la-BAYT-a-lol

Commonly used brand name(s):

In the U.S.

• Normodyne
• Trandate

Available Dosage Forms:

• Solution

Therapeutic Class: Antihypertensive

Pharmacologic Class: Alpha/Beta-Adrenergic Blocker

Uses For labetalol

Labetalol injection is used to treat severe high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

labetalol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

labetalol is available only with your doctor’s prescription .

Before Using labetalol

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 labetalol, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

No information is available on the relationship of age to the effects of labetalol in geriatric patients. However, elderly patients are more likely to have age-related liver and heart problems, which may require an adjustment in the dose for patients receiving labetalol injection .

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Using labetalol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol
• Amiodarone
• Arformoterol
• Bambuterol
• Bitolterol
• Broxaterol
• Clenbuterol
• Clonidine
• Colterol
• Diltiazem
• Dronedarone
• Fenoldopam
• Fenoterol
• Fentanyl
• Formoterol
• Halothane
• Hexoprenaline
• Isoetharine
• Levalbuterol
• Metaproterenol
• Pirbuterol
• Procaterol
• Reproterol
• Rimiterol
• Ritodrine
• Salmeterol
• Terbutaline
• Tretoquinol
• Tulobuterol
• Verapamil

Using labetalol 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.

• Acarbose
• Acetohexamide
• Alfuzosin
• Amlodipine
• Arbutamine
• Benfluorex
• Bunazosin
• Chlorpropamide
• Cimetidine
• Digoxin
• Doxazosin
• Enflurane
• Epinephrine
• Felodipine
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Guar Gum
• Insulin
• Insulin Aspart, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iobenguane I 131
• Isoflurane
• Lacidipine
• Lercanidipine
• Magnesium Sulfate
• Manidipine
• Metformin
• Mibefradil
• Miglitol
• Moxisylyte
• Nicardipine
• Nifedipine
• Nilvadipine
• Nimodipine
• Nisoldipine
• Nitrendipine
• Phenoxybenzamine
• Phentolamine
• Pranidipine
• Prazosin
• Repaglinide
• St John’s Wort
• Tamsulosin
• Terazosin
• Tolazamide
• Tolbutamide
• Trimazosin
• Troglitazone
• Urapidil

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 labetalol. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain)—May provoke chest pain if stopped too quickly .

• Asthma or
• Bradycardia (slow heartbeat) or
• Heart block or
• Heart failure or
• Low blood pressure, severe and prolonged—Should not use in patients with these conditions .

• Diabetes or
• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Lung disease (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

• Pheochromocytoma (adrenal gland tumor)—Use with caution. May require an increased dose .

Proper Use of labetalol

A nurse or other trained health professional will give you labetalol. labetalol is given through a needle placed in one of your veins .

Precautions While Using labetalol

Your doctor will only give you a few doses of labetalol, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor .

labetalol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

• Dizziness
• tingling of the scalp or skin

Less common

• Abdominal or stomach pain
• black, tarry stools
• blurred vision
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chills
• clay-colored stools
• confusion
• dark urine
• diarrhea
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, pounding, or irregular heartbeat or pulse
• feeling of constant movement of self or surroundings
• fever
• general tiredness and weakness
• headache
• itching skin
• light-colored stools
• loss of appetite
• nausea and vomiting
• palpitations
• sensation of spinning
• skin rash
• sweating
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• wheezing
• yellow eyes or skin

Rare

• Chest pain or discomfort
• cough
• difficult or labored breathing
• difficulty swallowing
• hives or welts
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of skin
• shortness of breath
• slow heartbeat
• swelling of eyelids, face, lips, hands, or feet
• tightness in chest
• troubled breathing or swallowing

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

Symptoms of overdose

• Convulsions
• dilated neck veins
• extreme fatigue
• irregular breathing
• loss of bladder control
• muscle spasm or jerking of all extremities
• noisy breathing
• sudden loss of consciousness
• 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:

More common

• Stuffy nose

Less common

• Acid or sour stomach
• belching
• change in taste or bad, unusual, or unpleasant (after) taste
• decreased interest in sexual intercourse
• heartburn
• inability to have or keep an erection
• increased yawning
• indigestion
• loss in sexual ability, desire, drive, or performance
• sleepiness or unusual drowsiness
• stomach discomfort or upset
• vomiting

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

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

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

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Generic Name: Lidocaine (L Y E-doe-cane)
Brand Name: Examples include L-M-X4 and LidaMantle

L-M-X4 Cream is used for:

Treating pain, itching, soreness, and discomfort of the skin or mucous membranes due to certain conditions such as eczema, scratches, minor burns, insect bites, and hemorrhoids.

L-M-X4 Cream is an anesthetic. It works by preventing nerves from transmitting painful impulses to the brain.

Do NOT use L-M-X4 Cream if:

• you are allergic to any ingredient in L-M-X4 Cream or to similar medications (eg, amide-type local anesthetics)
• there are signs of infection (eg, oozing, warmth, pain) or tissue damage in the affected area

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

Before using L-M-X4 Cream:

Some medical conditions may interact with L-M-X4 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 anesthetic medicine
• if you have heart, liver, or kidney problems

Some MEDICINES MAY INTERACT with L-M-X4 Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amiodarone, beta-blockers (eg, atenolol), cimetidine, or mexiletine because side effects, such as sluggishness, confusion, slow breathing, low blood pressure, or slow heartbeat, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if L-M-X4 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 L-M-X4 Cream:

Use L-M-X4 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash and completely dry the affected area. Apply a thin layer of L-M-X4 Cream to the affected area. Gently rub the medicine in until it is evenly distributed.
• Wash your hands immediately after using L-M-X4 Cream, unless your hands are part of the treated area.
• L-M-X4 Cream is for external use only. Avoid contact with eyes. If contact occurs, wash out the eye at once with water or saline and protect it until the numbness is gone.
• Do not bandage or wrap the affected area, unless directed otherwise by your doctor.
• If you miss a dose of L-M-X4 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.

Ask your health care provider any questions you may have about how to use L-M-X4 Cream.

Important safety information:

• L-M-X4 Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• L-M-X4 Cream may cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperatures until the numbness is gone.
• Use caution when applying L-M-X4 Cream over large areas.
• Do not use more medicine, apply more often, or use for longer than prescribed. Your condition will not improve faster, but the risk of side effects may be increased.
• Tell your doctor or dentist that you take L-M-X4 Cream before you receive any medical or dental care, emergency care, or surgery.
• PREGNANCY and BREAST-FEEDING: It is not known if L-M-X4 Cream can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using L-M-X4 Cream while you are pregnant. It is not known if L-M-X4 Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use L-M-X4 Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of L-M-X4 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:

Redness or swelling at the application site.

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); excessive irritation; signs of infection in the affected area (eg, warmth, oozing, pain).

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. L-M-X4 Cream may be harmful if swallowed.

Proper storage of L-M-X4 Cream:

Store L-M-X4 Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep L-M-X4 Cream out of the reach of children and away from pets.

General information:

• If you have any questions about L-M-X4 Cream, please talk with your doctor, pharmacist, or other health care provider.
• L-M-X4 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.
• Discard unused medicine and packaging in the trash out of the reach of children and pets.

This information is a summary only. It does not contain all information about L-M-X4 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.

Generic Name: l-methylfolate (L-METH il FOE late)
Brand Names: Deplin, Zervalx

What is l-methylfolate?

Folate is a form of B vitamin that occurs naturally in many foods. Folic acid is the man-made form of folate that is added to processed foods or vitamin and mineral supplements. Folate is needed in the human body for production of red blood cells.

A lack (deficiency) of folate in the human body can be caused by certain diseases, by taking certain medications, or by not getting enough folate in your diet. Folate deficiency can lead to decreased red blood cells, or anemia.

L-methylfolate is a medical food for use in people who have conditions related to folate deficiency.

The Zervalx brand of l-methylfolate is used in the following situations:

• in people who have high levels of a certain amino acid in their blood, a condition called hyperhomocysteinemia (HYE-per-HOE-moe-sis-tin-EE-mee-a). This condition can be related to folate deficiency or may be caused by receiving methotrexate (Rheumatrex, Trexall);

• in women with high-risk pregnancies who need additional folate in their diets to prevent hyperhomocysteinemia; or

• in people with certain types of anemia (a lack of red blood cells) that may be complicated by a folate deficiency.

The Deplin brand of l-methylfolate is used in the following situations:

• in people with major depressive disorder who have folate deficiency. Deplin is used together with anti-depressant medications in people with major depressive disorder and low folate levels.

• in people with schizophrenia who have hyperhomocysteinemia related to folate deficiency.

Deplin is not an antidepressant. However, it may enhance the effects of antidepressant medications.

L-methylfolate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about l-methylfolate?

Do not use l-methylfolate without the advice of a doctor. Never share this medication with another person, even if you believe they have the same condition you have. You should not use this medication if you have ever had an allergic reaction to l-methylfolate.

Before you take this medication, tell your doctor if you have a vitamin B12 deficiency, pernicious anemia, a history of bipolar disorder (manic depression), or if you are pregnant or breast-feeding.

Avoid drinking alcohol while you are taking l-methylfolate.

Tell your doctor about all other medications you use, especially seizure medications. Do not start a new medication without telling your doctor.

Use only the brand and strength of l-methylfolate that your doctor has prescribed. Do not switch brands without your doctor’s advice.

What should I discuss with my health care provider before taking l-methylfolate?

You should not use this medication if you have ever had an allergic reaction to l-methylfolate.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using l-methylfolate, tell your doctor if you have:

• a history of bipolar disorder (manic depression);

• vitamin B12 deficiency; or

• pernicious anemia.

Zervalx may be used throughout pregnancy or while you are trying to get pregnant. Before you take Deplin, tell your doctor if you are pregnant or breast-feeding.

How should I take l-methylfolate?

Do not use l-methylfolate without the advice of a doctor. Never share this medication with another person, even if you believe they have the same condition you have.

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

Use only the brand and strength of l-methylfolate that your doctor has prescribed. Do not switch brands without your doctor’s advice.

You may take l-methylfolate with or without food. Follow your doctor’s instructions.

L-methylfolate is only part of a complete program of treatment that may also include other medications, and psychological counseling when used in people with depression or schizophrenia. Follow your medication and counseling routines very closely.

Store l-methylfolate at room temperature away from moisture, heat, and light.

See also: L-methylfolate dosage in more detail

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose of l-methylfolate is not likely to cause life-threatening symptoms.

What should I avoid while taking l-methylfolate?

Avoid drinking alcohol while you are taking l-methylfolate.

L-methylfolate side effects

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

Less serious side effects may include:

• nausea;

• loss of appetite;

• bloating;

• gas; or

• bitter taste in your mouth.

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

L-methylfolate Dosing Information

Usual Adult Dose for Folic Acid Deficiency:

L-methylfolate (in the 7.5 mg or 15 mg strength marketed as Deplin tablets) is approved by the FDA for the distinct nutritional requirements of individuals who have suboptimal L-methylfolate levels in the cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD) with particular emphasis as adjunctive support for individuals who are on an antidepressant.
Dose: One 7.5 mg or one 15 mg Deplin tablet orally daily

L-methylfolate (in the 7.5 mg or 15 mg strength marketed as Deplin tablets) is also approved by the FDA for the distinct nutritional requirements of individuals who have suboptimal L-methylfolate levels in the cerebrospinal fluid, plasma, and/or red blood cells and have schizophrenia who present with negative symptoms and/or cognitive impairment, with particular emphasis as an adjunctive support for individuals who have stabilized on antipsychotics.
Dose: One 7.5 mg or one 15 mg Deplin tablet orally daily

L-methylfolate (in a 1 mg strength marketed as Zervalx tablets) is approved by the FDA as an orally administered prescription medical food for the dietary management of:
1) intermediate to higher risk pregnancies which require an increased dietary folate intake
2) hemolytic, megaloblastic, and/or sickle cell anemia complicated by folate deficiency
Dose: One 1 mg Zervalx tablet orally daily

Usual Adult Dose for Hyperhomocysteinemia:

L-methylfolate (in a 1 mg strength marketed as Zervalx tablets) is approved by the FDA as an orally administered prescription medical food for the dietary management of:
1) preconception hyperhomocysteinemia
2) methotrexate induced plasma hyperhomocysteinemia
Dose: One 1 mg Zervalx tablet orally daily

What other drugs will affect l-methylfolate?

Tell your doctor about all other medications you use, especially seizure medication such as:

• carbamazepine (Carbatrol, Tegretol);

• ethosuximide (Zarontin);

• fosphenytoin (Cerebyx);

• lamotrigine (Lamictal);

• phenobarbital (Solfoton);

• phenytoin (Dilantin);

• primidone (Mysoline); or

• valproic acid valproate.

Other drugs that can interact with l-methylfolate include:

• birth control pills;

• cholestyramine (Prevalite, Questran), colestipol (Colestid);

• colchicine;

• isotretinoin (Accutane);

• methylprednisolone (Medrol);

• methotrexate (Rheumatrex, Trexall);

• pancreatin (Hi-Vegi-Lip), pancrelipase (Cotazym, Pancrease, Ultrase);

• pentamidine (Nebupent);

• pyrimethamine (Daraprim);

• sulfasalazine (Azulfidine);

• triamterene (Dyrenium);

• trimethoprim (Proloprim, Bactrim, Septra); or

• a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), or sulindac (Clinoril).

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

Where can I get more information?

• Your pharmacist can provide more information about l-methylfolate.

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 05/11/2009 10:03:19 AM.

Generic Name: L-Methylfolate with Vitamins B6 and B12 (meth-ill-FOE-late/VYE-tah-min)
Brand Name: Metanx

L-Methylfolate with Vitamins B6 and B12 is used for:

Managing hyperhomocysteinemia and supplementing the diet. It may also be used for other conditions as determined by your doctor.

L-Methylfolate with Vitamins B6 and B12 is a vitamin combination. It provides nutritional supplementation for certain nutritional requirements.

Do NOT use L-Methylfolate with Vitamins B6 and B12 if:

• you are allergic to any ingredient in L-Methylfolate with Vitamins B6 and B12

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

Before using L-Methylfolate with Vitamins B6 and B12:

Some medical conditions may interact with L-Methylfolate with Vitamins B6 and B12. 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

Some MEDICINES MAY INTERACT with L-Methylfolate with Vitamins B6 and B12. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because its actions and side effects may be increased by L-Methylfolate with Vitamins B6 and B12
• Hydantoins (eg, phenytoin) because their effectiveness may be decreased by L-Methylfolate with Vitamins B6 and B12

This may not be a complete list of all interactions that may occur. Ask your health care provider if L-Methylfolate with Vitamins B6 and B12 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 L-Methylfolate with Vitamins B6 and B12:

Use L-Methylfolate with Vitamins B6 and B12 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• L-Methylfolate with Vitamins B6 and B12 may be taken with or without food.
• If you miss taking a dose of L-Methylfolate with Vitamins B6 and B12 for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use L-Methylfolate with Vitamins B6 and B12.

Important safety information:

• Do not take large doses of vitamins (megadoses or megavitamin therapy) unless directed to by your doctor.
• Check any other vitamin products you may be taking for folic acid content. Tell your doctor or pharmacist if any other medicine that you take contains folic acid.
• L-Methylfolate with Vitamins B6 and B12 is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREASTFEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using L-Methylfolate with Vitamins B6 and B12 during pregnancy. It is unknown if L-Methylfolate with Vitamins B6 and B12 is excreted in breast milk. If you are or will be breast-feeding while you are using L-Methylfolate with Vitamins B6 and B12, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of L-Methylfolate with Vitamins B6 and B12:

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:

Drowsiness; feeling of swelling of the entire body; mild diarrhea; numbness or tingling.

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); dizziness; itching.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of L-Methylfolate with Vitamins B6 and B12:

Store L-Methylfolate with Vitamins B6 and B12 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 L-Methylfolate with Vitamins B6 and B12 out of the reach of children and away from pets.

General information:

• If you have any questions about L-Methylfolate with Vitamins B6 and B12, please talk with your doctor, pharmacist, or other health care provider.
• L-Methylfolate with Vitamins B6 and B12 is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about L-Methylfolate with Vitamins B6 and B12. 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.

L-Methylfolate/

B12/

B6/

B2

Generic Name: L-Methylfolate/B12/B6/B2 (meth-ill-FOE-late)
Brand Name: Cerefolin

L-Methylfolate/B12/B6/B2 is used for:

Managing hyperhomocysteinemia or to supplement the diet. It may also be used to treat other conditions as determined by your doctor.

L-Methylfolate/B12/B6/B2 is a vitamin combination. It provides nutritional supplementation for certain nutritional requirements.

Do NOT use L-Methylfolate/B12/B6/B2 if:

• you are allergic to any ingredient in L-Methylfolate/B12/B6/B2

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

Before using L-Methylfolate/B12/B6/B2:

Some medical conditions may interact with L-Methylfolate/B12/B6/B2. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 Leber hereditary optic atrophy (an eye disease) or megaloblastic anemia

Some MEDICINES MAY INTERACT with L-Methylfolate/B12/B6/B2. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because its actions and side effects may be increased
• Hydantoins (eg, phenytoin) because the effectiveness of these medicines may be decreased, leading to increased seizure frequency

This may not be a complete list of all interactions that may occur. Ask your health care provider if L-Methylfolate/B12/B6/B2 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 L-Methylfolate/B12/B6/B2:

Use L-Methylfolate/B12/B6/B2 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• L-Methylfolate/B12/B6/B2 may be taken with or without food.
• If you miss taking a dose of L-Methylfolate/B12/B6/B2 for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use L-Methylfolate/B12/B6/B2.

Important safety information:

• Do not take large doses of vitamins unless directed to by your doctor.
• Check any other vitamin products you may be taking for folic acid content. Tell your doctor or pharmacist if any other medicine that you take contains folic acid.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using L-Methylfolate/B12/B6/B2 during pregnancy. It is unknown if L-Methylfolate/B12/B6/B2 is excreted in breast milk. If you are or will be breast-feeding while you are using L-Methylfolate/B12/B6/B2, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of L-Methylfolate/B12/B6/B2:

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:

Drowsiness; feeling of swelling of the entire body; mild diarrhea; numbness or tingling.

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).

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of L-Methylfolate/B12/B6/B2:

Store L-Methylfolate/B12/B6/B2 at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Keep L-Methylfolate/B12/B6/B2 out of the reach of children and away from pets.

General information:

• If you have any questions about L-Methylfolate/B12/B6/B2, please talk with your doctor, pharmacist, or other health care provider.
• L-Methylfolate/B12/B6/B2 is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about L-Methylfolate/B12/B6/B2. 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.

L-Methylfolate/

Methylcobalamin/

N-Acetylcysteine

Generic Name: L-Methylfolate/Methylcobalamin/N-Acetylcysteine (meth-ill-FOE-late/meth-ill-koe-BAL-a-min/a-se-teel-SIS-teen)
Brand Name: Cerefolin with NAC

L-Methylfolate/Methylcobalamin/N-Acetylcysteine is used for:

Supplying nutritional requirements of certain patients with neurovascular oxidative stress or high blood levels of homocysteine. It may also be used for other conditions as determined by your doctor.

L-Methylfolate/Methylcobalamin/N-Acetylcysteine is a nutritional supplement. It works by providing the body with folate, vitamin B₁₂, and a form of antioxidant, which helps to reduce or eliminate oxidative stress and lower homocysteine levels.

Do NOT use L-Methylfolate/Methylcobalamin/N-Acetylcysteine if:

• you are allergic to any ingredient in L-Methylfolate/Methylcobalamin/N-Acetylcysteine
• you are very ill

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

Before using L-Methylfolate/Methylcobalamin/N-Acetylcysteine:

Some medical conditions may interact with L-Methylfolate/Methylcobalamin/N-Acetylcysteine. 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, liver problems, kidney stones, or a history of ulcers

Some MEDICINES MAY INTERACT with L-Methylfolate/Methylcobalamin/N-Acetylcysteine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antibiotics (eg, penicillin, cephalexin, ciprofloxacin), cholestyramine, colchicine, colestipol, metformin, nitrous oxide, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), para-aminosalicylic acid, potassium chloride, or sulfasalazine because they may decrease the effectiveness of L-Methylfolate/Methylcobalamin/N-Acetylcysteine
• Fluorouracil or nitrates (eg, nitroglycerin) because their side effects may be increased
• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), primidone, pyrimethamine, or valproic acid because their effectiveness may be decreased by L-Methylfolate/Methylcobalamin/N-Acetylcysteine

This may not be a complete list of all interactions that may occur. Ask your health care provider if L-Methylfolate/Methylcobalamin/N-Acetylcysteine 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 L-Methylfolate/Methylcobalamin/N-Acetylcysteine:

Use L-Methylfolate/Methylcobalamin/N-Acetylcysteine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• L-Methylfolate/Methylcobalamin/N-Acetylcysteine may be taken with or without food.
• If you miss a dose of L-Methylfolate/Methylcobalamin/N-Acetylcysteine, 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 L-Methylfolate/Methylcobalamin/N-Acetylcysteine.

Important safety information:

• Diabetes patients – L-Methylfolate/Methylcobalamin/N-Acetylcysteine may cause incorrect test results with some ketone tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
• L-Methylfolate/Methylcobalamin/N-Acetylcysteine is not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking L-Methylfolate/Methylcobalamin/N-Acetylcysteine, discuss with your doctor the benefits and risks of using L-Methylfolate/Methylcobalamin/N-Acetylcysteine during pregnancy. L-Methylfolate/Methylcobalamin/N-Acetylcysteine is excreted in breast milk. Do not breastfeed while you are taking L-Methylfolate/Methylcobalamin/N-Acetylcysteine.

Possible side effects of L-Methylfolate/Methylcobalamin/N-Acetylcysteine:

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:

Bloated feeling; headache; itching; mild diarrhea; mild fever; nausea; vomiting.

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); lower back or side pain.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of L-Methylfolate/Methylcobalamin/N-Acetylcysteine:

Store L-Methylfolate/Methylcobalamin/N-Acetylcysteine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, light, and moisture. Keep L-Methylfolate/Methylcobalamin/N-Acetylcysteine out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about L-Methylfolate/Methylcobalamin/N-Acetylcysteine. 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.