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rituximab

30/06/10

Generic Name: rituximab (ri TUX i mab)
Brand Names: Rituxan

What is rituximab?

Rituximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Rituximab is used in combination with other cancer medicines to treat non-Hodgkin’s lymphoma or chronic lymphocytic leukemia. Rituximab is also used in combination with another drug called methotrexate to treat symptoms of adult rheumatoid arthritis.

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

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

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop using this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using rituximab. Visit your doctor regularly.

Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

What should I discuss with my healthcare provider before receiving rituximab?

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

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

liver disease or hepatitis B (or if you are a carrier of hepatitis B);
kidney disease;
systemic lupus erythematosus (SLE);
lung disease or a breathing disorder;
a history of heart disease, angina (chest pain), or heart rhythm disorder; or
a recent or active infection, including herpes, shingles, cytomegalovirus, or any infection that keeps coming back or does not clear up.

FDA pregnancy category C. It is not known whether rituximab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether rituximab passes into breast milk or if it could harm a nursing baby. Do not take rituximab without telling your doctor if you are breast feeding a baby.

Older adults may be more likely to have side effects from rituximab, causing breathing difficulty or heart rhythm problems.

How is rituximab given?

Rituximab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Before you receive rituximab, you may be given other medications to prevent certain side effects that rituximab can cause.

The medicine is usually given once per week for 4 to 8 weeks. In the treatment of rheumatoid arthritis, you may receive only two injections of rituximab, with 2 weeks in between treatments.

If you take any medications for high blood pressure, your doctor may ask you not to take them within 12 hours before you receive rituximab. This is to prevent your blood pressure from getting too low during your rituximab infusion. Follow your doctor’s instructions.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using rituximab.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your rituximab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving rituximab?

Do not receive a “live” vaccine while you are being treated with rituximab.

Rituximab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Rituximab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly. Call your doctor at once if you have any of these serious side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

sudden numbness or weakness, especially on one side of the body;
confusion, dizziness, loss of balance, blurred vision, and problems with speech or walking; or
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
uneven heartbeats, wheezing or trouble breathing;
urinating more or less than usual;
fever, chills, cough, body aches, flu symptoms;
easy bruising or bleeding;
a red, raised, blistering, scaly, itchy, or peeling skin rash;
severe constipation or stomach pain;
black, bloody, or tarry stools; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

pain where the IV needle is placed;
headache, back pain;
mild stomach pain, nausea, or diarrhea;
swelling in your hands or feet;
muscle or joint pain;
runny or stuffy nose; or
night sweats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rituximab Dosing Information

Usual Adult Dose for non-Hodgkin’s Lymphoma:

Relapsed or Refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s Lymphoma:
375 mg/m2 IV infusion once weekly for 4 or 8 doses. Patients who subsequently develop progressive disease may be safely retreated with rituximab 375 mg/m2 IV infusion once weekly for 4 doses. Currently there are limited data concerning more than 2 courses.

Diffuse large B-cell non-Hodgkin’s Lymphoma:
375 mg/m2 IV per infusion given on day 1 of each cycle of chemotherapy for up to 8 infusions

As a required component of ibritumomab tiuxetan therapeutic regimen:
rituximab 250 mg/m2 should be infused within 4 hours prior to the administration of Indium-111- (In-111-) ibritumomab tiuxetan and within 4 hours prior to the administration of Yttrium90- (Y-90-) ibritumomab tiuxetan. Administration of rituximab and In-111-ibritumomab tiuxetan should precede rituximab and Y-90-ibritumomab tiuxetan by 7 to 9 days.
(Note: The ibritumomab tiuxetan therapeutic regimen is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma, including patients with rituximab-refractory follicular non-Hodgkin’s lymphoma.)

Usual Adult Dose for Rheumatoid Arthritis:

Rheumatoid Arthritis: Rituximab is given in combination with methotrexate. Rituximab is given as two-1000 mg IV infusions separated by 2 weeks. Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions. Safety and efficacy of retreatment have not been established in controlled trials.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

Recommended dose: 375 mg/m2 the day prior to the initiation of fludarabine and cyclophosphamide chemotherapy, then 500 mg/m2 on day 1 of cycles 2 to 6 (every 28 days)

Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

What other drugs will affect rituximab?

Tell your doctor about all other medicines you use, especially:

cisplatin (Platinol);
adalimumab (Humira);
auranofin (Ridaura);
azathioprine (Imuran);
cyclosporine (Gengraf, Neoral, Sandimmune);
etanercept (Enbrel);
infliximab (Remicade);
leflunomide (Arava);
minocycline (Dynacin, Minocin, Vectrin);
sulfasalazine (Azulfidine);
blood pressure medications; or
medication to treat malaria, such as chloroquine (Aralen) or hydroxychloroquine (Plaquenil, Quineprox).

This list is not complete and other drugs may interact with rituximab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about rituximab.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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rituximab (Intravenous route)

30/06/10

ri-TUX-i-mab

Intravenous routeSolution

Fatal Infusion Reaction, Tumor Lysis Syndrome (TLS), Severe Mucocutaneous Reactions, and Progressive Multifocal Leukoencephalopathy (PML)
Infusion Reactions
- Rituximab administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue rituximab infusion and provide medical treatment for Grade 3 or 4 infusion reactions.
Tumor Lysis Syndrome (TLS)
- Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) with rituximab monotherapy.
Severe Mucocutaneous Reactions
- Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab.
Progressive Multifocal Leukoencephalopathy (PML)
- JC virus infection resulting in PML and death can occur in patients receiving rituximab .

Fatal infusion reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue rituximab infusion for severe reactions. Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of tumor lysis syndrome following treatment with rituximab monotherapy in patients with non-Hodgkin’s lymphoma. Severe and potentially fatal mucocutaneous reactions can occur. JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can also occur .

Commonly used brand name(s):

In the U.S.

Rituxan

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For rituximab

Rituximab injection is a monoclonal antibody. It is used to treat a type of cancer called non-Hodgkin’s lymphoma (NHL). It can be used alone or with other cancer medicines (chemotherapy).

Rituximab is also used in combination with fludarabine and cyclophosphamide (FC) for the treatment of chronic lymphocytic leukemia (CLL).

Rituximab may also be used in combination with methotrexate to reduce the signs and symptoms of rheumatoid arthritis and help keep joint damage from getting worse after at least one other medicine (e.g., adalimumab, etanercept, infliximab) has been used and did not work well.

rituximab is to be administered only by or under the immediate supervision of your doctor.

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

Chronic lymphocytic leukemia (cancer of the blood and lymph system).
Immune or idiopathic thrombocytopenic purpura (ITP) (a blood disease).
Waldenstrom’s macroglobulinemia (cancer of the blood).

Before Using rituximab

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 rituximab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rituximab 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

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rituximab injection in the elderly. However, elderly patients are more likely to have infections and age-related heart and lung problems, which may require caution in patients receiving rituximab injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

Using rituximab 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.

Rotavirus Vaccine, Live

Using rituximab 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.

Atorvastatin
Bacillus of Calmette and Guerin Vaccine, Live
Cisplatin
Influenza Virus Vaccine, Live
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine
Varicella Virus Vaccine
Yellow Fever Vaccine

Using rituximab 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.

Pneumococcal Vaccine Polyvalent

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 rituximab

You will receive rituximab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you rituximab. rituximab is given through a needle placed in one of your veins.

Rituximab must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

rituximab should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using rituximab

It is very important that your doctor check your progress at regular visits to make sure that rituximab is working properly. Blood tests may be needed to check for unwanted effects.

rituximab may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using rituximab. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using rituximab. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

rituximab may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). The risk for getting this infection is higher if you have rheumatoid arthritis. Talk to your doctor about the benefits of taking rituximab and the risk of this infection. Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

Call your doctor right away if you start to have a cough that won’t go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

While you are being treated with rituximab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. If you have rheumatoid arthritis, non-live virus vaccines should be given at least 4 weeks before receiving rituximab. Rituximab may lower your body’s resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal flu virus vaccine). Try to avoid persons who have taken 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 wear a protective face mask that covers the nose and mouth.

Rituximab may cause chest pain, fever, chills, itching, hives, flushing of the face, rash, troubled breathing, or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

rituximab may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Serious skin reactions can occur during treatment with rituximab. Stop using rituximab and check with your doctor right away if you have any of the following symptoms while using rituximab: blistering, peeling, or loosening of the skin; red, swollen, irritated, or scaly skin; skin peeling or fissures; fingernail changes; or fever or chills.

Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

rituximab may cause serious stomach and bowel problems, especially when used with other cancer medicines. Check with your doctor right away if you start having stomach pain while being treated with rituximab.

Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are using rituximab and for 12 months after stopping it. Talk to your doctor about effective birth control.

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 or vitamin supplements.

rituximab 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

Abdominal or stomach pain
back pain
black, tarry stools
bleeding gums
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the urine or stools
blurred vision
body aches or pain
chest pain
confusion
convulsions
cough or hoarseness
difficulty with breathing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
dry mouth
ear congestion
fever and chills
flushed, dry skin
flushing of the face
fruit-like breath odor
headache
hives or welts
increased hunger
increased thirst
increased urination
itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lower back or side pain
nasal congestion
nausea
nervousness
noisy breathing
pain or tenderness around the eyes and cheekbones
painful or difficult urination
pale skin
pinpoint red spots on the skin
pounding in the ears
rapid weight gain
runny nose
shortness of breath
skin rash
slow or fast heartbeat
sneezing
sore throat
sores, ulcers, or white spots in the mouth or on the lips
stuffy or runny nose
sweating
swelling of the tongue or throat
swollen glands
tightness of the chest
tingling of the hands or feet
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight gain or loss
vomiting
wheezing

Less common

Blistering, peeling, or loosening of the skin
blisters in the mouth
blisters on the trunk, scalp, or other areas
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
burning, tingling, numbness or pain in the hands, arms, feet, or legs
decreased frequency and amount of urination
diarrhea
difficulty with moving
discouragement
feeling of warmth
feeling sad or empty
increased thirst
irregular heartbeat
irritability
joint or muscle pain
loss of appetite
loss of interest or pleasure
muscle cramps
muscle pain or stiffness
nervousness
numbness or tingling in the hands, feet, or lips
pain at the place of injection
pain, swelling, or redness in the joints
red skin lesions, often with a purple center
red, itchy lining of the eye
redness of the face, neck, arms and occasionally, upper chest
stabbing pain
swelling of the face or fingers
swelling of the feet or lower legs
trouble concentrating
trouble sleeping

Incidence not known

Abdominal or stomach cramps or pain
blindness
blue-yellow color blindness
blurred vision or other change in vision
burning or stinging of the skin
decreased vision
dilated neck veins
dry cough
extreme fatigue
eye pain, tearing
general feeling of discomfort, illness, or weakness
irregular breathing
nosebleed
painful cold sores or blisters on the lips, nose, eyes, or genitals
redness of the eye
redness, soreness, or itching of the skin
sensitivity of the eye to light
severe abdominal or stomach pain
severe vomiting, sometimes with blood
sores, welting, or blisters
swelling, stiffness, redness, or warmth around many joints
swollen and inflamed joints
swollen lymph glands
vision loss

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

More common

Fear
increased cough
lack or loss of strength
muscle aching or cramping
night sweats
swollen joints
throat irritation

Less common

Agitation or anxiety
change in taste
dry eyes
excessive muscle tone
feeling of constant movement of self or surroundings
heartburn
increase in body movements
lightheadedness
muscle tension
pain or redness at the injection site
sensation of spinning
sleepiness
swelling of the stomach

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

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

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

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rivastigmine

30/06/10

Generic Name: rivastigmine (ri va STIG meen)
Brand Names: Exelon

What is rivastigmine?

Rivastigmine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Rivastigmine is used to treat mild to moderate dementia caused by Alzheimer’s or Parkinson’s disease.

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

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

Before taking rivastigmine, tell your doctor if you have a heart rhythm disorder such as “sick sinus syndrome” (slow heartbeats), an enlarged prostate, urination problems, asthma, obstructive pulmonary disease, or a seizure disorder such as epilepsy.

Stop using rivastigmine and call your doctor at once if the medicine causes you to have stomach pain, nausea and vomiting, and loss of appetite.

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

It is important to use rivastigmine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you stop taking rivastigmine for any reason, do not restart the medication without talking to your doctor first. You may need to restart treatment with a lower dose.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking rivastigmine.

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

What should I discuss with my healthcare provider before taking rivastigmine?

Before taking rivastigmine, tell your doctor if you have:

a heart rhythm disorder such as “sick sinus syndrome” (slow heartbeats);
an enlarged prostate or urination problems;
epilepsy or other seizure disorder; or
asthma or obstructive pulmonary disease.

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

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rivastigmine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take rivastigmine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

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

Rivastigmine is usually taken twice a day, in the morning and evening. Follow your doctor’s directions.

Take rivastigmine with food.

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

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking rivastigmine. You may need to stop using the medicine for a short time.

Take the rivastigmine capsule with a full glass of water. Do not use a regular table spoon to measure a dose of rivastigmine oral liquid (solution). Use the syringe provided.

You may swallow the oral liquid directly from the syringe or mix the medicine with a small glass of water, fruit juice, or soda. Do not use any other liquids to mix with rivastigmine oral liquid.

Stir the medicine mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

After using the syringe, wipe the outside of it with a clean tissue and put the syringe back into its case. Close the medicine bottle using the child resistant closure.

It is important to use rivastigmine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you stop taking rivastigmine for any reason, do not restart the medication without talking to your doctor first. You may need to restart treatment with a lower dose.

Store rivastigmine at room temperature away from moisture and heat in an upright position.

What happens if I miss a dose?

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

If you miss several doses in a row, call your doctor before taking any more of this medication.

What happens if I overdose?

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

Overdose symptoms may include severe nausea, vomiting, drooling, sweating, blurred vision, feeling light-headed, slow heartbeat, shallow breathing, muscle weakness, fainting, or seizure (convulsions).

What should I avoid while taking rivastigmine?

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

Rivastigmine side effects

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

stomach pain, nausea and vomiting, loss of appetite;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like blood or coffee grounds;
feeling light-headed, fainting;
chest pain;
confusion, agitation, extreme fear; or
pain or burning when you urinate.

Less serious side effects may include:

upset stomach, diarrhea;
weight loss;
weakness, dizziness;
swelling in your hands or feet;
joint pain;
cough, runny or stuffy nose;
increased sweating;
sleep problems (insomnia); or
headache.

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

Rivastigmine Dosing Information

Usual Adult Dose for Alzheimer’s Disease:

Initial Oral Dose: 1.5 mg orally twice a day with morning and evening meals.

After a minimum of two weeks of treatment, if the initial dosage is well tolerated, it may be increased to 3 mg twice a day. Subsequent increases to 4.5 mg and 6 mg twice a day should be attempted only after a minimum of 2 weeks at the previous dosage. The dosage of rivastigmine shown to be effective in controlled clinical trials is 3 to 6 mg twice a day. There is evidence from the clinical trials that dosages at the higher end of this range may be more beneficial.

Initial Patch Dose: 4.6 mg/24 hours

After a minimum of four weeks of treatment and if well tolerated, the dose of the patch be increased to 9.5 mg/24 hours, which is the recommended effective dose.

Maintenance Patch Dose: Dose increases should occur only after a minimum of four weeks at the previous dose, and only if the previous dose has been well tolerated. The maximum recommended dose is 9.5 mg/ 24 hours. Higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events.

Switching from Capsules or Oral Solution: Patients treated with capsules or oral solution may be switched to patches as follows:
A patient who is on a total daily dose of less than 6 mg of oral rivastigmine can be switched to patch dose of 4.6 mg/24 hours.
A patient who is on a total daily dose of 6 to 12 mg of oral rivastigmine may be directly switched to a patch dose of 9.5 mg/24 hours.
It is recommended to apply the first patch on the day following the last oral dose.

Usual Adult Dose for Parkinson’s Disease:

Initial dose: 1.5 mg orally twice a day with morning and evening meals

Subsequently, the dose may be increased to 3 mg orally twice a day and further to 4.5 mg twice a day and 6 mg twice a day (based on tolerability) with a minimum of 4 weeks at each dose.

Initial Patch Dose: 4.6 mg/24 hours

After a minimum of four weeks of treatment and if well tolerated, the dose of the patch be increased to 9.5 mg/24 hours, which is the recommended effective dose.

What other drugs will affect rivastigmine?

Before taking rivastigmine, tell your doctor if you are using any of the following drugs:

atropine (Donnatal, and others);
belladonna;
clidinium (Quarzan);
dicyclomine (Bentyl);
glycopyrrolate (Robinul);
hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);
mepenzolate (Cantil);
methantheline (Provocholine);
methscopolamine (Pamine);
propantheline (Pro-Banthine); or
scopolamine (Transderm-Scop).

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

Where can I get more information?

Your pharmacist can provide more information about rivastigmine.

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

Concise,R

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Rituxan

30/06/10

Generic Name: rituximab (ri TUX i mab)
Brand Names: Rituxan

What is rituximab?

Rituximab is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

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

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

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before receiving rituximab?

Do not receive this medication if you have ever had a severe allergic reaction to rituximab, or if you are allergic to mouse protein.

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

liver disease or hepatitis B (or if you are a carrier of hepatitis B);
kidney disease;
systemic lupus erythematosus (SLE);
lung disease or a breathing disorder;
a history of heart disease, angina (chest pain), or heart rhythm disorder; or
a recent or active infection, including herpes, shingles, cytomegalovirus, or any infection that keeps coming back or does not clear up.

Older adults may be more likely to have side effects from rituximab, causing breathing difficulty or heart rhythm problems.

How is rituximab given?

Rituximab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Before you receive rituximab, you may be given other medications to prevent certain side effects that rituximab can cause.

The medicine is usually given once per week for 4 to 8 weeks. In the treatment of rheumatoid arthritis, you may receive only two injections of rituximab, with 2 weeks in between treatments.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using rituximab.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your rituximab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving rituximab?

Do not receive a “live” vaccine while you are being treated with rituximab.

Rituximab side effects

sudden numbness or weakness, especially on one side of the body;
confusion, dizziness, loss of balance, blurred vision, and problems with speech or walking; or
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
uneven heartbeats, wheezing or trouble breathing;
urinating more or less than usual;
fever, chills, cough, body aches, flu symptoms;
easy bruising or bleeding;
a red, raised, blistering, scaly, itchy, or peeling skin rash;
severe constipation or stomach pain;
black, bloody, or tarry stools; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

pain where the IV needle is placed;
headache, back pain;
mild stomach pain, nausea, or diarrhea;
swelling in your hands or feet;
muscle or joint pain;
runny or stuffy nose; or
night sweats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rituximab?

Tell your doctor about all other medicines you use, especially:

cisplatin (Platinol);
adalimumab (Humira);
auranofin (Ridaura);
azathioprine (Imuran);
cyclosporine (Gengraf, Neoral, Sandimmune);
etanercept (Enbrel);
infliximab (Remicade);
leflunomide (Arava);
minocycline (Dynacin, Minocin, Vectrin);
sulfasalazine (Azulfidine);
blood pressure medications; or
medication to treat malaria, such as chloroquine (Aralen) or hydroxychloroquine (Plaquenil, Quineprox).

Where can I get more information?

Your doctor or pharmacist can provide more information about rituximab.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,R

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ritonavir

30/06/10

Generic Name: ritonavir (rit OH na vir)
Brand names: Norvir, Norvir Soft Gelatin

What is ritonavir?

Ritonavir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Ritonavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Ritonavir is not a cure for HIV or AIDS.

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

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

Life-threatening side effects may occur if you take ritonavir with alfuzosin (Uroxatral), amiodarone (Cordarone, Pacerone), bepridil (Vascor), flecainide (Tambocor), propafenone (Rythmol), quinidine (Quin-G), voriconazole (Vfend), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine.

There are many other medicines that can interact with ritonavir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What should I discuss with my healthcare provider before taking ritonavir?

You should not take ritonavir if you are allergic to it.

Do not take ritonavir with any of the following medications, or life-threatening side effects could occur:

alfuzosin (Uroxatral);
amiodarone (Cordarone, Pacerone);
cisapride (Propulsid);
flecainide (Tambocor);
lovastatin (Mevacor) or simvastatin (Zocor);
midazolam (Versed) or triazolam (Halcion);
pimozide (Orap);
propafenone (Rythmol);
quinidine (Quin-G);
sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);
St. John’s wort;
voriconazole (Vfend); or
ergot medicine such as ergotamine (Ergomar), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine).

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

liver disease (especially hepatitis B or C);
diabetes;
heart disease or heart rhythm disorder;
a bleeding disorder such as hemophilia; or
high cholesterol or triglycerides.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Ritonavir can make birth control pills or patches less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking ritonavir. You should not breast-feed while you are using ritonavir. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take ritonavir?

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

Ritonavir works best if you take it with food. Do not crush, chew, or break a ritonavir tablet. Swallow it whole. Shake ritonavir liquid well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Liquid ritonavir can be mixed with chocolate milk or a nutrition drink such as Ensure. Drink the mixture within 1 hour after mixing.

Use ritonavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor.

Your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Visit your doctor regularly.

Store ritonavir capsules in the refrigerator or at room temperature, away from heat or moisture. If you store the capsules at room temperature you must use them within 30 days. Store ritonavir tablets at room temperature away from heat or moisture. Store ritonavir liquid at room temperature with the cap tightly closed. Do not refrigerate.

See also: Ritonavir dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of ritonavir oral liquid could be fatal to a child.

What should I avoid while taking ritonavir?

If you also take didanosine (Videx), take it at least 2.5 hours before or after you take ritonavir.

Ritonavir oral liquid contains alcohol. Avoid drinking alcoholic beverages while using this medicine, and do not take disulfiram (Antabuse) or you could have an alcohol reaction. Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Ritonavir side effects

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

slow or uneven heart rate, feeling like you might pass out;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
increased urination or extreme thirst;
easy bruising or bleeding (nosebleed or bleeding gums);
signs of a new infection, such as fever or chills, cough, or flu symptoms;
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

mild nausea, vomiting, diarrhea, stomach pain;
numbness or tingling, especially around your mouth;
headache, mood changes; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ritonavir Dosing Information

Usual Adult Dose for HIV Infection:

As a pharmacokinetic booster for other protease inhibitors: 100 to 400 mg/day orally in 1 or 2 divided doses

FDA-approved dose:
Initial dose: 300 mg orally twice a day
Maintenance dose: Increase by 100 mg twice daily every 2 to 3 days to the full dose of 600 mg orally twice a day

Usual Pediatric Dose for HIV Infection:

Greater than 1 month:
Initial dose: 250 mg/m2 orally twice a day
Maintenance dose: Increase by 50 mg/m2 twice daily every 2 to 3 days to the full dose of 350 to 400 mg/m2 orally twice a day

If 400 mg/m2 twice a day is intolerable, the highest tolerated dose may be used for maintenance therapy in combination with other antiretrovirals; however, alternative therapy should be considered.

Maximum: 600 mg/dose

What other drugs will affect ritonavir?

Many drugs can interact with ritonavir. Below is just a partial list. Tell your doctor if you are using:

ADHD medication;
atovaquone (Malarone, Mepron) or quinine (Qualaquin);
dronabinol (Marinol);
maraviroc (Selzentry);
salmeterol (Advair, Serevent);
theophylline (Elixophyllin, Theo-24, Uniphyl);
steroid medication (prednisone, Advair, Flonase, Flovent, DexPak, Dexasone, Cortastat, and others);
an antibiotic (such as Biaxin, Mycobutin, Rifadin, Rimactane, Rifater);
an antifungal medication (such as Nizoral or Sporanox);
an antidepressant (Elavil, Vanatrip, Wellbutrin, Norpramin, nefazodone, Paxil, Zoloft, Desyrel, and others);
heart or blood pressure medication (Lopressor, Toprol, Blocadren, Norpace, Mexitil, digitalis, Lanoxin, Cartia, Cardizem, Plendil, Nifedical, Procardia, Calan, Covera, Isoptin, Verelan, and others);
cholesterol-lowering medicine (such as Lipitor, Zocor, Crestor);
medicines used to prevent organ transplant rejection;
any other HIV/AIDS medicines (especially Invirase, Prezista, Rescriptor, Lexiva, Crixivan, or Aptivus);
insulin or diabetes medication you take by mouth;
medicine to treat a psychiatric disorder;
erectile dysfunction medication (Viagra, Cialis, Levitra;
pain medication (such as Demerol, Darvon, Darvocet, Ultram, Ultracet);
a sedative (such as BuSpar, Tranxene, Prosom, Dalmane); or
seizure medications (such as Carbatrol, Tegretol, Lamictal, Klonopin, Depakote, Zarontin, Dilantin).

This list is not complete and many other medicines can interact with ritonavir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about ritonavir.

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

Concise,R

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ritonavir (Oral route)

30/06/10

rit-OH-na-vir

Oral routeCapsule, Liquid FilledSolutionTablet

Coadministration of ritonavir with sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs .

Commonly used brand name(s):

In the U.S.

Norvir

Available Dosage Forms:

Tablet
Capsule, Liquid Filled
Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For ritonavir

Ritonavir is used alone or in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Ritonavir will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Ritonavir will not keep you from spreading HIV to other people. People who receive ritonavir may continue to have other problems related to AIDS or HIV disease.

ritonavir is available only with your doctor’s prescription.

Before Using ritonavir

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 ritonavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ritonavir 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

Appropriate studies have not been performed on the relationship of age to the effects of ritonavir in infants younger than 1 month old. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of ritonavir have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of ritonavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ritonavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Using ritonavir 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.

Alfuzosin
Amiodarone
Astemizole
Bepridil
Cisapride
Conivaptan
Dihydroergotamine
Dronedarone
Encainide
Eplerenone
Ergoloid Mesylates
Ergonovine
Ergotamine
Flecainide
Lovastatin
Methylergonovine
Methysergide
Midazolam
Pimozide
Propafenone
Quinidine
Ranolazine
Sildenafil
Silodosin
Simvastatin
St John’s Wort
Terfenadine
Tolvaptan
Triazolam
Voriconazole

Using ritonavir 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.

Aprepitant
Bosentan
Colchicine
Dasatinib
Digoxin
Etravirine
Everolimus
Fentanyl
Fluticasone
Fusidic Acid
Garlic
Iloperidone
Ixabepilone
Lapatinib
Methylenedioxymethamphetamine
Nilotinib
Pazopanib
Rifabutin
Rifampin
Romidepsin
Salmeterol
Sunitinib
Tamsulosin
Temsirolimus
Topotecan
Venlafaxine
Vinblastine
Vincristine

Using ritonavir 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.

Acenocoumarol
Alprazolam
Amitriptyline
Amlodipine
Amprenavir
Bupropion
Carbamazepine
Cerivastatin
Clarithromycin
Clonazepam
Clozapine
Cyclosporine
Dalfopristin
Delavirdine
Desipramine
Dexamethasone
Didanosine
Diltiazem
Disopyramide
Docetaxel
Dutasteride
Efavirenz
Ethinyl Estradiol
Fluoxetine
Fosamprenavir
Imipramine
Indinavir
Itraconazole
Ketoconazole
Lamotrigine
Levonorgestrel
Levothyroxine
Maraviroc
Meperidine
Mestranol
Methadone
Methamphetamine
Metoprolol
Mexiletine
Nefazodone
Norelgestromin
Norethindrone
Norgestrel
Paroxetine
Phenobarbital
Phenytoin
Posaconazole
Prednisone
Quinupristin
Rifapentine
Risperidone
Tacrolimus
Tadalafil
Tenofovir Disoproxil Fumarate
Theophylline
Trazodone
Valproic Acid
Verapamil
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of ritonavir

Take ritonavir exactly as directed by your doctor. Do not change the dose or stop using ritonavir without checking first with your doctor. When your supply of ritonavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of ritonavir.

It is important that ritonavir be taken with food.

Swallow the tablet whole. Do not break, crush, or chew it.

For patients taking the oral liquid:

Shake the bottle well before using.
Use a specially marked measuring syringe or cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
You can mix the oral liquid with chocolate milk or nutritional drinks (such as Ensure® or Advera®) to make it taste better. You should drink ritonavir within one hour of mixing.

ritonavir works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. It is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses each day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Ritonavir must be taken with other medicines. Tell your doctor about all of the medications you are taking since the dose of ritonavir or other medications you take may need to be adjusted.

Read and follow carefully the patient information leaflet before starting ritonavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of ritonavir 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 ritonavir. 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 treatment of HIV infection:
- For oral dosage form (capsules):
  - Adults—600 milligrams (mg) two times a day.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage forms (solution or tablets):
  - Adults—600 milligrams (mg) two times a day.
  - Children 1 month of age and older—Dose is based on body size and must be determined by your doctor. The dose is 350 to 400 milligrams per square meter (mg/[m]2) of body size two times a day. However, the dose is usually not more than 600 mg two times a day.
  - Children up to 1 month of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ritonavir, 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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store the capsulesin the refrigerator. Store the oral liquid or tablets in a closed container at room temperature, away from heat and direct light. Do not refrigerate.

Precautions While Using ritonavir

It is very important that your doctor check the progress of you or your child at regular visits to make sure ritonavir is working properly. Blood tests may be needed to check for unwanted effects.

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

Do not use ritonavir if you or your child are also using alfuzosin (Uroxatral®), amiodarone (Cordarone®), astemizole (Hismanal®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, or Ergomar®), flecainide (Tambocor®), lovastatin (Mevacor®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), quinidine (Quinaglute®), sildenafil (Revatio®), simvastatin (Zocor®), terfenadine (Seldane®), triazolam (Halcion®), or voriconazole (Vfend®). Using these medicines together with ritonavir may increase your chance of having serious side effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Pancreatitis may occur while you are using ritonavir. Stop using ritonavir and check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

ritonavir may decrease the effects of some birth control pills. To avoid getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Serious skin reactions can occur with ritonavir. Check with your doctor right away if you or your child have any of the following symptoms while taking ritonavir: blistering, peeling, or loosening of the skin; fever; chills; cough; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; sore throat; sores, ulcers, or white spots in the mouth or on the lips; swelling of your hands, face, tongue, or throat; or unusual tiredness or weakness.

ritonavir may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you or your child have concerns.

ritonavir will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. ritonavir will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

ritonavir may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

ritonavir 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:

Less common

Fainting
feeling faint, dizzy, or lightheaded
feeling of warmth or heat
flushing or redness of the skin, especially on the face and neck
headache
sweating

Rare

Confusion
dehydration
dry or itchy skin
fruity mouth odor
increased hunger
increased thirst
increased urination
nausea
vomiting
weight loss

Incidence not known

Bloating
chills
constipation
convulsions
cough
darkened urine
decreased urination
difficulty with breathing
dry mouth
fast heartbeat
fever
hives or welts
increase in heart rate
indigestion
itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
loss of bladder control
muscle spasm or jerking of all extremities
noisy breathing
pains in the stomach, side, or abdomen, possibly radiating to the back
rapid breathing
redness of the skin
shortness of breath
skin rash
sudden loss of consciousness
sunken eyes
thirst
tightness in the chest
unusual tiredness or weakness
wheezing
wrinkled skin
yellow eyes or skin

More common

Acid or sour stomach
belching
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in sense of taste
diarrhea
dizziness
general feeling of discomfort or illness
heartburn
lack or loss of strength
sleepiness or unusual drowsiness
sleeplessness
trouble sleeping
unable to sleep
weakness

Less common

Body aches or pain
congestion
delusions
dementia
difficulty with moving
discouragement
dryness or soreness of the throat
excess air or gas in the stomach or intestines
fear
feeling sad or empty
full feeling
hoarseness
increased urge to urinate during the night
irritability
lack of appetite
loss of interest or pleasure
mood or mental changes
muscle pain or stiffness
nervousness
pain in the joints or in unspecified location
passing gas
runny nose
tender, swollen glands in the neck
throat irritation
tiredness
trouble concentrating
trouble with swallowing
voice changes
waking to urinate at night

Incidence not known

Gaining weight around your neck, upper back, breast, face, or waist

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

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

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Ritonavir Capsules

30/06/10

Generic Name: Ritonavir (rit-OH-na-vir)
Brand Name: Norvir

Use of ritonavir with certain nonsedating antihistamines (eg, astemizole, terfenadine), sedatives and tranquilizers (eg, midazolam, triazolam), heart medicines (antiarrhythmics such as bepridil, flecainide, propafenone, quinidine), or ergot-containing medicines may cause severe, even fatal, side effects. Tell your doctor if you use any of these types of medicines before taking ritonavir.

Ritonavir Capsules is used for:

Treating HIV in combination with other medicines.

Ritonavir Capsules is an HIV protease inhibitor. It works by blocking the growth of HIV.

Do NOT use Ritonavir Capsules if:

you are allergic to any ingredient in Ritonavir Capsules
you are taking alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, fluticasone, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, St. John’s wort, terfenadine, triazolam, or voriconazole

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

Before using Ritonavir Capsules:

Some medical conditions may interact with Ritonavir Capsules. 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 (including allergies to sulfas [eg, sulfamethoxazole], aspirin, or nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen]), foods, or other substances
if you have diabetes or high blood sugar, liver problems (eg, hepatitis B or C), hemophilia, high cholesterol or triglyceride levels, or a history of inflammation of the pancreas
if you have a history of heart problems (eg, heart failure, conduction abnormalities) or heart blood vessel problems
if you take another HIV protease inhibitor (eg, atazanavir, tipranavir)

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

St. John’s wort because it may decrease Ritonavir Capsules’s effectiveness
Alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, fluticasone, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, or triazolam because the risk of side effects, including irregular heartbeat, severe drowsiness, trouble breathing, or muscle problems, may be increased
Rifampin because it may decrease Ritonavir Capsules’s effectiveness
Voriconazole because its effectiveness may be decreased by Ritonavir Capsules
Many prescription and nonprescription medicines (eg, used for infections, HIV, inflammation, allergic reactions, breathing problems, pain, birth control, blood thinning, cancer, irregular heartbeat, other heart problems, high blood pressure, high cholesterol, immune suppression, erectile dysfunction, seizures, sleep disorders, depression, other mood or mental problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John’s wort) may interact with Ritonavir Capsules, increasing the risk of their side effects

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

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

An extra patient leaflet is available with Ritonavir Capsules. Talk to your pharmacist if you have questions about this information.
Take Ritonavir Capsules by mouth with food.
Continue to take Ritonavir Capsules even if you feel well. Do not miss any doses.
If you miss a dose of Ritonavir Capsules, take it as soon as you remember. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Ritonavir Capsules. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ritonavir Capsules.

Important safety information:

Ritonavir Capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ritonavir Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Ritonavir Capsules does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
Ritonavir Capsules is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Ritonavir Capsules, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Ritonavir Capsules. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
Patients taking sildenafil may experience low blood pressure, prolonged erections, and vision changes while taking Ritonavir Capsules. Talk to your doctor before taking sildenafil with Ritonavir Capsules.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Ritonavir Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).
Diabetes patients – Ritonavir Capsules 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 and blood cholesterol, may be performed while you use Ritonavir Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Ritonavir Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Ritonavir Capsules should be used with extreme caution in CHILDREN younger than 1 month old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ritonavir Capsules while you are pregnant. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Ritonavir Capsules to the baby.

Possible side effects of Ritonavir Capsules:

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:

Abnormal skin sensations around the mouth, fingers, and toes; changes in body fat; diarrhea; headache; nausea; stomach pain; taste changes; vomiting; weakness; weight loss.

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); dark urine; fainting; fever, chills, or sore throat; flushed face; gradual onset of drowsiness; increased blood sugar (excessive hunger, thirst, urination); inflammation of the pancreas (nausea; severe stomach pain; vomiting); irregular heartbeat; loss of appetite; loss of consciousness; pale stools; severe or persistent dizziness or lightheadedness; thirst; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Proper storage of Ritonavir Capsules:

Store Ritonavir Capsules in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Ritonavir Capsules may be stored at room temperature, below 77 degrees F (25 degrees C), if it is used within 30 days. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ritonavir Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Ritonavir Capsules, please talk with your doctor, pharmacist, or other health care provider.
Ritonavir Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

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Ritonavir Solution

30/06/10

Generic Name: Ritonavir (rit-OH-na-vir)
Brand Name: Norvir

Ritonavir Solution is used for:

Treating HIV in combination with other medicines.

Ritonavir Solution is an HIV protease inhibitor. It works by blocking the growth of HIV.

Do NOT use Ritonavir Solution if:

you are allergic to any ingredient in Ritonavir Solution
you are taking alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, fluticasone, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, St. John’s wort, terfenadine, triazolam, or voriconazole

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

Before using Ritonavir Solution:

Some medical conditions may interact with Ritonavir Solution. 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 (including allergies to sulfas [eg, sulfamethoxazole], aspirin, or nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen]), foods, or other substances
if you have diabetes or high blood sugar, liver problems (eg, hepatitis B or C), hemophilia, high cholesterol or triglyceride levels, or a history of inflammation of the pancreas
if you have a history of heart problems (eg, heart failure, conduction abnormalities) or heart blood vessel problems
if you have a history of alcohol abuse
if you take metronidazole or disulfiram
if you take another HIV protease inhibitor (eg, atazanavir, tipranavir)

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

St. John’s wort because it may decrease Ritonavir Solution’s effectiveness
Alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, fluticasone, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, or triazolam because the risk of side effects, including irregular heartbeat, severe drowsiness, trouble breathing, or muscle problems, may be increased
Rifampin because it may decrease Ritonavir Solution’s effectiveness
Voriconazole because its effectiveness may be decreased by Ritonavir Solution
Many prescription and nonprescription medicines (eg, used for infections, HIV, inflammation, allergic reactions, breathing problems, pain, birth control, blood thinning, cancer, irregular heartbeat, other heart problems, high blood pressure, high cholesterol, immune suppression, erectile dysfunction, seizures, sleep disorders, depression, other mood or mental problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John’s wort) may interact with Ritonavir Solution, increasing the risk of their side effects

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

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

An extra patient leaflet is available with Ritonavir Solution. Talk to your pharmacist if you have questions about this information.
Take Ritonavir Solution by mouth with food.
Shake well before each use.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
Continue to take Ritonavir Solution even if you feel well. Do not miss any doses.
If you miss a dose of Ritonavir Solution, take it as soon as you remember. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Ritonavir Solution. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ritonavir Solution.

Important safety information:

Ritonavir Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ritonavir Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Ritonavir Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
Ritonavir Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Ritonavir Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Ritonavir Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
Patients taking sildenafil may experience low blood pressure, prolonged erections, and vision changes while taking Ritonavir Solution. Talk to your doctor before taking sildenafil with Ritonavir Solution.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Ritonavir Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).
Diabetes patients – Ritonavir Solution 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 and blood cholesterol, may be performed while you use Ritonavir Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Ritonavir Solution with caution in the ELDERLY; they may be more sensitive to its effects.
Ritonavir Solution should be used with extreme caution in CHILDREN younger than 1 month old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ritonavir Solution while you are pregnant. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Ritonavir Solution to the baby.

Possible side effects of Ritonavir Solution:

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:

Abnormal skin sensations around the mouth, fingers, and toes; changes in body fat; diarrhea; headache; nausea; stomach pain; taste changes; vomiting; weakness; weight loss.

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); dark urine; fainting; fever, chills, or sore throat; flushed face; gradual onset of drowsiness; increased blood sugar (excessive hunger, thirst, urination); inflammation of the pancreas (nausea; severe stomach pain; vomiting); irregular heartbeat; loss of appetite; loss of consciousness; pale stools; severe or persistent dizziness or lightheadedness; thirst; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Proper storage of Ritonavir Solution:

Store Ritonavir Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate. Keep Ritonavir Solution out of the reach of children and away from pets.

General information:

If you have any questions about Ritonavir Solution, please talk with your doctor, pharmacist, or other health care provider.
Ritonavir Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

Comments (0)

Ritalin LA

30/06/10

Generic Name: methylphenidate (Oral route)

meth-il-FEN-i-date

Transdermal routePatch, Extended Release

Methylphenidate patch should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up .

Give cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur .

Oral routeTabletTablet, Extended ReleaseTablet, ChewableCapsule, Extended ReleaseSolution

Methylphenidate hydrochloride should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.

Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long term follow-up may be required because of the patient’s basic personality disturbances .

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, due to abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior including psychotic episodes. Careful supervision during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked .

Commonly used brand name(s):

In the U.S.

Concerta
Metadate CD
Metadate ER
Methylin
Methylin ER
Ritalin
Ritalin LA
Ritalin-SR

Available Dosage Forms:

Tablet, Extended Release
Capsule, Extended Release
Tablet, Chewable
Solution
Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Ritalin LA

Methylphenidate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, methylphenidate may be used in certain patients with the following condition:

Depressive disorder secondary to physical illness in patients who cannot take antidepressant medicines.

Before Using Ritalin LA

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children under 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of Concerta® extended release tablets have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

No information is available on the relationship of age to the effects of Ritalin® in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

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.

Brofaromine
Clorgyline
Furazolidone
Iproniazid
Isocarboxazid
Lazabemide
Linezolid
Moclobemide
Nialamide
Pargyline
Phenelzine
Procarbazine
Rasagiline
Selegiline
Toloxatone
Tranylcypromine

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.

Carbamazepine

Interactions with Food/Tobacco/Alcohol

Proper Use of methylphenidate

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you or your child think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

To help prevent trouble with sleeping, take the last dose of the short-acting tablets before 6 p.m., unless your doctor gives you or your child a different time.

If you or your child are taking the long-acting forms of this medicine:

The Concerta® extended release tablets, Ritalin LA® capsules, and Ritalin SR® tablets are to be swallowed whole with water or other liquids. Do not break, open, crush, or chew them before swallowing.
If you or your child are unable to swallow the Ritalin LA® extended-release capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce mixture can not be stored for future use.
If you are taking the Concerta® extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed into your body.
You may take Concerta® extended release tablets with or without food.

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.

For attention deficit hyperactivity disorder (ADHD):
- For short-acting oral dosage form (tablets):
  - Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
  - Teenagers and children above 6 years of age—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.
  - Children up to 6 years of age—Use and dose must be determined by the doctor.
- For long-acting oral dosage form (extended-release tablets):
  - For patients who have not been treated with Concerta®:
    - Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
    - Teenagers and children above 6 years of age—At first, 18 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
    - Children up to 6 years of age—Use and dose must be determined by your doctor.
  - For patients already using Concerta®:
    - Adults, teenagers, and children above 6 years of age—At first, 18 to 72 milligrams (mg) once a day in the morning, depending on your previous dose of methylphenidate. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
    - Children up to 6 years of age—Use and dose must be determined by your doctor.
- For long-acting oral dosage form (sustained-release tablets):
  - Adults, teenagers, and children above 6 years of age—The dose must be determined by the doctor.
  - Children up to 6 years of age—Use and dose must be determined by the doctor.
- For the long-acting oral dosage form (extended-release capsules):
  - Adults, teenagers, and children above 6 years of age—10 to 20 milligrams (mg) once a day, taken in the morning before breakfast. If needed, your doctor may increase the dose once a week by 10 mg a day as needed up to 60 mg a day.
  - Children up to 6 years of age—Use and dose must be determined by the doctor.
For narcolepsy:
- For short-acting oral dosage form (tablets):
  - Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
  - Teenagers and children above 6 years of age—At first, 5 mg two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.
- For long-acting oral dosage form (sustained-release tablets):
  - Adults and teenagers and children above 6 years of age—The dose must be determined by the doctor.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Ritalin LA

Your doctor should check you or your child’s progress at regular visits to make sure this medicine is working properly and to decide if you or your child should continue to take it. Blood tests may be needed to check for unwanted effects.

You or your child will also need to have your blood pressure measured before starting this medicine and while you or your child are using it. If you notice any change to you or your child’s recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

You or your child should not use this medicine if you have used a drug for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, shortness of breath, or fainting while taking this medicine.

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child’s height and weight to make sure that your child is growing properly.

Ritalin LA 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:

More common

Fast heartbeat

Less common

Chest pain
fever
joint pain
skin rash or hives

Rare

Black, tarry stools
blood in the urine or stools
blurred vision or other changes in vision
convulsions
crusting, dryness, or flaking of the skin
muscle cramps
pinpoint red spots on the skin
scaling, severe redness, soreness, or swelling of the skin
uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
unusual bleeding or bruising

Incidence not known

Confusion
cracks in the skin
delusions (false beliefs)
depersonalization (feeling like surroundings are not real)
depression (severe)
hallucinations (seeing, hearing, or feeling things that are not there)
hives or welts
loss of heat from the body
mood changes
numbness of the hands
painful or difficult urination
pale skin
red, irritated eyes
red, swollen, or scaly skin
severe or sudden headache
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sudden loss of coordination
sudden slurring of speech
swollen glands
troubled breathing with exertion
unusual behavior
unusual tiredness or weakness
weight loss
yellow skin or eyes

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

Symptoms of overdose

Agitation
confusion (severe)
convulsions
dryness of the mouth or mucous membranes
false sense of well-being
fast, pounding, or irregular heartbeat
fever
flushing
hallucinations (seeing, hearing, or feeling things that are not there)
headache (severe)
increased sweating
large pupils
muscle twitching
overactive reflexes
sweating
trembling or shaking
vomiting

More common

Loss of appetite
nervousness
sleeplessness
stuffy nose
trouble with sleeping
unable to sleep
unusually warm skin

Less common

Anger
dizziness
drowsiness
fear
headache
irritability
muscle aches
nausea
nervousness
runny nose
scalp hair loss
stomach pain
talking, feeling, and acting with excitement

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.

Advanced,R

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Ritalin LA Extended-Release Capsules

30/06/10

Generic Name: Methylphenidate (meth-il-FEN-i-date)
Brand Name: Ritalin LA

Use Ritalin LA Extended-Release Capsules with caution if you have a history of emotional problems, or alcohol or substance abuse. Abuse of Ritalin LA Extended-Release Capsules may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using Ritalin LA Extended-Release Capsules. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.

Ritalin LA Extended-Release Capsules are used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Ritalin LA Extended-Release Capsules are a central nervous system stimulant. Exactly how it works is not known.

Do NOT use Ritalin LA Extended-Release Capsules if:

you are allergic to any ingredient in Ritalin LA Extended-Release Capsules
you have severe anxiety, agitation, or tension
you have glaucoma
you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
you have serious heart problems (eg, heart defect, irregular heartbeat)
you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

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

Before using Ritalin LA Extended-Release Capsules:

Some medical conditions may interact with Ritalin LA Extended-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), or recent heart attack, or if a family member has a history of irregular heartbeat or sudden death
if you have a history of seizures or abnormal electroencephalograms (EEGs)
if you have a history of overactive thyroid, chronic fatigue, cystic fibrosis, or stomach or bowel problems (eg, blockage, inflammation, narrowing)
if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

Some MEDICINES MAY INTERACT with Ritalin LA Extended-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

MAOIs (eg, phenelzine) because severe high blood pressure may occur
Clonidine because serious side effects may occur
Pressor agents (eg, norepinephrine) because the risk of high blood pressure may be increased
Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Ritalin LA Extended-Release Capsules
Guanethidine or other medicines for high blood pressure because their effectiveness may be decreased by Ritalin LA Extended-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ritalin LA Extended-Release Capsules 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 Ritalin LA Extended-Release Capsules:

Use Ritalin LA Extended-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ritalin LA Extended-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ritalin LA Extended-Release Capsules refilled.
Take Ritalin LA Extended-Release Capsules by mouth in the morning. Talk with your doctor about how you should take Ritalin LA Extended-Release Capsules with regard to food.
Swallow Ritalin LA Extended-Release Capsules whole. Do not break, crush, chew, or divide before swallowing.
If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. The applesauce should NOT be warm. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
If you take an antacid, H₂ antagonist (eg, ranitidine), or proton pump inhibitor (eg, omeprazole), ask your doctor or pharmacist how to take it with Ritalin LA Extended-Release Capsules.
If you miss a dose of Ritalin LA Extended-Release Capsules, 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 Ritalin LA Extended-Release Capsules.

Important safety information:

Ritalin LA Extended-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ritalin LA Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose without checking with your doctor.
If your symptoms do not get better within 1 month or if they get worse, check with your doctor.
Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition.
Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Ritalin LA Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Ritalin LA Extended-Release Capsules may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Ritalin LA Extended-Release Capsules.
Caution is advised when using Ritalin LA Extended-Release Capsules in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
Ritalin LA Extended-Release Capsules should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ritalin LA Extended-Release Capsules while you are pregnant. It is not known if Ritalin LA Extended-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Ritalin LA Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Ritalin LA Extended-Release Capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Ritalin LA Extended-Release Capsules stops working well. Do not take more than prescribed.

Some people who use Ritalin LA Extended-Release Capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Ritalin LA Extended-Release Capsules. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Ritalin LA Extended-Release Capsules, your doctor will lower your dose over time.

Possible side effects of Ritalin LA Extended-Release Capsules:

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:

Dizziness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.

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; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, persistent crying, unusual sadness); seizures; severe or persistent dizziness or headache; suicidal thoughts or attempts; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.

Proper storage of Ritalin LA Extended-Release Capsules:

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

General information:

If you have any questions about Ritalin LA Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Ritalin LA Extended-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,R

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