Alfuzosina ratiopharm may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosina ratiopharm in the following countries:
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There are currently no drugs listed for "Intravenous Insulin Drip".
Calfadol may be available in the countries listed below.
Alfacalcidol is reported as an ingredient of Calfadol in the following countries:
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Bassamin may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Bassamin in the following countries:
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Céfétamet may be available in the countries listed below.
Céfétamet (DCF) is also known as Cefetamet (Rec.INN)
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Glossary
| DCF | Dénomination Commune Française |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Azitrox may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azitrox in the following countries:
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Amfadol Plus may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Amfadol Plus in the following countries:
Paracetamol is reported as an ingredient of Amfadol Plus in the following countries:
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Tiadyl may be available in the countries listed below.
Candesartan cilexetil (a derivative of Candesartan) is reported as an ingredient of Tiadyl in the following countries:
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Aniflazym may be available in the countries listed below.
Serrapeptase is reported as an ingredient of Aniflazym in the following countries:
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Suprapen may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Suprapen in the following countries:
Flucloxacillin is reported as an ingredient of Suprapen in the following countries:
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Metildopa may be available in the countries listed below.
Metildopa (DCIT) is known as Methyldopa in the US.
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Glossary
| DCIT | Denominazione Comune Italiana |
Generic Name: bacitracin (injection) (BAS i TRAY sin)
Brand names: Baci-IM, Baci-Rx
Bacitracin injection is an antibiotic that treats staph infection caused by a bacteria called staphylococcus (STAF-il-oh-KOK-us).
Bacitracin injection is used in infants to treat pneumonia. It is also used to treat an infection that causes pus to build up between the lungs and the membrane that covers them.
Bacitracin injection may also be used for purposes other than those listed in this medication guide.
Before your child receives bacitracin injection, tell the doctor if the child has a history of kidney disease.
Many other drugs can damage the kidneys and should not be used together with bacitracin. Tell your doctor if your child is receiving chemotherapy, medicines used to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, or any other injected antibiotics.
Serious side effects of bacitracin injection include urinating less than usual or not at all, blood in the urine, lower back pain, or painful urination.
Make sure your child receives this medication for the entire length of time prescribed by the doctor. Your child's symptoms may get better before the infection is completely treated. Bacitracin injection will not treat a viral infection such as the common cold or flu.
Before receiving bacitracin injection, tell your child's doctor if the child is allergic to any drugs, or if your child has a history of kidney disease. If your child has either of these conditions, he or she may not be able to receive bacitracin, or may need dosage adjustments or special tests during treatment.
This medication is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give your child this injection.
To be sure this medication is not causing harmful effects, your child's kidney function may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.
Make sure your child receives this medication for the entire length of time prescribed by the doctor. Your child's symptoms may get better before the infection is completely treated. Bacitracin injection will not treat a viral infection such as the common cold or flu.
Since bacitracin injection is usually given in a hospital, it is not likely your child will miss a dose.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while your child is receiving bacitracin injection.
urinating more than usual or more often;
urinating less than usual, or not at all (fewer wet diapers);
blood in the urine;
lower back pain; or
painful urination.
Less serious side effects include:
nausea, vomiting;
mild skin rash; or
pain, burning, or swelling where the medicine was injected.
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.
Before your child receives bacitracin, tell the doctor if your child is receiving any of the following drugs:
cancer medications (chemotherapy);
medicines used to treat a bowel disorder, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);
any other injected antibiotics such as amikacin (Amikin), amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), or streptomycin; or
antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir).
Many of these other drugs can damage the kidneys. If your child is receiving any of these drugs, he or she may not be able to receive bacitracin, or may need dosage adjustments or special tests during treatment.
There may be other drugs that can affect bacitracin injection. Tell your doctor about all your child's prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child's doctor.
Acetamol may be available in the countries listed below.
Paracetamol is reported as an ingredient of Acetamol in the following countries:
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Isonil may be available in the countries listed below.
Oxyphenonium Bromide is reported as an ingredient of Isonil in the following countries:
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Konazol may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Konazol in the following countries:
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Bupixamol may be available in the countries listed below.
Bupivacaine hydrochloride (a derivative of Bupivacaine) is reported as an ingredient of Bupixamol in the following countries:
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Alergoftal may be available in the countries listed below.
Antazoline phosphate (a derivative of Antazoline) is reported as an ingredient of Alergoftal in the following countries:
Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Alergoftal in the following countries:
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Adicanil may be available in the countries listed below.
Lisinopril is reported as an ingredient of Adicanil in the following countries:
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Apo-Alprazolam may be available in the countries listed below.
Alprazolam is reported as an ingredient of Apo-Alprazolam in the following countries:
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Alfuzosine Ranbaxy L.P. may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosine Ranbaxy L.P. in the following countries:
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Azol-Flucon may be available in the countries listed below.
Fluconazole is reported as an ingredient of Azol-Flucon in the following countries:
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Amiloride Hydrochloride (BANM, USAN) is known as Amiloride in the US.
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Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
Azulene Showa Yakuhin Kako may be available in the countries listed below.
Sodium Gualenate is reported as an ingredient of Azulene Showa Yakuhin Kako in the following countries:
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Amikacine Winthrop may be available in the countries listed below.
Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Amikacine Winthrop in the following countries:
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Fluometol NF Ofteno may be available in the countries listed below.
Fluorometholone is reported as an ingredient of Fluometol NF Ofteno in the following countries:
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Betanoid may be available in the countries listed below.
Betamethasone is reported as an ingredient of Betanoid in the following countries:
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am-pi-SIL-in SOE-dee-um, sul-BAK-tam SOE-dee-um
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antibiotic
Pharmacologic Class: Ampicillin
Ampicillin and sulbactam combination is used to treat bacterial infections in many different parts of the body.
Ampicillin and sulbactam combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, ampicillin and sulbactam will not work for colds, flu, or other virus infections.
ampicillin and sulbactam 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 ampicillin and sulbactam, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to ampicillin and sulbactam 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 ampicillin and sulbactam combination in children with skin infections. However, safety and efficacy have not been established in children below 1 year of age.
Appropriate studies have not been performed on the relationship of age to the effects of ampicillin and sulbactam combination in children with bowel or stomach infections. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of ampicillin and sulbactam combination in geriatric patients.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
Studies in women suggest that this medication poses minimal risk to the infant when used during 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 receiving ampicillin and sulbactam, 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 ampicillin and sulbactam 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 ampicillin and sulbactam. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you ampicillin and sulbactam in a hospital. ampicillin and sulbactam is given as a shot into one of your muscles or through a needle placed in one of your veins.
Your doctor will check your progress closely while you are receiving ampicillin and sulbactam. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
ampicillin and sulbactam may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive ampicillin and sulbactam.
Ampicillin and sulbactam combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Before you have any medical tests, tell the doctor in charge that you are taking ampicillin and sulbactam. The results of some tests may be affected by ampicillin and sulbactam.
ampicillin and sulbactam may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g. condoms, a diaphragm, or a contraceptive foam or jelly) while using ampicillin and sulbactam.
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 or nurse 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.
See also: ampicillin and sulbactam Injection 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.
Premil may be available in the countries listed below.
Repaglinide is reported as an ingredient of Premil in the following countries:
International Drug Name Search
Azo Cefasabal may be available in the countries listed below.
Phenazopyridine hydrochloride (a derivative of Phenazopyridine) is reported as an ingredient of Azo Cefasabal in the following countries:
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Generic Name: topical emollients (TOP i kal ee MOL i ents)
Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care
Emollients are substances that moisten and soften your skin.
Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.
There are many brands and forms of topical emollients available and not all are listed on this leaflet.
Topical emollients may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
deep wounds or open sores;
swelling, warmth, redness, oozing, or bleeding;
large areas of skin irritation;
any type of allergy; or
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.
Apply a small amount of topical emollient to the affected area and rub in gently.
If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.
If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.
Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.
Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.
Less serious side effects are more likely, and you may have none at all.
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.
It is not likely that other drugs you take orally or inject will have an effect on topically applied products. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Alfuzosine Winthrop may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosine Winthrop in the following countries:
International Drug Name Search
Silver Sulfadiazine (USAN) is known as Sulfadiazine in the US.
International Drug Name Search
Glossary
| USAN | United States Adopted Name |
Alfuzosina Stada may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosina Stada in the following countries:
International Drug Name Search
Azromax may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azromax in the following countries:
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Normastigmin mit Pilocarpin may be available in the countries listed below.
Neostigmine bromide (a derivative of Neostigmine) is reported as an ingredient of Normastigmin mit Pilocarpin in the following countries:
Pilocarpine hydrochloride (a derivative of Pilocarpine) is reported as an ingredient of Normastigmin mit Pilocarpin in the following countries:
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Azitrotek may be available in the countries listed below.
Azithromycin is reported as an ingredient of Azitrotek in the following countries:
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Diazemuls Emulsion for injection 5mg/ml
(diazepam)
Diazemuls contains diazepam which belongs to a group of medicines called benzodiazepines.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
Do not drink alcohol while you are using Diazemuls.
Alcohol may increase the sedative effects of Diazemuls and make you very sleepy.
You should not use Diazemuls if you are pregnant, planning to become pregnant or are breast feeding.
If you use Diazemuls late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing difficulties. If used regularly during late pregnancy, your baby may develop withdrawal symptoms. Ask your doctor or pharmacist for advice before using any medicine.
Diazemuls may affect your concentration or how your muscles work or may make you feel sleepy or forgetful. It may also affect alertness (especially if you don’t have enough sleep). Do not drive or use any tools or machines if you are affected in this way.
Diazemuls contains egg phospholipid and soya bean oil. If you are allergic to eggs or soya beans contact your doctor before using this medicine.
Diazemuls will be given by a doctor or a nurse as a slow intravenous injection (into a vein), or as a continuous infusion (into a vein).
If you are elderly or debilitated you are likely to be more sensitive to diazepam. Therefore, your dose may be reduced to one half the normal dose at the start of treatment.
If you think you have had too much Diazemuls, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling sleepy or deep sleep, muscle weakness or excitement. In more severe cases symptoms may include loss of co-ordination of movements, low blood pressureand breathing difficulties.
If you think you have missed a dose, let your nurse or doctor know.
Do not stop using your medicine without telling your doctor as he may wish to gradually reduce the number of injections you use before stopping them completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Diazemuls can cause side-effects, although not everybody gets them.
Local pain or inflammation of the vein used for the injection and sometimes a skin rash may occur at the site of the injection, which usually clears up in 1 or 2 days. Abnormal psychological reactions such as numbing of the emotions may occur in children and the elderly. Confusion is also more common in the elderly.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Store below 25°C. Do not freeze.
Do not use Diazemuls after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Diazemuls is a white, milky fluid.
Pack sizes are in boxes of 10x2ml ampoules.
Date of Revision: July 2009
L1438-33
Azukon may be available in the countries listed below.
Gliclazide is reported as an ingredient of Azukon in the following countries:
International Drug Name Search
Promon may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Promon in the following countries:
International Drug Name Search
Trisequens Orifarm may be available in the countries listed below.
Estradiol is reported as an ingredient of Trisequens Orifarm in the following countries:
Estradiol hemihydrate (a derivative of Estradiol) is reported as an ingredient of Trisequens Orifarm in the following countries:
Norethisterone 17ß-acetate (a derivative of Norethisterone) is reported as an ingredient of Trisequens Orifarm in the following countries:
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Class: Amphetamines
VA Class: CN801
Chemical Name: (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethly] hexanamide dimethanesulfonate
Molecular Formula: C15H25N3O (CH4O3S)2
CAS Number: 608137-32-2
Brands: Vyvanse
Amphetamines have a high potential for abuse.1
Administration of amphetamines for prolonged periods of time may lead to drug dependence.1
Particular attention should be paid to the possibility of individuals obtaining amphetamines for nontherapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.1
The possibility that family members may abuse the patient’s medication should be considered.5
Possible sudden death and serious cardiovascular events, particularly in individuals who abuse amphetamines.1 6 9 (See Sudden Death and Serious Cardiovascular Events under Cautions.)
Prodrug of dextroamphetamine; noncatechol, sympathomimetic amine with CNS-stimulating activity.1 8 28
Used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention deficit hyperactivity disorder (ADHD) (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction).1 3 6 7 8 28
Safety and efficacy established in children 6–12 years of age who met criteria for ADHD (combined type or predominantly hyperactive-impulsive type) and also in adults who met criteria for ADHD.1 2 3 4 29 30
Almost all studies comparing behavioral therapy versus stimulants alone have shown a much stronger therapeutic effect from stimulants than from behavioral therapy, and stimulants (e.g., amphetamines, methylphenidate) remain the drugs of choice for the management of ADHD.5 6 7 10 11 12 13 14 15 16 17 18 19 20
Drug therapy is not indicated in all patients with ADHD, and such therapy should be considered only after a complete evaluation including medical history has been performed.1 6 17 18
Use should depend on age, adequate diagnosis (based on medical, special psychological, educational, and social resources), and the clinician’s assessment of the severity, duration, and frequency of symptoms and should not depend solely on one or more behavioral characteristics.1 5 6 17
Administer once daily in the morning without regard to meals.1 Because of potential for insomnia, avoid administering in the afternoon.1 28 30
Capsule may be swallowed whole or may be opened and the entire contents dissolved in water immediately prior to administration; resulting solution should not be stored for use at a later time.1 28
Do not subdivide capsule contents; do not administer a dose less than the entire contents of one capsule.1
Available as lisdexamfetamine dimesylate; dosage expressed in terms of the salt.1
Adjust dosage according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.1 6 30
When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.1 6
Children 6–12 years of age: Initially, 30 mg once daily (as initial treatment for ADHD or in patients being switched to lisdexamfetamine from other drugs); dosage may be adjusted in 10- or 20-mg increments at weekly intervals; maximum 70 mg daily.1 28 30
If the initial 30-mg daily dosage is not tolerated, dosage may be decreased to 20 mg daily.27
Initially, 30 mg once daily (as initial treatment for ADHD or in patients being switched to lisdexamfetamine from other drugs); dosage may be adjusted in 10- or 20-mg increments at weekly intervals; maximum 70 mg daily.1 28
If the initial 30-mg daily dosage is not tolerated, dosage may be decreased to 20 mg daily.27
Children 6–12 years of age: Maximum 70 mg daily.1
Long-term use (i.e., >4 weeks) has not been studied systematically.1 If used for long-term therapy, periodically reevaluate the usefulness of the drug.1
Maximum 70 mg daily.1
Long-term use (i.e., >4 weeks) has not been studied systematically.1 If used for long-term therapy, periodically reevaluate the usefulness of the drug.1
No special population dosage recommendations at this time.1
Contraindicated in patients with advanced arteriosclerosis,1 5 28 symptomatic cardiovascular disease,1 5 28 moderate to severe hypertension,1 5 28 hyperthyroidism,1 5 28 known hypersensitivity or idiosyncrasy to sympathomimetic amines,1 5 glaucoma,1 5 28 or a history of drug abuse;1 5 28 within 14 days of MAO inhibitor therapy;1 5 28 and in agitated patients.1 28
Although amphetamines generally should not be used in patients with a history of drug abuse,1 5 some experts state that this is not an absolute contraindication, provided the patient can be monitored more carefully than would otherwise be indicated.5
Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.1 9
Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.31 32 33 FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.31 FDA is conducting an ongoing safety review of amphetamines and other stimulants to evaluate possible link between use of these agents and sudden death in children.31 32 33 Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.31
Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).1 5 6
In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.1 6 8 9 (See Contraindications under Cautions.)
Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.1 28
Least amount of lisdexamfetamine feasible should be prescribed or dispensed at one time in order to minimize possible overdosage.1
Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.1 28 Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.1
Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).1
May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.1 5
Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.1 6 If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1 6
May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.1 Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).1
Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.1 If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.1
Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.1 No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.1 6
Long-term (i.e., >12 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 6 Dose-related weight loss reported in children during 4 weeks of therapy with lisdexamfetamine.1
Manufacturer recommends monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.1 6 28 However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.7
Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.1 28 If seizures occur, discontinue therapy.1
Visual disturbances (e.g., difficulty with accommodation, blurred vision) reported with stimulants.1 28
Amphetamines reported to exacerbate motor and phonic tics and Tourette’s syndrome.1 However, a history of tics or their development during therapy is not an absolute contraindication to continued use.1 5 7 Nevertheless, evaluate for presence of tics and Tourette’s syndrome in children and their families prior to initiating stimulant therapy.1
Amphetamines may impair the ability to engage in potentially hazardous activities (e.g., operating machinery or vehicles).1
Category C.1 25
Risk of prematurity, low birth weight, and withdrawal symptoms (e.g., dysphoria, lassitude, agitation) in infants born to dependent women.1 25
Distributed into milk; discontinue nursing or the drug.1 25
Safety and efficacy of lisdexamfetamine not established in children 3–5 years of age.1 Amphetamines not recommended for ADHD in children <3 years of age.1 5 6 Not studied to date in adolescents.1
Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.1 (See Warnings under Cautions.)
Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.1 Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.31 32 33 (See Sudden Death and Serious Cardiovascular Events under Cautions.)
Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.1 (See Growth Suppression under Cautions.)
Lisdexamfetamine has not been studied in this population.1
Not specifically studied in hepatic impairment.27
Not specifically studied in renal impairment.27
Children 6–12 years of age: Decreased appetite,1 6 28 29 30 insomnia,1 6 28 29 30 upper abdominal pain,1 28 30 irritability,1 6 28 30 vomiting, 1 28 weight loss,1 6 28 30 nausea,1 28 dry mouth,1 28 dizziness,1 28 30 affect lability,1 rash,1 tic,1 pyrexia,1 somnolence.1
Adults: Decreased appetite,1 insomnia,1 dry mouth,1 diarrhea,1 nausea,1 anxiety,1 anorexia,1 jitteriness,1 increased BP,1 agitation,1 restlessness,1 hyperhidrosis,1 increased heart rate,1 tremor,1 dyspnea.1
Active metabolite (dextroamphetamine) inhibits MAO.1
Lisdexamfetamine is not metabolized by CYP isoenzymes.1 In vitro studies suggest only minor inhibition of CYP isoenzymes 1A2, 2D6, and 3A4 by amphetamine and/or its metabolites.1
Drug, Test, or Food | Interaction | Comments |
|---|---|---|
Acidifying agents, urinary (ammonium chloride, sodium acid phosphate, cranberry juice) | Increased urinary excretion and decreased serum concentrations and efficacy of amphetamines1 8 | |
Adrenergic blockers | Potential inhibition of adrenergic blockade1 | |
Alkalinizing agents (carbonic anhydrase inhibitors, sodium bicarbonate) | Decreased urinary excretion of amphetamines8 | |
Antidepressants, tricyclic (desipramine, protriptyline) | Enhanced activity of tricyclic antidepressants; desipramine or protriptyline cause striking and sustained increases in the concentration of dextroamphetamine in the brain; cardiovascular effects can be potentiated1 | |
Antihistamines | Amphetamines may counteract the sedative effects of antihistamines1 | |
Antihypertensives | Amphetamines may antagonize the hypotensive effects of antihypertensives1 | |
Chlorpromazine | Chlorpromazine inhibits the central stimulant effects of amphetamines by blocking dopamine and norepinephrine receptors1 | Can be used to treat amphetamine poisoning1 |
Ethosuximide | Intestinal absorption of ethosuximide may be delayed1 | |
Haloperidol | Haloperidol inhibits the central stimulant effects of amphetamines by blocking dopamine receptors1 | |
Lithium carbonate | Lithium may inhibit the anorectic and stimulatory effects of amphetamine1 | |
MAO inhibitors | MAO inhibitors slow the metabolism of amphetamines, increasing their effect on the release of norepinephrine and other monoamines leading to headaches and other signs of hypertensive crisis1 Toxic neurologic effects, hypertensive crisis, and malignant hyperpyrexia can occur, sometimes with fatal results1 | Amphetamines contraindicated in patients currently or recently (within 14 days) receiving MAO inhibitor1 |
Meperidine | Amphetamines potentiate the analgesic effect of meperidine1 | |
Methenamine | Acidifying agents used with methenamine increase urinary excretion and decrease efficacy of amphetamines1 | |
Norepinephrine | Amphetamines enhance the adrenergic effects of norepinephrine1 | |
Phenobarbital | Amphetamines may delay absorption of phenobarbital; concomitant use may produce a synergistic anticonvulsant action1 | |
Phenytoin | Amphetamines may delay absorption of phenytoin; concomitant use may produce a synergistic anticonvulsant action1 | |
Propoxyphene | In propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur1 | |
Sympathomimetic agents | Enhanced activity of sympathomimetic agents1 | Use with caution1 |
Test, plasma corticosteroids | Elevated plasma corticosteroid concentrations; this increase is greatest in the evening1 | |
Test, urinary steroids | Possible interference with urinary steroid determinations1 | |
Veratrum alkaloids | Amphetamines inhibit the hypotensive effect of veratrum1 |
Lisdexamfetamine (a prodrug of dextroamphetamine) is rapidly absorbed from the GI tract.1 28 Peak plasma concentrations of lisdexamfetamine occur in approximately 1 hour; concentrations are low and transient; nonquantifiable by 8 hours after administration.1 Peak plasma concentrations of dextroamphetamine occur in approximately 3.5–3.7 hours.1 3 30
Occurs within 2 hours after oral administration.3
Approximately 10–12 hours.1 8 27
Food (high-fat meal) delays time to peak plasma concentration of dextroamphetamine by about 1 hour but does not affect magnitude of peak plasma concentration or AUC of dextroamphetamine.1
Amphetamines readily cross the blood-brain barrier and are distributed into most body tissues.26
Amphetamines are distributed into milk in concentrations 3–7 times maternal blood concentrations.21 25
Lisdexamfetamine (a prodrug of dextroamphetamine) is converted to l-lysine and dextroamphetamine by first-pass intestinal and/or hepatic metabolism.1
Lisdexamfetamine is not metabolized by CYP isoenzymes.1
Excreted principally in urine.1 Approximately 96% of a 70-mg radiolabeled oral dose of lisdexamfetamine was recovered in urine; parent drug accounted for about 2% of the recovered radioactivity.1
Changes in urinary pH may alter excretion of amphetamines.1 (See Specific Drugs, Tests, and Foods under Interactions.)
Lisdexamfetamine: <1 hour;1 8 dextroamphetamine: 9.4–13 hours.3 8 30
Tight, light-resistant containers at 25°C (may be exposed to 15–30°C).1
Amphetamines are sympathomimetic amines with CNS stimulant activity.1 23
Lisdexamfetamine is a prodrug of dextroamphetamine; dextroamphetamine may block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneural space.1 23 28 30
Pharmacologic actions of amphetamines are qualitatively similar to those of ephedrine and include CNS and respiratory stimulation and sympathomimetic activity including pressor response, bronchodilation, and contraction of the urinary bladder sphincter.23 24
Theories of dysfunction in ADHD focus on the prefrontal cortex, which controls many executive functions (e.g., planning, impulse control).5 Stimulants have putative effects on central dopamine and norepinephrine pathways that are crucial in frontal lobe function.5
Produces an anorexigenic effect, leading to loss of weight.1 5 23 No primary effect on appetite has been demonstrated in humans and it has been postulated that anorexigenic effects are secondary to increased sympathetic activity resulting from release of norepinephrine and dopamine.22
Provide patient or caregiver with a copy of the manufacturer’s patient information (medication guide); discuss and answer questions about its contents as needed.1 Instruct patient or caregiver to read and understand contents of medication guide before initiating therapy and each time the prescription is refilled.1
Advise parents with concerns about long-term effects (e.g., effects on weight) and the need for continued therapy that drug holidays can be considered in consultation with the patient’s clinician.5 6 7 However, the benefits versus risks of such interruptions in therapy have not been established.7
Question about possible substance abuse, including in other family members (since they may abuse the patient’s medication supply).1
Advise to take drug in the morning to minimize insomnia.1
Advise that appetite suppression may occur.1 5 Giving the morning dose with a meal and providing a high-caloric drink or snack late in the evening when the stimulant effects have subsided may be helpful.5
Advise to inform clinician immediately if adverse cardiovascular (e.g., chest pain, shortness of breath, fainting) or psychiatric effects (e.g., hallucinations, delusional thinking, mania) occur.1
Instruct about the potential for amphetamines to impair patient’s ability to perform potentially hazardous activities, such as driving or operating heavy machinery.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses/conditions (e.g., cardiac/cardiovascular disease, thyroid disease, glaucoma, suicidal ideation or behaviors, mental/psychiatric disorder, seizures).1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.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.
Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.1
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 20 mg | Vyvanse (C-II) | Shire |
30 mg | Vyvanse (C-II) | Shire | ||
40 mg | Vyvanse (C-II) | Shire | ||
50 mg | Vyvanse (C-II) | Shire | ||
60 mg | Vyvanse (C-II) | Shire | ||
70 mg | Vyvanse (C-II) | Shire |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Vyvanse 20MG Capsules (SHIRE US INC.): 20/$125.99 or 30/$177.98
Vyvanse 30MG Capsules (SHIRE US INC.): 20/$126.99 or 30/$189.97
Vyvanse 40MG Capsules (SHIRE US INC.): 20/$113.99 or 30/$170.97
Vyvanse 50MG Capsules (SHIRE US INC.): 20/$118.57 or 30/$171.45
Vyvanse 70MG Capsules (SHIRE US INC.): 20/$117.29 or 30/$171.45
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 June 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Shire US Inc. Vyvanse (lisdexamfetamine dimesylate) capsules prescribing information. Wayne, PA; 2008 Apr.
2. Biederman J, Krishnan S, Zhang Y et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007; 29:450-63. [PubMed 17577466]
3. Shire US Inc., Wayne, PA: Personal communication.
4. Biederman J, Boellner SW, Childress A et al. Improvements in symptoms of attention-deficit/hyperactivity disorder in school-aged children with lisdexamfetamine (NRP-104) and mixed amphetamine salts, extended-release versus placebo. Poster presented at 159th annual meeting of the American Psychiatric Association. Toronto, Canada: 2006 May 24.
5. American Academy of Child and Adolescent Psychiatry. Practice parameter for the use of stimulant medications in the treatment of children, adolescents and adults. Washington, DC; 2001. From the AACAP website. Accessed 2007 Aug 15.
6. American Academy of Child and Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with attention deficit hyperactivity disorder. Washington, DC; 2007. From the AACAP website. Accessed 2007 Aug 15.
7. American Academy of Pediatrics Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical treatment guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001; 108:1033-44. [IDIS 470916] [PubMed 11581465]
8. Anon. Lisdexamfetamine dimesylate (Vyvanse) for ADHD. Med Lett Drugs Ther. 2007; 49:58-9.
9. US Food and Drug Administration. Adderall and Adderall XR (amphetamine): sudden death in children. Rockville, MD; 2005 Feb 9. Alert for Healthcare Professionals.
10. National Institutes of Health Office of Medical Applications of Research. NIH Consensus statement: diagnosis and treatment of attention deficit hyperactivity disorder. 1998; 16(Nov 16-18): in press. From NIH web site [1998 Nov 19]).
11. Swanson JM, Sergeant JA, Taylor E et al. Attention-deficit hyperactivity disorder and hyperkinetic disorder. Lancet. 1998; 351:429-33. [IDIS 403568] [PubMed 9482319]
12. Goldman LS, Genel M, Bexman RJ et al for the Council on Scientific Affairs et al. Diagnosis and treatment of attention-deficit/hyperactivity disorder in children and adolescents. JAMA. 1998; 279:1100-7. [IDIS 402940] [PubMed 9546570]
13. Shaffer D. Attention deficit hyperactivity disorder in adults. Am J Psychiatry. 1994; 151:633-8. [PubMed 7909410]
14. Spencer T, Biederman J, Wilens TE et al. Adults with attention-deficit/hyperactivity disorder: a controversial diagnosis. J Clin Psychiatry. 1998; 59(Suupl 7):59-68. [IDIS 409837] [PubMed 9680054]
15. Popper CW. Antidepressants in the treatment of attention-deficit/hyperactivity disorder. J Clin Psychiatry. 1997; 58(Suppl 14):14-29. [IDIS 398614] [PubMed 9418743]
16. Smith BH, Pelham WE, Gnagy E et al. Equivalent effects of stimulant treatment for attention-deficit hyperactivity disorder during childhood and adolescence. J Am Acad Child Adolesc Psychiatry. 1998; 37:314-21. [IDIS 402147] [PubMed 9519637]
17. The MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999; 56:1073-86. [IDIS 440533] [PubMed 10591283]
18. Taylor E. Development of clinical services for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999; 56:10979.
19. The MTA Cooperative Group. Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder. Arch Intern Med. 1999; 56:1088-96.
20. Pliszka SR, Greenhill LL, Crismon ML et al. The Texas Children’s Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part I. J Am Acad Child Adolesc Psychiatry. 2000; 39:908-19. [IDIS 449214] [PubMed 10892234]
21. Drugs used in obesity. In: Drug evaluations subscription. Chicago, IL: American Medical Association; III/PSY-6:1-16, Winter 1992.
22. Littner M, Johnson SF, McCall WV et al for the American Academy of Sleep Medicine Standards of Practice Committee. Practice parameters for the treatment of narcolepsy: an update for 2000. Sleep. 2001; 24:451-66. [PubMed 11403530]
23. Westfall TC, Westfall DP. Adrenergic agonists and antagonists. In: Brunton LL, Lazo JS, Parker KL, eds.Goodman and Gilman’s the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill; 2005:237-95.
24. GlaxoSmithKline. Dexedrine (dextroamphetamine sulfate) extended-release capsules and tablets prescribing information. Research Triangle Park, NC; 2007 Mar.
25. Amphetamine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:74-80.
26. Weiner N. Norepinephrine, epinephrine, and the sympathomimetic amines. In: Gilman AG, Goodman LS, Rall TW et al, eds.Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan; 1985:145-80.
27. Shire Pharmaceuticals, Wayne, PA: Personal communication.
28. Hussar DA. New drugs: aliskiren hemifumarate, lisdexamfetamine dimesylate, and lapatinib. J Am Pharm Assoc. 2007; 47:425-6, 428-30.
29. Biederman J, Boellner SW, Childress A et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007; 62:970-6. [PubMed 17631866]
30. Blick SK, Keating GM. Lisdexamfetamine. Pediatr Drugs. 2007; 9:129-35.
31. Food and Drug Administration. FDA Alert: Information for healthcare professionals: Communication about an ongoing safety review of stimulant medications [dexmethylphenidate (marketed as Focalin, Focalin XR), dextroamphetamine (marketed as Dexedrine, Dexedrine Spansules, Dextrostat, and generics), lisdexamfetamine (marketed as Vyvanse), methamphetamine (marketed as Desoxyn), methylphenidate (marketed as Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, and Ritalin-SR), mixed salts amphetamine (marketed as Adderall and Adderall XR), and pemoline (marketed as Cylert and generics)] used in children with attention-deficit/hyperactivity disorder (ADHD). Rockville, MD; 2009 Jun 23. From the FDA website.
32. Gould MS, Walsh BT, Munfakh JL et al. Sudden death and use of stimulant medications in youths. Am J Psychiatry. 2009; 166:992-1001. [PubMed 19528194]
33. Vitiello B, Towbin K. Stimulant treatment of ADHD and risk of sudden death in children. Am J Psychiatry. 2009; 166:955-7. [PubMed 19528196]
34. US Food and Drug Administration. AHRQ and FDA to collaborate in largest study ever of possible heart risks with ADHD medications. FDA News September 17, 2007. From FDA web site.
