QSYMIA Extended release capsule Ref.[50588] Active ingredients: Phentermine Topiramate

Source: FDA, National Drug Code (US)  Revision Year: 2022 

Product description

QSYMIA extended-release capsules are comprised of immediate-release phentermine hydrochloride (expressed as the weight of the free base) and extended-release topiramate. QSYMIA contains phentermine hydrochloride, a sympathomimetic amine anorectic, and topiramate, a sulfamate-substituted monosaccharide.

Phentermine Hydrochloride

The chemical name of phentermine hydrochloride is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C10H15N ∙ HCl and its molecular weight is 185.7 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder that is soluble in water, methanol, and ethanol.

Its structural formula is:

Topiramate

Topiramate is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C12H21NO8S and its molecular weight is 339.4. Topiramate is a white to off-white crystalline powder with a bitter taste. It is freely soluble in methanol and acetone, sparingly soluble in pH 9 to pH 12 aqueous solutions and slightly soluble in pH 1 to pH 8 aqueous solutions.

Its structural formula is:

QSYMIA

QSYMIA (phentermine and topiramate extended-release capsules) is for oral administration and available in four dosage strengths:

  • 3.75 mg/23 mg (phentermine 3.75 mg and topiramate 23 mg) (equivalent to 4.67 mg of Phentermine Hydrochloride USP).
  • 7.5 mg/46 mg (phentermine 7.5 mg and topiramate 46 mg) (equivalent to 9.33 mg of Phentermine Hydrochloride USP).
  • 11.25 mg/69 mg (phentermine 11.25 mg and topiramate 69 mg) (equivalent to 14.0 mg of Phentermine Hydrochloride USP).
  • 15 mg/92 mg (phentermine 15 mg and topiramate 92 mg) (equivalent to 18.66 mg of Phentermine Hydrochloride USP).

Each capsule contains the following inactive ingredients: FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and #6, ethylcellulose, gelatin, methylcellulose, microcrystalline cellulose, povidone, starch, sucrose, talc, titanium dioxide, and pharmaceutical black and white inks.

Dosage Forms and Strengths

QSYMIA extended-release capsules are available in four strengths (phentermine mg/topiramate mg):

  • 3.75 mg/23 mg – purple cap imprinted with VIVUS and purple body imprinted with 3.75/23
  • 7.5 mg/46 mg – purple cap imprinted with VIVUS and yellow body imprinted with 7.5/46
  • 11.25 mg/69 mg – yellow cap imprinted with VIVUS and yellow body imprinted with 11.25/69
  • 15 mg/92 mg – yellow cap imprinted with VIVUS and white body imprinted with 15/92
How Supplied

QSYMIA (phentermine and topiramate extended-release capsules) are available as follows (see Table 16):

Table 16. QSYMIA Presentations:

Strength
(phentermine mg/topiramate mg) 		Description How Supplied NDC
3.75 mg/23 mg extended-
release capsules 		Purple cap
imprinted
with VIVUS,
Purple body
imprinted
with 3.75/23 		Unit of Use Bottle
(14 capsules) 		62541-201-14
Pharmacy Bottle
(30 capsules) 		62541-201-30
7.5 mg/46 mg extended-
release capsules 		Purple cap
imprinted
with VIVUS,
Yellow body
imprinted
with 7.5/46 		Unit of Use Bottle
(30 capsules) 		62541-202-30
11.25 mg/69 mg extended-
release capsules 		Yellow cap
imprinted
with VIVUS,
Yellow body
imprinted
with 11.25/69 		Pharmacy Bottle
(30 capsules) 		62541-203-30
15 mg/92 mg extended-
release capsules 		Yellow cap
imprinted
with VIVUS,
White body
imprinted
with 15/92 		Unit of Use Bottle
(30 capsules) 		62541-204-30
3.75 mg/23 mg and
7.5 mg/46 mg extended-
release capsules 		Purple cap
imprinted
with VIVUS,
Purple body
imprinted
with 3.75/23
and Purple cap
imprinted
with VIVUS,
Yellow body
imprinted
with 7.5/46 		Starter Pack – Blister
Configuration
(28 Capsules) 		62541-210-28
11.25 mg/69 mg and
15 mg/92 mg extended-
release capsules 		Yellow cap
imprinted
with VIVUS,
Yellow body
imprinted
with 11.25/69 		Dose Escalation Pack –
Blister Configuration
(28 Capsules) 		62541-220-28

Manufactured for VIVUS LLC by Catalent Pharma Solutions, LLC, 1100 Enterprise Drive, Winchester, KY 40391

Drugs

Drug Countries
QSYMIA United States
 
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