoms of overdose (when swallowed)

• Abdominal or stomach pain


• diarrhea


• fever


• nausea


• not being able to pass urine


• thirst, severe


• vomiting

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.

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.

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Iobenguane sulfate I 131

Iobenguane sulfate I 131 Injection

Diagnostic - For Intravenous Use

Iobenguane sulfate I 131 Description

Iobenguane sulfate I 131 Injection is a sterile, pyrogen free radiopharmaceutical for intravenous injection. Each milliliter contains 0.69 mg of iobenguane sulfate, 85.1 MBq (2.30 mCi) of I 131 (as Iobenguane sulfate I 131 at calibration), 0.36 mg of sodium acetate, 0.27 mg of acetic acid, 4.2 mg of sodium chloride, 0.56 mg of methyl paraben, 0.056 mg of propylparaben and 0.01 mL of benzyl alcohol. Iobenguane sulfate I 131 is also known as I 131-meta-iodobenzylguanidine sulfate (I 131 MIBG) and has the following structural formula:

Iobenguane sulfate I 131

(I 131-meta-iodobenzylguanidine sulfate)

Physical Characteristics

Iobenguane sulfate I 131 is a radioiodinated arylalkylguanidine. It is similar in structure to the anti-hypertensive drug guanethidine and to the neurotransmitter norepinephrine.

Iodine 131 decays by beta and gamma emission and has a physical half-life of 8.04 days. The principal beta particles and those photons that are useful for detection and imaging are listed in Table 1.

Table 1: Principal Radiation Emission Data

Radiation	Mean Percentage Disintegration	Energy (kev)
Beta-1	2.1	69.4 avg
Beta-3	7.4	96.6 avg
Beta-4	89.3	191.6 avg
Gamma-7	6.14	284.3
Gamma-14	81.7	364.5
Gamma-17	7.17	637.0

External Radiation

The specific gamma ray constant for I 131 is 2.2 R/mCi/hr at 1cm. The first half-value thickness of lead (Pb) for I 131 is 0.24 cm. The relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2; i.e. the use of 2.55 cm of Pb will decrease the external radiation exposure by a factor of about 1,000.

Table 2: Radiation Attenuation by Lead Shielding*

* Calculations include the effect of buildup factors (the contribution of scatter photons to the dose rate). Radioactive decay factors should be applied to the stated value for radioactive concentration at the time of injection and are given in Table 3. [Data from the Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1987.]
Shield Thickness (Pb) cm	Coefficient of Attenuation
0.24	0.5
0.89	10-1
1.60	10-2
2.55	10-3
3.73	10-4

Table 3: Physical Decay Chart: I 131 Half-life = 8.04 Days

Days	Activity x Calibration	Days	Activity x Calibration
-14	3.343	1	0.917
-13	3.067	2	0.842
-12	2.814	3	0.772
-11	2.581	4	0.708
-10	2.368	5	0.650
-9	2.173	6	0.596
-8	1.993	7	0.547
-7	1.828	8	0.502
-6	1.677	9	0.460
-5	1.539	10	0.422
-4	1.412	11	0.387
-3	1.295	12	0.355
-2	1.188	13	0.326
-1	1.090	14	0.299
Calibration Date	1.000

Iobenguane sulfate I 131 - Clinical Pharmacology

General

Iobenguane sulfate I 131 enters adrenergic neurons and chromaffin cells primarily by the type I (active transport) mechanism of catecholamine uptake into adrenergic storage granules. Its uptake is blocked by drugs which interfere with catecholamine uptake (see drug interaction section). Within about 2 hours, 80% of Iobenguane sulfate I 131 distributes from plasma to erythrocytes and body tissues. After background clearance, visualization of abnormal adrenal medullary tissue peaks at about 48 hours post-injection. Normal adrenal glands are seen faintly in 2% of patients. Normal salivary glands, liver, spleen, and urinary bladder may also be seen to a lesser extent. Excretion is primarily by the kidneys.

Pharmacokinetics

The pharmacokinetics profile of Iobenguane sulfate I 131 fits a 3 compartment model. The physical half-life of I 131 is 8.04 days. The maximum biologic half-life of Iobenguane sulfate I 131 (including metabolites), computed by the Sigma minus method from urinary excretion data from patients with normal renal function, is about 5 days.

Metabolism

In patients with normal renal function, the major metabolites that account for less than 10% of the administered dose are m-iodohippuric action (MIHA), m-iodobenzoic acid (MIBA) and 4-hydroxy-3-iodobenzylguanidine (HIBG) and radioiodide. The enzymatic process responsible for metabolism has not been well characterized and the pharmacologic activity of these metabolites has not been studied.

In patients with normal renal function, about 50% of the injected radioactivity was recovered in urine during the first 24 hours after the infusion. About 90% was recovered in the urine by 4 days, primarily as unchanged iobenguane. Elimination is relatively independent of dose from 0.5 mCi (0.15 mg) to approximately 213 mCi (5mg).

Pharmacodynamics

Iobenguane sulfate I 131 localizes within intracellular adrenergic storage granules. Glomerular filtration is primarily responsible for extracellular clearance of Iobenguane sulfate I 131 from the body. In a 192 hour study of an anephric patient, elimination was not noted. The formation of metabolites increases in patients with renal impairment and may increase in patients with substantial tumor burdens (e.g.; an extensively metabolizing pheochromocytoma). Elimination by other routes is not well characterized. Iobenguane sulfate I 131 is not cleared by dialysis. Dosage adjustments in renally impaired patients have not been studied.

CLINICAL TRIALS

Three clinical trials were performed in a total of 397 evaluable patients with suspected pheochromocytoma. Of these subjects, 212 were males and 185 were females. The mean age was 46.3 years (range of 1-85 years). About two-thirds of the patients were between 31 and 60 years of age; 25 subjects were less than 20 years; 5 were less than 10 years of age. The mean weight of all subjects was 78.6 kg (range of 7.6-189 kgs).A racial distribution is not available.

Patients were entered into the study who, after consideration of their clinical history, physical examination and laboratory findings, were considered to have reasonable suspicion of having pheochromocytoma. Pregnant women were excluded. The diagnosis of pheochromocytoma was confirmed by other diagnostic procedures (plasma and urinary catecholamine, clonidine suppression tests and abdominal CT scans). Adult patients up to 65 kg received 0.5 mCi Iobenguane sulfate I 131, those >65 kg received 0.3 mCi/m2. Children received 0.3 mCi/m2.

Based upon dosimetry calculation from biodistribution studies, the mean dose was 0.519 mCi (range 0.10 to 1.10 mCi). All subjects had their thyroid gland iodine uptake blocked with Potassium Iodide Oral Solution (120 mg KI/day = 0.12 mL/day) or Lugol’s Solution (up to 40 mg I/day = 0.3 mL/day). In diagnosing pheochromocytoma, Iobenguane sulfate I 131 had an overall sensitivity of 71% and overall specificity rate of 94%. Within a subgroup of 293 patients who had the presence or absence of disease confirmed, there were 25 false negative and 7 false positive scans.

In further analysis of patients with confirmed pheochromocytoma, in patients who were not on medications that could potentially interfere with Iobenguane sulfate I 131 uptake, the sensitivity was 83%; in patients on potentially interfering medications, the sensitivity was reduced to 52%. The specificity was not altered. This suggests that in previously undiagnosed pheochromocytoma patients, the concomitant use of potentially blocking medications may confound the scan results.

In another trial, 72 patients were studied for suspected neuroblastoma. Of these subjects, there was an equal gender distribution. The mean age was 4.3 years (range 0.3-27 years); 46 of the 72 patients were between 1 and 5 years of age, 3 patients were over 15 years, 11 patients were under 1 year of age. The mean weight was 19.2 kg (range 3.1-115.1 kgs). A racial distribution is not available.

Patients suspected clinically of having neuroblastoma were included in the study. Most patients had other diagnostic procedures (bone scans, CT scans, MRI, etc.) before they were asked to participate in the study. Critically ill patients were generally excluded. Adults up to 65 kg received 0.5 mCi, those >65 kg received 0.3 mCi/m2 Iobenguane sulfate I 131. Children received 0.3 mCi/m2. Based on dosimetry calculations from biodistribution studies, the mean dose was 0.231 mCi (range from 0.063 to 1.031 mCi). All subjects received Potassium Iodide Oral Solution (120 mg KI/day = 0.12 mL/day) or Lugol’s Solution (up to 40 mg I/day = 0.3 mL/day) to block thyroid uptake. In this trial, Iobenguane sulfate I 131 localized neuro-blastomas with an 85.1% sensitivity and 92.0% specificity. There were 4 false negative and 2 false positive scans. None of the children on these trials were on medication that could potentially interfere with the uptake of Iobenguane sulfate I 131.

Indications and Usage for Iobenguane sulfate I 131

Iobenguane sulfate I 131 Injection is indicated as an adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytomas and neuroblastomas.

GERIATRIC USE

Clinical studies of Iobenguane sulfate I 131 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Contraindications

Iobenguane sulfate I 131 is contraindicated in patients with known hypersensitivity to iobenguane sulfate.

Warnings

As with other I 131 containing agents, in order to decrease thyroid accumulation of I 131, block the thyroid gland with iodine. (See DOSAGE AND ADMINISTRATION section)

During and following the injection, patients with known or suspected pheochromocytoma should be carefully monitored for hypertensive crises.

Precautions

General

Iobenguane sulfate I 131 IS CLEARED BY GLOMERULAR FILTRATION AND IS NOT DIALYZABLE. Caution should be exercised when administering the drug to renally impaired patients. Iobenguane sulfate I 131 is not recommended in anephric patients. The radiation dose to the anephric patient would be substantially increased due to the delayed biological elimination of the drug. Also, because of the lack of clearance, the target-to-background ratios would severely compromise the outcome of the study. Iobenguane sulfate I 131 use in patients with impaired renal function should be carefully considered. As with all radio-iodinated compounds, the patient should be well hydrated before and during examination.

Although iodinated contrast imaging agents have been confirmed to cause anaphylactic reactions in patients with hypersensitivity to iodine, the incidence of hypersensitivity reactions to Iobenguane sulfate I 131 is rare. Since hypersensitivity or immune reactions are not concentration dependent, emergency treatment measures should be available.

Cardiac

Electrocardiographic (ECG) changes have been documented in dogs after the administration of 18 times the mg/m2 conversion of the maximum human dose of Iobenguane sulfate I 131. The maximum no observable effect level (NOEL) is not known. It is unknown if Iobenguane sulfate I 131 can produce changes in ECG recordings in man.

Drug Interactions

There are literature reports about patients and about in-vitro systems which suggest that the following drugs have the potential to decrease uptake of Iobenguane sulfate I 131 in neuro-endocrine tumors and may lead to false negative results if administered concomitantly: anti-hypertensives (labetalol, reserpine, calcium channel blockers), amitriptyline and derivatives, imipramine and derivatives, doxepin, amoxapin, and loxapin, sympathetic-amines (phenyl-ephrine, phenylpropanolamine, pseudoephedrine, ephedrine) and cocaine. The clinical studies were not designed to show which drugs could cause false negative results. It is unknown if other drugs in the same classes have the same potential to inhibit the uptake of Iobenguane sulfate I 131. Increasing the dose of Iobenguane sulfate I 131 will not overcome any potential uptake-limiting effect of these drugs.

Normal biodistribution and excretion of Iobenguane sulfate I 131 leads to localization in adrenergic storage granules of the adrenal gland. It is also localized in salivary glands, liver, spleen and urinary bladder. As in all nuclear imaging procedures, careful positioning may be useful in distinguishing normal biodistribution of the agent from localization in sites of pathology.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Iobenguane sulfate I 131 have not been conducted to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Iobenguane sulfate I 131. It is also not known whether Iobenguane sulfate I 131 can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Therefore, Iobenguane sulfate I 131 should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

I 131 is excreted in human milk; it is not known if Iobenguane sulfate I 131 is excreted in human milk. Therefore, breast feeding should be substituted with formula feeding until the Iobenguane sulfate I 131 has cleared from the body of the nursing woman.

PEDIATRIC USE

The safety and effectiveness of Iobenguane sulfate I 131 have been reasonably established in pediatric patients with neuroblastoma and pheochromocytoma.

Safety, effectiveness, metabolism, urinary excretion and tumor specificity of Iobenguane sulfate I 131 is unknown in neonates.

Adverse Reactions

Transient episodes of marked hypertension have been reported in patients after injection of Iobenguane sulfate I 131. Some of these patients were on anti-hypertensives and others were not.

Nausea, vomiting and sleepiness have been reported after injection of higher than the recommended doses of Iobenguane sulfate I 131. The no effect level for these reactions has not been identified. An episode of fever, chills and hypotension has been reported. In clinical trials, no deaths have been attributed to the drug.

Iobenguane sulfate I 131 Dosage and Administration

Before administration of Iobenguane sulfate I 131, the patient’s thyroid gland should be blocked with Potassium Iodide Oral Solution (120 mg KI/day = 0.12 mL/day) or Lugol’s Solution (up to 40 mg I/day = 0.3 mL/day). The blocking iodine should be administered one day before and daily for 5 to 7 days after the dose of Iobenguane sulfate I 131

Adults

The recommended dose in adults is 0.5 mCi. In obese patients over 1.7 m2 (65 kg), the dose should be 0.3 mCi/m2 up to a maximum of 1.0 mCi.

Pediatric Patients

The recommended dose in pediatric patients is 0.3 mCi/m2 up to a maximum total dose of 0.5 mCi. The minimum recommended dose for adequate imaging is 0.135 mCi.

Iobenguane sulfate I 131 should be injected by slow intravenous infusion over 15-30 seconds (longer if necessary). Since the possibility of rebound hypertension exists, the patient’s vital signs should be carefully monitored during and after injection.

In order to maintain sterility, it is essential that the user follow directions and adhere to strict aseptic procedure. As in the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and clinical personnel.

Waterproof gloves should be worn by the user and a shielded syringe should be used during the preparation and administration of the dose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Radiation Dosimetry

The estimated absorbed radiation doses to adults and children from an intravenous dose of Iobenguane sulfate I 131 are shown in Table 4.

Table 4: Estimated Absorbed Radiation Doses*: Iobenguane Sulfate I-131

Organ	Adult		15 Years		10 years		5 years		1 years		Newborn
	mGy/ 37 MBq	rads/ 1mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi	mGy/ 18.5 MBq	rads/ 0.5 mCi
Urinary
Bladder
Wall	28.0	2.8	18.5	1.9	28.0	2.8	43.5	4.4	85.0	8.5	215.0	21.5
Liver	29.0	2.9	19.0	1.9	29.5	3.0	43.5	4.4	85.0	8.5	190.0	19.0
Spleen	22.0	2.2	15.5	1.6	24.5	2.5	38.5	3.9	70.0	7.0	195.0	19.5
Heart Wall	2.9	0.3	1.9	0.2	2.9	0.3	4.5	0.5	8.5	0.9	19.5	2.0
Adrenals	7.5	0.8	5.5	0.6	8.0	0.8	10.5	1.1	16.5	1.7	16.5	1.7
Gallbladder
Wall	5.1	0.5	3.0	0.3	4.4	0.4	7.0	0.7	12.5	1.3	28.0	2.8
Pancreas	3.8	0.4	2.4	0.2	3.8	0.4	6.0	0.6	10.5	1.1	23.5	2.4
Thyroid	3.3	0.3	2.6	0.3	4.0	0.40	8.5	0.9	16.5	1.7	24.0	2.4
Kidneys	3.2	0.3	2.0	0.2	3.1	0.3	4.9	0.5	8.5	0.9	20.0	2.0
Uterus	3.3	0.3	2.1	0.2	3.3	0.3	5.0	0.5	9.5	1.0	22.0	2.2
Ovaries	2.7	0.3	1.8	0.2	2.8	0.3	4.4	0.4	8.5	0.9	19.5	2.0
Testes	2.2	0.2	1.4	0.1	2.3	0.2	3.7	0.4	7.0	.7	17.5	1.8
Brain	1.7	0.2	1.1	0.1	1.9	0.2	3.1	0.3	6.0	0.6	15.0	1.5
Effective Dose Equivalent (rem)		0.7		0.5		0.8		1.2		2.2		5.0

* Based on data gathered in patients – Jacobsson et al, 4 International Radiopharmaceutical 

Dosimetry Symposium, CONF – 851113, pp. 389-398. 

Estimate calculated using phantoms of Christy & Eckerman (Report ORNL/TM-8381/V1 & V7).

The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.

The following organs each receive less than 1 rad per adult procedure: breasts, LLI wall, small intestine, stomach, ULI wall, lungs, muscle, red marrow, bone surfaces, skin and thymus.

If 0.5 mCi of Iobenguane sulfate I 131 is used for an adult dose, the organ burden would be half of the doses listed above. The thyroid gland estimated burden is in the unblocked state. When the thyroid gland is blocked with Lugol’s solution, uptake in minimal.

Peak scans were generally noted at 48 hours post-injection. However, serial scans at 24, 48 and 72 hours post-injection may be needed to optimally define the tumor.

How is Iobenguane sulfate I 131 Supplied

Each 2 ml glass vial contains a total volume of 0.5 mL with a total activity of, at calibration time,

42.6 MBq (1.15 mCi) of Iobenguane sulfate I 131 Injection.

Store the drug frozen at a temperature of -20 to -10°C.

 

Note

Two to three hours prior to use, thaw the vial in the leaded container, at room temperature.

Discard the unused portion of the drug after 4-6 hours if kept at room temperature.

In conformance with USP recommendations, Iodine 131 preparations should not be used after

the expiration date stated on the label.

NDC # 45567-0100-1

Manufactured in the USA by

Pharmalucence, Inc.

10 DeAngelo Drive

Bedford, MA 01730

 

This radiopharmaceutical is approved for distribution to persons licensed to use radioactive material listed in Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

RM 2I-006

03/08

Iobenguane sulfate I 131 INJECTION  Iobenguane sulfate I 131 injection  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45567-0100 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IOBENGUANE I-131 (IOBENGUANE I-131) IOBENGUANE I-131 2.3 mCi  in 2 mL

Inactive Ingredients Ingredient Name Strength IOBENGUANE I-131 0.69 mg  in 2 mL SODIUM ACETATE 0.36 mg  in 2 mL ACETIC ACID 0.27 mg  in 2 mL SODIUM CHLORIDE 4.2 mg  in 2 mL METHYLPARABEN 0.56 mg  in 2 mL PROPYLPARABEN 0.056 mg  in 2 mL BENZYL ALCOHOL 0.01 mL  in 2 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45567-0100-1 2 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020084	03/25/1994	09/07/2009

Labeler - Pharmalucence, Inc. (139261648)

Revised: 09/2009Pharmalucence, Inc.

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