OCTREOTIDE (Systemic)
Some commonly used brand names are:
In the U.S.?
- Sandostatin
- Sandostatin LAR Depot
In Canada?
Category
- Antidiarrheal, acquired immunodeficiency syndrome(AIDS)
- antidiarrheal, gastrointestinal tumor
- antihemorrhagic, bleeding gastroesophageal varices
- antihypoglycemic, pancreatic tumor
- antihypotensive, carcinoid crisis
- growth hormonesuppressant, acromegaly
Description
Octreotide (ok-TREE-oh-tide) is used to treat the severe diarrhea andother symptoms that occur with certain intestinal tumors. It does not curethe tumor but it helps the patient live a more normal life.
Also, this medicine is used to treat a condition called acromegaly, whichis caused by too much growth hormone in the body. Too much growth hormoneproduced in adults causes the hands, feet, and parts of the face to becomelarge, 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 determinedby your doctor.
Octreotide is available only with your doctor's prescription, in the followingdosage form:
Parenteral- Injection (U.S. and Canada)
Before Using This Medicine
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 followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to octreotide. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Studies have not been done in humans. However, studiesin rats and rabbits have not shown that octreotide causes birth defects orother problems, even when given in doses much larger than the human dose.
Breast-feeding?It is not known whether octreotide passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.
Children?The short-acting form of this medicine has been testedin a limited number of children as young as 1 month of age and has not beenshown 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 inadult patients, and there is no specific information comparing its use inchildren with use in other age groups.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing the use of octreotide in the elderly with use in other age groups,this medicine has been used in persons up to 83 years of age and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingoctreotide, it is especially important that your health care professionalknow if you are taking any of the following:
- Antidiabetic agents, sulfonylurea (diabetes medicine you take bymouth) or
- Diazoxide (e.g., Proglycem) or
- Glucagon or
- Insulin?Octreotide may cause high or low blood sugar; yourdoctor may need to change the dose of your diabetes medicine.
- Cyclosporine (e.g., Neoral)?Octreotide may cause decreasedamounts of cyclosporine in the blood and could cause rejection of the organtransplant.
- Growth hormone?Octreotide may cause high or low blood sugar;your doctor may need to change the dose of this medicine.
Other medical problems?The presence of other medicalproblems may affect the use of octreotide. Make sure you tell your doctorif you have any other medical problems, especially:
- Type 2 diabetes mellitus?Octreotide may cause highor low blood sugar; your doctor may need to change the dose of your diabetesmedicine.
- Gallbladder disease or gallstones (or history of)?This medicinemay increase the chance of having gallstones.
- Kidney disease (severe)?If you have this condition, octreotidemay remain in the body longer than normal; your doctor may need to changethe dose of your medicine.
Proper Use of This Medicine
To controlthe symptoms of your medical problem, this medicine must be taken as orderedby your doctor. Make sure that you understand exactlyhow 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 themedicine. Directions on how to prepare and inject themedicine are in the package. Read the directions carefully and askyour health care professional for additional explanation, if necessary.
It is important to follow any instructions from yourdoctor about the careful selection and rotation of injection sites on yourbody. This will help to prevent skin problems, such as irritation.
Some patients may feel pain, stinging, tingling, or burning sensationsat the place where they inject the medicine. These sensations usually lastonly 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 ratherthan cold from the refrigerator may reduce the discomfort. The medicine shouldbe 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-resistantdisposable container or dispose of them as directed by your healthcare professional. Do not reuse needles and syringes.
Dosing?The dose of octreotide will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 ofintestinal tumors:
- Adults and teenagers?At first, 20 milligrams (mg) injectedinto the gluteal muscle once every four weeks for two months. Then, the dosewill 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 onceevery four weeks for three months. Then, the dose will be adjusted by yourdoctor, based on your response to the medicine.
- For short-acting injection dosage form:
- For treating the severe diarrhea that occurs with certain types ofintestinal tumors:
- Adults and teenagers?At first, 50 micrograms (mcg) injectedunder 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 determinedby your doctor. The usual dose is 1 to 10 mcg per kilogram (kg) (0.45 to 4.5mcg 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 veinthree times a day. Then, the dose is slowly increased to 100 to 200 mcg threetimes 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 thismedicine, contact your doctor.
If you miss a dose of the short-acting form of this medicine, use it assoon 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 doubledoses. Although you will not be harmed by forgetting a dose, the symptomsthat you are trying to control (for example, diarrhea) may reappear. To beable to control your symptoms, your doses should be evenly spaced over a periodof 24 hours. If you have any questions about this, check with your healthcare professional.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store the ampuls of octreotide in the refrigerator until they areto be used. Ampuls of the short-acting form of octreotide may be kept at roomtemperature for 14 days when they are protected from light. If the ampulsare not protected from light, problems with the solution can develop muchsooner.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine and syringes are out of the reach of children.
Precautions While Using This Medicine
It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.
Side Effects of This Medicine
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 mayneed medical attention.
Also check with yourdoctor as soon as possible if any of the following side effects occur:
Less common or rare
Hyperglycemia (high blood sugar), including blurred vision, drowsiness,dry mouth, flushed dry skin, fruit-like breath odor, increased urination (frequencyand 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, behaviorchange similar to drunkenness, blurred vision, cold sweats, confusion, coolpale skin, difficulty in concentrating, drowsiness, excessive hunger, fastheartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness,slurred speech, or unusual tiredness or weakness; inflammation of the pancreas gland, including abdominal or stomach pain orbloating, nausea, or vomiting
Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:
More common
Constipation; diarrhea; headache; pain, stinging, tingling,or burning sensation at place of injection, with redness and swelling; passing of gas
Less common or rare
Backache; bladder pain; bloody or cloudy urine; blurred or lossof vision; chills; cough; difficult, burning, or painful urination; discouragement; disturbed color perception; dizziness or light-headedness; double vision; feeling sad or empty; fever; frequent urge to urinate; frequent urination usually with very small amounts of urine; general feeling of discomfort or illness; hair loss; halos around lights; irritability; itching skin; joint pain; lack or loss of appetite; loss of interest or pleasure; lowerback or side pain; muscle aches and pains; nausea; night blindness; overbright appearance of lights; rednessor flushing of face; runny nose; shivering; sore throat; stools that float, foul smelling, and fatty in appearance; sweating; swelling of feet or lower legs; tiredness; trouble concentrating; trouble sleeping; tunnel vision; unusual tiredness or weakness; vomiting
Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.
Additional Information
Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, octreotide is used in certain patients with the following medicalconditions:
- 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 relatingto proper use, precautions, or side effects for these uses.
Revised: 12/21/2005
