Hot Article Directory San Andrés y Providencia

Saturday, March 17, 2012

Sandoglobulin IGIV

Generic Name: immune globulin (intravenous) (IGIV) (im MYOON GLOB yoo lin)

Brand Names: Carimune, Flebogamma, Gammagard (obsolete), Gammagard S/D, Gammaplex, Gammar-P I.V., Gamunex, Octagam, Polygam S/D, Privigen, Sandoglobulin

What is immune globulin intravenous (IVIG)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

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

What is the most important information I should know about immune globulin?

Immune globulin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before using immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using immune globulin?

You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

To make sure you can safely use immune globulin, tell your doctor if you have any of these other conditions:

kidney disease;

diabetes (especially if you use insulin);

a history of stroke or blood clot;

heart disease or high blood pressure;

a condition called paraproteinemia; or

if you are over 65 years old.

FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known if immune globulin 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 is immune globulin intravenous given?

Immune globulin intravenous is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

IVIG should not be injected into a muscle or under the skin.

Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

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

This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

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

What should I avoid while using immune globulin?

Do not receive a "live" vaccine while using IVIG. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Immune globulin 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. Call your doctor at once if you have a serious side effect such as:

urinating less than usual or not at all;

drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

swelling, weight gain, feeling short of breath;

wheezing, chest tightness;

feeling like you might pass out;

fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or

pale or yellowed skin, dark colored urine, fever, confusion or weakness.

Less serious side effects may include:

mild headache;

dizziness;

tired feeling;

back pain, muscle cramps;

minor chest pain; or

flushing (warmth, redness, or tingly feeling).

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 immune globulin?

Immune globulin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;

medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

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

IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and other drugs may interact with immune globulin. 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 Sandoglobulin resources

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

Compare Sandoglobulin with other medications

Autoimmune Neutropenia
Bone Marrow Transplantation
Chronic Lymphocytic Leukemia
Evan's Syndrome
HIV Infection
Idiopathic Thrombocytopenic Purpura
Kawasaki Disease
Polymyositis/Dermatomyositis
Primary Immunodeficiency Syndrome

Where can I get more information?

Your pharmacist can provide more information about immune globulin intravenous.

See also: Sandoglobulin side effects (in more detail)

Friday, March 16, 2012

acebutolol

Generic Name: acebutolol (A se BUE toe lol)

Brand Names: Sectral

What is acebutolol?

Acebutolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Acebutolol is used to treat hypertension (high blood pressure) and heart rhythm disorders.

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

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

Do not stop taking acebutolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need to have any type of surgery, you may need to temporarily stop using acebutolol. Be sure the surgeon knows ahead of time that you are using acebutolol.

Acebutolol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which could increase drowsiness and dizziness while you are taking acebutolol.

Acebutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Keep using this medicine as directed, 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 acebutolol?

If you have any of these conditions, you may not be able to use acebutolol, or you may need a dosage adjustment or special tests during treatment:

asthma, bronchitis, emphysema;

diabetes;

low blood pressure;

a heart problem such as heart block, sick sinus syndrome, slow heart rate, or congestive heart failure;

depression;

liver or kidney disease;

a thyroid disorder;

myasthenia gravis;

pheochromocytoma; or

problems with circulation (such as Raynaud's syndrome).

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. Acebutolol 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.

How should I take acebutolol?

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

Take this medication with a full glass of water.

Take acebutolol at the same time every day.

Do not skip doses or stop taking acebutolol without first talking to your doctor. Stopping suddenly may make your condition worse.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. It is important that you not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon that you are using acebutolol. You may need to briefly stop using acebutolol before having surgery.

Keep using this medicine as directed, 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 acebutolol at room temperature away from moisture and heat.

See also: Acebutolol dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 4 hours away, 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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, or seizure (convulsions).

What should I avoid while taking acebutolol?

Acebutolol side effects

slow or uneven heartbeats;

feeling light-headed, fainting;

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

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

depression; or

cold feeling in your hands and feet.

Less serious side effects may include:

decreased sex drive, impotence, or difficulty having an orgasm;

sleep problems (insomnia);

tired feeling; or

anxiety, nervousness.

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.

Acebutolol Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 400 mg orally once a day or 200 mg orally twice a day.
Maintenance dose: 400 to 800 mg per day.

Usual Adult Dose for Premature Ventricular Depolarizations:

Initial dose: 200 mg orally twice a day.
Maintenance dose: 600 to 1200 mg per day in divided doses.

What other drugs will affect acebutolol?

Before taking acebutolol, tell your doctor if you are using:

allergy treatments (or if you are undergoing allergy skin-testing);

clonidine (Catapres);

guanabenz (Wytensin);

an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam);

a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), or metformin (Glucophage);

a heart medication such as nifedipine (Procardia, Adalat), reserpine (Serpasil), verapamil (Calan, Verelan, Isoptin), diltiazem (Cartia, Cardizem);

medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair); or

cold medicines, stimulant medicines, or diet pills.

This list is not complete and there may be other drugs that can interact with acebutolol. 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 acebutolol resources

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

acebutolol Advanced Consumer (Micromedex) - Includes Dosage Information

Acebutolol MedFacts Consumer Leaflet (Wolters Kluwer)

Acebutolol Prescribing Information (FDA)

Acebutolol Hydrochloride Monograph (AHFS DI)

Sectral Prescribing Information (FDA)

Compare acebutolol with other medications

High Blood Pressure
Premature Ventricular Depolarizations
Ventricular Tachycardia

Where can I get more information?

Your pharmacist can provide more information about acebutolol.

See also: acebutolol side effects (in more detail)

Monday, March 12, 2012

Codimal PH Syrup

Pronunciation: KOE-deen/fen-ill-EF-rin/peer-IL-a-meen
Generic Name: Codeine/Phenylephrine/Pyrilamine
Brand Name: Examples include Pro-Red AC and Zotex-C

Codimal PH Syrup is used for:

Treating symptoms of the common cold, flu, or hay fever, and other upper respiratory allergies such as cough, congestion, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. Codimal PH Syrup may also be used for other conditions as determined by your doctor.

Codimal PH Syrup is a narcotic antitussive (cough suppressant), antihistamine, and decongestant combination. The antitussive works by suppressing the cough center in the brain. The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose. The decongestant shrinks swollen nasal passages, which relieves nasal congestion.

Do NOT use Codimal PH Syrup if:

you are allergic to any ingredient in Codimal PH Syrup or any other codeine-related medicine (eg, dihydrocodeine)

you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Codimal PH Syrup:

Some medical conditions may interact with Codimal PH Syrup. 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 a history of alcohol or drug abuse, dependence on narcotics, or suicidal thoughts or behaviors

if you have increased pressure in the head, an unusual growth in the brain (eg, tumor), a recent head injury, Parkinson disease, Reye syndrome, the blood disease porphyria, or a blockage of your stomach, bowel, or bladder

if you have a history of epilepsy or seizures, asthma or other breathing problems (eg, sleep apnea), stomach or intestinal problems, chronic constipation, liver problems, glaucoma, an enlarged prostate gland or other prostate problems, difficulty urinating, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, overactive thyroid, seizures, or stroke

if you have recently had abdominal surgery

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

Barbiturate anesthetics (eg, thiopental), beta-blockers (eg, propranolol), cimetidine, catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, ketorolac, MAO inhibitors (eg, phenelzine), naltrexone, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Codimal PH Syrup may be increased, including dangerous sleepiness and a decrease in the ability to breathe

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Rifampin or risperidone because the effectiveness of Codimal PH Syrup may be decreased

Bromocriptine or hydantoins (eg, phenytoin) because the actions and side effects may be increased by Codimal PH Syrup

Guanadrel, guanethidine, mecamylamine, methyldopa, mexiletine, or reserpine because the effectiveness may be decreased by Codimal PH Syrup

Naltrexone because the effectiveness of Codimal PH Syrup will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids. You must not take naltrexone until you have stopped taking Codimal PH Syrup for 7 to 10 days and after a naloxone challenge test is negative.

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

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

Codimal PH Syrup may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

If you miss a dose of Codimal PH Syrup and you are taking it regularly, 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 Codimal PH Syrup.

Important safety information:

Codimal PH Syrup may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Codimal PH Syrup. Using Codimal PH Syrup alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

Do not drink alcohol while you are using Codimal PH Syrup. Avoid taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Codimal PH Syrup. Codimal PH Syrup will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

If your symptoms do not improve within 7 days or if you develop a high fever or persistent headache, check with your doctor.

Use Codimal PH Syrup with caution in the ELDERLY because they may be more sensitive to its effects, especially possible breathing problems and drowsiness.

Use Codimal PH Syrup with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is unknown if Codimal PH Syrup can cause harm to the fetus. If you become pregnant while taking Codimal PH Syrup, discuss with your doctor the benefits and risks of using Codimal PH Syrup during pregnancy. Codimal PH Syrup is excreted in breast milk. If you are or will be breast-feeding while you are using Codimal PH Syrup, check with your doctor or pharmacist to discuss the risks to your baby.

Use of Codimal PH Syrup can lead to TOLERANCE. When using for an extended period, Codimal PH Syrup may not work as well and may require different dosing. Talk with your doctor if Codimal PH Syrup stops working well.

Long-term use of Codimal PH Syrup can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness, when pain relief is more important. If using Codimal PH Syrup for an extended period of time, do not suddenly stop taking Codimal PH Syrup without your doctor's approval. WITHDRAWAL symptoms have occurred when Codimal PH Syrup is suddenly stopped and may include anxiety; diarrhea; fever; runny nose or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping use of Codimal PH Syrup.

Possible side effects of Codimal PH Syrup:

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; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; flushing or redness of face.

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: Codimal PH 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 agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slowed breathing; slow heartbeat.

Proper storage of Codimal PH Syrup:

Store Codimal PH Syrup 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 Codimal PH Syrup out of the reach of children and away from pets.

General information:

If you have any questions about Codimal PH Syrup, please talk with your doctor, pharmacist, or other health care provider.

Codimal PH Syrup 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 Codimal PH Syrup. 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

More Codimal PH resources

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

Compare Codimal PH with other medications

Cold Symptoms
Cough and Nasal Congestion

Friday, March 9, 2012

All Day Relief

naproxen sodium

Dosage Form: tablet
Meijer All Day Pain Relief Tablets Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

minor pain of arthritis

muscular aches

backache

menstrual cramps

headache

toothache

the common cold

temporarily reduces fever

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery

Ask a doctor before use if

the stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if you are

under a doctor’s care for any serious condition

taking any other drug

When using this product

take with food or milk if stomach upset occurs

the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

you have difficulty swallowing

it feels like the pill is stuck in your throat

you develop heartburn

redness or swelling is present in the painful area

any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

do not take more than directed

the smallest effective dose should be used

do not take longer than 10 days, unless directed by a doctor (see Warnings)

drink a full glass of water with each dose

Adults and

children

12 years

and older

take 1 tablet every 8 to 12 hours while symptoms last

for the first dose you may take 2 tablets within the first hour

do not exceed 2 tablets in any 8- to 12-hour period

do not exceed 3 tablets in a 24-hour period

Children

under 12

years

ask a doctor

Other information

each tablet contains: sodium 20 mg

store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

All Day Relief

Naproxen Sodium Tablets, 220 mg

Pain Reliever/Fever Reducer (NSAID)

Strength to last 12 hours

Actual Size

Compare to Aleve® active ingredient

All Day Relief Tablets Carton

All Day Relief
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	41250-490
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (NAPROXEN)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L490
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	41250-490-71	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		50 TABLET In 1 BOTTLE	This package is contained within the CARTON (41250-490-71)
2	41250-490-78	1 BOTTLE In 1 CARTON	contains a BOTTLE
2		100 TABLET In 1 BOTTLE	This package is contained within the CARTON (41250-490-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074661	05/29/1997

Labeler - Meijer Distribution Inc (006959555)

Revised: 05/2009Meijer Distribution Inc

More All Day Relief resources

All Day Relief Side Effects (in more detail)
All Day Relief Dosage
All Day Relief Use in Pregnancy & Breastfeeding
All Day Relief Drug Interactions
0 Reviews for All Day Relief - Add your own review/rating

Compare All Day Relief with other medications

Ankylosing Spondylitis
Aseptic Necrosis
Back Pain
Bursitis
Costochondritis
Diffuse Idiopathic Skeletal Hyperostosis
Dysautonomia
Fever
Frozen Shoulder
Gout, Acute
Headache
Juvenile Rheumatoid Arthritis
Muscle Pain
Osteoarthritis
Pain
Period Pain
Rheumatoid Arthritis
Sciatica
Spondylolisthesis
Tendonitis

Cyklokapron Tablets

Cyklokapron 500 mg film-coated tablets

Tranexamic acid

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet, Cyklokapron 500 mg film-coated tablets will be called Cyklokapron.

In this leaflet:

1. What Cyklokapron is for

2. Before you take Cyklokapron

3. How to take Cyklokapron

4. Possible side effects

5. How to store Cyklokapron

6. Further information.

What Cyklokapron is for

Cyklokapron belongs to a group of medicines called anti-fibrinolytic drugs. These are used to stop or reduce unwanted bleeding. When you bleed your body forms clots to stop the bleeding. In some people these break down causing too much bleeding. Cyklokapron stops these clots dissolving and so reduces unwanted bleeding.

Cyklokapron is used to prevent or reduce bleeding for a short period of time in many different conditions. You may have been prescribed it for one of the following:

Following prostate surgery (post-prostatectomy)

Following bladder surgery

Heavy periods (menorrhagia)

Nose bleeds (epistaxis)

Cervical surgery (conisation of the cervix)

Bleeding inside the eye (traumatic hyphaema)

Tooth removal (dental extraction) in haemophiliacs (people who bleed more easily than normal). You will know if this refers to you

A hereditary disease called angioneurotic oedema (HANO). A doctor will have told you if you have this.

Before you take Cyklokapron

Do not take Cyklokapron if:

You are allergic to tranexamic acid

You are allergic to any of the other ingredients of Cyklokapron (listed in section 6)

You have serious problems with your kidneys (kidney failure)

You have a blood clot in your blood vessels (called a `thrombosis’).

If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor before taking Cyklokapron if:

You have blood in your urine

You have ever had any uncontrollable bleeding

You have disseminated intravascular coagulation (DIC), a disease where your blood starts to clot throughout your body

You have been taking medicine to treat a hereditary disease called angioneurotic oedema (HANO) every day for a long time. If so, you may need to have regular eye tests and blood tests to check your liver is working properly

You are a woman with irregular periods

You have a history of blood clots in your blood vessels (called a `thrombosis’)

Anyone in your family has suffered from blood clots in their blood vessels

You have kidney disease.

If any of the above apply to you, talk to your doctor or pharmacist.

Tell your doctor if you are taking any of the following medicines:

Fibrinolytic drugs (used to help dissolve blood clots), such as streptokinase. This is because Cyklokapron will stop these drugs working

Any other medicine, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breastfeeding ask your doctor or pharmacist for advice before taking Cyklokapron.

How to take Cyklokapron

Always take Cyklokapron exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Remember: Your medicine should always be taken with a glass of water. The tablets should be swallowed whole. Do not crush or chew them.

Adults and the elderly:

The usual dose is 2 or 3 tablets taken two to three times daily

The exact dose you take will depend on why you have been prescribed these tablets

Follow your doctor’s instructions about how many tablets to take, when to take them and for how long.

Children:

Your doctor will tell you exactly how much medicine you should give your child. They will work out the dose according to how much your child weighs.

Patients with kidney problems:

Your doctor will tell you how much to take. The dose you take may be lower than the usual adult dose.

If you take more Cyklokapron than you should

If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest hospital casualty department.

Taking too much Cyklokapron may make you feel sick, be sick or be dizzy or light-headed upon standing.

If you forget to take Cyklokapron

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Cyklokapron Tablets Side Effects

Like all medicines Cyklokapron can cause side effects, although not everybody gets them.

If you notice any changes in your eyesight or an allergic skin reaction developing, stop taking Cyklokapron and tell your doctor immediately.

Common side effects

Feeling sick

Being sick

Diarrhoea.

These are usually mild and pass very quickly, but if they continue, tell your doctor or pharmacist.

Rare side effects:

Problems with your eyesight, especially your colour vision

A blood clot in your eye. This may cause bleeding in the eye, or a loss of vision

Itchy, red or swollen skin

A blood clot in your blood vessels (called a `thrombosis’).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Cyklokapron

Keep out of the reach and sight of children.

Do not use Cyklokapron after the expiry date on the carton. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information

What Cyklokapron contains:

The active substance is tranexamic acid. Each tablet contains 500 mg tranexamic acid.

The other ingredients are microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), talc (E553b), magnesium stearate (E572), colloidal anhydrous silica, povidone (E1201), methacrylate polymers, titanium dioxide (E171), polyethylene glycol 8000, vanillin.

What Cyklokapron looks like

Cyklokapron tablets are white, oblong film-coated tablets. They are marked with CY with an arc above and below the lettering.

The tablets come in plastic bottles containing 50 tablets or in blister packs containing 60 tablets.

Not all pack sizes are marketed.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

Manufacturers

MEDA Manufacturing GMBH

Neurather Ring 1

51063 Cologne

Germany

This leaflet was last updated on December 2009

If this leaflet is difficult to see or read, or you would like it in a different format, please contact

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford
CM22 6PU

T5004141

Monday, March 5, 2012

Alfuzosin Hydrochloride 2.5mg Tablets

ALFUZOSIN HYDROCHLORIDE

2.5MG TABLETS

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

In this leaflet:

1. What alfuzosin is and what it is used for

2. Before you take alfuzosin

3. How to take alfuzosin

4. Possible side effects

5. How to store alfuzosin

6. Further information

What Alfuzosin Is And What It Is Used For?

What alfuzosin is

The name of your medicine is Alfuzosin Hydrochloride 2.5mg Tablets (called alfuzosin throughout this leaflet). This belongs to a group of medicines called alpha-blockers.

How alfuzosin works

Alfuzosin can be used to treat the symptoms of Benign Prostatic Hypertrophy.

This is when the prostate gland enlarges (hyperplasia), but the growth is not cancerous (it is benign). It can cause problems in passing water (urine). This happens mainly in older men.

The prostate gland lies underneath the bladder. It surrounds the urethra. This is the tube that takes your water to the outside of the body.

If the prostate gets bigger, it presses on the urethra making it smaller. This makes it difficult to pass water.

Your tablets work by relaxing the prostate gland muscle. This allows the urethra to get bigger and so makes it easier to pass water.

In a few patients with benign prostatic hyperplasia, the prostate gland gets so big that it stops the flow of urine completely. This is called Acute Urinary Retention. This is very painful and you may need a short stay in hospital.

A thin, flexible tube (catheter) is passed into the bladder. This drains the water and relieves the pain.

During this time, alfuzosin may be used to help the water to flow again. This has only been shown to help in men aged over 65.

Alfuzosin is used to treat

Benign Prostatic Hypertrophy

Before You Take Alfuzosin

Do not take alfuzosin and tell your doctor if:

You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of this medicine (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

You are taking other alpha-blockers to treat Benign Prostatic Hypertrophy or possibly to lower your blood pressure. See section below on ‘Taking other medicines’.

You have, or have ever had, something called orthostatic hypotension. This is a drop in blood pressure which usually happens when you stand up. It can make you feel dizzy, light-headed or faint when you stand or sit up quickly

You have severe liver problems

Do not take this medicine if any of the above apply to you

Take special care and check with your doctor before taking alfuzosin if:

You have chest pain (angina)

You have a long term infection in your urinary tract (including your kidneys, bladder and urethra), had difficulty when passing water or had small crystals (stones) forming in the water.

If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used alfuzosin. This is because alfuzosin may cause complications during the surgery which can be managed if your specialist is prepared in advance

You are allergic (hypersensitive) to other alpha blockers such as doxazosin, tamsulosin

You are taking medicines for high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking this medicine. This is particularly important at the start of your treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking alfuzosin.

Taking alfuzosin with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because alfuzosin can affect the way some other medicines work. Also some medicines can affect the way alfuzosin works.

Do not take this medicine, and tell your doctor, if you are taking:

Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.

Tell your doctor if you are taking any of the following:

A medicine for high blood pressure, as you may get dizzy, weak or start sweating within a few hours of taking this medicine. If this happens, lie down until the symptoms have completely gone. Tell your doctor as he or she may decide to change the dose of your medicine.

Medicines for fungal infections (such as ketoconazole or itraconazole) and HIV (such as ritonavir).

Medicines such as glyceryl trinitrate for chest pain (angina)

Operations and tests while taking alfuzosin

If you are being treated for high blood pressure, your doctor should measure your blood pressure regularly, especially at the start of treatment.

If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking alfuzosin before the operation. Your doctor may decide to stop you having alfuzosin 24 hours before the operation.
This is because it can be dangerous as it can lower your blood pressure.

Taking alfuzosin with food and drink

You may feel dizzy or weak whilst taking alfuzosin. If this happens do not drink any alcohol.

Driving and using machines

You may feel dizzy and weak while taking alfuzosin. If this happens do not drive or operate any tools or machines.

Important information about some of the ingredients of alfuzosin

Lactose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before having this medicine.

How To Take Alfuzosin

Always take alfuzosin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

Swallow the tablets whole

The first dose should be taken just before bedtime

The actual dose of alfuzosin depends on your needs and the condition being treated but the usual doses are listed below

How much to take

Adults (under 65 years of age)

The usual dose is one tablet three times a day

Your doctor may increase this to a maximum of four tablets each day if needed

Elderly (over 65 years of age), patients with high blood pressure or patients with kidney problems

The usual dose is one tablet in the morning and one tablet in the evening,

Patients with liver problems

The usual dose is one tablet per day

Your doctor may increase this to one tablet in the morning and one tablet in the evening

If you take more alfuzosin than you should

Contact your local hospital Accident and Emergency department straight away. Tell the doctor or nurse how many tablets you have taken. Lie down as much as possible to help stop the side effects. Do not try to drive to the hospital yourself.

If you forget to take alfuzosin

Do not take a double dose to make up for a forgotten tablet. Miss it out and then go on as before.

If you stop taking alfuzosin

Keep taking your tablets, even if your symptoms improve. Only stop if your doctor tells you to. The symptoms are better controlled if you continue taking the same dose of this medicine.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, alfuzosin can cause side effects, although not everybody gets them.

Stop taking alfuzosin and see a doctor or go to a hospital straight away if:

You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to alfuzosin. This side effect is very rare

You have chest pain (angina). This usually only happens if you have had angina before. This side effect is very rare

You get a painful erection of the penis, not related to sexual activity, which will not go away. This side effect has only been reported in a very small number of people taking alfuzosin.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet

Common side effects (affects less than 1 in 10 people)

Feeling dizzy or faint

Headache

Feeling sick (nausea)

Weakness or tiredness

Diarrhoea

General feeling of being unwell

Feeling dizzy, light-headed or faint when you stand or sit up quickly (postural hypotension)

Dry mouth

Uncommon side effects (affects less than 1 in 100 people)

A fast heart beat (tachycardia), pounding in the chest and uneven heartbeat (palpitations)

Chest pain

Drowsiness

Rash and itching

Flushes

Problems with your vision

Runny nose, itching, sneezing, stuffy nose and/or burning eyes. These could be symptoms of an allergy

Water retention (may cause swollen arms of legs)

Lack of control over passing water

Additional side effects (frequency not known) which may occur are:

Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes

Occasionally problems have arisen during cataract surgery in patients taking alfuzosin. If you are due to have eye surgery because of cataract it is important that you tell the specialist before the operation that you are using, or have used, alfuzosin.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Alfuzosin

Keep this medicine in a safe place where children cannot see or reach it.

Store this medicine below 30°C. Store in the original packaging.

Do not use alfuzosin after the expiry date which is stated on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Alfuzosin Hydrochloride 2.5mg Tablets contain

Each tablet contains 2.5mg of alfuzosin hydrochloride as the active substance.

The other ingredients are, microcrystalline cellulose, lactose, povidone, sodium starch glycollate, magnesium stearate, methylhydroxypropylcellulose, polyethylene glycol 400, titanium dioxide suspension (E171).

What alfuzosin looks like and contents of the pack

Alfuzosin Hydrochloride 2.5mg Tablets are white film-coated tablets marked Xatral 2.5 on one side. They are supplied in blister packs of 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

Manufacturer is:

Sanofi Winthrop Industrie

30-39 Avenue Gustave Eiffel

3700 Tours

France

This leaflet was last revised in: September 2008

Thursday, March 1, 2012

Kenalog Cream

Generic Name: triamcinolone acetonide

Dosage Form: Cream USP

Kenalog Cream Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide is designated chemically as 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Graphic Formula:

Each gram of 0.025%, 0.1%, and 0.5% Kenalog Cream (Triamcinolone Acetonide Cream) provides 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in a vanishing cream base containing propylene glycol, cetearyl alcohol (and) ceteareth-20, white petrolatum, sorbitol solution, glyceryl monostearate, polyethylene glycol monostearate, simethicone, sorbic acid, and purified water.

Kenalog Cream - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Kenalog Cream

Kenalog Cream (Triamcinolone Acetonide Cream) 0.025%, 0.1% and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of any potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis. If HPA axis suppression or elevation of the body temperature occurs, an attempt should be made to withdraw the drug, to reduce the frequency of application, substitute a less potent steroid, or use a sequential approach when utilizing the occlusive technique.

Recovery of HPA axis function and thermal homeostasis are generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Occasionally, a patient may develop a sensitivity reaction to a particular occlusive dressing material or adhesive and a substitute material may be necessary.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

These preparations are not for ophthalmic use.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for dermatologic use only. Avoid contact with the eyes.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

Patients should report any signs of local adverse reactions especially under occlusive dressing.

Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone showed negative results.

Pregnancy: Teratogenic Effects

Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General).

Kenalog Cream Dosage and Administration

Apply Kenalog Cream (Triamcinolone Acetonide Cream) 0.025% to the affected area two to four times daily. Rub in gently.

Apply the 0.1% or the 0.5% Kenalog Cream (Triamcinolone Acetonide Cream), as appropriate, to the affected area two to three times daily. Rub in gently.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply Kenalog Cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is Kenalog Cream Supplied

Kenalog Cream® (Triamcinolone Acetonide Cream USP)

0.025%

tubes containing 15 g NDC 0003-0172-22

80 g NDC 0003-0172-68

0.1%

tubes containing 15 g NDC 0003-0506-20

60 g NDC 0003-0506-46

80 g NDC 0003-0506-49

0.5%

tubes containing 20 g NDC 0003-1483-20

Storage

Store at room temperature; avoid freezing.

APOTHECON®

A Bristol-Myers Squibb Company

Princeton, NJ 08540 USA

J3-555F+

January 1994+

KENALOG
triamcinolone acetonide ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0003-0172
Route of Administration	TOPICAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
triamcinolone acetonide (triamcinolone)	Active	0.25 MILLIGRAM In 1 GRAM
propylene glycol	Inactive
cetearyl alcohol (and) ceteareth-20	Inactive
white petrolatum	Inactive
sorbitol solution	Inactive
glyceryl monostearate	Inactive
polyethylene glycol monostearate	Inactive
simethicone	Inactive
sorbic acid	Inactive
water	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0003-0172-22	15 g (GRAM) In 1 TUBE	None
2	0003-0172-68	80 g (GRAM) In 1 TUBE	None

KENALOG
triamcinolone acetonide ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0003-0506
Route of Administration	TOPICAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
triamcinolone acetonide (triamcinolone)	Active	1 MILLIGRAM In 1 GRAM
propylene glycol	Inactive
cetearyl alcohol (and) ceteareth-20	Inactive
white petrolatum	Inactive
sorbitol solution	Inactive
glyceryl monostearate	Inactive
polyethylene glycol monostearate	Inactive
simethicone	Inactive
sorbic acid	Inactive
purified water	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0003-0506-20	15 g (GRAM) In 1 TUBE	None
2	0003-0506-46	60 g (GRAM) In 1 TUBE	None
3	0003-0506-49	80 g (GRAM) In 1 TUBE	None

KENALOG
triamcinolone acetonide ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0003-1483
Route of Administration	TOPICAL	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
triamcinolone acetonide (triamcinolone)	Active	5 MILLIGRAM In 1 GRAM
propylene glycol	Inactive
cetearyl alcohol (and) ceteareth-20	Inactive
white petrolatum	Inactive
sorbitol solution	Inactive
glyceryl monostearate	Inactive
polyethylene glycol monostearate	Inactive
simethicone	Inactive
sorbic acid	Inactive
purified water	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0003-1483-20	20 g (GRAM) In 1 TUBE	None

Revised: 01/2006APOTHECON

More Kenalog Cream resources

Kenalog Cream Use in Pregnancy & Breastfeeding
Kenalog Cream Drug Interactions
Kenalog Cream Support Group
22 Reviews for Kenalog - Add your own review/rating

Compare Kenalog Cream with other medications

Aphthous Ulcer
Atopic Dermatitis
Dermatitis
Lichen Planus
Psoriasis