Feverall rectal

Generic Name: acetaminophen (rectal) (a SEET a MIN oh fen)

Brand Names: Acephen, Feverall, Mapap, Uniserts

What is acetaminophen?

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen rectal is given as a suppository to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Acetaminophen may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen?

Do not use more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are using.

Do not use this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to use acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while using acetaminophen.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Using certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before using acetaminophen?

You should not use acetaminophen if you are allergic to it. Do not use this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to use acetaminophen.

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you have:

• liver disease; or


• 
  

  a history of alcoholism.

  
  

It is not known whether acetaminophen will harm an unborn baby. Before using acetaminophen, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use acetaminophen?

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

Do not use more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen suppository may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are using.

If you are treating a child, use a pediatric form of acetaminophen. Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor. Do not take an acetaminophen rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the acetaminophen suppository.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using acetaminophen and call your doctor if:

• 
  

  you still have a fever after 3 days of use;

  
  


• 
  

  you still have pain after 10 days of use (or 5 days if treating a child);

  
  


• 
  

  you have a sore throat, high fever, or nausea and vomiting;

  
  


• 
  

  you have a skin rash, ongoing headache, or any redness or swelling; or

  
  


• 
  

  if your symptoms get worse, or if you have any new symptoms.

  
  

Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store at room temperature away from heat and moisture. The rectal suppositories may also be stored in the refrigerator. Do not allow the medicine to freeze.

What happens if I miss a dose?

Since acetaminophen is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while using acetaminophen?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Using certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while using acetaminophen.

Acetaminophen side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  low fever with nausea, stomach pain, and loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

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 acetaminophen?

There may be other drugs that can interact with acetaminophen. Tell your doctor 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.

More Feverall resources

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

Compare Feverall with other medications

• Fever
• Muscle Pain
• Pain
• Sciatica

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen.

See also: Feverall side effects (in more detail)

Mycobacterium avium-intracellulare Medications

Topics under Mycobacterium avium-intracellulare

• Mycobacterium avium-intracellulare, Prophylaxis (7 drugs)

• Mycobacterium avium-intracellulare, Treatment (11 drugs)

Drug List:

Hydrocortisone Acetate Foam

Pronunciation: hye-droe-KOR-ti-sone
Generic Name: Hydrocortisone Acetate
Brand Name: Cortifoam

Hydrocortisone Acetate Foam is used for:

Treating inflammation of the rectum.

Hydrocortisone Acetate Foam is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.

Do NOT use Hydrocortisone Acetate Foam if:

• you are allergic to any ingredient in Hydrocortisone Acetate Foam


• you have a rectal obstruction, abscess, or perforation; irritation of the of peritoneum (lining of the abdomen); or fistulas


• you are taking mifepristone

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

Before using Hydrocortisone Acetate Foam:

Some medical conditions may interact with Hydrocortisone Acetate Foam. 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 parasitic, bacterial, fungal, or viral infection; diabetes; diarrhea; swelling of the esophagus; stomach problems; blockage or the intestine or other intestinal problems; measles; tuberculosis (TB); a positive TB skin test; chicken pox; shingles; herpes infection of the eye; ulcers; kidney problems; high blood pressure; thyroid problems; or you have received a recent vaccination


• if you have a history of heart failure or heart attack

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

• Barbiturates (eg, phenobarbital), carbamazepine, cholestyramine, colestipol, fluconazole, hydantoins (eg, phenytoin), lithium, rifampin, or thioamines (eg, propylthiouracil) because they may decrease Hydrocortisone Acetate Foam's effectiveness


• Aprepitant, clarithromycin, estrogens (eg, estradiol), macrolide immunosuppressants (eg, tacrolimus), nefazodone, or steroidal contraceptives (eg, birth control pills) because side effects such as adrenal gland or central nervous system problems may occur


• Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), live vaccines, macrolide immunosuppressants (eg, tacrolimus), nondepolarizing muscle relaxants (eg, vecuronium), ritodrine, or theophylline because their actions and the risk of their side effects may be increased by Hydrocortisone Acetate Foam


• Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), interleukin-2, mifepristone, or nondepolarizing muscle relaxants (eg, vecuronium) because their effectiveness may be decreased by Hydrocortisone Acetate Foam

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

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

• Shake well before each use.


• Do not insert any part of the aerosol container directly into the anus. Apply to anus only with the applicator.


• If you miss a dose of Hydrocortisone Acetate Foam, apply it as soon as possible. If you do not remember until the next day, 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 Hydrocortisone Acetate Foam.

Important safety information:

• If your symptoms do not get better within 2 to 3 weeks or if they get worse, check with your doctor.


• Do not use Hydrocortisone Acetate Foam for other rectal conditions at a later time.


• Check with your doctor or pharmacist concerning the use of a stool softener or bulk laxative to help improve your symptoms.


• Check with your doctor before having vaccinations while you are using Hydrocortisone Acetate Foam.


• If you get Hydrocortisone Acetate Foam in your eyes, immediately flush them with cool tap water.


• Hydrocortisone Acetate Foam may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocortisone Acetate Foam while you are pregnant. It is not known if Hydrocortisone Acetate Foam is found in breast milk. If you are or will be breast-feeding while you use Hydrocortisone Acetate Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hydrocortisone Acetate Foam:

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:

Rectal pain or burning.

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); infection; rectal pain, burning, itching, bleeding, or irritation not present before using Hydrocortisone Acetate Foam.

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. Hydrocortisone Acetate Foam may be harmful if swallowed.

Proper storage of Hydrocortisone Acetate Foam:

Store in an upright position at room temperature, between 68 and 77 degrees F (20 and 20 degrees C). Store away from heat, moisture, and light. Do not refrigerate. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120 degrees F (49 degrees C). Do not store in the bathroom. Keep Hydrocortisone Acetate Foam out of the reach of children and away from pets.

General information:

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


• Hydrocortisone Acetate Foam 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 Hydrocortisone Acetate Foam. 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.

Q-Tussin PE

Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA

What is Q-Tussin PE (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.

Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Q-Tussin PE (guaifenesin and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Alwayss ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

What should I discuss with my healthcare provider before taking Q-Tussin PE (guaifenesin and pseudoephedrine)?

You should not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

It is not known whether guaifenesin and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Q-Tussin PE (guaifenesin and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take with food if this medicine upsets your stomach. Do not take guaifenesin and pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.

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

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Q-Tussin PE (guaifenesin and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

Q-Tussin PE (guaifenesin and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness or headache;

  
  


• 
  

  feeling restless or excited;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  mild nausea, vomiting, or stomach upset;

  
  


• 
  

  mild loss of appetite;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

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 Q-Tussin PE (guaifenesin and pseudoephedrine)?

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

• 
  

  methyldopa (Aldomet);

  
  


• 
  

  blood pressure medications;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. Tell your doctor 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.

More Q-Tussin PE resources

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

• Congestac MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex D Prescribing Information (FDA)


• Mucinex D Consumer Overview


• Pseudovent Consumer Overview


• Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)


• Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Q-Tussin PE with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: Q-Tussin PE side effects (in more detail)

Savlon Antiseptic Liquid

1. Name Of The Medicinal Product

Savlon Antiseptic Liquid

2. Qualitative And Quantitative Composition

Active ingredients:	Cetrimide 3.0% w/v
	Chlorhexidine Gluconate 0.3% w/v

For excipients, see Section 6.1.

3. Pharmaceutical Form

Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

A general antiseptic for external first-aid use.

4.2 Posology And Method Of Administration

Adults, children and elderly

Savlon Antiseptic Liquid is for external use only and must be diluted with water as follows:

- First aid for cuts, grazes, minor burns and bites	2 capfuls (30ml) to a ½ litre of warm water
- Personal hygiene and midwifery	2 capfuls (30ml) to a ½ litre of warm water
- Bathing	5 capfuls (75ml) to the bathwater

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

Keep out of the eyes and ears.

Treat accidental splashes by washing open eyes with water for at least ten minutes, seek medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known restriction.

4.7 Effects On Ability To Drive And Use Machines

The ability to drive or use machines is not affected.

4.8 Undesirable Effects

In rare cases, skin irritation may occur; stop using and seek medical advice.

4.9 Overdose

If swallowed, wash out of mouth and drink plenty of milk or water; seek medical advice and show the container to the doctor.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorhexidine is an effective antiseptic with a wide range of activity against micro organisms, including gram positive and gram negative bacteria, fungi and viruses.

Cetrimide is a quaternary ammonium compound with surfactant and antiseptic properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isopropyl alcohol

Terpineol

Liquid deodoriser S53272TP

Benzyl benzoate

D-Gluconolactone

Sodium hydroxide

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

Colourless (clear) or blue (clear) blow moulded PVC plastic bottles with polypropylene screw cap.

White HDPE bottle with a polypropylene screw cap.

Pack sizes: 115 ml, 125 ml, 250 ml, 450 ml, 495 ml, 500 ml, 550 ml, 600 ml, 750 ml, 900 ml, 5000 ml.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0126

9. Date Of First Authorisation/Renewal Of The Authorisation

23 May 2003

10. Date Of Revision Of The Text

21 November 2008.

Legal category: GSL

Maalox Total Stomach Relief

Generic Name: bismuth subsalicylate (BIZ muth sub sa LISS i late)

Brand Names: Bismarex, Bismatrol, Bismatrol Maximum Strength, Kao-Tin Bismuth Subsalicylate Formula, Kaopectate, Maalox Total Stomach Relief, Peptic Relief, Pepto-Bismol, Pepto-Bismol Maximum Strength, Pink Bismuth

What is Maalox Total Stomach Relief (bismuth subsalicylate)?

Bismuth subsalicylate is an antacid and anti-diarrhea medication.

Bismuth subsalicylate is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

Bismuth subsalicylate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Maalox Total Stomach Relief (bismuth subsalicylate)?

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children. You should not use bismuth subsalicylate if you have a stomach ulcer, a recent history of stomach or intestinal bleeding, or if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.

Do not take more than 8 doses in one day (24 hours).

Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.

What should I discuss with my health care provider before taking Maalox Total Stomach Relief (bismuth subsalicylate)?

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Subsalicylate can cause a serious and sometimes fatal condition called Reye's syndrome in children. You should not use bismuth subsalicylate if you are allergic to it, or if you have:

• 
  

  a stomach ulcer;

  
  


• 
  

  a recent history of stomach or intestinal bleeding; or

  
  


• 
  

  if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  fever;

  
  


• 
  

  mucus in your stools;

  
  


• 
  

  diabetes;

  
  


• 
  

  arthritis; or

  
  


• 
  

  gout.

  
  

Do not take bismuth subsalicylate without medical advice if you are pregnant. Bismuth subsalicylate can pass into breast milk and may harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I take Maalox Total Stomach Relief (bismuth subsalicylate)?

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

Do not take more than 8 doses in one day (24 hours). Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed before you swallow it.

Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since bismuth subsalicylate is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. Do not take more than 8 doses in one day (24 hours).

What happens if I overdose?

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

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.

What should I avoid while taking Maalox Total Stomach Relief (bismuth subsalicylate)?

Ask your doctor or pharmacist before taking other antacids or diarrhea medications together with bismuth subsalicylate.

Maalox Total Stomach Relief (bismuth subsalicylate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

• 
  

  hearing loss or ringing in your ears;

  
  


• 
  

  diarrhea lasting longer than 2 days; or

  
  


• 
  

  worsened stomach symptoms.

  
  

Less serious side effects include:

• 
  

  constipation;

  
  


• 
  

  dark colored stools; or

  
  


• 
  

  black or darkened tongue.

  
  

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 Maalox Total Stomach Relief (bismuth subsalicylate)?

Ask a doctor or pharmacist if it is safe for you to use bismuth subsalicylate if you are also using any of the following drugs:

• 
  

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

  
  


• 
  

  insulin or oral diabetes medications;

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

  
  


• 
  

  medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or

  
  


• 
  

  other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

  
  

This list is not complete and other drugs may interact with bismuth subsalicylate. Tell your doctor 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.

More Maalox Total Stomach Relief resources

• Maalox Total Stomach Relief Side Effects (in more detail)
• Maalox Total Stomach Relief Use in Pregnancy & Breastfeeding
• Maalox Total Stomach Relief Drug Interactions
• 0 Reviews for Maalox Total Stomach Relief - Add your own review/rating

• Bismuth Subsalicylate Professional Patient Advice (Wolters Kluwer)


• Bismuth Subsalicylate MedFacts Consumer Leaflet (Wolters Kluwer)


• Bismatrol Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Bismatrol Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Maalox Total Stomach Relief with other medications

• Diarrhea
• Diarrhea, Chronic
• Helicobacter Pylori Infection
• Indigestion
• Lymphocytic Colitis

Where can I get more information?

• Your pharmacist can provide more information about bismuth subsalicylate.

See also: Maalox Total Stomach Relief side effects (in more detail)

iodixanol

Generic Name: iodixanol (eye oh DIX an ol)

Brand names: Visipaque, Visipaque RediFlo Cartridge

What is iodixanol?

Iodixanol is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Iodixanol contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Iodixanol is used to help diagnose certain disorders of the brain, blood vessels, and kidneys.

Iodixanol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about iodixanol?

Tell your doctor if you have asthma, hay fever, or a history of food or drug allergies, especially if you have had any type of reaction to another contrast agent.

Drink extra fluids before and after you receive iodixanol. This medication can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

Older adults may need special care in avoiding dehydration by drinking extra fluids before and after the radiologic test. Your kidney function may also need to be watched closely after you have received iodixanol.

Iodixanol should not be given to a child who has recently used a laxative (stool softener) or has not eaten properly before the test. You should not receive iodixanol if you have any type of active infection.

What should I discuss with my health care provider before receiving iodixanol?

Tell your doctor if you have ever had any type of reaction to another contrast agent.

Iodixanol should not be given to a child who has recently used a laxative (stool softener) or has not eaten properly before the test. You should not receive iodixanol if you have any type of active infection.

Before receiving iodixanol, tell your doctor if you have:

• 
  

  a brain tumor or hematoma;

  
  


• 
  

  a recent head or brain injury;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  kidney disease;

  
  


• 
  

  liver disease;

  
  


• 
  

  heart disease, including congestive heart failure;

  
  


• 
  

  sickle cell anemia;

  
  


• 
  

  a history of stroke, blood clots, or circulation problems;

  
  


• 
  

  asthma, hay fever, or a history of food or drug allergies;

  
  


• 
  

  diabetes;

  
  


• 
  

  a weak immune system caused by disease or by taking certain medicines such as steroids or cancer treatment;

  
  


• 
  

  an autoimmune disorder such as lupus, multiple sclerosis, or rheumatoid arthritis;

  
  


• 
  

  multiple myeloma (bone cancer);

  
  


• 
  

  pheochromocytoma;

  
  


• 
  

  a thyroid disorder.

  
  

If you have any of these conditions, you may not be able to receive iodixanol, or you may need a dosage adjustment or special tests during treatment.

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 iodixanol 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.

Older adults may need special care in avoiding dehydration by drinking extra fluids before and after the radiologic test. Your kidney function may also need to be watched closely after you have received iodixanol.

How is iodixanol used?

Iodixanol is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting, just before your radiologic test.

Drink extra fluids before and after you receive iodixanol. This medication can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

What happens if I miss a dose?

Since iodixanol is used only during your radiologic test, you will not be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of an iodixanol overdose may include difficulty breathing, fast or pounding heartbeats, and seizure (convulsions).

What should I avoid while receiving iodixanol?

Do not allow yourself to become dehydrated during the first few days after receiving iodixanol. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.

Iodixanol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  wheezing or trouble breathing; or

  
  


• 
  

  fever, chills, body aches, flu symptoms.

  
  

Other less serious side effects are more likely to occur, such as:

• 
  

  headache, dizziness, nervousness;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  pain, warmth, or cold feeling where the medicine was injected;

  
  


• 
  

  numbness, warmth, or tingly feeling;

  
  


• 
  

  unusual or unpleasant taste in your mouth;

  
  


• 
  

  skin redness or itching; or

  
  


• 
  

  sleep problems (insomnia).

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Iodixanol Dosing Information

Usual Adult Dose for Intra-arterial Digital Subtraction Angiography:

Iodixanol 270 mgI/mL or 320 mgI/mL is recommended for intra-arterial injection for intra-arterial digital subtraction angiography.

Carotid Arteries: 5 to 8 mL (320 mgI/mL)
Vertebral Arteries: 5 to 8 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 175 mL

Renal Arteries: 10 to 25 mL (270 mgI/mL)
Aortography: 20 to 50 mL (270 mgI/mL), 10 to 50 mL (320 mgI/mL)
Major Branches of Aorta: 5 to 30 mL (270 mgI/mL), 2 to 10 mL (320 mgI/mL)
Aortofemoral Runoffs: 6 to 15 mL (320 mgI/mL)
Peripheral Arteries: 3 to 15 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Adult Dose for Computed Tomography:

Intravenous administration of iodixanol injection (270 mgI/mL or 320 mgI/mL) is recommended for Contrast Enhanced Computed Tomography (CECT).

CECT of Head:
Bolus Infusion:
75 to 150 mL (270 mgI/ mL)
75 to 150 mL (320 mgI/ mL)
Maximum Total Volume: 150 mL

CECT of Body:
Bolus Infusion:
100 to 150 mL (270 mgI/ mL)
100 to 150 mL (320 mgI/ mL)
Maximum Total Volume: 150 mL

Usual Adult Dose for Urography:

Intravenous administration of iodixanol injection (270 mgI/mL or 320 mgI/mL) is recommended.

Excretory Urography:
Normal Renal Function:
1 mL/kg (270 mgI/ mL)
1 mL/kg (320 mgI/ mL)
Maximum Total Volume: 100 mL

Usual Adult Dose for Venography:

Intravenous administration of iodixanol injection (270 mgI/mL) is recommended.

Venography:
Per Lower Extremity:
50 to 100 mL (270 mgI/ mL)
Maximum Total Volume: 250 mL

Usual Adult Dose for Peripheral Arteriography:

Intra-arterial Administration:

Peripheral Arteries: 15 to 30 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Adult Dose for Cerebral Arteriography:

Intra-arterial Administration:

Carotid Arteries: 10 to 14 mL (320 mgI/mL)
Vertebral Arteries: 10 to 12 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 175 mL

Usual Adult Dose for Coronary Arteriography:

Intra-arterial Administration:

Right Coronary Artery 3 to 8 mL (320 mgI/mL)
Left Coronary Artery 3 to 10 mL (320 mgI/mL)
Left Ventricle 20 to 45 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 200 mL

Usual Adult Dose for Aortography:

Intra-arterial Administration:

Aortography: 30 to 70 mL (320 mgI/mL)
Major Branches of Aorta: 10 to 70 mL (320 mgI/mL)
Aortofemoral Runoffs: 20 to 90 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Adult Dose for Renal Arteriography:

Intra-arterial Administration:

Renal Arteries 8 to 18 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Pediatric Dose for Cerebral Arteriography:

Intra-arterial Administration:

Greater than 1 to 12 years of age:

1 to 2 mL/kg (320 mgI/mL)
The total dose should not exceed 4 mL/kg.

Greater than 12 years of age:

Carotid Arteries: 10 to 14 mL (320 mgI/mL)
Vertebral Arteries: 10 to 12 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 175 mL

Usual Pediatric Dose for Intra-arterial Digital Subtraction Angiography:

Iodixanol 270 mgI/mL or 320 mgI/mL is recommended for intra-arterial injection for intra-arterial digital subtraction angiography.

Greater than 12 years of age:

Carotid Arteries: 5 to 8 mL (320 mgI/mL)
Vertebral Arteries: 5 to 8 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 175 mL

Renal Arteries: 10 to 25 mL (270 mgI/mL)
Aortography: 20 to 50 mL (270 mgI/mL), 10 to 50 mL (320 mgI/mL)
Major Branches of Aorta: 5 to 30 mL (270 mgI/mL), 2 to 10 mL (320 mgI/mL)
Aortofemoral Runoffs: 6 to 15 mL (320 mgI/mL)
Peripheral Arteries: 3 to 15 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Pediatric Dose for Coronary Arteriography:

Intra-arterial Administration:

Greater than 1 to 12 years of age:

1 to 2 mL/kg (320 mgI/mL)
The total dose should not exceed 4 mL/kg.

Greater than 12 years of age:

Right Coronary Artery 3 to 8 mL (320 mgI/mL)
Left Coronary Artery 3 to 10 mL (320 mgI/mL)
Left Ventricle 20 to 45 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 200 mL

Usual Pediatric Dose for Renal Arteriography:

Intra-arterial Administration:

Greater than 12 years of age:

Renal Arteries 8 to 18 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Pediatric Dose for Aortography:

Intra-arterial Administration:

Greater than 1 to 12 years of age:

1 to 2 mL/kg (320 mgI/mL)
The total dose should not exceed 4 mL/kg.

Greater than 12 years of age:

Aortography: 30 to 70 mL (320 mgI/mL)
Major Branches of Aorta: 10 to 70 mL (320 mgI/mL)
Aortofemoral Runoffs: 20 to 90 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Pediatric Dose for Peripheral Arteriography:

Intra-arterial Administration:

Greater than 12 years of age:

Peripheral Arteries: 15 to 30 mL (320 mgI/mL)
Max Total Dose: Usually not to exceed 250 mL

Usual Pediatric Dose for Computed Tomography:

Intravenous administration of iodixanol injection (270 mgI/mL or 320 mgI/mL) is recommended for Contrast Enhanced Computed Tomography (CECT).

Greater than 1 to 12 years of age:

1 to 2 mL/kg (270 mgI/mL)
The total dose should not exceed 2 mL/kg.

Greater than 12 years of age:

CECT of Head:
Bolus Infusion:
75 to 150 mL (270 mgI/ mL)
75 to 150 mL (320 mgI/ mL)
Maximum Total Volume: 150 mL

CECT of Body:
Bolus Infusion:
100 to 150 mL (270 mgI/ mL)
100 to 150 mL (320 mgI/ mL)
Maximum Total Volume: 150 mL

Usual Pediatric Dose for Urography:

Intravenous administration of iodixanol injection (270 mgI/mL or 320 mgI/mL) is recommended.

Greater than 1 to 12 years of age:

1 to 2 mL/kg (270 mgI/mL)
The total dose should not exceed 2 mL/kg.

Greater than 12 years of age:

Excretory Urography:
Normal Renal Function:
1 mL/kg (270 mgI/ mL)
1 mL/kg (320 mgI/ mL)
Maximum Total Volume: 100 mL

Usual Pediatric Dose for Venography:

Intravenous administration of iodixanol injection (270 mgI/mL) is recommended.

Greater than 12 years of age:

Venography:
Per Lower Extremity:
50 to 100 mL (270 mgI/ mL)
Maximum Total Volume: 250 mL

What other drugs will affect iodixanol?

There may be other drugs that can affect iodixanol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More iodixanol resources

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

• Visipaque Prescribing Information (FDA)

Compare iodixanol with other medications

• Aortography
• Cerebral Arteriography
• Computed Tomography
• Coronary Arteriography
• Intra-arterial Digital Subtraction Angiography
• Peripheral Arteriography
• Renal Arteriography
• Urography
• Venography

Where can I get more information?

• Your doctor or pharmacist has more information about iodixanol written for health professionals that you may read.

See also: iodixanol side effects (in more detail)