Enddol may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Enddol in the following countries:
Paracetamol is reported as an ingredient of Enddol in the following countries:
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Folinsyra Actavis may be available in the countries listed below.
Folic Acid is reported as an ingredient of Folinsyra Actavis in the following countries:
International Drug Name Search
Likuden may be available in the countries listed below.
Griseofulvin is reported as an ingredient of Likuden in the following countries:
International Drug Name Search
Generic Name: brompheniramine (brome feh NEER a meen)
Brand names: BroveX, BroveX CT, Dimetane, Dimetane Extentab, Dimetapp Allergy, Dimetapp Allergy Liquigel, Lodrane 12 Hour, ...show all 28 brand names.
Brompheniramine is an antihistamine. Brompheniramine blocks the effects of the naturally occurring chemical histamine in the body.
Brompheniramine is used to sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.
Brompheniramine may also be used for purposes other than those listed in this medication guide.
Before taking brompheniramine, talk to your doctor if you have
glaucoma or increased pressure in the eye;
a stomach ulcer;
an enlarged prostate, bladder problems or difficulty urinating;
an overactive thyroid (hyperthyroidism);
hypertension or any type of heart problems; or
asthma.
You may not be able to take brompheniramine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Take brompheniramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Brompheniramine can be taken with or without food.
To ensure that you get a correct dose, measure the liquid form of brompheniramine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.
Symptoms of a brompheniramine overdose may include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.
Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.
Other, less serious side effects may be more likely to occur. Continue to take brompheniramine and talk to your doctor if you experience
sleepiness, fatigue, or dizziness;
headache;
dry mouth; or
difficulty urinating or an enlarged prostate.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Cold Symptoms:
Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release: 6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
Usual Adult Dose for Allergic Rhinitis:
Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release: 6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
Usual Adult Dose for Urticaria:
Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release: 6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
Usual Adult Dose for Allergic Reaction:
Immediate Release: 4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release: 6 mg to mg 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
IV, IM, subcutaneous: 5 mg to 20 mg every 6 to 12 hours. Duration of action is 3 to 12 hours.
Maximum parenteral dose 40 mg/day.
Usual Pediatric Dose for Allergic Rhinitis:
Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.
2 to 6 years:
Extended Release suspension:
2 mg orally twice daily, not to exceed 2 doses in 24 hours.
6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release suspension:
4 mg orally twice daily, not to exceed 2 doses in 24 hours.
> 12 years:
Immediate Release:
4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg sustained release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
Usual Pediatric Dose for Cold Symptoms:
Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.
2 to 6 years:
Extended Release suspension:
2 mg orally twice daily, not to exceed 2 doses in 24 hours.
6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release suspension:
4 mg orally twice daily, not to exceed 2 doses in 24 hours.
> 12 years:
Immediate Release:
4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg sustained release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
Usual Pediatric Dose for Urticaria:
Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.
2 to 6 years:
Extended Release suspension:
2 mg orally twice daily, not to exceed 2 doses in 24 hours.
6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release suspension:
4 mg orally twice daily, not to exceed 2 doses in 24 hours.
> 12 years:
Immediate Release:
4 mg to 8 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg sustained release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
Usual Pediatric Dose for Allergic Reaction:
Immediate Release:
0.125 mg/kg/dose orally every 6 hours. Maximum dose: 6 mg to 8 mg/day.
2 to 6 yrs:
Extended Release Suspension:
2.5 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
6 to 12 years:
Immediate Release:
2 mg to 4 mg orally every 6 to 8 hours. Maximum dose 12 to 16 mg/day.
Extended Release Suspension:
5 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
> 12 years:
Immediate Release:
4 mg orally every 6 hours as needed. The duration of action varies from patient to patient. Many patients will require dosing only twice daily.
Extended Release:
6 mg to 12 mg extended release orally twice daily as needed. The duration of action varies from patient to patient. Many patients will require dosing only once a day, preferably at bedtime to avoid drowsiness.
Maximum oral dose 24 mg/day.
IM, IV, subcutaneous :
0.5 mg/kg/day divided every 6 to 8 hours.
> 12 years:
5 mg to 20 mg every 6 to 12 hours. Duration of action is 3 to 12 hours.
Maximum parenteral dose 40 mg/day.
Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.
Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.
Drugs other than those listed here may also interact with brompheniramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
See also: brompheniramine side effects (in more detail)
Benzro may be available in the countries listed below.
Benzbromarone is reported as an ingredient of Benzro in the following countries:
International Drug Name Search
Finural may be available in the countries listed below.
Finasteride is reported as an ingredient of Finural in the following countries:
International Drug Name Search
Claritromycine PCH may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Claritromycine PCH in the following countries:
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Class: Anxiolytics, Sedatives, and Hypnotics; Miscellaneous
VA Class: CN300
Chemical Name: N-[2-[8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl-propanamide
Molecular Formula: C16H21NO2
CAS Number: 196597-26-9
Brands: Rozerem
REMS:
FDA approved a REMS for ramelteon to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Melatonin receptor agonist; hypnotic.1 2
Management of insomnia characterized by difficulty with sleep onset.1
Decreases sleep latency in patients with transient insomnia.1 2 Decreases sleep latency in patients with chronic insomnia receiving therapy for up to 35 days.1 2 3 4 5
Administer orally within 30 minutes of bedtime.1 2
Avoid administration with or immediately after a high-fat meal because of potentially decreased rate of absorption.1 2 (See Food under Pharmacokinetics.)
8 mg.1 2
Increased exposure to drug and active metabolite.1 (See Special Populations under Pharmacokinetics.) No specific dosage recommendations at this time.1 However, use with caution in patients with moderate hepatic impairment; avoid use in patients with severe hepatic impairment.1
No dosage adjustment necessary in patients with mild, moderate, or severe renal impairment or in those requiring chronic hemodialysis.1
Hypersensitivity to ramelteon or any ingredient in the formulation.1
Sleep disturbances may be a manifestation of a physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.1
Failure of insomnia to remit after a reasonable treatment period, exacerbation of insomnia, and/or emergence of new cognitive or behavioral abnormalities may indicate the presence of an underlying psychiatric or physical disorder requiring further patient evaluation.1
Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food while asleep.6
Potential risk of anaphylaxis and angioedema; may occur as early as with the first dose of drug.6
Cognitive and behavioral changes reported.1 In primarily depressed patients, exacerbation of depression and suicidal ideation reported following use of hypnotics.1
Immediately evaluate any new psychiatric abnormalities.1
Increased prolactin concentrations reported in patients with chronic insomnia receiving ramelteon 16 mg daily for 6 months.1
Abnormal morning cortisol concentrations (resulting in abnormal corticotropin [ACTH] stimulation test results) reported in 2 patients and prolactinoma reported in 1 patient receiving long-term (up to 12 months) therapy; causal relationship to drug not established.1
If unexplained amenorrhea, galactorrhea, decreased libido, or fertility problems occur, consider evaluating prolactin or testosterone concentrations.1
No evidence of abuse potential detected following administration of doses up to 20 times the recommended hypnotic dose in patients with a history of drug abuse or dependence.1 2
No evidence of physical dependence.1
No evidence of a withdrawal syndrome, including rebound insomnia, following discontinuance of long-term therapy (4, 8, or 16 mg daily for up to 35 days).1 2
Next-day residual effects (reduced immediate/delayed memory recall and increased sluggishness, fatigue, and irritation) detected at weeks 1 and 3 but not week 5 of therapy in adult patients receiving ramelteon 8 mg daily.1 2 Residual effects not detected in a similar study in geriatric patients receiving ramelteon 4 or 8 mg daily.1 2
No clinically meaningful changes in laboratory parameters, endocrine tests, vital signs, ECG recordings, or intensity of menstrual bleeding detected in patients with chronic insomnia following up to 1 year of therapy.2 Rebound insomnia not observed following 1 year of therapy.2
No respiratory depressant effect in patients with mild to moderate COPD.1 Effects in patients with severe COPD (e.g., those with elevated pCO2, those requiring nocturnal oxygen therapy) not studied; use in these patients not recommended.1
No differences in measures of apnea indices observed in patients with mild to moderate obstructive sleep apnea.1 Effects in patients with severe obstructive sleep apnea not studied; use in these patients not recommended.1
Category C.1
Distributed into milk in rats; not known whether distributed into human milk.1 Use not recommended.1
Safety and efficacy not established in pediatric patients.1
Increased exposure to drug and active metabolite.1 (See Special Populations under Pharmacokinetics.) However, no overall differences in safety or efficacy relative to younger adults.1
Use with caution in patients with moderate hepatic impairment; avoid use in patients with severe hepatic impairment.1 (See Special Populations under Pharmacokinetics.)
Headache, somnolence, dizziness, fatigue, nausea, exacerbation of insomnia, upper respiratory tract infection, diarrhea, myalgia, depression, dysgeusia, arthralgia.1
Metabolized principally by CYP1A2 and, to a lesser extent, by the CYP2C subfamily and by CYP3A4.1
Inhibitors of CYP1A2: Potential pharmacokinetic interaction (substantially increased serum ramelteon concentrations).1 Avoid concomitant use with strong CYP1A2 inhibitors; caution if used concomitantly with less potent CYP1A2 inhibitors.1
Inhibitors of CYP3A4 and CYP2C9: Potential pharmacokinetic interaction (increased serum concentrations of ramelteon and active metabolite).1 Caution if used concomitantly with potent inhibitors of CYP3A4 or CYP2C9.1
Inducers of CYP isoenzymes: Potential pharmacokinetic interaction (decreased serum concentrations of ramelteon and active metabolite).1 Possibly reduced ramelteon efficacy when used concomitantly with potent CYP inducers.1 2
Substrates of CYP isoenzymes 1A2, 2C9, 2C19, 2D6, and 3A4: Pharmacokinetic interaction unlikely.1
Drug or Test | Interaction | Comments |
|---|---|---|
Alcohol | Additive sedative effects1 | Avoid concomitant use1 |
Dextromethorphan | Pharmacokinetic interaction unlikely1 | |
Digoxin | Pharmacokinetic interaction unlikely1 | |
Fluconazole | Increased peak serum concentrations and AUC of ramelteon and active metabolite1 | Use concomitantly with caution1 |
Fluoxetine | Pharmacokinetic interaction unlikely1 | |
Fluvoxamine | Substantially increased peak serum concentration and AUC of ramelteon1 | Avoid concomitant use1 |
Ketoconazole | Increased peak serum concentration and AUC of ramelteon and active metabolite1 | Use concomitantly with caution1 |
Midazolam | Pharmacokinetic interaction unlikely1 | |
Omeprazole | Pharmacokinetic interaction unlikely1 | |
Rifampin | Decreased peak serum concentration and AUC of ramelteon and active metabolite1 | Concomitant use may reduce efficacy of ramelteon1 2 |
Theophylline | Pharmacokinetic interaction unlikely1 | |
Warfarin | Pharmacokinetic interaction unlikely1 | |
Urine Drug Screening | No false-positive results for urine drug screening of benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines1 |
Rapidly absorbed; following oral administration in fasting state, peak serum concentrations occur at approximately 0.75 hour.1
Total absorption is ≥84%; however, absolute oral bioavailability is 1.8% because of extensive first-pass metabolism.1
High-fat meal delays time to peak serum concentration by 45 minutes, reduces peak serum concentration by 22%, and increases AUC by 31%.1 (See Oral Administration under Dosage and Administration.)
In geriatric patients, peak serum concentrations and AUC of ramelteon are increased by 86 and 97%, respectively.1 Peak serum concentrations and AUC of active metabolite also are increased, but to a lesser extent.1
In patients with mild or moderate hepatic impairment, exposure to ramelteon is increased 4- or 10-fold, respectively.1 Exposure to active metabolite is marginally increased.1 Pharmacokinetic parameters not evaluated in patients with severe hepatic impairment (Child-Pugh class C).1 (See Hepatic Impairment under Cautions.)
Pharmacokinetic parameters not altered in patients with renal impairment or in those requiring chronic hemodialysis.1
Extensively distributed into tissues; not distributed selectively to red blood cells.1
Approximately 82% (mainly [70%] albumin).1
Metabolized principally by CYP1A2 and, to a lesser extent, by the CYP2C subfamily and by CYP3A4 to active (M-II) and inactive metabolites.1
Excreted in urine (84%) and feces (4%), principally as metabolites.1
1–2.6 hours (for ramelteon) and 2–5 hours (for active metabolite).1
Tightly-closed containers at 25°C (may be exposed to 15–30°C).1 Protect from moisture and humidity.1
Exhibits high affinity for melatonin MT1 and MT2 receptors.1 2 Agonist activity at these receptors may contribute to the drug’s sleep-inducing properties.1 2
Demonstrates lower selectivity for melatonin MT3 receptors than for MT1 and MT2 receptors.1 Has no appreciable affinity for the GABA receptor complex or for receptors that bind neuropeptides, cytokines, serotonin, dopamine, norepinephrine, acetylcholine, or opiates.1
Necessity of administering within 30 minutes of bedtime and limiting activities to only those necessary to prepare for bed.1 Avoid administration with or immediately after a high-fat meal.1
Necessity of avoiding driving, operating machinery, or performing hazardous tasks following administration.1 Importance of avoiding alcohol during therapy.1
Importance of consulting a clinician if worsening insomnia or emergence of new behavioral manifestations occurs.1
Importance of consulting a clinician if cessation of menses or galactorrhea (in women), decreased libido, or problems with fertility occur.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.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 | Tablets, film-coated | 8 mg | Rozerem | Takeda |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Rozerem 8MG Tablets (TAKEDA PHARMACEUTICALS): 30/$171.00 or 90/$472.99
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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Takeda Pharmaceuticals America, Inc. Rozerem (ramelteon) tablets prescribing information. Lincolnshire, IL; 2005 Aug.
2. Takeda Pharmaceuticals America, Inc., Lincolnshire, IL: Personal communication.
3. Zammit G, Roth T, Erman M et al. Double-blind, placebo-controlled polysomnography and outpatient trial to evaluate the efficacy and safety of ramelteon in adult patients with chronic insomnia. Sleep. 2005; 28(Suppl):A228-9.
4. Roth T, Seiden D, Weigand S et al. Phase III study to determine the efficacy of ramelteon in elderly patients with chronic insomnia. Proceedings of New Clinical Drug Evaluation Unit. June 6-9, 2005, Boca Raton, Fla. Poster abstract.
5. Roth T, Seiden D, Zee P et al. Phase III outpatient trial of ramelteon for the treatment of chronic insomnia in elderly patients. J Am Geriatr Soc. 2005; 53(Suppl):S25. Abstract.
6. Food and Drug Administration. Rozerem (ramelteon) tablets. [March 14, 2007: Takeda] MedWatch drug labeling changes. Rockville, MD; April 2007. From FDA websites () and ().
In the US, Menotropins (menotropins systemic) is a member of the drug class gonadotropins and is used to treat Female Infertility, Follicle Stimulation and Ovulation Induction.
US matches:
USAN
0009002-68-0
Pituitary gonadotropin
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| USAN | United States Adopted Name |
Trandolapril-DP may be available in the countries listed below.
Trandolapril is reported as an ingredient of Trandolapril-DP in the following countries:
International Drug Name Search
Ronic may be available in the countries listed below.
Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Ronic in the following countries:
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Finol may be available in the countries listed below.
Finasteride is reported as an ingredient of Finol in the following countries:
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Bisoblock may be available in the countries listed below.
Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoblock in the following countries:
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Mylotarg should not be used along with other chemotherapy medicines. Severe bone marrow problems occur even at normal doses of Mylotarg. Severe and sometimes fatal allergic reactions and lung problems have occurred with use of Mylotarg. Tell the doctor immediately if you experience rash; hives; difficulty breathing; swelling of the mouth, face, lips, or tongue; or severe dizziness. Mylotarg may also increase the risk of severe and sometimes fatal liver problems. This risk may be increased if you have liver problems, you have had a hematopoietic stem-cell transplant (HSCT), or you use Mylotarg in combination with other chemotherapy medicines. Contact your doctor immediately if you experience sudden weight gain, right-sided stomach pain, stomach swelling, yellowing of the eyes or skin, or dark urine. Your doctor will monitor you closely while you use Mylotarg.
Treating acute myeloid leukemia (AML) in patients 60 years of age and older who cannot take other cancer medications. It may also be used for other conditions as determined by your doctor.
Mylotarg is a chemotherapy agent. It works by binding to and breaking specific parts that the cancer cell needs to survive.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Mylotarg. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Mylotarg. However, no specific interactions with Mylotarg are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Mylotarg may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Mylotarg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Mylotarg.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; constipation; cough; diarrhea; dizziness; fatigue; headache; indigestion; joint pain; loss of appetite; mouth sores; nausea; pain or inflammation at the injection site; runny nose; sleeplessness; stomach pain; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in amount or frequency of urine; chest pain; dark urine; depression; fast or irregular heart rate; fever, chills, or sore throat; increased thirst; one-sided weakness; pink or red-colored urine; right-sided stomach pain; seizure; severe dizziness; severe headache; shortness of breath; slurred speech; stomach swelling; sudden weight gain; swelling of the arms, legs, or feet; unusual bleeding or bruising (eg, nosebleed, red or purple spots under the skin, unusual vaginal bleeding); vision changes; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Mylotarg side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Mylotarg is usually handled and stored by a health care provider. If you are using Mylotarg at home, store Mylotarg as directed by your pharmacist or health care provider.
This information is a summary only. It does not contain all information about Mylotarg. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
FDG-IBA may be available in the countries listed below.
Fludeoxyglucose (18F) is reported as an ingredient of FDG-IBA in the following countries:
International Drug Name Search
Bileco may be available in the countries listed below.
Bleomycin is reported as an ingredient of Bileco in the following countries:
Bleomycin sulfate (a derivative of Bleomycin) is reported as an ingredient of Bileco in the following countries:
International Drug Name Search
Class: Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: Bis(1 - methyl - ethyl)ester - (R) - 5 - [[2 - (6 - Amino - 9H - purin - 9 - yl) - 1 - methylethoxy]methyl] - 2,4,6,8 - tetraoxa - 5 - phosphanonanedioic acid 5-oxide (E)-2-butenedioate
Molecular Formula: C9H14N5O4P•H2O
CAS Number: 202138-50-9
Brands: Atripla, Truvada, Viread
Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.1 7 (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
Severe acute exacerbations of hepatitis reported following discontinuance of tenofovir in patients with HBV infection.1 Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after tenofovir is discontinued.1 If appropriate, resumption of treatment for HBV infection may be warranted.1
Antiretroviral with antiviral activity against hepatitis B virus (HBV); nucleotide reverse transcriptase inhibitor.1 2 3 5
Treatment of HIV-1 infection in conjunction with other antiretrovirals.1 6
For purposes of therapeutic decisions, tenofovir is grouped with nucleoside reverse transcriptase inhibitor (NRTI) antiretrovirals.6
A preferred NRTI for use in multiple-drug antiretroviral regimens for initial therapy in adults.6
Fixed-combination preparation containing tenofovir and emtricitabine (Truvada) used in conjunction with other antiretrovirals.13 Can be used to decrease pill burden,6 but should not be used as a component of a triple NRTI regimen.13
Fixed-combination preparation containing efavirenz, emtricitabine, and tenofovir (Atripla) used alone or in conjunction with other antiretrovirals.22 Used to decrease pill burden and improve compliance.22
Because of a high rate of virologic failure, triple NRTI regimens of tenofovir, abacavir, and lamivudine or tenofovir, didanosine, and lamivudine not recommended.6 9 12 Because of high rates of early virologic failure and rapid selection of resistant mutations, a regimen of tenofovir and didanosine not recommended for initial therapy.6
For patients coinfected with HBV, some experts recommend an NRTI combination of tenofovir and (emtricitabine or lamivudine); avoid use of regimens containing only 1 of these antiretrovirals (may increase risk of HBV resistance).6
Postexposure prophylaxis of HIV infection† in health-care workers and others exposed occupationally via percutaneous injury or mucous membrane or nonintact skin contact with blood, tissues, or other body fluids associated with risk for transmission of the virus.20 Used in conjunction with other antiretrovirals.20
Postexposure prophylaxis of HIV infection† in individuals who have had nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be infected with HIV when that exposure represents a substantial risk for HIV transmission.17 Used in conjunction with other antiretrovirals.17
Management of chronic HBV infection in adults with compensated liver function.1
May be effective in both hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients.1 26
Safety and efficacy not established in patients with decompensated liver disease.1 Insufficient data in nucleoside-experienced patients and in those with lamivudine-associated mutations at study entry to establish efficacy in these patients.1
Patients coinfected with both HBV and HIV who require treatment for HBV and who are not receiving antiretroviral therapy should receive an antiviral agent for HBV infection that does not have activity against HIV.6 28
Administer single-entity preparation (Viread) or fixed-combination preparation (Truvada) orally without regard to meals.1 6 13 Administer fixed-combination preparation (Atripla) orally once daily on an empty stomach, preferably at bedtime.22
Because dosage of tenofovir and emtricitabine cannot be adjusted individually, the fixed combination containing tenofovir and emtricitabine (Truvada) should not be used in pediatric patients or patients with severe renal impairment (Clcr <30 mL/minute).13
Because dosage of efavirenz, emtricitabine, and tenofovir cannot be adjusted individually, the fixed-combination containing efavirenz, emtricitabine, and tenofovir (Atripla) should not be used in patients with moderate to severe renal impairment (Clcr <50 mL/minute).22
Available as tenofovir disodium fumarate; dosage expressed in terms of tenofovir disodium fumarate.1
Dosage of Truvada and Atripla expressed as number of tablets.13 22
For treatment of HIV infection, Viread and Truvada must be given in conjunction with other antiretrovirals.1 6 13 Atripla may be used alone or in conjunction with other antiretrovirals.22
If used with atazanavir, adjustment in treatment regimen necessary.10 If used with didanosine, adjustment of didanosine dosage necessary.1 6 (See Specific Drugs under Interactions.)
Children 2–8 years of age: 8 mg/kg once daily under investigation.15
Children >8 years of age: Median dose 210 mg/m2 (maximum 300 mg) once daily under investigation.15
300 mg once daily.1 6
Truvada: 1 tablet once daily.13 6
Atripla: 1 tablet once daily.22
300 mg once daily.20
Initiate postexposure prophylaxis as soon as possible following exposure (within hours rather than days) and continue for 4 weeks, if tolerated.20
300 mg once daily.17
Initiate postexposure prophylaxis as soon as possible following exposure (preferably ≤72 hours after exposure) and continue for 28 days.17
300 mg once daily.1
Optimal duration of treatment unknown.1
Dosage adjustment not needed.1
Adjust dosage if Clcr <50 mL/minute.1 Dosage adjustment not necessary in patients with Clcr of 50–80 mL/minute.1
Clcr (mL/min) | Dosage |
|---|---|
30–49 | 300 mg once every 48 hours |
10–29 | 300 mg every 72–96 hours |
Hemodialysis patients | 300 mg once every 7 days or after a total of approximately 12 hours of hemodialysis (assuming 3 hemodialysis sessions/week each lasting approximately 4 hours) |
Manufacturer states dosage recommendations not available for patients with Clcr <10 mL/minute who are not undergoing hemodialysis.1
Clcr (mL/minute) | Dose and Dosing Interval |
|---|---|
≥50 | One tablet every 24 hours |
30–49 | One tablet every 48 hours (monitor clinical response and renal function since dosage has not been evaluated clinically) |
<30 (including hemodialysis patients) | Not recommended |
Atripla: Dosage adjustment not necessary in patients with Clcr ≥50 mL/minute.22 Not recommended in patients with Clcr< 50 mL/minute.22
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1
Manufacturer states none known.1
Possible lactic acidosis and severe hepatomegaly with steatosis (potentially fatal).1 6 7 Reported mostly in women; obesity and long-term therapy with NRTIs also may be risk factors.1 6 Has been reported in patients with no known risk factors.1
Cautious use recommended in patients with known risk factors for liver disease.1
Interrupt therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).1
Severe acute exacerbations of hepatitis reported following discontinuance of HBV therapy in patients with HBV infection.1
Closely monitor hepatic function at repeated intervals with both clinical and laboratory follow-up for several months or longer after tenofovir is discontinued.1 If appropriate, resumption of anti-HBV therapy may be warranted.1
Test all HIV-infected patients for presence of HBV before initiating tenofovir.1
Test all HBV-infected patients for HIV before initiating tenofovir.1
Use tenofovir with other highly active antiretroviral agents in individuals coinfected with HBV and HIV.1
Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with hypophosphatemia) reported.1
Avoid use in patients who are or have recently received nephrotoxic drugs.1
Obtain Clcr before starting tenofovir; monitor periodically thereafter.1 Monitor Clcr and serum phosphorus in those at risk for renal dysfunction.1
Do not use multiple tenofovir-containing preparations concomitantly.1
When used in fixed combination with emtricitabine (Truvada), consider the cautions, precautions, and contraindications associated with emtricitabine.13
When used in fixed combination with emtricitabine and efavirenz (Atripla), consider the cautions, precautions, and contraindications associated with the concomitant agents.22
Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance.1
During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.1
Decreases from baseline in bone mineral density (BMD) at lumbar spine and hip, increases in biochemical markers of bone metabolism, and increased serum parathyroid hormone reported in patients receiving tenofovir with lamivudine and efavirenz; clinical importance unclear.1
Osteomalacia associated with proximal renal tubulopathy reported during postmarketing surveillance.1
Consider supplementation with calcium or vitamin D; the effect of such supplementation has not been studied.1
Consider monitoring BMD in those with a history of pathologic bone fracture and in those at substantial risk for osteopenia.1 If bone abnormalities are suspected, obtain appropriate consultation.1
Triple NRTI regimens associated with early virologic failure and high rates of resistance.1 Use with caution; consider modifying the regimen.1
Category B.1 Antiretroviral Pregnancy Registry at 800-258-4263.1 18
Because of lack of data and concerns regarding potential fetal bone effects, experts recommend the drug be used in pregnant women only after careful consideration of other alternatives.18
Distributed into milk in rats; not known whether distributed into human milk.1
Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1
Safety and efficacy of single entity (Viread) or fixed-combination (Truvada, Atripla) not established in children1 15 <18 years of age.1 7 22
Clinical studies underway to evaluate investigational tablets and oral solution of tenofovir in HIV-infected children ≥2 years of age†.15
Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults; select dosage with caution.1
Limited data indicate dosage adjustment not needed in patients with hepatic impairment.1
Tenofovir principally eliminated by kidneys; pharmacokinetics likely to be affected.1
Monitor Clcr and serum phosphorus in patients with mild renal impairment (Clcr 50–80 mL/minute).1
Dosage adjustments necessary in those with Clcr <50 mL/minute.1 6 Closely monitor clinical response and renal function; safety and efficacy of reduced dosages not evaluated in clinical studies.1 (See Renal Impairment under Dosage and Administration.)
HIV Infection: Nausea, diarrhea, rash, headache, pain, depression, asthenia.1
HBV Infection: Nausea.1
Tenofovir and its prodrug are not substrates of CYP enzymes;1 tenofovir does not inhibit CYP3A4, 2D6, 2C9, or 2E1, but may have a slight inhibitory effect on 1A.1
Pharmacokinetic interactions with drugs that are inhibitors or substrates of hepatic microsomal enzymes unlikely.1
Potential increased plasma concentrations of tenofovir or the concomitant drug when used with drugs that reduce renal function or compete for active tubular secretion (e.g., acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir).1 Monitor for dose-related toxicities.6
Drug | Interaction | Comments |
|---|---|---|
Abacavir | Pharmacokinetic interaction unlikely1 In vitro evidence of additive or synergistic antiretroviral effects1 | |
Adefovir | Manufacturer of tenofovir states that tenofovir should not be used with adefovir for treatment of HBV infection1 | |
Atazanavir | Atazanavir: Decreased plasma concentrations and AUC of atazanavir (minimum concentrations decreased 40%); increased plasma concentrations and AUC of tenofovir1 6 10 Ritonavir-boosted atazanavir: Decreased plasma concentrations and AUC of atazanavir (minimum concentrations decreased 23%); increased plasma concentrations and AUC of tenofovir; 1 6 In vitro evidence of additive antiretroviral effects21 | Do not use tenofovir in conjunction with atazanavir without low-dose ritonavir1 6 Regimen of atazanavir 300 mg, ritonavir 100 mg, and tenofovir disoproxil fumarate 300 mg once daily with food recommended1 6 10 Monitor for tenofovir toxicity;1 discontinue tenofovir if adverse effects occur1 If used concomitantly with atazanavir and a histamine H2-receptor antagonist in treatment-experienced patients, a regimen of atazanavir 400 mg, tenofovir disoproxil fumarate 300 mg, and ritonavir 100 mg once daily with food is recommended21 |
Darunavir | Ritonavir-boosted darunavir: Increased plasma concentrations of tenofovir; no change in plasma concentrations of darunavir6 24 | Experts state clinical importance unknown6 Manufacturer of darunavir states usual dosage of ritonavir-boosted darunavir and tenofovir can be used;24 monitor for tenofovir toxicity6 |
Didanosine | Increased plasma concentrations and AUC of didanosine; no effect on tenofovir pharmacokinetics1 6 Early virologic failure and rapid selection of resistant mutations reported6 Increased risk of didanosine-associated adverse effects (e.g., pancreatitis, neuropathy)1 In vitro evidence of additive or synergistic antiretroviral effects1 | Concomitant use of didanosine and tenofovir: Not recommended for initial therapy6 Caution advised; reduce didanosine dosage; closely monitor for didanosine-associated adverse effects; discontinue didanosine if necessary1 In patients weighing ≥60 kg with Clcr ≥60 mL/minute, reduce didanosine dosage to 250 mg (delayed-release capsules) once daily; in patients weighing <60 kg with Clcr ≥60 mL/minute, reduce didanosine dosage to 200 mg (delayed-release capsules) once daily; administer without food or with a light meal1 6 14 19 |
Emtricitabine | No evidence of clinically important pharmacokinetic interactions1 13 In vitro evidence of additive or synergistic antiretroviral effects13 | |
Entecavir | No evidence of clinically important pharmacokinetic interaction1 | |
Estrogens/Progestins | Hormonal contraceptives containing ethinyl estradiol and norgestimate: Pharmacokinetic interaction unlikely1 | |
Histamine H2-receptor antagonists | Alterations in atazanavir concentrations possible with concomitant use of a histamine H2-receptor antagonist, tenofovir, and atazanavir (with or without ritonavir)21 | If used concomitantly with atazanavir and a histamine H2-receptor antagonist in treatment-experienced patients, a regimen of atazanavir 400 mg, tenofovir disoproxil fumarate 300 mg, and ritonavir 100 mg once daily with food is recommended;21 |
Indinavir | Slight alterations in indinavir and tenofovir concentrations;1 6 not clinically important1 In vitro evidence of additive or synergistic antiretroviral effects1 | No dosage adjustment needed6 |
Lamivudine | Pharmacokinetic interaction not clinically important;1 in vitro evidence of additive or synergistic antiretroviral effects1 | |
Lopinavir and ritonavir | Increased peak plasma concentration and AUC of tenofovir; decreased peak plasma concentration and AUC of lopinavir; decreased peak plasma concentration and AUC of ritonavir1 6 | Clinical importance unknown6 Monitor for tenofovir toxicity6 |
Methadone | Pharmacokinetic interaction unlikely1 | |
Nelfinavir | Pharmacokinetic interaction unlikely1 In vitro evidence of additive or synergistic antiretroviral effects1 | |
Nonnucleoside reverse transcriptase inhibitors (NNRTIs) | No evidence of pharmacokinetic interaction with efavirenz1 In vitro evidence of additive or synergistic antiretroviral effects with delavirdine, efavirenz, or nevirapine1 | |
Ribavirin | Pharmacokinetic interaction unlikely1 | |
Ritonavir | In vitro evidence of additive or synergistic antiretroviral effects1 | |
Saquinavir | Ritonavir-boosted saquinavir (saquinavir 1 g twice daily and ritonavir 100 mg twice daily): No clinically important change in saquinavir concentrations with tenofovir 300 mg once daily1 In vitro evidence of additive or synergistic antiretroviral effects1 | Ritonavir-boosted saquinavir: Dosage adjustment not needed 1 |
Stavudine | In vitro evidence of additive or synergistic antiretroviral effects1 | |
Tacrolimus | No evidence of clinically important pharmacokinetic interaction1 | |
Tipranavir | Ritonavir-boosted tipranavir: Decreased tenofovir concentrations; decreased tipranavir concentrations6 16 In vitro evidence of additive antiretroviral effects16 | Clinical importance unknown6 |
Zidovudine | In vitro evidence of additive or synergistic antiretroviral effects1 |
Tenofovir disoproxil fumarate is a diester prodrug of tenofovir.1 Oral bioavailability approximately 25%; peak plasma concentrations attained in about 1 hour in fasting patients.1
Fixed-combination tablet containing emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada) is bioequivalent to a 200-mg emtricitabine capsule and a 300-mg tenofovir disoproxil fumarate tablet given simultaneously.13
Fixed-combination tablet containing efavirenz 600 mg, tenofovir disoproxil fumarate 300 mg, and emtricitabine 200 mg (Atripla) is bioequivalent to a 600-mg efavirenz tablet, a 300-mg tenofovir disoproxil fumarate tablet, and a 200-mg emtricitabine capsule given simultaneously.22
Food delays time to peak plasma concentrations by approximately 1 hour.1 Administration with a high-fat meal increases oral bioavailability (14% increase in peak plasma concentrations; 40% increase in AUC);1 pharmacokinetics not appreciably affected by administration with a light meal.1
Crosses the human placenta.18 Not known whether tenofovir is distributed into human milk.1
In vitro binding to plasma or serum proteins is <0.7 or 7.2%, respectively, over tenofovir concentrations of 0.01–25 mcg/mL.1
Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylation by cellular enzymes to form the active tenofovir diphosphate.1
Tenofovir and its prodrug are not substrates of CYP enzymes.1
Eliminated principally by kidneys using glomerular filtration and active tubular secretion; approximately 32% of an oral dose excreted in urine within 24 hours.1
Approximately 17 hours.1
No substantial changes in tenofovir pharmacokinetics in individuals with moderate to severe hepatic impairment compared with those with normal hepatic function.1
Moderate or severe renal impairment results in increased plasma concentrations; dosage adjustment necessary if Clcr <50 mL/minute.1 (See Renal Impairment under Dosage and Administration.)
Viread: 25°C (may be exposed to 15–30°C).1
Truvada: 25°C (may be exposed to 15–30°C).13
Atripla: 25°C (may be exposed to 15–30°C).22
Tenofovir disoproxil fumarate is a prodrug and is inactive until the drug is hydrolyzed in vivo to tenofovir which is then phosphorylated to the active metabolite (tenofovir diphosphate).1 2 3 5
Active in vitro and in vivo against HIV-11 5 and HBV;1 6 26 some activity against HIV-2.1
Inhibits replication of retroviruses, including HIV-1, by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).1 2 3 5
Inhibits HBV replication through competitive inhibition of viral DNA polymerase.29
Weak inhibitor of mammalian DNA α- and β-polymerases and mitochondrial DNA γ-polymerase.1 4 5 Low potential to induce mitochondrial toxicity.4 5
HIV-1 resistant to tenofovir can be selected in vitro and have been reported in clinical isolates.1 5
Cross-resistance between tenofovir and some NRTIs reported.1 Cross-resistance with HIV protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs) unlikely.7
Critical nature of HIV therapy compliance.1 Importance of using tenofovir in conjunction with other antiretrovirals—not for monotherapy.1
Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.1 HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.1
Advise patient of the risks and benefits of tenofovir and other alternatives for treatment of HBV infection.1
Importance of reading patient package insert from manufacturer.1
Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.1
Importance of informing clinicians of concomitant medical problems such as renal or hepatic impairment.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising 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 | Tablets, film-coated | 300 mg | Viread | Gilead |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, film-coated | 300 mg with Emtricitabine 200 mg | Truvada | Gilead |
300 mg with Emtricitabine 200 mg and Efavirenz 600 mg | Atripta | Bristol-Myers Squibb and Gilead |
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.
Atripla 600-200-300MG Tablets (BRISTOL-MYERS SQUIBB/GILEAD): 30/$1795.72 or 90/$5154.14
Truvada 200-300MG Tablets (GILEAD SCIENCES): 30/$1071.69 or 90/$3180.65
Viread 300MG Tablets (GILEAD SCIENCES): 30/$771.97 or 90/$2196.03
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 November 2009. 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.
1. Gilead Sciences Inc. Viread (tenofovir disoproxil fumarate) tablets prescribing information. Foster City, CA; 2008 Nov.
2. Squires KE. Phase I/II trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother. 2001; 45:2733-9. [IDIS 469675] [PubMed 11557462]
3. Srinivas RV, Kim C et al. Anti-human immunodeficiency virus activity and cellular metabolism of a potential prodrug of the acyclic nucleoside phosphonate 9-R-(2-phosphonomethoxypropyl)adenine (PMPA), Bis(isopropyloxymethylcarbonyl)PMPA. Antimicrob Agents Chemother. 1998; 42:612-7. [PubMed 9517941]
4. Birkus G, Hitchcock MJM, Cihlar T. Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2002; 46:716-23 [PubMed 11850253]
5. Gilead Sciences, Inc. FDA advisory committee briefing document on Viread (tenofovir DF) for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents. NDA 21-356. Aug 30, 2001. From the FDA website.
6. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (November 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.
7. Gilead, Foster City, CA: Personal communication
8. Squires K, Pierone G, Berger D et al. Tenofovir DF: a 48-week final analysis from a phase III randomized, double blind placebo controlled study in antiretroviral experienced patients. Poster presented at the 9th Conference on Retroviruses and Opportunistic Infections. Seattle, WA: 2002 Feb 24-28. Poster No. 413-W
9. Manion DJ. Dear healthcare provider letter: early virologic non-response in patients with HIV infection treated with lamivudine, abacavir, and tenofovir. GlaxoSmithKline; 2003 Jul. From FDA website.
10. Hodder S. Dear healthcare provider letter: important new pharmacokinetic data for Reyataz (atazanavir sulfate) in combination with Viread (tenofovir disoproxil fumarate). Princeton, NJ: Bristol-Myers Squibb; 2003 Aug 8.
11. Gilead Sciences, Inc. Emtriva (emtricitabine) capsules prescribing information. Foster City, CA; 2005 Jul.
12. Toole J. Dear healthcare provider letter: high rate of virologic failure in patients with HIV infection treated with once-daily triple NRTI regimen containing didanosine, lamivudine, and tenofovir. Foster City, CA; 2003 Oct 14. From FDA website.
13. Gilead Sciences, Inc. Truvada (emtricitabine and tenofovir disoproxil fumarate) tablet prescribing information. Foster City, CA; 2008 May.
14. Bristol-Myers Squibb. Videx EC (didanosine) delayed-release capsules enteric-coated beadlets prescribing information. Princeton, NJ; 2006 Feb.
15. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children of the National Resource Center at the François-Xavier Bagnoud Center, Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection (February 23, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.
16. Boehringer Ingelheim. Aptivus (tipranavir) capsules prescribing information. Ridgefield, CT; 2005 Nov 11.
17. Center for Disease Control and Prevention. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: Recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005; 54(No. RR-2):1-19.
18. Perinatal HIV Guidelines Working Group. US Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States (April 29, 2009). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.
19. Bristol-Myers Squibb. Videx (didanosine) chewable/dispersible buffered tablets and pediatric powder for oral solution prescribing information. Princeton, NJ; 2006 Feb.
20. Center for Disease Control and Prevention. Updated U.S. public health service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005; 54(No. RR-9):1-17.
21. Bristol-Myers Squibb. Reyataz(atazanavir sulfate) prescribing information. Princeton, NJ; 2008 Mar
22. Bristol-Myers Squibb and Gilead. Atripla (efavirenz 600 mg/emtricitabine 200mg /tenofovir disoproxil fumarate 300mg) tablets prescribing information. Foster City, CA; 2007 May.
23. Gallant JE, DeJesus E, Arribas JR et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006; 354:251-60. [PubMed 16421366]
24. Tibotec. Prezista (darunavir) prescribing information. Raritan, NJ; 2006 Jun.
25. Hammer SM, Saag MS, Schechter M et al. Treatment of adult HIV infection: 2006 recommendations of the International AIDS Society–USA panel. JAMA. 2006; 296:827-43. [PubMed 16905788]
26. Marcellin P, Heathcote EJ, Buti M et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis. N Engl J Med.2008; 359:2442-55. [PubMed 19052126]
27. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007; 45:507-39. [PubMed 17256718]
28. Lok ASF, McMahon BJ. Corrections to AASLD guidelines on chronic hepatitis B. Hepatology. 2007; 45:1347. Letter.
29. Delaney WE, Ray AS, Yang H et al. Intracellular metabolism and in vitro activity of tenofovir against hepatitis B virus. Antimicro Agents Chemother. 2006; 50:2471-7.
