Invanz

Generic Name: ertapenem (Injection route)

er-ta-PEN-em

Commonly used brand name(s)

In the U.S.

• Invanz

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Beta-Lactam

Chemical Class: Carbapenem

Uses For Invanz

Ertapenem is used alone or in combination with other antibiotics to treat infections caused by bacteria in many different parts of the body. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections. Ertapenem is also used to prevent infections after having surgery of the colon and rectum .

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

Before Using Invanz

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 pediatrics-specific problems that would limit the usefulness of ertapenem in infants and children 3 months to 17 years of age. Use in infants younger than 3 months of age is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ertapenem in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution or adjustment of dosage in patients receiving ertapenem .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

• Valproic Acid

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.

• Probenecid

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

• Brain disease or


• Diarrhea or


• Seizures, history of—Use with caution. May make these conditions worse .

• Kidney disease—The effects of ertapenem may be increased because of slower removal of the medicine from the body .

Proper Use of Invanz

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Skipping doses or not completing the full course of therapy may decrease the usefulness of this medicine. It may also increase the likelihood that the bacteria causing your infection will develop resistance. If this happens, ertapenem and other medicines used to treat infections will not work in the future. Also, this medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, it must be given on a regular schedule.

This medicine is given as an injection into a muscle, or through a needle placed into a vein. Ertapenem may sometimes be given to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

Ertapenem should not be mixed with other medicines or with diluents containing dextrose .

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 injection dosage form:
  
  • For bacterial infections:
    
    • Adults and teenagers—1 gram (g) injected into a vein or injected into a muscle once a day. Your doctor will determine your injection site and the length of time that you will take it.
    
    
    • Children and infants (3 months to 12 years of age)—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 milligram (mg) per kilogram (kg) (or 6.8 mg per pound [lb]) of body weight injected into a vein or injected into a muscle twice a day. Your doctor will determine your injection site and the length of time you will take it.
    
    
    • Infants younger than 3 months of age—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

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.

Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze .

Store the medicine that has been mixed at room temperature and use it within 6 hours. You may also store this mixture for 24 hours in the refrigerator and use it within 4 hours after removing from the refrigerator. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution .

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets .

Precautions While Using Invanz

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects .

Some patients may develop tremors or seizures while receiving this medicine. If you already have a history of seizures and you are taking anticonvulsants (e.g., valproic acid, Depakene®), you should continue to take them unless otherwise directed by your doctor.

In some patients, ertapenem may cause diarrhea.

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or make it last longer.


• For mild diarrhea, diarrhea medicine containing kaolin (e.g., Kaopectate liquid) or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.


• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine .

This medicine is usually mixed with lidocaine (Xylocaine®). Do not inject this medicine into your muscle if you have had an allergic reaction to lidocaine .

Invanz 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

• Bleeding


• blistering


• burning


• coldness


• diarrhea


• discoloration of skin


• feeling of pressure


• hives


• infection


• inflammation


• itching skin


• lumps


• numbness


• pain


• redness of skin


• scarring


• skin rash


• soreness


• stinging


• swelling


• tenderness


• tingling


• ulceration


• unusually warm skin

Less common

• Bluish color changes in skin color


• dry, red, hot, or irritated skin


• fast, pounding, or irregular heartbeat or pulse


• pain, tenderness, or swelling of foot or leg

Rare

• Abdominal or stomach cramps


• abdominal tenderness


• bloating


• convulsions


• diarrhea, watery and severe, which may also be bloody


• fainting or loss of consciousness


• fast or irregular breathing


• fever


• increased thirst


• loss of bladder control


• muscle spasm or jerking of all extremities


• nausea


• sudden loss of consciousness


• swelling of eyes or eyelids


• tightness in chest


• trouble in breathing


• unusual tiredness or weakness


• unusual weight loss


• vomiting


• wheezing

Incidence not known

• Cough


• difficulty swallowing


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


• seeing, hearing, or feeling things that are not there


• shortness of breath

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:

More common

• Agitation


• chest pain


• confusion about identity, place, and time


• drowsiness


• headache


• mental depression

Less common

• Acid or sour stomach


• belching


• blurred vision


• body aches or pain


• congestion


• difficult or labored breathing


• difficulty having a bowel movement (stool)


• dizziness


• dryness or soreness of throat


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


• fear


• flushing


• heartburn


• hoarseness


• indigestion


• itching of the vagina or genital area


• lack or loss of strength


• leg pain


• nervousness


• pain during sexual intercourse


• pounding in the ears


• runny nose


• sleeplessness


• slow heartbeat


• sore mouth or tongue


• stomach discomfort, upset, or pain


• sudden sweating


• tender, swollen glands in neck


• thick, white vaginal discharge with no odor or with a mild odor


• tightness in chest


• trouble sleeping


• unable to sleep


• voice changes


• white patches in mouth and/or on tongue

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: Invanz side effects (in more detail)

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

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

More Invanz resources

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

• Invanz Prescribing Information (FDA)


• Invanz MedFacts Consumer Leaflet (Wolters Kluwer)


• Invanz Concise Consumer Information (Cerner Multum)


• Invanz Monograph (AHFS DI)


• Ertapenem Professional Patient Advice (Wolters Kluwer)

Compare Invanz with other medications

• Infection Prophylaxis
• Intraabdominal Infection
• Kidney Infections
• Pelvic Infections
• Pneumonia
• Skin Infection
• Urinary Tract Infection

Invirase

Pronunciation: sa-KWIN-a-vir MES-i-late
Generic Name: Saquinavir Mesylate
Brand Name: Invirase

Invirase is used for:

Treating HIV infection. Invirase must be taken along with ritonavir.

Invirase is a protease inhibitor. It works by blocking the growth activity of an enzyme (HIV protease) that the HIV virus needs to reproduce in the body.

Do NOT use Invirase if:

• you are allergic to any ingredient in Invirase or to ritonavir


• you have severe liver problems, certain electrolyte problems (eg, low blood potassium or magnesium levels), a certain type of irregular heartbeat (heart block) and you do not have a pacemaker, or if you are at risk of heart block


• you have a history of a certain type of irregular heartbeat (eg, congenital long QT syndrome, QT prolongation) or certain other heart problems


• you are taking alfuzosin, astemizole, certain benzodiazepines (eg, midazolam, triazolam), cisapride, conivaptan, a garlic supplement, an ergot derivative (eg, ergotamine, ergonovine), erythromycin, salmeterol, certain medicines to treat high cholesterol (eg, lovastatin, simvastatin) or irregular heartbeat (eg, amiodarone, bepridil, dofetilide, flecainide, propafenone, quinidine), pimozide, rifampin, St. John's wort, terfenadine, tolvaptan, or trazodone


• you are taking sildenafil for pulmonary arterial hypertension (PAH)

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

Before using Invirase:

Some medical conditions may interact with Invirase. 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, arrhythmia, congestive heart failure [CHF]), high blood cholesterol or triglycerides, hepatitis or other liver problems, severe kidney problems, hemophilia, or diabetes or a family history of diabetes


• if you have alcoholism or a history of alcohol abuse

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

• Astemizole, cisapride, erythromycin, pimozide, salmeterol, terfenadine, or certain medicines for irregular heartbeat (eg, amiodarone, bepridil, flecainide, propafenone, quinidine) because the risk of severe heart side effects (eg, irregular heartbeat) may be increased


• Ergot derivatives (eg, ergotamine, ergonovine) because the risk of severe blood vessel problems in the hands and feet may be increased


• Alfuzosin because the risk of severe low blood pressure may be increased


• Rifampin because the risk of severe liver problems may be increased


• Garlic supplements or St. John's wort because they may decrease Invirase's effectiveness


• Certain cholesterol medicines (eg, lovastatin, simvastatin), conivaptan, midazolam, sildenafil (when used for PAH), tolvaptan, or triazolam because the risk of their side effects may be increased by Invirase


• Many prescription and nonprescription medicines (eg, used for allergies, asthma, birth control, blood thinning, cancer, gout, irregular heartbeat or other heart problems, high blood pressure, high cholesterol, HIV infection, heartburn or reflux, erectile dysfunction, PAH, overactive bladder, immune system suppression, infections, mental or mood problems, anxiety, migraine headaches, pain, seizures, sleep), herbs found in multivitamin products, herbal teas, and dietary supplements (eg, garlic, St. John's wort) may interact with Invirase and increase the risk of side effects

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

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

• Invirase comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Invirase refilled.


• Take Invirase and ritonavir with a meal or within 2 hours after a full meal or large snack.


• Ritonavir should be taken at the same time as Invirase.


• Taking Invirase at the same times each day will help you to remember to take it.


• Take Invirase on a regular schedule to get the most benefit from it.


• Talk with your doctor before you eat grapefruit or drink grapefruit juice while you use Invirase.


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

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

Important safety information:

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


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Invirase. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Invirase may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Invirase.


• Do not stop taking Invirase or change your dose without talking to your doctor.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Invirase, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Invirase is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Invirase does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Invirase may increase triglyceride and lipid levels. The long-term chance of complications from these increased triglyceride and lipid levels, such as a heart attack and stroke, are not known at this time.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Invirase. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Hemophilia patients - Report all bleeding episodes to your doctor.


• Invirase may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, urinate more often than usual, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Invirase may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including liver function, thyroid function, electrocardiogram (ECG), blood cholesterol or triglyceride levels, blood glucose levels, blood electrolyte levels, and complete blood cell counts, may be performed while you use Invirase. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Invirase should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Invirase while you are pregnant. Do not breast-feed while taking Invirase. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Invirase to the baby.

Possible side effects of Invirase:

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

Anxiety; blurred vision; body fat changes; changes in sexual desire; constipation; diarrhea; dizziness; dry lips or skin; gas; headache; heartburn; mouth sores; nausea; night sweats; sleeplessness; stomach discomfort; taste changes; tenderness or bleeding of the gums; tiredness; vomiting; warts; weight gain.

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); back pain; blood in the vomit or stools; chest tightness or pain; confusion; coughing up blood; dark urine; depression or thoughts of suicide; difficulty urinating; excessive thirst, hunger, or urination; fainting; fast, slow, or irregular heartbeat; fever; flu-like symptoms; itching; loss of appetite; loss of coordination; numbness or tingling; pain in muscles or joints; pale stools; reddened, blistered, or swollen skin; seizures; severe or persistent cough; severe or persistent dizziness or lightheadedness; shortness of breath; stomach pain or tenderness; unusual bruising or bleeding; unusual vaginal discharge or odor; unusual weakness; white patches in the mouth; 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: Invirase side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Invirase:

Store Invirase at 77 degrees F (25 degrees C) in a tightly closed bottle. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store Invirase in the bathroom. Keep Invirase out of the reach of children and away from pets.

General information:

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


• Invirase 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 Invirase. 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 Invirase resources

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

• Invirase Prescribing Information (FDA)


• Invirase Consumer Overview


• Invirase Monograph (AHFS DI)


• Invirase Advanced Consumer (Micromedex) - Includes Dosage Information


• Fortovase Prescribing Information (FDA)

Compare Invirase with other medications

• HIV Infection
• Nonoccupational Exposure

Intal inhalation

Generic Name: cromolyn sodium (inhalation) (KROE moe lin SOE dee um)

Brand Names: Intal, Intal Inhaler

What is Intal (cromolyn sodium (inhalation))?

Cromolyn sodium is an anti-inflammatory medication. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium inhalation is used to prevent asthma attacks in people with bronchial asthma. Cromolyn sodium is also used to prevent bronchospasm (wheezing, chest tightness, trouble breathing) caused by exercise, pollutants in the air, or exposure to certain chemicals.

Cromolyn sodium inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Intal (cromolyn sodium (inhalation))?

You should not use this medication if you are allergic to cromolyn sodium.

Before using cromolyn sodium inhalation, tell your doctor if you have heart disease or a heart rhythm disorder, coronary artery disease, kidney disease, or liver disease.

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack. Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

What should I discuss with my healthcare provider before using Intal (cromolyn sodium (inhalation))?

You should not use this medication if you are allergic to cromolyn sodium.

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

• 
  

  heart disease or a heart rhythm disorder;

  
  


• 
  

  coronary artery disease;

  
  


• kidney disease; or


• liver disease.

FDA pregnancy category B. This medication is not expected to 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 cromolyn sodium 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 Intal (cromolyn sodium (inhalation))?

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.

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack.

Cromolyn sodium inhalation is given using a nebulizer or with a metered-dose inhaler. You will inhale the medication through a face mask or mouth piece. Do not swallow this medicine.

To prevent bronchial asthma attacks, cromolyn sodium inhalation is usually given 4 times daily. If you are using cromolyn sodium inhalation to prevent asthma caused by exercise, air pollutants, or exposure to chemicals, use the medicine 10 to 15 minutes (but not more than 1 hour) before exercising or exposure. Follow your doctor's instructions about your individual dosing schedule.

The instructions below are for standard use of the inhaler and nebulizer devices. Your doctor may want you to use your device differently. Be sure you understand all instructions that are specific to your use of this medication.

To use cromolyn sodium with a metered-dose inhaler:

• Uncap the mouthpiece of the inhaler and shake the inhaler gently.


• 
  

  Breathe out fully. Put the mouthpiece into your mouth and close your lips. Do not block the mouthpiece with your tongue. Tilt your head back and breathe in slowly while pushing down on the top of the canister. Take the inhaler out of your mouth and hold your breath for several seconds, then breathe out slowly.

  
  


• 
  

  Clean your inhaler twice a week by removing the canister and rinsing the mouthpiece under warm running water. Allow the parts to dry before putting the inhaler back together. Never place the medicine canister in water.

  
  

To use cromolyn sodium inhalation solution with a nebulizer:

• 
  

  Break open the ampule and empty the medicine into the chamber of the nebulizer. Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor.

  
  


• 
  

  Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.

  
  


• 
  

  Breathe in slowly and evenly until you have inhaled all of the medicine. The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.

  
  


• 
  

  Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

  
  

It may take up to 4 weeks of using cromolyn sodium before you get the full effect. For best results, keep using the medication as directed. Call your doctor if your symptoms do not improve after 4 weeks of treatment, or if they get worse.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store this medication at room temperature away from moisture and heat. Keep the inhaler canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture an inhaler canister.

Keep track of the number of sprays you have used and throw away the canister after 112 sprays if you use the 8.1-gram inhaler, or 200 sprays if you use the 14.2-gram inhaler, even if it feels like there is still medicine in the canister.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of cromolyn sodium inhalation is not likely to cause life-threatening symptoms.

What should I avoid while taking Intal (cromolyn sodium (inhalation))?

Avoid spraying the inhaler into your face or getting the medication in your eyes.

Do not mix cromolyn sodium inhalation with other medicines in a nebulizer.

Intal (cromolyn sodium (inhalation)) 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 a serious side effect such as:

• 
  

  severe wheezing or chest tightness just after inhaling the medication;

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or

  
  


• 
  

  fever, swollen glands, rash or itching, joint pain, and a general ill feeling.

  
  

Less serious side effects may include:

• 
  

  dry or irritated throat, temporary or occasional cough;

  
  


• 
  

  sneezing, stuffy or itchy nose, watery eyes;

  
  


• 
  

  burning or bleeding of your nose;

  
  


• 
  

  nausea, heartburn, stomach pain;

  
  


• 
  

  urinating more or less than usual;

  
  


• 
  

  dizziness, drowsiness, headache; 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 Intal (cromolyn sodium (inhalation))?

There may be other drugs that can interact with cromolyn sodium inhalation. 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 Intal resources

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

Compare Intal with other medications

• Asthma, Maintenance

Where can I get more information?

• Your pharmacist can provide more information about cromolyn sodium inhalation.

See also: Intal side effects (in more detail)

Indium Oxyquinoline

Dosage Form: Solution

For the Radiolabeling of Autologous Leukocytes

Rx ONLY

Diagnostic—For intravenous use

For single dose, single use only

Indium Oxyquinoline Description

Indium In 111 oxyquinoline (oxine) is a diagnostic radiopharmaceutical intended for radiolabeling autologous leukocytes. It is supplied as a sterile, non-pyrogenic, isotonic aqueous solution with a pH range of 6.5 to 7.5. Each mL of the solution contains 37 MBq, 1 mCi of indium In 111 [no carrier added, >1.85 GBq/µg indium (>50 mCi/µg indium)] at calibration time, 50 µg oxyquinoline, 100 µg polysorbate 80, and 6 mg of HEPES (N-2-hydroxyethylpiperazine-N'-2-ethane sulfonic acid) buffer in 0.75% sodium chloride solution. The drug is intended for single use only and contains no bacteriostatic agent. The radionuclidic impurity limit for indium 114m is not greater than 37 kBq, 1 µCi of indium 114m per 37 MBq, 1 mCi of indium In 111 at the time of calibration. The radionuclidic composition at expiration time is not less than 99.75% of indium In 111 and not more than 0.25% of indium In 114m/114.

Chemical name: Indium In 111 Oxyquinoline.

The precise structure of the indium In 111 oxyquinoline complex is unknown at this time. The empirical formula is (C9H6NO)3 In 111.

PHYSICAL CHARACTERISTICS

Indium In 111 decays by electron capture with a physical half-life of 67.2 hours (2.8 days). The energies of the photons that are useful for detection and imaging studies are listed in Table 1.

Table 1. Principal Radiation Emission Data*

Radiation	Mean %/ Disintegration	Mean Energy (keV)
* Kocher, David C., "Radioactive Decay Data Tables", DOE/TIC-11026, 115 (1981).
Gamma 2	90.2	171.3
Gamma 3	94	245.4

EXTERNAL RADIATION

The exposure rate constant for 37 MBq, 1 mCi indium In 111 is 8.3 × 10-4 C/kg/h (3.21 R/h) at 1 cm. The first half value thickness of lead (Pb) for indium In 111 is 0.023 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.834 cm of lead will decrease the external radiation exposure by a factor of about 1,000.

Table 2. Radiation Attenuation by Lead Shielding*

Shield Thickness (Pb) cm	Coefficient of Attenuation
* Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1984.
0.023	0.5
0.203	10-1
0.513	10-2
0.834	10-3
1.12	10-4

These estimates of attenuation do not take into consideration the presence of longer-lived contaminants with higher energy photons, namely indium In 114m/114.

To allow correction for physical decay of indium In 111, the fractions that remain at selected intervals before and after the time of calibration are shown in Table 3.

Table 3. Physical Decay Chart for Indium In 111, Half-life 67.2 hours

Day	Fraction Remaining	Day	Fraction Remaining
* Calibration Time
-2	1.641	2	0.610
-1	1.281	3	0.476
0*	1.000	4	0.372
1	0.781	5	0.290

Indium Oxyquinoline - Clinical Pharmacology

Indium forms a saturated (1:3) complex with oxyquinoline. The complex is neutral and lipid-soluble, which enables it to penetrate the cell membrane. Within the cell, indium becomes firmly attached to cytoplasmic components; the liberated oxyquinoline is released by the cell. It is thought likely that the mechanism of labeling cells with indium In 111 oxyquinoline involves an exchange reaction between the oxyquinoline carrier and subcellular components which chelate indium more strongly than oxyquinoline. The low stability constant of the oxyquinoline complex, estimated at approximately 10, supports this theory.

Following the recommended leukocyte cell labeling procedure, approximately 77% of the added indium In 111 oxyquinoline is incorporated in the resulting cell pellet (which represents approximately 3-4 × 108 WBC).

Cell clumping can occur and was found in about one fifth of the leukocyte preparations examined. The presence of red blood cells or plasma will lead to reduced leukocyte labeling efficiency. Transferrin in plasma competes for indium In 111 oxyquinoline.

After injection of labeled leukocytes into normal volunteers, about 30% of the dose is taken up by spleen and 30% by liver, reaching a plateau at 2-48 hours after injection. No significant clearance of radioactivity is observed at 72 hours in these two organs. Pulmonary uptake is 4-7.5% at 10 minutes but is lost rapidly; pulmonary radioactivity is usually visible in scans only up to about 4 hours after injection.

The human biodistribution studies in three normal subjects injected with indium In 111 oxyquinoline labeled leukocytes indicate a biexponential disappearance of indium In 111 from the blood when monitored for up to 72 hours. Between 9.5 to 24.4% of the injected dose remains in whole blood and clears with a biological half-time of 2.8 to 5.5 hours. The remainder (13-18%) clears from blood with a biological half-time of 64 to 116 hours.

Elimination from the body of injected indium In 111 oxyquinoline is probably mainly through decay to stable cadmium since only a negligible amount (less than 1%) of the dose is excreted in feces and urine in 24 hours.

Clearance from whole blood and biological distribution can vary considerably with the individual recipient, the condition of the injected cells and labeling techniques used.

Release of radioactivity from the labeled cells is about 3% at 1 hour and 24% at 24 hours.

Clearance from liver and spleen, for the purpose of calculating the radiation dose, is assumed to be equal to the physical half-life of indium In 111 (67.2 hours).

Indications and Usage for Indium Oxyquinoline

Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes.

Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.

Indium In 111 oxyquinoline labeled leukocyte imaging is not the preferred technique for the initial evaluation of patients with a high clinical probability of an abscess in a known location. Ultrasound or computed tomography may provide a better anatomical delineation of the infectious process and information may be obtained more quickly than with labeled leukocytes. If localization by these techniques is successful, labeled leukocytes should not be used as a confirmatory procedure. If localization or diagnosis by these methods fails or is ambiguous, indium In 111 oxyquinoline labeled leukocyte imaging may be appropriate.

Contraindications

None known.

Warnings

The content of the vial of indium In 111 oxyquinoline solution is intended only for use in the preparation of indium In 111 oxyquinoline labeled autologous leukocytes, and is not to be administered directly. Autologous leukocyte labeling is not recommended in leukopenic patients because of the small number of available leukocytes.

Due to radiation exposure, indium In 111 oxyquinoline labeled leukocytes could cause fetal harm when administered to pregnant women. If this radiopharmaceutical is used during pregnancy, the patient should be informed of the potential hazard to the fetus.

Indium In 111 oxyquinoline labeled autologous leukocytes should be used only when the benefit to be obtained exceeds the risks involved in children under eighteen years of age owing to the high radiation burden and the potential for delayed manifestation of long-term adverse effects.

Precautions

Clumping of cells may produce focal accumulations of radioactivity in lungs which do not wash out in 24 hours and thus may lead to false positive results. This phenomenon can be detected by imaging the chest immediately after injection.

The normally high uptake of indium In 111 oxyquinoline labeled leukocytes by spleen and liver may mask inflammatory lesions in these organs. Labeled leukocytes have been observed to accumulate in the colon and accessory spleens of patients with or without disease.

Chemotaxis of granulocytes deteriorates during storage and loss of chemotaxis may cause false negative scans. The spontaneous release of indium In 111 has been reported to range from about 3% at one hour to 24% at 24 hours [ten Berge, R.J.M., Natarajan, A.T., Hardeman, M.R., et al, Labeling with indium In 111 has detrimental effects on human lymphocytes, Journal of Nuclear Medicine, 24, 615-620 (1983)]. The maximum amount of time recommended between drawing the blood and reinjection should not exceed 5 hours. It is recommended that the labeled cells be used within one hour of preparation, if possible and in no case more than three hours after preparation.

Plasma and red cell contamination impairs labeling efficiency of leukocytes. Hemolyzed blood in labeled leukocytes may produce heart pool activity and should be avoided.

Cell aggregates of various degrees have been reported. Cell labeling techniques and standing of cell preparation may be contributing factors.

Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. A system of checks similar to the ones used for administering blood transfusions should be routine.

General

Strict aseptic techniques should be used to maintain sterility throughout the procedures for using this product.

Do not use after the expiration time and date (5 days after calibration time) stated on the label.

The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times.

Indium In 111 oxyquinoline, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management.

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Although earlier studies suggested that oxyquinoline (oxine) might have carcinogenic potential, recent studies have found no evidence of carcinogenicity in either rats or mice given oxyquinoline in feed at concentrations of 1,500 or 3,000 ppm for 103 weeks.

It has been reported [ten Berge, R.J.M., Natarajan, A.T., Hardeman, M.R., et al, Labeling with indium In 111 has detrimental effects on human lymphocytes, Journal of Nuclear Medicine, 24, 615-620 (1983)] that human lymphocytes labeled with recommended concentrations of indium In 111 oxyquinoline showed chromosome aberrations consisting of gaps, breaks and exchanges that appear to be radiation induced. At 555 kBq/107, 15 µCi/107 lymphocytes 93% of the cells were reported to be abnormal. The oncogenic potential of such lymphocytes has not been studied. It has been reported that the radiation dose to 108 leukocytes is 9 × 104 mGy (0.9 × 104 rads) from 18.5 MBq, 500 µCi [Goodwin, David A., Cell labeling with oxine chelates of radioactive metal ions: Techniques and clinical implications, Journal of Nuclear Medicine, 19, 557-559 (1978)].

Studies have not been performed to evaluate whether indium In 111 oxyquinoline affects fertility in male or female laboratory animals or humans.

Pregnancy Category C

Animal reproduction studies have not been conducted with Indium In 111 Oxyquinoline labeled leukocytes. It is also not known whether Indium In 111 Oxyquinoline labeled leukocytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

However, Indium Nitrate, a closely related compound, was teratogenic and embryopathic in hamsters. Indium In 111 Oxyquinoline labeled leukocytes should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability should be performed during the first few (approximately ten) days following the onset of menses.

Nursing Mothers

It is reported that indium 111 is secreted in human milk following administration of indium In 111 labeled leukocytes. Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

Safety and effectiveness in pediatric patients below age 18 have not been established (See Warnings).

Adverse Reactions

Sensitivity reactions (urticaria) have been reported. The presence of fever may mask pyrogenic reactions from indium In 111 oxyquinoline labeled leukocytes. The possibility of delayed adverse reactions has not been studied.

Indium Oxyquinoline Dosage and Administration

The recommended adult (70 kg) dose of indium In 111 oxyquinoline labeled autologous leukocytes is 7.4 to 18.5 MBq, 200-500 µCi. Indium In 111 oxyquinoline solution is intended for the radiolabeling of autologous leukocytes. The indium In 111 oxyquinoline labeled autologous leukocytes are administered intravenously.

Imaging is recommended at approximately 24 hours post injection. Typically, anterior and posterior views of the chest, abdomen and pelvis should be obtained with other views as required.

Aseptic procedures and a shielded syringe should be employed in the withdrawal of indium In 111 oxyquinoline from the vial. Similar procedures should be employed during the labeling procedure and the administration of the labeled leukocytes to the patient. The user should wear waterproof gloves during the entire procedure. The patient's dose should be measured by a suitable radioactivity calibration system immediately before administration. At this time, the leukocyte preparation should be checked for gross clumping and red blood cell contamination.

RADIATION DOSIMETRY

The estimated absorbed radiation doses to an adult patient weighing 70 kg from an intravenous dose of 18.5 MBq, 500 µCi of indium In 111 oxyquinoline labeled leukocytes including contributions from indium In 114m/114 as a radionuclidic impurity are shown in Table 4.

Table 4. Radiation Dose Estimate in a 70 kg Human for 18.5 MBq, 500 µCi at Expiry of Indium In 111 (99.75%) Oxyquinoline labeled leukocytes with Indium In 114m/114 (0.25%)

Assumptions: 30% to spleen, 30% to liver, 34% to red marrow, 6% to remainder of body, with no excretion.
Organ	mGy/18.5 MBq In 111	Rads/500 µCi In 111
Spleen	130	13
Liver	19	1.9
Red Marrow	13	1.3
Skeleton	3.64	0.364
Testes	0.1	0.01
Ovaries	1.9	0.19
Total Body	3.1	0.31
Organ	mGy/46.25 kBq In 114m/114	Rads/1.25 µCi In 114m/114
Spleen	70	7
Liver	7.1	0.71
Red Marrow	6.9	0.69
Skeleton	0.85	0.085
Testes	0.04	0.004
Ovaries	0.06	0.006
Total Body	0.6	0.06
Organ	Total Dose in mGy	Total Dose in Rads
Spleen	200	20
Liver	26.6	2.66
Red Marrow	19.9	1.99
Skeleton	4.5	0.45
Testes	0.14	0.014
Ovaries	2.0	0.2
Total Body	3.7	0.37

The dose of radiation absorbed by the organs will vary with the distribution of the blood cells in the organs, which in turn will depend on the predominance of the cell types labeled and their condition.

LABELING PROCEDURE

Sterile technique must be used throughout. It is important that all equipment used for the preparation of reagents be thoroughly cleaned to assure the absence of trace metal impurities. The user should wear waterproof gloves during the handling and administration procedure.

1. The following equipment is recommended:
   
   One (1) 60 mL or two (2) 30 mL sterile disposable plastic syringes with a 19 or 20 gauge needle (NOTE: Do not use a smaller gauge needle).
   
   Ring stand and clamp(s).
   
   Three (3) 50 mL sterile conical plastic centrifuge tubes with screw caps. Label each set with patient ID and "WBC", "LPP" and "Wash" respectively (NOTE: 3 centrifuge tubes per patient).
   
   Clinical Centrifuge with horizontal, 4 place rotor or equivalent.
   
   Sodium Chloride 0.9% Injection, USP.
   
   Three (3) disposable 5 or 10 mL syringes and 19 gauge needles.
   
   Syringe shield to dispense indium In 111 oxyquinoline.
   
   A dose calibrator.
   
   Butterfly catheter infusion set.
   
   Test tube rack.
   
   Lab timer.
   
   10 mL syringe with a 19 gauge or 20 gauge needle.
   
   19 gauge needle with filter (optional).


2. Withdraw from the patient 30-50 mL blood [preferably fifty (50) mL] using aseptic venipuncture technique using the 60 mL syringe fitted with a 19 gauge or 20 gauge needle and containing approximately 1000-1500 units heparin in 1-2 mL. Blood withdrawal should be smooth and slow so as not to produce bubbles or foaming.


3. Remove and dispose of the needle and replace with a syringe cap. Gently mix the contents of the syringe and label with the patient's ID, date and time.


4. Upon receipt of the full syringe for processing, the contents should again be gently mixed.


5. Clamp the syringe barrel to the ring stand in an upright (needle side up) position and tilt the syringe 10-20 degrees from its position perpendicular to the bench.


6. Allow the red cells to sediment 30-60 minutes, depending upon when the supernatant [leukocyte rich plasma (LRP)] looks clear of red blood cells.


7. Replace the syringe cap with an infusion set.


8. Collect the plasma (LRP) in the centrifuge tube marked "WBC" by expressing the LRP through the catheter tubing making sure not to get any red cells into the WBC tube.


9. Immediately centrifuge the capped WBC tube at 400-450 g for 5 minutes.


10. Transfer the supernatant to the leukocyte poor plasma (LPP) tube leaving behind 0.5-1.0 mL supernatant to cover the white cell button (NOTE: the button often contains a small number of red cells and may appear red).


11. Wash the white cell button with 4-6 mL Sodium Chloride (0.9%) Injection, USP. Resuspend the button by gentle swirling.


12. Centrifuge the capped WBC tube at 400-450 g for 5 minutes (alternatively, 150 g for 8 minutes) and discard all but 0.5-1.0 mL of the supernate to cover the cells.


13. Add 5.0 mL Sodium Chloride (0.9%) Injection, USP. Resuspend the cells by gentle swirling.


14. With the shielded syringe, draw up approximately 22.2 MBq, 600 µCi indium In 111 oxyquinoline. Check the amount of radioactivity in a dose calibrator set for indium In 111 and record for labeling efficiency calculations.
    
    Parenteral drug products should be inspected visually for particulate matter and discoloration before administration.


15. In several additions, add the indium In 111 oxyquinoline to the WBC tube, gently swirling after each addition.


16. Set the lab timer for 15 minutes and allow the capped WBC tube to incubate. Swirl the cell preparation several times during the incubation.


17. With a sterile plastic syringe, add half of the saved LPP (or about 8 mL) from the LPP tube. Cap and gently swirl the contents of WBC tube to resuspend the cells.


18. Centrifuge the WBC tube at 450 g for 5 minutes (or 150 g for 8 minutes). Decant supernatant into the wash tube leaving behind about 0.5 mL of the supernate to cover the cells.


19. Assay the activity in the WBC tube and in the wash tube in a dose calibrator and record.


20. With a sterile plastic syringe add the remaining LPP to the cell button and gently resuspend by swirling. With a sterile syringe fitted with a 19 gauge needle, resuspend the cells by drawing the cells up into the syringe and expressing the suspension against the tube gently once or twice. Alternatively, draw up the cells into a syringe fitted with the filtered 19 gauge needle, and replace the needle with an unfiltered 19 or 20 gauge needle.


21. Reserve in the WBC tube a minimum amount of white cell suspension for a WBC count. A microscopic examination should also be completed to observe for clumping. Draw up the patient's dose (7.4 to 18.5 MBq, 200-500 µCi) and check the syringe in the dose calibrator. Record the measurement.

QUALITY CONTROL

It is generally advantageous to record any observations on cell abnormalities (e.g., cell clumping). A trypan blue exclusion test may also be performed.

It is recommended that the preparation be used within one hour of labeling (See Precautions).

How is Indium Oxyquinoline Supplied

Indium In 111 oxyquinoline solution is supplied in a vial as a single use only product containing 37 MBq, 1.0 mCi in 1.0 mL aqueous solution at the calibration date stated on the label. Vials are packaged in individual lead shields.

(NDC 17156-021-01)

The contents of the vial are radioactive and adequate shielding and handling precautions must be maintained.

This radiopharmaceutical is licensed by Illinois Department of Nuclear Safety for distribution to persons licensed pursuant to 32 Ill. Adm. Code 330.260 (a) and Part 335, Subpart E, 335.4010, or under equivalent licenses of an Agreement State or a Licensing State.

SPECIAL HANDLING AND STORAGE

Indium In 111 oxyquinoline solution should be stored at room temperature (15-25 °C, 59-77 °F).

Indium In 111 oxyquinoline labeled autologous leukocytes should preferably be reinjected within one hour of labeling. The labeled cells may be stored at room temperature (15-25 °C, 59-77 °F) for up to three hours following completion of the cell labeling procedure. Reinjection of indium In 111 oxyquinoline labeled autologous leukocytes more than 5 hours after initial blood drawing is not recommended.

Sterile technique must be used throughout the collection, labeling and re-injection procedures.

Amersham Health

Medi-Physics, Inc.

Arlington Heights, IL 60004

1-800-654-0118

Printed in U.S.A.

Manufactured by:

Amersham plc,

Amersham, England

43-2015J

CODE IN.15PA

INDIUM IN 111 OXYQUINOLINE  indium in-111 oxyquinoline  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17156-021 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Indium In-111 Oxyquinoline (Indium In-111 Oxyquinoline) Active 1 MICROGRAM  In 1 MILLILITER Polysorbate 80 Inactive 100 MICROGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17156-021-01 1 VIAL In 1 BOX contains a VIAL 1 1 mL (MILLILITER) In 1 VIAL This package is contained within the BOX (17156-021-01)

Revised: 05/2006Amersham Health Medi Physics, Inc.

More Indium Oxyquinoline resources

• Indium Oxyquinoline Side Effects (in more detail)
• Indium Oxyquinoline Drug Interactions
• Indium Oxyquinoline Support Group
• 0 Reviews · Be the first to review/rate this drug

Isosorbide Dinitrate Extended-Release

Pronunciation: eye-soe-SOR-bide dye-NYE-trate
Generic Name: Isosorbide Dinitrate Extended-Release
Brand Name: Dilatrate-SR

Isosorbide Dinitrate Extended-Release is used for:

Preventing symptoms of angina (chest pain) caused by heart disease. Isosorbide Dinitrate Extended-Release is used alone or with other medicines. Isosorbide Dinitrate Extended-Release is NOT intended for the immediate relief of acute attacks of angina. It may also be used for other conditions as determined by your doctor.

Isosorbide Dinitrate Extended-Release is a nitrate. It works by relaxing the blood vessels in the body, allowing them to widen. This lets more blood flow through the blood vessels, which reduces the work the heart has to do to pump blood. This reduces the oxygen needs of the heart and makes chest pain go away.

Do NOT use Isosorbide Dinitrate Extended-Release if:

• you are allergic to any ingredient in Isosorbide Dinitrate Extended-Release


• you are taking a phosphodiesterase type 5 inhibitor (eg, sildenafil), a medicine often used for sexual dysfunction

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

Before using Isosorbide Dinitrate Extended-Release:

Some medical conditions may interact with Isosorbide Dinitrate Extended-Release. 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 bleeding in the brain, a recent head trauma, a heart attack, an overactive thyroid, or anemia (a low red blood cell count)

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

• Ethanol or phosphodiesterase type 5 inhibitors (eg, sildenafil) because side effects such as extremely low blood pressure, dizziness, or fainting may occur

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

Use Isosorbide Dinitrate Extended-Release as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Isosorbide Dinitrate Extended-Release by mouth on an empty stomach with a full glass of water (8 oz/240 mL).


• Swallow Isosorbide Dinitrate Extended-Release whole. Do not break, crush, or chew before swallowing.


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

Ask your health care provider any questions you may have about how to use Isosorbide Dinitrate Extended-Release.

Important safety information:

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


• Isosorbide Dinitrate Extended-Release 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.


• When you begin taking Isosorbide Dinitrate Extended-Release, it may give you a headache. This usually becomes less noticeable with time. This is a sign that the medicine is working. Do not change your dosing schedule to avoid headaches. Take aspirin or acetaminophen with Isosorbide Dinitrate Extended-Release to avoid headaches.


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

When used for long periods of time or at high doses, Isosorbide Dinitrate Extended-Release may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Isosorbide Dinitrate Extended-Release stops working well. Do not take more than prescribed. Some people who use Isosorbide Dinitrate Extended-Release for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as physical DEPENDENCE. If you stop taking Isosorbide Dinitrate Extended-Release suddenly, you may have WITHDRAWAL symptoms. These may include rapid heartbeat, chest pain, and even heart attack.

Possible side effects of Isosorbide Dinitrate Extended-Release:

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; flushing of the face and neck; headache; lightheadedness; nausea; 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); fainting; frequent or continuing chest pain; rapid heartbeat.

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 Dinitrate Extended-Release 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 confusion; diarrhea; difficulty breathing; dizziness; headache; irregular and/or forceful heartbeat; loss of consciousness; nausea; seizures; slow pulse; stomach pain; sweating; vision problems; vomiting.

Proper storage of Isosorbide Dinitrate Extended-Release:

Store Isosorbide Dinitrate Extended-Release 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 Isosorbide Dinitrate Extended-Release out of the reach of children and away from pets.

General information:

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


• Isosorbide Dinitrate Extended-Release 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 Isosorbide Dinitrate Extended-Release. 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 Dinitrate Extended-Release resources

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

Compare Isosorbide Dinitrate Extended-Release with other medications

• Angina
• Angina Pectoris Prophylaxis
• Esophageal Spasm
• Heart Failure
• Pulmonary Arterial Hypertension

Isosorbide Dinitrate/Hydralazine

Pronunciation: eye-soe-SOR-bide die-NYE-trate/hye-DRAL-a-zeen
Generic Name: Isosorbide Dinitrate/Hydralazine
Brand Name: BiDil

Isosorbide Dinitrate/Hydralazine is used for:

Treating heart failure in certain patients. It may also be used for other conditions as determined by your doctor.

Isosorbide Dinitrate/Hydralazine is a vasodilator combination. It works by relaxing and dilating (opening) the blood vessels in the body, allowing blood to flow through the vessels easier and at a lower pressure.

Do NOT use Isosorbide Dinitrate/Hydralazine if:

• you are allergic to nitrates or to any ingredient in Isosorbide Dinitrate/Hydralazine


• you are taking certain medicines for erectile or lung problems (eg, phosphodiesterase inhibitors [sildenafil, vardenafil, tadalafil])

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

Before using Isosorbide Dinitrate/Hydralazine:

Some medical conditions may interact with Isosorbide Dinitrate/Hydralazine. 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 blood problems (eg, anemia), dehydration problems, heart problems, low blood pressure, liver problems, lupus, or an overactive thyroid, or you have had a recent head injury or recent heart attack

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

• Medicines that affect your blood vessels, medicines that treat high blood pressure, or other vasodilators because they may increase the risk of Isosorbide Dinitrate/Hydralazine's side effects


• Monoamine oxidase (MAO) inhibitors (eg, furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) or phosphodiesterase inhibitors (sildenafil, tadalafil, vardenafil) because the risk of severe low blood pressure may be increased or because serious side effects may occur


• Beta-blockers (eg propranolol) or lisinopril because the risk of their side effects may be increased by Isosorbide Dinitrate/Hydralazine

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

Use Isosorbide Dinitrate/Hydralazine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Isosorbide Dinitrate/Hydralazine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Drinking extra fluids while you are taking Isosorbide Dinitrate/Hydralazine is recommended. Check with your doctor for instructions.


• Take Isosorbide Dinitrate/Hydralazine on a regular schedule to get the most benefit from it. Taking Isosorbide Dinitrate/Hydralazine at the same time each day will help you remember to take it.


• Continue to take Isosorbide Dinitrate/Hydralazine even if you feel well. Do not miss any doses.


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

Ask your health care provider any questions you may have about how to use Isosorbide Dinitrate/Hydralazine.

Important safety information:

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


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


• Isosorbide Dinitrate/Hydralazine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, fever, low fluid intake, excessive sweating, vomiting, or diarrhea can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of dizziness, lightheadedness, or weakness. If fainting occurs, notify your doctor as soon as possible.


• Isosorbide Dinitrate/Hydralazine may cause a vitamin B₆ deficiency. Talk with your doctor for more information.


• Tell your doctor or dentist that you take Isosorbide Dinitrate/Hydralazine before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including blood pressure checks, may be performed while you use Isosorbide Dinitrate/Hydralazine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Isosorbide Dinitrate/Hydralazine with caution in the ELDERLY; they may be more sensitive to its effects.


• Isosorbide Dinitrate/Hydralazine 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 Dinitrate/Hydralazine while you are pregnant. It is not known if Isosorbide Dinitrate/Hydralazine is found in breast milk. If you are or will be breast-feeding while you use Isosorbide Dinitrate/Hydralazine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Isosorbide Dinitrate/Hydralazine:

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; lightheadedness; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; difficult urination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; joint pain; numbness or tingling of the skin; persistent fatigue or weakness; runny nose; severe or persistent headache or dizziness; vision changes.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; confusion; fast or irregular heartbeat; flushing; severe headache; shock.

Proper storage of Isosorbide Dinitrate/Hydralazine:

Store Isosorbide Dinitrate/Hydralazine at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isosorbide Dinitrate/Hydralazine out of the reach of children and away from pets.

General information:

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


• Isosorbide Dinitrate/Hydralazine 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 Isosorbide Dinitrate/Hydralazine. 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 Dinitrate/Hydralazine resources

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

Compare Isosorbide Dinitrate/Hydralazine with other medications

• Heart Failure