Precose

Generic Name: acarbose (ah KAR bose)

Brand Names: Precose

What is Precose (acarbose)?

Acarbose slows the digestion of carbohydrates in the body, which helps control blood sugar levels.

Acarbose is used to treat type 2 diabetes. Acarbose is sometimes used in combination with insulin or other diabetes medications you take by mouth.

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

What is the most important information I should know about Precose (acarbose)?

Do not use this medication if you are allergic to acarbose, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). You also should not use acarbose if you have inflammatory bowel disease, an ulcer or blockage in your intestines, or cirrhosis of the liver.

Before taking acarbose, tell your doctor if you have liver disease, or any type of stomach or intestinal disorder.

Take acarbose with the first bite of a main meal, unless your doctor tells you otherwise.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Do not change your dose or stop taking acarbose without first talking to your doctor.

If you take acarbose with insulin or other diabetes medications, your blood sugar could get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Acarbose is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before taking Precose (acarbose)?

Do not use this medication if you are allergic to acarbose, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). You also should not use acarbose if you have:

• 
  

  inflammatory bowel disease;

  
  


• 
  

  a blockage in your intestines;

  
  


• 
  

  a digestive disorder affecting your intestines;

  
  


• 
  

  intestinal ulcer (of your colon); or

  
  


• cirrhosis of the liver.

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

• liver disease; or


• 
  

  a bowel or intestinal disorder; or

  
  


• 
  

  a stomach disorder.

  
  

FDA pregnancy category B. Acarbose is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether acarbose passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using acarbose.

How should I take Precose (acarbose)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take acarbose with the first bite of a main meal, unless your doctor tells you otherwise.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

If you take acarbose with insulin or other diabetes medications, your blood sugar could get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. Be sure your family and close friends know how to help you in an emergency.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking acarbose for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your acarbose dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Acarbose is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Precose dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take it with a meal). If it has been longer than 15 minutes since you started your meal, you may still take acarbose but it may be less effective than taking it with the first bite of the meal. Do not take acarbose between meals, and do not take extra medicine to make up a 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 bloating, gas, or stomach discomfort.

In case of overdose, do not eat or drink anything containing carbohydrates for the next 4 to 6 hours.

What should I avoid while taking Precose (acarbose)?

Avoid drinking alcohol. It can lower your blood sugar.

Avoid taking a digestive enzyme such as pancreatin, amylase, or lipase at the same time you take acarbose. These enzymes can make it harder for your body to absorb acarbose. Products that contain digestive enzymes include Arco-Lase, Cotazym, Donnazyme, Pancrease, Creon, and Ku-Zyme.

Precose (acarbose) side effects

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

• 
  

  severe stomach pain;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  mild stomach pain, gas, bloating;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  mild skin rash or itching.

  
  

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

What other drugs will affect Precose (acarbose)?

You may be more likely to have hyperglycemia (high blood sugar) if you are taking acarbose with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  digoxin (Lanoxin);

  
  


• 
  

  niacin (Advicor, Niaspan, Niacor, Simcor, Slo Niacin, and others), nicotine patches or gum;

  
  


• 
  

  diuretics (water pills);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  phenothiazines (Compazine and others);

  
  


• 
  

  thyroid medicine (Synthroid and others);

  
  


• 
  

  birth control pills and other hormones;

  
  


• 
  

  medicines for colds or asthma

  
  


• 
  

  seizure medications (Dilantin and others);

  
  


• 
  

  diet pills, stimulants, or medicines to treat ADHD; or

  
  


• 
  

  heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

  
  

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

• 
  

  insulin; or

  
  


• 
  

  an oral diabetes medication such as glipizide (Glucotrol, Metaglip), glimepiride (Amaryl, Avandaryl, Duetact), glyburide (DiaBeta, Micronase, Glucovance), and others.

  
  

This list is not complete and other drugs may affect your blood sugar or interact with acarbose. 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 Precose resources

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

• Precose Prescribing Information (FDA)


• Precose MedFacts Consumer Leaflet (Wolters Kluwer)


• Precose Monograph (AHFS DI)


• Precose Advanced Consumer (Micromedex) - Includes Dosage Information


• Acarbose Prescribing Information (FDA)


• Acarbose Professional Patient Advice (Wolters Kluwer)

Compare Precose with other medications

• Diabetes, Type 2

Where can I get more information?

• Your pharmacist can provide more information about acarbose.

See also: Precose side effects (in more detail)

Uniserts rectal

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

Brand Names: Acephen, Feverall, Mapap, Uniserts

What is acetaminophen?

Acetaminophen is a pain reliever and a fever reducer.

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

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

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

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

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

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

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

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

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

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

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

• liver disease; or


• 
  

  a history of alcoholism.

  
  

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

How should I use acetaminophen?

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

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

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

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

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

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

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

Stop using acetaminophen and call your doctor if:

• 
  

  you still have a fever after 3 days of use;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  

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

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

What happens if I miss a dose?

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

What happens if I overdose?

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

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

What should I avoid while using acetaminophen?

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

Acetaminophen side effects

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

• 
  

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

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

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

What other drugs will affect acetaminophen?

There may be other drugs that can interact with acetaminophen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Uniserts resources

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

Compare Uniserts with other medications

• Fever
• Muscle Pain
• Pain
• Sciatica

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen.

See also: Uniserts side effects (in more detail)

Sulfacetamide Ointment

Generic Name: Sulfacetamide (sul-fa-SEE-ta-mide)
Brand Name: Generic only. No brands available.

Sulfacetamide Ointment is used for:

Treating eye infections caused by certain bacteria.

Sulfacetamide Ointment is a sulfonamide. It works by restricting the production of folic acid, which bacteria need for growth. This kills the bacteria.

Do NOT use Sulfacetamide Ointment if:

• you are allergic to any ingredient in Sulfacetamide Ointment


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

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

Before using Sulfacetamide Ointment:

Some medical conditions may interact with Sulfacetamide Ointment. 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 discharge from your eye.

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

• Silver-containing products because they may decrease Sulfacetamide Ointment's effectiveness

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

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

• Sulfacetamide Ointment may be used around the eye or in the eye. To use Sulfacetamide Ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Sulfacetamide Ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• To clear up your infection completely, use Sulfacetamide Ointment for the full course of treatment. Keep using it even if you feel better in a few days.


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


• Continue to use Sulfacetamide Ointment even if you feel well. Do not miss any doses.


• If you miss a dose of Sulfacetamide Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Sulfacetamide Ointment only works against bacteria; it does not treat viral infections


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


• Long-term or repeated use of Sulfacetamide Ointment may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Sulfacetamide Ointment should be used with extreme caution in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Sulfacetamide Ointment:

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 irritation, stinging, or burning.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or persistent sore throat; new or worsening eye discharge, inflammation, or pain; joint pain; red, swollen, or blistered skin; vision changes; yellowing of the eyes or skin.

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

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. Sulfacetamide Ointment may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sulfacetamide Ointment:

Store Sulfacetamide Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Sulfacetamide Ointment out of the reach of children and away from pets.

General information:

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


• Sulfacetamide Ointment 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.

This information is a summary only. It does not contain all information about Sulfacetamide Ointment. 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 Sulfacetamide resources

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

Compare Sulfacetamide with other medications

• Conjunctivitis
• Trachoma

acetaminophen, caffeine, and phenyltoloxamine

Generic Name: acetaminophen, caffeine, and phenyltoloxamine (a SEET a MIN o fen KAF een, FEN il toe LOX a meen)

Brand Names: Flextra Plus

What is acetaminophen, caffeine, and phenyltoloxamine?

Acetaminophen is a pain reliever and fever reducer.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen.

Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of acetaminophen, caffeine, and phenyltoloxamine is used to treat mild pain and discomfort caused by headache, muscle aches, back pain, tooth pain, menstrual pain, arthritis, or the common cold or flu.

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

What is the most important information I should know about acetaminophen, caffeine, and phenyltoloxamine?

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid. Tell your doctor 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.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other pain, cold, allergy, 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 health care provider before taking acetaminophen, caffeine, and phenyltoloxamine?

You should not use this medication if you are allergic to acetaminophen (Tylenol) or phenyltoloxamine (RhinoFlex, Percogesic, Acuflex, and others). Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Tell your doctor 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.

To make sure you can safely take acetaminophen, caffeine, and phenyltoloxamine, tell your doctor if you have any of these other conditions:

• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines);

  
  


• liver or kidney disease;


• 
  

  cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  a stomach ulcer; or

  
  


• 
  

  if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

  
  

FDA pregnancy category C. It is not known whether acetaminophen, caffeine, and phenyltoloxamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, caffeine, and phenyltoloxamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using acetaminophen, caffeine, and phenyltoloxamine. Acetaminophen, caffeine, and phenyltoloxamine should not be given to a child younger than 12 years old.

How should I take acetaminophen, caffeine, and phenyltoloxamine?

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.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take for longer than 10 days in a row (or 5 days if treating a child). Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, if your symptoms get worse, or if you have any redness or swelling. Store at room temperature away from moisture and heat.

See also: Acetaminophen, caffeine, and phenyltoloxamine dosage (in more detail)

What happens if I miss a dose?

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

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 damage your liver.

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 tremors (uncontrolled shaking), fast heart rate, restless feeling, fever, and seizure (convulsions).

What should I avoid while taking acetaminophen, caffeine, and phenyltoloxamine?

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other pain, cold, allergy, 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. Avoid using other sources of caffeine, such as coffee, tea, or caffeinated soft drinks. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Acetaminophen, caffeine, and phenyltoloxamine side effects

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

• 
  

  fast or pounding heartbeat;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  increased thirst and urination;

  
  


• 
  

  severe diarrhea or stomach pain;

  
  


• 
  

  confusion, ringing in your ears, hearing problems;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  muscle weakness, loss of coordination; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling nervous;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth, nose or throat;

  
  


• 
  

  mild itching or skin rash;

  
  


• 
  

  upset stomach, constipation; or

  
  


• 
  

  memory problems.

  
  

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.

Acetaminophen, caffeine, and phenyltoloxamine Dosing Information

Usual Adult Dose for Cold Symptoms:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Adult Dose for Pain:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Adult Dose for Sinusitis:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Adult Dose for Headache:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Pain:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Sinusitis:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

Usual Pediatric Dose for Headache:

Acetaminophen/caffeine/phenyltoloxamine 425 mg-35 mg-45 mg oral capsule:
>=12 years: 1 capsule orally every 4 hours, not to exceed 6 capsules in 24 hours

What other drugs will affect acetaminophen, caffeine, and phenyltoloxamine?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by phenyltoloxamine.

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

• 
  

  leflunomide (Arava);

  
  


• 
  

  tizanadine (Zanaflex);

  
  


• 
  

  topiramate (Topamax);

  
  


• 
  

  zonisamide (Zonegran);

  
  


• 
  

  an antibiotic, antifungal medicine, or tuberculosis medicine;

  
  


• 
  

  a barbiturate such as phenobarbital (Solfoton);

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

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

  
  


• 
  

  cancer medications;

  
  


• 
  

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

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, 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, caffeine, and phenyltoloxamine. 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 acetaminophen, caffeine, and phenyltoloxamine resources

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

Compare acetaminophen, caffeine, and phenyltoloxamine with other medications

• Cold Symptoms
• Headache
• Pain
• Sinusitis

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, caffeine, and phenyltoloxamine.

See also: acetaminophen, caffeine, and phenyltoloxamine side effects (in more detail)

Arimidex

Generic Name: anastrozole (Oral route)

an-AS-troe-zole

Commonly used brand name(s)

In the U.S.

• Arimidex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Aromatase Inhibitor

Uses For Arimidex

Anastrozole is used to treat certain types of breast cancer in women who have already stopped menstruating (postmenopausal). It is also used for women who have already had other cancer treatments (e.g., tamoxifen).

Many breast cancer tumors grow in response to estrogen. This medicine interferes with the production of estrogen in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, limiting the growth of the tumor.

This medicine is available only with your doctor's prescription.

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

• Breast cancer, neoadjuvant treatment for hormone receptor-positive, operable or potentially operable, locally advanced disease in postmenopausal women (treatment for advanced breast cancer that may respond to surgery in women who have already stopped menstruating).

Before Using Arimidex

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of anastrozole in children.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tamoxifen

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (osteoporosis) or


• Hypercholesterolemia (high cholesterol or fat in the blood) or


• Ischemic heart disease (heart attack, angina), history of, or


• Liver disease—Use with caution. May make these conditions worse.

• Premenopausal women (have menstrual cycles)—Should not be used in these patients.

Proper Use of Arimidex

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

You may take this medicine with or without food.

Anastrozole sometimes causes nausea, vomiting, or diarrhea. However, it is very important that you continue to use the medicine, even if you begin to feel ill. Ask your doctor for ways to prevent these effects or make them less severe.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (tablets):
  
  • For breast cancer:
    
    • Adults—1 milligram (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Arimidex

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.

This medicine may increase your cholesterol or fat in the blood. If this happens, your doctor may give you medicine to lower the cholesterol and fat.

Stop taking this medicine and check with your doctor right away if you start having chest pains or shortness of breath. This medicine may increase the chance of heart attack or stroke in women who have a history of ischemic heart disease.

Arimidex 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:

More common

• Blurred vision


• chest pain or discomfort


• dizziness


• headache


• nervousness


• pounding in the ears


• shortness of breath


• slow or fast heartbeat


• swelling of the feet or lower legs

Less common

• Arm, back, or jaw pain


• chest tightness or heaviness


• cough or hoarseness


• difficult or painful urination


• dizziness, severe


• fever or chills


• headache, continuing


• increased blood pressure


• lower back or side pain


• nausea


• pain, tenderness, bluish color, or swelling of the foot or leg


• sore throat


• sudden shortness of breath


• sweating


• unusual tiredness or weakness


• vaginal bleeding (unexpected and heavy)

Incidence not known

• Blistering, peeling, or loosening of the skin


• hives


• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• red skin lesions, often with a purple center


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


• welts

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

• Acid or sour stomach


• back pain


• belching


• body aches or pain


• bone pain


• congestion


• constipation


• decrease in height


• diarrhea


• dry mouth


• dryness or soreness of the throat


• feeling of warmth


• fever


• flushing or redness of the skin, especially on the face and neck


• heartburn


• hot flashes


• increased appetite


• indigestion


• lack or loss of strength


• loss of appetite


• mood or mental changes


• pain in the back, ribs, arms, or legs


• pain, general


• pelvic pain


• runny nose


• skin rash


• stomach discomfort, upset, or pain


• tender, swollen glands in the neck


• trouble in swallowing


• voice changes


• vomiting


• weakness


• weight loss

Less common

• Anxiety and confusion


• breast pain


• chills


• cough producing mucus


• difficulty breathing


• dryness of the vagina


• general feeling of discomfort or illness


• itching of the skin


• joint pain and stiffness


• loss of hair


• muscle pain


• numbness or tingling of the hands or feet


• shivering


• sleepiness or unusual drowsiness


• trouble sleeping or sleeplessness


• weight gain


• wheezing

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: Arimidex 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 Arimidex resources

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

• Arimidex Prescribing Information (FDA)


• Arimidex Consumer Overview


• Arimidex Monograph (AHFS DI)


• Arimidex MedFacts Consumer Leaflet (Wolters Kluwer)


• Anastrozole Prescribing Information (FDA)


• Anastrozole Professional Patient Advice (Wolters Kluwer)

Compare Arimidex with other medications

• Breast Cancer
• Breast Cancer, Metastatic
• McCune-Albright Syndrome
• Pubertal Gynecomastia

Metrolyl (Metronidazole) 1g Suppositories

1. Name Of The Medicinal Product

Metrolyl* (Metronidazole) Suppositories 1g

2. Qualitative And Quantitative Composition

Each 1g suppository contains metronidazole BP 1g

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Suppository

White opaque suppository

4. Clinical Particulars

4.1 Therapeutic Indications

Metrolyl* is indicated in adults and children for the following indications:

Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of Bacteroides and including other species for which metronidazole is bactericidal e.g.: Fusobacteria, Eubacteria, Clostridia and anaerobic cocci.

Metrolyl* can be used in septicaemia, bacteraemia, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, peritonitis and post operative wound infection from which one or more of these anaerobes have been isolated.

Prevention of post operative infections due to anaerobic bacteria,particularly species of Bacteroides and anaerobic Streptococci.

.

4.2 Posology And Method Of Administration

Route of administration: Rectal

Treatment of Anaerobic Infections:

Adults and children over 10 years of age: 1 g suppository inserted into the rectum 8 hourly for 3 days. Oral medication with 400 mg 3 times a day should be substituted as soon as feasible. If rectal medication has to be continued for more than 3days then the suppositories should be inserted at 12 hourly intervals.

Children (5 -10 years): As for adults but with 500 mg suppositories and oral medication with 7.5 mg/kg bodyweight 3 times a day.

Infants and children under 5 years: As for children of 5-10 years but with a reducted dose of suppositories (1½ of a 500 mg suppository for 1-5 years and ¼ of a 500 mg suppository for under 1 year).

Prevention of Anaerobic Infections:

Used in appendectomy and post-operative medication for elective colonic surgery.

Adults and children over 10 years of age: 1 g suppository inserted into the rectum 2 hours before surgery and repeat at 8 hourly intervals until oral medication (200-400 mg 3 times a day) can be given to complete a 7day course.

If rectal medication is necessary after the third post-operative day, the frequency of administration should be reduced to 12 hourly.

Children (5-10 years): 500 mg suppositories administered as for adults until oral medication, 3.7 to 7.5 mg/kg bodyweight three times daily becomes a possibility.

4.3 Contraindications

Known sensitivity to metronidazole or any of the excipients.

4.4 Special Warnings And Precautions For Use

Metronidazole has no direct activity against aerobic or facultative anaerobic bacterium.

Clinical and laboratory monitoring e.g. leucocyte count, are advised if administration with Metrolyl for more than 10 days is considered to be necessary. Patients should be monitored for adverse reactions, such as peripheral or central neuropathy e.g. paraesthesia, ataxia, dizziness, convulsive seizures.

Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation.

There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might be persistant.

The half-life elimination of metronidazole remains the same in patients with renal failure, therefore there is no needs for dose reduction. However, such patients retain the metabolites of metronidazole, the clinical significance of this is not known.

In patients undergoing haemodialysis metronidazole and its metabolites are efficiently removed during an eight hour dialysis period. Therefore, Metronidazole should be re-administered immediately after haemodialysis.

No adjustment in the dosage of Metrolyl is required in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy, resulting in high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Therefore, Metrolyl should, be administered with caution in patients with hepatic encephalopathy, the daily dosage should be reduced to one third and administered once daily.

Metronidazole may cause darkened urine.

Due to inadequate evidence, the mutagenicity risk in humans (see section 5.3), with the use of Metrolyl for longer treatment than usually required should be carefully considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcohol

The consumption of alcohol during metronidazole therapy should be avoided since there could be a disulfiram-like reaction. Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.

Anticoagulant

Potentiation of warfarin-type anticoagulant therapy (except with heparin) has been reported so that dose adjustment of the anticoagulant may be needed.

Barbiturates

Phenobarbitone: The half-life of metronidazole is reduced from 7-8 hours to about 3 hours in patients receiving phenobarbitone.

In patients taking metronidazole, the assay of aspartate amino transferase may give spuriously low values; this depends on the method used.

Lithium

Lithium retention with evidence of possible renal damage has been reported where this compound and metronidazole have been used concurrently. Preferably, apart from monitoring lithium, creatinine and electrolyte concentrations, lithium therapy should be tapered and or withdrawn before use of metronidazole.

Anti-epileptics

Patients taking phenobarbital or phenytoin metabolise metronidazole at a much greater rate than normally reducing the half-life to approximately 3 hours.

Primidone: accelerates the metabolism of metronidazole resulting in a reduced plasma concentration.

Cytotoxics:

Busulfan: Increased risk of toxicity due to increased busulfan plasma concentration levels which may lead to severe busulfan toxicity.

Fluorouracil: Metronidazole reduces the clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.

Ulcer-healing drugs:

Cimetidine increases the plasma concentration of metronidazole by inhibiting its metabolism.

Disulfiram

Administration of metronidazole may lead to psychoses and confusion.

Ciclosporin: Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when coadministration is necessary.

4.6 Pregnancy And Lactation

There is inadequate data of the safety of metronidazole in pregnancy. Metrolyl should not be given during pregnancy or lactation unless the physician considers it essential, should this be the case then short, high-dosage regimens are not recommended.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned that drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders could occur, and advised them not to drive or operate machinery if they get the se symptoms.

4.8 Undesirable Effects

The frequency of adverse events listed below is defined using the following convention:

very common (

Serious adverse reactions occur rarely with standard recommended regimens. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.

Blood and lymphatic system disorders:

Very rare: agranulocytosis, neutropenia, thrombocytopenia, pancytopenia,

Not known: leucopenia.

Immune system disorders:

Rare: anaphylaxis

Not known: angiodema, urticaria, fever.

Metabolism and nutrition disorders:

Not known: anorexia.

Psychiatric disorders:

Very rare: psychotic disorders, including confusion and hallucinations.

Not known: depressed mood.

Nervous system disorders:

Uncommon: drowsiness, dizziness, convulsions, headaches

Very rare: encephalopathy (e.g. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (e.g. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug.

Not known: during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported. In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.

Eye disorders:

Very rare: vision disorders such as diplopia and myopia, which in most cases, is transient.

Gastrointestinal disorders:

Not known: taste disorders, oral mucositis, furry tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea.

Hepatobiliary disorders:

Very rare: abnormal liver function tests, cholestatic hepatitis, jaundice and pancreatitis reversible on drug withdrawal.

Skin and subcutaneous tissue disorders:

Very rare: skin rashes, pustular eruptions, pruritis, flushing

Not known: erythema multiforme.

Musculoskeletal, connective tissue and bone disorders:

Uncommon: asthenia

Very rare: myalgia, arthralgia.

Renal and urinary disorders:

Very rare: darkening of urine (due to metronidazole metabolite).

4.9 Overdose

After single doses up to 12 g metronidazole have been reported in suicidal attempts and accidental overdoses, vomiting, nausea, ataxia and disorientation were observed.

There is no specific antidote for metronidazole overdose. symptomatic and supportive treatment should be instituted.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic code: Antibacterials for systemic use, ATC code J01X D01.

Metronidazole has antiprotozoal and antibacterial properties and is effective against Trichomonas vaginalis and other protozoa including Entamoeba histolytica and Giardia lamblia, and against anaerobic bacteria.

5.2 Pharmacokinetic Properties

Metronidazole is readily absorbed from the rectal mucosa and widely distributed in body, maximum concentrations occur in the serum after about 1 hour and traces can be detected after 24 hours.

At least half the dose is excreted in the urine as metronidazole and its metabolites, including an acid oxidation product, a hydroxy derivative and glucoronide. Metronidazole diffuses across the placenta and is found in breast milk in concentrations equivalent to those in serum.

5.3 Preclinical Safety Data

Metronidazole has been shown to be carcinogenic in mice and rats following chronic oral administration, however, similar studies in the hamster have given negative results. Epidemiological studies have not provided clear evidence of a carcinogenic risk in humans.

Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects while other studies were negative.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hard fat (Witepsol E75 and W35).

6.2 Incompatibilities

Not known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Protect from light.

6.5 Nature And Contents Of Container

Sealed PVC moulds containing the suppositories inside a cardboard carton.

Pack size: 10

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 04416/0054

9. Date Of First Authorisation/Renewal Of The Authorisation

25 May 1982/30 April 1997

10. Date Of Revision Of The Text

10 May 2011

* trade mark

Zazole Vaginal Cream 0.8%

Dosage Form: vaginal cream
ZAZOLE® VAGINAL CREAM 0.8% (terconazole vaginal cream 0.8%)

Rx Only

Zazole Vaginal Cream 0.8% Description

Zazole® Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis - 1 - [p - [[2 - (2,4 - Dichlorophenyl) - 2 - (1 - H - 1,2,4 - triazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl] - 4 - isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows:

Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.

Zazole Vaginal Cream 0.8% - Clinical Pharmacology

Following intravaginal administration of terconazole in humans, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations.

Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to normal humans, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours. Results from similar studies in patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy women. The absorption characteristics of terconazole 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in normal volunteers.

Following oral (30 mg) administration of 14C-labelled terconazole, the harmonic half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%. Total radioactivity was eliminated from the blood with a harmonic half-life of 52.2 hours (range 44-60). Excretion of radioactivity was both by renal (32-56%) and fecal (47-52%) routes.

In vitro, terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.

Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultra-violet light.

Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream 0.8%.

Microbiology: Terconazole exhibits fungicidal activity in vitro against Candida albicans. Antifungal activity also has been demonstrated against other fungi. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥ 128 mcg/mL; therefore these beneficial bacteria are not affected by drug treatment. The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by the disruption of normal fungal cell membrane permeability. No resistance to terconazole has developed during successive passages of C. albicans.

Indications and Usage for Zazole Vaginal Cream 0.8%

Zazole® Vaginal Cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole® Vaginal Cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

Contraindications

Patients known to be hypersensitive to terconazole or to any of the components of the cream.

Warnings

None.

Precautions

General: Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.

Laboratory Tests: If there is a lack of response to terconazole, appropriate microbiological studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.

Drug Interactions: The therapeutic effect of this product is not affected by oral contraceptive usage.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenesis: Studies to determine the carcinogenic potential of terconazole have not been performed.

Mutagenicity: Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.

Impairment of Fertility: No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.

Pregnancy: Teratogenic Effects: Pregnancy Category C:

There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (50x the recommended intravaginal human dose of the 0.8% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats. Dosages at or below 10 mg/kg/day produced no embryotoxicity; however there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increase incidence of skeletal variants.

The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.8%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes. Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, 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 efficacy in children have not been established.

Geriatric Use: Clinical studies of terconazole vaginal cream 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.

Adverse Reactions

During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% were headache (21% vs 16% with placebo) and dysmenorrhea (6% vs 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole vaginal cream 0.8% 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% group and 0.3% with the placebo group.

Overdosage

Overdosage of terconazole in humans has not been reported to date. In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≃ 1280 and ≥ 640 mg/kg, respectively.

Zazole Vaginal Cream 0.8% Dosage and Administration

One full applicator (5 g) of Zazole® Vaginal Cream 0.8% (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of Zazole® Vaginal Cream 0.8% is not affected by menstruation.

How is Zazole Vaginal Cream 0.8% Supplied

Zazole® Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.

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

March 2008

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com   

I8347C

R3/08

#300

Zazole® VAGINAL CREAM 0.8% (terconazole vaginal cream 0.8%)

PATIENT INSTRUCTIONS

3-DAY THERAPY

Filling the applicator:

1. Remove the cap from the tube.
   
   
   


2. Use the pointed tip on the top of the cap, twisting several   times to puncture the seal on the tube.


3. Screw the applicator onto the tube.
   
   
   


4. Squeeze the tube from the bottom and fill the applicator until  the plunger stops.


5. Unscrew the applicator from the tube.

Using the applicator:

1. Lie on your back with your knees drawn up toward your chest.


2. Holding the applicator by the ribbed end of the barrel, insert the filled applicator into the vagina as far as it will comfortably go.
   
   
   


3. Slowly press the plunger of the applicator to release the cream into the vagina.


4. Remove the applicator from the vagina.


5. Apply one applicatorful each night for as many days at bedtime, as directed by your doctor.

Cleaning the applicator:

After each use, you should thoroughly clean the applicator by following the procedure below:

1. Pull the plunger out of the barrel.


2. Wash both pieces with lukewarm, soapy water, and dry them thoroughly.


3. Put the applicator back together by gently pushing the plunger into the barrel as far as  it will go.
   
   
   

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

See end flap for lot number and expiration date.

A WORD ABOUT YEAST INFECTIONS

Why do yeast infections occur?

Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge. Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.

How can I prevent yeast infections?

Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.

• Clothing: Tight jeans, nylon underwear, pantyhose, and wet bathing suits can hold in heat   and moisture (two conditions in which yeast organisms thrive). Looser pants or skirts, 100%  cotton underwear, and stockings may help avoid this problem.


• Diet: Cutting down on sweets, milk products, and artificial sweeteners may reduce the risk of  yeast infections.


• Antibiotics: Antibiotics work by eliminating disease-causing organisms. While they are helpful in curing other problems, antibiotics may lead to an overgrowth of Candida in the vagina.


• Pregnancy: Hormonal changes in the body during pregnancy encourage the growth of yeast. This is a very common time for an infection to occur. Until the baby is born, it may be hard to completely eliminate yeast infections. If you believe you are pregnant, tell your doctor.


• Menstruation: Sometimes monthly changes in hormone levels may lead to yeast infections.


• Diabetes: In addition to heat and moisture, yeast thrives on sugar. Because diabetics often   have sugar in their urine, their vaginas are rich in this substance. Careful control of diabetes  may help prevent yeast infections.

Controlling these factors can help eliminate yeast infections and may prevent them from coming back.

Some other helpful tips:

1. For best results, be sure to use the medication as prescribed by your doctor, even if  you feel better very quickly.


2. Avoid sexual intercourse, if your doctor advises you to do so.


3. If your partner has any penile itching, redness, or discomfort, he should consult his  physician and mention that you are being treated for a yeast infection.


4. You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medication leaks.


5. Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.


6. Wipe from front to rear (away from the vagina) after a bowel movement.


7. Don't douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance.


8. Don't scratch if you can help it. Scratching can cause more irritation and spread   the infection.


9. Discuss with your physician any medication you are already taking. Certain types of medication can make your vagina more susceptible to infection.


10. Eat nutritious meals to promote your general health.

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com

I8347C

R3/08

#300

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 20 G LABEL

NDC 0462-0347-20                   Rx only

ZAZOLE ®

VAGINAL CREAM 0.8%

(terconazole vaginal cream 0.8%)

Tube and Applicator

NET WT 20 grams Quantity by weight not by volume         PHARMADERM ®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 20 G CARTON

NDC 0462-0347-20                   Rx only

ZAZOLE ®

VAGINAL CREAM 0.8%

(terconazole vaginal cream 0.8%)

Tube and Applicator

NET WT 20 grams

Quantity by weight not by volume                                             PHARMADERM ®

ZAZOLE  terconazole  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0462-0347 Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength terconazole (terconazole) terconazole 8 mg  in 1 g

Inactive Ingredients Ingredient Name Strength Stearyl Alcohol   Cetyl Alcohol   Isopropyl Myristate   Butylated Hydroxyanisole   Water   Polysorbate 60   Propylene Glycol   Polysorbate 80

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0462-0347-20 20 g In 1 TUBE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021735	10/02/2009

Labeler -  Pharmaderm, A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Revised: 10/2009 Pharmaderm, A division of Nycomed US Inc.

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