Dosing instructions
Jul 30, 2017 12:47:03 GMT -5
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sportsrancho, tarheelblue004, and 1 more like this
Post by brotherm1 on Jul 30, 2017 12:47:03 GMT -5
So I assume the below was written by Mannkind and approved by the FDA? "Uses, Adult, PEDIATRIC, geriatric"? These appear to be new, perhaps to go with the recent packaging with various sized doses?
sportsrancho Avatar sportsrancho
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54 minutes ago
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Drugs & Diseases
insulin inhaled (Rx)
Brand and Other Names:Afrezza
Classes: Antidiabetics, Insulins; Antidiabetics, Rapid-Acting Insulins
SECTIONS
Dosing & Uses
Adult Pediatric Geriatric
Dosage Forms & Strengths
orally inhaled powder
Available as single-use cartridges
4 units/cartridge
8 units/cartridge
12 units/cartridge
MORE...
Diabetes Mellitus (Types 1 and 2)
Orally inhaled rapid-acting insulin indicated to improve glycemic control in adults with diabetes mellitus
Dosing must be individualized
Administer via oral inhalation only at the beginning of a meal
Administer using a single inhalation per cartridge
Mealtime dose conversion
Dosage adjustment may be needed when switching from insulin to inhaled insulin
NOTE: Also see starting mealtime conversion instructions below
Up to 4 units SC = 4 units inhaled
5-8 units SC = 8 units inhaled
9-12 units SC = 12 units inhaled
13-16 units SC = 16 units inhaled
17-20 units SC = 20 units inhaled
21-24 units SC = 24 units inhaled
Starting mealtime dose
Insulin naïve: 4 units at each meal initially
Converting from SC mealtime (prandial) insulin: Determine the appropriate inhaled insulin dose for each meal by converting from the injected dose using conversion table (above)
Using SC premixed insulin: Estimate the mealtime injected dose by dividing half of the total daily injected premixed insulin dose equally among the 3 meals of the day; convert each estimated injected mealtime dose to an appropriate inhaled insulin dose (use conversion table above); administer half of the total daily injected premixed dose as an injected basal insulin dose
Dose adjustment
Adjust the inhaled insulin dosage based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal
Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), and changes in renal or hepatic function or during acute illness
Carefully monitor blood glucose control in patients requiring high doses; if blood glucose control is not achieved with increased inhaled insulin doses, consider use of SC mealtime insulin
Dosing Considerations
Before initiating, perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients to identify potential lung disease
Limitations of use
Not a substitute for long-acting insulin; must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus
Not recommended for treatment of diabetic ketoacidosis
Safety and efficacy not established in patients who smoke and is not recommended in patients who smoke or who have recently stopped smoking
Administration
Keep inhaler level and white mouthpiece on top and purple base on the bottom after a cartridge has been inserted into the inhaler
Loss of drug effect can occur if the inhaler is turned upside down, held with the mouthpiece pointing down, or shaken (or dropped) after the cartridge has been inserted but before the dose has been administered
If any of the above occurs, the cartridge should be replaced before use
The inhaler can be used for up to 15 days from the date of first use; after 15 days of use, the inhaler must be discarded and replaced with a new inhaler
See complete illustrated administration instructions provided in packaging
Inhaled insulin doses >12 units
Doses >12 units require inhalations from multiple cartridges
To achieve the required total mealtime dose, patients should use a combination of 4-unit, 8-unit, and 12-unit cartridges
For doses >24 units, combinations of different multiple cartridges can be used
Storage
Before use, cartridges and inhaler should be at room temperature for 10 minutes
Cartridges not in use
Sealed [unopened] cartridges in foil package
Refrigerate at 2-8ºC (36-46ºF)
If foil package is not refrigerated, must use within 10 days
Cartridges in use
Store at room temperature (25ºC [77ºF]), excursions permitted 15-30ºC (59-86ºF)
Sealed [unopened] blister cards and strips: Must be used within 10 days
Opened strips: Must be used within 3 days
Inhaler
May be refrigerated, but should be at room temperature before use
Store between 2-25ºC (36-77ºF); excursions permitted
Next: Interactions
SECTIONS
insulin inhaled
Dosing & Uses
sportsrancho Avatar
Read more: mnkd.proboards.com/thread/8270/where-put-stuff-find-web#ixzz4oL0aitaM
sportsrancho Avatar sportsrancho
Postaholic
*****
54 minutes ago
saxcmann and brotherm1 like this
likePost Options
Drugs & Diseases
insulin inhaled (Rx)
Brand and Other Names:Afrezza
Classes: Antidiabetics, Insulins; Antidiabetics, Rapid-Acting Insulins
SECTIONS
Dosing & Uses
Adult Pediatric Geriatric
Dosage Forms & Strengths
orally inhaled powder
Available as single-use cartridges
4 units/cartridge
8 units/cartridge
12 units/cartridge
MORE...
Diabetes Mellitus (Types 1 and 2)
Orally inhaled rapid-acting insulin indicated to improve glycemic control in adults with diabetes mellitus
Dosing must be individualized
Administer via oral inhalation only at the beginning of a meal
Administer using a single inhalation per cartridge
Mealtime dose conversion
Dosage adjustment may be needed when switching from insulin to inhaled insulin
NOTE: Also see starting mealtime conversion instructions below
Up to 4 units SC = 4 units inhaled
5-8 units SC = 8 units inhaled
9-12 units SC = 12 units inhaled
13-16 units SC = 16 units inhaled
17-20 units SC = 20 units inhaled
21-24 units SC = 24 units inhaled
Starting mealtime dose
Insulin naïve: 4 units at each meal initially
Converting from SC mealtime (prandial) insulin: Determine the appropriate inhaled insulin dose for each meal by converting from the injected dose using conversion table (above)
Using SC premixed insulin: Estimate the mealtime injected dose by dividing half of the total daily injected premixed insulin dose equally among the 3 meals of the day; convert each estimated injected mealtime dose to an appropriate inhaled insulin dose (use conversion table above); administer half of the total daily injected premixed dose as an injected basal insulin dose
Dose adjustment
Adjust the inhaled insulin dosage based on the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal
Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), and changes in renal or hepatic function or during acute illness
Carefully monitor blood glucose control in patients requiring high doses; if blood glucose control is not achieved with increased inhaled insulin doses, consider use of SC mealtime insulin
Dosing Considerations
Before initiating, perform a detailed medical history, physical examination, and spirometry (FEV1) in all patients to identify potential lung disease
Limitations of use
Not a substitute for long-acting insulin; must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus
Not recommended for treatment of diabetic ketoacidosis
Safety and efficacy not established in patients who smoke and is not recommended in patients who smoke or who have recently stopped smoking
Administration
Keep inhaler level and white mouthpiece on top and purple base on the bottom after a cartridge has been inserted into the inhaler
Loss of drug effect can occur if the inhaler is turned upside down, held with the mouthpiece pointing down, or shaken (or dropped) after the cartridge has been inserted but before the dose has been administered
If any of the above occurs, the cartridge should be replaced before use
The inhaler can be used for up to 15 days from the date of first use; after 15 days of use, the inhaler must be discarded and replaced with a new inhaler
See complete illustrated administration instructions provided in packaging
Inhaled insulin doses >12 units
Doses >12 units require inhalations from multiple cartridges
To achieve the required total mealtime dose, patients should use a combination of 4-unit, 8-unit, and 12-unit cartridges
For doses >24 units, combinations of different multiple cartridges can be used
Storage
Before use, cartridges and inhaler should be at room temperature for 10 minutes
Cartridges not in use
Sealed [unopened] cartridges in foil package
Refrigerate at 2-8ºC (36-46ºF)
If foil package is not refrigerated, must use within 10 days
Cartridges in use
Store at room temperature (25ºC [77ºF]), excursions permitted 15-30ºC (59-86ºF)
Sealed [unopened] blister cards and strips: Must be used within 10 days
Opened strips: Must be used within 3 days
Inhaler
May be refrigerated, but should be at room temperature before use
Store between 2-25ºC (36-77ºF); excursions permitted
Next: Interactions
SECTIONS
insulin inhaled
Dosing & Uses
sportsrancho Avatar
Read more: mnkd.proboards.com/thread/8270/where-put-stuff-find-web#ixzz4oL0aitaM
