Pronunciation:

ok-TREE-oh-tide

Brand Names:

• Sandostatin
• Sandostatin LAR Depot

Dosage Forms:

• Solution
• Powder for Solution
• Powder for Suspension

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Somatostatin (class)

Uses of This Medicine:

Octreotide 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.

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.

Before Using This Medicine:

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.

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 in children 6 to 17 years and have not demonstrated pediatrics-specific problems that would limit the usefulness of octreotide in children .

Older adults—

Although appropriate studies on the relationship of age to the effects of octreotide have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of octreotide in the elderly. However, elderly patients are more likely to have age-related kidney or heart problems, which may require caution and dosage adjustment in patients receiving octreotide .

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.

Other 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.

• Bepridil
• Cisapride
• Levomethadyl
• Mesoridazine
• Pimozide
• Terfenadine
• Thioridazine
• Ziprasidone

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

• Type 1 and type 2 diabetes mellitus—Octreotide may cause high or low blood sugar; your doctor may need to change the dose of your diabetes medicine.

• Heart disease or heart rhythm problem—Your doctor may need to change the dose of your heart medicines .

• 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.

Proper Use of This 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 ampule opener, alcohol swabs, ampules 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 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 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 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 a dose of the long-acting form of this medicine, contact your doctor.

Storage—

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ampules 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.

Precautions While Using This Medicine:

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.

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 may need medical attention.

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

Less common or rare

Changes in menstrual periods

convulsions (seizures)

decreased sexual ability in males

depressed mood

dry skin and hair

dry, puffy skin

feeling cold

hoarseness or husky voice

muscle cramps and stiffness

slowed heartbeat

swelling of front part of neck

unconsciousness

unusual tiredness or weakness

weight gain

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

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

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 loss of 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

lower back or side pain

muscle aches and pains

nausea

night blindness

overbright appearance of lights

redness or flushing of face

runny nose

shivering

sore throat

stools that float, are foul smelling, and fatty in appearance

sweating

swelling of feet or lower legs

tiredness

trouble concentrating

trouble sleeping

tunnel vision

vomiting

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