Generic Name: chlorhexidine (Topical application route)

klor-HEX-i-deen

Commonly used brand name(s):

In the U.S.

  • Betasept
  • Biopatch w/Chlorhexidine Gluconate
  • Chlorostat
  • Dyna-Hex
  • Dyna-Hex2
  • Hibiclens
  • Hibistat
  • Operand Chg Surgical Scrub Brush
  • Operand Chlorhexidine Gluconate
  • Operand Closed Loop Chg Scrub

In Canada

  • Stanhexidine Solution
  • Stanley Chlorhexidine Tinted
  • Stanley Chlorhexidine Untinted

Available Dosage Forms:

  • Dressing
  • Gel/Jelly
  • Lotion
  • Solution
  • Liquid
  • Pad
  • Sponge
  • Cream

Therapeutic Class: Antibacterial Cleansing Agent

Uses For Operand Chlorhexidine Gluconate

Chlorhexidine belongs to a group of medicines called antiseptic antibacterial agents. It is used to clean the skin after an injury, before surgery, or before an injection. It works by killing or preventing the growth of bacteria on the skin.


Before Using Operand Chlorhexidine Gluconate

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

Because of chlorhexidine’s potential for causing excessive skin irritation and the risk of increased absorption through the skin, use in children less than 2 months of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of chlorhexidine in geriatric patients.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

  • Deep or open skin wounds—Should not use in patients with this condition.




Proper Use of chlorhexidine

This section provides information on the proper use of a number of products that contain chlorhexidine. It may not be specific to Operand Chlorhexidine Gluconate. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Chlorhexidine should only be used on the skin. Do not swallow it or get it in the eyes, ears, mouth, nose, genital area (sex organs), or anal area. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

Follow your doctor’s instructions about how to clean and care for your skin before and after you use this medicine. Make sure you understand all of the directions, and ask questions if you find something is not clear.

The Chloraprep® products contain large amounts of alcohol (70%) and are flammable. Do not use them or store them near a flame, heater, or electrical device. Do not use the medicine while you are smoking. Apply the medicine in a well-ventilated place. Do not cover the treated area until the medicine is completely dry. This is usually 3 minutes or longer for hairless skin. If you must apply the medicine to a hairy area of the body, wipe the area with a towel to remove extra medicine.

Different forms of the medicine are used in different ways. Be sure you understand the directions for the product you are given before you use it. Ask your doctor or pharmacist if you have any questions.

  • To use this medicine as a wound cleanser and general skin cleanser:
    • Rinse the area to be cleaned with water.
    • Apply the smallest amount of chlorhexidine needed to cover the skin or wound area and wash gently.
    • Thoroughly rinse the area again with water.

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 topical dosage form (solution or swabstick applicator):
    • For cleaning the skin or wounds:
      • Adults and children 2 months of age and older—Use when necessary, according to the directions on the label or your doctor’s instructions.
      • Children younger than 2 months of age—Use is not recommended.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

The Chloraprep® products contain large amounts of alcohol (70%) and are flammable. Do not store them near a flame, heater, or electrical device.


Precautions While Using Operand Chlorhexidine Gluconate

Check with your doctor if your skin problem becomes worse. Call your doctor if you have skin irritation that does not go away, such as redness, itching, or burning in the area where you used this medicine.

This medicine should not be used on a regular basis on large areas of the body. Follow your doctor’s instructions about how long to use this medicine.

This medicine may cause serious and permanent injury when placed in the eyes, ears, or mouth. Carefully follow all instructions before using this medicine to prevent serious side effects.

This medicine may cause a brown stain on clothing when chlorine is also present. These stains may not be removed by regular washing. Use only non-chlorine products to wash or bleach fabrics exposed to this medicine. If the medicine has directions on the package about washing fabrics, follow them carefully.

Operand Chlorhexidine Gluconate 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:

Incidence not known

  • Blistering, burning, itching, peeling, skin rash, redness, swelling, or other signs of irritation on the skin
  • swelling of the face, hands, or feet
  • trouble breathing

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.

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.

 

Generic Name: chlorhexidine (Topical application route)

klor-HEX-i-deen

Commonly used brand name(s):

In the U.S.

  • Betasept
  • Biopatch w/Chlorhexidine Gluconate
  • Chlorostat
  • Dyna-Hex
  • Dyna-Hex2
  • Hibiclens
  • Hibistat
  • Operand Chg Surgical Scrub Brush
  • Operand Chlorhexidine Gluconate
  • Operand Closed Loop Chg Scrub

In Canada

  • Stanhexidine Solution
  • Stanley Chlorhexidine Tinted
  • Stanley Chlorhexidine Untinted

Available Dosage Forms:

  • Dressing
  • Gel/Jelly
  • Lotion
  • Solution
  • Liquid
  • Pad
  • Sponge
  • Cream

Therapeutic Class: Antibacterial Cleansing Agent

Uses For Operand Closed Loop Chg Scrub

Chlorhexidine belongs to a group of medicines called antiseptic antibacterial agents. It is used to clean the skin after an injury, before surgery, or before an injection. It works by killing or preventing the growth of bacteria on the skin.


Before Using Operand Closed Loop Chg Scrub

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

Because of chlorhexidine’s potential for causing excessive skin irritation and the risk of increased absorption through the skin, use in children less than 2 months of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of chlorhexidine in geriatric patients.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

  • Deep or open skin wounds—Should not use in patients with this condition.




Proper Use of chlorhexidine

This section provides information on the proper use of a number of products that contain chlorhexidine. It may not be specific to Operand Closed Loop Chg Scrub. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Chlorhexidine should only be used on the skin. Do not swallow it or get it in the eyes, ears, mouth, nose, genital area (sex organs), or anal area. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

Follow your doctor’s instructions about how to clean and care for your skin before and after you use this medicine. Make sure you understand all of the directions, and ask questions if you find something is not clear.

The Chloraprep® products contain large amounts of alcohol (70%) and are flammable. Do not use them or store them near a flame, heater, or electrical device. Do not use the medicine while you are smoking. Apply the medicine in a well-ventilated place. Do not cover the treated area until the medicine is completely dry. This is usually 3 minutes or longer for hairless skin. If you must apply the medicine to a hairy area of the body, wipe the area with a towel to remove extra medicine.

Different forms of the medicine are used in different ways. Be sure you understand the directions for the product you are given before you use it. Ask your doctor or pharmacist if you have any questions.

  • To use this medicine as a wound cleanser and general skin cleanser:
    • Rinse the area to be cleaned with water.
    • Apply the smallest amount of chlorhexidine needed to cover the skin or wound area and wash gently.
    • Thoroughly rinse the area again with water.

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 topical dosage form (solution or swabstick applicator):
    • For cleaning the skin or wounds:
      • Adults and children 2 months of age and older—Use when necessary, according to the directions on the label or your doctor’s instructions.
      • Children younger than 2 months of age—Use is not recommended.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

The Chloraprep® products contain large amounts of alcohol (70%) and are flammable. Do not store them near a flame, heater, or electrical device.


Precautions While Using Operand Closed Loop Chg Scrub

Check with your doctor if your skin problem becomes worse. Call your doctor if you have skin irritation that does not go away, such as redness, itching, or burning in the area where you used this medicine.

This medicine should not be used on a regular basis on large areas of the body. Follow your doctor’s instructions about how long to use this medicine.

This medicine may cause serious and permanent injury when placed in the eyes, ears, or mouth. Carefully follow all instructions before using this medicine to prevent serious side effects.

This medicine may cause a brown stain on clothing when chlorine is also present. These stains may not be removed by regular washing. Use only non-chlorine products to wash or bleach fabrics exposed to this medicine. If the medicine has directions on the package about washing fabrics, follow them carefully.

Operand Closed Loop Chg Scrub 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:

Incidence not known

  • Blistering, burning, itching, peeling, skin rash, redness, swelling, or other signs of irritation on the skin
  • swelling of the face, hands, or feet
  • trouble breathing

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.

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.

 

Ophthetic Drops

30/06/10

Generic Name: Proparacaine (proe-PAR-a-kane)
Brand Name: Examples include Alcaine and Ophthetic

Ophthetic Drops are used for:

Numbing the eye during certain procedures.

Ophthetic Drops are a topical local anesthetic. It works on the nerves to decrease pain.

Do NOT use Ophthetic Drops if:

  • you are allergic to any ingredient in Ophthetic Drops

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

Before using Ophthetic Drops:

Some medical conditions may interact with Ophthetic Drops. 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

Some MEDICINES MAY INTERACT with Ophthetic Drops. Because little, if any, of Ophthetic Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

  • To use Ophthetic Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
  • To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
  • Ophthetic Drops are clear to straw-colored. If Ophthetic Drops becomes darker, do not use it. Throw away any medicine that has darkened.
  • Ophthetic Drops contains benzalkonium chloride, a preservative that may be absorbed by soft contact lenses. Ask your doctor about how long you should wait to put your contacts back in after using Ophthetic Drops.
  • If you miss a dose of Ophthetic Drops, contact your doctor.

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

Important safety information:

  • Do not exceed the recommended dose or use Ophthetic Drops for longer than prescribed without checking with your doctor.
  • Ophthetic Drops may cause drying or cracking of the fingertips if you get it on your hands. Be sure to wash your hands after using Ophthetic Drops.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while using Ophthetic Drops, discuss with your doctor the benefits and risks of using Ophthetic Drops during pregnancy. It is unknown if Ophthetic Drops are excreted in breast milk after topical use. If you are or will be breast-feeding while you are using Ophthetic Drops, check with your doctor to discuss the risks to your baby.

Possible side effects of Ophthetic Drops:

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:

Temporary burning, stinging, or redness of the eye.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); gray, ground-glass like appearance of the eye; pain, redness, or irritation of the eye; vision changes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Ophthetic Drops:

Store Ophthetic Drops in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Ophthetic Drops out of the reach of children and away from pets.

General information:

  • If you have any questions about Ophthetic Drops, please talk with your doctor, pharmacist, or other health care provider.
  • Ophthetic Drops are 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 Ophthetic Drops. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Generic Name: Oxymorphone (OX-i-MOR-fone)
Brand Name: Opana ER

Opana ER Extended-Release Tablets are used to treat constant (around-the-clock), moderate to severe pain that is expected to last for an extended amount of time. Opana ER Extended-Release Tablets are not for patients who only need occasional or “as-needed” pain relief.

Opana ER Extended-Release Tablets must be swallowed whole. Do NOT break, crush, dissolve, or chew Opana ER Extended-Release Tablets before swallowing it. Do not drink alcohol or take medicines that contain alcohol while you are using Opana ER Extended-Release Tablets. Doing any of these things may cause Opana ER Extended-Release Tablets to be absorbed into the body too quickly. This could result in very serious side effects, including severe trouble breathing and death from overdose. If you are unsure if any of your medicines contain alcohol, check with your doctor or pharmacist.

Opana ER Extended-Release Tablets are used for:

Treating pain in adults with constant (around-the-clock), moderate to severe pain that is expected to last for an extended period of time. Opana ER Extended-Release Tablets are not for use right after surgery if you have not already been using narcotic pain relievers, or if the pain is mild or not expected to last for an extended period of time.

Opana ER Extended-Release Tablets are an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Opana ER Extended-Release Tablets if:

  • you are allergic to any ingredient in Opana ER Extended-Release Tablets or any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone)
  • you have difficult or slowed breathing, high levels of carbon dioxide in the blood, or severe asthma, or you are having an asthma attack
  • you are in labor
  • you have moderate to severe liver problems
  • you have severe diarrhea, bowel problems caused by antibiotics or food poisoning, or certain other severe bowel problems (eg, paralytic ileus)
  • you are taking sodium oxybate (GHB) or an agonist/antagonist analgesic (eg, pentazocine)

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

Before using Opana ER Extended-Release Tablets:

Some medical conditions may interact with Opana ER Extended-Release Tablets. 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 lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD]), sleep apnea (you stop breathing when you sleep), curvature of the spine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), low blood pressure, dehydration, or low blood volume
  • if you have severe drowsiness, a recent head injury, growths in the brain, increased pressure in the brain, or a history of seizures (eg, epilepsy)
  • if you have liver or kidney problems, gallbladder or pancreas problems, adrenal gland problems (eg, Addison disease), an underactive thyroid, an enlarged prostate, a urinary blockage, or stomach or bowel problems (eg, inflammation), or if you have had recent stomach or bowel surgery.
  • if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence
  • if you are in poor health or shock, are very overweight, or will be having surgery

Some MEDICINES MAY INTERACT with Opana ER Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Barbiturate anesthetics (eg, thiopental), cimetidine, or sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • Anticholinergics (eg, scopolamine, benztropine) because the risk of severe constipation or trouble urinating may be increased
  • Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because the risk of a severe reaction including fever, seizures, and coma may be increased
  • Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Opana ER Extended-Release Tablets’s effectiveness and withdrawal may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Opana ER Extended-Release Tablets 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 Opana ER Extended-Release Tablets:

Use Opana ER Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Opana ER Extended-Release Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
  • Opana ER Extended-Release Tablets must only be taken by mouth.
  • Swallow Opana ER Extended-Release Tablets whole. Do not break, crush, dissolve, or chew the tablet.
  • If you are taking Opana ER Extended-Release Tablets for persistent pain, take it on a regular schedule to help control the pain more effectively.
  • Do not change your dose or suddenly stop taking Opana ER Extended-Release Tablets without checking with your doctor.
  • If Opana ER Extended-Release Tablets are no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Opana ER Extended-Release Tablets properly.
  • If you miss a dose of Opana ER Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Opana ER Extended-Release Tablets.

Important safety information:

  • Opana ER Extended-Release Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol, other opiate pain medicines, or certain other medicines. Use Opana ER Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol, take medicines that contain alcohol, or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Opana ER Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Opana ER Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Opana ER Extended-Release Tablets may be habit forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Opana ER Extended-Release Tablets may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.
  • Constipation is a common side effect of Opana ER Extended-Release Tablets. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Opana ER Extended-Release Tablets.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take Opana ER Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
  • Use Opana ER Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness, dizziness, confusion, and nausea.
  • Opana ER Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Opana ER Extended-Release Tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Opana ER Extended-Release Tablets while you are pregnant. It is unknown if Opana ER Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Opana ER Extended-Release Tablets.

When used for long periods of time or at high doses, Opana ER Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Opana ER Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Opana ER Extended-Release Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important. If you are taking Opana ER Extended-Release Tablets regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Opana ER Extended-Release Tablets are suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Opana ER Extended-Release Tablets.

Possible side effects of Opana ER Extended-Release Tablets:

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

Anxiety; constipation; decreased appetite; dizziness; drowsiness; dry mouth; gas; headache; lightheadedness; nausea; sweating; 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); confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; trouble urinating; unusual swelling; vision changes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; chest pain; cold and clammy skin; coma; difficult or slow breathing; limp muscles; numbness of an arm or leg; pinpoint pupils; severe drowsiness or dizziness; slow or irregular heartbeat.

Proper storage of Opana ER Extended-Release Tablets:

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

General information:

  • If you have any questions about Opana ER Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Opana ER Extended-Release Tablets are 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 Opana ER Extended-Release Tablets. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Opcon-A

30/06/10

Generic name: Naphazoline hydrochloride, Pheniramine maleate
Brand names: Naphcon-A, Opcon-A

Why is Opcon-A prescribed?

Naphcon-A, an eyedrop containing both a decongestant and an antihistamine, is used to relieve itchy, red eyes caused by ragweed, pollen, and animal hair.

Most important fact about Opcon-A

If Naphcon-A causes changes in your vision, be careful when driving or performing other tasks that could be hazardous.

How should you use Opcon-A?

Remove contact lenses before administering Naphcon-A. Do not use the solution if it becomes cloudy or changes color.

To administer the eyedrops, follow these steps:

1. Wash your hands thoroughly.
2. Gently pull your lower eyelid down to form a pocket between your eye and the lid.
3. Hold the eyedrop bottle on your forehead or the bridge of your nose.
4. Do not touch the applicator tip to your eye or any other surface.
5. Tilt your head back and squeeze Naphcon-A into your eye.
6. Close your eyes gently and keep them closed for a minute or two.
7. Do not rinse the dropper.

–If you miss a dose…

Use Naphcon-A only as needed.

–Storage instructions…

Store at room temperature in a tightly closed bottle. Protect from light.

Opcon-A side effects

Aside from temporarily enlarging your pupils, Naphcon is unlikely to cause side effects. However, overuse can cause reddening of the eyes.

Why should Opcon-A not be prescribed?

Do not take Naphcon-A if you have ever had an allergic reaction to it or are sensitive to any of its ingredients.

Do not use Naphcon-A if you have heart disease, high blood pressure, or trouble urinating because of enlargement of the prostate gland.

Do not use Naphcon-A if you have glaucoma.





Special warnings about Opcon-A

Contact your doctor before giving Naphcon-A to infants or children under 6 years of age. Swallowing Naphcon-A can cause stupor or coma and a serious drop in body temperature in an infant or child.

If your eyes hurt or continue to be red or irritated, if you experience changes in vision, if your eyes get worse, or if the itching and redness last more than 72 hours, stop using Naphcon-A and call your doctor.

Recommended dosage for Opcon-A

ADULTS

Place 1 or 2 drops in the affected eyes, up to 4 times a day.

Overdosage

Overdose from accidental oral use can have serious consequences, especially in young children. If you suspect an overdose, seek medical attention immediately.

 

Operand Douche

30/06/10

Generic Name: Povidone/Iodine (POE-vi-done/EYE-oh-dine)
Brand Name: Examples include Betadine and Operand

Operand Douche is used for:

Relieving minor vaginal irritation and itching. It may also be used to cleanse and deodorize the vaginal area.

Operand Douche is an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Operand Douche if:

  • you are allergic to any ingredient in Operand Douche
  • you are pregnant or breast-feeding

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

Before using Operand Douche:

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

  • if you are planning to become pregnant
  • 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 pelvic inflammatory disease (PID), a history of sexually transmitted diseases (STDs), or thyroid problems

Some MEDICINES MAY INTERACT with Operand Douche. However, no specific interactions are known at this time.

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

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

  • Follow the package directions for using Operand Douche, unless instructed otherwise by your doctor.
  • If you miss a dose of Operand Douche, 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 Operand Douche.

Important safety information:

  • If you have had a severe allergic reaction to Operand Douche or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Operand Douche or if a certain medicine contains iodine, contact your doctor or pharmacist.
  • If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible.
  • If symptoms of vaginal itching and irritation persist for more than 5 days, or if redness, swelling, or pain develops, stop use and contact your doctor.
  • Operand Douche is not a contraceptive agent. It will not prevent pregnancy.
  • Do not use Operand Douche sooner than 6 hours after intercourse if you were using a vaginal spermicide for contraception.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Operand Douche, discuss with your doctor the benefits and risks of using Operand Douche during pregnancy. It is unknown if Operand Douche is excreted in breast milk. Do not breast-feed while using Operand Douche.

Possible side effects of Operand Douche:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); chills; excessive vaginal dryness; fever; severe stomach pain; unusual vaginal discharge; vaginal pain, soreness, swelling, redness, or irritation.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Operand Douche may be harmful if swallowed.

Proper storage of Operand Douche:

Store Operand Douche at room temperature, between 68 and 77 degrees F (20 and 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. Keep Operand Douche out of the reach of children and away from pets.

General information:

  • If you have any questions about Operand Douche, please talk with your doctor, pharmacist, or other health care provider.
  • Operand Douche 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 Operand Douche. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Opana ER

30/06/10

Generic name: Oxymorphone hydrochloride
Brand names: Opana ER

Why is Opana ER prescribed?

Opana ER is used to treat moderate-to-severe pain in people needing around-the-clock opioid treatment for a long period of time. It should not be used 12 to 24 hours after surgery.

Most important fact about Opana ER

Do not break, chew, dissolve, or crush Opana ER tablets. Taking tablets in this way could cause a deadly dose of oxymorphone to be released into the body. Also, while on Opana ER therapy, you should not consume any alcohol, including prescription or nonprescription drugs that contain alcohol. Having alcohol with Opana ER may cause an overdose of oxymorphone.

How should you take Opana ER?

Opana ER should be taken on an empty stomach, at least one hour prior to or two hours after eating. Opana ER tablets should be swallowed whole and should not to be broken, chewed, dissolved, or crushed.

  • If you miss a dose…
    If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take two doses at once unless your doctor tells you to. If you are not sure about your dosing schedule, call your doctor.
  • Storage instructions…
    Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Opana ER.

  • Side effects may include:
    Constipation, dizziness (vertigo), feeling of tiredness, headache, itchiness, nausea, sleeplessness, sweating, vomiting

Why should Opana ER not be prescribed?

Do not take Opana ER if you have breathing problems, such as severe asthma, or if you are allergic to any of its ingredients. Also, you should not take Opana ER if you do not need pain treatment for a prolonged period of time.





Special warnings about Opana ER

Avoid taking broken, dissolved, or crushed Opana ER tablets. Taking anything other than whole tablets can lead to a fatal overdose of oxymorphone.

While using Opana ER, do not eat or drink anything that contains alcohol (e.g., alcoholic beverages or certain medications). Alcohol may cause an overdose of oxymorphone.

Opana ER can make you sleepy. Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how this medicine affects you.

Tell the doctor about your complete medical history, especially if you have a history of the following: breathing problems, liver or kidney problems, brain injury, Addison’s disease, seizures, problems urinating, prostate trouble, or a history of drug or alcohol dependency.

Possible food and drug interactions when taking Opana ER

If Opana ER is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Opana ER with the following:

Alcohol
General anesthetics
Hypnotics
Opioids
Phenothiazines
Sedatives
Tranquilizers

Special information if you are pregnant or breastfeeding

The effects of Opana ER during pregnancy and breastfeeding are unknown. Talk with your doctor before taking Opana ER if you are pregnant, plan to become pregnant, or are breastfeeding.

Recommended dosage for Opana ER

ADULTS

Initial Therapy
If you have never used an opioid drug before, the recommended initial dose of Opana ER is 5 milligrams every 12 hours. Depending on how you respond, the doctor may increase the dose slowly at increments of 5-10 milligrams every 12 hours.

Switching from Opana to Opana ER
If you are currently taking regular Opana, the doctor will decide which dosage of Opana ER is right for you.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

  • Symptoms of Opana ER overdose include:
    Cold and clammy skin, coma, constricted (small) pupils, death, heart problems, low blood pressure, problems breathing, severe sleepiness

 

Ony-Clear

30/06/10

Generic Name: miconazole topical (my CON a zole)
Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Ony-Clear (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete’s foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

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


What is the most important information I should know about Ony-Clear (miconazole topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Ony-Clear (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby.


How should I use Ony-Clear (miconazole topical)?

Use miconazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete’s foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.


What happens if I overdose?

An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Ony-Clear (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn’t allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.


Ony-Clear (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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

What other drugs will affect Ony-Clear (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

Where can I get more information?

  • Your pharmacist has additional information about miconazole topical written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 4/12/2009 4:40:17 PM.

 

Opana

30/06/10

Generic Name: oxymorphone (Oral route)

ox-i-MOR-fone

Oral routeTablet, Extended Release

Opana(R) ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Opana(R) ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Opana(R) ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Opana(R) ER is NOT intended for use as a prn analgesic.

Opana(R) ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed Opana(R) ER tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or nonprescription medications containing alcohol, while on Opana(R) ER therapy. The co-ingestion of alcohol with Opana(R) ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone .

OPANA(R) ER contains oxymorphone, a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. OPANA(R) ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Extended release tablets should be swallowed whole; not broken, chewed, dissolved, or crushed. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in increased plasma levels and a potentially fatal overdose of oxymorphone .

Commonly used brand name(s):

In the U.S.

  • Opana
  • Opana ER

Available Dosage Forms:

  • Tablet, Extended Release
  • Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Opana

Oxymorphone is a narcotic analgesic. It acts in the central nervous system (CNS) to relieve pain. Many of its side effects are also caused by actions in the CNS .

When oxymorphone is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of oxymorphone you should receive .

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


Before Using Opana

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 have not been performed on the relationship of age to the effects of oxymorphone in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of oxymorphone in the elderly. However, elderly patients are more likely to have age-related liver, kidney or heart problems, which may require an adjustment of dosage in patients receiving oxymorphone .

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adinazolam
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Aprobarbital
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Codeine
  • Dantrolene
  • Dezocine
  • Diazepam
  • Estazolam
  • Ethchlorvynol
  • Fentanyl
  • Flunitrazepam
  • Flurazepam
  • Fospropofol
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Ketazolam
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Midazolam
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nitrazepam
  • Nordazepam
  • Opium
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Phenobarbital
  • Prazepam
  • Propoxyphene
  • Quazepam
  • Remifentanil
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Temazepam
  • Thiopental
  • Triazolam

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

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:

  • Alcohol abuse, or history of, or
  • Addison’s disease or
  • Drug dependence, especially narcotic abuse, or history of or
  • Enlarged prostate or
  • Mental problems or
  • Pancreatitis (swelling of the pancreas) or
  • Urinating problems—The chance of side effects may be increased .
  • Asthma or
  • Brain disease or
  • Chronic obstructive pulmonary disease (COPD) or
  • Depression or
  • Head injury or
  • Heart disease or
  • Obesity, severe or
  • Scoliosis (an abnormal spine curve) or
  • Sleep apnea (breathing stops during sleep) or
  • Underactive thyroid—Use with caution. May increase risk of having breathing problems .
  • Breathing problems (e.g., asthma attack or severe asthma) or
  • Liver disease, moderate to severe or
  • Paralytic ileus (blockage of the bowel)—Should not be used in patients with these conditions .
  • Kidney disease or
  • Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
  • Seizures—Use with caution. This medicine may worsen this condition .
  • Shock—Blood pressure–lowering effects of this medicine may be increased .




Proper Use of oxymorphone

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

It is best to take this medicine on an empty stomach, at least one hour before or two hours after a meal .

Swallow the extended-release tablet whole. Do not crush, dissolve, break, or chew it .

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Withdrawal side effects may occur when the medicine is stopped suddenly because your body has become used to this medicine .

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 pain:
    • For oral dosage form (tablets):
      • Adults—At first, 5 milligrams (mg) every four to six hours. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor .
    • For oral dosage form (extended-release tablets):
      • Adults—At first, 5 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
      • 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 Opana

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

Oxymorphone may increase your risk of having serious breathing problems. Check with your doctor right away if you are having difficult or troubled breathing; irregular, fast, slow, or shallow breathing; pale or blue lips, fingernails, or skin; or shortness of breath .

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine .

Oxymorphone may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness .

Using this medicine for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems .

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using oxymorphone .

Opana 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:

Less common

  • Blurred vision
  • confusion
  • decreased urination
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • dry mouth
  • fast, pounding, racing, or irregular heartbeat or pulse
  • headache
  • nervousness
  • pounding in the ears
  • rapid breathing
  • shortness of breath
  • sunken eyes
  • sweating
  • swelling of hands, ankles, or feet
  • thirst
  • tightness in chest
  • unusual tiredness or weakness
  • wheezing
  • wrinkled skin

Rare

  • Abdominal pain
  • chest pain or discomfort
  • chills
  • cold sweats
  • cough
  • decrease in urine volume
  • decrease in consciousness
  • difficulty in passing urine [dribbling]
  • difficulty sleeping
  • difficulty swallowing
  • disorientation
  • drowsiness to profound coma
  • fear
  • fever
  • hallucination
  • hyperventilation
  • hives
  • hoarseness
  • irregular, slow, or shallow breathing
  • irritability
  • irritation
  • itching
  • joint pain, stiffness or swelling
  • lethargy
  • mood or other mental changes
  • painful urination
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • redness of skin
  • restlessness
  • severe constipation
  • severe vomiting
  • shaking
  • shortness of breath
  • skin rash
  • swelling of eyelids, face, or lips
  • trouble in holding or releasing urine
  • trouble sleeping
  • troubled breathing or swallowing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Cold and clammy skin
  • constricted, pinpoint, or small pupils [black part of eye]
  • decreased awareness or responsiveness
  • muscle weakness
  • no blood pressure or pulse
  • not breathing
  • severe sleepiness or unusual drowsiness
  • stopping of heart

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

  • Difficulty having a bowel movement (stool)
  • feeling of constant movement of self or surroundings
  • increased sweating
  • nausea or vomiting
  • relaxed and calm
  • sensation of spinning
  • sleepiness

Less common

  • Acid or sour stomach
  • belching
  • decreased appetite
  • decreased weight
  • diarrhea
  • discouragement
  • excess air or gas in stomach or intestines
  • feeling of warmth
  • feeling sad or empty
  • full or bloated feeling
  • heartburn
  • indigestion
  • lack of appetite
  • loss of interest or pleasure
  • passing gas
  • pressure in the stomach
  • redness of the face, neck, arms and occasionally, upper chest
  • sleeplessness
  • stomach discomfort or upset
  • swelling of abdominal or stomach area
  • tiredness
  • trouble concentrating
  • unable to sleep

Rare

  • Blistering, crusting, irritation, itching, or reddening of skin
  • cracked, dry, scaly skin
  • difficulty in thinking or concentrating
  • disturbed color perception
  • double vision
  • false or unusual sense of well-being
  • feeling jittery
  • halos around lights
  • loss of vision
  • mental depression
  • night blindness
  • nightmares or unusually vivid dreams
  • overbright appearance of lights
  • sudden sweating
  • tunnel vision
  • welts

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.

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.

 

Onxol

30/06/10

Generic Name: paclitaxel (PAK li TAK sel)
Brand Names: Onxol, Taxol

What is Onxol (paclitaxel)?

Paclitaxel is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Paclitaxel is used to treat breast cancer, lung cancer, and ovarian cancer. It is also used to treat AIDS-related Kaposi’s sarcoma.

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


What is the most important information I should know about Onxol (paclitaxel)?

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not be given this medication if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).

Before you receive paclitaxel, tell your doctor if you have liver disease, heart disease, or a severely weak immune system.

Paclitaxel can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

There are many other medicines that can interact with paclitaxel. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my healthcare provider before receiving Onxol (paclitaxel)?

You should not be given this medication if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).

Before you receive paclitaxel, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • heart disease; or

  • a severely weak immune system.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive paclitaxel.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive paclitaxel without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether paclitaxel passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is paclitaxel given?

Paclitaxel is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 24 hours to complete.

Paclitaxel is usually given every 3 weeks. Follow your doctor’s instructions.

Before your injection, you may be given other medications to help prevent a serious allergic reaction to paclitaxel.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

If any of this medication gets on your skin, wash the area with soap and warm water right away.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving paclitaxel.

Your heart rate may also be monitored through electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

Paclitaxel can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your paclitaxel injection.


What happens if I overdose?

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

Overdose symptoms may include numbness or tingling, fever, chills, mouth sores, unusual bleeding or weakness, or any signs of infection.

What should I avoid while using Onxol (paclitaxel)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are being treated with paclitaxel.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.


Onxol (paclitaxel) side effects

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

  • slow heart rate;

  • seizure (black-out or convulsions);

  • pale skin, easy bruising or bleeding, unusual weakness;

  • fever, chills, body aches, flu symptoms;

  • white patches or sores inside your mouth or on your lips;

  • numbness, tingling, or burning pain in your hands or feet;

  • increased blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats); or

  • warmth or redness under your skin.

Less serious side effects may include:

  • pain, swelling, redness, or skin color changes where the medicine was injected;

  • joint or muscle pain;

  • mild nausea, vomiting, diarrhea; or

  • hair loss.

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 Onxol (paclitaxel)?

There are many other medicines that can interact with paclitaxel. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about paclitaxel.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.05. Revision Date: 4/12/2009 4:39:49 PM.