Rinsulin NPH
Rinsulin NPH: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Rinsulin NPH
ATX code: A10AC01
Active ingredient: insulin-isophan (human genetic engineering) [Insulin-isophan (human biosynthetic)]
Manufacturer: Geropharm LLC (Russia)
Description and photo update: 2019-18-12
Prices in pharmacies: from 435 rubles.
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Rinsulin NPH - medium-term effect insulin preparation (NPH); a pancreatic hormone that regulates the metabolic process of carbohydrates, ensuring the maintenance of normal blood sugar levels.
Release form and composition
Rinsulin NPH dosage form is a suspension for subcutaneous administration: a white suspension that settles upon standing with the formation of a precipitate and a transparent colorless or almost colorless liquid above it; with gentle shaking, the precipitate is easily resuspended.
Packaging:
- 10 ml each in colorless glass vials, hermetically rolled with a combined cap made of aluminum and plastic with a rubber disc / sealed with a rubber stopper with a combined cap made of aluminum and plastic with a tear-off plastic strip; in a cardboard box 1 bottle and 1 instruction for the use of Rinsulin NPH;
- 3 ml in glass cartridges with rubber (rubber) plungers, rolled with a combined cap made of aluminum with a rubber disc, each cartridge contains a polished glass ball: 5 cartridges in a blister strip made of PVC (polyvinyl chloride) film and Al (aluminum) printed varnished foil, in a pack of cardboard 1 blister strip and 1 instruction for use; 1 cartridge, mounted in a plastic disposable multi-dose syringe pen Rinastra for multiple injections, in a carton box 5 pre-filled disposable multi-dose syringe pens, 1 instruction for the use of Rinsulin NPH and 1 instruction for the use of a syringe pen Rinastra.
Composition for 1 ml of suspension:
- active ingredient: insulin-isophane (human genetic engineering) - 100 International Units (IU);
- auxiliary ingredients: protamine sulfate - 0.34 mg; glycerol (glycerin) - 16 mg; crystalline phenol - 0.65 mg; metacresol - 1.6 mg; sodium hydrogen phosphate dihydrate - 2.25 mg; water for injection - up to 1 ml.
Types of information displays for medium-term effect (NPH) insulin on the package:
- Color: According to the International Diabetes Federation (IDF) Color Chart for Rinsulin NPH - light green stripe on the cartridge and on the packaging. The cartridge installed in the RinAstra NPH pen has a light green dose injection button; the label on the pen body has two light green stripes;
- digital: the type of Rinsulin is given in the form of a QR (Quick Response) -code - a barcode containing information for quick scanning using a mobile phone camera, referring a doctor or patient to a drug page on the GEROPHARM website;
- tactile: the type of Rinsulin is applied to the packaging in Braille (in the form of a convex indication); suitable for visually impaired patients.
Patient safety is ensured by:
- valve to control the first opening of the package;
- free edge of the foil for easy removal of the cartridge with the Rinsulin-NPH preparation;
- rounded blister surfaces with cartridges, without sharp edges; important for patients with diabetes mellitus with reduced sensitivity, who, without noticing, can damage the skin, because they do not feel pain.
Pharmacological properties
Pharmacodynamics
The active substance of Rinsulin NPH is genetically engineered human insulin of medium-term action, obtained using a method based on artificially created recombinant DNA (deoxyribonucleic acid), insulin-isophane. It interacts with a specific receptor on the outer cytoplasmic cell membrane. In this case, an insulin-receptor complex is formed, which stimulates intracellular processes, including the synthesis of a number of key glycolysis enzymes such as hexokinase, glycogen synthetase, and pyruvate kinase. A decrease in the level of glucose in the blood occurs due to an increase in its intracellular transfer, increased absorption and assimilation by tissues, stimulation of lipogenesis and glycogenesis, and a decrease in the rate of glucose production by the liver.
The insulin action profile has clinically significant variability both in different patients and in the same patient at different time periods. This is due to the dependence of the duration of action of insulin preparations on the absorption rate, which, in turn, is influenced by the dose, method and place of administration of the drug.
Rinsulin NPH after subcutaneous administration begins to act on average after 1.5 hours, the maximum effect develops between 4 and 12 hours, the total duration of the effect is up to 24 hours.
Pharmacokinetics
The completeness of absorption and the onset of therapeutic action depend on the injection site (thigh, abdomen, buttocks), the volume and concentration of injected insulin.
The substance is distributed unevenly through the tissues; does not penetrate through the placental barrier and into breast milk. It is destroyed mainly in the liver and kidneys under the influence of insulinase. Renal elimination is subject to 30 to 80% of insulin.
Indications for use
Rinsulin NPH is used to treat the following diseases:
- type 1 diabetes mellitus;
- type II diabetes mellitus: at the stage of resistance to oral hypoglycemic drugs or partial resistance to them (as part of combination therapy), as well as in the presence of intercurrent diseases;
- type 2 diabetes mellitus in pregnant women.
Contraindications
Rinsulin NPH is contraindicated to take with hypoglycemia and increased individual sensitivity to insulin or any of the auxiliary components of the suspension.
Rinsulin NPH, instructions for use: method and dosage
Rinsulin NPH suspension is intended for subcutaneous administration only. Intravenous administration of the drug is contraindicated.
In each case, the dose of the drug is determined by the attending physician individually, based on the concentration of glucose in the blood and the patient's response to therapy.
The average daily dose is determined at the rate of 0.5-1 IU / kg of body weight.
Rinsulin NPH is administered both as a monotherapy drug and in combination with short-acting insulin (Rinsulin R).
The temperature of the injected suspension should be at room temperature.
Typically, the suspension is injected subcutaneously into the thigh area, and the anterior abdominal wall, buttock, or shoulder are also suitable for injection. The injection sites within the anatomical region are regularly changed to prevent the development of lipodystrophy.
Insulin is injected under the skin with care to avoid getting the needle into the blood vessel. It is not recommended to massage the injection site after the procedure. The patient should be trained in the use of insulin delivery devices.
Rinsulin NPH cartridges
Before use, the cartridges are rolled 10 times between the palms in a horizontal position and shaken to resuspend the suspension until a homogeneous turbid suspension resembling milk looks like. Foam should not be allowed to appear, it can complicate the correct dose selection. Cartridges are carefully checked before use.
Rinsulin NPH is not suitable for use if solid white particles stick to the bottom or walls of the cartridge, giving the suspension a frozen appearance, or if after mixing it contains flakes. The ready-to-use, properly mixed suspension is a homogeneous, cloudy white suspension.
Refill cartridges are not designed and are not designed to mix directly with other insulins.
When using cartridges, observe the manufacturer's instructions for filling them into a pen-syringe and fixing the needle. The suspension is administered in accordance with the manufacturer's instructions for using a syringe pen.
The needle is intended for one-time use: after the injection of Rinsulin NPH, it is unscrewed using a special outer cap, and immediately destroyed in a safe way. Removing the needle immediately following injection ensures sterility and prevents air ingress, leakage and possible clogging of the needle. Then the cap is put on the handle, the needle is not reused.
Rinsulin NPH in multi-dose disposable syringe pens (injector pens)
The suspension in multi-dose disposable injector pens is mixed immediately before administration. The ready-to-use, properly mixed suspension is a homogeneous, cloudy white suspension.
Rinsulin NPH in a syringe pen is not used if the suspension has been frozen during transportation or storage.
Before using the pre-filled multi-dose syringe pens for multiple injections, remove them from the refrigerator and allow the suspension to reach room temperature. The procedure is carried out in strict accordance with the instructions set out in the instructions for the drug for the use of a syringe pen.
Rinsulin NPH in the injector pen and needles are for individual use only. Also, it is not allowed to re-fill the cartridge of the syringe-pen and reuse needles.
The syringe pen is closed with a cap to protect it from light. The pen used should not be stored in the refrigerator. The drug in use is stored at room temperature 15-25 ° C for no more than four weeks.
Preparation for injection with a disposable multi-dose syringe pen Rinastra for multiple injections:
- compliance with the rules of asepsis during the injection: wash your hands thoroughly with soap and water, choose a place for the injection of the needle; set the required dose of insulin in the pen, wipe the skin in the selected place with an alcohol napkin 1, let the alcohol dry;
- preparation of the suspension: before assembling, the injector handle is rolled ten times between the palms in a horizontal position and shaken to resuspend the suspension until a homogeneous turbid suspension resembling milk looks like;
- assembly of the syringe pen: hold the pen with one hand, remove the cap with the other hand, pulling it; wipe the rubber membrane (partition) with an alcohol wipe; select needle 2 from the set, remove the protective sticker from it; using an external nozzle, place the needle directly on the cartridge holder and tighten carefully; remove the external nozzle by pulling slightly and save it for later disposal of the used needle;
- preparation of the pen: being careful to remove the inner nozzle and discard; holding the pen with the needle 3 up, lightly tap the cartridge with your finger, expelling the air bubbles up (it is permissible if small bubbles remain); before each injection, a test of the suitability of a syringe pen is carried out to remove air from the needle.
Notes
1 Alcohol wipes help to minimize the risk of infection.
2 A new needle must be used for each injection of Rinsulin NPH into the pen.
3 The needle is exposed and becomes visible as the inner tip is removed.
Application of the Rinastra disposable multi-dose syringe pen for multiple injections:
- Dose selection: turn the dosage selector and set the dose of 2 units so that the number 2 in the dosage window coincides with the pointer 1. Each unit is set with a click.
- Checking the completeness of the dose: hold the syringe pen with the needle up, press the trigger until it stops; when the dosage selector reaches "0", you will hear a click, and a drop of liquid should appear at the tip of the needle. If this does not happen, until the situation is resolved, steps 1 and 2 are sequentially repeated, but no more than six times. In the absence of a drop of liquid, the needle must be removed, start repeating the steps with the instructions for assembling the syringe pen, from the moment you select a new needle. Before each injection of the suspension, checking for a drop of liquid at the tip of the needle is mandatory, it indicates the completeness of the dialed dose. Small loss of insulin is acceptable.
- Dose setting: the dosage selector is scrolled until the required dose coincides with the pointer in the dosage window. For example, if your doctor has prescribed a single dose of 40 units of insulin, you must scroll the selector dial to 40. You cannot dial a dose that exceeds the number of units remaining in the cartridge. When the dosage selector does not scroll, it is an indicator that there is not enough suspension in the pen. In doing so, it is thrown away or the remaining dose units are injected and a new pen is used to complete the administration of the prescribed dose.
- Needle insertion: after confirming the set of the required dose, rub the skin in the place chosen for injection with an alcohol wipe, clamp the skin area between the fingers and in one continuous motion insert the needle under the skin. In order to avoid accidental injury from a needle prick, the skin area should be at least 2.5 cm 2, the needle should not be inserted at an angle towards the fingers.
- Dose injection: press the start button until the value "0" in the dosage window coincides with the pointer. After the click of a stop, for another 10 seconds, the syringe pen is held at the injection site with the button pressed. Inaccurate adherence to instructions may result in the wrong dose being administered. If the syringe pen is not held at the injection site for a full 10 seconds, you may not have time to receive the required dose of the suspension. When insulin continues to flow from the needle after the injection is complete, subsequent injections hold the needle in the skin longer.
- Disposal of the needle: the outer tip is carefully placed on the needle until it stops, the needle is unscrewed and discarded together with the outer tip.
- Storage of the pen-injector: put a cap on the syringe-pen and store it until the next use, away from direct sunlight.
- Disposal of the pen-injector: an empty syringe-pen cannot be reused, it is disposed of.
Note
1 If the dose selector accidentally overshoots the desired dose, rotate it in the opposite direction to correct the value; while setting the dose, do not press the trigger button.
The pen syringe is an individual use item and cannot be used by others.
There is no need to try to repair the pen on your own. The problem is reported to the entity receiving the complaint as indicated in the PID.
Side effects
An adverse reaction caused by the effect of insulin on carbohydrate metabolism may be a hypoglycemic state. Its characteristic symptoms are dizziness, headache, hyperhidrosis, pallor of the skin, tremors, palpitations, hunger, agitation, paresthesia of the oral mucosa, decreased visual acuity. With severe hypoglycemia, the risk of developing hypoglycemic coma is increased.
On the part of the immune system, allergic reactions to insulin such as skin rash, angioedema (angioedema), anaphylactic shock can develop.
At the injection site of the Rinsulin NPH suspension, the appearance of hyperemia, edema and itching is likely, and with prolonged use, lipodystrophy.
Other side effects include edema and a transient decrease in visual acuity, usually observed at the beginning of the course.
The doctor is obliged to inform the patient that in case of the development of hypoglycemia or an episode of loss of consciousness, as with any other side effects not described above, the latter must seek qualified medical help.
Overdose
In case of an overdose of Rinsulin NPH, a hypoglycemic state may develop.
The patient is able to eliminate mild hypoglycemia by himself by ingesting food rich in carbohydrates, for example, sugar, for which, in case of diabetes mellitus, it is recommended to constantly have sugar, other sweets, cookies or sweet fruit juice with you. In the case of severe hypoglycemia with loss of consciousness, intravenous administration of a 40% dextrose (glucose) solution is required, as well as intramuscular, subcutaneous or intravenous administration of glucagon. After recovery of consciousness, to prevent the re-development of the hypoglycemic state, the patient is recommended to take foods high in carbohydrates.
special instructions
If the suspension, after shaking, does not become uniform white and evenly cloudy, Rinsulin NPH should not be used.
Insulin therapy requires constant monitoring of blood glucose levels.
In addition to an overdose of insulin, the following causes of hypoglycemia may be: replacement of the drug, increased physical activity, skipping meals, diarrhea, vomiting, changing the place of administration of the suspension, reducing the need for insulin diseases (dysfunction of the liver / kidneys, hypofunction of the pituitary gland, adrenal cortex or thyroid gland), as well as drug interactions with other substances / drugs.
Incorrect dosing or interruptions in insulin administration can lead to hyperglycemia, especially in patients with type 1 diabetes mellitus. As a rule, its initial symptoms develop gradually (from several hours to several days) and include frequent urination, dizziness, thirst, nausea / vomiting, redness and dryness of the skin, loss of appetite, dry mouth, acetone odor in exhaled air. If not treated with type 1 diabetes mellitus, hyperglycemia can lead to the development of life-threatening diabetic ketoacidosis.
Correction of the insulin dose is needed in patients with impaired thyroid, liver and kidney function, Addison's disease, hypopituitarism and patients over 65 years of age.
Patients with severe cerebral / coronary artery stenosis are advised to be careful when using Rinsulin NPH due to the increased risk of cerebral and cardiac complications of hypoglycemia.
A hypoglycemic agent should be used with caution in patients with proliferative retinopathy, especially those who do not receive laser photocoagulation therapy, since they are at risk of complete blindness (amaurosis).
Patients who increase the intensity of physical activity or change their dietary habits may need to adjust their insulin dose.
The need for insulin increases with concomitant diseases, especially infections and conditions accompanied by fever.
The transition to a new type of insulin or a drug from another manufacturer is performed under medical supervision.
The combined use of insulin preparations and drugs of the thiazolidinedione group in patients with type 2 diabetes mellitus can cause them to retain fluid in the body. This increases the risk of developing and progression of CHF (chronic heart failure), especially in diseases of the cardiovascular system and the presence of risk factors for CHF. Patients receiving this treatment should be screened regularly for signs of heart failure. If heart failure is diagnosed, therapy is performed in accordance with current standards while considering dose reduction or discontinuation of thiazolidinedione.
Reusable syringe pens with which Rinsulin NPH cartridges can be used:
- HumaPen Ergo II, HumaPen Luxura (manufactured by Eli Lilly and Company, USA);
- Autopen Classic 3 ml, 1 pc. (1–21 pcs.) AN3810, Autopen Classic 3 ml 2 pcs. (2–42 pcs.) AN3800 (manufactured by Owen Mumford Ltd., UK);
- OptiPen Pro1 (manufactured by Aventis Pharma Deutschland GmbH, Germany);
- BiomaticPen (manufactured by Ypsomed AG, Switzerland).
Use syringe pens strictly following the instructions provided by their manufacturers.
Influence on the ability to drive vehicles and complex mechanisms
With the primary appointment of insulin, a change in its type or significant physical / mental stress, the drug's effect on the psychophysical functions of a person is likely. During these periods, care should be taken when engaging in potentially hazardous activities that require concentration of attention and high speed of reactions, including when driving vehicles or various complex mechanisms.
Application during pregnancy and lactation
There are no special conditions governing the treatment of diabetes mellitus with insulin during pregnancy, since insulin does not pass through the placental barrier. Women with diabetes who are planning pregnancy, as well as during gestation, need to intensify the treatment of the disease. As a rule, the need for insulin decreases in the first trimester, gradually increasing in the second and third trimester. During delivery and in the postpartum period, the need for insulin can sharply decrease. But soon she quickly returns to the original level, which was observed before pregnancy.
There are no restrictions on the treatment of diabetes mellitus with Rinsulin NPH during lactation. However, a decrease in its dose may be required, which requires careful monitoring of the condition of a lactating woman for several months until the need for a hypoglycemic drug stabilizes.
Pediatric use
There is no data on limiting the use of Rinsulin NPH in pediatrics.
With impaired renal function
Impairment of renal function increases the likelihood of hypoglycemia in patients taking Rinsulin NPH. This may require adjusting your insulin dose and monitoring your blood glucose more often.
For violations of liver function
Hepatic impairment increases the likelihood of hypoglycemia in patients taking Rinsulin NPH. This may require adjusting your insulin dose and monitoring your blood glucose more often.
Use in the elderly
Elderly people receiving any insulin, including Rinsulin NPH, have an increased risk of hypoglycemia due to possible concomitant age-related pathologies and the simultaneous use of several drugs.
Patients over 65 years of age may need insulin dose adjustment.
Drug interactions
Medicines / substances that affect the patient's need for insulin:
- enhancing the hypoglycemic effect of insulin: inhibitors of monoamine oxidase, angiotensin-converting enzyme, carbonic anhydrase; hypoglycemic drugs for oral administration, non-selective β-blockers, anabolic steroids, bromocriptine, sulfonamides, octreotide, tetracyclines, ketoconazole, clofibrate, mebendazole, theophylline, pyridoxine, cyclophosphamide, lithium drugs, phenanfluramine, ethanol;
- weaken the hypoglycemic effect of insulin: growth hormone, glucagon, estrogens, contraceptives for oral steroids, loop diuretics, thiazides, iodine-containing thyroid hormones, heparin, tricyclic antidepressants, danazol, epinephrine, clonidine, sympathomimetics, blockers of the slow calcium channel blockers, histamine H 1 -receptors, phenytoin, diazoxide, morphine, nicotine;
- weakening / enhancing the effect of insulin: reserpine and salicylates.
Insulin decreases the patient's tolerance to ethanol.
Analogs
Rinsulin NPH analogues are Biosulin N, Vozulim-N, Gensulin N, Insuran NPKh, Insuman Bazal GT, Protafan NM Penfill, Protafan NM, Protamine-Insulin ChS, Rosinsulin S, Humodar B 100 Rek, Humulin NPH, etc.
Terms and conditions of storage
Keep out of the reach of children and protected from light at a temperature of 2 to 8 ° C, protect from freezing.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Rinsulin NPH
Rinsulin NPH, according to patients' reviews, is a universal hypoglycemic drug, since it is effective in the treatment of both type 1 and type 2 diabetes mellitus. It normalizes glucose concentration to an optimal level for a sufficiently long time (up to 12 hours), which is also an advantage in terms of choice. The drug is relatively inexpensive and suitable for the treatment of the elderly.
But some experts express dissatisfaction, pointing out the development of allergic reactions and cases of hypoglycemia in patients. In addition, when switching to Rinsulin NPH from other hypoglycemic agents, a significant increase in the dose of insulin was required in comparison with analogs taken earlier.
Price for Rinsulin NPH in pharmacies
Today, the current price of Rinsulin NPH, a suspension for subcutaneous administration of 100 IU / ml, is: 1 bottle of 10 ml - 428 rubles; cartridge 3 ml, 5 pcs. in a contour cell package - 937 rubles.
Rinsulin NPH: prices in online pharmacies
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Drug name Price Pharmacy |
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Rinsulin NPH 100 IU / ml suspension for subcutaneous administration 10 ml 1 pc. 435 r Buy |
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Rinsulin NPH 100 IU / ml suspension for subcutaneous administration 3 ml 5 pcs. RUB 1009 Buy |
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Rinsulin NPH 100 IU / ml suspension for subcutaneous administration 3 ml 5 pcs. 1560 RUB Buy |
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Rinsulin NPH suspension for n / a input. 100 IU / ml 3ml 5 pcs. (cartridge + syringe pen RinAstra II) 1608 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
