Abelcet

29/06/10

Generic Name: amphotericin b lipid complex (Intravenous route, Injection route)

am-foe-TER-i-sin B LIP-id KOM-plex

Commonly used brand name(s):

In the U.S.

  • Abelcet

Available Dosage Forms:

  • Powder for Solution
  • Suspension

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Abelcet

Amphotericin B lipid complex is an antifungal medicine. It is used to help the body overcome serious infections caused by fungus.

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


Before Using Abelcet

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cyclosporine

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:

  • Blood transfusion—Amphotericin B lipid complex may cause side effects affecting the lungs
  • Kidney disease—Amphotericin B lipid complex may make your kidney problems worse




Proper Use of Abelcet

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 injection dosage form:
    • For treatment of serious infection caused by fungus:
      • Adults and children—5 milligrams per kilogram (2.27 mg per pound) of body weight per day, injected slowly into a vein.

Abelcet 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 as soon as possible if any of the following side effects occur:

More common

  • Chills and fever
  • headache
  • nausea and vomiting

Less common

  • Difficulty in breathing
  • sore throat and fever
  • unusual bleeding or bruising
  • unusual tiredness and weakness

Rare

  • Increased or decreased urination

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

  • Diarrhea
  • loss of appetite
  • stomach pain

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

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

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

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

 

Abenol

29/06/10

Generic Name: acetaminophen (Oral route, Rectal route)

a-seet-a-MIN-oh-fen

Commonly used brand name(s):

In the U.S.

  • Actamin Maximum Strength
  • Altenol
  • Aminofen
  • Anacin Aspirin Free
  • Apra
  • Cetafen
  • Children’s Nortemp
  • Comtrex Sore Throat Relief
  • Dolono
  • Feverall
  • Genapap
  • Tylenol

In Canada

  • Abenol
  • Acetaminophen
  • Actimol Children’s
  • Actimol Infant
  • Atasol
  • Children’s Acetaminophen
  • Children’s Acetaminophen Bubble Gum Flavor
  • Children’s Acetaminophen Cherry Flavor
  • Children’s Acetaminophen Grape Flavor
  • Children’s Acetaminophen Suspension Bubble Gum Flavor – Ages 2 To 11
  • Children’s Acetaminophen Suspension Cherry Flavor
  • Children’s Acetaminophen Suspension Grape Flavor – Ages 2 To 11

Available Dosage Forms:

  • Solution
  • Tablet, Disintegrating
  • Suppository
  • Powder
  • Syrup
  • Tablet
  • Tablet, Chewable
  • Capsule
  • Powder for Solution
  • Suspension
  • Elixir
  • Tablet, Extended Release
  • Capsule, Liquid Filled
  • Liquid
  • Tablet, Effervescent

Therapeutic Class: Analgesic

Uses For Abenol

Acetaminophen is used to relieve pain and reduce fever. Unlike aspirin, it does not relieve the redness, stiffness, or swelling caused by rheumatoid arthritis. However, it may relieve the pain caused by mild forms of arthritis.

This medicine is available without a prescription.


Before Using Abenol

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

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults. However, some children’s products containing acetaminophen also contain aspartame, which may be dangerous if it is given to children with phenylketonuria.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Carbamazepine
  • Isoniazid
  • Phenytoin
  • Warfarin
  • Zidovudine

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

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

  • Cabbage

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:

  • Alcohol abuse or
  • Kidney disease (severe) or
  • Hepatitis or other liver disease—The chance of serious side effects may be increased
  • Phenylketonuria—Some brands of acetaminophen contain aspartame, which can make your condition worse




Proper Use of acetaminophen

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

Unless otherwise directed by your medical doctor or dentist :

  • Do not take more of this medicine than is recommended on the package label. If too much is taken, liver and kidney damage may occur.
  • Children up to 12 years of age should not take this medicine more than 5 times a day.

To use acetaminophen oral granules (e.g., Snaplets-FR):

  • Just before the medicine is to be taken, open the number of packets needed for one dose. Mix the granules inside of the packets with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen granules along with the food.

To use acetaminophen oral powders (e.g., Feverall Sprinkle Caps [Children's or Junior Strength]):

  • These capsules are not intended to be swallowed whole. Instead, just before the medicine is to be taken, open the number of capsules needed for one dose. Empty the powder from each capsule into 1 teaspoonful of water or other liquid. Drink the medicine along with the liquid. You may drink more liquid after taking the medicine. You may also mix the powder with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen powder along with the food.

For patients using acetaminophen suppositories:

  • If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
  • To insert the suppository:
    • First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

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 oral dosage forms (capsules, granules, powders, solution, suspension, or tablets) and rectal dosage forms (suppositories):
    • For pain or fever:
      • Adults and teenagers—325 or 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.The total dose should not be more than 4000 mg (for example, eight 500–mg tablets) a day.
      • Children—Acetaminophen dose is based on the child’s age.
        • Infants up to 3 months of age: 40 mg every four hours as needed.
        • Infants 4 to 12 months of age: 80 mg every four hours as needed.
        • Children 1 to 2 years of age: 120 mg every four hours as needed.
        • Children 2 to 4 years of age: 160 mg every four hours as needed.
        • Children 4 to 6 years of age: 240 mg every four hours as needed.
        • Children 6 to 9 years of age: 320 mg every four hours as needed.
        • Children 9 to 11 years of age: 320 to 400 mg every four hours as needed.
        • Children 11 to 12 years of age: 320 to 480 mg every four hours as needed.

Storage

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

Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze.

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Abenol

Check with your medical doctor or dentist:

  • If you are taking this medicine to relieve pain, including arthritis pain, and the pain lasts for more than 10 days for adults or 5 days for children or if the pain gets worse, new symptoms occur, or the painful area is red or swollen. These could be signs of a serious condition that needs medical or dental treatment.
  • If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, the fever gets worse, new symptoms occur, or redness or swelling is present. These could be signs of a serious condition that needs treatment.
  • If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

Check the labels of all prescription and nonprescription (over-the-counter [OTC]) medicines you now take. If any contain acetaminophen, check with your health care professional. Taking them together with this medicine may cause an overdose.

If you will be taking more than an occasional 1 or 2 doses of acetaminophen, do not drink alcoholic beverages. To do so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly, if you take more acetaminophen than is recommended on the package label, or if you take it regularly for a long time.

Taking certain other medicines together with acetaminophen may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your medical doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with acetaminophen for more than a few days unless your doctor has directed you to do so and is following your progress:

  • Aspirin or other salicylates
  • Diclofenac (e.g., Voltaren)
  • Diflunisal (e.g., Dolobid)
  • Etodolac (e.g., Lodine)
  • Fenoprofen (e.g., Nalfon)
  • Floctafenine (e.g., Idarac)
  • Flurbiprofen, oral (e.g., Ansaid)
  • Ibuprofen (e.g., Motrin)
  • Indomethacin (e.g., Indocin)
  • Ketoprofen (e.g., Orudis)
  • Ketorolac (e.g., Toradol)
  • Meclofenamate (e.g., Meclomen)
  • Mefenamic acid (e.g., Ponstel)
  • Nabumetone (e.g., Relafen)
  • Naproxen (e.g., Naprosyn)
  • Oxaprozin (e.g., Daypro)
  • Phenylbutazone (e.g., Butazolidin)
  • Piroxicam (e.g., Feldene)
  • Sulindac (e.g., Clinoril)
  • Tenoxicam (e.g., Apo-Tenoxicam)
  • Tiaprofenic acid (e.g., Surgam)
  • Tolmetin (e.g., Tolectin)

Acetaminophen may interfere with the results of some medical tests. Before you have any medical tests, tell the person in charge if you have taken acetaminophen within the past 3 or 4 days. If possible, it is best to call the laboratory where the test will be done about 4 days ahead of time, to find out whether this medicine may be taken during the 3 or 4 days before the test.

For diabetic patients:

  • Acetaminophen may cause false results with some blood glucose (sugar) tests. If you notice any change in your test results, or if you have any questions about this possible problem, check with your health care professional. This is especially important if your diabetes is not well-controlled.

For patients taking one of the products that contain caffeine in addition to acetaminophen:

  • Caffeine may interfere with the results of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose of acetaminophen, get emergency help at once, even if there are no signs of poisoning. Signs of severe poisoning may not appear for 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started as soon as possible. Treatment started more than 24 hours after the overdose is taken may not be effective.

Abenol 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:

Rare

  • Yellow eyes or skin

Symptoms of overdose

  • Diarrhea
  • increased sweating
  • loss of appetite
  • nausea or vomiting
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area

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

Rare

  • Bloody or black, tarry stools
  • bloody or cloudy urine
  • fever with or without chills (not present before treatment and not caused by the condition being treated)
  • pain in lower back and/or side (severe and/or sharp)
  • pinpoint red spots on skin
  • skin rash, hives, or itching
  • sores, ulcers, or white spots on lips or in mouth
  • sore throat (not present before treatment and not caused by the condition being treated)
  • sudden decrease in amount of urine
  • unusual bleeding or bruising
  • unusual tiredness or 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.

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

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

 

Abilify Discmelt

29/06/10

Generic Name: aripiprazole (Oral route)

ar-i-PIP-ra-zole

Oral routeTabletTablet, DisintegratingSolution

  • Increased Mortality In Elderly Patients With Dementia-Related Psychosis
    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
  • Suicidality and Antidepressant Drugs
    • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive aripiprazole or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aripiprazole is not approved for use in pediatric patients with depression .

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

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

Intramuscular routeSolution

  • Increased Mortality In Elderly Patients With Dementia-Related Psychosis
    • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
  • Suicidality and Antidepressant Drugs
    • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive aripiprazole or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aripiprazole is not approved for use in pediatric patients with depression .

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

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

Commonly used brand name(s):

In the U.S.

  • Abilify
  • Abilify Discmelt

Available Dosage Forms:

  • Tablet
  • Tablet, Disintegrating
  • Solution

Therapeutic Class: Antipsychotic

Uses For Abilify Discmelt

Aripiprazole is used to treat schizophrenia, which is a mental disorder. It is used alone or together with other medicines to treat mental depression and bipolar I disorder (manic-depressive illness). It is also used to treat irritability in children 6 to 17 years of age with autistic disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

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


Before Using Abilify Discmelt

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 have not been performed on the relationship of age to the effects of aripiprazole in children with schizophrenia younger than 13 years of age and in children with bipolar disorder younger than 10 years of age. Safety and efficacy have not been established in these age groups.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children with autistic disorder 6 to 17 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

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

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Metoclopramide

Using this medicine 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.

  • Hydromorphone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Ketoconazole
  • Quinidine

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:

  • Alcohol abuse, history of or
  • Depression or
  • Neuroleptic malignant syndrome (NMS), history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Alzheimer’s disease or
  • Dehydration or
  • Heart or blood vessel disease or
  • Heart attack, history of or
  • Heart failure or
  • Heart rhythm problems or
  • Hypotension (low blood pressure) or
  • Hypovolemia (decrease in blood volume) or
  • Ischemic heart disease, history of or
  • Trouble with swallowing—Use with caution. May cause side effects to become worse.
  • Diabetes or
  • Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels.
  • Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.




Proper Use of aripiprazole

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

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

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 bipolar mania:
    • For oral dosage forms (tablets and orally disintegrating tablets):
      • Adults—15 to 30 milligrams (mg) once a day.
      • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed up to a maximum of 30 mg once a day.
      • Children up to 10 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (solution):
      • Adults—15 to 25 milligrams (mg) once a day.
      • Children 10 years of age and older—At first, 2 mg once a day. Your dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed up to a maximum of 25 mg once a day.
      • Children up to 10 years of age—Use and dose must be determined by your doctor.
  • For depression:
    • For oral dosage forms (tablets, orally disintegrating tablets, and solution):
      • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For irritability in children with autistic disorder:
    • For oral dosage forms (tablets, orally disintegrating tablets, and solution):
      • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
      • Children up to 6 years of age—Use and dose must be determined by your doctor.
  • For schizophrenia:
    • For oral dosage forms (tablets and orally disintegrating tablets):
      • Adults—10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg.
      • Teenagers 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed up to a maximum of 30 mg once a day.
      • Children up to 13 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (solution):
      • Adults—10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg.
      • Teenagers 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed up to a maximum of 25 mg once a day.
      • Children up to 13 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

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.

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

Opened bottles of the oral liquid can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.


Precautions While Using Abilify Discmelt

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

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

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

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

Stop taking this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

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

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may increase the amount of sugar in your blood. Also, the oral solution form contains sugar. Check with your doctor right away if you or your child have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Abilify Discmelt 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:

More common

  • Difficulty with speaking
  • drooling
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • restlessness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back

Less common

  • Blurred vision
  • dizziness
  • headache
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • sticking out the tongue
  • trouble with breathing or swallowing
  • unusual facial expressions

Rare

  • Convulsions
  • fast heartbeat
  • high fever
  • high or low blood pressure
  • increased sweating
  • lip smacking or puckering
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • severe muscle stiffness
  • sudden loss of consciousness
  • tiredness
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusually pale skin

Incidence not known

  • Hives or welts
  • itching skin
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing

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

Symptoms of overdose

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • diarrhea
  • fast, pounding, or irregular heartbeat or pulse
  • increased sensitivity of the eyes to light
  • lack or loss of strength
  • nausea
  • sleepiness or unusual drowsiness
  • vomiting

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

  • Acid or sour stomach
  • anxiety
  • belching
  • blurred vision
  • difficulty having a bowel movement (stool)
  • dry mouth
  • fear
  • fever
  • headache
  • heartburn
  • hyperventilation
  • inability to sit still
  • indigestion
  • irritability
  • lightheadedness
  • need to keep moving
  • nervousness
  • rash
  • runny nose
  • shaking
  • sleeplessness
  • sore throat
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unable to sleep
  • weight gain

Less common

  • Accidental injury
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • congestion
  • coughing
  • difficulty with moving
  • dryness or soreness of throat
  • hoarseness
  • increased appetite
  • increased salivation
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • rapid weight gain
  • sneezing
  • stuffy nose
  • swollen joints
  • tender, swollen glands in the neck
  • tingling of the hands or feet
  • tremor
  • unusual weight gain or loss
  • voice changes

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

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

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

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

 

Ablavar

29/06/10

Generic Name: gadofosveset (Injection route)

gad-oh-FOS-ve-set

Injection routeSolution

  • Nephrogenic Systemic Fibrosis (NSF)
    • Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
      • acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73 m(2)), or
      • acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period
    • In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration .

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (GFR less than 30 mL/min/1.73 m(2)), or acute renal insufficiency (any severity) due to the hepato-renal syndrome or in the perioperative liver transplantation period. Avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced MRI. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. Do not exceed recommended dose and allow a sufficient time period for elimination prior to readministration .

Commonly used brand name(s):

In the U.S.

  • Ablavar

Available Dosage Forms:

  • Solution

Uses For Ablavar

Gadofosveset is a contrast agent. It is used in magnetic resonance angiography (MRA) to help create a clear picture of the blood vessels (arteries). The MRA scan is a special kind of diagnostic procedure. It uses magnets and computers to create images or “pictures” of the blood vessels in certain areas of the body. Gadofosveset is a gadolinium-based contrast agent (GBCA).

Gadofosveset is given by injection before MRA to help diagnose problems in the blood vessels (e.g., blockage of the arteries).

This medicine is to be used only by or under the direct supervision of a doctor.


Before Using Ablavar

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 have not been performed on the relationship of age to the effects of gadofosveset in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

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:

  • Asthma or allergies, history of or
  • Heart disease, history of or
  • Heart rhythm problems (e.g., QT prolongation) or
  • Kidney problems, severe (recent or long-term)—Use with caution. May cause side effects to become worse.




Proper Use of Ablavar

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have an MRA scan.


Precautions While Using Ablavar

Check with your doctor right away if you have burning or itching of the skin; red or dark patches on the skin; skin swelling, hardening, or tightening; joint stiffness; limited range of motion in the arms and legs; pain that is deep in the hip bone or ribs; or muscle weakness. These may be symptoms of a very serious disease called nephrogenic systemic fibrosis (NSF).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have cold clammy skin; confusion; dizziness; lightheadedness; a skin rash; itching; sweating; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.

This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Ablavar 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

  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing

Less common

  • Blurred vision
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • sweating

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

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • change in taste
  • feeling cold
  • loss of taste
  • nausea

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

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

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

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

 

A-Caro-25

29/06/10

Generic Name: beta carotene (Oral route)

bay-ta KAR-oh-teen

Commonly used brand name(s):

In the U.S.

  • A-Caro-25
  • Lumitene

Available Dosage Forms:

  • Capsule
  • Capsule, Liquid Filled
  • Liquid
  • Tablet

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin A (class)

Uses For A-Caro-25

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Beta-carotene is converted in the body to vitamin A, which is necessary for healthy eyes and skin.

A lack of vitamin A may cause a rare condition called night blindness (problems seeing in the dark). It may also cause dry eyes, eye infections, skin problems, and slowed growth. Your health care professional may treat these problems by prescribing either beta-carotene, which your body can change into vitamin A, or vitamin A for you.

Some conditions may increase your need for vitamin A. These include:

  • Cystic fibrosis
  • Diarrhea, continuing
  • Illness, long-term
  • Injury, serious
  • Liver disease
  • Malabsorption problems
  • Pancreas disease

Increased need for vitamin A should be determined by your health care professional.

Claims that beta-carotene is effective as a sunscreen have not been proven. Although beta-carotene supplements are being studied for their ability to reduce the risk of certain types of cancer and possibly heart disease, there is not enough information to show that this is effective.

Beta-carotene may be used to treat other conditions as determined by your doctor.

Beta-carotene is available without a prescription.

Once a product has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, beta-carotene is used in certain patients with the following medical conditions:

  • Polymorphous light eruption (a type of reaction to sun)
  • Erythropoietic protoporphyria photosensitivity reaction (a type of reaction to sun)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

It is documented that people who consume diets high in fruits and vegetables have a reduced risk of heart disease and certain cancers. Fruits and vegetables are rich in beta-carotene and other nutrients that may be beneficial.

Beta-carotene is found in carrots; dark-green leafy vegetables, such as spinach and green leaf lettuce; sweet potatoes; broccoli; cantaloupe; and winter squash. The body converts beta-carotene into vitamin A. Ordinary cooking does not destroy beta-carotene.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body needs other substances found in food, such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, some fat is needed so that beta-carotene can be absorbed into the body.


Before Using A-Caro-25

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, 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

Problems in children have not been documented with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been documented with intake of normal daily recommended amounts.

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

  • Eating disorders or
  • Kidney disease or
  • Liver disease—These conditions may cause high blood levels of beta-carotene, which may increase the chance of side effects




Proper Use of beta carotene

This section provides information on the proper use of a number of products that contain beta carotene. It may not be specific to A-Caro-25. Please read with care.

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 use as a dietary supplement:

  • For oral dosage forms (capsules or chewable tablets):
    • Adults and teenagers: 6 to 15 milligrams (mg) of beta-carotene (the equivalent of 10,000 to 25,000 Units of vitamin A activity) per day.
    • Children: 3 to 6 mg of beta-carotene (the equivalent of 5,000 to 10,000 Units of vitamin A activity) per day.

For other uses:

  • For oral dosage forms (capsules or tablets):
    • To treat or prevent a reaction to sun in patients with erythropoietic protoporphyria:
      • Adults and teenagers—30 to 300 milligrams (mg) of beta-carotene (the equivalent of 50,000 to 500,000 Units of vitamin A activity) a day.
      • Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.
    • To treat or prevent a reaction to sun in patients with polymorphous light eruption:
      • Adults and teenagers—75 to 180 mg of beta-carotene (the equivalent of 125,000 to 300,000 Units of vitamin A activity) a day.
      • Children—30 to 150 mg of beta-carotene (the equivalent of 50,000 to 250,000 Units of vitamin A activity) a day.

If you have high blood levels of vitamin A, your body will convert less beta-carotene to vitamin A.

Missed Dose

If you miss a dose of this medicine, 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.

If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this vitamin, try to remember to take it as directed every day.

If you miss a dose and you are using it as medicine, 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. Do not refrigerate. Keep from freezing.

Store the dietary supplement 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 A-Caro-25

Use of beta-carotene has been associated with an increased risk of lung cancer in people who smoke or who have been exposed to asbestos. One study of 29,000 male smokers found an 18% increase in lung cancer in the group receiving 20 mg of beta-carotene a day for 5 to 8 years. Another study of 18,000 people found 28% more lung cancers in people with a history of smoking and/or asbestos exposure. These people took 30 mg of beta-carotene in addition to 25,000 Units of retinol (a form of vitamin A) a day for 4 years. However, one study of 22,000 male physicians, some of them smokers or former smokers, found no increase in lung cancer. These people took 50 mg of beta-carotene every other day for 12 years. If you smoke or have a history of smoking or asbestos exposure, you should not take large amounts of beta-carotene supplements for long periods of time. However, foods that are rich in beta-carotene are considered safe and appear to lower the risk of some types of cancer and possibly heart disease.

A-Caro-25 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:

More common

  • Yellowing of palms, hands, or soles of feet, and to a lesser extent the face (this may be a sign that your dose of beta-carotene as a nutritional supplement is too high)

Rare

  • Diarrhea
  • dizziness
  • joint pain
  • unusual bleeding or bruising

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

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

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