NovoMix 30 FlexPen

NovoMix 30 FlexPen

insulin aspart + insulin aspart protamine

Manufacturer:

Novo Nordisk

Distributor:

Novo Nordisk
Concise Prescribing Info
Contents
Biphasic insulin aspart (30% soluble insulin aspart, 70% protamine crystallized insulin aspart)
Dosage/Direction for Use
SC Individualized dosage. Type 2 DM Can be given as monotherapy or in combination w/ oral antidiabetics: Starting dose: 6 u at breakfast & 6 u at dinner (evening meal) or 12 u once daily at dinner. When transferring from biphasic human insulin start w/ the same dose. Close glucose monitoring is recommended. It is generally recommended to move to bid when reaching 30 u by splitting the dose into equal breakfast & dinner doses. The morning dose can also be split in the morning & lunchtime doses (tid dosing). May be given to elderly but limited experience in >75 yr. Dose may need reduction in renal or hepatic impairment. May be used in childn ≥10 yr.
Administration
Should be taken with food: Administer immediately before or soon after a meal.
Special Precautions
Must not be administered IV, as it may result in severe hypoglycemia. IM administration should also be avoided. Not to be used in insulin infusion pumps. Seek physician's advice before travelling to different time zones. Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycemia & diabetic ketoacidosis. Omission of meal or unplanned strenuous physical exercise may lead to hypoglycemia, or if the dose is too high. Intensified insulin therapy may change the usual warning symptoms of hypoglycemia, & long-standing diabetes may reduce these warning symptoms. Transferring from other types of insulin should be done under strict medical supervision. Rapid onset of action should be considered in patients w/ delayed food absorption. Concomitant illness, especially infections & feverish conditions, usually increases the patient's insulin requirement. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland may require changes in the insulin dose. Rotate inj site continuously. Cases of CHF were reported when thiazolidinediones were used in combination w/ insulin, especially in patients w/ risk factors for development of CHF. Insulin antibodies may form & require dose adjustment. Renal or hepatic impairment may reduce the patient's insulin requirements. Hypoglycemia may impair ability to drive or operate machinery. Limited clinical experience in pregnancy & may require dose adjustment in lactation. Limited clinical data exists for childn 6-9 yr. There is limited experience in combination w/ OADs in patients >75 yr.
Adverse Reactions
Hypoglycemia. Urticaria, rash, eruptions, anaphylactic reactions; peripheral neuropathy, refraction disorder; lipodystrophy; inj site reactions, edema.
Drug Interactions
Decreased insulin requirements w/ oral antidiabetics, MAOIs, β-blockers, ACE inhibitors, salicylates, anabolic steroids & sulfonamides. Increased insulin requirements w/ OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone & danazol. β-blockers may mask the symptoms of hypoglycemia. Increased/decreased insulin requirements w/ octreotide/lanreotide. Intensified/reduced hypoglycemic effect w/ alcohol.
MIMS Class
Insulin Preparations
ATC Classification
A10AD05 - insulin aspart ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.
Presentation/Packing
Form
NovoMix 30 FlexPen susp for inj 100 U/mL
Packing/Price
3 mL x 5 × 1's (P2,385/box)
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