Lantus Solostar

Lantus Solostar

insulin glargine

Manufacturer:

sanofi-aventis

Distributor:

sanofi-aventis
Full Prescribing Info
Contents
Insulin glargine.
Description
The active substances is insulin glargine. Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
Excipients/Inactive Ingredients: The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see Important information about some of the ingredients of Lantus under Precautions) and hydrochloric acid (for pH adjustment) and water for injections.
Action
Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.
Indications/Uses
Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Diabetes mellitus is a disease where the body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar lowering action.
Dosage/Direction for Use
Always use this medicine exactly as the doctor has told. Check with a doctor or pharmacist if not sure.
Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these medicines are not interchangeable. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Consult the doctor for further information.
Dose: Based on life-style and the results of blood sugar (glucose) tests and previous insulin usage, the doctor will: determine how much Lantus per day the patient will need and at what time; tell when to check the blood sugar level, and whether there is a need to carry out urine tests, tell when the patient may need to inject a higher or lower dose of Lantus.
Lantus is a long-acting insulin. The doctor may instruct the patient to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Many factors may influence the blood sugar level. The patient should know these factors so that the patient will be able to react correctly to changes in the blood sugar level and to prevent it from becoming too high or too low.
Use in children and adolescents: Lantus can be used in adolescents and children aged 2 years and above. Use this medicine exactly as the doctor has told.
Frequency of administration: The patient needs one injection of Lantus every day, at the same time of the day.
Method of administration: Lantus is injected under the skin. Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.
The doctor will show in which area of the skin the patient should inject Lantus. With each injection, change the puncture site within the particular area of skin that the patient is using.
How to handle SoloStar: SoloStar is a pre-filled disposable pen containing insulin glargine.
A new needle must be attached before each use. Only use needles that are compatible for use with SoloStar (see Instructions for Use under Cautions for Usage).
A safety test must be performed before each injection.
Look at the cartridge before using the pen. Do not use SoloStar if the patient notices particles in it. Only use SoloStar if the solution is clear, colourless and water-like. Do not shake or mix it before use.
To prevent the possible transmission of disease, never share the pen with anyone else. This pen is for personal use only.
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Always use a new pen if the patient notices that the blood sugar control is unexpectedly getting worse. If the patient thinks there may be a problem with SoloStar, consult a doctor, pharmacist or nurse.
Empty pens must not be re-filled and must be properly discarded.
Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.
Insulin mix-ups: Always check the insulin label before each injection to avoid mix-ups between Lantus and other insulins.
Missed dose: If the patient missed a dose of Lantus or if 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.
Discontinuation: 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 Lantus without speaking to a doctor, who will tell the patient what needs to be done.
If the patient has any further questions on the use of this medicine, ask the doctor, pharmacist or nurse.
Overdosage
If too much Lantus is injected, the blood sugar level may become too low (hypoglycemia). Check the blood sugar frequently. In general, to prevent hypoglycemia the patient must eat more food and monitor the blood sugar.
Contraindications
Do not use Lantus if allergic to insulin glargine or to any of the other ingredients of this medicine (listed under Description).
Special Precautions
Talk to a doctor, pharmacist or nurse before using Lantus.
Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with the doctor.
If the blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia.
Travel: Before traveling consult a doctor. The patient may need to talk about: the availability of insulin in the country the patients is visiting; supplies of insulin, syringes 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 become ill.
Illnesses and injuries: In the following situations, the management of diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):  If ill or have 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, the patient will need the doctor. Make sure to contact the doctor early.
If the patient has type 1 diabetes (insulin dependent diabetes mellitus), do not stop insulin and continue to get enough carbohydrates. Always tell people who are caring for or treating the patient that the patient requires insulin.
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to the insulin dose.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) 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 Lantus: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.
Driving or using machines:
The ability to concentrate or react may be reduced if: the patient has hypoglycaemia (low blood sugar levels), the patient has hyperglycemia (high blood sugar levels), the patient has problems with eyesight.
Keep this possible problem in mind in all situations where it might put the patient and others at risk (such as driving a car or using machines). Contact the doctor for advice on driving if: having frequent episodes of hypoglycaemia, the first warning symptoms which may help recognise if hypoglycaemia are reduced or absent.
Use in Children: There is no experience with the use of Lantus in children below the age of 2 years.
Use In Pregnancy & Lactation
Ask the doctor or pharmacist for advice before taking any medicine.
Inform the doctor if planning to become pregnant, or if already pregnant. The insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful control of diabetes, and prevention of hypoglycemia, is important for the health of the baby.
If breastfeeding, consult the doctor as the patient may require adjustments in the insulin doses and diet.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient notices signs of blood sugar being too low (hypoglycaemia), take action to increase the blood sugar level straight away. Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in the blood. If the blood sugar level falls too low, the patient may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if the patient notices signs of severe allergic reaction.
Common reported side effects (may affect up to 1 in 10 people): Skin changes at the injection site: If injection of insulin is too often at the same skin site, fatty tissue under the skin at this site may either shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohypertrophy). The insulin may not work very well. Change the injection site with each injection to help prevent these skin changes.
Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.
Rare reported side effect (may affect up to 1 in 1,000 people): Eye reactions: A marked change (improvement or worsening) in the blood sugar control can disturb the vision temporarily. If the patient has proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
General disorders: In rare cases, insulin treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
Very rare reported side-effects (may affect up to 1 in 10,000 people): In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Use in children and adolescents: In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults.
There is no experience in children under 2 years.
Drug Interactions
Other medicines and Lantus: 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 to start or stop taking another medicine.
Tell the doctor or pharmacist if 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, the patient needs to take.
Medicines that may cause 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 acetylsalicylic acid, used to relieve pain and lower fever), sulfonamide antibiotics.
Medicines that may cause 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), atypical antipsychotic medicines (such as clozapine, olanzapine), protease inhibitors (used to treat HIV).
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 helps to recognise a hypoglycaemia.
If not sure whether the patient is taking one of those medicines ask the doctor or pharmacist.
Lantus with alcohol: The blood sugar levels may either rise or fall if the patient drinks alcohol.
Caution For Usage
Instructions for Use: SoloStar is a pre-filled pen for the injection of insulin. Talk with a doctor, pharmacist or nurse about proper injection technique before using SoloStar.
If unable to use SoloStar or follow all the instructions completely on the patient's own, SoloStar must only be used if the patient has help from a person who is able to follow the instructions completely. Hold the pen. To ensure that the patient read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right.
The patient can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.
Important information for use of SoloStar: Always attach a new needle before each use. Only use needles that are compatible for use with SoloStar.
Do not select a dose and/or press the injection button without a needle attached.
Always perform the safety test before each injection (see Step 3).
This pen is for personal use only. Do not share it with anyone else. 
If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Never use SoloStar if it is damaged or if not sure that it is working properly.
Always have a spare SoloStar in case the SoloStar is lost or damaged.
Step 1. Check the insulin: A. Check the label on the SoloStar to make sure that the patient has the correct insulin. The Lantus Solostar is grey with a purple injection button.
B. Take off the pen cap.
C. Check the appearance of the insulin. Lantus is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Step 2. Attach the needle: Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as it is attached (screw or push on, depending on the needle type).
If the needle is not kept straight while it is attached, it can damage the rubber seal and cause leakage, or break the needle.
Step 3. Perform a Safety test: Always perform the safety test before each injection. This ensures that the patient gets an accurate dose by: ensuring that pen and needle work properly; removing air bubbles.
A. Select a dose of 2 units by turning the dosage selector.
B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.
C. Hold the pen with the needle pointing upwards.
D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
E. Press the injection button all the way in. Check if insulin comes out of the needle tip.
The safety test may have to be performed several times before insulin is seen.
If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
If still no insulin comes out, the needle may be blocked. Change the needle and try again.
If no insulin comes out after changing the needle, the SoloStar may be damaged. Do not use this SoloStar.
Step 4. Select the dose: Set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If a dose greater than 80 units is needed, give it as two or more injections.
A. Check that the dose window shows "0" following the safety test.
B. Select the required dose. If the patient turn the selector past the desired dose, it can be turn back down.
Do not push the injection button while turning, as insulin will come out.
The dosage selector cannot be turned past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either the patient can inject what is remaining in the pen and complete the dose with a new SoloStar or use a new SoloStar for the full dose.
Step 5. Inject the dose: A. Use the injection method as instructed by the doctor, pharmacist or nurse.
B. Insert the needle into the skin.
C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to "0" as it is injected.
D. Keep the injection button pressed all the way in. Slowly count to 10 before withdrawing the needle from the skin. This ensures that the full dose will be delivered.
The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Step 6. Remove and discard the needle: Always remove the needle after each injection and store SoloStar without a needle attached.
This helps prevent: Contamination and/or infection, Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
If the injection is given by another person, or if giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
Follow recommended safety measures for removal and disposal of needles (contact a doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
B. Dispose of the needle safely, as instructed by the doctor, pharmacist or nurse.
C. Always put the pen cap back on the pen, then store the pen until the next injection.
Storage instructions: If the SoloStar is in cool storage, take it out 1 to 2 hours before injecting to allow it to warm up. Cold insulin is more painful to inject.
Discard the used SoloStar as required by local authorities.
Maintenance: Protect the SoloStar from dust and dirt.
Clean the outside of the SoloStar by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
It should be handled with care. Avoid situations where SoloStar might be damaged. If the patient is concerned that the SoloStar may be damaged, use a new one.
Storage
Not in-use pens: Store in a refrigerator (2°C-8°C). Do not freeze or place 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 not above 30°C and away from direct heat or direct light. The pen in use must not be stored in the refrigerator.
Do not use it after this time period.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer use.
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Soln for inj (pre-filled pen) 3.64 mg/mL (100 u/mL) x 3 mL (clear, colorless) x 5's.
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