HUMULIN R- insulin human injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

insulin human (UNII: 1Y17CTI5SR) (insulin human - UNII:1Y17CTI5SR)

Available from:

Physicians Total Care, Inc.

INN (International Name):

insulin human

Composition:

insulin human 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC DRUG

Therapeutic indications:

Humulin R U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus. Humulin R U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage). Humulin R U-100 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-100 or any of its excipients. NEVER SHARE NEEDLES AND SYRINGES. Correct Syringe Type Doses of insulin are measured in units . U-100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin R, it is important to use a syringe that is marked for U-100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high. Syringe Use To help avoid contamination and possible infection, follow these instructions exactly. Disposable syringes and needles should be used only

Product summary:

Humulin R U-100, Regular, insulin human injection, USP (rDNA origin), 100 units/mL, is supplied as follows:

Authorization status:

New Drug Application

Summary of Product characteristics

HUMULIN R - INSULIN HUMAN INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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HUMULIN R
REGULAR
INSULIN HUMAN INJECTION, USP
(RDNA ORIGIN)100 UNITS PER ML (U-100)
INFORMATION FOR THE PHYSICIAN
HUMULIN R
REGULAR
INSULIN HUMAN INJECTION, USP
(RDNA ORIGIN)
100 UNITS PER ML (U-100)
DESCRIPTION
Humulin R U-100 is a polypeptide hormone structurally identical to
human insulin synthesized through
rDNA technology in a special non-disease-producing laboratory strain
of _Escherichia coli_ bacteria.
Humulin R U-100 has the empirical formula C
H
N O S and a molecular weight of 5808.
Humulin R U-100 is a sterile, clear, aqueous, and colorless solution
that contains human insulin (rDNA
origin) 100 units/mL, glycerin 16 mg/mL and metacresol 2.5 mg/mL,
endogenous zinc (approximately
0.015 mg/100 units) and water for injection. The pH is 7.0 to 7.8.
Sodium hydroxide and/or
hydrochloric acid may be added during manufacture to adjust the pH.
Adequate insulin dosage permits patients with diabetes to effectively
utilize carbohydrates, proteins and
fats. Regardless of dose strength, insulin enables carbohydrate
metabolism to occur and thus to prevent
the production of ketone bodies by the liver. Some patients develop
severe insulin resistance such that
daily doses of several hundred units of insulin or more are required.
CLINICAL PHARMACOLOGY
Regulation of glucose metabolism is the primary activity of insulin.
Insulin lowers blood glucose by
stimulating peripheral glucose uptake by skeletal muscle and fat, and
by inhibiting hepatic glucose
production. Insulins inhibit lipolysis, proteolysis, and
gluconeogenesis, and enhance protein synthesis
and conversion of excess glucose into fat.
Administered insulin, including Humulin R U-100, substitutes for
inadequate endogenous insulin
secretion and partially corrects the disordered metabolism and
inappropriate hyperglycemia of diabetes
mellitus, which are caused by either a deficiency or a reduction in
the biologic effectiveness of insulin.
When administered in appropriate doses at pres