Wednesday, October 5, 2016

Doxazosin Mesylate



Class: alpha-Adrenergic Blocking Agents
VA Class: CV150
Chemical Name: 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(2,3-dihydro-1,4-benzodioxin-2-yl)carbonyl]piperazine monomethanesulfonate
Molecular Formula: C23H25N5O5•CH4O3S
CAS Number: 77883-43-3
Brands: Cardura

Introduction

Postsynaptic α1-adrenergic blocking agent; quinazoline derivative.1 2 3 4 5 6 7


Uses for Doxazosin Mesylate


Hypertension


Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 4 6 7


Current antihypertensive and urology guidelines (e.g., JNC 7) no longer recommend α1-blockers as preferred first-line therapy for patients with hypertension.66 70 82


May have potential favorable effects in hypertensive patients with benign prostatic hyperplasia or other urinary outflow obstruction.70 82


Benign Prostatic Hyperplasia (BPH)


Reduction of urinary obstruction and relief of associated manifestations in hypertensive or normotensive patients with symptomatic BPH.1 21 33 35 37 40 41 42 43 44 46


Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.66


May consider combined therapy with an α1-adrenergic blocker and 5α-reductase inhibitor for men with bothersome moderate to severe BPH and demonstrable prostatic enlargement.66 84 85 Has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression.66 Men at risk for BPH progression are most likely to benefit from combination therapy.66 84


Doxazosin Mesylate Dosage and Administration


Administration


Oral Administration


Administer orally once daily in the morning or evening.1 Effect of food on maximum plasma concentration and AUC is not clinically important.1


Dosage


Available as doxazosin mesylate; dosage expressed in terms of doxazosin.1


Individualize dosage according to patient response and tolerance.1 7 Initiate at low dosage to minimize frequency of postural hypotension and syncope.1


Postural effects are most likely to occur 2–6 hours after a dose; monitor BP during this period after first dose and with any dosage increases.1


If therapy is interrupted for several days, restart using initial dosage regimen.1


Pediatric Patients


Hypertension

Oral

Initially, 1 mg once daily.106 Increase dosage as necessary up to a maximum of 4 mg once daily.106


Adults


Hypertension

Oral

Initially, 1 mg once daily.1 7 70 Do not initiate with higher dosages.1


Depending on patient response (standing BP 2–6 and 24 hours after initial dose), may increase dosage to 2 mg once daily; make subsequent dosage adjustments by doubling dose at intervals of 2 weeks–1 month until desired BP control is achieved, drug is not tolerated, or maximum daily dosage of 16 mg is reached.1 7 70


Increased likelihood of excessive postural effects (e.g., syncope, postural dizziness/vertigo, postural hypotension) with dosages >4 mg daily; substantial risk of postural effects with dosages >16 mg daily.1


Careful monitoring of BP is recommended during initial titration or subsequent upward dosage adjustment;53 70 avoid large or abrupt reductions in BP.53


BPH

Oral

Initially, 1 mg once daily in the morning or evening;1 41 44 some clinicians recommend administration at bedtime to minimize postural effects.35 36 Do not initiate with higher dosages.1


To achieve desired improvement in symptoms and urodynamics, may increase dosage in a stepwise manner to 2, 4, and 8 mg daily as necessary, at intervals ≥1–2 weeks.1 41 42 43 44 Do not exceed 8 mg daily.


Evaluate BP routinely, particularly with initiation of therapy and subsequent dosage adjustment.1


Prescribing Limits


Pediatric Patients


Hypertension

Oral

Maximum 4 mg daily.76


Adults


Hypertension

Oral

Maximum 16 mg daily.1


BPH

Oral

Maximum 8 mg daily.1


Special Populations


Geriatric Patients


Hypertension

Select dosage carefully, usually initiating therapy at the low end of the dosage range, because of possible age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy;1 generally, increase dosage more slowly in geriatric patients than in younger adults.7


Cautions for Doxazosin Mesylate


Contraindications



  • Known hypersensitivity to doxazosin, quinazolines (e.g., prazosin, terazosin), or any ingredient in the formulation.1



Warnings/Precautions


Warnings


Postural Hypotension

Marked hypotension, especially in the upright position, can occur; may be accompanied by syncope and other postural effects (e.g., dizziness, lightheadedness, vertigo).1


Postural effects are most common after initial dose but may also occur when dosage is increased or when therapy is resumed after an interruption exceeding a few days.1


To decrease risk of excessive hypotension and syncope, initiate therapy at a low dosage (i.e., 1 mg daily) and titrate slowly; initiate concomitant antihypertensive agents with caution.1


If syncope or hypotension occurs, place patient in a recumbent position and institute supportive therapy as necessary; a transient hypotensive response is not a contraindication to further doses.1


Use with particular caution in patients in occupations in which orthostatic hypotension could be dangerous.1


Priapism

Priapism reported rarely; may lead to permanent impotence if not treated promptly.1


General Precautions


Prostate Cancer

Exclude possibility of prostate cancer before initiation of therapy for BPH.1


Hematologic Effects

Possible decreases in leukocyte and neutrophil counts in patients receiving α1-adrenergic blocking agents, including doxazosin.1


Specific Populations


Pregnancy

Category C.1


Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Caution if used in nursing women.1


Pediatric Use

Safety and efficacy not established in children <18 years of age.1


Geriatric Use

Geriatric patients may be particularly susceptible to postural effects.7


BPH: Safety and efficacy were similar in those ≥65 years of age compared with younger patients.1


Hypertension: Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; other clinical experience has not revealed age-related differences in response.1 Select dosage with caution.1 (See Geriatric Patients under Dosage and Administration.)


Hepatic Impairment

Use with caution in patients with hepatic impairment and those who are receiving other agents known to influence hepatic metabolism.1 (See Interactions.)


Common Adverse Effects


Dizziness, headache, drowsiness, fatigue, edema, nausea, dyspnea, somnolence, abdominal pain, diarrhea.1 2 3 4 6 7


Interactions for Doxazosin Mesylate


No formal drug interaction studies to date, but no interactions observed in patients receiving various agents concomitantly during clinical trials.1 (See Specific Drugs and Laboratory Tests.)


Antihypertensive Agents


Potential pharmacodynamic interaction (additive hypotensive effects; initiate additional antihypertensive agents with caution).1


Drugs Affecting Hepatic Metabolism


Potential pharmacokinetic interaction; use concomitantly with caution.1


Protein-bound Drugs


Potential pharmacokinetic interaction (displacement of doxazosin or other protein-bound drug); no information available to date on effect of other highly protein-bound drugs on doxazosin binding.1 Doxazosin has no effect on protein binding of certain drugs in vitro.1 (See Specific Drugs and Laboratory Tests.)


Specific Drugs and Laboratory Tests































































Drug or Test



Interaction



Comments



Acetaminophen



No interaction observed in clinical trials1



Amoxicillin



No interaction observed in clinical trials1



Antacids



No interaction observed in clinical trials1



β-Adrenergic blocking agents (e.g., atenolol, propranolol)



No interaction observed in clinical trials1



Chlorpheniramine



No interaction observed in clinical trials1



Cimetidine



Increased AUC (10%) of doxazosin1



Clinical importance unknown1



Codeine



No interaction observed in clinical trials1



Corticosteroids



No interaction observed in clinical trials1



Co-trimoxazole



No interaction observed in clinical trials1



Diazepam



No interaction observed in clinical trials1



Digoxin



No effect on digoxin protein binding in vitro1



Diuretics, thiazide (e.g., hydrochlorothiazide)



No interaction observed in clinical trials1



Erythromycin



No interaction observed in clinical trials1



Finasteride



Adverse effects with concomitant use generally reflect combined toxicity profile of each drug alone66 84



Hypoglycemic



No interaction observed in clinical trials1



NSAIAs (e.g., aspirin, ibuprofen, indomethacin)



No interaction observed in clinical trials; no effect on indomethacin protein binding in vitro1



Phenytoin



No effect on phenytoin protein binding in vitro1



Test for prostate specific antigen (PSA)



No effect on plasma PSA concentrations in patients receiving doxazosin for up to 3 years1



Warfarin



No effect on warfarin protein binding in vitro1


Doxazosin Mesylate Pharmacokinetics


Absorption


Bioavailability


Peak plasma concentrations attained within about 2–3 hours.1


Bioavailability is approximately 65%.1


Onset


In patients with hypertension, maximum reduction in BP usually occurs 2–6 hours after administration.1


In patients with BPH, decreased severity of symptoms and improved urinary flow rate observed within 1–2 weeks.1


Food


Food decreases mean maximum plasma concentrations and AUC by 18 and 12%, respectively; not statistically or clinically significant.1


Distribution


Extent


Crosses the placenta and is distributed into milk in animals; not known whether distributed into human milk.1


Plasma Protein Binding


Approximately 98%.1


Elimination


Metabolism


Extensively metabolized, principally in the liver by O-demethylation of quinazoline nucleus or hydroxylation of benzodioxan moiety, to several active metabolites; pharmacokinetics of metabolites not characterized.1


Elimination Route


Excreted in feces (63%) and urine (9%) mainly as metabolites; only 4.8% and trace amounts excreted unchanged in feces and urine, respectively.1


Half-life


Biphasic; terminal half-life is approximately 22 hours.1


Special Populations


In patient with cirrhosis (Child-Pugh class A), systemic exposure was increased by 40% after a single 2-mg dose.1 Effect of hepatic impairment on disposition not established in controlled clinical studies.1


In geriatric patients and patients with renal impairment, clinically important alterations in pharmacokinetics not observed to date.1


Stability


Storage


Oral


Tablets

<30°C.1


ActionsActions



  • Reduces peripheral vascular resistance and BP as a result of vasodilating effects; produces both arterial and venous dilation.1 2 3 4 6 7




  • Binds to α-adrenergic receptors on the prostate capsule, prostate adenoma, and the bladder trigone, resulting in decreased urinary outflow resistance in men.1 5




  • May improve to limited extent the serum lipid profile (e.g., small increases in HDL and HDL/total cholesterol ratio; small decreases in LDL, total cholesterol, and triglyceride concentrations).1 2 3 7



Advice to Patients



  • Possible syncopal and orthostatic symptoms, especially at initiation of therapy; importance of avoiding driving or other hazardous tasks where injury could occur for 24 hours after first dose, a dosage increase, or when resumed after therapy interruption.1




  • Importance of sitting or lying down when symptoms of lowered BP occur, and of rising carefully from a sitting or lying position.1




  • Importance of informing clinician if bothersome dizziness, lightheadedness, or palpitations occur.1




  • Possible drowsiness or somnolence; use caution when operating machinery or driving a motor vehicle until effects on individual are known.1




  • Importance of men seeking immediate medical attention if painful or sustained (for hours) erection occurs.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 concomitant illnesses.1




  • Importance of informing patients of other important precautionary information.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




























Doxazosin Mesylate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



1 mg (of doxazosin)*



Cardura (scored)



Pfizer



2 mg (of doxazosin)*



Cardura (scored)



Pfizer



4 mg (of doxazosin)*



Cardura (scored)



Pfizer



8 mg (of doxazosin)*



Cardura (scored)



Pfizer


Comparative Pricing


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.


Cardura 1MG Tablets (PFIZER U.S.): 30/$52.99 or 90/$158.96


Cardura 2MG Tablets (PFIZER U.S.): 30/$61.14 or 90/$153.95


Cardura 4MG Tablets (PFIZER U.S.): 30/$63.33 or 90/$159.39


Cardura 8MG Tablets (PFIZER U.S.): 30/$63.32 or 90/$172.5


Cardura XL 4MG 24-hr Tablets (PFIZER U.S.): 30/$60.99 or 90/$170.97


Doxazosin Mesylate 1MG Tablets (MYLAN): 30/$17.99 or 90/$47.97


Doxazosin Mesylate 2MG Tablets (TEVA PHARMACEUTICALS USA): 30/$19.99 or 90/$43.98


Doxazosin Mesylate 4MG Tablets (MYLAN): 30/$21.99 or 90/$59.97


Doxazosin Mesylate 8MG Tablets (TEVA PHARMACEUTICALS USA): 30/$23.99 or 90/$62.99



Disclaimer

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 May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




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81. Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. J Am Coll Cardiol. 2001;38:2101-2113.



82. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.



83. The Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. 1999 guidelines for the management of hypertension. J Hypertension. 1999; 17:392-403.



84. McConnell JD, Roehrborn CG, Bautista OM et al for the Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. The long-term effect of doxazosin, finasteride, and combination theprapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003; 349:2387-98. [IDIS 508413] [PubMed 14681504]



85. Vaughan ED. Medical management of benign prostatic hyperplasia—are two drugs better than one? N Engl J Med. 2003; 349:2440-51. Editorial.



86. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Complete Version. Bethesda, MD: 2003 Nov 5. Hypertension. 2003; 42:1206-52. [PubMed 14656957]



87. Milroy E. Clinical overview of prazosin in the treatment of prostatic obstruction. Urol Int. 1990; 45(Suppl 1):1-3. [PubMed 1690474]



88. Kondo A, Gotoh M, Saito M et al. The efficacy of prazosin HCl in the treatment of urinary flow obstruction due to prostatic hypertrophy. Urol Int. 1990; 45(Suppl 1):4-17. [PubMed 1690480]



89. Aoki H, Ohninata M, Tsuzuki T et al. Clinical studies on the effectiveness of prazosin HCl (Minipress tablets) in the treatment of dysuria accompanying benign prostatic hyperplasia. Urol Int. 1990; 45(Suppl 1):18-25. [PubMed 1690476]



90. Shapiro E. Embryologic development of the prostate. Insights into the etiology and treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990; 17:487-93. [PubMed 1695777]



91. Rowden AM, Mowers RM. Prazosin in benign prostatic hypertrophy. DICP Ann Pharmacother. 1989; 23:474-5.



92. Lepor H. Alpha adrenergic antagonists for the treatment of symptomatic BPH. Int J Clin Pharmacol Ther Toxicol. 1989; 27:151-5. [PubMed 2469658]



93. Lepor H. Role of alpha-adrenergic blockers in the treatment of benign prostatic hyperplasia. Prostate Suppl. 1990; 3:75-84. [PubMed 1689172]



94. Chapple CR, Aubry ML, James S et al. Characterisation of human prostatic adrenoceptors using pharmacology receptor binding and localisation. Br J Urol. 1989; 63:487-96. [PubMed 2471572]



95. Staub WR, Staub JS. Phenoxybenzamine in benign prostatic obstruction. JAMA. 1988; 260:2220. [IDIS 246399] [PubMed 2459421]



96. Hieble JP, Caine M, Zalaznik E. In vitro characterization of the alpha-adrenoceptors in human prostate. Eur J Pharmacol. 1985; 107:111-7. [PubMed 2579826]



97. Caine M. Alpha-adrenergic mechanisms in dynamics of benign prostatic hypertrophy. Urology. 1988; 32(Suppl 6):16-20. [PubMed 2462300]



98. Abrams PH, Shah PJ, Stone R et al. Bladder outflow obstruction treated with phenoxybenzamine. Prog Clin Biol Res. 1981; 78:269-75. [PubMed 6174998]



99. Barry MJ. Phenoxybenzamine in benign prostatic obstruction. JAMA. 1988; 260:2220.



100. Gerstenberg T, Blaabjerg J, Nielsen ML et al. Phenoxybenzamine reduces bladder outlet obstruction in benign prostatic hyperplasia: a urodynamic investigation. Invest Urol. 1980; 18:29-31. [IDIS 118319] [PubMed 6157651]



101. Caine M, Perlberg S, Meretyk S. A placebo-controlled double-blind study of the effect of phenoxybenzamine in benign prostatic obstruction. Br J Urol. 1978; 50:551-4. [PubMed 88984]



102. Caine M. Clinical experience with alpha-adrenoceptor antagonists in benign prostatic hypertrophy. Fed Proc. 1986; 45:2604-8. [PubMed 2428670]



103. Griffiths DJ, Schröder FH. Phenoxybenzamine in prostatic obstruction. Urol Int. 1984; 39:241-2. [PubMed 6207651]



104. Caine M, Perlberg S, Shapiro A. Phenoxybenzamine for benign prostatic obstruction: review of 200 cases. Urology. 1981; 17:542-6. [PubMed 6166111]



105. Reviewers’ comments (personal observations) on prazosin.



106. National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004; 114(Suppl 2):555-76. [PubMed 15286277]



More Doxazosin Mesylate resources


  • Doxazosin Mesylate Side Effects (in more detail)
  • Doxazosin Mesylate Dosage
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  • Drug Images
  • Doxazosin Mesylate Drug Interactions
  • Doxazosin Mesylate Support Group
  • 11 Reviews for Doxazosin Mesylate - Add your own review/rating


  • Doxazosin Prescribing Information (FDA)

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Compare Doxazosin

difluprednate Ophthalmic


dye-floo-PRED-nate


Commonly used brand name(s)

In the U.S.


  • Durezol

Available Dosage Forms:


  • Emulsion

Therapeutic Class: Anti-Inflammatory


Pharmacologic Class: Adrenal Glucocorticoid


Uses For difluprednate


Difluprednate is used to treat eye pain and inflammation (redness and swelling) caused by eye surgery. difluprednate belongs to the group of medicines known as corticosteroids (steroids or cortisone-like medicines) .


difluprednate is available only with your doctor's prescription .


Before Using difluprednate


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 difluprednate, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to difluprednate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


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


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of difluprednate in the elderly .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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


Interactions with Medicines


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


Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Cataract surgery—Use with caution. May cause delayed healing .

  • Eye infection, virus (e.g., herpes simplex)—Should not be used in patients with this condition .

  • Glaucoma—Use with caution. May make this condition worse .

Proper Use of difluprednate


Your doctor will tell you how much of difluprednate to use and how often. Do not use more medicine or use it more often than your doctor tells you to. difluprednate is not for long-term use .


To use the eye drops:


  • First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.

  • If you think you did not get the drop of medicine into your eye properly, use another drop.

  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Always keep the container tightly closed .

Do not wear contact lenses while you are using difluprednate .


Dosing


The dose of difluprednate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of difluprednate. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For ophthalmic dosage form (eye drops):
    • For eye pain or inflammation:
      • Adults—Use one drop in the affected eye(s) four times a day. Start using the medicine 24 hours after surgery, and keep using it until your doctor tells you to stop. Your doctor may adjust your dose if needed.

      • Children—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of difluprednate, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using difluprednate


Your eye doctor will want to examine your eye(s) at regular visits to make sure the medicine is working properly and is not causing unwanted effects .


Difluprednate eye drops are not for long-term use. Steroid eye drops may cause glaucoma (increased pressure inside the eye) or posterior subcapsular cataracts (a rare type of cataract) if used too long .


If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it .


If your symptoms do not improve or if your condition becomes worse, check with your doctor .


difluprednate Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Blurred vision

  • change in color vision

  • decreased vision or other changes in vision

  • difficulty seeing at night

  • eye discomfort

  • eye pain

  • eye redness

  • increase in blood flow to the whites of the eyes

  • increased sensitivity of the eyes to sunlight

  • sensitivity of the eyes to light

  • swelling or redness of the eye and lining of the eyelid

Less common
  • Eyelid irritation and crusting

  • painful irritation of the front clear part of the eye

  • tearing

  • throbbing eye pain

  • watering of the eyes

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:


Rare
  • Burning, itching, or soreness of the eye

  • feeling of having something in the eye

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: difluprednate Ophthalmic side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More difluprednate Ophthalmic resources


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


  • Durezol Prescribing Information (FDA)

  • Durezol Monograph (AHFS DI)

  • Durezol Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Durezol Consumer Overview



Compare difluprednate Ophthalmic with other medications


  • Postoperative Ocular Inflammation

doxorubicin


Generic Name: doxorubicin (DOX oh ROO bi sin)

Brand names: Adriamycin, Adriamycin RDF, Rubex, Adriamycin PFS


What is doxorubicin?

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


Doxorubicin is used to treat different types of cancers that affect the breast, bladder, ovary, thyroid, stomach, lungs, bones, nerve tissues, bones, muscles, joints, and soft tissues. Doxorubicin is also used to treat Hodgkin's disease and certain types of leukemia.


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


What is the most important information I should know about doxorubicin?


You should not use this medication if you are allergic to doxorubicin or similar medications (Cerubidine, Ellence, Idamycin, Novantrone), or if you have an untreated or uncontrolled infection, severe liver disease, severe heart problems, or if you have recently had a heart attack. Doxorubicin can have serious side effects on your heart. Before you are treated with doxorubicin, tell your doctor if you have a history of heart disease, heart rhythm disorder, congestive heart failure, or heart attack.

Also tell your doctor about all other medicines you use, especially about any other cancer medications or treatments you have received (including radiation).


Do not use doxorubicin if you are pregnant. It could harm the unborn baby. Doxorubicin can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while using doxorubicin, or you could develop a serious infection.

Using doxorubicin may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.


What should I discuss with my healthcare provider before taking doxorubicin?


Before you are treated with doxorubicin, tell your doctor about all other cancer medications and treatments you have received, including radiation. You should not use this medication if you are allergic to doxorubicin or similar medications (Cerubidine, Ellence, Idamycin, Novantrone), or if you have:

  • an untreated or uncontrolled infection (including mouth sores);




  • severe liver disease;




  • severe heart problems; or




  • if you have recently had a heart attack.



To make sure you can safely receive doxorubicin, tell your doctor if you have any of these other conditions:



  • liver or kidney disease;




  • a weak immune system caused by prior cancer treatments;




  • heart disease, a heart rhythm disorder, congestive heart failure; or




  • if you have ever had a heart attack.




Using doxorubicin may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk. FDA pregnancy category D. Do not use doxorubicin if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant or plan to become pregnant. Use birth control to prevent pregnancy while you are receiving doxorubicin. Doxorubicin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using doxorubicin.

How should I take doxorubicin?


Doxorubicin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.


Doxorubicin is sometimes given together with other cancer medications. You may be given other medications to prevent nausea, vomiting, or infections.


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


If any of this medication accidentally gets on your skin, wash it thoroughly with soap and warm water.


Doxorubicin can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

See also: Doxorubicin dosage (in more detail)

What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your doxorubicin injection.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.


What should I avoid while taking doxorubicin?


Do not receive a "live" vaccine while using doxorubicin, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.


Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.


Doxorubicin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

  • pain, burning, irritation, or skin changes where the injection was given;




  • feeling short of breath, even with mild exertion;




  • swelling, rapid weight gain (especially in your face and midsection);




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • fast, slow, or uneven heartbeats;




  • anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;




  • chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • lower back pain, blood in your urine, urinating less than usual or not at all;




  • numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;




  • muscle weakness, tightness, or contraction;




  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;




  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.



Less serious side effects may include:



  • missed menstrual periods;




  • darkening of your skin or nails;




  • temporary hair loss;




  • feeling weak or tired;




  • mild nausea, diarrhea; or




  • eye redness, puffy eyelids.



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.


Doxorubicin Dosing Information


Usual Adult Dose for Breast Cancer:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Neuroblastoma:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Hodgkin's Disease:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Ovarian Cancer:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Wilms' Tumor:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Stomach Cancer:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Lymphoma:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Osteosarcoma:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Bladder Cancer:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Acute Myeloblastic Leukemia:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Thyroid Cancer:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Bronchogenic Carcinoma:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Soft Tissue Sarcoma:

When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m2 IV every 21 to 28 days. Alternatively, 60 to 75 mg/m2 IV once every 21 days. The lower doses are recommended for patients with inadequate marrow reserves due to old age, prior therapy, or neoplastic marrow infiltration.

Usual Adult Dose for Multiple Myeloma:

(In combination with other chemotherapeutic agents as a part of the VAD regimen)
9 mg/m2/day IV continuous infusion on days 1 through 4

Usual Pediatric Dose for Malignant Disease:

35 to 75 mg/m2 as a single dose repeated every 21 days, or 20 to 30 mg/m2 once weekly, or 60 to 90 mg/m2 given as a continuous infusion over 96 hours every 3 to 4 weeks.


What other drugs will affect doxorubicin?


Many drugs can interact with doxorubicin. Below is just a partial list. Tell your doctor if you are using:



  • acetaminophen (Tylenol);




  • an antibiotic or antifungal medication;




  • auranofin (Ridaura) or gold injections to treat arthritis;




  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • dexrazoxane (Totect, Zinecard);




  • progesterone (Prometrium);




  • rosiglitazone (Avandia, Avandamet, Avandaryl);




  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;




  • birth control pills or hormone replacement therapy;




  • cholesterol medications such as atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin), and others;




  • drugs that weaken your immune system, such as adalimumab (Humira), certolizumab (Cimzia), clozapine (Clozaril, FazaClo), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and others;




  • heart rhythm or blood pressure medicine such as amiodarone (Cordarone, Pacerone), benazepril (Lotensin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), enalapril (Vasotec), labetalol (Normodyne, Trandate), lisinopril (Prinivil, Zestril), methyldopa (Aldomet), quinapril (Accupril), ramipril (Altace), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;




  • HIV/AIDS medications;




  • non-steroidal anti-inflammatory drugs (NSAIDs) such as (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;




  • other cancer medications, especially cyclophosphamide Cytoxan, Cytoxan Lyophilized, Neosar), cytarabine (Cytosar, DepoCyt, Tarabine), etoposide (Etopophos, VePesid), paclitaxel (Taxol, Onxol), sorafenib (Nexavar); or




  • seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), divalproex (Depakote), phenobarbital (Solfoton), phenytoin (Dilantin), valproic acid (Depakene, Stavzor).



This list is not complete and there may be other drugs that can interact with doxorubicin. Tell your doctor about all your 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 doctor.



More doxorubicin resources


  • Doxorubicin Dosage
  • Doxorubicin Use in Pregnancy & Breastfeeding
  • Doxorubicin Drug Interactions
  • Doxorubicin Support Group
  • 2 Reviews for Doxorubicin - Add your own review/rating


  • doxorubicin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Adriamycin Prescribing Information (FDA)

  • Doxorubicin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Doxorubicin Prescribing Information (FDA)

  • Doxorubicin Hydrochloride Monograph (AHFS DI)

  • Rubex Prescribing Information (FDA)



Compare doxorubicin with other medications


  • Acute Lymphoblastic Leukemia
  • Acute Myeloblastic Leukemia
  • Bladder Cancer
  • Breast Cancer
  • Cancer
  • Hodgkin's Lymphoma
  • Lung Cancer
  • Lymphoma
  • Multiple Myeloma
  • Neuroblastoma
  • Osteosarcoma
  • Ovarian Cancer
  • Soft Tissue Sarcoma
  • Stomach Cancer
  • Thyroid Cancer
  • Wilms' Tumor


Where can I get more information?


  • Your doctor or pharmacist can provide more information about doxorubicin.


Doctors Foster and Smith Dental Cleans Pad





Dosage Form: FOR ANIMAL USE ONLY

Drs. Foster and Smith Dental Cleans Pads help promote healthy teeth and gums through regular use. Also reduce bad breath and plaque build up. For Dogs and Cats.



DIRECTIONS FOR USE


Hold animal's head steady with one hand and gently wipe teeth and gums with pad. Use additional pads as needed until entire mouth has been cleaned.



ACTIVE INGREDIENT


0.1% Chlorhexidine Gluconate



OTHER INGREDIENTS


Water, Glycerin, Polysorbate 80, Peppermint Flavor, carmine Color.



Item# 8523


For Questions or to Reorder:


1-800-562-7169 or www.drsfostersmith.com



Doctors


Foster and smith


DentalClens


Pads


Cleans teeth and gums


Freshens breath


90 pads


Formulated by our veterinarians










DOCTORS FOSTER AND SMITH 
chlorhexidine gluconate  cloth










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)65713-902
Route of AdministrationDENTALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorhexidine Gluconate (CHLORHEXIDINE)Chlorhexidine Gluconate0.55 g  in 103.6 g










Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLYSORBATE 80 


















Product Characteristics
Colorbrown (carmine color)Score    
ShapeSize
FlavorPEPPERMINT (peppermint flavor)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
165713-902-05103.6 g In 1 JARNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/23/2010


Labeler - Doctors Foster and Smith (122135148)

Registrant - United Pet Group (931135730)









Establishment
NameAddressID/FEIOperations
JUNGLE LABORATORIES CORPORATION032615270manufacture
Revised: 02/2010Doctors Foster and Smith



Depakene


Generic Name: valproic acid (Oral route)


val-PROE-ik AS-id


Oral route(Syrup;Capsule, Liquid Filled;Capsule, Delayed Release)

Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives. Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity. Patients should be monitored closely and liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Valproate can produce teratogenic effects such as neural tube defects (eg, spina bifida). Accordingly, the use of valproate products in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus .


Oral route(Tablet, Enteric Coated;Tablet, Extended Release;Capsule, Delayed Release)

Hepatotoxicity (some cases fatal), usually occurring during the first 6 months of treatment, has been reported in patients receiving valproic acid and its derivatives. Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity. Monitor patients closely, and perform liver function tests prior to therapy and at frequent intervals thereafter. Valproate can produce teratogenic effects such as neural tube defects (eg, spina bifida). Accordingly, the use of divalproex sodium in women of childbearing potential requires that the benefits of its use be weighed against the risk of injury to the fetus. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. If pancreatitis is diagnosed, valproate should ordinarily be discontinued .



Commonly used brand name(s)

In the U.S.


  • Depakene

  • Depakote

  • Depakote DR

  • Depakote ER

  • Depakote Sprinkles

  • Stavzor

In Canada


  • Alti-Valproic

Available Dosage Forms:


  • Capsule, Delayed Release

  • Syrup

  • Capsule, Liquid Filled

  • Tablet, Extended Release

  • Tablet, Enteric Coated

  • Tablet, Delayed Release

Therapeutic Class: Antimanic


Pharmacologic Class: Histone Deacetylase Inhibitor


Chemical Class: Valproic Acid (class)


Uses For Depakene


Valproic acid is used alone or together with other medicines to control certain types of seizures (convulsions) in the treatment of epilepsy. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.


Valproic acid is also used to treat the manic phase of bipolar disorder (manic-depressive illness), and helps prevent migraine headaches.


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


Before Using Depakene


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of valproic acid in children. However, safety and efficacy have not been established in children with epilepsy below 10 years of age; and in children with migraine below 12 years of age. Because of valproic acid's toxicity, use in children below 2 years of age requires extreme caution.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valproic acid in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving valproic acid.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


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


  • Doripenem

  • Ertapenem

  • Imipenem

  • Ketorolac

  • Lamotrigine

  • Meropenem

  • Naproxen

  • Primidone

  • Vorinostat

  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acyclovir

  • Aspirin

  • Betamipron

  • Carbamazepine

  • Cholestyramine

  • Clomipramine

  • Erythromycin

  • Ethosuximide

  • Felbamate

  • Fosphenytoin

  • Ginkgo

  • Lopinavir

  • Lorazepam

  • Mefloquine

  • Nimodipine

  • Nortriptyline

  • Olanzapine

  • Oxcarbazepine

  • Panipenem

  • Phenobarbital

  • Phenytoin

  • Rifampin

  • Rifapentine

  • Risperidone

  • Ritonavir

  • Rufinamide

  • Topiramate

  • Zidovudine

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Brain disease, severe or

  • Congenital metabolism disorders (born with a disease that affects metabolism) or

  • Mental retardation with severe seizure disorders—Use with caution. May increase risk for more serious side effects.

  • Liver disease or

  • Urea cycle disorder (genetic disorder)—Should not be used in patients with these conditions.

  • Pancreatitis (inflammation of the pancreas) or

  • Thrombocytopenia (low platelet count)—May make these conditions worse.

Proper Use of valproic acid

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


Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.


This medicine comes with a medication guide and patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


Swallow the delayed-release capsules and oral capsules whole with a full glass of water. Do not split, crush, or chew it. You may take this medicine with food.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage forms (capsules, delayed-release capsules, and solution):
    • For seizures:
      • Adults and children 10 years of age or older—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 10 to 15 milligrams (mg) per kilogram (kg) of body weight a day to start. Your doctor may increase your dose gradually every week by 5 to 10 mg per kg of body weight if needed. However, the dose is usually not more than 60 mg per kg of body weight a day. If the total dose a day is greater than 250 mg, it is usually divided into smaller doses and taken two or more times during the day.

      • Children below 10 years of age—Use and dose must be determined by your doctor.



  • For oral dosage form (delayed-release capsules):
    • For mania:
      • Adults—At first, 750 milligrams (mg) once a day, usually divided in smaller doses. Your doctor may increase your dose as needed.

      • Children—Use and dose must be determined by your doctor.


    • For migraine:
      • Adults—At first, 250 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Depakene


It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.


Using this medicine while you are pregnant (especially during first trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


It is very important to take folic acid before getting pregnant and during early pregnancy to lower chances of harmful side effects to your unborn baby. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product.


Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.


Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.


Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.


Valproic acid may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.


Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.


Valproic acid may cause serious allergic reactions that affect several parts of the body (e.g., liver or kidney). Check with your doctor right away if you have more than one of the following symptoms: fever; dark urine; headache; rash; stomach pain; swollen lymph glands in the neck, armpit, or groin; unusual tiredness; or yellow eyes or skin.


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


Check with your doctor if you have unusual drowsiness, dullness, tiredness, weakness; or feeling of sluggishness; confusion; low body temperature; or loss of consciousness while taking this medicine.


Valproic acid may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these adverse effects, tell your doctor right away.


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.


Depakene Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Black, tarry stools

  • bleeding gums

  • bloating or swelling of the face, arms, hands, lower legs, or feet

  • blood in the urine or stools

  • confusion

  • cough or hoarseness

  • crying

  • delusions

  • dementia

  • depersonalization

  • diarrhea

  • difficult or labored breathing

  • dysphoria

  • euphoria

  • fever or chills

  • general feeling of discomfort or illness

  • headache

  • joint pain

  • loss of appetite

  • lower back or side pain

  • mental depression

  • muscle aches and pains

  • nausea

  • nervousness

  • painful or difficult urination

  • paranoia

  • pinpoint red spots on the skin

  • quick to react or overreact emotionally

  • rapid weight gain

  • rapidly changing moods

  • runny nose

  • shakiness in the legs, arms, hands, or feet

  • shivering

  • shortness of breath

  • sleepiness or unusual drowsiness

  • sore throat

  • sweating

  • tightness in the chest

  • tingling of the hands or feet

  • trembling or shaking of the hands or feet

  • trouble with sleeping

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • unusual weight gain or loss

  • vomiting

  • wheezing

Less common
  • Abnormal dreams

  • absence of or decrease in body movement

  • anxiety

  • bloody nose

  • bloody or cloudy urine

  • blurred vision

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

  • change in personality

  • change in walking and balance

  • changes in patterns and rhythms of speech

  • chest pain

  • chills

  • clumsiness or unsteadiness

  • cold sweats

  • constipation

  • darkened urine

  • degenerative disease of the joint

  • difficult, burning, or painful urination

  • difficulty with moving

  • discouragement

  • dizziness

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • dry mouth

  • excessive muscle tone

  • fast, irregular, pounding, or racing heartbeat or pulse

  • fear

  • feeling of warmth or heat

  • feeling sad or empty

  • flushing or redness of the skin, especially on the face and neck

  • frequent urge to urinate

  • heavy non-menstrual vaginal bleeding

  • hyperventilation

  • increased need to urinate

  • indigestion

  • irritability

  • lack of appetite

  • lack of coordination

  • large, flat, blue, or purplish patches in the skin

  • leg cramps

  • lip smacking or puckering

  • loss of bladder control

  • loss of interest or pleasure

  • loss of strength or energy

  • multiple swollen and inflamed skin lesions

  • muscle pain or stiffness

  • muscle tension or tightness

  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected

  • pains in the stomach, side, or abdomen, possibly radiating to the back

  • passing urine more often

  • pounding in the ears

  • puffing of the cheeks

  • rapid or worm-like movements of the tongue

  • rapid weight gain

  • restlessness

  • seeing, hearing, or feeling things that are not there

  • shakiness and unsteady walk

  • slurred speech

  • small red or purple spots on the skin

  • sweating

  • swollen joints

  • tiredness

  • trouble with concentrating

  • trouble with speaking

  • twitching

  • uncontrolled chewing movements

  • uncontrolled movements of the arms and legs

  • unsteadiness, trembling, or other problems with muscle control or coordination

  • vomiting of blood or material that looks like coffee grounds

  • yellow eyes or skin

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


Symptoms of overdose
  • Change in consciousness

  • fainting

  • loss of consciousness

  • slow or irregular heartbeat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Acid or sour stomach

  • belching

  • body aches or pain

  • change in vision

  • congestion

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

  • hair loss or thinning of the hair

  • hearing loss

  • heartburn

  • impaired vision

  • lack or loss of strength

  • loss of memory

  • problems with memory

  • rash

  • seeing double

  • sleeplessness

  • tender, swollen glands in the neck

  • trouble with swallowing

  • unable to sleep

  • uncontrolled eye movements

  • voice changes

  • weight gain

  • weight loss

Less common
  • Absent, missed, or irregular menstrual periods

  • back pain

  • burning, dry, or itching eyes

  • change in taste or bad unusual or unpleasant (after) taste

  • coin-shaped lesions on the skin

  • cough producing mucus

  • cramps

  • dandruff

  • discharge or excessive tearing

  • dry skin

  • earache

  • excess air or gas in the stomach or intestines

  • eye pain

  • feeling of constant movement of self or surroundings

  • full feeling

  • heavy bleeding

  • increased appetite

  • itching of the vagina or genital area

  • itching skin

  • loss of bowel control

  • neck pain

  • oily skin

  • pain

  • pain during sexual intercourse

  • pain or tenderness around the eyes and cheekbones

  • passing gas

  • rash with flat lesions or small raised lesions on the skin

  • redness or swelling in the ear

  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

  • redness, swelling, or soreness of the tongue

  • sensation of spinning

  • sneezing

  • stiff neck

  • stopping of menstrual bleeding

  • thick, white vaginal discharge with no odor or with a mild odor

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: Depakene side effects (in more detail)



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More Depakene resources


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


  • Depakene Prescribing Information (FDA)

  • Depakene MedFacts Consumer Leaflet (Wolters Kluwer)

  • Valproic Acid Monograph (AHFS DI)

  • Depacon MedFacts Consumer Leaflet (Wolters Kluwer)

  • Depacon Prescribing Information (FDA)

  • Stavzor Prescribing Information (FDA)

  • Stavzor Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Stavzor Consumer Overview



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