Project Description

Protamin-insulin HS

(suspension for injections 100 Units/ml)-10 ml in vial –  Protamin-insulinum HS

international nonproprietary name

Insulin (human).

Ref

BP-0114

Pharmacotherapeutic group

Hypoglycemic preparation, insulin of prolonged duration.

Composition of the preparation

Genetically engineered insulin – 100 IU, protamine sulphate – 0,35 mg, twice-substituted 2-aqueous sodium phosphate – 1,96 mg, phenol -0,65 mg, metacresol – 1,5 mg, glycerin – 16 mg, water for injections – up to 1 ml.

Pharmacological action

On subcutaneous administration (in the subcutaneous fatty tissue) protamin insulin HS starts to act within 1,5 hours and has a maximal effect between 4th and 12th hour; the duration of action is up to 24 hours. Because of prolonged action protamin insulin HS is frequently prescribed in combination with insulin medications of short duration.

Indications 

For treatment of insulin diabetes.

special indication

The vial with the protamin insulin HS, that we are currently using, should be kept at the room temperature (up to 25°С) for not more than 6 weeks.

Keep the vial with the preparation away from heat and direct sunlight. Not freeze it.

Keep Protamin insulin HS out of reach of children.

Never use insulin after the expiration date indicated on the package.

Never use Protamine insulin HS if it is not transparent, colorless or almost colorless.

Effect on the capability to drive and work with the machines:

The primary prescription of insulin, change of its type and occurrence of significant physical and mental stresses may influence the capability to drive or to work with various mechanisms, as well as to carry out potentially dangerous types of activity that require a high attention and quick psychic and motor reactions.

special warning

Not established

Dosage and method of administration

Subcutaneously. In patient with hyperglycemia and glycosuria that are not removed with the diet during 2 – 3 days, the dose is 0,5-1 Units/kg, then the dose should be corrected in accordance with glycemic and glucosuric profile. The ratio of administration should be different (usually the dose is prescribed with 3-5 ratio), at that the summarized dose should be divided in several parts in proportion with the caloric value of the meals. Injections to be made 15 minutes before the meals.

overdosage

Overdosing may lead to the development of hypoglycemia.

Treatment: the patient may remove the symptoms of slight hypoglycemia himself. He should take sugar or products rich in carbohydrates. Therefore, patients with diabetes are recommended to bring sugar, sweats, biscuits or sweat fruit juice with them.

In severe cases, when a patient loses consciousness, glucose solution 70% should be administered intravenously; glucagons – intramuscularly, subcutaneously or intravenously. Consciousness recovered, the patient is recommended to take food rich in carbohydrates in order to prevent further development of hypoglycemia.

safety measures

Not established

Side effects

Protamine insulin HS may induce hypoglycemia, reddening, swelling and itching at the site of injection (so called, allergic reaction). As a rule, on continuing to use the preparation these symptoms disappear within several weeks.

A first treatment with insulin may provoke vision impairment and edema of the extremities.

Frequent injections at the same site may lead to skin and subcutaneous fatty cellular tissue thickening (lipodystrophy).

Contraindications

Hypoglycemia. Higher individual sensitivity to insulin or any component of the preparation.

Interactions with other medicinal preparations

There are a number of medications that affect the need in insulin.

Oral sugar-reducing medications, monoamine oxidase inhibitors, nonselective beta-adrenoblockers, hypertension-transforming enzyme inhibitors, salicylates, anabolic steroids and glucorticoids, oral contraceptives, thiazide diuretics, thyroid hormones, sympathomimetic, danazol and oktreotid.

The form of release

Suspension for subcutaneous administration 100 Units/ml in vials 10 ml.