Pramlintide dosage

What Pramlintide is

Pramlintide is a synthetic 37-amino-acid analog of human amylin, FDA-approved in 2005 as Symlin for adjunctive use with mealtime insulin in type 1 and type 2 diabetes; Drugs@FDA now lists all Symlin products as discontinued.

Pramlintide is an analog of human amylin, which is co-located with insulin in beta-cell secretory granules and co-secreted in response to food intake ^1. Actions In human studies, pramlintide slowed gastric emptying, reduced the postprandial rise in plasma glucagon and modulated satiety, decreasing caloric intake ^1. In nonclinical studies amylin suppresses glucagon secretion and regulates food intake through… How it works →

Schedules by time period

Label regimens and laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.

Dosing as stated on the FDA label

• Type 2 diabetes using mealtime insulin: reduce mealtime insulin (including premixed) by 50%, then start at 60 micrograms subcutaneously immediately before each major meal; increase to 120 micrograms when no clinically significant nausea has occurred for at least 3 days; reduce to 60 micrograms if significant nausea persists ^1.
• Type 1 diabetes: reduce mealtime insulin by 50%, then start at 15 micrograms before each major meal; increase to the next increment (30, 45 or 60 micrograms) when no clinically significant nausea has occurred for at least 3 days; decrease to 30 micrograms if nausea persists at 45 or 60 micrograms ^1.
• A major meal is defined in the label as at least 250 kcal or at least 30 g of carbohydrate. Administration instructions are in the label and are not reproduced here ^1.

How long did human studies run?

No human study durations are recorded for Pramlintide.

Side effects reported in studies

• Nausea
  48% versus 17% (type 1); 28% versus 12% (type 2) · Pooled placebo-controlled trials (type 1 n=716 vs 538; type 2 n=292 vs 284) ¹
• Anorexia
  17% versus 2% (type 1); 9% versus 2% (type 2) · Same pools ¹
• Vomiting
  11% versus 7% (type 1); 8% versus 4% (type 2) · Same pools ¹
• Headache
  13% versus 7% · Type 2 diabetes pool ¹
• Inflicted injury
  14% versus 10% · Type 1 diabetes pool ¹
• Patient-ascertained severe hypoglycemia, months 0-3
  16.8% versus 10.8% (type 1, no insulin reduction); 8.2% versus 2.1% (type 2) · Six-month placebo-controlled trials ¹

Supplies and handling

• Lyophilized vial
  Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
• Sterile diluent
  The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
• Graduated syringes
  Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
• Alcohol prep pads
  For wiping vial stoppers before each puncture.
• Nitrile gloves
  Clean gloves for aseptic handling.
• Sharps container
  Puncture-resistant container for used needles.

Storage

The label directs refrigerated storage (2-8°C) protected from light for unopened pens, not frozen; after first use, pens may be refrigerated or kept up to 30°C and used within 30 days ^1.

• Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
• Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
• Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent

The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.

Shook the vial and it foamed

Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.

The solution is cloudy or has particles

Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.

The powder cake looks melted or shrunken before reconstitution

This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.

Liquid sprayed back when the needle was removed

Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status

FDA-approved (initial U.S. approval 2005) as Symlin under NDA 021332; as of 2026-10-24 Drugs@FDA lists all Symlin products as discontinued ^1,2.

United States (FDA)

FDA-approved (initial U.S. approval 2005) as Symlin, NDA 021332; Drugs@FDA lists all three Symlin products as discontinued as of 2026-10-24 ^1,2.

Sport (WADA)

Amylin analogs, including pramlintide, were not mentioned on the WADA 2026 Prohibited List page reviewed ^5.

Status varies by country and changes over time. How we describe regulatory status.

Pramlintide compared with related compounds

Frequently asked questions

References

1. SYMLIN (pramlintide acetate) injection, prescribing information (SymlinPen; DailyMed, label revised 12/2019) FDA label (DailyMed). 2019
2. Drugs@FDA (openFDA) application record NDA 021332, SYMLIN U.S. FDA. 2026
3. A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes Diabetes Care. 2002
4. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity Diabetes Care. 2008
5. World Anti-Doping Agency Prohibited List 2026 (online version) WADA. 2026
6. PubChem compound record for pramlintide PubChem. 2026