【用法用量】可在50微克，每日三次启动这种低剂量开始可允许改编为患者胃肠道不良反应谁需要更高剂量。的IGF-I（生长调节素C）的水平，每2周，可用于指导滴定。另外，后Sandostatin®（醋酸奥曲肽）行政许可的剂量更迅速的滴定0-8小时倍数增长的激素水平。的目标是实现生长激素水平小于5毫微克/毫升或IGF-I（生长调节素C）的男性小于1.9 U / ml的水平，且小于2.2 U / ml的中位女性。最常见的是有效的剂量为100微克每日三次，但一些患者需要高达500微克每日三次发挥最大功效。剂量大于300微克/天很少导致额外的生化益处，并且如果增加剂量不能提供额外的好处，剂量应减少。的IGF-I（生长调节素C）或生长激素水平应在6个月的时间间隔重新评估。
善得定每年应该从谁收到照射评估疾病患者的活动被收回约4周。如果生长激素或IGF-I（生长调节素C）水平增加和体征和症状复发，善宁治疗可以恢复。
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.
Wednesday, 24 August 2016
Brand Name: Sandostatin LAR Injection Contents: octreotide acetate Strengths: 20 mg Form: Injection Manufactured By: Novartis pharma stein AG
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