2010/06/19

Somatuline

Composition, structure and packing

Lyophilisates for suspension for a / m the introduction of long acting white or white with kremovatym color dispersed in the attached solvent to form a suspension of white or white with kremovatym color.
1 vial.
lanreotida acetate 40 mg
which corresponds to the content lanreotida 30 mg



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

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

Glass Bottles (1) together with the solvent (amp. 1 pc.) - Blister packs (1) disposable polypropylene syringes, needles for injection (2 pcs.) - Pack carton.

Clinical and pharmacological groups: An analogue of somatostatin

Registration № №:
lyophilisates d / prepara. sus. d / i / m administration prolongs. of 30 mg: PL. 1 pc. in compl. with the solvent, syringe and 2 needles - P № 010212/01, 29.07.05

Pharmacological action

Synthetic peptide, which is an analog of the natural hormone somatostatin.

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

He has more pronounced in peripheral somatostatinovym tropic receptors (pituitary and pancreatic) than to the central. This is due to its selectivity with respect to the secretion of growth hormone and exocrine secretion of pancreas and intestinal glands.

Pharmacokinetics

Absorption

Absorption lanreotida characterized the first phase of rapid release of peptide, located on the surface of microspheres, which is replaced by a slow second phase of release. C max of the first phase, amounting to 6.8 ± 3.8 mg / l, observed in 1.4 ± 0.8 h and C max of the second phase, amounting to 2.5 ± 0.9 mg / l, observed in 1.9 ± 1.8 days. The absolute bioavailability of 46.1 ± 16.7%.

Distribution

Study of binding lanreotida blood components showed that this interaction is unlikely at this level.

Patients with acromegaly and in healthy individuals similar pharmacokinetics. At the same concentration of growth hormone and insulin-like growth factor (IGF-1) decreased for at least 14 days after a single injection of the drug. With a constant injection of the drug for several months cumulation is not marked.

Withdrawal

The average retention time of 8 ± 1 days and T1 / 2 5.2 ± 2.5 days. These figures confirm the prolonged release of the drug.

Statement
acromegaly;
carcinoid tumor (as a symptomatic therapy).

Dosage regimen

Application Somatulina possible only in specialized institutions. The drug is introduced only in / m.

Treatment starts with the introduction of the test (if it is ineffective further therapy is impractical), and evaluate the response (the dynamics of secretion of growth hormone, growth, symptoms associated with carcinoid tumor).

Dosage regimen and duration of therapy set individually.

The drug is prescribed in the / m in a dose of 30 mg 1 time in 14 days. With the lack of effectiveness can increase the frequency of drug administration up to 1 injection every 10 days.

Dissolution lyophilizate in the attached solvent must be performed immediately before injection by smooth shaking the contents of vial to obtain a homogeneous suspension of white or white with kremovatym color. Preparation of the suspension should not be mixed with other drugs.

Side effect

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

On the part of the digestive system: diarrhea or soft stool, steatorrhea, abdominal pain, flatulence, nausea, vomiting and in rare cases, prolonged use may form gall stones (asymptomatic cholelithiasis).

On the part of metabolism: in rare cases - raising the level of glucose in the blood, impaired glucose tolerance.

Contraindications
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug's components.

Application of pregnancy and breastfeeding

The drug is contraindicated during pregnancy and lactation.

Patients who receive therapy Somatulinom should be warned of a possible violation of the reproductive function, as well as whether to use contraception during treatment Somatulinom and within 3 months after treatment.

Application for violations of liver function

If abnormal liver function should be adjusted dose.

Application for violations of renal function

In case of violation of renal function should be adjusted dose.

Cautions

In appointing Somatulina patients with diabetes (both type 1 and type 2) should be regular monitoring of blood glucose and, if necessary, to adjust the dose of hypoglycemic drugs.

When gastrointestinal carcinoid tumors treated Somatulinom appointed after the removal of the existing intestinal obstruction by tumor.

In the treatment of acromegaly should be careful monitoring of the pituitary gland.

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

If any function of the liver or kidneys should adjust the dose of the drug.

In case of simultaneous appointment with cyclosporine (oral), it is necessary to adjust the dose of cyclosporine.

Overdose

Symptoms: possible manifestations of increased side effects from the digestive system, electrolyte disturbances.

Treatment: perform symptomatically.

Drug Interactions

When applied simultaneously with insulin increases its hypoglycemic effect, which requires correction insulin.

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Drug prescription.

Terms and Conditions of storage

List B. The drug should be stored out of reach of small children at a temperature of 2 ° to 8 ° C (refrigerated). Shelf life - 2 years.

Expiration preparation of suspensions of 6 h when stored at room temperature.