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Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
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Tramadol Hydrochloride Extended-Release Capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
C16 H25 NO2 . HCl
The molecular weight of tramadol hydrochloride, USP is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release Capsules contain a total dose of tramadol hydrochloride USP 100, 200 and 300 mg in a combination of immediate-release and extended-release components.
|100 mg||25 mg||75 mg|
|200 mg||50 mg||150 mg|
|300 mg||50 mg||250 mg|
Tramadol Hydrochloride Extended-Release Capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, FD & C Blue #2 aluminum lake (E132), D & C Red #7 calcium lake (E180), D & C Yellow #10 aluminum lake, lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion.