A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Sandostatin Side Effects, and Drug Interactions - Octreotide (Injection)
Sandostatin Side Effects, and Drug Interactions - Octreotide (Injection)
SIDE EFFECTS
Gallbladder Abnormalities
Gallbladder abnormalities, especially stones and/or biliary sludge, frequently
develop in patients on chronic Sandostatin® (octreotide
acetate) therapy (See WARNINGS).
Cardiac
In acromegalics, sinus bradycardia (<50 bpm) developed in 25%; conduction
abnormalities occurred in 10% and arrhythmias developed in 9% of patients
during Sandostatin® (octreotide acetate) therapy ( See
PRECAUTIONS—General).
Gastrointestinal
Diarrhea, loose stools, nausea and abdominal discomfort were each seen
in 34%-61% of acromegalic patients in US studies although only 2.6% of
the patients discontinued therapy due to these symptoms. These symptoms
were seen in 5%-10% of patients with other disorders.
The frequency of these symptoms was not dose-related, but diarrhea and
abdominal discomfort generally resolved more quickly in patients treated
with 300 mcg/day than in those treated with 750 mcg/day. Vomiting, flatulence,
abnormal stools, abdominal distention, and constipation were each seen
in less than 10% of patients.
Hypo/Hyperglycemia
Hypoglycemia and hyperglycemia occurred in 3% and 16% of acromegalic
patients, respectively, but only in about 1.5% of other patients. Symptoms
of hypoglycemia were noted in approximately 2% of patients.
Hypothyroidism
In acromegalics, biochemical hypothyroidism alone occurred in 12% while
goiter occurred in 6% during Sandostatin® (octreotide acetate)
therapy (See PRECAUTIONS—General).
In patients without acromegaly, hypothyroidism has only been reported
in several isolated patients and goiter has not been reported.
Other Adverse Events
Pain on injection was reported in 7.7%, headache in 6% and dizziness
in 5%. Pancreatitis was also observed (See WARNINGS
and PRECAUTIONS).
Other Adverse Events 1%-4%
Other events (relationship to drug not established), each observed in
1%-4% of patients, included fatigue, weakness, pruritus, joint pain, backache,
urinary tract infection, cold symptoms, flu symptoms, injection site hematoma,
bruise, edema, flushing, blurred vision, pollakiuria, fat malabsorption,
hair loss, visual disturbance and depression.
Other Adverse Events <1%
Events reported in less than 1% of patients and for which relationship
to drug is not established are listed;
Gastrointestinal: hepatitis, jaundice, increase in liver
enzymes, GI bleeding, hemorrhoids, appendicitis, gastric/peptic ulcer,
gallbladder polyp;
Integumentary: rash, cellulitis, petechiae, urticaria, basal
cell carcinoma;
Musculoskeletal: arthritis, joint effusion, muscle pain,
Raynaud’s phenomenon;
Cardiovascular: chest pain, shortness of breath, thrombophlebitis,
ischemia, congestive heart failure, hypertension, hypertensive reaction,
palpitations, orthostatic BP decrease, tachycardia;
CNS: anxiety, libido decrease, syncope, tremor, seizure,
vertigo, Bell’s Palsy, paranoia, pituitary apoplexy, increased intraocular
pressure, amnesia, hearing loss, neuritis;
Respiratory: pneumonia, pulmonary nodule, status asthmaticus;
Endocrine: galactorrhea, hypoadrenalism, diabetes insipidus,
gynecomastia, amenorrhea, polymenorrhea, oligomenorrhea, vaginitis;
Urogenital: nephrolithiasis, hematuria;
Hematologic: anemia, iron deficiency, epistaxis;
Miscellaneous: otitis, allergic reaction, increased CK,
weight loss.
Evaluation of 20 patients treated for at least 5 months has failed to
demonstrate titers of antibodies exceeding background levels. However,
antibody titers to Sandostatin® (octreotide acetate) were
subsequently reported in three patients and resulted in prolonged duration
of drug action in two patients. Anaphylactoid reactions, including anaphylactic
shock, have been reported in several patients receiving Sandostatin®
(octreotide acetate).
DRUG INTERACTIONS
Sandostatin® (octreotide acetate) has been associated
with alterations in nutrient absorption, so it may have an effect on absorption
of orally administered drags. Concomitant administration of Sandostatin®(octreotide
acetate) with cyclosporine may decrease blood levels of cyclosporine and
result in transplant rejection.
Patients receiving insulin, oral hypoglycemic agents, beta blockers,
calcium channel blockers, or agents to control fluid and electrolyte balance,
may require dose adjustments of these therapeutic agents.
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