Thursday, 21 January 2010

Furosemide Galenica




Furosemide Galenica may be available in the countries listed below.


Ingredient matches for Furosemide Galenica



Furosemide

Furosemide is reported as an ingredient of Furosemide Galenica in the following countries:


  • Italy

International Drug Name Search

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Monday, 18 January 2010

Penicilina Benzatinica MF




Penicilina Benzatinica MF may be available in the countries listed below.


Ingredient matches for Penicilina Benzatinica MF



Benzylpenicillin

Benzylpenicillin benzathine (a derivative of Benzylpenicillin) is reported as an ingredient of Penicilina Benzatinica MF in the following countries:


  • Peru

International Drug Name Search

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Saturday, 16 January 2010

Finasterid Helvepharm




Finasterid Helvepharm may be available in the countries listed below.


Ingredient matches for Finasterid Helvepharm



Finasteride

Finasteride is reported as an ingredient of Finasterid Helvepharm in the following countries:


  • Switzerland

International Drug Name Search

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Wednesday, 13 January 2010

Tinidazolo




Tinidazolo may be available in the countries listed below.


Ingredient matches for Tinidazolo



Tinidazole

Tinidazolo (DCIT) is known as Tinidazole in the US.

International Drug Name Search

Glossary

DCITDenominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.
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Sunday, 10 January 2010

Mildox




Mildox may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Mildox



Doxycycline

Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Mildox in the following countries:


  • South Africa

International Drug Name Search

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Saturday, 9 January 2010

Clarix




Clarix may be available in the countries listed below.


Ingredient matches for Clarix



Brimonidine

Brimonidine tartrate (a derivative of Brimonidine) is reported as an ingredient of Clarix in the following countries:


  • Poland

Clarithromycin

Clarithromycin is reported as an ingredient of Clarix in the following countries:


  • Bahrain

  • Oman

  • Peru

Oxymetazoline

Oxymetazoline hydrochloride (a derivative of Oxymetazoline) is reported as an ingredient of Clarix in the following countries:


  • Venezuela

International Drug Name Search

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Wednesday, 6 January 2010

Secsilen




Secsilen may be available in the countries listed below.


Ingredient matches for Secsilen



Secnidazole

Secnidazole is reported as an ingredient of Secsilen in the following countries:


  • Ecuador

International Drug Name Search

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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.




References



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55. Upjohn Company. Caverject (alprostadil) injection for intracavernosal use prescribing information. Kalamazoo, MI; 1995 Jul.



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57. The ALLHAT collaborative research group. Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA. 2000; 283:1967-75. [IDIS 444771] [PubMed 10789664]



58. Lasagna L. Diuretics vs α-blockers for treatment of hypertension: lessons from ALLHAT. JAMA. 2000; 283:2013-4. [IDIS 444774] [PubMed 10789671]



59. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]



60. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]



61. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]



62. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.



63. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]



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72. Cushman WC, Ford CE, Cutler JA, et al. Success and predictors of blood pressure control in diverse North American settings: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2002;4:393-404.



73. Black HR, Elliott WJ, Neaton JD et al. Baseline characteristics and elderly blood pressure control in the CONVINCE trial. Hypertension. 2001; 37:12-18. [PubMed 11208750]



74. Black HR, Elliott WJ, Grandits G, et al. Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial. JAMA. 2003;289:2073-2082.



75. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint Reduction in Hypertension Study (LIFE). Lancet. 2002;359:995-1003.



76. The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000;342:145-153.



77. PROGRESS Collaborative Group. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet. 2001;358:1033-41.



78. Wing LMH, Reid CM, Ryan P, et al, for Second Australian National Blood Pressure Study Group. A comparison of outcomes with angiotensin-converting-enzyme inhibitors and diuretics for hypertension in the elderly. N Engl J Med. 2003;348:583-92.



79. Psaty BM, Smith NL, Siscovich DS et al. Health outcomes associated with antihypertensive therapies used as first-line agents: a systematic review and meta-analysis. JAMA. 1997; 277:739-45. [IDIS 380501] [PubMed 9042847]



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Friday, 1 January 2010

Flomax


Flomax is a brand name of tamsulosin, approved by the FDA in the following formulation(s):


FLOMAX (tamsulosin hydrochloride - capsule; oral)



  • Manufacturer: BOEHRINGER INGELHEIM

    Approval date: April 15, 1997

    Strength(s): 0.4MG [RLD][AB]

Has a generic version of Flomax been approved?


A generic version of Flomax has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Flomax and have been approved by the FDA:


tamsulosin hydrochloride capsule; oral



  • Manufacturer: IMPAX LABS

    Approval date: March 2, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: MYLAN

    Approval date: April 27, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: SANDOZ

    Approval date: April 27, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: SUN PHARM INDS LTD

    Approval date: July 15, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: SYNTHON PHARMS

    Approval date: April 27, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: TEVA PHARMS

    Approval date: April 27, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: WOCKHARDT

    Approval date: April 27, 2010

    Strength(s): 0.4MG [AB]


  • Manufacturer: ZYDUS PHARMS USA INC

    Approval date: April 27, 2010

    Strength(s): 0.4MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Flomax. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Flomax.

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • December 22, 2012 - INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL

    • June 22, 2013 - PEDIATRIC EXCLUSIVITY

See also...

  • Flomax Consumer Information (Drugs.com)
  • Flomax Consumer Information (Wolters Kluwer)
  • Flomax Consumer Information (Cerner Multum)
  • Flomax Advanced Consumer Information (Micromedex)
  • Flomax AHFS DI Monographs (ASHP)
  • Tamsulosin Consumer Information (Wolters Kluwer)
  • Tamsulosin Consumer Information (Cerner Multum)
  • Tamsulosin Advanced Consumer Information (Micromedex)
  • Tamsulosin Hydrochloride AHFS DI Monographs (ASHP)
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