SEO PLR Content Marketing Texas: 2012

Saturday, October 6, 2012

Novo-Hydrocort Topical application

Generic Name: hydrocortisone butyrate (Topical application route)

hye-droe-KOR-ti-sone BUE-ti-rate

Commonly used brand name(s)

In the U.S.

Locoid

Locoid Lipocream

In Canada

Barriere-Hc

Cortate

Cort-Eze

Cortoderm Mild Ointment

Cortoderm Regular Ointment

Emo-Cort

Emo-Cort Scalp Solution

Hydrocortisone Cream

Novo-Hydrocort

Novo-Hydrocort Cream

Prevex Hc

Sarna Hc

Available Dosage Forms:

Ointment

Lotion

Cream

Solution

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Novo-Hydrocort

Hydrocortisone butyrate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Novo-Hydrocort

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in children 3 months of age or older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in the elderly.

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.

Proper Use of hydrocortisone butyrate

This section provides information on the proper use of a number of products that contain hydrocortisone butyrate. It may not be specific to Novo-Hydrocort. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical cream or lotion on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 4 weeks.

To use:

Wash your hands with soap and water before and after using this medicine.

Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

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

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

For atopic dermatitis:
- For topical dosage forms (cream and lotion):
  - Children 3 months to 18 years of age—Apply to the affected area of the skin two times per day.
  - Children younger than 3 months of age—Use and dose must be determined by your doctor.

For redness, itching, and swelling of the skin:
- For topical dosage forms (cream and ointment):
  - Adults—Apply to the affected area of the skin two or three times per day.
  - Children—Apply to the affected area of the skin two or three times per day.

For seborrheic dermatitis:
- For topical dosage form (solution):
  - Adults—Apply to the affected area of the skin two or three times per day.
  - Children—Apply to the affected area of the skin two or three times per day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Novo-Hydrocort

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Novo-Hydrocort Side Effects

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

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

Less common

Burning sensation of skin

flushing or redness of skin

itching skin

red, scaling, or crusted skin

scaly rash

skin irritation

unusually warm skin

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

irritation

itching, scaling, severe redness, soreness, or swelling of the skin

redness and scaling around the mouth

thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

thinning, weakness, or wasting away of the skin

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

Less common

Acne or pimples

lightening of normal skin color

Incidence not known

Burning and itching of the skin with pinhead-sized red blisters

burning, itching, and pain in hairy areas, or pus at the root of the hair

increased hair growth on the forehead, back, arms, and legs

reddish purple lines on the arms, face, legs, trunk, or groin

softening of the skin

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.

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.

Compare Novo-Hydrocort Topical application with other medications

Anal Itching
Aphthous Stomatitis, Recurrent
Atopic Dermatitis
Dermatitis
Eczema
Gingivitis
Hemorrhoids
Proctitis
Pruritus
Psoriasis
Seborrheic Dermatitis
Skin Rash
Ulcerative Colitis, Active

Monday, October 1, 2012

Xyzal

Generic Name: levocetirizine (Oral route)

lee-voe-se-TIR-a-zeen

Commonly used brand name(s)

In the U.S.

Xyzal

Available Dosage Forms:

Solution

Tablet

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Piperazine (class)

Uses For Xyzal

Levocetirizine is an antihistamine used to relieve the symptoms of hay fever and hives of the skin. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some persons to have hives, with severe itching of the skin.

This medicine is available only with your doctor's prescription.

Before Using Xyzal

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levocetirizine in children. Safety and efficacy have not been established in infants younger than 6 months old.

Use in children 6 months to 11 years of age with kidney disease is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levocetirizine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving levocetirizine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

Interactions with Food/Tobacco/Alcohol

Proper Use of Xyzal

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You may take this medicine with or without food.

Measure the oral solution with a marked measuring spoon, oral syringe, or medicine cup.

Dosing

For oral dosage forms (solution or tablets):
- For hay fever or hives:
  - Adults and children 12 years of age and older—5 milligrams (mg) or 10 milliliters (mL) once a day in the evening. Your doctor may adjust your dose as needed.
  - Children 6 to 11 years of age—2.5 mg (half tablet) or 5 mL once a day in the evening.
  - Children 6 months to 5 years of age—1.25 mg or 2.5 mL once a day in the evening.
  - Infants up to 6 months old—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Xyzal

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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

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

Xyzal Side Effects

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

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

Less common

Bloody nose

fever

Incidence not known

Anxiety

attack, assault, or force

blurred or loss of vision

cough

dark urine

difficult or labored breathing

difficulty with swallowing

disturbed color perception

dizziness

double vision

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

general tiredness and weakness

halos around lights

hives or welts

hyperventilation

irritability

itching skin

joint or muscle pain

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

light-colored stools

nausea and vomiting

nervousness

night blindness

overbright appearance of lights

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

restlessness

seizures

shaking

shortness of breath

skin rash

tightness in the chest

trouble with sleeping

tunnel vision

upper right abdominal pain

wheezing

yellow eyes and skin

More common

Headache

muscle aches

sleepiness or unusual drowsiness

sore throat

stuffy or runny nose

Less common

Body aches or pain

congestion

diarrhea

dryness or soreness of the throat

earache

hoarseness

redness or swelling in the ear

tender, swollen glands in the neck

trouble with swallowing

voice changes

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: Xyzal side effects (in more detail)

More Xyzal resources

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

Xyzal Prescribing Information (FDA)

Xyzal Consumer Overview

Xyzal Monograph (AHFS DI)

Xyzal MedFacts Consumer Leaflet (Wolters Kluwer)

Levocetirizine Prescribing Information (FDA)

Compare Xyzal with other medications

Allergies
Hay Fever
Urticaria

Nutropin AQ NuSpin

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Refrigerated)
Brand Name: Nutropin AQ NuSpin

Nutropin AQ NuSpin is used for:

Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or other conditions (eg, chronic kidney problems, idiopathic short stature). It may also be used for other conditions as determined by your doctor.

Nutropin AQ NuSpin 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 Nutropin AQ NuSpin if:

you are allergic to any ingredient in Nutropin AQ NuSpin

you have been or are 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 certain eye problems caused by diabetes (eg, diabetic retinopathy)

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 Nutropin AQ NuSpin:

Some medical conditions may interact with Nutropin AQ NuSpin. 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 endocrine problems, including pituitary or adrenal gland problems; diabetes or a family history of diabetes; eye problems caused by diabetes; or an underactive thyroid

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

if you have curvature of the spine (scoliosis), kidney or liver problems, ear or hearing problems (eg, repeated ear infection), Prader-Willi syndrome, are severely overweight, or have had recent major surgery or trauma

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

Corticosteroids (eg, prednisone) because they may decrease Nutropin AQ NuSpin's effectiveness

Anticonvulsants (eg, phenytoin, carbamazepine) or cyclosporine because the risk of their side effects may be increased or their effectiveness may be decreased by Nutropin AQ NuSpin

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

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

An extra patient leaflet is available with Nutropin AQ NuSpin. Talk to your pharmacist if you have questions about this information.

Nutropin AQ NuSpin is given as an injection. A health care provider will teach you how to use it. Be sure you understand how to use Nutropin AQ NuSpin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Allow Nutropin AQ NuSpin to come to room temperature before you use it.

Check the injection device to be sure the correct dose is dialed before you use a dose of Nutropin AQ NuSpin.

Wash your hands before and immediately after using Nutropin AQ NuSpin.

Use a new needle each time you inject Nutropin AQ NuSpin. Do not reuse needles.

Do not use Nutropin AQ NuSpin if it contains particles, is cloudy or discolored, or if the pen or cartridge is cracked or damaged.

Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.

Always rotate injection sites each time you use Nutropin AQ NuSpin.

Do not shake Nutropin AQ NuSpin. Swirl gently to mix it.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Nutropin AQ NuSpin, 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 Nutropin AQ NuSpin.

Important safety information:

Nutropin AQ NuSpin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Nutropin AQ NuSpin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Rare, sometimes fatal, lung and breathing problems may be caused by Nutropin AQ NuSpin 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 Nutropin AQ NuSpin, contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Nutropin AQ NuSpin. Nutropin AQ NuSpin may need to be stopped.

Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Nutropin AQ NuSpin. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.

Rarely, children using Nutropin AQ NuSpin 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.

Nutropin AQ NuSpin may have benzyl alcohol, metacresol, or glycerin in it. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol, metacresol, or glycerin.

Diabetes patients - Nutropin AQ NuSpin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine or your diet.

Lab tests, including blood sugar levels and thyroid function, may be performed while you use Nutropin AQ NuSpin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Nutropin AQ NuSpin with caution in the ELDERLY; they may be more sensitive to its effects.

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

Possible side effects of Nutropin AQ NuSpin:

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:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

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; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; 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: Nutropin AQ NuSpin 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 Nutropin AQ NuSpin:

Before mixing, store Nutropin AQ NuSpin in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from heat, moisture, and light. Do not use Nutropin AQ NuSpin past the expiration date on the product label. After mixing, store Nutropin AQ NuSpin according to the product label. Contact your pharmacist if you have any questions about the proper storage of Nutropin AQ NuSpin. Keep Nutropin AQ NuSpin, as well as needles and syringes, out of the reach of children and away from pets.

General information:

If you have any questions about Nutropin AQ NuSpin, please talk with your doctor, pharmacist, or other health care provider.

Nutropin AQ NuSpin 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 Nutropin AQ NuSpin. 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 Nutropin AQ NuSpin resources

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

Compare Nutropin AQ NuSpin with other medications

Adult Human Growth Hormone Deficiency
Growth Retardation, Chronic Renal Failure
Hypopituitarism
Idiopathic Short Stature
Pediatric Growth Hormone Deficiency
Short Stature for Age
Turner's Syndrome

Wednesday, September 26, 2012

Prostin E2 Vaginal Gel 1 mg and 2 mg

Prostin E2 Vaginal Gel 1 mg/ 2 mg

Dinoprostone

Pharmacia Logo

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, midwife 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, midwife or pharmacist.

In this leaflet:

1. What Prostin E2 Vaginal gel is and what it is used for

2. Before you are given Prostin E2 Vaginal gel

3. How Prostin E2 Vaginal gel is given to you

4. Possible side effects

5. How to store Prostin E2 Vaginal gel

6. Further information

What Prostin E2 Vaginal Gel is and what it is used for

Prostin E2 Vaginal Gel contain the prostaglandin dinoprostone and is used to "induce" labour. This means that the medicine will help your uterus (womb) to start contracting and you will go into labour. Dinoprostone is similar to the natural ‘E2’, type of prostaglandins which are made in your body when labour starts. Your doctor would have satisfied himself/herself that there are no conditions making the induction unsafe. It will only be given to you in a hospital or clinic which has an obstetric and maternity unit.

Before you are given Prostin E2 Vaginal Gel

Most women can be treated with Prostin E2 Vaginal Gel. Some women may need extra checks during treatment and for some women a different treatment may be better. Your doctor or midwife will ask you questions before giving you Prostin E2 Vaginal Gel to make sure it is safe for you. If you do not understand any of the questions, ask your doctor or midwife to explain.

Do not use Prostin E2 Vaginal gel:

If you have had an allergic reaction (e.g.wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin) to dinoprostone or any other prostaglandin or any of the other ingredients in the gel, which are listed in Section 6 below.

Your doctor or midwife will not use Prostin E2 to start or strengthen your labour in certain circumstances if:

you have heart, lung, kidney or liver disease

you have had a Caesarean section or any major surgery to your womb.

the size of your baby’s head means there may be a problem with the delivery.

there has been or there is suspected fetal distress (your baby is short of oxygen).

you had a difficult labour or traumatic delivery in a previous pregnancy.

you have already had six or more full-term pregnancies.

your waters have broken.

you have a past history or existing infection of your womb, ovaries or tubes (pelvic inflammatory disease) unless you are receiving treatment for these, or if you have ever had such an infection in the past.

you have been told that you have or might have placenta praevia (where the placenta lies across the entrance to the womb, rather than being high up and out of the way during birth). This causes bleeding from the vagina during pregnancy and may require that your baby is delivered by Caesarean section.

during your pregnancy you have had bleeding from the vagina and the cause of the bleeding is not known.

your baby is not lying with his or her head down.

Take special care with Prostin E2:

Tell your doctor or midwife if you have or have had in the past any of the following conditions as they may want to monitor you more closely.

heart, lung, kidney or liver disease.

glaucoma (raised pressure in the eye)

epilepsy

suffered from asthma

hypertension (high blood pressure) at any time, including during this or any previous pregnancy

been told you had abnormally strong contractions of your womb during a previous labour

scarring of your womb from a previous operation

Your doctor or midwife will ask you questions before giving you Prostin E2 Vaginal Gel to make sure they are safe for you.

If you do not understand any of the questions, ask your doctor or midwife to explain.

Taking other medicines:

Prostin E2 Vaginal Gel can make you more sensitive to another medicine called oxytocin which is used to strengthen contractions. Medical staff will normally try not to use this medicine at the same time as Prostin E2 Vaginal gel. If you need this medicine, your doctor or midwife will make sure they are not given to you close together and will watch over the contractions very carefully.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Pregnancy

Prostin E2 Vaginal gel will only be given to you in the late stages of pregnancy to induce labour.

Breastfeeding

Although prostaglandins are present in breast milk they will not harm your baby and you may breastfeed as normal after delivery.

Driving and using machinery

No effect on your ability to drive or use machinery is expected after being given Prostin E2 Vaginal gel

How Prostin E2 Vaginal gel is given to you

Prostin E2 Vaginal Gel can only be used in a hospital or a clinic with a specialist obstetric unit. Before you are given this medicine, you will be examined by your doctor or midwife. They need to know the position of your baby’s head and how dilated (wide) your cervix (neck of the womb) is.

You will be given a numbered score after you have been examined. This is known as the Bishop score. The lower your Bishop score, the less ready you are to go into labour without any help. In this case, a higher dose of Prostin E2 Vaginal Gel is given.

Prostin E2 Vaginal Gel will be inserted into the posterior fornix (an area high up in your vagina) while you are lying down. You will then be asked to stay lying down for at least 30 minutes.

The usual dose is 1 mg. If you this is your first pregnancy and you have a low Bishop score, you will be given 2 mg.

Your doctor or midwife may decide to give you a second dose of gel if you do not start having contractions or if you are only having weak contractions. Because this treatment can take a long time to have an effect in some women, your doctor or midwife will not give you a second dose until they are sure that this is needed. You should not have a second dose for at least six hours and many doctors and midwives will wait much longer than this. This means that you could even have your second dose the following day. You should not be given more than 4 mg.

Your doctor or midwife should be keeping a very close eye on you during your treatment. They should be able to act quickly if you have side-effects or if your womb reacts too strongly to the dose you are given.

Your doctor or midwife will do internal checks to make sure that your cervix is opening enough. They will also check your contractions (to make sure that they are not too strong) and your baby (to make sure he or she does not get distressed).

Possible side effects

Like all medicines Prostin E2 Vaginal gel can cause side effects, although not everybody gets them.

If you have asthma, Prostin E2 Vaginal gel could cause you to have an asthmatic attack. You must tell your doctor or midwife if you suffer from asthma or if you have difficulty breathing.

Rare side effects

Rare but serious side effects which can sometimes happen include the following:

tearing or bursting of the wall of your womb (uterine rupture)

heart attack

allergic reactions (symptoms may include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin).

If you get any of these symptoms please tell your doctor or midwife straight away.

Common side effects

vomiting (being sick)

nausea (feeling sick)

diarrhoea.

These have seldom been bad enough for the woman to stop the treatment.

Other side effects

As prostaglandins make the body go into labour in the same way as it would happen naturally, anything that can happen in a natural labour can also happen if you have been given Prostin E2 Gel. Talk to your midwife or doctor about this if you want to know more, as they will be able to give you the information that you need.

sudden blockage of a blood vessel with amniotic fluid (the fluid which surrounds the baby) or by a blood clot in the lungs. This could cause chest pain and shortness of breath.

placenta becoming detached

stillbirth or death of the newborn baby

abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby

itching, soreness or rash of the vaginal area

high blood pressure in the mother

very quick opening of the cervix

running a high temperature

backache

rash

baby born with an Apgar score lower than seven. (The Apgar score, which is measured on a scale of one to ten, is used to describe the baby’s condition at birth. A low Apgar Score means that the baby’s heart or lungs are not working properly.)

Studies have shown proliferation (thickening) of bone in new-born infants who have been treated with prostaglandins for a long time. There is no evidence that this occurs following short-term treatment with Prostin E2 Vaginal Gel.

If you think you may be having any of the above side effects, or you are worried about anything unusual happening during your labour, please tell your doctor or midwife.

How to store Prostin E2 Vaginal gel

The medicine will be kept out of the reach and sight of children.

Prostin E2 Vaginal gel will not be given to you after the expiry date. The expiry date refers to the last day of that month.

Your hospital pharmacist will store this medicine in a refrigerator at 2 to 8 °C before use.

Further information

What Prostin E2 Vaginal Gel contains:

The active substance is called dinoprostone.

The other ingredients are Triacetin and colloidal silicon dioxide.

What Prostin E2 Vaginal gel looks like and contents of the pack

Prostin E2 Vaginal gel is packed in syringes that contain 1 mg or 2 mg of dinoprostone in 3 grams of gel. Each pack contains one pre-filled syringe and the syringes are for single use only.

Marketing Authorisation Holder:

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Manufacturer:

Pfizer Manufacturing Belgium NV

Rijksweg 12

B-2870 Puurs

Belgium

For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.

This leaflet was last updated in July2008.

Ref: PR 1_1

Tuesday, September 25, 2012

mycophenolate mofetil

mye-koe-FEN-oh-late MOE-fe-til

Oral route(Capsule;Tablet;Powder for Suspension)

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe, and they should have complete information requisite for the follow-up of the patient. Female contraception must be used due to increased risk of congenital malformations and pregnancy loss .

Commonly used brand name(s)

In the U.S.

Cellcept

Available Dosage Forms:

Powder for Suspension

Capsule

Tablet

Therapeutic Class: Immune Suppressant

Uses For mycophenolate mofetil

Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity in patients who receive organ transplants (e.g., kidney, heart, or liver).

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate prevents the white blood cells from rejecting the transplanted organ.

mycophenolate mofetil is available only with your doctor's prescription.

Before Using mycophenolate mofetil

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 mycophenolate mofetil, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate in children receiving kidney transplants. However, safety and efficacy have not been established in infants younger than 3 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of mycophenolate in children receiving heart or liver transplants. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mycophenolate in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving mycophenolate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mycophenolate mofetil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using mycophenolate mofetil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Activated Charcoal

Adenovirus Vaccine Type 4, Live

Adenovirus Vaccine Type 7, Live

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Azathioprine

Bacillus of Calmette and Guerin Vaccine, Live

Cholestyramine

Colesevelam

Colestipol

Dexlansoprazole

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Esomeprazole

Influenza Virus Vaccine, Live

Lansoprazole

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Measles Virus Vaccine, Live

Metronidazole

Mumps Virus Vaccine, Live

Norfloxacin

Omeprazole

Pantoprazole

Poliovirus Vaccine, Live

Rabeprazole

Rifampin

Rotavirus Vaccine, Live

Rubella Virus Vaccine, Live

Smallpox Vaccine

Typhoid Vaccine

Varicella Virus Vaccine

Yellow Fever Vaccine

Using mycophenolate mofetil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ciprofloxacin

Cyclosporine

Desogestrel

Dienogest

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Iron

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Sevelamer

Valacyclovir

Interactions with Food/Tobacco/Alcohol

Proper Use of mycophenolate mofetil

Take mycophenolate mofetil exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

mycophenolate mofetil should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take mycophenolate mofetil on an empty stomach, either one hour before or 2 hours after meals, unless your doctor tells you otherwise.

Mycophenolate capsules and tablets should be swallowed whole. Do not break, crush, open, or chew them.

It is important that you handle mycophenolate mofetil with care. Avoid inhaling the powder from the capsule or allowing the powder or the oral liquid to touch your skin or eyes. If the medicine gets on your skin, wash it thoroughly with soap and water. If the medicine gets in your eyes, wash them with plain water. Should a spill occur, wipe it up using paper towels wetted with water to remove the powder or liquid.

You should use the oral dispenser from the pharmacist to measure the correct amount of suspension. If you have any questions about this, ask your doctor or pharmacist.

Use only the brand of mycophenolate tablets that your doctor ordered. Different brands may not work the same way.

If you are also using antacids that contain aluminum or magnesium (such as Maalox® or Mylanta®), do not use them at the same time as mycophenolate. Use them 1 hour before or 2 hours after your dose. If you have questions, talk with your doctor about the best times to use your medicines.

Dosing

The dose of mycophenolate mofetil 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 mycophenolate mofetil. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules, suspension, or tablets):
- For heart transplants:
  - Adults—1.5 grams two times a day.
  - Older adults—1.5 grams two times a day.
  - Children—Use and dose must be determined by your doctor.
- For kidney transplants:
  - Adults—1 gram two times a day.
  - Older adults—1 gram two times a day.
  - Teenagers and children above 3 months of age—Dose is based on body size as determined by the doctor. The suspension dose is 600 milligrams (mg) per square meter [m(2)] two times a day. The capsules and tablets are given as 750 mg to 1 gram two times a day.
  - Infants younger than 3 months of age—Use and dose must be determined by your doctor.
- For liver transplants:
  - Adults—1.5 grams two times a day.
  - Older adults—1.5 grams two times a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of mycophenolate mofetil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The oral suspension can also be kept in the refrigerator. Throw away any unused suspension after 60 days.

Precautions While Using mycophenolate mofetil

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using mycophenolate mofetil while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using mycophenolate mofetil to make sure you are not pregnant. Your birth control pills may not work as well while you are using mycophenolate mofetil. You must use two forms of birth control together for 1 month before starting mycophenolate mofetil, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of mycophenolate mofetil. Use birth control pills together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using mycophenolate mofetil may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Mycophenolate can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

mycophenolate mofetil may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

mycophenolate mofetil may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

While you are receiving mycophenolate, and after you stop, do not have any immunizations (vaccinations) without your doctor's approval. Mycophenolate will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Do not stop taking mycophenolate mofetil without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take mycophenolate mofetil.

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

mycophenolate mofetil Side Effects

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

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

More common

Abdominal or stomach cramps or pain

black, tarry stools

bladder pain

bleeding gums

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

blood in the urine or stools

bloody or cloudy urine

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

confusion

convulsions

cough or hoarseness

decreased urine

difficult or labored breathing

difficult, burning, or painful urination

dizziness

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

drowsiness

dry mouth

fainting

fast, slow, pounding, or irregular heartbeat or pulse

fever or chills

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

irregular heartbeats

irregular pulse

irritability

lightheadedness

loss of appetite

lower back or side pain

mood changes

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

muscle pain or cramps

muscle spasms (tetany) or twitching

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

rapid weight gain

rapid, shallow breathing

seizures

shortness of breath

sore throat

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

stomach pain and bloating

sweating

swollen glands

tightness in the chest

tingling of the hands or feet

trembling

tremor

troubled breathing

troubled breathing with exertion

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

weakness or heaviness of the legs

wheezing

Incidence not known

Back pain

bloating

constipation

convulsions

coughing or spitting up blood

darkened urine

general feeling of illness

indigestion

night sweats

pain

pains in the stomach, side, or abdomen, possibly radiating to the back

severe headache

sudden high fever or low-grade fever for months

tenderness

watery or bloody diarrhea

yellow eyes or skin

More common

Acid or sour stomach

belching

fear or nervousness

heartburn

lack or loss of strength

rash

sleeplessness

unable to sleep

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: mycophenolate mofetil side effects (in more detail)

More mycophenolate mofetil resources

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

Mycophenolate Mofetil Prescribing Information (FDA)

Mycophenolate Mofetil MedFacts Consumer Leaflet (Wolters Kluwer)

CellCept Prescribing Information (FDA)

Cellcept Consumer Overview

Compare mycophenolate mofetil with other medications

Autoimmune Hepatitis
Bullous Pemphigoid
Cogan's Syndrome
Crohn's Disease
Dermatomyositis
Evan's Syndrome
Graft-versus-host disease
High Cholesterol
Inflammatory Bowel Disease
Multiple Sclerosis
Myasthenia Gravis
Nephrotic Syndrome
Organ Transplant, Rejection Prophylaxis
Pemphigoid
Pemphigus
Psoriatic Arthritis
Pulmonary Fibrosis
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Ulcerative Colitis
Uveitis

Nacon Sustained-Release Tablets

Pronunciation: KAR-bin-OX-a-meen/METH-skoe-POL-a-meen/SOO-doe-e-FED-rin
Generic Name: Carbinoxamine/Methscopolamine/Pseudoephedrine
Brand Name: Examples include Nacon and Pannaz

Nacon Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Nacon Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Nacon Sustained-Release Tablets if:

you are allergic to any ingredient in Nacon Sustained-Release Tablets

you are pregnant or breast-feeding

you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

you have severe heart blood vessel disease; severe high blood pressure; narrow-angle glaucoma; severe bleeding; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); peptic ulcer; a blockage of your stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or uncontrolled bleeding

you are unable to urinate or are having an asthma attack

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

Before using Nacon Sustained-Release Tablets:

Some medical conditions may interact with Nacon Sustained-Release Tablets. 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 diabetes, an enlarged prostate or other prostate problems, bladder or kidney problems, severe bowel problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood vessel problems, blood clots, trouble urinating, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, stroke, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

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

Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased

Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Nacon Sustained-Release Tablets's side effects

Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by Nacon Sustained-Release Tablets

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Nacon Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nacon Sustained-Release Tablets 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 Nacon Sustained-Release Tablets:

Use Nacon Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Nacon Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Do not take Nacon Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after taking Nacon Sustained-Release Tablets.

Swallow Nacon Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Nacon Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.

If you miss a dose of Nacon Sustained-Release Tablets 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 Nacon Sustained-Release Tablets.

Important safety information:

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

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

Nacon Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.

Nacon Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

Nacon Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.

Do not take diet or appetite control medicines while you are taking Nacon Sustained-Release Tablets without checking with your doctor.

Nacon Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Nacon Sustained-Release Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Nacon Sustained-Release Tablets for a few days before the tests.

If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Nacon Sustained-Release Tablets.

Nacon Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking Nacon Sustained-Release Tablets.

Tell your doctor or dentist that you take Nacon Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

Diabetes patients - Nacon Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Use Nacon Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Nacon Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: It is not known if Nacon Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nacon Sustained-Release Tablets while you are pregnant. Nacon Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Nacon Sustained-Release Tablets.

Possible side effects of Nacon Sustained-Release Tablets:

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; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; 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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, light-headedness, or headache; tremor; vision changes.

See also: Nacon 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 deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of Nacon Sustained-Release Tablets:

Store Nacon Sustained-Release Tablets 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 Nacon Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Nacon Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Nacon Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

This information is a summary only. It does not contain all information about Nacon Sustained-Release Tablets. 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 Nacon resources

Nacon Side Effects (in more detail)
Nacon Use in Pregnancy & Breastfeeding
Nacon Drug Interactions
Nacon Support Group
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Rhinitis

Monday, September 24, 2012

Physiolyte

Dosage Form: Irrigating Solution

Balanced Electrolyte Solution for Irrigation.

For All General Irrigation, Washing, and Rinsing Purposes.

Not for Injection by Usual Parenteral Route.

Physiolyte Description

Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes.

Each 100 mL contains:

Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g

Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride

USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g

Water for Injection USP qs

Glacial Acetic Acid USP has been added to adjust the pH

pH: 6.8 (6.3–7.3)

Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter)

Concentration of Electrolytes (mEq/liter): Sodium 140

Potassium 5; Magnesium 3; Chloride 98; Acetate (CH3COO−) 27

Gluconate (HOCH2(CHOH)4COO−) 23

It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.

Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Sodium Chloride USP	NaCl	58.44
Sodium Acetate Trihydrate USP	CH3COONa•3H2O	136.08
Potassium Chloride USP	KCl	74.55
Magnesium Chloride Hexahydrate USP	MgCl2•6H2O	203.30
Sodium Gluconate USP		218.14

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Physiolyte - Clinical Pharmacology

Physiolyte exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.

Physiolyte provides an isotonic calcium-free balanced electrolyte irrigation with the same ionic composition as Isolyte® S (Multi-Electrolyte Solution) a multiple electrolyte solution for IV replacement of acute extracellular fluid losses.

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular and cardiac conduction and irritability.

Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during their metabolism to carbon dioxide and water, and serve as alkalinizing agents.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Physiolyte

Physiolyte® (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Contraindications

Physiolyte is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations.

Do not warm above 150°F (66°C).

After opening container, it's contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Precautions

General

Use aseptic technique when preparing and administering sterile irrigation solutions for irrigating body cavities, wounds and urethral catheters or for wetting dressings that come in contact with the body tissues.

Use only if solution is clear and container and seal are intact.

Do not use for irrigation that may result in absorption of large amounts into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.

When used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the plastic irrigation container. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Physiolyte® (A Physiological Irrigating Solution) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Physiolyte (A Physiological Irrigating Solution). It is also not known whether Physiolyte (A Physiological Irrigating Solution) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Physiolyte (A Physiological Irrigating Solution) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when Physiolyte is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Physiolyte in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use

Clinical studies of Physiolyte (A Physiological Irrigating Solution) have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Use in Patients with Renal Insufficiency/Failure

Clinical studies of Physiolyte (a Physiological Irrigation Solution) have not been performed to determine whether patients with renal failure respond differently from those with normal renal function. Given the potential for systemic absorption, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Increased caution should be exercised when administering Physiolyte to patients with impaired fluid and electrolyte homeostasis.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Physiolyte Dosage and Administration

As required for irrigation.

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

How is Physiolyte Supplied

Physiolyte® (A Physiological Irrigating Solution) is supplied sterile and nonpyrogenic in 1000 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case.

NDC	Cat. No.	Size
Physiolyte (A Physiological Irrigating Solution)
0264-2205-00	R5510-01	1000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Rx only

Issued: July 2003

Physiolyte and Isolyte S are registered trademarks and PIC is a trademark of B. Braun Medical Inc.

Made in USA

Directions For Use of PIC Containers

Not for injection.

Aseptic technique is required.

Caution – Before use, perform the following checks:
(a)

Read the label. Ensure solution is the one ordered and is within the expiration date.

(b)

Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seal are intact.

Single unit container. Discard unused portion.

2.: Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.
3.: Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour.
4.: Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.

B. Braun Medical Inc.

Irvine, CA USA 92614-5895

Y36-002-478

Physiolyte
sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0264-2205
Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Sodium Chloride (Sodium Chloride)	Active	0.53 GRAM In 100 MILLILITER
Sodium Gluconate (Sodium Gluconate)	Active	0.5 GRAM In 100 MILLILITER
Sodium Acetate (Sodium Acetate)	Active	0.37 GRAM In 100 MILLILITER
Potassium Chloride (Potassium Chloride)	Active	0.037 GRAM In 100 MILLILITER
Magnesium Chloride (Magnesium Chloride)	Active	0.03 GRAM In 100 MILLILITER
Water	Inactive
Glacial Acetic Acid	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0264-2205-00	16 CONTAINER In 1 CASE	contains a CONTAINER
1		1000 mL (MILLILITER) In 1 CONTAINER	This package is contained within the CASE (0264-2205-00)

Revised: 10/2008B. Braun Medical Inc.

More Physiolyte resources

Physiolyte Side Effects (in more detail)
Physiolyte Dosage
Physiolyte Support Group
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Saturday, October 6, 2012

Commonly used brand name(s)

Uses For Novo-Hydrocort

Before Using Novo-Hydrocort

Allergies

Pediatric

Geriatric

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

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Proper Use of hydrocortisone butyrate

Dosing

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Novo-Hydrocort Side Effects

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Monday, October 1, 2012

Commonly used brand name(s)

Uses For Xyzal

Before Using Xyzal

Allergies

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Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

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Nutropin AQ NuSpin is used for:

Do NOT use Nutropin AQ NuSpin if:

Before using Nutropin AQ NuSpin:

How to use Nutropin AQ NuSpin:

Important safety information:

Possible side effects of Nutropin AQ NuSpin:

If OVERDOSE is suspected:

General information:

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Wednesday, September 26, 2012

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

In this leaflet:

What Prostin E2 Vaginal Gel is and what it is used for

Before you are given Prostin E2 Vaginal Gel

Do not use Prostin E2 Vaginal gel:

Your doctor or midwife will not use Prostin E2 to start or strengthen your labour in certain circumstances if:

Take special care with Prostin E2:

Taking other medicines:

Pregnancy and breastfeeding

Driving and using machinery

How Prostin E2 Vaginal gel is given to you

Possible side effects

Rare side effects

Common side effects

Other side effects

How to store Prostin E2 Vaginal gel

Further information

What Prostin E2 Vaginal Gel contains:

What Prostin E2 Vaginal gel looks like and contents of the pack

Marketing Authorisation Holder:

Manufacturer:

Tuesday, September 25, 2012

Commonly used brand name(s)

Uses For mycophenolate mofetil

Before Using mycophenolate mofetil

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines