MACROPIN
MACROPIN (insulin, human biosynthetic)
THERAPEUTIC INDICATION
MACROPIN (insulin, human biosynthetic) is indicated for the treatment of insulin requiring diabetic patients.
MACROPIN R only should be used for the treatment of emergencies such as diabetic coma and pre-coma and in diabetics undergoing surgery, but not MACROPIN N, or MACROPIN 70/30.
In switching patients from animal source insulins to MACROPIN, it is possible that the patients will require a change in dosage; the adjustment may be made with the first dose or over a period of several weeks. Any change of insulin should be made cautiously and only under medical supervision.
Changes in refinement, purity, strength, brand, type and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage.
POSOLOGY AND METHOD OF AMINISTRATION
The dosage should be determined by the physician, according to the requirements of the patient.
New Patients
Patients receiving insulin for the first time can be started on MACROPIN (insulin, human biosynthetic) in the same manner as they would be on animal-source insulin.
Patients should be monitored closely during the adjustment period.
Transfer Patients
When transferring patients from animal-source insulin to MACROPIN, use the same dose and dosage schedule.
Some patients transferring to MACROPIN will require a change in dosage from that used with animal-source insulin. If an adjustment is needed, it may be made with the first dose or over a period of several weeks.
Changes in total daily dosage, the number of injections per day, and/or timing of injections may be necessary to achieve maximum glycemic control.
When a patient on high doses of animal insulin is switched to MACROPIN, it may be appropriate to reduce the starting dosage and monitor the patient carefully.
Patients who have systemic allergy to pork or beef insulin may also react to human insulin. In such patients, appropriate procedures (intradermal testing and, if necessary, desensitization) should be undertaken before therapeutic doses of human insulin are administered.
A few patients who experienced hypoglycemic reactions after being transferred to MACROPIN have reported that the early warning symptoms, i.e., nervousness, sweating, and palpitations, were less pronounced than they were with animal-source insulin.
Formulations of MACROPIN appear to produce a slightly faster onset and slightly shorter duration of action than the corresponding forms of animal-source insulins.
MACROPIN R is a clear, colorless solution. It may be administered by subcutaneous, intra-muscular or intravenous injection.
MACROPIN N and MACROPIN 70/30 are suspensions. They should be administered by subcutaneous injection only.
Subcutaneous administration, preferably by the patient, should be in the upper arms, thighs, buttocks or abdomen. Injection sites should be rotated so that the same site is not used more than approximately once a month.
Care should be taken to ensure that a blood vessel has not been entered. The injection site should not be massaged.
Mixing Instructions:
The rapid action of MACROPIN R is preserved when mixed with MACROPIN N; independent of the time lag between mixing and administration, and independent of the proportion of regular insulin incorporated in the 70/30.
The effects of mixing MACROPIN with animal-source insulins have not been studied. This practice is not recommended.
CONTRAINDICATIONS
Hypoglycemia (for details see SYMPTOMS AND TREATMENT OF OVERDOSAGE)
MACROPIN (insulin, human biosynthetic) is contraindicated in patients with hypersensitivity to human insulin or any of its excipients contained in the formulation (unless used as part of a desensitization program).
MACROPIN N, MACROPIN 70/30, should not be given intravenously or used for treatment of diabetic coma.
WARNINGS
A few patients who experienced hypoglycemic reactions after being transferred to MACROPIN (insulin, human biosynthetic) have reported that these early warning symptoms were less pronounced than they were with animal-source insulin.
Under no circumstances should any MACROPIN 70/30 be given intravenously.
Do not use the MACROPIN N or MACROPIN 70/30 if you see lumps that float or that stick to the sides of the vial, or if the contents of the vial are clear and remain clear after the bottle is shaken or rotated. NOTE: The contents of the vial of MACROPIN R should be clear. Do not use if cloudy.
PRECAUTIONS
GENERAL:
Visual disturbances in uncontrolled diabetes due to refractive changes are reversed during the early phase of effective management. However, since alteration in osmotic equilibrium between the lens and ocular fluids may not stabilize for a few weeks after initiating therapy, it is wise to postpone prescribing new corrective lenses for 3 to 6 weeks.
Insulin requirements may be increased during illness or emotional disturbances or if the patient is receiving concurrent administration of drugs with hyperglycemic activity, e.g. oral contraceptives, corticosteroids, or thyroid replacement therapy.
Insulin requirements may be decreased in the presence of renal or hepatic impairment or in the presence of agents such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), beta-adrenergic blockers, alcohol, angiotensin converting enzyme inhibitors and angiotensin II receptor blockers.
The number and size of daily doses and the time of administration, as well as diet and exercise, are problems that require direct and continuous medical supervision. Usually, the most satisfactory injection time is before breakfast.
Prompt recognition and appropriate management of the allergic complications of insulin therapy are important for the safe and effective control of diabetes mellitus.
Transferring from Other Insulins — A small number of patients transferring from insulins of animal source to insulins of recombinant DNA origin may require a reduced dosage, especially if they are tightly controlled and bordering on hypoglycemia. The dosage reduction may occur with the first dose or over a period of several weeks. There is a risk of hypoglycemia if the insulin requirement is decreased, and both the physician and the patient should be aware of this possibility. The risk can be considered to be minimal if the daily dose is less than 40 units.
USE IN OBSTETRICS:
It is essential to maintain good control of the insulin-diabetic patient throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.
NURSING MOTHERS:
Diabetic patients who are nursing may require adjustments in insulin dose and/or diet.
DRUG INTERACTIONS
Hormones that tend to counteract the hypoglycemic effects of insulin include growth hormone, corticotropin, glucocorticoids, thyroid hormone, and glucagon. Epinephrine not only inhibits the secretion of insulin, but also stimulates glycogen breakdown to glucose. Thus, the presence of such diseases as acromegaly, Cushing’s syndrome, hyperthyroidism, and pheochromocytoma complicate the control of diabetes.
The hypoglycemic action of insulin may also be antagonized by diphenylhydantoin. Insulin’s hypoglycemic action can be increased in some patients by concomitant administration of anabolic steroids, MAO inhibitors, guanethidine, alcohol, propranolol (masking effect), or other drugs affecting beta adrenergic receptors, or by daily doses of 1.5 to 6 g of salicylates.
Insulin requirements can be increased, decreased, or unchanged in patients receiving diuretics. Concomitant administration of oral contraceptives can cause a decrease in glucose tolerance in diabetic women possibly resulting in increased daily insulin requirements.
The physician should be consulted when using other medications in addition to human insulin.
ADVERSE REACTIONS
As with all insulins, local inflammatory responses may result from improper cleansing of the skin, contamination of the injection site with alcohol, use of an antiseptic containing impurities or accidental intracutaneous rather than subcutaneous injection. Local reactions that result in skin sensitivity phenomena usually subside spontaneously.
Insulin lipohypertrophy has been reported. This complication has been ascribed to the local pharmacologic effects of the subcutaneous injection of insulin. A few cases of lipoatrophy and serum sickness have also been reported.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Cause
Hypoglycemia (low blood glucose, also called “insulin reaction”) can occur if the patient takes too much insulin, misses meals, exercises or works too hard just before a meal, or has an infection or becomes ill (especially with diarrhea or vomiting) or if the body’s need for insulin change for other reasons.
Symptoms and Treatment
Hypoglycemia may occur in any patient receiving insulin and is most commonly manifested by hunger, nervousness, warmth and sweating, and palpitations. Patients also may experience headache, confusion, drowsiness, fatigue, anxiety, blurred vision, diplopia, or numbness of the lips, nose, or fingers. The clinical manifestations of hypoglycemia can be masked by the concomitant administration of propranolol or other beta adrenergic blockers.
Symptoms are likely to appear anytime when the blood sugar concentration falls below 2.2 mmol/L (40 mg/100 mL) but may occur with a sudden drop in blood glucose even when the value remains above 2.2 mmol/L (40 mg/100 mL).
If a patient is unable to take soluble carbohydrate or fruit juice orally, hypoglycemia is treated with 10 to 20 g of dextrose intravenously or glucagon may be given subcutaneously or intramuscularly.
STABILITY AND STORAGE:
Insulin should be stored in a cold place (2-8°C), preferably in a refrigerator, but not in a freezer. Do not let it freeze or leave it in direct sunlight. Expiration dates are stated on the labels.
SHELF LIFE: Expiry 24 months from manufacturing date
PACKING UNITS:
MACROPIN R: 40IU/mL x 10 mL x 1 vial
100IU/mL x 10 mL x 1 vial
MACROPIN N : 40IU/mL x 10 mL x 1 vial
100IU/mL x 10 mL x 1 vial
MACROPIN 70/30 : 40IU/mL x 10 mL x 1 vial
100IU/mL x 10 mL x 1 vial
SPECIFICATION: Manufacture’s
- Keep out of reach of children
- Read carefully the enclosed packing insert before use
- Sold only by prescription
- For further information, consult with your physician
Manufactured by:
NANOGEN PHARMACEUTICAL BIOTECHNOLOGY CO., LTD.
Lot I – 5C, Saigon Hitech Park, Tang Nhon Phu A Ward, Dist. 9, HCM City, Vietnam