Balziva

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Balziva (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Balziva (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. 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.

What should I discuss with my healthcare provider before taking Balziva (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

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

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Balziva (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

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, and vaginal bleeding.

What should I avoid while taking Balziva (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Balziva (ethinyl estradiol and norethindrone) 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 any of these serious side effects:

• 
  

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

  
  


• 
  

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

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Balziva (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. 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 Balziva resources

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

• Balziva Prescribing Information (FDA)


• Aranelle Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Balziva with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Menstrual Disorders

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Balziva side effects (in more detail)

Baraclude

Pronunciation: en-TEK-a-vir
Generic Name: Entecavir
Brand Name: Baraclude

Baraclude may increase the risk of severe and sometimes fatal lactic acidosis (buildup of lactic acid in the blood) or liver problems when used alone or with other medicines. The risk may be greater in women, in patients who are very overweight, or in patients who have been on Baraclude or similar medicines for a prolonged period of time. Patients with certain serious liver problems may also have a higher risk of developing lactic acidosis. Contact your doctor right away if you experience muscle pain, fast or irregular heartbeat, stomach pain, trouble breathing, an unusually cold feeling in the arms or legs, unusual tiredness or fatigue, yellowing of the skin or eyes, dark urine, pale stools, or persistent loss of appetite.

A severe worsening of your condition may occur if you stop taking Baraclude. Do not change your dose or stop taking Baraclude without first talking to your doctor. Lab tests, including liver function tests, may be performed for at least several months after you stop taking Baraclude.

Baraclude should not be used in patients who also have HIV infection and are not receiving highly active antiretroviral therapy (HAART). If you have HIV infection or think that you may have been exposed to HIV, talk with your doctor before you begin to take Baraclude.

Baraclude is used for:

Treating hepatitis B virus infection in certain patients.

Baraclude is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the blood. It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells.

Do NOT use Baraclude if:

• you are allergic to any ingredient in Baraclude


• you have HIV infection and you are not receiving HAART

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

Before using Baraclude:

Some medical conditions may interact with Baraclude. 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 HIV infection or kidney problems, or if you are on dialysis


• if you have a history of liver problems or you have had a liver transplant


• if you are very overweight


• if you have received medicine to treat hepatitis B in the past or if you have been taking nucleoside analogues for a long time

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

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Baraclude's side effects. Ask your doctor if you are unsure if any of your medicines may harm the kidneys.

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

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

• An extra patient leaflet is available with Baraclude. Talk to your pharmacist if you have questions about this information.


• Take Baraclude on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.


• Baraclude works best if it is taken at the same time each day.


• Continue to take Baraclude even if you feel well. Do not miss any doses.


• If you miss a dose of Baraclude, 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 Baraclude.

Important safety information:

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


• Baraclude does not stop you from spreading hepatitis B virus to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have hepatitis B virus infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors. A vaccine is available to protect people at risk from becoming infected with hepatitis B virus.


• Do not change your dose without checking with your doctor.


• Baraclude is not a cure for hepatitis B virus infection. Remain under the care of your doctor.


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


• Lab tests, including liver and kidney function and HIV and hepatitis B virus antibody, may be performed while you use Baraclude and for several months after you stop Baraclude. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


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


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

Possible side effects of Baraclude:

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

Diarrhea; dizziness; drowsiness; headache; indigestion; nausea; tiredness; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark-colored urine; difficulty breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; light-colored bowel movements; loss of appetite for several days; muscle pain; severe dizziness or lightheadedness; severe or prolonged nausea or vomiting; severe tiredness; stomach pain (with or without nausea or vomiting); weakness; yellowing of the skin or eyes.

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

See also: Baraclude 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 Baraclude:

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

General information:

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


• Baraclude 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 Baraclude. 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 Baraclude resources

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

• Baraclude Prescribing Information (FDA)


• Baraclude Consumer Overview


• Baraclude Monograph (AHFS DI)


• Baraclude Advanced Consumer (Micromedex) - Includes Dosage Information


• Entecavir Professional Patient Advice (Wolters Kluwer)

Compare Baraclude with other medications

• Hepatitis B

Baricon Suspension

barium sulfate

Dosage Form: oral suspension
LAFAYETTE

BARICON™

BARIUM SULFATE FOR SUSPENSION


Rx only

Baricon Suspension Description

Baricon is a lemon-vanilla flavored, high density barium sulfate formulation for aqueous suspension and use as a contrast medium in double contrast stomach examinations.

The product contains 98% w/w barium sulfate USP, sucrose, simethicone, suspending agents, sorbitol, flavoring, sodium citrate and saccharin sodium. Barium sulfate has the empirical formula of BaSO4.

Baricon Suspension - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Baricon Suspension

Baricon is indicated for use as a contrast medium in double contrast stomach examinations.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis or known hypersensitivity to barium sulfate formulations.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.


Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Aspiration of smaller amounts may cause inflammation.


Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.


Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

Precautions

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.


Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.


Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.


Patient preparation for diagnostic gastrointestinal examination frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. It is of the utmost importance to be completely prepared to treat any such occurrence.


Due to increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.


Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.


A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.


Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.


Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, nausea, procedural site reactions, rash and vomiting.

Overdosage

In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

Baricon Suspension Dosage and Administration

Individual technique will determine the suspension quantity, concentration, and specific procedure used. The following are suggested for Baricon use in double contrast stomach examinations.

Patient Preparation

Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations, done separately or combined with an upper gastrointestinal series, is the same.

Mixing Directions:

• Fill the Water Measuring Tube to overflow (approximately 74 mL) and add to the contents of the bottle.

• Secure the bottle cap, invert and shake vigorously for 10 seconds in an up and down motion.

• Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds.

• Just prior to patient administration remix to assure suspension uniformity.

• Use within 6 hours of preparation. Discard unused portion.


The Baricon unit dose bottle prepares approximately 145 mL of 230% w/v high density barium sulfate suspension. Use within 6 hours of preparation. Discard unused suspension.

ADMINISTRATION

While techniques may vary, it is suggested that the patient place a gas producing agent such as sodium bicarbonate on the tongue and wash down with 10 mL of water. Immediately following the sodium bicarbonate and while the patient is in the upright position, have the patient drink the Baricon Suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate).


For single patient use only. Properly discard unused portion.

How is Baricon Suspension Supplied

Catalog No. 149112. NDC 68240-628-12. 340 gm unit dose bottle; thirty-six (36) bottles and two (2) Water Measuring Tubes per case.


Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).


Baricon is a trademark of Lafayette Pharmaceuticals, Incorporated.


DIN: 00390909

Distributed in Canada by:

tyco Healthcare    

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A


Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com


MID 1304671

Rev 04/2009

DOUBLE CONTRAST

UPPER G.I.

• Unit dose


• High density


• Low viscosity

tyco

Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 340 gm Bottle

L A F A Y E T T E

BARICON™

BARIUM SULFATE

FOR SUSPENSION

Catalog No. 149112

DOUBLE CONTRAST / UPPER G.I.

Rx only

340 gm

BARICON

Barium Sulfate for Suspension


NDC 68240-628-12

Catalog No. 149112


A lemon-vanilla flavored 98% w/w barium sulfate formulation for aqueous suspension and use in air contrast stomach examinations.


Contents: Barium sulfate USP, sucrose, simethicone, suspending agents, sorbitol, flavoring, sodium citrate and saccharin sodium.


Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.


Dosage and Administration: See package insert for complete instructions.


Mixing Directions:

• Fill the Baricon Water Measuring Tube to overflow (74 mL) and add to the contents of the bottle. Secure the bottle cap.


• Invert and shake vigorously for 10 seconds in an up and down motion.


• Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds.


• Just prior to patient administration, remix to assure suspension uniformity.


• Use within 6 hours of preparation.

For single patient use only. Properly discard unused portion.


This bottle prepares approximately 145 mL of 230% w/v high density barium sulfate suspension.


Storage: Store at 25ºC (77°F); excursions permitted to 15° to 30°C (59° to 86°F).


Net Contents: 340 gm

MID 1170360

Rev 04/2009


DIN: 00390909

Distributed in Canada by:

tyco Healthcare

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

tyco

Healthcare

Mallinckrodt

BARICON  barium sulfate  for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68240-628 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .98 g  in 1 g

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM   TRISODIUM CITRATE DIHYDRATE   SORBITOL   CARRAGEENAN   CROSCARMELLOSE SODIUM   SUCROSE

Product Characteristics Color      Score      Shape Size Flavor LEMON, VANILLA Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68240-628-12 36 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 340 g In 1 BOTTLE, PLASTIC This package is contained within the CASE (68240-628-12)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2009	04/30/2011

Labeler - Mallinckrodt Inc. (810407189)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Medical, S.A. de C.V.		810407189	analysis, manufacture

Revised: 08/2010Mallinckrodt Inc.

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• Computed Tomography

Bayer

Pronunciation: AS-pir-in
Generic Name: Aspirin
Brand Name: Examples include Aspiritab and Bayer

Bayer is used for:

Treating minor aches and pains (eg, caused by headache, muscle aches, backache, arthritis, the common cold, toothache, menstrual cramps). It is used in certain patients to decrease the risk of stroke, heart attack, and death associated with stroke or heart attack. It may also be used for other conditions as determined by your doctor.

Bayer is a salicylate. It works by inhibiting several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Do NOT use Bayer if:

• you are allergic to any ingredient in Bayer


• you are a child or teenager with influenza (flu) or chicken pox


• you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets


• you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or an NSAID (eg, ibuprofen, naproxen, celecoxib)


• you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

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

Before using Bayer:

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

• if you are pregnant, plan 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 or other substances


• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day


• if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chicken pox, or vitamin K deficiency


• if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

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

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Bayer's effectiveness


• Anticoagulants (eg, heparin, warfarin) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of their side effects, including risk of bleeding, may be increased by Bayer


• Insulin and oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating), may be increased by Bayer


• Methotrexate or valproic acid because the risk of their actions and side effects may be increased by Bayer


• Angiotensin-converting enzyme inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Bayer

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

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

• Take Bayer by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Bayer with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Bayer.


• Use Bayer exactly as directed on the package, unless instructed differently by your doctor. If you are taking Bayer without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of Bayer and you are taking it regularly, 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 Bayer.

Important safety information:

• Bayer has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Talk to your doctor before you take Bayer or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Bayer. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Bayer with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


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


• Aspirin has been linked to a serious illness called Reye syndrome. Do not give Bayer to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• If Bayer has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.


• Tell your doctor or dentist that you take Bayer before you receive any medical or dental care, emergency care, or surgery.


• Do not take Bayer for at least 7 days after any surgery unless directed by your health care provider.


• Do not take Bayer for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.


• Different brands of Bayer may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bayer while you are pregnant. Bayer is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Bayer is found in breast milk. If you are or will be breast-feeding while you use Bayer, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Bayer:

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:

Heartburn; nausea; 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); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; vomiting.

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

See also: Bayer 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; fever; hearing loss; lethargy; lightheadedness, especially upon standing; nausea; rapid breathing; rapid or irregular heartbeat; ringing in the ears; seizures; shortness of breath; stomach pain; vomiting.

Proper storage of Bayer:

Store Bayer at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bayer out of the reach of children and away from pets.

General information:

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


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

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• Angina
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• Ischemic Stroke, Prophylaxis
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• Prosthetic Heart Valves
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• Revascularization Procedures, Prophylaxis
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Bacitracin topical

Class: Antibacterials
VA Class: DE101
CAS Number: 1405-87-4
Brands: Baciguent, Baci-Rx, Bactine First Aid Antibiotic Plus Anesthetic, Band-Aid with Antibiotic, Betadine Brand First Aid Antibiotics + Moisturizer, Betadine Brand First Aid Antibiotics + Pain Reliever, Campho-Phenique First Aid Antibiotic Plus Pain Reliever Maximum Strength, Double Antibiotic, Mycitracin Plus Pain Reliever, Neosporin, Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving, Polysporin, Spectrocin Plus, Triple Antibiotic, Triple Antibiotic Extra, Zeba-Rx

Introduction

Polypeptide antibiotic.

Uses for Bacitracin

Superficial Skin Infections

Topically (alone or in combination with other anti-infectives) to prevent or treat superficial skin infections caused by susceptible organisms.^a

May be useful for preventing infection in minor skin injuries (e.g., cuts, scrapes, burns).^a

Role of topical anti-infectives for treatment of superficial skin infections has not been fully elucidated.^a

Self-medication with topical anti-infectives to treat superficial skin infections currently is not recommended.^a

Treatment of serious or extensive skin infections usually requires systemic anti-infective therapy.^a

Bacitracin Dosage and Administration

Administration

Apply ointment or powder topically to cleansed area.^a

May cover affected area with a sterile bandage following use of ointments, powders, or sprays.^a

Has been used for topical compresses in 0.9% sodium chloride injection or sterile water for injection (250–1000 units/mL).^a

Dosage

Adults

Superficial Skin Infections

Topical

Ointment: Apply amount equal to the surface area of a fingertip to the affected area 1–3 times daily.^a

Powder: Use a light dusting on affected area 1–3 times daily.^a

Prescribing Limits

Maximum 1 week of use unless directed by a physician.^a

Cautions for Bacitracin

Contraindications

• 
  

  Known history of hypersensitivity to bacitracin or any ingredients in the formulations.^a

  
  


• 
  

  Avoid use in atopic individuals.^a

  
  

Warnings/Precautions

Sensitivity Reactions

Rashes and allergic anaphylactoid reactions have occurred, but topical application has low order of toxicity.^a

If itching, burning, inflammation, or other signs of sensitivity occur, discontinue use and consult a clinician.^a

Sensitivity to neomycin also may indicate sensitivity to bacitracin.^a

Patch testing (e.g., 1% bacitracin in petrolatum) may be useful in diagnosing suspected allergic contact dermatitis when hypersensitivity to other topical antibiotics (e.g., neomycin) is suspected.^a

General Precautions

Overgrowth of nonsusceptible organisms, particularly Candida, may occur; institute appropriate therapy if superinfection occurs.^a

Topical use of bacitracin should not replace appropriate surgical management or other measures.^a

Consider systemic anti-infective therapy if a deep-seated infection is present.^a

Corticosteroids in topical anti-infective combination preparations may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the antibiotics or other ingredients in the formulations; weigh benefits against risks.^a

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.^b

Lactation

Not known whether topical bacitracin is distributed into milk.^b

Bacitracin Pharmacokinetics

Absorption

Bioavailability

Not absorbed to any appreciable extent from intact or denuded skin, wounds, or mucous membranes.^a

Stability

Storage

Topical

Ointment

15–30°C.^a

Powder

2–15°C; protect from direct sunlight.^a

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Topical

Vehicle Compatibility

Compatiblea
Lanolin
Paraffins
Petrolatum
White wax
Incompatible
Water-miscible bases

Mixture Compatibility

Incompatiblea
Benzalkonium chloride
Benzoates
Cetylpyridinium chloride
Heavy metal salts
Salicylates
Sodium lauryl sulfate
Tannates

Actions and SpectrumActions

• 
  

  Polypeptide antibiotic produced by Bacillus subtilis; consists of 3 separate compounds, bacitracin A (chief constituent), B, and C.^a

  
  


• 
  

  Bactericidal or bacteriostatic, depending on concentration attained at infection site and infecting organism's susceptibility.^a

  
  


• 
  

  Inhibits bacterial cell-wall synthesis, damages the bacterial plasma membrane and is active against protoplasts.^a

  
  


• 
  

  Active against many gram-positive organisms such as staphylococci (including some penicillin-resistant staphylococci), streptococci, anaerobic cocci, corynebacteria, and clostridia; in vitro, bacitracin 0.05–5 mcg/mL inhibits most susceptible strains of Staphylococcus aureus.^a

  
  


• 
  

  Active against gonococci, meningococci, and fusobacteria, but not most other gram-negative organisms.^a

  
  


• 
  

  Also active against Actinomyces israelii, Treponema pallidum, and T. vincenti.^a

  
  


• 
  

  The activity of bacitracin is not impaired by blood, pus, necrotic tissue, or large inocula.^a

  
  


• 
  

  In susceptible bacteria, bacitracin resistance seldom occurs; if it does occur, it emerges slowly.^a

  
  


• 
  

  Staphylococci, including penicillin-resistant staphylococci, are increasingly becoming resistant.^a

  
  


• 
  

  No cross-resistance with other antibiotics.^a

  
  

Advice to Patients

• 
  

  Importance of discontinuing bacitracin and consulting a clinician if itching, burning, inflammation, or other signs of sensitivity occur.^a

  
  


• 
  

  Importance of understanding that topical bacitracin preparations are intended for external use only.^a

  
  


• 
  

  Importance of not using in the eyes or applying over large areas of the body.

  
  


• 
  

  Importance of first consulting a clinician when considering use for self-medication for deep or puncture wounds, animal bites, or serious burns.^a

  
  


• 
  

  Importance of discontinuing use and consulting a clinician if condition persists or worsens when used to prevent infection in minor skin injuries (e.g., cuts, scrapes, burns).^a

  
  


• 
  

  Importance of not using for >1 week unless directed by a clinician.^a

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  
  


• 
  

  Importance of informing patients of other important precautionary information.^a (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bacitracin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*
Topical	Ointment	500 units/g*	Baciguent	Lee Pharmaceuticals

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bacitracin Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Ointment	400 units/g with Neomycin Sulfate 0.5% (0.35% of neomycin) and Polymyxin B Sulfate 5000 units (of polymyxin B) per g*	Triple Antibiotic Ointment	Alpharma, Pfeiffer

Bacitracin Zinc

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder
Topical	Ointment	500 units (of bacitracin) per g	Bacitracin Zinc Ointment	Alpharma, Rugby

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Bacitracin Zinc Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Topical	Ointment	400 units (of bacitracin) per g with Neomycin Sulfate 0.5% (0.35% of neomycin) and Polymyxin B Sulfate 5000 units (of polymyxin B) per g	Neosporin	Pfizer
			Triple Antibiotic Ointment
		500 units (of bacitracin) per g with Lidocaine 4%, Neomycin Sulfate 0.5% (0.35% of neomycin), and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g*	Bactine First Aid Antibiotic Plus Anesthetic	Bayer
			Campho-Phenique First Aid Antibiotic Plus Pain Reliever Maximum Strength	Bayer
			Mycitracin Plus Pain Reliever (with parabens)	J&J Consumer
			Spectrocin Plus	Numark
			Triple Antibiotic Extra	IVAX
			Triple Antibiotic Plus Ointment Maximum Strength	Alpharma, G&W, Major
			Triple Antibiotic with Lidocaine Ointment Maximum Strength	Clay-Park, Moore
		500 units (of bacitracin) per g with Neomycin Sulfate 0.5% (0.35% of neomycin) and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g	Mycitracin Triple Antibiotic First Aid Ointment Maximum Strength (with parabens)	J&J Consumer
		500 units (of bacitracin) per g with Polymyxin B Sulfate 10,000 units (of polymyxin B) per g and Pramoxine Hydrochloride 1%	Betadine Brand First Aid Antibiotics + Pain Reliever	Purdue Frederick
		500 units (of bacitracin) per g, with Neomycin Sulfate 0.5% (0.35% of neomycin), Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Pramoxine Hydrochloride 1%	Neosporin Plus Maximum Strength First Aid Antibiotic/Pain Relieving Ointment	Pfizer
		500 units (of bacitracin) per g with Polymyxin B Sulfate 10,000 units (of polymyxin B) per g	Bacitracin-Polymyxin Ointment	Clay-Park, Major, Rugby
			Band-Aid with Antibiotic Ointment	J&J Consumer
			Betadine Brand First Aid Antibiotics + Moisturizer Ointment	Purdue Frederick
			Double Antibiotic Ointment	Fougera
			Polysporin Ointment	Pfizer
	Powder	500 units (of bacitracin) per g with Polymyxin B Sulfate 10,000 units (of polymyxin B) per g	Polysporin Powder	Pfizer

Anti-infective combinations including bacitracin are also commercially available in combination with corticosteroids for topical use.

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2004:3305-6.

b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002: 120/b.

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• Bacitracin topical Use in Pregnancy & Breastfeeding
• Bacitracin topical Support Group
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• Bacterial Skin Infection

Baby Gasz

Generic Name: simethicone (Oral route)

sye-METH-i-kone

Commonly used brand name(s)

In the U.S.

• Alka-Seltzer Anti-Gas


• Anti-Gas Ultra Strength


• Baby Gasz


• Equilizer Gas Relief


• Gas Aid Maximum Strength


• Gas-X


• Genasyme


• Maalox Anti-Gas


• Mylanta Gas


• Mylicon


• Mytab Gas


• Phazyme

In Canada

• Ovol


• Phazyme Liquid Gas Relief, Maximum Strength

Available Dosage Forms:

• Tablet, Chewable


• Liquid


• Capsule


• Syrup


• Suspension


• Tablet


• Solution


• Capsule, Liquid Filled

Therapeutic Class: Antiflatulent

Uses For Baby Gasz

Simethicone is used to relieve the painful symptoms of too much gas in the stomach and intestines.

Simethicone may also be used for other conditions as determined by your doctor.

Simethicone is available without a prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, simethicone is used in certain patients before the following tests:

• Before a gastroscopy


• Before a radiography of the bowel

Before Using Baby Gasz

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of simethicone in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of simethicone

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

For effective use of simethicone:

• Follow your doctor's instructions if this medicine was prescribed.


• Follow the manufacturer's package directions if you are treating yourself.

Take this medicine after meals and at bedtime for best results.

For patients taking the chewable tablet form of this medicine:

• It is important that you chew the tablets thoroughly before you swallow them. This is to allow the medicine to work faster and more completely.

For patients taking the oral liquid form of this medicine:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount you should take is to be measured with the specially marked dropper or measuring spoon.

Avoid foods that seem to increase gas. Chew food thoroughly and slowly. Reduce air swallowing by avoiding fizzy, carbonated drinks. Do not smoke before meals. Develop regular bowel habits and exercise regularly. Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient.

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 symptoms of too much gas:
  
  • For oral dosage forms (capsules or tablets):
    
    • Adults and teenagers—Usual dose is 60 to 125 milligrams (mg) four times a day, after meals and at bedtime. The dose should not be more than 500 mg in twenty-four hours.
    
    
    • Children—Dose must be determined by the doctor.
    
    
  
  
  • For oral dosage form (chewable tablets):
    
    • Adults and teenagers—Usual dose is 40 to 125 mg four times a day, after meals and at bedtime or the dose may be 150 mg three times a day, after meals. The dose should not be more than 500 mg in twenty-four hours.
    
    
    • Children—Dose must be determined by the doctor.
    
    
  
  
  • For oral dosage form (suspension):
    
    • Adults and teenagers—Usual dose is 40 to 95 mg four times a day, after meals and at bedtime. The dose should not be more than 500 mg in twenty-four hours.
    
    
    • Children—Dose must be determined by the doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Baby Gasz Side Effects

There have not been any common or important side effects reported with this medicine. However, if you notice any side effects, check with your doctor.

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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B-Complex/Vitamin C/Folic Acid/Iron/Minerals

Pronunciation: VYE-ta-min C/FOE-lik AS-id/EYE-urn/MIN-er-als
Generic Name: B-Complex/Vitamin C/Folic Acid/Iron/Minerals
Brand Name: Examples include Hemocyte Plus and Ferrocite Plus

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.

B-Complex/Vitamin C/Folic Acid/Iron/Minerals is used for:

Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.

B-Complex/Vitamin C/Folic Acid/Iron/Minerals is a vitamin, folic acid, iron, and mineral combination. It works by providing vitamins, folic acid, iron, and minerals to the body.

Do NOT use B-Complex/Vitamin C/Folic Acid/Iron/Minerals if:

• you are allergic to any ingredient in B-Complex/Vitamin C/Folic Acid/Iron/Minerals


• you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis), hemolytic anemia, pernicious anemia, or you have high levels of iron in your blood

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

Before using B-Complex/Vitamin C/Folic Acid/Iron/Minerals:

Some medical conditions may interact with B-Complex/Vitamin C/Folic Acid/Iron/Minerals. 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 sickle cell anemia or a history of other blood problems (eg, porphyria, thalassemia)


• if you have a peptic ulcer or stomach or bowel problems (eg, ulcerative colitis)


• if you have glucose-6-phosphate-dehydrogenase (G6PD) deficiency, have a bleeding problem, have had multiple blood transfusions, or are receiving dialysis


• if you have a history of seizures

Some MEDICINES MAY INTERACT with B-Complex/Vitamin C/Folic Acid/Iron/Minerals. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because the risk of its side effects may be increased by B-Complex/Vitamin C/Folic Acid/Iron/Minerals


• Doxycycline, hydantoins (eg, phenytoin), mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by B-Complex/Vitamin C/Folic Acid/Iron/Minerals

This may not be a complete list of all interactions that may occur. Ask your health care provider if B-Complex/Vitamin C/Folic Acid/Iron/Minerals 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 B-Complex/Vitamin C/Folic Acid/Iron/Minerals:

Use B-Complex/Vitamin C/Folic Acid/Iron/Minerals as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take B-Complex/Vitamin C/Folic Acid/Iron/Minerals by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you also take antacids, bisphosphonates (eg, etidronate), cephalosporins (eg, cefdinir), doxycycline, hydantoins (eg, phenytoin), levodopa, methyldopa, penicillamine, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, minocycline), or thyroid hormones (eg, levothyroxine), ask your doctor or pharmacist how to take them with B-Complex/Vitamin C/Folic Acid/Iron/Minerals.


• If you miss a dose of B-Complex/Vitamin C/Folic Acid/Iron/Minerals, 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 B-Complex/Vitamin C/Folic Acid/Iron/Minerals.

Important safety information:

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


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use B-Complex/Vitamin C/Folic Acid/Iron/Minerals unless your doctor tells you to.


• B-Complex/Vitamin C/Folic Acid/Iron/Minerals has folic acid and iron in it. Before you start any new medicine, check the label to see if it has folic acid or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• B-Complex/Vitamin C/Folic Acid/Iron/Minerals has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.


• This product may contain tartrazine dye (FD & C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• B-Complex/Vitamin C/Folic Acid/Iron/Minerals may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking B-Complex/Vitamin C/Folic Acid/Iron/Minerals.


• Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use B-Complex/Vitamin C/Folic Acid/Iron/Minerals. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• B-Complex/Vitamin C/Folic Acid/Iron/Minerals should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using B-Complex/Vitamin C/Folic Acid/Iron/Minerals while you are pregnant. B-Complex/Vitamin C/Folic Acid/Iron/Minerals is found in breast milk. If you are or will be breast-feeding while you use B-Complex/Vitamin C/Folic Acid/Iron/Minerals, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of B-Complex/Vitamin C/Folic Acid/Iron/Minerals:

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; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach pain.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.

Proper storage of B-Complex/Vitamin C/Folic Acid/Iron/Minerals:

Store B-Complex/Vitamin C/Folic Acid/Iron/Minerals 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 B-Complex/Vitamin C/Folic Acid/Iron/Minerals out of the reach of children and away from pets.

General information:

• If you have any questions about B-Complex/Vitamin C/Folic Acid/Iron/Minerals, please talk with your doctor, pharmacist, or other health care provider.


• B-Complex/Vitamin C/Folic Acid/Iron/Minerals 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 B-Complex/Vitamin C/Folic Acid/Iron/Minerals. 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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