Free Articles Directory Sudan: July 2012

Monday, 30 July 2012

Climara Transdermal

Generic Name: estradiol (Transdermal route)

es-tra-DYE-ol

Transdermal route(Emulsion)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .

Transdermal route(Patch, Extended Release)

Transdermal route(Gel/Jelly)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .

Transdermal route(Spray)

Unopposed estrogens increase the risk of endometrial cancer. Adding a progestin will reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogen alone have been reported. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogens combined with progestins have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible. Breast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure. Patients should strictly adhere to recommended instructions for use .

Commonly used brand name(s)

In the U.S.

Alora

Climara

Divigel

Elestrin

Esclim

Estraderm

Estrasorb

EstroGel

Evamist

Menostar

Vivelle

Vivelle-Dot

In Canada

Estradot Transdermal

Estradot Transdermal Therapeutic System

Estradot Transdermal Therapeutic System

Oesclim

Rhoxal-Estradiol Derm 50

Rhoxal-Estradiol Derm 75

Roxal-Estradiol Derm 100

Vivelle 100 Mcg

Vivelle 25 Mcg

Vivelle 37.5 Mcg

Available Dosage Forms:

Patch, Extended Release

Gel/Jelly

Spray

Emulsion

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

Uses For Climara

Estradiol transdermal spray is used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen.

Estradiol is an estrogen hormone. The hormone from the spray is absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes") in women during menopause.

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

Before Using Climara

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

Use of estradiol transdermal spray is not indicated in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of estradiol transdermal spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving estradiol transdermal spray.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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 receiving this medicine, 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 this medicine 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.

Isotretinoin

Theophylline

Tizanidine

Tranexamic Acid

Using this medicine 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.

Alprazolam

Amoxicillin

Ampicillin

Amprenavir

Aprepitant

Atazanavir

Bacampicillin

Betamethasone

Bexarotene

Bosentan

Carbamazepine

Clarithromycin

Colesevelam

Cyclosporine

Darunavir

Delavirdine

Doxycycline

Efavirenz

Etravirine

Fosamprenavir

Fosaprepitant

Fosphenytoin

Ginseng

Griseofulvin

Itraconazole

Ketoconazole

Lamotrigine

Levothyroxine

Licorice

Minocycline

Modafinil

Mycophenolate Mofetil

Mycophenolic Acid

Nelfinavir

Nevirapine

Oxcarbazepine

Oxytetracycline

Phenobarbital

Phenytoin

Pioglitazone

Prednisolone

Primidone

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rosuvastatin

Rufinamide

Selegiline

St John's Wort

Tacrine

Telaprevir

Tetracycline

Tipranavir

Topiramate

Troglitazone

Troleandomycin

Voriconazole

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine

Grapefruit Juice

Proper Use of estradiol

This section provides information on the proper use of a number of products that contain estradiol. It may not be specific to Climara. 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.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, breast, 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 comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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

To use the spray:

The spray form of this medicine comes in an applicator that delivers a measured amount of estradiol to the skin with each spray. When using a new spray applicator, prime the pump by holding the spray upright and pumping 3 times. Priming is only necessary the first time you use a new spray applicator; do not prime again.

Apply the medicine to clean, dry, and unbroken skin on the inside of the forearm between the elbow and the wrist. Do not apply the medicine directly to your breasts or in or around the vagina.

Allow the medicine to dry for at least 2 minutes before dressing, and at least 1 hour before washing.

If your doctor tells you to increase your dose, move the applicator to an area of the skin next to your previous application site, before applying the second or third spray.

Do not rub Evamist® spray into your skin.

Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid being close with your child, wear clothes with long sleeves to cover the application site.

If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.

Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Always place the protective cover back on the applicator of the spray.

Do not use the applicator for more than 75 sprays.

Apply sunscreen at least 1 hour before applying Evamist®.

The spray contains alcohol and is flammable. Avoid using it near an open flame or while smoking.

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 transdermal dosage form (spray):
- For hot flashes and other symptoms caused by menopause:
  - Adults—At first, one spray once a day, usually in the morning. Your doctor may adjust your dose as needed.
  - Children—Use is not recommended.

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.

Do not use Evamist® spray if it has been more than 12 hours since you missed your last dose.

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 Climara

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using large doses of this medicine over a long period of time may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine.

Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.

Using this medicine alone may increase your risk of getting cancer of the uterus (womb). Check with your doctor right away if you have unusual vaginal bleeding while you are using this medicine.

Stop using this medicine and check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to this medicine.

Do not allow your pets to lick or touch the arm where this medicine was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines or drink grapefruit juice unless you discuss it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Climara 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:

Incidence not known

Abdominal or stomach cramps or pain

acid or sour stomach

anxiety

backache

belching

blistering, peeling, or loosening of the skin

bloating

blurred vision

breast tenderness, enlargement, pain, or discharge

change in vaginal discharge

changes in skin color

changes in vision

chest pain or discomfort

chills

clay-colored stools

clear or bloody discharge from the nipple

confusion

constipation

convulsions

cough

darkening of the urine

diarrhea

difficulty with breathing

difficulty with swallowing

dimpling of the breast skin

dizziness or lightheadedness

double vision

fainting

fast heartbeat

fever

fluid-filled skin blisters

full or bloated feeling or pressure in the stomach

headache

headache, severe and throbbing

heartburn

hives

indigestion

inverted nipple

irregular heartbeats

itching of the skin

itching of the vagina or genital area

joint or muscle pain

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

light-colored stools

loss of appetite

loss of bladder control

lump in the breast or under the arm

migraine headache

mood or mental changes

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

muscle spasm or jerking of all extremities

nausea

noisy breathing

numbness and tingling around the mouth, fingertips, or feet

pain during sexual intercourse

pain in the ankles or knees

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

pain or feeling of pressure in the pelvis

pain, redness, or swelling in the arm, foot, or leg

painful, red lumps under the skin, mostly on the legs

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

persistent crusting or scaling of the nipple

poor insight and judgment

problems with memory or speech

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

rash

red, irritated eyes

redness or swelling of the breast

sensitivity to the sun

shortness of breath

skin thinness

sore on the skin of the breast that does not heal

sore throat

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

stomach discomfort, upset, or pain

sudden loss of consciousness

sudden shortness of breath or troubled breathing

sweating

swelling

swelling of the abdominal or stomach area

thick, white vaginal discharge with no odor or with a mild odor

tightness in the chest

tremor

trouble recognizing objects

trouble thinking and planning

trouble walking

unexpected or excess milk flow from the breasts

unpleasant breath odor

unusual tiredness or weakness

unusually heavy or unexpected menstrual bleeding

vaginal bleeding or spotting

vomiting

vomiting of blood

wheezing

yellow eyes or skin

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

Less common

Back pain

difficulty with moving

muscle aches

muscle pain or stiffness

stuffy or runny nose

Incidence not known

Decreased interest in sexual intercourse

heavy bleeding

hives or welts

inability to have or keep an erection

increased hair growth, especially on the face

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

irritability

leg cramps

loss in sexual ability, desire, drive, or performance

loss of scalp hair

mental depression

mood disturbances

patchy brown or dark brown discoloration of the skin

redness of the skin

twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

weight 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.

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.

Sunday, 29 July 2012

Jevtana

Generic Name: cabazitaxel (Intravenous route)

ka-baz-i-TAX-el

Intravenous route(Solution)

Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. Do not give cabazitaxel if neutrophil counts are 1,500 cells/mm(3) or less. Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue cabazitaxel if severe reactions occur, and administer appropriate therapy. Cabazitaxel is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80 .

Commonly used brand name(s)

In the U.S.

Jevtana

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For Jevtana

Note: Women of childbearing potential should not use or handle this medicine. Cabazitaxel can cause birth defects in male fetuses.

Cabazitaxel injection is given together with a steroid medicine (e.g., prednisone, Deltasone®, Sterapred®) to treat men with metastatic (cancer that has already spread) prostate cancer. It is used in patients who have already been treated with other medicines that did not work well.

Cabazitaxel belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Jevtana

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cabazitaxel injection in the pediatric population. 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 cabazitaxel injection in the elderly. However, elderly patients are more likely to have unwanted side effects, which may require caution in patients receiving cabazitaxel.

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

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

Atazanavir

Carbamazepine

Clarithromycin

Indinavir

Itraconazole

Ketoconazole

Nefazodone

Nelfinavir

Phenobarbital

Phenytoin

Rifabutin

Rifampin

Rifapentine

Ritonavir

Saquinavir

St John's Wort

Telithromycin

Voriconazole

Interactions with Food/Tobacco/Alcohol

Proper Use of Jevtana

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine is usually given every three weeks and taken together with oral prednisone. Your doctor will tell you how much medicine to take and how often.

You may also receive other medicines to help prevent allergic reactions and nausea from the injection.

Precautions While Using Jevtana

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Women who are pregnant or may become pregnant should avoid touching or handling this medicine. This medicine can get into the body through the skin and may harm an unborn male baby.

Cabazitaxel can temporarily lower the number of white blood cells in your blood, increasing 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; a cough or hoarseness; lower back or side pain; or painful or difficult urination.

This medicine may cause serious allergic reactions. Tell your doctor right away if you start to have a cough; dizziness; wheezing; trouble with breathing; chest or throat tightness; swelling in your face or hands; fever; chills; rash; itching or hives; skin redness; or lightheadedness or faintness while you are receiving this medicine.

Kidney failure may occur while you are receiving this medicine. Check with your doctor right away if you have agitation; confusion; decreased urine output; dizziness; a headache; hostility; irritability; lethargy; muscle twitching; nausea; rapid weight gain; seizures; stupor; swelling of the face, ankles, or hands; or unusual tiredness or weakness.

Cancer medicines can cause diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.

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 (e.g., St. John's wort) or vitamin supplements.

Jevtana 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 or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

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

blood in the urine or stools

burning while urinating

burning, numbness, tingling, or painful sensations

chest pain

chills

cough

difficult or labored breathing

difficult or painful urination

fever

lower back or side pain

pale skin

pinpoint red spots on the skin

rapid weight gain

shortness of breath

sore throat

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

swollen glands

tightness in the chest

tingling of the hands or feet

troubled breathing with exertion

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness in the arms, hands, legs, or feet

wheezing

Less common

Blurred vision

confusion

decreased urination

dizziness

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

dry mouth

fainting

fast, slow, or irregular heartbeat

increase in heart rate

lightheadedness

rapid breathing

sunken eyes

sweating

thirst

wrinkled skin

More common

Abdominal or stomach pain

acid or sour stomach

belching

change in taste

constipation

cracked lips

decreased weight

diarrhea

difficulty with swallowing

hair loss

headache

heartburn

indigestion

lack or loss of strength

loss of appetite

nausea

stomach discomfort, upset, or pain

thinning of the hair

vomiting

weight loss

Less common

Back pain

difficulty with moving

muscle pain or stiffness

muscle spasms

pain in the joints

pain, itching, burning, swelling, or a lump under your skin where the needle is placed

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: Jevtana side effects (in more detail)

More Jevtana resources

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

Jevtana Prescribing Information (FDA)

Jevtana Consumer Overview

Jevtana Monograph (AHFS DI)

Jevtana MedFacts Consumer Leaflet (Wolters Kluwer)

Cabazitaxel Professional Patient Advice (Wolters Kluwer)

Compare Jevtana with other medications

Prostate Cancer

Monday, 23 July 2012

Migard

Migard 2.5 mg film-coated tablets

Frovatriptan

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.

In this leaflet:

1. What Migard is and what it is used for

2. Before you take Migard

3. How to take Migard

4. Possible side effects

5. How to store Migard

6. Further information

What Migard Is And What It Is Used For

Migard 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT₁) selective receptor agonists).

Migard 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing).

Migard 2.5 mg tablets should not be used to prevent a migraine attack.

Before You Take Migard

The diagnosis of migraine must have been clearly established by your doctor

Do not take Migard

If you are allergic (hypersensitive) to frovatriptan or any of the other ingredients of Migard 2.5 mg tablets.

if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

if you have had a stroke or a transient ischaemic attack (TIA),

if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

if you have severe liver disease,

in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT₁) agonists).

Take special care with Migard

if you are a patient at risk of coronary artery disease, including if:

> you are a heavy smoker or a user of nicotine substitution therapy

> you are a post-menopausal female or a male aged over 40 years

In any of these cases ask for your doctor’s advice before taking Migard.

In very rare cases a feeling of tightness or pain in the chest can occur when taking triptans, even in patients with no history of cardio-vascular disease. If this occurs contact your doctor and do not take an additional dose of this medicine.

Using other medicines

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

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Migard 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Migard 2.5 mg tablets.

especially other triptans (5-HT₁ agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Migard 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Migard with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrubt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Migard 2.5 mg tablets, consult your doctor or pharmacist.

Taking Migard with food and drink

Migard 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Migard 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Migard and during this time any breast milk expressed should be discarded.

Driving and using machines

Migard 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Important information about some of the ingredients of Migard

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Migard

Always take Migard 2.5 mg tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.

Take Migard 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Migard 2.5 mg tablet for any following attacks.

If you obtain relief after the first dose, but later on suffer from the re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Migard 2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Migard should not be used in patients under 18 years of age.

As there is little experience in patients over 65 years, the use of Migard is not recommended in patients in this age group.

If you take more Migard than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

If you stop taking Migard

No special precautions are necessary when stopping the drug.

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

Migard Side Effects

Like all medicines, Migard 2.5 mg tablets can cause side effects, although not everybody gets them.

A feeling of tightness or pains in the chest, sometimes intense and potentially extending to the throat, can occur within minutes of taking the medicine; if this occurs contact your doctor and do not take an additional dose of this medicine.

The side-effects reported during clinical studies with Migard 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

nausea (feeling sick), dry mouth, digestion problems, stomach pain,

fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or exaggeration of the sensations of touch, extreme sleepiness,

hot flushes,

tightness in the throat,

sight disturbances,

increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

awareness of heart beat (palpitations), fast heart beat, increased blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

feeling hot, reduced tolerance of heat and cold, pain, weakness, fever, thirst, sluggishness, increased energy, generally feeling unwell, foggy head or lightheadedness, sensation of spinning,

anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

coldness in the hands and feet,

irritation of the nose, inflamed sinus, sore throat and/or voice box,

muscle stiffness, muscle and joint pain, pain in the hands and feet, back pain, painful joints,

eye pain, eye irritation, painful oversensitivity to light,

itchiness,

ringing in the ears, earache,

dehydration,

passing urine frequently, production of large amounts of urine.

high blood pressure.

The following were rare (estimated frequency is more than 1 person out of 10,000 and less than 1 person out of 1000):

muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

fever

loss of memory, abnormal dreams, personality disorder,

nosebleed, hiccups, overbreathing, breathing disorder, sore throat,

night blindness,

skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

slow heart beat,

ear discomfort, earache, ear itchiness, sensitive hearing,

increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

low sugar in the blood,

passing urine frequently at night, pain in the kidneys,

self-inflicted injury (eg bite or bruising),

swollen lymph nodes,

breast pain or discomfort.

There have been a very few cases of allergic reactions to Migard, with skin rash and sometimes serious whole-body allergic-type reactions (anaphylaxis), with possible sudden difficulty in breathing, fast heart beat and palpitations. If this occurs, get medical help immediately.

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 Migard

Do not use Migard 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Blister: store in the original package.

Bottle: keep the container tightly closed.

Keep out of the reach and sight of children.

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 Migard contains

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet.

The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Migard looks like and contents of the pack

Migard 2.5 mg tablets are available in the form of round film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 1, 2, 3, 4, 6 or 12 tablets.

Each child-proof bottle contains 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611

Luxembourg

Manufacturer:

Almac Pharma Services Limited

Almac House

20 Seagoe Industrial Estate

Craigavon – County Armagh

Northern Ireland

BT63 5UA

United Kingdom

Berlin-Chemie AG

Glienicker Weg 125 – D-12489 Berlin

Germany

A.Menarini Manufacturing Logistics and services s.r.l.

Via Campo di Pile – L’Aquila (AQ)

Italy

Laboratorios Menarini S.A.

Alfonso XII

587, E-08918 Badalona (Barcelona)

Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

France (RMS) : Isimig

Austria : Eumitan

Belgium : Migard

Czech Republic : Recur

Estonia : Migard

Denmark : Migard

Finland : Migard

Germany : Migard

Greece : Pitunal

Hungary : Migard

Iceland : Migard

Ireland : Miguar

Italy : Rilamig

Latvia : Migard

Lithuania : Migard

Luxembourg : Migard

Norway : Migard

Poland : Migard

Portugal : Migard

Slovakia : Migard

Slovenia : Migard

Spain : Forvey

Sweden : Migard

The Netherlands : Migard

United Kingdom : Migard

This leaflet was last approved in June 2009.

Frovatriptan developed by Vernalis Ltd

Sunday, 22 July 2012

Potassium Chloride Injection

Dosage Form: injection, solution
Potassium Chloride 2 mEq/mL Injection Concentrate, USP 5 mL Single dose Vial

Description

Concentrate Must Be Diluted Before Use

For Intravenous Infusion Only

Must Be Diluted Prior To Injection

Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium chloride, SUP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid.

Each mL of Potassium chloride for Injection Concentrate contains 2 mEq of K+ and CL-equivalent to 149 mg of potassium chloride and has an osmalarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K+ and CL- equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L (calc).

pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide.

Some packages are intended for multiple dose use and contain preservatives (0,05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section.

Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.

Clinical Pharmacology

Potassium is the chief cation of body cells (160 mEq/L) of intracellular water) and is concenrtned with the maintenance of body fluid composition and electrolyte balance. Potassium 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.

Normally about 80-90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well, so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

Indications and Usage

Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

Contraindications

Potassium chloride for Injection Concentrate is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.

Warnings

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with renal insufficiency , administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia.

The administration of intravenous solutions 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 concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Precautions

General

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added.

Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Pregnancy

Teratogenic Effects: Pregnancy Category C- Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phelbitis extending from the site of injection, extravasation, hypervolemia, and hyperkalemia.

Too rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption or neuromuscular function, and intestinal ileus and dilatation.

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

Overdosage

In the event of fluid overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.

In the even of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

Treatment of hyperkalemia includes the following;

Dextrose Injection, USP 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL/hour.

Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.

Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

Dosage and Administration

Potassium Chloride for Injection Concentrate must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft of bag type containers are used.

The dose and rate of administration are dependent upon the specific condition of each patient.

If the serum potassium level is greater than 2.5 mEq/L, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/L. The 24 hour total dose should not exceed 200 mEq.

If urgent treatment is indicated (serum potassium level less than 2mEq/L and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as a dextrose may lower serum potassium levels.

Prior to entering a vial, cleanse the rubber closure with a suitable antiseptic agent.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

How Supplied

The following are packaged in plastic vials.

Product No.	NDC No.	Total Potassium Ion	Potassium Chloride per mL	Volume
95505	63323-965-05	10 mEq (0.39 g)	149 mg	5 mL in a 10 mL vial
96510	63323-965-10	20 mEq (0.78)	149 mg	10 mL in a 10 mL vial
96515	63323-965-15	30 mEq (1.17)	149 mg	15 mL in a 20 mL vial
96520	63323-965-20	40 mEq (1.56)	149 mg	20 mL in a 20 mL vial

These are Single Dose Vials, no preservative added, packaged 25 vials per tray. Unused portion of vial should be discarded.

Product No.	NDC No.	Total Potassium Ion	Potassium Chloride per mL	Volume
96730	63323-967-30	60 mEq (2.35g)	149 mg	30 mL in a 30 mL vial

This is a Multiple Dose Vial, preserved with 0.05% methylparaben and 0.005% propylparaben, packaged 25 vials per tray.

Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]

Use only if solution is clear, seal intact and undamaged.

Vial stoppers do not contain natural rubber latex.

APP Pharmaceuticals, LLC

Schaumburg, IL 60173

45767F

Revised April 2008

Sample Outer Label

POTASSIUM CHLORIDE
potassium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	52584-965 (63323-965)
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium Chloride (Potassium Cation)	Potassium Chloride	2 meq in 1 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	52584-965-05	1 VIAL In 1 BAG	contains a VIAL, SINGLE-DOSE
1		5 mL In 1 VIAL, SINGLE-DOSE	This package is contained within the BAG (52584-965-05)
2	52584-965-10	1 VIAL In 1 BAG	contains a VIAL, SINGLE-DOSE
2		10 mL In 1 VIAL, SINGLE-DOSE	This package is contained within the BAG (52584-965-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088901	08/01/2010

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 04/2011General Injectables & Vaccines, Inc

More Potassium Chloride Injection resources

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

Compare Potassium Chloride Injection with other medications

Hypokalemia
Prevention of Hypokalemia

Gavilyte N

Dosage Form: powder, for solution
GaviLyteTM –N with Flavor Pack

Rx Only

DESCRIPTION

GaviLyte –N is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride and one 2 g flavor pack (optional). When dissolved in water to a volume of 4 liters, GaviLyte –N (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. GaviLyte –N is administered orally or via nasogastric tube as a gastrointestinal lavage. GaviLyte –N Flavor Pack is available in lemon flavor. This preparation can be used without the addition of a GaviLyte –N Flavor Pack.

CLINICAL PHARMACOLOGY

GaviLyte –N induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.

INDICATIONS AND USAGE

GaviLyte –N is indicated for bowel cleansing prior to colonoscopy.

CONTRAINDICATIONS

GaviLyte –N is contraindicated in patients known to be hypersensitive to any of the components. GaviLyte –N is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

WARNINGS

GaviLyte –N Flavor Pack is for use only in combination with the contents of the accompanying 4 liter container. No additional ingredients, e.g. flavorings, should be added to the solution. GaviLyte –N should be used with caution in patients with severe ulcerative colitis. Use of GaviLyte –N in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

PRECAUTIONS

General

Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of GaviLyte –N, especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of GaviLyte –N.

Information for Patients

GaviLyte –N produces a watery stool which cleanses the bowel before examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking GaviLyte –N.

Adults drink 240 mL (8 oz.) every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Any unused portion should be discarded. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Continue drinking until the watery stool is clear and free of solid matter. Any unused portion should be discarded. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of GaviLyte –N administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.

Use of GaviLyte –N in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

Drug Interactions

Oral medication administered within one hour of the start of administration of GaviLyte –N may be flushed from the gastrointestinal tract and not absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic and reproductive studies with animals have not been performed.

Pregnancy

Category C. Animal reproduction studies have not been conducted with GaviLyte –N. It is also not known whether GaviLyte –N can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte –N should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness of GaviLyte –N in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of GaviLyte –N in adults with additional safety and efficacy data from published studies of similar formulations.

ADVERSE REACTIONS

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GaviLyte –N. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reaction following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like” infiltrate on chest X-ray after vomiting and aspirating PEG.

DOSAGE AND ADMINISTRATION

GaviLyte –N is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to GaviLyte –N administration, but in no case should solid food be given for at least two hours before the solution is given.

Oral administration

Adults: At a rate of 240 mL (8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed. Pediatric Patients(aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric tube administration:Adults: At a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour). Pediatric Patients(aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear.

The first bowel movement should occur approximately one hour after the start of GaviLyte –N administration. Ingestion of 4 liters of GaviLyte –N solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients.

Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer GaviLyte –N on the evening before the examination.

Preparation of the solution: GaviLyte –N solution is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to insure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.

HOW SUPPLIED

GaviLyte –N with Flavor Pack is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has an attached lemon flavor pack, in powdered form, for the addition of the flavor pack by the pharmacist prior to dispensing.

GaviLyte –N with Flavor Pack: PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and lemon flavor pack 2 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

STORAGE: Store in sealed container at 25°C. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

NDC 43386-050-19

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Distributed by:

GAVIS Pharmaceuticals, LLC

Somerset, NJ 08873

GLB-050-4L-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GAVILYTE - N
polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	43386-050
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350)	POLYETHYLENE GLYCOL 3350	420 g in 438.4 g
SODIUM CHLORIDE (CHLORIDE ION)	SODIUM CHLORIDE	11.2 g in 438.4 g
SODIUM BICARBONATE (SODIUM CATION)	SODIUM BICARBONATE	5.72 g in 438.4 g
POTASSIUM CHLORIDE (POTASSIUM CATION)	POTASSIUM CHLORIDE	1.48 g in 438.4 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL, DL-
SACCHARIN SODIUM
MALTODEXTRIN
ACACIA

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	43386-050-19	438.4 g In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090019	05/28/2009

Labeler - GAVIS Pharmaceuticals, LLC (829838551)

Registrant - Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, Inc.		793518643	MANUFACTURE, REPACK

Establishment
Name	Address	ID/FEI	Operations
Dow Chemical Company		801038019	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Baker Inc.		001213481	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Church and Dwight Co, Inc.		001211952	API MANUFACTURE

Revised: 05/2009GAVIS Pharmaceuticals, LLC

More Gavilyte N resources

Gavilyte N Use in Pregnancy & Breastfeeding
Gavilyte N Support Group
39 Reviews for Gavilyte N - Add your own review/rating

Compare Gavilyte N with other medications

Bowel Preparation
Constipation, Chronic
Gastrointestinal Decontamination

Thursday, 19 July 2012

Eth-Oxydose

Generic Name: oxycodone (Oral route)

ox-i-KOE-done hye-droe-KLOR-ide

Oral route(Tablet, Extended Release)

Oxycodone hydrochloride is an opioid agonist and a Schedule II controlled substance with an abuse potential similar to morphine. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Oxycodone hydrochloride controlled-release tablets are indicated for continuous, around the clock analgesia for an extended period of time; not for use on an as needed basis. The 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg, are only for use in opioid-tolerant patients as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids. Oxycodone hydrochloride controlled-release tablets must be swallowed whole to avoid a rapid release of the drug which can be potentially fatal. Concomitant use with CYP3A4 inhibitors may result in an increase in oxycodone plasma concentrations and may cause potentially fatal respiratory depression .

Commonly used brand name(s)

In the U.S.

Dazidox

Eth-Oxydose

Oxecta

Oxycontin

Oxycontin CR

Oxydose

Oxyfast

Oxy IR

Roxicodone

Roxicodone Intensol

In Canada

Oxy-IR

Available Dosage Forms:

Tablet, Extended Release

Tablet

Capsule

Solution

Therapeutic Class: Analgesic

Chemical Class: Oxycodone

Uses For Eth-Oxydose

Oxycodone is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Oxycodone acts on the central nervous system (CNS) to relieve pain.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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

Before Using Eth-Oxydose

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone in the pediatric population. 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 oxycodone in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving oxycodone.

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

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Acetophenazine

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Atazanavir

Brofaromine

Bromazepam

Brotizolam

Buprenorphine

Buspirone

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Clorgyline

Codeine

Dantrolene

Desflurane

Dexmedetomidine

Dezocine

Diazepam

Diphenhydramine

Doxylamine

Enflurane

Erythromycin

Escitalopram

Estazolam

Eszopiclone

Ethchlorvynol

Ethopropazine

Fentanyl

Flumazenil

Flunitrazepam

Fluphenazine

Flurazepam

Fluvoxamine

Fospropofol

Furazolidone

Halazepam

Halothane

Hydrocodone

Hydromorphone

Hydroxyzine

Indinavir

Iproniazid

Isocarboxazid

Isoflurane

Itraconazole

Ketamine

Ketazolam

Ketoconazole

Lazabemide

Levorphanol

Linezolid

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Mesoridazine

Metaxalone

Methdilazine

Methocarbamol

Methohexital

Midazolam

Moclobemide

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nefazodone

Nelfinavir

Nialamide

Nitrazepam

Nitrous Oxide

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pargyline

Pentazocine

Pentobarbital

Perphenazine

Phenelzine

Phenobarbital

Prazepam

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propiomazine

Propofol

Propoxyphene

Quazepam

Ramelteon

Rasagiline

Remifentanil

Ritonavir

Saquinavir

Secobarbital

Selegiline

Sertraline

Sevoflurane

Sodium Oxybate

Sufentanil

Tapentadol

Telithromycin

Temazepam

Thiethylperazine

Thiopental

Thioridazine

Toloxatone

Tranylcypromine

Triazolam

Trifluoperazine

Triflupromazine

Trimeprazine

Zaleplon

Zolpidem

Miconazole

Rifampin

St John's Wort

Voriconazole

Interactions with Food/Tobacco/Alcohol

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

Ethanol

Proper Use of oxycodone

This section provides information on the proper use of a number of products that contain oxycodone. It may not be specific to Eth-Oxydose. Please read with care.

Take this medicine only 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Oxycodone extended-release tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the Oxecta® or OxyContin® tablet whole with water. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time. Also, do not give this medicine through nasogastric or feeding tubes.

Oxycodone extended-release tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Dosing

For oral dosage form (extended-release tablets):
- For moderate to severe pain:
  - Patients switching from regular oxycodone forms:
    - Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from other narcotic medicines:
    - Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 doses during the day. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.

For oral dosage form (immediate-release tablets):
- For moderate to severe pain:
  - Patients who are not taking narcotic medicines:
    - Adults—At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from fixed-ratio oral narcotic/non-narcotic combinations:
    - Adults—Your doctor will determine whether or not to continue the non-narcotic pain medicine. Also, the total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.
  - Patients switching from other narcotic medicines:
    - Adults—The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. Your doctor may adjust your dose if needed.
    - Children—Use and dose must be determined by your doctor.

For oral dosage forms (liquid concentrate, solution, or tablets):
- For moderate to severe pain:
  - Adults—10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Oxycodone can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused extended-release tablets and immediate-release tablets down the toilet.

Precautions While Using Eth-Oxydose

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

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

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

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

This medicine may make you dizzy, drowsy, or lightheaded. 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.

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

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using 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.

Eth-Oxydose 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

Chills

cold sweats

confusion

difficult or labored breathing

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

fever

shortness of breath

tightness in the chest

twitching

wheezing

Rare

Abdominal or stomach pain

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

blood in the urine

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

chest pain

convulsions

cough

decrease in the frequency of urination

decrease in urine volume

decreased urine output

difficult or painful urination

difficulty in passing urine (dribbling)

difficulty with swallowing

dizziness

dry mouth

fainting

fast or irregular heartbeat

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth or heat

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

frequent urination

headache

hives

increase in heart rate

increased thirst

increased volume of pale, dilute urine

itching

lightheadedness

muscle pain or cramps

nausea or vomiting

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

rapid breathing

rapid weight gain

severe constipation

severe vomiting

shakiness in the legs, arms, hands, or feet

skin rash

sunken eyes

sweating

swelling or puffiness of the face

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thirst

tingling of the hands or feet

trembling or shaking of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

wrinkled skin

Incidence not known

Blurred vision

choking

clay-colored stools

cold, clammy skin

dark urine

diarrhea

fast, weak pulse

gagging

irregular, fast, slow, or shallow breathing

loss of appetite

low blood pressure or pulse

pale or blue lips, fingernails, or skin

trouble with swallowing

unconsciousness

unpleasant breath odor

very slow breathing

very slow heartbeat

yellow eyes or skin

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

Symptoms of overdose

Change in consciousness

chest pain or discomfort

constricted, pinpoint, or small pupils (black part of the eye)

decreased awareness or responsiveness

extreme drowsiness

loss of consciousness

no muscle tone or movement

severe sleepiness

slow or irregular heartbeat

More common

Difficulty having a bowel movement (stool)

drowsiness

lack or loss of strength

relaxed and calm feeling

sleepiness or unusual drowsiness

Less common

Abnormal dreams

acid or sour stomach

anxiety

belching

burning feeling in the chest or stomach

false or unusual sense of well-being

heartburn

hiccups

indigestion

nervousness

sleeplessness

stomach discomfort, upset, or pain

tenderness in the stomach area

trouble with sleeping

unable to sleep

weight loss

Rare

Absent, missed, or irregular menstrual periods

bad, unusual or unpleasant (after) taste

bloated or full feeling

body aches or pain

change in taste

change in walking and balance

changes in vision

clumsiness or unsteadiness

congestion

continuing ringing or buzzing or other unexplained noise in the ears

cracks in the skin

crying

decreased interest in sexual intercourse

dental caries or tooth decay

depersonalization

depression

difficulty with speaking

dry skin

dryness or soreness of the throat

dysphoria

excess air or gas in the stomach or intestines

excessive muscle tone

feeling of constant movement of self or surroundings

feeling of unreality

general feeling of discomfort or illness

headache, severe and throbbing

hearing loss

hives or welts

hoarseness

hyperventilation

inability to have or keep an erection

increase in body movements

increased appetite

increased cough

irritability

loss in sexual ability, desire, drive, or performance

loss of heat from the body

loss of memory

loss of strength or energy

mental depression

muscle pain or weakness

muscle stiffness

muscle tension or tightness

neck pain

paranoia

passing of gas

problems with memory

quick to react or overreact emotionally

rapidly changing moods

red, swollen skin

restlessness

runny nose

scaly skin

sensation of spinning

sense of detachment from self or body

severe sleepiness

stomach pain, fullness, or discomfort

stopping of menstrual bleeding

swelling or inflammation of the mouth

tender, swollen glands in the neck

unusual weak feeling

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: Eth-Oxydose side effects (in more detail)

More Eth-Oxydose resources

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

OxyContin Prescribing Information (FDA)

OxyContin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Oxycodone Monograph (AHFS DI)

Oxycodone MedFacts Consumer Leaflet (Wolters Kluwer)

Oxycodone Prescribing Information (FDA)

Oxycontin Consumer Overview

Oxyfast Concentrate MedFacts Consumer Leaflet (Wolters Kluwer)

Roxicodone Prescribing Information (FDA)

Compare Eth-Oxydose with other medications

Pain

Monday, 30 July 2012

Climara Transdermal

Commonly used brand name(s)

Uses For Climara

Before Using Climara

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of estradiol

Dosing

Missed Dose

Storage

Precautions While Using Climara

Climara Side Effects

Sunday, 29 July 2012

Jevtana

Commonly used brand name(s)

Uses For Jevtana

Before Using Jevtana

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of Jevtana

Precautions While Using Jevtana

Jevtana Side Effects

More Jevtana resources

Compare Jevtana with other medications

Monday, 23 July 2012

Migard

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

In this leaflet:

What Migard Is And What It Is Used For

Before You Take Migard

Do not take Migard

Take special care with Migard

Using other medicines

Taking Migard with food and drink

Pregnancy and breast-feeding

Driving and using machines

Important information about some of the ingredients of Migard

How To Take Migard

If you take more Migard than you should

If you stop taking Migard

Migard Side Effects

How To Store Migard

Further Information

What Migard contains

What Migard looks like and contents of the pack

Marketing Authorisation Holder and Manufacturer

Sunday, 22 July 2012

Potassium Chloride Injection

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Sample Outer Label

More Potassium Chloride Injection resources

Compare Potassium Chloride Injection with other medications

Gavilyte N

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS