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INDICATIONS AND USAGE
Diltiazem is indicated for thetreatment ofhypertension. It may be used alone or incombination with otherantihypertensivemedications.
Diltiazem is indicated for themanagement ofchronicstableangina.
CONTRAINDICATIONS
Diltiazem is contraindicated in (1)patients withsicksinussyndrome except in the presence of afunctioningventricularpacemaker, (2)patients with second- or third-degree AVblock except in the presence of afunctioningventricularpacemaker, (3)patients withhypotension (less than 90 mm Hgsystolic), (4)patients who have demonstratedhypersensitivity to thedrug, and (5)patients withacutemyocardialinfarction andpulmonarycongestion documented byx-ray on admission.
WARNINGS
1. CardiacConduction. Diltiazem prolongs AVnoderefractoryperiods without significantly prolongingsinusnoderecoverytime, except inpatients withsicksinussyndrome. Thiseffect may rarely result in abnormally slowheartrates (particularly inpatients withsicksinussyndrome) or second- or third-degree AVblock (13 of 3290patients or 0.40%).Concomitant use of diltiazem withbeta-blockers or digitalis may result inadditiveeffects oncardiacconduction. Apatient with Prinzmetal'sangina developedperiods ofasystole (2 to 5 seconds) after a singledose of 60 mg of diltiazem
2. CongestiveHeart Failure. Although diltiazem has anegativeinotropiceffect in isolatedanimaltissuepreparations,hemodynamicstudies in humans withnormalventricularfunction have not shown areduction incardiacindex nor consistentnegativeeffects oncontractility (dp/dt). Anacutestudy oforal diltiazem inpatients with impairedventricularfunction (ejectionfraction 24% ± 6%) showed improvement inindices ofventricularfunction withoutsignificant decrease incontractilefunction (dp/dt). Worsening ofcongestiveheartfailure has been reported inpatients with preexistingimpairment ofventricularfunction.Experience with the use of diltiazem incombination withbeta-blockers inpatients with impairedventricularfunction is limited. Caution should be exercised when using thiscombination.
3. Hypotension. Decreases inbloodpressure associated with diltiazemtherapy may occasionally result insymptomatichypotension.
4. AcuteHepaticInjury. Mildelevations oftransaminases with and withoutconcomitantelevation inalkalinephosphatase andbilirubin have been observed inclinicalstudies. Suchelevations were usuallytransient and frequently resolved even withcontinued diltiazemtreatment. In rare instances,significantelevations inenzymes such asalkalinephosphatase, LDH,SGOT,SGPT, and other phenomena consistent withacutehepaticinjury have been noted. Thesereactions tended to occur early aftertherapyinitiation (1 to 8 weeks) and have beenreversible upon discontinuation ofdrugtherapy. Therelationship to diltiazem is uncertain in somecases, but probable in some
DOSAGE AND ADMINISTRATION The route of administration is oral.
DASAV: The dosage is individualized and may start with one tablet of 30 mg, two or three times a day or two or three tablets two or three times a day.
DASAV: The dosage is individualized with a tablet of 90 mg or 120 mg every 12 hours up to 360 mg daily. Or a 300 mg tablet once a day.
The experience of specialists has shown that in general, doses less than 120 mg per day are effective in ischemic pictures and doses higher than this have been effective in the treatment ofhypertension.
