Drugplain

Novolin 70/30 100 [iU]/mL

Human Insulin · INJECTION, SUSPENSION · A-S Medication Solutions

No Recall History
Plain English

Novolin 70/30 is a injection, suspension containing human insulin at 100 [iU]/mL, taken subcutaneous. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Novolin 70/30
Generic Name
Human Insulin
NDC Code (Product)
50090-0403
Manufacturer
A-S Medication Solutions
Strength
100 [iU]/mL
Dosage Form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Marketing Status
Application #
BLA019991
Drug Class
Insulin [EPC]
Marketing Start
06/25/1991

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. NOVOLIN 70/30 is a mixture of human insulin isophane, an intermediate-acting human insulin, and human insulin, a short-acting human insulin, indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions. ( 2.1 ) • Inject subcutaneously in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) • Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) • Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes prior to start of meal. ( 2.2 ) • NOVOLIN 70/30 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). ( 2.2) 2.1 Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. • NOVOLIN 70/30 is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature. • To resuspend vial, roll the vial gently in your hands in a horizontal position 10 times until the suspension appears uniformly white and cloudy. Inject immediately. • To resuspend FlexPen, gently move the pen up and down 20 times so the glass ball moves from one end of the cartr

Contraindications

4 CONTRAINDICATIONS NOVOLIN 70/30 is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients who have had hypersensitivity reactions to NOVOLIN 70/30 or any of its excipients [see Warnings and Precautions ( 5.5 )] . • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to NOVOLIN 70/30 or any of its excipients ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with NOVOLIN 70/30 Drugs that May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN 70/30 is co-administered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of NOVOLIN 70/30 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLIN 70/30 is co-administered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLIN 70

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Medication Errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLIN 70/30. Because some of 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. Adverse reactions associated with insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypersensitivity reactions Severe

Frequently Asked Questions

What is Novolin 70/30 used for?

Novolin 70/30 contains Human Insulin. It is a injection, suspension taken subcutaneous. Consult your doctor for specific uses.

Is Novolin 70/30 a controlled substance?

Novolin 70/30 is not classified as a controlled substance by the DEA.

What is the generic name for Novolin 70/30?

The generic name for Novolin 70/30 is Human Insulin. There are 5 other brand versions of Human Insulin.

What is the NDC code for Novolin 70/30 100 [iU]/mL?

The NDC (National Drug Code) for Novolin 70/30 100 [iU]/mL is 50090-0403, listed by A-S Medication Solutions.

Product NDC

50090-0403

Package NDC

50090-0403-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)