Friday, 24 December 2010

Verlost




Verlost may be available in the countries listed below.


Ingredient matches for Verlost



Ranitidine

Ranitidine is reported as an ingredient of Verlost in the following countries:


  • Ethiopia

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


  • Greece

International Drug Name Search

Friday, 10 December 2010

Pe-Tam




Pe-Tam may be available in the countries listed below.


Ingredient matches for Pe-Tam



Paracetamol

Paracetamol is reported as an ingredient of Pe-Tam in the following countries:


  • Belgium

  • Luxembourg

International Drug Name Search

Tuesday, 7 December 2010

oxazepam



ox-AZ-e-pam


Commonly used brand name(s)

In the U.S.


  • Serax

Available Dosage Forms:


  • Tablet

  • Capsule

Therapeutic Class: Antianxiety


Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting


Uses For oxazepam


Oxazepam is used to relieve symptoms of anxiety, including anxiety caused by depression, and the symptoms of alcohol withdrawal. oxazepam may also be used to treat tension, agitation, and irritability in older patients.


Oxazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.


oxazepam is available only with your doctor's prescription.


Before Using oxazepam


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 oxazepam, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to oxazepam 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 oxazepam in children below 6 years of age. 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 oxazepam in the elderly. However, severe drowsiness, dizziness, lightheadedness, fainting, or unusual behavior are more likely to occur in the elderly, which may require an adjustment in the dose for patients receiving oxazepam.


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 oxazepam, 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 oxazepam 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.


  • Alfentanil

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Butabarbital

  • Butalbital

  • Carisoprodol

  • Chloral Hydrate

  • Chlorzoxazone

  • Codeine

  • Dantrolene

  • Ethchlorvynol

  • Fentanyl

  • Fospropofol

  • Hydrocodone

  • Hydromorphone

  • Levorphanol

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Morphine

  • Morphine Sulfate Liposome

  • Oxycodone

  • Oxymorphone

  • Pentobarbital

  • Phenobarbital

  • Primidone

  • Propoxyphene

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Thiopental

  • Zolpidem

Using oxazepam 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.


  • St John's Wort

  • Theophylline

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using oxazepam with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use oxazepam, or give you special instructions about the use of food, alcohol, or tobacco.


  • Cabbage

Other Medical Problems


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


  • Alcohol abuse, or history of, or

  • Drug abuse or dependence, or history of—Dependence on oxazepam may develop.

  • Hypotension (low blood pressure)—Use with caution. May make this condition worse.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Mental illness (e.g., bipolar disorder, schizophrenia)—Should not be used in patients with this condition.

Proper Use of oxazepam


Take oxazepam only 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.


Dosing


The dose of oxazepam 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 oxazepam. 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 form (capsules):
    • For anxiety:
      • Adults—10 to 30 milligrams (mg) three or four times per day.

      • Older Adults—At first, 10 milligrams (mg) three times per day. Your doctor may increase your dose if needed.

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


    • For alcohol withdrawal:
      • Adults—15 to 30 milligrams (mg) three or four times per day.

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



Missed Dose


If you miss a dose of oxazepam, 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 oxazepam


It is very important that your doctor check your progress at regular visits to make sure oxazepam is working properly. Blood tests may be needed to check for unwanted effects.


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


oxazepam may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy, unsteady, or less alert than they are normally. Make sure you know how you react to oxazepam before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think or see well.


oxazepam will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates (used for seizures); muscle relaxants; or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking oxazepam. Check with your doctor before taking any of the above while you are using oxazepam.


Do not stop taking oxazepam without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), stomach or muscle cramps, tremors, vomiting, or sweating.


oxazepam is for short-term use only, which is generally considered less than 4 months. If your condition does not improve or if it becomes worse, check with your doctor.


oxazepam 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:


Rare
  • Abdominal or stomach pain

  • black, tarry stools

  • chest pain

  • chills

  • clay-colored stools

  • cough

  • dark urine

  • dizziness

  • fainting

  • fever with or without chills

  • headache

  • itching

  • light-colored stools

  • loss of appetite

  • nausea and vomiting

  • painful or difficult urination

  • rash

  • shakiness and unsteady walk

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

  • shortness of breath

  • slurred speech

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • stomach pain

  • swelling

  • swollen glands

  • unpleasant breath odor

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

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting of blood

  • yellow eyes or skin

Incidence not known
  • Being forgetful

  • confusion about identity, place, and time

  • cough or hoarseness

  • decreased awareness or responsiveness

  • false or unusual sense of well-being

  • fever and sore throat

  • general feeling of tiredness or weakness

  • hallucinations

  • loss of bladder control

  • loss of memory

  • lower back or side pain

  • nightmares

  • pale skin

  • problems with memory

  • severe sleepiness

  • trouble sleeping

  • unusual excitement, nervousness, restlessness, or irritability

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


Symptoms of overdose
  • Blurred vision

  • change in consciousness

  • confusion

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

  • drowsiness

  • loss of consciousness

  • loss of strength or energy

  • muscle pain or weakness

  • sweating

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

  • unusual weak feeling

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
  • Decreased interest in sexual intercourse

  • feeling of constant movement of self or surroundings

  • inability to have or keep an erection

  • increased in sexual ability, desire, drive, or performance

  • increased interest in sexual intercourse

  • loss in sexual ability, desire, drive, or performance

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

  • sensation of spinning

Incidence not known
  • Double vision

  • menstrual changes

  • seeing double

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: oxazepam 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 oxazepam resources


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


  • oxazepam Concise Consumer Information (Cerner Multum)

  • Oxazepam Prescribing Information (FDA)

  • Oxazepam Professional Patient Advice (Wolters Kluwer)

  • Oxazepam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Oxazepam Monograph (AHFS DI)



Compare oxazepam with other medications


  • Alcohol Withdrawal
  • Anxiety

Saturday, 4 December 2010

Azitrocin




Azitrocin may be available in the countries listed below.


Ingredient matches for Azitrocin



Azithromycin

Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitrocin in the following countries:


  • Italy

  • Mexico

International Drug Name Search

Friday, 3 December 2010

Pabi-Dexamethason




Pabi-Dexamethason may be available in the countries listed below.


Ingredient matches for Pabi-Dexamethason



Dexamethasone

Dexamethasone is reported as an ingredient of Pabi-Dexamethason in the following countries:


  • Poland

International Drug Name Search

Saturday, 6 November 2010

Voltaren Actigo Extra




Voltaren Actigo Extra may be available in the countries listed below.


Ingredient matches for Voltaren Actigo Extra



Diclofenac

Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Voltaren Actigo Extra in the following countries:


  • Czech Republic

International Drug Name Search

Friday, 5 November 2010

Doxycycline


Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: 4 - (Dimethylamino) - 1,4,4a,5,5a,6,11,12a - octahydro - 3,5,10,12,12a - pentahydroxy - 6 - methyl - 1,11 - dioxo - 2 - naphthacenecarboxamide monohydrate
Molecular Formula: C22H24N2O8•H20
CAS Number: 17086-28-1
Brands: Oracea

Introduction

Semisynthetic tetracycline antibiotic.1


Available as 40-mg capsules (Oracea) containing 2 types of doxycycline beads (i.e., 30 mg as immediate-release beads and 10 mg as delayed-release beads).1


Uses for Doxycycline


Rosacea


Treatment of inflammatory lesions (papules and pustules) associated with rosacea (acne rosacea).1


Safety and efficacy not established for treatment of the erythematous, telangiectatic, or ocular components of rosacea.1


The 40-mg capsules of doxycycline (Oracea) are not indicated for the treatment or prevention of bacterial infections or to reduce the number of or eliminate organisms associated with bacterial disease.1 (See Selection and Use of Anti-infectives under Cautions).


Doxycycline Dosage and Administration


Administration


Oral Administration


Administer orally in the morning, on an empty stomach, at least 1 hour before or 2 hours after a meal.1


Give with adequate amounts of fluid to reduce risk of esophageal irritation and ulceration.1


Dosage


Adults


Rosacea

Oral

40 mg once daily in the morning.1


Prescribing Limits


Adults


Oral

Efficacy of the 40-mg capsules of doxycycline (Oracea) not established beyond 16 weeks and safety not established beyond 9 months of therapy.1


Exceeding the dosage of doxycycline recommended for rosacea may increase the incidence of adverse effects (e.g., development of drug-resistant bacteria).1


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.1


Renal Impairment


Dosage adjustment not required.9


Geriatric Patients


No specific dosage recommendations at this time.1


Cautions for Doxycycline


Contraindications



  • Known hypersensitivity to doxycycline or other tetracyclines.1



Warnings/Precautions


Warnings


Fetal/Neonatal Morbidity

Animal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity.1


Use not recommended in pregnant women.1 Avoid pregnancy during therapy.1 If pregnancy occurs, immediately discontinue and apprise of potential fetal hazard.1


Use not recommended for individuals of either gender who are attempting to conceive a child.1


Dental and Bone Effects

Avoid use during tooth development (the last half of pregnancy, infancy, childhood up to 8 years of age); potential for permanent tooth discoloration and enamel hypoplasia.1


Tetracyclines form a stable calcium complex in any bone-forming tissue.1 Reversible decrease in fibula growth rate has occurred in premature infants receiving oral tetracyclines.1


Superinfection/Clostridium difficile-associated Colitis

Treatment with anti-infectives may permit overgrowth of clostridia.1 5 6 7 8 Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1 5 6 7 8


Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone.1 5 6 7 8 Manage moderate to severe cases with fluid, electrolyte, protein supplementation, and appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) as clinically indicated.1 5 6 7 8


Renal Effects

Tetracyclines have antianabolic effects and may increase BUN concentrations.1 This effect usually is not clinically important in patients with normal renal function; however, high serum tetracycline concentrations may result in azotemia, hyperphosphatemia, and acidosis in patients with impaired renal function.1 (See Renal Impairment under Cautions.)


Sensitivity Reactions


Photosensitivity Reactions

Possible photosensitivity reaction (e.g., exaggerated sunburn reaction).1


Avoid unnecessary exposure to sunlight or artificial UV light (sunlamps, solariums).1


General Precautions


Superinfection/Candidiasis

Doxycycline may result in overgrowth of nonsusceptible organisms, including fungi.1 If superinfection occurs, discontinue doxycycline and initiate appropriate therapy.1


Tetracyclines may increase the incidence of vaginal candidiasis.1 Use with caution in patients with a history of or predisposition to candidiasis.1


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of other antibacterials, use the 40-mg capsules of doxycycline (Oracea) only for the treatment of rosacea.1


Doxycycline 40-mg capsules are not to be used for the treatment or prevention of bacterial infections or to reduce or eliminate organisms associated with bacterial disease.1 The dosage regimen used for the treatment of rosacea results in doxycycline plasma concentrations that are too low for the treatment of bacterial infections.1


Autoimmune Syndromes

Tetracyclines have been associated with autoimmune syndromes (e.g., lupus-like syndrome, autoimmune hepatitis, vasculitis, serum sickness).1


If symptoms suggestive of an autoimmune syndrome develop (e.g., fever, rash, arthralgia, malaise), immediately discontinue use of tetracyclines and perform appropriate tests (liver function tests, ANA, CBC) to evaluate the patient.1


Tissue Hyperpigmentation

Tetracyclines are known to cause hyperpigmentation in many organs (e.g., nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae, and heart valves).1


Nervous System Effects

Tetracyclines have been reported to cause bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults.1 These effects usually resolve when the drug is discontinued.1


Laboratory Monitoring

Periodically assess organ system function (including hematopoietic, renal, and hepatic function).1 Perform appropriate tests for autoimmune syndromes if indicated.1


Specific Populations


Pregnancy

Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Lactation

Distributed into milk.1 Discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy not established; use not recommended.1


Possible permanent tooth discoloration in children <8 years of age.1 (See Dental and Bone Effects under Cautions.) Do not use in infants or children <8 years of age.1


Renal Impairment

Serum half-life of doxycycline is not altered in patients with severe renal impairment;1 renal impairment does not appear to result in excessive accumulation of doxycycline.10 (See Renal Effects under Cautions.)


Excessive drug accumulation and possible liver toxicity may occur if usual dosages of some tetracyclines are used in patients with renal impairment.1 Dosage adjustment of tetracyclines may be necessary in patients with renal impairment; serum tetracycline concentrations should be monitored in patients receiving long-term therapy.1


Common Adverse Effects


Nasopharyngitis,1 hypertension,1 sinusitis,1 increased AST,1 upper respiratory tract infection,4 headache,4 diarrhea.4


Interactions for Doxycycline


Specific Drugs and Laboratory Tests







































Drug



Interaction



Comments



Antacids (aluminum-, calcium- or magnesium- containing)



Decreased absorption of doxycycline1



Give antacids containing aluminum, calcium, or magnesium 1–2 hours before or after doxycycline9



Anticoagulants, oral



Decreased plasma prothrombin activity1



Monitor PT carefully; adjust anticoagulant dosage as needed1



Anticonvulsants (carbamazepine, barbiturates, phenytoin)



Possible decreased doxycycline half-life1



Bismuth subsalicylate



Decreased absorption of doxycycline1



If concomitant use cannot be avoided, give doxycycline at least 2-3 hours before bismuth subsalicylate9



Hormonal contraceptives



Decreased effectiveness of oral contraceptive1



Use of a second form of contraceptive during treatment with doxycycline is advised1



Iron-containing preparations



Decreased absorption of doxycycline1



Give doxycycline 2 hours before or 3 hours after iron-containing preparations9



Methoxyflurane (no longer commercially available in the US)



Fatal renal toxicity1



Penicillins



Decreased efficacy of penicillins1



Avoid concomitant use1



Proton-pump inhibitors



Decreased absorption of doxycycline1



Retinoids, oral (e.g., acitretin, isotretinoin)



Additive adverse CNS effect of pseudotumor cerebri (benign intracranial hypertension)1



Avoid concomitant use1



Urinary catecholamine assay



Possible false elevation secondary to interference with fluorescence test1


Doxycycline Pharmacokinetics


Absorption


Bioavailability


Oracea is not bioequivalent to other commercially available doxycycline preparations.1


Food


Decreased rate and extent of absorption when administered with a high-fat, high-protein meal including dairy products.1


Special Populations


Bioavailability is reported to be reduced at high pH; may be clinically important in patients with gastrectomy, gastric bypass surgery, or those who otherwise are achlorhydric.1


Distribution


Extent


Crosses the placenta and is distributed into milk.1


Plasma Protein Binding


>90%.1


Elimination


Metabolism


Major metabolites not identified.1


Elimination Route


Excreted in urine (29–55% by 72 hours) and feces as unchanged drug.1


Half-life


21 hours.1


Special Populations


No significant difference in serum half-life of patients with normal and severely impaired renal function.1 Hemodialysis does not alter the serum half-life.1


Stability


Storage


Oral


Capsules

Tight, light-resistant containers at 15–30°C.1


ActionsActions



  • Semisynthetic tetracycline antibiotic; also has anti-inflammatory and immunomodulatory effects.1 2 3




  • Mechanism(s) by which doxycycline reduces inflammatory lesions (papules and pustules) in patients with rosacea not known.2 Effects may result at least in part from the anti-inflammatory and antiangiogenic actions of the drug.2




  • The plasma concentrations of doxycycline achieved during therapy with the 40-mg capsules (Oracea) are less than the concentration required to treat bacterial diseases.1




  • Causes no long-term effects on bacterial flora of the oral cavity, skin, intestinal tract, or vagina.1



Advice to Patients



  • Importance of taking dose in the morning, on an empty stomach (at least 1 hour before or 2 hours after a meal) and drinking sufficient amounts of fluid to reduce the risk of esophageal irritation and ulceration.1 Importance of not lying down immediately following the dose.9




  • Importance of avoiding exposure to direct sunlight or UV light while taking doxycycline.1 When exposure cannot be avoided, importance of wearing protective clothing.1 Importance of discontinuing the drug and informing clinician at the first sign of skin erythema.1




  • Importance of taking only as prescribed; increasing dosage above 40 mg daily may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.1




  • Importance of women using alternative nonhormonal contraceptive measures because of the potential interaction with hormonal contraceptives.1




  • Advise patients that autoimmune syndromes have been observed with doxycycline; importance of discontinuing the drug and informing clinician if arthralgia, fever, rash, or malaise occurs.1




  • Advise patients that doxycycline therapy can cause discoloration of skin, scars, teeth, or gums.1




  • Importance of providing patient a copy of manufacturer's patient information.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant diseases.1




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy, advise pregnant women of risk to the fetus, and advise males to utilize effective contraception during therapy.1




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



Preparations


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













Doxycycline

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules (containing beads)



40 mg (immediate-release 30 mg with delayed-release 10 mg)



Oracea



CollaGenex



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 August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. CollaGenex. Oracea (doxycycline, USP) capsules 40 mg prescribing information. Newtown, PA; 2006 May 26.



2. Sapadin AN, Fleischmajer R. Tetracyclines: nonantibiotic properties and their clinical implications. J Am Acad Dermatol. 2006; 54:258-65. [PubMed 16443056]



3. Anon. Low-dose doxycycline (Oracea) for rosacea. Med Lett Drugs Ther. 2007; 49:5-6.



4. Del Rosso JQ, Webster GF, Jackson M et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007; 56:791-802. [PubMed 17367893]



5. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]



6. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]



7. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]



8. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]



9. Collagenex, Newtown, PA: Personal communication.



10. Pfizer. Vibramycin calcium (doxycycline calcium) oral suspension syrup, Vibramycin hyclate (doxycycline hyclate) capsules, Vibramycin monohydrate (doxycycline monohydrate) for oral suspension, Vibra-tabs (doxycycline hyclate) film coated tablets prescribing information. New York, NY. 2003 Sep.



More Doxycycline resources


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


  • Doxycycline Professional Patient Advice (Wolters Kluwer)

  • Doxycycline Prescribing Information (FDA)

  • Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer)

  • doxycycline Advanced Consumer (Micromedex) - Includes Dosage Information

  • Adoxa MedFacts Consumer Leaflet (Wolters Kluwer)

  • Alodox Prescribing Information (FDA)

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

  • Doryx Prescribing Information (FDA)

  • Monodox Prescribing Information (FDA)

  • Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer)

  • Oracea Consumer Overview

  • Oracea Prescribing Information (FDA)

  • Periostat Prescribing Information (FDA)

  • Periostat MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vibramycin Prescribing Information (FDA)



Compare Doxycycline with other medications


  • Acne
  • Actinomycosis
  • Amebiasis
  • Anthrax
  • Anthrax Prophylaxis
  • Bacterial Infection
  • Bartonellosis
  • Bronchitis
  • Brucellosis
  • Bullous Pemphigoid
  • Chlamydia Infection
  • Cholera
  • Cutaneous Bacillus anthracis
  • Ehrlichiosis
  • Enterocolitis
  • Epididymitis, Sexually Transmitted
  • Gastroenteritis
  • Granuloma Inguinale
  • Inclusion Conjunctivitis
  • Lyme Disease
  • Lyme Disease, Arthritis
  • Lyme Disease, Carditis
  • Lyme Disease, Erythema Chronicum Migrans
  • Lyme Disease, Neurologic
  • Lymphogranuloma Venereum
  • Malaria
  • Malaria Prevention
  • Melioidosis
  • Mycoplasma Pneumonia
  • Nongonococcal Urethritis
  • Ocular Rosacea
  • Ornithosis
  • Pelvic Inflammatory Disease
  • Pemphigoid
  • Pemphigus
  • Periodontitis
  • Plague
  • Pleural Effusion
  • Pneumonia
  • Proctitis
  • Prostatitis
  • Psittacosis
  • Rabbit Fever
  • Rheumatoid Arthritis
  • Rickettsial Infection
  • Rosacea
  • Skin Infection
  • STD Prophylaxis
  • Syphilis, Early
  • Syphilis, Latent
  • Tertiary Syphilis
  • Trachoma
  • Upper Respiratory Tract Infection
  • Urinary Tract Infection

Thursday, 4 November 2010

Azitromicina Tarbis




Azitromicina Tarbis may be available in the countries listed below.


Ingredient matches for Azitromicina Tarbis



Azithromycin

Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromicina Tarbis in the following countries:


  • Spain

International Drug Name Search

Wednesday, 3 November 2010

Rifater


Rifater is a brand name of isoniazid/pyrazinamide/rifampin, approved by the FDA in the following formulation(s):


RIFATER (isoniazid; pyrazinamide; rifampin - tablet; oral)



  • Manufacturer: SANOFI AVENTIS US

    Approval date: May 31, 1994

    Strength(s): 50MG;300MG;120MG [RLD]

Has a generic version of Rifater been approved?


No. There is currently no therapeutically equivalent version of Rifater available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rifater. 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 Rifater.

See also...

  • Rifater Consumer Information (Wolters Kluwer)
  • Rifater Consumer Information (Cerner Multum)
  • Rifater Advanced Consumer Information (Micromedex)
  • Isoniazid/Pyrazinamide/Rifampin Consumer Information (Wolters Kluwer)
  • Isoniazid, pyrazinamide, and rifampin Consumer Information (Cerner Multum)
  • Isoniazid/pyrazinamide/rifampin Consumer Information (Cerner Multum)
  • Rifampin, isoniazid, and pyrazinamide Advanced Consumer Information (Micromedex)

Tuesday, 26 October 2010

Phaeva




Phaeva may be available in the countries listed below.


Ingredient matches for Phaeva



Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Phaeva in the following countries:


  • France

Gestodene

Gestodene is reported as an ingredient of Phaeva in the following countries:


  • France

International Drug Name Search

Saturday, 23 October 2010

Albezol




Albezol may be available in the countries listed below.


Ingredient matches for Albezol



Albendazole

Albendazole is reported as an ingredient of Albezol in the following countries:


  • Venezuela

International Drug Name Search

Friday, 22 October 2010

Rokulan




Rokulan may be available in the countries listed below.


Ingredient matches for Rokulan



Clopidogrel

Clopidogrel besilate (a derivative of Clopidogrel) is reported as an ingredient of Rokulan in the following countries:


  • Germany

International Drug Name Search

Sunday, 17 October 2010

Fungotopic




Fungotopic may be available in the countries listed below.


Ingredient matches for Fungotopic



Bifonazole

Bifonazole is reported as an ingredient of Fungotopic in the following countries:


  • Chile

International Drug Name Search

Sunday, 10 October 2010

Dampo Solvopect




Dampo Solvopect may be available in the countries listed below.


Ingredient matches for Dampo Solvopect



Carbocisteine

Carbocisteine is reported as an ingredient of Dampo Solvopect in the following countries:


  • Netherlands

International Drug Name Search

Friday, 8 October 2010

Salbutamol WFZ Polfa




Salbutamol WFZ Polfa may be available in the countries listed below.


Ingredient matches for Salbutamol WFZ Polfa



Salbutamol

Salbutamol is reported as an ingredient of Salbutamol WFZ Polfa in the following countries:


  • Czech Republic

  • Slovakia

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Salbutamol WFZ Polfa in the following countries:


  • Vietnam

International Drug Name Search

Thursday, 7 October 2010

CAM




In the US, CAM is a member of the drug class topical emollients and is used to treat Dry Skin.

Ingredient matches for CAM



Ephedrine

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


  • United Kingdom

International Drug Name Search

Amoclox




Amoclox may be available in the countries listed below.


Ingredient matches for Amoclox



Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoclox in the following countries:


  • Bahrain

International Drug Name Search

Tuesday, 5 October 2010

Onymax




Onymax may be available in the countries listed below.


Ingredient matches for Onymax



Terbinafine

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


  • Italy

  • Poland

  • Switzerland

International Drug Name Search

Monday, 4 October 2010

Instillatio Aluminii Acetico-tartarici




Instillatio Aluminii Acetico-tartarici may be available in the countries listed below.


Ingredient matches for Instillatio Aluminii Acetico-tartarici



Aluminium Acetotartrate

Aluminium Acetotartrate is reported as an ingredient of Instillatio Aluminii Acetico-tartarici in the following countries:


  • Slovakia

International Drug Name Search

Tuesday, 28 September 2010

Aripez




Aripez may be available in the countries listed below.


Ingredient matches for Aripez



Donepezil

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


  • Ireland

International Drug Name Search

Sunday, 26 September 2010

Vinblastina Ciclum Farma




Vinblastina Ciclum Farma may be available in the countries listed below.


Ingredient matches for Vinblastina Ciclum Farma



Vinblastine

Vinblastine sulfate (a derivative of Vinblastine) is reported as an ingredient of Vinblastina Ciclum Farma in the following countries:


  • Spain

International Drug Name Search

Nomégestrol Arrow




Nomégestrol Arrow may be available in the countries listed below.


Ingredient matches for Nomégestrol Arrow



Nomegestrol

Nomegestrol acetate (a derivative of Nomegestrol) is reported as an ingredient of Nomégestrol Arrow in the following countries:


  • France

International Drug Name Search

Tuesday, 14 September 2010

Negasunt




Negasunt may be available in the countries listed below.


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

Ingredient matches for Negasunt



Propoxur

Propoxur is reported as an ingredient of Negasunt in the following countries:


  • United Kingdom

International Drug Name Search

Sunday, 12 September 2010

Xylocaine-Astra




Xylocaine-Astra may be available in the countries listed below.


Ingredient matches for Xylocaine-Astra



Lidocaine

Lidocaine is reported as an ingredient of Xylocaine-Astra in the following countries:


  • Luxembourg

International Drug Name Search

Monday, 6 September 2010

Ultralanum Plain Ointment




Ultralanum Plain Ointment may be available in the countries listed below.


Ingredient matches for Ultralanum Plain Ointment



Fluocortolone

Fluocortolone monohydrate and 21-caproate (a derivative of Fluocortolone) is reported as an ingredient of Ultralanum Plain Ointment in the following countries:


  • Bahrain

  • Egypt

  • Iran

  • Iraq

  • Jordan

  • Kuwait

  • Lebanon

  • Qatar

  • Saudi Arabia

  • Syria

  • United Arab Emirates

  • United Kingdom

  • Yemen

International Drug Name Search

Oxistat Cream


Pronunciation: ox-ee-KON-uh-zole
Generic Name: Oxiconazole
Brand Name: Oxistat


Oxistat Cream is used for:

Treating fungal infections, such as athlete's foot, jock itch, and ringworm. It may also be used for other conditions as determined by your doctor.


Oxistat Cream is an antifungal. It works by killing or preventing the growth of the fungus.


Do NOT use Oxistat Cream if:


  • you are allergic to any ingredient in Oxistat Cream

  • you are taking astemizole or terfenadine

Contact your doctor or health care provider right away if any of these apply to you.



Before using Oxistat Cream:


Some medical conditions may interact with Oxistat Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Oxistat Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin), H1 antagonists (eg, astemizole, terfenadine), or sulfonylureas (eg, glyburide) because their actions and the risk of their side effects may be increased by Oxistat Cream

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxistat Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Oxistat Cream:


Use Oxistat Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Oxistat Cream is for external use only. Avoid contact with the eyes, nose, mouth, genital area, and other mucous membranes.

  • Clean the affected area with soap and water and dry thoroughly.

  • Apply enough medicine to cover the affected area. Rub in gently.

  • Do not cover area with bandages or other occlusive dressings unless directed otherwise by your doctor.

  • Wash your hands immediately after using Oxistat Cream, unless your hands are a part of the treated area.

  • To clear up your infection completely, use Oxistat Cream for the full course of treatment. Keep using it even if you feel better in a few days.

  • If you miss a dose of Oxistat Cream and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Oxistat Cream.



Important safety information:


  • Be sure to use Oxistat Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

  • If your symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxistat Cream while you are pregnant. Oxistat Cream is found in breast milk. Do not breast-feed while taking Oxistat Cream.


Possible side effects of Oxistat Cream:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Mild stinging.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nodules; reddening, blistering, peeling, itching, or burning of skin; scaling; skin cracking; swelling of the hair follicles.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Oxistat side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Oxistat Cream may be harmful if swallowed.


Proper storage of Oxistat Cream:

Store Oxistat Cream between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Keep Oxistat Cream out of the reach of children and away from pets.


General information:


  • If you have any questions about Oxistat Cream, please talk with your doctor, pharmacist, or other health care provider.

  • Oxistat Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Oxistat Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Oxistat resources


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


Compare Oxistat with other medications


  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor

Wednesday, 1 September 2010

Meloxicam-GA




Meloxicam-GA may be available in the countries listed below.


Ingredient matches for Meloxicam-GA



Meloxicam

Meloxicam is reported as an ingredient of Meloxicam-GA in the following countries:


  • Australia

International Drug Name Search

Tuesday, 17 August 2010

Emportal




Emportal may be available in the countries listed below.


Ingredient matches for Emportal



Lactitol

Lactitol monohydrate (a derivative of Lactitol) is reported as an ingredient of Emportal in the following countries:


  • Spain

International Drug Name Search

Friday, 13 August 2010

Dofetilide


Class: Class III Antiarrhythmics
VA Class: CV300
Chemical Name: N-[4-[2-[Methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl] methanesulfonamide
Molecular Formula: C19H27N3O5S2
CAS Number: 115256-11-6
Brands: Tikosyn


Because of the arrhythmogenic potential, hospitalize and monitor closely (provision of Clcr calculations, continuous ECG monitoring, and cardiac resuscitation) patients for 3 days during treatment initiation.1 2 (See Arrhythmogenic Effects under Cautions.) Clinicians and pharmacies in institutions must confirm their participation in a designated Tikosyn educational program before prescribing or ordering the drug.1 2 9 10 12 (See General under Dosage and Administration.)


REMS:


FDA approved a REMS for dofetilide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of dofetilide and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Class III antiarrhythmic agent; a methanesulfonamide derivative.1 2 3 4 5


Uses for Dofetilide


Supraventricular Tachyarrhythmias


Maintenance of normal sinus rhythm in patients with previous atrial fibrillation/atrial flutter of >1 week's duration.1 2 4 5 11 Reserve for patients in whom atrial fibrillation/atrial flutter was highly symptomatic.1 2 4


Conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.1 2 4 5 11 Has not been shown to be effective in patients with paroxysmal atrial fibrillation.1 2


Dofetilide Dosage and Administration


General



  • Initiate therapy and adjust dosage in a hospital setting where the patient can be monitored by personnel trained in the management of serious ventricular arrhythmias.1 2 (See Boxed Warnings.) Closely monitor patients for 3 days (until steady-state plasma concentrations are obtained) whenever treatment is initiated or dosage is increased.1 2 12 When the dosage is increased, the need for rehospitalization is not eliminated by previously successful use of such dosages.1 2




  • Individualize dosage carefully according to calculated Clcr and QTc interval.1 2 Prior to treatment initiation, calculate the Clcr and determine QTc interval.1 2 (See QT Interval Determination under Dosage and Administration.)




  • Administer appropriate anticoagulant therapy in patients with atrial fibrillation.1 2




  • Maintain serum potassium concentrations within the normal range before treatment initiation and during therapy.1 2




  • Must be obtained through a restricted distribution program.1 2 3 4 5 9 10 Not available through community pharmacies.1 2 9 10 12 May verify the status of clinicians who have participated in these programs via the internet ().9 10 12 b For information regarding such educational programs, contact the manufacturer at 877-845-6796.9 10 12 b



Renal Function Assessment



  • Prior to treatment initiation, calculate the Clcr.1 2 Reduce initial dosage if Clcr <60 mL/minute.1 2 (See Table 1.)




  • Because the increase in the QT interval and the risk of ventricular arrhythmias are directly related to plasma drug concentrations, adjust dosage based on calculated Clcr.1 2




  • Estimate the patient’s Clcr by using the following formulas:




  • Reevaluate renal function every 3 months or as medically warranted.1 If renal function deteriorates, adjust dosage.1 (See Table 1.)1 2



Ccr male = [(140 - age) × weight (in kg)] / [72 × serum creatinine (in mg/dL)]Ccr female = 0.85 × Ccr male


QT Interval Determination



  • Prior to treatment initiation, determine the QTc interval using an average of 5–10 beats or the QT interval, if the heart rate is <60 bpm.1 2




  • Use is contraindicated if the QTc interval >440 msec (500 msec in patients with ventricular conduction abnormalities).1 2 (See Contraindications under Cautions.)




  • Within 2–3 hours after administering the first dose, determine the QTc interval again.1 2 Adjust subsequent dosage based on the QTc interval.1 2 (See Table 2.)




  • Within 2–3 hours after each subsequent dose (for in-hospital doses 2–5), determine the QTc interval.1 2 12 No further downward titration of dosage based on QTc interval is recommended.1 2 However, if at any time after the second dose is given the QTc >500 msec (550 msec in patients with ventricular conduction abnormalities), discontinue use.1 2




  • Perform continuous ECG monitoring for a minimum of 3 days or for a minimum of 12 hours after electrical or pharmacologic conversion to normal sinus rhythm, whichever is greater.1 2




  • Reevaluate QTc interval every 3 months or as medically warranted.1 If QTc >500 msec (550 msec in patients with ventricular conduction abnormalities), discontinue use and carefully monitor the patient until the QTc interval returns to baseline values.1 2



Drug Transfer



  • A transition period is recommended prior to initiating therapy in patients receiving other antiarrhythmic agents.1 2 Withhold class I and class III antiarrhythmic agents for ≥3 half-lives prior to initiating dofetilide.1 Withhold amiodarone for ≥3 months or until serum amiodarone concentrations are <0.3 mcg/mL prior to administering dofetilide.1 (See Drugs that Prolong QT Interval under Interactions.)



Administration


Administer orally twice daily without regard to meals.1 2


Dosage


Adults


Supraventricular Tachyarrhythmias

Oral

Initially, 500 mcg twice daily; modify dosage according to Clcr and QTc interval.1 2 12 (See Table 1 and Table 2.)













Table 1. Initial Dosage in Adults Based on Renal Function

Calculated Clcr (mL/minute)



Dosage



>60



500 mcg twice daily



40–60



250 mcg twice daily



20 to <40



125 mcg twice daily



<20



Dofetilide is contraindicated


Within 2–3 hours after administration of the first dose, determine the QTc interval.1 2 If QTc interval has increased by >15% or >500 msec (550 msec in patients with ventricular conduction abnormalities), adjust subsequent dosages as follows:1 2











Table 2. Dosage Modification for QTc Prolongation

Initial Dosage (Based on Clcr)



Adjusted Dosage (for QTc Prolongation)



500 mcg twice daily



250 mcg twice daily



250 mcg twice daily



125 mcg twice daily



125 mcg twice daily



125 mcg once daily


For subsequent monitoring of the QT interval, see QT Interval Determination under Dosage and Administration.


Therapy may be initiated at lower dosages due to the risk of torsades de pointes.1 2


Prescribing Limits


Adults


Supraventricular Tachyarrhythmias

Oral

Dosages >500 mcg twice daily have been associated with an increased incidence of torsades de pointes.1 2 (See Arrhythmogenic Effects under Cautions.)


Special Populations


Hepatic Impairment


No dosage adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh class A or B).1 2 Use with particular caution in patients with severe hepatic insufficiency (Child-Pugh class C).1 2


Renal Impairment


Modify dosage according to the degree of renal impairment.1 2 (See Table 1.) For calculation of the patient's Clcr, see Renal Function Assessment under Dosage and Administration.


Not studied in those undergoing dialysis; dosage recommendations are not known.1


Geriatric Patients


Select dosage with caution because of age-related decreases in renal function.1 2 12 (See Table 1.)


Cautions for Dofetilide


Contraindications



  • Congenital or acquired long QT syndromes; baseline QT or QTc interval >440 msec (500 msec in patients with ventricular conduction abnormalities).1 2




  • Severe renal impairment (calculated Clcr <20 mL/minute).1 2




  • Concomitant use of verapamil or cation transport system inhibitors (e.g., cimetidine, ketoconazole, megestrol, prochlorperazine, or trimethoprim [alone or in combination with sulfamethoxazole]).1 2 b (See Specific Drugs under Interactions.)




  • Concomitant use of hydrochlorothiazide alone or in combination with triamterene.1




  • Known hypersensitivity to dofetilide.1 2 12



Warnings/Precautions


Warnings


Arrhythmogenic Effects

May cause serious ventricular arrhythmias, principally polymorphic ventricular tachycardia associated with QT interval prolongation (i.e., torsades de pointes).1 2 3 4 5 6 7 8 11 Generally occurs within the first 3 days of initiation of therapy.1 2 The risk is threefold greater in women than in men.1 2 (See Boxed Warnings.)


Reduce risk of torsades de pointes by controlling the plasma concentration (e.g., adjustment of initial dofetilide dosage according to Clcr, avoiding certain drug interactions) and monitoring the ECG for excessive increases in the QT interval.1 2


Mortality

Limited evidence suggests a possible excess mortality as a result of dofetilide use.1


General Precautions


Cardiovascular Conduction

No apparent adverse effects on conduction velocity.1 2 AV nodal conduction unaffected in normal volunteers or in patients with first degree heart block.1 2 Used safely in conjunction with pacemakers.1 2


Metabolic Effects

Hypokalemia or hypomagnesemia may increase the risk of torsades de pointes.1 2 Closely monitor patients experiencing prolonged or excessive diarrhea, sweating, vomiting, loss of appetite, or thirst.1 2 Closely monitor patients receiving concomitant therapy with drugs that may increase the risk of such electrolyte imbalance (e.g., diuretics).1 2 (See Specific Drugs under Interactions.)


Specific Populations


Pregnancy

Category C.1 2


Lactation

Not known whether dofetilide is distributed into milk.1 2 Use not recommended.1 2


Pediatric Use

Safety and efficacy not established.1 2


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 2 Select dosage with caution because of age-related decreases in renal function.1 2 12


Renal Impairment

If clearance is decreased, dosage adjustments are necessary depending on degree of renal impairment.1 b Safety and efficacy not established in patients with Clcr <20 mL/minute.1 2 (See Table 1 under Dosage and Administration for dosage adjustment based on Clcr.)


Hepatic Impairment

Not studied in patients with severe hepatic impairment; use with particular caution in these patients.1 2 (See Hepatic Impairment under Dosage and Administration.)


Common Adverse Effects


Headache, chest pain, dizziness.1


Interactions for Dofetilide


Metabolized by CYP3A4,1 a but has a low affinity for this isoenzyme.1 Does not inhibit CYP isoenzymes.b


Carefully screen patient's medication history, including all OTC, prescription, and herbal/natural preparations with emphasis on those that may affect dofetilide pharmacokinetics.1 b If discontinuance of dofetilide is necessary to permit administration of potentially interacting drug(s), allow a washout period of at least 2 days.1 b


Drugs Inhibiting Renal Tubular Cationic Transport


Pharmacokinetic interaction (decreased dofetilide elimination).1 2 12 May increase the risk of torsades de pointes1 2 12 (See Elimination under Pharmacokinetics, and see Contraindications under Cautions.) Use concurrent therapy with care.1


Drugs Secreted by Renal Tubular Cationic Transport


Potential pharmacokinetic interaction (decreased dofetilide elimination and increased plasma concentration).1 2 12 May increase risk of torsades de pointes.1 2 12


Use concurrent therapy with care.1


Substances Affecting Hepatic Microsomal Enzymes


Inhibitors of CYP3A4: Potential pharmacokinetic interaction (decreased dofetilide metabolism and possible increased systemic exposure).1 2 12 Concomitant use not recommended.1 12 b


Drugs that Prolong QT Interval


Potential pharmacodynamic interaction (increased risk of ventricular arrhythmias).1 2 Concomitant use not recommended.1 12 b


Specific Drugs and Foods






























































































































Drug or Food



Interaction



Comments



Amiloride



Potential decreased dofetilide elimination and increased plasma dofetilide concentrations;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1



Amiodarone



Potential increased plasma dofetilide concentrations;1 possible increased risk of ventricular arrhythmias1



Withhold amiodarone for at least 3 months or until serum amiodarone concentrations are <0.3 mcg/mL prior to administering dofetilide1



Amlodipine



Pharmacokinetic interaction unlikely1 b



Antacids (aluminum or magnesium hydroxides)



Pharmacokinetic interaction unlikely1 b



Consider as alternative therapy for cimetidine1 b



Antiarrhythmic agents



Possible increased risk of ventricular arrhythmias1 2



Concomitant use not recommended.1 b 12 Withhold class I and class III antiarrhythmic agents for at least 3 half-lives prior to initiating dofetilide1



Antidepressants, tricyclic



Possible increased risk of ventricular arrhythmias1 2



Concomitant use not recommended1 b 12



Antifungal agents, azole



Potential decreased dofetilide metabolism and possible increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use certain azoles concomitantly with caution1 b


Concomitant use of ketoconazole is contraindicated1 2



Antiretroviral agents, HIV protease inhibitors



Potential decreased dofetilide metabolism and possible increased systemic exposure;1 2 12 possible increased risk of torsades de pointes2 12



Use concomitantly with caution1 b



Bepridil



Possible increased risk of ventricular arrhythmias1 2



Concomitant use not recommended1 b 12



Cannabinoids



Potential decreased dofetilide metabolism and possible increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Cimetidine



Decreased dofetilide elimination; possible increased risk of torsades de pointes1 2 12



Concomitant use contraindicated1 2



Cisapride



Possible increased risk of ventricular arrhythmias1 2



Concomitant use not recommended1 b 12



Digoxin



Pharmacokinetic interaction unlikely.1 2 Uncertain potential pharmacodynamic interaction (increased risk of torsades de pointes).1



Diltiazem



Potential decreased dofetilide metabolism and possible increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Diuretics, potassium-depleting



Possible increased risk of electrolyte imbalance (i.e., hypokalemia or hypomagnesemia) and increased risk of torsades de pointes1 2



Close monitoring recommended during concomitant therapy1 2


Concomitant use of hydrochlorothiazide or in combination with triamterene is contraindicated1 2



Glyburide



Pharmacokinetic interaction with dofetilide unlikely1



Grapefruit juice



Potential decreased dofetilide metabolism and possible increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Hormone replacement therapy



Pharmacokinetic interaction unlikely1 b



Hydrochlorothiazide (with or without triamterene)



Increased dofetilide AUC and peak plasma concentrations;1 possible increased risk of QT interval prolongation1



Concomitant use contraindicated1



Ketoconazole



Decreased dofetilide elimination;1 2 possible increased risk of torsades de pointes1 2 12



Concomitant use contraindicated1 2



Macrolides, oral



Possible increased risk of ventricular arrhythmias1 2



Concomitant use not recommended1 b 12



Megestrol



Decreased dofetilide elimination;1 2 possible increased risk of torsades de pointes1 2 12



Concomitant use contraindicated1 2



Metformin



Decreased dofetilide elimination and increased plasma dofetilide concentration;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Nefazodone



Potential decreased dofetilide metabolism and increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Norfloxacin



Potential decreased dofetilide metabolism and increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Omeprazole



Pharmacokinetic interaction unlikely1 2



Consider as alternative therapy for cimetidine1 b



Oral contraceptives



Pharmacokinetic interaction unlikely1 b



Phenothiazines



Possible increased risk of ventricular arrhythmias1 2



Concomitant use not recommended1



Phenytoin



Pharmacokinetic interaction unlikely1 b



Prochlorperazine



Decreased dofetilide elimination;1 2 possible increased risk of torsades de pointes1 2 12



Concomitant use contraindicated1 2



Propranolol



Pharmacokinetic interaction unlikely1 b



Quinine



Potential decreased dofetilide metabolism and increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Ranitidine



Pharmacokinetic interaction unlikely1 2



Consider ranitidine as alternative therapy for cimetidine1 b



SSRIs



Potential decreased dofetilide metabolism and increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b



Theophylline



Pharmacokinetic interaction unlikely1 2



Triamterene



Potential decreased dofetilide elimination and increased plasma concentrations1 2 12



Use concomitantly with caution1 b


Concomitant use of hydrochlorothiazide in combination with triamterene is contraindicated1 2



Trimethoprim (with or without sulfamethoxazole)



Decreased dofetilide elimination;2 possible increased risk of torsades de pointes1 2 12



Concomitant use contraindicated1 2



Verapamil



Increased plasma dofetilide concentrations;1 2 possible increased risk of torsades de pointes1 2 12



Concomitant use contraindicated1 2



Warfarin



Pharmacodynamic or pharmacokinetic interaction unlikely1 2



Zafirlukast



Potential decreased dofetilide metabolism and possible increased systemic exposure;1 2 12 possible increased risk of torsades de pointes1 2 12



Use concomitantly with caution1 b


Dofetilide Pharmacokinetics


Absorption


Bioavailability


Absolute bioavailability is >90%.1 a Peak plasma concentrations are attained within 2–3 hours.a Steady-state plasma concentrations are attained within 2–3 days.1


Food


Food delays absorption but does not affect total bioavailability.2


Distribution


Extent


Apparent volume of distribution is 3 L/kg.1 In animal studies, in utero growth and survival is affected adversely.1 Not known whether dofetilide is distributed into human milk.1


Plasma Protein Binding


60–70%.1 a


Elimination


Metabolism


Metabolized by CYP3A4,1 a but the drug has a low affinity for this isoenzyme.1


Elimination Route


Excreted principally in urine (80%); urinary excretion is mainly as unchanged drug (80%) and inactive or minimally active metabolites (20%).1 Eliminated via glomerular filtration and active tubular secretion.1


Half-life


Terminal half-life is approximately 10 hours.1 2


Special Populations


With decreasing Clcr (renal impairment), the overall drug systemic clearance is decreased and plasma concentration increased.1 Not known whether hemodialysis removes dofetilide from plasma.1


Pharmacokinetics not altered in patients with mild to moderate hepatic insufficiency (Child-Pugh class C).1 Pharmacokinetics not studied in patients with severe hepatic insufficiency (Child-Pugh class C).1 2


Stability


Storage


Oral


Capsules and Tablets

15–30°C in tight, well closed containers.1 Protect from moisture and humidity.1


Actions



  • More selective in its cellular actions than some other class III antiarrhythmic agents (e.g., amiodarone, sotalol).4 5 7 11




  • Prolongs the action potential duration and effective refractory period in both atrial and ventricular cardiac tissue, principally due to delayed repolarization.1 2 4 5 11 Selectively inhibits the rapidly activating component of the potassium channel (delayed rectifier potassium current IKr) involved in repolarization of cardiac cells.1 2 3 4 5 8 11




  • Does not affect cardiac conduction velocity and sinus node function.1 2 4 5 7 11 Has no effect on sodium channels (associated with class I antiarrhythmic agents) or β- or α-adrenergic receptors at clinically relevant concentrations.1 2 4 11




  • Negligible effects on heart rate or BP.2 4 5 11 12 May improve slightly cardiac contractility.2 4 5 11 12



Advice to Patients



  • Importance of reading the manufacturer’s patient information prior to beginning therapy and rereading it each time the prescription is refilled in case patient status has changed.1 2




  • Importance of informing a clinician immediately if new rapid heartbeats, lightheadedness, or fainting occur.1 2 If a clinician cannot be contacted, proceed to the nearest hospital emergency room.1 2




  • Importance of informing a clinician immediately if excessive or prolonged diarrhea, sweating, vomiting, or loss of appetite or thirst occurs.1




  • Importance of adherence to dosage and medical appointment schedule.1 2 Take drug at same time each day and omit any missed doses.1 2




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.1 2




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2




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



Preparations


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


Distribution of dofetilide is restricted. (See General under Dosage and Administration.)























Dofetilide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



0.125 mg



Tikosyn



Pfizer



0.25 mg



Tikosyn



Pfizer



0.5 mg



Tikosyn



Pfizer


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Tikosyn 125MCG Capsules (PFIZER U.S.): 60/$245.15 or 180/$714.17


Tikosyn 250MCG Capsules (PFIZER U.S.): 60/$246.98 or 180/$719.96


Tikosyn 500MCG Capsules (PFIZER U.S.): 60/$245.99 or 120/$474.98



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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Pfizer. Tikosyn (dofetilide) capsules prescribing information. New York, NY; 2004 Mar.



2. Pfizer. Tikosyn (dofetilide) product monograph and confirmation of education. New York, NY. From Tikosyn web site (). 2000 March.



3. Anon. Dofetilide for atrial fibrillation. Med Lett Drugs Ther. 2000; 42:41-2.



4. Kalus JS, Mauro VF. Dofetilide: a class III-specific antiarrhythmic agent. Ann Pharmacother. 2000; 34:44-56. [IDIS 439892] [PubMed 10669186]



5. Lenz TL, Hilleman DE. Dofetilide, a new class III antiarrhythmic agent. Pharmacotherapy. 2000; 20:776-86. [IDIS 449491] [PubMed 10907968]



6. Greenbaum RA, Campbell TJ, Channer KS et al. Conversion of atrial fibrillation and maintenance of sinus rhythm by dofetilide: the EMERALD (European and Australian Multicenter Evaluative Research on Atrial Fibrillation Dofetilide) study. Circulation. 1998; 98(Suppl I):I-633. Abstract No. 3326.



7. Torp-Pedersen C, Moller M, Bloch-Thomsen PE et al for the Danish Investigations of Arrhythmia and Mortality on Dofetilide Study Group. Dofetilide in patients with congestive heart failure and left ventricular dysfunction. N Engl J Med. 1999; 341:857-65.



8. Stevenson WG, Stevenson LW. Atrial fibrillation in heart failure. N Engl J Med. 1999; 341:910-1. Editorial. [IDIS 434468] [PubMed 10486424]



9. Pfizer. Become a confirmed TIKOSYN prescriber. From web site. Accessed October 11, 2000.



10. Pfizer. Become a confirmed TIKOSYN institution. From web site. Accessed October 11, 2000.



11. McClellan KJ, Markham A. Dofetilide: a review of its use in atrial fibrillation and atrial flutter. Drugs. 1999; 58:1043-59. [PubMed 10651390]



12. Pfizer, New York, NY: Personal communication.



a. Mounsey JP, DiMarco JP. Dofetilide Circulation. 2000; 102:2665-70.



b. Pfizer. Tikosyn (dofetilide) product monograph and confirmation of education. New York, NY. From Tikosyn web site. 2002 March.



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