Octride

Description

Octride Injection

Generic Name: Octreotide

Manufacturer: Sun Pharmaceutical Industries Ltd.

Availability: Available in Nepal

Indications

Octride Injection is used to treat a variety of conditions, including:

• Acromegaly: A hormonal disorder resulting from excessive growth hormone.
• Variceal Hemorrhage: Bleeding from enlarged veins, particularly in the esophagus, often associated with liver cirrhosis.
• Secretory Neoplasms: Tumors that secrete excessive hormones or peptides, such as carcinoid tumors and VIPomas.
• Following Pancreatic Surgery: To prevent complications.
• HIV-Associated Diarrhea: To manage severe, persistent diarrhea in HIV patients.

Dosage and Administration

Important Note: The safety and efficacy of Octride Injection have not been established in children.

Adult Dosing

1. Acromegaly

• Solution (Rapid-Acting):
  • Initial Dose: 50 mcg subcutaneously (SC) every 8 hours.
  • Titration: May be increased up to 500 mcg SC every 8 hours if necessary, based on patient response.
  • After successful treatment with the solution for 2 weeks, transition to the depot injection.
• Suspension (Depot Injection – IM):
  • Initial Dose: 20 mg intramuscularly (IM) into the gluteal muscle every 4 weeks for 3 months.
  • Titration: Doses can be adjusted between 10-30 mg IM every 4 weeks depending on the patient’s clinical and biochemical response (GH and IGF-1 levels).
  • Maximum Dose: Do not exceed 40 mg IM every 4 weeks.
  • Dose Adjustment Guidelines:
    • Symptoms Controlled (GH < 1 ng/mL and normal IGF-1): Decrease dose to 10 mg IM every 4 weeks.
    • Symptoms Well-Controlled (GH < 2.5 ng/mL and normal IGF-1): Maintain dose at 20 mg IM every 4 weeks.
    • Symptoms Uncontrolled (GH > 2.5 ng/mL or elevated IGF-1): Increase dose to 30 mg IM every 4 weeks. If symptoms persist, further increase to 40 mg IM.

2. Carcinoid Tumor

• Solution (Rapid-Acting):
  • Initial Dose: 100-600 mcg/day SC, divided every 6-12 hours.
  • Titration: May be increased up to 1500 mcg/day.
  • After successful treatment with the solution for 2 weeks, transition to the depot injection.
• Suspension (Depot Injection – IM):
  • Dose: 20 mg IM every 4 weeks, provided the regular injection was well tolerated.

3. Prophylaxis of Complications Following Pancreatic Surgery

• Adult: 100 mcg of a rapid-acting preparation administered subcutaneously (SC) three times a day (TID) for 7 consecutive days. Treatment should begin at least 1 hour before the operation.

4. HIV-Associated Diarrhea

• Adult:
  • Initial Dose: 100 mcg subcutaneously (SC) three times a day (TID).
  • Titration: If symptoms are not controlled after 1 week, increase the dose to 500 mcg SC TID.

5. Variceal Hemorrhage in Patients with Cirrhosis

• Adult (Continuous Intravenous (IV) Infusion):
  • Dose: 25 mcg/hour for 48 hours.
  • Duration: May extend up to 5 days in patients at high risk of re-bleeding.

Special Populations

• Hepatic Impairment (Cirrhosis):
  • Adult: 10 mg IM every 4 weeks initially, then titrate to effect.
• Renal Impairment:
  • Without Dialysis: Dose adjustment is generally not necessary.
  • With Dialysis: 10 mg IM every 4 weeks initially, then titrate to effect.

Administration

Intravenous (IV) Preparation

• Common Diluent for IV Bolus/Intermittent Infusion: 50-100 mcg per 50 mL of 0.9% Sodium Chloride (NS).
• Common Diluent for Continuous IV Infusion: 1200 mcg per 250 mL of 0.9% Sodium Chloride (NS).
• Minimum Volume: 50 mL NS.

IV/IM Administration Routes

• Intramuscular (IM):
  • Administer the suspension (depot injection) immediately after reconstitution.
  • Inject deeply into the gluteal muscle. Avoid injection into the deltoid muscle.
• Intravenous (IV):
  • Octreotide can be administered via IV push (IVP), IV piggyback (IVPB), or continuous IV infusion.
  • IV Push (Regular Injection Only): Administer undiluted over 3 minutes.
  • IV Piggyback (IVPB): Administer over 15-30 minutes.
  • Continuous Infusion: For esophageal variceal bleeding, administer at a rate of 25-50 mcg/hour.

Contraindications

• Hypersensitivity to Octreotide or any component of the formulation.

Precautions

Exercise caution when administering Octride Injection in patients with:

• Renal disease
• Increased risk of gall bladder disease (e.g., gallstones)
• Diabetes Mellitus (DM)
• Hypothyroidism

Specific Considerations:

• Pregnancy and Lactation:
  • Pregnancy: Use with caution.
  • Lactation: It is unknown whether octreotide crosses into breast milk. Avoid giving to lactating women.
• Children: Safety and efficacy have not been established.
• Elderly: Use with caution.
• Long-Term Therapy: Monitor vitamin B12 levels during long-term treatment as octreotide can affect its absorption.

Interactions

• Dosage Adjustment of Concurrent Therapy: Octreotide may necessitate dosage adjustments for:
  • Calcium channel blockers
  • Oral hypoglycemics
  • Beta-blockers
  • Diuretics
• Bromocriptine: May increase the concentration of bromocriptine.
• Potentially Fatal Interactions:
  • Insulin: Requirements for insulin may be reduced, necessitating careful blood glucose monitoring.
  • Ciclosporin: Reduction in ciclosporin bioavailability and efficacy.

Adverse Effects

Common Side Effects (>10% incidence):

• Gallbladder Problems (>60%): Decreased gallbladder contractility, gallstones, cholecystitis, cholestatic hepatitis.
• Dysglycemia (25%) – both hyperglycemia and hypoglycemia.
• Hypothyroidism (25%).
• Bradycardia (25%).

Less Common Side Effects (1-10% incidence):

• ECG changes (10%)
• Arrhythmia (9%)
• Pancreatitis
• Upper respiratory tract infection
• Fatigue
• Headache
• Malaise
• Rash
• Diarrhea
• Nausea
• Vomiting
• Pain at injection site
• Joint pain
• Blurred vision

Mechanism of Action

Octreotide is a synthetic analog of somatostatin, a naturally occurring hormone. Its primary actions include:

• Suppression of Growth Hormone (GH): It effectively suppresses both basal and stimulated secretion of GH.
• Suppression of LH Response: Reduces luteinizing hormone (LH) response to gonadotropin-releasing hormone.
• Reduction of Gastrointestinal Hormones: Decreases the secretion of various gastrointestinal hormones and peptides, including:
  • Gastrin
  • Vasoactive Intestinal Peptide (VIP)
  • Insulin
  • Glucagon
  • Secretin
  • Motilin
  • Pancreatic Polypeptide