1. Drug profile DOBUTAMINE

2. injection 250 mg per 5 ml ampule Store away from light & moisture at 15-30C(59-86F) Brand Name Manufacture Dosage Form Strength Storage Condition

3. injection Store away from light & moisture at 15-30C(59- 86F) 250mg×20ml Brand Name Manufacture Dosage Form Strength Storage Condition

4. injection 250 mg per 5 ml ampule Store away from light & moisture at 15-30C(59-86F) Brand Name Manufacture Dosage Form Strength Storage Condition

5. injection 250 mg per 5 ml ampule Store away from light & moisture at 15-30C(59-86F) Brand Name Manufacture Dosage Form Strength Storage Condition

6. injection 250 mg per 5 ml ampule Store away from light & moisture at 15-30C(59-86F) Brand Name Manufacture Dosage Form Strength Storage Condition

7. ISTRY

8. Chemical class

9. white crystalline powder, Physical Properties sparingly soluble in water & Alcohol soluble in pyridine molecular Molecular weight is 337.84 pka is 9.5 Molecular Formula: C18H23NO3HCl

10. PHARMACO KINETICSKINETICS

11. absorption : orally poor Administered by continuous IV infusion.

12. Bioavailability: 100% %age of Protein Binding: 50% (Catecholamines)

13. Volume of Distribution 0.202+/-0.084 L/Kg BBB/ Placental Barrier BBB: No Placental Barrier: Not known

14. Time for onset of action 1-2 mins Time for Peak Blood level 10 -12 mins

15. METABOLISM AND EXCRETION Site of Metabolism Liver Active metabolite No Half life 2 mins Route of excretion Major: Urine Minor: Faeces

17. THERAPEUTIC/ PHARMACOLOGICAL CLASS β -1 adrenergic agonist Inotropic sympathomimetic Cardiotonic Agents

18. Mechanism Of Action It directly effects β -1 receptor & stimulates adenylyl cyclase produces cAMP activates kinase protein phosphorylate Ca channel influx of Ca +2 contractility of heart & stroke volume that cardiac output. It has mild effect on β-2 & α receptors so reduces vascular resistance.

19. Indication/ Therapeutic Use

20. Adverse Effects Tachycardia Marked increase in systolic BP Phlebitis Nausea Headache Rare:  Thrombocytopenia  Shortness of breath  Arrhythmias  Angina pain

21. Contraindication/ Precaution Pregnancy Category B Idiopathic hypertrophic sub aortic stenosis Hypersensitivity to dobutamine or bisulfites Pregnancy Category B Idiopathic hypertrophic sub aortic stenosis Hypersensitivity to dobutamine or bisulfites

22. DOSAGE AND ADMINISTRATION: SR.NOIndication Route of Administration Recommended Dosage Range Duration of therapy Infants/Neonates mg/Kg/day & Frequency ChildAdult 1. Cardiac inotropic agent Continuous iv infusion 2-15 mcg/kg/min 5ug/kg initially then 2-20 ug/kg/min afterwards 2.5-5ug upto 40mcg/kg/ min Shouldnot exceed from 48 hrs 2. Cardiac decompensation Continuous iv infusion 2-15 mcg/kg/min Shouldnot exceed from 48 hrs 3.Acute heart failure Continuous iv infusion 2-15 mcg/kg/min 2.5-10 ug/kg/min Shouldnot exceed from 48 hrs 4.Cardiac shock Continuous iv infusion 2-15 mcg/kg/min 5ug/kg/mi n for 8min then upto 20 ug/kg/min Shouldnot exceed from 48 hrs 5.

23. Guidelines FOR IV ROUTE: Storage time & temperature after reconstruction Store in air tight container at 15-30 o, use within 24 hrs

24. DRUG-DRUG INTERACTION:

25. Tricyclic antidepressants Tricyclic antidepressants (TCAs) may markedly enhance the pressor response to parenteral direct-acting sympathomimetic agents The mechanism is TCA inhibition of norepinephrine reuptake in adrenergic neurons, resulting in increased stimulation of adrenergic receptors. Parenteral administration of direct-acting sympathomimetic agents should preferably be avoided during therapy with tricyclic antidepressants except in cases of emergency (e.g., treatment of anaphylaxis). If concomitant use is necessary, initial dose and rate of administration of the sympathomimetic should be reduced, and cardiovascular status including blood pressure should be monitored closely Mechanism Recommendation

26. Beta blockers Beta-blockers may antagonize the cardiostimulatory effects of pressor agents by blocking beta-1 adrenergic receptors in the heart. In addition, peripheral vascular resistance may increase due to unopposed alpha-adrenergic effects of pressor agents in the presence of beta-blockade No specific intervention is necessary, but pharmacist should be alert to the potential for diminished cardiac response when pressor agents are used in patients treated with beta-blockers, including ophthalmic formulations. Mechanism Recommendation

27. DRUG-LAB INTERACTION: produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.

28. Toxic Dose Sign & Symptoms Rare anorexiaanorexia,nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropic and chronotropic effects of dobutamine on the myocardium may causehypertension, tachyarrhythmiasnauseatremoranxietypalpitationsheadachechest paininotropicmyocardiumhypertension toxicology

29. discontinuing administration, establishing an airway, ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy. Protect the patient’s airway and support ventilation and perfusion. Management/Treatment

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