Blog Atlanta: 2016

Monday, October 17, 2016

mecasermin rinfabate

Generic Name: mecasermin rinfabate (meh KAZ er men RIN fa bayt)

Brand Names: iPlex

What is mecasermin rinfabate?

Mecasermin rinfabate is a man-made form of insulin-like growth factor-1 (IGF-1), which is normally produced by the body. IGF-1 is important for the growth of bones and muscles.

Mecasermin rinfabate is used to treat growth failure in children whose bodies do not make enough IGF-1.

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

What is the most important information I should know about mecasermin rinfabate?

Your child should not use mecasermin rinfabate if your child has cancer, has finished growing (the bone growth plates are closed), or has other causes of growth failure.

This medicine must be given 20 minutes before or after the child eats a meal or snack. Do not use the medicine if the meal or snack is not eaten for any reason. Wait until the child has eaten and 20 minutes have passed before giving the mecasermin rinfabate injection. Mecasermin rinfabate may lower blood sugar levels if it is used without eating.

Always eat a meal or snack 20 minutes before or after injecting mecasermin rinfabate.

Mecasermin rinfabate may cause a bone problem in the top of the upper leg. Get medical attention right away if your child develops a limp or has hip or knee pain.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them in your child. Always keep a source of sugar available in case your child has symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause fainting, seizure (convulsions), or death. If your child has severe hypoglycemia and cannot eat or drink, give an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Mecasermin rinfabate may cause a temporary increase in pressure within the brain. Call your doctor at once if your child has pain behind the eyes, and nausea with vomiting.

Mecasermin rinfabate may worsen scoliosis. If your child has scoliosis, he or she will need to be checked often for an increase in the curve of the spine.

What should I discuss with my healthcare provider before using mecasermin rinfabate?

Your child should not use mecasermin rinfabate if the child:

has finished growing (the bone growth plates are closed);

has cancer; or

has other causes of growth failure.

Before receiving this medication, tell your child's doctor if the child has:

diabetes;

kidney problems;

liver problems; or

scoliosis (a curved spine).

If your child has any of these conditions, he or she may need a dose adjustment or special tests to safely use mecasermin rinfabate.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether mecasermin rinfabate passes into breast milk or if it could harm a nursing baby. This medication should not be used while breast-feeding a baby.

How should I use mecasermin rinfabate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your child's prescription label.

Your child's doctor may occasionally change the dose to make sure your child gets the best results from this medication.

Mecasermin rinfabate is given as an injection (shot) under the skin in your child's upper arm, upper thigh, stomach area, or buttocks. Never inject the medicine into a muscle or a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not inject your child at home if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use a different place in the injection skin area each time you give an injection. Your care provider will show you the places on your child's body where you can safely inject the medication. Do not inject into the same place two times in a row.

Do not draw the mecasermin rinfabate dose into a syringe until you are ready to give your child an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Your child may need to eat or restrict certain foods while using this medication. Follow the doctor's instructions about diet and medication.

To be sure this medication is helping your child's condition, the child's blood will need to be tested on a regular basis. An eye exam may also be needed. Do not miss any scheduled appointments.

Store this medication in the freezer until you are ready to use it. It is best to keep the medicine in a deep freezer at a temperature of 4 degrees below 0 Fahrenheit (or -20 degrees Celsius) so it does not thaw between uses.

When you are ready to use the medication, take it out of the freezer and allow it to thaw at room temperature for 45 minutes. Do not warm the medication with hot water or a microwave. Once the medicine thaws, it must be used within 1 hour.

Mecasermin rinfabate can be stored frozen for up to 2 months. Do not use the medication if it has been frozen for longer than 2 months.

What happens if I miss a dose?

Give the injection as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until the next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Always have the child eat a meal or snack 20 minutes before or after injecting mecasermin rinfabate.

What happens if I overdose?

Seek emergency medical attention if you think your child has received too much of this medicine.

Overdose symptoms may include symptoms of low blood sugar such as headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating.

What should I avoid while using mecasermin rinfabate?

Avoid giving this medication if your child is sick or cannot eat.

Do not give a mecasermin rinfabate injection if the child does not eat a meal or snack within 20 minutes before or after the injection. Mecasermin rinfabate may lower blood sugar levels if it is used without eating.

Mecasermin rinfabate side effects

Stop using mecasermin rinfabate and 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.

Mecasermin rinfabate may cause a temporary increase in pressure within the brain. Symptoms include pain behind the eyes, and nausea with vomiting. Call your doctor at once if your child has a headache with vomiting.

Mecasermin rinfabate may cause a bone problem called "slipped capital femoral epiphysis." This happens when the top of the upper leg (femur) slips apart. Get medical attention for your child right away if your child develops a limp or has hip or knee pain.

Mecasermin rinfabate may cause hypoglycemia, or low blood sugar. Symptoms of low blood sugar may include dizziness, headache, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, or fast or uneven heart rate. Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Other sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause fainting, seizure (convulsions), or death. If your child has severe hypoglycemia and cannot eat or drink, give an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Mecasermin rinfabate may cause the tonsils to become enlarged. This can result in snoring, sleep apnea (breathing stops during sleep), trouble swallowing, or a build-up of fluid in the middle ear. Call your doctor if your child has any of these symptoms.

Mecasermin rinfabate may cause worsened scoliosis (caused by fast growth). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine.

Mecasermin rinfabate may also cause pain, redness, bruising, or skin changes where the shot was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Mecasermin rinfabate Dosing Information

Usual Pediatric Dose for Primary IGF-1 Deficiency:

Growth failure in children with severe primary Insulin-like Growth Factor-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.

3 years old to adult (closed epiphyses):
initial dose: 0.5 mg/kg once daily by subcutaneous injection. To establish tolerability, glucose monitoring should be considered at treatment initiation or when a dose has been increased. The dosage can be titrated up to the maximum of 2 mg/kg per day. Doses should be administered at approximately the same time each day. If the patient is unable to eat shortly before or after a dose for any reason, that dose should be withheld. Subsequent doses should never be increased to make up for one or more missed doses.

What other drugs will affect mecasermin rinfabate?

Before using mecasermin rinfabate, tell the doctor if your child uses any diabetes medications such as insulin or medicines taken by mouth (Glucotrol, Diabeta, Micronase, Orinase, and others). If your child is using any of these drugs, he or she may need a dose adjustment or special tests to safely use mecasermin rinfabate.

There may be other drugs not listed that can affect mecasermin rinfabate. Tell your doctor about all the prescription and over-the-counter medications your child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.

More mecasermin rinfabate resources

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

Iplex Advanced Consumer (Micromedex) - Includes Dosage Information

iPlex Consumer Overview

Compare mecasermin rinfabate with other medications

Muscular Dystrophy
Primary IGF-1 Deficiency

Where can I get more information?

Your pharmacist can provide more information about mecasermin rinfabate.

See also: mecasermin rinfabate side effects (in more detail)

mecamylamine

Generic Name: mecamylamine (meck a MILL a meen)

Brand Names: Inversine

What is mecamylamine?

Mecamylamine is used to treat moderate to severe hypertension (high blood pressure). Because of its many side effects, mecamylamine is not commonly used.

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

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

Use caution when driving, operating machinery, or performing other hazardous activities. Mecamylamine may cause dizziness. If you experience dizziness, avoid these activities. If you experience dizziness, rise slowly from a sitting or lying position to avoid falling. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking mecamylamine.

Take mecamylamine every day at the same time, usually after meals.

Call your doctor if you experience tremor, abdominal pain, abdominal distention, or diarrhea.

Who should not take mecamylamine?

Before taking this medication, tell your doctor if you

have arteriosclerosis (poor blood flow in the arteries, or "hardening of the arteries") in your heart (coronary) or to the head (cerebral);

have recently had a heart attack;

have glaucoma;

have kidney disease; or

have difficulty urinating as a result of an enlarged prostate or some other cause.

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

Mecamylamine is in the FDA pregnancy category C. This means that it is not known whether mecamylamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether mecamylamine passes into breast milk. Do not take mecamylamine without first talking to your doctor if you are breast-feeding a baby.

How should I take mecamylamine?

Take mecamylamine 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. Take mecamylamine after meals.

Take each dose at the same time every day.

Do not stop taking this medication unless your doctor approves. Not taking your medication could make your condition much worse. Store mecamylamine at room temperature away from moisture and heat.

See also: Mecamylamine dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a mecamylamine overdose include fainting, dizziness, weakness, confusion, nausea, vomiting, diarrhea, constipation, difficulty urinating, anxiety, dry mouth, large pupils, blurred vision, and an irregular heartbeat.

What should I avoid while taking this mecamylamine?

Mecamylamine side effects

If you experience any of the following serious side effects, stop taking mecamylamine and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

abdominal pain, abdominal distention, or diarrhea.

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

nausea, vomiting, or constipation;

dry mouth;

decreased appetite;

dizziness and fainting;

drowsiness or weakness;

dilated (large) pupils and blurred vision; or

difficulty urinating.

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.

Mecamylamine Dosing Information

Usual Adult Dose for Hypertension:

Moderately severe to severe essential hypertension or uncomplicated malignant hypertension:

Initial dose: usually 2.5 mg orally twice a day. The initial regulation of dosage should be determined by blood pressure readings in the erect position at the time of maximal effect of the drug, as well as by other signs and symptoms of orthostatic hypotension.

Maintenance dose: Increase dose as needed in increments of 2.5 mg at intervals of not less than 2 days until the desired blood pressure is achieved. In severe or urgent cases, larger increments at smaller intervals may be needed. The maintenance dosage should be just below that which causes signs of mild postural hypotension. The average total daily dosage is 25 mg orally in divided doses (generally 2 to 4 doses, but more if necessary in severe cases when smooth control is difficult to obtain). However, as little as 2.5 mg daily may be adequate in some patients.

What other drugs will affect mecamylamine?

Generally, mecamylamine should not be used during treatment with antibiotics or sulfa-based drugs. Tell your doctor if you are taking drugs of either of these types.

Other drugs used to lower high blood pressure may increase the effects of mecamylamine, and serious side effects could occur. Tell your doctor about all medicines you take to lower high blood pressure or to treat other heart conditions.

Anesthesia (use of drugs that put you to sleep for surgery) may also increase the effects of mecamylamine. Tell your doctor or dentist that you are taking mecamylamine before you have surgery.

Drugs other than those listed here may also interact with mecamylamine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More mecamylamine resources

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

mecamylamine Advanced Consumer (Micromedex) - Includes Dosage Information

Mecamylamine MedFacts Consumer Leaflet (Wolters Kluwer)

Inversine Prescribing Information (FDA)

Compare mecamylamine with other medications

High Blood Pressure

Where can I get more information?

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

See also: mecamylamine side effects (in more detail)

Maxifed-G CDX

Pronunciation: KOE-deen/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Codeine/Guaifenesin/Pseudoephedrine
Brand Name: Examples include Ambifed CD and Maxifed-G CDX

Maxifed-G CDX is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Maxifed-G CDX is a decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant loosens mucus and lung secretions in the chest and makes coughs more productive.

Do NOT use Maxifed-G CDX if:

you are allergic to any ingredient in Maxifed-G CDX or any other codeine- or morphine-related medicine (eg, oxycodone)

you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

you are having an asthma attack

you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Maxifed-G CDX:

Some medical conditions may interact with Maxifed-G CDX. 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 morphine, codeine, or any other opiate (eg, dihydrocodeine, hydrocodone, oxycodone)

if you have a history of glaucoma; an enlarged prostate gland or other prostate problems; heart problems; diabetes; high blood pressure; blood vessel problems; stroke; liver or kidney problems; blockage of the stomach, bowel, or bladder; adrenal gland problems; or thyroid problems

if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery

if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

if you have a fever, severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)

if you have very poor health or a history of alcohol abuse, other substance abuse, or suicidal thoughts or actions

if you are taking medicine for high blood pressure or depression

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

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAOIs (eg, phenelzine ), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Maxifed-G CDX's side effects

Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Maxifed-G CDX's effectiveness

Bromocriptine or sodium oxybate (GHB) because the risk of their side effects may be increased by Maxifed-G CDX

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Maxifed-G CDX

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

Use Maxifed-G CDX as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Maxifed-G CDX by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Drink plenty of water while taking Maxifed-G CDX.

If you miss a dose of Maxifed-G CDX, 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 Maxifed-G CDX.

Important safety information:

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

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

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

Do not take diet or appetite control medicines while you are taking Maxifed-G CDX without checking with your doctor.

Maxifed-G CDX has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 days, if they get worse, or if they go away and then come back, check with your doctor.

If your symptoms occur along with fever, rash, or persistent headache, contact your doctor.

Do not use Maxifed-G CDX for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Maxifed-G CDX may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Maxifed-G CDX. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Maxifed-G CDX may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Maxifed-G CDX.

Tell your doctor or dentist that you take Maxifed-G CDX before you receive any medical or dental care, emergency care, or surgery.

Use Maxifed-G CDX with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.

Caution is advised when using Maxifed-G CDX in CHILDREN; they may be more sensitive to its effects, especially excitability.

Maxifed-G CDX should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

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

Possible side effects of Maxifed-G CDX:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; vomiting; weakness.

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); blurred vision or other vision changes; confusion; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; persistent trouble sleeping; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; uncontrolled muscle movement.

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: Maxifed-G CDX 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow or rapid breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Maxifed-G CDX:

Store Maxifed-G CDX 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 Maxifed-G CDX out of the reach of children and away from pets.

General information:

If you have any questions about Maxifed-G CDX, please talk with your doctor, pharmacist, or other health care provider.

Maxifed-G CDX 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 Maxifed-G CDX. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Maxifed-G CDX resources

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

Ambifed CD Concise Consumer Information (Cerner Multum)

Novahistine Expectorant Concise Consumer Information (Cerner Multum)

Compare Maxifed-G CDX with other medications

Cold Symptoms

Menest

Generic Name: esterified estrogens (ess TER ih fied ESS troe jenz)

Brand Names: Estratab, Menest

What are Menest (esterified estrogens)?

Estrogen is a female sex hormone necessary for many processes in the body.

Esterified estrogens are naturally occurring female sex hormones that are used to treat symptoms of menopause; deficiency in ovary function (including underdevelopment of female sexual characteristics and some types of infertility); some types of breast cancer in men and in postmenopausal women; degeneration of the vagina; and urethra and prostate cancer. In addition, esterified estrogens are used to prevent osteoporosis.

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

What is the most important information I should know about Menest (esterified estrogens)?

Esterified estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with esterified estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking esterified estrogens.

Do not take esterified estrogens if you are pregnant.

Who should not take Menest (esterified estrogens)?

Do not take esterified estrogens without first talking to your doctor if you have

a circulation, bleeding, or blood-clotting disorder;

undiagnosed, abnormal vaginal bleeding; or

any type of breast, uterine, or hormone-dependent cancer.

Taking esterified estrogens may be dangerous in some cases if you have any of the conditions listed above.

Before taking esterified estrogens, tell your doctor if you have

high blood pressure, angina, or heart disease;

high levels of cholesterol or triglycerides in your blood;

liver disease;

kidney disease;

asthma;

epilepsy;

migraines;

diabetes;

depression;

gallbladder disease;

uterine fibroids; or

had a hysterectomy (uterus removed).

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

Esterified estrogens are in the FDA pregnancy category X. This means that esterified estrogens will cause birth defects in an unborn baby. Do not take this medication if you are pregnant or are planning a pregnancy. Esterified estrogens may decrease milk flow and have other effects on milk composition. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Menest (esterified estrogens)?

Take this medication 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. Take esterified estrogens with food or milk to lessen stomach upset.

Try to take every dose at the same time each day. You may be taking it every day, or you may be taking it every day for 3 weeks with 1 week off each month to mimic your body's natural cycle. Follow the directions on your prescription label.

If you are taking esterified estrogens to treat cancer, you may be taking it several times a day in very large doses.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking esterified estrogens.

Store esterified estrogens at room temperature away from moisture and heat.

See also: Menest dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of this medication is unlikely to threaten life. Consult an emergency room or poison control center for advice.

Symptoms of an overdose of esterified estrogens include nausea, vomiting, and breakthrough bleeding in females.

What should I avoid while taking Menest (esterified estrogens)?

There are no restrictions on food, beverages, or activity while taking esterified estrogens unless your doctor directs otherwise.

Menest (esterified estrogens) side effects

If you experience any of the following serious side effects, stop taking esterified estrogens and seek emergency medical attention:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

a blood clot (pain, redness, and swelling in an arm or leg, shortness of breath, chest pain, headache, blurred vision, or confusion);

a lump in a breast; or

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take esterified estrogens and talk to your doctor if you experience

decreased appetite, nausea, or vomiting;

swollen or tender breasts;

acne or skin color changes;

decreased sex drive;

migraine headaches or dizziness;

water retention (swollen hands, feet, or ankles);

problems with wearing contact lenses;

depression; or

changes in your menstrual cycle or breakthrough bleeding.

It is unclear to what extent estrogen treatments may affect the risk of breast cancer.

What other drugs will affect Menest (esterified estrogens)?

Before taking esterified estrogens, tell your doctor if you are taking any of the following medicines:

an anticoagulant (blood thinner) such as warfarin (Coumadin);

a thyroid medication such as Synthroid, Levoxyl, Levothroid, and others;

insulin or an oral diabetes medicine such as glipizide (Glucotrol) or glyburide (Diabeta, Micronase);

tamoxifen (Nolvadex);

didanosine (Videx);

phenytoin (Dilantin) or ethotoin (Peganone);

carbamazepine (Tegretol);

phenobarbital (Solfoton, Luminal);

primidone (Mysoline); or

rifampin (Rifadin).

A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with esterified estrogens. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Menest resources

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

Menest Prescribing Information (FDA)

Menest Advanced Consumer (Micromedex) - Includes Dosage Information

Menest MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Menest with other medications

Atrophic Urethritis
Atrophic Vaginitis
Breast Cancer
Breast Cancer, Palliative
Hypoestrogenism
Oophorectomy
Osteoporosis
Postmenopausal Symptoms
Primary Ovarian Failure
Prostate Cancer

Where can I get more information?

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

See also: Menest side effects (in more detail)

Mesnex

mesna

Dosage Form: tablet, injection
Mesnex (mesna) Injection

Mesnex (mesna) Tablets

Rx only

Mesnex Description

Mesnex is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide (IFEX ). The active ingredient mesna is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows:

HS—CH2—CH2SO3—Na+

Mesnex Injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. Mesnex Injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. Mesnex Injection multidose vials also contain 10.4 mg of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5.

Mesnex Tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. Excipients include lactose, microcrystalline cellulose, calcium phosphate, cornstarch, povidone, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, and simethicone.

Mesnex - Clinical Pharmacology

Mechanism of Action

Mesnex was developed as a prophylactic agent to reduce the risk of hemorrhagic cystitis induced by ifosfamide.

Analogous to the physiological cysteine-cystine system, mesna is rapidly oxidized to its major metabolite, mesna disulfide (dimesna). Mesna disulfide remains in the intravascular compartment and is rapidly eliminated by the kidneys.

In the kidney, the mesna disulfide is reduced to the free thiol compound, mesna, which reacts chemically with the urotoxic ifosfamide metabolites (acrolein and 4-hydroxy-ifosfamide) resulting in their detoxification. The first step in the detoxification process is the binding of mesna to 4-hydroxy-ifosfamide forming a nonurotoxic 4-sulfoethylthioifosfamide. Mesna also binds to the double bonds of acrolein and to other urotoxic metabolites.

In multiple human xenograft or rodent tumor model studies of limited scope, using IV or IP routes of administration, mesna in combination with ifosfamide (at dose ratios of up to 20-fold as single or multiple courses) failed to demonstrate interference with antitumor efficacy.

Pharmacokinetics

At doses of 2-4 g/m2, the terminal elimination half-life of ifosfamide is about 4-8 hours. As a result, in order to maintain adequate levels of mesna in the urinary bladder during the course of elimination of the urotoxic ifosfamide metabolites, repeated doses of Mesnex are required.

IV-IV-IV Regimen

After intravenous administration of an 800-mg dose, the half-lives of mesna and dimesna in the blood are 0.36 hours and 1.17 hours, respectively. Approximately 32% and 33% of the administered dose was eliminated in the urine in 24 hours as mesna and dimesna, respectively. The majority of the dose recovered was eliminated within 4 hours. Mesna has a plasma clearance of 1.23 L/h/kg.

IV-Oral-Oral Regimen

The half-life of mesna ranged from 1.2-8.3 hours after administration of intravenous plus oral doses of Mesnex, as recommended in the DOSAGE AND ADMINISTRATION section. The urinary bioavailability of oral mesna ranged from 45-79% of intravenously administered mesna. Food does not affect the urinary availability of orally administered mesna. Approximately 18-26% of the combined intravenous and oral mesna dose appears as free mesna in the urine. When compared to intravenously administered mesna, the intravenous plus oral dosing regimen increases systemic exposures (150%) and provides more sustained excretion of mesna in the urine over a 24-hour period. Approximately 5% of the mesna dose is excreted during the 12-24 hour interval, as compared to negligible amounts in patients given the IV regimen. The fraction of the administered dose of mesna excreted in the urine is independent of dose. Protein binding of mesna is in a moderate range (69-75%).

Special Populations

Gender Effect

An analysis was conducted in four male and four female volunteers; no differences in plasma pharmacokinetics were detected.

Pediatrics and Geriatrics

Pharmacokinetic data of Mesnex in pediatric and geriatric patients are not available.

Hepatic and Renal Insufficiency

No clinical studies were conducted to evaluate the effect of hepatic impairment or renal impairment on the pharmacokinetics of Mesnex.

Drug-Drug Interaction

No clinical drug interaction studies have been conducted with Mesnex.

Clinical Studies

IV Mesna

Hemorrhagic cystitis produced by ifosfamide is dose dependent (Table 1). At a dose of 1.2 g/m2 ifosfamide administered daily for 5 days, 16-26% of the patients who received conventional uroprophylaxis (high fluid intake, alkalinization of the urine, and the administration of diuretics) developed hematuria (>50 RBC/hpf or macrohematuria) (Morgan, Einhorna, Costanzi). In contrast, none of the patients who received Mesnex Injection together with this dose of ifosfamide developed hematuria (Einhorna,b ). In two randomized studies, (Fukuoka, Scheef), higher doses of ifosfamide, from 2 to 4 g/m2 administered for 3-5 days, produced hematuria in 31-100% of the patients. When Mesnex was administered together with these doses of ifosfamide, the incidence of hematuria was less than 7%.

* Ifosfamide dose 1.2 g/m2 d x 5 † Ifosfamide dose 2 to 4 g/m2 d x 3-5
Table 1
Percent of Mesnex Patients Developing Hematuria (≥50 RBC/hpf or macrohematuria)
Study	Conventional Uroprophylaxis (number of patients)	Standard Mesnex IV Regimen (number of patients)
Uncontrolled Studies
MORGAN*	16% (7/44)	-
COSTANZI*	26% (11/43)	-
EINHORNa*	18% (7/38)	0% (0/21)
EINHORNb*	-	0% (0/32)
Controlled Studies
FUKUOKA†	31% (14/46)	6% (3/46)
SCHEEF†	100% (7/7)	0% (0/8)

Oral Mesna

Clinical studies comparing recommended intravenous and oral mesna dosing regimens demonstrated incidences of grade 3-4 hematuria of <5%. Study D07093-0018 was an open label, randomized, two-way crossover study comparing three IV doses with an initial IV dose followed by two oral doses of mesna in patients with cancer treated with ifosfamide at a dose of 1.2-2.0 g/m2 for 3-5 days. Study MED504 was a randomized, multicenter study in cancer patients receiving ifosfamide at 2.0 g/m2 for 5 days. In both studies, development of grade 3 or 4 hematuria was the primary efficacy endpoint. The percent of patients developing hematuria in each of these studies is presented in Table 2.

Table 2
Percent of Mesnex Patients Developing Grade 3 or 4 Hematuria
	Mesnex Dosing Regimen
Study	Standard IV Regimen (number of patients)	IV + Oral Regimen (number of patients)
D07093-0018	0% (0/30)	3.6% (1/28)
MED504	3.7% (1/27)	4.3% (1/23)

A crossover pharmacokinetic study supports the low incidence of grade 3 or 4 hematuria with the recommended intravenous and oral mesna dosing regimens used in the two controlled studies.

Indications and Usage for Mesnex

Mesnex is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Contraindications

Mesnex is contraindicated in patients known to be hypersensitive to mesna or other thiol compounds.

Warnings

Allergic reactions to mesna ranging from mild hypersensitivity to systemic anaphylactic reactions have been reported. Patients with autoimmune disorders who were treated with cyclophosphamide and mesna appeared to have a higher incidence of allergic reactions. The majority of these patients received mesna orally.

Mesnex has been developed as an agent to reduce the risk of ifosfamide-induced hemorrhagic cystitis. It will not prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide therapy.

Mesnex does not prevent hemorrhagic cystitis in all patients. Up to 6% of patients treated with mesna have developed hematuria (>50 RBC/hpf or WHO grade 2 and above). As a result, a morning specimen of urine should be examined for the presence of hematuria (microscopic evidence of red blood cells) each day prior to ifosfamide therapy. If hematuria develops when Mesnex is given with ifosfamide according to the recommended dosage schedule, depending on the severity of the hematuria, dosage reductions or discontinuation of ifosfamide therapy may be initiated.

In order to reduce the risk of hematuria, Mesnex must be administered with each dose of ifosfamide as outlined in the DOSAGE AND ADMINISTRATION section. Mesnex is not effective in reducing the risk of hematuria due to other pathological conditions such as thrombocytopenia.

Because of the benzyl alcohol content, the multidose vial should not be used in neonates or infants and should be used with caution in older pediatric patients.

Precautions

Information for Patients

Healthcare providers should advise patients taking Mesnex to drink at least a quart of liquid a day. Patients should be informed to report if their urine has turned a pink or red color, if they vomit within 2 hours of taking oral Mesnex, or if they miss a dose of oral Mesnex. See Patient Information Leaflet for Mesnex Tablets.

Laboratory Tests

A false positive test for urinary ketones may arise in patients treated with Mesnex. In this test, a red-violet color develops which, with the addition of glacial acetic acid, will return to violet.

Drug Interactions

No clinical drug studies have been conducted.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Mesnex.

Mutagenesis

Mesna was not genotoxic in the in vitro Ames bacterial mutagenicity assay, the in vitro mammalian lymphocyte chromosomal aberration assay or the in vivo mouse micronucleus assay.

Impairment of Fertility

No studies on male or female fertility were conducted. No signs of male or female reproductive organ toxicity were seen in 6-month oral rat studies (at doses up to 2000 mg/kg/day) or 29-week oral dog studies (520 mg/kg/day; both studies approximately 10-fold higher than the maximum recommended human dose on a body surface area basis).

Pregnancy

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at oral doses of 1000 mg/kg in rabbits and 2000 mg/kg in rats (approximately 10 times the maximum recommended total daily IV-oral-oral human dose on a body surface area basis) and have revealed no evidence of harm to the fetus due to mesna. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether mesna or dimesna is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from mesna, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Mesnex Tablets in pediatric patients have not been established.

Because of the benzyl alcohol content in Mesnex Injection, the multidose vial should not be used in neonates or infants and should be used with caution in older pediatric patients.

Geriatric Use

Clinical studies of mesna did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. However, the ratio of ifosfamide to mesna should remain unchanged.

Adverse Reactions

Mesnex adverse reaction data are available from four phase I studies in which single IV bolus doses of 600-1200 mg Mesnex Injection without concurrent chemotherapy were administered to a total of 53 subjects and single oral doses of 600-2400 mg of Mesnex Tablets were administered to a total of 82 subjects.

The most frequently reported side effects (observed in two or more patients) for patients receiving single doses of Mesnex IV were headache, injection site reactions, flushing, dizziness, nausea, vomiting, somnolence, diarrhea, anorexia, fever, pharyngitis, hyperaesthesia, influenza-like symptoms, and coughing. Among patients who received a single 1200-mg dose as an oral solution, rigors, back pain, rash, conjunctivitis, and arthralgia were also reported. In two phase I multiple-dose studies where patients received Mesnex Tablets alone or IV Mesnex followed by repeated doses of Mesnex Tablets, flatulence and rhinitis were reported. In addition, constipation was reported by patients who had received repeated doses of IV Mesnex.

Because mesna is used in combination with ifosfamide or ifosfamide-containing chemotherapy regimens, it is difficult to distinguish the adverse reactions which may be due to Mesnex from those caused by the concomitantly administered cytotoxic agents.

Adverse reactions reasonably associated with mesna administered IV and orally in four controlled studies in which patients received ifosfamide or ifosfamide-containing regimens are presented in Table 3.

* All grades
Table 3
Incidence of Adverse Events and Incidence of Most Frequently Reported Adverse Events in Controlled Studies
Mesna Regimen	IV-IV-IV	IV-Oral-Oral
N exposed	119 (100.0%)	119 (100.0%)
Incidence of AEs	101 (84.9%)	106 (89.1%)
Most Frequently Reported Adverse Events (Preferred Terms)
	N (%)	N (%)
Nausea	65 (54.6)	64 (53.8)
Vomiting	35 (29.4)	45 (37.8)
Constipation	28 (23.5)	21 (17.6)
Leukopenia	25 (21.0)	21 (17.6)
Fatigue	24 (20.2)	24 (20.2)
Fever	24 (20.2)	18 (15.1)
Anorexia	21 (17.6)	19 (16.0)
Thrombocytopenia	21 (17.6)	16 (13.4)
Anemia	20 (16.8)	21 (17.6)
Granulocytopenia	16 (13.4)	15 (12.6)
Asthenia	15 (12.6)	21 (17.6)
Abdominal Pain	14 (11.8)	18 (15.1)
Alopecia	12 (10.1)	13 (10.9)
Dyspnea	11 (9.2)	11 (9.2)
Chest Pain	10 (8.4)	9 (7.6)
Hypokalemia	10 (8.4)	11 (9.2)
Diarrhea	9 (7.6)	17 (14.3)
Dizziness	9 (7.6)	5 (4.2)
Headache	9 (7.6)	13 (10.9)
Pain	9 (7.6)	10 (8.4)
Sweating Increased	9 (7.6)	2 (1.7)
Back Pain	8 (6.7)	6 (5.0)
Hematuria*	8 (6.7)	7 (5.9)
Injection Site Reaction	8 (6.7)	10 (8.4)
Edema	8 (6.7)	9 (7.6)
Edema Peripheral	8 (6.7)	8 (6.7)
Somnolence	8 (6.7)	12 (10.1)
Anxiety	7 (5.9)	4 (3.4)
Confusion	7 (5.9)	6 (5.0)
Face Edema	6 (5.0)	5 (4.2)
Insomnia	6 (5.0)	11 (9.2)
Coughing	5 (4.2)	10 (8.4)
Dyspepsia	4 (3.4)	6 (5.0)
Hypotension	4 (3.4)	6 (5.0)
Pallor	4 (3.4)	6 (5.0)
Dehydration	3 (2.5)	7 (5.9)
Pneumonia	2 (1.7)	8 (6.7)
Tachycardia	1 (0.8)	7 (5.9)
Flushing	1 (0.8)	6 (5.0)

Postmarketing Surveillance

Allergic reactions, decreased platelet counts associated with allergic reactions, hypertension, hypotension, increased heart rate, increased liver enzymes, injection site reactions (including pain and erythema), limb pain, malaise, myalgia, ST-segment elevation, tachycardia, and tachypnea have been reported as part of postmarketing surveillance.

Overdosage

There is no known antidote for Mesnex. Oral doses of 6.1 and 4.3 g/kg were lethal to mice and rats, respectively. These doses are approximately 15 and 22 times the maximum recommended human dose on a body surface area basis. Death was preceded by diarrhea, tremor, convulsions, dyspnea, and cyanosis.

Mesnex Dosage and Administration

For the prophylaxis of ifosfamide induced hemorrhagic cystitis, Mesnex may be given on a fractionated dosing schedule of three bolus intravenous injections or a single bolus injection followed by two oral administrations of Mesnex Tablets as outlined below.

Intravenous Schedule

Mesnex is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The total daily dose of mesna is 60% of the ifosfamide dose.

The recommended dosing schedule is outlined below:

	0 Hours	4 Hours	8 Hours
Ifosfamide	1.2 g/m2	–	–
Mesnex	240 mg/m2	240 mg/m2	240 mg/m2

Intravenous and Oral Dosing

Mesnex Injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration. Mesnex Tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. The total daily dose of mesna is 100% of the ifosfamide dose.

The recommended dosing schedule is outlined below:

	0 Hours	2 Hours	6 Hours
Ifosfamide	1.2 g/m2	–	–
Mesnex Injection	240 mg/m2	–	–
Mesnex Tablets	–	480 mg/m2	480 mg/m2

Patients who vomit within two hours of taking oral mesna should repeat the dose or receive intravenous mesna. The efficacy and safety of this ratio of IV and PO mesna has not been established as being effective for daily doses of IFEX higher than 2.0 g/m2.

The dosing schedule should be repeated on each day that ifosfamide is administered. When the dosage of ifosfamide is adjusted (either increased or decreased), the ratio of Mesnex to IFEX should be maintained.

Preparation of Intravenous Solutions/Stability

The Mesnexmultidose vials may be stored and used for up to 8 days.

For IV administration the drug can be diluted by adding the Mesnex Injection solution to any of the following fluids obtaining final concentrations of 20 mg mesna/mL:

5% Dextrose Injection, USP

5% Dextrose and 0.2% Sodium Chloride Injection, USP

5% Dextrose and 0.33% Sodium Chloride Injection, USP

5% Dextrose and 0.45% Sodium Chloride Injection, USP

0.92% Sodium Chloride Injection, USP

Lactated Ringer’s Injection, USP

For example:

One mL of Mesnex Injection multidose vial 100 mg/mL may be added to 4 mL of any of the solutions listed above to create a final concentration of 20 mg mesna/mL.

Diluted solutions are chemically and physically stable for 24 hours at 25°C (77°F).

Mesna is not compatible with cisplatin or carboplatin.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

How is Mesnex Supplied

Mesnex (mesna) Injection 100 mg/mL

NDC 0338-1305-01 1 g Multidose Vial, Box of 1 vial of 10 mL

NDC 0338-1305-03 1 g Multidose Vial, Box of 10 vials of 10 mL
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Mesnex (mesna) Tablets

NDC 67108-3565-9 400 mg scored tablets packaged in box of 10 tablets
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Mesnex (mesna) Injection manufactured by:

Mesnex (mesna) Tablets manufactured for:

Baxter, Mesnex and Ifex are trademarks of Baxter International Inc.

U.S. Patent Nos.:5,262,169, 5,252,341 and 5,696,172

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)

Made in Germany

Rev Feb 2009

USA C 18

HA-30-01-119

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label - Vial

Container Label 1g Multidose Vial

1 Multidose Vial

NDC 0338-1305-01

Mesnex (mesna) Injection

FOR INTRAVENOUS USE

Rx only

Carton Label - Vial

Carton Label 1g Multidose Vial

1 Multidose Vial

NDC 0338-1305-01

Mesnex (mesna) Injection

FOR INTRAVENOUS USE

Rx only

Baxter

Manufactured by

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Container Label - Tablets

Container Label 400 mg Tablets

List 3565-9

Rx only

400 mg

Mesnex

(mesna) Tablets

Baxter Healthcare Corporation

460-656-00

USA 5363 9222

(01)00067108356590

Lot-number:/Expires:

JMXXX

MM.JJJJ

Carton Label - Tablets

Carton Label 400 mg Tablets

10 400 mg Tablets

NDC 67108-3565-9

400 mg

Mesnex

(mesna) Tablets

Rx only

Each tablet contains 400 mg mesna.

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)

[see USP Controlled Room Temperature].

For ORAL ADMINISTRATION

Dosage: See package insert for directions for use. Should not be prescribed without thorough

knowledge of dose, indications, and toxicology as contained in accompanying literature.

Manufactured for:

Baxter

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Mesnex
mesna injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0338-1305
Route of Administration	INTRAVENOUS	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MESNA (MESNA)	MESNA	100 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM	0.25 mg in 1 mL
SODIUM HYDROXIDE
BENZYL ALCOHOL	10.4 mg in 10 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0338-1305-01	1 VIAL In 1 BOX	contains a VIAL, MULTI-DOSE
1		10 mL In 1 VIAL, MULTI-DOSE	This package is contained within the BOX (0338-1305-01)
2	0338-1305-03	10 VIAL In 1 BOX	contains a VIAL, MULTI-DOSE
2		10 mL In 1 VIAL, MULTI-DOSE	This package is contained within the BOX (0338-1305-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019884	12/30/1988

Labeler - Baxter Healthcare Corporation (005083209)

Registrant - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Operations
BAXTER ONCOLOGY GMBH		344276063	MANUFACTURE

Revised: 07/2009Baxter Healthcare Corporation

More Mesnex resources

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

Mesnex Concise Consumer Information (Cerner Multum)

Mesnex Monograph (AHFS DI)

Mesnex Advanced Consumer (Micromedex) - Includes Dosage Information

Mesnex MedFacts Consumer Leaflet (Wolters Kluwer)

Mesna Professional Patient Advice (Wolters Kluwer)

Mesna MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Mesnex with other medications

Hemorrhagic Cystitis Prophylaxis

Methamphetamine

Pronunciation: meth-am-FET-ah-meen
Generic Name: Methamphetamine
Brand Name: Desoxyn

Methamphetamine has a high risk for abuse. Long-term use of Methamphetamine may lead to dependence. Use Methamphetamine only as prescribed and do not share it with others.

Methamphetamine is used for:

Treating attention deficit disorders with hyperactivity in children. It is also used on short-term basis (ie, a few weeks) in combination with other treatments to treat obesity. Methamphetamine may also be used for other conditions as determined by your doctor.

Methamphetamine is a central nervous system stimulant. The exact way it works is unknown. It controls the release of certain chemicals in the brain that affect mood, behavior, and appetite.

Do NOT use Methamphetamine if:

you are allergic to any ingredient in Methamphetamine

you have anorexia, symptomatic heart disease, moderate to severe high blood pressure, narrowing of your arteries, glaucoma, uncontrolled high blood pressure, an overactive thyroid, a history of drug or substance abuse, or you are agitated

you are taking guanethidine or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Methamphetamine:

Some medical conditions may interact with Methamphetamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of mental or mood problems, heart problems, the blood disease porphyria, seizures, or high blood pressure

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

Furazolidone, MAO inhibitors (eg, phenelzine), or urinary alkalinizers (eg, sodium bicarbonate) because side effects, including increased blood pressure, dizziness, and decreased heart rate, may occur

Phenothiazines (eg, chlorpromazine) because they may decrease Methamphetamine's effectiveness

Insulin, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Methamphetamine

Guanethidine because its effectiveness may be decreased by Methamphetamine

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

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

Methamphetamine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Methamphetamine refilled.

Take Methamphetamine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Take Methamphetamine 10 to 14 hours before bedtime unless your doctor tells you differently.

If you miss a dose of Methamphetamine, 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 Methamphetamine.

Important safety information:

Methamphetamine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Methamphetamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor.

Methamphetamine may cause sleeplessness. Do not take Methamphetamine late in the day.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). Caffeine can increase the side effects of Methamphetamine.

Check the labels on all your medicines (eg, cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of these products.

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

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

Methamphetamine may interfere with certain lab tests, including corticosteroid levels. Be sure your doctor and lab personnel know you are taking Methamphetamine.

Methamphetamine may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Methamphetamine.

Methamphetamine should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if Methamphetamine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Methamphetamine while you are pregnant. Methamphetamine is found in breast milk. Do not breast-feed while taking Methamphetamine.

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

Some people who use Methamphetamine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Methamphetamine suddenly, you may have WITHDRAWAL symptoms. These may include severe tiredness, weakness, and mental depression.

Possible side effects of Methamphetamine:

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; diarrhea; dizziness; dry mouth; exaggerated sense of well-being; headache; loss of appetite; mild nervousness; nausea; upset stomach.

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); agitation or restlessness; blurred vision; change in sexual ability or desire; changes in speech; chest pain; difficulty moving; fainting; fast or irregular heartbeat; fever; mental/mood changes; pounding in chest; seizures; severe headaches; shortness of breath; stomach pain; tremor; trouble sleeping; uncontrolled muscle movements (eg, tics); unusual weakness or tiredness; vomiting.

See also: Methamphetamine 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 confusion; fast breathing; severe mental/mood changes; severe or persistent headache; severe restlessness.

Proper storage of Methamphetamine:

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

General information:

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

Methamphetamine 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 Methamphetamine. 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

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