Apomorphine (a-poe-MOR-feen) is used to treat Parkinson’s disease, sometimes referred to as *??shaking palsy.*?? By improving muscle control and reducing stiffness, this medicine allows more normal movements of the body as the disease symptoms are reduced.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to apomorphine. Also tell your doctor and pharmacist if you are allergic to sulfites, *??sulfa*?? containing medicines or any other substances, such as foods, preservatives, or dyes.

Pregnancy: Apomorphine has not been studied in pregnant women. However, studies in animals have shown that apomorphine causes birth defects or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known whether apomorphine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of apomorphine in children with use in other age groups.

Older adults: Confusion, hallucinations, falls causing bone and joint injuries, heart, lung, or stomach problems may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of apomorphine.

Other 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 apomorphine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol: Should be avoided while using this medicine; may add to the effects that apomorphine has on blood pressure

• Alosetron (e.g., Lotronex) or
• Dolasetron (e.g., Anzemet) or
• Granisetron (e.g., Kytril) or
• Ondansetron (e.g., Zofran) or
• Palonosetron (e.g., Aloxi): Should NOT be used with this medicine; could cause severe low blood pressure and loss of consciousness

• Antihypertensives (high blood pressure medicines) or
• Vasodilators (medicines that widen blood vessels which increases blood flow such as diazoxide [e.g., Hyperstat], hydralazine [e.g., Apresoline], nitroprusside [e.g., Nipride]): Extra caution should be used. Using these together with apomorphine may effect blood pressure more than taking apomorphine alone.

• Dopamine antagonists (drugs used for psychiatric problems such as chlorpromazine [e.g., Thorazine], haloperidol [e.g., Haldol], metoclopramide [e.g., Reglan], thiothixene [e.g., Navane]): May cause apomorphine to not work as well

• Dyskinesia (difficulty performing voluntary movements without tics and spasms): May be worsened by apomorphine

• Heart disease or problems or
• Hypokalemia (abnormally low potassium in the blood) or
• Hypomagnesemia (abnormally low magnesium in the blood)
• Stroke: Extra caution should be used because heart problems have been reported with apomorphine use.

• Kidney problems: The starting dose of apomorphine will need to be reduced.

• Liver problems: Caution should be used because the amount of apomorphine in the blood may be increased.

• Psychotic disorder: The doctor needs to know if the patient is being treated with an antispsychotic medicine to decide whether or not to use this medicine.

• Sleeping disorder: This medicine could increase the risk of being drowsy or sleepy during daily activities.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, make sure you clearly understand and carefully follow your doctor’s instructions.

Use this medicine only as directed by your doctor. Do not use more or less of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increased the chance of side effects.

This medicine should be injected just under the skin (i.e., subcutaneously), and not into a vein (i.e., intravenously).

Your doctor will also prescribe another medicine called an antiemetic to take when you are using apomorphine. Antiemetic medicines help reduce nausea and vomiting that can occur with apomorphine use.

Dosing:

The dose of apomorphine 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.

• For parenteral dosage form (injection):
  • For treatment of Parkinson’s disease
    • Adults: Your doctor will use a test dose of 0.2 mL and base your starting dose on how your body responds to the test dose.
    • Children: Use and dose must be determined by your doctor.

Missed dose:

Call your doctor or pharmacist for instructions.

Storage:

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

When you are using apomorphine, you should avoid drinking alcohol.

Do not take medicines that cause sleepiness while taking apomorphine.

Do not take other medicines unless they have been discussed with your doctor.

If you take too much apomorphine, you may experience more side effects or they may be stronger than usual. You should contact your doctor or have someone take you to an emergency room right away.

Tell your doctor if you are having trouble with drowsiness and sleepiness during the day.

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

Do not get up too quickly from a lying or sitting position. This could cause dizziness and faintness to occur.

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

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

• More common
  • Chest pain, discomfort, or pressure;  chills; cold sweats; confusion ; dizziness, faintness, or lightheadedness when getting up from lying or sitting position; falling asleep during activity; mood or mental changes; seeing, hearing, or feeling things that are not there; swelling; twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs 
  
  

• Less common
  • Arm, back, neck or jaw pain or discomfort;  chest tightness or heaviness; fainting; fast or irregular heartbeat; nausea ; no blood pressure or pulse;  shortness of breath; stopping of heart; sweating; unconsciousness; vomiting 
  
  

• Rare
  • Irregular heartbeat; recurrent fainting  
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site; blurred vision; dizziness; drowsiness; runny nose; sleepiness; yawning 
  
  

• Rare
  • Painful or prolonged erection of the penis 
  
  

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

In the U.S.:

• Antidyskinetic (dopamine antagonist)

Drospirenone ( droh-SPYE-re-none) and estradiol (es-tra-DYE-ole ) are female hormones called progestins and estrogens that make up this combination medicine. These female hormones 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 in postmenopausal women who still have a uterus. Estrogen helps relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness. Estrogen can also help to relieve a genital skin condition called vaginal or vulvar atrophy. Progestin helps to regulate the effects of estradiol.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to drospirenone or estradiol. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Drospirenone/estradiol should not be used during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Breast-feeding: Drospirenone/estradiol passes into the breast milk and can change the content or lower the amount of breast milk. Use of this medicine is not recommended in nursing mothers.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. However, use of drospirenone/estradiol by postmenopausal women 65 years of age and older may increase the chances of dementia.

Other medicines: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Abnormal genital or vaginal bleeding of unknown causes or
• Adrenal gland problems or
• Breast cancer, known, suspected or history of, or
• Cancer of the uterus or
• Liver problems or disease: This medicine should NOT be used.

• Asthma or
• Diabetes or
• Endometriosis or
• Epilepsy (seizures) or
• High cholesterol or triglycerides (or history of) or
• Hypocalcemia (too little calcium in the blood) or
• Hyponatremia (too little sodium in the blood) or
• Liver tumor, benign, or
• Lupus or
• Migraine or
• Porphyria (problem with metabolism causing stomach pain and mental confusion): This medicine should be used with caution. It can cause these conditions to become worse.

• Blood clots in deep veins or the pulmonary artery or
• Heart attack, active or recent (within the past year) or
• Stroke, active or recent: This medicine should NOT be used.

• Blood clot risk factors (e.g., obesity, personal or family history of blood clots, or lupus) or
• Heart disease risk factors (e.g., diabetes, high cholesterol, high blood pressure, obesity, tobacco use): Your doctor will help you lower your chances of having heart disease.

• Heart problems or
• Liver problems: These conditions could be affected by fluid retention (e.g., water weight gain). The patient should be observed when taking this medicine because estradiol may cause some fluid retention.

• Hypothyroid (too little thyroid hormone): Dose of thyroid medicine may need to be increased.

Dosing:

Read the enclosed patient leaflet carefully before taking this medicine.

You should not take this medicine if you have had a hysterectomy.

You should not take this medicine to prevent heart disease or dementia.

Tell your doctor if you take any medicine or supplement that increases potassium levels. Your doctor may want to prescribe a different medicine for you or have your blood tested to check potassium levels.

Swallow the tablet whole. Do not crush or chew.

The dose of drospirenone/estradiol 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 drospirenone/estradiol. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage forms (tablets)
  • For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
    • Adults: Oral, 1 tablet (drospirenone 0.5 mg/ estradiol 1 mg) once a day.

Missed dose:

Call your doctor or pharmacist for instructions.

Storage:

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visitsevery 3 to 6 months to discuss whether you need to continue taking this medicine.

If you are going to have surgery or will be on bed rest, you need to inform your doctor. You may need to stop taking drospirenone/estradiol during this time.

Check with your doctor immediately if vaginal bleeding occurs.

It is important that you check your breasts by self-examination regularly and have clinical examinations and mammographies as required by your doctor. Report unusual breast lumps or discharge right away.

If you are scheduled for any lab tests, tell your doctor or lab technician that you are taking this medicine. Certain blood tests are affected by estradiol.

Tell your doctor about any risk factors for heart disease that you may have, such as high blood pressure, diabetes, tobacco use, high cholesterol, and obesity. It is important that you work with your doctor to lower these risk factors.

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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

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

• More common
  • Breast pain; full or bloated feeling ; heavy nonmenstrual vaginal bleeding; pressure in the stomach; surgery; swelling of abdominal or stomach area 
  
  

• Less common
  • Bloating or swelling of face, arms, hands, legs, or feet; change in vaginal discharge; increased clear or white vaginal discharge; pain or feeling of pressure in pelvis; rapid weight gain; tingling of hands or feet; unusual weight gain or loss; vaginal bleeding 
  
  

• Incidence not known
  • Abdominal pain; anxiety; blurred vision; change in vision; chest pain or discomfort; clear or bloody discharge from nipple; confusion;  constipation; cough; coughing up blood; depression; difficulty in speaking; dimpling of breast skin; dizziness or lightheadedness; double vision; dry mouth; fainting ; fast heartbeat; headache ; headache, severe and throbbing;  inability to move arms, legs, or facial muscles;  inability to speak; incoherent speech; increased urination; inverted nipple ; loss of appetite; lump in breast or under the arm; metallic taste; muscle weakness; nausea and vomiting ; numbness or weakness in your arm or leg, or on one side of your body; pain or discomfort in arms, jaw, back, or neck; pain or redness in your lower leg (calf); persistent crusting or scaling of nipple ; poor insight and judgment;  problems with memory, vision, speech, or walking;  redness or swelling of breast; seeing double; shortness of breath; slow speech; sore on the skin of the breast that does not heal; sudden or severe headache; sudden shortness of breath or troubled breathing; sweating; thirst; trouble recognizing objects ; trouble thinking and planning;  trouble walking; unusual tiredness or weakness; weight loss 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Accidental injury; back pain; body aches or pain; chills; diarrhea; difficulty in breathing; ear congestion; fever, sneezing, or sore throat; general feeling of discomfort or illness ; joint pain; loss of voice ; muscle aches and pains;  nasal congestion; pain in arms or legs; pain or tenderness around eyes and cheekbones;  runny nose; shivering;  stuffy or runny nose; sweating;  tightness of chest or wheezing; trouble sleeping  
  
  

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

In the U.S.:

• Estrogen-progestin
• Ovarian hormone therapy agent

Anidulafungin (ay-nid-yoo-la-FUN-jin) is an antifungal. It is used to help the body overcome serious fungus infections.

This medicine is available only with your doctor’s prescription, in the following dosage form:

Parenteral
• Injection (U.S.)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to anidulafungin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Anidulafungin has not been studied in pregnant women. However, studies in animals have shown that anidulafungin causes birth defects or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known whether anidulafungin passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children: Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of anidulafungin in children with use in other age groups.

Older adults: This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Allergies to other echinocandin antifungal drugs (Caspofungin [e.g., Cancidas], Micafungin [e.g., Mycamine]): You should not use anidulafungin.

• Liver problems: This medicine may cause liver problems to become worse.

Dosing:

The dose of anidulafungin 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 anidulafungin.

• For injection dosage form:
  • Adults: At first, the dose is 200 milligrams (mg) injected into the vein. After that, the dose is 100 mg a day injected into a vein. For a fungal infection of the esophagus, the first dose is 100 mg and after that the dose is 50 mg a day.
  • Children: Use and dose must be determined by your doctor.

It is important that you adhere to your doctor’s treatment plan for you.

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

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

• Less common
  • Black, tarry stools; chills; cough; decreased urine; dry mouth; fever;  increased thirst; irregular heartbeat; loss of appetite; lower back or side pain; mood or mental changes;  muscle pain or cramps; nausea or vomiting; numbness or tingling in hands, feet or lips;  painful or difficult urination; pale skin; seizures; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; unusual bleeding or bruising ; unusual tiredness or weakness 
  
  

• Rare
  • Abdominal or stomach pain; back pain ; bleeding gums; blood in urine or stools; bloody stools;  bluish color of skin; blurred or loss of vision; changes in skin color; chest pain; chest tightness; clay-colored stools ; confusion; constipation ; dark urine; depression ; diarrhea; dizziness; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; drowsiness ; extra heartbeats; fainting ; fast heartbeat; fatigue ; flushed, dry skin; flushing ; fruit-like breath odor;  headache; high blood pressure;  hives or welts; incoherent speech;  increased hunger; increased urination; infection of blood; irregular fast heartbeat ; irritability; itching ; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; light-colored stools; metallic taste;  muscle spasms (tetany) or twitching; muscle weakness ; nervousness; pain, redness or swelling in arm or leg; pain, tenderness, and swelling of foot or leg; palpitations; pinpoint red spots on skin; pounding in the ears; redness of skin;  restlessness; skin rash;  slow heartbeat; sore mouth or tongue; sweating; swelling of feet or lower legs; swollen glands; trembling ; trouble breathing; unexplained weight loss; unpleasant breath odor; unusually warm skin; vomiting of blood ; weakness; weight loss ; white patches in the mouth or throat or on the tongue; white patches with diaper rash; yellow eyes or skin 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• Rare
  • Acid or sour stomach; belching; bloating or swelling of face, arms, hands, lower legs, or feet ; disturbed color perception;  double vision; eye pain;  feeling of warmth; feeling unusually cold; halos around light; hot flushes; indigestion; loss of bowel control; night blindness; over bright appearance of lights; rapid weight gain;  redness of the face, neck, arms and occasionally, upper chest; shivering; stomach discomfort, upset, or pain; tingling of hands or feet; tunnel vision; unusual weight gain or loss; upper stomach pain 
  
  

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

In the U.S.:

• Antifungal, systemic

Sodium Tetradecyl Sulfate (SOE-dee-um tet-ra-DEK-ul SUL-fate) is a type of medicine called a sclerosing agent. It is used for the treatment of small varicose veins of the lower extremities.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Parenteral
• Injection (U.S.)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to sodium tetradecyl sulfate. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Sodium tetradecyl sulfate has not been studied in pregnant women or animals.

Breast-feeding: It is not known whether sodium tetradecyl sulfate passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of sodium tetradecyl sulfate in children with use in other age groups.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of sodium tetradecyl sulfate in the elderly with use in other age groups.

Other 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 sodium tetradecyl sulfate, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antiovulatory drugs: May increase your risk for adverse reactions

• Allergic conditions or
• Bedridden or
• Cellulitis or
• Deep vein incompetence or
• Huge superficial veins with connections to deeper veins or
• Infections or
• Migrans or
• Respiratory diseases or
• Skin diseases or
• Thrombophlebitis or
• Valvular vein incompetence or
• Varicosities caused by abdominal and pelvic tumors (unless the tumor has been removed): Sodium tetradecyl sulfate should not be administered

• Asthma or
• Blood dyscrasias or
• Diabetes or
• Hyperthyroidism or
• Neoplasm or
• Sepsis or
• Tuberculosis: Sodium tetradecyl sulfate should not be administered

• Peripheral arteriosclerosis or
• Thromboangiitis obliterans (Buerger’s disease): Extreme caution should be used; sodium tetradecyl sulfate may make these conditions worse

The importance of a preinjection evaluation.

The importance of slow injections with a small amount (not over 2 milliliters) of sodium tetradecyl sulfate solution.

Dosing:

The dose of sodium tetradecyl sulfate will be different for different patients. Your doctor will administer the injections. The following information includes only the average doses of sodium tetradecyl sulfate.

• For injection dosage form:
  • For varicose veins:
    • Adults: 0.5 to 2 milliliters injected into the vein, depending on the size and degree of varicosity.
    • Children: Use and dose must be determined by your doctor.

The occurrence of embolism up to 4 weeks following injection of sodium of tetradecyl sulfate.

The possible development of deep vein thrombosis.

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

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

• Frequency not known
  • Anxiety; burning;  chest pain; cough; difficulty breathing; difficulty swallowing;  dizziness or lightheadedness; fast heartbeat; fainting; hayfever;  hives; itching; nausea; noisy breathing; pain, redness, or swelling in arm or leg; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; raised red swellings on the skin, lips, tongue, or in the throat ;  redness of skin; skin rash;  sudden shortness of breath or troubled breathing;  tightness in chest; unusual tiredness or weakness ; vomiting; wheezing  
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• Frequency not known
  • Headache; pain, local; pain or redness at site of injection;  pale skin at site of injection; peeling or sloughing of skin; ulceration at site of injection  
  
  

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

In the U.S.:

• Sclerosing agent

Sorafenib ( sor-a-FE-nib ) is an anticancer medicine used to treat adults with kidney cancer called advanced renal carcinoma.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to sorafenib. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Sorafenib has not been studied in pregnant women. However, studies in animals have shown that sorafenib may cause unwanted effects in the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known whether sorafenib passes into breast milk. However, sorafenib is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of sorafenib in children with use in other age groups.

Older adults: This medicine has been tested and has not been shown to cause different side effects or problems in older people than is does in younger adults. However, elderly patients are more likely to be sensitive and may require a lower dose.

Other 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 sorafenib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Doxorubicin (e.g., Adriamycin): May increase your chance for side effects from doxorubicin

• Drugs metabolized by UGT1A1 such as irinotecan (e.g., Camptosar): May increase your chance for side effects from irinotecan

Read the patient information leaflet before taking sorafenib and each time the prescription is refilled.

Take this medicine exactly as prescribed.

Swallow the tablet whole with water.

Take on an empty stomach (at least 1 hour before or 2 hours after a meal).

Use of effective birth control during sorafenib treatment and for at least 2 weeks after stopping treatment for both male and female patients.

Dosing:

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

• For oral dosage form (tablets):
  • Kidney cancer
    • Adults: 400 milligrams (2 x 200 milligram tablets) taken twice daily, without food (at least 1 hour before or 2 hours after a meal).
    • Children: Use and dose must be determined by your doctor.

Missed dose:

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

Storage:

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Regular visits: If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for high blood pressure that may be caused by this medicine.

Check with your doctor if any redness, pain, swelling or blisters on the palms of your hands or soles of your feet occur.

Check with your doctor if any chest pain.

Report any bleeding.

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

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

• More common
  • Bleeding gums; blurred vision; coughing up blood; difficulty in breathing or swallowing; dizziness;  headache; increased menstrual flow or vaginal bleeding ; nervousness; nosebleeds ; paralysis; pounding in the ears; prolonged bleeding from cuts; red or black, tarry stools; red or dark brown urine; shortness of breath;  slow or fast heartbeat 
  
  

• Reported during clinical trials
  • Area rash; black, tarry stools; bleeding gums; bloating; blood in urine or stools; bone pain ; chest pain or discomfort;  chills; clay-colored stools;  coma; confusion; continuing ringing or buzzing or other unexplained noise in ears;  constipation; convulsions;  cough; dark urine; decreased urine output; depressed mood;  difficulty in moving; dry skin and hair; feeling cold; enlarged pupils; fever; hair loss;  hearing loss; hives; hoarseness or husky voice;  increased sensitivity of eyes to light; increased sweating, possibly with fever or cold; clammy skin;  increased thirst; indigestion; itching;  joint pain; loss of appetite;  lower back or side pain; muscle cramps and stiffness ; muscle pain or cramps;  nausea or vomiting; pains in stomach, side, or abdomen, possibly radiating to the back; pain or discomfort in arms, jaw, back or neck; painful or difficult urination; pale skin;  pinpoint red spots on skin; reddening of the skin, especially around ears; severe chest pain;  severe headache; stiff or sore neck; sore throat; sores, ulcers, or white spots on lips or in mouth; stomach discomfort upset or pain; sweating; swelling of eyes, face, or inside of nose; swelling of face, ankles, or hands; swollen glands;  swollen joints; troubled breathing with exertion ; unpleasant breath odor;  unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood;  weight gain; yellow eyes or skin 
  
  

• Symptoms of Overdose

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

  • Diarrhea; flushing;  impaired wound healing; increased sweating; suppressed reaction to skin tests;  thin, fragile skin 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Blistering, peeling, redness, and/or swelling of palms of hands or bottoms of feet; burning, tingling, numbness or pain in the hands, arms, feet, or legs; diarrhea ; difficulty having a bowel movement (stool); dry skin; numbness, pain, tingling, or unusual sensations in palms of hands or bottoms of feet;  sensation of pins and needles; stabbing pain ; thinning of hair; tightness in chest ; weight loss; wheezing  
  
  

• Reported during clinical trials
  • Acid or sour stomach; acne; belching; blistering, peeling, loosening of skin; bloating; bone pain; burning feeling in chest or stomach; burning, itching, and pain in hairy areas;  cracked lips; cracks in the skin;  decreased appetite; decreased interest in sexual intercourse; decreased urination;  difficulty in moving; discouragement; dry mouth; fainting;  feeling of warmth, redness of the face, neck, arms and occasionally, upper chest; feeling sad or empty;  flushing, redness of skin; gas;  general feeling of discomfort or illness; heartburn ; inability to have or keep an erection; increase in heart rate; irritability ; lack or loss of strength;  lightheadedness; loss in sexual ability, desire, drive, or performance; loss of ability to use or understand speech or language; loss of heat from the body; loss of interest or pleasure; mouth pain; pus at root of hair; rapid breathing; red irritated eyes ; red, swollen skin, scaly skin;  rough, scratchy sound to voice; runny nose; shivering; skin rash encrusted, scaly and oozing; sore throat;  sores, ulcers, or white spots in mouth or on lips;  sunken eye; swelling of the breasts or breast soreness in both females and males; swelling or inflammation of the mouth; tenderness in stomach area; thirst; trouble concentrating; trouble sleeping; unusually warm skin ; wrinkled skin 
  
  

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

In the U.S.:

• Antineoplastic

Pregabalin (pre-GAB-a-lin ) is used to help control some types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

This medicine is also used to manage a condition called post-herpetic neuralgia (pain after *??shingles*??). It is also used for pain caused by nerve damage associated with diabetes.

Pregabalin is available only with your doctor’s prescription, in the following dosage form:

Oral
• Capsules (U.S. and Canada)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to pregabalin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy: Pregabalin has not been studied in pregnant women. However, studies in pregnant animals have shown that pregabalin may cause unwanted effects in offspring when given to the mother in doses larger than the largest human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known whether pregabalin passes into breast milk. However, pregabalin is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pregabalin in children with use in other age groups.

Older adults: This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients are more likely to be more sensitive to pregabalin than younger adults and may require a lower dose.

Other 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 pregabalin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antidiabetic drugs (e.g., Thiazolidinedione [ciglitazone]): May cause weight gain and/or fluid retention, and may increase your risk of serious side effects

• Diabetes mellitus: May increase your weight and may increase your risk for skin ulcerations

• Heart disease: May increase your chance of side effects

• Kidney disease: Your doctor may lower your dose of pregabalin

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

Pregabalin may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Read the patient information leaflet prior to beginning pregabalin therapy

Dosing:

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

The number of capsules 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 taking pregabalin.

• For oral dosage form (capsules):
  • For diabetic nerve pain:
    • Adults: Oral, 150 milligrams per day, divided (50 mg three times a day).
    • Children: Dose must be determined by your doctor.
  • For epilepsy:
    • Adults: Oral, 150 to 600 milligrams per day. The total daily dose should be divided and given two or three times a day.
    • Children: Dose must be determined by your doctor.
  • For post-herpetic neuralgia:
    • Adults: Oral, 150 to 300 milligrams per day. The total daily dose should be divided and given two or three times a day.
    • Children: Dose must be determined by your doctor.

Missed dose:

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

Storage:

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits, especially for the first few months you take pregabalin. This is necessary to allow dose adjustments and to reduce any unwanted effects.

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

Pregabalin may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble in thinking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well. If these reactions are especially bothersome, check with your doctor.

This medicine may cause you to keep extra fluid in your body or cause you to gain weight. If this side effect is bothersome, check with your doctor.

Do not suddenly stop taking your pregabalin. If you have been instructed to stop taking pregabalin, ask your healthcare professional how to slowly decrease the dose. This is to decrease the chance of having discontinuation symptoms such as dizziness, nausea, headache, vomiting, irritability, nightmares, prickling or tingling feelings.

Report any unexplained muscle pain, tenderness, or weakness particularly if accompanied by a fever.

For patients with diabetes, check with your doctor if you notice changes to your skin or skin sores while taking pregabalin.

Notify your doctor if you become pregnant, if you plan to become pregnant, or if you father a child while taking pregabalin.

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

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

• Less common
  • Difficult or labored breathing; shortness of breath; tightness in chest;  wheezing 
  
  

• Rare
  • Blistering, peeling, loosening of skin;  chills; cough; difficulty swallowing; diarrhea; dizziness ; fast heartbeat; hives ; itching; joint or muscle pain; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; red irritated eyes ; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in mouth or on lips; unusual tiredness or weakness 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Accidental injury; bloating or swelling of face, arms, hands, lower legs, or feet; blurry vision; burning, tingling, numbness or pain in the hands, arms, feet, or legs; change in walking and balance; clumsiness; confusion ; delusions; dementia; difficulty having a bowel movement (stool);  difficulty in speaking; double vision; dry mouth; fever;  headache; hoarseness; increased appetite; lack of coordination;  loss of memory; lower back or side pain; mood or mental changes; painful or difficult urination; problems with memory;  rapid weight gain; seeing double;  shakiness and unsteady walk; sensation of pins and needles; sleepiness or unusual drowsiness; stabbing pain; swelling; tingling of hands or feet; trembling, or other problems with muscle control or coordination;  trembling or shaking of hands or feet; shakiness in legs, arms, hands, feet ; unusual weight gain or loss 
  
  

• Less common
  • Anxiety; bloated full feeling; burning, crawling, itching, numbness, prickling, “pins and needles” , or tingling feelings; changes in vision; chest pain; cold sweats; coma; cool pale skin;  cough producing mucus; decrease or change in vision ; depression; eye disorder ; excess air or gas in stomach or intestines; false or unusual sense of well-being;  general feeling of discomfort or illness; increased hunger; joint pain;  loss of appetite; loss of bladder control; loss of strength or energy; muscle aches and pains;  muscle weakness;  muscle twitching or jerking; nausea; nervousness; nightmares;  noisy breathing; pain; passing gas; rhythmic movement of muscles ; runny nose; seizures; shivering; slurred speech; sweating; trouble sleeping; twitching; uncontrolled eye movements ; vomiting 
  
  

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

In the U.S.:

In Canada:

• Anticonvulsant
• antineuralgic

Doxycycline ( dox-i-SYE-kleen) is used to treat infections and to help control acne. Doxycycline may also be used for other problems as determined by your doctor. Doxycycline will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Oral
• Delayed-release tablets (U.S. )

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to doxycycline. Also tell your doctor and pharmacist if you are allergic to any other tetracyclines, or foods, preservatives, or dyes.

Pregnancy: Use is not recommended during the last half of pregnancy. If doxycycline is taken during that time, it may cause the unborn infant’s teeth to become discolored and may slow down the growth of the infant’s teeth and bones.

Breast-feeding: Doxycycline passes into breast milk and has been shown to cause the nursing baby’s teeth to become discolored and may slow down the growth of the baby’s teeth and bones. It may be necessary for you to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children: Doxycycline may cause permanent discoloration of teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger unless directed by the child’s doctor.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of doxycycline in the elderly with use in other age groups.

Other 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 doxycycline, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antacids or
• Aluminum-containing medicine or
• Calcium supplements such as calcium carbonate or
• Iron-containing medicine or
• Magnesium salicylate (e.g., Magan): Use of these medicines with doxycycline may decrease the effect of doxycycline.

• Anticoagulant therapy: Your doctor may adjust your dose of anticoagulant therapy.

• Penicillins: Use of doxycycline with penicillins may decrease the effect of penicillins.

• Methoxyflurane (e.g., Metofane): May increase your risk for serious side effects

• Oral contraceptives (birth control pills): Use with doxycycline may result in oral contraceptives being less effective.

This medicine may be taken with food or milk if it upsets your stomach.

Do not give doxycycline to infants or children 8 years of age and younger unless directed by your doctor. Doxycycline may cause permanently discolored teeth and other problems in patients in these age groups.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Drink plenty of fluid to avoid esophageal irritation and ulceration.

Dosing:

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

The number of tablets 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 taking doxycycline.

• For oral dosage form (delayed-release tablets):
  • For infections:
    • Adults and children older than 8 years of age who weigh more than 100 pounds: 100 milligrams (mg) every 12 hours the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.
    • Children older than 8 years of age who weigh 100 pounds or less: Dose is based on body weight. The usual dose is 2 mg per pound of body weight divided into two doses on the first day of treatment, followed by 1 mg per pound of body weight given as a single daily dose or divided into two doses on subsequent days.
    • Infants and children 8 years of age and younger: Doxycycline is usually not used in young children because it can permanently stain teeth.
  • For the prevention of malaria:
    • Adults and teenagers: 100 milligrams once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
    • Children older than 8 years of age: Dose is based on body weight. The usual dose is 2 mg per kg of body weight once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
    • Infants and children 8 years of age and younger: Doxycycline is usually not used in young children because it can permanently stain teeth.
  • For inhalation anthrax (post-exposure):
    • Adults and children weighing 100 pounds or more: 100 milligrams twice a day for 60 days.
    • Children weighing less than 100 pounds: 1 milligram per pound of body weight, twice a day for 60 days.

Missed dose:

If you miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood or urine. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage:

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking doxycycline. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking doxycycline. If you have any questions about this, check with your health care professional.

Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

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

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

• Frequency not known
  • Bloating; clay colored stools;  cough; dark urine;  decreased appetite; diarrhea;  diarrhea, watery and severe, which may also be bloody;  difficulty swallowing; dizziness;  fast heartbeat; feeling of discomfort; fever; headache;  hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; hives or welts; increased thirst; inflammation of joints ;  itching; joint or muscle pain; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs;  loss of appetite; nausea and vomiting; numbness or tingling of face, hands, or feet;  pain; rash; redness and soreness of eyes; redness of skin;  shortness of breath; sore throat;  sores in mouth;  stomach cramps;  stomach pain or tenderness; swelling of feet or lower legs; swollen lymph glands;  tightness in chest; unusual tiredness or weakness ; unusual weight loss;  wheezing; yellow eyes or skin 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• Incidence not known
  • Back, leg, or stomach pains; black, tarry stools; bleeding gums;  blood in urine or stools; blurred vision; bulging soft spot on head of an infant;  change in ability to see colors, especially blue or yellow;  chest pain, discomfort, or burning; chills; cracks in the skin; decrease in vision ; difficulty breathing;  discoloration of thyroid glands; double vision; general body swelling; heartburn; increased sensitivity of skin to sunlight;  loss of appetite; loss of heat from the body; lower back or side pain; nosebleeds ; pain or burning in throat;  pain with swallowing; painful or difficult urination ; pale skin; pinpoint red spots on skin; rash with flat lesions or small raised lesions on the skin; red, swollen skin; redness or other discoloration of skin;  redness, swelling, or soreness of tongue; scaly skin ; severe nausea; severe stomach pain;  severe sunburn;  sores, ulcers, or white spots on lips or tongue or inside the mouth; unusual bleeding or bruising; vomiting blood 
  
  

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

In the U.S.:

• Antiacne agent, systemic
• antibacterial; antiprotozoal
• antimalarial; intrapleural sclerosing agent

Mometasone ( moe-MET-a-sone) belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It is used to help prevent the symptoms of asthma. When used regularly every day, inhaled mometasone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Inhaled mometasone works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine is available only with your doctor’s prescription, in the following dosage forms:

Oral
• Powder for inhalation (U.S.)

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

Allergies: Allergies: Tell your doctor if you have ever had any unusual allergic reactions to mometasone. Also tell your health care professional if you are allergic to any other substances such as foods, dyes, or preservatives.

Pregnancy: Mometasone has not been studied in pregnant women. However, studies in animals have shown that mometasone causes birth defects. Also, too much use of corticosteroids during pregnancy may cause other unwanted effects in the infant, such as slower growth and reduced adrenal gland function. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known if mometasone inhalation powder is distributed in breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine who wish to breast-feed should discuss this with their doctor.

Children: This medicine has only been tested in children 12 years of age or older. Mometasone powder for inhalation may adversely effect the adrenal gland and stunt growth in pediatric patients. Before this medicine is given to a child, you and your child’s doctor should talk about the good this medicine will do as well as the risks of using it.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mometasone inhalation powder in the elderly with use in other age groups.

• Eye problems such as:
• Cataracts or
• Glaucoma or
• Intraocular pressure increased: Mometasone may make these conditions worse

• Liver problems: May increase the amount of mometasone that stays in the body
• Immobilization for long periods of time or
• Osteoporosis, family history: Mometasone may make your bones weaker and increase the chance of a broken bone after a minor fall or injury.

• Infections: Mometasone may make infections like chickenpox and measles more dangerous; it might also hide the effects of certain infections

• Tuberculosis of the respiratory tract: Mometasone may either hide the effects of this disease or make it worse

Dosing:

The dose of mometasone inhalation powder 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 mometasone inhalation powder. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of powder that you inhale 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 taking mometasone inhalation powder

• For asthma (treatment)
  • If you have had previous asthma therapy with bronchodilators alone:
    • Adults: 220 mcg once daily in the evening
    • Children: Use and dose must be determined by your doctor.
  • If you have had previous asthma therapy with inhaled corticosteroids alone:
    • Adults: 220 mcg once daily in the evening
    • Children: Use and dose must be determined by your doctor.
  • If you have had previous asthma therapy with oral corticosteroids:
    • Adults: 440 mcg twice daily
    • Children: Use and dose must be determined by your doctor.

Storage:

To store this medicine:

• Keep out of the reach of children.
• Store at room temperature.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Check with your doctor if:

• You go through a period of unusual stress to your body, such as surgery, injury, or infection.
• You have an asthma attack that does not improve after you take a bronchodilator medicine.
• Your asthma symptoms do not improve or your condition worsens.
• You are exposed to the chickenpox or measles.

Your doctor may want you to carry a medical identification card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

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

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

• More common
  • Body aches or pain; cold or flu-like symptoms; congestion; cough ; dryness or soreness of throat 
  
  

• Less common
  • Abdominal or stomach pain; diarrhea ; fever or chills; loss of appetite; lower back or side pain; nausea 
  
  

• Rare
  • White patches inside nose or mouth 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Difficulty in moving; discouragement ; fatigue;  feeling sad or empty ; increased abdominal pain and cramping during menstrual periods; irritability ; lack of appetite ; loss of interest or pleasure ;  muscle pain or stiffness; musculoskeletal pain; nasal burning and irritation; pain in joints;  stomach discomfort following meals; stuffy or runny nose or headache; tiredness ;  trouble concentrating;  trouble sleeping; unexplained runny nose or sneezing;  upset stomach 
  
  

• Less common
  • Accidental injury; bladder pain;  bloody or cloudy urine; bloody mucus or unexplained nosebleeds; chest congestion; chills;  cough;  diarrhea;  difficult, burning, or painful urination ;  flatulence;  frequent urge to urinate;  general feeling of discomfort or illness;  lower back or side pain ; menstrual changes;  nausea ; post-procedure pain;  shivering;  sore throat;  sweating;  unusual tiredness or weakness;  vomiting 
  
  

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

In the U.S.:

• Anti-inflammatory (inhalation)
• Antiasthmatic

Ziconotide ( Zi-KOE-noe-tide) is a medicine that reduces chronic pain in the body.

Intrathecal ziconotide is given by or under the direct supervision of a doctor. It is available in the following dosage forms:

Intrathecal
• Injection (U.S.)

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

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to ziconotide. Also tell your doctor and pharmacist if you are allergic to any other substances.

Pregnancy: Ziconotide has not been studied in pregnant women. However, studies in animals have shown that ziconotide can cause bone problems or death in the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known whether ziconotide passes into the breast milk. However, ziconotide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ziconotide in children with use in other age groups.

Older adults: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Confusion may be especially likely to occur in older adults who are usually more sensitive than younger adults to the effects of ziconotide.

Other medicines: Other 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 ziconotide, it is especially important that your health care professional knows if you are taking any of the following:

• Opioids, intrathecal

• Infection at the microinfusion injection site or
• Spinal canal obstruction that impairs circulation of the CSF or
• Uncontrolled bleeding diathesis: Ziconotide should not be used if these conditions are present

• Psychosis: Ziconotide may make this condition worse

Dosing:

The dose of ziconotide will be different for different patients. The dose that is used may depend on a number of things.

Storage:

To store this medicine:

• Store in the refrigerator. However, keep the medicine from freezing.
• Protect from light

It is very important that your doctor check your progress at regular visits.

Contact your doctor right away if you are confused, less alert, or unusually tired

Tell your doctor right away if you have changes in mood, hallucinations, or unusual sensations in your mouth.

Ziconotide may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Serious infection or meningitis can occur if the catheter becomes disconnected. It is very important that you follow your doctor’s instructions about the care of the catheter and the use of the infusion pump.

If you or your caregiver notice signs of meningitis such as nausea, vomiting, seizures, fever, headache, and/or stiff neck, tell your doctor right away.

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

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

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

• More common
  • Seeing, hearing, or feeling things that are not there; thoughts of killing oneself 
  
  

• Less common
  • Chest pain; chills;  confusion; convulsions;  cough; dark-colored urine;  dizziness; drowsiness;  fainting; fast heartbeat;  fever; general feeling of illness;  lightheadedness; muscle spasm or jerking of all extremities ; muscle stiffness; rapid, shallow breathing; shortness of breath; ; sneezing;  sore throat; stiff neck or back;  tightness in chest; troubled breathing; trouble concentration; trouble sleeping ; unusual tiredness or weakness;  wheezing 
  
  

• Symptoms of overdose

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

  • Decreased awareness or responsiveness;  severe sleepiness; shakiness and unsteady walk; trembling or other problems with muscle control or coordination ; uncontrolled eye movements;  unsteadiness 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Burning; change in walking and balance ; clumsiness or unsteadiness;  confusion; crawling feelings;  diarrhea; dizziness; excessive muscle tone, muscle tension or tightness; fear; feeling of constant movement of self or surroundings; fever; headache;  itching; lack or loss of strength;  lightheadedness; loss of appetite ; nausea; nervousness;  numbness; problems with speech or speaking; sensation of spinning; trembling, or other problems with muscle control or coordination;  uncontrolled eye movements; urinary retention; vomiting; weight loss 
  
  

• Less common
  • Acid or sour stomach; back pain; bad, unusual or unpleasant (after)taste;  belching; bladder pain;  bloody or cloudy urine; bruising;  cerebrospinal fluid abnormal; change in taste; congestion; constipation; continuing ringing or buzzing or other unexplained noise in ears ; crying; decreased awareness or responsiveness; dehydration;  depersonalization; depression;  difficult, burning or painful urination; difficulty in moving; difficulty seeing at night; double vision; dry mouth ; dry skin; dryness or soreness of throat ; dysphoria; euphoria; fainting; fast or irregular heartbeat ; feeling that others can hear your thoughts, are watching you, or can control your behavior; frequent urge to urinate; hearing loss;  heartburn ; hoarseness;  hostility; increased sensitivity of eyes to sunlight ; increased sensitivity to pain or touch; indigestion; loss of bladder control ; loss of memory or problems with memory; lung disorder; neck pain; nerve pain; pain in joints; pale skin; pounding in ears; quick to react or overreact emotionally;  rapidly changing moods; red, scaly, swollen or peeling areas of skin; redness or pain at catheter site; runny nose; severe muscle stiffness ; sleeplessness; slow or fast heartbeat; stomach discomfort, upset or pain ; sweating; swelling or redness in joints; tender, swollen glands in neck ; trouble in swallowing;  unusual bleeding or bruising; unusual tiredness or weakness; voice changes;  warmth on skin; weakness or heaviness in legs 
  
  

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

In the U.S.:

• Analgesic