Drug Interaction:
Drugs that alter GI motility- because of its effects on gastric emptying, do not consider pramilintide
therapy for patients taking drugs that alter GI motility- eg anticholinergic drugs eg atropine and
agents that slow the intestinal absorption of nutrients eg alphaglucosidase inhibitors
Pramilintide delays absorption of concomittantly administered drugs eg analgesics
Administer the agent at least 1 hour prior to or 2 hours after pramilintide injection
Indication:
Diabetes mellitus
Adverse Reaction:
Adverse reactions-
CNS- dizziness 5% fatigue 6% headache 12%
GI - abdominal pain 8% amorexia 8% nausea 26% vomiting 7%
Respiratory - coughing 5% pharyngitis 4%
Contra-Indications:
Hypersensitivity to the pramlitide or its components
Special Precaution-
Patient selection- proper patient selection is critical to safe and effective use of pramlintide
Hypoglycemia- pramilintide alone does not cause hypoglycemia
However pramilintide is indicated to be coadministered with insulin therapy and in this
setting pramlintide increases the risk of insulin induced severe hypoglycemia
Drugs that increase the susceptibility to hypoglycemia- addition of any antihyperglycemic
agents eg insulin , sulfonyl urea or to other agents that may increase risk of hypoglycemia
may necessiciate insulin dose adjustments and monitoring of blood glucose
eg. ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifyline,
propoxyphene, salicylates, sulfonamide antibiotics.
Hypersensitivity reactions- patients may experience redness, swelling, or itching,
at the site of injection
Hazardous tasks- severe hypoglycemia associated with praminlintide occurs within the first
3 hours following a pramlintide injection. If severe hypoglycemia occurs while operating
a motor vehicle or while engaging in high risk activities serious injuries can occur.
Pregnancy- use pramlintide during pregnancy only if the potential benefit justifies the
potential isk to the fetus.
Lactation- administer to nursing women only if the potential benefit outweighs the potential
risk to the infant
Children- safety and efficacy in children havenot been established
Elderly- carefully manage pramlitide and insulin regimens to obviate an increased risk
of severe hypoglycemia
Monitoring- monitor blood glucose frequently including pre and post meals and at bed time.
Dosages/ Overdosage Etc:
Indication-
Diabetes mellitus
Dosage-
Type I diabetes- initiate pramilitide at a dose of 15mcg and titrate at 15mcg increments to a
maintenance dose of 30 to 60 mcg as tolerated
Type II diabetes - initiate pramilitide at a dose of 60mcg and increase at a dose of 120mcg as
tolerated by the patient
Monitoring- monitor blood glucose levels frequently including before and after meals
Patient Information:
1. Inform patients the potential risks and advantages of pramlintide therapy
2. Inform patients about self management practices including glucose monitoring,
proper injection technique,timing of dosage, and proper storage of pramlintide
3. Inform patients of the importance of adherance to meal planning, physical activity,
recognition and and management of hypoglycemia, and hyperglycemia and
assesssment of diabetes complications
4. Instruct patients on handling of special situations such as intercurrent conditions
( illness or stress) an inadquate or omitted insulin dose, inadvertant administrationn
of increased insulin or pramilintide dose, inadequate food intake or missed meals.
5. Always administer pramilintide and insulin as separate injections and never mix
the injection
6. Advice women with diabetes to inform their health care provider if they are pregnant
or planning to become pregnant.
Pharmacology/ Pharmacokinetics:
Ref- Drug Facts And comparisons(2010)
Pharmacology-
Pramlinide is Amylin analg and is co-located with insulin in sceretory granules and
co-secreted with insulinby pancreatic beta-cells in response to food intake.
Amylin and insulin show similar fasting and postprandial patterns to healthy individuals
Pharmacokinetics-
The absolute bio-availability of a single subcutaneous dose of pramlinide is approximately
30 to 40% .
Subcutaneous admin of different doses of pramlinamide into the abdominal area or
thigh of healthy subjects resulted in dose-propotionate maximu plasma concentrations
Cmax and overall exposure (expressed as area under the plasma concentraion curve or
AUC are indicated below-
Mean Pharmacokinetic Parameters Following Administration of Single
Subcutaneous Doses of Pramlinide
S C dose AUC(0-a) Cmax Tmax Elimin t 1/2
mcg ( pmol*min/L) (pmol/L) (min) (min)
30 3750 39 21 55
60 6778 79 20 49
90 8507 102 19 51
120 11970 147 21 48
Pregnancy and lactation:
Pregnancy-
Use pramlintide during pregnancy only if the potential benefit justifies the
potential isk to the fetus.
Lactation-
Administer to nursing women only if the potential benefit outweighs the potential
risk to the infant
Children-
Safety and efficacy in children havenot been established
Elderly-
Carefully manage pramlitide and insulin regimens to obviate an increased risk
of severe hypoglycemia
Manufacturer Details