In the U.S.—

In Canada—

• Antidiarrheal, acquired immunodeficiency syndrome (AIDS)
• antidiarrheal, gastrointestinal tumor
• antihemorrhagic, bleeding gastroesophageal varices
• antihypoglycemic, pancreatic tumor
• antihypotensive, carcinoid crisis
• growth hormone suppressant, acromegaly

Octreotide ( ok-TREE-oh-tide) is used to treat the severe diarrhea and other symptoms that occur with certain intestinal tumors. It does not cure the tumor but it helps the patient live a more normal life.

Also, this medicine is used to treat a condition called acromegaly, which is caused by too much growth hormone in the body. Too much growth hormone produced in adults causes the hands, feet, and parts of the face to become large, thick, and bulky. Other problems such as arthritis also can develop. Octreotide works by reducing the amount of growth hormone that the body produces.

Octreotide may also be used for other medical conditions as determined by your doctor.

Octreotide is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to octreotide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. However, studies in rats and rabbits have not shown that octreotide causes birth defects or other problems, even when given in doses much larger than the human dose.

Breast-feeding—It is not known whether octreotide passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—The short-acting form of this medicine has been tested in a limited number of children as young as 1 month of age and has not been shown to cause different side effects or problems than it does in adults.

Studies on the long-acting form of this medicine have been done only in adult patients, and there is no specific information comparing its use in children with use in other age groups.

Older adults—This medicine has been used in persons up to 83 years of age and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other 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. When you are taking octreotide, it is especially important that your health care professional know if you are taking any of the following:

• Antidiabetic agents, sulfonylurea (diabetes medicine you take by mouth) or
• Diazoxide (e.g., Proglycem) or
• Glucagon or
• Insulin—Octreotide may cause high or low blood sugar; your doctor may need to change the dose of your diabetes medicine

• Growth hormone—Octreotide may cause high or low blood sugar; your doctor may need to change the dose of this medicine

• Diabetes mellitus (sugar diabetes)—Octreotide may cause high or low blood sugar; your doctor may need to change the dose of your diabetes medicine

• Gallbladder disease or gallstones (or history of)—This medicine may increase the chance of having gallstones

• Kidney disease (severe)—If you have this condition, octreotide may remain in the body longer than normal; your doctor may need to change the dose of your medicine

To control the symptoms of your medical problem, this medicine must be taken as ordered by your doctor. Make sure that you understand exactly how to take this medicine.

Octreotide is packaged in a kit containing an ampul opener, alcohol swabs, ampuls of the medicine, and, in some kits, a vial of diluent to mix with the medicine. Directions on how to prepare and inject the medicine are in the package. Read the directions carefully and ask your health care professional for additional explanation, if necessary.

It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites on your body. This will help to prevent skin problems, such as irritation.

Some patients may feel pain, stinging, tingling, or burning sensations at the place where they inject the medicine. These sensations usually last only a few moments and may be eased by rubbing the spot after the injection. Injecting the medicine after it has been warmed to room temperature rather than cold from the refrigerator may reduce the discomfort. The medicine should be taken from the refrigerator 20 to 60 minutes before it is to be used. However, do not use heat to warm it faster because heat can destroy the medicine.

Put used needles and syringes in a puncture-resistant disposable container or dispose of them as directed by your health care professional. Do not reuse needles and syringes .

Dosing—

The dose of octreotide 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 octreotide. If your dose is different, do not change it unless your doctor tells you to do so.

• For long-acting injection dosage form:
  • For treating the severe diarrhea that occurs with certain types of intestinal tumors:
    • Adults and teenagers—At first, 20 milligrams (mg) injected into the gluteal muscle once every four weeks for two months. Then, the dose will be adjusted by your doctor, based on your response to the medicine.
    • Children—Use and dose must be determined by your doctor.
  • For treating acromegaly:
    • Adults—At first, 20 mg injected into the gluteal muscle once every four weeks for three months. Then, the dose will be adjusted by your doctor, based on your response to the medicine.
• For short-acting injection dosage form:
  • For treating the severe diarrhea that occurs with certain types of intestinal tumors:
    • Adults and teenagers—At first, 50 micrograms (mcg) injected under the skin two or three times a day. Then, the dose is slowly increased. Some people may need doses as high as 600 mcg a day for the first two weeks. Thereafter, the dose is usually between 50 and 1500 mcg per day.
    • Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 10 mcg per kilogram (kg) (0.45 to 4.5 mcg per pound) of body weight a day, injected under the skin.
  • For treating acromegaly:
    • Adults—At first, 50 mcg injected under the skin or into a vein three times a day. Then, the dose is slowly increased to 100 to 200 mcg three times a day. Higher doses may be needed, as determined by your doctor.

Missed dose—

If you miss a dose of the long-acting form of this medicine, contact your doctor.

If you miss a dose of the short-acting form of this medicine, use it as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Although you will not be harmed by forgetting a dose, the symptoms that you are trying to control (for example, diarrhea) may reappear. To be able to control your symptoms, your doses should be evenly spaced over a period of 24 hours. If you have any questions about this, check with your health care professional.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store the ampuls of octreotide in the refrigerator until they are to be used. Ampuls of the short-acting form of octreotide may be kept at room temperature for 14 days when they are protected from light. If the ampuls are not protected from light, problems with the solution can develop much sooner.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine and syringes are out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted 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:

• Less common or rare
  • Convulsions (seizures);  unconsciousness  
  
  

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

• More common
  • Irregular heartbeat;  slow heartbeat  
  
  

• Less common or rare
  • Hyperglycemia (high blood sugar), including blurred vision, drowsiness, dry mouth, flushed dry skin, fruit-like breath odor, increased urination (frequency and volume), ketones in urine, loss of appetite, nausea, stomachache, tiredness, troubled breathing (rapid and deep), unusual thirst, or vomiting;  hypoglycemia (low blood sugar), including anxious feeling, behavior change similar to drunkenness, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness;  inflammation of the pancreas gland, including abdominal or stomach pain or bloating, nausea, or vomiting 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  diarrhea;  pain, stinging, tingling, or burning sensation at place of injection, with redness and swelling;  passing of gas 
  
  

• Less common or rare
  • Dizziness or light-headedness;  fever ;  hair loss;  redness or flushing of face;  swelling of feet or lower legs  
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, octreotide is used in certain patients with the following medical conditions:

• Acquired immunodeficiency syndrome (AIDS)-related diarrhea
• Chemotherapy-induced diarrhea
• Insulin-producing tumors of the pancreas

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