Dosing & Uses
Dosage Forms & Strengths
insulin isophane human/insulin regular human
injectable suspension
- (70 units/30 units)/mL
Type 1 Diabetes Mellitus
Suggested guidelines for beginning dose
Ketones moderate or less: 0.5 U/kg/day SC
Ketones large: 0.7 U/kg/day SC
Typically, 50-75% of total daily dose is given as intermediate- or long-acting insulin
May use this combination product if the dosage ratio of NPH (isophane) to regular is 2:1
Type 2 Diabetes Mellitus
Suggested guidelines for beginning dose; adjust according to blood glucose levels
Initial dose: 0.5-1 units/kg/day in divided doses
Typically, 50-75% of total daily dose is given as intermediate- or long-acting insulin
May use this combination product if the dosage ratio of NPH (isophane) to regular is 2:1
Morning
- Give 2/3rds of daily insulin SC
- Ratio of regular insulin to NPH (isophane) insulin 1:2
Evening
- Give 1/3 of daily insulin SC
Administration
Administer within 15 min before a meal or immediately after a meal
Store unopened vials/pens refrigerated; do not freeze
Opened (in-use) product may be stored at ambient room temperature (below 86°F [30°C]) and away from heat and light
Dosage Adjustment Strategies
Dosage of human insulin, which is always expressed in USP units, must be based on the results of blood and urine glucose tests and must be carefully individualized to optimal effect
Dose adjustments should be based on regular blood glucose testing (See Dosage Adjustment Strategies)
Adjust to achieve appropriate glucose control
Look for consistent pattern in blood sugars for >3 days
- Compare blood glucose for same time each day
- For each time of day: calculate blood glucose range
- Calculate median blood glucose
- Consider eating and activity patterns during day
Adjust only one insulin dose at a time
- Correct hypoglycemia first
- Correct highest blood sugars next
- If all blood sugars are high (within 2.75 mmol/L [50 mg/dL]): correct morning fasting blood glucose 1st
- Many sliding scales exist to determine exact insulin dose based on frequent blood glucose monitoring
- - Commonly written for q4hr blood glucose test
- - Sliding scale coverage usually begins after blood glucose >11 mmol/L (200 mg/dL)
- - If coverage is needed q4hr x 24 hr, then base insulin dose is adjusted first; sliding scale doses may be adjusted upwards as well
- Change insulin doses in small increments
- - Type I diabetes: 1-2 U change
- - Type II diabetes: 2-3 U change
Dosage Forms & Strengths
insulin isophane human/insulin regular human
injectable suspension
- (70 units/30 units)/mL
Type 1 Diabetes Mellitus
Suggested guidelines for beginning dose
Ketones moderate or less: 0.5 U/kg/day SC
Ketones large: 0.7 U/kg/day SC
Increased dose may be required during growth spurts
Typically, 50-75% of total daily dose is given as intermediate- or long-acting insulin
May use this combination product if the dosage ratio of NPH (isophane) to regular is 2:1
Administration
Administer within 15 min before a meal or immediately after a meal
Store unopened vials/pens refrigerated; do not freeze
Opened (in-use) product may be stored at ambient room temperature (below 86°F [30°C]) and away from heat and light
Dosage Adjustment Strategies
Dosage of human insulin, which is always expressed in USP units, must be based on the results of blood and urine glucose tests and must be carefully individualized to optimal effect
Dose adjustments should be based on regular blood glucose testing (See Dosage Adjustment Strategies)
Adjust to achieve appropriate glucose control
Look for consistent pattern in blood sugars for >3 days
- Compare blood glucose for same time each day
- For each time of day: calculate blood glucose range
- Calculate median blood glucose
- Consider eating and activity patterns during day
Adjust only one insulin dose at a time
- Correct hypoglycemia first
- Correct highest blood sugars next
- If all blood sugars are high (within 2.75 mmol/L [50 mg/dL]): correct morning fasting blood glucose 1st
- Many sliding scales exist to determine exact insulin dose based on frequent blood glucose monitoring
- - Commonly written for q4hr blood glucose test
- - Sliding scale coverage usually begins after blood glucose >11 mmol/L (200 mg/dL)
- - If coverage is needed q4hr x 24 hr, then base insulin dose is adjusted first; sliding scale doses may be adjusted upwards as well
- Change insulin doses in small increments; for type I diabetes - 1-2 U change
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- ethanol
ethanol, insulin isophane human/insulin regular human. Other (see comment). Avoid or Use Alternate Drug. Comment: Alcohol may either increase or decrease the blood glucose lowering effect of insulin; alcohol may decrease endogenous glucose production (increased hypoglycemia risk) or worsen glycemic control by adding calories.
- macimorelin
insulin isophane human/insulin regular human, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may transiently elevate growth hormone (GH) concentrations may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin.
Monitor Closely (61)
- acarbose
acarbose, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- albiglutide
albiglutide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- alogliptin
alogliptin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- aspirin
aspirin increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with high doses of salicylates (3 g/day or more) may increase risk for hypoglycemia. Insulin dose adjustment and increased frequency of glucose monitoring may be required.
- azilsartan
azilsartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- bexagliflozin
bexagliflozin increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin to avoid hypoglycemia when coadministered with bexagliflozin.
- canagliflozin
canagliflozin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- candesartan
candesartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- chlorpropamide
chlorpropamide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- dapagliflozin
dapagliflozin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- deflazacort
insulin isophane human/insulin regular human and deflazacort both decrease serum potassium. Use Caution/Monitor.
- disopyramide
disopyramide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and disopyramide may require insulin dosage adjustment and increased glucose monitoring.
- dulaglutide
dulaglutide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- empagliflozin
empagliflozin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- eprosartan
eprosartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- ertugliflozin
ertugliflozin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Consider a lower dose of insulin or insulin secretagogue to avoid hypoglycemia when coadministered with ertugliflozin.
- exenatide injectable solution
exenatide injectable solution, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- exenatide injectable suspension
exenatide injectable suspension, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- fluoxetine
fluoxetine increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and fluoxetine may require insulin dosage adjustment and increased glucose monitoring.
- glimepiride
glimepiride, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- glipizide
glipizide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- glucagon
glucagon decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Use Caution/Monitor. Endogenous glucagon is a regulatory hormone that increases blood glucose levels; exogenous glucagon is often used to treat hypoglycemia in patients with diabetes mellitus.
- glucagon intranasal
glucagon intranasal decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Use Caution/Monitor. Endogenous glucagon is a regulatory hormone that increases blood glucose levels; exogenous glucagon is often used to treat hypoglycemia in patients with diabetes mellitus.
- glyburide
glyburide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- irbesartan
irbesartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- lanreotide
lanreotide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- linagliptin
linagliptin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- liraglutide
liraglutide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- lithium
lithium, insulin isophane human/insulin regular human. unspecified interaction mechanism. Use Caution/Monitor. Lithium salts may cause either hypoglycemia or hyperglycemia. Insulin dosage adjustment and increased glucose monitoring may be required.
- lonapegsomatropin
lonapegsomatropin decreases effects of insulin isophane human/insulin regular human by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
lonapegsomatropin decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone. - losartan
losartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- magnesium salicylate
magnesium salicylate increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with high doses of salicylates (3 g/day or more) may increase risk for hypoglycemia. Insulin dose adjustment and increased frequency of glucose monitoring may be required.
- metformin
metformin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- metoclopramide intranasal
metoclopramide intranasal increases effects of insulin isophane human/insulin regular human by Other (see comment). Use Caution/Monitor. Comment: Increased GI motility by metoclopramide may increase delivery of food to the intestines and increase blood glucose. Monitor blood glucose and adjust insulin dosage regimen as needed.
- miglitol
miglitol, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- nateglinide
nateglinide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- niacin
niacin decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Use Caution/Monitor. Concomitant use of insulin and niacin may require insulin dosage adjustment and increased glucose monitoring.
- octreotide
octreotide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- olmesartan
olmesartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- pasireotide
pasireotide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.
- pentamidine
pentamidine, insulin isophane human/insulin regular human. unspecified interaction mechanism. Use Caution/Monitor. Pentamidine may cause either hypoglycemia or hyperglycemia followed by the opposing effect. Insulin dosage adjustment and increased glucose monitoring may be required.
- pioglitazone
pioglitazone, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- rosiglitazone
rosiglitazone, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- sacubitril/valsartan
sacubitril/valsartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- salsalate
salsalate increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with high doses of salicylates (3 g/day or more) may increase risk for hypoglycemia. Insulin dose adjustment and increased frequency of glucose monitoring may be required.
- saxagliptin
saxagliptin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- semaglutide
semaglutide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of insulin with GLP-1 agonists may increase hypoglycemia risk. Lowering the insulin dose may reduce hypoglycemia risk.
- sitagliptin
sitagliptin, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of insulin isophane human/insulin regular human by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of insulin isophane human/insulin regular human by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
- somapacitan
somapacitan decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- somatrogon
somatrogon decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- somatropin
somatropin decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- sotagliflozin
sotagliflozin increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypoglycemia risk increased. Lower dose of insulin may be required.
- sulfadiazine
sulfadiazine increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and sulfonamide antibiotics may require insulin dosage adjustment and increased glucose monitoring.
- sulfisoxazole
sulfisoxazole increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and sulfonamide antibiotics may require insulin dosage adjustment and increased glucose monitoring.
- telmisartan
telmisartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
- testosterone intranasal
testosterone intranasal increases effects of insulin isophane human/insulin regular human by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.
- tolazamide
tolazamide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- tolbutamide
tolbutamide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- valsartan
valsartan increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and ARBs may require insulin dosage adjustment and increased glucose monitoring.
Minor (0)
Adverse Effects
Frequency Not Defined
Hypoglycemia
Insulin resistance
Lipodystrophy
Lipohypertrophy
Local allergic reaction
Hypokalemia
Postmarketing Reports
Localized cutaneous amyloidosis
Warnings
Contraindications
Hypoglycemia
Documented hypersensitivity reactions to product or excipients
Cautions
Never share pen between patients even if needle is changed
Intermediate-acting insulin, do not use for circumstances that require rapid-acting insulin
Caution with decreased insulin requirements (eg, diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)
Caution with increased insulin requirements (eg, fever, hyperthyroidism, trauma, infection, surgery)
Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure, monitor for signs and symptoms of heart failure and treat accordingly and consider discontinuing thiazolidinediones
Hypoglycemia may be life-threatening; increase frequency of blood glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness
Severe, life-threatening, generalized allergy, hypersensitivity, including anaphylaxis, can occur; discontinue therapy, monitor, and treat if indicated
Hyperglycemia or hypoglycemia with changes in insulin regimen
- Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
- Changes should be made cautiously and only under close medical supervision and frequency of blood glucose monitoring should be increased
- Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis reported to result in hyperglycemia; a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia
- Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring
- Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change injection site to unaffected areas and closely monitor for hypoglycemia
- For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed
Hypokalemia may be life-threatening; monitor potassium levels in patients at risk for hypokalemia and treat if indicated
- Hyperglycemia or hypoglycemia with changes in insulin regimen
- Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
- Changes should be made cautiously and only under close medical supervision and frequency of blood glucose monitoring should be increased
- Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis reported to result in hyperglycemia; a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia
- Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring
- Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change injection site to unaffected areas and closely monitor for hypoglycemia
- For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed
Pregnancy & Lactation
Pregnancy
Available data from published studies over decades have not established association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal Outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy; animal reproduction studies were not performed
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
Lactation
Available data from published literature suggests that exogenous human insulin products, are transferred into human milk; there are no adverse reactions reported in breastfed infants in the literature; there are no data on effects of exogenous human insulin products, on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy, and any potential adverse effects on breastfed infant from drug, or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Regulates glucose metabolism
Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis, and enhances protein synthesis
Insulin NPH and insulin regular is a combination insulin product with intermediate duration that has more rapid onset than that of insulin NPH alone
Pharmacokinetics
Onset: 1-1.5 hr (NPH); 0.5 hr (regular)
Peak: 4-12 hr (NPH); 2.5-5 hr (regular)
Duration: Up to 24 hr (NPH); 8 hr (regular)
Bioavailability: IM, SC, IP: well absorbed
Protein Bound: 5% (not bound to serum binding-protein, but present as a monomer in plasma)
Vd: 0.15 L/kg
Metabolism: Liver >50%; kidney 30%; adipose tissue/muscle 20%
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Novolin 70-30 FlexPen U-100 Insulin subcutaneous - | 100 unit/mL (70-30) insulin pen |  | |
| Novolin 70/30 U-100 Insulin subcutaneous - | 100 unit/mL (70-30) vial |  | |
| Humulin 70/30 (U-100) Insulin KwikPen subcutaneous - | 100 unit/mL (70-30) insulin pen |  | |
| Humulin 70/30 U-100 Insulin subcutaneous - | 100 unit/mL (70-30) vial |  | |
| Humulin 70/30 U-100 Insulin subcutaneous - | 100 unit/mL (70-30) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
insulin NPH and regular human subcutaneous
INSULIN HUMAN ISOPHANE SUSPENSION 50/REGULAR 50 - INJECTION
(IN-sue-lin HYOO-muhn EYE-sew-fane)
COMMON BRAND NAME(S): Humulin 50-50
USES: Combination isophane/regular insulin is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.This man-made insulin product is the same as human insulin. It replaces the insulin that your body would normally make. It is a mixture of 50% intermediate-acting insulin (isophane) and 50% short-acting insulin (regular). It starts to work as quickly as regular insulin but lasts longer. This insulin product works by helping blood sugar (glucose) get into cells so your body can use it for energy. This product may be used alone or with other oral diabetes drugs (such as metformin).
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using combination isophane/regular insulin and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist.Learn all preparation and usage instructions from your health care professional and the product package.Before using, gently roll the vial or cartridge, turning it upside down and right side up 10 times to mix the medication. Do not shake the container. Check this product visually for particles or discoloration. If either is present, do not use the insulin. Combination isophane/regular insulin should look evenly cloudy/milky after mixing. Do not use if you see clumps of white material, a "frosty" appearance, or particles stuck to the sides of the vial or cartridge.Before injecting each dose, clean the injection site with rubbing alcohol. Change where you inject each time to lessen the risk of problems or damage under the skin (for example, pits/lumps or thickened skin). Inject this medication under the skin as directed by your doctor, usually once or twice a day. Because this insulin product contains a short-acting insulin, not eating right after a dose of this insulin may lead to low blood sugar (hypoglycemia). This insulin product may be injected in the stomach area, the thigh, the buttocks, or the back of the upper arm. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. Do not rub the area after the injection. Do not inject into skin that is red, swollen, itchy, or damaged. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature.This product should not be mixed with any other insulin.Do not change brands or types of insulin without directions on how to do so from your doctor.Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.The dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar.Check your blood sugar regularly as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).
SIDE EFFECTS: Injection site reactions (such as pain, redness, irritation) or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using combination isophane/regular insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; 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.Do not use this medication when you have low blood sugar (hypoglycemia).Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, kidney disease, liver disease, thyroid problems.You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.Limit alcohol while using this medication because it can increase your risk of developing low blood sugar.It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Check your blood sugar before and after exercise. You may need a snack before exercising.If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.Children may be more sensitive to the side effects of this drug, especially low blood sugar.Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: repaglinide.Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: signs of low blood sugar such as sweating, shakiness, loss of consciousness, fast heartbeat.
NOTES: Do not share this medication, needles, or syringes with others.Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.Lab and/or medical tests (such as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be done while you are taking this medication. Keep all medical and lab appointments.Keep extra supplies of insulin, syringes, and needles on hand.
MISSED DOSE: It is very important to follow your insulin regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of insulin.
STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Protect insulin from light and heat. Do not store in the bathroom. Do not freeze, and do not use insulin that has been frozen. Throw away all insulin products after the expiration date on the package, or after the specified number of days after it has been opened or kept at room temperature, whichever date is earlier. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised August 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
