Drug Information Sheet("Kusuri-no-Shiori")
Self-injection
Published: 09/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
Brand name:LANTUS XR Inj. SoloStar
Active ingredient:Insulin Glargine(Genetical Recombination)
Dosage form:limpid and colorless injection, (band/injection button) apple green
Print on wrapping:
Effects of this medicine
This medicine is a human insulin analogue (insulin with a different amino-acid sequence) that lowers blood glucose
levels by inhibiting glucose production in the liver and promoting uptake of glucose in the muscle and fatty tissue.
It is usually used to treat diabetes mellitus for which insulin therapy is indicated.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have been eating poorly due to hypoglycemic symptoms, gastrointestinal disorders such as diarrhea and
vomiting, or cold.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<<
to be written by a healthcare professional>>
・In general, for adults, in the early phase, inject 4 to 20 units subcutaneously at a time, once a day. In some cases,
this medicine may be used concomitantly with other insulin preparations. This medicine should be injected at the
same time every day. Although the dosage may be adjusted according to the symptoms or examination findings, the
maintenance dose, including that of other insulin preparations, is 4 to 80 units a day in general. However, the dose
may exceed 80 units if necessary. Strictly follow the instructions.
・Use a type A disposable syringe needle (compliant with JIS T3226-2) intended for exclusive use with this medicine.
・If you find any problem when you attach the type A needle to Lantus XR Inj. SoloStar, such as leakage of the
solution for injection, change the needle to a new one.
・Make sure to attach a new needle every time immediately before injection.
・Inject this medicine subcutaneously into an upper arm or the femoral, abdominal or lumbar region. If a next dose is
to be injected in the same region, the injection site should be at least 2 to 3 cm apart from the previous site. Do
not inject into a vein.
・Do not share Lantus XR Inj. SoloStar with anyone.
・Do not use this medicine without the cartridge. Do not remove the medicinal solution from the cartridge using the
syringe.
・If you miss a dose, consult with your doctor. You should never inject two doses at one time.
・If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
・Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・Strictly follow the instructions on dietary/exercise therapy.
・Pay extra attention when you engage in dangerous operations such as working at heights or driving a car, since
development of hypoglycemia during such operations may lead to an accident.
・You may become susceptible to hypoglycemia by not eating or after heavy exercise, and persistent hypoglycemia
may result in a fatal accident.
・Be aware of the preventive methods and treatments for hypoglycemia (taking supplemental sugar, beverage, etc.,
immediately in case you notice any symptoms), and inform your family and persons around you about these
methods.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hypoglycemia, insomnia, hypoesthesia, vitreous bleeding,
hepatic steatosis, generalized itch, injection site reaction, injection site swelling and injection site bleeding. If any of
these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・lassitude, a strong sense of hunger, cold sweat [hypoglycemia]
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・generalized skin reaction (rash), angioneurotic edema (swelling of eyelids/lips), bronchospasm [shock, anaphylaxis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of children.
・Do not freeze unused Lantus XR Inj. SoloStar. Store it in a light shielding condition (at 2 to 8 degrees Celsius).
When taking this medicine out of the refrigerator for subcutaneous injection, warm it back up to room temperature
before use.
・After you start using this medicine, store away from light and freezing. Do not store in the refrigerator.
・Do not use this medicine that has passed for more than 6 weeks since started using.
・Ask your pharmacy or medical institution on how to discard them.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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