Threamine DM

Generic Name: chlorpheniramine/dextromethorphan/phenylpropanolamine (klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)

Brand Names: Cheracol Plus, Kophane, Therahist, Threamine DM, Triaminicol Multi Symptom Cough and Cold, Tricodene Forte, Tricodene NN, Triphenicol

What is Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow and allows nasal and respiratory (breathing) passages to open up.

Chlorpheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), and coughs associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/dextromethorphan/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine/dextromethorphan/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Take chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

To ensure that you get a correct dose, measure the liquid form of chlorpheniramine/dextromethorphan/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include dry mouth, large pupils, flushing, nausea, vomiting, hyperactivity, or hallucinations.

What should I avoid while taking Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking chlorpheniramine/dextromethorphan/phenylpropanolamine.

Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

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.

What other drugs will affect Threamine DM (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, dextromethorphan, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Threamine DM resources

• Threamine DM Drug Interactions
• Threamine DM Support Group
• 0 Reviews for Threamine DM - Add your own review/rating

Compare Threamine DM with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine/dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Many formulations of chlorpheniramine/dextromethorphan/phenylpropanolamine are available over-the-counter. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

thyrotropin Injection

thye-roe-TROE-pin

Commonly used brand name(s)

In the U.S.

• Thyrogen

In Canada

• Thytropar

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Thyroid Function

Pharmacologic Class: Pituitary Hormone, Anterior

Uses For thyrotropin

Thyrotropin is used in a test to determine how well your thyroid is working. It may also be used for other conditions as determined by your doctor.

Thyrotropin is to be administered only by or under the immediate supervision of your doctor.

Before Using thyrotropin

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 thyrotropin, the following should be considered:

Allergies

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

thyrotropin has been tested in children and 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 the elderly. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of thyrotropin in the elderly with use in other age groups, thyrotropin is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of thyrotropin. Make sure you tell your doctor if you have any other medical problems, especially:

• Hardening of the arteries or


• Heart disease or


• High blood pressure—Thyrotropin increases body metabolism and causes the heart to work harder, which may make these conditions worse

• Untreated underactive adrenal gland or


• Untreated underactive pituitary gland—Use of thyrotropin may severely worsen these conditions

Proper Use of thyrotropin

For your doctor to properly treat your medical condition, you must receive every dose of thyrotropin. After the last dose, the doctor may want to perform certain tests that are very important.

It is important that your doctor check your progress to make sure that thyrotropin is working properly and to check for unwanted effects.

Dosing

The dose of thyrotropin 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 thyrotropin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For testing the thyroid gland:
    
    • Adults and children—10 International Units (IU) injected under the skin or into a muscle once a day for one to three days. If thyroid testing is being done after surgery, thyrotropin will usually be given for three to seven days.
    
    
  
  

thyrotropin Side Effects

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

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

Rare - more common in patients who have received thyrotropin previously

• Faintness


• itching, redness, or swelling at place of injection


• skin rash


• tightness of throat


• wheezing

Symptoms of overdose

• Chest pain


• fast or irregular heartbeat


• irritability


• nervousness


• shortness of breath


• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Flushing of face


• frequent urge to urinate


• headache


• nausea and vomiting


• stomach discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: thyrotropin Injection side effects (in more detail)

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

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

More thyrotropin Injection resources

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

Compare thyrotropin Injection with other medications

• Diagnosis and Investigation
• Thyroid Cancer

Sodium Thiosulfate Lotion

Pronunciation: SOE-dee-um THYE-oh-SUL-fate/SAL-i SIL-ik AS-id
Generic Name: Sodium Thiosulfate
Brand Name: Versiclear Lotion

Sodium Thiosulfate Lotion is used for:

Treating tinea versicolor, a fungal infection of the skin.

Sodium Thiosulfate Lotion is a topical antifungal and keratolytic agent. It works by killing the fungus that causes tinea versicolor. The keratolytic helps the antifungal reach the deep layers of the skin.

Do NOT use Sodium Thiosulfate Lotion if:

• you are allergic to any ingredient in Sodium Thiosulfate Lotion

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

Before using Sodium Thiosulfate Lotion:

Some medical conditions may interact with Sodium Thiosulfate Lotion. 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 cut, scraped, irritated, or damaged skin at the application site

Some MEDICINES MAY INTERACT with Sodium Thiosulfate Lotion. Because little, if any, of Sodium Thiosulfate Lotion is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Sodium Thiosulfate Lotion 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 Sodium Thiosulfate Lotion:

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

• Shake well before each use.


• Wash your hands thoroughly before and after using Sodium Thiosulfate Lotion, unless your hands are part of the treated area.


• Wash, rinse, and dry the affected area before you apply Sodium Thiosulfate Lotion.


• Apply a thin film of Sodium Thiosulfate Lotion to all affected areas as directed by your health care provider.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• To clear up your infection completely, use Sodium Thiosulfate Lotion for the full course of treatment. Keep using it even if your symptoms improve in a few days.


• If you miss a dose of Sodium Thiosulfate Lotion, use it as soon as you remember. Continue to use it as directed by your doctor or the package label.

Ask your health care provider any questions you may have about how to use Sodium Thiosulfate Lotion.

Important safety information:

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


• Do not use Sodium Thiosulfate Lotion on or around the eyes. If you get Sodium Thiosulfate Lotion in your eyes, immediately flush with cool tap water.


• If you use topical products too often, your condition may become worse. Talk with your doctor before you use any other medicines or cleansers on your skin.


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


• If your symptoms do not get better or if they get worse, check with your doctor.


• Sodium Thiosulfate Lotion 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 Sodium Thiosulfate Lotion while you are pregnant. It is not known if Sodium Thiosulfate Lotion is found in breast milk after topical use. If you are or will be breast-feeding while you use Sodium Thiosulfate Lotion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sodium Thiosulfate Lotion:

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

Mild, temporary burning or stinging at the application site.

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); new or worsening irritation, pain, redness, blistering, or severe burning at the application site.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

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 Sodium Thiosulfate Lotion:

Store Sodium Thiosulfate Lotion at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Thiosulfate Lotion out of the reach of children and away from pets.

General information:

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


• Sodium Thiosulfate Lotion 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 Sodium Thiosulfate Lotion. 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 Sodium Thiosulfate resources

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

Compare Sodium Thiosulfate with other medications

• Tinea Versicolor

Zorprin

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

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

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

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

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

• 
  

  a recent history of stomach or intestinal bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

• 
  

  asthma or seasonal allergies;

  
  


• 
  

  stomach ulcers;

  
  


• liver disease;


• kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease, high blood pressure, or congestive heart failure;

  
  


• 
  

  gout; or

  
  


• 
  

  nasal polyps.

  
  

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin 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 take aspirin?

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

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin 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:

• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fever lasting longer than 3 days;

  
  


• 
  

  swelling, or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Less serious side effects may include:

• 
  

  upset stomach, heartburn;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  headache.

  
  

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 aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking aspirin, tell your doctor if you are using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

  
  

This list is not complete and there may be other drugs that can interact with aspirin. 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 Zorprin resources

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

• Aspirin Monograph (AHFS DI)


• Aspirin Prescribing Information (FDA)


• Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information


• ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Zorprin with other medications

• Angina
• Angina Pectoris Prophylaxis
• Ankylosing Spondylitis
• Antiphospholipid Syndrome
• Aseptic Necrosis
• Back Pain
• Fever
• Heart Attack
• Ischemic Stroke
• Ischemic Stroke, Prophylaxis
• Juvenile Rheumatoid Arthritis
• Kawasaki Disease
• Myocardial Infarction, Prophylaxis
• Niacin Flush
• Osteoarthritis
• Pain
• Prevention of Thromboembolism in Atrial Fibrillation
• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Rheumatic Fever
• Rheumatoid Arthritis
• Sciatica
• Systemic Lupus Erythematosus
• Thromboembolic Stroke Prophylaxis
• Transient Ischemic Attack

Where can I get more information?

• Your pharmacist can provide more information about aspirin.

See also: Zorprin side effects (in more detail)

Lickables Nutritional Gel Chicken

Dosage Form: FOR ANIMAL USE ONLY
Lickables Nutritional Gel Natural Hairball Chicken Flavored

Ingredients

INGREDIENTS: Soybean Oil, Hydrogenated Vegetable Oil, Cod Liver Oil, Flaxseed Oil, Vitamin E, Sorbitol, Soy Protein, Chicken Flavor, Lecithin, Tuna Flavor, Maple Flavor, Beeswax, Methylcellulose, Chamomile

Directions

DIRECTIONS: A few tasty licks from your finger or from a dish, will start your cat on a life free from hairballs.

Dosage

DOSAGE for cats: Feed a 1-1/4 inch ribbon (1/2 teaspoon) daily or as needed. For kittens over 4 weeks, use half doses.

SHAKE WELL - FOR SUPPLEMENTAL FEEDING ONLY

• STORE IN A COOL PLACE


• FOR ANIMAL USE ONLY

Guaranteed Analysis per Teaspoon (6 grams)

Guaranteed Analysis per Teaspoon (6 grams)

Crude Protein (Min)      0.7%

Crude Fat (Min)          72.4%

Crude Fiber (Max)        1.9%

Moisture (Max)            2.9%

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN AND PETS

Principal Display Panel

Petrolatum Free

98% NATURAL INGREDIENTS

Lickables Nutritional Gel

Natural Hairball

Chicken Flavored for Cats & Kittens

Aid in Elimination of Swallowed

Hair and Hairballs

NET WT. 3 oz (85.0 gm)

Tube Label Image

Tube Label Image

LICKABLES NATURAL HAIRBALL CHICKEN FLAVORED  hairball relief  gel

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 66818-072 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Soybean Oil (Soybean Oil) Soybean Oil 3.9 g  in 6 g Palm Oil (Palm Oil) Palm Oil 1.68 g  in 6 g

Inactive Ingredients Ingredient Name Strength Cod liver Oil   Alpha-tocopherol acetate   Chymopapain   Wax, yellow   Sorbitol

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66818-072-05 85 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		06/26/2008

Labeler - American Animal Health, Inc. (102617875)

Registrant - American Animal Health, Inc. (102617875)

Establishment
Name	Address	ID/FEI	Operations
American Pharmaceuticals and Cosmetics, Inc.		038023805	analysis

Revised: 07/2009American Animal Health, Inc.

Zoloft

Pronunciation: SER-tra-leen
Generic Name: Sertraline
Brand Name: Zoloft

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Zoloft outweigh the risks.

Family and caregivers must closely watch patients who take Zoloft. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Zoloft is used for:

Treating depression or obsessive-compulsive disorder (OCD). It may be used to treat panic disorder or posttraumatic stress disorder (PTSD). It may also be used to treat premenstrual dysphoric disorder (PMDD; a severe form of premenstrual syndrome) or social anxiety disorder. It may also be used for other conditions as determined by your doctor.

Zoloft is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve certain mood problems.

Do NOT use Zoloft if:

• you are allergic to any ingredient in Zoloft


• you are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), or St. John's wort within the last 14 days


• you are taking astemizole, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine, venlafaxine), sibutramine, other SSRIs (eg, citalopram, fluoxetine), terfenadine, thioridazine, or tryptophan

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Zoloft:

Some medical conditions may interact with Zoloft. 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 or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse


• if you have a history of seizures, heart problems, liver problems, stomach or bowel bleeding, or metabolism problems


• if you are dehydrated, have low blood sodium levels, or drink alcohol


• if you will be having electroconvulsive therapy (ECT)

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

• Anorexiants (eg, phentermine), bupropion, fenfluramine derivatives (eg, dexfenfluramine), fentanyl, linezolid, MAOIs (eg, phenelzine, selegiline), meperidine, methylene blue, metoclopramide, nefazodone, serotonin 5-HT₁ receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, duloxetine, venlafaxine), other SSRIs (eg, citalopram, fluoxetine), St. John's wort, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur


• Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased


• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of high or low blood sodium levels may be increased


• Tramadol because the risk of seizures may be increased


• Astemizole , phenothiazines (eg, chlorpromazine, thioridazine), or terfenadine because severe heart problems, including irregular heartbeat, may occur


• Carbamazepine or cyproheptadine because they may decrease Zoloft's effectiveness


• Aripiprazole, beta-blockers (eg, propanolol), clozapine, digoxin, flecainide, lithium, phenytoin, pimozide, propafenone, risperidone, tricyclic antidepressants (eg, amitriptyline), or valproate (eg, valproic acid) because the risk of their side effects may be increased by Zoloft


• Tamoxifen because its effectiveness may be decreased by Zoloft

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

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

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


• Take Zoloft by mouth with or without food.


• Taking Zoloft at the same time each day will help you remember to take it.


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


• Do not suddenly stop taking Zoloft without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Zoloft and whenever a change in dose is made.


• If you miss a dose of Zoloft, 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 Zoloft.

Important safety information:

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


• Do not drink alcohol while you are taking Zoloft.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Zoloft; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Zoloft for longer than prescribed without checking with your doctor.


• Children and teenagers who take Zoloft may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Zoloft closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• If your doctor tells you to stop taking Zoloft, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor when you should start to take your new medicines after you have stopped taking Zoloft.


• Zoloft may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Zoloft. Your risk may be greater if you take Zoloft with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Zoloft. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Zoloft may interfere with certain lab tests, including certain urine tests for benzodiazepines. Be sure your doctor and lab personnel know you are taking Zoloft.


• Caution is advised when using Zoloft in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.


• Caution is advised when using Zoloft in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.


• Zoloft should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• Zoloft may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Zoloft.


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

Possible side effects of Zoloft:

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

Anxiety; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; nervousness; stomach upset; tiredness; trouble sleeping; vomiting; weight loss.

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); bizarre behavior; black or bloody stools; chest pain; confusion; decreased bladder control; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.

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: Zoloft side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; fainting; fast, slow, or irregular heartbeat; hair loss; hallucinations; seizures; severe or persistent diarrhea, dizziness, drowsiness, nausea, or vomiting; tremor.

Proper storage of Zoloft:

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

General information:

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


• Zoloft 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 summary only. It does not contain all information about Zoloft. 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 Zoloft resources

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

• Zoloft Prescribing Information (FDA)


• Zoloft Consumer Overview


• Zoloft Monograph (AHFS DI)


• Zoloft Advanced Consumer (Micromedex) - Includes Dosage Information


• Sertraline Prescribing Information (FDA)

Compare Zoloft with other medications

• Depression
• Obsessive Compulsive Disorder
• Panic Disorder
• Post Traumatic Stress Disorder
• Postpartum Depression
• Premenstrual Dysphoric Disorder
• Social Anxiety Disorder

Zebutal

butalbital, acetaminophen and caffeine

Dosage Form: capsule
Zebutal® Capsules Brand of Butalbital, Acetaminophen, and Caffeine Capsules, USP


Rx Only


Rev. 09/11

BOXED WARNING

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

DESCRIPTION

Zebutal® Capsules brand of Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration. Each Zebutal® Capsule contains:

Butalbital, USP                     50 mg

Acetaminophen, USP          500 mg

Caffeine, USP                     40 mg

In addition, each capsule contains the following inactive ingredients: Colloidal Silicon Dioxide, Magnesium Stearate, Sodium Lauryl Sulfate, and Sodium Starch Glycolate.

Capsule shell contains: D&C Red #33, D&C Yellow #10, FD&C Red #40, Gelatin and Titanium Dioxide. The imprinting ink contains Titanium Dioxide.

Butalbital (5-allyl-5-isobutyl-barbituric acid), a white, odorless crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate. It has the following structural formula:

                 

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

                 

Caffeine (1,3,7-trimethylxanthine),a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

                 

CLINICAL PHARMACOLOGY

The combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics:

The behavior of the individual components is described below.

Butalbital:

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% was conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium.  The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential distribution of butalbital into either plasma or blood cells. (see OVERDOSAGE for toxicity information).

Acetaminophen:

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. (See OVERDOSAGE for toxicity information.)

Caffeine:

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion, results in about equal amounts of 1-methyl-xanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug. (See OVERDOSAGE for toxicity information).

INDICATIONS AND USAGE

Zebutal® Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

CONTRAINDICATIONS

This product is contraindicated under the following conditions:

• Hypersensitivity or intolerance to any component of this product.


• Patients with porphyria.

WARNINGS

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Zebutal® capsules immediately and seek medical care if they experience these symptoms. Do not prescribe Zebutal® capsules for patients with acetaminophen allergy.

PRECAUTIONS

General:  

Zebutal® Capsules should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Information for Patients/Caregivers:

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

• Do not take Zebutal® capsules if you are allergic to any of its ingredients.


• If you develop signs of allergy such as a rash or difficulty breathing stop taking Zebutal® capsules and contact your healthcare provider immediately.


• Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Laboratory Tests:

 In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions:

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Zebutal® Capsules may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions:

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects:

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers:

Barbiturates, acetaminophen and caffeine are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use:

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

Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed: All adverse events tabulated below are classified as infrequent.

Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congesion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Abuse and Dependence:

Butalbital:Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increased; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

OVERDOSAGE

Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms:

Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment:

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. 

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

DOSAGE AND ADMINISTRATION  

Oral: one capsule every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Zebutal® Capsules brand of butalbital 50 mg (Warning: May be habit-forming), acetaminophen 500 mg and caffeine 40 mg are supplied as salmon/red capsules printed "170" in white ink and are available in:

NDC 59630-170-11     Bottles of 100 capsules.

Store at 20-25oC (68-77oF) [See USP Controlled Room Temperature]. Protect from light and moisture.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured For:

Shionogi Inc.

Florham Park, NJ 07932

Manufactured By:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised September 2011

ZEB-PI-1

PRINCIPAL DISPLAY PANEL

Zebutal® Butalbital, Acetaminophen, Caffeine Capsules, USP

NDC 59630-170-11

Zebutal  butalbital, acetaminophen and caffeine  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59630-170 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg CAFFEINE (CAFFEINE) CAFFEINE 40 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   MAGNESIUM STEARATE   SODIUM LAURYL SULFATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   TITANIUM DIOXIDE   D&C RED NO. 33   FD&C RED NO. 40   D&C YELLOW NO. 10   GELATIN

Product Characteristics Color RED (RED) Score no score Shape CAPSULE (CAPSULE) Size 21mm Flavor Imprint Code 170 Contains

Packaging # NDC Package Description Multilevel Packaging 1 59630-170-11 100 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040261	10/28/1998

Labeler - Shionogi Inc. (949127786)

Establishment
Name	Address	ID/FEI	Operations
West-ward Pharmaceutical Corp		001230762	MANUFACTURE

Revised: 11/2011Shionogi Inc.

More Zebutal resources

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

• Anolor 300 Advanced Consumer (Micromedex) - Includes Dosage Information


• Dolgic LQ Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Dolgic Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Fioricet Consumer Overview


• Nonbac Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Zebutal with other medications

• Headache

Zofran

Pronunciation: on-DAN-se-tron
Generic Name: Ondansetron
Brand Name: Zofran

Zofran is used for:

Preventing nausea and vomiting associated with cancer chemotherapy or surgery. It may also be used for other conditions as determined by your doctor.

Zofran is a serotonin 5-HT₃ receptor blocker. It works by blocking a chemical thought to be a cause of nausea and vomiting in certain situations (eg, chemotherapy).

Do NOT use Zofran if:

• you are allergic to any ingredient in Zofran


• you are taking apomorphine


• you have a certain type of irregular heartbeat (congenital long QT syndrome)

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

Before using Zofran:

Some medical conditions may interact with Zofran. 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 had an allergic reaction to another serotonin 5-HT₃ receptor blocker (eg, dolasetron, granisetron)


• if you have liver problems, heart problems (eg, congestive heart failure, slow or irregular heartbeat, QT prolongation), or electrolyte problems (eg, low potassium or magnesium levels)


• if you take medicines that may affect your heartbeat. Check with your doctor if you are unsure if any of your medicines may affect your heartbeat

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

• Apomorphine because the risk of its side effects may be increased by Zofran


• Antineoplastic agents (eg, cyclophosphamide) or tramadol because their effectiveness may be decreased by Zofran

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

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

• Zofran is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Zofran at home, a health care provider will teach you how to use it. Be sure you understand how to use Zofran. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Zofran if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is important that Zofran be given prior to cancer chemotherapy as directed. If you miss a dose of Zofran, contact your doctor or pharmacist.

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

Important safety information:

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


• Zofran should be used with extreme caution in CHILDREN younger than 4 months old; safety and effectiveness in these children have not been confirmed. Certain strengths of Zofran are not recommended in CHILDREN. If you have questions about using Zofran in children, contact 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 Zofran while you are pregnant. It is not known if Zofran is found in breast milk. If you are or will be breast-feeding while you use Zofran, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zofran:

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

Constipation; diarrhea; dizziness; drowsiness; headache; irritation, redness, pain, or burning at the site of injection; tiredness.

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, throat, or tongue; wheezing; unusual hoarseness); chest or jaw pain, numbness of an arm or leg,or sudden severe headache or vomiting; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness; skin tingling or numbness; stomach pain; trouble urinating; uncontrolled muscle movements; vision changes or loss.

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: Zofran side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness; slowed/irregular heartbeat; sudden, temporary blindness.

Proper storage of Zofran:

Zofran is usually handled and stored by a health care provider. If you are using Zofran at home, store Zofran as directed by your pharmacist or health care provider. Keep Zofran out of the reach of children and away from pets.

General information:

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


• Zofran 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 Zofran. 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 Zofran resources

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

• Zofran Prescribing Information (FDA)


• Zofran Consumer Overview


• Zofran Monograph (AHFS DI)


• Zofran Advanced Consumer (Micromedex) - Includes Dosage Information


• Ondansetron Prescribing Information (FDA)


• Zofran ODT Prescribing Information (FDA)


• Zuplenz Prescribing Information (FDA)


• Zuplenz Consumer Overview


• Zuplenz Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Zofran with other medications

• Alcohol Dependence
• Gastroenteritis
• Nausea/Vomiting
• Nausea/Vomiting, Chemotherapy Induced
• Nausea/Vomiting, Postoperative
• Nausea/Vomiting, Radiation Induced
• Obsessive Compulsive Disorder
• Postanesthetic Shivering
• Pruritus