Download Humulin ®R U-500 WAHT-CG-768 - Worcestershire Acute Hospitals

Humulin®R U-500 Concentrated Insulin
Presentation:
Humulin®R (human insulin r-DNA origin) U-500 (500 units per
ml, concentrated Insulin) clear colourless solution, 20ml vial
Indications:
Humulin®R U-500 insulin is a treatment option for patients with
type 1 and type 2 diabetes mellitus who require more than 200
units of insulin a day.
Humulin®R U-500 is useful for the treatment of insulin resistant
patients requiring high doses of insulin since a large dose can
be administered subcutaneously in a reasonable volume.
When managing diabetes with Humulin®R U-500 important steps must be taken to
reduce the risk of prescribing and administration errors. It is extremely important that
healthcare professionals prescribing or administering Humulin®R U-500 understand
the strength is different to standard insulin currently available (ref: table page 2).
Dosage and Administration:
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By Subcutaneous injection only. It should not be used intravenously or
intramuscularly.
The injection should be followed by food in the patient approximately 30
minutes after administration.
Humulin®R U-500 should either be injected subcutaneously into the
abdominal wall, thigh or upper arm. Patients should be encouraged to selfadminister their own insulin wherever possible (Refer to trust guideline
WAHT-CG-447, MedPolSOP9). The Diabetic Specialist Nurses can advise
patients on injection site(s) and technique. (Refer to trust guideline WAHTEND-006).
Humulin®R U-500 is usually administered two or three times daily. Dosage
will be determined by a Doctor/Prescriber and will vary between patients in
accordance with their needs.
Adjustment of dosage may be needed if patients experience a change in their
physical activity or food intake. Insulin requirements may differ in patients
during periods of illness or stress.
Humulin®R U-500 should be administered using a standard U-100 insulin
syringe.
Humulin®R U-500 should be prescribed as both actual dose (number of units)
and unit markings on a U-100 insulin syringe to ensure the patient receives
the correct dosage of insulin (ref: chart page 3). It should be prescribed on the
trust’s subcutaneous insulin prescription chart (WR2169).
5 units of Humulin®R U-500 is equal to 1 unit marking on a U-100 insulin
syringe (ref: table page 2).
All insulin doses should be measured and administered using a specific U100 insulin syringe. Intravenous syringes must never be used to administered
insulin to patients.
The use of abbreviations for the word units is not allowed and must be clearly
written in full on insulin prescription charts.
As with all insulin, the duration of action will vary according to the dose, site of
injection, blood-flow, temperature and level of physical activity in the patient.
Humulin®R U-500
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See table below for commonly prescribed dosages of Humulin®R U-500 and
the equivalent unit markings on a U-100 insulin syringe:
Conversion chart for Humulin®R U-500 insulin dose when using a U-100
insulin syringe
Dosage
(units)of
®
Humulin R
Unit markings
on U-100 insulin
syringe
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Dosage
(units)of
®
Humulin R
105
110
115
120
125
130
135
140
145
150
155
160
165
170
175
180
185
190
195
200
Unit markings on
U-100 insulin
syringe
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Dosage
(units)of
®
Humulin R
205
210
215
220
225
230
235
240
245
250
255
260
265
270
275
280
285
290
295
300
Unit markings
on U-100
insulin
syringe
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
For doses other than those listed the following formula can be used:
Prescribed dose of
Humulin®R (units)
divide by 5 = unit markings on U-100 insulin syringe
Example:
340 units of
Humulin®R
Humulin®R U-500
divide by 5 = 68 unit markings on U-100 insulin syringe
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Example Prescription:
DATE
INSULIN TYPE
Breakfast
Lunch
Humulin R U-500
20 unit markings
= 100
UNITS
Doctor Signature/Bleep
Nurse signature
Doctor Signature/Bleep
Nurse signature
Doctor J Bloggs
UNITS
Nurse signature
UNITS
UNITS
Nurse signature
Tea
Bedtime
24 unit markings
= 120
UNITS
Nurse signature
UNITS
Nurse signature
UNITS
Nurse signature
UNITS
Nurse signature
Contraindications:
Humulin®R U-500 is contraindicated in patients with hypoglycaemia and in any
patients who have experienced hypersensitivity to Humulin®R U-500 and any of its
excipients.
Side effects:
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Hypoglycaemia is the most common side-effect experienced by patients taking
Humulin® R U-500 insulin. Hypoglycaemia when using Humulin® R can be
prolonged and severe and can occur 18-24 hours after the last injection.
Symptoms of mild to moderate hypoglycaemia can occur suddenly and may
include: sweating, dizziness, palpitations, tremor, hunger, restlessness, tingling in
hands, feet, lips or tongue, lightheadedness, inability to concentrate, headache,
drowsiness, sleep disturbances, anxiety, blurred vision, slurred speech,
depressed mood, irritability, abnormal behaviour, unsteady movement,
personality changes. Symptoms of severe hypoglycaemia can include:
Disorientation, unconsciousness, seizures, impaired brain function, coma or
death.
Lipodystrophy can occur with the administration of insulin subcutaneously.
Hypokalaemia can result as insulin stimulates potassium movement into cells
possibly leading to low serum potassium levels. If left untreated this could lead to
respiratory paralysis, ventricular arrhythmias or even death.
Hypersensitivity & Allergic reactions. Local allergy reactions may occur at the
injection site including erythema, local oedema and itching. Systemic allergy
reactions to insulin are less common but are potentially serious. Symptoms can
include all over body rash, shortness of breath, wheezing, low blood pressure,
tachycardia & sweating. Severe cases of generalised allergy (anaphylaxis) may
be life threatening and require urgent medical attention.
Weight gain can occur with insulin therapy and has been attributed to the
anabolic effects of insulin.
Peripheral oedema. Insulin may cause sodium and water retention in certain
patients who have previously experienced poor metabolic control which has
improved with intensified insulin therapy.
Monitoring:
Blood glucose levels should be measured carefully following administration in
accordance with local guidance.
Humulin®R U-500
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Renal & Hepatic impairment:
The manufacturer advises caution in renal impairment. An increase in blood glucose
monitoring and/or dose reduction of insulin may be necessary in patients with renal
or hepatic impairment.
Compatibility
Do not mix Humulin®R U-500 with any other insulin. Administration is via
subcutaneous injection only. It should not be used intravenously or intramuscularly.
Common Drug Interactions
Drugs that may increase blood-glucose lowering effects of Humulin®R U-500 and
increase risk of hypoglycaemia are:
Drug
Effect
Oral antidiabetic drugs
e.g. metformin, gliclazide,
sitagliptin
Antidepressants
(specifically MAOI’s &
SSRIs)
ACE-inhibitors
Concurrent use of agents which lower blood glucose levels are
not recommended with Humulin®R U-500 due to lack of data.
Beta-adrenergic blockers
Can cause hypoglycaemia enhancing blood glucose lowering
effect of Humulin®R (ref: table page 5).
May increase blood glucose lowering effect.
Angiotensin II receptor
antagonists (e.g. losartan,
candesartan)
Inhibitors of pancreatic
function i.e.octreotide
Disopyramide
Fibrates (e.g. bezafibrate,
fenofibrate)
Pentoxifylline
Sulfonamide antibiotics
(e.g. Co-trimoxazole &
sulfadiazine)
Alcohol
May enhance blood glucose lowering effect when administered
with Humulin®R U-500.
May increase blood glucose lowering effect.
May increase risk of hypoglycaemia.
Enhanced hypoglycaemia effect.
Enhanced hypoglycaemia effect.
May lead to enhanced blood glucose lowering effect.
May lead to enhanced hypoglycaemia effect.
Increased risk of hypoglycaemia (ref: table page 5).
Drugs that may reduce the blood-glucose lowering effect of Humulin®R U-500 and
increase risk of hyperglycaemia are:
Drug
Effect
Corticosteroids
Can lead to hyperglycaemia leading to reduced blood-glucose
lowering effect of Humulin®R U-500.
May cause hyperglycaemia, decreasing the effect of
Humulin®R.
May cause glucose intolerance leading to hyperglycaemia.
Isoniazid
Oestrogens (HRT & oral
contraceptives)
Diuretics (e.g.Thiazides,
loop diuretics)
Protease inhibitors
Humulin®R U-500
Can cause hyperglycaemia decreasing the effect of Humulin®R
U-500.
Can cause insulin resistance leading to reduced blood-glucose
lowering effect of Humulin®R U-500.
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Somatropin (Human
growth hormone)
Danazol
May cause hyperglycaemia decreasing the effect of
Humulin®R.
May cause insulin resistance leading to reduced blood-glucose
lowering effect of Humulin®R U-500.
Atypical antipsychotics
May cause hyperglycaemia decreasing the effect of Humulin®R
U-500.
Sympathomimetic agents May cause hyperglycaemia decreasing the effect of Humulin®R
(i.e.ephedrine)
U-500.
Thyroid hormones
May reduce blood-glucose lowering effect of Humulin®R U-500.
Drugs that can increase or reduce the blood-glucose lowering effect of Humulin®R U500 leading to hypoglycaemia or hyperglycaemia are:
Drug
Effect
Beta-adrenergic blockers
Can cause both hypoglycaemia (ref: table page 4) and
hyperglycaemia decreasing blood glucose lowering effect of
Humulin®R U-500.
May increase or decrease blood glucose levels leading to a
reduced or enhanced effect of Humulin®R insulin
May increase or decrease blood glucose levels leading to a
reduced or enhanced effect of Humulin®R U-500 insulin (ref:
table page 5).
Can
cause
increased
hypoglycaemia
followed
by
hyperglycaemia after administration.
Increased risk of hyperglycaemia or hypoglycaemia (ref: table
page 4)
Lithium salts
clonidine
Pentamidine isetionate
Alcohol
Drugs which have the potential to mask signs and symptoms of hypoglycaemia are:
Further Information
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Do not use vial if it has become viscous or cloudy. The vial should only be used if
the solution is clear and colourless.
Humulin®R U-500 is currently an unlicensed medication in the UK. For further
advice on prescribing and supplying unlicensed medication to patients please
contact Medicines Information on ext: 30235.
Please ensure patients have an insulin passport which contains the correct & upto-date information regarding their Humulin®R U-500 insulin (Refer to trust
guideline MedPolSOP26).
Drug
Effect
Beta-adrenergic blockers
Clonidine
May mask symptoms of hypoglycaemia episode
May mask symptoms of hypoglycaemia episode
Guanethidine monosulfate
May mask symptoms of hypoglycaemia episode
Storage
Unopened vials of Humulin®R U-500 should be kept in a refrigerator between 2-8oC
and should not be used after the expiry date on the label.
Do not use Humulin®R U-500 if it has been frozen.
Humulin®R U-500
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Opened (in-use) vial of Humulin®R U-500 should be kept in the refrigerator or at
room temperature and used within 28 days of opening.
Keep Humulin®R U-500 away from heat and direct sunlight. Throw away any opened
vial after 28 days of use, even if there is insulin left in the vial.
Overdosage:
In the case of overdose the following symptoms can occur:
- Hypoglycaemia – mild episodes of hypoglycaemia can usually be treated with
oral glucose. Severe symptoms of hypoglycaemia can include seizures, coma
and neurological impairment. Hypoglycaemia when using Humulin®R U-500
can be prolonged and severe. Please refer to the trust treatment protocol for
hypoglycaemia WHAT-END-004 for further information).
- Hypokalaemia – which must be treated appropriately.
Additional management of the observed clinical effects should be initiated as
appropriate.
Summary - Humulin®R U-500
Strength
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Dose
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500 units per 1ml (five times more concentrated
than U-100 insulin)
Variable amongst patients and determined by
Prescriber
Usually administered two or three times daily
before food.
Administration Route
Subcutaneous route only.
Prescribing
Expressed as both units and unit markings on U100 insulin syringe on insulin prescription charts
(ref: table page 2, example prescription page 3).
Humulin®R U-500 should not be mixed with any
other insulin or medications
Unopened vials between 2-8oC in a refrigerator.
Opened vials in a refrigerator or at room
temperature. Do not store above 25oC. Protect from
heat and direct sunlight
Compatibility
Storage
Monograph Approved by MSC:
Joanne Shuck
Specialist Clinical Pharmacist, Diabetes & Endocrinology
Avon 1, WRH
References:
1. The British Medical Association and The Royal Pharmaceutical Society of Great
Britain. British National Formulary, No. 64: September 2012. The Bath Press,
Bath.
2. UCL Hospitals. Injectable Drug Administration Guide. 2007 Blackwell Publishing
Oxford.
Humulin®R U-500
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3. Summary of Product Characteristics. Humulin®R U-500 Insulin Human Injection
(Supplied with insulin). Accessed: 04/03/13.
4. National Patient Safety Agency (NPSA). June 2010. Rapid Response Report.
Safe Administration of Insulin. Accessed via: www.nrls.npsa.nhs.uk. Accessed
on: 04/03/13.
Humulin®R U-500
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