Positive ANA Titer: The prolonged administration of procainamide
often leads in the development of a positive anti-nuclear antibody
(ANA) test, with or without symptoms of a lupus erythematosus-like
syndrome. If a positive ANA titer develops, the benefits versus
risks of continued procainamide therapy should be assessed.
Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is
p-amino-N-[2-(diethylamino) ethyl]-benzamide monohydrochloride,
molecular weight 271.79.
Procainamide Hydrochloride Extended-release Tablets meet USP Drug Release
Dissolution Test 5
Procainamide Hydrochloride differs from procaine which is the p-aminobenzoyl
ester of 2-(diethylamino)-ethenol. Procainamide as the free base has a
pKa of 9.23; the monohydrochloride is very soluble in water. Procainamide
Hydrochloride Extended-release Tablets, USP is available for oral administration
as pink, scored, film-coated tablets containing 500 mg Procainamide hydrochloride,
as light orange to tan, scored, film-coated tablets containing 750 mg
procainamide hydrochloride, and as red scored film-coated tablets containing
1000 mg procainamide hydrochloride.
All strengths of Procainamide Hydrochloride contain calcium silicate,
carnauba wax, NF; diethyl phthalate, NF; dimethyl Polysiloxane fluid;
ethylcellulose, NF; hydroxypropyl methylcellulose 2910, USP; magnesium
stearate NF; and vanillin, NF. The individual strengths contain additional
ingredients as follows:
500 mg: D&C Red No. 30, aluminum lake; hydroxypropyl methylcellulose,
USP; Polyethylene glycol, NF; polysorbate 80, NF; and titanium dioxide,
750 mg: D&C Yellow No. 10, aluminum lake; FD&C Yellow. No 6, aluminum
lake: hydroxypropyl methylcellulose, USP; polyethylene glycol. NF; polysorbate
80, NF; and titanium dioxide, USP.
1000 mg: FD&C Red No. 40, aluminum lake; polyethylene glycol,
NF; Polysorbate 80, NF; and titanium dioxide, USP.
Procainamide Hydrochloride Extended-release Tablets contain a tablet
matrix, designed for the controlled release of the drug through the gastrointestinal
tract. The extended wax tablet Matrix, which is not absorbed, may be detected
in the stool.