HUMULIN 70/30 (70% human insulin
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED HUMULIN 70/30 100 units per mL (U-100) is available as: 10 mL vials NDC 0002-8715-01 (HI-710) 3 mL vials NDC 0002-8715-17 (HI-713) 5 x 3 mL prefilled pen NDC 0002-8770-59 (HP-8770) 5 x 3 mL HUMULIN 70/30 KwikPen (prefilled) NDC 0002-8803-59 (HP-8803) Each prefilled HUMULIN 70/30 pen and HUMULIN 70/30 KwikPen is for use by a single patient. HUMULIN 70/30 pens and HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person. Protect from heat and light. Do not freeze. Do not use after the expiration date. Not In-Use (Unopened) HUMULIN 70/30 Vials Refrigerated Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Room Temperature If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31days. In-Use (Opened) HUMULIN 70/30 Vials Refrigerated Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Vials must be used within 31 days or be discarded, even if they still contain HUMULIN 70/30. Room Temperature If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31 days, even if the vial still contains HUMULIN 70/30. Not In-Use (Unopened) HUMULIN 70/30 Pen and KwikPen Refrigerated Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Room Temperature If stored at room temperature, below 86°F (30°C) the pen must be discarded after 10 days. In-Use (Opened) HUMULIN 70/30 Pen and KwikPen Refrigerated Do NOT store in a refrigerator. Room Temperature Store at room temperature, below 86°F (30°C) and the pen must be discarded after 10 days, even if the pen still contains HUMULIN 70/30. See storage table below: Not In-Use (Unopened) Refrigerated Not In-Use (Unopened) Room Temperature In-Use (Opened) 10 mL vial 3 mL vial Until expiration date 31 days 31 days, refrigerated/room temperature 3 mL pen 3 mL HUMULIN 70/30 KwikPen (prefilled) Until expiration date 10 days 10 days, room temperature. Do not refrigerate.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: Humulin 70/30 70/30 GENERIC: Insulin human DOSAGE: INJECTION, SUSPENSION ADMINSTRATION: SUBCUTANEOUS NDC: 52125-415-08 ACTIVE INGREDIENT(S): Insulin human 100[iU] in 1mL INACTIVE INGREDIENT(S): Glycerin Water Hydrochloric acid Sodium Phosphate, Dibasic Protamine sulfate Metacresol Phenol Sodium hydroxide Zinc PACKAGING: 10 mL in 1 VIAL MM43 MM44
- HOW SUPPLIED HUMULIN 70/30 100 units per mL (U-100) is available as: 10 mL vials NDC 0002-8715-01 (HI-710) 3 mL vials NDC 0002-8715-17 (HI-713) 5 x 3 mL prefilled pen NDC 0002-8770-59 (HP-8770) 5 x 3 mL HUMULIN 70/30 KwikPen (prefilled) NDC 0002-8803-59 (HP-8803) Each prefilled HUMULIN 70/30 pen and HUMULIN 70/30 KwikPen is for use by a single patient. HUMULIN 70/30 pens and HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person. Protect from heat and light. Do not freeze. Do not use after the expiration date. Not In-Use (Unopened) HUMULIN 70/30 Vials Refrigerated Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Room Temperature If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31days. In-Use (Opened) HUMULIN 70/30 Vials Refrigerated Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Vials must be used within 31 days or be discarded, even if they still contain HUMULIN 70/30. Room Temperature If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31 days, even if the vial still contains HUMULIN 70/30. Not In-Use (Unopened) HUMULIN 70/30 Pen and KwikPen Refrigerated Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Room Temperature If stored at room temperature, below 86°F (30°C) the pen must be discarded after 10 days. In-Use (Opened) HUMULIN 70/30 Pen and KwikPen Refrigerated Do NOT store in a refrigerator. Room Temperature Store at room temperature, below 86°F (30°C) and the pen must be discarded after 10 days, even if the pen still contains HUMULIN 70/30. See storage table below: Not In-Use (Unopened) Refrigerated Not In-Use (Unopened) Room Temperature In-Use (Opened) 10 mL vial 3 mL vial Until expiration date 31 days 31 days, refrigerated/room temperature 3 mL pen 3 mL HUMULIN 70/30 KwikPen (prefilled) Until expiration date 10 days 10 days, room temperature. Do not refrigerate.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: Humulin 70/30 70/30 GENERIC: Insulin human DOSAGE: INJECTION, SUSPENSION ADMINSTRATION: SUBCUTANEOUS NDC: 52125-415-08 ACTIVE INGREDIENT(S): Insulin human 100[iU] in 1mL INACTIVE INGREDIENT(S): Glycerin Water Hydrochloric acid Sodium Phosphate, Dibasic Protamine sulfate Metacresol Phenol Sodium hydroxide Zinc PACKAGING: 10 mL in 1 VIAL MM43 MM44
Overview
HUMULIN 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) is a human insulin suspension. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN 70/30 is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation and mixing with human insulin injection. The amino acid sequence of HUMULIN 70/30 is identical to human insulin and has the empirical formula C 257 H 383 N 65 O 77 S 6 with a molecular weight of 5808. HUMULIN 70/30 is a sterile white suspension. Each milliliter of HUMULIN 70/30 contains 100 units of insulin human, 0.24 mg of protamine sulfate, 16 mg of glycerin, 3.78 mg of dibasic sodium phosphate, 1.6 mg of metacresol, 0.65 mg of phenol, zinc oxide content adjusted to provide 0.025 mg zinc ion, 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.
Indications & Usage
INDICATIONS & USAGE HUMULIN 70/30 is a fixed ratio premix recombinant human insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus.
Dosage & Administration
DOSAGE & ADMINISTRATION Only administer subcutaneously (in abdominal wall, thigh, upper arm, or buttocks). ( 2.2 ) Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) See Full Prescribing Information for dosage adjustments due to drug interactions and patients with renal and hepatic impairment. ( 2.3 ) Administer approximately 30-45 minutes before a meal. ( 2.4 ) Inspect HUMULIN 70/30 visually before use. It should not contain particulate matter and should appear uniformly cloudy after mixing. Do not use HUMULIN 70/30 if particulate matter is seen. Do not mix HUMULIN 70/30 with any other insulins or diluents. HUMULIN 70/30 should only be administered subcutaneously. Administer in the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy, rotate the injection site within the same region from one injection to the next [see Adverse Reactions ( 6 )] . Do not administer HUMULIN 70/30 intravenously or intramuscularly and do not use HUMULIN 70/30 in an insulin infusion pump. Individualize and adjust the dosage of HUMULIN 70/30 based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ), and Use in Specific Populations ( 8.6 , 8.7 )] . The proportion of rapid acting and long acting insulin is fixed in a premixed insulin such as HUMULIN 70/30. Independent adjustment of the basal or prandial dose is not possible when using a premixed insulin. Physiological factors, disease states and concomitant drugs may impact the onset and duration of action of all insulins. HUMULIN 70/30 dose requirements may change with changes in level of physical activity, meal patterns (i.e., macronutrient content or timing of food intake), during major illness, or with some coadministered drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 ), and Use in Specific Populations ( 8.6 , 8.7 )] . HUMULIN 70/30 should be given subcutaneously approximately 30-45 minutes before a meal.
Warnings & Precautions
WARNINGS
Contraindications
HUMULIN 70/30 is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )], and In patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients [see Warnings and Precautions ( 5.4 )] .
Adverse Reactions
The following adverse reactions are discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypokalemia [see Warnings and Precautions ( 5.5 )] . The following additional adverse reactions have been identified during post-approval use of HUMULIN 70/30. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Allergic Reactions Some patients taking HUMULIN 70/30 have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions ( 5.4 )] . Peripheral Edema Some patients taking HUMULIN 70/30 have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Lipodystrophy Administration of insulin subcutaneously, including HUMULIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.2 )] in some patients. Weight gain Weight gain has occurred with some insulin therapies including HUMULIN 70/30 and has been attributed to the anabolic effects of insulin and the decrease in glycosuria. Immunogenicity Development of antibodies that react with human insulin have been observed with all insulin, including HUMULIN 70/30.
Drug Interactions
Drugs that Affect Glucose Metabolism : Adjustment of insulin dosage may be needed. ( 7.1 , 7.2 , 7.3 ) Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine) : Signs and symptoms of hypoglycemia may be reduced or absent. ( 5.3 , 7.4 ) The risk of hypoglycemia associated with HUMULIN 70/30 use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide). Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs. The glucose lowering effect of HUMULIN 70/30 may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs. The glucose lowering effect of HUMULIN 70/30 may be increased or decreased when co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs. The signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.3 )] may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMULIN 70/30.
Purpose
OTC - PURPOSE
Keep Out of Reach of Children
OTC - KEEP OUT OF REACH OF CHILDREN
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