Project Description

Insulin-long SMC

(injection suspension 100 units/ml) –

international nonproprietary name

Insulin zinc suspension.

Ref

BP-0066

Pharmacotherapeutic group

Hypoglycemic drug, insulin of media duration action.

Composition of the preparation

Insulin- long SMC is a neutral suspension of multi component pork insulin, containing 30% of amorphous and 70% of crystal insulin.

Content of 1 ml of the drug: active substance: pork insulin 100 units; auxiliary substances: sodium chloride, zinc chloride, nipagin, water for injections.

Pharmacological action

Pharmacodynamics

Insulin-long SMC is of media action.

It interacts with specific receptors on the external cytoplasmatic membrane cells and forms insulin-receptor complex. By the activation of biosynthesis of cyclic adenosine monophosphate (in fatty cells and hepatic cells) or directly penetrating into the cell (muscle), insulin-receptor complex stimulates intracellular processes, inclusive synthesis of a number of key enzymes of glycolysis (hexokinase, pyruvate kinase, glycogen synthetase and others). It reduces glucose in blood due to its intracellular transportation, higher absorption and assimilation by tissues, stimulation of lipogenesis, glycohenogenesis, protein synthesis, reduction of glucose production by liver, etc.

Insulin effect duration is mainly determined by absorption rate subject to certain factors (dose, administration and introduction place). Hence, insulin profile varies significantly either in patients or in one person only.

On average, after s.c. injection, insulin- long SMC effect is produced in 61-3 h., max.effect between 16-20 h., the duration is 24 h.

Pharmacokinetics

Total absorption and initial effect depends on place of injection (abdomen, femur, buttock), dose (volume of injected insulin), concentration of insulin in a drug, etc. It is distributed irregularly between tissues, does not penetrate via placenta barrier and breast milk. It is mainly broken by insulinase in liver and kidneys. Itisrenalexcreted(30—80%)

Indications 

Diabetes type 1 (insulin-dependent).

Diabetes type 2 (insulin-independent): resistance phase to oral hypoglycemic agents, partial resistance to these agents (in combined therapy), intercurrent diseases.

special indication

Do not use insulin-long SMC if after shaking the suspension is homogenously white and turbid.

Control regularly glucose level in blood during insulin therapy.

Hypoglycemia is caused besides insulin overdose: change of the preparation, loss of meals intake, vomit, diarrhea, physical stress, diseases decreasing insulin demand (hepatic and renal failure, hypo-function of adrenal cortex, of hypophysis or thyroid gland), change of injection place and interaction with other drugs.

Incorrect dosing or insulin injection interval, particularly in patients with diabetes of type 1, may provoke hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually during several hours or days. These are thirst, frequent urination, nausea, vomit, vertigo, redness and dry skin, dry mouth, loss of appetite, acetone odor of expired air. Without treatment gyperglycemia under diabetes of type 1 may cause vitally dangerous diabetic ketoacidosis.

The drug may be administered in diabetes of type 1 (insulin-dependent) in children and pregnancy with allergic reaction, lipodystrophy or resistance to other insulin preparations.

In pregnancy, lactation, in children of prepubertal age, correct the dose (elevated risk of hypoglycemia). In pregnancy control decrease (1 trimester) or increase (II or III trimester) of insulin demand.

In lactation control regularly the treatment during several months (stabilization of insulin demand).

Insulin dose shall be corrected in thyroid gland disorder, Addison’s disease, hypopituitarism, liver and renal failure and diabetes on patients after 65.

Insulin dose correction may be necessary if the patient’s physical activity is increased or if he changes the usual diet.

Concomitant diseases, in particular infections and conditions accompanied with fever, increase insulin demand.

Change of insulin under the control of glucose level in blood.

The drug decreases tolerance to alcohol.

Due to possible precipitation in some catheters insulin pumps are not recommended.

Ability of driving and operating mechanisms

At the initial insulin administration, change of insulin or under physical and psychic stress possible decrease of ability to drive or operate various mechanisms, and other potentially dangerous activities with higher attention and rapid psychic and motion reactions.

special warning

Not established

Dosage and method of administration

Insulin-long SMC is for s.c.injections. Do not administer i.v. injection!

The dose of the drug is determined by a doctor in every single case on the basis of glucose level in blood.

Average daily dose of the drug varies between 0.5 – 1 U/kg of the body weigh subject to individual properties of the patient and glucose level in blood.

Insulintemperatureisambient.

Insulin-long SMC is usually for s.c.injection in femur. Injection is also possible in the anterior abdominal wall, femur, buttock or deltoid muscle region.

Change place of injection within anatomic zone to prevent lipodystrophy.

Insulin-long SMCmay be injected independently or in combination with insulin of short effect (monoinsulin MC).

overdosage

Overdose may cause hypoglycemia.

Treatmentе: the patient may eliminate light hypoglycemia with sugar intake or meals rich of carbohydrates. Patients with diabetes are recommended to have always sugar with them, sweets, cookies or sweet juice.

In acute conditions of loss of consciousness i.v.injection of 40^ glucose solution; i.m./s.c./i.v. glycagon. After recovery the patient is recommended to eat meals rich of carbons to avoid the repeated development of hypoglycemia.

safety measures

Not established

Side effects

Conditioned influence on carbohydrate metabolism: hypoglycemia (pail skin, hyperhidrosis, palpitation, tremor, hunger, excitation, paresthesia in mouth, headache). Marked hypoglycemia may cause hypoglycemic coma.

Allergic reactions: rare skin eruption, Quincke’s edema, very rare anaphylactic shock.

Local reactions: hyperemia, edema and itch in place of injection, in long treatment lipodystrophy in place of injection.

Other— edema causing refraction disorder (usually at the beginning).

Contraindications

Hypoglycemia. Individual hypersensitivity to insulin or any of its components.

Interactions with other medicinal preparations

Some drugs influence insulin demand.

Antihyperglycemic action of insulin is enhanced by oral hypoglycemic drugs, inhibitors МАО, inhibitors of non-selective beta-adrenergic blockers, sulphanilamides, anabolitic steroids, tetraciclyne, clophibrat, cyclophosphamide, phenphluramin, ethanol-preparations. Antihyperglycemic action of the drug is decreased by oral contraceptives, glycocorticoids, thyroid hormones, thiazide(-type) diuretic, heparin, lithium preparations, tricyclic antidepressants. Under reserpin and salicylate drug effect either decreased or increased.

The form of release

s.c.injection 100 units/ml in vial 10 ml.