poly-L-lactic acid/carboxymethylcellulose/mannitol

Action and Spectrum

Drug Interaction

Adverse Reaction

Frequency Defined

1-10%

Injection site papule (8.6%)

Headache (4.3%)

Nasopharyngitis (6%)

Injection site erythema (3.4%)

Acne (2.6%)

Pain (2.6%)

Injection site nodule (8.6%)

Swelling (1.7%)

Injection site hemorrhage (1.7%)

Injection site pain (9.5%)

Black Box Warning

Contraindication / Caution

Pregnancy / Lactation

Pregnancy warnings:   

US FDA pregnancy category: C

Lactation:

Excreted into human milk is unknown

Pregnancy Categories:     

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.  

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.  

Category N: There is no data available for the drug under this category

Pharmacology

Adminstartion

Patient Information Leaflet

Patient information leaflet

Generic Name: poly-L-lactic acid/carboxymethylcellulose/mannitol

Why do we use poly-L-lactic acid/carboxymethylcellulose/mannitol?

poly-L-lactic acid/carboxymethylcellulose/mannitol (Sculptra Aesthetic) is a type of dermal filler that is FDA-approved for cosmetic use. It is primarily used to treat deep wrinkles and restore lost volume in areas of the face like the cheeks and chin. The main active ingredient in Sculptra is poly-L-lactic acid, which is a biocompatible and biodegradable synthetic material.

The treatment involves injecting Sculptra into the skin, which then stimulates the body’s natural collagen production. Collagen is a protein that provides structural support to the skin, making it firmer and more youthful-looking. As Sculptra stimulates collagen production, the results of the treatment improve over time, typically becoming most noticeable around four to six months after the initial injection.

PLLA is a biodegradable and biocompatible polymer that is often used in the manufacture of medical devices such as suture material, drug delivery systems, and tissue engineering scaffolds. It is also used in facial injectables to stimulate collagen production and improve the appearance of wrinkles.

CMC is a water-soluble, gel-forming polymer that is used in a range of products, including eye drops, oral medication suspensions, and topical creams. It is added to these products to improve the consistency, stability, and viscosity of the formulations.

Mannitol is a sugar alcohol that is used as a sweetener in many foods and beverages. It is also used in some medical products, such as injectable solutions, to help prevent dehydration and maintain blood flow to the kidneys. It is also used to reduce pressure inside the eye in conditions such as glaucoma.