APIDRA Solostar Insulin Glulisine 3.49mg / mL (100units / mL) Solution for SC Injection 10mL
RXDRUG-BR-1046
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older. Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar.
It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
Dosage/Direction for Use
Always use this medicine exactly as the doctor has instructed. Check with the doctor or pharmacist if not sure.
Based on the life-style and the results of the blood sugar (glucose) tests and the previous insulin usage, the doctor will determine how much Apidra will be needed.
Apidra is a short-acting insulin. The doctor may instruct to use it in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
When switching from another insulin to insulin glulisine, the doctor may have to adjust the dosage.
Many factors may influence the blood sugar level. These factors should be known so that the patient can react correctly to changes in the blood sugar level and to prevent it from becoming too high or too low.
Method of administration: Apidra is injected under the skin (subcutaneously).
The doctor will show which area of the skin Apidra should be injected. 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.
Frequency of administration: Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Instructions for proper use: How to handle SoloStar: SoloStar is a pre-filled disposable pen containing insulin glulisine. Apidra in a pre-filled pen is only suitable for injecting just under the skin. Speak to the doctor if insulin needs to be injected by another method.
Read carefully the Instructions for use under Patient Counselling Information. The pen must be used as described in these Instructions for use.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Before use always attach a new needle, and perform a safety test. Only use needles that are compatible for use with SoloStar (see Instructions for use under Patient Counselling Information).
Look at the cartridge sealed in the disposable pen injector before using it. Only use it if the solution is clear, colourless and has no visible particles in it. Do not shake or mix it before use.
Always use a new pen if the blood sugar control is unexpectedly getting worse. For any problem with SoloStar, please consult the Health Care Professional.
If the patient forgets to use Apidra: If the patient missed a dose of Apidra or has not injected enough insulin, the blood sugar level may become too high (hyperglycaemia). Check the blood sugar frequently.
Do not take a double dose to make up for a forgotten dose.
If the patient stops using Apidra: This could lead to severe hyperglycaemia (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 Apidra without speaking to a doctor, who will instruct what needs to be done.
For any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Insulin mix-ups: Always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
Based on the life-style and the results of the blood sugar (glucose) tests and the previous insulin usage, the doctor will determine how much Apidra will be needed.
Apidra is a short-acting insulin. The doctor may instruct to use it in combination with an intermediate, long-acting insulin, a basal insulin or with tablets used to treat high blood sugar levels.
When switching from another insulin to insulin glulisine, the doctor may have to adjust the dosage.
Many factors may influence the blood sugar level. These factors should be known so that the patient can react correctly to changes in the blood sugar level and to prevent it from becoming too high or too low.
Method of administration: Apidra is injected under the skin (subcutaneously).
The doctor will show which area of the skin Apidra should be injected. 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.
Frequency of administration: Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Instructions for proper use: How to handle SoloStar: SoloStar is a pre-filled disposable pen containing insulin glulisine. Apidra in a pre-filled pen is only suitable for injecting just under the skin. Speak to the doctor if insulin needs to be injected by another method.
Read carefully the Instructions for use under Patient Counselling Information. The pen must be used as described in these Instructions for use.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Before use always attach a new needle, and perform a safety test. Only use needles that are compatible for use with SoloStar (see Instructions for use under Patient Counselling Information).
Look at the cartridge sealed in the disposable pen injector before using it. Only use it if the solution is clear, colourless and has no visible particles in it. Do not shake or mix it before use.
Always use a new pen if the blood sugar control is unexpectedly getting worse. For any problem with SoloStar, please consult the Health Care Professional.
If the patient forgets to use Apidra: If the patient missed a dose of Apidra or has not injected enough insulin, the blood sugar level may become too high (hyperglycaemia). Check the blood sugar frequently.
Do not take a double dose to make up for a forgotten dose.
If the patient stops using Apidra: This could lead to severe hyperglycaemia (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 Apidra without speaking to a doctor, who will instruct what needs to be done.
For any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Insulin mix-ups: Always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
Overdosage
If the patient has injected too much Apidra, the blood sugar level may become too low (hypoglycaemia). Check the blood sugar frequently. In general, to prevent hypoglycaemia, eat more food and monitor the blood sugar.
Contraindications
Do not use Apidra: If the patient is allergic to insulin glulisine or any of the other ingredients of this medicine (listed in Description).
If the blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia.
If the blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia.
Special Precautions
Apidra in a pre-filled pen is only suitable for injecting just under the skin (see Dosage & Administration). Speak to the doctor if insulin needs to be injected by another method.
Talk to the doctor, pharmacist or nurse before using Apidra.
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with the doctor.
Special patient groups: If the patient has liver or kidney problems, speak to the doctor as a lower dose may be needed.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Travel: Before travelling consult the doctor. The patient may need to talk about: The availability of the insulin in the country being visited; supplies of insulin, needles, etc; correct storage of the insulin while travelling; timing of meals and insulin administration while travelling; 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 feeling unwell or becoming ill.
Illnesses and injuries: In the following situations, the management of the diabetes may require extra care: If the patient is ill or has a major injury then the blood sugar level may increase (hyperglycaemia).
If the patient is not eating enough, the blood sugar level may become too low (hypoglycaemia).
In most cases, a doctor will be needed. Make sure to contact a doctor early.
If the patient has type 1 diabetes (insulin dependent diabetes mellitus), do not stop the insulin and continue to get enough carbohydrates. Always tell people who are caring or treating the patient that insulin is required.
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 doctor as soon as possible if the patient experiences signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Important information about some of the ingredients of Apidra: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Apidra contains metacresol: Apidra contains metacresol, which may cause allergic reactions.
Driving and using machines: The ability to concentrate or react may be reduced if: The patient has hypoglycaemia (low blood sugar levels); the patient has hyperglycaemia (high blood sugar levels).
Keep this possible problem in mind in all situations where the patient and others might be put at risk (such as driving a car or using machines).
Contact the doctor for advice on driving if: The patient has frequent episodes of hypoglycaemia; the first warning symptoms which help the patient to recognise hypoglycaemia are reduced or absent.
Talk to the doctor, pharmacist or nurse before using Apidra.
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with the doctor.
Special patient groups: If the patient has liver or kidney problems, speak to the doctor as a lower dose may be needed.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Travel: Before travelling consult the doctor. The patient may need to talk about: The availability of the insulin in the country being visited; supplies of insulin, needles, etc; correct storage of the insulin while travelling; timing of meals and insulin administration while travelling; 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 feeling unwell or becoming ill.
Illnesses and injuries: In the following situations, the management of the diabetes may require extra care: If the patient is ill or has a major injury then the blood sugar level may increase (hyperglycaemia).
If the patient is not eating enough, the blood sugar level may become too low (hypoglycaemia).
In most cases, a doctor will be needed. Make sure to contact a doctor early.
If the patient has type 1 diabetes (insulin dependent diabetes mellitus), do not stop the insulin and continue to get enough carbohydrates. Always tell people who are caring or treating the patient that insulin is required.
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 doctor as soon as possible if the patient experiences signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Important information about some of the ingredients of Apidra: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Apidra contains metacresol: Apidra contains metacresol, which may cause allergic reactions.
Driving and using machines: The ability to concentrate or react may be reduced if: The patient has hypoglycaemia (low blood sugar levels); the patient has hyperglycaemia (high blood sugar levels).
Keep this possible problem in mind in all situations where the patient and others might be put at risk (such as driving a car or using machines).
Contact the doctor for advice on driving if: The patient has frequent episodes of hypoglycaemia; the first warning symptoms which help the patient to recognise hypoglycaemia are reduced or absent.
Use In Pregnancy & Lactation
Pregnancy and breast-feeding: If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Inform the doctor if the patient is planning to become pregnant, or if she is already pregnant. The insulin dose may need to be changed during pregnancy and after giving birth. Careful control of diabetes, and prevention of hypoglycaemia, is important for the health of the baby.
There are no or limited data on the use of Apidra in pregnant women.
If the patient is breast-feeding, consult the doctor as adjustments in insulin doses and diet may be required.
Inform the doctor if the patient is planning to become pregnant, or if she is already pregnant. The insulin dose may need to be changed during pregnancy and after giving birth. Careful control of diabetes, and prevention of hypoglycaemia, is important for the health of the baby.
There are no or limited data on the use of Apidra in pregnant women.
If the patient is breast-feeding, consult the doctor as adjustments in insulin doses and diet may be required.
Adverse Reactions
Hypoglycaemia. Skin & allergic reactions at the inj site (eg, reddening, unusual intense pain, itching, hives, swelling or inflammation).
Drug Interactions
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 dose to avoid blood sugar levels that are either too low or too high. Be careful when starting or stopping another medicine.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. Before taking a medicine, ask the doctor if it can affect the blood sugar level and what action, if any, needs to be taken.
Medicines that may cause the blood sugar level to fall (hypoglycaemia) include: All other medicines 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); monoamine oxidase (MAO) inhibitors (used to treat depression); pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever); sulfonamide antibiotics.
Medicines that may cause the blood sugar level to rise (hyperglycaemia) include: Corticosteroids (such as "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 (pancreas hormone used to treat severe hypoglycaemia); isoniazid (used to treat tuberculosis); oestrogens and progestogens (such as in the contraceptive pill used for birth control); phenothiazine derivatives (used to treat psychiatric disorders); somatropin (growth hormone); sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma); thyroid hormones (used to treat thyroid gland disorders); protease inhibitors (used to treat HIV); atypical antipsychotic medicines (such as olanzapine and clozapine).
The blood sugar level may either rise or fall if the patient takes: Beta-blockers (used to treat high blood pressure); clonidine (used to treat high blood pressure); lithium salts (used to treat psychiatric disorders).
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help recognise a hypoglycaemia.
If not sure whether the patient is taking one of those medicines, ask the doctor or pharmacist.
Apidra with alcohol: The blood sugar levels may either rise or fall with alcohol intake.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. Before taking a medicine, ask the doctor if it can affect the blood sugar level and what action, if any, needs to be taken.
Medicines that may cause the blood sugar level to fall (hypoglycaemia) include: All other medicines 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); monoamine oxidase (MAO) inhibitors (used to treat depression); pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever); sulfonamide antibiotics.
Medicines that may cause the blood sugar level to rise (hyperglycaemia) include: Corticosteroids (such as "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 (pancreas hormone used to treat severe hypoglycaemia); isoniazid (used to treat tuberculosis); oestrogens and progestogens (such as in the contraceptive pill used for birth control); phenothiazine derivatives (used to treat psychiatric disorders); somatropin (growth hormone); sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma); thyroid hormones (used to treat thyroid gland disorders); protease inhibitors (used to treat HIV); atypical antipsychotic medicines (such as olanzapine and clozapine).
The blood sugar level may either rise or fall if the patient takes: Beta-blockers (used to treat high blood pressure); clonidine (used to treat high blood pressure); lithium salts (used to treat psychiatric disorders).
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help recognise a hypoglycaemia.
If not sure whether the patient is taking one of those medicines, ask the doctor or pharmacist.
Apidra with alcohol: The blood sugar levels may either rise or fall with alcohol intake.
Caution For Usage
Do not use this medicine if it does not appear clear and colourless.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment. For caution against possible variation of physical aspect of medicine.
Storage
Not in-use pens: Store in a refrigerator (2°C-8°C).
Do not freeze.
Do not put SoloStar next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
In-use pens: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C and away from direct heat or direct light. The pen in use must not be stored in a refrigerator.
Do not use it after this time period.
Do not freeze.
Do not put SoloStar next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
In-use pens: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C and away from direct heat or direct light. The pen in use must not be stored in a refrigerator.
Do not use it after this time period.
MedsGo Class
Insulin Preparations
Features
Brand
Apidra Solostar
Full Details
Dosage Strength
3.49 mg / ml (equivalent to 100 Units / ml)
Drug Ingredients
- Insulin Glulisine
Drug Packaging
Solution for Injection (S.C.) 10ml
Generic Name
Insulin Glulisine
Dosage Form
Solution For Injection (S.C.)
Registration Number
BR-1046
Drug Classification
Prescription Drug (RX)
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