Apidra

Each mL of the solution for injection contains insulin glulisine 100 units equivalent to 3.49 mg. Each vial contains 10 mL of solution for injection (1,000 units).
It contains sodium <1 mmol (23 mg) per dose ie, essentially 'sodium-free'.
Insulin glulisine is made by biotechnology. It has a rapid onset of action (within 10-20 min) and a short duration of action (about 4 hrs).

Pharmacotherapeutic Group: Antidiabetic.

Apidra is an antidiabetic agent, used to reduce high blood sugar in adults, adolescents and children ≥6 years with diabetes mellitus. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.

Based on patient's lifestyle, results of blood sugar (glucose) tests and previous insulin dosage, the physician will determine how much Apidra that patient needs.
Apidra is a short-acting insulin. It may be used in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
In switching from another insulin to insulin glulisine, dosage may have to be adjusted by the physician.
Many factors may influence the blood sugar level. Patients should know these factors to react correctly to changes in the blood sugar level and prevent it from becoming too high or too low.
If the patient missed a dose of Apidra or not enough insulin was injected, blood sugar level may become too high (hyperglycemia). Check blood sugar frequently. Do not take a double dose to make up for a forgotten dose.
Administration: Apidra should be taken shortly (0-15 min) before or soon after meals. Apidra is injected under the skin (SC). The physician will show the patient in which area of the skin that should be injected with Apidra. Apidra can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall. The effect will be slightly quicker if the insulin is injected into the abdomen. As for all insulins, injection sites and infusion sites within an injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.

If too much Apidra is injected, blood sugar level may become too low (hypoglycemia). Check blood sugar frequently. In general, to prevent hypoglycemia, the patient must eat more food and monitor blood sugar.

Hypersensitivity to insulin glulisine or any of the other ingredients of Apidra. Hypoglycemia.

Follow closely the instructions for dosage, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with the physician.
If the patient has liver or kidney problems, inform the physician as a lower dose may be needed.
Before traveling consult the physician. The patient may need to talk about the availability of insulin in the country the patient is visiting; supplies of insulin, injection syringes; correct storage of insulin while traveling; timing of meals and insulin administration while traveling; the possible effects of changing to different time zones; possible new health risks in the countries to be visited; what to do in emergency situations when the patient feels unwell or becomes ill.
Illnesses and Injuries: In the following situations, the management of diabetes may require a lot of care: If the patient is ill or has a major injury, blood sugar level may increase (hyperglycemia); not eating enough, blood sugar level may become too low (hypoglycemia).
If the patient has type I diabetes (insulin-dependent diabetes mellitus), the patient should not stop insulin and continue to get enough carbohydrates.
If the patient stopped using Apidra, this could lead to severe hyperglycemia (very high blood sugar) and ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop taking Apidra without consulting the physician.
Some patients with long-standing type 2 diabetes mellitus and heart disease, or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure.
Inform the physician as soon as possible if the patient experiences signs of heart failure eg, unusual shortness of breath or rapid increase in weight, or localized swelling (edema).
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate or react may be reduced if he has hypoglycemia (low blood sugar levels) or hyperglycemia (high blood sugar levels). Keep this possible problem in mind in all situations where the patient might put himself and others at risk (eg, driving a car or operating machines). Contact the physician for advice on driving if there are frequent episodes of hypoglycemia and/or the 1st warning symptoms which help recognize hypoglycemia are reduced or absent.
Use in pregnancy: Ask the physician or pharmacist for advice before taking any medicine.
Inform the physician if the patient is planning to become pregnant, or if already pregnant. Insulin dosage may need to be changed during pregnancy and after giving birth. Careful control of diabetes and prevention of hypoglycemia are important for the health of the baby.
There are no adequate data on the use of Apidra in pregnant women.
Use in lactation: Consult a physician as breastfeeding women may require adjustments in insulin doses and diet.
Use in children: There is insufficient clinical information on the use of Apidra in children <6 years.

Use in pregnancy: Ask the physician or pharmacist for advice before taking any medicine.
Inform the physician if the patient is planning to become pregnant, or if already pregnant. Insulin dosage may need to be changed during pregnancy and after giving birth. Careful control of diabetes and prevention of hypoglycemia are important for the health of the baby.
There are no adequate data on the use of Apidra in pregnant women.
Use in lactation: Consult a physician as breastfeeding women may require adjustments in insulin doses and diet.

Hypoglycemia (low blood sugar) can be very serious. If blood sugar level falls too much, the patient may become unconscious. Serious hypoglycemia may cause brain damage and may be life-threatening. If the patient has symptoms of low blood sugar, actions to increase blood sugar levels should be taken immediately.
Contact the physician immediately if patient experience the following symptoms: Large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. These could be symptoms of generalized allergy to insulin including anaphylactic reaction which may be life-threatening.
Very Common (>1/10 Patients): Hypoglycemia: Hypoglycemia (low blood sugar) means that there is not enough sugar in the blood.
Common (>1/100 but <1/10 Patients): Skin and Allergic Reactions: Reactions at the injection site may occur eg, reddening, unusually intense pain on injection, itching, hives, swelling or inflammation at the injection site. They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.
Uncommon (>1/1,000 but <1/100 Patients): Systemic Allergic Reactions: Generalized allergy to insulin. Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, fall in blood pressure with rapid heartbeat and sweating. Severe cases of generalized reactions, including anaphylactic reaction, may be life-threatening.
Rare (>1/10,000 but <1/1,000 Patients): Skin Changes at the Injection Site (Lipodystrophy): If the patient injects insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin injected in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
Other side effects include: Hyperglycemia (high blood sugar) means that there is too much sugar in the blood. If the patient's blood sugar level is too high, this indicates that the patient could have needed more insulin than injected.
Eye Reactions: A marked change (improvement or worsening) in blood sugar control can disturb the patient's vision temporarily. If the patient has proliferative retinopathy (an eye disease related to diabetes), severe hypoglycemic attacks may cause temporary loss of vision.

Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust the insulin dosage to avoid blood sugar levels that are either too low or too high. Be careful when starting or stopping taking another medicine.
Tell the physician or pharmacist if taking, have recently taken or might have taken any other medicines. Before taking a medicine ask the physician if it can affect the blood sugar level and what action, if any, may need to be taken.
Medicines that may Cause Blood Sugar Level to Fall (Hypoglycemia): All other medicines used to treat diabetes, angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), disopyramide (used to treat certain heart conditions), fluoxetine (used to treat depression), fibrates (used to lower high levels of blood lipids), MAOIs (used to treat depression), pentoxifylline, propoxyphene, salicylates (eg, aspirin, used to relieve pain and lower fever) and sulfonamide antibiotics.
Medicines that may Cause Blood Sugar Level to Rise (Hyperglycemia): Corticosteroids (eg, cortisone, used to treat inflammation), danazol (medicine acting on ovulation), diazoxide (used to treat high blood pressure), diuretics (used to treat high blood pressure or excessive fluid retention), glucagon (pancreatic hormone used to treat severe hypoglycemia), isoniazid (used to treat tuberculosis), estrogens and progestogens (eg, in the contraceptive pill used for birth control), phenothiazine derivatives (used to treat psychiatric disorders), somatropin (growth hormone), sympathomimetic medicines [eg, epinephrine (adrenaline) or salbutamol, terbutaline used to treat asthma], thyroid hormones (used to treat thyroid gland disorders), protease inhibitors (used to treat HIV), atypical antipsychotic medications (eg, olanzapine and clozapine).
Blood Sugar Level may Either Rise or Fall with: β-blockers (used to treat high blood pressure), clonidine (used to treat high blood pressure), and lithium salts (used to treat psychiatric disorders). Pentamidine (used to treat some infections caused by parasites) may cause hypoglycemia which may sometimes be followed by hyperglycemia. β-blockers like other sympatholytic medicines (eg, clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help to recognize a hypoglycemia.
If the patient is not sure whether to take one of those medicines, ask the physician or pharmacist.
Blood sugar level may either rise or fall with alcohol.

Instructions for Use and Handling: Handling the Vial: Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system.
Check the vial before using. Use only if the solution is clear, colorless and has no visible particles in it. Do not shake or mix before use.
Always use a new vial if blood sugar control is unexpectedly getting worse because the insulin may have lost some of its effectiveness. If there's a problem with Apidra, have it checked by the physician or pharmacist. It is recommended that the date of the 1st use be noted on the label.
Mixing Two Types of Insulin: Apidra must not be mixed with any preparation other than NPH human insulin. If Apidra is mixed with NPH human insulin, it should be drawn into the syringe first. Injection should be given immediately after mixing.
Handling an Infusion Pump System: Apidra must never be mixed with diluent or any other insulin when used in a pump. Use the type of pump system recommended by the physician. Read and follow the instructions that accompany the insulin infusion pump. Follow the physician's instructions about the basal infusion rate and the mealtime insulin boluses to be taken. To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, blood sugar level should be measured regularly.
The infusion set and reservoir should be changed every 48 hrs using aseptic technique.
An alternative insulin should always be available for injection under the skin in case of pump system failure.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist on how to dispose of medicines no longer required. These measures will help to protect the environment.

Unopened Vials: Store in a refrigerator (2-8°C). Do not freeze. Do not put Apidra next to the freezer compartment or a freezer pack. Keep the vial in the outer carton in order to protect from light.
Opened Vials: Once in use, the vial may be stored for a maximum of 4 weeks not above 25°C in the outer carton away from direct heat or light. Do not use the vial after this time period.

Insulin Preparations

A10AB06 - insulin glulisine ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.

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