Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**DOSAGE AND ADMINISTRATION** The drug (10 mg or 50 mg as diltiazem hydrochloride) is dissolved in at least 5 ml of physiological saline or glucose solution for injection before use and administered as follows: - Tachyarrhythmia (supraventricular) Usually for adults, 10 mg of diltiazem hydrochloride as a single dosage is intravenously injected slowly for about 3 minutes. The dosage may be adjusted depending on the patient's age and symptoms. - Emergency treatment for abnormal hypertension during operation Intravenous bolus injection: Usually for adults, 10 mg of diltiazem hydrochloride as a single dosage is intravenously injected slowly for about one minute. The dosage may be adjusted depending on the patient's age and symptoms. Intravenous drip infusion: Usually for adults, 5 to 15 mcg of diltiazem hydrochloride/kg body weight per minute is intravenously injected in drip infusion. After blood pressure is lowered to the target level, adjust the drip infusion rate while monitoring blood pressure. - Hypertensive emergency Usually for adults, 5 to 15 mcg of diltiazem hydrochloride/kg body weight per minute is intravenously injected in drip infusion. After blood pressure is lowered to the target level, adjust the drip infusion rate while monitoring blood pressure. - Unstable angina Usually for adults, 1 to 5 mcg of diltiazem hydrochloride/kg body weight per minute is intravenously injected in drip infusion. The dosage should be started with a low dose and may be adjusted depending on the patient's symptoms. The maximum dosage should be 5 mcg of diltiazem hydrochloride/kg body weight per minute.
INTRAVENOUS
Medical Information
**INDICATIONS** - Tachyarrhythmia (supraventricular) - Emergency treatment for abnormal hypertension during operation - Hypertensive emergency - Unstable angina
**CONTRAINDICATIONS (HERBESSER Injection is contraindicated in the following patients.)** 1. Patients with severe hypotension or cardiogenic shock \[The symptoms may be exacerbated.\] 2. Patients with 2nd or more degree atrioventricular block or sick sinus syndrome (continuous sinus bradycardia less than 50 beats/ minute, sinus arrest, sinoatrial block, etc.) \[Excessively inhibitory effect of the drug on cardiac stimulus-formation and conduction may occur.\] 3. Patients with severe congestive heart failure \[The symptoms of heart failure may be exacerbated.\] 4. Patients with severe cardiomyopathy \[The symptoms of heart failure may be exacerbated.\] 5. Patients with a history of hypersensitivity to any of the ingredients in the drug 6. Pregnant women or women who may possibly be pregnant \[See PRECAUTIONS -Use during Pregnancy, Delivery or Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.\]
C08DB01
diltiazem
Manufacturer Information
PHARMAFORTE SINGAPORE PTE LTD
MITSUBISHI TANABE PHARMA CORPORATION
Active Ingredients
Documents
Package Inserts
Herbesser Injection PI.pdf
Approved: September 3, 2010