Sandostatin Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Octreotide acetate

Indications/Uses

Symptomatic control & reduction of growth hormone (GH) & 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. Relief of symptoms associated w/ functional gastro-entero-pancreatic (GEP) endocrine tumors eg, carcinoid tumors w/ features of the carcinoid syndrome, VIPomas, glucagonomas, gastrinomas/Zollinger-Ellison syndrome, usually in conjunction w/ PPIs, or H₂-antagonist therapy, octreotide, insulinomas, for pre-op control of hypoglycemia & for maintenance therapy, GRFomas. Control of refractory diarrhea associated w/ AIDS. Prevention of complications following pancreatic surgery. Emergency management to stop bleeding & to protect from re-bleeding owing to gastro-esophageal varices in patients w/ cirrhosis.

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Dosage/Direction for Use

Acromegaly Initially 0.05-0.1 mg SC every 8 or 12 hr. Max: 1.5 mg/day. Gastro-entero-pancreatic endocrine tumors Initially 0.05 SC once daily or bid; can be gradually increased to 0.1-0.2 mg tid. AIDS-related refractory diarrhea Initially 0.1 mg SC tid, dose should be titrated on an individual basis up to 0.25 mg tid. Complications following pancreatic surgery 0.1 mg SC tid for 7 consecutive days, starting on the day of op, at least 1 hr before laparotomy. Bleeding gastroesophageal varices 25 mcg/hr for 5 days by continuous IV infusion. Can be used in dilution w/ physiological saline. Cirrhotic patient w/ bleeding gastroesophageal varices Up to 50 mcg/hr for 5 days by continuous IV.

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Overdosage

View Sandostatin overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity. Lactation.

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Special Precautions

Female patients of childbearing potential should be advised to use adequate contraception if necessary. Monitor thyroid function in patients receiving prolonged treatment. Carefully monitor patients as GH-secreting pituitary tumors may expand. CV related events; dose adjustments of drugs eg, β-blockers, Ca-channel blockers or agents to control fluid & electrolyte balance, may be necessary. Ultrasonic exam of the gallbladder before & at about 6-12-mth interval. Monitor blood glucose levels in patients treated for bleeding gastroesophageal varices (mandatory). Monitor vit B₁₂ levels in patients who have a history of vit B₁₂ deprivation. Pregnancy.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hyperglycemia; headache; diarrhea, abdominal pain, nausea, constipation, flatulence; cholelithiasis; inj site reaction. Hypothyroidism, thyroid disorder; hypoglycemia, glucose tolerance impaired, decreased appetite; dizziness; bradycardia; dyspnea; dyspepsia, vomiting, abdominal distension, steatorrhea, loose stools, feces discolored; cholecystitis, biliary sludge, hyperbilirubinemia; pruritus, rash, alopecia; asthenia; increased transaminase.

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Drug Interactions

Reduce intestinal absorption of ciclosporin & cimetidine. Increased bioavailability of bromocriptine. May decrease metabolic clearance of compd known to be metabolized by CYP540 enzymes. Drugs mainly metabolized by CYP3A4 (eg, terfenadine) & which have a low therapeutic index; β-blockers, Ca channel blockers, or agents to control fluid & electrolyte balance; insulin & antidiabetics.

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Caution For Usage

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Storage

View Sandostatin storage conditions for details to ensure optimal shelf-life.

Description

View Sandostatin description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Trophic Hormones & Related Synthetic Drugs / Other Gastrointestinal Drugs

ATC Classification

H01CB02 - octreotide ; Belongs to the class of antigrowth hormone. Used in hypothalamic hormone preparations.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Sandostatin soln for inj 100 mcg/mL

Packing/Price

1 mL x 5 × 1's

Form

Sandostatin soln for inj 500 mcg/mL

Packing/Price

1 mL x 5 × 1's

Sandostatin

octreotide

Manufacturer:

Novartis Healthcare

Distributor:

Novartis Healthcare