OVERVIEW
Sandostatin (octreotide) is a man-made protein that is similar to a hormone in the body called somatostatin. Octreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.
Sandostatin is used to treat acromegaly. Octreotide is also used to reduce flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIP adenomas).
Sandostatin may also be used for purposes not listed in this medication guide.
Important information
Use Sandostatin exactly as prescribed by your doctor. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before using Sandostatin, tell your doctor if you have diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease.
You may be shown how to use an IV at home. Do not self-inject Sandostatin if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine. Be sure to follow the instructions for the exact type of Sandostatin your doctor has prescribed for you.
To be sure Sandostatin is helping your condition and not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested often. Do not miss any follow up visits to your doctor for blood or urine tests. Call your doctor at once if you have a serious side effect such as easy bruising or bleeding, slow heart rate, or severe pain in your upper stomach spreading to your back.
Before taking this medicine
You should not use Sandostatin if you are allergic to octreotide.
To make sure you can safely use Sandostatin, tell your doctor if you have any of these other conditions:
- diabetes;
- gallbladder disease;
- heart disease, high blood pressure, or heart rhythm disorder;
- thyroid problems;
- pancreatitis;
- liver disease; or
- kidney disease (or if you are on dialysis).
Sandostatin is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Using Sandostatin can affect certain hormones that may make it easier for you to get pregnant, even if you were unable to get pregnant before. Talk to your doctor about using birth control to avoid unwanted pregnancy.
It is not known whether octreotide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
SIDE EFFECTS
Applies to octreotide: powder for solution, powder for suspension, solution
As well as its needed effects, octreotide (the active ingredient contained in Sandostatin) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking octreotide, check with your doctor or nurse immediately:
More common:
- Abdominal or stomach pain
- blurred vision
- constipation
- depressed mood
- dizziness
- dry mouth
- dry skin and hair
- fainting
- fast, slow, or irregular heartbeat
- feeling cold
- flushed, dry skin
- fruit-like breath odor
- hair loss
- hoarseness or husky voice
- increased hunger
- increased thirst
- increased urination
- muscle cramps and stiffness
- nausea
- severe stomach pain with nausea and vomiting
- sweating
- troubled breathing
- unexplained weight loss
- unusual tiredness or weakness
- vomiting
- weight gain
Less common or rare:
- Abdominal or stomach bloating
- anxious feeling
- behavior change similar to drunkenness
- changes in menstrual periods
- cold sweats
- confusion
- convulsions (seizures)
- cool, pale skin
- decreased sexual ability in males
- difficulty with concentrating
- drowsiness
- headache
- loss of appetite
- muscle cramps and stiffness
- nightmares
- restless sleep
- shakiness
- slurred speech
- swelling of the front part of the neck
- tiredness
- troubled breathing (rapid and deep)
- unconsciousness
- unusual thirst
Incidence not known:
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chills
- darkened urine
- fever
- indigestion
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- severe constipation
- unusual bleeding or bruising
- yellow eyes or skin
If any of the following symptoms of overdose occur while taking octreotide, get emergency help immediately:
Symptoms of overdose:
- Abdominal or stomach discomfort
- decreased appetite
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, shallow breathing
- feeling of warmth
- general feeling of discomfort
- light-colored stools
- muscle pain or cramping
- no blood pressure or pulse
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- sleepiness
- stopping of heart
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- upper right abdominal or stomach pain
- weakness
- weight loss
Severity: Minor
Some octreotide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:
- Pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
- passing of gas
Less common or rare:
- Backache
- bladder pain
- cloudy urine
- cough
- difficult, burning, or painful urination
- disturbed color perception
- double vision
- frequent urge to urinate
- frequent urination usually with very small amounts of urine
- general feeling of discomfort or illness
- halos around lights
- itching skin
- joint pain
- lack of appetite
- loss of vision
- lower back or side pain
- muscle aches and pains
- night blindness
- overbright appearance of lights
- runny nose
- shivering
- sore throat
- stools that float, are foul smelling, and fatty in appearance
- trouble concentrating
- trouble sleeping
- tunnel vision
DOSAGE
andostatin® (octreotide acetate) may be administered subcutaneously or intravenously. Subcutaneous injection is the usual route of administration of Sandostatin for control of symptoms. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Multiple subcutaneous injections at the same site within short periods of time should be avoided. Sites should be rotated in a systematic manner.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulates and/or discoloration are observed. Proper sterile technique should be used in the preparation of parenteral admixtures to minimize the possibility of microbial contamination. Sandostatin is not compatible in Total Parenteral Nutrition (TPN) solutions because of the formation of a glycosyl octreotide conjugate which may decrease the efficacy of the product.
Sandostatin is stable in sterile isotonic saline solutions or sterile solutions of dextrose 5% in water for 24 hours. It may be diluted in volumes of 50-200 mL and infused intravenously over 15-30 minutes or administered by IV push over 3 minutes. In emergency situations (e.g., carcinoid crisis) it may be given by rapid bolus.
The initial dosage is usually 50 mcg administered twice or three times daily. Upward dose titration is frequently required. Dosage information for patients with specific tumors follows.
Acromegaly
Dosage may be initiated at 50 mcg t.i.d. Beginning with this low dose may permit adaptation to adverse gastrointestinal effects for patients who will require higher doses. IGF-I (somatomedin C) levels every 2 weeks can be used to guide titration. Alternatively, multiple growth hormone levels at 0-8 hours after Sandostatin® (octreotide acetate) administration permit more rapid titration of dose. The goal is to achieve growth hormone levels less than 5 ng/mL or IGF-I (somatomedin C) levels less than 1.9 U/mL in males and less than 2.2 U/mL in females. The dose most commonly found to be effective is 100 mcg t.i.d., but some patients require up to 500 mcg t.i.d. for maximum effectiveness. Doses greater than 300 mcg/day seldom result in additional biochemical benefit, and if an increase in dose fails to provide additional benefit, the dose should be reduced. IGF-I (somatomedin C) or growth hormone levels should be re-evaluated at 6-month intervals.
Sandostatin should be withdrawn yearly for approximately 4 weeks from patients who have received irradiation to assess disease activity. If growth hormone or IGF-I (somatomedin C) levels increase and signs and symptoms recur, Sandostatin therapy may be resumed.
Carcinoid Tumors
The suggested daily dosage of Sandostatin during the first 2 weeks of therapy ranges from 100-600 mcg/day in 2-4 divided doses (mean daily dosage is 300 mcg). In the clinical studies, the median daily maintenance dosage was approximately 450 mcg, but clinical and biochemical benefits were obtained in some patients with as little as 50 mcg, while others required doses up to 1500 mcg/day. However, experience with doses above 750 mcg/day is limited.
VIPomas
Daily dosages of 200-300 mcg in 2-4 divided doses are recommended during the initial 2 weeks of therapy (range 150-750 mcg) to control symptoms of the disease. On an individual basis, dosage may be adjusted to achieve a therapeutic response, but usually doses above 450 mcg/day are not required.
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