SSZ Aplicaps may be available in the countries listed below.
Sulfadiazine silver (a derivative of Sulfadiazine) is reported as an ingredient of SSZ Aplicaps in the following countries:
International Drug Name Search
Generic Name: dexamethasone (Oral route)
dex-a-METH-a-sone
In the U.S.
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Adrenal Glucocorticoid
Dexamethasone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis. Dexamethasone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.
This medicine is available only with your doctor's prescription.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dexamethasone in children. However, pediatric patients are more likely to have slower growth and bone problems if dexamethasone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexamethasone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for elderly patients receiving dexamethasone.
| 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. |
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.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
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.
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.
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:
This section provides information on the proper use of a number of products that contain dexamethasone. It may not be specific to Dexamethasone Intensol. Please read with care.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
The Dexamethasone Intensol™ solution is a concentrated liquid. Measure the concentrated liquid with the special oral dropper that comes with the package. The liquid should be added to water, juice, soda or a soda-like beverage, applesauce, or pudding. Stir the mixture well and drink or eat it right away. Do not store the mixture for future use.
If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.
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.
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.
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 away any unused Dexamethasone Intensol™ solution 90 days after the bottle is opened for the first time.
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 unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.
While you are being treated with dexamethasone, do not have any immunizations (vaccines) without your doctor's approval. Dexamethasone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.
This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking this medicine.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.
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.
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:
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:
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.
For topical use only. Not for oral, ophthalmic, or intravaginal use.
Rx only
Desoximetasone Ointment USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
Each gram of Desoximetasone Ointment USP, 0.25% contains 2.5 mg of desoximetasone in an ointment base consisting of fractionated coconut oil and white petrolatum.
The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11β,16α)-.
Desoximetasone has the molecular formula C22H29FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.
The structural formula is:
Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Pharmacokinetic studies in men with Desoximetasone Ointment USP, 0.25% with tagged desoximetasone showed no detectable level (limit of sensitivity: 0.003 µg/mL) in 1 subject and 0.004 and 0.006 µg/mL in the remaining 2 subjects in the blood when it was applied topically on the back followed by occlusion for 24 hours. The extent of absorption for the ointment was 7% based on radioactivity recovered from urine and feces. Seven days after application, no further radioactivity was detected in urine or feces. Studies with other similarly structured steroids have shown that predominant metabolite reaction occurs through conjugation to form the glucuronide and sulfate ester.
Desoximetasone Ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Desoximetasone Ointment USP, 0.25% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Keep out of reach of children.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.
Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Desoximetasone Ointment USP, 0.25% should be discontinued until the infection has been adequately treated.
Patients using topical corticosteroids should receive the following information and instructions:
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.
The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Desoximetasone was nonmutagenic in the Ames test.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of Desoximetasone Ointment USP, 0.25%.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Desoximetasone Ointment USP, 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. Safety and effectiveness of Desoximetasone Ointment USP, 0.25% in pediatric patients below the age of 10 have not been established.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
In controlled clinical studies the incidence of adverse reactions was low (0.3%) for Desoximetasone Ointment USP, 0.25% and included mild burning sensation at the site of application.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Apply a thin film of Desoximetasone Ointment USP, 0.25% to the affected skin areas twice daily. Rub in gently.
Desoximetasone Ointment USP, 0.25% is supplied in 15 gram (NDC 51672-1262-1), 60 gram (NDC 51672-1262-3) and 100 gram (NDC 51672-1262-7) tubes.
Store at controlled room temperature between 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: November, 2010
PK-6353-1
85
NDC 51672-1262-7
100 g
Desoximetasone
Ointment USP, 0.25%
FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.
Rx only
Keep this and all medications out of the reach of children.
TARO
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074286 | 06/07/1996 | |
| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE | |
Progesteron Stricker may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Progesterone is reported as an ingredient of Progesteron Stricker in the following countries:
International Drug Name Search
Antinaus may be available in the countries listed below.
Prochlorperazine maleate (a derivative of Prochlorperazine) is reported as an ingredient of Antinaus in the following countries:
International Drug Name Search
Generic Name: dexamethasone (injection) (DEX a METH a sone)
Brand Names: Cortastat, Cortastat 10, Cortastat LA, De-Sone LA, Dexacen-4, Dexasone, Dexasone LA, Solurex, Solurex LA
Dexamethasone is in a class of drugs called steroids. Dexamethasone prevents the release of substances in the body that cause inflammation.
Dexamethasone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, breathing disorders, inflammatory eye conditions, blood cell disorders, leukemia, or endocrine disorders.
Dexamethasone may also be used for other purposes not listed in this medication guide.
Before using dexamethasone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.
Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.
Avoid activities that place too much stress on your joints. Dexamethasone can decrease pain and swelling, and you may be tempted to increase your activity if you are feeling better. Any joint damage may go unnoticed while you are being treated with dexamethasone.
Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are being treated with dexamethasone. Vaccines may not work as well while you are using a steroid. Ask your doctor when you can safely receive a live vaccine after your dexamethasone treatment ends.
Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before using this medication, tell your doctor about any illness or infection you have had within the past several weeks.
Other medical conditions you should tell your doctor about before using dexamethasone include:
asthma;
liver disease (such as cirrhosis);
kidney disease;
a thyroid disorder;
a history of malaria;
osteoporosis;
a muscle disorder such as myasthenia gravis;
glaucoma or cataracts;
herpes simplex infection of the eyes;
stomach ulcers, ulcerative colitis, or diverticulitis;
depression or mental illness;
congestive heart failure;
high blood pressure; or
if you have recently had a heart attack.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use dexamethasone.
Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.
Dexamethasone is given as an injection into a muscle or through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using dexamethasone.
Since dexamethasone injection is given as needed by a healthcare professional, it is not likely that you will miss a dose.
A single large dose of dexamethasone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
Avoid activities that place too much stress on your joints. Dexamethasone can decrease pain and swelling, and you may be tempted to increase your activity if you are feeling better. Any joint damage may go unnoticed while you are being treated with dexamethasone.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.
Do not receive a "live" vaccine while you are being treated with dexamethasone. Vaccines may not work as well while you are using a steroid. Ask your doctor when you can safely receive a live vaccine after your dexamethasone treatment ends.
problems with your vision;
swelling, rapid weight gain, feeling short of breath;
severe depression, unusual thoughts or behavior, seizure (convulsions);
bloody or tarry stools, coughing up blood;
pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
sleep problems (insomnia), mood changes;
acne, dry skin, thinning skin, bruising or discoloration;
slow wound healing;
increased sweating;
headache, dizziness, spinning sensation;
nausea, stomach pain, bloating; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
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.
There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:
aspirin (taken on a daily basis or at high doses);
a diuretic (water pill);
a blood thinner such as warfarin (Coumadin);
diet pills, or cough and cold medications;
indomethacin (Indocin); or
seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
This list is not complete and there may be other drugs that can interact with dexamethasone. 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.
See also: Dexacen-4 side effects (in more detail)
Generic Name: interferon alfa-2a ( in ter FEAR on AL fa 2 A)
Brand Names: Roferon-A
Interferon alfa-2a is a protein. Interferons are released in the body in response to viral infections. Interferons are important for fighting viruses in the body, regulating reproduction of cells, and regulating the immune system.
Interferon alfa-2a is used to treat chronic hepatitis C, hairy cell leukemia, AIDS-related Kaposi's sarcoma, and some types of chronic myelogenous leukemia (CML).
Interferon alfa-2a may also be used for purposes other than those listed in this medication guide.
Some patients taking interferon alfa-2a have developed a drop in the number of white blood cells and platelets. If the number of these blood cells are too low, there is an increased risk of infection or bleeding. Contact your doctor immediately if you develop a fever, symptoms of an infection, or unusual bleeding or bruising.
Before using interferon alfa-2a, talk to your doctor if you
a history of depression, suicidal thoughts, anxiety, drug or alcohol abuse, or another mental illness;
an active infection;
heart disease or history of a heart attack;
an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis;
have a suppressed immune system or have received an organ transplant,
have a seizure disorder,
have diabetes,
have bone marrow suppression,
You may not be able to use interferon alfa-2a, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Use interferon alfa-2a exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.
Interferon alfa-2a is used as an intramuscular or subcutaneous injection only. Your doctor or nurse will give you detailed instructions on how and where to inject this medication. Do not inject this medication if you are unsure how.
Drink 6 to 8 full glasses of water daily to ensure adequate hydration, especially at the start of treatment.
Flulike symptoms are likely to occur. They are most common at the start of therapy and may decrease with continued use. Over-the-counter fever reducers such as acetaminophen (Tylenol, others), ibuprofen (Motrin, Advil, others), and naproxen (Aleve), plenty of fluid, and taking the medication at bedtime may help to alleviate these symptoms.
Do not inject interferon alfa-2a if it is discolored or has particles in it.
Do not change the brand or generic formulation of interferon alfa-2a that you are using without first talking to your doctor or pharmacist. Some brands of interferon alfa-2a are interchangeable while others are not. Your doctor and/or pharmacist know which brand/generic formulations may be substituted for another.
Do not shake the vial of interferon alfa-2a. If mixing is required, the vial should be gently swirled.
If the interferon alfa-2a you are using is preservative-free, use only one dose from each vial. Throw away any medicine that is not used with the first dose, do not save it for later use
Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.
Your doctor may want you to have blood tests performed before and periodically during treatment with an interferon alfa-2a.
It is not known whether treatment with alfa interferon will prevent the transmission of hepatitis to others. It is also not known whether alfa interferons will cure hepatitis or prevent cirrhosis, liver failure, or liver cancer that may be the result of infection with a hepatitis virus.
Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and use only the next regularly scheduled dose. Do not use a double dose of this medication.
Symptoms of interferon alfa-2a overdose are not well known but may include decreased appetite, chills, fever, and muscle aches.
Some patients taking interferon alfa-2a have developed a drop in the number of white blood cells and platelets. If the number of these blood cells are too low, there is an increased risk of infection or bleeding. Contact your doctor immediately if you develop a fever, symptoms of an infection, or unusual bleeding or bruising.
Flu-like symptoms are likely to occur. They are most common at the start of therapy and may decrease with continued use. Over-the-counter fever reducers such as acetaminophen (Tylenol, others), ibuprofen (Motrin, Advil, others), and naproxen (Aleve), plenty of fluids, and taking the medication at bedtime may help to alleviate these symptoms. Continue to use interferon alfa-2a and notify your doctor if you experience
fever or chills;
fatigue;
headache;
muscle aches or sore joints;
numbness or tingling;
nausea, vomiting, or loss of appetite;
diarrhea;
dizziness or drowsiness;
nervousness or anxiety;
insomnia;
loss or thinning of hair;
increased sweating;
itching or a rash; or
pain, redness, or bruising at the injection site.
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.
Usual Adult Dose for Chronic Hepatitis C:
3 million intl units subcutaneously or IM three times a week for 48 to 52 weeks (12 months). Alternatively 6 million intl units three times a week for the first 12 weeks (3 months), followed by 3 million intl units three times a week for 36 weeks (9 months).
Usual Adult Dose for Chronic Myelogenous Leukemia:
9 million intl units daily subcutaneously or IM.
Usual Adult Dose for Hairy Cell Leukemia:
Induction dose: 3 million intl units daily subcutaneously or IM for 16 to 24 weeks.
Maintenance dose: 3 million intl units three times a week for up to 24 consecutive months.
Usual Adult Dose for Kaposi's Sarcoma:
Induction dose: 36 million intl units daily subcutaneously or IM for 10 to 12 weeks.
Maintenance dose: 36 million intl units three times a week.
Usual Adult Dose for Lymphoma:
Study (n=5) - Lymphomatoid Papulosis
3 to 15 million intl units three times per week subcutaneously for up to 13 months.
Usual Adult Dose for Renal Cell Carcinoma:
Study (n=75) Metastatic Renal-Cell Carcinoma
subcutaneous injection three times weekly, 4.5 million units titrated upwards to 18 million units, as tolerated, during the first 4 weeks (weekly dose increases). The individual maintenance dose, based on tolerability of side effects, was continued for 3 weeks (out of a 4-week cycle), up to 2 years if the patient responds or has stable disease.
Usual Pediatric Dose for Chronic Myelogenous Leukemia:
Study (n=15)
2.5 to 5 million intl units/m2/day IM
Study (n=12) Philadelphia Chromosome-Positive CML
5 million intl units/m2/day subcutaneously (combined with Cytarabine 20 mg/m2/day for 10 days monthly).
Before using interferon alfa-2a, tell your doctor if you are taking theophylline (Theo-Dur, Theochron, Theolair, others). Interferon alfa-2a may increase theophylline levels in the body, which could become dangerous.
Other drugs may also interact with interferon alfa-2a. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
Interferon alfa-2a is available with a prescription under the brand name Roferon-A. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
See also: interferon alfa-2a side effects (in more detail)
Apo-Fina may be available in the countries listed below.
Fenofibrate is reported as an ingredient of Apo-Fina in the following countries:
International Drug Name Search
Generic Name: Aripiprazole
Class: Atypical Antipsychotics
Chemical Name: 3,4-dihydro-7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-2(1H)-Quinolinone
Molecular Formula: C23H27Cl2N3O2
CAS Number: 129722-12-9
Special Alerts:
[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.
BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.
RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .
Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) compared with those receiving placebo (2.6%).1 73
Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).1 73
Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 73 (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
Atypical antipsychotic agent.2 7
Symptomatic management of schizophrenia.1
Management of acute manic and mixed episodes associated with bipolar I disorder.1 67
Administer orally once daily without regard to meals.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Oral solution may be given at same dose on mg-per-mg basis as the 5-, 10-, 15-, or 20-mg tablet strengths of the drug up to a dose of 25 mg.1 However, if oral solution is used in patients receiving aripiprazole 30-mg tablets, use a dose of 25 mg of the oral solution.1
Initial and target dosage is 10 or 15 mg once daily.1
Dosages ranging from 10–30 mg daily were effective in clinical trials; dosages exceeding 10–15 mg daily did not result in greater efficacy.1
Adjust dosage at intervals of not less than 2 weeks, the time needed to achieve steady-state concentrations.1
In patients responding to aripiprazole therapy, continue the drug as long as clinically necessary and tolerated, but at lowest possible effective dosage; periodically reassess need for continued therapy.1
Long-term efficacy of aripiprazole has not been established, and optimum duration of therapy currently is not known.1 However, aripiprazole has been used as maintenance therapy for up to 26 weeks in clinical trials, and maintenance therapy with antipsychotic agents is well established.1
Initial dosage of 30 mg once daily as tablets was used in clinical trials.1 67
Dosage was decreased to 15 mg once daily in clinical trials if initial 30-mg dosage was not well tolerated.1 67
Safety of dosages >30 mg daily has not been established.1
Long-term efficacy (i.e., >6 weeks) of aripiprazole has not been established, and optimum duration of therapy currently is not known.1 Periodically reevaluate the long-term risks and benefits of the drug for the individual patient.1
Reduce aripiprazole dosage to one-half the usual dosage in patients receiving concomitant therapy with inhibitors of CYP3A4 (e.g., ketoconazole) or CYP2D6 (e.g., fluoxetine, paroxetine, quinidine)1 ; increase aripiprazole dosage to the usual dosage after discontinuance of the CYP3A4 or CYP2D6 inhibitor.1
Increase aripiprazole dosage to 20–30 mg daily upon initiation of concomitant therapy with drugs that induce CYP3A4 (e.g., carbamazepine);1 additional dosage escalation should be based on clinical evaluation.1 Decrease aripiprazole dosage to 10–15 mg daily if the CYP3A4 inducer is discontinued.1
Known hypersensitivity to aripiprazole or any ingredient in the formulation.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.1 73
Increased incidence of adverse cerebrovascular effects (e.g., stroke, TIA), including fatalities, observed in geriatric patients (78–88 years of age) with dementia-related psychosis treated with aripiprazole in several placebo-controlled studies.1 A statistically significant dose-response relationship for adverse cerebrovascular effects was observed in patients receiving the drug in a fixed-dose study.1
Safety and efficacy not established in patients with dementia-related psychosis;1 exercise caution if used.1 (See Boxed Warning and see Geriatric Use under Cautions.)
Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported.1
Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, has been reported.1 Consider discontinuance of aripiprazole.1
Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents.1 11 12 14 15 16 17 18 20 21 22 23 25 40 41 42 46 65 Although there have been few reports of hyperglycemia in patients receiving aripiprazole, it is not known whether the paucity of such reports is due to relatively limited experience with the drug.1 8 18 59 60 61 62 63
Closely monitor patients with preexisting diabetes mellitus for worsening of glucose control and perform fasting glucose tests at baseline and periodically for patients with risk factors for diabetes (e.g., obesity, family history of diabetes).11 12 If manifestations of hyperglycemia occur, perform fasting blood glucose testing.1 11 12 14 15 16 17 18 19 20 21 22 23
Orthostatic hypotension reported.1 Use with caution in patients with known cardiovascular or cerebrovascular disease and/or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy).1
Possible risk of seizures;1 use with caution in patients with a history of seizures or with conditions known to lower the seizure threshold (e.g., dementia of the Alzheimer’s type, geriatric patients).1
Disruption of ability to reduce core body temperature possible; use caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).1
Somnolence reported;1 most prominent in patients with schizophrenia receiving the aripiprazole 30-mg daily dosage during clinical trials.1 Potential impairment of judgment, thinking, or motor skills.1
Esophageal dysmotility and aspiration possible;1 use with caution in patients at risk for aspiration pneumonia (e.g., geriatric patients, those with advanced Alzheimer’s dementia).1
Attendant risk with psychotic illnesses; closely supervise high-risk patients.1 Prescribe in the smallest quantity consistent with good patient management to reduce the risk of overdosage.1
Weight gain possible.1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Category C.
Distributed into milk in rats.1 Not known whether aripiprazole or its metabolites are distributed into milk in humans.1 Women receiving aripiprazole should not breast-feed.1
Safety and efficacy not established in children <18 years of age.1 8
Experience in those ≥65 years of age is insufficient to determine whether they respond differently from younger adults.1
Tolerability profile may differ in patients ≥65 years of age with dementia-related psychosis, including psychosis in association with dementia of the Alzheimer’s type, compared with that in younger patients with schizophrenia.1 Possible increased risk of death.1 73 (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)
In short-term studies, headache, agitation, anxiety, insomnia, nausea, dyspepsia, somnolence, akathisia, vomiting, constipation, lightheadedness, asthenia, extrapyramidal syndrome, accidental injury.1
With longer-term (e.g., 26 weeks) use, adverse effects generally were consistent with those reported in short-term trials, except for a higher incidence of tremor.1
Unlikely to cause clinically important pharmacokinetic interactions with drugs metabolized by CYP isoenzymes.1
Extensively metabolized in the liver principally via dehydrogenation, hydroxylation, and N-dealkylation by CYP2D6 and CYP3A4 isoenzymes.1
CYP3A4 inducers or inhibitors of CYP3A4 or CYP2D6: Potential pharmacokinetic interaction (altered aripiprazole metabolism and plasma concentrations); dosage adjustment recommended.1 (See Special Populations under Dosage and Administration and see Specific Drugs under Interactions.)
Inhibitors or inducers of CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2E1: Pharmacokinetic interaction unlikely.1
Substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4: Pharmacokinetic interaction unlikely.1
Drug | Interaction | Comments |
|---|---|---|
Carbamazepine | Possible decrease in plasma aripiprazole concentrations1 | Increased aripiprazole dosage recommended1 |
CNS agents or alcohol | Possible additive CNS effects1 | Use with caution1 |
Dextromethorphan | No change in dextromethorphan metabolism observed1 | |
Famotidine | Potential decreased aripiprazole absorption; not clinically important1 | No dosage adjustment necessary1 |
Fluoxetine | Possible increase in plasma aripiprazole concentrations1 | Reduction of aripiprazole dosage recommended1 |
Hypotensive agents | Possible additive hypotensive effects1 | Use with caution1 |
Ketoconazole | Possible increase in plasma aripiprazole concentrations1 | Reduction of aripiprazole dosage recommended1 |
Lithium | Pharmacokinetic interaction unlikely1 | |
Omeprazole | Pharmacokinetic interaction unlikely1 | |
Paroxetine | Possible increase in plasma aripiprazole concentrations1 | Reduction of aripiprazole dosage recommended1 |
Quinidine | Possible increase in plasma aripiprazole concentrations1 | Reduction of aripiprazole dosage recommended1 |
Valproate | Potential decreased plasma aripiprazole concentrations; not clinically important1 | No dosage adjustment necessary1 |
Warfarin | Pharmacokinetic interaction unlikely1 |
Absolute oral bioavailability of tablets is 87%.1
Peak plasma concentrations for tablets are achieved within 3–5 hours; steady-state concentrations achieved within 14 days.1
Well absorbed when administered as oral solution with higher plasma aripiprazole concentrations after administration of oral solution than with tablets at equivalent doses.1 (See Dosage under Dosage and Administration.)
Oral solution-to-tablet ratios of geometric mean maximum plasma concentrations and AUC were 122 and 114%, respectively.1
Administration of aripiprazole with a high-fat meal affected rate but not extent of absorption.1
Large volume of distribution following IV administration indicates extensive extravascular distribution.1
Distributed into milk in rats; not known whether distributed into milk in humans.1
Aripiprazole and its major metabolite, dehydro-aripiprazole, are >99% bound, principally to albumin.1
Extensively metabolized in the liver principally via dehydrogenation, hydroxylation, and N-dealkylation by CYP2D6 and CYP3A4 isoenzymes.1
Approximately 18% and <1% excreted unchanged in feces and urine, respectively.1
75 hours and 94 hours, for aripiprazole and dehydro-aripiprazole, respectively.1
In patients with the poor metabolizer CYP2D6 phenotype (approximately 8% of Caucasians), exposure to aripiprazole is increased by about 80%, while exposure to its active metabolite is decreased by approximately 30%.1 The elimination half-life for aripiprazole in poor metabolizers of the drug is approximately 146 hours.1
2–8°C.1 After opening, store containers at 2–8°C; can use for up to 6 months.1
25°C (may be exposed to 15–30°C).1
Exact mechanism of antipsychotic action has not been fully elucidated; may involve the drug’s activity at dopamine D2 and serotonin type 1 (5-HT1A) and type 2 (5-HT2A) receptors.1 2 3 4 5 6 7
Unlike other atypical antipsychotic agents, aripiprazole demonstrates partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.1 2 3 4 5 6 7 The major active metabolite, dehydro-aripiprazole, exhibits affinity for D2 receptors similar to that of the parent compound.1
Antagonism at other receptors (e.g., α1-adrenergic receptors, histamine H1 receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence).1
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Risk of somnolence and impairment of judgment, thinking, or motor skills; avoid driving, operating machinery, or performing hazardous tasks until effects on the individual are known.1
Importance of avoiding alcohol during aripiprazole therapy.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of avoiding overheating or dehydration.1
Importance of being aware that aripiprazole oral solution contains 400 mg of sucrose and 200 mg of fructose per mL.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 5 mg/5 mL | Abilify (with parabens and propylene glycol) | Otsuka (also promoted by Bristol-Myers Squibb) |
Tablets | 5 mg | Abilify | Otsuka (also promoted by Bristol-Myers Squibb) | |
10 mg | Abilify | Otsuka (also promoted by Bristol-Myers Squibb) | ||
15 mg | Abilify | Otsuka (also promoted by Bristol-Myers Squibb) | ||
20 mg | Abilify | Otsuka (also promoted by Bristol-Myers Squibb) | ||
30 mg | Abilify | Otsuka (also promoted by Bristol-Myers Squibb) |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Abilify 10MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$531.98 or 90/$1556.97
Abilify 15MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$500.99 or 90/$1479.91
Abilify 2MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$531.98 or 90/$1569.9
Abilify 20MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$715.98 or 90/$2089.86
Abilify 30MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$715.98 or 90/$2075.28
Abilify 5MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$531.98 or 90/$1569.9
Abilify Discmelt 10MG Dispersible Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$609.96 or 90/$1779.95
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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