Generic Name: amcinonide (Topical application route)

am-SIN-oh-nide

Commonly used brand name(s):

In the U.S.

• Cyclocort

In Canada

• Amcinonide
• Cyclocort Cream
• Cyclocort Lotion
• Cyclocort Ointment

Available Dosage Forms:

• Cream
• Ointment
• Lotion

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Cyclocort Ointment

Amcinonide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Cyclocort Ointment

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amcinonide topical in the pediatric population. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of amcinonide topical in geriatric patients.

Pregnancy

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of amcinonide

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

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, lotion, and ointment):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two to three times per day.
    • Children—Apply to the affected area of the skin two to three times per day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Cyclocort Ointment

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

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Cyclocort Ointment Side Effects

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

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

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

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:

Incidence not known

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

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

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

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Generic Name: Cyanocobalamin (B12) (sigh-an-oh-koe-BAL-uh-min)
Brand Name: Cobal 1000

Cyanocobalamin (B12) is used for:

Maintaining normal vitamin B₁₂ blood levels in certain patients with pernicious anemia. It is also used to treat or prevent low blood levels of vitamin B₁₂ that may be caused by other conditions.

Cyanocobalamin (B12) is a form of vitamin B₁₂. It works by replacing vitamin B₁₂ in the body.

Do NOT use Cyanocobalamin (B12) if:

• you are allergic to any ingredient in Cyanocobalamin (B12), including cobalt

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

Before using Cyanocobalamin (B12):

Some medical conditions may interact with Cyanocobalamin (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 an infection, Leber disease (weakened eye nerve), a buildup of waste in the blood (uremia), any kind of anemia, or low blood levels of iron or folic acid
• if you are a vegetarian
• if you drink alcohol on a regular basis

Some MEDICINES MAY INTERACT with Cyanocobalamin (B12). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Chloramphenicol or other medicine that may decrease your bone marrow because effectiveness of Cyanocobalamin (B12) may be decreased; ask your doctor if you are unsure if any of your medicines may decrease your bone marrow
• Colchicine or para-aminosalicylic acid because the effectiveness of Cyanocobalamin (B12) may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin (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 Cyanocobalamin (B12):

Use Cyanocobalamin (B12) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cyanocobalamin (B12) is usually administered as an injection at your doctor’s office, hospital, or clinic. If you are using Cyanocobalamin (B12) at home, carefully follow the injection procedures taught to you by your health care provider.
• If Cyanocobalamin (B12) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Cyanocobalamin (B12), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyanocobalamin (B12).

Important safety information:

• Heavy alcohol intake for more than 2 weeks may decrease the effectiveness of Cyanocobalamin (B12). Check with your doctor if you drink alcohol on a regular basis.
• Do not substitute folic acid for Cyanocobalamin (B12) without first checking with your doctor. Folic acid may prevent anemia but may not prevent other serious symptoms such as spinal cord problems.
• You should have blood tests every 3 to 6 months to monitor your progress.
• Certain medicines, including antibiotics, methotrexate, or pyrimethamine, may interfere with lab tests for vitamin B₁₂ and folic acid. Be sure your doctor and lab personnel know all the medicines that you are taking.
• Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Cyanocobalamin (B12) unless directed by your doctor.
• LAB TESTS, including complete blood cell counts, platelet counts, and blood potassium, vitamin B₁₂, and folic acid levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Cyanocobalamin (B12) contains benzyl alcohol, a preservative. Do not use Cyanocobalamin (B12) in NEWBORNS or INFANTS because serious and sometimes fatal nervous system problems and other side effects may occur.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cyanocobalamin (B12), discuss with your doctor the benefits and risks of using Cyanocobalamin (B12) during pregnancy. Cyanocobalamin (B12) is excreted in breast milk. If you are or will be breast-feeding while you are using Cyanocobalamin (B12), check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cyanocobalamin (B12):

All medicines may cause side effects, but many people have no, or minor, side effects. If any of the following most COMMON side effects continue or become bothersome, check with your doctor: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary diarrhea.

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); calf pain, swelling, or tenderness; chest pain; feeling of swelling throughout the entire body; fever, chills, or persistent sore throat; irregular heartbeat; muscle weakness or cramping; shortness of breath; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. 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 Cyanocobalamin (B12):

Store Cyanocobalamin (B12) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store upright. Do not freeze. Do not store in the bathroom. Keep Cyanocobalamin (B12) out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin (B12), please talk with your doctor, pharmacist, or other health care provider.
• Cyanocobalamin (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 Cyanocobalamin (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.

Generic Name: Cyanocobalamin (B12) (sigh-an-oh-koe-BAL-uh-min)
Brand Name: Generic only. No brands available.

Cyanocobalamin (B12) Chewable Tablets are used for:

Treating or preventing low blood levels of vitamin B₁₂. It may also be used for other conditions as determined by your doctor.

Cyanocobalamin (B12) Chewable Tablets are a form of vitamin B₁₂. It works by replacing vitamin B₁₂ in the body.

Do NOT use Cyanocobalamin (B12) Chewable Tablets if:

• you are allergic to any ingredient in Cyanocobalamin (B12) Chewable Tablets, including cobalt

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

Before using Cyanocobalamin (B12) Chewable Tablets:

Some medical conditions may interact with Cyanocobalamin (B12) Chewable Tablets. 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 an infection, Leber disease (weakened eye nerve), a buildup of waste in the blood (uremia), any kind of anemia, or low blood levels of iron or folic acid
• if you are a vegetarian
• if you drink alcohol on a regular basis

Some MEDICINES MAY INTERACT with Cyanocobalamin (B12) Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Chloramphenicol or other medicine that may decrease your bone marrow because effectiveness of Cyanocobalamin (B12) Chewable Tablets may be decreased; ask your doctor if you are unsure if any of your medicines may decrease your bone marrow
• Colchicine or para-aminosalicylic acid because the effectiveness of Cyanocobalamin (B12) Chewable Tablets may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin (B12) Chewable Tablets 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 Cyanocobalamin (B12) Chewable Tablets:

Use Cyanocobalamin (B12) Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cyanocobalamin (B12) Chewable Tablets may be taken with or without food.
• Chew thoroughly before swallowing.
• If you miss a dose of Cyanocobalamin (B12) Chewable Tablets, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyanocobalamin (B12) Chewable Tablets.

Important safety information:

• Heavy alcohol intake for more than 2 weeks may decrease the effectiveness of Cyanocobalamin (B12) Chewable Tablets. Check with your doctor if you drink alcohol on a regular basis.
• You may need to have blood tests every 3 to 6 months to monitor your progress.
• Certain medicines, including antibiotics, methotrexate, or pyrimethamine, may interfere with lab tests for vitamin B₁₂ and folic acid. Be sure your doctor and lab personnel know all the medicines that you are taking.
• Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Cyanocobalamin (B12) Chewable Tablets unless directed by your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cyanocobalamin (B12) Chewable Tablets, discuss with your doctor the benefits and risks of using Cyanocobalamin (B12) Chewable Tablets during pregnancy. Cyanocobalamin (B12) Chewable Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Cyanocobalamin (B12) Chewable Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cyanocobalamin (B12) Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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).

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 Cyanocobalamin (B12) Chewable Tablets:

Store Cyanocobalamin (B12) Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store upright. Do not freeze. Do not store in the bathroom. Keep Cyanocobalamin (B12) Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin (B12) Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Cyanocobalamin (B12) Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cyanocobalamin (B12) Chewable Tablets. 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: Cyanocobalamin (B12) (sigh-an-oh-koe-BAL-uh-min)
Brand Name: Generic only. No brands available.

Cyanocobalamin (B12) Controlled-Release Tablets are used for:

Treating or preventing low blood levels of vitamin B₁₂. It may also be used for other conditions as determined by your doctor.

Cyanocobalamin (B12) Controlled-Release Tablets are a form of vitamin B₁₂. It works by replacing vitamin B₁₂ in the body.

Do NOT use Cyanocobalamin (B12) Controlled-Release Tablets if:

• you are allergic to any ingredient in Cyanocobalamin (B12) Controlled-Release Tablets, including cobalt

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

Before using Cyanocobalamin (B12) Controlled-Release Tablets:

Some medical conditions may interact with Cyanocobalamin (B12) Controlled-Release Tablets. 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 an infection, Leber disease (weakened eye nerve), a buildup of waste in the blood (uremia), any kind of anemia, or low blood levels of iron or folic acid
• if you are a vegetarian
• if you drink alcohol on a regular basis

Some MEDICINES MAY INTERACT with Cyanocobalamin (B12) Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Chloramphenicol or other medicine that may decrease your bone marrow because effectiveness of Cyanocobalamin (B12) Controlled-Release Tablets may be decreased; ask your doctor if you are unsure if any of your medicines may decrease your bone marrow
• Colchicine or para-aminosalicylic acid because the effectiveness of Cyanocobalamin (B12) Controlled-Release Tablets may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin (B12) Controlled-Release Tablets 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 Cyanocobalamin (B12) Controlled-Release Tablets:

Use Cyanocobalamin (B12) Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cyanocobalamin (B12) Controlled-Release Tablets may be taken with or without food.
• Swallow Cyanocobalamin (B12) Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Cyanocobalamin (B12) Controlled-Release Tablets, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cyanocobalamin (B12) Controlled-Release Tablets.

Important safety information:

• Heavy alcohol intake for more than 2 weeks may decrease the effectiveness of Cyanocobalamin (B12) Controlled-Release Tablets. Check with your doctor if you drink alcohol on a regular basis.
• You may need to have blood tests every 3 to 6 months to monitor your progress.
• Certain medicines, including antibiotics, methotrexate, or pyrimethamine, may interfere with lab tests for vitamin B₁₂ and folic acid. Be sure your doctor and lab personnel know all the medicines that you are taking.
• Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Cyanocobalamin (B12) Controlled-Release Tablets unless directed by your doctor.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cyanocobalamin (B12) Controlled-Release Tablets, discuss with your doctor the benefits and risks of using Cyanocobalamin (B12) Controlled-Release Tablets during pregnancy. Cyanocobalamin (B12) Controlled-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Cyanocobalamin (B12) Controlled-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cyanocobalamin (B12) Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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).

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 Cyanocobalamin (B12) Controlled-Release Tablets:

Store Cyanocobalamin (B12) Controlled-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store upright. Do not freeze. Do not store in the bathroom. Keep Cyanocobalamin (B12) Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin (B12) Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Cyanocobalamin (B12) Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cyanocobalamin (B12) Controlled-Release Tablets. 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.

Cyanocobalamin/

Folic Acid/

Iron/

Vitamin C

Generic Name: Cyanocobalamin/Folic Acid/Iron/Vitamin C (SYE-an-oh-koe-BAL-a-min/FOE-lik AS-id/EYE-urn/VYE-ta-min)
Brand Name: Examples include FerroGels Forte and Maxaron Forte

Cyanocobalamin/Folic Acid/Iron/Vitamin C is used for:

Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.

Cyanocobalamin/Folic Acid/Iron/Vitamin C is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body.

Do NOT use Cyanocobalamin/Folic Acid/Iron/Vitamin C if:

• you are allergic to any ingredient in Cyanocobalamin/Folic Acid/Iron/Vitamin C
• you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or you have high levels of iron in your blood

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

Before using Cyanocobalamin/Folic Acid/Iron/Vitamin C:

Some medical conditions may interact with Cyanocobalamin/Folic Acid/Iron/Vitamin C. 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 pernicious anemia or a history of other blood problems (eg, porphyria, thalassemia)
• if you have a peptic ulcer or stomach or bowel problems (eg, ulcerative colitis)
• if you have glucose-6-phosphate-dehydrogenase (G6PD) deficiency, have a bleeding problem, have had multiple blood transfusions, or are receiving dialysis
• if you have a history of seizures

Some MEDICINES MAY INTERACT with Cyanocobalamin/Folic Acid/Iron/Vitamin C. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because the risk of its side effects may be increased by Cyanocobalamin/Folic Acid/Iron/Vitamin C
• Bisphosphonates (eg, alendronate), cephalosporins (eg, cefdinir), hydantoins (eg, phenytoin), levodopa, methyldopa, penicillamine, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Cyanocobalamin/Folic Acid/Iron/Vitamin C

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin/Folic Acid/Iron/Vitamin C 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 Cyanocobalamin/Folic Acid/Iron/Vitamin C:

Use Cyanocobalamin/Folic Acid/Iron/Vitamin C as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cyanocobalamin/Folic Acid/Iron/Vitamin C by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you also take a bisphosphonate (eg, alendronate), a cephalosporin (eg, cefdinir), methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, doxycycline), ask your doctor or pharmacist how to take it with Cyanocobalamin/Folic Acid/Iron/Vitamin C.
• If you miss a dose of Cyanocobalamin/Folic Acid/Iron/Vitamin C, 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 Cyanocobalamin/Folic Acid/Iron/Vitamin C.

Important safety information:

• Do not take more than the recommended dose without checking with your doctor.
• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Cyanocobalamin/Folic Acid/Iron/Vitamin C unless your doctor tells you to.
• Cyanocobalamin/Folic Acid/Iron/Vitamin C has folic acid and iron in it. Before you start any new medicine, check the label to see if it also has folic acid or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Cyanocobalamin/Folic Acid/Iron/Vitamin C has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.
• Cyanocobalamin/Folic Acid/Iron/Vitamin C may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Cyanocobalamin/Folic Acid/Iron/Vitamin C.
• Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Cyanocobalamin/Folic Acid/Iron/Vitamin C. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Cyanocobalamin/Folic Acid/Iron/Vitamin C should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Cyanocobalamin/Folic Acid/Iron/Vitamin C while you are pregnant. Cyanocobalamin/Folic Acid/Iron/Vitamin C is found in breast milk. If you are or will be breast-feeding while you use Cyanocobalamin/Folic Acid/Iron/Vitamin C, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cyanocobalamin/Folic Acid/Iron/Vitamin C:

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; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach 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. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.

Proper storage of Cyanocobalamin/Folic Acid/Iron/Vitamin C:

Store Cyanocobalamin/Folic Acid/Iron/Vitamin C at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyanocobalamin/Folic Acid/Iron/Vitamin C out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin/Folic Acid/Iron/Vitamin C, please talk with your doctor, pharmacist, or other health care provider.
• Cyanocobalamin/Folic Acid/Iron/Vitamin C 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 Cyanocobalamin/Folic Acid/Iron/Vitamin C. 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.

Cyanocobalamin/

Vitamin C/

Folic Acid/

Iron

Generic Name: Cyanocobalamin/Folic Acid/Iron/Vitamin C (SYE-an-oh-koe-BAL-a-min/FOE-lik AS-id/EYE-urn/VYE-ta-min)
Brand Name: Examples include FerroGels Forte and Maxaron Forte

Cyanocobalamin/Vitamin C/Folic Acid/Iron is used for:

Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.

Cyanocobalamin/Vitamin C/Folic Acid/Iron is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body.

Do NOT use Cyanocobalamin/Vitamin C/Folic Acid/Iron if:

• you are allergic to any ingredient in Cyanocobalamin/Vitamin C/Folic Acid/Iron
• you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or you have high levels of iron in your blood

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

Before using Cyanocobalamin/Vitamin C/Folic Acid/Iron:

Some medical conditions may interact with Cyanocobalamin/Vitamin C/Folic Acid/Iron. 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 pernicious anemia or a history of other blood problems (eg, porphyria, thalassemia)
• if you have a peptic ulcer or stomach or bowel problems (eg, ulcerative colitis)
• if you have glucose-6-phosphate-dehydrogenase (G6PD) deficiency, have a bleeding problem, have had multiple blood transfusions, or are receiving dialysis
• if you have a history of seizures

Some MEDICINES MAY INTERACT with Cyanocobalamin/Vitamin C/Folic Acid/Iron. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because the risk of its side effects may be increased by Cyanocobalamin/Vitamin C/Folic Acid/Iron
• Bisphosphonates (eg, alendronate), cephalosporins (eg, cefdinir), hydantoins (eg, phenytoin), levodopa, methyldopa, penicillamine, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Cyanocobalamin/Vitamin C/Folic Acid/Iron

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin/Vitamin C/Folic Acid/Iron 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron:

Use Cyanocobalamin/Vitamin C/Folic Acid/Iron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cyanocobalamin/Vitamin C/Folic Acid/Iron by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you also take a bisphosphonate (eg, alendronate), a cephalosporin (eg, cefdinir), methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, doxycycline), ask your doctor or pharmacist how to take it with Cyanocobalamin/Vitamin C/Folic Acid/Iron.
• If you miss a dose of Cyanocobalamin/Vitamin C/Folic Acid/Iron, 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron.

Important safety information:

• Do not take more than the recommended dose without checking with your doctor.
• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Cyanocobalamin/Vitamin C/Folic Acid/Iron unless your doctor tells you to.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron has folic acid and iron in it. Before you start any new medicine, check the label to see if it also has folic acid or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Cyanocobalamin/Vitamin C/Folic Acid/Iron.
• Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Cyanocobalamin/Vitamin C/Folic Acid/Iron. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron while you are pregnant. Cyanocobalamin/Vitamin C/Folic Acid/Iron is found in breast milk. If you are or will be breast-feeding while you use Cyanocobalamin/Vitamin C/Folic Acid/Iron, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cyanocobalamin/Vitamin C/Folic Acid/Iron:

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; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach 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. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.

Proper storage of Cyanocobalamin/Vitamin C/Folic Acid/Iron:

Store Cyanocobalamin/Vitamin C/Folic Acid/Iron at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyanocobalamin/Vitamin C/Folic Acid/Iron out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin/Vitamin C/Folic Acid/Iron, please talk with your doctor, pharmacist, or other health care provider.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron. 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.

Cyanocobalamin/

Vitamin C/

Folic Acid/

Iron/

Succinic Acid

Generic Name: Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid (SYE-an-oh-koe-BAL-a-min/VYE-ta-min/FOE-lik AS-id/EYE-urn/sux-IN-ic AS-id)
Brand Name: Ferrex 150 Forte Plus

Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid is used for:

Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.

Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body.

Do NOT use Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid if:

• you are allergic to any ingredient in Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid
• you have certain iron metabolism problems (eg, hemochromatosis, hemosiderosis) or have high levels of iron in your blood

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

Before using Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid:

Some medical conditions may interact with Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid. 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 pernicious anemia, hemolytic anemia, or a history of other blood problems (eg, porphyria, thalassemia)
• if you have a peptic ulcer, stomach or bowel problems (eg, ulcerative colitis), or liver problems
• if you have glucose-6-phosphate-dehydrogenase (G6PD) deficiency or a bleeding problem, have had multiple blood transfusions, or if you are receiving dialysis
• if you have a history of seizures

Some MEDICINES MAY INTERACT with Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluorouracil because the risk of its side effects may be increased by Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid
• Bisphosphonates (eg, alendronate), cephalosporins (eg, cefdinir), hydantoins (eg, phenytoin), levodopa, methyldopa, penicillamine, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid:

Use Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you also take an antacid, a bisphosphonate (eg, alendronate), a cephalosporin (eg, cefdinir), methyldopa, penicillamine, a quinolone (eg, ciprofloxacin), or a tetracycline (eg, doxycycline), ask your doctor or pharmacist how to take it with Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid.
• If you miss a dose of Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid, 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid.

Important safety information:

• Do not take more than the recommended dose without checking with your doctor.
• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid unless your doctor tells you to.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid has folic acid and iron in it. Before you start any new medicine, check the label to see if it also has folic acid or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years of age. In case of an overdose, call a doctor or poison control center right away.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid.
• Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid while you are pregnant. Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid is found in breast milk. If you are or will be breast-feeding while you use Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid:

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; dark or green stools; diarrhea; nausea; stomach pain; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent stomach 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. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent diarrhea, nausea, stomach pain, or vomiting; sluggishness; vomiting blood; weakness.

Proper storage of Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid:

Store Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid, please talk with your doctor, pharmacist, or other health care provider.
• Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid 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 Cyanocobalamin/Vitamin C/Folic Acid/Iron/Succinic Acid. 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: hydroxocobalamin (injection) (hye DROX o koe BAL a min)
Brand Names: Cyanokit

What is hydroxocobalamin?

Hydroxocobalamin is a form of vitamin B-12. It is used as an antidote to cyanide poisoning. Hydroxocobalamin works by helping cells in the body convert cyanide to a form that can be removed from the body through urination.

Hydroxocobalamin is used in an emergency to treat cyanide poisoning. This type of poisoning can occur if you are exposed to smoke from a house or industrial fire, if you swallow or breathe in cyanide, or if you get cyanide on your skin.

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

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

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.

Hydroxocobalamin is usually given in an emergency, so you may not have time to tell your caregivers about any drugs you take or medical conditions you have. However, you will need follow-up medical care after receiving this medication. Tell your doctor if you have high blood pressure, heart disease, or congestive heart failure.

You may develop an acne-like skin rash from 1 week to as late as 4 weeks after you are treated with hydroxocobalamin. This rash should go away without treatment. Call your doctor if you have a rash that does not clear up on its own.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you have recently received a hydroxocobalamin injection.

What should I discuss with my health care provider after receiving hydroxocobalamin?

Hydroxocobalamin is usually given in an emergency, so you may not have time to tell your caregivers about any medical conditions you have. However, you will need follow-up medical care after receiving this medication. Tell your doctor if you have:

• high blood pressure;

• heart disease; or

• congestive heart failure.

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 hydroxocobalamin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take hydroxocobalamin?

Hydroxocobalamin is given as an injection through a needle placed into a vein, most often in an emergency situation. The medicine must be given slowly through an IV infusion, and can take about 15 minutes to complete.

Hydroxocobalamin is usually given only once. However, you may receive a second dose if needed.

You may develop an acne-like skin rash from 1 week to as late as 4 weeks after you were treated with hydroxocobalamin. This rash should go away without treatment. Call your doctor if you have a rash that does not clear up on its own.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you have recently received a hydroxocobalamin injection.

What happens if I miss a dose?

Since hydroxocobalamin is used in an emergency, you will most likely be given only one or two doses of this medication.

What happens if I overdose?

An overdose of hydroxocobalamin is extremely unlikely.

What should I avoid while taking hydroxocobalamin?

If your skin turns red after receiving this medication, avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroxocobalamin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• fast or uneven heart rate;

• bright red blood in your stools; or

• swelling in your hands or feet.

Less serious side effects are more likely to occur, such as:

• red coloring of your skin or urine (this may last up to 2 weeks);

• nausea, vomiting, diarrhea, stomach pain;

• acne, skin rash or itching;

• warmth or redness under your skin;

• dry throat, trouble swallowing;

• headache, dizziness, memory problems, restless feeling;

• pain, swelling, or irritation of your skin where the injection was given; or

• eye redness or irritation.

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.

What other drugs will affect hydroxocobalamin?

Hydroxocobalamin is usually given in an emergency, so you may not have time to tell your caregivers about any other medications you are using. However, you will need follow-up medical care after receiving hydroxocobalamin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor if you have recently be treated with hydroxocobalamin.

Where can I get more information?

• Your doctor or pharmacist has information about hydroxocobalamin written for health professionals that you may read.

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:40:06 PM.

Generic Name: cyclandelate (sye KLAN de late)
Brand Names: Cyclospasmol

What is cyclandelate?

Cyclandelate is in a class of drugs called vasodilators. Cyclandelate relaxes veins and arteries, which makes them wider and allows blood to pass through them more easily.

These actions may help treat the symptoms of conditions such as leg cramps, arteriosclerosis (hardening of the arteries), Raynaud’s phenomenon, and other conditions that involve poor blood flow in your veins and arteries.

Cyclandelate is not commercially available in the United States.

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

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

Cyclandelate is not commercially available in the United States.

Take cyclandelate with food or an antacid to lessen stomach discomfort.

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

Before taking this medication, tell your doctor if you have

• serious coronary artery disease;

• peripheral or cerebral vascular disease;

• glaucoma, or

• bleeding or blood problems.

The safety of cyclandelate for use by pregnant or nursing women has not been established. Do not take cyclandelate without first talking to your doctor if you are pregnant or are breast-feeding a baby.

How should I take cyclandelate?

Take cyclandelate 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 cyclandelate with food or an antacid to lessen stomach discomfort. Cyclandelate is usually taken two to four times a day, before meals and at bedtime. Follow your doctor’s instructions. Store cyclandelate at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for 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 cyclandelate overdose include lightheadedness, weakness, fainting, headache, and a faint heartbeat.

What should I avoid while taking cyclandelate?

There are no restrictions on foods, beverages, or activities during therapy with cyclandelate. Follow any special instructions you receive from your doctor.

Cyclandelate side effects

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

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

• heartburn, stomach upset, or belching;

• flushing;

• headache;

• a fast heartbeat; or

• weakness.

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

What other drugs will affect cyclandelate?

Drugs used to treat high blood pressure and other heart conditions may increase the effects of cyclandelate. Special monitoring may be necessary.

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

Where can I get more information?

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

What does my medication look like?

Cyclandelate was formerly available with a prescription under the brand names Cyclan and Cyclospasmol in 200 mg and 400 mg capsules. Cyclandelate was also formerly available in a generic tablet formulation. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 2/13/04 4:00:53 PM.

sye-KLAN-de-late

Available Dosage Forms:

• Capsule

Therapeutic Class: Peripheral Vasodilator

Uses For cyclandelate

Cyclandelate belongs to the group of medicines commonly called vasodilators. These medicines increase the size of blood vessels. Cyclandelate is used to treat problems resulting from poor blood circulation.

cyclandelate was available only with your doctor’s prescription .

Wyeth-Ayerst discontinued the distribution of cyclandelate in April 1997

Before Using cyclandelate

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 cyclandelate, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

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

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Angina (chest pain) or
• Bleeding problems or
• Glaucoma or
• Hardening of the arteries or
• Heart attack (recent) or
• Stroke (recent)—The chance of unwanted effects may be increased.

Proper Use of cyclandelate

If cyclandelate upsets your stomach, it may be taken with meals, milk, or antacids.

Dosing

The dose of cyclandelate will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of cyclandelate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treating poor circulation:
    • Adults—At first, 1.2 to 1.6 grams a day. This is taken in divided doses before meals and at bedtime. Then, your doctor will gradually lower your dose to 400 to 800 milligrams (mg) a day. This is divided into two to four doses.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using cyclandelate

It may take some time for cyclandelate to work. If you feel that the medicine is not working, do not stop taking it on your own. Instead, check with your doctor.

The helpful effects of cyclandelate may be decreased if you smoke.

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

cyclandelate 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.

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

Less common

• Belching, heartburn, nausea, or stomach pain
• dizziness
• fast heartbeat
• flushing of face
• headache
• sweating
• tingling sensation in face, fingers, or toes
• weakness

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

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

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