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中国科学院研究生院权威支持(北京)　电 话：010-　传 真：010-Humalog 75-25
Generic Name: 75-25 insulin lispro suspension and 25 insulin lispro injection
Brand Name: Humalog 75-25
Last reviewed on RxList: 3/26/2013
humalog 75-25 (75-25 insulin lispro suspension and 25 insulin lispro injection) drug
Drug Description
HUMALOG& Mix75/25&
(75% insulin lispro protamine) Suspension and (25% insulin lispro) Injection,
(rDNA origin) 100 Units per ML (U-100)
DESCRIPTION
Humalog& Mix75/25&
[75% insulin lispro protamine suspension and 25% insulin lispro injection,
(rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood
glucose-lowering agent and insulin lispro protamine suspension, an
intermediate-acting -lowering agent. Chemically, insulin lispro is
Lys(B28), Pro(B29) human insulin , created when the
positions 28 and 29 on the insulin B-chain are reversed. Insulin lispro is
synthesized in a special non- laboratory strain of Escherichia coli bacteria
that has been genetically altered to produce insulin lispro. Insulin lispro
protamine suspension (NPL component) is a suspension of crystals produced from
combining insulin lispro and protamine sulfate under appropriate conditions for
crystal formation.
Insulin lispro has the
following primary structure:
Insulin lispro has the
empirical formula C257H383N65O77S6
and a molecular weight of 5808, both identical to that of human insulin.
Humalog Mix75/25 vials and Pens
contain a sterile suspension of insulin lispro protamine suspension mixed with
soluble insulin lispro for use as an injection.
Each milliliter of Humalog
Mix75/25 injection contains insulin lispro 100 units, 0.28 mg protamine
sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 1.76 mg Metacresol,
content adjusted to provide 0.025 mg zinc ion, 0.715 mg , and
Water for Injection. Humalog Mix75/25 has a pH of 7.0 to 7.8. Hydrochloric acid
10% and/or sodium hydroxide 10% may have been added to adjust pH.
For Consumers
What are the precautions when taking 75-25 insulin lispro suspension and 25 insulin lispro injection (Humalog 75-25)?
Before taking this medication, tell your doctor or pharmacist if yo
or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.
Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell...
Indications & Dosage
INDICATIONS
Humalog Mix75/25, a mixture of 75%
protamine suspension and 25% insulin lispro injection, (rDNA origin), is
indicated in the treatment of patients with
for the control
of . Humalog Mix75/25 has a more rapid onset of glucose-lowering
activity compared with Humulin 70/30 while having a similar duration of action.
This profile is achieved by combining the rapid onset of Humalog with the
intermediate action of insulin lispro protamine suspension.
DOSAGE AND ADMINISTRATION
Table 1*: Summary of Pharmacodynamic Properties of
Insulin Products (Pooled Cross-Study Comparison)
Insulin Products
Dose, U/kg
Time of Peak Activity, Hours After Dosing
Percent of Total Activity Occurring inthe First 4 Hours
2.4 (0.8 - 4.3)
70% (49 - 89%)
0.32 (0.26 - 0.37)
4.4 (4.0 - 5.5)
54% (38 - 65%)
Humalog Mix75/25
2.6 (1.0 - 6.5)
35% (21 - 56%)
Humulin 70/30
4.4 (1.5 - 16)
32% (14 - 60%)
Humalog Mix50/50
2.3 (0.8 - 4.8)
45% (27 - 69%)
Humulin 50/50
3.3 (2.0 - 5.5)
44% (21 - 60%)
0.32 (0.27 - 0.40)
5.5 (3.5 - 9.5)
14% (3.0 - 48%)
NPL component
5.8 (1.3 - 18.3)
22% (6.3 - 40%)
* The information supplied in
Table 1 indicates when peak insulin activity can be expected and the percent of
the total insulin activity occurring during the first 4 hours. The information
was derived from 3 separate glucose clamp studies in nondiabetic subjects.
Values represent means, with ranges provided in parentheses.
Humalog Mix75/25 is intended
only for subcutaneous administration. Humalog Mix75/25 should not be
administered intravenously. Dosage regimens of Humalog Mix75/25 will vary among
patients and should be determined by the healthcare provider familiar with the
patient's metabolic needs, eating habits, and other lifestyle variables.
Humalog has been shown to be equipotent to Regular human insulin on a molar
basis. One unit of Humalog has the same glucose-lowering effect as one unit of
Regular human insulin, but its effect is more rapid and of shorter duration.
Humalog Mix75/25 has a similar glucose-lowering effect as compared with Humulin
70/30 on a unit for unit basis. The quicker glucose-lowering effect of Humalog
is related to the more rapid
rate of insulin lispro from
subcutaneous tissue.
Humalog Mix75/25 starts
more quickly than Regular human insulin, allowing for
convenient dosing immediately before a meal (within 15 minutes). In contrast,
mixtures containing Regular human insulin should be given 30 to 60 minutes
before a meal.
The rate of insulin absorption and consequently the onset
of activity are known to be affected by the site of injection, exercise, and
other variables. As with all insulin preparations, the time course of action of
Humalog Mix75/25 may vary considerably in different individuals or within the
same individual. Patients must be educated to use proper injection techniques.
Humalog Mix75/25 should be inspected visually before use.
Humalog Mix75/25 should be used only if it appears uniformly cloudy after
mixing. Humalog Mix75/25 should not be used after its expiration date.
HOW SUPPLIED
Humalog Mix75/25 [75% insulin lispro protamine suspension
and 25% insulin lispro injection, (rDNA origin)] is available in the following
package sizes: each presentation containing 100 units insulin lispro per mL
10 mL vials
5 x 3 mL prefilled insulin delivery devices (Pen)
5 x 3 mL prefilled insulin delivery devices (KwikPen&)
Humalog Mix75/25 should be
stored in a refrigerator [2& to 8&C (36& to 46&F)], but not in the freezer. Do
not use Humalog Mix75/25 if it has been frozen. Unrefrigerated [below 30&C
(86&F)] vials must be used within 28 days or be discarded, even if they still
contain Humalog Mix75/25. Unrefrigerated [below 30&C (86&F)] Pens, and KwikPens
must be used within 10 days or be discarded, even if they still contain Humalog
Mix75/25. Protect from direct heat and light. See table below:
Not In-Use (Unopened) Room Temperature [Below 30&C (86&F)]
Not In-Use (Unopened) Refrigerated
In-Use (Opened) Room Temperature [Below30&C (86&F)]
10 mL Vial
Until expiration date
28 days,refrigerated/room temperature.
3 mL Pen and KwikPen (prefilled)
Until expiration date
10 days. Do not refrigerate.
Marketed by: Lilly USA, LLC,
Indianapolis, IN 46285, USA. .
Side Effects & Drug Interactions
SIDE EFFECTS
Clinical studies comparing Humalog Mix75/25 with human
mixtures did not demonstrate a difference in frequency of adverse
events between the two treatments.
Adverse events commonly associated with human insulin
therapy include the following:
Body as a Whole & allergic reactions (see ).
Skin and Appendages & injection site
reaction, , , rash.
(see WARNINGS AND ).
DRUG INTERACTIONS
Insulin requirements may be increased by medications with
hyperglycemic activity such as corticosteroids, isoniazid, certain
lipid-lowering drugs (e.g., ), , oral contraceptives,
phenothiazines, and
replacement therapy.
Insulin requirements may be decreased in the presence of
drugs that increase insulin sensitivity or have
activity, such as
oral antidiabetic agents, salicylates, sulfa antibiotics, certain
(monoamine oxidase inhibitors),
-converting-enzymeinhibitors, angiotensin II receptor blocking
agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g.,
octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of
hypoglycemia in some patients.
Warnings & Precautions
Humalog differs from Regular human insulin by its
rapid onset of action as well as a shorter duration of activity. Therefore, the
dose of Humalog Mix75/25 should be given within 15 minutes before a meal.
Hypoglycemia is the most common adverse effect
associated with the use of insulins, including Humalog Mix75/25. As with all
insulins, the timing of hypoglycemia may differ among various insulin
formulations. Glucose monitoring is recommended for all patients with diabetes.
Any change of insulin should be made cautiously and
only under medical supervision. Changes in insulin strength, manufacturer, type
(e.g., Regular, NPH, analog), species, or method of manufacture may result in
the need for a change in dosage.
Fluid retention and heart failure with concomitant use
of PPAR-gamma agonists: Thiazolidinediones (TZDs), which are peroxisome
proliferator-activated receptor () gamma agonists, can cause dose-related
fluid retention, particularly when used in combination with . Fluid retention
may lead to or exacerbate . Patients treated with insulin,
including Humalog Mix75/25, and a PPAR-gamma agonist should be observed for
signs and symptoms of heart failure. If heart failure develops, it should be
managed according to currentstandards of care, and discontinuation or dose
reduction of the PPAR-gamma agonist must be considered.
PRECAUTIONS
are among the potential
clinical adverse effects associated with the use of all insulins. Because of
differences in the action of Humalog Mix75/25 and other insulins, care should
be taken in patients in whom such potential side effects might be clinically
relevant (e.g., patients who are fasting, have , or are
using - lowering drugs or patients taking drugs sensitive to serum
potassium level).
and hypersensitivity are among other potential
clinical adverse effects associated with the use of all insulins.
As with all insulin preparations, the time course of
Humalog Mix75/25 action may vary in different individuals or at different times
in the same individual and is dependent on site of injection, blood supply,
temperature, and physical activity.
Adjustment of dosage of any insulin may be necessary if
patients change their physical activity or their usual meal plan. Insulin
requirements may be altered during illness, emotional disturbances, or other
Hypoglycemia
As with all insulin preparations,
may be associated with the administration of Humalog Mix75/25. Rapid changes in
serum glucose concentrations may induce symptoms of hypoglycemia in persons
with , regardless of the glucose value. Early warning symptoms of
hypoglycemia may be different or less pronounced under certain conditions, such
as long duration of diabetes, diabetic nerve disease, use of medications such
as beta-blockers, or intensified diabetes control.
Renal Impairment
As with other insulins, the requirements for Humalog
Mix75/25 may be reduced in patients with renal impairment.
Hepatic Impairment
Although impaired
function does not affect the
or disposition of Humalog, careful glucose monitoring and dose
adjustments of insulin, including Humalog Mix75/25, may be necessary.
Local Allergy & As with any insulin therapy,
patients may experience redness, swelling, or itching at the site of injection.
These minor reactions usually resolve in a few days to a few weeks. In some
instances, these reactions may be related to factors other than insulin, such
as irritants in the skin cleansing agent or poor injection technique.
Systemic Allergy & Less common, but potentially
more serious, is generalized
to insulin, which may cause rash
(including ) over the whole body, shortness of breath, ,
reduction in blood pressure, rapid pulse, or sweating. Severe cases of
generalized allergy, including anaphylactic reaction, may be life threatening.
Localized reactions and generalized myalgias have been reported with the use of
cresol as an injectable excipient.
Antibody Production & In clinical trials,
antibodies that cross-react with human insulin and insulin lispro were observed
in both human insulin mixtures and insulin lispro mixtures treatment groups.
Information for Patients
Patients should be informed of the potential risks and
advantages of Humalog Mix75/25 and alternative therapies. Patients should not
mix Humalog Mix75/25 with any other insulin. They should also be informed about
the importance of proper insulin storage, injection technique, timing of
dosage, adherence to meal planning, regular physical activity, regular blood
glucose monitoring, periodic
testing, recognition and management
of hypo- and , and periodic assessment for diabetes complications.
Patients should be advised to inform their physician if
they are pregnant or intend to become pregnant.
Refer patients to the
leaflet for
information on normal appearance, timing of dosing (within 15 minutes before a
meal), storing, and common adverse effects.
For Patients Using Insulin Pen Delivery Devices: Before
starting therapy, patients should readthe Patient Information leaflet that
accompanies the drug product and the User Manual thataccompanies the delivery
device and re-read them each time the prescription is renewed. Patients should
be instructed on how to properly use the delivery device, prime the Pen to a
stream of insulin, and properly dispose of needles. Patients should be advised
not to share their Pens with others.
Laboratory Tests
As with all insulins, the therapeutic response to Humalog
Mix75/25 should be monitored by periodic
tests. Periodic
measurement of hemoglobin A1c is recommended for the monitoring of long-term
glycemic control.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to
evaluate the
of Humalog, Humalog Mix75/25, or Humalog
Mix50/50. Insulin lispro was not mutagenic in a battery of in vitro and in vivo
genetic toxicity assays (bacterial mutation tests, unscheduled DNA synthesis,
assay, chromosomal
tests, and a micronucleus test).
There is no evidence from animal studies of impairment of fertility induced by
insulin lispro.
Teratogenic Effects - Pregnancy Category B
Reproduction studies with insulin lispro have been
performed in pregnant rats and rabbits at
doses up to 4 and 0.3
times, respectively, the average human dose (40 units/day) based on body
surface area. The results have revealed no evidence of impaired fertility or
harm to the fetus due to insulin lispro. There are, however, no adequate and
well-controlled studies with Humalog, Humalog Mix75/25, or Humalog Mix50/50 in
pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
It is unknown whether insulin lispro is excreted in
significant amounts in human milk. Many drugs, including human insulin, are
excreted in human milk. For this reason, caution should be exercised when
Humalog Mix75/25 is administered to a nursing woman. Patients with diabetes who
are lactating may require adjustments in Humalog Mix75/25 dose, meal plan, or
Pediatric Use
Safety and effectiveness of Humalog Mix75/25 in patients
less than 18 years of age have not been established.
Geriatric Use
Clinical studies of Humalog Mix75/25 did not include
sufficient numbers of patients aged 65 and over to determine whether they
respond differently than younger patients. In general, dose selection for an
elderly patient should take into consideration the greater frequency of
decreased hepatic, renal, or cardiac function, and of concomitant disease or
other drug therapy in this population.
Overdosage & Contraindications
may occur as a result of an excess of
relative to food intake, energy expenditure, or both. Mild episodes of
hypoglycemia usually can be treated with oral glucose. Adjustments in drug
dosage, meal patterns, or exercise, may be needed. More severe episodes with
coma, , or neurologic impairment may be treated with
/subcutaneous glucagon or concentrated intravenous glucose.
intake and observation may be necessary because
hypoglycemia may recur after apparent clinical recovery.
CONTRAINDICATIONS
Humalog Mix75/25 is contraindicated during episodes of
hypoglycemia and in patients sensitive to insulin lispro or any of the
excipients contained in the formulation.
Clinical Pharmacology
CLINICAL PHARMACOLOGY
Antidiabetic Activity
The primary activity of
, including Humalog Mix75/25, is the regulation of glucose .
In addition, all insulins have several anabolic and anti-catabolic actions on
many tissues in the body. In muscle and other tissues (except the brain),
insulin causes rapid transport of glucose and
intracellularly,
promotes anabolism, and inhibits protein . In the liver, insulin
promotes the uptake and storage of glucose in the form of glycogen, inhibits
gluconeogenesis, and promotes the conversion of excess glucose into fat.
Insulin lispro, the
rapid-acting component of Humalog Mix75/25, has been shown to be equipotent to
Regular human insulin on a molar basis. One unit of Humalog& has the
same glucose-lowering effect as one unit of Regular human insulin, but
its effect is more rapid and of shorter duration. Humalog Mix75/25 has a
similar glucose-lowering effect as compared with Humulin& 70/30 on a
unit for unit basis.
Pharmacokinetics
Absorption
Studies in nondiabetic subjects and patients with type 1
(insulin-dependent)
demonstrated that Humalog, the rapid-acting
component of Humalog Mix75/25, is absorbed faster than Regular human insulin
(U-100). In nondiabetic subjects given subcutaneous doses of Humalog ranging
from 0.1 to 0.4 U/kg, peak serum concentrations were observed 30 to 90 minutes
after dosing. When nondiabetic subjects received equivalent doses of Regular
human insulin, peak insulin concentrations occurred between 50 to 120 minutes
after dosing. Similar results were seen in patients with .
Figure 1: Serum Immunoreactive Insulin (IRI)
Concentrations, After Subcutaneous Injection of Humalog Mix75/25 or Humulin
70/30 in Healthy Nondiabetic Subjects.
Humalog Mix75/25 has two phases
of . The early phase represents insulin lispro and its distinct
characteristics of rapid onset. The late phase represents the prolonged action
of insulin lispro protamine suspension. In 30 healthy nondiabetic subjects
given subcutaneous doses (0.3 U/kg) of Humalog Mix75/25, peak serum
concentrations were observed 30 to 240 minutes (median, 60 minutes) after
dosing (see Figure 1). Identical results were found in patients with type 1
diabetes. The rapid absorption characteristics of Humalog are maintained with
Humalog Mix75/25 (see Figure 1).
Figure 1 represents serum
insulin concentration versus time curves of Humalog Mix75/25 and Humulin 70/30.
Humalog Mix75/25 has a more rapid absorption than Humulin 70/30, which has been
confirmed in patients with type 1 diabetes.
Distribution
Radiolabeled distribution
studies of Humalog Mix75/25 have not been conducted. However, the volume of
distribution following injection of Humalog is identical to that of Regular
human insulin, with a range of 0.26 to 0.36 L/kg.
Metabolism
Human metabolism studies of
Humalog Mix75/25 have not been conducted. Studies in animals indicate that the
metabolism of Humalog, the rapid-acting component of Humalog Mix75/25, is
identical to that of Regular human insulin.
Elimination
Humalog Mix75/25 has two absorption phases, a rapid and a
prolonged phase, representative of the insulin lispro and insulin lispro
protamine suspension components of the mixture. As with other
intermediate-acting insulins, a meaningful terminal phase half-life cannot be calculated
after administration of Humalog Mix75/25 because of the prolonged insulin
lispro protamine suspension absorption.
Pharmacodynamics
Studies in nondiabetic subjects and patients with
diabetes demonstrated that Humalog has a more rapid onset of glucose-lowering
activity, an earlier peak for glucose-lowering, and a shorter duration of
glucose-lowering activity than Regular human insulin. The early onset of
activity of Humalog Mix75/25 is directly related to the rapid absorption of
Humalog. The time course of action of insulin and insulin analogs, such as
Humalog (and hence Humalog Mix75/25), may vary considerably in different
individuals or within the same individual. The parameters of Humalog Mix75/25
activity (time of onset, peak time, and duration) as presented in Figures 2 and
3 should be considered only as general guidelines. The rate of insulin
absorption and consequently the onset of activity is known to be affected by
the site of injection, exercise, and other variables (see General under ).
In a glucose clamp study performed in 30 nondiabetic
subjects, the onset of action and glucose-lowering activity of Humalog, Humalog& Mix50/50&, Humalog Mix75/25, and insulin lispro protamine suspension (NPL
component) were compared (see Figure 2). Graphs of mean glucoseinfusion rate
versus time showed a distinct insulin activity profile for each formulation.
The rapid onset of glucose-lowering activity characteristic of Humalog was
maintained in Humalog Mix75/25.
In separate glucose clamp studies performed in
nondiabetic subjects, pharmacodynamics of Humalog Mix75/25 and Humulin 70/30
were assessed and are presented in Figure 3. Humalog Mix75/25 has a duration of
activity similar to that of Humulin 70/30.
Figure 2: Insulin Activity
After Injection of Humalog, Humalog Mix50/50, Humalog Mix75/25, or Insulin
Lispro Protamine Suspension (NPL Component) in 30 Nondiabetic Subjects.
Figure 3: Insulin Activity
After Injection of Humalog Mix75/25 and Humulin 70/30 in Nondiabetic Subjects.
Figures 2 and 3 represent
insulin activity profiles as measured by glucose clamp studies in healthy
nondiabetic subjects.
Figure 2 shows the time
activity profiles of Humalog, Humalog Mix50/50, Humalog Mix75/25, and insulin
lispro protamine suspension (NPL component).
Figure 3 is a comparison of the
time activity profiles of Humalog Mix75/25 (see Figure 3a) andof Humulin 70/30
(see Figure 3b) from two different studies.
Special Populations
Age and Gender & Information on the
effect of age on the pharmacokinetics of Humalog Mix75/25 is unavailable.
Pharmacokinetic and pharmacodynamic comparisons between men and women
administered Humalog Mix75/25 showed no gender differences. In large Humalog
clinical trials, sub-group analysis based on age and gender demonstrated that
differences between Humalog and Regular human insulin in
parameters are maintained across sub-groups.
Smoking & The effect of
smoking on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has
not been studied.
Pregnancy & The effect of
pregnancy on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has
not been studied.
Obesity & The effect of
and/or subcutaneous fat thickness on the pharmacokinetics and
pharmacodynamics of Humalog Mix75/25 has not been studied. In large clinical
trials, which included patients with
up to and including 35
kg/m2, no consistent differences were observed between Humalog and
Humulin& R with respect to postprandialglucose parameters.
Renal Impairment & The effect of renal
impairment on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has
not been studied. In a study of 25 patients with
and a wide
range of renal function, the pharmacokinetic differences between Humalog
and Regular human insulin were generally maintained. However, the sensitivity
of the patients to insulin did change, with an increased response to insulin as
the renal function declined. Careful glucose monitoring and dose reductions of
insulin, including Humalog Mix75/25, may be necessary in patients with renal
dysfunction.
Hepatic Impairment & Some studies with human
insulin have shown increased circulating levels of insulin in patients with
failure. The effect of hepatic impairment on the pharmacokinetics and
pharmacodynamics of Humalog Mix75/25 has not been studied. However, in a study
of 22 patients with type 2 diabetes, impaired hepatic function did not affect
the subcutaneous absorption or general disposition of Humalog when compared
with patients with no history of hepatic dysfunction. In that study, Humalog
maintained its more rapid absorption and elimination when compared with Regular
human insulin. Careful glucose monitoring and dose adjustments of insulin,
including Humalog Mix75/25, may be necessary in patients with hepatic
dysfunction.
Medication Guide
PATIENT INFORMATION
(HU-ma-log) Mix75/25& 75% insulin ispro protamine suspension and 25% insulin
lispro injection (rDNA origin)
Important:
Know your insulin. Do not change the type of
insulin you use unless told to do so by your healthcare provider. Your insulin
dose and the time you take your dose can change with different types of insulin.
Make sure you have the right type and strength of insulin
prescribed for you.
Read the Patient Information that comes with Humalog
Mix75/25 before you start using it and each time you get a refill. There may be
new information. This leaflet does not take the place of talking with your
healthcare provider about your
or treatment. Make sure that you know
how to manage your diabetes. Ask your healthcare provider if you have questions
about managing your diabetes.
What is Humalog Mix75/25?
Humalog Mix75/25 is a mixture of fast-acting and
longer-acting man-made insulins. Humalog Mix75/25 is used to control high blood
sugar (glucose) in people with diabetes.
Humalog Mix75/25 comes in:
10 mL vials (bottles) for use with a syringe
Prefilled pens
Who should not take Humalog Mix75/25?
Do not take Humalog Mix75/25 if:
your blood sugar is too low (). After
treating your low blood sugar, follow your healthcare provider's instructions
on the use of Humalog Mix75/25.
you are allergic to anything in Humalog Mix75/25. See the
end of this leaflet for a complete list of ingredients in Humalog Mix75/25.
What should I tell my healthcare provider before
taking Humalog Mix75/25?
Before you use Humalog Mix75/25, tell your healthcare
provider if you:
have liver or kidney problems or any other medical
conditions. Medical conditions can affect your insulin needs and your dose
of Humalog Mix75/25.
take any other medicines, especially ones commonly called
TZDs (thiazolidinediones).
or other heart problems. If you have
heart failure, it may get worse while you take TZDs with Humalog Mix75/25.
are pregnant or breastfeeding. You and your
healthcare provider should talk about the best way to manage your diabetes
while you are pregnant or breastfeeding. Humalog Mix75/25 has not been studied
in pregnant or nursing women.
take other medicines, including prescription and
non-prescription medicines, vitamins and herbal supplements. Many medicines
can affect your blood sugar levels and insulin needs. Your Humalog Mix75/25
dose may need to change if you take other medicines.
Know the medicines you take. Keep a list of your
medicines with you to show to all of your healthcare providers.
How should I use Humalog Mix75/25?
Talk to your healthcare provider if you have any
questions. Your healthcare provider will tell you the right syringes to use
with Humalog Mix75/25 vials. Your healthcare provider should show you how to
inject Humalog Mix75/25 before you start using it. Read the User Manual that
comes with your Humalog Mix75/25 prefilled pen.
Use Humalog Mix75/25 exactly as prescribed by your
healthcare provider.
Humalog Mix75/25 starts working faster than other
insulins that contain regular human insulin. Inject Humalog Mix75/25
fifteen minutes or less before a meal. If you do not plan to eat within 15
minutes, delay the injection until the correct time (15 minutes before eating).
Check your blood sugar levels as told by your
healthcare provider.
Mix Humalog Mix75/25 well before each use. For
Humalog Mix75/25 in a vial, carefully shake or rotate the vial until completely
mixed. For prefilled pens, carefully follow the User Manual for instructions on
mixing the pen. Humalog Mix75/25 should be cloudy or milky after mixing well.
Look at your Humalog Mix75/25 before each injection. If
it is not evenly mixed or has solid particles or clumps in it, do not use.
Return it to your pharmacy for new Humalog Mix75/25.
Inject your dose of Humalog Mix75/25 under the skin of
your stomach area, upper arm, upper leg, or buttocks. Never inject Humalog
Mix75/25 into a muscle or vein.
Change (rotate) your injection site with each dose.
Your insulin needs may change because of:
other medicines you take
changes in eating
physical activity changes
Follow your healthcare provider's instructions to make
changes in your insulin dose.
Never mix Humalog Mix75/25 in the same syringe with
other insulin products.
Never use Humalog Mix75/25 in an insulin pump.
Always carry a quick source of sugar to treat low
blood sugar, such as glucose tablets, hard candy, or juice.
What are the possible side effects of Humalog
Low Blood Sugar (Hypoglycemia). Symptoms of low
blood sugar include:
feeling shaky or shakiness
lightheadedness
irritability
fast heartbeat
Low blood sugar symptoms can happen suddenly. Symptoms of
low blood sugar may be different for each person and may change from time to
time. Severe low blood sugar can cause seizures and death. Low blood sugar may
affect your ability to drive a car or use mechanical equipment, risking injury
to yourself or others. Know your symptoms of low blood sugar. Low blood sugar
can be treated by drinking juice or regular soda or eating glucose tablets,
sugar, or hard candy. Follow your healthcare provider's instructions for
treating low blood sugar. Talk to your healthcare provider if low blood sugar
is a problem for you.
Serious allergic reactions (whole body allergic
reaction). Severe, life-threatening allergic reactions can happen with
insulin. Get medical help right away if you develop a rash over your whole
body, have trouble breathing, , a fast heartbeat, orsweating.
Reactions at the injection site (local allergic
reaction). You may get redness, swelling, and itching at the injection site.
If you keep having injection site reactions or they are serious, you need to
call your healthcare provider. Do not inject insulin into a skin area that is
red, swollen, or itchy.
Skin thickens or pits at the injection site
(lipodystrophy). This can happen if you don'tchange (rotate) your injection
sites enough.
Humalog Mix75/25 may cause serious side effects,
including:
swelling of your hands and feet
heart failure. Taking certain diabetes pills
called thiazolidinediones or &TZDs& with Humalog Mix75/25 may cause heart
failure in some people. This can happen even if you have never had heart
failure or heart problems before. If you already have heart failure it may get
worse while you take TZDs with Humalog Mix75/25. Your healthcare provider should
monitor you closely while you are taking TZDs with Humalog Mix75/25. Tell your
healthcare provider if you have any new or worse symptoms of heart failure
including:
shortness of breath
swelling of your ankles or feet
sudden weight gain
Treatment with TZDs and Humalog Mix75/25 may need to be
adjusted or stopped by your healthcare provider if you have new or worse heart
These are not all the side effects from Humalog Mix75/25.
Ask your healthcare provider or pharmacist for more information.
How should I store Humalog Mix75/25?
Store all unopened (unused) Humalog Mix75/25 in the
original carton in a refrigerator at 36&F to 46&F (2&C to 8&C). Do not
Do not use Humalog Mix75/25 that has been frozen.
Do not use after the expiration date printed on the
carton and label.
Protect Humalog Mix75/25 from extreme heat, cold or
After starting use (open):
Vials: Keep in the refrigerator or at room
temperature below 86&F (30&C) for up to 28 days. Keep open vials away from
direct heat or light. Throw away an opened vial 28 days after first use, even
if there is insulin left in the vial.
Prefilled Pens: Do not store a prefilled pen that
you are using in the refrigerator. Keep at room temperature below 86&F (30&C)
for up to 10 days. Throw away a prefilled pen 10days after first use, even if
there is insulin left in the pen.
General information about Humalog Mix75/25
Use Humalog Mix75/25 only to treat your diabetes. Do not
share it with anyone else, even if they also have diabetes. It may harm them.
This leaflet summarized the most important information
about Humalog Mix75/25. If you would like more information about Humalog
Mix75/25 or diabetes, talk with your healthcare provider. You can ask your
healthcare provider or pharmacist for information about Humalog Mix75/25 that
is written for healthcare providers.
For questions you may call 1-800-LillyRx (1-800-545-5979)
or visit .
What are the ingredients in Humalog Mix75/25?
Active ingredients: insulin lispro protamine
suspension and insulin lispro.
Inactive ingredients: protamine sulfate, glycerin,
dibasic sodium phosphate, metacresol,
(zinc ion),
for injection.
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Instructions for Use
HUMALOG& Mix75/25& KwikPen&
75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA
Read the Instructions for Use
before you start taking HUMALOG Mix75/25 and each time you get a refill. There
may be new information. This information does not take the place of talking to
your healthcare provider about your medical condition or your treatment.
HUMALOG& Mix75/25&
KwikPen& (&Pen&) is a disposable pen containing 3 mL (300 units) of U-100
HUMALOG& Mix75/25& [75% insulin lispro protamine suspension and 25%
insulin lispro injection (rDNA origin)] insulin. You can inject from 1 to 60
units in a single injection.
Do not share your HUMALOG
Mix75/25 KwikPen or needles with anyone else. You may give an infection to them
or get an infection from them.
This Pen is not recommended
for use by the blind or visually impaired without the assistance of a person
trained in the proper use of the product.
Supplies you will need to
give your HUMALOG Mix75/25 injection:
HUMALOG Mix75/25 KwikPen
HUMALOG Mix75/25 KwikPen compatible needle (Becton, Dickinson
and Company Pen Needles recommended)
Alcohol swab
Preparing HUMALOG Mix75/25
Wash your hands with soap and
Check the HUMALOG Mix75/25
KwikPen Label to make sure you are taking the right type of insulin. This is
especially important if you use more than 1 type of insulin.
Do not use HUMALOG Mix75/25 past
the expiration date printed on the Label.
Always use a new needle for each injection to help ensure sterility
and prevent blocked needles.
Pull the Pen Cap straight off.
Wipe the Rubber Seal with an alcohol swab.
Do not twist the cap.
Do not remove the KwikPen Label.
Gently roll the Pen ten times.
the Pen ten times.
HUMALOG Mix75/25 should look
white and cloudy after mixing. Do not use if it looks clear or contains
any lumps or particles.
Pull off the Paper Tab from
Outer Needle Shield.
Push the capped Needle straight
onto the Pen and turn the Needle forward until it is tight.
Pull off the Outer Needle
Shield. Do not throw it away.
Pull off the Inner Needle
Shield and throw it away.
Priming your HUMALOG
Mix75/25 KwikPen:
Prime before each injection. Priming ensures the Pen
is ready to dose and removes air that may collect in the cartridge during
normal use. If you do not prime before each injection, you may get too
much or too little insulin.
Turn the Dose Knob to select 2 units.
Hold your Pen with the Needle
pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
Hold your Pen with Needle
pointing up. Push the Dose Knob in until it stops, and &0& is seen in the Dose
Window. Hold the Dose Knob in and count to 5 slowly.
A stream of insulin should be seen from the needle.
If you do not see a
stream of insulin, repeat steps 6 to 8, no more than 4 times.
If you still do not see
a stream of insulin, change the needle and repeat steps 6 to 8.
Selecting your dose
Turn the Dose Knob to select
the number of units you need to inject. The Dose Indicator should line up with
your dose.
The dose can be corrected by turning
the Dose Knob in either direction until the correct dose lines up with the Dose
Indicator.
The even numbers are
printed on the dial. The odd numbers, after the number 1, are shown as
full lines.
The HUMALOG Mix75/25 KwikPen will not let you dial more
than the number of units left in the Pen.
If your dose is more than the number of units left in the
Pen, you may either:
inject the amount left in your Pen and then use a new Pen
to give the rest of your dose, or
get a new Pen and inject the full dose.
The Pen is designed to deliver a total of 300 units of
insulin. The cartridge contains an additional small amount of insulin that
can't be delivered.
Giving your HUMALOG Mix75/25
injection:
Inject your HUMALOG Mix75/25 as
your healthcare provider has shown you.
Change (rotate) your injection site for each injection.
Do not try to change your dose
while injecting HUMALOG Mix75/25.
Choose your injection site.
HUMALOG Mix75/25 is injected
under the skin (subcutaneously) of your stomach area, buttocks, upper legs or
upper arms.
Wipe the skin with an alcohol
swab, and let the injection site dry before you inject your dose.
Insert the Needle into your
Put your thumb on the Dose Knob
and push the Dose Knob in until it stops. Hold the Dose Knob in and slowly
count to 5.
Pull the Needle out of your
You should see &0& in the Dose
Window. If you do not see &0& in the Dose Window, you did not receive your full
If you see blood after you take
the Needle out of your skin, press the injection site lightly with a piece of
gauze or an alcohol swab. Do not rub the area.
A drop of insulin at the needle
tip is normal. It will not affect your dose.
If you do not think you
received your full dose, do not take another dose. Call Lilly or your
healthcare provider for assistance.
Carefully replace the Outer
Needle Shield.
Unscrew the capped Needle and
throw it away.
Do not store the Pen with the
Needle attached to prevent leaking, blocking of the Needle, and air from
entering the Pen.
Replace the Pen Cap by lining
up the Cap Clip with the Dose Indicator and pushing straight on.
After your injection
Put your used needles and pens
in a FDA-cleared sharps disposal container right away after use. Do not throw
away (dispose of) loose needles and pens in
your household trash.
If you do not have a
FDA-cleared sharps disposal container, you may use a household container that
made of a heavy-duty plastic,
can be closed with a
tight-fitting, puncture-resistant lid, without sharps being able to come out,
upright and stable during use,
leak-resistant, and
properly labeled to warn of
hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your
community guidelines for the right way to dispose of your sharps disposal
container. There may be state or local laws about how you should throw away
used needles and pens. For more information about safe sharps disposal, and for
specific information about sharps disposal in the state that you live in, go to
the FDA's website at: http://www.fda.gov/safesharpsdisposal
How should I store my
HUMALOG Mix75/25 KwikPen?
Store unused HUMALOG Mix75/25
Pens in the refrigerator at 36&F to 46&F (2&C to 8&C). The Pen you are
currently using can be stored out of the refrigerator below 86&F (30&C).
Do not freeze HUMALOG Mix75/25. Do not use HUMALOG Mix75/25 if it
has been frozen.
Unused HUMALOG Mix75/25 Pens
may be used until the expiration date printed on the Label, if kept in the
refrigerator.
The HUMALOG Mix75/25 Pen you
are using should be thrown away after 10 days, even if it still has insulin left in it.
Keep HUMALOG Mix75/25 away from
heat and out of the light.
General information about
the safe and effective use of HUMALOG Mix75/25 KwikPen
Keep HUMALOG Mix75/25
KwikPen and needles out of the reach of children.
Do not use your Pen if any part
looks broken or damaged.
Always carry an extra Pen in
case yours is lost or damaged.
If you can not remove the Pen
Cap, gently twist the Pen Cap back and forth, and then pull the Pen Cap
straight off.
If it is hard to push the Dose Knob or the Pen is not working the right way:
Your Needle may be blocked. Put
on a new Needle and prime the Pen.
You may have dust, food, or
liquid inside the Pen. Throw the Pen away and get a new one.
It may help to push the Dose
Knob more slowly during your injection.
Use the space below to keep
track of how long you should use each HUMALOG Mix75/25 KwikPen.
Write down the date you start
using your HUMALOG Mix75/25 KwikPen. Count forward 10 days.
Write down the date you should
throw it away.
Pen 1 - First used on[Date]
_______ + 10 days = Throw out on [Date]______
Pen 1 - First used on [Date]_______
Throw out on [Date]_______
Pen 2 - First used on [Date]
_______ Throw out on [Date]_______
Pen 3 - First used on [Date]
_______ Throw out on [Date]_______
Pen 4 - First used on [Date]_______
Throw out on[Date] _______
Pen 5 - First used on [Date]
_______ Throw out on [Date]_______
If you have any questions or
problems with your HUMALOG Mix75/25 KwikPen, contact Lilly at 1-800-Lilly-Rx
(1-800-545-5979) or call your healthcare provider for help. For more
information on HUMALOG Mix75/25 KwikPen and insulin, go to .
These Instructions for Use have
been approved by the U.S. Food and Drug Administration.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the
website or call 1-800-FDA-1088.
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