Uropipedil

Uropipedil may be available in the countries listed below.

Ingredient matches for Uropipedil

Pipemidic Acid

Pipemidic Acid is reported as an ingredient of Uropipedil in the following countries:

• Spain

International Drug Name Search

PMS-Gemfibrozil

PMS-Gemfibrozil may be available in the countries listed below.

Ingredient matches for PMS-Gemfibrozil

Gemfibrozil

Gemfibrozil is reported as an ingredient of PMS-Gemfibrozil in the following countries:

• Canada

International Drug Name Search

Ultramidol

Ultramidol may be available in the countries listed below.

Ingredient matches for Ultramidol

Bromazepam

Bromazepam is reported as an ingredient of Ultramidol in the following countries:

• Portugal

International Drug Name Search

Liver Metastasis in Adenocarcinoma Medications

Drugs associated with Liver Metastasis in Adenocarcinoma

The following drugs and medications are in some way related to, or used in the treatment of Liver Metastasis in Adenocarcinoma. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Fudr

Disipal

Disipal may be available in the countries listed below.

UK matches:

• Disipal Tablets
• Disipal Tablets (SPC)

Ingredient matches for Disipal

Orphenadrine

Orphenadrine hydrochloride (a derivative of Orphenadrine) is reported as an ingredient of Disipal in the following countries:

• Greece


• Israel


• Italy


• Luxembourg


• New Zealand


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ironcrose

Ironcrose may be available in the countries listed below.

Ingredient matches for Ironcrose

Iron Sucrose

Iron Sucrose is reported as an ingredient of Ironcrose in the following countries:

• Greece

International Drug Name Search

Chorionic Gonadotropin

In some countries, this medicine may only be approved for veterinary use.

In the US, Chorionic Gonadotropin (chorionic gonadotropin (hcg) systemic) is a member of the drug class gonadotropins and is used to treat Female Infertility, Hypogonadism - Male, Ovulation Induction and Prepubertal Cryptorchidism.

US matches:

• Chorionic Gonadotropin


• Chorionic gonadotropin Subcutaneous, Intramuscular, Injection

Ingredient matches for Chorionic Gonadotropin

Chorionic Gonadotrophin

Chorionic Gonadotrophin is reported as an ingredient of Chorionic Gonadotropin in the following countries:

• Canada


• United States

International Drug Name Search

Asprim

Asprim may be available in the countries listed below.

Ingredient matches for Asprim

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Asprim in the following countries:

• Dominican Republic

International Drug Name Search

Diclofénac Biogaran

Diclofénac Biogaran may be available in the countries listed below.

Ingredient matches for Diclofénac Biogaran

Diclofenac

Diclofenac diethylamine (a derivative of Diclofenac) is reported as an ingredient of Diclofénac Biogaran in the following countries:

• France

International Drug Name Search

Ufocard

Ufocard may be available in the countries listed below.

Ingredient matches for Ufocard

Nitrendipine

Nitrendipine is reported as an ingredient of Ufocard in the following countries:

• Greece

International Drug Name Search

Cervical Ripening Medications

Drugs associated with Cervical Ripening

The following drugs and medications are in some way related to, or used in the treatment of Cervical Ripening. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Cytotec

Ureotop

Ureotop may be available in the countries listed below.

Ingredient matches for Ureotop

Urea

Urea is reported as an ingredient of Ureotop in the following countries:

• Germany

International Drug Name Search

Bronlukast

Bronlukast may be available in the countries listed below.

Ingredient matches for Bronlukast

Zafirlukast

Zafirlukast is reported as an ingredient of Bronlukast in the following countries:

• Dominican Republic

International Drug Name Search

Urogliss

Urogliss may be available in the countries listed below.

Ingredient matches for Urogliss

Chlorhexidine

Chlorhexidine dihydrochloride (a derivative of Chlorhexidine) is reported as an ingredient of Urogliss in the following countries:

• Netherlands

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Urogliss in the following countries:

• Netherlands

International Drug Name Search

Umpimycin Vet

Umpimycin Vet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Umpimycin Vet

Benzylpenicillin

Benzylpenicillin benethamin (a derivative of Benzylpenicillin) is reported as an ingredient of Umpimycin Vet in the following countries:

• Finland

Framycetin

Framycetin sulfate (a derivative of Framycetin) is reported as an ingredient of Umpimycin Vet in the following countries:

• Finland

Penethamate Hydriodide

Penethamate Hydriodide is reported as an ingredient of Umpimycin Vet in the following countries:

• Finland

International Drug Name Search

Cyklokapron

Pronunciation: TRAN-ex-AM-ik AS-id
Generic Name: Tranexamic Acid
Brand Name: Cyklokapron

Cyklokapron is used for:

Reducing or preventing excessive bleeding and reducing the need for blood clotting factor transfusions during or after tooth extractions in patients with hemophilia. It is also used to prevent or reduce bleeding during certain medical procedures (eg, cervical surgery) and to treat certain bleeding problems (eg, nosebleeds, bleeding inside the eye, heavy menstrual periods) in patients whose blood does not clot well. It is also used to treat hereditary angioneurotic edema. It may also be used for other conditions as determined by your doctor.

Cyklokapron is an antifibrinolytic. It works by preventing blood clots from breaking down too quickly. This helps to reduce excessive bleeding.

Do NOT use Cyklokapron if:

• you are allergic to any ingredient in Cyklokapron


• you have blood clots (eg, in the leg, lung, eye, brain), a history of blood clots, or conditions that may increase your risk of blood clots (eg, certain heart valve problems, certain types of irregular heartbeat, certain blood clotting problems)


• you have bleeding in the brain, blood in the urine, or bleeding related to kidney problems


• you have a disturbance of color vision


• you have irregular menstrual bleeding of unknown cause


• you are using medicine to help your blood clot (eg, factor IX complex concentrates or anti-inhibitor coagulant concentrates)

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

Before using Cyklokapron:

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

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


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


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


• if you have a history of kidney problems, diabetes, polycystic ovary syndrome, bleeding or blood clotting problems, a certain blood problem called disseminated intravascular coagulation (DIC), eye or vision problems, or bleeding in the brain


• if you are very overweight


• if you have a personal or family history of blood clots or endometrial cancer


• if you also take estrogen or tamoxifen

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

• Hormonal birth control (eg, birth control pills), medicines to help your blood clot (eg, anti-inhibitor coagulant concentrates, factor IX complex concentrates), or tretinoin (all-trans retinoic acid) because the risk of blood clots may be increased


• Desmopressin, hydrochlorothiazide, nitroglycerin, ranitidine, or sulbactam-ampicillin because the risk of heart attack may be increased


• Anticoagulants (eg, warfarin) because they may decrease Cyklokapron's effectiveness

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

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

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


• Do not use Cyklokapron 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.


• Continue to use Cyklokapron for the full course of treatment even if you feel well. Do not miss any doses.


• If you miss a dose of Cyklokapron, contact your doctor immediately.

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

Important safety information:

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


• The risk of a stroke, a heart attack, or other blood clots may be increased when Cyklokapron is used with hormonal birth control (eg, birth control pills). The risk may be greater if you are very overweight or if you smoke cigarettes, especially if you are older than 35 years. Discuss any questions or concerns with your doctor.


• If your symptoms do not get better (eg, after 2 or 3 menstrual cycles if being used for heavy menstrual bleeding), if they get worse, or if Cyklokapron seems to stop working, check with your doctor.


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


• Lab tests, including eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Cyklokapron should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.


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


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cyklokapron while you are pregnant. Cyklokapron is found in breast milk. If you are or will be breast-feeding while you are using Cyklokapron, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cyklokapron:

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; nausea; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, swelling, or tenderness; chest pain; confusion; coughing up blood; decreased urination or difficulty urinating; eye problems; fainting; numbness of an arm or leg; one-sided weakness; pain, swelling, or redness at the injection site; seizures; severe or persistent dizziness or light-headedness; shortness of breath; slurred speech; sudden, severe headache or vomiting; vision changes or problems (eg, disturbance of color vision, sharpness, or field of vision).

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: Cyklokapron 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 dizziness when you stand up; fainting; light-headedness; mental or mood changes; muscle twitching; rash; seizures; severe diarrhea, nausea, or vomiting; vision problems.

Proper storage of Cyklokapron:

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

General information:

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


• Cyklokapron 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 Cyklokapron. 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 Cyklokapron resources

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

• Cyklokapron Prescribing Information (FDA)


• Cyklokapron Advanced Consumer (Micromedex) - Includes Dosage Information


• Tranexamic Acid Professional Patient Advice (Wolters Kluwer)


• Lysteda Prescribing Information (FDA)


• Lysteda Advanced Consumer (Micromedex) - Includes Dosage Information


• Lysteda Consumer Overview

Compare Cyklokapron with other medications

• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A

Kezoral

Kezoral may be available in the countries listed below.

Ingredient matches for Kezoral

Ketoconazole

Ketoconazole is reported as an ingredient of Kezoral in the following countries:

• Singapore

International Drug Name Search

Bioflac

Bioflac may be available in the countries listed below.

Ingredient matches for Bioflac

Meloxicam

Meloxicam is reported as an ingredient of Bioflac in the following countries:

• Brazil

International Drug Name Search

Unexym

Unexym may be available in the countries listed below.

Ingredient matches for Unexym

Pancreatin

Pancreatin is reported as an ingredient of Unexym in the following countries:

• Germany

International Drug Name Search

Namicin

Namicin may be available in the countries listed below.

Ingredient matches for Namicin

Lomefloxacin

Lomefloxacin hydrochloride (a derivative of Lomefloxacin) is reported as an ingredient of Namicin in the following countries:

• Bangladesh

International Drug Name Search

Cec Hexal

Cec Hexal may be available in the countries listed below.

Ingredient matches for Cec Hexal

Cefaclor

Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Cec Hexal in the following countries:

• Austria


• Romania

International Drug Name Search

Urecure

Urecure may be available in the countries listed below.

Ingredient matches for Urecure

Propiverine

Propiverine hydrochloride (a derivative of Propiverine) is reported as an ingredient of Urecure in the following countries:

• Japan

International Drug Name Search

Floxabid

Floxabid may be available in the countries listed below.

Ingredient matches for Floxabid

Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Floxabid in the following countries:

• Bangladesh

International Drug Name Search

typhoid vaccine (live), oral

Generic Name: typhoid vaccine (live), oral (TYE foid vax EEN)

Brand Names: Vivotif Berna

What is typhoid vaccine?

Typhoid (also called "typhoid fever") is a serious disease caused by Salmonella typhi bacteria. Typhoid can be fatal if left untreated.

Typhoid can cause high fever, muscle aches, severe headache, weakness, confusion or agitation, loss of appetite, stomach pain, diarrhea or constipation, and rose-colored spots on the skin.

Untreated typhoid infection may lead to kidney failure, or intestinal bleeding caused by perforation (forming of a hole), which can be fatal. If the infection spreads to the gallbladder, the infected person may become a chronic carrier of the bacteria that causes typhoid. A carrier may have no symptoms but is capable of spreading the infection to others.

Typhoid is spread through contact with the stool (bowel movements) of a person infected with the bacteria. This usually occurs by eating food or drinking water that has become contaminated with feces from an infected person. Once in the digestive tract, typhoid infection can spread to the blood and other parts of the body.

Typhoid fever is most common in non-industrialized parts of the world, especially Asia, Africa, and Central or South America. People who travel to those regions are at risk of coming into contact with the disease.

The typhoid vaccine is used to help prevent this disease in adults and children who are at least 6 years old. Although not part of a routine immunization schedule in the U.S., typhoid vaccine is recommended for people who travel to areas where the disease is common.

This vaccine works by exposing you to a small amount of the bacteria, which causes your body to develop immunity to the disease.

Typhoid vaccine will not treat an active infection that has already developed in the body, and will not prevent any disease caused by bacteria other than Salmonella typhi.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

What is the most important information I should know about typhoid vaccine?

You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have fever with any type of infection or illness, or a weak immune system caused by disease or by using certain medicines such as chemotherapy. Typhoid vaccine should not be used in a person who is a typhoid carrier.

Before you receive this vaccine, tell the doctor if you have any illness with vomiting or diarrhea, if you are taking an antibiotic or sulfa drug (Azulfidine, Bactrim, Cotrim, Gantrisin, Septra, SMX-TMP, Sulfazine), or if you plan to start taking an anti-malaria medication within 10 days after receiving typhoid vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

In addition to receiving typhoid vaccine, take precautions while traveling such as avoiding raw fruits or vegetables that cannot be peeled, drinks that contain ice, flavored ices that may have been made with contaminated water, unbottled or unboiled water, or any food or beverage purchased from a street vendor.

What should I discuss with my healthcare provider before receiving typhoid vaccine?

Typhoid vaccine should not be used in a person who is a typhoid carrier. You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have:

• 
  

  fever with any type of infection or illness;

  
  


• 
  

  a weak immune system caused by disease such as HIV/AIDS or cancer; or

  
  


• 
  

  a weak immune system caused by using certain medicines such as chemotherapy.

  
  

You may not be able to receive this vaccine if you have:

• 
  

  stomach flu or any illness with vomiting or diarrhea;

  
  


• 
  

  if you are taking an antibiotic, especially a sulfa drug such as sulfasalazine (Azulfidine, Sulfazine), sulfamethoxazole (Bactrim, Cotrim, Septra, SMX-TMP), or sulfisoxazole (Gantrisin); or

  
  


• 
  

  if you plan to start taking an anti-malaria medication within 10 days after receiving a typhoid oral vaccine.

  
  

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with typhoid. It is not known whether typhoid vaccine passes into breast milk, or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is typhoid vaccine given?

Typhoid vaccine is recommended for adults and children in the following situations:

• 
  

  people who travel to countries where typhoid fever is common;

  
  


• 
  

  people who will have long-term exposure to food or water that may be contaminated with typhoid;

  
  


• 
  

  people who live with someone who is a typhoid carrier; and

  
  


• 
  

  laboratory workers who may come into contact with Salmonella typhi in a work setting.

  
  

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze. Take the capsule on an empty stomach, at least 1 hour before a meal.

Swallow the capsule as quickly as possible after placing it in your mouth. Take with a full glass of cold or lukewarm water or other beverage. Do not use warm or hot drinks such as coffee, tea, or warm milk. The liquid you use to help swallow the typhoid vaccine capsule should not be warmer than your body temperature (98.6 degrees F).

Do not crush, chew, or break a typhoid vaccine capsule. Swallow the pill whole. The enteric-coated pill has a special coating to release the vaccine slowly into your body. Breaking the pill could damage this coating.

The complete series of 4 vaccine capsules should provide protection against typhoid for up to 5 years. Another series of 4 capsules is then recommended every 5 years during possible exposure to typhoid. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the Centers for Disease Control and Prevention (CDC).

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of capsules every 5 years during continued exposure, you may not be fully protected against the disease.

Wash your hands often to help prevent typhoid when you are in an area where contamination is possible.

What happens if I miss a dose?

Contact your doctor if you forget to take a capsule on the scheduled day. You may need to start over to make sure you are fully protected against the disease.

Be sure to receive another series of 4 capsules every 5 years during continued exposure to typhoid.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur when taken as directed.

What should I avoid before or after getting typhoid vaccine?

In addition to receiving typhoid vaccine, take precautions while traveling to further prevent coming into contact with bacteria that cause typhoid fever:

• 
  

  Avoid eating leafy vegetables such as spinach or lettuce, which are harder to wash properly.

  
  


• 
  

  Avoid eating raw fruits or vegetables that cannot be peeled, or that have been peeled by another person.

  
  


• 
  

  Avoid drinks that contain ice, or frozen treats and flavored ices that may have been made with contaminated water.

  
  


• 
  

  Avoid eating foods you have not cooked or prepared yourself. Use clean surfaces and utensils when preparing food.

  
  


• 
  

  Drink only bottled water (carbonated is best) or water that has been boiled for at least 1 minute.

  
  


• 
  

  Avoid any food or beverage purchased from a street vendor.

  
  

Typhoid vaccine side effects

You should not receive a booster dose if you had a life-threatening allergic reaction after taking a typhoid vaccine capsule.

Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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

Less serious side effects include:

• 
  

  low fever;

  
  


• 
  

  headache;

  
  


• 
  

  nausea, vomiting, diarrhea, stomach pain; or

  
  


• 
  

  mild skin rash.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Typhoid vaccine (live), oral Dosing Information

Usual Adult Dose for Typhoid Prophylaxis:

One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] on alternate days, e.g., days 1, 3, 5 and 7.

Immunization with all 4 doses should be completed at least 1 week prior to potential exposure to Salmonella typhi.

Usual Pediatric Dose for Typhoid Prophylaxis:

>= 6 years: One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] on alternate days, e.g., days 1, 3, 5 and 7.

Immunization with all 4 doses should be completed at least 1 week prior to potential exposure to Salmonella typhi.

What other drugs will affect typhoid vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

You should not take an anti-malaria medication called proguanil (Malarone) for at least 10 days after you have received your last dose of typhoid vaccine. Proguanil may make typhoid vaccine less effective.

There may be other drugs that can affect this vaccine. 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 typhoid vaccine (live), oral resources

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

Compare typhoid vaccine (live), oral with other medications

• Typhoid Prophylaxis

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: typhoid vaccine (live), side effects (in more detail)

Urinaron

Urinaron may be available in the countries listed below.

Ingredient matches for Urinaron

Flavoxate

Flavoxate hydrochloride (a derivative of Flavoxate) is reported as an ingredient of Urinaron in the following countries:

• Japan

International Drug Name Search

Ureotop + VAS

Ureotop + VAS may be available in the countries listed below.

Ingredient matches for Ureotop + VAS

Tretinoin

Tretinoin is reported as an ingredient of Ureotop + VAS in the following countries:

• Germany

Urea

Urea is reported as an ingredient of Ureotop + VAS in the following countries:

• Germany

International Drug Name Search

DayQuil

Generic Name: acetaminophen, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, DEX troe me THOR fan, SOO doe ee FED rin)

Brand Names: Alka-Seltzer Plus Flu Liquigels, Comtrex Non-Drowsy, DayQuil, Dayquil Liquicaps, Daytime Cold, Non-Drowsy Daytime, Robitussin Honey Flu Non-Drowsy, Theraflu (pseudoephedrine) Daytime Severe Cold, Theraflu Severe Cold & Congestion Non-Drowsy, Triaminic Cough & Sore Throat (pseudoephedrine), Triaminic Softchew Throat Pain and Cough, Triaminic Softchews Cough & Sore Throat (pseudoephedrine)

What is DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

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

The combination of acetaminophen, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, and pseudoephedrine if you have:

• 
  

  liver disease, cirrhosis, or a history of alcoholism;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  diabetes;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  pheochromocytoma (an adrenal gland tumor); or

  
  


• 
  

  cough with mucus, or cough caused by emphysema or chronic bronchitis.

  
  

It is not known whether acetaminophen, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

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

How should I take DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine)?

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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

The chewable tablet must be chewed thoroughly before you swallow it.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

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

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine) 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. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, fast, slow, or uneven heart rate;

  
  


• 
  

  severe dizziness, feeling like you might pass out;

  
  


• 
  

  mood changes, confusion, hallucinations;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  fever;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  mild headache;

  
  


• 
  

  mild nausea, diarrhea, upset stomach;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  feeling nervous, restless, irritable, or anxious; or

  
  


• 
  

  sleep problems (insomnia).

  
  

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 DayQuil (acetaminophen, dextromethorphan, and pseudoephedrine)?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

• 
  

  leflunomide (Arava);

  
  


• 
  

  tapentadol (Nucynta);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  migraine headache medicine;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

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

More DayQuil resources

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

• DayQuil Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare DayQuil with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, dextromethorphan, and pseudoephedrine.

See also: DayQuil side effects (in more detail)

Urecholine

In the US, Urecholine (bethanechol systemic) is a member of the drug class miscellaneous genitourinary tract agents and is used to treat Abdominal Distension, GERD and Urinary Retention.

US matches:

• Urecholine

Ingredient matches for Urecholine

Bethanechol

Bethanechol Chloride is reported as an ingredient of Urecholine in the following countries:

• United States

International Drug Name Search

Urgo Ibuprofen

Urgo Ibuprofen may be available in the countries listed below.

Ingredient matches for Urgo Ibuprofen

Ibuprofen

Ibuprofen is reported as an ingredient of Urgo Ibuprofen in the following countries:

• Czech Republic


• Romania

International Drug Name Search

Mobicam

Mobicam may be available in the countries listed below.

Ingredient matches for Mobicam

Meloxicam

Meloxicam is reported as an ingredient of Mobicam in the following countries:

• Ireland


• Taiwan

International Drug Name Search

Sulfadoxina

Sulfadoxina may be available in the countries listed below.

Ingredient matches for Sulfadoxina

Sulfadoxine

Sulfadoxina (DCIT) is known as Sulfadoxine in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Urbason Solubile

Urbason Solubile may be available in the countries listed below.

Ingredient matches for Urbason Solubile

Methylprednisolone

Methylprednisolone 21-(sodium succinate) (a derivative of Methylprednisolone) is reported as an ingredient of Urbason Solubile in the following countries:

• Austria


• Italy


• Spain

International Drug Name Search

Oranvital

Oranvital may be available in the countries listed below.

Ingredient matches for Oranvital

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Oranvital in the following countries:

• Ethiopia

International Drug Name Search

Urion

Urion may be available in the countries listed below.

Ingredient matches for Urion

Alfuzosin

Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Urion in the following countries:

• France


• Germany


• Luxembourg

International Drug Name Search

Equiminth

Equiminth may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Equiminth

Abamectin

Abamectin is reported as an ingredient of Equiminth in the following countries:

• Australia

International Drug Name Search

Urizine

Urizine may be available in the countries listed below.

Ingredient matches for Urizine

Cinnarizine

Cinnarizine is reported as an ingredient of Urizine in the following countries:

• Singapore

International Drug Name Search

Urispadol

Urispadol may be available in the countries listed below.

Ingredient matches for Urispadol

Flavoxate

Flavoxate hydrochloride (a derivative of Flavoxate) is reported as an ingredient of Urispadol in the following countries:

• Denmark

International Drug Name Search

Axid Pulvules

Generic Name: nizatidine (ni ZA ti deen)

Brand Names: Axid, Axid AR, Axid Pulvules

What is Axid Pulvules (nizatidine)?

Nizatidine is in a group of drugs called histamine-2 blockers. Nizatidine works by decreasing the amount of acid the stomach produces.

Nizatidine is used to treat ulcers in the stomach and intestines. Nizatidine also treats heartburn and erosive esophagitis caused by gastroesophageal reflux disease (GERD), a condition in which acid backs up from the stomach into the esophagus.

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

What is the most important information I should know about Axid Pulvules (nizatidine)?

You should not use this medication if you are allergic to nizatidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or famotidine (Pepcid).

Before taking nizatidine, tell your doctor if you have kidney or liver disease, or stomach cancer or other problems.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or famotidine (Pepcid) while you are taking nizatidine, unless your doctor has told you to.

Nizatidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Nizatidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

What should I discuss with my healthcare provider before taking Axid Pulvules (nizatidine)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medication if you are allergic to nizatidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or famotidine (Pepcid).

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

• kidney disease;


• liver disease; or


• 
  

  stomach cancer or other problems.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Nizatidine can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking this medication. Do not give this medication to a child younger than 12 years old without the advice of a doctor.

How should I take Axid Pulvules (nizatidine)?

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.

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

Although most ulcers heal within 4 weeks of nizatidine treatment, it may take up to 8 to 12 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nizatidine.

Nizatidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light. Throw away any unused nizatidine liquid that is older than 30 days.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include blurred vision, watery eyes, drooling, nausea, vomiting, or diarrhea.

What should I avoid' while taking Axid Pulvules (nizatidine)?

Nizatidine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It can increase the risk of damage to your stomach.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or famotidine (Pepcid) while you are taking nizatidine, unless your doctor has told you to.

Axid Pulvules (nizatidine) 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 nizatidine and call your doctor at once if you have a serious side effect such as:

• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  unusual bleeding, purple or red pinpoint spots under your skin;

  
  


• 
  

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

  
  


• 
  

  fever, confusion; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  headache, dizziness;

  
  


• 
  

  mild rash;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  runny or stuffy nose, sore throat, cough.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Axid Pulvules (nizatidine)?

Tell your doctor about all other medications you use, especially aspirin.

There may be other drugs that can interact with nizatidine. 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 Axid Pulvules resources

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

• Nizatidine Prescribing Information (FDA)


• Nizatidine Professional Patient Advice (Wolters Kluwer)


• Axid MedFacts Consumer Leaflet (Wolters Kluwer)


• Axid Monograph (AHFS DI)


• Axid Prescribing Information (FDA)


• Axid Consumer Overview


• Axid AR Prescribing Information (FDA)

Compare Axid Pulvules with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Where can I get more information?

• Your pharmacist can provide more information about nizatidine.

See also: Axid Pulvules side effects (in more detail)

Epelin

Epelin may be available in the countries listed below.

Ingredient matches for Epelin

Phenytoin

Phenytoin is reported as an ingredient of Epelin in the following countries:

• Brazil

Phenytoin sodium salt (a derivative of Phenytoin) is reported as an ingredient of Epelin in the following countries:

• Brazil

International Drug Name Search

Miansérine Biogaran

Miansérine Biogaran may be available in the countries listed below.

Ingredient matches for Miansérine Biogaran

Mianserin

Mianserin hydrochloride (a derivative of Mianserin) is reported as an ingredient of Miansérine Biogaran in the following countries:

• France

International Drug Name Search

Umezar

Umezar may be available in the countries listed below.

Ingredient matches for Umezar

Diltiazem

Diltiazem is reported as an ingredient of Umezar in the following countries:

• Colombia

International Drug Name Search

Praxiten

Praxiten may be available in the countries listed below.

Ingredient matches for Praxiten

Oxazepam

Oxazepam is reported as an ingredient of Praxiten in the following countries:

• Austria


• Bosnia & Herzegowina


• Croatia (Hrvatska)


• Germany


• Slovenia

International Drug Name Search

Uroleap

Uroleap may be available in the countries listed below.

Ingredient matches for Uroleap

Benzbromarone

Benzbromarone is reported as an ingredient of Uroleap in the following countries:

• Japan

International Drug Name Search

Lotemax Eye Ointment

loteprednol etabonate

Dosage Form: ophthalmic ointment
FULL PRESCRIBING INFORMATION

Indications and Usage for Lotemax Eye Ointment

LOTEMAX® ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Lotemax Eye Ointment Dosage and Administration

Apply a small amount (approximately ½ inch ribbon) into the conjunctival sac(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

Dosage Forms and Strengths

LOTEMAX is supplied sterile in a 3.5 gram tube filled with loteprednol etabonate ophthalmic ointment, 0.5%.

Contraindications

LOTEMAX ointment, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Warnings and Precautions

Intraocular pressure (IOP) increase

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored even though it may be difficult in children and uncooperative patients.

Cataracts

Use of corticosteroids may result in posterior subcapsular cataract formation.

Delayed healing

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Bacterial infections

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

Viral infections

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal infections

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

Contact Lens Wear

Patients should not wear contact lenses during their course of therapy with LOTEMAX ointment.

Amblyopia

LOTEMAX (loteprednol etabonate ophthalmic ointment), 0.5% should not be used in children following ocular surgery.  Its use may interfere with amblyopia treatment by hindering the child’s ability to see out of the operated eye (see Pediatric Use, 8.4).

Topical ophthalmic use only

Lotemax is not indicated for intraocular administration.

Adverse Reactions

Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

The most common ocular adverse event reported at approximately 25% in subjects in clinical studies with Lotemax ointment was anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, were conjunctival hyperemia, corneal edema, and eye pain. Many of these events may have been the consequence of the surgical procedure. The only non-ocular adverse event occurring at ≥ 1% was headache (1.5%).

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic effects: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (150 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (25 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥ 5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥ 50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥ 50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (25 times the maximum daily clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥ 5 mg/kg/day.

Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period.

LOTEMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

Nursing Mothers

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when LOTEMAX ointment is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

LOTEMAX (loteprednol etabonate ophthalmic ointment) 0.5% should not be used in children following ocular surgery.  Its use may interfere with amblyopia treatment by hindering the child’s ability to see out of the operated eye.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Lotemax Eye Ointment Description

LOTEMAX (loteprednol etabonate ophthalmic ointment) 0.5% is a sterile, topical corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder.

Loteprednol etabonate is represented by the following structural formula:

Chemical Name:

chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate

Each gram contains:

ACTIVE: Loteprednol Etabonate 5 mg (0.5%);

INACTIVES: Mineral Oil and White Petrolatum.

Lotemax Eye Ointment - Clinical Pharmacology

Mechanism Of Action

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established. However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.

Pharmacokinetics

The systemic exposure to loteprednol etabonate following ocular administration of LOTEMAX ointment has not been studied in humans. However, results from a bioavailability study with LOTEMAX suspension in normal volunteers established that plasma concentrations of loteprednol etabonate and Δ¹ cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate suspension, 8 times daily for 2 days or 4 times daily for 42 days. The maximum systemic exposure to loteprednol following administration of the ointment product dosed four times daily is not expected to exceed exposures attained with LOTEMAX suspension dosed up to two drops four times daily.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (2500 and 1250 times the maximum daily clinical dose, respectively) prior to and during mating did not impair fertility in either gender.

Clinical Studies

In two independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 805 subjects meeting a protocol-specified threshold amount of anterior chamber inflammation, LOTEMAX ointment was more effective compared to its vehicle for complete resolution of post-operative anterior chamber cell, flare, and pain following cataract surgery. Primary endpoint was complete resolution of anterior chamber cells and flare (cell count of 0 and no flare) and no pain at post-operative day 8. The individual clinical trial results are provided below.

In the 2 studies, Lotemax had statistically significant higher incidence of complete clearing of anterior chamber cells and flare at post-operative day 8 (24-32% vs. 11-14%) and also had a statistically significant higher incidence of subjects that were pain free at post-operative day 8 (73-78% vs. 41-45%).

How Supplied/Storage and Handling

LOTEMAX (loteprednol etabonate ophthalmic ointment), 0.5% is a sterile ointment supplied in a tin tube with a pink polypropylene cap in the following size:

3.5 gram (NDC 24208-443-35)

Do not use if tamper evident skirt is visible on bottom of cap.

Storage: Store between 15°–25°C (59°–77°F).

Rx only.

Patient Counseling Information

Risk of Contamination

Patients should be advised not to touch the eyelid or surrounding areas with the tip of the tube. The cap should remain on the tube when not in use.

Patients should be advised to wash hands prior to using LOTEMAX ointment.

Do not use if tamper evident skirt is visible on bottom of cap.

Contact Lens Wear

Patients should also be advised not to wear contact lenses during their course of therapy.

Risk of Secondary Infection

If pain, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician.

MANUFACTURER INFORMATION

Bausch & Lomb Incorporated

Tampa, Florida 33637 USA

©Bausch & Lomb Incorporated

U.S. Patent No. 4,996,335

Lotemax is a registered trademark of Bausch & Lomb Incorporated

Principal Display Panel - Tube label

NDC 24208-443-35

Lotemax

loteprednol etabonate

ophthalmic ointment 0.5%

Sterile

Rx only

Net. wt.

1/8oz. (3.5g)

USUAL DOSAGE:

See Package Insert.

See crimp of tube or carton for Lot Number and Expiration Date.

DO NOT USE IF TAMPER EVIDENT SKIRT ON BOTTOM OF CAP IS VISIBLE.

Principal display panel - carton label

NDC 24208-443-35

Bausch & Lomb

Lotemax

loteprednol etabonate

ophthalmic ointment 0.5%

Sterile

Rx only

Net. wt. 1/8oz. (3.5g)

LOTEMAX  loteprednol etabonate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-443 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOTEPREDNOL ETABONATE (LOTEPREDNOL) LOTEPREDNOL ETABONATE 5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-443-35 1 TUBE In 1 CARTON contains a TUBE 1 3.5 g In 1 TUBE This package is contained within the CARTON (24208-443-35)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA200738	04/15/2011

Labeler - Bausch & Lomb Incorporated (196603781)

Revised: 04/2011Bausch & Lomb Incorporated

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• Japan

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Cardioplen may be available in the countries listed below.

UK matches:

• Cardioplen XL 2.5, 5, 10mg prolonged release tablets
• Cardioplen XL 2.5, 5, 10mg prolonged release tablets (SPC)

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Felodipine is reported as an ingredient of Cardioplen in the following countries:

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Primatene

epinephrine

Dosage Form: inhalant
Primatene®

MIST

Primatene® Mist (CFC) will not be available after December 31, 2011.

Talk to your doctor and/or pharmacist about other asthma medicines.

Drug Facts

Active ingredient (in each inhalation)

Epinephrine 0.22 mg

Purpose

Bronchodilator

Uses

• for temporary relief of occasional symptoms of mild asthma:
  
  • wheezing
  
  
  • tightness of chest
  
  
  • shortness of breath
  
  

Warnings

Asthma alert

Because asthma can be life threatening, see a doctor if you

• are not better in 20 minutes


• get worse


• need 12 inhalations in any day


• use more than 9 inhalations a day for more than 3 days a week


• have more than 2 asthma attacks in a week

For inhalation only

Do not use

• unless a doctor said you have asthma


• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ever been hospitalized for asthma


• heart disease


• high blood pressure


• diabetes


• thyroid disease


• seizures


• narrow angle glaucoma


• a psychiatric or emotional condition


• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions


• taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

When using this product

• Increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommeded dose.


• nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away.


• avoid caffeine-containing foods or beverages.


• avoid dietary supplements containing ingredients reported or claimed to have stimulant effect.


• do not puncture or throw into incinerator. Contents under pressure.


• do not use or store near open flame or heat above 120°F (49°C). May cause bursting.

Contains CFC 12, 114, substances which harm public health and environment by destroying ozone in the upper atmosphere.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed dosage


• supervise children using this product


• adults and children 4 years and over: start with one inhalation, then wait at least 1minute. If not relieved, use once more. Do not use again for at least 3 hours.


• children under 4 years of age: ask a doctor

Other information

• store at room temperature, between 20-25°C (68-77°F)


• contains no sulfites


• see insert for mouthpiece use and care instructions

Inactive ingredients

ascorbic acid, dehydrated alcohol (34%), dichlorodifluoromethane (CFC 12), dichlorotetrafluoroethane (CFC 114), hydrochloric acid, nitric acid, purified water

Questions or comments?

call 1-8 Primatene or 1-877-462-8363

DIRECTIONS FOR USE OF MOUTHPIECE

The Primatene Mist mouthpiece, which is enclosed in the Primatene Mist 15 mL size (not the refill size), should be used for inhalation only with Primatene Mist.

1. Take plastic cap off mouthpiece. (For refills, use mouthpiece from previous purchase.)
2. Take plastic mouthpiece off bottle.
3. Place short end of mouthpiece on bottle.
4. Turn bottle upside down. Place thumb on bottom of mouthpiece over circular button and forefinger on top of vial. Empty the lungs as completely as possible by exhaling.
5. Place mouthpiece in mouth with lips closed around opening. Inhale deeply while squeezing mouthpiece and bottle together. Release immediately and remove unit from mouth, then complete taking the deep breath, drawing medication into your lungs, holding breath as long as comfortable.
6. Exhale slowly keeping lips nearly closed. This helps distribute the medication in the lungs.
7. For storage, place long end of mouthpiece back on bottle and cover with plastic cap.

CARE OF THE MOUTHPIECE

The Primatene Mist mouthpiece should be washed after each use with hot, soapy water, rinsed thoroughly, and dried with a clean, lint-free cloth.

If the unit becomes clogged and fails to spray, please write and send the clogged unit to:

Armstrong Pharmaceuticals, Inc., 423 La Grange Street, West Roxbury, MA 02132

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Primatene®

MIST

Epinephrine Inhalation Aerosol Bronchodilator

For the Temporary Relief of

BRONCHIAL ASTHMA

WITH MOUTHPIECE FOR ORAL INHALATION

Primatene® Mist (CFC) will not be available after December 31, 2011.

Talk to your doctor and/or pharmacist about other asthma medicines.

1/2 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Refill Carton

Primatene®

MIST

Epinephrine Inhalation Aerosol Bronchodilator

For the Temporary Relief of

BRONCHIAL ASTHMA

INHALER

REFILL

USE WITH

Primatene

MOUTHPIECE

Primatene® Mist (CFC) will not be available after December 31, 2011.

Talk to your doctor and/or pharmacist about other asthma medicines.

1/2 FL OZ (15 mL)

Primatene MIST  epinephrine  inhalant

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 17270-503 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Epinephrine (Epinephrine) Epinephrine 0.22 mg

Inactive Ingredients Ingredient Name Strength Ascorbic Acid   alcohol   dichlorodifluoromethane   dichlorotetrafluoroethane   hydrochloric acid   nitric acid   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17270-503-00 1 INHALER In 1 CARTON contains a INHALER 1 300 SPRAY In 1 INHALER This package is contained within the CARTON (17270-503-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA087907	05/23/1984

Primatene MIST REFILL  epinephrine  inhalant

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 17270-504 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Epinephrine (Epinephrine) Epinephrine 0.22 mg

Inactive Ingredients Ingredient Name Strength Ascorbic Acid   alcohol   dichlorodifluoromethane   dichlorotetrafluoroethane   hydrochloric acid   nitric acid   water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17270-504-00 1 INHALER, REFILL In 1 CARTON contains a INHALER, REFILL 1 300 SPRAY In 1 INHALER, REFILL This package is contained within the CARTON (17270-504-00)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA087907	05/23/1984

Labeler - Armstrong Pharmaceuticals, Inc. (001185115)

Establishment
Name	Address	ID/FEI	Operations
Armstrong Pharmaceuticals, Inc.		001185115	MANUFACTURE

Revised: 07/2010Armstrong Pharmaceuticals, Inc.

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• Primatene Side Effects (in more detail)
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• Primatene Drug Interactions
• Primatene Support Group
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