Universal reference book for medicines
Product name: LANTUS ® SoloStar ® (LANTUS ® SoloStar ® )

Active substance: insulin glargine

Type: Long-acting human insulin

Manufacturer: SANOFI-AVENTIS DEUTSCHLAND (Germany)

Composition, form of production and packaging
The solution for administration is
transparent, colorless or almost colorless.

1 ml

insulin glargine 100 ED (3.6378 mg)

Auxiliary substances: m-cresol 2.7 mg, zinc chloride 62.6 μg (corresponding to 30 μg zinc), glycerol 85% 20 mg, sodium hydroxide up to pH 4, hydrochloric acid up to pH 4, water d / and - up to 1 ml.

3 ml - colorless glass cartridges (1) - SoloStar® pen-syringe pens (5) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Insulin glargine is an analog of human insulin, obtained by recombinant DNA of bacteria of the species Escherichia coli (strains K12) and characterized by low solubility in a neutral medium.

In the composition of the preparation Lantus ® SoloStar ® is completely soluble, which is provided by acid reaction of the solution for injection (pH 4).
After introduction into the subcutaneous fat, the acid reaction of the solution is neutralized, which leads to the formation of micro-precipitates, from which small amounts of insulin glargine are continuously released, providing a smooth (without peaks) profile of the concentration-time curve, as well as a prolonged effect of the drug.
Insulin glargine is metabolized to two active metabolites M1 and M2.

Relationship with insulin receptors: the binding kinetics to specific insulin receptors in insulin glargine and its metabolites M1 and M2 is very similar to that of human insulin, and therefore insulin glargine is capable of carrying out a biological action similar to that of endogenous insulin.

The most important action of insulin and its analogs, incl.
and insulin glargine, is the regulation of glucose metabolism. Insulin and its analogues reduce the concentration of glucose in the blood, stimulating the absorption of glucose by peripheral tissues (especially skeletal muscle and fat tissue) and inhibiting the formation of glucose in the liver. Insulin inhibits lipolysis in adipocytes and inhibits proteolysis, simultaneously increasing protein synthesis.
The prolonged action of insulin glargine is directly associated with a reduced rate of its absorption, which allows the drug to be applied once a day.
After the sc administration, the onset of its action occurs, on average, after 1 hour. The average duration of action is 24 hours, the maximum - 29 hours. The duration of action of insulin and its analogues, such as insulin glargine, can vary significantly for different individuals or for one and the same person.
The efficacy of using Lantus ® SoloStar ® in children over the age of 2 with type 1 diabetes was shown.
In children in the age group 2-6 years, the incidence of hypoglycemia with clinical manifestations with insulin glargine was numerically lower both during the day and at night compared with the use of insulin isophane (an average of 25.5 episodes vs. 33 episodes in one patient for one year).
In five-year follow-up of patients with type 2 diabetes mellitus, there was no significant difference in the progression of diabetic retinopathy in the treatment of insulin glargine compared to insulin-isophane.

Relationship with the receptors of insulin-like growth factor 1 (IGF-1): the affinity of insulin glargine to the IGF-1 receptor is approximately 5-8 times higher than in human insulin (but approximately 70-80 times lower than in IGF-1), at the same time, compared with human insulin, in the metabolites of glargine M1 and M2 insulin, the affinity for the IGF-1 receptor is somewhat less.

The total therapeutic concentration of insulin (insulin glargine and its metabolites), determined in patients with type 1 diabetes, was markedly lower than that required for half-maximal binding to IGF-1 receptors and subsequent activation of the mitogen-proliferative pathway through IGF-1 receptors.
The physiological concentrations of endogenous IGF-1 can activate the mitogen-proliferative pathway; However, the therapeutic concentrations of insulin detected in insulin therapy, including treatment with Lantus ® SoloStar ® , are significantly lower than the pharmacological concentrations required to activate the mitogenic-proliferative pathway.
The ORIGIN study was an international, multicentre, randomized trial conducted in 12,537 patients with a high risk of developing cardiovascular disease and with impaired fasting glucose (NGH), impaired glucose tolerance (HTG), or an early stage Type 2 diabetes mellitus.
Participants in the study were randomized to groups (1: 1): a group of patients receiving insulin glargine (n = 6264), which was titrated to achieve fasting blood glucose (5.35 mmol), and a group of patients receiving standard treatment (n = 6273 ).
The first end point of the study was the time to the development of cardiovascular death, the first development of nonfatal myocardial infarction or nonfatal stroke, and the second endpoint was the time before the first occurrence of any complication from the above or before the revascularization procedure (coronary, carotid or peripheral arteries) , or before hospitalization for the development of heart failure.

Secondary endpoints were mortality for any reason and a combined measure of microvascular outcome.

The ORIGIN study showed that treatment with insulin glargine compared with standard hypoglycemic therapy did not change the risk of developing cardiovascular complications or cardiovascular mortality;
there was no difference in the indices of any component that makes up the endpoints, mortality from all causes, combined index of microvascular outcomes.
At the beginning of the study, the median of HbA1c was 6.4%.
Median values ​​of the indicator HbA1c during treatment were in the range of 5.9-6.4% in the group of insulin glargine and 6.2-6.6% in the standard treatment group throughout the observation period.
In the group of patients receiving insulin glargine, the incidence of severe hypoglycaemia was 1.05 episodes per 100 patient-years of therapy, and in the group of patients who received standard hypoglycemic therapy 0.3 episodes per 100 patient-years of therapy.
The incidence of mild hypoglycemia was 7.71 episodes per 100 patient-years of therapy in the group receiving insulin glargine, and 2.44 episodes per 100 patient-years of therapy in the group of patients receiving standard hypoglycemic therapy. In a 6-year study, 42% of patients in the insulin glargine group did not have any cases of hypoglycemia.
The median change in body weight compared with the outcome at the last visit of treatment was 2.2 kg higher in the group of insulin glargine than in the standard treatment group.

PHARMACOKINETICS

A comparative study of the concentrations of insulin glargine and insulin-isophane in blood serum in healthy people and patients with diabetes mellitus, after the administration of drugs, showed a slower and much longer absorption, as well as a lack of peak concentration in insulin glargine compared with insulin-isophane .
In a single day during the day, the administration of the preparation Lantus ® SoloStar ® C ss insulin glargine in the blood is achieved after 2-4 days with daily administration. When I / in the introduction of T 1/2 insulin glargine and human insulin were comparable.
When insulin glargine was injected into the abdomen, shoulder, or thigh, no significant differences in insulin concentrations in serum were found.

In comparison with human insulin of average duration of action, insulin glargine is characterized by less variability in the pharmacokinetic profile, both in the same and in different patients.

In humans, in the subcutaneous fat, insulin glargine is partially cleaved from the carboxyl terminus (C-terminus) of the β chain / beta chain with the formation of two active metabolites: M1 (21A-Gly-insulin) and M2 (21A- Gly-des-30 B -Thr-insulin) M1 metabolite predominantly circulates in the blood plasma Systemic exposure of M1 metabolite increases with increasing dose of the drug Comparing the pharmacokinetics and pharmacodynamics data showed that the effect of the drug is mainly due to systemic exposure of the metabolite M1. The overwhelming majority
The patients did not manage to detect insulin glargine and M2 metabolite in the systemic blood stream.In cases when it was possible to detect insulin glargine and M2 metabolite in blood, their concentrations did not depend on the administered dose of Lantus ® SoloStar ® .
Pharmacokinetics in specific patient groups

Age and sex: information on the effect of age and sex on the pharmacokinetics of insulin glargine is absent.
However, these factors did not cause differences in the safety and efficacy of the drug.
Smoking: Within the framework of clinical studies, subgroup analysis did not reveal differences in the safety and efficacy of insulin glargine for this group of patients compared to the general population.

Obesity: obese patients showed no difference in the safety and efficacy of insulin glargine and insulin-isophane compared to patients with normal body weight.

Indicators of pharmacokinetics in children

In children with type 1 diabetes at the age of 2 to 6 years, the concentrations of insulin glargine and its main metabolites M1 and M2 in blood plasma before the introduction of the next dose were similar to those in adults, indicating that there was no accumulation of insulin glargine and its metabolites at constant use of insulin glargine in children.

INDICATIONS

- diabetes, requiring insulin treatment, in adults, adolescents and children older than 2 years.

DOSING MODE

Lantus ® SoloStar ® should be administered SC once / day at any time of the day, but every day at the same time.

In patients with type 2 diabetes, Lantus ® SoloStar ® can be used both as monotherapy and in combination with other hypoglycemic drugs.
Target values ​​of blood glucose concentration, as well as dose and time of administration or intake of hypoglycemic drugs should be determined and adjusted individually.
Dose adjustment may also be required, for example, with a change in the patient's body weight, lifestyle, changes in the time of administration of the insulin dose, or in other conditions that may increase the predisposition to hypo- or hyperglycaemia.
Any changes in the dose of insulin should be conducted with caution and under medical supervision.
Lantus ® SoloStar ® is not an insulin of choice for the treatment of diabetic ketoacidosis.
In this case, preference should be given to / in the introduction of short-acting insulin. In treatment regimens that include injections of basal and prandial insulin, 40-60% of the daily insulin dose in the form of insulin glargine is usually administered to meet the need for basal insulin.
In patients with type 2 diabetes mellitus, who take hypoglycemic drugs for oral administration, the combination therapy begins with a dose of 10 mg of glargine 10 times daily and then the treatment regimen is adjusted individually.

In all patients with diabetes it is recommended to monitor the concentration of glucose in the blood.

Transition from treatment with other hypoglycemic drugs to Lantus ® SoloStar ®

When transferring a patient from a treatment regimen with insulin of medium duration or a long-term effect to a treatment regimen using the Lantus ® SoloStar ®preparation, it may be necessary to correct the amount (doses) and time of administration of short-acting insulin or an analogue thereof during the day or change the doses of oral hypoglycemic drugs .

When transferring patients from a single day of insulin-isophane administration to a single day during the day, the initial dose of insulin Lantus ® SoloStar ® usually does not change (that is, the amount of ED of the preparation Lantus ® SoloStar ® per day is equal to the amount of ME insulin isophane per day ).

When transferring patients from twice daily insulin-isophane administration to a single administration of Lantus ® SoloStar ® before bedtime in order to reduce the risk of hypoglycemia in the night and early morning hours, the initial daily dose of insulin glargine is usually reduced by 20% (compared with the daily dose insulin-isophane), and then it is adjusted depending on the patient's reaction.

Lantus ® SoloStar ® should not be mixed with other insulin preparations or diluted.
It is necessary to make sure that the syringes do not contain the remains of other medicines. When mixing or diluting, the profile of insulin glargine can change in time.
When switching from human insulin to Lantus ® SoloStar ® and during the first weeks after it, careful metabolic monitoring (monitoring of blood glucose concentration) is recommended under medical supervision, with correction, if necessary, of an insulin dosage regimen.
As with other human insulin analogues, this is especially true for patients who, due to their antibodies to human insulin, require the use of high doses of human insulin. In such patients, with insulin glargine, a significant improvement in the response to insulin administration can be observed.
With the improvement of metabolic control and the resulting increase in the sensitivity of tissues to insulin, it may be necessary to adjust the dosage regimen of insulin.

Mixing and dilution

The preparation Lantus ® SoloStar ® should not be mixed with other insulins.
Mixing can change the time / effect ratio of the Lantus ® SoloStar ® preparation, as well as lead to precipitation.
Lantus ® SoloStar ® can be used in children older than 2 years .
Application in children under the age of 2 years has not been studied.
In elderly patients with diabetes mellitus, the use of moderate initial doses is recommended, their slow increase and the use of moderate maintenance doses.

Mode of application

The preparation Lantus ® SoloStar ® is introduced in the form of SC injections.
The preparation Lantus ® SoloStar ® is not intended for intravenous administration.
The long duration of the action of insulin glargine is observed only when it is injected into the subcutaneous fat.
In / in the administration of a usual subcutaneous dose can cause severe hypoglycemia. Lantus ® SoloStar ® should be injected into the subcutaneous fat of the abdomen, shoulders or thighs. The injection sites should alternate with each new injection within the recommended areas for the administration of the drug. As with other types of insulin, the degree of absorption, and therefore the onset and duration of its action, can change under the influence of physical activity and other changes in the patient's condition.
Lantus ® SoloStar ® is a clear solution, not a suspension.
Therefore, no resuspension is required before use. If the Lantus ® SoloStar ® pen injector fails, insulin glargine can be removed from the cartridge in a syringe (suitable for 100 IU / ml insulin) and injected.
Rules for the use and handling of a pre-filled SoloStar ® pen

Before the first use, the syringe pen should be held at room temperature for 1-2 hours.

Before use, inspect the cartridge inside the syringe pen.
It should only be used if the solution is clear, colorless, contains no visible solid particles and resembles water in a consistency.
Empty SoloStar ® pens must not be reused and must be destroyed.

To prevent infection, the pre-filled syringe pen should only be used by one patient and not transferred to another person.

Before using the SoloStar® pen, you should read the usage information carefully.

Before each use, it is necessary to carefully connect a new needle to the syringe pen and conduct a safety test.
It is necessary to use only needles that are compatible with SoloStar ® .
It is necessary to take special precautions to avoid accidents involving the use of a needle and the possibility of transfer of infection.

Do not use the SoloStar ® pen when it is damaged or if it is not sure that it will work properly.

You should always have a spare SoloStar® pen in case you lose or damage an existing SoloStar® pen.

If the SoloStar® pen is stored in the refrigerator, it should be taken 1-2 hours before the proposed injection so that the solution takes room temperature.
The introduction of chilled insulin is more painful. The used SoloStar ® syringe pen must be destroyed.
The SoloStar® syringe handle must be protected from dust and dirt.
The outer side of the SoloStar ® syringe can be cleaned by wiping it with a damp cloth. Do not immerse in liquid, rinse and lubricate the SoloStar ® syringe, as this can damage it.
Injection pen SoloSTAR ® accurately dispenses insulin and safe in operation. It also requires careful handling. To avoid situations where damage may occur pen SoloSTAR ® . For suspected lesion existing instance pen SoloSTAR ® , use a new syringe handle.
Step 1. Control Insulin
is necessary to check the label on the syringe handle SoloSTAR ® to ensure that it contains the corresponding insulin. For preparation Lantus ® syringe-pen SoloSTAR ®gray with a purple button for the injection. After removal of the syringe cap-handle control the appearance of the contained insulin: insulin solution should be transparent, colorless, free from visible particulate matter and water resemble in consistency.
Step 2. Connecting needles
should be used only needle compatible with syringe handle SoloSTAR ® . For each subsequent injection, always use a new sterile needle. After removal of the needle cap Carefully place on shprits- handle.
Step 3: Perform safety test
before each injection administration is necessary to test for safety and to make sure that the syringe-pen and the needle are working well and the air bubbles are removed.
Metered dose of 2 units.
The outer and inner needle caps should be removed.
With a pen syringe needle up, gently tap the cartridge with insulin finger so that any air bubbles are headed toward the needle.
Fully click on the injection button.
If insulin appears at the needle tip, it means that the syringe-pen and the needle are working properly.
If the appearance of insulin at the needle tip is not observed, the step 3 may be repeated up until insulin appears at the needle tip.
Step 4. Selection dose
The dose can be set with an accuracy of up to 1 unit of the minimum dose (1 unit) to a maximum of (80 units). If you must enter a dose greater than 80 units, there should be two or more injections.
Batching window must show "0" after the safety tests. Thereafter, the required dose can be set.
Step 5. Introduction of dose
the patient should be informed on the injection technique medical professional.
The needle must be inserted under the skin.
Introducing injection button must be pressed all the way. It is held in this position for a further 10 seconds before the extraction of the needle. This ensures administration of the selected dose of insulin completely.
Step 6. Remove and discard the needle
In all cases, the needle after each injection should be removed and discarded. This ensures prevention of contamination and / or introduction of infection of air into the container for insulin and insulin leakage.
When removing and disposing of the needle, special precautions should be implemented. Follow recommended safety measures for removal and ejection of needles (for example, the technique of putting on the cap with one hand) in order to reduce the risk of accidents associated with the use of the needle, and to prevent infection.
After removal of the needle should close the pen SoloSTAR ® cap.
SIDE EFFECT

Determining the frequency of adverse reactions (in accordance with the MedDRA classification): very common (10%?), Often; (1% <10?) sometimes (? 0.1%, <1%); rare (? 0.01%, <0.1%), very rare (<0.01%), frequency not known (frequency can not be determined from the available data).
Side effects associated with the impact on carbohydrate metabolism:very often - hypoglycemia (especially if the dose of insulin exceeds the need for it). Symptoms of hypoglycaemia usually occur suddenly. Often, however, neuropsychiatric disorders in the background neyroglikopenii (tiredness, unusual tiredness or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss, convulsions) is usually preceded by symptoms of adrenergic kontrregulyatsii (activation of sympatic system in response to hypoglycemia): hunger, irritability, nervous agitation or tremor, anxiety, pallor, "cold" sweat ahikardiya expressed palpitations (faster than developing hypoglycaemia and the heavier it is, the signs of adrenergic kontrregulyatsii more pronounced).
Attacks of severe hypoglycemia, especially repetitive, can lead to damage to the nervous system. Episodes long and expressed hypoglycemia may endanger the lives of patients, since with an increase in fatal hypoglycemia even possible.
Allergic reactions: rare - immediate type allergic reactions to insulin (including insulin glargine) or formulation auxiliaries - generalized skin reactions, angioneurotic edema, bronchospasm, hypotension, shock. These reactions may represent a threat to the life of the patient.
The use of insulin can induce the formation of antibodies thereto. The formation of antibodies cross-react with human insulin were observed with similar frequency in the application of insulin, isophane insulin and glargine. In rare cases, the presence of such antibodies to insulin may necessitate dose adjustment in order to eliminate the tendency to the development of hypo- or hyperglycaemia.
From the nervous system: very rarely - dysgeusia.
On the part of the organ of vision: rarely - visual impairment, retinopathy.
Significant changes in the regulation of blood glucose levels can cause temporary visual impairment due to changes in tissue turgor and the refractive index of the lens eye.
The long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. Against the background of insulin, accompanied by sharp fluctuations in blood glucose levels, may be a temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, especially not receiving treatment photocoagulation, episodes of severe hypoglycemia can lead to the development of transient loss of vision.
Skin and subcutaneous tissue disorders:frequently (1-2%) - as well as in the treatment of any other insulin formulations, it is possible lipodystrophy capable local slow absorption of insulin; infrequently - lipoatrophy. Constant change of injection locations within body regions recommended for p / insulin administration, can reduce the severity of the reaction or to prevent its development.
On the part of the musculoskeletal system: very rarely - myalgia.
Metabolism: rare - sodium retention, edema (especially if Intensified insulin therapy leads to an improvement of previously insufficient regulation of metabolic processes).
Local reactions:frequently (3-4%) - redness, pain, itching, hives, swelling or inflammation at the injection site. In most cases, minor reactions resolved within a period of from several days to several weeks.
The safety profile for patients younger than 18 years, in general, similar to the safety profile for patients older than 18 years. In patients younger than 18 years of relatively more likely to occur at the injection site reactions and skin reactions (rash, urticaria). Safety data in children under 2 years are not available.
CONTRAINDICATIONS

- children up to 2 years (no clinical data on the application);
- hypersensitivity to insulin glargine or to any of the support components of the preparation.
PREGNANCY AND LACTATION

In animal studies, no direct or indirect evidence has been obtained about the embryotoxic or foetotoxic effect of insulin glargine.
To date, no relevant statistical data regarding the use of the drug during pregnancy. While the application of the drug Lantus ® SoloSTAR ® from 100 pregnant women with diabetes. And during pregnancy outcome in these patients did not differ from those of the pregnant women with diabetes who received other drugs of insulin.
Use of the drug Lantus ® SoloSTAR ® pregnant should be performed with caution. Required careful monitoring of blood glucose levels.
For patients with previously held or gestational diabetes is important during pregnancy to maintain glycemic control. Insulin requirements may be reduced in I trimester and generally increase during trimesters II and III.
Immediately after delivery, insulin requirements decreases rapidly (increased risk of hypoglycaemia). In these conditions is essential careful control of blood glucose concentration.
In women during breastfeeding may require adjustment of insulin dosage regimen and diet.
APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with renal impairment, insulin requirements may be reduced due to the weakening of his elimination processes. Elderly patients progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with severe hepatic impairment, insulin requirements may be reduced due to the reduced capacity for gluconeogenesis and slower biotransformation of insulin.
APPLICATION FOR CHILDREN

In children under the age of 6 years - the absence of clinical data on the use.
APPLICATION IN ELDERLY PATIENTS

Elderly patients progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
SPECIAL INSTRUCTIONS

Lantus ® SoloSTAR ® is not a drug of choice for the treatment of diabetic ketoacidosis. In such cases, in / in a short-acting insulin.
In connection with the limited experience of the drug Lantus ® SoloSTAR ® it was not possible to estimate its efficacy and safety in patients with impaired liver function or renal insufficiency patients moderate or severe.
In patients with renal impairment, insulin requirements may be reduced due to the weakening of his elimination processes. Elderly patients progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
In patients with severe hepatic impairment, insulin requirements may be reduced due to the reduced capacity for gluconeogenesis and slower biotransformation of insulin.
In the case of ineffective control over the level of blood glucose, as well as a trend towards the development of hypo- or hyperglycemia, before proceeding to the correction of the dosing regime, check the accuracy of compliance with the prescribed regimen, and places of administration of competent art p / injection taking into account all the factors affecting it.
hypoglycemia
Time of hypoglycemia depends on the profile of action of insulin and can thus be varied by changing the treatment regimen. Due to the increase time of exposure of long-acting insulin formulation at application Lantus ® SoloSTAR ® , one should expect a smaller probability of nocturnal hypoglycemia, whereas in the early morning hours, this probability is higher. At occurrence of hypoglycemia in patients receiving Lantus ® SoloSTAR ® , must consider the possibility of slowing down the output of the state hypoglycemia due to prolonged action of insulin glargine.
In patients who have episodes of hypoglycemia may be of particular clinical importance, including in patients with severe stenosis of the coronary arteries or the vessels of the brain (risk of cardiac and cerebral hypoglycemia complications), as well as in patients with proliferative retinopathy, particularly if they do not receive treatment photocoagulation (risk of transient loss of vision due to hypoglycemia), you should take special precautions and carefully monitor blood glucose.
Patients should be warned about the conditions under which, the harbingers of the symptoms of hypoglycemia may be reduced, become less pronounced or be absent in certain risk groups, which include:
- patients in whom the regulation of blood glucose significantly improved;
- Patients in whom hypoglycaemia develops gradually;
- elderly patients;
- Patients translated from animal insulin to human insulin;
- Patients with neuropathy;
- Patients with a long history of diabetes;
- patients suffering from mental disorders;
- Patients receiving concomitant treatment with other drugs.
Such situations can lead to the development of severe hypoglycemia (with the possible loss of consciousness) before the patient is aware that he develops hypoglycemia.
If you have normal or reduced performance of glycated hemoglobin, is necessary to consider the possibility of repeating unrecognized hypoglycemia episodes (especially at night).
Patient compliance with dosing regimens, diet and nutrition, proper use of insulin and control symptoms of hypoglycemia contribute to a significant reduction in the risk of hypoglycemia. In the presence of factors that increase susceptibility to hypoglycemia, especially need careful observation, because It may require adjustment of insulin dose. These factors include:
- change the site of injection of insulin;
- increased sensitivity to insulin (e.g., elimination of stress factors);
- unaccustomed, increased or prolonged physical activity;
- intercurrent illness accompanied by vomiting, diarrhea;
- violation of diet and nutrition;
- missed meals;
- consumption of alcohol;
- some uncompensated endocrine disorders (e.g., hypothyroidism, or adenohypophysis insufficiency of the adrenal cortex);
- concomitant treatment with certain other medicines.
intercurrent disease
When intercurrent diseases require more intensive control of blood glucose. In many cases, the analysis shows the presence of ketone bodies in urine, it is also often required insulin correction dosing regimen. Insulin requirement is often increased. Patients with type 1 diabetes must continue to regular consumption of at least a small amount of carbohydrates, even when eating only small amounts or no opportunity to eat, as well as vomiting. These patients should never discontinue insulin completely.
OVERDOSE

Symptoms: moderate and severe hypoglycemia accompanied by coma, convulsions or neurological disorders.
Treatment: episodes of moderate hypoglycemia typically cropped by oral fast utilizable carbohydrates. You may need to change the drug dosing regimen, diet or physical activity.
More episodes of severe hypoglycemia accompanied coma, seizures or neurological disorders, require / m or p / glucagon administration, and on / in a concentrated dextrose solution. It may require prolonged intake of carbohydrates and surveillance specialist since hypoglycemia possible relapse after apparent clinical improvement.
DRUG INTERACTION

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates and sulfa antimicrobial agents may enhance the hypoglycemic effect of insulin, and increase the susceptibility to the development of hypoglycemia. In these combinations may require correction insulin glargine doses.
Corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, progestins, derivatives of phenothiazine, COMAT
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