Fentanyl Buccal mucosa, Oromucosal

FEN-ta-nil SIT-rate

Buccal mucosa route(Film;Lozenge/Troche;Tablet)

Due to the risk of fatal respiratory depression, immediate-release transmucosal fentanyl is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Keep out of reach of children. Use with CYP3A4 inhibitors may cause fatal respiratory depression. When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product. When dispensing, do not substitute with any other fentanyl products. Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program .

Commonly used brand name(s)

In the U.S.

• Actiq


• Fentora


• Onsolis

Available Dosage Forms:

• Tablet


• Lozenge/Troche


• Film

Therapeutic Class: Analgesic

Chemical Class: Fentanyl

Uses For fentanyl

Fentanyl belongs to the group of medicines called narcotic analgesics, which are medicines used to relieve pain. The oral transmucosal or buccal form of fentanyl is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which “breaks through” the medication used to control the persistent pain. Oral transmucosal or buccal fentanyl is only used in patients who are already taking narcotic analgesics.

Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of oral transmucosal or buccal fentanyl you should receive.

fentanyl is available only with your doctor's prescription. Buccal fentanyl film is available only under a restricted distribution program called FOCUS® Program.

Before Using fentanyl

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 fentanyl, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fentanyl 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 buccal fentanyl in children below 18 years of age, or oral transmucosal fentanyl in children below 16 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oral transmucosal or buccal fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of narcotic analgesics than younger adults and are more likely to have age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving oral transmucosal or buccal fentanyl.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 fentanyl, 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 fentanyl with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using fentanyl 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.

• Adinazolam


• Alfentanil


• Alprazolam


• Amiodarone


• Amobarbital


• Amprenavir


• Anileridine


• Aprepitant


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Citalopram


• Clarithromycin


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Codeine


• Crizotinib


• Dantrolene


• Dezocine


• Diazepam


• Diltiazem


• Erythromycin


• Estazolam


• Ethchlorvynol


• Fentanyl


• Fluconazole


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fosamprenavir


• Fospropofol


• Furazolidone


• Halazepam


• Hydrocodone


• Hydromorphone


• Imatinib


• Iproniazid


• Isocarboxazid


• Itraconazole


• Ketazolam


• Ketoconazole


• Levorphanol


• Linezolid


• Lopinavir


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Moclobemide


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nefazodone


• Nelfinavir


• Nialamide


• Nicardipine


• Nifedipine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pargyline


• Paroxetine


• Pazopanib


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Prazepam


• Procarbazine


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Quazepam


• Ranolazine


• Rasagiline


• Remifentanil


• Ritonavir


• Secobarbital


• Selegiline


• Sertraline


• Sibutramine


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiethylperazine


• Thiopental


• Thioridazine


• Toloxatone


• Tranylcypromine


• Triazolam


• Trifluoperazine


• Troleandomycin


• Vemurafenib

Using fentanyl 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.

• Atazanavir


• Azithromycin


• Carbamazepine


• Clotrimazole


• Dirithromycin


• Econazole


• Indinavir


• Josamycin


• Mepartricin


• Miconazole


• Miokamycin


• Nevirapine


• Phenytoin


• Rifampin


• Rokitamycin


• Roxithromycin


• Saquinavir


• Spiramycin


• Voriconazole

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 fentanyl with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use fentanyl, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol


• Grapefruit Juice

Other Medical Problems

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

• Alcohol abuse, or history of or


• Drug dependence, especially narcotic abuse or dependence, history of—Dependence may be more likely to develop.

• Diabetes—Use with caution. Oral transmucosal fentanyl contains sugar.

• Emphysema or other chronic lung disease or


• Head injuries—Use with caution. Some of the side effects of oral transmucosal or buccal fentanyl can cause serious problems in patients who have these medical problems.

• Hypotension (low blood pressure) or


• Mental illness or


• Seizures, history of or


• Slow heartbeat or other heart problems—Oral transmucosal or buccal fentanyl can make these conditions worse.

• Kidney disease or


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

Proper Use of fentanyl

Oral transmucosal or buccal fentanyl comes with patient instructions. If you are switching from the oral transmucosal form of fentanyl to buccal form, make sure you read the patient instructions carefully. These forms are very different.

It is very important that you understand the requirements of the FOCUS® program, and become familiar with the FOCUS® educational materials and Medication Guide. Ask your doctor or pharmacist before starting buccal fentanyl film treatment.

• How to use oral transmucosal fentanyl:


• Keep medication in sealed pouch until ready to use.


• The foil package should be opened with scissors immediately prior to product use.


• Place the medicine in mouth between the cheek and lower gum, occasionally moving the medicine from one side to the other using the handle.


• The medicine should be sucked, not chewed.


• Suck the medicine over a 15-minute period.

• How to use buccal fentanyl:


• Keep the medication in sealed pouch until ready to use.


• Remove the tablet from the blister unit just before product use. Do not push the tablet through the blister as this may cause damage to the tablet.


• Do not store the tablet after removing it from the blister package. It should be used immediately.


• Place the medicine in your mouth between the upper cheek and gum, above a back molar.


• Allow the tablet to dissolve. It usually takes around 14 to 25 minutes for the tablet to dissolve completely.


• Do not suck, chew, or swallow the tablet. If the tablet did not dissolve completely after 30 minutes, you may swallow it with a glass of water.

To use the buccal fentanyl film:

• The foil package should be opened with scissors immediately prior to product use.


• Separate the layers of the foil package and remove the film. Do not cut or tear the film.


• Use your tongue to wet the side of your cheek, or rinse your mouth with water to wet the area in your mouth where you will place the film.


• Hold the film in place on your clean, dry finger with the pink side facing up.


• Press the film against your cheek. Hold it there for 5 seconds.


• Leave the film in place until it dissolves. It usually dissolves within 15 to 30 minutes after you apply it. Do not touch or move the film while it dissolves.


• If your doctor tells you to use more than one film, place the new film on the other side of your mouth.


• Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.

Use only the brand of fentanyl that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of fentanyl 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 fentanyl. 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 cancer pain:
  
  • For buccal dosage form (film):
    
    • Adults—At first, one 200 microgram (mcg) film during an episode of breakthrough cancer pain. Your doctor may increase your dose as needed. However, patients should not use fentanyl for more than four 200 mcg film per episode of breakthrough pain a day.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For buccal dosage form (tablets):
    
    • Adults—At first, 100 micrograms (mcg) during an episode of breakthrough cancer pain. Dosing may be repeated if pain is not relieved by a single dose. Redosing may start 30 minutes after taking fentanyl and the same dosage strength should be used. Your doctor may increase your dose as needed. Patients should not use more than 4 tablets per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their doctor to determine if a dosage adjustment is warranted.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For oral transmucosal dosage form (lozenge):
    
    • Adults—At first, 200 micrograms (mcg) during an episode of breakthrough cancer pain. Redosing may start 15 minutes after the previous dose has been completed (30 minutes after the start of the previous dose). Patients should not use more than 2 units per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their doctors to determine if a dosage adjustment is warranted.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of fentanyl, 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.

Do not use if the foil pouch has been opened. A temporary storage bottle is provided as part of the Actiq® Welcome Kit. This container is to be used by patients or their caregivers in the event that a partially consumed unit cannot be disposed of promptly. If additional assistance is required, refer to 1-800-615-0187.

Dispose of any unopened buccal fentanyl tablets that are no longer needed. To dispose, remove the buccal fentanyl tablets from the blister packages and flush down the toilet. Do not flush the blister packages or cartons down the toilet. If additional assistance is required, call 1-800-896-5855.

To dispose any unneeded buccal fentanyl film: remove the film from its foil package and flush down the toilet. Do not flush the foil packages or cartons down the toilet. If additional assistance is required, call 1-800-526-3840.

Precautions While Using fentanyl

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure that fentanyl is working properly and to check you for any problems or unwanted effects that may be caused by fentanyl.

Oral transmucosal or buccal fentanyl contains a medicine in an amount which can be fatal to a child. Patients and their caregivers should keep oral transmucosal or buccal fentanyl out of the reach of children and discard open units properly.

Do not use buccal fentanyl film if you need pain medicine for just a short time, such as during a headache or migraine attack, or when recovering from surgery or an injury.

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

Oral transmucosal or buccal fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to fentanyl before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using fentanyl. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using oral transmucosal or buccal fentanyl.

If you have been using fentanyl regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects.

Using too much oral transmucosal or buccal fentanyl, or taking too much of another narcotic while using oral transmucosal or buccal fentanyl, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin; low blood pressure; pinpoint pupils of the eyes; and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

Check with your dentist at regular times while using fentanyl. fentanyl contains sugar and may increase your chance for tooth decay or other trouble with your teeth or gums.

fentanyl may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not use buccal fentanyl if you have taken a monoamine oxidase (MAOI) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

fentanyl Side Effects

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

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

More common

• Black, tarry, stools


• blurred vision


• chest pain


• confusion


• convulsions


• cough


• decreased urine


• difficult or labored breathing


• dizziness


• dry mouth


• fainting


• fever or chills


• increased thirst


• irregular heartbeat


• lightheadedness


• loss of appetite


• lower back or side pain


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• painful or difficult urination


• pale skin


• pounding in the ears


• rapid breathing


• shortness of breath


• sneezing


• sore throat


• sunken eyes


• swelling of the hands, ankles, feet, or lower legs


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing


• wrinkled skin

Less common

• Abdominal or stomach pain


• change in walking and balance


• clumsiness or unsteadiness


• decreased awareness or responsiveness


• decreased frequency of urination


• headache


• muscle twitching or jerking


• pounding in the ears


• rhythmic movement of the muscles


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


• seizures


• severe constipation


• severe sleepiness


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


• slow or fast heartbeat


• thinking abnormalities


• trembling or shaking of the hands or feet

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

Symptoms of overdose

• Extremely shallow or slow breathing

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

• Back pain


• diarrhea


• difficulty having a bowel movement (stool)


• difficulty in moving


• discouragement


• feeling sad or empty


• irritability


• lack or loss of strength


• loss of interest or pleasure


• muscle stiffness


• pain in the joints


• sleepiness or unusual drowsiness


• sleeplessness


• tiredness


• trouble concentrating


• trouble sleeping


• unable to sleep


• weight loss

Less common

• Changes in vision


• excessive muscle tone


• feeling of constant movement of self or surroundings


• feeling of warmth or heat


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


• irritation, pain, or sores at the site of application


• itching skin


• muscle tension or tightness


• rash


• sensation of spinning


• sweating

Incidence not known

• Tooth pain


• trouble with gums


• trouble with teeth

After you stop using fentanyl, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Restlessness


• speech disorder


• stomach cramps


• weakness

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: fentanyl Buccal mucosa, Oromucosal side effects (in more detail)

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Eplerenone

Generic Name: eplerenone (ep LER e none)

Brand Names: Inspra

What is eplerenone?

Eplerenone blocks the actions of the hormone aldosterone in the body. Aldosterone is important for the regulation of blood pressure.

Eplerenone is used to treat congestive heart failure after a heart attack. Eplerenone is also used to treat high blood pressure (hypertension).

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

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

You may not be able to take this medication if you have severe kidney disease, high potassium levels in your blood, or type 2 diabetes with protein in your urine.

You also may not be able to take eplerenone if you are also taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or troleandomycin (Tao).

Before taking eplerenone, tell your doctor if you have kidney or liver disease, high cholesterol, or high triglycerides.

Do not use salt substitutes or potassium supplements while taking eplerenone, unless your doctor has told you to. To be sure this medication is helping your condition and is not causing harmful effects, your blood pressure will need to be checked on a regular basis. Your potassium levels will also need to be checked with frequent blood tests. Visit your doctor regularly. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

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

You may not be able to take this medication if you are allergic to eplerenone, or if you have:

• 
  

  high potassium levels in your blood (hyperkalemia);

  
  


• severe kidney disease;


• 
  

  type 2 diabetes with protein in your urine; or

  
  


• 
  

  if you are also taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or troleandomycin (Tao).

  
  

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

• 
  

  kidney disease;

  
  


• 
  

  liver disease; or

  
  


• 
  

  high cholesterol or triglycerides;

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether eplerenone 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.

How should I take eplerenone?

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.

Eplerenone may be taken with or without food.

To be sure this medication is helping your condition and is not causing harmful effects, your blood pressure will need to be checked on a regular basis. Your potassium levels will also need to be checked with frequent blood tests. Visit your doctor regularly. If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life. Store at room temperature away from moisture and heat.

See also: Eplerenone 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.

Overdose symptoms may include slow heart rate, weak pulse, muscle weakness, dizziness, or feeling like you might pass out.

What should I avoid while taking eplerenone?

Do not use salt substitutes or potassium supplements while taking eplerenone, unless your doctor has told you to.

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

  
  

Less serious side effects may include:

• 
  

  diarrhea, stomach pain;

  
  


• 
  

  cough;

  
  


• 
  

  dizziness;

  
  


• 
  

  tired feeling;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  vaginal bleeding; or

  
  


• 
  

  breast swelling or tenderness.

  
  

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.

Eplerenone Dosing Information

Usual Adult Dose for Congestive Heart Failure:

Congestive heart failure post-myocardial infarction:
Initial dosage: 25 mg orally once daily. Dosage should titrated to the target dose of 50 mg once daily preferably within 4 weeks.

Usual Adult Dose for Hypertension:

50 mg orally once daily. Patients with an inadequate blood pressure response should be increased to 50 mg twice a day.

What other drugs will affect eplerenone?

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

• 
  

  lithium (Lithobid, Eskalith, others);

  
  


• 
  

  other blood pressure medications such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), or valsartan (Diovan);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);

  
  


• 
  

  an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  
  


• 
  

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

  
  


• 
  

  HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir, Kaletra);

  
  


• 
  

  an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with eplerenone. 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 eplerenone resources

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

• eplerenone Advanced Consumer (Micromedex) - Includes Dosage Information


• Eplerenone Prescribing Information (FDA)


• Eplerenone Professional Patient Advice (Wolters Kluwer)


• Eplerenone Monograph (AHFS DI)


• Eplerenone MedFacts Consumer Leaflet (Wolters Kluwer)


• Inspra Prescribing Information (FDA)

Compare eplerenone with other medications

• Heart Failure
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about eplerenone.

See also: eplerenone side effects (in more detail)

Ferrous Sulfate Controlled-Release Capsules

Pronunciation: FER-us SUL-fate
Generic Name: Ferrous Sulfate
Brand Name: Examples include Fe Caps and Slow Fe

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years old. Keep this product out of the reach of children. In case of an accidental overdose, call a doctor or poison control center right away.

Ferrous Sulfate Controlled-Release Capsules are used for:

Preventing or treating low levels of iron in the blood. It may also be used for other conditions as determined by your doctor.

Ferrous Sulfate Controlled-Release Capsules are an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.

Do NOT use Ferrous Sulfate Controlled-Release Capsules if:

• you are allergic to any ingredient in Ferrous Sulfate Controlled-Release Capsules


• you have high levels of iron in your blood

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

Before using Ferrous Sulfate Controlled-Release Capsules:

Some medical conditions may interact with Ferrous Sulfate Controlled-Release Capsules. 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


• if you have inflammation of the intestines, Crohn disease, digestive problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Ferrous Sulfate Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Ferrous Sulfate Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrous Sulfate Controlled-Release Capsules 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 Ferrous Sulfate Controlled-Release Capsules:

Use Ferrous Sulfate Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ferrous Sulfate Controlled-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Ferrous Sulfate Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.


• Take Ferrous Sulfate Controlled-Release Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Ferrous Sulfate Controlled-Release Capsules.


• If you are also taking an antacid, a bisphosphonate (eg, alendronate), a cephalosporin (eg, cephalexin), methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, minocycline) along with Ferrous Sulfate Controlled-Release Capsules, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Ferrous Sulfate Controlled-Release Capsules and your other medicines.


• Certain foods and drinks may decrease the amount of Ferrous Sulfate Controlled-Release Capsules that works in your body. Ask your doctor or pharmacist how you should take Ferrous Sulfate Controlled-Release Capsules if you consume whole grain breads or cereal, dairy products, coffee, or tea.


• If you miss a dose of Ferrous Sulfate Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ferrous Sulfate Controlled-Release Capsules.

Important safety information:

• Do not take large doses of vitamins while you use Ferrous Sulfate Controlled-Release Capsules unless your doctor tells you to.


• Do NOT take more than the recommended dose or take for longer than 6 months without checking with your doctor.


• Ferrous Sulfate Controlled-Release Capsules has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• Lab tests, including complete blood cell counts and blood iron levels, may be performed while you use Ferrous Sulfate Controlled-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Ferrous Sulfate Controlled-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ferrous Sulfate Controlled-Release Capsules while you are pregnant. Ferrous Sulfate Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Ferrous Sulfate Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ferrous Sulfate Controlled-Release Capsules:

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:

Constipation; darkened or green stools; diarrhea; nausea; stomach upset.

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); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

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: Ferrous Sulfate 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. Symptoms may include difficulty breathing; loss of consciousness; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.

Proper storage of Ferrous Sulfate Controlled-Release Capsules:

Store Ferrous Sulfate Controlled-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ferrous Sulfate Controlled-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Ferrous Sulfate Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Ferrous Sulfate Controlled-Release Capsules are 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 Ferrous Sulfate Controlled-Release Capsules. 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 Ferrous Sulfate resources

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

Compare Ferrous Sulfate with other medications

• Anemia Associated with Chronic Renal Failure
• Iron Deficiency Anemia
• Vitamin/Mineral Supplementation and Deficiency
• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Nor-QD

Generic Name: norethindrone (nor eth IN drone)

Brand Names: Aygestin, Camila, Errin, Jolivette, Nor-QD, Nora-Be, Ortho Micronor

What is Nor-QD (norethindrone)?

Norethindrone is a form of progesterone, a female hormone. Norethindrone prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Norethindrone is used for birth control (contraception) to prevent pregnancy. Norethindrone is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance.

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

What is the most important information I should know about Nor-QD (norethindrone)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, breast cancer, abnormal vaginal bleeding, liver disease, or if you have recently had an incomplete miscarriage or abortion.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Norethindrone does not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases.

What should I discuss with my healthcare provider before using Nor-QD (norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant. Do not use this medication if you are allergic to norethindrone, or if you have:

• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  breast cancer;

  
  


• 
  

  abnormal vaginal bleeding; or

  
  


• 
  

  if you have recently had an incomplete miscarriage or abortion.

  
  

Before using norethindrone, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take norethindrone.

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  migraines;

  
  


• 
  

  kidney disease;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  a history of depression or mental illness;

  
  


• 
  

  high cholesterol or triglycide (fatty acid) levels in your blood;

  
  


• 
  

  asthma; or

  
  


• 
  

  seizures or epilepsy.

  
  

Norethindrone can pass into breast milk. Make sure your doctor knows if you are breast-feeding a baby while taking this medication. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

How should I take Nor-QD (norethindrone)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using norethindrone.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

See also: Nor-QD dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Missing a pill increases your risk of becoming pregnant. If you are more than 3 hours late in taking your dose, use back-up birth control such as condoms or a spermicide for at least the next 48 hours.

If you miss a period for two months in a row, call your doctor because you might be pregnant.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Nor-QD (norethindrone)?

Do not smoke while using norethindrone, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by norethindrone.

Norethindrone will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Nor-QD (norethindrone) 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

  
  


• 
  

  pain or swelling in one or both legs;

  
  


• 
  

  migraine headache;

  
  


• 
  

  swelling in your hands or feet, rapid weight gain;

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes);

  
  


• 
  

  severe pelvic pain;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, swelling, or tenderness;

  
  


• 
  

  dizziness;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased acne or hair growth;

  
  


• 
  

  changes in weight;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  skin itching or rash;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  mild headache.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Nor-QD (norethindrone)?

Some drugs can make norethindrone less effective, which may result in pregnancy. Before using norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  griseofulvin (Fulvicin, Grisactin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  ketoconazole (Nizoral) or itraconazole (Sporanox);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).

  
  

There may be other drugs that can interact with norethindrone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Nor-QD resources

• Nor-QD Side Effects (in more detail)
• Nor-QD Dosage
• Nor-QD Use in Pregnancy & Breastfeeding
• Drug Images
• Nor-QD Drug Interactions
• Nor-QD Support Group
• 0 Reviews for Nor-QD - Add your own review/rating

• Nor-QD Prescribing Information (FDA)


• Nor-QD Advanced Consumer (Micromedex) - Includes Dosage Information


• Nor-QD MedFacts Consumer Leaflet (Wolters Kluwer)


• Aygestin MedFacts Consumer Leaflet (Wolters Kluwer)


• Aygestin Monograph (AHFS DI)


• Aygestin Prescribing Information (FDA)


• Camila Prescribing Information (FDA)


• Errin Prescribing Information (FDA)


• Jolivette Prescribing Information (FDA)


• Nora-BE Prescribing Information (FDA)


• Ortho Micronor Prescribing Information (FDA)

Compare Nor-QD with other medications

• Abnormal Uterine Bleeding
• Amenorrhea
• Birth Control
• Endometriosis

Where can I get more information?

• Your pharmacist can provide more information about norethindrone.

See also: Nor-QD side effects (in more detail)

FML S. O.P

Generic Name: fluorometholone ophthalmic (FLURE oh METH oh lone)

Brand Names: Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.

What is FML S.O.P. (fluorometholone ophthalmic)?

Fluorometholone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Fluorometholone ophthalmic (for the eyes) is used to treat eye swelling caused by infections, injury, surgery, or other conditions.

Fluorometholone ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about FML S.O.P. (fluorometholone ophthalmic)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of viral or fungal eye infection, ocular herpes, tuberculosis, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, if you have herpes, or if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

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

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 stop using fluorometholone suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

What should I tell my healthcare provider before using FML S.O.P. (fluorometholone ophthalmic)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of infection, especially:

• 
  

  a fungal eye infection;

  
  


• 
  

  any type of viral eye infection, such as ocular herpes;

  
  


• 
  

  tuberculosis; or

  
  


• 
  

  an untreated infection in your eye or elsewhere, including chickenpox.

  
  

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use fluorometholone.

FDA pregnancy category C. Fluorometholone ophthalmic may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fluorometholone ophthalmic 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.

How should I use FML S.O.P. (fluorometholone ophthalmic)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using your eye drops or ointment.

To apply the eye drops:

• Shake the bottle gently before each use to be sure the medicine is well mixed.


• 
  

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

  
  


• 
  

  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.

  
  


• 
  

  Use only the number of drops 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.

To apply the ointment:

• 
  

  You may warm the ointment by holding the medicine tube in your hand for a few minutes before use. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

  
  

Do not stop using fluorometholone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

To be sure this medication is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

Store fluorometholone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube tightly capped. Do not allow this medicine to freeze.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of fluorometholone ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using FML S.O.P. (fluorometholone ophthalmic)?

Do not wear any contact lens that has not been approved by your doctor.

Do not use fluorometholone ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Fluorometholone can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

FML S.O.P. (fluorometholone 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  pain behind your eyes, sudden vision changes, severe headache;

  
  


• 
  

  sudden eye irritation;

  
  


• 
  

  blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  
  


• 
  

  signs of new eye infection, such as swelling, draining, or crusting of your eyes.

  
  

Less serious side effects may include:

• 
  

  increased sensitivity to light; or

  
  


• 
  

  mild stinging, burning, itching, or irritation in your eyes.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect FML S.O.P. (fluorometholone ophthalmic)?

Before using fluorometholone, tell your doctor if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

This list is not complete and there may be other drugs that can interact with fluorometholone ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More FML S.O.P. resources

• FML S.O.P. Side Effects (in more detail)
• FML S.O.P. Use in Pregnancy & Breastfeeding
• FML S.O.P. Drug Interactions
• FML S.O.P. Support Group
• 0 Reviews for FML S.O.P. - Add your own review/rating

• Flarex Prescribing Information (FDA)


• Flarex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluor-Op Prescribing Information (FDA)


• Fluor-Op MedFacts Consumer Leaflet (Wolters Kluwer)

Compare FML S.O.P. with other medications

• Eye Dryness/Redness
• Eye Redness/Itching
• Eyelash Hypotrichosis

Where can I get more information?

• Your pharmacist can provide more information about fluorometholone ophthalmic.

See also: FML S.O.P. side effects (in more detail)

Eraxis

Generic Name: anidulafungin (Intravenous route)

ay-nid-ue-la-FUN-jin

Commonly used brand name(s)

In the U.S.

• Eraxis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antifungal

Pharmacologic Class: Glucan Synthesis Inhibitor

Chemical Class: Echinocandin

Uses For Eraxis

Anidulafungin is an antifungal. It is used to help the body overcome serious fungus infections. This medicine is available only with your doctor's prescription.

Before Using Eraxis

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

Allergies

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

Pediatric

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

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Allergies to other echinocandin antifungal drugs (Caspofungin [e.g., Cancidas], Micafungin [e.g., Mycamine])—You should not use anidulafungin.

• Liver problems—This medicine may cause liver problems to become worse.

Proper Use of Eraxis

Dosing

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

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

• For injection dosage form:
  
  • Adults—At first, the dose is 200 milligrams (mg) injected into a vein. After that, the dose is 100 mg a day injected into a vein. For a fungal infection of the esophagus, the first dose is 100 mg and after that the dose is 50 mg a day.
  
  
  • Children—Use and dose must be determined by your doctor.
  
  

Precautions While Using Eraxis

It is important that you adhere to your doctor's treatment plan for you.

Eraxis 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:

Less common

• Black, tarry stools


• chills


• cough


• decreased urine


• dry mouth


• fever


• increased thirst


• irregular heartbeat


• loss of appetite


• lower back or side pain


• mood or mental changes


• muscle pain or cramps


• nausea or vomiting


• numbness or tingling in hands, feet or lips


• painful or difficult urination


• pale skin


• seizures


• shortness of breath


• sore throat


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


• unusual bleeding or bruising


• unusual tiredness or weakness

Rare

• Abdominal or stomach pain


• back pain


• bleeding gums


• blood in urine or stools


• bloody stools


• bluish color of skin


• blurred or loss of vision


• changes in skin color


• chest pain


• chest tightness


• clay-colored stools


• confusion


• constipation


• dark urine


• depression


• diarrhea


• dizziness


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


• drowsiness


• extra heartbeats


• fainting


• fast heartbeat


• fatigue


• flushed, dry skin


• flushing


• fruit-like breath odor


• headache


• high blood pressure


• hives or welts


• incoherent speech


• increased hunger


• increased urination


• infection of blood


• irregular fast heartbeat


• irritability


• itching


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs


• light-colored stools


• metallic taste


• muscle spasms (tetany) or twitching


• muscle weakness


• nervousness


• pain, redness or swelling in arm or leg


• pain, tenderness, and swelling of foot or leg


• palpitations


• pinpoint red spots on skin


• pounding in the ears


• redness of skin


• restlessness


• skin rash


• slow heartbeat


• sore mouth or tongue


• sweating


• swelling of feet or lower legs


• swollen glands


• trembling


• trouble breathing


• unexplained weight loss


• unpleasant breath odor


• unusually warm skin


• vomiting of blood


• weakness


• weight loss


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash


• yellow eyes or 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:

Rare

• Acid or sour stomach


• belching


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


• disturbed color perception


• double vision


• eye pain


• feeling of warmth


• feeling unusually cold


• halos around light


• hot flushes


• indigestion


• loss of bowel control


• night blindness


• over bright appearance of lights


• rapid weight gain


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


• shivering


• stomach discomfort, upset, or pain


• tingling of hands or feet


• tunnel vision


• unusual weight gain or loss


• upper stomach pain

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: Eraxis 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 Eraxis resources

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

• Eraxis Prescribing Information (FDA)


• Eraxis Consumer Overview


• Eraxis Monograph (AHFS DI)


• Eraxis MedFacts Consumer Leaflet (Wolters Kluwer)


• Anidulafungin Professional Patient Advice (Wolters Kluwer)

Compare Eraxis with other medications

• Candida Infections, Systemic
• Esophageal Candidiasis

Exforge HCT

Pronunciation: am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Amlodipine/Valsartan/Hydrochlorothiazide
Brand Name: Exforge HCT

Exforge HCT may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Exforge HCT is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Exforge HCT is a calcium channel blocker, angiotensin II receptor blocker, and thiazide diuretic combination. It works by relaxing the blood vessels and helping the kidneys remove fluid from the body.

Do NOT use Exforge HCT if:

• you are allergic to any ingredient in Exforge HCT or to any other sulfonamide medicine (eg, sulfamethoxazole)


• you are pregnant


• you have severe liver problems, severe kidney problems, or you are unable to urinate


• you are taking dofetilide or ketanserin

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

Before using Exforge HCT:

Some medical conditions may interact with Exforge HCT. 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 a woman of childbearing age


• 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 a history of angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with another angiotensin II receptor blocker (eg, losartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)


• if you are dehydrated, have low blood volume, have swelling or fluid retention, are on a low-salt (sodium) diet, or have high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium)


• if you have gallbladder, liver, or kidney problems; asthma; gout or high blood levels of uric acid; lupus; parathyroid gland problems; low blood pressure; blood vessel problems; heart problems (eg, heart failure, angina, narrowing of heart blood vessels), or high blood cholesterol or lipid levels


• if you have a history of a stroke, heart attack, or recent kidney transplant


• if you have diabetes, especially if you are also taking aliskiren


• if you are on dialysis, will be having surgery, or you have recently had nerve surgery


• if you are taking another medicine for blood pressure or heart problems


• if you have never taken another medicine for high blood pressure

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

• Dofetilide or ketanserin because the risk of irregular heartbeat may be increased


• Aliskiren, potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, ramipril) because the risk of kidney problems and high blood potassium levels may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, naproxen) because they may decrease Exforge HCT's effectiveness and the risk of serious kidney problems may be increased


• Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), conivaptan, corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), itraconazole, ketoconazole, narcotic pain relievers (eg, morphine), HIV protease inhibitors (eg, ritonavir), rifampin, sildenafil, or other medicines for high blood pressure because they may increase the risk of Exforge HCT's side effects


• Aspirin, cholestyramine, or colestipol because they may decrease Exforge HCT's effectiveness


• Carbamazepine, diazoxide, digoxin, lithium, or simvastatin because the risk of their side effects and toxic effects may be increased by Exforge HCT


• Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by Exforge HCT

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

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

• An extra patient leaflet is available with Exforge HCT. Talk to your pharmacist if you have questions about this information.


• Take Exforge HCT by mouth with or without food.


• Exforge HCT may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Exforge HCT.


• Take Exforge HCT on a regular schedule to get the most benefit from it. Taking Exforge HCT at the same time each day will help you remember to take it.


• Continue to take Exforge HCT even if you feel well. Do not miss any doses.


• If you miss a dose of Exforge HCT, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Exforge HCT may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Exforge HCT with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Exforge HCT may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• It may take up to 2 weeks or more for Exforge HCT to work fully. Do not stop using Exforge HCT or change your dose of Exforge HCT without checking with your doctor.


• Exforge HCT contains hydrochlorothiazide, a sulfonamide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Exforge HCT. Contact your doctor immediately if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Your doctor may also prescribe a potassium supplement for you. If so, take the potassium supplement exactly as prescribed. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk for low blood pressure. Contact your doctor for instructions.


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


• Exforge HCT may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


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


• Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.


• Exforge HCT may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking Exforge HCT.


• Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Exforge HCT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Exforge HCT with caution in the ELDERLY; they may be more sensitive to its effects.


• Exforge HCT should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Exforge HCT may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Exforge HCT is found breast milk. Do not breast-feed while taking Exforge HCT.

Possible side effects of Exforge HCT:

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:

Dizziness; headache; indigestion; light-headedness; mild back pain; muscle spasms; nausea; sore throat or discomfort when swallowing; stuffy nose; tiredness; upset stomach.

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; unusual hoarseness); blurred vision or other vision changes (eg, decreased vision clearness); burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe joint); mental or mood changes (eg, depression); numbness of an arm or leg; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; sudden, severe headache; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual thirst, tiredness, or weakness.

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: Exforge HCT 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. Symptoms may include fainting; flushing; severe or persistent dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, drowsiness; dry eyes; fast heartbeat; nausea; restlessness; unusual thirst, tiredness, or weakness; vomiting).

Proper storage of Exforge HCT:

Store Exforge HCT at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Exforge HCT out of the reach of children and away from pets.

General information:

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


• Exforge HCT 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 Exforge HCT. 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 Exforge HCT resources

• Exforge HCT Side Effects (in more detail)
• Exforge HCT Use in Pregnancy & Breastfeeding
• Exforge HCT Drug Interactions
• Exforge HCT Support Group
• 1 Review for Exforge HCT - Add your own review/rating

• Exforge HCT Prescribing Information (FDA)


• Exforge HCT Advanced Consumer (Micromedex) - Includes Dosage Information


• Exforge HCT Consumer Overview

Compare Exforge HCT with other medications

• High Blood Pressure