Octreda (Solution) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

H01CB02 (Octreotide)

Active Substance

Octreotide (Rec.INN registered by WHO)

Dosage Form

Octreda

Solution for infusion and subcutaneous administration 0.1 mg/ml

Dosage Form, Packaging, and Composition

Solution for infusion and subcutaneous administration

1 ml – ampoules – cardboard packs – By prescription
1 ml – ampoules (10 pcs.) – cardboard packs – By prescription
1 ml – ampoules (20 pcs.) – cardboard packs – By prescription
1 ml – ampoules (5 pcs.) – cardboard packs – By prescription

Clinical-Pharmacological Group

Somatostatin analogue. A drug for intensive care in gastroenterology

Pharmacotherapeutic Group

Pituitary and hypothalamic hormones and their analogues; hypothalamic hormones; somatostatin and its analogues

Pharmacological Action

A synthetic analogue of somatostatin, characterized by a longer duration of action. It inhibits the secretion of growth hormone by the anterior pituitary gland, as well as the secretion of thyroid-stimulating hormone.

It inhibits the exocrine and endocrine (insulin, glucagon) secretion of the pancreas, as well as the secretion of gastrin, hydrochloric acid, cholecystokinin, secretin, digestive enzymes, vasoactive intestinal peptide, and some other peptides and biologically active substances whose secretion is carried out by the gastroenteropancreatic system.

It suppresses gastric and intestinal motility.

Pharmacokinetics

After subcutaneous injection, it is rapidly and completely absorbed into the systemic circulation. The C_max of the active substance in plasma is achieved within 30 minutes. Plasma protein binding is 65%. Binding to blood cells is extremely insignificant. The V_d is 0.27 l/kg.

The total clearance is 160 ml/min. The T_1/2 after subcutaneous injection is 100 minutes. After intravenous administration, the elimination process occurs in 2 phases, with T_1/2 of 10 minutes and 90 minutes, respectively.

Indications

Acromegaly (with insufficient effectiveness of surgical treatment, radiotherapy, drug therapy with dopamine receptor agonists); tumors characterized by increased production of somatoliberin (growth hormone-releasing factor); relief of symptoms caused by the presence of secreting tumors of the gastroenteropancreatic system (including carcinoid tumors with carcinoid syndrome, glucagonomas, insulinomas, gastrinomas); prevention of complications after pancreatic surgery; diarrhea in AIDS patients refractory to other types of therapy.

For the purpose of stopping bleeding and preventing re-bleeding from esophageal varices in liver cirrhosis (in combination with endoscopic sclerosing therapy).

ICD codes

Dosage Regimen

Determine the individual dosage based on the specific disease, therapeutic goals, and patient response.

For acromegaly, initiate therapy with 0.05-0.1 mg via subcutaneous injection every 8-12 hours. Titrate the dose based on growth hormone and IGF-1 levels. The typical maintenance dose ranges from 0.2 to 0.3 mg daily.

For carcinoid tumors and other neuroendocrine tumors, administer 0.05 mg subcutaneously once or twice daily. Gradually increase the dose to 0.1-0.2 mg three times daily based on symptom control and tolerance.

For the management of esophageal variceal bleeding, use intravenous administration. Administer a 0.05 mg intravenous bolus followed by a continuous intravenous infusion at 0.025-0.05 mg per hour for 2-5 days.

For prevention of pancreatic surgery complications, administer 0.1 mg subcutaneously three times daily for 7 consecutive days, starting at least one hour before surgery.

In patients with AIDS-related diarrhea, the usual subcutaneous dose is 0.1-0.25 mg three times daily. Adjust based on clinical response.

Rotate subcutaneous injection sites to prevent local irritation. For intravenous infusion, dilute the required dose in 50-200 ml of 0.9% Sodium Chloride or 5% Dextrose solution. Administer over 15-30 minutes.

Monitor blood glucose levels regularly, especially during dose titration, due to the risk of hypoglycemia or hyperglycemia.

Adverse Reactions

From the digestive system anorexia, abdominal pain, nausea, vomiting, bloating, diarrhea, steatorrhea; impaired glucose tolerance; rarely – severe pain in the epigastrium, tenderness on palpation, tension of the abdominal wall muscles, acute hepatitis, hyperbilirubinemia, increased activity of liver enzymes; with long-term use in some cases – formation of gallstones.

Local reactions pain, burning, itching, redness, swelling at the injection site.

Contraindications

Hypersensitivity to octreotide.

Use in Pregnancy and Lactation

Octreotide should be used during pregnancy and lactation only for strict indications.

Special Precautions

The drug should be used with caution in cholelithiasis, diabetes mellitus.

Before starting and during treatment, an ultrasound examination of the gallbladder is recommended. It should be borne in mind that Octreotide does not have antitumor activity.

During treatment, systematic monitoring of blood glucose concentration is necessary, especially in patients with bleeding from esophageal varices in liver cirrhosis, due to an increased risk of hyperglycemia.

Drug Interactions

Somatostatin analogues may reduce the clearance of substances metabolized with the participation of cytochrome P450 isoenzymes, which may be due to the suppression of growth hormone.

With simultaneous use, the bioavailability of bromocriptine increases; with insulin – a strengthening of the hypoglycemic effect is possible; with cyclosporine – the absorption of cyclosporine decreases; with cimetidine – the absorption of cimetidine slows down.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.