Apresoline (Hydralazine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Essential hypertension, alone or as an adjunct.

DOSAGE AND ADMINISTRATION

Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2-4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels.

      The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of Apresoline.

      In a few resistant patients, up to 300 mg of Apresoline daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of Apresoline combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

HOW SUPPLIED

Tablets 10 mg – round, pale yellow, dry-coated (imprinted CIBA 37)

      Bottles of 100........................... NDC 0083-0037-30

Tablets 25 mg – round, deep blue, dry-coated (imprinted CIBA 39)

      Bottles of 100........................... NDC 0083-0039-30

Tablets 50 mg – round, light blue, dry-coated (imprinted CIBA 73)

      Bottles of 100........................... NDC 0083-0073-30

Tablets 100 mg – round, peach, dry-coated (imprinted CIBA 101)

      Bottles of 100........................... NDC 0083-0101-30

Samples, when available, are identified by the word SAMPLE appearing on each tablet.

Do not store above 86ºF (30 C).

Dispense in tight, light-resistant container (USP).

666692                                          C95-14 (Rev. 5/95)

C I B A

Ciba-Geigy Corporation

Pharmaceuticals Division

Summit, New Jersey 07901