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Wednesday, 18 April 2012

Cenestin

Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)

Commonly used brand name(s)

In the U.S.

Alora

Cenestin

Climara

Divigel

Elestrin

Emcyt

Enjuvia

Esclim

Estinyl

EstroGel

Evamist

Femtrace

Gynodiol

Menest

Menostar

Ogen .625

Ogen 1.25

Ogen 2.5

Premarin

Vivelle

Vivelle-Dot

In Canada

Estraderm

Estradot Transdermal

Estradot Transdermal Therapeutic System

Estradot Transdermal Therapeutic System

Estrogel

Oesclim

Rhoxal-Estradiol Derm 50

Rhoxal-Estradiol Derm 75

Roxal-Estradiol Derm 100

Vivelle 100 Mcg

Vivelle 25 Mcg

Available Dosage Forms:

Tablet

Patch, Extended Release

Gel/Jelly

Spray

Emulsion

Tablet, Enteric Coated

Capsule

Uses For Cenestin

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).

To help prevent weakening of bones (osteoporosis) in women past menopause.

In the treatment of selected cases of breast cancer in men and women.

In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:

Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.

Osteoporosis caused by lack of estrogen before menopause.

Turner's syndrome (a genetic disorder).

Before Using Cenestin

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

Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

Interactions with Medicines

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

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

Rotavirus Vaccine, Live

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.

Adenovirus Vaccine Type 4, Live

Adenovirus Vaccine Type 7, Live

Bacillus of Calmette and Guerin Vaccine, Live

Boceprevir

Felbamate

Influenza Virus Vaccine, Live

Isotretinoin

Measles Virus Vaccine, Live

Mumps Virus Vaccine, Live

Paclitaxel

Paclitaxel Protein-Bound

Rotavirus Vaccine, Live

Rubella Virus Vaccine, Live

Smallpox Vaccine

St John's Wort

Theophylline

Tizanidine

Tranexamic Acid

Typhoid Vaccine

Varicella Virus Vaccine

Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of estrogen

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

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, 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.

This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

For patients taking any of the estrogens by mouth or by injection:

Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):

Wash and dry your hands thoroughly before and after handling the patch.

Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.

Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.

Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.

If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.

Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):

Washing and drying hands thoroughly before each application.

Apply while you are sitting comfortably. Apply one pouch to each leg every morning.

Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

Rub any remaining emulsion on both hands on the buttocks.

Washing and drying hands thoroughly after application.

To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:

Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.

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

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

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

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 conjugated estrogens

For oral dosage form (tablets):
- For treating breast cancer in women after menopause and in men:
  - Adults—10 milligrams (mg) three times a day for at least 3 months.
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
- To prevent loss of bone (osteoporosis):
  - Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
- For treating ovary problems (female hypogonadism or for starting puberty):
  - Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.
- For treating ovary problems (failure or removal of both ovaries):
  - Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating prostate cancer:
  - Adults—1.25 to 2.5 milligram (mg) three times a day.

For injection dosage form:
- For controlling abnormal bleeding of the uterus:
  - Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.

For esterified estrogens

For oral dosage form (tablets):
- For treating breast cancer in women after menopause and in men:
  - Adults—10 milligrams (mg) three times a day for at least three months.
- For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
  - Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating ovary problems (failure or removal of both ovaries):
  - Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating ovary problems (female hypogonadism):
  - Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating symptoms of menopause:
  - Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating prostate cancer:
  - Adults—1.25 to 2.5 mg three times a day.

For estradiol

For oral dosage form:
- For treating breast cancer in women after menopause and in men:
  - Adults—10 milligrams (mg) three times a day for at least 3 months.
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
  - Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.
- For treating prostate cancer:
  - Adults—1 to 2 milligrams (mg) three times a day.
- To prevent loss of bone (osteoporosis):
  - Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

For topical emulsion dosage form (skin lotion):
- For treating symptoms of menopause:
  - Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.

For transdermal dosage form (skin patches):
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
  - For the Climara patches
  - Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
  - For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
  - Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

For estradiol cypionate

For injection dosage form:
- For treating ovary problems (female hypogonadism):
  - Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
- For treating symptoms of menopause:
  - Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.

For estradiol valerate

For injection dosage form:
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.
- For treating prostate cancer:
  - Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.

For estrone

For injection dosage form:
- For controlling abnormal bleeding of the uterus:
  - Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
- For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
- For treating prostate cancer:
  - Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.

For estropipate

For oral dosage form (tablets):
- For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
  - Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
- To prevent loss of bone (osteoporosis):
  - Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.

For ethinyl estradiol

For oral dosage form (tablets):
- For treating breast cancer in women after menopause and in men:
  - Adults—1 milligram (mg) three times a day.
- For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
  - Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.
- For treating prostate cancer:
  - Adults—0.15 to 3 milligrams (mg) a day.
- For treating symptoms of menopause:
  - Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

For ethinyl estradiol and norethindrone

For oral dosage form (tablets):
- For treating symptoms of menopause:
  - Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
- To prevent loss of bone (osteoporosis):
  - Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.

Missed Dose

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

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

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Cenestin

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.

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

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

Cenestin Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

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.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

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

More common

Breast pain (in females and males)

fast heartbeat

fever

hives

hoarseness

increased breast size (in females and males)

irritation of the skin

itching of the skin

joint pain, stiffness, or swelling

rash

redness of the skin

shortness of breath

swelling of the eyelids, face, lips, hands, or feet

swelling of the feet and lower legs

tightness in the chest

troubled breathing or swallowing

weight gain (rapid)

wheezing

Less common or rare

Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)

chest pain

chills

cough

heavy non-menstrual vaginal bleeding

lumps in, or discharge from, breast (in females and males)

pains in the stomach, side, or abdomen

yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only

Headache (sudden or severe)

loss of coordination (sudden)

loss of vision or change of vision (sudden)

pains in the chest, groin, or leg, especially in the calf of leg

shortness of breath (sudden and unexplained)

slurring of speech (sudden)

weakness or numbness in the arm or leg

Incidence not known

Abdominal or stomach bloating

abdominal or stomach cramps

acid or sour stomach

anxiety

backache

belching

blindness

blistering, peeling, or loosening of the skin

blue-yellow color blindness

blurred vision

change in vaginal discharge

changes in skin color

changes in vision

chest discomfort

clay-colored stools

clear or bloody discharge from nipple

confusion

constipation

convulsions

dark urine

decrease in the amount of urine

decreased vision

depression

diarrhea

difficulty with breathing

difficulty with speaking

dimpling of the breast skin

dizziness

double vision

dry mouth

eye pain

fainting

fluid-filled skin blisters

full feeling in upper abdomen or stomach

full or bloated feeling or pressure in the stomach

headache

heartburn

inability to move the arms, legs, or facial muscles

inability to speak

incoherent speech

increased urination

indigestion

inverted nipple

irregular heartbeats

light-colored stools

lightheadedness

loss of appetite

loss of bladder control

lump under the arm

metallic taste

migraine headache

mood or mental changes

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

muscle pain

muscle spasm or jerking of all extremities

muscle weakness

nausea

noisy breathing

numbness or tingling of the hands, feet, or face

pain in the ankles or knees

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

pain or feeling of pressure in the pelvis

pain, tenderness, swelling of the foot or leg

painful or tender cysts in the breasts

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

pains in the chest, groin, or legs, especially calves of the legs

partial or complete loss of vision in the eye

pelvic pain

persistent crusting or scaling of nipple

pinpoint red or purple spots on the skin

prominent superficial veins over affected area

red, irritated eyes

redness or swelling of the breast

sensitivity to the sun

severe headaches of sudden onset

skin thinness

skin warmth

slow speech

sore on the skin of the breast that does not heal

sore throat

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

stomach discomfort, upset, or pain

sudden loss of consciousness

sudden loss of coordination

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

sudden vision changes

swelling of the abdominal or stomach area

swelling of the fingers or hands

thirst

tremor

unpleasant breath odor

unusual tiredness or weakness

vomiting

vomiting of blood

weight loss

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

Abnormal growth filled with fluid or semisolid material

accidental injury

bladder pain

bloated full feeling

bloody or cloudy urine

body aches or pain

coating or white patches on tongue

congestion

cough producing mucus

decrease in amount of urine

difficult, burning, or painful urination

discouragement

dryness of the throat

ear congestion or pain

excess air or gas in the stomach or intestines

fear

feeling of warmth

feeling sad or empty

frequent urge to urinate

general feeling of discomfort or illness

headache, severe and throbbing

increased clear or white vaginal discharge

irritability

itching of the vaginal, rectal or genital areas

lack of appetite

lack or loss of strength

loss of interest or pleasure

mild dizziness

neck pain

nervousness

pain

pain during sexual intercourse

painful or difficult urination

pain or tenderness around the eyes and cheekbones

passing gas

redness of the face, neck, arms, and occasionally, upper chest

runny nose

skin irritation or redness where skin patch was worn

shivering

sleeplessness

sneezing

sore mouth or tongue

stuffy nose

sudden sweating

tender, swollen glands in the neck

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

tiredness

trouble concentrating

trouble sleeping

unable to sleep

voice changes

Less common

Blemishes on the skin

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

burning or stinging of the skin

diarrhea (mild)

difficulty with moving

dizziness (mild)

increased hair growth, especially on the face

lower abdominal or stomach pain or pressure

mood or mental changes

muscle stiffness

painful cold sores or blisters on the lips, nose, eyes, or genitals

pimples

pounding in the ears

problems in wearing contact lenses

slow heartbeat

tooth or gum pain

unusual decrease in sexual desire (in males)

unusual increase in sexual desire (in females)

white or brownish vaginal discharge

Incidence not known

Abnormal turning out of cervix

changes in appetite

dull ache or feeling of pressure or heaviness in the legs

flushed, dry skin

fruit-like breath odor

increased hunger

irritability

large amount of triglyceride in the blood

leg cramps

patchy brown or dark brown discoloration of the skin

poor insight and judgment

problems with memory or speech

trouble recognizing objects

trouble thinking and planning

trouble walking

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

unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of the scalp hair in some people.

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.

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Monday, 16 April 2012

Availnex Chewable Tablets

Pronunciation: KAR-boe-SIS-te-een
Generic Name: Carbocysteine
Brand Name: Availnex

Availnex Chewable Tablets are used for:

Dietary management of patients with pulmonary oxidative stress, especially patients with chronic obstructive pulmonary disease (COPD).

Availnex Chewable Tablets are a medical food. It helps to increase antioxidants in the body.

Do NOT use Availnex Chewable Tablets if:

you are allergic to any ingredient in Availnex Chewable Tablets, including soy

you are breast-feeding

the patient is an infant

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

Before using Availnex Chewable Tablets:

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

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

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

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

if you have or have had an ulcer in the stomach or intestines

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

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

How to use Availnex Chewable Tablets:

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

Take Availnex Chewable Tablets by mouth before eating or with a meal.

Chew Availnex Chewable Tablets well or allow it to dissolve completely in your mouth before swallowing.

Drinking extra fluids while you are taking Availnex Chewable Tablets are recommended. Check with your doctor for instructions.

Continue to take Availnex Chewable Tablets even if you feel well. Do not miss any doses.

If you miss a dose of Availnex Chewable Tablets, 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 Availnex Chewable Tablets.

Important safety information:

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

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

Availnex Chewable Tablets should not be used in INFANTS; safety and effectiveness in infants 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 Availnex Chewable Tablets while you are pregnant. Do not breast-feed while taking Availnex Chewable Tablets.

Possible side effects of Availnex Chewable Tablets:

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

Diarrhea; nausea; stomach upset.

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); blood in the stools; irregular heartbeat; symptoms of low blood sugar (eg, dizziness, drowsiness, fainting, weakness, increased hunger, increased sweating, headache, chills, tremors); vomit that looks like blood or coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Availnex side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Availnex Chewable Tablets:

Store Availnex Chewable Tablets 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 Availnex Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Availnex Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

Availnex Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Availnex resources

Availnex Side Effects (in more detail)
Availnex Use in Pregnancy & Breastfeeding
Availnex Support Group
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Saturday, 14 April 2012

Gentak Ointment

Pronunciation: jen-ta-MYE-sin
Generic Name: Gentamicin
Brand Name: Gentak

Gentak Ointment is used for:

Treating surface eye infections caused by certain bacteria.

Gentak Ointment is a topical antibiotic. It works by slowing the growth of, or killing, sensitive bacteria.

Do NOT use Gentak Ointment if:

you are allergic to any ingredient in Gentak Ointment

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

Before using Gentak Ointment:

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

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

Ask your health care provider if Gentak Ointment 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 Gentak Ointment:

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

Gentak Ointment may be used around the eye or in the eye, as directed by your doctor. To use Gentak Ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Gentak Ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.

To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

Do not wear contact lenses while you are using Gentak Ointment. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.

Gentak Ointment is only for the eye. Do not get it in your nose or mouth.

To clear up your infection completely, use Gentak Ointment for the full course of treatment. Keep using it even if you feel better in a few days.

Using Gentak Ointment at the same times each day will help you to remember to use it.

If you miss a dose of Gentak Ointment, 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 Gentak Ointment.

Important safety information:

Gentak Ointment may cause blurred vision. Use Gentak Ointment with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Gentak Ointment 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.

Be sure to use Gentak Ointment for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Gentak Ointment may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

Do not use Gentak Ointment for future eye problems without checking with your doctor.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gentak Ointment while you are pregnant. If you are or will be breast-feeding while you use Gentak Ointment, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gentak Ointment:

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:

Bloodshot eye; burning or stinging of the eye.

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); delayed healing of the cornea; hallucinations; redness, itching or swelling of the eyelids; ulcers of the cornea.

See also: Gentak side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Gentak Ointment:

Store Gentak Ointment 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, light, and moisture. Do not freeze. Keep Gentak Ointment out of the reach of children and away from pets.

General information:

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

Gentak Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Gentak resources

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

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Conjunctivitis, Bacterial

Friday, 13 April 2012

Sulfacetamide

Dosage Form: Ophthalmic Ointment

STERILE

Rx only

Sulfacetamide Description

Sulfacetamide Sodium Ointment USP, 10%, is a sterile, topical anti-bacterial agent for ophthalmic use. Each gram contains Sulfacetamide Sodium USP, 100 mg in an ointment base of white petrolatum and mineral oil.

Sulfacetamide sodium is an odorless, white, crystalline powder. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in benzene, chloroform, and ether. Chemically it is N-sulfanilylacetamide monosodium salt monohydrate, and is represented by the following structural formula:

Sulfacetamide - Clinical Pharmacology

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeroginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

Indications and Usage for Sulfacetamide

For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms:

Escherichia coli, Staphylococcus aureus, Staphylococcus pneumonia, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Contraindications

Hypersensitivity to sulfonamides or to any ingredient of the preparation.

Warnings

FOR TOPICAL EYE USE ONLY-NOT FOR INJECTION.

FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

Precautions

General: Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.

Ophthalmic ointments may retard corneal wound healing.

The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in the purulent exudates. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.

At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS).

Information for patients: To avoid contamination, do not touch tip of container to eye, eyelid or any surface.

Drug Interactions: Sulfacetamide preparations are incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered Sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy:Teratogenic effects. Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in children below the age of two months have not been established.

Adverse Reactions

Bacterial and fungal corneal ulcers have been developed during treatment with sulfonamide ophthalmic preparations.

The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).

Sulfacetamide Dosage and Administration

For conjunctivitis and other superficial ocular infections: Apply a small amount (approximately one-half inch ribbon) into the conjunctival sac(s) of the affected eye(s) every three to four hours and at bedtime. Dosages may be tapered by increasing the time interval between doses as the condition responds. The ointment may be used as adjunct to the solution. The usual duration of treatment is seven to ten days.

How is Sulfacetamide Supplied

Sulfacetamide Sodium Ophthalmic Ointment USP, 10%, is supplied in 3.5 gram

(1/8 Oz) sterile, tamperproof tubes, NDC 0168-0079-38

Store at controlled room temperature 15°-30°C (59°-86°F).

E. FOUGERA & CO.

a division of Altana Inc.

MELVILLE, NEW YORK 11747

I27938D

#19

R3/98

Sulfacetamide SODIUM
Sulfacetamide sodium ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0168-0079
Route of Administration	OPHTHALMIC	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Sulfacetamide Sodium (Sulfacetamide)	Active	100 MILLIGRAM In 1 GRAM
white petrolatum	Inactive
mineral oil	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0168-0079-38	3.5 g (GRAM) In 1 TUBE	None

Revised: 03/2007E. FOUGERA & CO.

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Conjunctivitis
Trachoma

Wednesday, 11 April 2012

Bonefos Capsules

1. Name Of The Medicinal Product

Bonefos Capsules.

2. Qualitative And Quantitative Composition

Pale yellow, hard gelatin capsules, printed 'BONEFOS' in black and containing 500 mg sodium clodronate tetrahydrate, equivalent to 400 mg anhydrous sodium clodronate.

3. Pharmaceutical Form

Capsules for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

BONEFOS Capsules are indicated for the management of osteolytic lesions, hypercalcaemia and bone pain associated with skeletal metastases in patients with carcinoma of the breast or multiple myeloma.

BONEFOS Capsules are also indicated for the maintenance of clinically acceptable serum calcium levels in patients with hypercalcaemia of malignancy initially treated with an intravenous bisphosphonate.

4.2 Posology And Method Of Administration

Adequate fluid intake should be maintained during treatment.

Adults:

A daily dose of 1600 mg should be taken as a single dose. When higher daily doses are used, the part of the dose exceeding 1600 mg should be taken separately (as a second dose) as recommended below.

The single daily dose and the first dose of two should preferably be taken in the morning on an empty stomach together with a glass of water. The patient should then refrain from eating, drinking (other than plain water), and taking any other oral drugs for one hour.

When twice daily dosing is used, the first dose should be taken as recommended above. The second dose should be taken between meals, more than two hours after and one hour before eating, drinking (other than plain water), or taking any other oral drugs.

Clodronate should in no case be taken with milk, food or drugs containing calcium or other divalent cations because they impair the absorption of clodronate.

The oral bioavailability of bisphosphonates is poor. Bioequivalence studies have shown appreciable differences in bioavailability between different oral formulations of sodium clodronate, as well as marked inter- and intra-patient variability. Dose adjustment may be required if the formulation is changed.

Dose adjustment is not recommended when switching between BONEFOS capsule and tablet formulations (please refer to the pharmacokinetics section below for additional information).

Renal impairment:

Clodronate is eliminated mainly via the kidneys. Therefore, it should be used with caution in patients with renal failure; daily doses exceeding 1600mg should not be used continuously.

In patients with mild renal failure (50 – 80 ml/min) no dose reduction is recommended.

In patients with moderate renal impairment (creatinine clearance between 10 and 30 ml/min), the daily dose should be reduced to half the adult dose, i.e. 800 mg sodium clodronate. Sodium clodronate is contra-indicated in patients with creatinine clearance below 10 ml/min.

Children:

BONEFOS has not been evaluated in children.

Elderly:

There are no special dosage recommendations in the elderly. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

4.3 Contraindications

Bonefos Capsules are contraindicated in patients with severe renal failure (creatinine clearance below 10ml/min), hypersensitivity to the active substance or to any of the excipients and in patients receiving concomitant treatment with other bisphosphonates.

4.4 Special Warnings And Precautions For Use

Patients with renal insufficiency

BONEFOS Capsules should be administered with care to patients with renal insufficiency. It is recommended that appropriate monitoring of hydration status and renal function with serum creatinine measurement be carried out during treatment. Serum calcium should be monitored periodically.

Dental conditions and osteonecrosis of the jaw

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.

Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

Atypical fractures of the femur

Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.

During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of other bisphosphonates is contraindicated. Patients receiving NSAIDs in addition to sodium clodronate have developed renal dysfunction. However, a synergistic action has not been established. As aminoglycosides can cause hypocalcaemia concomitant clodronate should be administered with caution.

Concomitant use of estramustine phosphate with clodronate has been reported to increase the serum concentration of estramustine phosphate by 80% at the maximum.

Bonefos forms complexes with divalent metal ions, and therefore simultaneous administration with food, antacids and mineral supplements may impair absorption.

4.6 Pregnancy And Lactation

There are limited amount of data from the use of clodronate in pregnant women. Bonefos is not recommended during pregnancy and in women of childbearing potential not using effective contraception. Although in animals clodronate passes through the placental barrier it is not known if it passes into the fetus in humans. Furthermore, it is not known if clodronate can cause fetal damage or affect reproduction in humans. Studies in animals have shown reproductive toxicity (see section 5.3).

It is unknown whether clodronate is excreted in human milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatement with Bonefos.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The most common reported drug reaction is diarrhoea which is usually mild and occurs more commonly with higher doses.

These adverse reactions may occur when using Bonefos:

System Organ Class	Common	Rare	Frequency unknown
Metabolism and nutrition disorders	Asymptomatic hypocalcemia	Symptomatic hypocalcemia. Increased levels of serum parathyroid hormone associated with decreased serum calcium levels. Increased levels of serum alkaline phosphatase*
Gastrointestinal disorders	Diarrhoea Nausea Vomiting**
Hepatobiliary disorders	Levels of transaminases increased - usually within normal range	Levels of transaminases increased to more than twice the normal range without associated abnormal hepatic function
Skin and subcutaneous tissue disorders		Hypersensitivity reaction manifesting as skin reaction e.g. pruritus, urticaria, exfoliative dermatitis
Respiratory, thoracic and mediastinal disorders		Bronchospasm in patients with and without a previous history of asthma.	Impairment of respiratory function in patients with aspirin-sensitive asthma. Hypersensitivity reactions manifesting as respiratory disorder.
Renal and urinary disorders			Impairment of renal function (elevation of serum creatinine and proteinuria), severe renal damage. Single cases of renal failure, in rare cases with fatal outcome, especially with concomitant use of NSAIDs, most often diclofenac.
Musculoskeletal and connective tissue disorders		Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction; from post-marketing experience)	Isolated cases of osteonecrosis of the jaw, primarily in patients previously treated with amino-bisphosphonates such as zoledronate and pamidronate (see Section 4.4). Severe bone, joint and/or muscle pain has been reported in patients taking Bonefos. However, such reports have been infrequent and in randomised placebo controlled studies no differences are apparent between placebo and Bonefos treated patients. The onset of symptoms varied from days to several months after starting Bonefos.

* in patients with metastatic disease, may also be due to hepatic and bone disease.

** usually mild – use of the divided dose regimen rather than a single daily dose may improve gastro-intestinal tolerance.

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

4.9 Overdose

Symptoms:

Increases in serum creatinine and renal dysfunction have been reported with high intravenous doses of clodronate. It is theoretically possible that hypocalcaemia may develop up to 2 or 3 days following the overdose.

Treatment:

Treatment of overdose should be symptomatic. Adequate hydration should be ensured, and renal function and serum calcium should be monitored. Serum calcium should be monitored and oral or parenteral calcium supplementation may be needed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Clodronate is a bisphosphonate (formerly diphosphonate), a group of analogues of pyrophosphate which have been shown, in vitro, to inhibit the formation and dissolution of calcium phosphate (hydroxyapatite). In vivo, they have been shown to inhibit bone resorption to a greater or lesser extent, depending on the compound , and clodronate is one of the most effective in this respect.

5.2 Pharmacokinetic Properties

Absorption

As with other bisphosphonates, the gastrointestinal absorption of clodronate is low, about 2%. The absorption of clodronate is rapid, the peak serum concentration after a single oral dose is reached within 30 minutes. Due to the strong affinity of clodronate for calcium and other divalent cations, the absorption is negligible when clodronate is taken with meals or drugs containing divalent cations. In a study, where clodronate administration 2 h before breakfast was used as the reference treatment, a dose-breakfast interval of 1 h or 0.5 h decreased the bioavailability of clodronate, but the difference was not statistically significant (relative bioavailability 91% and 69%, respectively). In addition, there is large inter- and intraindividual variation in the gastrointestinal absorption of clodronate. Despite the large intraindividual variation in the absorption of clodronate, the exposure to clodronate remains constant during long-term treatment.

Distribution and elimination

The plasma protein binding of clodronate is low, and the distribution volume is 20-50 l. The elimination of clodronate from serum is characterized by two clearly distinguished phases: the distribution phase with a half-life of about 2 hours, and an elimination phase which is very slow because clodronate is strongly bound to bone. Clodronate is mainly eliminated via the kidneys. About 80% of the absorbed clodronate appears in urine during a follow-up of a few days. The substance which is bound to bone (about 20% of the absorbed amount) is excreted more slowly, and the renal clearance is about 75% of the plasma clearance.

Clodronate is removed by haemodialysis. The dose studied is 300mg given by slow infusion 2 h before haemodialysis. 35% of clodronate dose collected in the 4 h dialysate. No other doses were studied. Furthermore, as stated by the authors: “Bone uptake of clodronate and presumably clinical effectivity decreased with a dose reduction of clodronate”.

Characteristics in patients

Because clodronate affects bone there is no clear relationship between plasma or blood concentrations of clodronate and the therapeutic activity or with adverse drug reactions. Apart from renal insufficiency, which decreases the renal clearance of clodronate, the pharmacokinetic profile is not affected by any known factor related to age, drug metabolism or other pathological conditions.

Data from a bioequivalence study show that, based on serum clodronate concentrations, the relative bioavailability of the tablet formulation is 91% (90% confidence interval 76-107%) of that of the capsule formulation. Urinary excretion of clodronate from one Bonefos 800 mg tablet is 92% (90% confidence interval 80-107%) of that of two Bonefos 400 mg capsules.

5.3 Preclinical Safety Data

Systemic tolerance:

Repeated dose oral and intravenous toxicity studies in rats and mini-pigs up to 6 to 12 months duration respectively have been performed. . At oral daily doses up to 480 mg/kg in rats and 800 mg/kg in mini-pigs no test substance related mortality was noted. In these studies, the effect of clodronate was observed in the following organs (the observed changes within brackets): bone (sclerosis related to the pharmacological effects of clodronate), gastrointestinal tract (irritation), blood (lymphopenia, effects on hemostasis), kidneys (dilated tubules, proteinuria), and liver (elevation of serum transaminases).

Reproduction toxicity:

In reproductive toxicity studies in the rat, clodronate at exposures at or below clinical exposure levels caused maternal mortality around the time of parturition and is believed to be as a result of hypocalcaemia. In teratology studies in rats and rabbits at oral daily dosages of 200 mg/kg and 300mg/kg respectively (0.5 to 2 times the maximum clinical dose based on body surface area, mg/m²), no adverse or teratogenic effects were observed in the offspring. At higher doses associated with maternal toxicity, there was reduced litter size in the rabbit and a reduction in foetal body weight, reduced ossification and renal pelvis dilation in the rat.

In fertility studies in the rat, clodronate 600 mg/kg/day in males was associated with reduced body weight, lesions in the testes and epididymides and reduced mating performance.

After one month of subcutaneous administration of clodronate to newborn rats, skeletal changes resembling osteopetrosis were found, which are related to the pharmacological effects of clodronate.

Carcinogenicity:

Clodronate has not shown genotoxic potential. No carcinogenic effects have been observed in long term studies with rats and mice.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium stearate, colloidal silica, lactose and talc. The capsule shell contains gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

6.2 Incompatibilities

None stated.

6.3 Shelf Life

The shelf life expiry date for this product shall not exceed 5 years from the date of its manufacture.

6.4 Special Precautions For Storage

BONEFOS Capsules should be stored below 25 °C.

6.5 Nature And Contents Of Container

Bonefos capsules are packaged in HDPE containers or clear PVC/aluminium blister packs.

Registered pack sizes are 28, 30, 100, 112 and 120 capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berks RG14 1JA

Trading as Bayer plc, Bayer Schering Pharma

8. Marketing Authorisation Number(S)

PL 00010/0521

9. Date Of First Authorisation/Renewal Of The Authorisation

01 May 2008

10. Date Of Revision Of The Text

16 August 2011

LEGAL CATEGORY

POM

Monday, 9 April 2012

Insulin Lispro Vials

Pronunciation: IN-su-lin LIS-pro
Generic Name: Insulin Lispro
Brand Name: Humalog

Insulin Lispro Vials are used for:

Treating diabetes mellitus. Insulin Lispro Vials are usually used with a longer-acting insulin or insulin pump therapy. In some patients, it may be used with a sulfonylurea antidiabetic instead of a longer-acting insulin.

Insulin Lispro Vials are a fast-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Lispro Vials if:

you are allergic to any ingredient in Insulin Lispro Vials

you are having an episode of low blood sugar

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

Before using Insulin Lispro Vials:

Some medical conditions may interact with Insulin Lispro Vials. 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 drink alcoholic beverages or smoke

if you have kidney or liver problems; nerve problems; adrenal, pituitary or thyroid problems; or diabetic ketoacidosis

if you use 3 or more insulin injections per day

if you are fasting, have high blood sodium levels, or are on a low salt diet

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

Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs

Angiotensin-converting (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased

Corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Lispro Vials's effectiveness, resulting in high blood sugar

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

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

An extra patient leaflet is available with Insulin Lispro Vials. Talk to your pharmacist if you have questions about this information.

Use Insulin Lispro Vials within 15 minutes before or immediately after a meal, unless directed otherwise by your doctor.

If you will be using Insulin Lispro Vials at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Lispro Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

You may use Insulin Lispro Vials in an insulin pump if you are directed to do so by your doctor. If you are using an insulin pump, do NOT dilute Insulin Lispro Vials or mix it together with any other type of insulin.

Insulin Lispro Vials should be clear and colorless. Do not use Insulin Lispro Vials if it contains particles, is cloudy and discolored, or if the vial is cracked or damaged.

If you are mixing Insulin Lispro Vials with another insulin, draw Insulin Lispro Vials into the syringe first. Inject the dose immediately after mixing, as directed by your doctor.

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

Injection sites within an injection area (abdomen, thigh, upper arm) must be rotated from one injection to the next.

Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.

Insulin Lispro Vials begins lowering blood sugar within minutes after an injection. The peak effect occurs within 30 to 90 minutes after a dose. The effect lasts for up to 2 to 5 hours.

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.

It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you should ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Lispro Vials.

Important safety information:

Insulin Lispro Vials may cause dizziness, drowsiness, or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Lispro Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing high or low blood sugar.

Do not use more than the recommended dose, use Insulin Lispro Vials more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.

Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.

Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.

Tell your doctor or dentist that you take Insulin Lispro Vials before you receive any medical or dental care, emergency care, or surgery.

If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.

Carry an ID card at all times that says you have diabetes.

An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If not treated, loss of consciousness, coma, or death may occur. If these symptoms occur, tell your doctor right away.

Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.

Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Lispro Vials.

Lab tests, including fasting blood glucose levels and hemoglobin A_1c levels, may be performed while you use Insulin Lispro Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Insulin Lispro Vials with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.

Insulin Lispro Vials should be used with extreme caution in CHILDREN younger than 3 years old; safety and effectiveness in these 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 Insulin Lispro Vials while you are pregnant. It is not known if Insulin Lispro Vials are found in breast milk. If you are or will be breast-feeding while you use Insulin Lispro Vials, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Lispro Vials:

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:

Redness, swelling, itching, or mild pain at the injection site.

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; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness; wheezing.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Lispro Vials:

Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Lispro Vials. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Insulin Lispro Vials has been frozen or overheated, throw it away. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.

Avoid temperatures above 98.6 degrees F (37 degrees C). Do not leave Insulin Lispro Vials in a car on a warm or sunny day. Do not use Insulin Lispro Vials after the expiration date stamped on the label. Keep Insulin Lispro Vials, as well as syringes and needles, out of the reach of children and away from pets. If you are using Insulin Lispro Vials in an insulin pump, or if Insulin Lispro Vials has been mixed with other medicines or diluted, you may need to store it differently. Ask your doctor, pharmacist, or other health care provider how to store Insulin Lispro Vials.

General information:

If you have any questions about Insulin Lispro Vials, please talk with your doctor, pharmacist, or other health care provider.

Insulin Lispro Vials are to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Insulin Lispro resources

Insulin Lispro Use in Pregnancy & Breastfeeding
Insulin Lispro Drug Interactions
Insulin Lispro Support Group
4 Reviews for Insulin Lispro - Add your own review/rating

Compare Insulin Lispro with other medications

Diabetes, Type 1
Diabetes, Type 2

Wednesday, 18 April 2012

Cenestin

Commonly used brand name(s)

Uses For Cenestin

Before Using Cenestin

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of estrogen

Dosing

Missed Dose

Storage

Precautions While Using Cenestin

Cenestin Side Effects

Monday, 16 April 2012

Availnex Chewable Tablets

Availnex Chewable Tablets are used for:

Do NOT use Availnex Chewable Tablets if:

Before using Availnex Chewable Tablets:

How to use Availnex Chewable Tablets:

Important safety information:

Possible side effects of Availnex Chewable Tablets:

If OVERDOSE is suspected:

General information:

More Availnex resources

Saturday, 14 April 2012

Gentak Ointment

Gentak Ointment is used for:

Do NOT use Gentak Ointment if:

Before using Gentak Ointment:

How to use Gentak Ointment:

Important safety information:

Possible side effects of Gentak Ointment:

If OVERDOSE is suspected:

General information:

More Gentak resources

Compare Gentak with other medications

Friday, 13 April 2012

Sulfacetamide

Sulfacetamide Description

Sulfacetamide - Clinical Pharmacology

Indications and Usage for Sulfacetamide

Contraindications

Warnings

Precautions

Adverse Reactions

Sulfacetamide Dosage and Administration

How is Sulfacetamide Supplied

More Sulfacetamide resources

Compare Sulfacetamide with other medications

Wednesday, 11 April 2012

Bonefos Capsules

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container