Sandostatin

DRUG DESCRIPTION

Sandostatin® (octreotide acetate) Injection, a cyclic octapeptide prepared
as a clear sterile solution of octreotide, acetate salt, in a buffered lactic
acid solution for administration by deep subcutaneous (intrafat) or intravenous
injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-Lthreonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-,
cyclic (2→7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide
with pharmacologic actions mimicking those of the natural hormone somatostatin.

Sandostatin (octreotide acetate) Injection is available as: sterile 1-mL ampuls in 3 strengths,
containing 50, 100, or 500 mcg octreotide (as acetate), and sterile 5-mL multi-dose
vials in 2 strengths, containing 200 and 1000 mcg/mL of octreotide (as acetate).

Each ampul also contains:

lactic acid, USP............................................. 3.4 mg

mannitol, USP................................................ 45 mg

sodium bicarbonate, USP .............................. qs to pH 4.2 ±0.3

water for injection, USP...................................qs to 1 mL

Each mL of the multi-dose vials also contains:

lactic acid, USP ............................................. 3.4 mg

mannitol, USP................................................. 45 mg

phenol, USP....................................................5.0 mg

sodium bicarbonate, USP ............................... qs to pH 4.2 ±0.3

water for injection, USP...................................qs to 1 mL

Lactic acid and sodium bicarbonate are added to provide a buffered solution,
pH to 4.2 ±0.3.

The molecular weight of octreotide acetate is 1019.3 (free peptide, C₄₉H₆₆N₁₀O₁₀S₂)
and its amino acid sequence is:

H-D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-Thr-ol,

xCH₃COOH           where
x = 1.4 to 2.5

What are the possible side effects of octreotide (Sandostatin, Sandostatin LAR Depot)?

Stop using octreotide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow or irregular heartbeats;


• gallbladder problems (stomach pain);


• pancreatitis (pain in the upper stomach or back, nausea, vomiting, fever, bloating, yellowing of the skin or eyes);


• thyroid problems (may be...

Read All Potential Side Effects and See Pictures of Sandostatin »

What are the precautions when taking octreotide acetate (Sandostatin)?

Before using octreotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (e.g., cirrhosis), diabetes, thyroid problems, gallbladder problems (e.g., gallstones), nutrition problems (e.g., decreased fat absorption, vitamin B12 deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised when using...

Read All Potential Precautions of Sandostatin »

Sandostatin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, loose/oily stools, constipation, stomach upset, gas, bloating, dizziness, or headache may occur. Pain and irritation at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of gallbladder/liver problems (e.g., fever, stomach/abdominal pain, severe nausea/vomiting, yellowing eyes/skin, unexplained pain in the back/right shoulder), signs of underactive thyroid (e.g., unexplained weight gain, cold intolerance, slow heartbeat, severe constipation, unusual/extreme tiredness, growth/lump/swelling on the front of the neck), worsening heart condition symptoms (e.g., trouble breathing, slow/fast/irregular heartbeat), numbness/tingling of the arms/legs.

This medication may infrequently cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger. Follow your doctor's instructions to treat low blood sugar (e.g., eat a quick source of sugar such as glucose gel/tablets, table sugar, or honey, or drink fruit juice or non-diet soda). Tell your doctor immediately if you experience symptoms of high or low blood sugar while taking this medication. Monitor your blood sugar levels as directed by your doctor.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using octreotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (e.g., cirrhosis), diabetes, thyroid problems, gallbladder problems (e.g., gallstones), nutrition problems (e.g., decreased fat absorption, vitamin B12 deficiency).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised when using this drug in children. Use of this medication for long periods (e.g., longer than 1 year) may slow a child's growth rate. However, the growth rate catches up after treatment with the drug is stopped. Consult your doctor for more information.

This medication may restore the normal ability to become pregnant in females with acromegaly who have infertility. Females of childbearing age should discuss reliable forms of birth control with the doctor. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Sandostatin Patient Information Including Side Effects

Brand Names: Sandostatin, Sandostatin LAR Depot

Generic Name: octreotide (injectable) (Pronunciation: ok TREE oh tide)

• What is octreotide (Sandostatin)?


• What are the possible side effects of octreotide (Sandostatin)?


• What is the most important information I should know about octreotide (Sandostatin)?


• What should I discuss with my healthcare provider before using octreotide (Sandostatin)?


• How should I use octreotide (Sandostatin)?


• What happens if I miss a dose (Sandostatin)?


• What happens if I overdose (Sandostatin)?


• What should I avoid while using octreotide (Sandostatin)?


• What other drugs will affect octreotide (Sandostatin)?


• Where can I get more information?

What is octreotide (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.

Octreotide 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).

Octreotide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of octreotide (Sandostatin)?

Stop using octreotide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• slow or irregular heartbeats;


• gallbladder problems (stomach pain);


• pancreatitis (pain in the upper stomach or back, nausea, vomiting, fever, bloating, yellowing of the skin or eyes);


• thyroid problems (may be detected by blood tests);


• low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or


• high blood sugar (increased thirst and urination; flushed or dry skin; drowsiness).

Less serious side effects may include:

• nausea or vomiting;


• diarrhea;


• mild stomach pain or gas;


• constipation; or


• pain or irritation where you injected the medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about octreotide (Sandostatin)?

Before using octreotide, tell your doctor if you have diabetes, gallbladder disease, heart disease, thyroid problems, pancreatitis, kidney disease, or liver disease.

Octreotide is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. Be sure to follow the instructions for the exact type of octreotide your doctor has prescribed for you.

While using octreotide, call your doctor if you have severe stomach pain, fever, bloating, nausea and vomiting, or jaundice (yellowing of the skin or eyes). These may be signs of serious side effects

Related Drug Centers

• Sandostatin


• Sandostatin LAR