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mitomycin

30/06/10

Generic Name: mitomycin (MYE toe MYE sin)
Brand Names: Mutamycin

What is mitomycin?

Mitomycin is an antineoplastic medication. Mitomycin interferes with the growth of cancer cells and slows their growth and spread in the body.

Mitomycin is used to treat cancer of the stomach and pancreas.

Mitomycin may also be used for purposes other than those listed in this medication guide.

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

Mitomycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of mitomycin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection); kidney damage (little or no urine production, blood in the urine, lower back or side pain, difficulty urinating, or swelling of the ankles or feet); lung and heart problems; and others. Talk to your doctor about the possible side effects from treatment with mitomycin.

Tell your doctor or nurse right away if you notice redness, pain or swelling at the place of injection or anywhere else on your skin.

What should I discuss with my healthcare provider before using mitomycin?

Do not use mitomycin without first talking to your doctor if you have

kidney disease;
poorly functioning bone marrow; or
a bleeding or blood clotting disorder

The use of mitomycin may be dangerous if you have any of the conditions listed above.

Mitomycin may be harmful to an unborn baby. Do not use mitomycin without first talking to your doctor if you are pregnant. Discuss with your doctor the appropriate use of birth control during treatment with mitomycin if necessary. It is not know whether mitomycin passes into breast milk. Breast-feeding should be avoided during treatment with mitomycin.

How should I use mitomycin?

Mitomycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with mitomycin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Tell your doctor or nurse right away if you notice redness, pain or swelling at the place of injection or anywhere else on your skin.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with mitomycin to monitor progress and side effects.

Your healthcare provider will store mitomycin as directed by the manufacturer. If you are storing mitomycin at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of mitomycin.

What happens if I overdose?

If, for any reason an overdose of mitomycin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a mitomycin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using mitomycin?

Mitomycin can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

Mitomycin side effects

If you experience any of the following serious side effects from mitomycin, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
kidney damage (little or no urine production, blood in the urine, lower back or side pain, difficulty urinating, or swelling of the ankles or feet);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
redness, pain or swelling at the place of injection or elsewhere on the skin;
severe nausea, vomiting, diarrhea, or loss of appetite; or
shortness of breath or difficulty breathing.

Other, less serious side effects may be more likely to occur. Continue taking mitomycin and talk to your doctor if you experience:

mild to moderate nausea, vomiting, or loss of appetite;
headache;
blurred vision;
drowsiness or dizziness;
weakness; or
confusion.

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.

Mitomycin Dosing Information

Usual Adult Dose for Stomach Cancer:

For use in treatment of disseminated adenocarcinoma of the stomach in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed:

After full hematologic recovery from any previous chemotherapy, the following dosage schedule may be used at 6 to 8 week intervals: 20 mg/m2 intravenously as a single dose via a functioning intravenous catheter.

Usual Adult Dose for Pancreatic Cancer:

For use in treatment of disseminated adenocarcinoma of the pancreas in proven combination with other approved chemotherapeutic agents or as palliative treatment when other modalities have failed:

Usual Adult Dose for Bladder Cancer:

40 mg by intravesical installation

What other drugs will affect mitomycin?

Do not receive “live” vaccines during treatment with mitomycin. Administration of a live vaccine may be dangerous during treatment with mitomycin.

Other drugs may also interact with mitomycin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with mitomycin.

Where can I get more information?

Your healthcare provider may have additional information about mitomycin that you may read.

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,M

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mitomycin (Intravenous route)

30/06/10

mye-toe-MYE-sin

Intravenous routePowder for Solution

Mitomycin for injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Hemolytic Uremic Syndrome (HUS) a serious complication of chemotherapy, consisting primarily of microangiopathic hemolytic anemia, thrombocytopenia, and irreversible renal failure has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin as a single agent or in combination with other cytotoxic drugs, however, most cases occur at doses greater than or equal to 60 mg of mitomycin. Blood product transfusion may exacerbate the symptoms associated with this syndrome.

The incidence of the syndrome has not been defined .

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of mitomycin. Hemolytic Uremic Syndrome (HUS) has been reported in patients receiving systemic mitomycin. The syndrome may occur at any time during systemic therapy with mitomycin but most cases occur at doses greater than or equal to 60 mg. Blood product transfusion may exacerbate the symptoms associated with this syndrome .

Commonly used brand name(s):

In the U.S.

Mutamycin

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antineoplastic Agent

Uses For mitomycin

Mitomycin belongs to the group of medicines known as antineoplastics. It is used to treat some kinds of cancer.

Mitomycin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by mitomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with mitomycin, you and your doctor should talk about the good mitomycin will do as well as the risks of using it.

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

Before Using mitomycin

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 mitomycin, the following should be considered:

Allergies

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

Pediatric

Although there is no specific information comparing use of mitomycin in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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

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 mitomycin 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 mitomycin 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.

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

Interactions with Food/Tobacco/Alcohol

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

Proper Use of mitomycin

Mitomycin is usually given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to remember to take them at the right times.

mitomycin often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of mitomycin 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 mitomycin. 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.

Precautions While Using mitomycin

It is very important that your doctor check your progress at regular visits to make sure that mitomycin is working properly and to check for unwanted effects.

While you are being treated with mitomycin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Mitomycin 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 take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Mitomycin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
Avoid contact sports or other situations where bruising or injury could occur.

If mitomycin accidentally seeps out of the vein into which it is injected, it may damage the skin and cause scarring. In some patients, this may occur weeks or even months after mitomycin is given. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection or anywhere else on your skin.

mitomycin 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.

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

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

Less common

Black, tarry stools
blood in urine or stools
cough or hoarseness
fever or chills
lower back or side pain
painful or difficult urination
pinpoint red spots on skin
unusual bleeding or bruising

Rare

Redness or pain, especially at place of injection

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

Less common

Cough
decreased urination
shortness of breath
sores in mouth and on lips
swelling of feet or lower legs

Rare

Bloody vomit

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

Loss of appetite
nausea and vomiting

Less common

Numbness or tingling in fingers and toes
purple-colored bands on nails
skin rash
unusual tiredness or weakness

Mitomycin sometimes causes a temporary loss of hair. After treatment has ended, normal hair growth should return.

After you stop using mitomycin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Blood in urine

Also, check with your doctor if you notice any of the following:

Black, tarry stools
blood in stools
cough or hoarseness
decreased urination
fever or chills
lower back or side pain
painful or difficult urination
pinpoint red spots on skin
red or painful skin
shortness of breath
swelling of feet or lower legs
unusual bleeding or bruising

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.

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

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Mission Prenatal

30/06/10

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)
Brand Names: Advance Care Plus, Bright Beginnings, Cenogen Ultra, CitraNatal 90 DHA, CitraNatal Assure, CitraNatal DHA, CitraNatal Rx, Complete Natal, Complete-RF, CompleteNate, Concept DHA, Concept OB, Dualvit OB, Duet, Duet Chewable, Duet DHA, Duet DHA EC, Edge OB, Folbecal, Foltabs, Foltabs 90 plus DHA, Foltabs plus DHA, Gesticare, Gesticare DHA, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Inatal Ultra, Lactocal-F, Marnatal-F Plus, Maternity, Maxinate, Mission Prenatal, Mission Prenatal HP, Multinatal Plus, Nata 29 OB, Nata 29 Prenatal, Natachew, Natafort, Natelle, Natelle C, Natelle Plus with DHA, Natelle Prefer, Natelle-ez, Neevo, Neevo DHA, Nestabs CBF, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Complete with DHA, OB Natal One, Ob-20, OptiNate, Pre-H-Cal, Precare, Precare Conceive, Precare Premier, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs CBF, Prenatabs FA, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal 19, Prenatal AD, Prenatal Elite, Prenatal H, Prenatal Low Iron, Prenatal Multivitamins, Prenatal Plus, Prenatal Plus Iron, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenate Elite Plus Iron, Prenavite FC, Prenavite PC, PreNexa, Previte Rx, PrimaCare, PrimaCare Advantage, PrimaCare One, Pruet DHA, Pruet DHA EC, RE OB 90 Plus DHA, RE OB Plus DHA, Renate, Renate DHA, Renate DHA Extra, RightStep, Se-Care, Se-Care Conceive, Se-Natal 90, Se-Natal One, Select-OB, Select-OB+DHA, Strongstart, Stuart Prenatal with Beta Carotene, Tandem DHA, Tandem OB, Tri Rx, TriAdvance, TriCare, Trinatal Rx, Trinate, UltimateCare Advance, UltimateCare One, Ultra-Natal, Verotin-BY, Verotin-GR, Vinatal 600, Vinatal Forte, Vinate 90, Vinate Advanced (New Formula), Vinate AZ, Vinate AZ Extra, Vinate C, Vinate Calcium, Vinate Care, Vinate Good Start, Vinate GT, Vinate IC, Vinate II (New Formula), Vinate III, Vinate M, Vinate One, Vinate PN Care, Vinate Ultra, Vitafol PN, Vitafol-OB, Vitafol-OB+DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaphil Plus DHA 90, Vitaspire, Viva DHA, Vynatal F.A.

What are Mission Prenatal (prenatal multivitamins)?

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while-breast-feeding.

How should I take prenatal vitamins?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

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

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

It is important to take prenatal vitamins regularly to get the most benefit.

Store this medication at room temperature away from moisture and heat.

Store prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

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.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;
headache; or
unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);
heart or blood pressure medications;
tretinoin (Vesanoid);
isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);
trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

This list is not complete and there may be other medications that can interact with or be affected by prenatal vitamins. 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 prenatal vitamins.

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,M

Comments (0)

Mission Prenatal HP

30/06/10

What are Mission Prenatal HP (prenatal multivitamins)?

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while-breast-feeding.

How should I take prenatal vitamins?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

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

It is important to take prenatal vitamins regularly to get the most benefit.

Store this medication at room temperature away from moisture and heat.

Store prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;
headache; or
unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);
heart or blood pressure medications;
tretinoin (Vesanoid);
isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);
trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

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,M

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Mithracin

30/06/10

Generic Name: plicamycin (plih CA my sin)
Brand Names: Mithracin

What is Mithracin (plicamycin)?

Plicamycin is a cancer (antineoplastic) medication. Plicamycin interferes with the growth of cancer cells and slows their growth and spread in the body.

Plicamycin is used to treat cancer of the testicles. Plicamycin is also used in the treatment of treat too much calcium in the blood (hypercalcemia) and too much calcium in the urine (hypercalciuria) associated with a variety of advanced forms of cancer.

Plicamycin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mithracin (plicamycin)?

Plicamycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of plicamycin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with plicamycin.

Plicamycin should not be used in women who are or may become pregnant.

Who should not take Mithracin (plicamycin)?

Before taking plicamycin, tell your doctor if you have

liver disease;
kidney disease;
bone marrow problems; or
a bleeding disorder.

You may not be able to take plicamycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Plicamycin is in the FDA pregnancy category X. This means that plicamycin is known to cause birth defects in an unborn baby. Plicamycin may also affect egg production in women and sperm production in men. Do not take plicamycin if you are pregnant or could become pregnant during treatment. Contraceptive measures are recommended during treatment with plicamycin. It is not known whether plicamycin passes into breast milk. Do not take plicamycin without first talking to your doctor if you are breast feeding a baby.

How should I take Mithracin (plicamycin)?

Plicamycin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with plicamycin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with plicamycin to monitor progress and side effects.

Your healthcare provider will store cladribine as directed by the manufacturer. If you are storing cladribine, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of plicamycin injection.

What happens if I overdose?

If for any reason an overdose of plicamycin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a plicamycin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while taking Mithracin (plicamycin)?

Plicamycin can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with plicamycin. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Mithracin (plicamycin) side effects

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
blood in the urine;
black or tarry stools;
signs of infection such as fever; chills, or sore throat;
nose bleed (epistaxis) or vomiting blood (hematemesis); or
unusual bleeding or bruising.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:

nausea, vomiting, diarrhea, or decreased appetite;
mouth sores;
drowsiness and extremely deep sleep;
a general discomfort or uneasiness;
headache or depression;
a rash; or
facial flushing..

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Mithracin (plicamycin)?

Do not receive “live” vaccines during treatment with plicamycin. Administration of a live vaccine may be dangerous during treatment with plicamycin.

Other drugs may interact with plicamycin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with plicamycin.

Where can I get more information?

Your pharmacist has additional information about plicamycin written for health professionals that you may read.

What does my medication look like?

Plicamycin is available with a prescription under the brand name Mithracin. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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,M

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misoprostol

30/06/10

Generic Name: misoprostol (mye so PRAH stole)
Brand Names: Cytotec

What is misoprostol?

Misoprostol reduces stomach acid and replaces protective substances in the stomach that are inhibited by nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin.

Misoprostol is used to prevent the formation of ulcers in the stomach during treatment with aspirin or an NSAID such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Aleve, Anaprox, Naprelan), oxaprozin (Daypro), indomethacin (Indocin), diclofenac (Voltaren, Cataflam), etodolac (Lodine), piroxicam (Feldene), meloxicam (Mobic), tolmetin (Tolectin), nabumetone (Relafen), and fenoprofen (Nalfon). NSAIDs and aspirin are used to treat pain, fever, arthritis, and inflammatory conditions.

Misoprostol may also be used for purposes other than those listed in this medication guide.

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

Do not take misoprostol for the prevention of stomach ulcers if you are pregnant or if you might become pregnant during treatment. If you do become pregnant during treatment with misoprostol, stop taking the medication and contact your doctor immediately. Misoprostol is in the FDA pregnancy category X. This means that misoprostol is known to be harmful to an unborn baby. Misoprostol can cause miscarriage or spontaneous abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. Misoprostol has also been reported to cause uterine rupture (tearing) when given after the eighth week of pregnancy, which can result in severe bleeding, hysterectomy, and/or maternal or fetal death. A pregnancy test with negative results will be required within 2 weeks of starting treatment with misoprostol, and treatment will begin only on the second or third day of a regular menstrual cycle. Also, appropriate contraception will be needed to prevent pregnancy during treatment and for one menstrual cycle following treatment. In some cases, misoprostol may be used under the supervision of a doctor for the induction of labor and delivery or abortion. Do not share this medication with anyone else. Misoprostol has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant.

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

Before taking misoprostol, tell your doctor if you have inflammatory bowel disease, irritable bowel syndrome, or other intestinal problems. You may need a dosage adjustment or special monitoring during treatment with misoprostol.

Do not take misoprostol for the prevention of stomach ulcers if you are pregnant or if you might become pregnant during treatment. If you do become pregnant during treatment with misoprostol, stop taking the medication and contact your doctor immediately. Misoprostol is in the FDA pregnancy category X. This means that misoprostol is known to be harmful to an unborn baby. Misoprostol can cause miscarriage or spontaneous abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. Misoprostol has also been reported to cause uterine rupture (tearing) when given after the eighth week of pregnancy, which can result in severe bleeding, hysterectomy, and/or maternal or fetal death. A pregnancy test with negative results will be required within 2 weeks of starting treatment with misoprostol, and treatment will begin only on the second or third day of a regular menstrual cycle. Also, appropriate contraception will be needed to prevent pregnancy during treatment and for one menstrual cycle following treatment. In some cases, misoprostol may be used under the supervision of a doctor for the induction of labor and delivery or abortion. It is not known whether misoprostol passes into breast milk. Do not take misoprostol without first talking to your doctor if you are breast-feeding a baby.

How should I take misoprostol?

Take misoprostol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Misoprostol is usually taken four times a day, with meals and at bedtime. Follow your doctor’s instructions.

Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These problems usually occur during the first few weeks of treatment and stop after about a week. The occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these symptoms persist for longer than 8 days or if they are severe.

Take misoprostol for the full amount of time prescribed by your doctor. Treatment usually continues for as long as aspirin or an NSAID is taken.

Do not share this medication with anyone else. Misoprostol has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant. Store misoprostol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

The symptoms of a misoprostol overdose are not well known but might include stomach upset, stomach pain, diarrhea, drowsiness, tremor, seizures, difficulty breathing, fever, low blood pressure, and an irregular heart beat.

What should I avoid while taking misoprostol?

The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.

There are no restrictions on food, beverages, or activities during treatment with misoprostol unless otherwise directed by your doctor.

Misoprostol side effects

Stop taking misoprostol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may also occur. Continue to take misoprostol and talk to your doctor if you experience

vomiting;
flatulence;
constipation;
headache; or
menstrual cramps, spotting, or increased or irregular menstruation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Misoprostol Dosing Information

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

200 mcg orally 4 times a day after meals and at bedtime.

Usual Adult Dose for Gastric Ulcer:

200 mcg orally 4 times a day after meals and at bedtime.

Usual Adult Dose for Duodenal Ulcer:

200 mcg orally 4 times a day after meals and at bedtime. Alternatively, 400 mcg orally 2 times a day may be used.

Usual Adult Dose for Labor Induction:

25 mcg vaginally every 4 to 6 hours.

Usual Adult Dose for Postpartum Bleeding:

Prophylaxis: 400 to 600 mcg orally or rectally after delivery of the baby, but before delivery of the placenta.

Usual Adult Dose for Cervical Ripening:

Before surgical abortion: 400 mcg vaginally, 3 to 4 hours before suction curettage.

Usual Adult Dose for Abortion:

First Trimester of Pregnancy: 400 mcg orally once as a single dose 48 hours after mifepristone administration. Alternatively, 800 mcg vaginally 48 hours after mifepristone administration. When used with methotrexate, 5 to 7 days later give 800 mcg vaginally (misoprostol dose may be repeated 24 hours later if needed).

In Failed Pregnancy or Fetal Death: 800 mcg vaginally once or twice (doses given 24 hours apart).

Second Trimester of Pregnancy: 600 mcg vaginally, 36 to 48 hours after mifepristone administration, followed by 400 mcg orally or vaginally every 3 hours to a maximum of 5 doses in the first 24 hours.

Third Trimester of Pregnancy – Fetal Death: 100 mcg vaginally every 12 hours.

Usual Adult Dose for Gynecologic Surgery:

Study (n=204) – Operative hysteroscopy: 400 mcg orally 12 to 24 hours before surgery.

Usual Pediatric Dose for NSAID-Induced Ulcer Prophylaxis:

Study (n=25)
>7 years: 9.8 mcg/kg/day, given in two equally divided doses daily, to a maximum of 800 mcg/day.

What other drugs will affect misoprostol?

The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.

Drugs other than those listed here may also interact with misoprostol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist has more information about misoprostol written for health professionals that you may read.

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,M

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misoprostol (Oral route)

30/06/10

mye-soe-PROST-ol

Oral routeTablet

Misoprostol administration to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion beyond the eight week of pregnancy. Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).

Patients must be advised of the abortifacient property and warned not to give the drug to others.

Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, misoprostol may be prescribed if the patient

has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
will begin misoprostol on the second or third day of the next menstrual period

Administration of misoprostol to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy. Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of developing gastric ulcers or complications. Women must have a negative serum pregnancy test within 2 weeks prior to beginning therapy and effective contraceptive measures must be used. Oral and written warnings of the hazards of misoprostol, including the risk of possible contraception failure, must be given to the patient prior to initiating therapy .

Commonly used brand name(s):

In the U.S.

Cytotec

Available Dosage Forms:

Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Prostaglandin

Uses For misoprostol

Misoprostol is taken to prevent stomach ulcers in patients taking anti-inflammatory drugs, including aspirin. Misoprostol may also be used for other conditions as determined by your doctor.

Misoprostol helps the stomach protect itself against acid damage. It also decreases the amount of acid produced by the stomach.

misoprostol is available only with your doctor’s prescription.

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

Abortion, first trimester
Abortion, second trimester
Cervical ripening
Induction of labor
Postpartum hemorrhage

Before Using misoprostol

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 misoprostol, the following should be considered:

Allergies

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

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

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Interactions with Medicines

Using misoprostol 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.

Phenylbutazone

Interactions with Food/Tobacco/Alcohol

Proper Use of misoprostol

Misoprostol is best taken with or after meals and at bedtime, unless otherwise directed by your doctor. To help prevent loose stools, diarrhea, and abdominal cramping, always take misoprostol with food or milk.

Dosing

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

To prevent stomach ulcers in patients taking anti-inflammatory medicines including aspirin:
- For oral dosage form (tablets):
  - Adults—200 micrograms (mcg) four times a day, with or after meals and at bedtime. Or, your dose may be 400 mcg two times a day with the last dose taken at bedtime. Your doctor may reduce the dose to 100 mcg if you are sensitive to high doses.
  - Children and teenagers—Dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using misoprostol

Misoprostol may cause miscarriage if taken during pregnancy. Therefore, if you suspect that you may have become pregnant, stop taking misoprostol immediately and check with your doctor.

misoprostol may cause diarrhea, stomach cramps, or nausea in some people. These effects will usually disappear within a few days as your body adjusts to the medicine. However, check with your doctor if the diarrhea, cramps, or nausea is severe and/or does not stop after a week. Your doctor may have to lower the dose of misoprostol you are taking.

misoprostol 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.

More common

Abdominal or stomach pain (mild)
diarrhea

Less common or rare

Bleeding from vagina
constipation
cramps in lower abdomen or stomach area
gas
headache
heartburn, indigestion, or acid stomach
nausea and/or vomiting

Symptoms of overdose

Abdominal pain
convulsions (seizures)
diarrhea
drowsiness
fast or pounding heartbeat
fever
low blood pressure
slow heartbeat
tremor
troubled breathing

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,M

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Mirtazapine Tablets

30/06/10

M,Professional

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mirtazapine

30/06/10

Generic Name: mirtazapine (mir TAH zah peen)
Brand Names: Remeron, Remeron SolTab

What is mirtazapine?

Mirtazapine is an antidepressant. Mirtazapine affects chemicals in the brain that may become unbalanced and cause depression.

Mirtazapine is used to treat major depressive disorder.

Mirtazapine may also be used for purposes other than those listed in this medication guide.

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

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Do not use mirtazapine if you have used an MAO inhibitor within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you have bipolar disorder, liver or kidney disease, seizures, heart disease, a history of heart attack or stroke, or a history of drug abuse or suicidal thoughts.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Avoid drinking alcohol. It can increase some of the side effects of mirtazapine. Mirtazapine 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 mirtazapine?

You should not take this medication if you are allergic to mirtazapine.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Do not use mirtazapine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you are allergic to any drugs, or if you have:

liver or kidney disease;
bipolar disorder (manic depression);
seizures or epilepsy;
heart disease, including angina (chest pain);
a history of heart attack or stroke; or
a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use mirtazapine, or you may need a dosage adjustment or special tests during treatment.

Mirtazapine is in the FDA pregnancy category C. This means that it is not known whether mirtazapine will harm an unborn baby. Do not take mirtazapine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether mirtazapine passes into breast milk. Do not take mirtazapine without first talking to your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

The orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of mirtazapine if you have phenylketonuria (PKU).

How should I take mirtazapine?

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

Take the regular tablet form of mirtazapine with water.

To take mirtazapine orally disintegrating tablets (Remeron SolTab):

Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may break the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. No water is needed.

Mirtazapine is usually taken once a day at bedtime. Follow your doctor’s instructions.

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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.

What should I avoid while taking mirtazapine?

Avoid drinking alcohol. It can increase some of the side effects of mirtazapine. Mirtazapine 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.

Mirtazapine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips; or
feeling like you might pass out.

Less serious side effects include:

drowsiness, dizziness, weakness;
nausea, stomach pain;
constipation;
increased appetite, weight gain;
dry mouth; or
thirst.

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.

Mirtazapine Dosing Information

Usual Adult Dose for Depression:

Initial dose: 15 mg orally once a day at bedtime.
Maintenance dose: 15 to 45 mg per day.

What other drugs will affect mirtazapine?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by mirtazapine. Tell your doctor if you need to use any of these other medicines while you are taking mirtazapine.

There may be other drugs that can interact with mirtazapine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about mirtazapine.

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,M

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mirtazapine (Oral route)

30/06/10

mir-TAZ-a-peen

Oral routeTabletTablet, Disintegrating

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of mirtazapine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Mirtazapine is not approved for use in pediatric patients .

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s):

In the U.S.

Remeron
Remeron Soltab

In Canada

Remeron RD

Available Dosage Forms:

Tablet, Disintegrating
Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tetracyclic

Uses For mirtazapine

Mirtazapine is used to treat mental depression.

mirtazapine is available only with your doctor’s prescription.

Before Using mirtazapine

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 mirtazapine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mirtazapine 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 any benefit to using mirtazapine in children with depression. Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking the medicine. Because of this toxicity, use in children is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of mirtazapine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving mirtazapine .

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 mirtazapine 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.

Isocarboxazid
Linezolid
Metoclopramide
Rasagiline
Selegiline
Tranylcypromine

Using mirtazapine 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.

Clonidine
Fluoxetine
Fluvoxamine
Olanzapine
Procarbazine
Tramadol
Venlafaxine

Using mirtazapine 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.

Diazepam

Interactions with Food/Tobacco/Alcohol

Using mirtazapine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use mirtazapine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of mirtazapine

Take mirtazapine only as directed by your doctor in order to improve your condition as much as possible. Do not take more of it and do not take it more often than your doctor ordered.

Mirtazapine may be taken with or without food, on a full or empty stomach. If your doctor tells you to take it a certain way, follow your doctor’s instructions.

For patients using the oral disintegrating tablet form of mirtazapine:

Make sure your hands are dry.
Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
Immediately place the tablet on top of the tongue. Do not break or split the tablet.
The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet .

Dosing

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

For oral dosage form (tablets and oral disintegrating tablets):
- For mental depression:
  - Adults—At first, 15 milligrams (mg) once a day, preferably in the evening just before you go to sleep. Your doctor may increase the dose if necessary. However, the dose usually is not more than 45 mg a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of mirtazapine, 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 mirtazapine

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Do not take mirtazapine with monoamine oxidase (MAO) inhibitors (e.g., furazolidone, phenelzine, procarbazine, selegiline, or tranylcypromine) or sooner than 14 days after stopping an MAO inhibitor. Do not take an MAO inhibitor sooner than 14 days after stopping mirtazapine. To do so may increase the chance of serious side effects.

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

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

Check with your doctor immediately if you develop fever, chills, sore throat, or sores in the mouth. These may be signs of a very serious blood problem that has occurred rarely in patients taking mirtazapine.

Mirtazapine may cause drowsiness or trouble in thinking. Make sure you know how you react to mirtazapine before you drive, use machines, or do other jobs that require you to be alert and clearheaded.

Dizziness, light-headedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

mirtazapine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth feels dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

mirtazapine 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

Decreased or increased movement
mood or mental changes, including abnormal thinking, agitation, anxiety, confusion, and feelings of not caring
shortness of breath
skin rash
swelling

Rare

Convulsions (seizures)
decreased sexual ability
menstrual pain
missing periods
mood or mental changes, including anger, feelings of being outside the body, hallucinations (seeing, hearing, or feeling things that are not there), mood swings, and unusual excitement
mouth sores
sore throat, chills, or fever

More common

Constipation
dizziness
drowsiness
dryness of mouth
increased appetite
weight gain

Less common

Abdominal pain
abnormal dreams
back pain
dizziness or fainting when getting up suddenly from a lying or sitting position
increased need to urinate
increased sensitivity to touch
increased thirst
low blood pressure
muscle pain
nausea
sense of constant movement of self or surroundings
trembling or shaking
vomiting
weakness

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,M

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