Search Cape Verde: September 2012

Sunday, September 30, 2012

Tarka

Pronunciation: tran-DOLE-a-pril/ver-AP-a-mil
Generic Name: Trandolapril/Verapamil
Brand Name: Tarka

Tarka may cause injury or death to the fetus if taken after the third month of pregnancy. If you think you may be pregnant, contact your doctor right away.

Tarka is used for:

Treating high blood pressure. It may also be used for certain conditions as determined by your doctor.

Tarka is an angiotensin-converting enzyme (ACE) inhibitor and calcium channel blocker combination. It works by helping to relax blood vessels, which helps to lower blood pressure.

Do NOT use Tarka if:

you are allergic to any ingredient in Tarka or to another ACE inhibitor (eg, lisinopril)

you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or unusual hoarseness), including angioedema caused by treatment with an ACE inhibitor

you have certain heart problems (eg, left ventricular dysfunction, sick sinus syndrome, second- or third-degree heart block and do not have a pacemaker), very low blood pressure, or moderate to severe congestive heart failure (CHF)

you have atrial fibrillation or flutter and a pre-excitation syndrome (extra conduction pathway in the heart), such as Wolff-Parkinson-White (WPW) syndrome or Lown-Ganong-Levine (LGL) syndrome

you have shock caused by serious heart problems

you are in your second or third trimester of pregnancy

you are taking dofetilide, erythromycin, everolimus, or disopyramide

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

Before using Tarka:

Some medical conditions may interact with Tarka. 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 are able to become pregnant

if you have a history of heart problems (eg, aortic stenosis, heart failure), blood vessel problems, blood flow problems, bone marrow problems, kidney or liver problems, nervous system problems, muscular dystrophy, a neuromuscular disease, or fluid in the lungs

if you have a history of stroke, a recent heart attack, or a kidney transplant

if you have an autoimmune disease (eg, lupus, rheumatoid arthritis, scleroderma)

if you are dehydrated or have low blood volume or low blood pressure

if you have high potassium levels, low blood sodium levels, or are on a low-salt (sodium) diet

if you have diabetes, especially if you are also taking aliskiren

if you are receiving treatments to reduce sensitivity to bee or wasp stings

if you are having dialysis or apheresis, or are scheduled to have major surgery

if you are taking another blood pressure medicine or you are being treated for cancer

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

Diuretics (eg, furosemide, hydrochlorothiazide) or quinazolines (eg, prazosin) because the risk of low blood pressure may be increased

Aldosterone blockers (eg, eplerenone), aliskiren, potassium-sparing diuretics (eg, spironolactone), potassium supplements, or trimethoprim because the risk of high blood potassium levels may be increased

Angiotensin receptor blockers (eg, losartan) because the risk of serious kidney problems and high blood potassium levels may be increased

Insulin, sulfonylureas (eg, glipizide), or other oral diabetes medicines (eg, metformin) because the risk of low blood sugar may be increased

Certain gold-containing medicines (eg, sodium aurothiomalate) because flushing, low blood pressure, nausea, and vomiting may occur

Cephalosporin antibiotics (eg, cephalexin), clindamycin, clonidine, ketolide antibiotics (eg, telithromycin), lincomycin, macrolide antibiotics (eg, clarithromycin, erythromycin), or ritonavir because they may increase the risk of Tarka's side effects

Barbiturates (eg, phenobarbital), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin), rifampin, salicylates (eg, aspirin), or St. John's wort because they may decrease Tarka's effectiveness

Aspirin, beta-blockers (eg, propranolol), carbamazepine, colchicine, cyclosporine, digoxin, disopyramide, dofetilide, doxorubicin, dronedarone, eletriptan, erythromycin, everolimus, flecainide, HMG-CoA reductase inhibitors (eg, simvastatin), indomethacin, lithium, narcotic pain medicines (eg, fentanyl), paclitaxel, quinidine, ranolazine, theophyllines (eg, aminophylline), thiopurines (eg, azathioprine), or tolvaptan because the risk of their side effects may be increased by Tarka

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

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

Take Tarka by mouth with food.

Eating grapefruit or drinking grapefruit juice may affect the amount of Tarka in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.

Take Tarka on a regular schedule to get the most benefit from it. Taking Tarka at the same time each day will help you remember to take it.

Continue to use Tarka even if you feel well. Do not miss any doses.

If you miss a dose of Tarka, 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 Tarka.

Important safety information:

Tarka may cause dizziness, lightheadedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Tarka with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tarka; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Tarka may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. If lightheadedness occurs, especially during the first few days of treatment, contact your health care provider.

Tarka may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or unusual hoarseness.

Tarka may not work as well in black patients. They may also be at greater risk of side effects. Contact your doctor if your symptoms do not improve or if they become worse.

Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.

Rarely, Tarka may lower the ability of your body to fight infection. This risk may be greater if you have certain other health problems (eg, kidney problems, collagen vascular disease). Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

Check with your doctor before you use a salt substitute or a product that has potassium in it.

Proper dental care is important while you are taking Tarka. Brush and floss your teeth carefully to reduce swelling and tenderness of your gums while you are using Tarka, and visit the dentist regularly.

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

Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.

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

Lab tests, including liver function, kidney function, complete blood cell counts, and blood pressure, may be performed while you use Tarka. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Tarka should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Tarka may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Tarka is found in breast milk. Do not breast-feed while taking Tarka.

Possible side effects of Tarka:

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; dizziness; lightheadedness when sitting up or standing; nausea; persistent, dry cough; tiredness.

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; unusual hoarseness); chest pain; decreased urination; difficulty swallowing; fainting; muscle pain or cramping; numbness of an arm or leg; one-sided weakness; shortness of breath; slurred speech; stomach pain (with or without nausea or vomiting); swelling of the hands or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent stomach pain, fever, general feeling of being unwell); symptoms of low blood pressure (eg, fainting, severe dizziness or lightheadedness); tender, bleeding, or swollen gums; unusually fast, slow, or irregular heartbeat.

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: Tarka side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness or lightheadedness; unusually fast, slow, or irregular heartbeat; weakness.

Proper storage of Tarka:

Store Tarka at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tarka out of the reach of children and away from pets.

General information:

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

Tarka 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 Tarka. 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 Tarka resources

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

Tarka Prescribing Information (FDA)

Tarka Concise Consumer Information (Cerner Multum)

Tarka Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Tarka with other medications

High Blood Pressure

Simply Cough

Generic Name: dextromethorphan (Oral route)

dex-troe-meth-OR-fan

Commonly used brand name(s)

In the U.S.

Babee Cof Syrup

Benylin Pediatric Formula

Children's Pedia Care

Creomulsion

Creo-Terpin

Delsym

Dexalone

ElixSure Cough Children's

Father John's Medicine

Miltuss

Nycoff

Pediacare

Pediacare Long-Acting Cough

Robafen Cough

Robitussin

Silphen DM

Simply Cough

St. Joseph

Vicks 44 Cough Relief

Available Dosage Forms:

Suspension, Extended Release

Solution

Capsule

Syrup

Lozenge/Troche

Elixir

Liquid

Tablet

Capsule, Liquid Filled

Suspension

Therapeutic Class: Antitussive

Uses For Simply Cough

Dextromethorphan is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Simply Cough

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

Allergies

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

Pediatric

Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.

Geriatric

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 dextromethorphan in the elderly with use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

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

Clorgyline

Iproniazid

Isocarboxazid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

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

Abiraterone

Amitriptyline

Amoxapine

Citalopram

Clomipramine

Desipramine

Desvenlafaxine

Doxepin

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Imipramine

Linezolid

Milnacipran

Nortriptyline

Paroxetine

Protriptyline

Sertraline

Sibutramine

Trimipramine

Venlafaxine

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

Clobazam

Haloperidol

Quinidine

Vemurafenib

Interactions with Food/Tobacco/Alcohol

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

Proper Use of dextromethorphan

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

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing

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

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

For lozenge dosage form:
- For cough:
  - Adults and children 12 years of age and older—5 to 15 mg every two to four hours, as needed.
  - Children 6 to 12 years of age—5 to 15 mg every two to six hours, as needed.
  - Children 4 to 6 years of age—5 mg every four hours, as needed.
  - Children and infants up to 4 years of age—Use is not recommended .

For syrup dosage form:
- For cough:
  - Adults and children 12 years of age and older—30 mg every six to eight hours, as needed.
  - Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed.
  - Children 4 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
  - Children and infants up to 4 years of age—Use is not recommended .

For extended-release oral suspension dosage form :
- For cough:
  - Adults and children 12 years of age and older—60 mg every twelve hours, as needed.
  - Children 6 to 12 years of age—30 mg every twelve hours, as needed.
  - Children 4 to 6 years of age—15 mg every twelve hours, as needed.
  - Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

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

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.

Precautions While Using Simply Cough

If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.

Simply Cough Side Effects

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

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

Symptoms of overdose

Blurred vision

confusion

difficulty in urination

drowsiness or dizziness

nausea or vomiting (severe)

shakiness and unsteady walk

slowed breathing

unusual excitement, nervousness, restlessness, or irritability (severe)

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

Less common or rare

Confusion

constipation

dizziness (mild)

drowsiness (mild)

headache

nausea or vomiting

stomach pain

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

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

See also: Simply Cough side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Simply Cough resources

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

Compare Simply Cough with other medications

Cough

Wednesday, September 26, 2012

Torisel

Generic Name: temsirolimus (Intravenous route)

tem-sir-OH-li-mus

Commonly used brand name(s)

In the U.S.

Torisel

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Uses For Torisel

Temsirolimus injection is an anticancer medicine that is used to treat advanced kidney cancer.

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

Before Using Torisel

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of temsirolimus injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of temsirolimus injection have not been performed in the geriatric population. However, elderly patients are more likely to have diarrhea, edema (swelling), and pneumonia, which may require caution in patients receiving temsirolimus injection.

Pregnancy

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

Adenovirus Vaccine Type 4, Live

Adenovirus Vaccine Type 7, Live

Atazanavir

Bacillus of Calmette and Guerin Vaccine, Live

Carbamazepine

Clarithromycin

Dexamethasone

Indinavir

Influenza Virus Vaccine, Live

Itraconazole

Ketoconazole

Measles Virus Vaccine, Live

Mumps Virus Vaccine, Live

Nefazodone

Nelfinavir

Phenobarbital

Phenytoin

Poliovirus Vaccine, Live

Rifabutin

Rifampin

Ritonavir

Rotavirus Vaccine, Live

Rubella Virus Vaccine, Live

Saquinavir

Smallpox Vaccine

St John's Wort

Telithromycin

Typhoid Vaccine

Varicella Virus Vaccine

Voriconazole

Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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

Grapefruit Juice

Proper Use of Torisel

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

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.

You will receive a medicine to prevent allergic reactions (e.g., diphenhydramine, Benadryl®) before you receive this medicine.

Precautions While Using Torisel

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

Using this medicine while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during treatment with temsirolimus and for at least 3 months after stopping treatment. If you think you have become pregnant while using this medicine, tell your doctor right away.

Temsirolimus may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.

This medicine may cause flushing, headaches, and lightheadedness or faintness, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or urination. Your doctor may give you insulin or other medicines that can lower the amount of sugar in your blood.

While you are being treated with temsirolimus, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Temsirolimus may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal flu virus vaccine, measles, mumps, rubella, oral polio vaccine, BCG, yellow fever, varicella, or TY21a typhoid vaccine). Try to avoid being around persons who have received live vaccines. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Treatment with temsirolimus may also increase the chance of getting other infections. If you can, avoid people with colds or other infections. If you think you are getting a cold or other infection, check with your doctor.

This medicine may cause a serious lung problem. Check with your doctor immediately if you are having tightness in the chest, shortness of breath, difficulty with breathing, or wheezing.

Temsirolimus may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; diarrhea; fever; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

This medicine may increase your chance of having acute kidney disease that is not related to the worsening of your kidney cancer. Talk to your doctor about this risk.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several weeks before and after having surgery.

Grapefruit and grapefruit juice may increase the effects of temsirolimus by increasing the amount of medicine in your blood. You should not eat grapefruit or drink grapefruit juice while receiving this medicine.

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

Torisel Side Effects

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

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

More common

Bladder pain

bloody nose

bloody or cloudy urine

body aches or pain

chest pain

congestion

cough or hoarseness

cracked lips

diarrhea

difficult or labored breathing

difficult, burning, or painful urination

difficulty with swallowing

dryness or soreness of the throat

fever or chills

frequent urge to urinate

headache

lack or loss of strength

lower back or side pain

shortness of breath

sneezing

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach pain

stuffy or runny nose

swelling of the hands, ankles, feet, or lower legs

swelling or puffiness of the face

tender, swollen glands in the neck

tightness in the chest

voice changes

vomiting

wheezing

Incidence not known

Blistering, peeling, or loosening of the skin

convulsions

dark-colored urine

itching

joint or muscle pain

muscle cramps or spasms

muscle stiffness

pain or redness at the injection site

pale skin at injection site

red skin lesions, often with a purple center

red, irritated eyes

unusual tiredness or weakness

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

Symptoms of overdose

Abdominal or stomach cramps

black, tarry stools

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

loss of bladder control

muscle spasm or jerking of all extremities

severe mood or mental changes

severe vomiting, sometimes with blood

sudden loss of consciousness

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

unusual behavior

More common

Back pain

blemishes on the skin

change in taste

difficulty having a bowel movement (stool)

difficulty with moving

discoloration of the fingernails or toenails

dry skin

loss of appetite

loss of taste

nausea

pain in the joints

pimples

rash

sleeplessness

swollen joints

trouble with sleeping

unable to sleep

weight loss

Less common

Discouragement

feeling sad or empty

irritability

loss of interest or pleasure

tiredness

trouble concentrating

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

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

See also: Torisel side effects (in more detail)

More Torisel resources

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

Torisel Prescribing Information (FDA)

Torisel Consumer Overview

Torisel Monograph (AHFS DI)

Torisel MedFacts Consumer Leaflet (Wolters Kluwer)

Temsirolimus Professional Patient Advice (Wolters Kluwer)

Compare Torisel with other medications

Renal Cell Carcinoma

Friday, September 21, 2012

Sopamycetin Otic

Generic Name: chloramphenicol (Otic route)

klor-am-FEN-i-kol

Commonly used brand name(s)

In Canada

Chloromycetin

Sopamycetin

Available Dosage Forms:

Solution

Therapeutic Class: Antibacterial

Chemical Class: Chloramphenicol (class)

Uses For Sopamycetin

Chloramphenicol belongs to the family of medicines called antibiotics. Chloramphenicol otic drops are used to treat infections of the ear canal. This medicine may be used alone or with other medicines that are taken by mouth for ear canal infections.

Chloramphenicol is available only with your doctor's prescription.

Before Using Sopamycetin

Allergies

Pediatric

Gray syndrome may be especially likely to occur in children, who are usually more sensitive than adults to the effects of chloramphenicol. Report any of these effects to your health care professional: blue tone to the skin, changes in blood pressure or heart rate, eating problems, irregular breathing, passage of loose green stools, or stomach bloating with or without vomiting. Your health care professional should monitor blood levels of chloramphenicol if possible.

Geriatric

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 this medicine in the elderly with use in other age groups.

Breast Feeding

Interactions with Medicines

Citalopram

Voriconazole

Ceftazidime

Chlorpropamide

Cyclosporine

Dicumarol

Fosphenytoin

Phenytoin

Rifampin

Rifapentine

Tacrolimus

Tetanus Toxoid

Tolbutamide

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 chloramphenicol

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

To use:

Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 1 or 2 minutes to allow the medicine to come into contact with the infection. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out.

To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing

For otic solution (ear drops) dosage form:
- For infections of the ear canal:
  - Adults and children—Use 2 or 3 drops in the affected ear two to three times a day.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Sopamycetin

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

Sopamycetin Side Effects

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

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

Rare - may also occur weeks or months after you stop using this medicine

Bluish tone to the skin

changes in blood pressure or heart rate

eating problems

irregular breathing

pale skin

passage of loose green stools

sore throat and fever

stomach bloating with or without vomiting

unusual bleeding or bruising

unusual tiredness or weakness

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

Less common

Blindness or changes in vision

burning, itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine

diarrhea

fever

hallucinations

headache

mental confusion

mild depression

nausea

stomach pain

swollen mouth and tongue

unpleasant taste

vomiting

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.

More Sopamycetin Otic resources

Sopamycetin Otic Drug Interactions
Sopamycetin Otic Support Group
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Thursday, September 20, 2012

Tarceva

Generic Name: erlotinib hydrochloride

Dosage Form: tablets
FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE

Non-Small Cell Lung Cancer (NSCLC)

Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen [see Clinical Studies (14.1)].

Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting [see Clinical Studies (14.3)].

Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.3)].

2. DOSAGE AND ADMINISTRATION

Recommended Dose - NSCLC

The recommended daily dose of Tarceva for non-small cell lung cancer is 150 mg taken at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity occurs. There is no evidence that treatment beyond progression is beneficial.

Recommended Dose - Pancreatic Cancer

The recommended daily dose of Tarceva for pancreatic cancer is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the gemcitabine package insert). Treatment should continue until disease progression or unacceptable toxicity occurs.

Dose Modifications

In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment with Tarceva should be interrupted pending diagnostic evaluation. If Interstitial Lung Disease (ILD) is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as necessary [see Warnings and Precautions (5.1)].

Diarrhea can usually be managed with loperamide. Patients with severe diarrhea who are unresponsive to loperamide or who become dehydrated may require dose reduction or temporary interruption of therapy. Patients with severe skin reactions may also require dose reduction or temporary interruption of therapy.

When dose reduction is necessary, the Tarceva dose should be reduced in 50 mg decrements.

In patients who are taking Tarceva with a strong CYP3A4 inhibitor such as, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, or grapefruit or grapefruit juice, a dose reduction should be considered if severe adverse reactions occur. Similarly, in patients who are taking Tarceva with an inhibitor of both CYP3A4 and CYP1A2 like ciprofloxacin, a dose reduction of Tarceva should be considered if severe adverse reactions occur. [see Drug Interactions (7)].

Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3 to 4/5. Use of alternative treatments lacking CYP3A4 inducing activity is strongly recommended. If an alternative treatment is unavailable, an increase in the dose of Tarceva should be considered as tolerated at two week intervals while monitoring the patient’s safety. The maximum dose of Tarceva studied in combination with rifampicin is 450 mg. If the Tarceva dose is adjusted upward, the dose will need to be reduced immediately to the indicated starting dose upon discontinuation of rifampicin or other inducers. Other CYP3A4 inducers include, but are not limited to rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort. These too should be avoided if possible [see Drug Interactions (7)].

Cigarette smoking has been shown to reduce erlotinib exposure. Patients should be advised to stop smoking. If a patient continues to smoke, a cautious increase in the dose of Tarceva, not exceeding 300 mg may be considered, while monitoring the patient’s safety. However, efficacy and long-term safety (> 14 days) of a dose higher than the recommended starting doses have not been established in patients who continue to smoke cigarettes. If the Tarceva dose is adjusted upward, the dose should be reduced immediately to the indicated starting dose upon cessation of smoking [see Clinical Pharmacology (12.3)].

Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh B), patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B and C) should be closely monitored during therapy with Tarceva [see WARNINGS and PRECAUTIONS (5.2 )]. Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range. In the setting of worsening liver function tests, before they become severe, dose interruption and/or dose reduction with frequent liver function test monitoring should be considered. Tarceva dosing should be interrupted or discontinued if total bilirubin is >3 x ULN and/or transaminases are >5 x ULN in the setting of normal pretreatment values [see Warnings and Precautions (5.2 , 5.3 ), Adverse Reactions (6.3) and Use in Specific Populations (8.6 )].

3. DOSAGE FORMS AND STRENGTHS

25 mg tablets

White film-coated tablets for daily oral administration. Round, biconvex face and straight sides, white film-coated, printed in orange with a “T” and “25” on one side and plain on the other side.

100 mg tablets

White film-coated tablets for daily oral administration. Round, biconvex face and straight sides, white film-coated, printed in gray with “T” and “100” on one side and plain on the other side.

150 mg tablets

White film-coated tablets for daily oral administration. Round, biconvex face and straight sides, white film-coated, printed in maroon with “T” and “150” on one side and plain on the other side.

4. CONTRAINDICATIONS

None.

5. WARNINGS AND PRECAUTIONS

Pulmonary Toxicity

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors. In the randomized single-agent NSCLC study [see CLINICAL STUDIES (14.1)], the incidence of ILD-like events (0.8%) was the same in both the placebo and Tarceva groups. In the pancreatic cancer study - in combination with gemcitabine – [see Clinical Studies (14.3)], the incidence of ILD-like events was 2.5% in the Tarceva plus gemcitabine group vs. 0.4% in the placebo plus gemcitabine group.

The overall incidence of ILD-like events in approximately 4900 Tarceva-treated patients from all studies (including uncontrolled studies and studies with concurrent chemotherapy) was approximately 0.7%. Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome and lung infiltration. Symptoms started from 5 days to more than 9 months (median 39 days) after initiating Tarceva therapy. In the lung cancer trials most of the cases were associated with confounding or contributing factors such as concomitant/prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections.

In the event of an acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever, Tarceva therapy should be interrupted pending diagnostic evaluation. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed [see Dosage and Administration (2.3 )].

Patients with Hepatic Impairment

In a pharmacokinetic study in patients with moderate hepatic impairment (Child-Pugh B) associated with significant liver tumor burden, 10 out of 15 patients died on treatment or within 30 days of the last Tarceva dose. One patient died from hepatorenal syndrome, 1 patient died from rapidly progressing liver failure and the remaining 8 patients died from progressive disease. Six out of the 10 patients who died had baseline total bilirubin > 3 x ULN suggesting severe hepatic impairment. Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B and C) should be closely monitored during therapy with Tarceva. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range [see Clinical Pharmacology (12.3) and Dosage and Administration (2.3 )].

Hepatotoxicity

Cases of hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Therefore, periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) is recommended. In the setting of worsening liver function tests, dose interruption and/or dose reduction with frequent liver function test monitoring should be considered. Tarceva dosing should be interrupted or discontinued if total bilirubin is >3 x ULN and/or transaminases are >5 x ULN in the setting of normal pretreatment values [see Adverse Reactions (6.3) and Dosage and Administration (2.3 )].

Renal Failure

Cases of hepatorenal syndrome, acute renal failure (including fatalities), and renal insufficiency have been reported. Some were secondary to baseline hepatic impairment while others were associated with severe dehydration due to diarrhea, vomiting, and/or anorexia or concurrent chemotherapy use. In the event of dehydration, particularly in patients with contributing risk factors for renal failure (eg, pre-existing renal disease, medical conditions or medications that may lead to renal disease, or other predisposing conditions including advanced age), Tarceva therapy should be interrupted and appropriate measures should be taken to intensively rehydrate the patient. Periodic monitoring of renal function and serum electrolytes is recommended in patients at risk of dehydration [see Adverse Reactions (6.3) and Dosage and Administration (2.3 )].

Myocardial infarction/ischemia

In the pancreatic carcinoma trial, six patients (incidence of 2.3%) in the Tarceva/gemcitabine group developed myocardial infarction/ischemia. One of these patients died due to myocardial infarction. In comparison, 3 patients in the placebo/gemcitabine group developed myocardial infarction (incidence 1.2%) and one died due to myocardial infarction.

Cerebrovascular accident

In the pancreatic carcinoma trial, six patients in the Tarceva/gemcitabine group developed cerebrovascular accidents (incidence: 2.3%). One of these was hemorrhagic and was the only fatal event. In comparison, in the placebo/gemcitabine group there were no cerebrovascular accidents.

Microangiopathic Hemolytic Anemia with Thrombocytopenia

In the pancreatic carcinoma trial, two patients in the Tarceva/gemcitabine group developed microangiopathic hemolytic anemia with thrombocytopenia (incidence: 0.8%). Both patients received Tarceva and gemcitabine concurrently. In comparison, in the placebo/gemcitabine group there were no cases of microangiopathic hemolytic anemia with thrombocytopenia.

Use in Pregnancy

Pregnancy Category D

Women of childbearing potential should avoid becoming pregnant while being treated with Tarceva. Erlotinib administered to rabbits during organogenesis at doses that result in plasma drug concentrations of approximately 3 times those in humans (AUCs at 150 mg daily dose) was associated with embryo/fetal lethality and abortion. When erlotinib was administered to female rats prior to mating and through the first week of pregnancy, at doses 0.3 or 0.7 times the clinical dose of 150 mg, on a mg/m2 basis, there was an increase in early resorptions that resulted in a decrease in the number of live fetuses. [see Use in Specific Populations (8.1)]

Elevated International Normalized Ratio and Potential Bleeding

International Normalized Ratio (INR) elevations and infrequent reports of bleeding events including gastrointestinal and non-gastrointestinal bleedings have been reported in clinical studies, some associated with concomitant warfarin administration. Patients taking warfarin or other coumarin-derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR. [see Adverse Reactions (6.3)].

6. ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety evaluation of Tarceva is based on 856 cancer patients who received Tarceva as monotherapy, 308 patients who received Tarceva 100 or 150 mg plus gemcitabine, and 1228 patients who received Tarceva concurrently with other chemotherapies.

There have been reports of serious events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors [see Warnings and Precautions (5) and Dosage and Administration (2.3 )].

Non-Small Cell Lung Cancer

Adverse events, regardless of causality, that occurred in at least 10% of patients treated with single-agent Tarceva at 150 mg and at least 3% more often than in the placebo group in the randomized trial of patients with NSCLC are summarized by NCI-CTC (version 2.0) Grade in Table 1.

The most common adverse reactions in patients receiving single-agent Tarceva 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9% and 6%, respectively, in Tarceva-treated patients. Rash and diarrhea each resulted in study discontinuation in 1% of Tarceva-treated patients. Six percent and 1% of patients needed dose reduction for rash and diarrhea, respectively. The median time to onset of rash was 8 days, and the median time to onset of diarrhea was 12 days.

Table 1: Adverse Reactions Occurring More Frequently (≥ 3%) in the Single Agent Tarceva Group than in the Placebo Group and in ≥10% of Patients in the Tarceva Group.
	Tarceva 150 mg N = 485			Placebo N = 242
NCI-CTC Grade	Any Grade	Grade 3	Grade 4	Any Grade	Grade 3	Grade 4
MedDRA Preferred Term	%	%	%	%	%	%
Rash	75	8	<1	17	0	0
Diarrhea	54	6	<1	18	<1	0
Anorexia	52	8	1	38	5	<1
Fatigue	52	14	4	45	16	4
Dyspnea	41	17	11	35	15	11
Cough	33	4	0	29	2	0
Nausea	33	3	0	24	2	0
Infection	24	4	0	15	2	0
Vomiting	23	2	<1	19	2	0
Stomatitis	17	<1	0	3	0	0
Pruritus	13	<1	0	5	0	0
Dry skin	12	0	0	4	0	0
Conjunctivitis	12	<1	0	2	<1	0
Keratoconjunctivitis sicca	12	0	0	3	0	0
Abdominal pain	11	2	<1	7	1	<1

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) were observed in patients receiving single-agent Tarceva 150 mg. These elevations were mainly transient or associated with liver metastases. Grade 2 (>2.5 – 5.0 x ULN) ALT elevations occurred in 4% and <1% of Tarceva and placebo treated patients, respectively. Grade 3 (>5.0 – 20.0 x ULN) elevations were not observed in Tarceva-treated patients. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe. [see Dosage and Administration (2.3)]

Pancreatic Cancer

Adverse events, regardless of causality, that occurred in at least 10% of patients treated with Tarceva 100 mg plus gemcitabine in the randomized trial of patients with pancreatic cancer are summarized by NCI-CTC (version 2.0) Grade in Table 2.

The most common adverse reactions in pancreatic cancer patients receiving Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea. In the Tarceva plus gemcitabine arm, Grade 3/4 rash and diarrhea were each reported in 5% of Tarceva plus gemcitabine-treated patients. The median time to onset of rash and diarrhea was 10 days and 15 days, respectively. Rash and diarrhea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine. The 150 mg cohort was associated with a higher rate of certain class-specific adverse reactions including rash and required more frequent dose reduction or interruption.

Table 2: Adverse Reactions Occurring in ≥ 10% of Tarceva-treated Pancreatic Cancer Patients: 100 mg cohort
*Includes all MedDRA preferred terms in the Infections and Infestations System Organ Class
	Tarceva + Gemcitabine 1000 mg/m2 IV N=259			Placebo + Gemcitabine 1000 mg/m2 IV N=256
NCI-CTC Grade	Any Grade	Grade 3	Grade 4	Any Grade	Grade 3	Grade 4
MedDRA Preferred Term	%	%	%	%	%	%
Fatigue	73	14	2	70	13	2
Rash	69	5	0	30	1	0
Nausea	60	7	0	58	7	0
Anorexia	52	6	<1	52	5	<1
Diarrhea	48	5	<1	36	2	0
Abdominal pain	46	9	<1	45	12	<1
Vomiting	42	7	<1	41	4	<1
Weight decreased	39	2	0	29	<1	0
Infection*	39	13	3	30	9	2
Edema	37	3	<1	36	2	<1
Pyrexia	36	3	0	30	4	0
Constipation	31	3	1	34	5	1
Bone pain	25	4	<1	23	2	0
Dyspnea	24	5	<1	23	5	0
Stomatitis	22	<1	0	12	0	0
Myalgia	21	1	0	20	<1	0
Depression	19	2	0	14	<1	0
Dyspepsia	17	<1	0	13	<1	0
Cough	16	0	0	11	0	0
Dizziness	15	<1	0	13	0	<1
Headache	15	<1	0	10	0	0
Insomnia	15	<1	0	16	<1	0
Alopecia	14	0	0	11	0	0
Anxiety	13	1	0	11	<1	0
Neuropathy	13	1	<1	10	<1	0
Flatulence	13	0	0	9	<1	0
Rigors	12	0	0	9	0	0

In the pancreatic carcinoma trial, 10 patients in the Tarceva/gemcitabine group developed deep venous thrombosis (incidence: 3.9%). In comparison, 3 patients in the placebo/gemcitabine group developed deep venous thrombosis (incidence 1.2%). The overall incidence of grade 3 or 4 thrombotic events, including deep venous thrombosis, was similar in the two treatment arms: 11% for Tarceva plus gemcitabine and 9% for placebo plus gemcitabine.

No differences in Grade 3 or Grade 4 hematologic laboratory toxicities were detected between the Tarceva plus gemcitabine group compared to the placebo plus gemcitabine group.

Severe adverse events (≥grade 3 NCI-CTC) in the Tarceva plus gemcitabine group with incidences < 5% included syncope, arrhythmias, ileus, pancreatitis, hemolytic anemia including microangiopathic hemolytic anemia with thrombocytopenia, myocardial infarction/ischemia, cerebrovascular accidents including cerebral hemorrhage, and renal insufficiency [see Warnings and Precautions (5)].

Liver function test abnormalities (including elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) have been observed following the administration of Tarceva plus gemcitabine in patients with pancreatic cancer. Table 3 displays the most severe NCI-CTC grade of liver function abnormalities that developed. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe [see Dosage and Administration (2.3)].

Table 3: Liver Function Test Abnormalities (most severe NCI-CTC grade) in Pancreatic Cancer Patients: 100 mg Cohort
	Tarceva + Gemcitabine 1000 mg/m2 IV N = 259			Placebo + Gemcitabine 1000 mg/m2 IV N = 256
NCI-CTC Grade	Grade 2	Grade 3	Grade 4	Grade 2	Grade 3	Grade 4
Bilirubin	17 %	10%	<1%	11%	10%	3%
ALT	31%	13%	<1%	22%	9%	0%
AST	24%	10%	<1%	19%	9%	0%

NSCLC and Pancreatic Cancer Indications

During the NSCLC and the combination pancreatic cancer trials, infrequent cases of gastrointestinal bleeding have been reported, some associated with concomitant warfarin or NSAID administration. [see Warnings and Precautions (5.9)]. These adverse events were reported as peptic ulcer bleeding (gastritis, gastroduodenal ulcers), hematemesis, hematochezia, melena and hemorrhage from possible colitis. Cases of acute renal failure or renal insufficiency, including fatalities, with or without hypokalemia have been reported. [see Warnings and Precautions (5.4)]. Cases of Grade 1 epistaxis were also reported in both the single-agent NSCLC and the pancreatic cancer clinical trials.

NCI-CTC Grade 3 conjunctivitis and keratitis have been reported infrequently in patients receiving Tarceva therapy in the NSCLC and pancreatic cancer clinical trials. Corneal ulcerations may also occur. [see Patient Counseling Information (17)].

Hair and nail disorders including alopecia, hirsutism, eyelash/eyebrow changes, paronychia and brittle and loose nails have been reported in clinical trials and during post-marketing use of Tarceva.

In patients who develop skin rash, the appearance of the rash is typically erythematous and maculopapular and it may resemble acne with follicular pustules, but is histopathologically different. This skin reaction commonly occurs on the face, upper chest and back, but may be more generalized or severe (NCI-CTC Grade 3 or 4) with desquamation. Associated symptoms may include itching, tenderness and/or burning. Dry skin with or without digital skin fissures may occur.

Hepatic failure has been reported in patients treated with single-agent Tarceva or Tarceva combined with chemotherapy in clinical studies and during post-marketing use of Tarceva [see Warnings and Precautions (5.3 )]; it is not possible to reliably estimate the frequency or establish a causal relationship to Tarceva treatment.

In general, no notable differences in the safety of Tarceva monotherapy or in combination with gemcitabine could be discerned between females or males and between patients younger or older than the age of 65 years [see Use in Specific Populations (8.4)]. The safety of Tarceva appears similar in Caucasian and Asian patients.

7. DRUG INTERACTIONS

Erlotinib is metabolized predominantly by CYP3A4, and inhibitors of CYP3A4 would be expected to increase exposure. Co-treatment with the potent CYP3A4 inhibitor ketoconazole increases erlotinib AUC by 2/3. When Tarceva was co-administered with ciprofloxacin, an inhibitor of both CYP3A4 and CYP1A2, the erlotinib exposure [AUC] and maximum concentration [Cmax] increased by 39% and 17% respectively. Caution should be used when administering or taking Tarceva with ketoconazole and other strong CYP3A4 inhibitors such as, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole and grapefruit or grapefruit juice. [see Dosage and Administration (2.3 )].

Pre-treatment with the CYP3A4 inducer rifampicin for 7 days prior to Tarceva decreased erlotinib AUC by about 2/3 to 4/5, which is equivalent to a dose of about 30 to 50 mg in NSCLC patients. In a separate study, treatment with rifampicin for 11 days, with co-administration of a single 450 mg dose of Tarceva on day 8 resulted in a mean erlotinib exposure (AUC) that was 57.6% of that observed following a single 150 mg Tarceva dose in the absence of rifampicin treatment [see Dose Modifications (2.3

Sunday, September 30, 2012

Tarka

Tarka is used for:

Do NOT use Tarka if:

Before using Tarka:

How to use Tarka:

Important safety information:

Possible side effects of Tarka:

If OVERDOSE is suspected:

General information:

More Tarka resources

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Simply Cough

Commonly used brand name(s)

Uses For Simply Cough

Before Using Simply Cough

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of dextromethorphan

Dosing

Missed Dose

Storage

Precautions While Using Simply Cough

Simply Cough Side Effects

More Simply Cough resources

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Wednesday, September 26, 2012

Torisel

Commonly used brand name(s)

Uses For Torisel

Before Using Torisel

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of Torisel

Precautions While Using Torisel

Torisel Side Effects

More Torisel resources

Compare Torisel with other medications

Friday, September 21, 2012

Sopamycetin Otic

Commonly used brand name(s)

Uses For Sopamycetin

Before Using Sopamycetin

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of chloramphenicol

Dosing

Missed Dose

Storage

Precautions While Using Sopamycetin

Sopamycetin Side Effects

More Sopamycetin Otic resources

Thursday, September 20, 2012

Tarceva

Non-Small Cell Lung Cancer (NSCLC)

Pancreatic Cancer

2. DOSAGE AND ADMINISTRATION

Recommended Dose - NSCLC

Recommended Dose - Pancreatic Cancer

Dose Modifications

3. DOSAGE FORMS AND STRENGTHS

4. CONTRAINDICATIONS

5. WARNINGS AND PRECAUTIONS

Pulmonary Toxicity