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progestin contraceptives (Oral route, Parenteral route)

30/06/10

Commonly used brand name(s):

In the U.S.

Aygestin
Camila
Errin
Jolivette
Next Choice
Nora-BE
Nor-QD
Ortho Micronor
Ovrette
Plan B
Plan B One-Step
Provera

Available Dosage Forms:

Tablet

Uses For progestin contraceptive

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman’s egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner’s sperm to reach the egg. The fertilization of the woman’s egg with her partner’s sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor’s prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using progestin contraceptive

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using progestin contraceptive for 2 years or longer.

Geriatric

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

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Interactions with Medicines

Using medicines in this class 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

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.

Proper Use of progestin contraceptive

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using progestin contraceptive.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take progestin contraceptive only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

Your injection is given by a health care professional every 3 months.
To stop using medroxyprogesterone injection for contraception, simply do not have another injection.
Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.
Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.
When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.
Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor’s orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

The dose medicines in this class 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 these medicines. 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 levonorgestrel
For oral dosage form (tablets):
- For emergency contraception for preventing pregnancy:
  - Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.

For medroxyprogesterone
For muscular injection dosage form
- For preventing pregnancy:
  - Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
For subcutaneous injection dosage form
- For preventing pregnancy:
  - Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).

For norethindrone
For oral dosage form (tablets):
- For preventing pregnancy:
  - Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

For norgestrel
For oral dosage form (tablets):
- For preventing pregnancy:
  - Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

When you miss 1 day’s dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.
If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using progestin contraceptive

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to progestin contraceptive before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

If vaginal bleeding continues for an unusually long time.
If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

Aminoglutethimide (e.g., Cytadren®)
Carbamazepine (e.g., Tegretol®)
Phenobarbital
Phenytoin (e.g., Dilantin®)
Rifabutin (e.g., Mycobutin®)
Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

progestin contraceptive Side Effects

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

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods
heavier uterine bleeding between regular monthly periods
lighter uterine bleeding between menstrual periods
or stopping of menstrual periods

Less common

Mental depression
skin rash
unexpected or increased flow of breast milk

Incidence not known – for patients taking Depo-Provera Contraceptive Injection

Cough
decrease in height
difficulty swallowing
fast heartbeat
hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips or tongue
pain in back, ribs, arms, or legs
pain or swelling in arms or legs without any injury
shortness of breath
skin rash
tightness in chest
wheezing

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

More common

Abdominal pain or cramping
diarrhea
dizziness
fatigue
mild headache
mood changes
nausea
nervousness
pain or irritation at the injection site
swelling of face, ankles, or feet
unusual tiredness or weakness
vomiting
weight gain

Less common

Acne
breast pain or tenderness
brown spots on exposed skin, possibly long-lasting
hot flashes
loss or gain of body, facial, or scalp hair
loss of sexual desire
trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using progestin contraceptive, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

Delayed return to fertility
stopping of menstrual periods
unusual menstrual bleeding (continuing)

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.

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Proglycem

30/06/10

Generic Name: diazoxide (oral) (DYE az OX ide)
Brand Names: Proglycem

What is diazoxide?

Diazoxide given orally raises blood sugar by slowing the release of insulin from the pancreas.

Diazoxide is used to treat low blood sugar (hypoglycemia) related to certain cancers that affect the pancreas and cause it to release too much insulin.

Diazoxide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about oral diazoxide?

You should not take this medication if you are allergic to diazoxide or diuretics (water pills). Oral diazoxide should not be used to treat occasional hypoglycemia related to diet.

Before taking diazoxide, tell your doctor if you have congestive heart failure, kidney disease, gout, high cholesterol, or low potassium.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If your blood sugar gets too high (hyperglycemia), you may have symptoms such as increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin, nausea, and vomiting. Tell your doctor right away if you have any of these symptoms.

To be sure this medication is helping your condition and not causing harmful effects, your urine will need to be tested often for the presence of glucose (sugar) or ketones. You may be able to do this testing at home. Call your doctor if you have any abnormal test result.

Your doctor may also want you to have blood or urine tests at regular intervals. Do not miss any scheduled appointments.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are taking diazoxide.

If your condition does not improve after taking diazoxide for 2 to 3 weeks, stop taking the medication and talk to your doctor.

What should I discuss with my health care provider before receiving diazoxide?

You should not take this medication if you are allergic to diazoxide or diuretics (water pills). Oral diazoxide should not be used to treat occasional hypoglycemia related to diet.

Before taking diazoxide, tell your doctor if you are allergic to any drugs, or if you have:

congestive heart failure;
kidney disease;
gout;
high cholesterol or triglycerides; or
low levels of potassium in your blood (hypokalemia).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take diazoxide.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant before you take diazoxide. Diazoxide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take diazoxide?

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

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

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with the marked medicine dropper provided, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Diazoxide usually begins to work within 1 hour, and its effects can last up to 8 hours.

Your doctor may also want you to have blood or urine tests at regular intervals. Do not miss any scheduled appointments. If your condition does not improve after taking diazoxide for 2 to 3 weeks, stop taking the medication and talk to your doctor. Store diazoxide at room temperature away from moisture, heat, and light.

See also: Proglycem dosage in more detail

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include increased thirst or urination, fruity breath odor, nausea, and vomiting, or feeling like you might pass out.

What should I avoid while taking diazoxide?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are taking diazoxide.

Diazoxide side effects

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

shortness of breath, swelling in your hands or feet;
rapid pulse;
fast or pounding heartbeats;
chest pain;
blurred vision, eye pain, or seeing halos around lights;
easy bruising or bleeding, unusual weakness;
fever, chills, body aches, flu symptoms;
urinating less than usual; or
feeling like you might pass out.

Less serious side effects may include:

temporary increase in growth of body hair (especially in women and children;
nausea, vomiting, stomach pain, loss of appetite;
diarrhea;
decreased sense of taste;
headache, dizziness, anxiety;
weakness; or
mild itching or skin rash.

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

What other drugs will affect diazoxide?

The following drugs can interact with diazoxide. Tell your doctor if you have recently taken any of these:

a diuretic (water pill);
chlorpromazine (Thorazine);
phenytoin (Dilantin);
a blood thinner such as warfarin (Coumadin); or
drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax).

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

Where can I get more information?

Your doctor or pharmacist can provide more information about diazoxide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Proglycem Suspension

30/06/10

Generic Name: Diazoxide (dye-az-OX-ide)
Brand Name: Proglycem

Proglycem Suspension is used for:

Treating low blood sugar.

Proglycem Suspension is a glucose-elevating agent. It works by blocking the release of insulin from the pancreas, which helps to increase blood sugar.

Do NOT use Proglycem Suspension if:

you are allergic to any ingredient in Proglycem Suspension or to other thiazides (eg, hydrochlorothiazide)
you have functional low blood sugar

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

Before using Proglycem Suspension:

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

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have heart problems, kidney problems, low potassium levels in the blood, or high blood pressure
if you have a history of aneurysm

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

Hydantoins (eg, phenytoin), sulfonylureas (eg, glipizide), or thiazide-type diuretics (eg, hydrochlorothiazide) because the effectiveness of these medicines may be decreased

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

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

Shake well before using.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
Proglycem Suspension works best if it is taken on a regular schedule.
Continue to use Proglycem Suspension even if you feel well. Do not miss any doses.
If you miss a dose of Proglycem Suspension, 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 Proglycem Suspension.

Important safety information:

Follow the dietary plan as provided by your doctor.
Using a kit, test your urine or blood sugar as instructed by your doctor.
LAB TESTS, including blood glucose determinations, platelet counts, and serum urea nitrogen, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Proglycem Suspension, discuss with your doctor the benefits and risks of using Proglycem Suspension during pregnancy. Use Proglycem Suspension with caution during labor and delivery. It is unknown if Proglycem Suspension is excreted in breast milk. Do not breast-feed while taking Proglycem Suspension.

Possible side effects of Proglycem Suspension:

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

Diarrhea; excessive hair growth; headache; loss of appetite; nausea; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive drowsiness; excessive hunger or thirst; fast or irregular heartbeat; frequent urination; fruity breath; sudden weight gain; sweating; swelling of the feet or ankles.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include continued loss of appetite; drowsiness; flushed, dry skin; fruit-like breath odor; increased urination; unusual thirst.

Proper storage of Proglycem Suspension:

Store Proglycem Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Proglycem Suspension out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Proglycem Suspension. 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: May 5, 2010

Database Edition 10.2.1.002

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Progesterone Insert

30/06/10

Generic Name: Progesterone (proe-JES-ter-one)
Brand Name: Endometrin

Progesterone Insert is used for:

Supporting embryo implants and early pregnancy in certain women. It is also used as part of an assisted reproductive technology (ART) treatment program. It may also be used for other conditions as determined by your doctor.

Progesterone Insert is a hormone. It works by changing the lining of the uterus.

Do NOT use Progesterone Insert if:

you are allergic to any ingredient in Progesterone Insert
you have vaginal bleeding of an unknown cause, you have had a recent miscarriage, or the embryo is implanted outside the uterus (ectopic pregnancy)
you know or suspect that you have breast cancer
you have bleeding in the brain or severe blood vessel problems
you have a history of bleeding or blood clotting problems (eg, blood clots in the legs, lungs, or eyes), heart attack, stroke, or liver disease
you are using other vaginal products (eg, vaginal antifungal creams)

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

Before using Progesterone Insert:

Some medical conditions may interact with Progesterone Insert. 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 heart or blood vessel problems, depression or other mental/mood problems, or cancer

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

Carbamazepine or rifampin because they may decrease Progesterone Insert’s effectiveness
Other vaginal products (eg, vaginal antifungal creams) because they may alter Progesterone Insert’s actions

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

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

An extra patient leaflet is available with Progesterone Insert. Talk to your pharmacist if you have questions about this information.
Wash your hands before and after using Progesterone Insert.
Unwrap the applicator and place one insert in the space provided at the end of the applicator.
You may use Progesterone Insert while standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina. Push the plunger to release the insert, then remove the applicator and throw it away in the trash.
If you miss a dose of Progesterone Insert, 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 Progesterone Insert.

Important safety information:

Progesterone Insert may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Insert with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not use Progesterone Insert at the same time as other vaginal therapy without checking with your doctor.
Progesterone Insert may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
Progesterone Insert should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Progesterone Insert is used to support early pregnancy. Progesterone Insert is found in breast milk. If you are or will be breast-feeding while you use Progesterone Insert, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Progesterone Insert:

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:

Bloating; breast tenderness; constipation; cramping; drowsiness; fluid retention; headache; nausea; stomach pain; tiredness; vaginal burning or irritation; vomiting.

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

Severe allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf or leg pain, swelling, or tenderness; change in emotions, mood, or behavior; chest pain; coughing up blood; fainting; one-sided weakness; pain in the groin; partial or complete loss of vision; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; unusual vaginal itching, discharge, or odor; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Progesterone Insert:

Store Progesterone Insert at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not remove from the sealed foiled pouch until just before use. Keep Progesterone Insert out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Progesterone Insert. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

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progesterone vaginal

30/06/10

Generic Name: progesterone vaginal (proe JESS te role VAJ in ul)
Brand Names: Crinone, Endometrin, FIRST-Progesterone VGS 100, FIRST-Progesterone VGS 200, FIRST-Progesterone VGS 25, FIRST-Progesterone VGS 400, FIRST-Progesterone VGS 50, Menopause Formula Progesterone, Prochieve

What is progesterone vaginal?

Progesterone is a female hormone important for ovulation and menstruation. Progesterone causes changes in the lining of your uterus, making it easier for a fertilized egg to attach to the uterus at the beginning of pregnancy. Progesterone then helps your body maintain the pregnancy.

Progesterone vaginal is used in fertility treatment as part of Assisted Reproductive Technology (ART) for women unable to get pregnant due to a lack of natural progesterone in the body.

Progesterone vaginal is also used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body.

This medication also prevents overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

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

What is the most important information I should know about progesterone vaginal?

Do not use progesterone vaginal without your doctor’s consent if you are pregnant, unless you are using the medication as part of your fertility treatment. Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use an effective form of birth control while you are using this medication. Some forms of this medication may contain plant-based oils. Do not use progesterone vaginal without telling your doctor if you have any type of food allergy. Using progesterone vaginal can increase your risk of blood clots, stroke, heart attack, or breast cancer. You should not use this medication if you have: a history of stroke or blood clot, circulation problems, severe liver disease, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you have recently had a tubal pregnancy or an incomplete abortion.

Progesterone vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, progesterone vaginal may be given for up to 12 weeks into a pregnancy. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Progesterone vaginal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before using progesterone vaginal?

Some forms of this medication may contain plant-based oils. Do not use progesterone vaginal without telling your doctor if you have any type of food allergy. You should not use progesterone vaginal if you have ever had an allergic reaction to it, or if you have:

a history of stroke, blood clot, or circulation problems;
breast or uterine cancer;
abnormal vaginal bleeding;
liver disease; or
if you have recently had a tubal pregnancy or an incomplete or “missed” abortion.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely use progesterone:

high blood pressure, heart disease, congestive heart failure;
migraines,
asthma;
kidney disease;
seizures or epilepsy;
diabetes; or
a history of depression.

How should I use progesterone vaginal?

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use other vaginal medications within 6 hours before or after using progesterone vaginal. Use only vaginal products that your doctor has recommended.

Progesterone vaginal gel should be applied directly into the vagina using only the applicator provided with the medicine. A disposable applicator should be used only once and then thrown away.

Progesterone vaginal suppositories are made at the pharmacy and provided to you in a dispensing cup fitted with a mold and a special tool to push each suppository out through the bottom of the mold. Your pharmacist can show you how to dispense the suppositories from the mold.

Before inserting the vaginal suppository, remove the wrapping and throw it away. Avoid handling the suppository too long or it will begin to melt in your hand.

It is normal to have vaginal discharge for several days after using this medication. Talk with your doctor if you have concerns about any vaginal discharge.

Store progesterone vaginal at room temperature away from moisture and heat. Some brands of progesterone vaginal suppositories should be stored in a refrigerator. Follow the instructions provided with your medication.

What happens if I miss a dose?

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

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a progesterone vaginal overdose are not known.

What should I avoid while using progesterone vaginal?

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progesterone vaginal side effects

sudden headache, numbness or weakness (especially on one side of the body), shortness of breath, or problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder;
pain or swelling in one or both legs;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
fever, chills, body aches, flu symptoms;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;
diarrhea, constipation, bloating;
dizziness, drowsiness, tired feeling;
pain in your vaginal or rectal area;
pain during intercourse;
loss of interest in sex;
breast pain, swelling, or tenderness;
joint or muscle pain;
increased night-time urination; or
vaginal itching, burning, or discharge.

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

Progesterone vaginal Dosing Information

Usual Adult Dose for Amenorrhea:

5 to 10 mg IM for six to eight consecutive days.

400 mg orally for 10 days. Give dose in the evening.

Secondary Amenorrhea:
90 mg intravaginally, 4% gel, every other day for a total of six doses. If no response observed, the administration of the 8% gel every other day for a total of six doses may be used.

Usual Adult Dose for Uterine Bleeding:

5 to 10 mg IM daily for 6 doses.

Usual Adult Dose for Endometrial Hyperplasia — Prophylaxis:

200 mg orally for 12 consecutive days, per 28 day cycle. Give dose in the evening.

Usual Adult Dose for Progesterone Insufficiency:

Assisted Reproductive Technology (ART) – Gel:
90 mg of the 8% gel, once daily intravaginally, in women who require supplementation.
90 mg of the 8% gel, twice daily intravaginally, in women with partial or complete ovarian failure who require replacement.
If pregnancy occurs, therapy with the intravaginal gel may be continued until placental autonomy is achieved, up to 10 to 12 weeks.

Assisted Reproductive Technology (ART) – Vaginal Insert
100 mg administered vaginally two or three times daily starting at oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose in this age group has not been determined.

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: rub 1/4 to 1/2 teaspoon into the palms of the hands, soles of the feet, or other soft areas of skin once or twice daily.

Usual Adult Dose for Premature Labor:

Study (n=459) – National Institute of Child Health and Human Development (NICHD) – Prevention of Recurrent Preterm Delivery in Women at High Risk: 17-alpha-hydroxyprogesterone caproate (17P) 250 mg IM once weekly starting on the 21st week of gestation through time of delivery or week 36 of gestation.

Study (n=142) – Reduce Incidence of Spontaneous Preterm Birth in Women at Increased Risk: 100 mg vaginal suppository daily, between 24 and 34 weeks of gestation.

Usual Adult Dose for Seizures:

(Study=25) – Catamenial epilepsy [complex partial or secondary generalized motor seizures]:
200 mg lozenge three times daily administered in relation to pattern of seizure exacerbation during luteal phase of menstrual cycle. For patients with perimenstrual exacerbation, dose was provided on day 23 through day 25 of menstrual cycle. For patients with seizure exacerbation during entire luteal phase, dose was provided on day 15 through day 25 of each menstrual cycle. The desired progesterone serum level was between 5 and 25 ng/mL 4 hours after taking the lozenge. All patients continued taking their best antiseizure medication.

Usual Adult Dose for Perimenopausal Symptoms:

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: Rub 1/4 to 1/2 teaspoonful into the palms of the hands, soles of feet, or other soft area once or twice daily.

What other drugs will affect progesterone vaginal?

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

Where can I get more information?

Your pharmacist can provide more information about progesterone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,P

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Progest

30/06/10

Generic Name: progesterone (proe JESS te role)
Brand Names: First Progesterone MC10, First Progesterone MC5, Progest, Prometrium

What is Progest (progesterone)?

Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. Progesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

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

What is the most important information I should know about Progest (progesterone)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Do not use this medication if you have any of the following conditions: a history of breast cancer, abnormal vaginal bleeding, liver disease, if you are pregnant, or if you have had a stroke, heart attack, or blood clot within the past year.

Progesterone is sometimes given for only a short period of time, such as 6 to 12 days at a time during each menstrual cycle. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before using Progest (progesterone)?

Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy. Do not use progesterone if you have:

a history of breast cancer;
abnormal vaginal bleeding that a doctor has not checked;
liver disease;
if you are pregnant; or
if you have had a stroke, heart attack, or blood clot within the past year.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use progesterone:

heart disease, circulation problems;
risk factors for coronary artery disease (such as smoking, being overweight, and having high blood pressure or high cholesterol);
migraines,
asthma;
kidney disease;
seizures or epilepsy;
a history of depression; or
diabetes.

Do not use progesterone without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Progesterone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Progest (progesterone)?

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take the pill form of progesterone with a full glass of water.

Apply progesterone cream to the skin as directed by your doctor.

Progesterone injection is given as a shot into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using progesterone.

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

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

What happens if I miss a dose?

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a progesterone overdose are not known.

What should I avoid while using Progest (progesterone)?

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progest (progesterone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
fast or pounding heartbeats;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
unusual or unexpected vaginal bleeding;
migraine headache;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
fever, chills, body aches, flu symptoms;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, diarrhea, bloating, stomach cramps;
dizziness, spinning sensation;
hot flashes;
mild headache;
joint pain;
breast pain or tenderness;
cough;
acne or increased hair growth;
changes in weight; or
vaginal itching, dryness, or discharge.

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

What other drugs will affect Progest (progesterone)?

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

Where can I get more information?

Your pharmacist can provide more information about progesterone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,P

Comments (0)

progesterone

30/06/10

Generic Name: progesterone (proe JESS te role)
Brand Names: First Progesterone MC10, First Progesterone MC5, Progest, Prometrium

What is progesterone?

Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

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

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

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before using progesterone?

Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy. Do not use progesterone if you have:

a history of breast cancer;
abnormal vaginal bleeding that a doctor has not checked;
liver disease;
if you are pregnant; or
if you have had a stroke, heart attack, or blood clot within the past year.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use progesterone:

heart disease, circulation problems;
risk factors for coronary artery disease (such as smoking, being overweight, and having high blood pressure or high cholesterol);
migraines,
asthma;
kidney disease;
seizures or epilepsy;
a history of depression; or
diabetes.

How should I use progesterone?

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take the pill form of progesterone with a full glass of water.

Apply progesterone cream to the skin as directed by your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using progesterone.

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

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

What happens if I miss a dose?

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a progesterone overdose are not known.

What should I avoid while using progesterone?

Progesterone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Progesterone side effects

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
fast or pounding heartbeats;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
unusual or unexpected vaginal bleeding;
migraine headache;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
fever, chills, body aches, flu symptoms;
a breast lump; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, diarrhea, bloating, stomach cramps;
dizziness, spinning sensation;
hot flashes;
mild headache;
joint pain;
breast pain or tenderness;
cough;
acne or increased hair growth;
changes in weight; or
vaginal itching, dryness, or discharge.

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

Progesterone Dosing Information

Usual Adult Dose for Amenorrhea:

5 to 10 mg IM for six to eight consecutive days.

400 mg orally for 10 days. Give dose in the evening.

Usual Adult Dose for Uterine Bleeding:

5 to 10 mg IM daily for 6 doses.

Usual Adult Dose for Endometrial Hyperplasia — Prophylaxis:

200 mg orally for 12 consecutive days, per 28 day cycle. Give dose in the evening.

Usual Adult Dose for Progesterone Insufficiency:

Usual Adult Dose for Premature Labor:

Study (n=142) – Reduce Incidence of Spontaneous Preterm Birth in Women at Increased Risk: 100 mg vaginal suppository daily, between 24 and 34 weeks of gestation.

Usual Adult Dose for Seizures:

Usual Adult Dose for Perimenopausal Symptoms:

What other drugs will affect progesterone?

Where can I get more information?

Your pharmacist can provide more information about progesterone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,P

Comments (0)

Progesterone Oil

30/06/10

Generic Name: Progesterone (proe-JES-ter-one)
Brand Name: Generic only. No brands available.

Progesterone Oil is used for:

Treating absent menstrual periods. It may also be used to treat abnormal uterine bleeding caused by hormone imbalance. It may also be used for other conditions as determined by your doctor.

Progesterone Oil is a progestin hormone. It works by restoring a normal balance progesterone. This helps to regulate the menstrual cycle and to stop abnormal uterine bleeding that occurs when the body does not make enough progesterone on its own.

Do NOT use Progesterone Oil if:

you are allergic to progesterone, progesterone-like medicines, benzyl alcohol, or sesame seeds or oil
you have a history of certain blood vessel problems; blood clots (eg, in the legs, lungs, eyes); bleeding in the brain or stroke; liver problems; cancer of the breast, ovary, uterus, cervix, or genitals; undiagnosed vaginal bleeding; or miscarriage
you are pregnant

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

Before using Progesterone Oil:

Tell your health care provider 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 cancer, an abnormal mammogram, fibrocystic breast disease, lumps in the breast, bleeding from your nipples
if you have a history of kidney problems, high blood pressure, migraine headaches, asthma, heart problems, seizures, high blood sugar or diabetes, high cholesterol, or mental or mood problems (eg, depression)
if you have a family history of breast cancer

Some MEDICINES MAY INTERACT with Progesterone Oil. Tell your health care provider if you are taking any of the following medicines.

Rifampin because it may decrease Progesterone Oil’s effectiveness

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

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

An extra patient leaflet is available with Progesterone Oil. Talk to your pharmacist if you have questions about this information.
Progesterone Oil is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using Progesterone Oil at home, a health care provider will teach you how to use it. Be sure you understand how to use Progesterone Oil. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Progesterone Oil if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
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 Progesterone Oil, contact your doctor as soon as possible.

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

Important safety information:

Progesterone Oil may cause drowsiness, dizziness, lightheadedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Oil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Progesterone Oil may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
Progesterone Oil may cause a decrease in the amount of calcium in your bones. A decrease in bone calcium is of most concern if you have the following risk factors: adolescence, bone disease, anorexia nervosa (an eating disorder), a strong family history of osteoporosis, taking certain medicines (eg, for epilepsy or steroids), or drinking a lot of alcohol or smoking cigarettes often. When Progesterone Oil is stopped, the calcium in bones begins to come back. Your health care provider may recommend that you take calcium or vitamin D to help lower the amount of calcium lost from your bones.
Diabetes patients – Progesterone Oil may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Progesterone Oil may interfere with certain lab tests, including urinary steroid levels, gonadotropin and other hormone levels, thyroid function, blood clotting tests, and blood cholesterol. Be sure your doctor and lab personnel know you are using Progesterone Oil.
Lab tests, including breast exams, pap smears, pelvic exams, and blood calcium and bone density tests, may be performed while you use Progesterone Oil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Progesterone Oil should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Progesterone Oil if you are pregnant. If you think you may be pregnant, contact your doctor right away. Progesterone Oil is found in breast milk. If you are or will be breast-feeding while you use Progesterone Oil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Progesterone Oil:

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:

Acne; drowsiness; nausea; pain, redness, and swelling at injection site; trouble sleeping; 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, throat, or tongue); breast pain or tenderness; calf or leg pain or swelling; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; chest pain; coughing up blood; fast or irregular heartbeat; fever; flushing; lumps in the breast; mental or mood changes (eg, anxiety, depression); seizures; severe dizziness or fainting; severe stomach pain; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache or vomiting; swelling of fingers or ankles; unusual weight gain or loss; vision problems (eg, double vision, partial or complete loss of vision); weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Progesterone Oil:

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

General information:

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

This information is a summary only. It does not contain all information about Progesterone Oil. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

Progesterone Gel

30/06/10

Generic Name: Progesterone (pro-JESS-ter-ohn)
Brand Name: Crinone and Prochieve

Progesterone Gel is used for:

Supplementing or replacing progesterone in infertile women with progesterone deficiency. It is also used in certain women who do not menstruate and have not responded to lower strengths of Progesterone Gel. It may also be used for other conditions as determined by your doctor.

Progesterone Gel is a hormone. It works by preparing the uterus (womb) for implantation of a fertilized egg and protecting the lining of the uterus. It is also needed for the maintenance of a healthy pregnancy.

Do NOT use Progesterone Gel if:

you are allergic to any ingredient in Progesterone Gel
you have cancer of the breast , ovary, lining of the uterus, cervix, or vagina; a history of blood clots or clotting problems; vaginal bleeding of unknown cause; or liver disease; or you have had a stroke, a recent miscarriage, or bleeding in the brain

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

Before using Progesterone Gel:

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

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have heart or blood vessel problems, bleeding problems, high blood pressure, high cholesterol or lipid levels, diabetes, kidney problems, asthma, migraine headaches, or lupus
if you have a history of seizures, depression or other mental/mood problems, cancer, or tobacco use
if you have a family history of blood clots
if you are very overweight

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

Rifampin because it may decrease Progesterone Gel’s effectiveness

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

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

An extra patient leaflet is available with Progesterone Gel. Talk to your pharmacist if you have questions about this information.
Review the patient insert for proper preparation and use of the vaginal applicator.
If you miss a dose of Progesterone Gel, 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 Progesterone Gel.

Important safety information:

Progesterone Gel may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Progesterone Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
Do not use Progesterone Gel at the same time as other vaginal therapy without checking with your doctor. If other vaginal therapy is to be used, administer it 6 or more hours before or after Progesterone Gel, unless advised otherwise by your health care provider.
Progesterone Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
Diabetes patients – Progesterone Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Lab tests, including monthly breast self-exams, yearly breast exams, Pap smears, and pelvic exams, may be performed while you use Progesterone Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Progesterone Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Progesterone Gel while you are pregnant. Progesterone Gel is found in breast milk. If you are or will be breast-feeding while you use Progesterone Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Progesterone Gel:

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

Breast enlargement; breast pain; changes in sex drive; constipation; cramps; depression; diarrhea; difficult or painful sexual intercourse; drowsiness; fatigue; fluid retention/bloating; headache; increased appetite; joint pain; nausea; nervousness; pain around vaginal area; sleep disorder; urination at night; vomiting.

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); abnormal vaginal bleeding; breast lumps; calf/leg pain or tenderness; change in emotions, mood, or behavior; chest pain; coughing blood; dizziness; fainting; inflammation of the eye; numbness of arm or leg; one-sided weakness; pain in the groin; partial or complete loss of vision; seizure; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; tremor; unusual vaginal discharge or odor; vaginal itching; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Progesterone Gel:

Store Progesterone Gel at room temperature, below 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Progesterone Gel out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Progesterone Gel. 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: May 5, 2010

Database Edition 10.2.1.002

Med-facts,P

Comments (0)

Profender Topical Solution

30/06/10

Generic Name: praziquantel and emodepside
Dosage Form: FOR ANIMAL USE ONLY

Profender®
(emodepside/praziquantel)
Topical Solution

CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the order of a licensed veterinarian.

Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections in cats and kittens that are at least 8 weeks of age and weigh at least 2.2 lbs (1 kg).

DESCRIPTION:

PROFENDER [1.98% emodepside/7.94% praziquantel] Topical Solution is a clear yellow ready to use solution packaged in single unit dosing applicator tubes for topical (dermal) treatment of cats 8 weeks of age and older and weighing at least 2.2 lbs (1 kg). The formulation and dosage schedule is designed to provide a minimum of 1.36 mg/lb (3 mg/kg) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel based on body weight. Emodepside, a semi-synthetic molecule, is a cyclic depsipeptide. The chemical name is Cyclo [D-2- hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4- morpholinyl)phenyl]-D-2-hydroxypropanoyl- N-methyl-L-leucyl-D-2-hydroxypropanoyl-Nmethyl- L-leucyl-3-[4-(4-morpholinyl)phenyl]- D-2-hydroxypropanoyl-N-methyl-L-leucyl]. Praziquantel is an isoquinoline cestocide. The chemical name is 2-Cyclohexylcarbonyl- 1,2,3,6,7,11b-hexahydro-4H-pyrazine-2,1-a-isoquinoline- 4-one.

INDICATIONS:

Profender Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.

Profender Topical Solution Dosage and Administration

The recommended minimum dose is 1.36 mg/lb (3 mg/kg) emodepside + 5.45 mg/lb (12 mg/kg) praziquantel as a single topical dose. A single treatment is effective and a second treatment should not be necessary. If re-infection occurs, the product can be re-applied after 30 days.

1. Select the package that correctly corresponds with the body weight of the cat. (See Table below.)

Cat Weight*	Profender Topical Solution	Volume (mL)	Emodepside (mg)	Praziquantel (mg)
2.2-5.5 lbs.	Small	0.35	7.5	30.0
>5.5-11 lbs.	Medium	0.70	15.0	60.1
>11-17.6 lbs.	Large	1.12	24.0	96.1

2. Remove one unit dose tube from the package.

3. While holding the tube in an upright position, remove the cap from the tube.

4. Turn the cap over and place the other end of cap onto the tip of the tube.

5. Twist the cap to break the seal and then remove cap from the tube.

6. Part the hair on the back of the cat’s neck at the base of the head, until the skin is visible.

7. To ensure the entire contents of the tube are administered, place the tip of the tube on the skin and squeeze the entire contents directly onto the skin. Lift tube away from the skin before releasing pressure on the tube.

Do not apply to broken skin or if hair coat is wet.

Do not get this product in the cat’s mouth or eyes or allow the cat to lick the application site for one hour. Oral exposure can cause salivation and vomiting. Treatment at the base of the head will minimize the opportunity for ingestion while grooming. In households with multiple pets, keep animals separated to prevent licking of the application site.

Stiff hair, a damp appearance of the hair, or a slight powdery residue may be observed at the treatment site. These effects are temporary and do not affect the safety or effectiveness of the product.

HUMAN WARNINGS:

Not for human use. Keep out of reach of children.

To prevent accidental ingestion of the product, children should not come in contact with the application site for twenty-four (24) hours while the product is being absorbed. Pregnant women, or women who may become pregnant, should avoid direct contact with, or wear disposable gloves when applying, this product. Studies performed in rats and rabbits suggest that emodepside may interfere with fetal development in those species.

Profender Topical Solution may be irritating to skin and eyes. Reactions such as facial, tongue and hand swelling have been reported in humans in rare instances. Avoid contact with the application area while it is wet and wash hands thoroughly with soap and warm water after handling. People with known hypersensitivity to butylhydroxyanisole, emodepside or praziquantel should administer the product with caution. If the product accidentally gets into eyes, flush thoroughly with water. May be harmful if swallowed. In case of accidental ingestion or if skin or eye irritation occurs, call a poison control center or physician for treatment advice.

The Material Safety Data Sheet (MSDS) provides additional occupational safety information. For customer service or to obtain product information, including the MSDS, call 1-800-633-3796. For medical emergencies or to report an adverse reaction, call 1-800-422-9874.

PRECAUTIONS:

Safe use of this product has not been evaluated in cats less than 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy or in lactating queens. The effectiveness of this product when used before bathing has not been evaluated.

Use with caution in sick or debilitated cats. Oral ingestion or exposure should be avoided. Use with caution in heartworm positive cats. The cats enrolled in the field study were heartworm antigen and antibody negative prior to entering the study. In a laboratory study, cats artificially infected with adult heartworms and treated with Profender Topical Solution had fewer worms recovered than the placebo control group. (See ANIMAL SAFETY.:)

ADVERSE REACTIONS:

Field study: In a controlled, double-masked field safety study, owners administered Profender Topical Solution to 606 cats. Adverse reactions reported by the cat owners included licking/ excessive grooming in 18 cats (3.0%), scratching treatment site in 15 cats (2.5%), salivation in 10 cats (1.7%), lethargy in 10 cats (1.7%), alopecia in 8 cats (1.3%), agitation/nervousness in 7 cats (1.2%), vomiting in 6 cats (1.0%), diarrhea in 3 cats (0.5%), eye irritation in 3 cats (0.5%), respiratory irritation in 1 cat (0.2%) and shaking/tremors in 1 cat (0.2%). All adverse reactions were self-limiting.

Laboratory effectiveness studies: One cat died 10 days after receiving Profender Topical Solution. The necropsy showed chronic active cholangiohepatitis. While the use of the drug did not appear to be the direct cause of death, treatment with the drug cannot be ruled out as a contributing factor (See PRECAUTIONS:). One cat treated with a vehicle placebo (formulation minus the active ingredients) showed salivation, gagging, lethargy and a swollen tongue.

Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in foreign markets: application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), salivation, pruritus, lethargy, vomiting, diarrhea, dehydration, ataxia, loss of appetite, facial swelling, rear leg paresis, seizures, hyperesthesia, twitching, and death.

EFFECTIVENESS:

In a total of 13 controlled laboratory studies to establish effectiveness, 149 cats were treated with Profender Topical Solution. In the field study conducted at 13 veterinary clinics/hospitals, 837 purebred or crossbred cats from single and multicat households were enrolled to evaluate safety and effectiveness under field conditions of use. Of those, 606 received a single treatment with Profender Topical Solution. Cats ranged in age between 2 months and 17 years and weighed between 0.8 lbs (0.36 kg) and 21 lbs (9.62 kg). Data from these studies demonstrated Profender Topical Solution is safe and effective for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults).

ANIMAL SAFETY:

In a field study, Profender Topical Solution was used in cats receiving other frequently used products including: analgesics, anti-fungals, nonsteroidal anti-inflammatories, anthelmintics, antimicrobials, flea and tick products, sedatives, anesthetics, cardiac medications, anxiolytics, hormonal treatments, steroids, otic and ophthalmic preparations, and vaccines.

Dose Tolerance Study in Cats: Profender Topical Solution was applied topically one time to young cats at 10X the recommended label use rate. Two cats salivated. Another cat exhibited tremors and lethargy. These signs were self-limiting.

Oral Safety Studies in Cats: Profender Topical Solution was administered orally at the recommended topical dose to young adult cats. The cats exhibited salivation, vomiting, tremors, abnormal gait, abnormal respiration and weight loss. These signs were self-limiting.

General Safety Study in Kittens: Profender Topical Solution was topically applied at 0X (vehicle control), 1X, 3X and 5X the maximum dose to 48 healthy 8-week-old kittens every two weeks for six doses. One 5X kitten experienced salivation and tremors and another 5X kitten experienced salivation on the day of dosing. A third 5X kitten experienced tremors the day after dosing. Three cats vomited within 24 hours of dosing, one each in vehicle control, 3X and 5X groups.

Safety Study in Heartworm Positive Cats: Cats artificially infected with adult heartworms harvested from dogs were treated topically with Profender Topical Solution at 0X, 1X or 5X the recommended dose once a month for three treatments. Clinical signs included salivation (one 1X and three 5X cats), labored breathing (all groups) and lethargy (one 5X cat). At the study conclusion, the 1X and 5X cats had fewer live heartworms recovered than the 0X group.

STORAGE INFORMATION:

Store at or below 77ºF (25ºC).

Protect from freezing.

How is Profender Topical Solution Supplied

Code Number Applications per Package

03615026 40 – 0.35 mL tubes (10 blisters of 4 tubes)

03615034 40 – 0.70 mL tubes (10 blisters of 4 tubes)

03615042 24 – 1.12 mL tubes (6 blisters of 4 tubes)

Profender is protected by the following U.S. Patents:

5 514 773, 5 589 503, and other patents pending.

Made in Germany

NADA 141-275, Approved by FDA

Bayer, the Bayer Cross and Profender are

trademarks of Bayer.

03615026/03615034/03615042, R.0

April, 2007

Bayer HealthCare LLC

Animal Health Division

P.O. Box 390

Shawnee Mission, Kansas 66201 U.S.A.

Principal Display Panel

PROFENDER
emodepside/praziquantel solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	68823-0234
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAZIQUANTEL (PRAZIQUANTEL)	PRAZIQUANTEL	30 mg in 0.35 mL
EMODEPSIDE (EMODEPSIDE)	EMODEPSIDE	7.5 mg in 0.35 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	68823-0234-7	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		4 TUBE In 1 BLISTER PACK	This package is contained within the BOX (68823-0234-7) and contains a TUBE
1		0.35 mL In 1 TUBE	This package is contained within a BLISTER PACK and a BOX (68823-0234-7)
2	68823-0234-8	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		4 TUBE In 1 BLISTER PACK	This package is contained within the BOX (68823-0234-8) and contains a TUBE
2		0.70 mL In 1 TUBE	This package is contained within a BLISTER PACK and a BOX (68823-0234-8)
3	68823-0234-9	6 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		4 TUBE In 1 BLISTER PACK	This package is contained within the BOX (68823-0234-9) and contains a TUBE
3		1.12 mL In 1 TUBE	This package is contained within a BLISTER PACK and a BOX (68823-0234-9)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141275	06/29/2007

Labeler - Bayer HealthCare LLC Animal Health Division (320324445)

Registrant - Bayer HealthCare LLC Animal Health Divisions (152266193)

Revised: 05/2009Bayer HealthCare LLC Animal Health Division

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