Sandostatin/Sandostatin LAR

Sandostatin/Sandostatin LAR

octreotide

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sandostatin Octreotide acetate. Sandostatin LAR Octreotide acetate as microspheres
Indications/Uses
Sandostatin: Symptomatic control & reduction of growth hormone & IGF-1 plasma levels in patients w/ acromegaly who are inadequately controlled by surgery or RT. Acromegalic patients unfit or unwilling to undergo surgery or in the interim period until RT becomes fully effective. Symptomatic relief in functional gastroenteropancreatic (GEP) endocrine tumors. Control of refractory diarrhea associated w/ AIDS. Prevention of complications following pancreatic surgery. Emergency management to stop bleeding & to protect from re-bleeding due to gastroesophageal varices in patients w/ cirrhosis in association w/ specific treatment eg, endoscopic sclerotherapy. Sandostatin LAR: Patients w/ acromegaly in whom surgery or RT is inappropriate or ineffective or in the interim period until RT becomes fully effective. Symptomatic treatment of GEP endocrine tumors. Advanced neuroendocrine tumors of midgut or unknown primary tumor location.
Dosage/Direction for Use
Sandostatin Acromegaly Initially 0.05-0.1 mg SC 8 or 12 hrly. Max: 1.5 mg/day. GEP endocrine tumors Initially 0.05 mg once or bid SC. May be increased gradually to 0.1-0.2 mg tid. AIDS-related refractory diarrhea Initially 0.1 mg tid SC, if the diarrhea is not controlled after 1 wk of treatment, the dose should be titrated up to 0.25 mg tid. Complications following pancreatic surgery 0.1 mg tid SC for 7 consecutive days starting on the day of operation at least 1 hr before laparotomy. Bleeding gastroesophageal varices 25 mcg/hr for 5 days by continuous IV infusion. Sandostatin LAR Intragluteal inj Acromegaly Initially 20 mg at 4-wk interval for 3 mth. May be increased to 30 mg every 4 wk if w/in 3 mth period clinical symptoms & biochemical parameters (GH; IGF 1) are not fully controlled (GH conc >2.5 mcg/L), or 40 mg every 4 wk if after 3 mth GH, IGF 1 &/or symptoms are not adequately controlled w/ 30 mg dose. Patient whose GH conc are consistently <1 mcg/L, IGF 1 serum conc normalized, & most reversible signs/symptoms have disappeared after 3 mth 10 mg every 4 wk. GEP endocrine tumors Initially 20 mg at 4-wk interval. May be reduced to 10 mg every 4 wk after 3 mth of treatment in patients w/ symptoms & biological markers are well controlled. May be increased to 30 mg every 4 wk after 3 mth of treatment in patients w/ partially controlled symptoms. Advanced neuroendocrine tumors of midgut or unknown primary tumor location 30 mg every 4 wk.
Special Precautions
Bradycardia. Cholelithiasis, cholecystitis & biliary duct dilatation; cholangitis. May impair post-prandial glucose tolerance; hypoglycemia. May affect glucose regulation & reduce glucose requirements in patients w/ concomitant type I DM. May increase depth & prolong duration of hypoglycemia in patients w/ insulinomas. Depressed vit B12 levels & abnormal Schilling's tests. Monitor patients for serious complications eg, visual field defects; w/ insulinomas. Monitor thyroid function in prolonged treatment; glucose tolerance & antidiabetic treatment; vit B12 levels during therapy in patients w/ history of vit B12 deprivation. Perform ultrasonic exam of gallbladder before & at 6-mth interval during therapy. Assess GH & IGF 1 every 6 mth in patients on stable dose. Concomitant use w/ β-blockers, Ca channel blockers, or agents to control fluid & electrolyte balance. Female patients of child-bearing potential should use adequate contraception during treatment. Pregnancy. Not to breastfeed during treatment. Ped patients <18 yr.
Adverse Reactions
Hyperglycaemia; headache; diarrhoea, abdominal pain, nausea, constipation, flatulence; cholelithiasis; inj site reaction. Hypothyroidism, thyroid disorder (eg, decreased TSH, total & free T4); hypoglycaemia, impaired glucose tolerance, decreased appetite; dizziness; bradycardia; dyspnoea; dyspepsia, vomiting, abdominal distension, steatorrhoea, loose stools, discoloured faeces; cholecystitis, biliary sludge, hyperbilirubinaemia; pruritus, rash, alopecia; asthenia; increased transaminase.
Drug Interactions
Concomitant use w/ β-blockers, Ca-channel blockers, agents to control fluid & electrolyte balance; insulin & antidiabetics. Reduced absorption of ciclosporin. Delayed absorption of cimetidine. Increased bioavailability of bromocriptine. May decrease metabolic clearance of compd known to be metabolized by CYP450 enzymes; other drugs metabolized by CYP3A4 w/ low therapeutic index eg, quinidine, terfenadine.
MIMS Class
Other Gastrointestinal Drugs / Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01CB02 - octreotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.
Presentation/Packing
Form
Sandostatin inj 0.1 mg/mL
Packing/Price
5 × 1's
Form
Sandostatin LAR powd for inj 20 mg
Packing/Price
(+ pre-filled syringe) 1's
Form
Sandostatin LAR powd for inj 30 mg
Packing/Price
(+ pre-filled syringe) 1's
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