Dilatrend Special Precautions





Full Prescribing Info
Special Precautions
Chronic Congestive Heart Failure: In chronic heart failure patients, worsening cardiac failure or fluid retention may occur during up-titration of Dilatrend. If such symptoms occur, diuretics should be increased and the Dilatrend dose should not be advanced until clinical stability resumes. Occasionally, it may be necessary to lower the Dilatrend dose or, in rare cases, temporarily discontinue it. Such episodes do not preclude subsequent successful titration of Dilatrend. Dilatrend should be used with caution in combination with digitalis glycosides, as both drugs slow AV conduction.
Renal Function in Congestive Heart Failure: Reversible deterioration of renal function has been observed with Dilatrend therapy in chronic heart failure patients with low blood pressure (systolic BP <100 mmHg), ischemic heart disease and diffuse vascular disease and/or underlying renal insufficiency.
Left Ventricular Dysfunction Following Acute Myocardial Infarction: Before treatment with carvedilol is initiated, the patient must be clinically stable and should have received an ACE inhibitor for at least the preceding 48 hrs, and the dose of the ACE inhibitor should have been stable for at least the preceding 24 hrs (see Dosage & Administration).
Chronic Obstructive Pulmonary Disease (COPD): Dilatrend should be used with caution in patients with COPD with a bronchospastic component who are not receiving oral or inhaled medication, and only if the potential benefit outweighs the potential risk.
In patients with a tendency to bronchospasm, respiratory distress can occur as a result of a possible increase in airway resistance. Patients should be closely monitored during initiation and up-titration of Dilatrend and the dose of Dilatrend should be reduced if any evidence of bronchospasm is observed during treatment.
Diabetes: Care should be taken in the administration of Dilatrend to patients with diabetes mellitus, as the early signs and symptoms of acute hypoglycemia may be masked or attenuated. In chronic heart failure patients with diabetes, the use of Dilatrend may be associated with worsening control of blood glucose.
Peripheral Vascular Disease: Dilatrend should be used with caution in patients with peripheral vascular disease as β-blockers can precipitate or aggravate symptoms of arterial insufficiency.
Raynaud's Phenomenon: Dilatrend should be used with caution in patients suffering from peripheral circulatory disorders (eg, Raynaud's phenomenon) as there may be exacerbation of symptoms.
Thyrotoxicosis: Dilatrend, like other agents with β-blocking properties, may obscure the symptoms of thyrotoxicosis.
Anesthesia and Major Surgery: Caution should be exercised in patients undergoing general surgery, because of the synergistic negative inotropic effects of Dilatrend and anesthetic drugs.
Bradycardia: Dilatrend may induce bradycardia. If the patient's pulse rate decreases to <55 beats/min, the dosage of Dilatrend should be reduced.
Hypersensitivity: Care should be taken in administering Dilatrend to patients with a history of serious hypersensitivity reactions and in those undergoing desensitisation therapy, as β-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.
Psoriasis: Patients with a history of psoriasis associated with β-blocker therapy should take Dilatrend only after consideration of the risk-benefit ratio.
Concomitant Use of Calcium-Channel Blockers: Careful monitoring of ECG and blood pressure is necessary in patients receiving concomitant therapy with calcium-channel blockers of the verapamil or diltiazem type or other antiarrhythmic drugs.
Pheochromocytoma: In patients with pheochromocytoma, an α-blocking agent should be initiated prior to the use of any β-blocking agent. Although Dilatrend has both α- and β-blocking pharmacological activities, there is no experience with its use in this condition. Caution should therefore be taken in the administration of Dilatrend to patients suspected of having pheochromocytoma.
Prinzmetal's Variant Angina: Agents with nonselective β-blocking activity may provoke chest pain in patients with Prinzmetal's variant angina. There is no clinical experience with Dilatrend in these patients although the α-blocking activity of Dilatrend may prevent such symptoms. Caution should, however, be taken in the administration of Dilatrend to patients suspected of having Prinzmetal's variant angina.
Contact Lenses: Wearers of contact lenses should bear in mind the possibility of reduced lacrimation.
Withdrawal Syndrome: Dilatrend treatment should not be discontinued abruptly, particularly in patients suffering from ischemic heart disease. The withdrawal of Dilatrend should be gradual (over a period of 2 weeks).
Effects on the Ability to Drive or Operate Machinery: Fitness to Drive: No studies have been performed on the effects of Dilatrend on patients' fitness to drive or to operate machinery.
Because of individually variable reactions (eg, dizziness, tiredness), the ability to drive, operate machinery or work without firm support may be impaired. This applies particularly at the start of treatment, after dose increases, on changing products and in combination with alcohol.
Use in pregnancy: β-Blockers reduce placental perfusion, which may result in intrauterine fetal death, and immature and premature deliveries. In addition, adverse effects (especially hypoglycemia and bradycardia) may occur in the fetus and neonate. There may be an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period. There is no evidence from animal studies that Dilatrend has any teratogenic effects.
There is no adequate clinical experience with Dilatrend in pregnant women.
Dilatrend should not be used during pregnancy unless the potential benefit outweighs the potential risk.
Use in lactation: Animal studies demonstrated that Dilatrend or its metabolites are excreted in breast milk. It is not known whether Dilatrend is excreted in human milk. Breastfeeding is therefore not recommended during administration of Dilatrend.
Use in children: The safety and efficacy of Dilatrend in patients <18 years have not been established.
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