Methyl Aminolevulinate Cream

Pronunciation: METH-il a-MEE-noe-LEV-ue-LIN-ate
Generic Name: Methyl Aminolevulinate
Brand Name: Metvixia

Methyl Aminolevulinate Cream is used for:

Treating certain skin lesions (actinic keratoses) on the face or scalp. It is used along with red light treatment.

Methyl Aminolevulinate Cream is a photosensitizing agent. It works by slowing the growth of skin cells in the areas exposed to red light, which helps the skin to become less scaly and thick.

Do NOT use Methyl Aminolevulinate Cream if:

• you are allergic to any ingredient in Methyl Aminolevulinate Cream; peanuts, peanut oil, or almond oil


• you are allergic to porphyrins


• you have a history of sensitivity to sunlight

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

Before using Methyl Aminolevulinate Cream:

Some medical conditions may interact with Methyl Aminolevulinate Cream. 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 blood clotting problem, the blood disorder porphyria, or an immune system problem (eg, HIV)


• if you have or have had skin cancer or other growths on your body

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

• Medicines that may increase photosensitivity, such as griseofulvin, phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), sulfonylureas (eg, glyburide), tetracyclines (eg, doxycycline), or thiazide diuretics (eg, hydrochlorothiazide). Ask your doctor if you are unsure if any of your medicines may increase this risk

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

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

• An extra patient leaflet is available with Methyl Aminolevulinate Cream. Talk to your doctor if you have questions about this information.


• Methyl Aminolevulinate Cream will be applied at your doctor's office. Methyl Aminolevulinate Cream is used during two treatment sessions 1 week apart. Each treatment session is a two-part procedure. During each treatment session, Methyl Aminolevulinate Cream will be applied and you will receive a red light treatment on the same day.


• Once Methyl Aminolevulinate Cream is applied, a special bandage will be placed over the treated area. Avoid exposure of treated areas to sunlight, bright indoor light, or extreme cold. After you have received Methyl Aminolevulinate Cream, your health care provider will give you the red light treatment. This is the second and final treatment step.


• Before receiving the red light treatment, Methyl Aminolevulinate Cream will be rinsed off of your skin with water and you will be given goggles to protect your eyes. Do not stare into the light. The red light will not heat your skin.


• During the red light treatment, you will experience pain, tingling, stinging, prickling, or burning of the treated area. The red light treatment can be stopped and restarted if needed. These effects stop at the end of treatment, which lasts for about 7 to 10 minutes.


• After the red light treatment, keep the treated area covered and away from light for 48 hours.


• If for any reason you cannot have the red light treatment after Methyl Aminolevulinate Cream is applied, rinse the cream off your skin and protect it from light. Continue to avoid bright light for at least 2 days.


• If you miss a dose of Methyl Aminolevulinate Cream, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Methyl Aminolevulinate Cream.

Important safety information:

• The treated area will be sensitive to light. Avoid exposing the treated area to sunlight and bright indoor light (eg, lamps, tanning beds, nearby lights) during the treatment period before the red light treatment and at least 48 hours after the red light treatment. Stinging, burning, flushing, and swelling may occur if the lesions are exposed to bright light.


• Wear a wide-brimmed hat or similar head-covering of light, opaque material when exposed to sunlight or sources of bright light.


• Sunscreens will not protect you from light sensitivity reactions. Do not use sunscreens on the treated lesions.


• Do not apply any other medicine, creams, or lotions to the treated lesions unless instructed otherwise by your doctor.


• Methyl Aminolevulinate Cream is for topical application to actinic keratoses on the face or scalp only. Avoid getting Methyl Aminolevulinate Cream in your eyes, on skin near your eyes, or on the mucous membranes of the mouth or nose.


• Methyl Aminolevulinate Cream may be harmful if swallowed. If you or someone you know may have taken Methyl Aminolevulinate Cream by mouth, contact your local poison control center or emergency room immediately.


• Burning, redness, stinging, and swelling of the treated skin should be gone in 3 weeks. If treated skin lesions get worse or if they do not completely resolve after 3 weeks, check with your doctor.


• Use Methyl Aminolevulinate Cream with caution in the ELDERLY; they may be more sensitive to its effects.


• Methyl Aminolevulinate Cream should be used with extreme caution in CHILDREN younger than 18 years of age; 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 Methyl Aminolevulinate Cream while you are pregnant. It is not known if Methyl Aminolevulinate Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Methyl Aminolevulinate Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Methyl Aminolevulinate Cream:

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:

Burning; crusting; flushing; itching; pain; redness; scabbing; scaling; skin blisters; stinging; swelling; tenderness; tightness.

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); bleeding; change of skin color; oozing; pustules; severe or persistent burning, inflammation, irritation, pain, redness, or tenderness; swelling of the eyes or eyelids; ulceration; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Methyl Aminolevulinate side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Methyl Aminolevulinate Cream may be harmful if swallowed.

Proper storage of Methyl Aminolevulinate Cream:

Methyl Aminolevulinate Cream is usually handled and stored by a health care provider. Keep Methyl Aminolevulinate Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Methyl Aminolevulinate Cream, please talk with your doctor, pharmacist, or other health care provider.


• Methyl Aminolevulinate Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Methyl Aminolevulinate resources

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

Compare Methyl Aminolevulinate with other medications

• Actinic Keratosis

Mafenide Cream

Pronunciation: MA-fe-NIDE
Generic Name: Mafenide
Brand Name: Sulfamylon

Mafenide Cream is used for:

Treating or preventing skin infections in patients with serious burns. Mafenide Cream is used in combination with other medicines.

Mafenide Cream is an antibacterial agent. It works by killing sensitive bacteria in a way that is not exactly known.

Do NOT use Mafenide Cream if:

• you are allergic to any ingredient in Mafenide Cream

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

Before using Mafenide Cream:

Some medical conditions may interact with Mafenide Cream. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have glucose-6-phosphate dehydrogenase deficiency, kidney problems, or lung or breathing problems (eg, asthma)

Some MEDICINES MAY INTERACT with Mafenide Cream. However, no specific interactions with Mafenide Cream are known at this time.

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

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

• Mafenide Cream is for external use only. Avoid getting Mafenide Cream in your eyes or mouth. If you get Mafenide Cream in your eyes, rinse immediately with cool tap water.


• Mafenide Cream should be applied with a sterile gloved hand. Apply the cream to the affected area at a thickness of 1/16 inch.


• Wash hands after using Mafenide Cream unless the hands are part of the treated area.


• Dressings are usually not required when using Mafenide Cream. If your doctor decides that dressings are needed, apply only a thin layer of dressing.


• Follow the directions provided by your doctor for bathing or washing the affected area.


• To prevent or clear up your infection completely, continue using Mafenide Cream for the full course of treatment even if you feel better in a few days. Do not miss any doses.


• If you miss a dose of Mafenide Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Mafenide Cream.

Important safety information:

• Mafenide Cream may be harmful if swallowed. If you or someone you know may have taken Mafenide Cream by mouth, contact your local poison control center or emergency room immediately.


• Mafenide Cream contains sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.


• LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Mafenide Cream during pregnancy. It is unknown if Mafenide Cream is excreted in breast milk. Do not breast-feed while taking Mafenide Cream.

Possible side effects of Mafenide Cream:

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:

Blistering, burning sensation, itching, redness, or pain at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the skin; dark urine; fast or irregular heartbeat; rapid breathing; softening or thinning of the skin; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mafenide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea.

Proper storage of Mafenide Cream:

Store Mafenide Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mafenide Cream out of the reach of children and away from pets.

General information:

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


• Mafenide Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mafenide resources

• Mafenide Side Effects (in more detail)
• Mafenide Dosage
• Mafenide Use in Pregnancy & Breastfeeding
• Mafenide Support Group
• 0 Reviews for Mafenide - Add your own review/rating

Compare Mafenide with other medications

• Burns, External

Macrobid

Pronunciation: NYE-troe-fure-AN-toin
Generic Name: Nitrofurantoin
Brand Name: Macrobid

Macrobid is used for:

Treating and preventing urinary tract infections caused by certain bacteria.

Macrobid is an antibiotic for specific use in the urinary tract. It works by killing sensitive bacteria.

Do NOT use Macrobid if:

• you are allergic to any ingredient in Macrobid


• you are pregnant and at term (38 to 42 weeks pregnant), you are about to go into labor, or you are in labor


• you have decreased kidney function or decreased urination, or if you are unable to urinate


• you have a history of liver problems or yellowing of the skin or eyes after taking any form of Macrobid


• the patient is younger than 1 month old

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

Before using Macrobid:

Some medical conditions may interact with Macrobid. 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 anemia, diabetes, blood electrolyte problems, glucose-6-phosphate dehydrogenase (G6PD) deficiency, kidney problems, liver problems, nerve problems (eg, peripheral neuropathy), porphyria (a certain blood problem), or low levels of vitamin B in your blood


• if you have a history of lung problems (eg, diffuse interstitial pneumonitis, pulmonary fibrosis)


• if you have very poor health

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

• Probenecid or sulfinpyrazone because they may increase the risk of Macrobid's side effects or decrease Macrobid's effectiveness

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

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

• Take Macrobid by mouth with food.


• Drinking extra fluids while you are taking Macrobid is recommended. Check with your doctor for instructions.


• Do not take an antacid that has magnesium trisilicate in it while you are taking Macrobid. Check with your pharmacist if you are unsure which antacids have magnesium trisilicate in them.


• To clear up your infection completely, take Macrobid for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Macrobid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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


• Macrobid may rarely cause severe and sometimes fatal lung problems. If this occurs, it is usually in patients who take Macrobid for 6 months or longer. These problems may occur without warning signs. If you will be using Macrobid for a long period of time, your doctor may perform lung function tests to check for side effects. Tell your doctor right away if you develop fever, chills, chest pain, unusual cough, trouble breathing (especially while you are being active), other breathing problems, or persistent feeling of being unwell.


• Macrobid may rarely cause severe and sometimes fatal liver problems. Tell your doctor right away if you develop yellowing of the skin or eyes; pale stools; or severe or persistent nausea, loss of appetite, or stomach pain.


• Macrobid may rarely cause severe and sometimes fatal nerve problems. The risk may be greater in patients who have decreased kidney function, anemia, diabetes, electrolyte problems, or low blood vitamin B levels. Tell your doctor right away if you develop numbness, burning, or tingling in the hands or feet.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Long-term or repeated use of Macrobid may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Macrobid only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Macrobid for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Macrobid may discolor the urine. This is normal and not a cause for concern.


• Diabetes patients - Macrobid may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.


• Lab tests, including liver function, kidney function, and lung function, may be performed while you use Macrobid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Macrobid with caution in the ELDERLY; they may be more sensitive to its effects, especially lung or liver problems.


• Macrobid should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• Macrobid should not be used in CHILDREN younger than 1 month old; the risk of anemia may be greater in these children.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Macrobid while you are pregnant. Do NOT take Macrobid if you are at term (38 to 42 weeks pregnant), if you are about to go into labor, or if you are in labor. Macrobid is found in breast milk. Do not breast-feed infants younger than 1 month old while you are taking Macrobid. If your child is older than 1 month, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Macrobid:

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:

Gas; headache; loss of appetite; mild diarrhea; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or watery stools; bluish skin or nails; blurred vision or other vision changes (eg, vision loss); butterfly-shaped rash on the nose and cheeks; confusion; eye pain; joint or muscle pain; mood or mental changes (eg, depression); persistent feeling of being unwell; red, swollen, blistered, or peeling skin; severe or persistent diarrhea; severe or persistent headache; severe stomach pain or cramps; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, severe or persistent nausea or loss of appetite, stomach pain); symptoms of lung problems (eg, fever, chills, chest pain, shortness of breath, unusual or persistent cough); tingling, numbness, or burning of the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Macrobid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include vomiting.

Proper storage of Macrobid:

Store Macrobid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Macrobid out of the reach of children and away from pets.

General information:

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


• Macrobid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Macrobid resources

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

• Macrobid Prescribing Information (FDA)


• Macrobid Consumer Overview


• Nitrofurantoin Professional Patient Advice (Wolters Kluwer)


• Nitrofurantoin Monograph (AHFS DI)


• Furadantin Advanced Consumer (Micromedex) - Includes Dosage Information


• Furadantin Prescribing Information (FDA)


• Macrodantin Prescribing Information (FDA)

Compare Macrobid with other medications

• Bladder Infection
• Prevention of Bladder infection
• Urinary Tract Infection

MicRhogam Ultra-Filtered

Generic Name: rho(d) immune globulin (Injection route, Intramuscular route, Intravenous route)

roe-dee i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin. IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least eight hours after administration for ITP. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period. If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect) .

Commonly used brand name(s)

In the U.S.

• BayRho-D


• HyperRHO S/D


• MicRhogam Ultra-Filtered


• Rhogam


• RhoGAM Ultra-Filtered Plus


• Rhophylac


• WinRho SDF

In Canada

• Winrho SDF

Available Dosage Forms:

• Powder for Solution


• Solution


• Injectable

Therapeutic Class: Immune Serum

Uses For MicRhogam Ultra-Filtered

Rho(D) immune globulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho(D) immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive. It belongs to a group of medicines called immunizing agents. Rho(D) immune globulin works to boost the immune system and prevent excessive bleeding.

The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby's blood can get into her system and cause her to make antibodies. When the same woman has a second baby with Rh-positive blood, the antibodies will destroy the red blood cells in the baby. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent them from making antibodies.

This medicine is to be administered only by or under the supervision of your doctor.

Before Using MicRhogam Ultra-Filtered

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 Rho(D) immune globulin in children. It is not recommended for an infant with Rh-positive blood whose mother is Rh-negative.

Geriatric

Although appropriate studies on the relationship of age to the effects of Rho(D) immune globulin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Rho(D) immune globulin in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, and might have conditions that require an adjustment in the dose for patients receiving Rho(D) immune globulin.

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

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

Interactions with Medicines

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

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.

• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Varicella Virus 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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, severe or


• Blood clotting problems, history of or


• Breathing problems, severe or


• Disseminated intravascular coagulation (blood clotting problem) or


• Kidney problems or


• Pulmonary edema (fluid in the lungs), history of—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or


• Heart or blood vessel problems or


• Hyperviscosity (thick blood), history of or


• Stroke—Use with caution. May cause side effects to become worse.

• Autoimmune hemolytic anemia (bleeding problem) or


• Hemolysis, active (red blood cells are being destroyed) or


• Immunoglobulin A (IgA) deficiency with antibodies against IgA—Should not be used in patients with these conditions.

• Diabetes—The liquid form of WinRho® contains maltose. Some glucose testing systems will not work properly if maltose is in the blood. Discuss this with your doctor.

Proper Use of rho(d) immune globulin

This section provides information on the proper use of a number of products that contain rho(d) immune globulin. It may not be specific to MicRhogam Ultra-Filtered. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

Precautions While Using MicRhogam Ultra-Filtered

It is very important that your doctor check the progress of you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have back pain; shaking chills; a fever; dark urine; a decreased amount of urine; a sudden weight gain; swelling of the hands or feet; or shortness of breath after receiving this medicine. These may be symptoms of a serious blood problem called intravascular hemolysis (IVH).

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis (hardening of the arteries) or circulation problems. Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.

While you are being treated with Rho(D) immune globulin, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving Rho(D) immune globulin.

MicRhogam Ultra-Filtered 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:

Rare

• Bloody urine


• decreased frequency of urination or amount of urine


• fever


• increased blood pressure


• increased thirst


• loss of appetite


• lower back pain


• nausea or vomiting


• pale skin


• swelling of the face, fingers, or lower legs


• troubled breathing


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain

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

Less common

• Soreness at the place of injection

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

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

See also: MicRhogam Ultra-Filtered side effects (in more detail)

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

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

More MicRhogam Ultra-Filtered resources

• MicRhogam Ultra-Filtered Side Effects (in more detail)
• MicRhogam Ultra-Filtered Use in Pregnancy & Breastfeeding
• MicRhogam Ultra-Filtered Drug Interactions
• MicRhogam Ultra-Filtered Support Group
• 2 Reviews for MicRhogam Ultra-Filtered - Add your own review/rating

Compare MicRhogam Ultra-Filtered with other medications

• Idiopathic Thrombocytopenic Purpura
• Rh-Isoimmunization

Mineral Oil Emulsion

Pronunciation: MIHN-er-uhl OYL
Generic Name: Mineral Oil
Brand Name: Examples include Kondremul and Liqui-Doss

Mineral Oil Emulsion is used for:

Relieving occasional constipation and bowel irregularity.

Mineral Oil Emulsion is a lubricant laxative that works by slowing the absorption of water from the bowel, which softens the stool.

Do NOT use Mineral Oil Emulsion if:

• you are allergic to any ingredient in Mineral Oil Emulsion


• you have a blockage in your intestines


• you are bedridden

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

Before using Mineral Oil Emulsion:

Some medical conditions may interact with Mineral Oil Emulsion. 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 heart failure, appendicitis, difficulty swallowing, stomach pain, nausea, vomiting, or rectal bleeding

Some MEDICINES MAY INTERACT with Mineral Oil Emulsion. However, no specific interactions with Mineral Oil Emulsion are known at this time.

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

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

• Take Mineral Oil Emulsion on an empty stomach at least 1 hour before or 2 hours after eating.


• Take Mineral Oil Emulsion at least 2 hours before bedtime.


• Shake well before using.


• Pour the measured dose into a drinking glass and add a small amount (less than 2 ounces/30 mL) of water, milk, fruit juice, or soft drink. Stir and drink. Follow with additional liquid if needed.


• If you miss a dose of Mineral Oil Emulsion, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Mineral Oil Emulsion.

Important safety information:

• Do not use this medication for more than 1 week unless directed to do so by your health care provider.


• Use of Mineral Oil Emulsion for a long time may result in loss of normal bowel function.


• Do not take additional laxatives or stool softeners with Mineral Oil Emulsion unless directed by your doctor.


• If you notice a sudden change in bowel habits which lasts for 2 weeks or more, do not continue using Mineral Oil Emulsion. Instead, check with your doctor.


• Do not take Mineral Oil Emulsion if you have difficulty swallowing without consulting your doctor.


• Mineral Oil Emulsion is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Mineral Oil Emulsion during pregnancy. It is unknown if Mineral Oil Emulsion is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the risks to your baby.

Possible side effects of Mineral Oil Emulsion:

All medicines may cause side effects, but many people have no, or minor, side effects. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); failure to have a bowel movement within 12 hours of taking Mineral Oil Emulsion; rectal bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mineral side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; stomach cramps.

Proper storage of Mineral Oil Emulsion:

Store Mineral Oil Emulsion at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat and light. Protect from freezing. Keep Mineral Oil Emulsion out of the reach of children and away from pets.

General information:

• If you have any questions about Mineral Oil Emulsion, please talk with your doctor, pharmacist, or other health care provider.


• Mineral Oil Emulsion is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mineral Oil resources

• Mineral Oil Side Effects (in more detail)
• Mineral Oil Use in Pregnancy & Breastfeeding
• Mineral Oil Drug Interactions
• Mineral Oil Support Group
• 0 Reviews · Be the first to review/rate this drug

Mifeprex

Generic Name: Mifepristone
Class: Oxytocics
VA Class: HS200
Chemical Name: (11 - β,17 - β) - 11 - [4 - (Dimethylamino)phenyl] - 17 - hydroxy - 17 - (1 - propynyl) - estra - 4,9 - dien - 3 - one
Molecular Formula: C₂₉H₃₅NO₂
CAS Number: 84371-65-3

• 
  

  Risk of serious bacterial (e.g., Clostridium sordellii) infection and sepsis, which can present without fever, bacteremia, or significant findings on pelvic examination.¹ Deaths reported very rarely in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.^{1 33} (See Infection and Sepsis under Cautions and see Advice to Patients.)

  
  


• 
  

  Prolonged heavy vaginal bleeding may be a sign of incomplete abortion or other complications; may require prompt medical or surgical intervention.¹ (See Hemorrhage under Cautions and see Advice to Patients.)

  
  


• 
  

  Discuss medication guide and patient agreement with patients.¹ Ensure that patients know whom to call and what to do in an emergency.¹ If patients visit an emergency room or clinician other than the original prescriber, advise patients to present medication guide to alert clinician of recent medical abortion.^{1 31 32}

  
  

REMS:

FDA approved a REMS for mifepristone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of mifepristone and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Progesterone-receptor antagonist; a synthetic derivative of norethindrone.^{1 2 3 4 5 6 7 8 9 19}

Uses for Mifeprex

Termination of Pregnancy

Termination of intrauterine pregnancy through 49 days of gestation, dated from first day of last menstrual period or determined by clinical examination or ultrasonographic scan.^{1 2 3 4 5 6 7 10 11 19 20 21 22 23 27} Two days after mifepristone, misoprostol must be administered to induce uterine contraction unless complete abortion has been confirmed.^{1 11 27}

Has been used with vaginal† administration of misoprostol for termination of pregnancy;^{2 10 11 27} however, such use very rarely has resulted in fatal bacterial infection and sepsis.^{1 33 37 38 39} (See Infection and Sepsis under Cautions.)

Mifeprex Dosage and Administration

General

• 
  

  Restricted distribution program; not available through community pharmacies.^{1 22 28} Contact distributor at 877-432-7596.^{1 22}

  
  


• 
  

  Clinicians must sign prescriber’s agreement form before ordering from distributor or prescribing; agreement and order forms available on Internet ().^{22 28}

  
  


• 
  

  Before administration, patient must read manufacturer’s medication guide; both patient and clinician must sign patient agreement form.^{1 22 23 24}

  
  


• 
  

  Remove any intrauterine contraceptive device (IUD) prior to administration of mifepristone.¹

  
  


• 
  

  Medical facilities equipped to provide blood transfusions, resuscitation, and/or surgical intervention must be available during treatment and follow-up.^{1 22}

  
  


• 
  

  Regimen requires 3 visits with clinician: day 1 mifepristone administration; day 3 misoprostol administration (unless complete abortion confirmed); and day 14 follow-up examination to confirm complete pregnancy termination and to assess severity of any continued bleeding.^{1 22}

  
  


• 
  

  May require medications for treatment of adverse effects (e.g., cramping, GI symptoms) after misoprostol administration.¹

  
  

Administration

Oral Administration

Administer orally as a single dose without regard to meals.¹

Dosage

Adults

Termination of Pregnancy

Oral

600 mg as a single dose.¹ Two days later, administer misoprostol 400 mcg orally unless complete abortion confirmed.¹

Cautions for Mifeprex

Contraindications

• 
  

  Confirmed or suspected ectopic pregnancy, undiagnosed adnexal mass, or IUD currently in place.¹ (See General under Dosage and Administration.)

  
  


• 
  

  Chronic adrenal failure or long-term corticosteroid therapy.¹

  
  


• 
  

  Known hypersensitivity to mifepristone, misoprostol, or other prostaglandins.¹

  
  


• 
  

  Hemorrhagic disorders, inherited porphyrias, or concurrent anticoagulant therapy.¹

  
  


• 
  

  Inability to understand effects of or to comply with treatment regimen.¹

  
  


• 
  

  Inadequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusion, and emergency resuscitation during treatment and follow-up.¹

  
  

Warnings/Precautions

Warnings

Hemorrhage

Vaginal bleeding heavier than with normal menses occurs in almost all women receiving mifepristone and misoprostol.^{1 3 11 19 20 21 29} Bleeding or spotting expected for average of 9–16 days;^{1 19 20} in ≤8% of patients may last ≥30 days.^{1 10 19 20 29}

Prolonged heavy vaginal bleeding (i.e., soaking through 2 thick full-size sanitary pads per hour for 2 consecutive hours) may indicate incomplete abortion or other complications; may require prompt medical or surgical intervention to prevent hypovolemic shock.¹ Advise patients to seek immediate medical attention if prolonged heavy vaginal bleeding or syncope occurs.¹ (See Advice to Patients.)

Treat excessive bleeding with uterotonics, vasoconstrictors, saline infusions, and/or blood transfusions or curettage; caution in patients with hemostatic disorders, hypocoagulability, or severe anemia.¹

Infection and Sepsis

Serious bacterial infection (including very rare cases of fatal septic shock) reported; causal relationship to mifepristone-misoprostol regimen not established.^{1 33 37 39}

Serious bacterial (e.g., C. sordellii) infection and sepsis can present without fever, bacteremia, or substantial findings on pelvic examination.^{1 33 39} Deaths reported very rarely in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.^{1 33 39} These deaths occurred in women who received misoprostol intravaginally†; causal relationship to risk of infection or death not established.^{1 33 37 38 39} C. sordellii infections also reported very rarely following childbirth (vaginal delivery and cesarean section) and in other gynecologic and nongynecologic conditions.^{1 33 39}

Maintain a high index of suspicion to rule out serious infection and sepsis (e.g., from C. sordellii) if sustained fever (temperature ≥38°C persisting for >4 hours), severe abdominal pain, or pelvic tenderness occurs within several days of medical abortion, or if abdominal pain/discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea), with or without fever, occurs >24 hours after administration of misoprostol.^{1 33 37 38} (See Advice to Patients.) Consider obtaining CBC to identify patients with hidden infection.^{37 38}

If infection is suspected, FDA recommends initiating appropriate anti-infective therapy that includes coverage against anaerobic bacteria (e.g., C. sordellii) immediately; optimum anti-infective regimen not established.^{37 38} Routine anti-infective prophylaxis not recommended at this time because of insufficient data.^{37 38}

Confirmation of Pregnancy Termination

Risk of fetal harm if pregnancy continues.^{1 23 24} Perform clinical examination or ultrasonographic scan 14 days after administration to confirm pregnancy termination; failure should be managed with surgical termination.^{1 22 23 24}

Ruptured Ectopic Pregnancy

Ruptured ectopic pregnancy, including fatal hemorrhage, reported, although causality not established.^{29 30} Mifepristone is not effective for termination of ectopic pregnancy.^{1 22} (See Contraindications under Cautions.) Consider possibility that ectopic pregnancy may be present and establish plan for its management.^{1 22}

Death

At least 2 unexplained deaths reported.^{36 37} One was determined by FDA to be unrelated to abortion or to use of mifepristone or misoprostol.³⁶ Cause of the other reported death, which was preceded by manifestations of infection, was still under investigation when the 2006–07 edition of AHFS Drug Information Essentials went to press.³⁶

Pending further investigation, be aware of specific circumstances and directions for use as well as risks (e.g., sepsis) associated with mifepristone.³⁷

Inform patients of early manifestations that may warrant immediate medical evaluation.³⁷ (See Warnings under Cautions and also see Advice to Patients.)

Major Toxicities

MI

MI reported, although causality to mifepristone-misoprostol regimen not established.^{29 30}

General Precautions

Medical Personnel and Facilities

Clinicians should be able to assess gestational age of embryo, diagnose ectopic pregnancy, and provide or ensure availability of surgical intervention in cases of incomplete abortion or severe bleeding.^{1 22} Patients must have access to medical facilities equipped to provide blood transfusions and resuscitation.^{1 22}

Suppression of Rh Isoimmunization

Consider administration of Rh_o(D) immune globulin in Rh_o(D)-negative women.^{1 3 10 11 18}

Other Medical Conditions

Safety, efficacy, and pharmacokinetics not studied in patients with chronic medical conditions (e.g., severe anemia; insulin-dependent diabetes mellitus; hypertension; cardiovascular, respiratory, hepatic, or renal disease), history of heavy smoking, or in women >35 years of age who smoke ≥10 cigarettes daily.¹

Specific Populations

Pregnancy

Category X.

Used for termination of pregnancy (through 49 days of gestation); no other FDA-approved indication for use in pregnancy.¹

Lactation

Not known whether mifepristone is distributed into milk;¹ discard milk for several days after administration.^{1 23}

Pediatric Use

Safety and efficacy not established in females <18 years of age.¹

Common Adverse Effects

Abdominal pain, nausea, headache, vomiting, diarrhea, dizziness, fatigue, back pain, uterine hemorrhage.¹ Note that vaginal bleeding and uterine cramping are expected effects.¹ (See Hemorrhage under Cautions.)

Interactions for Mifeprex

Extensively metabolized by CYP3A4.^{1 3}

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma mifepristone concentrations); however, specific drugs and food not studied to date.¹

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma mifepristone concentrations); however, specific drugs and food not studied to date.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP3A4: Potential pharmacokinetic interaction (increased serum substrate concentrations); caution if administered concurrently with drugs that are CYP3A4 substrates and have a narrow therapeutic range.¹

Specific Drugs and Foods

Drug or Food	Interaction
Carbamazepine	Possible decreased serum mifepristone concentrations1
Dexamethasone	Possible decreased serum mifepristone concentrations1
Erythromycin	Possible increased serum mifepristone concentrations1
Grapefruit juice	Possible increased serum mifepristone concentrations1
Itraconazole	Possible increased serum mifepristone concentrations1
Ketoconazole	Possible increased serum mifepristone concentrations1
Phenobarbital	Possible decreased serum mifepristone concentrations1
Phenytoin	Possible decreased serum mifepristone concentrations1
Rifampin	Possible decreased serum mifepristone concentrations1
St. John’s wort	Possible decreased serum mifepristone concentrations1

Mifeprex Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed from the GI tract following oral administration.^{1 3} Absolute bioavailability is 69%,¹ but is reduced to 40% after first pass effect.^{a 3} Peak plasma concentrations attained in about 1–2 hours.^{1 a}

Distribution

Extent

Not known whether mifepristone is distributed into milk.¹

Plasma Protein Binding

98% (mainly to albumin and α₁-acid glycoprotein).¹

Elimination

Metabolism

Extensively metabolized in the liver by CYP3A4 to 3 major active metabolites.^{1 3}

Elimination Route

Excreted in feces (83%) and in urine (9%).^{1 a}

Half-life

Initial elimination half-life, 12–72 hours; terminal elimination half-life, 18 hours.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions

• 
  

  Binds to progesterone receptor, antagonizing endometrial and myometrial effects of progesterone, resulting in down-regulation of progesterone-dependent genes.^{1 2 3 4 5 6 7 8 27} Inhibition of progesterone in pregnancy results in detachment of conception product and pregnancy termination.^{1 2 3 5 6 8 9} Also promotes uterine contractions and softening of cervix.^{1 2 3 4 5 6 7 9 27}

  
  


• 
  

  Sensitizes myometrium to effects of prostaglandins (e.g., misoprostol) that stimulate uterine contraction and expulsion of the products of conception.^{1 2 3 4 5 6 7 9 27}

  
  


• 
  

  At higher doses, exhibits antiglucocorticoid activity.^{1 3 5 6 7 8 9}

  
  

Advice to Patients

• 
  

  Importance of carefully reading medication guide and reading and signing the patient agreement form before receiving mifepristone.^{1 22 23 24 31} If visiting an emergency room or a clinician other than the original prescriber, present medication guide to alert clinician of recent medical abortion.^{1 31 32}

  
  


• 
  

  Importance of understanding procedures for emergency situations and of obtaining a telephone number for emergency contact with clinicians.^{1 23 24}

  
  


• 
  

  Possible need for surgical intervention if complete abortion does not occur following mifepristone and misoprostol administration.^{1 22 23 24} Risk of fetal malformation if the pregnancy continues.^{1 23 24}

  
  


• 
  

  Importance of adherence to treatment regimen and follow-up appointment schedule.¹

  
  


• 
  

  Risk of severe infection and bleeding.¹ Contact clinician (or visit emergency room if clinician is unavailable) if sustained fever (temperature ≥38°C persisting for >4 hours), severe abdominal pain, prolonged heavy bleeding (soaking through 2 thick full-size sanitary pads per hour for 2 consecutive hours), or syncope occurs within several days of medical abortion,^{1 31 32} or if abdominal pain/discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea), with or without fever, occurs >24 hours after administration of misoprostol.^{1 34 35}

  
  


• 
  

  Importance of initiating contraception immediately after confirmation of abortion or before resuming sexual intercourse; risk of pregnancy exists immediately after termination of existing pregnancy and before normal menses begin.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal preparations.^{1 23}

  
  


• 
  

  Importance of women informing their clinician if they are breast-feeding.^{1 23}

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Distribution of mifepristone is restricted.^{22 28} (See General under Dosage and Administration.)

Mifepristone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablet	200 mg	Mifeprex (with povidone; single-dose packet containing 3 tablets)	Danco

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Danco Laboratories, LLC; Mifeprex (mifepristone) oral tablet prescribing information. New York, NY; 2005 Jul.

2. Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000; 342:946-56.

3. Heikinheimo O. Clinical pharmacokinetics of mifepristone. Clin Pharmacokinet. 1997; 33:7-17. [PubMed 9250420]

4. Mahajan DK, London SN. Mifepristone (RU486): a review. Fertil Steril. 1997; 68:967-76. [IDIS 398835] [PubMed 9418681]

5. Avrech OM, Bukovsky I, Golan A et al. Mifepristone (RU486) alone or in combination with a prostaglandin analogue for termination of early pregnancy: a review. Fertil Steril. 1991; 56:385-93. [IDIS 289661] [PubMed 1894013]

6. Spitz IM, Bardin CW. Mifepristone (RU 486)—a modulator of progestin and glucocorticoid action. N Engl J Med. 1993; 329:404-12. [IDIS 318211] [PubMed 8326975]

7. Brogden RN, Goa KL, Faulds D. Mifepristone: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993; 45:384-409. [PubMed 7682909]

8. Baulieu EE. RU-486 as an antiprogesterone steroid: from receptor to contragestion and beyond. JAMA. 1989; 262:1808-14. [IDIS 259553] [PubMed 2674487]

9. Mifegyne (mifepristone), a new antiprogestagen with potential therapeutic use in human fertility control.Drugs. 1988; 35:187-91.

10. Grimes DA. Medical abortion in early pregnancy: a review of the evidence. Obstet Gynecol. 1997; 89:790-6. [IDIS 386385] [PubMed 9166323]

11. Newhall EP, Winikoff B. Abortion with mifepristone and misoprostol: regimens, efficacy, acceptability and future directions.Am J Obstet Gynecol. 2000; 183:S44-53. [IDIS 451553] [PubMed 10944369]

12. Searle. Cytotec (misoprostol) oral tablets prescribing information. Skokie, IL; 2000 Oct 2.

13. Monk JP, Clissold SP. Misoprostol: a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of peptic ulcer disease. Drugs. 1987; 33:1-30. [IDIS 228650] [PubMed 3102205]

14. Cullen M, Searle. Dear health care provider: Important drug warning concerning unapproved use of intravaginal or oral misoprostol in pregnant women for induction of labor or abortion. Skokie, IL; 2000 Aug 23. From FDA web site ()

15. American College of Obstetricians and Gynecologists. News release: ACOG issues letter on safety of misoprostol. Washington, DC; 2000 Oct 12.

16. Anon. ACOG committee opinion: induction of labor with misoprostol. Obstet Gynecol. 1999; 94:1-2. (IDIS 440248)

17. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Induction of labor. Practice Bulletin No. 10. Washington, DC: American College of Obstetricians and Gynecologists; 1999 Nov.

18. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Prevention of Rh D alloimmunization. Practice Bulletin No. 4. Washington, DC: American College of Obstetricians and Gynecologists; 1999 May.

19. Spitz IM, Bardin CW, Benton L et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med. 1998; 338:1241-7. [IDIS 403670] [PubMed 9562577]

20. Peyron R, Aubény E, Targosz V et al. Early termination of pregnancy with mifepristone (RU 486) and the orally active prostaglandin misoprostol. N Engl J Med. 1993; 328:1509-13. [IDIS 314636] [PubMed 8479487]

21. Aubény E, Peyron R, Turpin CL et al. Termination of early pregnancy (up to 63 days of amenorrhea) with mifepristone and increasing doses of misoprostol. Int J Fertil Menopausal Stud. 1995; 40:85-91. [Originally published as Termination of early pregnancy (up to and after 63 days of amenorrhea) with mifepristone (RU 486) and increasing doses of misoprostol. Corrected in erratum: Int J Fertil Menopausal Stud. 1996; 41:56.]

22. Danco Laboratories. Mifeprex (mifepristone) tablets, 200 mg: prescriber’s agreement. From FDA website (). (undated)

23. Danco Laboratories. Mifepristone medication guide. From FDA website (). 6 Nov 2000.

24. Danco Laboratories. Patient agreement: Mifeprex (mifepristone) tablets. From FDA website (). 21 Sept 2000.

25. Population Council, New York, NY: Personal communication.

26. Pharmacia & Upjohn, Skokie, IL: Personal communication.

27. Anon. Mifepristone (RU 486). Med Lett Drugs Ther. 2000; 42: 101-102.

28. Anon. Mifepristone questions and answers. From FDA website (). 28 Sept 2000.

29. Danco Laboratories. Dear health care provider letter regarding new safety information for mifepristone. New York, NY; 2002 Apr. From FDA website ()

30. Food and Drug Administration. Mifepristone questions and answers. Rockville, MD; 2002 Apr 17. From FDA website ()

31. Danco Laboratories. Mifepristone medication guide. From FDA website (). 12 Nov 2004.

32. Danco Laboratories. Patient agreement: Mifeprex (mifepristone) tablets. From FDA website (). 12 Nov 2004.

33. Danco Laboratories. Dear health care provider letter regarding new safety information for mifepristone. New York, NY; 2005 Jul. From FDA website ().

34. Danco Laboratories. Mifepristone medication guide. From FDA website (). 19 Jul 2005.

35. Danco Laboratories. Patient agreement: Mifeprex (mifepristone) tablets. From FDA website (). 19 Jul 2005.

36. Food and Drug Administration. Mifeprex (mifepristone) information (April 10, 2006 update). Rockville, MD; 2006 Apr 10. From FDA website ().

37. Food and Drug Administration. FDA Public Health Advisory: Sepsis and Medical Abortion Update (March 17, 2006). Rockville, MD; 2006 Mar 17. From FDA website ().

38. Food and Drug Administration. FDA Public Health Advisory: Sepsis and Medical Abortion (November 4, 2005 update). Rockville, MD; 2005 Nov 4. From FDA website ().

39. Fischer M, Bhatnagar J, Guarner J et al. Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med. 2005; 353:2352-60. [PubMed 16319384]

a. Sarkar NN. Mifepristone: bioavailability, pharmacokinetics and use-effectiveness. Eur J Obstet Gynecol Reprod Biol. 2002; 101:113-20. [PubMed 11858883]

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Meperidine

Pronunciation: me-PER-ih-deen
Generic Name: Meperidine
Brand Name: Demerol

Meperidine is used for:

Short-term treatment of moderate to severe pain. It may also be used before or during surgery (eg, to support anesthesia), for pain relief during labor and delivery, or for other conditions as determined by your doctor.

Meperidine is a narcotic analgesic. It works in the brain and nervous system to decrease pain.

Do NOT use Meperidine if:

• you are allergic to any ingredient in Meperidine


• you have severely slow or difficult breathing


• you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you are taking ritonavir, sibutramine, or sodium oxybate (GHB)

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

Before using Meperidine:

Some medical conditions may interact with Meperidine. 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 had an allergic reaction to any codeine- or morphine-related medicine (eg, hydrocodone, oxycodone, dihydrocodeine, hydromorphone)


• if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale); low levels of oxygen or high levels of carbon dioxide in the blood; sickle cell anemia; adrenal gland problems (eg, Addison disease, pheochromocytoma); curvature of the spine (scoliosis); thyroid problems; low blood pressure; an enlarged prostate; urinary blockage or trouble urinating; lung, liver, or kidney problems; heart problems (eg, fast or irregular heartbeat); seizures; or stomach or bowels problems (eg, inflammatory bowel disease)


• if you have or have recently had any head injury, brain tumor or other growths, or increased pressure in the brain


• if you drink alcohol; are going through withdrawal from alcohol or other substances; or have a history of alcohol or substance abuse or dependence, mental or mood problems, or suicidal thoughts or attempts


• if you have severe diarrhea due to taking an antibiotic (pseudomembranous colitis), constipation, stomach pain, low blood volume, dehydration, drowsiness, or severe weakness, or have had recent surgery

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

• Mixed narcotic agonist/antagonists (eg, butorphanol, pentazocine), naltrexone, or rifamycins (eg, rifampin) because they may decrease Meperidine's effectiveness


• Furazolidone or MAOIs (eg, phenelzine) because the risk of serious side effects, including coma, difficulty breathing, low blood pressure, seizures, and irregular heartbeat, may be increased


• Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) or sibutramine because the risk of side effects, including increased body temperature, mental or mood changes, muscle twitching, or severe drowsiness, may be increased


• Acyclovir, cimetidine, phenothiazines (eg, chlorpromazine), phenytoin, or ritonavir because the risk of side effects of Meperidine may be increased


• Muscle relaxers (eg, cyclobenzaprine) or sodium oxybate (GHB) because actions and side effects may be increased by Meperidine

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

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

• Meperidine is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Meperidine at home, a health care provider will teach you how to use it. Be sure you understand how to use Meperidine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Tell your doctor if you still experience pain or if your pain gets worse while using Meperidine.


• Do not use Meperidine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Meperidine and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Meperidine may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Meperidine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Meperidine may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Meperidine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Meperidine may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty or water, and exercise to prevent constipation. If you become constipated while taking Meperidine, talk with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Prolonged use of Meperidine may increase the risk of toxicity, including seizures.


• Do not suddenly stop taking Meperidine without first checking with your doctor. If you have been taking Meperidine for more than a few weeks and your doctor tells you to stop taking it, your dose may need to be gradually lowered as directed by your doctor to avoid side effects.


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


• Use Meperidine with caution in the ELDERLY; they may be more sensitive to its effects.


• Use Meperidine with extreme caution in CHILDREN; they may be more sensitive to its effects, especially slowed or difficult breathing.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Meperidine while you are pregnant. Meperidine is found in breast milk. Do not breast-feed while using Meperidine.

When used for long periods of time or at high doses, Meperidine 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 Meperidine stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Meperidine. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Meperidine, you may experience WITHDRAWAL symptoms, including anxiety; appetite loss; backache; chills; diarrhea; enlarged pupils; fast heartbeat or breathing rate; increased tears; irritability; muscle or joint pain; nausea; restlessness; runny nose; severe or persistent dizziness; sleeplessness; stomach cramps; sweating; vomiting; weakness; and yawning.

Possible side effects of Meperidine:

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:

Constipation; dizziness; drowsiness; flushing; light-headedness; loss of appetite; nausea; sweating; vomiting.

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); chest pain; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; numbness of an arm or a leg; seizure; severe or persistent constipation or stomach pain; severe or persistent dizziness or light-headedness; slowed, shallow, or difficult breathing; sudden severe headache, nausea, or vomiting; tremor; uncontrolled muscle movements; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Meperidine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; cold and clammy skin; fainting; limp muscles; loss of consciousness; low body temperature; seizures; severe dizziness or light-headedness; severe drowsiness; slowed heartbeat; slowed, shallow, or difficult breathing; small pupils.

Proper storage of Meperidine:

Meperidine is usually handled and stored by a health care provider. If you are using Meperidine at home, store Meperidine as directed by your pharmacist or health care provider. Keep Meperidine out of the reach of children and away from pets.

General information:

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


• Meperidine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Meperidine resources

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

• Meperidine Prescribing Information (FDA)


• meperidine Concise Consumer Information (Cerner Multum)


• meperidine Advanced Consumer (Micromedex) - Includes Dosage Information


• Meperidine Hydrochloride Monograph (AHFS DI)

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• Light Sedation
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