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Cardiovascular Agents

Diltiazem STADA® 60 mg

Pack size:

Box of 3 blisters x 10 tablets.

 

Composition:

Each tablet contains diltiazem hydrochloride 60 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. 

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Prophylaxis and treatment of angina pectoris.
     
  • Orally taken with a glass of water before meals, swallowed the whole tablet, should not be chewed, broken, crushed.
  • Adults:
    The usual dose is one tablet (60 mg) three times daily. However, patient responses may vary and dosage requirements can differ significantly between individual patients. If necessary the divided dose may be increased to 360 mg/day. Higher doses up to 480 mg/day have been used with benefit in some patients especially in unstable angina. There is no evidence of any decrease in efficacy at these high doses.
  • Elderly and patients with impaired hepatic or renal function:
    The recommended starting dose is one tablet (60 mg) twice daily. The heart rate should be measured regularly in these groups of patients and the dose should not be increased if the heart rate falls below 50 beats per minute.
  • Children:
    Safety and efficacy in children have not been established. Therefore diltiazem is not recommended for use in children.


Or as prescribed by physicians.

 

  • Hypersensitivity to diltiazem or to any ingredient of the drug.
  • Sinus dysfunction.
  • 2nd and 3rd degree atrioventricular block.
  • Left ventricular failure with pulmonary stasis.
  • Severe bradycardia (less than 50 beats per minute).
  • Lactation.
  • Concurrent use with dantrolene infusion.
  • Combination with ivabradine.
  • Patients with severe hypotension (less than 90 mmHg systolic).
  • Patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

     

Very common

  • Peripheral oedema.

Common

  • Headache, dizziness.
  • Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations.
  • Flushing.
  • Constipation, dyspepsia, gastric pain, nausea.
  • Erythema.
  • Malaise.

Uncommon

  • Nervousness, insomnia.
  • Bradycardia.
  • Orthostatic hypotension.
  • Vomiting, diarrhea.
  • Hepatic enzymes increase (AST, ALT, LDH, ALP increase).

Rare

  • Dry mouth.
  • Urticaria.

Not known

  • Thrombocytopenia.
  • Mood changes (including depression).
  • Extrapyramidal syndrome.
  • Sinoatrial block, congestive heart failure, sinus arrest, cardiac arrest (asystole).
  • Vasculitis (including leukocytoclastic vasculitis).
  • Gingival hyperplasia.
  • Hyperglycemia.
  • Hepatitis.
  • Skin and subcutaneous tissue: Photosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Stevens-Johnson's syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever.
  • Gynecomastia.

     

  • Close observation is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block).
  • Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.
  • In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.
  • Treatment with diltiazem may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered.
  • Diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk of developing an intestinal obstruction.
  • Careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose.
  • Pregnancy: There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity in certain animal species (rat, mice, rabbit). Diltiazem is therefore not recommended during pregnancy, as well as in women of child-bearing potential not using effective contraception.
  • Lactation: As diltiazem is known to enter the breast milk and there is no experience of possible effects in infants, infants should be weaned if treatment of the mother with diltiazem is necessary.
  • On the basis of reported adverse drug reactions, i.e. dizziness, drowsiness (common), the ability to drive and use machines could be altered. However, no studies have been performed.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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