Brand Name

      US Brand Name

      Gleolan


      Description

      Aminolevulinic acid is used to help your doctor see an image of a malignant (cancer) tissue during surgery in patients with glioma (tumor in the brain or spine). It is an optical imaging agent.

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

      This product is available in the following dosage forms:

      • Powder for Solution

      Before Using

      In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 aminolevulinic acid in children. 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 aminolevulinic acid in the elderly. However, some elderly patients are more sensitive to the effects of this medicine than younger adults.

      Breastfeeding

      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.

      Drug Interactions

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

      Receiving this diagnostic test 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.

      • Acetazolamide
      • Acetohexamide
      • Balofloxacin
      • Bendroflumethiazide
      • Benzthiazide
      • Besifloxacin
      • Chlorothiazide
      • Chlorpromazine
      • Chlorpropamide
      • Chlortetracycline
      • Chlorthalidone
      • Cinoxacin
      • Ciprofloxacin
      • Clopamide
      • Demeclocycline
      • Diazoxide
      • Dixyrazine
      • Doxycycline
      • Enoxacin
      • Flumequine
      • Fluphenazine
      • Gatifloxacin
      • Gemifloxacin
      • Gliclazide
      • Glimepiride
      • Glipizide
      • Gliquidone
      • Glyburide
      • Griseofulvin
      • Hydrochlorothiazide
      • Hydroflumethiazide
      • Indapamide
      • Levofloxacin
      • Lomefloxacin
      • Lymecycline
      • Mafenide
      • Meclocycline
      • Methacycline
      • Methdilazine
      • Methotrimeprazine

      Other Interactions

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

      • Allergy to porphyrins or
      • Porphyria, acute or chronic—Should not be used in patients with these conditions.
      • Kidney disease or
      • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

      Proper Use

      A doctor or other trained health professional will give you this medicine in a hospital. It is given by mouth before surgery.


      Precautions

      It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

      This medicine may cause photosensitivity (increased sensitivity to sunlight). Avoid exposure to sunlight or room lights for 48 hours after surgery.

      If you are using medicine that can cause photosensitivity (eg, griseofulvin, St. John’s wort, diuretic, phenothiazine, quinolone, sulfa drug, sulfonylurea, tetracycline, or topical preparations containing aminolevulinic acid), do not take it 24 hours before and after receiving aminolevulinic acid.

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

      Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

      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.


      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:

      Less common

      • Blindness over half the field of vision
      • blurred vision
      • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
      • confusion
      • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
      • inability to move the legs or arms
      • paralysis of one side of the body
      • partial or slight paralysis
      • problems with movement, walking, or speech
      • seizure
      • sweating
      • unusual tiredness or weakness

      Rare

      • Blistering, crusting, irritation, itching, or reddening of the skin
      • cracked, dry, scaly skin
      • headache
      • increased sensitivity of the skin to sunlight
      • redness or other discoloration of the skin
      • severe sunburn
      • skin rash
      • swelling
      • vomiting

      Incidence not known

      • Cough
      • difficulty swallowing
      • dizziness
      • drowsiness
      • fast heartbeat
      • hives or welts
      • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
      • muscle tremors
      • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
      • rapid, deep breathing
      • restlessness
      • shakiness and unsteady walk
      • stomach cramps
      • tightness in the chest
      • unsteadiness, trembling, or other problems with muscle control or coordination
      • unusual tiredness or weakness

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

      Symptoms of overdose

      • Blue lips, fingernails, or skin
      • difficult or troubled breathing
      • irregular, fast, slow, or shallow breathing

      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

      • Fever
      • nausea

      Rare

      • Chills
      • diarrhea

      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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