Ambien CR

Generic Name: zolpidem (Oral route, Oromucosal route, Sublingual route)

zole-PI-dem

Commonly used brand name(s)

In the U.S.

• Ambien


• Ambien CR


• Edluar


• Zolpimist

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Spray

Therapeutic Class: Nonbarbiturate Hypnotic

Uses For Ambien CR

Zolpidem belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Zolpidem is used to treat insomnia (trouble in sleeping). Zolpidem helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

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

Before Using Ambien CR

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:

Sleep medicines may cause a special type of memory loss or "amnesia". When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zolpidem only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

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 zolpidem in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolpidem in the elderly. However, confusion, dizziness, and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem. Elderly patients may require a lower dose to help reduce unwanted effects.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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.

• Alprazolam


• Buspirone


• Butabarbital


• Chlordiazepoxide


• Chlorpromazine


• Clonazepam


• Clorazepate


• Dexmedetomidine


• Diazepam


• Diphenhydramine


• Doxylamine


• Estazolam


• Eszopiclone


• Ethchlorvynol


• Flumazenil


• Flurazepam


• Fospropofol


• Halazepam


• Hydromorphone


• Hydroxyzine


• Lorazepam


• Meprobamate


• Midazolam


• Oxazepam


• Oxycodone


• Pentobarbital


• Phenobarbital


• Prazepam


• Promethazine


• Propofol


• Quazepam


• Ramelteon


• Secobarbital


• Tapentadol


• Temazepam


• Thioridazine


• Triazolam


• Zaleplon

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.

• Bupropion


• Carbamazepine


• Ciprofloxacin


• Desipramine


• Ketoconazole


• Rifampin


• Sertraline


• St John's Wort


• Telaprevir


• Venlafaxine

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. 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 may cause an increased risk of certain side effects 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


• food

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, history of or


• Drug abuse or dependence, history of—Dependence on zolpidem may develop.

• Diseases affecting metabolism or disease involving blood circulation—Caution should be used in patients with these medical problems.

• Emphysema, asthma, bronchitis, or other chronic lung disease or


• Mental depression, history of or


• Mental illness, history of or


• Myasthenia gravis (severe muscle weakness) or


• Sleep apnea (temporary stopping of breathing during sleep)—Use with caution. Zolpidem may make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. Higher blood levels of zolpidem may result, increasing the chance of side effects.

Proper Use of zolpidem

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

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. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take zolpidem just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

You should swallow the extended-release tablets whole. Do not divide, crush, or chew them.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Zolpidem should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.

To use the oral spray:

• Pull the child-resistant cap to separate it from the base.


• Remove the clear protective cap from the pump.


• Hold the container upright with the black spray opening pointed directly into your mouth.


• Fully press down on the pump to make sure that a full dose (5 mg) of is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given.


• Put the clear protective cap back over the pump after each use.

To use the sublingual tablets:

• Do not open the blister pack that contains the tablet until you are ready to take it. Do not use the tablet if the seal of the blister pack is broken.


• Remove the tablet from the blister pack by peeling back the top layer of paper, then push the tablet through the foil.


• Place the tablet under your tongue. It should melt quickly. Do not crush, chew, or swallow the tablet. Do not eat or drink anything after using this medicine.


• If you are taking Intermezzo®, check the time before you take this medicine. Intermezzo® should be taken only if at least 4 hours of sleep remain before the planned time of awakening.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 the treatment of insomnia (trouble in sleeping):
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—12.5 milligrams (mg) once a day at bedtime.
    
    
    • Older adults—6.25 mg once a day at bedtime.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For oral dosage form (oral spray):
    
    • Adults—10 milligrams (mg) or 2 sprays into the mouth at bedtime.
    
    
    • Older adults—5 mg or 1 spray into the mouth at bedtime.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (sublingual tablets):
    
    • Adults—
      
      • Edluar™: 10 milligrams (mg) placed under the tongue at bedtime.
      
      
      • Intermezzo®: 1.75 mg (for women) and 3.5 mg (for men) placed under the tongue at bedtime.
      
      
    
    
    • Older adults—Intermezzo®: 1.75 mg (for both men and women) placed under the tongue at bedtime.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—10 milligrams (mg) once a day at bedtime.
    
    
    • Older adults—5 mg once a day at bedtime.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

Throw the child-resistant container of the oral spray when the 60 sprays have already been used.

Precautions While Using Ambien CR

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that 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; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to zolpidem before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.

If you will be taking zolpidem for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.

After taking zolpidem for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ambien CR 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

• Clumsiness or unsteadiness


• confusion


• mental depression

Rare

• Dizziness, lightheadedness, or fainting


• falling


• fast heartbeat


• hallucinations (seeing, hearing, or feeling things that are not there)


• skin rash


• swelling of the face


• trouble with sleeping


• unusual excitement, nervousness, or irritability


• wheezing or difficulty with breathing

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

Symptoms of overdose

• Clumsiness or unsteadiness (severe)


• dizziness (severe)


• double vision or other vision problems


• drowsiness (severe)


• nausea (severe)


• slow heartbeat


• troubled breathing


• vomiting (severe)

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

• Sleepiness or unusual drowsiness

Less common

• Abdominal or stomach pain


• abnormal or decreased touch sensation


• abnormal sensation of movement


• appetite disorder


• balance disorder


• binge eating


• bladder pain


• bloated


• bloody or cloudy urine


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in hearing


• chest discomfort


• chills


• confusion about identity, place, and time


• constipation


• continuing ringing or buzzing or other unexplained noise in the ears


• daytime drowsiness


• diarrhea


• difficult, burning, or painful urination


• difficulty with moving


• difficulty with swallowing


• discouragement


• double vision or other vision problems


• drugged feelings


• dryness of mouth


• ear drainage


• earache


• excess air or gas in the stomach or intestines


• eye redness


• false or unusual sense of well-being


• fear


• feeling of unreality


• feeling sad or empty


• fever


• frequent bowel movements


• frequent urge to urinate


• full feeling


• general feeling of discomfort or illness


• generalized slowing of mental and physical activity


• headache


• hearing loss


• heartburn


• hives or welts


• itching ears


• joint pain


• lack of appetite


• lack of feeling or emotion


• lack or loss of self-control


• lack or loss of strength


• longer or heavier menstrual periods


• loss of balance


• loss of interest or pleasure


• memory problems


• mood swings


• muscle aches, cramping, pain, or stiffness


• nausea


• nervousness


• nightmares or unusual dreams


• pain in the joints


• passing gas


• redness of the skin


• redness or soreness of the throat


• sense of detachment from self or body


• shortness of breath or troubled breathing


• skin rash


• skin wrinkling


• sneezing


• sore throat


• stress symptoms


• stuffy or runny nose


• swollen joints


• tiredness


• trouble concentrating


• trouble with sleeping


• vision blurred


• visual depth perception altered


• vomiting

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: Ambien CR 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 Ambien CR resources

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

• Ambien CR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ambien CR Prescribing Information (FDA)


• Zolpidem Prescribing Information (FDA)


• Ambien Consumer Overview


• Ambien Prescribing Information (FDA)


• Ambien MedFacts Consumer Leaflet (Wolters Kluwer)


• Ambien Monograph (AHFS DI)


• Edluar Prescribing Information (FDA)


• Edluar MedFacts Consumer Leaflet (Wolters Kluwer)


• Edluar Consumer Overview


• Intermezzo Consumer Overview


• ZolpiMist Consumer Overview


• Zolpimist Prescribing Information (FDA)


• Zolpimist Oral Spray MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ambien CR with other medications

• Insomnia

Gamunex-C

Pronunciation: i-MUNE GLOB-ue-lin
Generic Name: Immune Globulin (Human)
Brand Name: Examples include Gammagard and Gamunex-C

Gamunex-C may increase the risk of serious and sometimes fatal kidney problems. The risk may be greater if you already have kidney problems. The risk may also be greater if you have diabetes, dehydration or low blood volume, a blood infection, or a condition called paraproteinemia. You may also be at increased risk if you are over 65 years old or if you take another medicine that may harm your kidneys. Contact your doctor right away if you experience decreased urination, lower back or flank pain, swelling or bloating, sudden weight gain, shortness of breath, or weakness.

Serious kidney problems occur more commonly in patients who receive immune globulin intravenous (IGIV) products that contain sucrose. Gamunex-C does not contain sucrose.

Discuss any questions or concerns with your doctor.

Gamunex-C is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. Some brands of Gamunex-C are also used to treat patients with idiopathic thrombocytopenic purpura (ITP) or chronic inflammatory demyelinating polyneuropathy (CIDP). It may also be used for other conditions as determined by your doctor.

Gamunex-C is an immune globulin. It works by providing antibodies that fight infection.

Do NOT use Gamunex-C if:

• you are allergic to any ingredient in Gamunex-C or to another immune globulin


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to blood or products that are produced from blood


• you have immunoglobulin A (IgA) deficiency with antibodies against IgA and a history of allergic reaction to IgA

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

Before using Gamunex-C:

Some medical conditions may interact with Gamunex-C. 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 antibodies to IgA


• if you have recently received any vaccines, will be receiving a live vaccine (eg, measles, mumps, rubella), have been exposed to measles, or are at risk of measles exposure (eg, traveling to an area where measles is common)


• if you have heart problems, blood vessel problems (eg, narrowed arteries), thick blood, or a blood clotting disorder; a history of a stroke, a heart attack, or blood clots; or if you are at risk of any of these problems


• if you have diabetes, dehydration or low blood volume, a blood infection, a weakened immune system, a condition called paraproteinemia, high protein levels in the blood, high blood triglyceride levels, asthma, kidney problems, or are at risk of kidney problems


• if you have a history of migraine headaches


• if you are very overweight or will be confined to a bed or a chair for a long period of time


• if you have recently used another immune globulin product

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

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


• Hydantoins (eg, phenytoin) because unexpected hypersensitivity reactions may occur


• Live vaccines (eg, measles, mumps, and rubella) because their effectiveness may be decreased by Gamunex-C

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

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

• If you will be using Gamunex-C at home as an injection under the skin (subcutaneous injection), an extra patient leaflet is available with Gamunex-C. Talk to your pharmacist if you have questions about this information.


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


• If you will be using Gamunex-C as an injection under the skin, be sure NOT to inject it into a muscle or vein. Be sure you know how and where to inject Gamunex-C (eg, into the abdomen, thigh, upper arm).


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


• Do not use Gamunex-C if it has ever been frozen.


• Do not shake Gamunex-C.


• Do not mix Gamunex-C with any other medicine.


• Do NOT use Gamunex-C as an injection under the skin for ITP or CIDP. If you have ITP or CIDP, it should only be given as an injection in your vein at your doctor's office, hospital, or clinic. Discuss any questions or concerns with your doctor.


• Throw away any medicine that is left in the vial after you use a dose of Gamunex-C.


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


• If you miss a dose of Gamunex-C, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Gamunex-C.

Important safety information:

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


• Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with immunoglobulin medicines. This syndrome usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.


• Gamunex-C may cause live vaccines to be less effective. Talk with your doctor before you receive any vaccine while you are using Gamunex-C.


• Gamunex-C is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Gamunex-C. Discuss any questions or concerns with your doctor.


• Gamunex-C may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Gamunex-C.


• Lab tests, including antibody and immune globulin levels, blood thickness, urine output, and kidney function, may be performed while you use Gamunex-C. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Gamunex-C with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems and blood clots.


• Caution is advised when using Gamunex-C in CHILDREN; they may be more sensitive to its effects, especially fever or vomiting.


• Gamunex-C should be used with extreme caution in CHILDREN with CIDP. It should also be used with extreme caution if given as an injection under the skin in CHILDREN. Safety and effectiveness have not been established.


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

Possible side effects of Gamunex-C:

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:

Chills; cough; diarrhea; dizziness; flushing; headache; joint or back pain; muscle cramps; nausea; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; tiredness or weakness; vomiting.

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

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue); blue lips, arms, hands, legs, or feet; calf pain, tenderness, or swelling; chest pain or tightness; confusion; coughing up blood; dark urine; fainting; fast or irregular heartbeat; fever; mental or mood changes; numbness of an arm or a leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache or dizziness; severe stomach or back pain; shortness of breath or trouble breathing; slurred speech; swelling; symptoms of aseptic meningitis (eg, severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, severe nausea and vomiting); symptoms of kidney problems (eg, decreased urination, lower back or flank pain, shortness of breath, swelling or bloating, sudden weight gain); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; wheezing; yellowing of the skin or eyes.

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

See also: Gamunex-C side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Gamunex-C:

Store Gamunex-C in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If necessary, Gamunex-C may be stored at room temperature under 77 degrees F (25 degrees C) for a period of time. Check with your pharmacist about how long your brand of Gamunex-C may be stored at room temperature. Follow the storage instructions for Gamunex-C very closely. Do not use it if the expiration date on the container has passed. Store away from heat and light. Do not store in the bathroom. Keep Gamunex-C out of the reach of children and away from pets.

General information:

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


• Gamunex-C is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gamunex-C. 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 Gamunex-C resources

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

• Gamunex-C Prescribing Information (FDA)


• Gammagard Advanced Consumer (Micromedex) - Includes Dosage Information


• Gammagard Consumer Overview

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Half Inderal LA 80mg

1. Name Of The Medicinal Product

Half Inderal LA 80mg

2. Qualitative And Quantitative Composition

Propranolol hydrochloride Ph Eur 80 mg

3. Pharmaceutical Form

Pink/lavender or white opaque capsules containing propranolol hydrochloride in a prolonged release formulation.

4. Clinical Particulars

4.1 Therapeutic Indications

a) Management of angina

b) Prophylaxis of migraine

c) Management of essential tremor

d) Relief of situational anxiety and generalised anxiety, particularly those of somatic type

e) Adjunctive management of thyrotoxicosis

f) Prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices

g) Control of hypertension

4.2 Posology And Method Of Administration

For oral administration.

Adults

Hypertension: The usual starting dose is one 160 mg Inderal LA capsule daily, taken either morning or evening. An adequate response is seen in most patients at this dosage. If necessary, it can be increased in 80 mg Half-Inderal LA increments until an adequate response is achieved. A further reduction in blood pressure can be obtained if a diuretic or other antihypertensive agent is given in addition to Inderal LA and Half-Inderal LA.

Angina, essential tremor, thyrotoxicosis and the prophylaxis of migraine: One Half-Inderal LA capsule daily, taken either morning or evening, may be sufficient to provide adequate control in many patients. If necessary the dose may be increased to one Inderal LA capsule per day and an additional Half-Inderal LA increment may be given.

Situational and generalised anxiety: One Half-Inderal LA capsule taken daily should be sufficient to provide short-term relief of acute situational anxiety. Generalised anxiety, requiring longer term therapy, usually responds adequately at the same dosage. In individual cases, the dosage may be increased to one Inderal LA capsule per day. Treatment should be continued according to response. Patients should be reviewed after 6 to 12 months' treatment.

Portal hypertension: Dosage should be titrated to achieve approximately 25% reduction in resting heart rate. Dosing should begin with one 80 mg Half-Inderal LA capsule daily, increasing to one 160 mg Inderal LA capsule daily depending on heart rate response. Further 80 mg Half-Inderal LA increments may be added up to a maximum dose of 320 mg once daily.

Patients who are already established on equivalent daily doses of Inderal tablets should be transferred to the equivalent doses of Half-Inderal LA or Inderal LA daily, taken either morning or evening.

Children

Inderal LA and Half-Inderal LA are not intended for use in children.

Elderly Patients

Evidence concerning the relation between blood level and age is conflicting. It is suggested that treatment should start with one Half-Inderal LA capsule once daily. The dose may be increased to one Inderal LA capsule daily or higher as appropriate.

4.3 Contraindications

Inderal LA and Half-Inderal LA must not be used if there is a history of bronchial asthma or bronchospasm. The product label states the following warning: “Do not take Inderal LA if you have a history of asthma or wheezing”. A similar warning appears in the Patient Information Leaflet.

Bronchospasm can usually be reversed by beta₂ agonist bronchodilators such as salbutamol. Large doses of the beta₂ agonist bronchodilator may be required to overcome the beta blockade produced by propranolol and the dose should be titrated according to the clinical response; both intravenous and inhalational administration should be considered. The use of intravenous aminophylline and/or the use of ipratropium (given by nebuliser) may also be considered. Glucagon (1 to 2 mg given intravenously) has also been reported to produce a bronchodilator effect in asthmatic patients. Oxygen or artificial ventilation may be required in severe cases.

Inderal LA and Half-Inderal LA, as with other beta-blockers, must not be used in patients with any of the following conditions: known hypersensitivity to the substance, bradycardia, cardiogenic shock, hypotension, metabolic acidosis, after prolonged fasting, severe peripheral arterial circulatory disturbances, second or third degree heart block, sick sinus syndrome, untreated phaeochromocytoma, uncontrolled heart failure or Prinzmetal's angina.

Inderal LA and Half-Inderal LA must not be used in patients prone to hypoglycaemia, i.e. patients after prolonged fasting or patients with restricted counter-regulatory reserves.

4.4 Special Warnings And Precautions For Use

Inderal LA and Half-Inderal LA as with other beta-blockers:

• although contra-indicated in uncontrolled heart failure (see Section 4.3) may be used in patients whose signs of heart failure have been controlled. Caution must be exercised in patients whose cardiac reserve is poor.

• should not be used in combination with calcium channel blockers with negative inotropic effects (e.g. verapamil, diltiazem), as it can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or SA or AV conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta blocker nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.

• should not be used in patients with Prinzmetal's angina and beta-1 selective agents should be used with care (see section 4.3).

• although contra-indicated in severe peripheral arterial circulatory disturbances (see section 4.3) may also aggravate less severe peripheral arterial circulatory disturbances.

• due to its negative effect on conduction time, caution must be exercised if it is given to patients with first degree heart block.

• may block/modify the signs and symptoms of the hypoglycaemia (especially tachycardia). Inderal LA and Half-Inderal LA occasionally causes hypoglycaemia, even in non-diabetic patients, e.g., elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose. Severe hypoglycaemia associated with Inderal LA and Half-Inderal LA has rarely presented with seizures and/or coma in isolated patients. Caution must be exercised in the concurrent use of Inderal LA and Half-Inderal LA and hypoglycaemic therapy in diabetic patients. Inderal LA and Half-Inderal LA may prolong the hypoglycaemic response to insulin (see section 4.3).

• may mask the signs of thyrotoxicosis.

• should not be used in untreated phaeochromocytoma. However, in patients with phaeochromocytoma, an alpha-blocker may be given concomitantly.

• should be used to treat the elderly with caution starting with a lower dose (see section 4.2).

• will reduce heart rate as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms that may be attributable to a slow heart rate, the dose may be reduced.

• may cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.

Abrupt withdrawal of beta-blockers is to be avoided. The dosage should be withdrawn gradually over a period of 7 to 14 days. An equivalent dosage of another beta-blocker may be substituted during the withdrawal period to facilitate a reduction in dosage below Inderal LA 80mg. Patients should be followed during withdrawal especially those with ischaemic heart disease.

When a patient is scheduled for surgery and a decision is made to discontinue beta-blocker therapy, this should be done at least 24 hours prior to the procedure. The risk/benefit of stopping beta blockade should be made for each patient.

Since the half-life may be increased in patients with significant hepatic or renal impairment, caution must be exercised when starting treatment and selecting the initial dose.

Inderal LA and Half-Inderal LA must be used with caution in patients with decompensated cirrhosis (see section 4.2).

In patients with portal hypertension, liver function may deteriorate and hepatic encephalopathy may develop. There have been reports suggesting that treatment with propranolol may increase the risk of developing hepatic encephalopathy (see section 4.2).

Interference with laboratory tests: Inderal LA and Half-Inderal LA have been reported to interfere with the estimation of serum bilirubin by the diazo method and with the determination of catecholamines by methods using fluorescence.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Inderal LA and Half-Inderal LA modify the tachycardia of hypoglycaemia. Caution must be exercised in the concurrent use of Inderal LA or Half-Inderal LA and hypoglycaemic therapy in diabetic patients. Propranolol may prolong the hypoglycaemic response to insulin (see section 4.3 and 4.4).

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating effect on atrial-conduction time and induce negative inotropic effect.

Digitalis glycosides, in association with beta-blockers, may increase atrio-ventricular conduction time.

Combined use of beta-blockers and calcium channel blockers with negative inotropic effects eg, verapamil, diltiazem, can lead to an exaggeration of these effects, particularly in patients with impaired ventricular function and/or sino-atrial or atrio-ventricular conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-blocker nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.

Concomitant therapy with dihydropyridine calcium channel blockers eg, nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

Concomitant use of sympathomimetic agents, eg, adrenaline, may counteract the effect of beta-blockers. Caution must be exercised in the parenteral administration of preparations containing adrenaline to patients taking beta-blockers as, in rare cases, vasoconstriction, hypertension and bradycardia may result.

Administration of propranolol during infusion of lidocaine may increase the plasma concentration of lidocaine by approximately 30%. Patients already receiving propranolol tend to have higher lidocaine levels than controls. The combination should be avoided.

Concomitant use of cimetidine will increase the plasma levels of propranolol, and concomitant use of alcohol may increase the plasma levels of propranolol.

Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are co-administered, the beta-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped.

Caution must be exercised if ergotamine, dihydroergotamine or related compounds are given in combination with propranolol since vasospastic reactions have been reported in a few patients.

Concomitant use of prostaglandin synthetase inhibiting drugs, e.g. ibuprofen or indometacin, may decrease the hypotensive effects of propranolol.

Concomitant administration of propranolol and chlorpromazine may result in an increase in plasma levels of both drugs. This may lead to an enhanced antipsychotic effect for chlorpromazine and an increased antihypertensive effect for propranolol.

Caution must be exercised when using anaesthetic agents with Inderal LA and Half-Inderal LA. The anaesthetist should be informed and the choice of anaesthetic should be the agent with as little negative inotropic activity as possible. Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.

Pharmacokinetic studies have shown that the following agents may interact with propranolol due to effects on enzyme systems in the liver which metabolise propranolol and these agents: quinidine, propafenone, rifampicin, theophylline, warfarin, thioridazine and dihydropyridine calcium channel blockers such as nifedipine, nisoldipine, nicardipine, isradipine and lacidipine. Owing to the fact that blood concentrations of either agent may be affected, dosage adjustments may be needed according to clinical judgement, (see also the interaction above concerning concomitant therapy with dihydropyridine calcium channel blockers).

4.6 Pregnancy And Lactation

Pregnancy: As with all drugs, Inderal LA and Half-Inderal LA should not be given during pregnancy unless their use is essential. There is no evidence of teratogenicity with Inderal.

However beta-blockers reduce placental perfusion, which may result in intra-uterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia in the neonate and bradycardia in the foetus) may occur. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period.

Lactation: Most beta-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent. Breast feeding is therefore not recommended following administration of these compounds.

4.7 Effects On Ability To Drive And Use Machines

The use of Inderal LA or Half-Inderal LA is unlikely to result in any impairment of the ability of patients to drive or operate machinery. However, it should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Undesirable Effects

Inderal LA and Half-Inderal LA are usually well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of propranolol.

The following undesired events, listed by body system, have been reported.

Common (1-9.9%)

General: Fatigue and/or lassitude (often transient)

Cardiovascular: Bradycardia, cold extremities, Raynaud's phenomenon.

CNS: Sleep disturbances, nightmares.

Uncommon (0.1-0.9%)

GI: Gastrointestinal disturbance, such as nausea, vomiting, diarrhoea.

Rare (0.01-0.09%)

General: Dizziness.

Blood: Thrombocytopaenia.

Cardiovascular: Heart failure deterioration, precipitation of heart block, postural hypotension, which may be associated with syncope, exacerbation of intermittent claudication.

CNS: Hallucinations, psychoses, mood changes, confusion, memory loss.

Skin: Purpura, alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.

Neurological: Paraesthesia.

Eyes: Dry eyes, visual disturbances.

Respiratory: Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome.

Very rare (<0.01%)

Endocrine system: Hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis, patients on concomitant antidiabetic therapy, patients with prolonged fasting and patients with chronic liver disease has been reported.

Investigations: an increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

Nervous system: Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported.

Discontinuance of the drug should be considered if, according to clinical judgement, the well being of the patient is adversely affected by any of the above reactions. Cessation of therapy with a beta-blocker should be gradual. In the rare event of intolerance manifested as bradycardia and hypotension, the drug should be withdrawn and, if necessary, treatment for overdosage instituted.

4.9 Overdose

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

General treatment should include: close supervision, treatment in an intensive care ward, the use of gastric lavage, activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of plasma or plasma substitutes to treat hypotension and shock.

Excessive bradycardia can be countered with atropine 1 to 2 mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1 to 10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 to 10 microgram/kg/minute by intravenous infusion may be given. Dobutamine, because of its positive inotropic effect, could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Propranolol is a competitive antagonist at both beta₁ and beta₂-adrenoceptors. It has no agonist activity at the beta adrenoceptor, but has membrane stabilising activity at concentrations exceeding 1 to 3 mg/litre, though such concentrations are rarely achieved during oral therapy. Competitive beta blockade has been demonstrated in man by a parallel shift to the right in the dose-heart rate response curve to beta agonists such as isoprenaline.

Propranolol, as with other beta-blockers, has negative inotropic effects, and is therefore contra-indicated in uncontrolled heart failure.

Propranolol is a racemic mixture and the active form is the S (-) isomer. With the exception of inhibition of the conversion of thyroxine to triiodothyronine it is unlikely that any additional ancillary properties possessed by R (+) propranolol, in comparison with the racemic mixture will give rise to different therapeutic effects.

Propranolol is effective and well tolerated in most ethnic populations, although the response may be less in black patients.

The sustained release preparation of propranolol maintains a higher degree of beta₁-blockade 24 hours after dosing compared with conventional propranolol.

5.2 Pharmacokinetic Properties

Propranolol is completely absorbed after oral administration and peak plasma concentrations occur 1-2 hours after dosing in fasting patients. Following oral dosing with the sustained release preparation of propranolol, the blood profile is flatter than after conventional Inderal but the half-life is increased to between 10 and 20 hours. The liver removes up to 90% of an oral dose with an elimination half-life of 3 to 6 hours. Propranolol is widely and rapidly distributed throughout the body with highest levels occurring in the lungs, liver, kidney, brain and heart. Propranolol is highly protein bound (80 to 95%).

5.3 Preclinical Safety Data

Propranolol is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in this Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Erythrosine (E127)

Ethyl cellulose Ph Eur. (E462)

Gelatin Ph Eur. (E441)

Iron oxide, red (E172)

Iron oxide, black (E172)

Methylhydroxypropylcellulose Ph Eur. (E464)

Microcrystalline cellulose Ph Eur. (E460)

Titanium dioxide Ph Eur. (E171)

Sodium lauryl sulphate Ph Eur.

Shellac (E904)

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25°C, protected from light and moisture.

6.5 Nature And Contents Of Container

Patient calendar pack of 28 capsules.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by the prescriber.

7. Marketing Authorisation Holder

AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

UK

8. Marketing Authorisation Number(S)

PL 17901/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

11^th June 2000

10. Date Of Revision Of The Text

19^th May 2009

Cortrosyn

Pronunciation: KOE-sin-TROE-pin
Generic Name: Cosyntropin
Brand Name: Cortrosyn

Cortrosyn is used for:

Helping doctors diagnose adrenal gland problems (eg, Addison disease, adrenal insufficiency caused by steroid use, tumors). It may also be used for other conditions as determined by your doctor.

Cortrosyn is a man-made (synthetic) portion of the natural hormone corticotropin (ACTH). It works by stimulating the adrenal cortex to produce and secrete adrenocortical hormones.

Do NOT use Cortrosyn if:

• you are allergic to any ingredient in Cortrosyn


• you are using interleukin-2 (eg, aldesleukin)

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

Before using Cortrosyn:

Some medical conditions may interact with Cortrosyn. 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 kidney disease

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

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low electrolyte (eg, potassium, sodium) levels may be increased


• Itraconazole because it may increase the risk of Cortrosyn's side effects


• Carbamazepine because it may decrease Cortrosyn's effectiveness


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased and the risk of their side effects may be increased by Cortrosyn


• Interleukin-2 (eg, aldesleukin), mifepristone, quinolones (eg, levofloxacin), or ritodrine because the risk of their side effects may be increased by Cortrosyn

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

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

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


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


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


• If you miss a dose of Cortrosyn, contact your doctor right away.

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

Important safety information:

• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortrosyn while you are pregnant. It is not known if Cortrosyn is found in breast milk. If you are or will be breast-feeding while you use Cortrosyn, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cortrosyn:

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:

Redness or swelling at the injection site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast, slow, or irregular heartbeat; severe or persistent headache or dizziness; swelling of the hands, ankles, or feet.

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

See also: Cortrosyn side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Cortrosyn:

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

General information:

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


• Cortrosyn is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

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

• Cortrosyn Prescribing Information (FDA)


• Cosyntropin Prescribing Information (FDA)

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• Adrenocortical Insufficiency

T-Tussin DM

Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E

What is T-Tussin DM (dextromethorphan and guaifenesin)?

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

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.

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

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about T-Tussin DM (dextromethorphan and guaifenesin)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking T-Tussin DM (dextromethorphan and guaifenesin)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take T-Tussin DM (dextromethorphan and guaifenesin)?

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

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

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

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking T-Tussin DM (dextromethorphan and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

T-Tussin DM (dextromethorphan and guaifenesin) side effects

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

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations; or

  
  


• 
  

  slow, shallow breathing.

  
  

Less serious side effects may include:

• 
  

  dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  skin rash or itching; or

  
  


• 
  

  nausea, vomiting, or stomach upset.

  
  

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 T-Tussin DM (dextromethorphan and guaifenesin)?

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

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  quinidine (Quinaglute, Quinidex);

  
  


• 
  

  ranolazine (Ranexa);

  
  


• 
  

  ritonavir (Norvir);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  medicines to treat high blood pressure; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More T-Tussin DM resources

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

• Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex DM Prescribing Information (FDA)


• Mucinex DM Maximum Strength Prescribing Information (FDA)


• Robitussin DM infant drops


• Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Tussin DM Prescribing Information (FDA)

Compare T-Tussin DM with other medications

• Cough
• Expectoration

Where can I get more information?

• Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: T-Tussin DM side effects (in more detail)

Lansoprazole Delayed-Release Capsules

Generic Name: Lansoprazole (lan-SOE-pra-zole and na-PROX-en)
Brand Name: Prevacid NapraPAC

Lansoprazole Delayed-Release Capsules contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Lansoprazole Delayed-Release Capsules for a long time. Do not use Lansoprazole Delayed-Release Capsules right before or after bypass heart surgery.

Lansoprazole Delayed-Release Capsules may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Lansoprazole Delayed-Release Capsules are used for:

Treating rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis in certain patients with a history of gastric ulcer. It may also be used for other conditions as determined by your doctor.

Lansoprazole Delayed-Release Capsules are a combination package that contains an NSAID and a proton pump inhibitor (PPI). Exactly how the NSAID works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat symptoms of pain and inflammation. The PPI works by decreasing the amount of acid produced in the stomach. This decreases the risk of developing an ulcer from using an NSAID.

Do NOT use Lansoprazole Delayed-Release Capsules if:

• you are allergic to any ingredient in Lansoprazole Delayed-Release Capsules


• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)


• you have recently had or will be having bypass heart surgery


• you have moderate to severe kidney problems


• you are in the last 3 months of pregnancy


• you are taking an HIV protease inhibitor (eg, atazanavir)

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

Before using Lansoprazole Delayed-Release Capsules:

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

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


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


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


• if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, cancer)


• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases


• if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke or drink alcohol, or you have a history of alcohol abuse

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

• Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased


• Clarithromycin, probenecid, or voriconazole because they may increase the risk of Lansoprazole Delayed-Release Capsules's side effects


• Cyclosporine, digoxin, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Lansoprazole Delayed-Release Capsules


• Ampicillin, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, ketaconazole) beta-blockers (eg, propranolol), clopidogrel, diuretics (eg, furosemide, hydrochlorothiazide), HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Lansoprazole Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lansoprazole Delayed-Release Capsules 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 Lansoprazole Delayed-Release Capsules:

Use Lansoprazole Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lansoprazole Delayed-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lansoprazole Delayed-Release Capsules refilled.


• Take Lansoprazole Delayed-Release Capsules by mouth before eating, unless your doctor tells you otherwise. Naproxen may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.


• Take Lansoprazole Delayed-Release Capsules with a full glass of water (8 oz/240 mL).


• Swallow the lansoprazole capsule whole. Do not break, crush, or chew before swallowing.


• If you are taking sucralfate, take Lansoprazole Delayed-Release Capsules at least 30 minutes before taking sucralfate.


• If you also take an imidazole antifungal (eg ketoconazole), take it at least 2 hours before taking Lansoprazole Delayed-Release Capsules.


• If you also take antacids or cholestyramine, ask your doctor or pharmacist how to take them with Lansoprazole Delayed-Release Capsules.


• Continue to take Lansoprazole Delayed-Release Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Lansoprazole Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lansoprazole Delayed-Release Capsules.

Important safety information:

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


• Serious stomach ulcers or bleeding can occur with the use of an NSAID. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Lansoprazole Delayed-Release Capsules with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Lansoprazole Delayed-Release Capsules has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Lansoprazole Delayed-Release Capsules unless your doctor tells you to.


• Lansoprazole Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Lansoprazole Delayed-Release Capsules.


• Lab tests, including kidney or liver function, complete blood cell counts, and blood pressure, may be performed while you use Lansoprazole Delayed-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Lansoprazole Delayed-Release Capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients.


• Use Lansoprazole Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.


• Lansoprazole Delayed-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Lansoprazole Delayed-Release Capsules may harm the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lansoprazole Delayed-Release Capsules while you are pregnant. Lansoprazole Delayed-Release Capsules should not be used during labor. Lansoprazole Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Lansoprazole Delayed-Release Capsules.

Possible side effects of Lansoprazole Delayed-Release Capsules:

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

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision, hearing, or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Lansoprazole Delayed-Release Capsules:

Store Lansoprazole Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lansoprazole Delayed-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Lansoprazole Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Lansoprazole Delayed-Release Capsules 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 summary only. It does not contain all information about Lansoprazole Delayed-Release Capsules. 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 Lansoprazole resources

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

Compare Lansoprazole with other medications

• Ankylosing Spondylitis
• Osteoarthritis
• Rheumatoid Arthritis