Octreotide Injection, Intramuscular

ok-TREE-oh-tide

Commonly used brand name(s):

In the U.S.

  • Sandostatin
  • Sandostatin LAR Depot

Available Dosage Forms:

  • Powder for Suspension
  • Powder for Solution
  • Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somatostatin (class)

Uses For octreotide

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, octreotide 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 octreotide

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 octreotide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to octreotide 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

The short-acting form of octreotide 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 octreotide 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 .

Geriatric

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 CategoryExplanation
All TrimestersBAnimal 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 octreotide 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

Using octreotide 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.

  • Acecainide
  • Acetophenazine
  • Ajmaline
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Aprindine
  • Arsenic Trioxide
  • Astemizole
  • Azimilide
  • Bretylium
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Clarithromycin
  • Cyclosporine
  • Desipramine
  • Dibenzepin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Doxepin
  • Droperidol
  • Encainide
  • Enflurane
  • Erythromycin
  • Ethopropazine
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Fluphenazine
  • Foscarnet
  • Gemifloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Isoflurane
  • Isradipine
  • Lidoflazine
  • Lorcainide
  • Mefloquine
  • Methotrimeprazine
  • Nortriptyline
  • Pentamidine
  • Perphenazine
  • Pipotiazine
  • Pirmenol
  • Prajmaline
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propafenone
  • Propiomazine
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Risperidone
  • Sematilide
  • Sertindole
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Tedisamil
  • Telithromycin
  • Thiethylperazine
  • Trifluoperazine
  • Triflupromazine
  • Trimeprazine
  • Trimethoprim
  • Trimipramine
  • Vasopressin
  • Zolmitriptan
  • Zotepine

Using octreotide 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.

  • Pegvisomant

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 octreotide. 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)—octreotide 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 octreotide

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

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 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.

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 octreotide, 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 octreotide, 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 octreotide

It is very important that your doctor check your progress at regular visits to make sure that octreotide is working properly and to check for unwanted effects.

octreotide 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:

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.

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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