SOMATULIN

Active material: Lanreotid
When ATH: H01CB03
CCF: Somatostatin analogues
ICD-10 codes (testimony): E22.0, E34.0
When CSF: 11.17.02
Manufacturer: BEAUFOUR IPSEN INTERNATIONAL (France)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Lyophilisate for suspension for the / m of prolonged action white or white with Valium a color shade, dispersible in the enclosed solvent to form a slurry of white or white with Valium a color shade.

Excipients: copolymers (lactide-glycolide and lactic-glikolik), mannitol, sodium carboxymethylcellulose, polysorbate 80.

Solvent: mannitol, water d / and (2 ml).

Glass Bottles (1) together with the solvent (amp. 1 PC.) – blisters (1) with a disposable polypropylene syringe, needles for injection (2 PC.) – packs cardboard.

Pharmacological action

Synthetic peptide, an analogue of the natural hormone somatostatin.

Like natural somatostatin, lanreotide inhibits pathologically increased secretion of growth hormone, and secretion of many peptides and other biologically active substances, produced in the gastro-entero-pancreatic endocrine system (incl. gastrin, insulin, glucagon, digestive enzymes, hydrochloric acid, vazointestinalny peptide, Serotonin).

It has a pronounced affinity for peripheral somatostatin receptors (pituitary and pancreatic), than the central. This is due to the selectivity of growth hormone secretion and pancreatic exocrine secretion and intestinal glands.

Pharmacokinetics

Absorption

Absorption lanreotide characterized the first phase of rapid release of the peptide, located on the surface of the microspheres, which is replaced by a second phase of slow release. C_max Phase, component of 6.8 ± 3.8 mg / l, observed after 1.4 ± 0.8 h and C_max Phase II, component of 2.5 ± 0.9 mg / l, It observed after 1.9 ± 1.8 days. The absolute bioavailability of 46.1 ± 16.7 %.

Distribution

The study of the binding of lanreotide to blood components showed, it is unlikely that such an interaction at this level.

Patients, suffering from acromegaly, and pharmacokinetics in healthy individuals similar. The concentration of growth hormone and insulin-like growth factor (RAF-1) falling within, at least, 14 days after a single injection. With the constant introduction of the drug for several months, the cumulation is not checked.

Deduction

The average retention time of 8 ± 1 days and T_1/2 5.2± 2.5 days. These figures confirm a sustained release of the drug.

Testimony

- Akromegalija;

- Carcinoid tumors (as symptomatic therapy).

Dosage regimen

Application Somatulinom possible only in specialized institutions. The drug is administered only in / m.

Treatment starts with the introduction of trial (in the event of the ineffectiveness of further therapy is impractical) and evaluate response (the dynamics of growth hormone secretion of growth, symptoms, associated with carcinoid tumors).

The dosage regimen and duration of therapy is determined individually.

The drug is prescribed in / m at a dose 30 mg 1 once every 14 days. In inefficiency can increase the frequency of administration to 1 injection every 10 days.

Dissolution of freeze-dried product in the accompanying solvent should be performed immediately before injection by continuously shaking the vial until a homogeneous suspension of white or white with Valium a color shade. The suspension should not be mixed with other drugs.

Side effect

Local reactions: itch, burning, moderate transient pain at the injection site, sometimes accompanied by hyperemia.

From the digestive system: diarrhea or soft stool, celiac disease, abdominal pain, flatulence, nausea, vomiting; in rare cases, with prolonged use, may form gallstones (asymptomatic cholelithiasis).

Metabolism: rarely – increase in blood glucose level, change in glucose tolerance.

Contraindications

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Patients, undergoing therapy Somatulinom, You should be aware of a possible violation of the reproductive function, as well as the appropriateness of the use of contraceptives during treatment and for Somatulinom 3 months after the end of treatment.

Cautions

In appointing Somatulinom patients with diabetes (as a type of 1, and such 2) should regularly monitor blood glucose levels and, if necessary, to adjust the dose of hypoglycemic drugs.

When carcinoid tumors of the gastrointestinal tract treatment Somatulinom appointed after the removal of the existing intestinal obstruction, tumor.

In the treatment of acromegaly, careful monitoring of the pituitary gland.

Prolonged treatment every 6 months should be performed ultrasound of the gallbladder.

If abnormal liver function or kidney disease should adjust the dose of the drug.

When concomitant administration with cyclosporine (orally), you need to adjust the dose of cyclosporine.

Overdose

Symptoms: may increase the side effects of the digestive system, electrolyte abnormalities.

Treatment: symptomatic therapy.

Drug Interactions

In an application with its enhanced insulin hypoglycemic effect, that require dose adjustment of insulin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C (in a refrigerator). Shelf life – 2 year.

Shelf life of prepared suspension 6 hours if stored at room temperature.