Cinacalcet

Pronunciation: SIN-a-KAL-set
Generic Name: Cinacalcet
Brand Name: Sensipar

Cinacalcet is used for:

Treating an overactive parathyroid gland in dialysis patients with chronic kidney disease. It is also used to treat high blood calcium levels in patients with parathyroid cancer. It is also used to treat severe high blood calcium levels in patients with an overactive parathyroid gland who are unable to undergo surgery to remove the parathyroid gland. It may also be used for other conditions as determined by your doctor.

Cinacalcet is a calcimimetic agent. It works by causing the parathyroid to produce less parathyroid hormone (PTH), which helps to lower blood calcium levels.

Do NOT use Cinacalcet if:

• you are allergic to any ingredient in Cinacalcet


• you have low blood calcium levels

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

Before using Cinacalcet:

Some medical conditions may interact with Cinacalcet. 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 liver problems


• if you have a history of low blood pressure; fast, slow, or irregular heartbeat; heart problems (eg, heart failure); bone problems; low blood calcium levels; or seizures


• if you are taking medicine to prevent seizures

Some MEDICINES MAY INTERACT with Cinacalcet.

• Azole antifungals (eg, itraconazole, ketoconazole) or erythromycin because they may increase the risk of Cinacalcet's side effects


• Carvedilol, flecainide, metoprolol, thioridazine, tricyclic antidepressants (eg, amitriptyline), or vinblastine because the risk of their side effects may be increased by Cinacalcet

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

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

• Take Cinacalcet by mouth with food or shortly after a meal.


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


• If you miss a dose of Cinacalcet, 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 Cinacalcet.

Important safety information:

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


• Lab tests, including calcium, phosphorous, and parathyroid hormone blood levels, may be performed while you take Cinacalcet. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Cinacalcet while you are pregnant. It is not known if Cinacalcet is found in breast milk. Do not breast-feed while taking Cinacalcet.

Possible side effects of Cinacalcet:

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

Constipation; diarrhea; dizziness; headache; loss of appetite; nausea; tiredness; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling of the skin; chest pain; confusion; decreased urination; depression; fainting; fast, slow, or irregular heartbeat; joint pain; muscle aches, cramps, pain, spasms, or weakness; seizures; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; swelling of the hands or feet; tremors; unusual bone pain; unusual thirst; unusual tiredness or weakness; very dry mouth.

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: Cinacalcet 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 burning, numbness, or tingling of the skin; muscle aches, cramps, pain, spasms, or weakness; seizures.

Proper storage of Cinacalcet:

Store Cinacalcet at 77 degrees F (25 degrees C). 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 Cinacalcet out of the reach of children and away from pets.

General information:

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


• Cinacalcet 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 Cinacalcet. 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 Cinacalcet resources

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

• Cinacalcet Monograph (AHFS DI)


• cinacalcet Advanced Consumer (Micromedex) - Includes Dosage Information


• Sensipar Prescribing Information (FDA)


• Sensipar Consumer Overview

Compare Cinacalcet with other medications

• Hypercalcemia of Malignancy
• Secondary Hyperparathyroidism

Cleocin T Gel

Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Examples include Cleocin T and Clindamax

Cleocin T Gel is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Cleocin T Gel is a topical lincomycin antibiotic. It works by killing sensitive bacteria that cause acne and reducing the amount of free fatty acids that irritate the skin surface.

Do NOT use Cleocin T Gel if:

• you are allergic to any ingredient in Cleocin T Gel or to lincomycin


• you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

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

Before using Cleocin T Gel:

Some medical conditions may interact with Cleocin T Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a gastrointestinal (bowel) disease or diarrhea

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

• Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because their actions and the risk of their side effects may be increased by Cleocin T Gel


• Erythromycin because it may decrease Cleocin T Gel's effectiveness

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

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

• Cleocin T Gel is for topical use on the skin only.


• Clean and dry the affected area. Cover the affected and surrounding area with a thin film of medicine.


• Cleocin T Gel works best if it is used at the same time each day.


• Continue to use Cleocin T Gel even if your condition improves. Do not miss any doses.


• If you miss a dose of Cleocin T Gel, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cleocin T Gel.

Important safety information:

• Cleocin T Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Several weeks may pass before you see improvement in your acne. Continue using Cleocin T Gel for the full time recommended by your doctor.


• Be sure to use Cleocin T Gel for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Do not get Cleocin T Gel in your eyes or on the inside of your nose or mouth. If you accidentally get the medicine in your eye, immediately flush with a large amount of cool tap water.


• If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Cleocin T Gel, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Cleocin T Gel should not be used in CHILDREN younger than 12 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 using Cleocin T Gel while you are pregnant. It is not known if Cleocin T Gel is found in breast milk. Do not breast-feed while taking Cleocin T Gel.

Possible side effects of Cleocin T Gel:

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:

Dryness; itching; oiliness or oily skin.

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); blood or mucus in stools; bloody or severe diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.

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: Cleocin T 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. Cleocin T Gel may be harmful if swallowed.

Proper storage of Cleocin T Gel:

Store Cleocin T Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Protect from freezing. Keep Cleocin T Gel out of the reach of children and away from pets.

General information:

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


• Cleocin T Gel 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 Cleocin T Gel. 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 Cleocin T resources

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

Compare Cleocin T with other medications

• Acne
• Perioral Dermatitis

Children's Acetaminophen Cherry Flavor

Generic Name: acetaminophen (Oral route, Rectal route)

a-seet-a-MIN-oh-fen

Commonly used brand name(s)

In the U.S.

• Actamin Maximum Strength


• Altenol


• Aminofen


• Anacin Aspirin Free


• Apra


• Cetafen


• Children's Nortemp


• Comtrex Sore Throat Relief


• Dolono


• Feverall


• Genapap


• Tylenol

In Canada

• Abenol


• Acetaminophen


• Actimol Children's


• Actimol Infant


• Atasol


• Children's Acetaminophen


• Children's Acetaminophen Bubble Gum Flavor


• Children's Acetaminophen Cherry Flavor


• Children's Acetaminophen Grape Flavor


• Children's Acetaminophen Suspension Bubble Gum Flavor - Ages 2 To 11


• Children's Acetaminophen Suspension Cherry Flavor


• Children's Acetaminophen Suspension Grape Flavor - Ages 2 To 11

Available Dosage Forms:

• Solution


• Tablet, Disintegrating


• Suppository


• Powder


• Syrup


• Tablet


• Tablet, Chewable


• Capsule


• Powder for Solution


• Suspension


• Elixir


• Tablet, Extended Release


• Capsule, Liquid Filled


• Liquid


• Tablet, Effervescent

Therapeutic Class: Analgesic

Uses For Children's Acetaminophen Cherry Flavor

Acetaminophen is used to relieve minor aches and pain and reduce fever. Unlike aspirin, it does not relieve the redness, stiffness, or swelling caused by rheumatoid arthritis. However, it may relieve the pain caused by mild forms of arthritis.

This medicine is available without a prescription.

Before Using Children's Acetaminophen Cherry Flavor

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of acetaminophen in children. However, do not administer the over-the-counter products to children under 2 years old unless your doctor has instructed you to do so.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen in the elderly.

Pregnancy

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

Breast Feeding

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 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 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.

• Acenocoumarol


• Carbamazepine


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

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:

• Alcohol abuse, or history of or


• Kidney disease, severe or


• Liver disease (including hepatitis)—The chance of serious side effects may be increased.

• Phenylketonuria (PKU)—Some brands of acetaminophen contain aspartame, which can make your condition worse.

Proper Use of acetaminophen

This section provides information on the proper use of a number of products that contain acetaminophen. It may not be specific to Children's Acetaminophen Cherry Flavor. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may cause an overdosage. Liver damage can occur if large amounts of acetaminophen are taken for a long time.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

You may take this medicine with or without food.

If you are taking this medicine without the advice of your doctor, carefully read and follow the drug facts label and dosing instructions on the medicine package. This is to avoid confusion and dosing errors. Ask your doctor if you have any questions.

For patients using the oral liquid with syringe (e.g. Little Fevers®):

• Shake the bottle well before each use.


• Measure the dose with the provided dose syringe (e.g., AccuSafe™) that comes with the package. Do not use any other syringe, dropper, spoon, or dosing device when giving this medicine to your child.


• Remove the cap, attach the syringe to the flow restrictor, and invert the bottle.


• Pull back the syringe until filled with the dose prescribed by your doctor.


• Slowly give the medicine into your child's mouth (towards the inner cheek).


• Replace the cap back tightly.

For patients using the oral liquid with dropper:

• Shake the bottle well before each use.


• Measure the dose with the provided dropper. Do not use any other syringe, dropper, spoon, or dosing device when giving this medicine to your child.


• Remove the cap, insert the dropper and withdraw the dose prescribed by your doctor.


• Slowly give the medicine into your child's mouth (towards the inner cheek).


• Replace the cap back tightly.

For patients using acetaminophen oral granules (e.g., Snaplets-FR):

• Just before the medicine is to be taken, open the number of packets needed for one dose.


• Mix the granules inside of the packets with a small amount of soft food, such as applesauce, ice cream, or jam.


• Eat the acetaminophen granules along with the food.

For patients using acetaminophen oral powders (e.g., Feverall® Sprinkle Caps [Children's or Junior Strength]):

• These capsules are not intended to be swallowed whole. Instead, just before the medicine is to be taken, open the number of capsules needed for one dose.


• Empty the powder from each capsule into 1 teaspoonful (5 mL) of water or other liquid.


• Drink the medicine along with the liquid. You may drink more liquid after taking the medicine.


• You may also mix the powder with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen powder along with the food.

For patients using acetaminophen suppositories:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.


• To insert the suppository:
  
  • First remove the foil wrapper and moisten the suppository with cold water.
  
  
  • Lie down on your side and use your finger to push the suppository well up into the rectum.
  
  

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 pain or fever:
  
  • For oral dosage forms (capsules, granules, powders, solution, suspension, or tablets) and rectal dosage forms (suppositories):
    
    • Adults and teenagers—325 or 500 milligrams (mg) every 3 or 4 hours, 650 mg every 4 to 6 hours, or 1000 mg every 6 hours as needed. The total dose should not be more than 4000 mg (for example, eight 500–mg tablets) a day.
    
    
    • Children—Dose is based on the child's age, do not administer the over-the-counter products to children under the age of 2 unless directed to do so by your doctor:
      
      • Children 11 to 12 years of age: 320 to 480 mg every 4 hours as needed.
      
      
      • Children 9 to 11 years of age: 320 to 400 mg every 4 hours as needed.
      
      
      • Children 6 to 9 years of age: 320 mg every 4 hours as needed.
      
      
      • Children 4 to 6 years of age: 240 mg every 4 hours as needed.
      
      
      • Children 2 to 4 years of age: 160 mg every 4 hours as needed.
      
      
      • Children 1 to 2 years of age: 120 mg every 4 hours as needed.
      
      
      • Infants 4 to 12 months of age: 80 mg every 4 hours as needed.
      
      
      • Infants up to 3 months of age: 40 mg every 4 hours as needed.
      
      
    
    
  
  

Missed Dose

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

Storage

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

Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Children's Acetaminophen Cherry Flavor

It is very important that your doctor check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

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

Stop using this medicine and check with your doctor or dentist right away:

• If you are taking this medicine to relieve pain, including arthritis pain, and the pain lasts for more than 10 days for adults or 5 days for children or if the pain gets worse, new symptoms occur, or the painful area is red or swollen. These could be signs of a serious condition that needs medical or dental treatment.


• If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, the fever gets worse, new symptoms occur, or redness or swelling is present. These could be signs of a serious condition that needs treatment.


• If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Adding these medicines to the medicine that you are already taking may cause you to get more than a safe amount of acetaminophen. Talk to your doctor before taking more than one medicine that contains acetaminophen.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

If you will be taking more than an occasional 1 or 2 doses of acetaminophen, do not drink alcoholic beverages. To do so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly, if you take more acetaminophen than is recommended on the package label, or if you take it regularly for a long time.

Taking certain other medicines together with acetaminophen may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with acetaminophen for more than a few days unless your doctor has directed you to do so and is following your progress:

• Aspirin or other salicylates


• Diclofenac (e.g., Voltaren®)


• Diflunisal (e.g., Dolobid®)


• Etodolac (e.g., Lodine®)


• Fenoprofen (e.g., Nalfon®)


• Floctafenine (e.g., Idarac®)


• Flurbiprofen, oral (e.g., Ansaid®)


• Ibuprofen (e.g., Motrin®)


• Indomethacin (e.g., Indocin®)


• Ketoprofen (e.g., Orudis®)


• Ketorolac (e.g., Toradol®)


• Meclofenamate (e.g., Meclomen®)


• Mefenamic acid (e.g., Ponstel®)


• Nabumetone (e.g., Relafen®)


• Naproxen (e.g., Naprosyn®)


• Oxaprozin (e.g., Daypro®)


• Phenylbutazone (e.g., Butazolidin®)


• Piroxicam (e.g., Feldene®)


• Sulindac (e.g., Clinoril®)


• Tenoxicam (e.g., Apo-Tenoxicam®)


• Tiaprofenic acid (e.g., Surgam®)


• Tolmetin (e.g., Tolectin®).

Acetaminophen may interfere with the results of some medical tests. Before you have any medical tests, tell the person in charge if you have taken acetaminophen within the past 3 or 4 days. If possible, it is best to call the laboratory where the test will be done about 4 days ahead of time, to find out whether this medicine may be taken during the 3 or 4 days before the test.

For diabetic patients:

• Acetaminophen may cause false results with some blood glucose (sugar) tests. If you notice any change in your test results, or if you have any questions about this possible problem, check with your doctor. This is especially important if your diabetes is not well-controlled.

For patients taking one of the products that contain caffeine in addition to acetaminophen:

• Caffeine may interfere with the results of a test that uses adenosine (e.g., Adenocard®) or dipyridamole (e.g., Persantine®) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose of acetaminophen, get emergency help at once, even if there are no signs of poisoning. Signs of severe poisoning may not appear for 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started as soon as possible. Treatment started more than 24 hours after the overdose is taken may not be effective.

Children's Acetaminophen Cherry Flavor Side Effects

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

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

Rare

• Bloody or black, tarry stools


• bloody or cloudy urine


• fever with or without chills (not present before treatment and not caused by the condition being treated)


• pain in the lower back and/or side (severe and/or sharp)


• pinpoint red spots on the skin


• skin rash, hives, or itching


• sore throat (not present before treatment and not caused by the condition being treated)


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


• sudden decrease in the amount of urine


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

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

Symptoms of overdose

• Diarrhea


• increased sweating


• loss of appetite


• nausea or vomiting


• stomach cramps or pain


• swelling, pain, or tenderness in the upper abdomen or stomach area

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: Children's Acetaminophen Flavor side effects (in more detail)

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

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More Children's Acetaminophen Cherry Flavor resources

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Chorionic Gonadotropin

choriogonadotropin alfa

Dosage Form: injection
Chorionic Gonadotropin For Injection, USP

Chorionic Gonadotropin Description

Human Chorionic Gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha sub-units of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH).  The beta sub-units of these hormones differ in amino acid sequence.  Chorionic Gonadotropin is obtained from the human pregnancy urine. It is standardized by a biological assay procedure.

Chorionic Gonadotropin for Injection, USP is available in multiple dose vials containing 10,000 USP Units with accompanying Bacteriostatic Water for Injection for reconstitution.  When reconstituted with 10 mL of the accompanying diluent each vial contains:

Chorionic Gonadotropin                         10,000 Units

Mannitol                                                 100 mg

Benzyl alcohol                                        0.9%

Water for Injection                                  q.s.

Buffered with dibasic sodium phosphate and monobasic sodium phosphate. Hydrochloric acid and/or sodium hydroxide may have been used for pH adjustment (6.0-8.0).  Nitrogen gas is used in the freeze drying process.

Chorionic Gonadotropin - Clinical Pharmacology

The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well.  It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.  Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present. This descent is usually reversible when HCG is discontinued. During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function.  During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone and preventing menstruation.  HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.

Indications and Usage for Chorionic Gonadotropin

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY.  THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR ‘‘NORMAL’’ DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.

1. Prepubertal cryptorchidism not due to anatomical obstruction.  In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty.  HCG thus may help predict whether or not orchiopexy will be needed in the future.  Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary.  Therapy is usually instituted between the ages four and nine.


2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.


3. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

Contraindications

Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.

Warnings

HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions and adverse reactions described in the package insert for menotropins.  The principal serious adverse reactions are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births and (4) Arterial thromboembolism.

Anaphylaxis and other hypersensitivity reactions have been reported with urinary-derived HCG products.

Precautions

General

Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism.  Therapy should be discontinued if signs of precocious puberty occur. 

Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine or asthma.

Drug/Laboratory Test Interactions

Chorionic Gonadotropin may interfere with radioimmunoassay for gonadotropins, particularly luteinizing hormone.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of Chorionic Gonadotropin.

Pediatric Use

Safety and effectiveness of Chorionic Gonadotropin in children below the age of four have not been established.

Pregnancy

Teratogenic Effects: Pregnancy Category C– Chorionic Gonadotropin may cause fetal harm when administered to a pregnant woman.  Defects of forelimbs and central nervous system and alterations in sex ratio have been reported in mice receiving combined gonadotropin and Chorionic Gonadotropin therapy in dosages to induce superovulation. Multiple ovulations with resulting plural gestations (mostly twins) have been reported to occur in approximately 20% of pregnancies when conception has followed Chorionic Gonadotropin therapy.

Nursing Mothers

It is not known whether Chorionic Gonadotropin is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when Chorionic Gonadotropin is administered to a nursing woman.

Adverse Reactions

Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.

Chorionic Gonadotropin Dosage and Administration

Intramuscular Use Only

The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient and the physician’s preference.  The following regimens have been advocated by various authorities.

Prepubertal Cryptochidism Not Due To Anatomical Obstruction

1. 4,000 USP Units three times weekly for three weeks.


2. 5,000 USP Units every second day for four injections.


3. 15 injections of 500 to 1,000 USP Units over a period of six weeks.


4. 500 USP Units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later giving 1,000 USP Units per injection.

Selected Cases Of Hypogonadotropic Hypogonadism In Males

1. 500 to 1,000 USP Units three times a week for three weeks, followed by the same dose twice a week for three weeks.


2. 4,000 USP Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP Units three times weekly for an additional three months.

Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins (see prescribing information for menotropins for dosage and administration for that drug product).  5,000 to 10,000 USP Units one day following the last dose of menotropins.  (A dosage of 10,000 Units is recommended in the labeling for menotropins.)

IMPORTANT: USE COMPLETELY WITHIN 60 DAYS AFTER RECONSTITUTION. REFRIGERATE AFTER RECONSTITUTION.

DIRECTIONS FOR RECONSTITUTION

Two-Vial Package

Withdraw sterile air from lyophilized vial and inject into diluent vial.  Remove 10 mL from diluent vial and add to lyophilized vial; agitate gently until solution is complete.

How is Chorionic Gonadotropin Supplied

Chorionic Gonadotropin for Injection, USP, lyophilized, is supplied in two-vial packages including Bacteriostatic Water for Injection as diluent as follows:

Product No.	NDC No.
25021	63323-025-10	Chorionic Gonadotropin for Injection, USP, 10,000 USP Units in a 10 mL multiple dose vial with accompanying diluent in packages of 10.

The product is assayed in accord with the USP method and potencies refer to USP Units

(International Units) defined in terms of the USP Chorionic Gonadotropin Reference Standard.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

45792G

Revised: April 2011

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Chorionic Gonadotropin 10 mL Multiple Dose Vial Label

25021

Chorionic Gonadotropin for Injection, USP

10,000 USP units

For IM Use Only

Multiple Dose Vial

Rx only

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Chorionic Gonadotropin 10 mL Multiple Dose Vial Carton Panel

NDC 63323-025-10

25021

Chorionic Gonadotropin for Injection, USP

10,000 USP units

With Bacteriostatic Water for

Injection, USP as Diluent

For IM Use Only

Two-Vial Set

10 mL

Multiple Dose Vials

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY - Bacteriostatic Water 10 mL Multiple Dose Vial Label

95106

Bacteriostatic Water For Injection, USP 

NOT FOR USE IN NEWBORNS

10 mL

Multiple Dose Vial

Rx only

Chorionic Gonadotropin  choriogonadotropin alfa  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63323-025

Packaging # NDC Package Description Multilevel Packaging 1 63323-025-10 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE   10 mL Part 2 1 VIAL, MULTI-DOSE   10 mL

Part 1 of 2 Chorionic Gonadotropin  choriogonadotropin alfa  injection, powder, lyophilized, for solution

Product Information       Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHORIOGONADOTROPIN ALFA (CHORIOGONADOTROPIN ALFA) CHORIOGONADOTROPIN ALFA 10000 [USP'U]  in 10 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 100 mg  in 10 mL BENZYL ALCOHOL   SODIUM PHOSPHATE, MONOBASIC   SODIUM PHOSPHATE, DIBASIC   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10 mL In 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017067 04/21/2011

Part 2 of 2 WATER  water  injection, solution

Product Information       Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength No Active Ingredients Found

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   WATER   HYDROCHLORIC ACID   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10 mL In 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017067 04/21/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017067	04/21/2011

Labeler - APP Pharmaceuticals, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
APP Pharmaceuticals, LLC		023648251	MANUFACTURE

Revised: 04/2011APP Pharmaceuticals, LLC

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chondroitin, glucosamine, and methylsulfonylmethane

Generic Name: chondroitin, glucosamine, and methylsulfonylmethane (kon DROI tin, gloo KOSE a meen, and METH il sul FON il METH ane)

Brand names: Glucosamine & Chondroitin with MSM, Glucosamine Chondroitin MSM Complex, Osteo Bi-Flex Advanced, Osteo Bi-Flex Plus MSM, Glucosamine & Chondroitin with MSM

What is chondroitin, glucosamine, and methylsulfonylmethane?

Chondroitin is a naturally occurring substance formed of sugar chains. Chondroitin is believed to help the body maintain fluid and flexibility in the joints.

Glucosamine is a naturally occurring substance that is believed to help develop and renew cartilage (the hard connective tissue mainly located on bones near joints in the body), and keep it lubricated for better joint movement and flexibility.

Methylsulfonylmethane is a naturally occurring form of sulfur that helps support muscles and tendons in the body.

The combination of chondroitin, glucosamine, and methylsulfonylmethane is used to aid in maintaining healthy joints. It is also used as a nutritional supplement in people with osteoarthritis or other inflammatory joint disorders.

Not all uses for chondroitin, glucosamine, and methylsulfonylmethane have been approved by the FDA. Chondroitin, glucosamine, and methylsulfonylmethane should not be used in place of medication prescribed for you by your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Chondroitin, glucosamine, and methylsulfonylmethane may also be used for purposes not listed in this product guide.

What is the most important information I should know about chondroitin, glucosamine, and methylsulfonylmethane?

Not all uses for this product have been approved by the FDA. Chondroitin, glucosamine, and methylsulfonylmethane should not be used in place of medication prescribed for you by your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Before using this product, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use chondroitin, glucosamine, and methylsulfonylmethane if you have diabetes, a bleeding or blood clotting disorder such as hemophilia, if you have allergies to certain drugs, if you are overweight, or if you are on a low-salt diet.

Do not take chondroitin, glucosamine, and methylsulfonylmethane without the medical advice if you are using insulin, or a blood thinner such as warfarin (Coumadin, Jantoven). Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin, glucosamine, and methylsulfonylmethane. Chitosan can make it harder for your body to absorb chondroitin.

What should I discuss with my healthcare provider before taking chondroitin, glucosamine, and methylsulfonylmethane?

You should not use this product if you are allergic to it.

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

• 
  

  diabetes;

  
  


• 
  

  a bleeding or blood clotting disorder such as hemophilia;

  
  


• 
  

  if you have allergies to certain drugs;

  
  


• 
  

  if you are overweight; or

  
  


• 
  

  if you are on a low-salt diet.

  
  

It is not known whether chondroitin, glucosamine, and methylsulfonylmethane will harm an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using this product. It is not known whether chondroitin, glucosamine, and methylsulfonylmethane passes into breast milk or if it could harm a nursing baby. Do not use this product without telling your healthcare provider if you are breast-feeding a baby.

How should I take chondroitin, glucosamine, and methylsulfonylmethane?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use chondroitin, glucosamine, and methylsulfonylmethane, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

It may take up several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a few weeks of treatment.

Glucosamine may increase the glucose (sugar) levels in your blood. If you have diabetes, you may need to check your blood sugar more often while taking this medication. You may also need to adjust your insulin dosage. Do not change your dose or medication schedule without advice from your doctor.

Chondroitin, glucosamine, and methylsulfonylmethane may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking chondroitin, glucosamine, and methylsulfonylmethane?

Avoid taking chitosan (usually marketed as a weight-loss product) while you are taking chondroitin, glucosamine, and methylsulfonylmethane. Chitosan can make it harder for your body to absorb chondroitin.

Chondroitin, glucosamine, and methylsulfonylmethane 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.

Less serious side effects may include:

• 
  

  mild nausea, upset stomach;

  
  


• 
  

  heartburn; or

  
  


• 
  

  diarrhea.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect chondroitin, glucosamine, and methylsulfonylmethane?

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

• 
  

  insulin; or

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven).

  
  

This list is not complete and other drugs may interact with chondroitin, glucosamine, and methylsulfonylmethane. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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• Chondroitin, glucosamine, and methylsulfonylmethane Drug Interactions
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• 1 Review for Chondroitin, glucosamine, and methylsulfonylmethane - Add your own review/rating

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Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

Cholografin Meglumine

Dosage Form: injection, solution

NOT FOR INTRATHECAL USE

FOR INTRAVENOUS USE ONLY

Cholografin Meglumine Description

Cholografin Meglumine (lodipamide Meglumine Injection 52%) is a radiopaque contrast agent for rapid intravenous cholangiography and cholecystography supplied as a sterile, aqueous solution. Each mL provides 520 mg iodipamide meglumine; at manufacture, 3.2 mg sodium citrate buffer and 0.4 mg edetate disodium sequestering agent are added per mL. The pH has been adjusted between 6.5 and 7.7 with meglumine and iodipamide. Each mL of solution also contains approximately 0.91 mg (0.039 mEq) sodium [18.2 mg/20 mL] and 257 mg organically bound iodine (5.2 g/20 mL). At the time of manufacture, the air in the container is replaced by nitrogen.

The appearance of the solution may vary from essentially colorless to light amber. Solutions which have become substantially darker, however, should not be used.

Cholografin Meglumine - Clinical Pharmacology

Following intravenous administration of Cholografin Meglumine, iodipamide is carried to the liver where it is rapidly secreted. The contrast medium appears in the bile within 10 to 15 minutes after injection, thus permitting visualization of the hepatic and common bile ducts, even in cholecystectomized patients. The biliary ducts are readily visualized within about 25 minutes after administration, except in patients with impaired liver function. The gallbladder begins to fill within an hour after injection; maximum filling is reached after two to two and one-half hours. The contrast medium is finally eliminated in the feces without passing through the enterohepatic circulation, except for approximately 10 percent of the intravenously administered dose which is excreted through the kidneys.

The LD50 for intravenous administration of a 52% iodipamide meglumine solution in mice is 6.2 ± 0.3 mL/kg (equivalent to 3224 ± 156 mg iodipamide meglumine/kg).

Indications and Usage for Cholografin Meglumine

Cholografin Meglumine is indicated for intravenous cholangiography and cholecystography as follows: (a) visualization of the gallbladder and biliary ducts in the differential diagnosis of acute abdominal conditions, (b) visualization of the biliary ducts, especially in patients with symptoms after cholecystectomy, and (c) visualization of the gallbladder in patients unable to take oral contrast media or to absorb contrast media from the gastrointestinal tract.

Contraindications

Cholografin is contraindicated for use in intrathecal procedures.

lodipamide meglumine is contraindicated in patients with a hypersensitivity to salts of iodipamide or who exhibit sensitivity reactions to the test dose. It is also contraindicated in patients with concomitant severe impairment of renal and liver function.

Warnings

Severe Adverse Events–Inadvertent Intrathecal Administration

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death,convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not inadvertently administered intrathecally.

The possibility exists for inadvertent administration into the intrathecal space during epidural administrations. Therefore, epidural administration procedures, such as pain management catheter placement, should not be performed with use of this product.

General

Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available.

Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.

Since iodine-containing contrast agents may alter the results of thyroid function tests, such tests, if indicated, should be performed prior to the administration of this preparation.

A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of iodipamide meglumine, but calls for extreme caution in administration.

Precautions

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with situations which may arise as a result of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself.

After intravascular administration of a radiopaque agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes, since severe delayed reactions have been known to occur.

These severe, life-threatening reactions suggest hypersensitivity to the radiopaque agent, which has prompted the use of several pretesting methods, none of which can be relied upon to predict severe reactions. Many authorities question the value of any pretest. A history of bronchial asthma or allergy, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Such a history, by suggesting histamine sensitivity and a consequent proneness to reactions, may be more accurate than pretesting in predicting the likelihood of a reaction, although not necessarily the severity or type of reaction in the individual case.

The sensitivity test most often performed is the slow injection of 0.5 to 1.0 mL of the radiopaque medium, administered intravenously, prior to injection of the full diagnostic dose. It should be noted that the absence of a reaction to the test dose does not preclude the possibility of a reaction to the full diagnostic dose. If the test dose causes an untoward response of any kind, the necessity for continuing with the examination should be carefully reevaluated and, if it is deemed essential, the examination should be conducted with all possible caution. In rare instances reactions to the test dose itself may be extremely severe; therefore, close observation of the patient, and facilities for emergency treatment, appear indicated.

Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension. The possibility of thrombosis should be borne in mind when intravenous techniques are employed.

Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast media or two or more days afterwards.

Some clinicians feel it may be advisable to have a continuous intravenous infusion running prior to and during administration of the drug.

The admixture of Benadryl® (Diphenhydramine Hydrochloride Injection) with Cholografin Meglumine (lodipamide Meglumine Injection USP 52%) may cause a precipitate which may form in the syringe or tubing. If antihistamines are administered concomitantly, they should not be mixed with the contrast agent but administered at another site.

Usage in Pregnancy

The safety of iodipamide meglumine for use during pregnancy has not been established; therefore, it should be used in pregnant patients, only when, in the judgment of the physician, its use is deemed essential to the welfare of the patient.

Adverse Reactions

Local reactions at the site of injection are not observed, unless excessive amounts are extravasated during injection. After too rapid administration, mild transient symptoms such as restlessness, sensations of warmth, sneezing, perspiration, salivation, flushing, pressure in the upper abdomen, dizziness, nausea, vomiting, chills, fever, headache, pallor and tremors may occur. These symptoms disappear when the injection has been completed. Rarely, swollen eyelids, laryngospasm, respiratory difficulties, hypotension, cardiac reactions and cyanosis have been reported. Hypersensitivity reactions may occur. In rare instances, despite the most careful sensitivity testing, anaphylactoid reactions may occur.

Renal function tests may be altered and renal failure may occur.

Cholografin Meglumine Dosage and Administration

Cholografin Meglumine (lodipamide Meglumine Injection USP 52%) is for intravenous use only.

Directions For Use

Preparation of the Patient: For best results, the usual preliminary measures for cholecystography are recommended, particularly in cholecystectomized patients, i.e., a low residue diet on the day before examination and administration of castor oil the night before or neostigmine at the time of examination to dispel excess intestinal gas. Cholecystography is preferably carried out in the morning with the patient fasting.

Dose: The usual adult dose is 20 mL. For infants and children, the suggested dose is 0.3 to 0.6 mL/kg of body weight; the dosage for infants and children should not exceed 20 mL.

Note: The dose should not be repeated for 24 hours.

Administration: After warming to body temperature, Cholografin Meglumine should be given by slow intravenous injection, following the usual precautions of intravenous administration. It is important that the preparation be injected slowly over a period of 10 minutes. Use of a narrow bore hypodermic needle will ensure a slow rate of injection. During the injection, the patient should be watched for untoward reactions such as a feeling of warmth, flushing and occasionally nausea. Nausea indicates that the injection rate is too rapid.

Radiography: A scout film should be exposed routinely before the intravenous injection is made.

Position of the Patient: With the patient prone and the right side elevated, radiographs are made in the posterior-anterior projection. Some radiologists prefer the supine position with the left side elevated. Serial 10-minute exposures should be started 10 minutes after the injection is made and continued until optimal visualization of the biliary ducts is obtained. Wet films should be examined immediately by the radiologist. In some cases a 15-degree rotation or the upright position may prove helpful. Depending on the situation revealed by the roentgenograms in which the duct is first seen, the position of the subject should be changed to displace the shadow of the common bile duct from that of the spine. Tomography is a useful technique for enhancing bile duct visualization after administration of the radiopaque medium.

Examination of the gallbladder should be started about two hours after administration. The standard positions in routine examination of the gallbladder should be used unless otherwise indicated. There is no need for the patient to remain quiet awaiting the time for the gallbladder film to be exposed. Moderate activity on the part of the patient will, in most cases, preclude “stratification” of the contrast agent in the gallbladder. If the contrast medium should stratify in the gallbladder, decubitus as well as upright films should be obtained. Additional exposures may be made after the ingestion of a fatty meal.

If visualization is not achieved after two and one-half hours, the patient should be returned for a 24-hour film, whenever possible. Occasionally, delayed opacification of the gallbladder will occur in 24 hours.

In infants and children, gallbladder visualization may be expected to occur 30 minutes to four hours after administration.

Note: In the presence of liver disease (BSP retention greater than 30 to 40 percent), the contrast medium is not excreted efficiently by the liver and visualization is usually not achieved. Visualization is rarely achieved in the presence of a serum bilirubin of 3.0 mg per 100 mL if the elevated bilirubin level is due to mechanical obstruction or hepatocellular damage. In the presence of severe liver damage, the contrast agent is excreted by the kidneys.

Interpretation: When intravenous cholecystography and cholangiography are used as an aid in the differential diagnosis of acute abdominal conditions, visualization of the gallbladder is considered strong evidence against a diagnosis of acute cholecystitis, while nonvisualization of the gallbladder two and one-half hours after administration with visualization of the bile ducts is considered strong evidence in favor of a diagnosis of acute cholecystitis (if the bile ducts are only faintly visualized, gallbladder films four hours after administration may occasionally show visualization of the gallbladder). When neither the bile ducts nor the gallbladder is visualized, the study provides no definitive information with regard to determining the presence or absence of acute cholecystitis.

How is Cholografin Meglumine Supplied

Cholografin Meglumine (lodipamide Meglumine Injection USP 52%) is available in single dose vials of 20 mL (NDC 0270-0265-20).

Storage

Protect from light; store at 20–25°C (68–77°F) [See USP]; avoid excessive heat.

In the event that crystallization occurs, the solution may be clarified by placing the vial in hot water and shaking gently for several minutes or until the solids redissolve. If cloudiness persists, discard the preparation. Allow the solution to cool to body temperature before administering.

Manufactured for

Bracco Diagnostics Inc.

Princeton, NJ 08543

by Patheon Italia S.p.A.

03013 Ferentino (Italy)

Revised July 2006

255101

Printed in USA

Cholografin Meglumine  iodipamide meglumine  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0270-0265 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Iodipamide meglumine (iodipamide) Active 520 MILLIGRAM  In 1 MILLILITER edetate disodium Inactive 0.4 MILLIGRAM  In 1 MILLILITER sodium citrate Inactive 3.2 MILLIGRAM  In 1 MILLILITER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0270-0265-20 10 VIAL In 1 PACKAGE contains a VIAL 1 20 mL (MILLILITER) In 1 VIAL This package is contained within the PACKAGE (0270-0265-20)

Revised: 06/2008Bracco Diagnostics Inc.

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Cholinoid

Pronunciation: VYE-ta-mins/lye-po-TROE-piks
Generic Name: Vitamins with Lipotropics
Brand Name: Examples include Cholinoid and Vita-Plus G

Cholinoid is used for:

Providing vitamins and certain other nutrients as a supplement to the diet. It may also be used for other conditions as determined by your doctor.

Cholinoid is a combination of vitamins and lipotropic factors. It works by providing vitamins to the body. Exactly how the lipotropics work is unknown.

Do NOT use Cholinoid if:

• you are allergic to any ingredient in Cholinoid

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

Before using Cholinoid:

Some medical conditions may interact with Cholinoid. 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 anemia

Some MEDICINES MAY INTERACT with Cholinoid. However, no specific interactions with Cholinoid are known at this time.

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

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

• Take Cholinoid with regard to food as directed on the package labeling or by your doctor.


• If you miss a dose of Cholinoid, 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 Cholinoid.

Important safety information:

• Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. Keep this product out of the reach of children. If an accidental overdose does occur, seek immediate medical attention or call a poison control center.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed to do so by your doctor.


• Some vitamin supplements contain vitamin C (ascorbic acid). If your brand contains vitamin C, it may cause incorrect test results with some urine glucose tests. If you have diabetes, check with your doctor before adjusting the dose of your diabetes medicine or changing your diet.


• If your brand contains vitamin C, it may also cause incorrect test results with kits used to check for blood in the stool. Check with your doctor if you are taking Cholinoid when using this test kit.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cholinoid, discuss with your doctor the benefits and risks of using Cholinoid during pregnancy. Cholinoid is excreted in breast milk. If you are or will be breast-feeding while you are using Cholinoid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cholinoid:

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:

Mild breath odor; upset stomach.

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).

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: Cholinoid 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 Cholinoid:

Store Cholinoid 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 Cholinoid out of the reach of children and away from pets.

General information:

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


• Cholinoid 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 Cholinoid. 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.

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