Wednesday, October 5, 2016

doxazosin



dox-AZ-oh-sin


Commonly used brand name(s)

In the U.S.


  • Cardura

  • Cardura XL

Available Dosage Forms:


  • Tablet, Extended Release

  • Tablet

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Alpha-1 Adrenergic Blocker


Uses For doxazosin


Doxazosin belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension).


High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Doxazosin works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.


Doxazosin is also used to treat benign (noncancerous) enlargement of the prostate (benign prostatic hyperplasia [BPH]). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems in urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.


Doxazosin helps relax the muscles in the prostate and the opening of the bladder. This may help increase the flow of urine and/or decrease the symptoms. However, doxazosin will not shrink the prostate. The prostate may continue to get larger. This may cause the symptoms to become worse over time. Therefore, even though doxazosin may lessen the problems caused by enlarged prostate now, surgery still may be needed in the future.


Doxazosin is available only with your doctor's prescription.


Before Using doxazosin


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 doxazosin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to doxazosin 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


Studies on doxazosin have been done only in adult patients, and there is no specific information comparing use of doxazosin in children with use in other age groups.


Geriatric


Dizziness, lightheadedness, or fainting may be especially likely to occur in elderly patients with high blood pressure, because these patients are usually more sensitive than younger adults to the effects of doxazosin.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking doxazosin, 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 doxazosin 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.


  • Acebutolol

  • Alprenolol

  • Atenolol

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bucindolol

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Dilevalol

  • Esmolol

  • Labetalol

  • Levobunolol

  • Mepindolol

  • Metipranolol

  • Metoprolol

  • Nadolol

  • Nebivolol

  • Nifedipine

  • Oxprenolol

  • Penbutolol

  • Pindolol

  • Propranolol

  • Sildenafil

  • Sotalol

  • Tadalafil

  • Talinolol

  • Tertatolol

  • Timolol

  • Vardenafil

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Gastrointestinal (stomach and intestines) blockage—May increase the effect of doxazosin which could increase the chance of side effects.

  • Heart problems—May make condition worse.

  • Hypotension (decrease in blood pressure)—Possible increased chance of fainting, especially after the first dose or a dose increase of doxazosin.

  • Kidney disease—Possible increased sensitivity to the effects of doxazosin

  • Liver disease—The effects of doxazosin may be increased, which may increase the chance of side effects

  • Prostate cancer—Your doctor will want to make sure that you do not have prostate cancer before starting you on doxazosin.

Proper Use of doxazosin


For the regular tablet—To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.


For the extended-release tablet—


  • Take in the morning with breakfast each day.

  • Swallow whole. Do not crush or chew.

  • Your doctor will not prescribe the extended-release tablet form of doxazosin for high blood pressure. It can only be used in men for benign enlargement of the prostate.

For patients taking doxazosin for high blood pressure :


  • In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

  • Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

  • Remember that doxazosin will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

For patients taking doxazosin for benign enlargement of the prostate:


  • Remember that doxazosin will not shrink the size of your prostate but it does help to relieve the symptoms of this condition. You may still need to have surgery later.

  • It may take up to 2 weeks before your symptoms improve.

Dosing


The dose of doxazosin 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 doxazosin. 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 (tablets):
    • For benign enlargement of the prostate:
      • Adults—At first, 1 milligram (mg) once a day, in the morning or in the evening. Your doctor may increase your dose slowly up to 8 mg once a day.


    • For high blood pressure:
      • Adults—1 mg once a day to start. Your doctor may increase your dose slowly to as much as 16 mg once a day.

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



  • For oral dosage form (extended-release tablets):
    • For benign enlargement of the prostate:
      • Adults—At first, 4 milligram (mg) once a day, in the morning with breakfast. Your doctor may increase your dose slowly up to 8 mg once a day.



Missed Dose


If you miss a dose of doxazosin, 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.


Precautions While Using doxazosin


It is important that your doctor check your progress at regular visits to make sure that doxazosin is working properly. This is especially important for elderly patients, who may be more sensitive to the effects of doxazosin.


For patients taking doxazosin for high blood pressure :


  • Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness, lightheadedness, or sudden fainting may occur after you take doxazosin, especially when you get up from a lying or sitting position. These effects are more likely to occur when you take the first dose of doxazosin. Taking the first dose at bedtime may prevent problems. However, be especially careful if you need to get up during the night. These effects may also occur with any doses you take after the first dose. Getting up slowly may help lessen this problem. If you feel dizzy, lie down so that you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.


The dizziness, lightheadedness, or sudden fainting is more likely to occur if you drink alcohol, stand for a long time, exercise, or if the weather is hot. While you are taking doxazosin, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for a long time.


Doxazosin may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to doxazosin before you drive, use machines, or do anything else that could be dangerous if you are dizzy, drowsy, or are not alert. After you have taken several doses of doxazosin, these effects should lessen.


The possibility of priapism, a painful or prolonged erection of the penis, is a rare side effect that can occur when taking doxazosin and must have immediate medical attention.


doxazosin 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 as soon as possible if any of the following side effects occur:


More common
  • Dizziness or lightheadedness

Less common
  • Blurred vision

  • confusion

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

  • fainting (sudden)

  • fast and pounding heartbeat

  • irregular heartbeat

  • shortness of breath

  • sweating

  • swelling of feet or lower legs

Rare
  • Painful or prolonged erection of the penis (called priapism), although extremely rare, must have immediate medical attention. If painful or prolonged erection occurs, call your doctor or go to an emergency room as soon as possible

Incidence not known
  • Abdominal or stomach pain

  • area rash

  • black, tarry stools

  • bleeding gums

  • blood in urine or stools

  • chest pain or discomfort

  • chills

  • clay-colored stools

  • cough

  • dark urine

  • diarrhea

  • difficulty breathing

  • difficult, burning, or painful urination

  • fever

  • general tiredness and weakness

  • headache, sudden and severe

  • inability to speak

  • itching

  • lab results that show problems with liver

  • light-colored stools

  • loss of appetite

  • noisy breathing

  • pain or discomfort in arms, jaw, back or neck

  • pinpoint red or purple spots on skin

  • rash

  • seizures

  • slow or irregular heartbeat

  • slurred speech

  • sore throat

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

  • swollen glands

  • temporary blindness

  • tightness in chest

  • unpleasant breath odor

  • unusual bleeding or bruising

  • upper right abdominal pain

  • vomiting

  • vomiting of blood

  • weakness in arm and/or leg on one side of the body, sudden and severe

  • wheezing

  • yellow eyes and skin

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


More common
  • Headache

  • lack or loss of strength

  • unusual tiredness or weakness

Less common
  • Acid or sour stomach

  • back pain

  • belching

  • bladder pain

  • cloudy urine

  • difficulty in moving

  • frequent urge to urinate

  • heartburn

  • indigestion

  • joint pain

  • lower back or side pain

  • muscle aching, cramping, or weakness

  • muscle pains or stiffness

  • nausea

  • nervousness, restlessness, unusual irritability

  • runny nose

  • sleepiness or drowsiness

  • sneezing

  • sore throat

  • stomach discomfort, upset or pain

  • swollen joints

Incidence not known
  • Anxiety

  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling

  • change in frequency or urination

  • dry mouth

  • feeling of warmth

  • frequent urination

  • general feeling of discomfort or illness

  • hair loss

  • hives or welts

  • hyperventilation

  • increased urge to urinate during the night

  • increased volume of pale dilute urine

  • loss of appetite

  • painful urination

  • redness of skin

  • redness of the face, neck, arms and occasionally upper chest

  • shaking

  • swelling of the breasts or breast soreness in both females and males

  • thinning of hair

  • trouble in holding or releasing urine

  • trouble sleeping

  • waking to urinate at night

  • weight loss

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: doxazosin side effects (in more detail)



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More doxazosin resources


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


  • Doxazosin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Doxazosin Prescribing Information (FDA)

  • Cardura Prescribing Information (FDA)

  • Cardura Monograph (AHFS DI)

  • Cardura Consumer Overview

  • Cardura XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cardura XL Prescribing Information (FDA)



Compare doxazosin with other medications


  • Benign Prostatic Hyperplasia
  • High Blood Pressure
  • Raynaud's Syndrome

dorzolamide and timolol ophthalmic


Generic Name: dorzolamide and timolol ophthalmic (dor ZOLE a mide and TYE moe lol off THAL mik)

Brand Names: Cosopt


What is dorzolamide and timolol ophthalmic?

Dorzolamide ophthalmic reduces the amount of fluid in the eye, which decreases pressure inside the eye.


Timolol ophthalmic is a beta-blocker that also reduces pressure inside the eye.


The combination of dorzolamide and timolol ophthalmic (for the eyes) is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Dorzolamide and timolol ophthalmic may also be used for purposes not listed in this medication guide.


What is the most important information I should know about dorzolamide and timolol ophthalmic?


Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using dorzolamide and timolol ophthalmic. Do not use the medications at the same time.


Dorzolamide and timolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

What should I discuss with my healthcare provider before using dorzolamide and timolol ophthalmic?


You should not use this medication if you are allergic to dorzolamide (Cosopt or Trusopt) or timolol (Blocadren, Betimol, Istalol, Timoptic), or if you have:

  • a history of asthma;




  • chronic obstructive pulmonary disease (COPD); or




  • a serious heart condition such as "AV block," slow heartbeats, heart failure, or if you have recently had a heart attack.



To make sure you can safely use dorzolamide and timolol ophthalmic, tell your doctor if you have any of these other conditions:



  • narrow-angle glaucoma;




  • breathing problems such as bronchitis or emphysema;




  • a history of heart disease or congestive heart failure;




  • diabetes;




  • a muscle disorder such as myasthenia gravis;




  • kidney disease;




  • liver disease; or




  • a thyroid disorder.




FDA pregnancy category C. It is not known whether dorzolamide and timolol ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dorzolamide and timolol ophthalmic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using this medicine. Do not use this medicine in a child younger than 2 years old.

How should I use dorzolamide and timolol ophthalmic?


Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Wash your hands before using the eye drops.

To apply the eye drops:



  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.




  • Use only the number of drops your doctor has prescribed.




  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.




  • If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop. Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.




Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.


Tell your doctor right away if you have any eye injury or infection, or if you need to have any type of surgery, especially eye surgery. You may need to stop using dorzolamide and timolol ophthalmic for a short time.


Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?


Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include feeling short of breath, confusion, muscle pain or weakness, fast or slow heart rate, wheezing, trouble breathing, chest pain, fainting, or seizure (convulsions).


What should I avoid while using dorzolamide and timolol ophthalmic?


Dorzolamide and timolol ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use other eye medications during treatment with dorzolamide and timolol ophthalmic unless your doctor tells you to.


Dorzolamide and timolol ophthalmic side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when dorzolamide and timolol is used in the eyes, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.


Stop using dorzolamide ophthalmic and call your doctor at once if you have a serious side effect such as:

  • swelling or redness of your eyelids;




  • eye redness, pain, discomfort, or sensitivity to light;




  • drainage, crusting, or oozing of your eyes or eyelids;




  • wheezing, gasping, or other breathing problems;




  • swelling, rapid weight gain;




  • feeling short of breath, even with mild exertion; or




  • severe skin reaction: fever, sore throat, cough, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.



Less serious side effects may include:



  • blurred vision, cloudy vision, double vision, drooping eyelid;




  • dry or watery eyes;




  • bitter or unusual taste in your mouth;




  • burning, stinging, or itching in your eyes;




  • cough, flu symptoms;




  • dry eyes;




  • nausea, upset stomach;




  • sore throat, stuffy nose;




  • dizziness, headache; or




  • stomach or back pain.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Dorzolamide and timolol ophthalmic Dosing Information


Usual Adult Dose for Intraocular Hypertension:

Instill 1 drop into the affected eye(s) twice daily.

Usual Adult Dose for Glaucoma (Open Angle):

Instill 1 drop into the affected eye(s) twice daily.

Usual Pediatric Dose for Intraocular Hypertension:

2 years or older:
Instill 1 drop into the affected eye(s) twice daily.

Usual Pediatric Dose for Glaucoma (Open Angle):

2 years or older:
Instill 1 drop into the affected eye(s) twice daily.


What other drugs will affect dorzolamide and timolol ophthalmic?


Tell your doctor about all other medicines you use, especially:



  • cimetidine (Tagamet);




  • clonidine (Catapres);




  • clozapine (Clozaril, FazaClo);




  • digitalis (digoxin, Lanoxin, Lanoxicaps);




  • isoniazid (for treating tuberculosis);




  • methimazole (Tapazole);




  • pioglitazone (Actos);




  • reserpine;




  • ropinirole (Requip);




  • terbinafine (Lamisil);




  • ticlopidine (Ticlid);




  • an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);




  • anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;




  • heart or blood pressure medication such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;




  • a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);




  • HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir, Kaletra);




  • medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril); or




  • other glaucoma medications such as acetazolamide (Diamox), brinzolamide (Azopt), or methazolamide (Neptazane).



This list is not complete and other drugs may interact with dorzolamide and timolol ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More dorzolamide and timolol ophthalmic resources


  • Dorzolamide and timolol ophthalmic Side Effects (in more detail)
  • Dorzolamide and timolol ophthalmic Dosage
  • Dorzolamide and timolol ophthalmic Use in Pregnancy & Breastfeeding
  • Dorzolamide and timolol ophthalmic Drug Interactions
  • Dorzolamide and timolol ophthalmic Support Group
  • 0 Reviews for Dorzolamide and timolol - Add your own review/rating


Compare dorzolamide and timolol ophthalmic with other medications


  • Glaucoma, Open Angle
  • Intraocular Hypertension


Where can I get more information?


  • Your pharmacist can provide more information about dorzolamide and timolol ophthalmic.

See also: dorzolamide and timolol side effects (in more detail)


doxepin



Generic Name: doxepin (Sinequan) (DOX e pin)

Brand Names: SINEquan


What is doxepin (Sinequan)?

Doxepin is in a group of drugs called tricyclic antidepressants. Doxepin affects chemicals in the brain that may become unbalanced.


Doxepin (Sinequan or other generic name) is used to treat symptoms of depression and/or anxiety associated with alcoholism, psychiatric conditions, or manic-depressive conditions.


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


What is the most important information I should know about doxepin (Sinequan)?


You should not use doxepin if you are allergic to it, or if you have glaucoma or problems with urination. Do not use doxepin if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take doxepin before the MAO inhibitor has cleared from your body.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.



Video: Treatment for Depression







Treatments for depression are getting better everyday and there are things you can start doing right away.





Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking doxepin (Sinequan)?


You should not use doxepin if you are allergic to it, or if you have glaucoma or problems with urination. Do not use doxepin if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take doxepin before the MAO inhibitor has cleared from your body.

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



  • sleep apnea (breathing stops during sleep); or




  • bipolar disorder (manic-depression).




  • diabetes (doxepin may raise or lower blood sugar).



You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.


Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.


FDA pregnancy category C. It is not known whether doxepin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether doxepin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give doxepin to anyone younger than 18 years old without the advice of a doctor.

How should I take doxepin (Sinequan)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Your doctor may occasionally change your dose to make sure you get the best results.


Measure doxepin oral concentrate (liquid) with the special dose-measuring dropper provided. Do not use a regular table spoon. If you do not have a dose-measuring dropper, ask your pharmacist for one.


Empty the measured dose from the medicine dropper into a small glass (4 ounces) of water, milk, orange juice, grapefruit juice, tomato juice, prune juice, or pineapple juice. Do not use grape juice or a carbonated soft drink to mix doxepin oral concentrate. Stir the mixture and drink all of it right away. Do not save it for later use.


It may take 2 to 3 weeks before your depression symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve. Do not stop using doxepin suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using doxepin. Store at room temperature away from moisture, heat, and light.

See also: Doxepin dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of doxepin can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, agitation, vomiting, dilated pupils, blurred vision, confusion, hallucinations, feeling hot or cold, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.


What should I avoid while taking doxepin (Sinequan)?


Do not drink alcohol. Doxepin can increase the effects of alcohol, which could be dangerous. Doxepin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Doxepin (Sinequan) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.


Call your doctor at once if you have any of these serious side effects:

  • fast heart rate;




  • confusion, hallucinations, unusual thoughts, seizure (convulsions);




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




  • feeling like you might pass out;




  • restless muscle movements in your eyes, tongue, jaw, or neck;




  • tremors or uncontrollable shaking;




  • urinating less than usual or not at all; or




  • extreme thirst with headache, nausea, vomiting, and weakness.



Less serious side effects may include:



  • feeling dizzy, drowsy, or tired;




  • nausea, vomiting, diarrhea, constipation, loss of appetite;




  • dry mouth, increased sweating;




  • weight gain;




  • lack of coordination;




  • numbness or tingly feeling;




  • blurred vision, headache, ringing in your ears;




  • mild skin rash or itching;




  • decreased sex drive; or




  • breast swelling (in men).



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Doxepin Dosing Information


Usual Adult Dose for Anxiety:

For Mild Anxiety:
Initial dose: 25 mg per day in 1 to 3 divided doses.
Maintenance dose: 25 to 50 mg per day in 1 to 3 divided doses.

For Moderate Anxiety:
Initial dose: 75 mg per day in 1 to 3 divided doses.
Maintenance dose: 75 to 150 mg per day in 1 to 3 divided doses.

For Severe Anxiety:
Initial dose: 150 mg per day in 1 to 3 divided doses.
Maintenance dose: 150 to 300 mg per day in 1 to 3 divided doses.

The maximum single dose should not exceed 150 mg.

Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg per day. Antianxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for 2 to 3 weeks.

Dose selection for the geriatric patient should start at the lower end of the dosing range.

Usual Adult Dose for Depression:

For Mild Depression:
Initial dose: 25 mg per day in 1 to 3 divided doses.
Maintenance dose: 25 to 50 mg per day in 1 to 3 divided doses.

For Moderate Depression:
Initial dose: 75 mg per day in 1 to 3 divided doses.
Maintenance dose: 75 to 150 mg per day in 1 to 3 divided doses.

For Severe Depression:
Initial dose: 150 mg per day in 1 to 3 divided doses.
Maintenance dose: 150 to 300 mg per day in 1 to 3 divided doses.

The maximum single dose should not exceed 150 mg.

Additional therapeutic effect is rarely to be obtained by exceeding a dose of 300 mg per day. Antianxiety effect is apparent before the antidepressant effect. Optimal antidepressant effect may not be evident for 2 to 3 weeks.

Dose selection for the geriatric patient should start at the lower end of the dosing range.

Usual Adult Dose for Urticaria:

Studies:
10 mg orally three times daily.

Usual Adult Dose for Insomnia:

Recommended dose: 6 mg orally once daily
A 3 mg orally once daily dose may be appropriate for some patients, if clinically indicated.
Doxepin should be taken within 30 minutes of bedtime.
To minimize the potential for next day effects, doxepin should not be taken within 3 hours of a meal.
The total doxepin dose should not exceed 6 mg per day.

Usual Geriatric Dose for Insomnia:

Recommended starting dose in patients 65 years old or older: 3 mg orally once daily
The daily dose can be increased to 6 mg orally once daily, if clinically indicated.
Doxepin should be taken within 30 minutes of bedtime.
To minimize the potential for next day effects, doxepin should not be taken within 3 hours of a meal.
The total doxepin dose should not exceed 6 mg per day.


What other drugs will affect doxepin (Sinequan)?


Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by doxepin. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.

Before taking doxepin, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).


Tell your doctor about all other medicines you use, especially:



  • cimetidine (Tagamet);




  • tolazamide (Tolinase);




  • heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Quin-G); or




  • phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine), and others.




There are many other drugs that can interact with doxepin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More doxepin resources


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


  • doxepin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Doxepin Prescribing Information (FDA)

  • Doxepin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Doxepin Hydrochloride Monograph (AHFS DI)

  • Silenor Consumer Overview

  • Sinequan Prescribing Information (FDA)

  • Sinequan Monograph (AHFS DI)

  • Sinequan MedFacts Consumer Leaflet (Wolters Kluwer)



Compare doxepin with other medications


  • Anxiety
  • Depression
  • Insomnia
  • Irritable Bowel Syndrome
  • Reflex Sympathetic Dystrophy Syndrome
  • Urticaria


Where can I get more information?


  • Your pharmacist can provide more information about doxepin (Sinequan).


Doxycycline Hyclate




Doxycycline Hyclate CAPSULES, USP

Rev. 11/11

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Hyclate capsules and other antibacterial drugs. Doxycycline Hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.



Doxycycline Hyclate Description


Doxycycline Hyclate is a broad-spectrurn antibiotic synthetically derived from oxytetracycline. The structural formula is as follows:



with a molecular formula of C22H24N2O8•H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 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. Doxycycline is a light yellow crystalline powder. Doxycycline Hyclate is soluble in water.


Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.


Each capsule for oral administration contains Doxycycline Hyclate equivalent to 100 mg of doxycycline (anhydrous).  Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.


100 mg gelatin capsule shell contains: FD&C Blu e#1, silicon dioxide, sodium lauryl sulfate and titanium dioxide.  The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A, Alcohol and Synthetic Black Iron Oxide.



Doxycycline Hyclate - Clinical Pharmacology


Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.


Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours decreasing to 1.45 mcg/mL at 24 hours. Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min). This percentage excretion may fall as low as 1-5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18-22 hours) in individuals with normal and severely impaired renal function.


Hemodialysis does not alter serum half-life.


Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.



Microbiology


The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracyclines is common.



Gram-Negative Bacteria


Neisseria gonorrhoeae

Calymmatobacterium granulomatis

Haemophilus ducreyi

Haemophilus influenzae

Yersinia pestis (formerly Pasteurella pestis)

Francisella tularensis (formerly Pasteurelia tularensis)

Vibrio cholera (formerly Vibrio comma)

Bartonella bacilliformis

Brucella species


Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended:


Escherichia coli

Klebsiella species

Enterobacter aerogenes

Shigella species

Acinetobacter species (formerly Mima species and Herellea species)

Bacteroides species



Gram-Positive Bacteria


Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.


Streptococcus pyogenes

Streptococcus pneumoniae

Enterococcus group (Streptococcus faecalis and Streptococcus faecium)

Alpha-hemolytic streptococci (viridans group)



Other Microorganisms


















  Rickettsiae  Clostridium species
  Chlamydia psittaci  Fusobacterium fusiforme
  Chlamydia trachomatis  Actinomyces species
  Mycoplasma pneumoniae  Bacillus anthracis
  Ureaplasma urealyticum  Propionbacterium acnes
  Borrelia recurrentis  Entamoeba species
  Treponema pallidum  Balantidium coli
  Treponema pertenue  Plasmodium falciparum

Doxycycline has been found to be active against the asexual erythrocytic forms of Plasmodium falciparum but not against the gametocytes of P. falciparum. The precise mechanism of action of the drug is not known.


Susceptibility tests

Diffusion techniques: Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents. One such standard procedure1 has been recommended for use with disks to test susceptibility or organisms to doxycycline, uses the 30-mcg tetracycline-class disk or the 30- mcg doxycycline disk. Interpretation involves the correlation of the diameter obtained in the disk test with the minimum inhibitory concentration (MIC) for tetracycline or doxycycline, respectively.


Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30-mcg tetracycline-class disk or the 30-mcg doxycycline disk should be interpreted according to the following criteria:
















  Zone Diameter (mm)  Interpretation
  tetracycline  doxycycline  
  ≥19  ≥16  Susceptible
  15-18  13-15  Intermediate
  ≤14  ≤12  Resistant

A report of “Susceptible” indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of “Intermediate” suggests that the organism would be susceptible if a high dosage is used or if the infection is confined to tissues and fluids in which antimicrobial levels are attained. A report of “Resistant” indicates that achievable concentrations are unlikely to be inhibitory, and other therapy should be selected.


Standardized procedures require the use of laboratory control organisms. The 30-mcg tetracycline-class disk or the 30-mcg doxycycline disk should give the following zone diameters:













  Organism  Zone Diameter (mm)
    tetracycline  doxycycline
  E. coli ATCC 25922  18-25  18-24
  S. aureus ATCC 25923  19-28  23-29

Dilution techniques


Use a standardized dilution method2 (broth, agar, microdilution) or equivalent with tetracycline powder. The MIC values obtained should be interpreted according to the following criteria:










  MIC (mcg/mL)  Interpretation
  ≤4  Susceptible
  8  Intermediate
  ≥16  Resistant

As with standard diffusion techniques, dilution methods require the use of laboratory control organisms. Standard tetracycline powder should provide the following MIC values:












  Organism  MIC (mcg/mL)
  E. coli ATCC 25922  1.0-4.0
  S. aureus ATCC 29213  0.25-1.0
  E. faecalis ATCC 29212  8-32
  P. aeruginosa ATCC 27853  8-32

Indications and Usage for Doxycycline Hyclate


To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, Doxycycline Hyclate Capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 



Treatment


Doxycyline is indicated for the treatment of the following infections:


  • Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.

  • Respiratory tract infections caused by Mycoplasma pneumoniae.

  • Lymphogranuloma venereum caused by Chlamydia trachomatis.

  • Psittacosis (ornithosis) caused by Chlamydia psittaci.

  • Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.

  • Inclusion conjunctivitis caused by Chlamydia trachomatis.

  • Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.

  • Nongonococcal urethritis caused by Ureaplasma urealyticum.

  • Relapsing fever due to Borrelia recurrentis.

Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:


  • Chancroid caused by Haemophilus ducreyi.

  • Plague due to Yersinia pestis (formerly Pasteurella pestis).

  • Tularemia due to Francisella tularensis (formerly Pasteurella tularensis).

  • Cholera caused by Vibrio cholerae (formerly Vibrio comma).

  • Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus).

  • Brucellosis due to Brucella species (in conjunction with streptomycin).

  • Bartonellosis due to Bartonella bacilliformis.

  • Granuloma inguinale caused by Calymmatobacterium granulomatis.

Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.


Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:


  • Escherichia coli.

  • Enterobacter aerogenes (formerly Aerobacter aerogenes).

  • Shigella species.

  • Acinetobacter species (formerly Mima species and Herellea species).

  • Respiratory tract infections caused by Haemophilus influenzae.

  • Respiratory tract and urinary tract infections caused by Klebsiella species.

Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:


  • Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

  • Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

When penicillin is contraindicated, doxycycyline is an alternative drug in the treatment of the following infections:


  • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.

  • Syphilis caused by Treponema pallidum.

  • Yaws caused by Treponema pertenue.

  • Listeriosis due to Listeria monocytogenes.

  • Vincent's infection caused by Fusobacterium fusiforme.

  • Actinomycosis caused by Actinomyces israelii.

  • Infections caused by Clostridium species.

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.


In severe acne, doxycycline may be useful adjunctive therapy.



Prophylaxis


Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. See DOSAGE AND ADMINISTRATION section and Information for Patients subsection of the PRECAUTIONS section.



Contraindications


This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.



Warnings


THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP, EXCEPT FOR ANTHRAX, INCLUDING INHALATIONAL ANTHRAX (POSTEXPOSURE), UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.


Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Doxycycline Hyclate capsules, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.


C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.


IF CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.


All tetracyclines form a stable calcium complex in any bone- forming tissue. A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.


Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.


The antianabolic action of the tetracyclines may cause an increase in BUN. Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.


Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.



Precautions



General


As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted.


Bulging fontanels in infants and benign intracranial hypertension in adults have been reported in individuals receiving tetracyclines. These conditions disappeared when the drug was discontinued. Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy, when indicated.


Doxycycline offers substantial but not complete suppression of the asexual blood stages of Plasmodium strains.


Doxycycline does not suppress P. falciparum's sexual blood stage gametocytes. Subjects completing this prophylactic regimen may still transmit the infection to mosquitoes outside endemic areas.


Prescribing Doxycycline Hyclate Capsules in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.



Information for Patients


Patients taking doxycycline for malaria prophylaxis should be advised:


  • that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.

  • to avoid being bitten by mosquitoes by using personal protective measures that avoid contact with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent.)

  • that doxycycline prophylaxis:
    • should begin 1 to 2 days before travel to the malarious area.

    • should be continued daily while in the malarious area and after leaving the malarious area.

    • should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area.

    • should not exceed 4 months.


All patients taking doxycycline should be advised:


  • to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruptions, etc.) occurs. Sunscreen or sunblock should be considered (see WARNINGS).

  • to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS).

  • that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See Drug Interactions).

  • that the absorption of tetracyclines is reduced when taking bismuth subalicylate (See Drug Interactions).

  • that the use of doxycycline might increase the incidence of vaginal candidiasis.

Patients should be counseled that antibacterial drugs including Doxycycline Hyclate capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Doxycycline Hyclate capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Doxycycline Hyclate capsules or other antibacterial drugs in the future.


Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.



Laboratory Tests


In venereal disease, when co-existing syphilis is suspected, dark field examinations should be done before treatment is started and the blood serology repeated monthly for at least 4 months.


In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic studies, should be performed.



Drug Interactions


Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.


Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.


Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.


Absorption of tetracycline is impaired by bismuth subsalicylate.


Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.


The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.


Concurrent use of tetracycline may render oral contraceptives less effective.



Drug/Laboratory Test Interactions


False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibiotics, oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).


Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibiotics (tetracycline, oxytetracycline).


Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.



Pregnancy: Teratogenic Effects. Pregnancy Category D


There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for treatment of anthrax exposure. An expert review of published data on experiences with doxycycline use during pregnancy by TERIS -The Teratogen Information System - concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as limited to fair), but the data are insufficient to state that there is no riska.


A case-control study (18,515 mothers of infants with congenital anomalies and 32,804 mothers of infants with no congenital anomalies) shows a weak but marginally statistically significant association with total malformations and use of doxycycline anytime during pregnancy. (Sixty-three (0.19%) of the controls and 56 (0.30%) of the cases were treated with doxycycline.) This association was not seen when the analysis was confined to maternal treatment during the period of organogenesis (i.e., in the second and third months of gestation) with the exception of a marginal relationship with neural tube defect based on only two exposed casesb.


A small prospective study of 81 pregnancies describes 43 pregnant women treated for 10 days with doxycycline during early first trimester. All mothers reported their exposed infants were normal at 1 year of agec.


Nonteratogenic effects

(See WARNINGS)



Labor and Delivery


The effect of tetracyclines on labor and delivery is unknown.



Nursing Mothers


Tetracyclines are excreted in human milk, however, the extent of absorption of tetracyclines, including doxycycline, by the breastfed infant is not known. Short-term use by lactating women is not necessarily contraindicated; however, the effects of prolonged exposure to doxycycline in breast milk are unknownd. Because of the potential for adverse reactions in nursing infants from doxycycline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. (See WARNINGS).



Pediatric Use


See WARNINGS and DOSAGE AND ADMINISTRATION.



Adverse Reactions


Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines:


Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed. (See DOSAGE AND ADMINISTRATION).


Skin: toxic epidermal necrolysis, Steven-Johnson sydrome, erythema multiforme, maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS).


Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See WARNINGS).


Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.


Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.


Other: bulging fontanels in infants and intracranial hypertension in adults. (See PRECAUTIONS -General).


When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. No abnormalities of thyroid function studies are known to occur.


To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



Overdosage


In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.



Doxycycline Hyclate Dosage and Administration


THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.


Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.


In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.


For children above eight years of age: The recommended dosage schedule for children weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For children over 100 lb the usual adult dose should be used.


The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.


When used in streptococcal infections, therapy should be continued for 10 days.


Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS).


If gastric irritation occurs, it is recommended that doxycycline be given with food or milk. The absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibiotic in patients with renal impairment.


Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. The dose may be administered with food, including milk or carbonated beverage, as required.


Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis: 100 mg, by mouth, twice a day for 7 days.


Nongonococcal urethritis (NGU) caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for 7 days.


Syphilis - early: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks.


Syphilis of more than one year's duration: Patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks.


Acute epididymo-orchitis caused by N. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days.


Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.


For the prophylaxis of malaria: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1 to 2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.



Inhalational Anthrax (post-exposure)


ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days.


CHILDREN: weighing less than 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 lb or more should receive the adult dose.



How is Doxycycline Hyclate Supplied


Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsules printed “West-ward 3142” in Black Ink.


  •  Bottles of 14 capsules.

  •  Bottles of 20 capsules

  •  Bottles of 50 capsules.

  •  Bottles of 500 capsules.

  •  Unit Dose Boxes of 100 capsules.

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.


Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.



ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY


Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.


Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.


Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.



REFERENCES


  1. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, Fourth Edition. Approved Standard NCCLS Document M2- A4, Vol. 10, No. 7 NCCLS, Villanova, PA, April 1990.

  2. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8 NCCLS, Villanova, PA, April 1990.


  3. aFriedman JM and Polifka JE- Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149-195.

    bCziezel AE and Rockenbauer M, Teratogenic study of doxycycline. Obstet Gynecol 1997;89:524-528.

    cHorne HW Jr. and Kundsin RB, The role of mycoplasma among 81 consecutive pregnancies: a prospective study, Int J Fertil 1980; 25:315-317.

    dHale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000: 225-226.



Manufactured By:

Hikma Pharmaceuticals

P.O. Box 182400

Amman 11118 - Jordan


Distributed By:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724


Revised November 2011



PRINCIPAL DISPLAY PANEL


Doxycycline Hyclate Capsules, USP

100 mg

NDC 0143-9803










DOXYCYCLATE HYCLATE 
Doxycycline Hyclate  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0143-9803
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Doxycycline Hyclate (DOXYCYCLINE ANHYDROUS)DOXYCYCLINE ANHYDROUS100 mg




























Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
FD&C BLUE NO. 1 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
BUTYL ALCOHOL 
PROPYLENE GLYCOL 
ALCOHOL 


















Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeWestward;3142
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
10143-9803-05500 CAPSULE In 1 BOTTLE, PLASTICNone
20143-9803-1414 CAPSULE In 1 BOTTLE, PLASTICNone
30143-9803-2020 CAPSULE In 1 BOTTLE, PLASTICNone
40143-9803-5050 CAPSULE In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06239609/01/1990


Labeler - West-ward Pharmaceutical Corp (001230762)
Revised: 01/2012West-ward Pharmaceutical Corp

Doxorubicin


Pronunciation: dox-oh-ROO-bi-sin
Generic Name: Doxorubicin
Brand Name: Adriamycin

Doxorubicin is for intravenous (IV) use only and should only be given under the supervision of a doctor experienced in the use of cancer chemotherapy agents. If Doxorubicin accidentally leaks into surrounding tissue, the skin and/or muscle may be severely damaged. Notify your doctor immediately if redness, pain, or swelling at or around the injection site occur.


Doxorubicin may cause severe and possibly life-threatening heart problems (eg, heart failure). These problems may occur during therapy or sometimes months to years after receiving Doxorubicin. In some cases, heart problems are irreversible. The risk may be increased if you are using certain medicines that may affect heart function (eg, trastuzumab), or have a history of heart problems, radiation treatment to the chest area, or previous therapy with other anthracyclines (eg, epirubicin). The risk of developing heart problems varies depending on your dose and condition, although it can occur at any dose whether or not you are at risk. Notify your doctor immediately if you develop cough; fast, slow, or irregular heartbeat; shortness of breath; sudden, unexplained weight gain; or swelling of the hands, ankles, or feet.


Another type of cancer (acute myelogenous leukemia [AML]) and a certain blood problem (myelodysplastic syndrome [MDS]) have been reported in patients treated with anthracyclines, including Doxorubicin. The risk varies depending on your dose and other medicines and/or radiation therapy. Discuss any questions or concerns with your doctor.


Doxorubicin may cause bone marrow suppression. Notify your doctor immediately if you develop easy bruising or bleeding, unusual tiredness or weakness, or signs of an infection (eg, fever, chills, persistent sore throat).


Tell your doctor if you have liver problems because your dose will have to be decreased. Your doctor will closely monitor you while you are using Doxorubicin.





Doxorubicin is used for:

Treating various types of cancer.


Doxorubicin is an antineoplastic antibiotic. It works by killing cancer cells.


Do NOT use Doxorubicin if:


  • you are allergic to any ingredient in Doxorubicin or to similar medicines (eg, epirubicin)

  • you have certain bone marrow problems (eg, low blood platelet levels, low red blood cell levels, low white blood cell levels)

  • you have severe liver problems

  • you have severe heart problems, severe irregular heartbeat, or recently had a heart attack

  • you have taken or will be taking palifermin within 24 hours before or after using Doxorubicin

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



Before using Doxorubicin:


Some medical conditions may interact with Doxorubicin. 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 able to become pregnant

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

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

  • if you have swelling or soreness of the mouth or tongue, blood vessel disease, an infection, or liver problems

  • if you plan to receive any vaccines

  • if you are older than 50 years old

  • if you have a history of heart problems or radiation treatment (or are currently receiving radiation treatment), or if you have previously received Doxorubicin or similar medicines (eg, epirubicin, daunorubicin)

  • if you are taking medicines that may affect heart function (eg, calcium channel blockers, trastuzumab). Ask your doctor if you are unsure if any of your medicines may affect heart function

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


  • Calcium channel blockers (eg, diltiazem, verapamil), cyclophosphamide, or trastuzumab because the risk of heart problems (eg, heart failure) may be increased

  • Cyclosporine, cytarabine, paclitaxel, progesterone, or streptozocin because it may increase the risk of Doxorubicin's side effects

  • Phenobarbital because it may decrease Doxorubicin's effectiveness

  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased

  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer

  • Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Doxorubicin

  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of Doxorubicin's side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Doxorubicin 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 Doxorubicin:


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


  • Doxorubicin is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any questions that you may have about Doxorubicin.

  • If Doxorubicin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

  • Drinking extra fluids while you are using Doxorubicin is recommended. Check with your doctor for instructions.

  • Your doctor may prescribe another medicine to lessen nausea and vomiting that can occur when using Doxorubicin. Discuss any questions with your doctor.

  • If Doxorubicin accidentally spills on your skin, wash it off immediately with soap and water.

  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

  • If you miss a dose of Doxorubicin, contact your doctor immediately.

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



Important safety information:


  • Doxorubicin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

  • Doxorubicin may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.

  • Caregivers of children should take precautions (eg, wear latex gloves) to prevent contact with the patient's urine and other body fluids for at least 5 days after treatment.

  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are using Doxorubicin. Talk with your doctor before you receive any vaccine.

  • Doxorubicin may cause the urine to turn red. This is harmless and usually goes away 1 to 2 days after receiving a dose of Doxorubicin.

  • Doxorubicin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Doxorubicin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Lab tests, including liver and kidney function, complete blood cell counts, blood uric acid and electrolyte levels, and heart function, may be performed to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Tell your doctor or dentist that you take Doxorubicin before you receive any medical or dental care, emergency care, or surgery.

  • Use Doxorubicin with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

  • Caution is advised when using Doxorubicin in CHILDREN; they may be more sensitive to its effects, especially heart problems (eg heart failure) and developing a certain other type of cancer (AML).

  • Doxorubicin may damage sperm. Use effective birth control methods (eg, condoms) while using Doxorubicin. Discuss any questions or concerns with your doctor.

  • Women using Doxorubicin may develop absence of menstrual periods or early menopause.

  • PREGNANCY and BREAST-FEEDING: Doxorubicin has been shown to cause harm to the fetus. Avoid becoming pregnant while you are using it. If you are able to become pregnant, talk with your doctor about using an effective form of birth control. If you become pregnant, discuss with your doctor the benefits and risks of using Doxorubicin during pregnancy. Doxorubicin is excreted in breast milk. Do not breast-feed while using Doxorubicin.


Possible side effects of Doxorubicin:


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:



Diarrhea; hair loss; loss of appetite; nausea; stomach pain; tiredness; weakness; weight changes.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; dizziness; flushed face; tightness in the chest; swelling of the mouth, face, lips, or tongue); absence of menstrual cycle; black, tarry stools; chest pain; fainting; fast, slow, or irregular heartbeat; headache; loose or bloody stools; pain, redness, burning, stinging, swelling, or open sores at the injection site; rectal bleeding or irritation; redness or discharge of the eyes; redness, pain, swelling, peeling, tingling, or blistering of the palms of the hands and the soles of the feet; severe or persistent nausea or vomiting; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; swelling or soreness of the mouth or tongue; symptoms of dehydration (eg, dry mouth or eyes, decreased urination, fast heartbeat, sluggishness, unusual thirst); symptoms of infection (eg, fever, chills, cough, sore throat, burning or painful urination); unusual bruising or bleeding; unusual tiredness or weakness; vomiting.



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.



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. Symptoms may include swelling or soreness of the mouth or tongue; unusual bruising or bleeding.


Proper storage of Doxorubicin:

Doxorubicin is usually handled and stored by a health care provider. If you are using Doxorubicin at home, store Doxorubicin as directed by your pharmacist or health care provider. Keep Doxorubicin out of the reach of children and away from pets.


General information:


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

  • Doxorubicin 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 Doxorubicin. 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 Doxorubicin resources


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


  • Doxorubicin Prescribing Information (FDA)

  • Adriamycin Prescribing Information (FDA)

  • Doxorubicin Hydrochloride Monograph (AHFS DI)

  • Rubex Prescribing Information (FDA)

  • doxorubicin Concise Consumer Information (Cerner Multum)

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



Compare Doxorubicin with other medications


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