DILTIAZEM Hydrochloride FORZEM 30 milligrams

DILTIAZEM Hydrochloride


Generic Name: DILTIAZEM Hydrochloride
Brand Name: FORZEM
Dosage Strength: 30 milligrams
Dosage Form: Film-Coated Tablet


(Indication) Management of chronic stable angina and angina due to coronary artery spasm. Alone or in combination, it is also used for the treatment of hypertension.


(Dosage) Angina Pectoris: Initially, 30 mg 3 or 4 times a day, the dosage being increased gradually at 1- or 2-day intervals as needed and tolerated, or as prescribed by the physician.
Hypertension: 60 mg 3 times a day.

(Contraindications) Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker; 2nd- or 3rd-degree AV block except in the presence of a functioning ventricular pacemaker; hypotension (<90 mm Hg systolic); hypersensitivity to Angiozem; and acute myocardial infarction and pulmonary congestion documented by x-ray on admission.
Use in lactation: Diltiazem should not be given to nursing women until more information becomes available concerning its safety on infants.

(Precautions) General: Diltiazem is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameter 8 of renal and hepatic functions should be monitored at regular intervals.
Angiozem should be used with caution in patients with impaired renal or hepatic function. In subacute and chronic dog and rat studies designed to produce toxicity, high doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of ≥125 mg/kg in rats were associated with histological changes in the liver which were reversible when the drug was discontinued. In dogs, doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing.
Dermatological events (see Adverse Reactions) may be transient and may disappear despite continued use of diltiazem. However, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have also been infrequently reported. Should a dermatologic reaction persist, Angiozem should be discontinued.

(Side Effects) The following represent occurrences observed in clinical studies of angina patients. In many cases, the relationship to diltiazem has not been established. The most common occurrences from these studies as well as their frequency of presentation are: Edema (2.4%), headache (2.1%), nausea (1.9%) dizziness (1.5%), rashes (1.3%), asthenia (1.2%). Ankle edema, hypotension, flushing and gastrointestinal disturbances (including anorexia, vomiting, constipation or diarrhea, taste disturbances and weight gain) may occur. Rashes, possibly due to hypersensitivity, are normally mild and transient, but in a few cases, erythema multiforme or exfoliative dermatitis has developed. Transient elevations in liver enzyme values, and occasionally hepatitis, have been reported.
The following events were reported infrequently (<1%):
Cardiovascular: Angina, arrhythmia, AV block (1st degree), AV block (2nd or 3rd degree, see Warnings), bradycardia, bundle-branch block, congestive heart failure, ECG abnormality, flushing, hypotension, palpitations, syncope.
CNS: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tremor.
Gastrointestinal: Anorexia, constipation, diarrhea, dysgeusia, dyspepsia, mild elevations of alkaline phosphatase, SGOT, SGPT and LDH.
Dermatological: Petechiae, photosensitivity, pruritus, urticaria.
Others: Amblyopia, CPK elevation, dry mouth, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence and muscle cramps, nasal congestion, nocturia, osteoarticular pain, polyuria, sexual difficulties, tinnitus.

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