Procan-SR
Name: Procan-SR
Description
| WARNING: 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, USP.
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.
Side effects
Cardiovascular System: Hypotension following oral PA administration is rare. Hypotension and serious disturbances of cardiorhythm such as ventricular asystole or fibrillation are more common after intravenous administration (see OVERDOSAGE, WARNINGS). Second degree heart block has been reported in 2 of almost 500 patients taking PA orally.
Multisystem Effects: A lupus erythematosus-like syndrome of arthralgia, pleural or abdominal pain, and sometimes arthritis, pleural effusion, pericarditis, fever, chills, myalgia, and possibly related hematologic or skin lesions (see Below) is fairly common after prolonged PA administration, perhaps more often in patients who are slow acetylators (see