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SymlinPen

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Overview

What is SymlinPen?

SYMLIN (pramlintide acetate) injection is an anti-diabetic medication for use in patients with diabetes treated with insulin. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine).

The structural formula of pramlintide acetate is shown below:

Pramlintide acetate is a white powder that has a molecular formula of CHNOS• × CHO (3≤ × ≤8); the molecular weight is 3949.4. Pramlintide acetate is soluble in water.

SYMLIN is formulated as a clear, isotonic, sterile solution for subcutaneous administration. The disposable multidose SymlinPen pen-injector contains 1000 mcg/mL of pramlintide (as acetate). The formulation contains 2.25 mg/mL of metacresol as a preservative, D-mannitol as a tonicity modifier, acetic acid, sodium acetate as pH modifiers, and water for injection. SYMLIN has a pH of approximately 4.0.



What does SymlinPen look like?



What are the available doses of SymlinPen?

SYMLIN is supplied as a sterile injection in the following dosage forms:

What should I talk to my health care provider before I take SymlinPen?

How should I use SymlinPen?

SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

SYMLIN dosage differs depending on whether the patient has type 1 or type 2 diabetes [see].

SYMLIN should be used only in patients who can fully understand and adhere to proper insulin adjustments and glucose monitoring.

Insulin and SYMLIN dose adjustments should be made only as directed by a healthcare professional skilled in the use of insulin.

When initiating SYMLIN, reduce mealtime insulin doses, including premixed insulins, by 50% to reduce the risk of hypoglycemia.

To reduce the risk of nausea, wait at least 3 days before titrating SYMLIN to the next dose increment.

Monitor blood glucoses frequently, including pre- and post-meals and at bedtime, particularly when initiating SYMLIN or increasing the SYMLIN dose. After the initial 50% reduction in mealtime insulin dose, individualize insulin dose adjustments based on glycemic control and tolerability (e.g., if nausea occurs it may affect the dose of insulin required). An increased frequency of mild-to-moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia.

If SYMLIN therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN therapy is reinstituted [see ].


What interacts with SymlinPen?

Sorry No Records found


What are the warnings of SymlinPen?

Sorry No Records found


What are the precautions of SymlinPen?

Sorry No Records found


What are the side effects of SymlinPen?

Sorry No records found


What should I look out for while using SymlinPen?

SYMLIN is contraindicated in patients with any of the following:


What might happen if I take too much SymlinPen?

Single 10 mg doses of SYMLIN (83 times the maximum recommended dose of 120 mcg for patients with type 2 diabetes) were administered to 3 healthy volunteers. All 3 individuals reported severe nausea associated with vomiting, diarrhea, vasodilatation, and dizziness. No hypoglycemia was reported. Pramlintide has a short half-life (approximately 48 minutes in healthy individuals). Initiate supportive measures in the case of overdose.


How should I store and handle SymlinPen?

SYMLIN pen-injectors not in use:SYMLIN pen-injectors in use:Storage conditions are summarized in Table 9.SYMLIN pen-injectors not in use:SYMLIN pen-injectors in use:Storage conditions are summarized in Table 9.SYMLIN pen-injectors not in use:SYMLIN pen-injectors in use:Storage conditions are summarized in Table 9.Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 30 and 500. Manufactured by: ANSHI PHARMACEUTICAL (ZHONGSHAN) INC. Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 30 and 500. Manufactured by: ANSHI PHARMACEUTICAL (ZHONGSHAN) INC. Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 30 and 500. Manufactured by: ANSHI PHARMACEUTICAL (ZHONGSHAN) INC. Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pramlintide is an analog of human amylin. Amylin is colocated with insulin in secretory granules and cosecreted with insulin by pancreatic beta cells in response to food intake. Amylin and insulin show similar fasting and postprandial patterns in healthy individuals (Figure 1).

In patients with type 1 and type 2 diabetes, there is reduced secretion from pancreatic beta cells of both insulin and amylin in response to food.

Amylin affects the rate of postprandial glucose appearance through a variety of mechanisms, as determined by nonclinical studies. Amylin slows gastric emptying (i.e., the rate at which food is released from the stomach to the small intestine) without altering the overall absorption of nutrients. In addition, amylin suppresses glucagon secretion (not normalized by insulin alone), which leads to suppression of endogenous glucose output from the liver. Amylin also regulates food intake due to centrally-mediated modulation of appetite.

In human studies, pramlintide, acting as an amylin analog, slows gastric emptying, reduces the postprandial rise in plasma glucagon, and modulates satiety leading to decreased caloric intake.

Non-Clinical Toxicology
SYMLIN is contraindicated in patients with any of the following:

See .

Proper patient selection is critical to the safe and effective use of SYMLIN.

Patients meeting any of the following criteria should NOT be considered for SYMLIN therapy:

SYMLIN should be prescribed with caution to persons with visual or dexterity impairment.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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