Drug Info

Brand Name: Symbyax
Other brand Name(s):
Generic Name(s):
Generic Ingredient(s): Olanzapine and Fluoxetine

Patient Information Sheet from the US Food and Drug Administration

Olanzapine/Fluoxetine (marketed as Symbyax)

This is a summary of the most important information about Symbyax. For details, talk to your healthcare professional.

FDA ALERT [7/2006] – Possible Life-Threatening Serotonin Syndrome When Used With Triptan Medicines

A life-threatening condition called serotonin syndrome can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, one of the medicines in Symbyax, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together. Signs and symptoms of serotonin syndrome include the following:

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. This information comes from reports sent to FDA and knowledge of how these medicines work. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Before you take Symbyax and a triptan together, talk to your healthcare professional. If you must take these medicines together, be aware of the possibility of serotonin syndrome, and get medical care right away if you think serotonin syndrome is happening to you.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

FDA ALERT [7/2006] – Infant Persistent Pulmonary Hypertension

The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal.

Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.

The study results showed that:

• babies born to mothers who took selective serotonin reuptake inhibitors (SSRIs), one of the medicines in Symbyax,
• 20 weeks or later in their pregnancies,
• had a higher chance (were 6 times as likely) to have persistent pulmonary hypertension (PPHN),
• than babies born to mothers who did not take antidepressants during pregnancy.

The FDA plans to further look at the role of SSRIs in babies with PPHN.

Talk to your doctor if you are taking Symbyax and are pregnant or are planning to have a baby. You and your doctor will need to talk about the best way to treat your depression during pregnancy.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

What is Symbyax?

• Symbyax contains two medicines, olanzapine and fluoxetine. Olanzapine is in a class of medications called atypical antipsychotics. Antipsychotic medicines are used to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness. Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It is used to treat depression, obsessive-compulsive disorder, bulimia, and panic disorder.
• Symbyax is used to treat adults who have depression with bipolar disorder. Bipolar disorder is a mental illness that causes extreme mood swings.

Who Should Not Take Symbyax?

Never take Symbyax if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Symbyax close in time to an MAOI can result in serious, sometimes fatal, reactions, including:

• High body temperature
• Coma
• Seizures (convulsions)

Do not take a MAOI within 5 weeks of stopping Symbyax. MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Never take Symbyax if you are taking Mellaril (thioridazine), used to treat schizophrenia. Also, do not take Mellaril within 5 weeks of stopping Symbyax. Taking Symbyax close in time to Mellaril can result in serious heart beat problems.

What are The Risks?

The following are the risks and potential side effects of Symbyax therapy. However, this list is not complete.

Symbyax can cause serious problems such as:

• Suicidal thoughts or actions. Persons taking Symbyax may be more likely to think about killing themselves or actually try to do so, especially when Prozac is first started or the dose is changed. People close to persons taking Prozac can help by paying attention to changes in user’s moods or actions. Contact your healthcare professional right away if someone using Prozac talks about or shows signs of killing him or herself. If you are taking Prozac yourself and you start thinking about killing yourself, tell your healthcare professional about this side effect right away.
  
  
• Increased chance of death in elderly persons. Elderly patients treated with atypical antipsychotics, such as Symbyax, for dementia had a higher chance for death than patients who did not take the medicine. Symbyax is not approved for dementia.
  
  
• A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
• A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
  
  
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
• Strokes have happened in older patients treated for mental illness from dementia. Symbyax is not approved for this use.
  
  
• Bleeding problems. Symbyax may cause bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal antiinflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding.
  
  
• Sexual problems. You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).
  

• Mania. You may become hyperactive, excitable or elated.
  
  
• Low salt levels in the blood. Weakness, confusion, or trouble thinking can be caused by low salt levels in the blood.
  
  
• Other serious side effects may include low blood pressure seen as dizziness, and possibly fainting; increased heart beat; seizures; liver problems; increased body temperature; and difficulty swallowing.
  
  
• The most common side effects include sleepiness, dry mouth, dizziness, restlessness, diarrhea, weight gain, increased appetite, and tremor.

What Should I Tell My Healthcare Professional?

Before you start taking Symbyax, tell your healthcare professional if you:

• have or had heart problems
• have or had seizures.
• have or had diabetes or increased blood sugar
• have or had liver disease
• are trying to become pregnant, are already pregnant, or are breast-feeding.
• are taking fluoxetine, Prozac, Prozac Weekly, Sarafem, olanzapine, Zyprexa, or Zyprexa Zydis. These medicines each contain an ingredient that is also found in Symbyax.
• drink alcohol

Are There Any Interactions With Drugs or Foods?

Because certain other medications can interact with Symbyax, review all medications that you are taking with your healthcare professional, including those that you take without a prescription.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following
medications:

• blood pressure medicines
• levodopa and other medicines called dopamine agonists
• omeprazole
• rifampin
• carbamazepine
• fluvoxamine
• clozapine
• haloperidol
• phenytoin
• lithium
• pimozide
• sumatriptan
• warfarin

Avoid drinking alcohol while taking Symbyax.

Is There Anything Else I Need to
Know?

• Dizziness, and sometimes fainting, caused by a drop in blood pressure may happen with Symbyax, especially when you first start taking this medicine or when the dose is increased.
• Symbyax may impair judgment, thinking, or motor skills. You should be careful in operating machinery, including automobiles, until you know how Symbyax affects you.
• It is important to avoid overheating and dehydration while taking Symbyax. Symbyax may make it harder to lower your body temperature.

Date created: April 2005, updated September 6, 2006

Brand Name: Tyzeka
Other brand Name(s):
Generic Name(s): Telbivudine
Generic Ingredient(s):

Patient Information Sheet from the US Food and Drug Administration

Telbivudine (marketed as Tyzeka)

This is a summary of the most important information about Tyzeka. For details, talk to your healthcare professional.

What Is Tyzeka?

Tyzeka is a prescription medicine used for chronic hepatitis B virus (HBV) in adults who also have active liver damage.

• Tyzeka will not cure HBV
• Tyzeka may lower the amount of HBV in the body
• Tyzeka may lower the ability of HBV to multiply and infect new liver cells
• Tyzeka may improve the condition of your liver
• Tyzeka does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Talk with your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them.
• Tyzeka has not been studied in children and is not recommended for anyone less than 16 years old

Who Should Not Take Tyzeka?

• You should not take Tyzeka if you are allergic to telbivudine or any of the other ingredients in Tyzeka.
• Tyzeca is not recommended for anyone less than 16 years old.

What Are The Risks?

The following are the major potential risks and side effects of Tyzeka therapy. However, this list is not complete.

Tyzeka can cause serious side effects such as:

• lactic acidosis. Some people who have taken medicines like Tyzeka have developed a serious condition called lactic acidosis. Lactic acidosis is build up of acid in the blood. It is a medical emergency and must be treated in the hospital. Call your health care professional right away if you get any of the following signs of lactic acidosis:
• you feel very weak or tired
• you have unusual muscle pain
• you have trouble breathing
• you have stomach pain with nausea and vomiting
• you feel cold, especially in your arms and legs
• you feel dizzy or light-headed
• you have a fast or irregular heartbeat
• liver problems.
  Some people who take medicines like Tyzeka have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your health care professional right away if you get any of the following signs of liver problems:
• your skin or the white part of your eyes turns yellow (jaundice)
• your urine turns dark
• your bowel movements (stools) turn light in color
• you don’t feel like eating food for several days or longer
• you feel sick to your stomach (nausea)
• you have lower stomach pain
• muscle pain, weakness, or tenderness (myopathy). Some people who have taken medicines like Tyzeka have developed persistent unexplained muscle pain, muscle weakness, or muscle tenderness. If you develop any of these symptoms, call your health care professional right away.
• worsening of hepatitis after stopping Tyzeka. Your hepatitis B infection may get worse or become very serious if you stop taking Tyzeka. You should:
• take your Tyzeka exactly as prescribed
• do not stop taking Tyzeka without talking to your healthcare professional
• be sure to refill your prescription or talk to your healthcare provider if you are running low on Tyzeka. Do not run out of Tyzeka.
• Your healthcare professional will need to monitor your health and do regular blood tests to check your liver if you stop taking Tyzeka. Tell your health care professional right away about any new or unusual symptoms that you notice after you stop taking Tyzeka.
• Some common side effects that may occur with Tyzeka include:
• tiredness
• headache
• fever
• muscle related symptoms
• stomach pain
• joint pain
• diarrhea
• cough

You should report any new or continuing symptom to your healthcare professional. This list of side effects is
not complete. Ask your doctor for more information. It is important to stay under your doctor’s care while taking Tyzeka. Your doctor will test the level of the hepatitis B virus in your blood regularly.

What should I Tell My Healthcare Professional?

Before you start taking Tyzeka, tell your healthcare professional about all of your medical conditions, including if you:

• have kidney problems. You may need a lower dose of Tyzeka.
  
• are pregnant or planning to become pregnant. It is not known if Tyzeka is safe to use during pregnancy. It is not known whether Tyzeka helps prevent a pregnant mother from passing HBV to her baby. You and your health care professional will need to decide if Tyzeka is right for you. If you use Tyzeka while you are pregnant, talk to your healthcare professional.
• are breast-feeding. It is not known if Tyzeka can pass into your breast milk or if it can harm your baby.

Can Other Medicines Or Food Affect Tyzeka?

Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Tyzeka may interact with other medicines that leave the body through the kidneys. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

How Do I Take Tyzeka?

• Take Tyzeka exactly as prescribed. Your healthcare professional will tell you how much Tyzeka to take.
• Do not change your dose or stop taking Tyzeka without talking to your doctor. Your hepatitis B symptoms may get worse or become very serious if you stop taking Tyzeka.
• If you forget to take Tyzeka, take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time. Call your healthcare professional if you are not sure what to do.
• When your supply of Tyzeka starts to run low, get more from your healthcare professional. Do not run out of Tyzeka.
• If you take more than the prescribed dose of Tyzeka, call your healthcare provider right away.

Link to Tyzeka's Approved Labeling

Date Approved: October, 2006

Date created: January 30, 2007

Brand Name: Xifaxan
Other brand Name(s):
Generic Name(s): Rifaximin
Generic Ingredient(s):

Consumer Information Sheet from the US Food and Drug Administration

Brand Name: Vyvanse
Other brand Name(s):
Generic Name(s): Lisdexamfetamine dimesylate
Generic Ingredient(s):

MEDICATION GUIDE from the US Food and Drug Administration

VYVANSE

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving
away Vyvanse may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Vyvanse?

Vyvanse should not be taken if you or your child:

● have heart disease or hardening of the arteries

● have moderate to severe high blood pressure

● have hyperthyroidism

● have an eye problem called glaucoma

● are very anxious, tense, or agitated

● have a history of drug abuse

● are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

● is sensitive to, allergic to, or had a reaction to other stimulant medicines

Vyvanse has not been studied in children less than 6 years old. Vyvanse is not recommended for use in children less than 3 years old.

Vyvanse may not be right for you or your child. Before starting Vyvanse tell your or your child’s doctor about all health conditions (or a family history of) including:

● heart problems, heart defects, high blood pressure

● mental problems including psychosis, mania, bipolar illness, or depression

● tics or Tourette’s syndrome

● liver or kidney problems

● thyroid problems

● seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Vyvanse be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.Vyvanse and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Vyvanse. Your doctor will decide whether Vyvanse can be taken with other medicines.

Especially tell your doctor if you or your child takes:

● anti-depression medicines including MAOIs

● anti-psychotic medicines

● lithium

● blood pressure medicines

● seizure medicines

● narcotic pain medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Vyvanse without talking to your doctor first.

How should Vyvanse be taken?

● Take Vyvanse exactly as prescribed. Vyvanse comes in 3 different strength capsules. Your doctor may adjust the dose until it is right for you or your child.

● Take Vyvanse once a day in the morning.

● Vyvanse can be taken with or without food.

● From time to time, your doctor may stop Vyvanse treatment for awhile to check ADHD symptoms.

● Your doctor may do regular checks of the blood, heart, and blood pressure while taking Vyvanse. Children should have their height and weight checked often while taking Vyvanse. Vyvanse treatment may be stopped if a problem is found during these check-ups.

● If you or your child takes too much Vyvanse or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Vyvanse? See “What is the most important information I should know about Vyvanse?” for information on reported heart and mental problems.

Other serious side effects include:

● slowing of growth (height and weight) in children

● seizures, mainly in patients with a history of seizures

● eyesight changes or blurred vision

Common side effects include:

● upper belly pain • decreased appetite

● dizziness • dry mouth

● irritability • trouble sleeping

● nausea • vomiting

● weight loss

Vyvanse may affect you or your child’s ability to drive or do other dangerous activities. Talk to your doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store Vyvanse?

• Store Vyvanse in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from light.

• Keep Vyvanse and all medicines out of the reach of children.

General information about Vyvanse

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Vyvanse for a condition for which it was not prescribed. Do not give Vyvanse to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Vyvanse. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Vyvanse that was written for healthcare professionals.

For more information about Vyvanse, please contact Shire US Inc. at 1-800-828-2088 or visit www.Vyvanse.com.

What are the ingredients in Vyvanse?

Active Ingredient:
lisdexamfetamine dimesylate

Inactive Ingredients:
microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28, D&C Yellow #10, FC&C Blue #1 and FC&C red #40.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

2/23/2007

Brand Name: Tekturna
Other brand Name(s):
Generic Name(s): Aliskiren
Generic Ingredient(s):

PATIENT INFORMATION from Novartis

Tekturna® (pronounced tek-turn-a)

(aliskiren)

Tablets

Dosing Strengths:

150 mg tablets

300 mg tablets

Available by Prescription Only

Please read all of the available information before you start taking Tekturna. This leaflet does not take the place of talking with your doctor about your condition and treatment. If you have any questions about Tekturna, ask your doctor or pharmacist, visit www.Tekturna.com, or call 1-888-Tekturna (1-888-835-8876).

IMPORTANT WARNING: If you get pregnant, stop taking Tekturna and call your doctor right away. Tekturna may harm an unborn baby, causing injury and even death. If you plan to become pregnant, talk to your doctor about other treatment options before taking Tekturna.

What Is High Blood Pressure (Hypertension)?

Blood pressure is the force that pushes the blood through your blood vessels to all the organs of your body. You have high blood pressure when the force of your blood moving through your blood vessels is too great. Renin (pronounced REE-nin) is a chemical in the body that starts a process that makes blood vessels narrow, leading to high blood pressure. High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

What Is Tekturna?

Tekturna is a type of prescription medicine called a direct renin inhibitor that works in the body to help lower blood pressure (hypertension).

How Does Tekturna Work?

Tekturna reduces the effect of renin and the harmful process that narrows blood vessels. Tekturna helps blood vessels relax and widen so blood pressure is lowered.

Who Should Not Take Tekturna?

· If you get pregnant,stop taking Tekturna and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure.

· Do not take Tekturna if you are allergic to any of its ingredients.

Aliskiren is the active ingredient in Tekturna. The inactive ingredients (the ingredients that bind the tablet together) are colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. These inactive ingredients are considered safe and are commonly used in many medications. Talk to your doctor if you have questions. Tekturna has not been studied in children under 18 years of age.

What Should I Tell My Doctor Before Taking Tekturna?

Tell your doctor about all your medical conditions, including whether you:

· are pregnant or planning to become pregnant.

· are breast-feeding. It is not known if Tekturna passes into your breast milk. You should choose either to take Tekturna or breast- feed, but not both.

· have kidney problems.

· are allergic to any of the ingredients in Tekturna.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

· other medicines for high blood pressure or a heart problem.

· water pills (also called “diuretics”).

· medicines for treating fungus or fungal infections.

Your doctor or pharmacist will know what medicines are safe to take together.

How Should I Take Tekturna?

· Take Tekturna once a day, at the same time each day. As with any blood pressure medication, it is important to take Tekturna on a regular daily basis exactly as prescribed by your doctor.

· Tekturna can be taken by itself or safely in combination with other medicines to lower high blood pressure. It can also be safely taken in combination with medications for other conditions such as high cholesterol or diabetes. Your doctor may change your dose if needed.

· Tekturna can be taken with or without food.

If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time. If you take too much Tekturna, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

What Are Possible Side Effects Of Tekturna?

Tekturna may cause the following serious side effect:

· Low blood pressure (hypotension).

Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy. Call your doctor right away.

Side effects were usually mild and brief. Few patients decided to stop taking Tekturna because of side effects. In clinical studies, the most common side effect experienced by more patients taking Tekturna than patients taking a sugar pill (placebo) was diarrhea. Other less common reactions to Tekturna include cough and rash.

If you develop an allergic reaction involving swelling of the face, lips, throat and/or tongue which may cause difficulty in breathing and swallowing, stop taking Tekturna and contact your doctor immediately.

For a complete list of side effects, ask your doctor or pharmacist. Tell your doctor if you get any side effect that bothers you or will not go away.

How Do I Store Tekturna?

· Store Tekturna tablets at room temperature between 59o to 86oF.

· Keep Tekturna in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.

· Keep Tekturna and all medicines out of the reach of children.

General Information About Tekturna

Do not give Tekturna to other people, even if they have the same condition or symptoms you have. It may harm them.

This leaflet summarizes the most important information about Tekturna.

For more information about Tekturna, ask your doctor or pharmacist, visit www.Tekturna.com, or call 1-888-Tekturna (1-888-835-8876).

MARCH 2007

Brand Name: Janumet
Other brand Name(s):
Generic Name(s):
Generic Ingredient(s): Sitagliptin, Metformin HCl

Patient Information from Merck & Co.

JANUMET™ (JAN-you-met)

Tablets

Read the Patient Information that comes with JANUMET before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

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

Metformin hydrochloride, one of the ingredients in JANUMET, can cause a rare but serious side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking JANUMET and call your doctor right away if you get any of the following symptoms of lactic acidosis:

• You feel very weak and tired.
• You have unusual (not normal)muscle pain.
• You have trouble breathing.
• You have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You have a slow or irregular heart beat.

You have a higher chance of getting lactic acidosis if you:

• have kidney problems.
• have liver problems.
• have congestive heart failure that requires treatment with medicines.
• drink a lot of alcohol (very often or short-term "binge" drinking).
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and don't drink enough fluids.
• have certain x-ray tests with injectable dyes or contrast agents.
• have surgery.
• have a heart attack, severe infection, or stroke.
• are 80 years of age or older and have not had your kidney function tested.

What is JANUMET?

JANUMET tablets contain two prescription medicines, sitagliptin (JANUVIA™) and metformin. JANUMET is used along with diet and exercise to lower blood sugar in patients with type 2 diabetes who have already been treated with either JANUVIA or metformin and their blood sugar is not controlled well enough, or patients who are currently taking both JANUVIA and metformin as separate medicines.

General information about the use of JANUMET:

• helps to improve the levels of insulin after a meal.
• helps the body respond better to the insulin it makes naturally.
• decreases the amount of sugar made by the body.
• is unlikely to cause low blood sugar (hypoglycemia).

JANUMET has not been studied in children under 18 years of age.

Who should not take JANUMET?

Do not take JANUMET if you:

• have type 1 diabetes.
• have certain kidney problems.
• have conditions called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
• are going to receive an injection of dye or contrast agents for an x-ray procedure, JANUMET will need to be stopped for a short time. Talk to your doctor about when to stop JANUMET and when to start again. See “What is the most important information I should know about JANUMET?”

What should I tell my doctor before and during treatment with JANUMET?

JANUMET may not be right for you. Tell your doctor about all of your medical conditions, including if you:

• have kidney problems.
• have liver problems.
• have heart problems, including congestive heart failure.
• are older than 80 years. Patients over 80 years should not take JANUMET unless their kidney function is checked and it is normal.
• drink alcohol a lot (all the time or short-term “binge” drinking).
• are pregnant or plan to become pregnant. It is not known if JANUMET will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant. If you use JANUMET during pregnancy, talk with your doctor about how you can be on the JANUMET registry. The toll-free telephone number for the pregnancy registry is 1-800-986-8999.
• are breast-feeding or plan to breast-feed. It is not known if JANUMET will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUMET.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JANUMET may affect how well other drugs work and some drugs can affect how well JANUMET works.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Talk to your doctor before you start any new medicine.

How should I take JANUMET?

• Your doctor will tell you how many JANUMET tablets to take and how often you should take them. Take JANUMET exactly as your doctor tells you.
• Your doctor may need to increase your dose to control your blood sugar.
• Take JANUMET with meals to lower your chance of an upset stomach.
• Continue to take JANUMET as long as your doctor tells you.
• If you take too much JANUMET, call your doctor or poison control center right away.
• If you miss a dose, take it with food as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of JANUMET at the same time.
• You may need to stop taking JANUMET for a short time. Call your doctor for instructions if you:
• are dehydrated (have lost too much body fluid). Dehydration can occur if you are sick with severe vomiting, diarrhea or fever, or if you drink a lot less fluid than normal.
• plan to have surgery.
• are going to receive an injection of dye or contrast agent for an x-ray procedure.

See “What is the most important information I should know about JANUMET?” and “Who should not take JANUMET?”

• When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
• Monitor your blood sugar as your doctor tells you to.
• Stay on your prescribed diet and exercise program while taking JANUMET.
• Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
• Your doctor will monitor your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
• Your doctor will do blood tests to check your kidney function before and during treatment with JANUMET.

What are the possible side effects of JANUMET?

JANUMET can cause serious side effects. See “What is the most important information I should know about JANUMET?”

Common side effects when taking JANUMET include:

• stuffy or runny nose and sore
  throat
• diarrhea
• nausea and vomiting
• gas, stomach discomfort, indigestion
• weakness
• headache

Taking JANUMET with meals can help reduce the common stomach side effects of metformin that usually occur at the beginning of treatment. If you have unusual or unexpected stomach problems, talk with your doctor. Stomach problems that start up later during treatment may be a sign of something more serious.

These are not all the possible side effects of JANUMET. For more information, ask your doctor.

Tell your doctor if you have any side effect that bothers you, is unusual, or does not go away.

How should I store JANUMET?

Store JANUMET at room temperature, 68-77ºF (20-25ºC).

Keep JANUMET and all medicines out of the reach of children.

General information about the use of JANUMET

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use JANUMET for a condition for which it was not prescribed. Do not give JANUMET to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about JANUMET. If you would like to know more information, talk with your doctor. You can ask your doctor or pharmacist for information about JANUMET that is written for health professionals. For more information go to www.JANUMET.com OR CALL 1-800-622-4477.

What are the ingredients in JANUMET?

Active ingredients: sitagliptin and metformin hydrochloride.

Inactive ingredients: microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and black iron oxide.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart problems, kidney problems, blindness, and amputation.

High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.

Issued March 2007

Brand Name: Invega
Other brand Name(s):
Generic Name(s): Paliperidone
Generic Ingredient(s):

Patient Information Sheet from the US Food and Drug Administration

Paliperidone (marketed as Invega)

This is a summary of the most important information about Invega. For details, talk to your healthcare professional.

What Is Invega?

Invega Extended-Release Tablets are used to treat schizophrenia. Invega is an atypical antipsychotic medicine.

Who Should Not Use Invega?

You should not take Invega if you are allergic to paliperidone, risperidone or to any of the ingredients in
Invega.

What Are The Risks?

The following are the major potential risks and side effects of Invega therapy. However, this list is not complete.

• Increased chance of death and strokes in elderly patients with dementia. Elderly patients with dementia who are treated with atypical antipsychotics, such as Invega, have a higher chance for death than patients who do not take these medicines. Invega is not approved to treat dementia.
• QT prolongation (a serious heart problem). Talk to your healthcare professional if you have or had any heart problems.
• Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem. NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Get medical help right away if you have these symptoms.
• Tardive dyskinesia (TD), a movement problem. Uncontrollable, slow or jerky facial or body movements that may not go away. Call your healthcare professional right away if you get muscle movements that cannot be stopped.
• High blood sugar and diabetes.
  These side effects may even lead to death in some patients. Patients with diabetes or those who have a higher chance for diabetes should have their blood sugar checked often.
• Dizziness and fainting, caused by a drop in blood pressure may happen with Invega, especially when you first start taking this medicine or when the dose is increased. Get up slowly when sitting or lying down.
• Impaired judgment, thinking, or motor skills. You should be careful when driving or using machines until you know how Invega affects you.
• Overheating and dehydration. Invega may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated. Be careful when exercising or doing activities in the heat.
• Other serious side effects may include: seizures, trouble swallowing, suicide, an erection that does not go away, and fever and bruising (thrombotic thrombocytopenic purpura).
• Some common side effects with Invega include: restlessness, involuntary movements, tremors and muscle stiffness, fast heart beat, headache, sleepiness, anxiety, dizziness, upset stomach and nausea.

What Should I Tell My Healthcare Professional?

Before you start taking Invega, tell your healthcare professional if you:

• have or had heart problems
• have or have had seizures
• have or had diabetes or increased blood sugar
• have or had liver disease
• have or had problems with your esophagus, stomach or small or large intestine
• drink alcohol
• are pregnant, trying to become pregnant, or are breast-feeding.

Invega has not been studied in children under 18 years of age.

Can Other Medicines Or Food Affect Invega?

Invega and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Invega may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Especially tell your healthcare professional if you take:

• blood pressure medicines
• levodopa and medicines called dopamine agonists

Avoid drinking alcohol while taking Invega.

How Should I Take Invega?

• Take Invega once a day in the morning.
• Swallow Invega tablets whole with water or other liquid. Do not chew, divide, or crush Invega tablets.
• Invega can be taken with or without food.
• The tablet shell will pass though your body and you may see it in your stool.

Link to Invega's Approved Labeling

Date Approved: December 19, 2006

Date created: March 30, 2007

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG)."


NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called “corticosteroids” and “anticoagulants”
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are use to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:

• about all of your medical conditions.
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant.
  NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding.
  Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one
  part or side of your body
• slurred speech
• swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

• nausea
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.



Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over–the–counter). Talk to your healthcare provider before using over–the–counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Date created: June 15, 2005

Brand Name: Januvia
Other brand Name(s):
Generic Name(s): Sitagliptin Phosphate
Generic Ingredient(s):

Patient Information Sheet from the US Food and Drug Administration

PDF Print Version

This is a summary of the most important information about Januvia. For details, talk to your healthcare professional.

What Is Januvia?

Januvia is a prescription medicine used along with diet and exercise to lower blood sugar in patients with type 2 diabetes mellitus (type 2 diabetes). Januvia may be taken alone or along with certain other medicines to control blood sugar.

• Januvia lowers blood sugar when blood sugar is high, especially after a meal.
• Januvia also lowers blood sugar between meals.
• Januvia helps to improve the levels of insulin produced by your own body after a meal.
• Januvia decreases the amount of sugar made by the body.
• Januvia is unlikely to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work when your blood sugar is low.

Januvia has not been studied in children under 18 years of age.

Januvia has not been studied with medicines known to cause low blood sugar, such as sulfonylureas or insulin. Ask your healthcare professional if you are taking a sulfonylurea or other medicine that can cause low blood sugar.

Who Should Not Take Januvia?

You should not take Januvia if you have any of the following conditions:

• type 1 diabetes mellitus
• diabetic ketoacidosis (increased ketones in the blood or urine)

What Are The Risks?

The most common side effects that may occur with Januvia include:

• upper respiratory infection
• stuffy or runny nose and sore throat
• headache

Januvia may occasionally cause stomach discomfort and diarrhea.

Tell your healthcare professional if you have any side effects that bothers you or that does not go away. Other side effects may occur when using Januvia. For more information, ask your healthcare professional.

What Should I Tell My Healthcare Professional?

Before you start taking Januvia, tell your healthcare professional if you:

• have any allergies
• have kidney problems
• are pregnant or plan to become pregnant, because Januvia may not be right for you. It is not known if Januvia will harm your unborn baby. If you are pregnant, talk with your healthcare professional about the best way to control your blood sugar while you are pregnant. If you use Januvia during pregnancy, talk with your healthcare professional about how you can be on the Januvia registry. The toll-free telephone number for the pregnancy registry is: 1-800-986-8999.
• are breast-feeding or plan to breast-feed. Januvia may be passed in your milk to your baby. Talk with your healthcare professional about the best way to feed your baby if you are taking Januvia.

During periods of stress on the body, such as fever, trauma, infection or surgery, your medication needs may change; contact your doctor right away.

Can Other Medicines Or Food Affect Januvia?

Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

How Should I Take Januvia?

• Take Januvia exactly as your healthcare professional tells you to take it.
• Take Januvia by mouth once a day.
• Take Januvia with or without food.
• If you have kidney problems, your doctor may prescribe lower doses of Januvia. Your healthcare professional may perform blood tests on you from time to time to measure how well your kidneys are working.
• Your healthcare professional may prescribe Januvia along with certain other medicines that lower blood sugar.

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of Januvia.

If you take too much Januvia, call your healthcare professional or local Poison Control Center right away.

Link to Januvia's
Approved Labeling

PDF requires the free Adobe Acrobat Reader

Back to Top Back to Drug Index

Date created: November 7, 2006,
updated December 4, 2006

Brand Name: Lucentis
Other Brand Name(s):
Generic Name(s): Ranibizumab
Generic Ingredient(s):

Patient Information Sheet from the US Food and Drug Administration

Ranibizumab (marketed as Lucentis)

This is a summary of the most important information about Lucentis. For details, talk to your eye surgeon.

What Is Lucentis?

Lucentis is a medicine injected into the eye for the treatment of wet age-related macular degeneration (AMD).

Lucentis has not been studied in children.

Who Should Not Be Treated With Lucentis?

You should not be given Lucentis if you have any of the following conditions:

• if you are allergic to Lucentis or any of its ingredients
• if you have an infection in or around the eye

What Are The Risks?

The following are the major potential risks and side effects of Lucentis therapy. However, this list is not complete.

• Serious eye infection
• Detached retina
• Increases in eye pressure
• Blood clots and bleeding in the eye
• Inflammation inside the eye

Call your eye doctor right away if your eye becomes sensitive to light, painful, or you develop a change
in vision during treatment with Lucentis.

Your eye doctor will carefully monitor your eye right after your injection and during the week following your
injection.

• Some common side effects that may occur with Lucentis include:
• blood in the eye
• red eye
• eye pain
• small specks in your vision

What Should I Tell My Ophthalmologist (Eye Surgeon)?

Before you start taking Lucentis,
tell your ophthalmologist if you:

• are trying to become pregnant, are already pregnant, or are breast-feeding
• are allergic to Lucentis or to any of the ingredients in Lucentis

Can Other Medicines Or Food Affect Lucentis?

Lucentis and certain other medicines can interact with each other. Some patients have developed a serious
eye inflammation when receiving treatment with both Lucentis and verteporfin (Visudyne) photodynamic therapy (PDT).

Tell your eye surgeon about all the medicines you take including prescription and non-prescription medicines including aspirin, vitamins, and herbal supplements. Some medicines may affect
how Lucentis works or Lucentis may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your ophthalmologist.

How Do I Receive Lucentis?

• Lucentis is usually injected into the eye once a month.
• Lucentis may be injected into the eye once every 3 months after the first 4 monthly injections, if once a month injections are not possible. This dosing schedule is less effective in treating wet age-related macular degeneration

FDA Approved: June 30, 2006

FDA Created: September 12, 2006