Brand Name: NovoLog
Generic Name: insulin aspart

Dosage Form: injection

Contents:

Indications and Usage
Dosage and Administration 
Dosage Forms and Strengts
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied / Storage and Handling

NovoLog, insulin aspart, patient information (in plain English)

Indications and Usage

Treatment of diabetes mellitus

NovoLog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

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Dosage and Administration

Dosing

NovoLog is an insulin analog with an earlier onset of action than regular human insulin. The dosage of NovoLog must be individualized. NovoLog given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin [see Warnings and Precautions, How Supplied/Storage and Handling]. The total daily insulin requirement may vary and is usually between 0.5 to 1.0 units/kg/day. When used in a meal-related subcutaneous injection treatment regimen, 50 to 70% of total insulin requirements may be provided by NovoLog and the remainder provided by an intermediate-acting or long-acting insulin. Because of NovoLog's comparatively rapid onset and short duration of glucose lowering activity, some patients may require more basal insulin and more total insulin to prevent pre-meal hyperglycemia when using NovoLog than when using human regular insulin.

Do not use NovoLog that is viscous (thickened) or cloudy; use only if it is clear and colorless. NovoLog should not be used after the printed expiration date.

Subcutaneous Injection

NovoLog should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because NovoLog has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action of NovoLog will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

NovoLog may be diluted with Insulin Diluting Medium for NovoLog for subcutaneous injection. Diluting one part NovoLog to nine parts diluent will yield a concentration one-tenth that of NovoLog (equivalent to U-10). Diluting one part NovoLog to one part diluent will yield a concentration one-half that of NovoLog (equivalent to U-50).

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Continuous Subcutaneous Insulin Infusion (CSII) by External Pump

NovoLog can also be infused subcutaneously by an external insulin pump [see Warnings and Precautions, How Supplied/Storage and Handling]. Diluted insulin should not be used in external insulin pumps. Because NovoLog has a more rapid onset and a shorter duration of activity than human regular insulin, pre-meal boluses of NovoLog should be infused immediately (within 5-10 minutes) before a meal. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant interpatient variability, approximately 50% of the total dose is usually given as meal-related boluses of NovoLog and the remainder is given as a basal infusion. Change the NovoLog in the reservoir, the infusion sets and the infusion set insertion site at least every 48 hours.

Intravenous Use

NovoLog can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions, How Supplied/Storage and Handling]. For intravenous use, NovoLog should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. NovoLog has been shown to be stable in infusion fluids such as 0.9% sodium chloride.

Inspect NovoLog for particulate matter and discoloration prior to parenteral administration.

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Dosage Forms and Strengts

NovoLog is available in the following package sizes: each presentation contains 100 units of insulin aspart per mL (U-100).

• 10 mL vials
• 3 mL PenFill cartridges for the 3 mL PenFill cartridge delivery device (with or without the addition of a NovoPen® 3 PenMate®) with NovoFine® disposable needles
• 3 mL NovoLog FlexPen Prefilled Syringe

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Contraindications

NovoLog is contraindicated

• during episodes of hypoglycemia
• in patients with hypersensitivity to NovoLog or one of its excipients.

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Warnings and Precautions

Administration

NovoLog has a more rapid onset of action and a shorter duration of activity than regular human insulin. An injection of NovoLog should immediately be followed by a meal within 5-10 minutes. Because of NovoLog's short duration of action, a longer acting insulin should also be used in patients with type 1 diabetes and may also be needed in patients with type 2 diabetes. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy.

Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. As with all insulin preparations, the time course of NovoLog action may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, temperature, and physical activity. Patients who change their level of physical activity or meal plan may require adjustment of insulin dosages. Insulin requirements may be altered during illness, emotional disturbances, or other stresses.

Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Hypoglycemia

Hypoglycemia is the most common adverse effect of all insulin therapies, including NovoLog. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person and/or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with NovoLog.

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations [see Clincal Pharmacology]. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia [see Drug Interactions]. As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., patients who are fasting or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.

Rapid changes in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as longstanding diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control [see Drug Interactions]. These situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to the patient's awareness of hypoglycemia. Intravenously administered insulin has a more rapid onset of action than subcutaneously administered insulin, requiring more close monitoring for hypoglycemia.

Hypokalemia

All insulin products, including NovoLog, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia that, if left untreated, may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations, and patients receiving intravenously administered insulin).

Renal Impairment

As with other insulins, the dose requirements for NovoLog may be reduced in patients with renal impairment [see Clinical Pharmacology].

Hepatic Impairment

As with other insulins, the dose requirements for NovoLog may be reduced in patients with hepatic impairment [see Clinical Pharmacology].

Hypersensitivity and Allergic Reactions

Local Reactions - As with other insulin therapy, patients may experience redness, swelling, or itching at the site of NovoLog injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of NovoLog. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in NovoLog.

Systemic Reactions - Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin product, including NovoLog. Anaphylactic reactions with NovoLog have been reported post-approval. Generalized allergy to insulin may also cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis. In controlled clinical trials, allergic reactions were reported in 3 of 735 patients (0.4%) treated with regular human insulin and 10 of 1394 patients (0.7%) treated with NovoLog. In controlled and uncontrolled clinical trials, 3 of 2341 (0.1%) NovoLog-treated patients discontinued due to allergic reactions.

Antibody Production

Increases in anti-insulin antibody titers that react with both human insulin and insulin aspart have been observed in patients treated with NovoLog. Increases in anti-insulin antibodies are observed more frequently with NovoLog than with regular human insulin. Data from a 12-month controlled trial in patients with type 1 diabetes suggest that the increase in these antibodies is transient, and the differences in antibody levels between the regular human insulin and insulin aspart treatment groups observed at 3 and 6 months were no longer evident at 12 months. The clinical significance of these antibodies is not known. These antibodies do not appear to cause deterioration in glycemic control or necessitate increases in insulin dose.

Mixing of Insulins

• Mixing NovoLog with NPH human insulin immediately before injection attenuates the peak concentration of NovoLog, without significantly affecting the time to peak concentration or total bioavailability of NovoLog. If NovoLog is mixed with NPH human insulin, NovoLog should be drawn into the syringe first, and the mixture should be injected immediately after mixing.
• The efficacy and safety of mixing NovoLog with insulin preparations produced by other manufacturers have not been studied.
• Insulin mixtures should not be administered intravenously.

Continuous Subcutaneous Insulin Infusion by External Pump

When used in an external subcutaneous insulin infusion pump, NovoLog should not be mixed with any other insulin or diluent. When using NovoLog in an external insulin pump, the NovoLog-specific information should be followed (e.g., in-use time, frequency of changing infusion sets) because NovoLog-specific information may differ from general pump manual instructions.

Pump or infusion set malfunctions or insulin degradation can lead to a rapid onset of hyperglycemia and ketosis because of the small subcutaneous depot of insulin. This is especially pertinent for rapid-acting insulin analogs that are more rapidly absorbed through skin and have a shorter duration of action. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection may be required [see Dosage and Administration, Warnings and Precautions , and How Supplied/Storage and Handling].

NovoLog is recommended for use in pump systems suitable for insulin infusion as listed below.

Pumps:

MiniMed 500 series and other equivalent pumps.

Reservoirs and infusion sets:

NovoLog is recommended for use in reservoir and infusion sets that are compatible with insulin and the specific pump. In-vitro studies have shown that pump malfunction, loss of metacresol, and insulin degradation, may occur when NovoLog is maintained in a pump system for longer than 48 hours. Reservoirs and infusion sets should be changed at least every 48 hours.

NovoLog should not be exposed to temperatures greater than 37°C (98.6°F). NovoLog that will be used in a pump should not be mixed with other insulin or with a diluent [see Dosage and Administration, Warnings and Precautions, and How Supplied/Storage and Handling].

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Adverse Reactions

Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

• Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including NovoLog [see Warnings and Precautions].

• 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. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

• Lipodystrophy

Long-term use of insulin, including NovoLog, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy.

• Weight gain

Weight gain can occur with some insulin therapies, including NovoLog, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

• Peripheral Edema

Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

• Frequencies of adverse drug reactions

The frequencies of adverse drug reactions during NovoLog clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus (Adverse events with frequency ≥ 5% and occurring more frequently with NovoLog compared to human regular insulin are listed)

	NovoLog + NPH N= 596		Human Regular Insulin + NPH N= 286
Preferred Term	N	(%)	N	(%)
Hypoglycemia *	448	75%	205	72%
Headache	70	12%	28	10%
Injury accidental	65	11%	29	10%
Nausea	43	7%	13	5%
Diarrhea	28	5%	9	3%

* Hypoglycemia is defined as an episode of blood glucose concentration

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (except for hypoglycemia, adverse events with frequency ≥ 5% and occurring more frequently with NovoLog compared to human regular insulin are listed)

	NovoLog + NPH N= 91		Human Regular Insulin + NPH N= 91
	N	(%)	N	(%)
Hypoglycemia*	25	27%	33	36%
Hyporeflexia	10	11%	6	7%
Onychomycosis	9	10%	5	5%
Sensory disturbance	8	9%	6	7%
Urinary tract infection	7	8%	6	7%
Chest pain	5	5%	3	3%
Headache	5	5%	3	3%
Skin disorder	5	5%	2	2%
Abdominal pain	5	5%	1	1%
Sinusitis	5	5%	1	1%

* Hypoglycemia is defined as an episode of blood glucose concentration

Postmarketing Data

The following additional adverse reactions have been identified during postapproval use of NovoLog. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. Medication errors in which other insulins have been accidentally substituted for NovoLog have been identified during postapproval use.

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Drug Interactions

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

• The following are examples of substances that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics.
• The following are examples of substances that may reduce the blood-glucose-lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), atypical antipsychotics.
• Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
• Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
• The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic products such as beta-blockers, clonidine, guanethidine, and reserpine.

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Use in Specific Populations

Pregnancy

Pregnancy Category B. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking NovoLog.

An open-label, randomized study compared the safety and efficacy of NovoLog (n=157) versus regular human insulin (n=165) in 322 pregnant women with type 1 diabetes. Two-thirds of the enrolled patients were already pregnant when they entered the study. Because only one-third of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Both groups achieved a mean HbA1c of ~ 6% during pregnancy, and there was no significant difference in the incidence of maternal hypoglycemia.

Subcutaneous reproduction and teratology studies have been performed with NovoLog and regular human insulin in rats and rabbits. In these studies, NovoLog was given to female rats before mating, during mating, and throughout pregnancy, and to rabbits during organogenesis. The effects of NovoLog did not differ from those observed with subcutaneous regular human insulin. NovoLog, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 U/kg/day (approximately 32 times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area) and in rabbits at a dose of 10 U/kg/day (approximately three times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area). The effects are probably secondary to maternal hypoglycemia at high doses. No significant effects were observed in rats at a dose of 50 U/kg/day and in rabbits at a dose of 3 U/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1.0 U/kg/day for rats and equal to the human subcutaneous dose of 1.0 U/kg/day for rabbits, based on U/body surface area.

Nursing Mothers

It is unknown whether insulin aspart is excreted in human milk. Use of NovoLog is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric Use

NovoLog is approved for use in children for subcutaneous daily injections and for subcutaneous continuous infusion by external insulin pump. Please see Section CLINICAL STUDIES for summaries of clinical studies.

Geriatric Use

Of the total number of patients (n= 1,375) treated with NovoLog in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. One-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). The HbA1c response to NovoLog, as compared to human insulin, did not differ by age, particularly in patients with type 2 diabetes. Additional studies in larger populations of patients 65 years of age or over are needed to permit conclusions regarding the safety of NovoLog in elderly compared to younger patients. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of NovoLog action have not been performed.

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Overdosage

Excess insulin administration may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

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Description

NovoLog (insulin aspart [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. NovoLog is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker's yeast). Insulin aspart has the empirical formula C₂₅₆H₃₈₁N₆₅0₇₉S₆ and a molecular weight of 5825.8.

Figure 1. Structural formula of insulin aspart.

NovoLog is a sterile, aqueous, clear, and colorless solution, that contains insulin aspart 100 Units/mL, glycerin 16 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 mcg/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, and sodium chloride 0.58 mg/mL. NovoLog has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.

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Clinical Pharmacology

Mechanism Of Action

The primary activity of NovoLog is the regulation of glucose metabolism. Insulins, including NovoLog, bind to the insulin receptors on muscle and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Pharmacodynamics

Studies in normal volunteers and patients with diabetes demonstrated that subcutaneous administration of NovoLog has a more rapid onset of action than regular human insulin.

In a study in patients with type 1 diabetes (n=22), the maximum glucose-lowering effect of NovoLog occurred between 1 and 3 hours after subcutaneous injection (see Figure 2). The duration of action for NovoLog is 3 to 5 hours. The time course of action of insulin and insulin analogs such as NovoLog may vary considerably in different individuals or within the same individual. The parameters of NovoLog activity (time of onset, peak time and duration) as designated in Figure 2 should be considered only as general guidelines. The rate of insulin absorption and onset of activity is affected by the site of injection, exercise, and other variables [see Warnings and Precautions].

Figure 2. Serial mean serum glucose collected up to 6 hours following a single pre-meal dose of NovoLog (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes.

A double-blind, randomized, two-way cross-over study in 16 patients with type 1 diabetes demonstrated that intravenous infusion of NovoLog resulted in a blood glucose profile that was similar to that after intravenous infusion with regular human insulin. NovoLog or human insulin was infused until the patient's blood glucose decreased to 36 mg/dL, or until the patient demonstrated signs of hypoglycemia (rise in heart rate and onset of sweating), defined as the time of autonomic reaction (R) (see Figure 3).

Figure 3. Serial mean serum glucose following intravenous infusion of NovoLog (hatched curve) and regular human insulin (solid curve) in 16 patients with type 1 diabetes. R represents the time of autonomic reaction.

Pharmacokinetics

The single substitution of the amino acid proline with aspartic acid at position B28 in NovoLog reduces the molecule's tendency to form hexamers as observed with regular human insulin. NovoLog is, therefore, more rapidly absorbed after subcutaneous injection compared to regular human insulin.

In a randomized, double-blind, crossover study 17 healthy Caucasian male subjects between 18 and 40 years of age received an intravenous infusion of either NovoLog or regular human insulin at 1.5 mU/kg/min for 120 minutes. The mean insulin clearance was similar for the two groups with mean values of 1.2 l/h/kg for the NovoLog group and 1.2 l/h/kg for the regular human insulin group.

Bioavailability and Absorption - NovoLog has a faster absorption, a faster onset of action, and a shorter duration of action than regular human insulin after subcutaneous injection (see Figure 2 and Figure 4). The relative bioavailability of NovoLog compared to regular human insulin indicates that the two insulins are absorbed to a similar extent.

Figure 4. Serial mean serum free insulin concentration collected up to 6 hours following a single pre-meal dose of NovoLog (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes.

In studies in healthy volunteers (total n=l07) and patients with type 1 diabetes (total n=40), NovoLog consistently reached peak serum concentrations approximately twice as fast as regular human insulin. The median time to maximum concentration in these trials was 40 to 50 minutes for NovoLog versus 80 to 120 minutes for regular human insulin. In a clinical trial in patients with type 1 diabetes, NovoLog and regular human insulin, both administered subcutaneously at a dose of 0.15 U/kg body weight, reached mean maximum concentrations of 82 and 36 mU/L, respectively. Pharmacokinetic/pharmacodynamic characteristics of insulin aspart have not been established in patients with type 2 diabetes.

The intra-individual variability in time to maximum serum insulin concentration for healthy male volunteers was significantly less for NovoLog than for regular human insulin. The clinical significance of this observation has not been established.

In a clinical study in healthy non-obese subjects, the pharmacokinetic differences between NovoLog and regular human insulin described above, were observed independent of the site of injection (abdomen, thigh, or upper arm).

Distribution and Elimination - NovoLog has low binding to plasma proteins (<10%), similar to that seen with regular human insulin. After subcutaneous administration in normal male volunteers (n=24), NovoLog was more rapidly eliminated than regular human insulin with an average apparent half-life of 81 minutes compared to 141 minutes for regular human insulin.

Specific Populations

Children and Adolescents - The pharmacokinetic and pharmacodynamic properties of NovoLog and regular human insulin were evaluated in a single dose study in 18 children (6-12 years, n=9) and adolescents (13-17 years [Tanner grade > 2], n=9) with type 1 diabetes. The relative differences in pharmacokinetics and pharmacodynamics in children and adolescents with type 1 diabetes between NovoLog and regular human insulin were similar to those in healthy adult subjects and adults with type 1 diabetes.

Gender - In healthy volunteers, no difference in insulin aspart levels was seen between men and women when body weight differences were taken into account. There was no significant difference in efficacy noted (as assessed by HbAlc) between genders in a trial in patients with type 1 diabetes.

Obesity - A single subcutaneous dose of 0.1 U/kg NovoLog was administered in a study of 23 patients with type 1 diabetes and a wide range of body mass index (BMI, 22-39 kg/m2). The pharmacokinetic parameters, AUC and Cmax, of NovoLog were generally unaffected by BMI in the different groups - BMI 19-23 kg/m2 (N=4); BMI 23-27 kg/m2 (N=7); BMI 27-32 kg/m2 (N=6) and BMI >32 kg/m2 (N=6). Clearance of NovoLog was reduced by 28% in patients with BMI >32 kg/m2 compared to patients with BMI

Renal Impairment - Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. A single subcutaneous dose of 0.08 U/kg NovoLog was administered in a study to subjects with either normal (N=6) creatinine clearance (CLcr) (> 80 ml/min) or mild (N=7; CLcr = 50-80 ml/min), moderate (N=3; CLcr = 30-50 ml/min) or severe (but not requiring hemodialysis) (N=2; CLcr = Warnings and Precautions].

Hepatic Impairment - Some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure. A single subcutaneous dose of 0.06 U/kg NovoLog was administered in an open-label, single-dose study of 24 subjects (N=6/group) with different degree of hepatic impairment (mild, moderate and severe) having Child-Pugh Scores ranging from 0 (healthy volunteers) to 12 (severe hepatic impairment). In this small study, there was no correlation between the degree of hepatic failure and any NovoLog pharmacokinetic parameter. Careful glucose monitoring and dose adjustments of insulin, including NovoLog, may be necessary in patients with hepatic dysfunction [see Warnings and Precautions].

The effect of age, ethnic origin, pregnancy and smoking on the pharmacokinetics and pharmacodynamics of NovoLog has not been studied.

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Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of NovoLog. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with NovoLog at 10, 50, and 200 U/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area, respectively). At a dose of 200 U/kg/day, NovoLog increased the incidence of mammary gland tumors in females when compared to untreated controls. The incidence of mammary tumors for NovoLog was not significantly different than for regular human insulin. The relevance of these findings to humans is not known. NovoLog was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes. In fertility studies in male and female rats, at subcutaneous doses up to 200 U/kg/day (approximately 32 times the human subcutaneous dose, based on U/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.

Animal Toxicology And/Or Pharmacology

In standard biological assays in mice and rabbits, one unit of NovoLog has the same glucose-lowering effect as one unit of regular human insulin. In humans, the effect of NovoLog is more rapid in onset and of shorter duration, compared to regular human insulin, due to its faster absorption after subcutaneous injection (see Section CLINICAL PHARMACOLOGY Figure 2 and Figure 4).

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Clinical Studies

Subcutaneous Daily Injections

Two six-month, open-label, active-controlled studies were conducted to compare the safety and efficacy of NovoLog to Novolin R in adult patients with type 1 diabetes. Because the two study designs and results were similar, data are shown for only one study (see Table 3). NovoLog was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals. NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbA1c and the incidence rates of severe hypoglycemia (as determined from the number of events requiring intervention from a third party) were comparable for the two treatment regimens in this study (Table 3) as well as in the other clinical studies that are cited in this section. Diabetic ketoacidosis was not reported in any of the adult studies in either treatment group.

Table 3. Subcutaneous NovoLog Administration in Type 1 Diabetes (24 weeks; n=882)

	NovoLog + NPH	Novolin R + NPH
N	596	286
Baseline HbA1c (%)*	7.9 ±1.1	8.0 ± 1.2
Change from Baseline HbA1c (%)	-0.1 ± 0.8	0.0 ± 0.8
Treatment Difference in HbA1c ,Mean (95% confidence interval)	-0.2 (-0.3, -0.1)
Baseline insulin dose (IU/kg/24 hours)*	0.7 ± 0.2	0.7 ± 0.2
End-of-Study insulin dose (IU/kg/24 hours)*	0.7 ± 0.2	0.7 ± 0.2
Patients with severe hypoglycemia (n, %)â€	104 (17%)	54 (19%)
Baseline body weight (kg)* Weight Change from baseline (kg)*	75.3 ± 14.5 0.5 ± 3.3	75.9 ± 13.1 0.9 ± 2.9

* Values are Mean ± SD

† Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

A 24-week, parallel-group study of children and adolescents with type 1 diabetes (n = 283) aged 6 to 18 years compared two subcutaneous multiple-dose treatment regimens: NovoLog (n = 187) or Novolin R (n = 96). NPH insulin was administered as the basal insulin. NovoLog achieved glycemic control comparable to Novolin R, as measured by change in HbA1c (Table 4) and both treatment groups had a comparable incidence of hypoglycemia. Subcutaneous administration of NovoLog and regular human insulin have also been compared in children with type 1 diabetes (n=26) aged 2 to 6 years with similar effects on HbA1c and hypoglycemia.

Table 4. Pediatric Subcutaneous Administration of NovoLog in Type 1 Diabetes (24 weeks; n=283)

	NovoLog + NPH	Novolin R + NPH
N	187	96
Baseline HbA1c (%) *	8.3 ± 1.2	8.3 ± 1.3
Change from Baseline HbA1c (%)	0.1 ± 1.0	0.1 ± 1.1
Treatment Difference in HbA1c, Mean (95% confidence interval)	0.1 (-0.5, 0.1)
Baseline insulin dose (IU/kg/24 hours) *	0.4 ± 0.2	0.6 ± 0.2
End-of-Study insulin dose (IU/kg/24 hours) *	0.4 ± 0.2	0.7 ± 0.2
Patients with severe hypoglycemia (n, %)â€	11 (6%)	9 (9%)
Diabetic ketoacidosis (n, %)	10 (5%)	2 (2%)
Baseline body weight (kg) * Weight Change from baseline (kg) *	50.6 ± 19.6 2.7 ± 3.5	48.7 ± 15.8 2.4 ± 2.6

* Values are Mean ± SD

† Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

One six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of NovoLog to Novolin R in patients with type 2 diabetes (Table 5). NovoLog was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals. NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbAlc and the rates of severe hypoglycemia (as determined from the number of events requiring intervention from a third party) were comparable for the two treatment regimens.

Table 5. Subcutaneous NovoLog Administration in Type 2 Diabetes (6 months; n=176)

	NovoLog + NPH	Novolin R + NPH
N	90	86
Baseline HbA1c (%) *	8.1 ± 1.2	7.8 ± 1.1
Change from Baseline HbA1c (%)	-0.3 ± 1.0	-0.1 ± 0.8
Treatment Difference in HbA1c, Mean (95% confidence interval)	- 0.1 (-0.4, -0.1)
Baseline insulin dose (IU/kg/24 hours) *	0.6 ± 0.3	0.6 ± 0.3
End-of-Study insulin dose (IU/kg/24 hours) *	0.7 ± 0.3	0.7 ± 0.3
Patients with severe hypoglycemia (n, %) â€	9 (10%)	5 (8%)
Baseline body weight (kg) * Weight Change from baseline (kg) *	88.4 ± 13.3 1.2 ± 3.0	85.8 ± 14.8 0.4 ± 3.1

* Values are Mean ± SD

† Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

Continuous Subcutaneous Insulin Infusion (CSII) by External Pump

Two open-label, parallel design studies (6 weeks [n=29] and 16 weeks [n=118]) compared NovoLog to buffered regular human insulin (Velosulin) in adults with type 1 diabetes receiving a subcutaneous infusion with an external insulin pump. The two treatment regimens had comparable changes in HbA1c and rates of severe hypoglycemia.

Table 6. Adult Insulin Pump Study in Type 1 Diabetes (16 weeks; n=118)

	NovoLog	Buffered human insulin
N	59	59
Baseline HbA1c (%) *	7.3 ± 0.7	7.5 ± 0.8
Change from Baseline HbA1c (%)	0.0 ± 0.5	0.2 ± 0.6
Treatment Difference in HbA1c, Mean (95% confidence interval)	0.3 (-0.1, 0.4)
Baseline insulin dose (IU/kg/24 hours) *	0.7 ± 0.8	0.6 ± 0.2
End-of-Study insulin dose (IU/kg/24 hours) *	0.7 ± 0.7	0.6 ± 0.2
Patients with severe hypoglycemia (n, %) â€	1 (2%)	2 (3%)
Baseline body weight (kg) * Weight Change from baseline (kg) *	77.4 ± 16.1 0.1 ± 3.5	74.8 ± 13.8 -0.0 ± 1.7

* Values are Mean ± SD

† Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

A randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes (n=298) aged 4-18 years compared two subcutaneous infusion regimens administered via an external insulin pump: NovoLog (n=198) or insulin lispro (n=100). These two treatments resulted in comparable changes from baseline in HbA1c and comparable rates of hypoglycemia after 16 weeks of treatment (see Table 7).

Table 7. Pediatric Insulin Pump Study in Type 1 Diabetes (16 weeks; n=298)

	NovoLog	Lispro
N	198	100
Baseline HbA1c (%) *	8.0 ± 0.9	8.2 ± 0.8
Change from Baseline HbA1c (%)	-0.1 ± 0.8	-0.1 ± 0.7
Treatment Difference in HbA1c, Mean (95% confidence interval)	-0.1 (-0.3, 0.1)
Baseline insulin dose (IU/kg/24 hours) *	0.9 ± 0.3	0.9 ± 0.3
End-of-Study insulin dose (IU/kg/24 hours) *	0.9 ± 0.2	0.9 ± 0.2
Patients with severe hypoglycemia (n, %) â€	19 (10%)	8 (8%)
Diabetic ketoacidosis (n, %)	1 (0.5%)	0 (0)
Baseline body weight (kg) * Weight Change from baseline (kg) *	54.1 ± 19.7 1.8 ± 2.1	55.5 ± 19.0 1.6 ± 2.1

* Values are Mean ± SD

† Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

An open-label, 16-week parallel design trial compared pre-prandial NovoLog injection in conjunction with NPH injections to NovoLog administered by continuous subcutaneous infusion in 127 adults with type 2 diabetes. The two treatment groups had similar reductions in HbA1c and rates of severe hypoglycemia (Table 8) [see Indications and Usage, Dosage and Administration, Warnings and Precautions and How Supplied/Storage and Handling].

Table 8. Pump Therapy in Type 2 Diabetes (16 weeks; n=127)

	NovoLog pump	NovoLog + NPH
N	66	61
Baseline HbA1c (%) *	8.2 ± 1.4	8.0 ± 1.1
Change from Baseline HbA1c (%)	-0.6 ± 1.1	-0.5 ± 0.9
Treatment Difference in HbA1c, Mean (95% confidence interval)	0.1 (0.4, 0.3)
Baseline insulin dose (IU/kg/24 hours) *	0.7 ± 0.3	0.8 ± 0.5
End-of-Study insulin dose (IU/kg/24 hours) *	0.9 ± 0.4	0.9 ± 0.5
Baseline body weight (kg) * Weight Change from baseline (kg) *	96.4 ± 17.0 1.7 ± 3.7	96.9 ± 17.9 0.7 ± 4.1

* Values are Mean ± SD

Intravenous Administration of NovoLog

See Section Clinical Pharmacology/Pharmacodynamics.

top

How Supplied /Storage and Handling

NovoLog is available in the following package sizes: each presentation containing 100 Units of insulin aspart per mL (U-100).

10 mL vials	NDC 0169-7501-11
3 mL PenFill cartridges*	NDC 0169-3303-12
3 mL NovoLog FlexPen Prefilled syringe	NDC 0169-6339-10

 

* NovoLog PenFill cartridges are designed for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices (with or without the addition of a NovoPen 3 PenMate) with NovoFine disposable needles.

Recommended Storage

Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze NovoLog and do not use NovoLog if it has been frozen. NovoLog should not be drawn into a syringe and stored for later use.

Vials: After initial use a vial may be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. Opened vials may be refrigerated.

Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.

PenFill cartridges or NovoLog FlexPen Prefilled Syringes:

Once a cartridge or a NovoLog FlexPen Prefilled syringe is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. Cartridges or NovoLog FlexPen Prefilled syringes in use must NOT be stored in the refrigerator. Keep all PenFill® cartridges and disposable NovoLog FlexPen Prefilled syringes away from direct heat and sunlight. Unpunctured PenFill cartridges and NovoLog FlexPen Prefilled syringes can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused PenFill cartridges and NovoLog FlexPen Prefilled syringes in the carton so they will stay clean and protected from light.

Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPen Prefilled Syringe without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.

Pump:

NovoLog in the pump reservoir should be discarded after at least every 48 hours of use or after exposure to temperatures that exceed 37°C (98.6°F).

Summary of Storage Conditions:

The storage conditions are summarized in the following table:

Table 9. Storage conditions for vial, PenFill cartridges and NovoLog FlexPen Prefilled syringe

NovoLog presentation	Not in-use (unopened) Room Temperature (below 30°C)	Not in-use (unopened) Refrigerated	In-use (opened) Room Temperature (below 30°C)
10 mL vial	28 days	Until expiration date	28 days (refrigerated/room temperature)
3 mL PenFill cartridges	28 days	Until expiration date	28 days (Do not refrigerate)
3 mL NovoLog FlexPen Prefilled syringe	28 days	Until expiration date	28 days (Do not refrigerate)

Storage of Diluted NovoLog

NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.

Storage of NovoLog in Infusion Fluids

Infusion bags prepared as indicated under Dosage and Administration (2) are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.

last updated 12/2008

NovoLog, insulin aspart, patient information (in plain English)

Detailed Info on Signs, Symptoms, Causes, Treatments of Diabetes

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

back to: Browse all Medications for Diabetes

Thoughtful quotes about suffering and pain.

Words of Wisdom

 

"The greatest grief's are those we cause ourselves." (author unknown)

"The world breaks everyone and after many are strong at the broken places." (Hemingway)

"Although the world is full of suffering, it is full also of the overcoming of it." (Helen Keller)

"All the best transformations are accompanied by pain. That's the point of them." (Fay Weldon)

"A wounded deer leaps highest" (Emily Dickinson)

"Perhaps everything terrible is in its deepest being something that wants help from us." (Rainer Maria Rilke)

"Let your tears come. Let them water your soul." (Eileen Mayhew)

"Where there is sorrow there is holy ground." (Oscar Wilde)

"Sorrow makes us very good or very bad." (George Sand)

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"That which oppresses me, is it my soul trying to come out in the open, or the soul of the world knocking at my heart for entrance." (Ravindranath Tagore)

"There is no birth of consciousness without pain." (Carl Jung)

"It is significant that the experience of despair is a yoga. Despair is often the first step on the path to spiritual life, and many people do not awaken to the reality of God and the experience of transformation in their lives until they go through the experience of emptiness, disillusion, and despair." (Bede Griffith)

"Where I am, I don't know, I'll never know, in the silence you don't know, you must go on, I can't go on, I'll go on." (Samuel Beckett)

"God comes through the wound." (Marion Woodman)

"...my deprivation had been my greatest blessing. What counts is not what you have lost but what you have left." (Harold Russell)

"It's hard to tell our bad luck from our good luck sometimes. Hard to tell sometimes for many years to come." (Merle Shain)

"All suffering prepares the soul for vision." (Martin Buber)

"The heart that breaks open can contain the whole universe." (Joanna Macy)

"Those times of depression tell you that it's either time to get out of the story your in and move into a new story, or that you're in the right story but there's some piece of it you are not living out." (Carol S. Pearson)

"We are healed of a suffering only by experiencing it to the full." (Marcel Proust)

"I bend but I do not break" (Jean de La Fontaine)

"The greater the obstacle , the more glory in overcoming it." (Moliere)

"Rebellion against your handicaps gets you nowhere. Self-pity gets you nowhere. One must have the adventurous daring to accept oneself as a bundle of possibilities and undertake the most interesting game in the world - making the most of one's best." (Harry Emerson Fosdick)

next:War and Peace

The Core: The original birth personality.

Personalities: The fragmented pieces of a child's psyche that holds trauma.

Hysterical Neurosis/Multiple Personality Disorder: The presence of two or more separate and distinct personalities who take turns using the body.

Other terms used for personalities: Alter egos, alter states, selves, parts (a subjective term).

Executive: When a personality (alter ego) has control of the body.

Host personality: Another term for the personality that has control of the body.

Dissociate: Webster's definition - to break the connection between or to disunite.

Switch: To switch from one personality to another.

Who's out? A common question used to determine which personality is executive or host.

Co-conscious(ness): (The Core) A state of being aware of what the other personalities are doing and saying.

Hysterical Conversion Symptoms/body memories: Physical phenomenon such as pain, smells, tastes, etc.; re-experienced again.

Re-live: A total memory recall (includes visual, emotional, physical and all other senses).

Dx: Internet Slang referring to the term 'Diagnosed'. When were you Dxed?=When were you diagnosed?

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next:   Dissociative Identity Disorder/ Multiple Personality Disorder FAQ (frequently asked questions)

WHO RUNS THIS PLACE?

Currently SagePlace is primarily a one- woman show run by Tammie Fowles with technical assistance and support provided by Andy Rancourt and Kevin Fowles.

WHAT IS THE BIRTHQUAKE WORKBOOK AND HOW DO I USE IT?

The BirthQuake workbook provides members of the SagePlace community a tool to work on issues related to change, growth, healing and transformation. By responding to the questions contained in each workbook section, members can share their experience and wisdom, ask for feedback, and both receive and provide support. The Questions can be answered individually or you can just post your overall response to the group of questions. If you would like to explore the questions in the order they were written, then start with (1) The Quake then move to (2) The Haunted (3) Discovering Meaning (4) Embracing the Spirit (5) Nature as Nurturer (6) The Body-Mind Dance (7) Calling Forth The Source and (8) The Journey. To learn about obtaining the workbook and participating in a BirthQuake workshop via the internet email Tammie

HOW MUCH DOES IT COST TO PARTICIPATE IN AN INTERNET BIRTHQUAKE WORKSHOP?

The cost of participation in an internet BirthQuake workshop is based on donations. We ask that you donate what you feel comfortable donating from $1.00 to what ever you wish.. Proceeds from the workshop are directly applied to costs related to maintaining this website and providing assistance to non-profit organizations devoted to service.

HOW ELSE CAN I PARTICIPATE AT SAGEPLACE?

By emailing us your own thoughts, experiences, favorite books and quotes regarding personal and or global healing and transformation that we can share with others in the guest room, by participating in scheduled chats, and joining the BirthQuake and SagePlace mailing list.

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HOW CAN I SUPPORT SAGEPLACE?

Although it does require considerable time and money to operate and maintain SagePlace and we would like offer further services while at the same time making this site self-supporting through sponsorships appropriate, advertising, and donations, what we are tremendously greatly for are visitors efforts to engage in personal and global healing as well as their written submissions of their own experiences and wisdom.

next:BirthQuake: Journey to Wholeness

Stanton,

I adopted a lovely baby; she is now four years old. Although at first I noticed she seemed somewhat slow to develop (crawling, rolling over, speaking), it is now clear that she has real developmental problems. I know some things about her birth mother, and these suggest that this mother used drugs. I am afraid I have adopted a crack baby! (I realize that meth amphetamines are frequently the culprit now, rather than crack.) If this is true, I fear that I face a lifetime of problems with my beautiful child.

How likely is it that she is a crack baby? Are the same problems as for crack babies evident in the babies of mothers who used methamphetamines? Lastly, what can I do about it?

Marianne

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Dear Marianne,

I have written extensively about the crack baby myth - that use of crack during pregnancy has permanent effects that mar the baby for life. Although research has never supported such an idea, this myth persists - and is propagated by the media. I periodically update this information.

Finally, in February 2004, a blue-ribbon panel of medical and other researchers released a public letter decrying the continuing use of the term: "we are writing to request that the terms 'crack baby' and 'crack addicted baby' be dropped from usage. These terms and similarly stigmatizing terms, such as 'ice babies' and 'meth babies,' lack scientific validity and should not be used."

The researchers continued: "Throughout almost 20 years of research, none of us has identified a recognizable condition, syndrome or disorder that should be termed 'crack baby.' Some of our published research finds subtle effects of prenatal cocaine exposure in selected developmental domains, while other of our research publications do not."

In another interesting declaration, the group warned equally against using the term "crack-addicted" baby: "Addiction is a technical term that refers to compulsive behavior that continues in spite of adverse consequences. By definition, babies cannot be 'addicted' to crack or anything else."

Children identified with problems stemming from crack us, as I have said repeatedly, are generally suffering from impoverished and other negative environments after birth. Remedial program - but programs that are designed for every child show good benefits for children identified as coming from mothers who used crack heavily.

Moreover, thinking of and labeling your child as a crack baby can itself be harmful. Based on another study of babies of drug-using mothers, the chief investigator, Deborah Frank, of Boston University's School of Medicine, noted, "This stereotype does as much harm, if not more, to children as the actual physiological impact of prenatal exposure. The negative expectations of these children are in itself very harmful."

Among the dangers of the myth of crack babies, the panel on such children noted, was that child abusers frequently claimed that foster children in their care showed signs of damage (including starvation) because they were actually crack babies, when in fact the children were currently being abused!

According to Frank (who was one of the panel members), children of heavy crack users who received supportive interventions showed better progress than comparable babies whose mothers had not used drugs!

So, the path is clear for you - seek appropriate assistance in addressing your child's deficiencies. There is nothing - at least as far as her birth mother's drug use - that will prevent her from forging ahead with proper help.

References:

Frank, D., et al. (2002). Level of Prenatal Cocaine Exposure and Scores on the Bayley Scales of Infant Development: Modifying Effects of Caregiver, Early Intervention, and Birth Weight. Pediatrics, 110, 1143-1152

Lewis, D. et al. (February 25, 2004). Top Medical Doctors and Scientists Urge Major Media Outlets to Stop Perpetuating "Crack Baby" Myth. Press Release, Brown University.

next: Is My Masturbation Ruining My Marriage, Even Though We Have an Excellent Sex Life?
~ all Stanton Peele articles
~ addictions library articles
~ all addictions articles

How do you know if your partner may be addicted to the Internet? Impairment to real life relationships appears to the be the number one problem caused by Internet Addiction. Internet Addicts gradually spend less time with real people in their lives in exchange for solitary time in front of a computer. Partners first rationalize the Internet-obsessed user's behavior as "a phase" in hopes that the attraction will soon dissipate. However, when addictive behavior continues, arguments about the increased volume of time and energy spent online soon ensue, but such complaints are often deflected as part of the denial exhibited by Internet Addicts. Internet Addicts become angry and resentful at others who question or try to take away their time from using the Internet. For example, "I don't have a problem," or "I am having fun, leave me alone," might be an Internet addict's response. These behaviors create distrust that over time hurt the quality of once stable relationships. The following Internet addiction test will help you determine if you may be dealing with Internet addiction in your home. Remember when answering, only consider time your partner uses the Internet for non-academic or non-job related tasks.

Please answer the following questions using this scale:

1 = Not Applicable or Rarely.
2 = Occasionally.
3 = Frequently.
4 = Often.
5 = Always.

1. How often does your partner desire or demand his or her privacy when on-line?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

2. How often does your partner neglect household chores to spend more time online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

3. How often does your partner prefer to spend time online rather than with the rest of your family?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

4. How often does your partner form new relationships with fellow online users?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

5. How often do you complain about the amount of time your partner spends on-line?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

6. How often does your partner's work or employment suffer because of the amount of time he or she spends online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

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7. How often does your partner check his or her e-mail before doing something else?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

8. How often does your partner seem withdrawn from others since being online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

9. How often does your partner become defensive or secretive when asked what he or she does online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

10. How often does your partner try to sneak on-line against your wishes?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

11. How often does your partner ignore spending romantic evenings with you since discovering the online world?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

12. How often does your partner receive strange phone calls from new "online" friends?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

13. How often does your partner snap, yell, or act annoyed if bothered while online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

14. How often does your partner come to bed late because he or she stays up late online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

15. How often does your partner seem preoccupied with being back on-line when off-line?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

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16. How often does your partner lie or try to hide how long he or she spends online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

17. How often does your partner choose to spend time online than doing once enjoyed hobbies and/or outside interests?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

18. How often does your partner prefer to spend time online rather than making-love?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

19. How often does your partner choose to spend more time online than going out with friends?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

20. How often does your partner feel depressed, moody, or nervous when off-line which seems to goes away once back online?

1 = Rarely
2 = Occasionally
3 = Frequently
4 = Often
5 = Always

Your Score:

After you've answered all the questions, add the numbers you selected for each response to obtain a final score. The higher the score, the greater the level of your partner's Internet addiction. Here's a general scale to help measure the score:

20 - 49 points: Your partner is an average on-line user. He or she may surf the Web a bit too long at times, but seems to have control of their usage.

50 - 79 points: Your partner seems to be experiencing occasional to frequent problems because of the Internet. You should consider the full impact of the Internet on your partner's life and on your relationship.

80 - 100 points: Scores in this range indicate that Internet usage may be causing significant problems in your partner's life and your relationship. You should evaluate how the Internet has impacted your relationship and address these problems now.

Underlying such addictive on-line behavior can be a cyberaffair that is about to come between you and your spouse. To learn more about how to deal with cyberaffairs, please read our exclusive new booklet, Infidelity Online: An Effective Guide to Rebuild your Relationship after a Cyberaffair. And if your partner has scored too high for your comfort, please refer to:

Caught in the Net - to read about being a Cyberwidow and Co-dependency related to Internet addiction.

Our Virtual Clinic - for immediate consultation on how to help your situation.

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next:  Bidding Till You're Broke
~ all center for online addiction articles
~ all articles on addictions

There are various medications that can be used to help alcoholics stop drinking and deal with the symptoms of alcohol withdrawal and the craving for alcohol.

Often, people want to know, "Isn't there a pill that can fix the addiction to alcohol?" Unfortunately, there is not a pill that can cure the addiction, but there are medications that can perhaps make it easier to effectively participate in the treatment for alcoholism.

The Food and Drug Administration (FDA) has approved only three drugs in the past 55 years to treat alcoholism. Each of these drugs acts differently in the body to interrupt the addiction process. They are , ReVia, and Campral.

Antabuse

For those with an alcohol problem, the oldest medication thought to "cure" the disease is Antabuse (disulfiram). Wyeth-Ayerst Laboratories Division first marketed Antabuse in 1948. This drug causes many unpleasant effects when the individual consumes alcohol, even in small amounts. The effects can range from facial flushing, headache and mild nausea to severe vomiting and increased blood pressure and heart rate.

The expectation is that as a person associates these negative symptoms with drinking, the individual will be less likely to want to drink another time. Usually, the threat of becoming ill after a drink of alcohol will deter most motivated people. However, the effectiveness of the drug depends mostly on the individual's motivation for remaining abstinent.

Drawbacks to Antabuse

While will build up in the person's system those who choose to resume drinking will simply stop taking the medication for a few days prior to consuming alcohol.

Another problem is that people have reported experiencing very mild reactions with the use of mouthwash that has a percentage of alcohol in it, foods with vinegar like salad dressings and ketchup, and certain colognes and aftershave. Your doctor should talk to you about what is best to avoid and what to experiment with in terms of over-the-counter products and medicines.

Antabuse should not be prescribed for people with cirrhosis or other chronic medical conditions, including heart disease or diabetes. Let your doctor make this decision. This drug should also not be prescribed for people over 60 years of age. Severe reactions to Antabuse have included heart attacks, and some cases have even resulted in death.

ReVia

The FDA approved the use of ReVia (naltrexone) in December 1994 for the treatment of alcoholism. It was initially marketed by DuPont Merck Pharmaceutical company for treating narcotic dependency. ReVia blocks the parts of the brain that experience pleasure from drug/alcohol use.

Studies began to show that when used to assist with treating alcoholism, the drug helped to decrease alcohol relapse and craving when it was used over a period of three to six months. The success of the drug, however, is likely dependent on a person's simultaneous involvement in a structured treatment program that can educate them on addiction, recovery, and relapse prevention behaviors.

The studies on ReVia and alcoholism treatment all occurred in settings that combined psychotherapy and psycho-education with the medication. Therefore, the FDA approved ReVia for alcoholism only as an adjunct to traditional supportive therapy. According to the FDA, "This drug is non-addictive but can cause liver toxicity if prescribed at doses higher than recommended.

Drawbacks to ReVia

ReVia is not recommended for people with active hepatitis and other liver diseases (www.fda.gov)." Side effects include nausea, headache, dizziness, fatigue, and sometimes vomiting and insomnia. This is a daily medication to be taken orally; however, a long-acting injection is being developed.

Campral

Campral (acamprosate) is the newest drug approved by the FDA to assist with alcohol abstinence. It was approved in July 2004 for marketing and distribution by Forest Pharmaceuticals, Inc. Though the exact workings of the drug are not understood, it is believed that Campral can restore imbalanced brain chemicals to a normal balance, thereby reducing cravings and thus relapses.

Campral is prescribed once someone has made the decision to remain abstinent and he/she is currently alcohol-free. The medication is most effective when combined with a structured treatment program that can teach relapse prevention skills, or provides social support, such as community self-help groups.

Drawbacks to Campral

Campral has been used in Europe for over 10 years and has been shown to be useful for individuals with mild to moderate liver problems. Side effects have been reported as diarrhea, fatigue, nausea, gas, and itching. The most common side effect, diarrhea, usually resolves with time.

In all cases, a primary care physician or psychiatrist can prescribe and monitor the medications. Also, in all cases the recommendation is to use medication as a part of a comprehensive plan for treating addiction. The person with an alcohol problem should be willing to participate in some sort of supportive treatment program, ranging from community self-help groups like Alcoholics Anonymous / Narcotics Anonymous, Rational Recovery, etc, to a structured treatment program involving a combination of group and individual therapy and education. Recovering from addiction involves a lifestyle change. The medications can only assist in making the changes easier by reducing cravings and/or drinking behaviors so that you can focus on recovery.

About the author: Ms. Laura Buck, LCSW, CAC, is a clinical social worker currently in private practice at Paoletta Psychological Services in Mercer, PA. Ms. Buck has worked as a clinicial social worker with addictions and mental health for the past five years.

next: Attitudes That Can Lead to a Drug or Alcohol Relapse
~ addictions library articles
~ all addictions articles

For Men Only

The most hotly contested battlefield in the gender wars may not necessarily be in the bedroom. It may be the bathroom. The seat-up vs. seat-down debate rages on and some interpret this as a sign of male insensitivity and overall cloddishness.

Although it doesn't rate up there with the unisex restroom in the Ally McBeal television show, the signage for the toilets at one Phoenix, Arizona advertising-public relations firm is an eye-catcher.

Instead of the plain old "Men" and "Women" on the politically correct male and female door signs, the restrooms entries at Cramer-Krasselt are adorned with tasteful, nearly look-alike 3-inch square photos of a toilet. There is one difference -- one has the seat up and the other has the seat down.

The Considerate Seat™

Is someone trying to tell us something?

Come on, guys! Maybe it's time to be a little more considerate. Like paying attention to the little things.

As a professional speaker, I lead seminars on personal relationships. In our discussions of "paying attention to the little things," taking the garbage out, leaving the toilet seat up and rolling the toilet paper the wrong way (among other things) seem to almost always creep into the conversation.

Although we may laugh at such trivial things, the truth is, it is important to our partners to do the little things consistently. It shows them we value and respect them.

Inventor, Tim Seniuk has the perfect solution to the "leaving the toilet seat up" problem. He has invented a toilet seat that goes down automatically after about two minutes. This $37 investment could save your marriage!

You will never again have to worry about experiencing the "porcelain splash" in the middle of the night! ;-)

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Indifference is like water to a fire. The flame of love grows dim with indifference to your partner's needs. By far the most common and important way in which you can exercise your attention to your partner is by listening. Listening is an act of love.

Women can often tell a man's interest in them by the length of his attention span. It's one thing to pay attention and quite another to acknowledge her request and then remember to do it more than once without having to be reminded. She is not your mother.

Being attentive to your love partner's needs, regardless of what importance you may place on them, will support things going well in and out of the bedroom. Think about it.It is unreasonable, and a breach of trust, to deny your lover's report of her feelings. When she expresses a need, it's your responsibility to do what you can to fulfill that need. Partners who love each other make this a priority.

Make a list of things you know that pleases your partner and remember do them consistently. Where is it written that a man should have only one job and a woman two? Housework is not just the woman's job!

If you feel that it is solely her responsibility to go about cleaning the house, paying the bills, taking care of the children, feeding the pets, emptying the trash, washing the clothes, vacuuming the carpet, getting the groceries, planning and cooking your dinner, all with great gusto, you are dead wrong!

For a relationship to work, BOTH partners must give 100% all the time! It's never easy and it's possible. Taking care of what needs to be taken care of is a SHARED responsibility. Relationship enrichment can only occur when both partners work together.

Reach agreement about taking out the garbage, which way the toilet paper should roll; in or out and putting the toilet seat down after you have completed your bathroom task and all the other helpful things you can do. Have them be random acts of thoughtfulness.

By the way, here's a frivolous fact: According to a 1999 survey by the Scott Paper Company, more than sixty percent prefer that their toilet paper roll over the top, twenty nine percent from the bottom. Eleven percent don't care. We thought you should know.

Intentionally add a little pizzazz to your love relationship. Do it in playful ways. Exercise your sense of humor. It enlivens your spirit, breeds happiness and causes you and the one you love to experience fully the love you feel for one another.

Leave a note on the toilet seat (after you've put it down) that says, "I put the seat down because I love you, not because I should," and add a smiley face. Do things that make each other smile. Smiles and knowing nods from your lover create a sense of unity that adds longevity to your relationship.

Life is like a roll of toilet paper. The closer it gets to the end, the faster it goes. So, maybe it's time to make the best use of your time to show your partner that you are sensitive to the little things.

And one more thing. If you leave sprinkles on the seat. . . wipe them off! ;-)

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I encourage the men in my seminars to use their bathroom experience as an opportunity to ponder the thought that. . .

"Foreplay begins with putting the toilet seat down without being asked!"

Some final advice to women - Lest you unwittingly place your bottom directly on the porcelain, "Look before you sit!" Perhaps some of these days us guys will comprehend the complexity and significance of this relationship problem.

 The Troublesome Toilet Seat - The toilet seat dilemma taken to an extreme! Funny stuff.

The Bathroom Diaries - This well-organized directory identifies the best and worst public pit stops across the globe.

The Happiest Potties on Earth - Where would that be? Disneyland, of course! More than you need to know about the Disneyland potties.

 - A thief broke into the local police station and stole all the toilets. A police spokesperson was quoted as saying, "We have absolutely nothing to go on."

 

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Therapy and nicotine replacement help smokers quit.

Combined behavioral and nicotine replacement therapy for nicotine addiction consists of two main components:

• The transdermal nicotine patch or nicotine gum reduces symptoms of withdrawal, producing better initial abstinence.
• The behavioral component concurrently provides support and reinforcement of coping skills, yielding better long-term outcomes.

Through behavioral skills training, patients learn to avoid high-risk situations for smoking relapse early on and later to plan strategies to cope with such situations. Patients practice skills in treatment, social, and work settings. They learn other coping techniques, such as cigarette refusal skills, assertiveness, and time management. The combined treatment is based on the rationale that behavioral and pharmacological treatments operate by different yet complementary mechanisms that produce potentially additive effects.

References:

Fiore, M.C.; Kenford, S.L.; Jorenby, D.E.; Wetter, D.W.; Smith, S.S.; and Baker, T.B. Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments. Chest 105: 524-533, 1994.

Hughes, J.R. Combined psychological and nicotine gum treatment for smoking: a critical review. Journal of Substance Abuse 3: 337-350, 1991.

American Psychiatric Association: Practice Guideline for the Treatment of Patients with Nicotine Dependence. American Psychiatric Association, 1996.

Source: National Institute of Drug Abuse, "Principles of Drug Addiction Treatment: A Research Based Guide."

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