Serostim

Pronunciation: soe-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Nonrefrigerated)
Brand Name: Serostim

Serostim is used for:

Increasing lean body weight, body mass, and physical endurance in certain patients with HIV infection. It is usually used along with other medicines that treat HIV infection. It may also be used for other conditions as determined by your doctor.

Serostim is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.

Do NOT use Serostim if:

• you are allergic to any ingredient in Serostim


• you have or are currently being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing


• you have premature epiphyseal closure (your bone growth is complete) or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)


• you have Prader-Willi syndrome and are severely overweight or have severe breathing problems

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

Before using Serostim:

Some medical conditions may interact with Serostim. 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 pituitary or adrenal gland problems, diabetes or a family history of diabetes, an underactive thyroid, curvature of the spine (scoliosis), kidney or liver problems, breathing problems, or Prader-Willi syndrome


• if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer


• if you are severely overweight or have had recent major surgery or trauma

Some MEDICINES MAY INTERACT with Serostim. However, no specific interactions with Serostim are known at this time.

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

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

• Serostim is sometimes used at home as an injection. Before you use Serostim, a health care provider will provide detailed instructions for its appropriate use. Ask any questions that you may have about Serostim or giving injections.


• If you are using Serostim at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial/container is cracked or damaged in any way, do not use it.


• Always change the location where you inject Serostim.


• Do not shake Serostim. Swirl the vial gently to mix it.


• If you miss a dose of Serostim, use 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 use 2 doses at once.

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

Important safety information:

• Serostim may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.


• Rare, sometimes fatal, lung and breathing problems may be caused by Serostim in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Serostim, contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Serostim. Serostim may need to be stopped.


• Rarely, children using Serostim have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.


• Never reuse needles and syringes. Follow your health care provider's instructions for proper disposal of needles and syringes. Ask your health care provider or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full.


• Serostim may contain benzyl alcohol. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol.


• Diabetes patients - Serostim may affect your blood sugar levels. Check your blood sugar levels closely and ask your doctor before adjusting your diabetes medicine or changing your diet.


• Lab tests, including blood electrolytes, thyroid function, and eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Serostim with caution in the ELDERLY because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss the benefits and risks of using Serostim during pregnancy with your doctor. It is unknown if Serostim is excreted in breast milk. If you plan to breast-feed while you are using Serostim, talk with your doctor about the risks to your baby.

Possible side effects of Serostim:

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:

Breast enlargement; headache; mild swelling (eg, of the hands or feet); muscle or joint pain; nausea; nerve tingling; numbness.

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); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; constant feeling of need to empty the bowel; curvature of the spine; depression; ear infection; excessive thirst or hunger; fast heartbeat; fever; frequent urination; infection; nausea; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; severe, persistent, or unusual headaches; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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: Serostim 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: excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Serostim:

Store unmixed medicine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. Use Serostim immediately after mixing. Discard any unused medicine. Contact your pharmacist if you have questions about the proper storage of Serostim. Keep Serostim, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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


• Serostim 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 Serostim. 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 Serostim resources

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

• Serostim Advanced Consumer (Micromedex) - Includes Dosage Information


• Serostim Prescribing Information (FDA)


• Somatropin Professional Patient Advice (Wolters Kluwer)


• Genotropin Prescribing Information (FDA)


• Genotropin Advanced Consumer (Micromedex) - Includes Dosage Information


• Humatrope Prescribing Information (FDA)


• Norditropin Prescribing Information (FDA)


• Nutropin Prescribing Information (FDA)


• Nutropin AQ Prescribing Information (FDA)


• Nutropin Depot Prescribing Information (FDA)


• Omnitrope Consumer Overview


• Omnitrope Prescribing Information (FDA)


• Saizen Prescribing Information (FDA)


• Tev-Tropin Prescribing Information (FDA)


• Zorbtive Prescribing Information (FDA)


• Zorbtive Consumer Overview

Compare Serostim with other medications

• AIDS Related Wasting
• Cachexia
• Short Stature for Age

Synalar Cream

Pronunciation: floo-oh-SIN-oh-lone
Generic Name: Fluocinolone
Brand Name: Generic only. No brands available.

Synalar Cream is used for:

Relieving itching and inflammation of the skin. It may also be used for other conditions as determined by your doctor.

Synalar Cream is a topical corticosteroid. Exactly how it works is unknown.

Do NOT use Synalar Cream if:

• you are allergic to any ingredient in Synalar Cream

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

Before using Synalar Cream:

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

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


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


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


• if you have measles, chickenpox, or tuberculosis


• if you have hardening or thinning of the skin or a skin infection


• if you have recently been vaccinated or you have had a positive tuberculin skin test

Some MEDICINES MAY INTERACT with Synalar Cream. Because little, if any, of Synalar Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Synalar Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Synalar Cream:

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

• Synalar Cream is for external use only.


• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Synalar Cream, unless your hands are part of treated area.


• If Synalar Cream is applied to a hairy site, the hair should be parted to allow the medicine direct contact with the skin.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• If you miss a dose of Synalar Cream, use 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 use 2 doses at once.

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

Important safety information:

• Avoid contact with eyes. In case of contact, wash eyes immediately with water.


• If Synalar Cream was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.


• Synalar Cream has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not use Synalar Cream for any conditions other than the one for which it was prescribed.


• Talk with your doctor before you receive any vaccine while you are using Synalar Cream.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Synalar Cream.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Synalar Cream while you are pregnant. It is not known if Synalar Cream is found in breast milk. If you are or will be breast-feeding while you use Synalar Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Synalar Cream:

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

Dryness; itching.

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); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Synalar Cream; thinning, softening, or discoloration of the skin.

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: Synalar 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Synalar Cream:

Store Synalar Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Avoid temperatures above 104 degrees F (40 degrees C). Do not freeze. Do not store in the bathroom. Keep Synalar Cream out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Synalar resources

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

Compare Synalar with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Sclerosus

crotamiton Topical

kroe-TAM-i-ton

Commonly used brand name(s)

In the U.S.

• Eurax

Available Dosage Forms:

• Cream


• Lotion

Therapeutic Class: Scabicide

Uses For crotamiton

Crotamiton is used to treat scabies infection. It is also used to relieve the itching of certain skin conditions.

crotamiton is available only with your doctor's prescription.

Before Using crotamiton

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 crotamiton, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to crotamiton 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 crotamiton have been done only in adult patients, and there is no specific information comparing use of crotamiton in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of crotamiton in the elderly with use in other age groups.

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 crotamiton. Make sure you tell your doctor if you have any other medical problems, especially:

• Severely inflamed skin or raw oozing areas of the skin—Use of crotamiton on these areas may make the condition worse

Proper Use of crotamiton

Keep crotamiton away from the mouth. It may be harmful if swallowed.

Use crotamiton only as directed. Do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

Keep crotamiton away from the eyes and other mucous membranes, such as the inside of the nose. It may cause irritation. If you should accidentally get some in your eyes, flush them thoroughly with water at once.

crotamiton usually comes with patient directions. Read them carefully before using.

If you take a bath or shower before using crotamiton, dry the skin well before applying crotamiton.

For patients using crotamiton for scabies:

• Apply enough medicine to cover the entire skin surface from the chin down, and rub in well. This applies especially to folds and creases in the skin and to the hands, feet (including the soles), between fingers and toes, and moist areas (such as underarms and groin).


• Do not wash off the first coat of crotamiton.


• Apply a second coat of crotamiton 24 hours after the first one.


• The next day, put on freshly washed or dry-cleaned clothing and change bedding in order to prevent reinfection.


• Then, 48 hours after the second application of crotamiton, take a cleansing bath to remove the medicine.


• Your sexual partners, especially, and all members of your household may need to be treated also, since the infection may spread to persons in close contact. If these persons are not being treated or if you have any questions about this, check with your doctor.

Dosing

The dose of crotamiton 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 crotamiton. 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 topical dosage forms (cream and lotion):
  
  • For scabies:
    
    • Adults—Use two times. Apply one time the first day, and one time the second day. For severe cases, treatment may be repeated one time after one week.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For pruritus:
    
    • Adults—Use when necessary according to the directions on the label or your doctor's instructions.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 crotamiton

If your condition does not improve or if it becomes worse, check with your doctor.

For patients using crotamiton for scabies:

• To prevent reinfection or spreading of the infection to other people, good health habits are also required. These include machine washing all underwear, pajamas, sheets, pillowcases, towels, and washcloths in very hot water and drying them using the hot cycle of a dryer. Clothing or bedding that cannot be washed in this way should be dry cleaned.

crotamiton 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:

Rare

• Skin irritation or rash not present before use of crotamiton

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: crotamiton Topical 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 crotamiton Topical resources

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

• Eurax Prescribing Information (FDA)


• Eurax Monograph (AHFS DI)


• Eurax Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Eurax Consumer Overview

Compare crotamiton Topical with other medications

• Pruritus
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Nalfon

Generic Name: Fenoprofen Calcium
Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Molecular Formula: C₃₀H₂₆CaO₆•2H₂O
CAS Number: 53746-45-5

• Cardiovascular Risk


• 
  

  Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).^{137 b} Risk may increase with duration of use.^{137 b} Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.^{100 137 b} (See Cardiovascular Effects under Cautions.)

  
  


• 
  

  Contraindicated for the treatment of pain in the setting of CABG surgery.^{100 137 b}

  
  

• GI Risk


• 
  

  Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).^{137 b} Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.^{137 b} Geriatric individuals are at greater risk for serious GI events.^{100 137 b} (See GI Effects under Cautions.)

  
  

Introduction

Prototypical NSAIA;^{100 b} propionic acid derivative;^b structurally and pharmacologically related to flurbiprofen, ibuprofen, ketoprofen, and naproxen.^{b d}

Uses for Nalfon

Consider potential benefits and risks of fenoprofen therapy as well as alternative therapies before initiating therapy with the drug.^{100 137 b} Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.^{100 137 b}

Pain

Relief of mild to moderate pain in adults.^{100 b}

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.^{100 b d}

Has been used in the symptomatic treatment of juvenile rheumatoid arthritis†.^{b c}

Also has been used with some success in the treatment of ankylosing spondylitis† and acute gouty arthritis†.^{b d}

Nalfon Dosage and Administration

General

• 
  

  Consider potential benefits and risks of fenoprofen therapy as well as alternative therapies before initiating therapy with the drug.^{100 137 b}

  
  

Administration

Oral Administration

Administer orally.^{100 b}

Administration with meals, milk, or antacids may minimize adverse GI effects.^{100 b d}

Dosage

Available as fenoprofen calcium; dosage expressed in terms of fenoprofen.^{100 b}

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.^{100 137 b} Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.^{100 137 b}

Adults

Pain

Oral

For mild to moderate pain, 200 mg every 4–6 hours as needed.^{100 b}

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Initially, 300–600 mg 3 or 4 times daily.^{100 b d} Adjust dose and frequency as necessary based on severity of symptoms and clinical response (maximum 3.2 g daily).^{100 b}

Patients with rheumatoid arthritis may require higher dosages than those with osteoarthritis.^{100 b}

Symptomatic improvement usually begins in a few days, but an additional 2–3 weeks may be needed to determine response.^{100 b}

Prescribing Limits

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Maximum 3.2 g daily.^{100 b}

Special Populations

Renal Impairment

No dosage adjustments recommended.¹⁰⁰

Use not recommended in patients with advanced renal disease.¹⁰⁰

Hepatic Impairment

No dosage adjustments recommended.

Cautions for Nalfon

Contraindications

• 
  

  Known hypersensitivity to fenoprofen or any ingredient in the formulation.^{100 d}

  
  


• 
  

  History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.^{100 137 d}

  
  


• 
  

  Treatment of perioperative pain in the setting of CABG surgery.^{100 137}

  
  


• 
  

  History of significant renal impairment.¹⁰⁰

  
  

Warnings/Precautions

Warnings

Cardiovascular Effects

Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.¹³⁸ Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.^{141 142 143} Information not available on risk associated with fenoprofen at this time.^{141 142 143}

Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events) and at the lowest effective dosage for the shortest duration necessary.^{100 137}

Peripheral edema, palpitations, tachycardia (including supraventricular tachycardia), atrial fibrillation, and ECG changes reported.^{100 b}

Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).¹³⁸

No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.^{100 137 138} (See Specific Drugs under Interactions.)

Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.^{100 137} Use with caution in patients with hypertension; monitor BP.^{100 137} Impaired response to certain diuretics may occur.^{100 137} (See Specific Drugs under Interactions.)

Fluid retention and edema reported.^{100 137} Caution in patients with fluid retention or heart failure.^{100 137}

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;^{100 104 105 108} increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.^{100 124 127 134}

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;^{107 124 125 126} alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)^{107 124 125} or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).¹²⁵

Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.^{100 137}

Potential for overt renal decompensation.^{100 137} Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.^{100 137 140} (See Renal Impairment under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactoid reactions reported.^{100 137}

Immediate medical intervention and discontinuance for anaphylaxis.^{100 137}

Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.^{100 137 d}

Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.^{100 137} Discontinue at first appearance of rash or any other signs of hypersensitivity (e.g., blisters, fever, pruritus).^{100 137}

General Precautions

Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.¹⁰⁰

Elevations of serum ALT or AST reported.¹⁰⁰

Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.¹⁰⁰ Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.¹⁰⁰

Hematologic Effects

Anemia reported rarely.^{100 137} Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.^{100 137 d}

May inhibit platelet aggregation and prolong bleeding time.^{100 137 d}

CNS Effects

Drowsiness and dizziness reported; may impair ability to perform activities requiring mental alertness.^{100 b}

Ocular Effects

Adverse ocular effects reported in patients receiving NSAIA therapy; ophthalmologic evaluation recommended if visual disturbances occur.^{100 b}

Otic Effects

Safety not established in patients with hearing impairment; auditory function tests should be performed periodically in these patients during prolonged therapy.^{100 b}

Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.¹⁰⁰

May mask certain signs of infection.^b

Obtain CBC and chemistry profile periodically during long-term use.¹⁰⁰

Specific Populations

Pregnancy

Category C.¹⁰⁰ Avoid use in third trimester because of possible premature closure of the ductus arteriosus.¹⁰⁰

Lactation

Fenoprofen is distributed into milk.^{b d} Discontinue nursing or the drug.^{100 b}

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹⁰⁰

Geriatric Use

Use with caution in patients ≥65 years of age.¹⁰⁰ Geriatric patients appear to tolerate therapy less well (e.g., possible higher incidence of adverse GI effects, greater risk of developing renal decompensation) than younger individuals.^{100 b} Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.^{100 b}

Renal Impairment

Has not been evaluated in patients with severe renal impairment.^{100 b} Use not recommended in patients with advanced renal disease.^{100 b}

Common Adverse Effects

Dyspepsia,^{100 d} nausea,^{100 d} constipation,^{100 d} headache,¹⁰⁰ somnolence,¹⁰⁰ dizziness,¹⁰⁰ nervousness,¹⁰⁰ asthenia,¹⁰⁰ and peripheral edema.¹⁰⁰

Interactions for Nalfon

Protein-bound Drugs

Possible pharmacokinetic interaction; potential for fenoprofen to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs (e.g., oral anticoagulants, hydantoins, salicylates, sulfonamides, and sulfonylureas).^{100 b d} Observe for adverse effects if used with other protein-bound drugs.^{100 b}

Specific Drugs

Drug	Interaction	Comments
ACE inhibitors	Reduced BP response to ACE inhibitor possible 100 137 144 Possible deterioration of renal function in individuals with renal impairment144	Monitor BP100 144 b
Angiotensin II receptor antagonists	Reduced BP response to angiotensin II receptor antagonist possible144 Possible deterioration of renal function in individuals with renal impairment144	Monitor BP144 b
Antacids (aluminum- and magnesium-containing)	Did not affect fenoprofen absorption in one study; other antacids not evaluated for possible interactionsa b d
Anticoagulants (e.g., warfarin)	Possible bleeding complications100 137 144	Caution and careful monitoring advised100 144 b
Aspirin	Increased risk of GI ulceration or other complications 100 137 Possible decreased plasma concentrations and half-life of fenoprofen100 b d No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs 100 138	Concomitant use generally not recommended100 d
Diuretics (furosemide and thiazides)	Reduced natriuretic effects100 137	Monitor for diuretic efficacy and renal failure100 137
Lithium	Increased plasma lithium concentrations100 137	Monitor for lithium toxicity 100 137
Methotrexate	Possible toxicity associated with increased plasma methotrexate concentrations during concomitant NSAIA use100 b	Caution advised100 b
Phenobarbital	Possible decreased plasma concentrations and plasma half-life of fenoprofen100 b d	Dosage adjustment may be necessary when phenobarbital is initiated or discontinued100 b d

Nalfon Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.^{100 b d} Peak plasma concentrations usually attained within 2 hours.^{100 b}

Onset

Onset of analgesic activity reportedly occurs within 15–30 minutes following oral administration.^b

Duration

Duration of analgesic activity: 4–6 hours.^b

Food

Food delays and diminishes peak plasma fenoprofen concentrations.^{100 a b d}

Distribution

Extent

Distributed into milk;^{b d} does not appear to cross the placenta.^{b d}

Plasma Protein Binding

Approximately 99% (mainly to albumin).^{100 b d}

Elimination

Metabolism

Extensively metabolized in the liver.^{b d} Fenoprofen's major metabolite, 4′-hydroxyfenoprofen, probably is inactive.^b

Elimination Route

Eliminated principally in urine as unchanged drug (2–5%), 4′-hydroxyfenoprofen (2–5%), their glucuronide or other conjugates (90%), and unidentified conjugates (2–5%).^{100 b d}

Half-life

2.5–3 hours.^{100 b d}

Special Populations

Not substantially removed by hemodialysis or peritoneal dialysis.¹⁰⁰

Stability

Storage

Oral

Capsules and Tablets

Tight containers at 20–25°C.¹⁰⁰

ActionsActions

• 
  

  Inhibits cyclooxygenase-1 (COX-1) and COX-2.^{118 119 120 121 122 123 b}

  
  


• 
  

  Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.^{100 118 119 120 121 122 123 b d}

  
  

Advice to Patients

• 
  

  Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.^{100 137}

  
  


• 
  

  Risk of serious cardiovascular events with long-term use.^{100 b} Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.^{100 b}

  
  


• 
  

  Risk of GI bleeding and ulceration.^{100 111 115 b} Importance of notifying a clinician if signs and symptoms of serious adverse GI effects occur.^{100 b}

  
  


• 
  

  Risk of serious skin reactions.^{100 b} Importance of discontinuing fenoprofen calcium and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.^{100 b}

  
  


• 
  

  Risk of anaphylactoid and other sensitivity reactions.^{100 b} Importance of seeking immediate medical attention if an anaphylactic reaction occurs.^{100 b}

  
  


• 
  

  Risk of hepatotoxicity.^{100 b} Importance of discontinuing therapy and contacting a clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.^{100 b}

  
  


• 
  

  Importance of notifying clinician if signs and symptoms of unexplained weight gain or edema develop.¹⁰⁰

  
  


• 
  

  Risk of dizziness and potential for drug to impair mental alertness; use caution when driving or operating machinery until effects on individual are known.^{100 b}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰⁰ Importance of avoiding fenoprofen in late pregnancy (third trimester).^{100 b}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.¹⁰⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰⁰ (See Cautions.)

  
  

Preparations

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

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

Fenoprofen Calcium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	200 mg (of fenoprofen)*	Nalfon	Pedinol
		300 mg (of fenoprofen)*	Fenoprofen Calcium Capsules	Par, Sandoz, Watson
			Nalfon	Pedinol
	Tablets, film-coated	600 mg (of fenoprofen)*	Fenoprofen Calcium Tablets	Mylan, Purepac, Teva

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Fenoprofen Calcium 600MG Tablets (MYLAN): 30/$33.99 or 90/$79.97

Nalfon 200MG Capsules (PEDINOL): 100/$91.99 or 300/$249.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

100. Pedinol Pharmacal Inc. Nalfon (fenoprofen calcium) capsules prescribing information. Farmingdale, NY; 2006 Jan.

101. Gurney JR, Mills RJ. Assessment of thyroid function: complications after treatment with fenoprofen. BMJ. 1986; 292:1560. [IDIS 217988] [PubMed 3087516]

102. Tillman J, Leask JTS, Logue FC et al. Assessment of thyroid function: complications after treatment with fenoprofen. BMJ. 1986; 293:206. [IDIS 219567] [PubMed 3089454]

103. Thornes HM, Carr D. Fenoprofen and free triiodothyronine measurement. Lancet. 1986; 2:101. [IDIS 219180] [PubMed 2873356]

104. Palmer JF. Letter sent to Talbott MW of Eli Lilly and Company regarding labeling revisions about gastrointestinal adverse reactions to Nalfon (fenoprofen). Rockville, MD: Food and Drug Administration, Division of Oncology and Radiopharmaceutical Drug Products; 1988 Sep.

105. Food and Drug Administration. Labeling revisions for NSAIDs. FDA Drug Bull. 1989; 19:3-4.

106. Searle. Cytotec (misoprostol) prescribing information. 1989 Jan.

107. Anon. Drug for rheumatoid arthritis. Med Lett Drugs Ther. 2000; 42:57-64. [PubMed 10887424]

108. Soll AH, Weinstein WM, Kurata J et al. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991; 114:307-19. [IDIS 277370] [PubMed 1987878]

109. Kolodzik JM, Eilers MA, Angelos MG. Nonsteroidal anti-inflammatory drugs and coma: a case report of fenoprofen overdose. Ann Emerg Med. 1990; 19:378-81. [PubMed 2321822]

110. Corticosteroid interactions: nonsteroidal anti-inflammatory drugs (NSAIDs). In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:562.

111. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet. 1994; 343:769-72. [IDIS 328176] [PubMed 7907735]

112. Hollander D. Gastrointestinal complications of nonsteroidal anti-inflammatory drugs: prophylactic and therapeutic strategies. Am J Med. 1994; 96:274-81. [IDIS 328041] [PubMed 8154516]

113. Schubert TT, Bologna SD, Yawer N et al. Ulcer risk factors: interaction between Helicobacter pylori infection, nonsteroidal use, and age. Am J Med. 1993; 94:413-7. [IDIS 314155] [PubMed 8475935]

114. Piper JM, Ray WA, Daugherty JR et al. Corticosteroid use and peptic ulcer disease: role of nonsteroidal anti-inflammatory drugs. Ann Intern Med. 1991; 114:735-40. [IDIS 280191] [PubMed 2012355]

115. Bateman DN, Kennedy JG. Non-steroidal anti-inflammatory drugs and elderly patients: the medicine may be worse than the disease. BMJ. 1995; 310:817-8. [IDIS 345154] [PubMed 7711609]

116. Ciba Geigy, Ardsley, NY: Personal communication on diclofenac 28:08.04.

117. Reviewers’ comments (personal observation) on diclofenac 28:08.04.

118. Hawkey CJ. COX-2 inhibitors. Lancet. 1999; 353:307-14. [IDIS 418284] [PubMed 9929039]

119. Kurumbail RG, Stevens AM, Gierse JK et al. Structural basis for selective inhibition of cyclooxygenase-2 by anti-inflammatory agents. Nature. 1996; 384:644-8. [PubMed 8967954]

120. Riendeau D, Charleson S, Cromlish W et al. Comparison of the cyclooxygenase-1 inhibitory properties of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors, using sensitive microsomal and platelet assays. Can J Physiol Pharmacol. 1997; 75:1088-95. [PubMed 9365818]

121. DeWitt DL, Bhattacharyya D, Lecomte M et al. The differential susceptibility of prostaglandin endoperoxide H synthases-1 and -2 to nonsteroidal anti-inflammatory drugs; aspirin derivatives as selective inhibtors. Med Chem Res. 1995; 5:325-43.

122. Cryer B, Dubois A. The advent of highly selective inhibitors of cyclooxygenase—a review. Prostaglandins Other Lipid Mediators. 1998; 56:341-61. [PubMed 9990677]

123. Simon LS. Role and regulation of cyclooxygenase-2 during inflammation. Am J Med. 1999; 106(Suppl 5B):37-42S.

124. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999; 340:1888-99. [IDIS 426864] [PubMed 10369853]

125. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines.. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002; 46:328-46. [IDIS 476480] [PubMed 11840435]

126. Lanza FL and the members of the Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. A guideline for the treatment and prevention of NSAID-induced ulcers. Am J Gastroenterol. 1998; 93:2037-46. [IDIS 417402] [PubMed 9820370]

127. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol. 1999; 26(suppl 56):18-24.

128. in’t Veld BA, Ruitenberg A, Hofman A et al. Nonsteroidal antiinflammatory drugs and the risk of Alzheimer’s disease. N Engl J Med. 2001; 345:1515-21. [PubMed 11794217]

129. Breitner JCS, Zandi PP. Do nonsteroidal antiinflammatory drugs reduce the risk of Alzheimer’s disease? N Engl J Med. 2001; 345:1567-8. Editorial.

130. McGeer PL, Schulzer M, McGeer EG. Arthritis and anti-inflammatory agents as possible protective factors for Alzheimer’s disease: a review of 17 epidemiologic studies. Neurology. 1996; 47:425-32. [IDIS 371394] [PubMed 8757015]

131. Beard CM, Waring SC, O’sBrien PC et al. Nonsteroidal anti-inflammatory drug use and Alzheimer’s disease : a case-control study in Rochester, Minnesota, 1980 through 1984. Mayo Clin Proc. 1998; 73:951-5. [IDIS 416502] [PubMed 9787743]

132. in’t Veld BA, Launer LJ, Hoes AW et al. NSAIDs and incident Alzheimer’s disease: the Rotterdam Study. Neurobiol Aging. 1998; 19:607-11. [PubMed 10192221]

133. Stewart WF, Kawas C, Corrada M et al. Risk of Alzheimer’s disease and duration of NSAID use. Neurology. 1997; 48:626-32. [IDIS 383303] [PubMed 9065537]

134. Pharmacia. Daypro (oxaprozin) caplets prescribing information. Chicago, IL; 2002 May.

135. Chan FKL, Hung LCT, Suen BY et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med. 2002; 347:2104-10. [IDIS 490812] [PubMed 12501222]

136. Graham DY. NSAIDs, Helicobacter pylori, and Pandora’s box. N Engl J Med. 2002; 347:2162-4. [IDIS 490815] [PubMed 12501230]

137. US Food and Drug Administration. Proposed NSAID Package Insert Labeling Template 1. From the FDA website (). Accessed 10 Oct 2005.

138. Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. 2005 Apr 6.

139. Cush JJ. The safety of COX-2 inhibitors: deliberations from the February 16-18, 2005, FDA meeting. From the American College of Rheumatology website (). Accessed 2005 Oct 12.

140. Novartis Pharmaceuticals. Diovan (valsartan) capsules prescribing information (dated 1997 Apr). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:2013-5.

141. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006; 296: 1633-44. [PubMed 16968831]

142. Kearney PM, Baigent C, Godwin J et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006; 332: 1302-5. [PubMed 16740558]

143. Graham DJ. COX-2 inhibitors, other NSAIDs, and cardiovascular risk; the seduction of common sense. JAMA. 2006; 296:1653-6. [PubMed 16968830]

144. Merck & Co. Clinoril (sulindac) tablets prescribing information. Whitehouse Station, NJ; 2006 Feb.

145. Chou R, Helfand M, Peterson K et al. Comparative effectiveness and safety of analgesics for osteoarthritis. Comparative effectiveness review no. 4. (Prepared by the Oregon evidence-based practice center under contract no. 290-02-0024.) . Rockville, MD: Agency for Healthcare Research and Quality. 2006 Sep. Available at: .

a. Chernish SM, Rubin A, Rodda BE et al. The physiological disposition of fenoprofen in man. IV. The effects of position of subject, food ingestion and antacid ingestion on the plasma levels of orally administered fenoprofen. J Med. 1972; 3: 249-57. [PubMed 4508566]

b. AHFS drug information 2007. McEvoy GK, ed. Fenoprofen. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2054-2058.

c. Brewer EJ, Giannini EH, Baum J et al. Aspirin and fenoprofen (Nalfon) in the treatment of juvenile rheumatoid arthritis results of the double blind-trial: a segment II study. J Rheumatol. 1982; 9: 123-8.

d. Brogden RN, Pinder RM, Speight TM et al. Fenoprofen: a review of its pharmacological properties and therapeutic efficacy in rheumatic diseases. Drugs. 1977; 13: 241-65.

More Nalfon resources

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

• Nalfon Prescribing Information (FDA)


• Nalfon Concise Consumer Information (Cerner Multum)


• Nalfon Advanced Consumer (Micromedex) - Includes Dosage Information


• Nalfon MedFacts Consumer Leaflet (Wolters Kluwer)


• Fenoprofen Prescribing Information (FDA)


• Fenoprofen MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nalfon with other medications

• Gout, Acute
• Osteoarthritis
• Pain
• Rheumatoid Arthritis

silodosin

Generic Name: silodosin (SIL oh DOE sin)

Brand Names: Rapaflo

What is silodosin?

Silodosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Silodosin helps relax the muscles in the prostate and bladder neck, making it easier to urinate.

Silodosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

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

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

You should not take silodosin if you have severe kidney or liver disease, or if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal), itraconazole (Sporanox), or ritonavir (Norvir).

Do not take silodosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), or terazosin (Hytrin).

Silodosin may cause dizziness or fainting, especially when you first start taking it. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Silodosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using silodosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with silodosin. Tell your doctor about all medications you use.

What should I discuss with my health care provider before taking silodosin?

You should not take silodosin if you are allergic to it, or if you have:

• 
  

  severe kidney disease;

  
  


• 
  

  severe liver disease; or

  
  


• 
  

  if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal), itraconazole (Sporanox), or ritonavir (Norvir).

  
  

Do not take silodosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), or terazosin (Hytrin).

If you have liver or kidney disease or a history of prostate cancer, you may need a silodosin dose adjustment or special tests to safely take this medication.

Silodosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using silodosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, silodosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Silodosin is not for use in children.

How should I take silodosin?

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.

Silodosin is usually taken once daily with a meal. Silodosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture, heat, and light.

See also: Silodosin 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 extreme dizziness or fainting.

What should I avoid while taking silodosin?

Silodosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of silodosin.

Silodosin 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 silodosin and call your doctor at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out; or

  
  


• penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

• 
  

  mild dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  diarrhea;

  
  


• 
  

  abnormal ejaculation; or

  
  


• 
  

  runny or stuffy nose, sore throat.

  
  

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.

Silodosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

8 mg orally once a day with a meal

What other drugs will affect silodosin?

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

• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  antifungal medication such as clotrimazole (Mycelex Troche) or voriconazole (Vfend);

  
  


• 
  

  erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), or nelfinavir (Viracept), saquinavir (Invirase); or

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

This list is not complete and there are many other drugs that can interact with silodosin. 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 silodosin resources

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

• silodosin Advanced Consumer (Micromedex) - Includes Dosage Information


• Silodosin Professional Patient Advice (Wolters Kluwer)


• Silodosin MedFacts Consumer Leaflet (Wolters Kluwer)


• Silodosin Monograph (AHFS DI)


• Rapaflo Prescribing Information (FDA)


• Rapaflo Consumer Overview

Compare silodosin with other medications

• Benign Prostatic Hyperplasia

Where can I get more information?

• Your pharmacist can provide more information about silodosin.

See also: silodosin side effects (in more detail)

Amiloride

Pronunciation: a-MILL-oh-ride
Generic Name: Amiloride
Brand Name: Midamor

Amiloride may cause high blood potassium levels that can be fatal if not corrected. High blood potassium levels occur more commonly in patients with kidney problems, diabetes, elderly patients, those who are severely ill, or patients who are not taking an agent used to increase excretion of potassium. If you develop muscle weakness or irregular heartbeat, notify your doctor immediately.

Amiloride is used for:

Preventing development of low blood potassium or helping to restore normal blood potassium in patients with high blood pressure or heart failure. It is usually used with other medicines. It may also be used for other conditions as determined by your doctor.

Amiloride is a potassium-sparing diuretic. It works by making the kidneys eliminate sodium (salt) and water from the body while retaining potassium.

Do NOT use Amiloride if:

• you are allergic to any ingredient in Amiloride


• you are taking potassium supplements or potassium-sparing diuretics (eg, aldosterone, triamterene)


• you are unable to urinate


• you have high blood potassium levels or kidney problems due to diabetes or other severe kidney disease

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

Before using Amiloride:

Some medical conditions may interact with Amiloride. 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 heart problems, diabetes, kidney damage caused by diabetes, liver or kidney problems, low blood sodium levels, or a high acidity of body fluids, or you are dehydrated

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

• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin II receptor antagonists (eg, valsartan), cyclosporine, other potassium-sparing diuretics (eg, aldosterone, triamterene) or potassium supplements because high blood potassium levels may occur and cause listlessness, confusion, abnormal skin sensations of the arms and legs, heaviness of the limbs, slow or irregular heartbeat, or stopping of the heart


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin) because they may decrease Amiloride's effectiveness and increase the risk of kidney problems and high blood potassium levels


• Lithium or quinidine because the risk of their side effects and toxicity may be increased by Amiloride

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

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

• Take Amiloride by mouth with food.


• Amiloride 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 miss a dose of Amiloride, 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 Amiloride.

Important safety information:

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


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


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


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


• Amiloride should not be used 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 Amiloride while you are pregnant. It is not known if Amiloride is found in breast milk. Do not breast-feed while taking Amiloride.

Possible side effects of Amiloride:

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; headache; loss of appetite; nausea; weakness.

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); dry mouth; excessive thirst; slowed heart rate; unusual muscle weakness; unusual tiredness; 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.

See also: Amiloride 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 lightheadedness; nausea; vomiting; weakness.

Proper storage of Amiloride:

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

General information:

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


• Amiloride 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 Amiloride. 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 Amiloride resources

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

• Amiloride Prescribing Information (FDA)


• Amiloride Hydrochloride Monograph (AHFS DI)


• Midamor Prescribing Information (FDA)


• amiloride Concise Consumer Information (Cerner Multum)


• amiloride Advanced Consumer (Micromedex) - Includes Dosage Information

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Uniserts oral/rectal

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)

Brand Names: Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Children's Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Genebs, Infants Tylenol Concentrated Drops, Leader 8 Hour Pain Reliever, Little Fevers, Little Fevers Children's Fever/Pain Reliever, Mapap, Mapap Arthritis Pain, Mapap Extra Strength Rapid Burst, Mapap Infant Drops, Mapap Infants', Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Medi-Tabs, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Triaminic Fever & Pain, Triaminic Infant Drops, Tycolene, Tylenol, Tylenol Arthritis Caplet, Tylenol Arthritis Gelcap, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Cool Caplet Extra Strength, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat Daytime, Vitapap

What is acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

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

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

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

You should not take acetaminophen if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:

• liver disease; or


• 
  

  a history of alcoholism.

  
  

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. It is not known whether acetaminophen will harm an unborn baby. Before taking acetaminophen, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

How should I take acetaminophen?

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

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label. Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

• 
  

  you still have a fever after 3 days of use;

  
  


• 
  

  you still have pain after 7 days of use (or 5 days if treating a child);

  
  


• 
  

  you have a skin rash, ongoing headache, or any redness or swelling; or

  
  


• 
  

  if your symptoms get worse, or if you have any new symptoms.

  
  

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking acetaminophen?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Acetaminophen 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 taking this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  nausea, upper stomach pain, itching, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

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.

What other drugs will affect acetaminophen?

Ask a doctor or pharmacist if it is safe for you to use acetaminophen if you are also using any of the following drugs:

• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  cancer medications;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medications.

  
  

This list is not complete and there may be other drugs that can interact with acetaminophen. 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 Uniserts oral/rectal resources

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

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Where can I get more information?

• Your pharmacist can provide more information about acetaminophen.

See also: Uniserts/rectal side effects (in more detail)