Inopin

Inopin Injection (50 mg/5 mL): Clear, colorless sterile solution in clear glass ampoule.
Each 5 mL contains Dopamine hydrochloride 50 mg.
Inopin Injection (250 mg/10 mL): Clear, colorless sterile solution in clear glass ampoule.
Each 10 mL contains Dopamine hydrochloride 250 mg.

Pharmacology: Pharmacodynamics: Dopamine stimulates both adrenergic and dopaminergic receptors, lower doses are mainly dopaminergic stimulating and produce renal and mesenteric vasodilation, higher doses also are both dopaminergic and beta₁-adrenergic stimulating and produce cardiac stimulation and renal vasodilation; large doses stimulate alpha-adrenergic receptors.
Pharmacokinetics: Following IV administration, the onset of action of Dopamine occurs within 5 minutes, and the drug has a duration of action of less than 10 minutes. Dopamine is widely distributed in the body but does not cross the blood-brain barrier to a substantial extent. Dopamine has a plasma half-life of about 2 minutes. Dopamine is metabolized in the liver, kidneys, and plasma by monoamineoxidase (MAO) and catechol-O-methyltransferase to the inactive compounds homovanillic acid (HVA) and 3,4-dihydroxyphenylacetic acid. In patients receiving MAO inhibitors, the duration of action of Dopamine may be as long as 1 hour. About 25% of a dose of Dopamine is metabolized to norepinephrine within the adrenergic nerve terminals. Dopamine is excreted in urine principally as HVA and its sulfate and glucuronide conjugates and 3,4-dihydroxyphenylacetic acid. A very small fraction of a dose is excreted unchanged. Following administration of radiolabeled Dopamine, approximately 80% of the radioactivity reportedly is excreted in urine within 24 hours.
Pediatric: The reported clearance rate of Dopamine in critically ill infants and children has ranged from 46 to 168 mL/kg/min, with the higher values seen in the younger patients. The apparent volume of distribution in neonates is reported as 0.6 to 4 L/kg, leading to an elimination half-life of 5 to 11 minutes.

Acute hypotension: INOPIN is indicated for the correction of hypotension, unresponsive to adequate fluid volume replacement.
Cardiogenic shock caused by myocardial infarction, trauma, endotoxic septicemia, open heart surgery or renal failure.
Congestive heart failure: INOPIN is indicated to improve cardiac output during cardiac decompensation. It is useful in the short-term management of severe congestive heart failure refractory to digitalis and diuretics.

INOPIN is administered by IV infusion by diluting with suitable intravenous infusion solution e.g., 0.9% sodium chloride injection, 5% dextrose injection prior to administration. INOPIN is inactivated in alkaline solution; therefore it should not be added to 5% sodium bicarbonate or other alkaline diluent solution.
The initial rate is 2 to 5 µg per kg body-weight per minute and gradually increases 5 to 10 μg per kg body-weight per minute according to the patient's blood pressure, cardiac output, and urine output. Up to 20 to 50 µg per kg body-weight per minute may be required in seriously ill patient.
Pediatric population: The safety and efficacy of Dopamine in pediatric patients has not been established.

Acute overdosage of Dopamine may result in excessive elevation of blood pressure. The rate of infusion of Dopamine should be decreased or the drug should be discontinued temporarily until the patient is stabilized. Because of Dopamine's short duration of action, these measures usually provide adequate management of toxicity. In cases of severe toxicity, administration of a short-acting α-adrenergic blocking agent (e.g., phentolamine) should be considered.

Pheochromocytoma; uncorrected tachyarrhythmias; ventricular fibrillation.
Hypersensitivity to sulfites.

Discontinuation of therapy: When discontinuing the infusion, it may be necessary to gradually decreases the dose of Dopamine while expanding blood volume with IV fluids, since sudden cessation may result in marked hypotension.
Cardiovascular effects: Ventricular arrhythmias: If an increased number of ectopic beats are observed, reduce the dose if possible.
Decreased pulse pressure: If a disproportionate rise in the diastolic pressure (i.e., a marked decrease in the pulse pressure) is observed in patients receiving Dopamine, decrease the infusion rate and carefully observe the patient for further evidence of predominant vasoconstrictor activity.
Hypotension: At lower infusion rates, if hypotension occurs, rapidly increase the infusion rate until adequate blood pressure is obtained. If hypotension persists, discontinue Dopamine and administer a more potent vasoconstrictor agent, such as norepinephrine.
Hypovolemia: Prior to treatment with Dopamine, ensure that hypovolemia is fully corrected, if possible, with either whole blood or plasma as indicated. Monitoring of central venous pressure or left ventricular filling pressure may be helpful in detecting and treating hypovolemia.
Hypoxia, hypercapnia, acidosis: These conditions, which may also reduce the effectiveness and/or increase the incidence of adverse reactions of Dopamine, must be identified and corrected prior to, or concurrently with administration of Dopamine.
Occlusive vascular disease: Closely monitor patients with a history of occlusive vascular disease (e.g., atherosclerosis, arterial embolism, Raynaud disease, cold injury [e.g., frostbite], diabetic endarteritis, Buerger disease) for any changes in color or temperature of the skin in the extremities. If a change in skin color or temperature occurs and is thought to be the result of compromised circulation to the extremities, weigh the benefits of continued Dopamine infusion against the risk of possible necrosis. This condition may be reversed by either decreasing the rate or discontinuing the infusion.
Extravasation: Infuse Dopamine into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. Large veins of the antecubital fossa are preferred to veins in the dorsum of the hand or ankle. Administration into umbilical arterial catheter is not recommended. Only use less suitable infusion sites when larger veins are unavailable and if the patient's condition requires immediate attention. Switch to more suitable sites as rapidly as possible. Continuously monitor the infusion site for free flow. If extravasation occurs, infiltrate the area with diluted phentolamine (5 to 10 mg in 10 to 15 mL of saline) with a fine hypodermic needle. Phentolamine should be administered as soon as possible after extravasation is noted.
Sulfite sensitivity: INOPIN contains sodium metabisulfite, this sodium metabisulfite may cause allergic-type reactions, including anaphylactic symptoms, and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and is probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Pregnancy: Adverse events have been observed in some animal reproduction studies. It is not known if Dopamine crosses the placenta. In general, medications used for advanced cardiovascular life support (ACLS) in pregnant women are given at the same dose as nonpregnant patients.
Lactation: It is not known if Dopamine is excreted in breast milk. The drug should be used with caution in nursing women.

Cardiovascular: Angina pectoris, atrial fibrillation, bradycardia, ectopic beats, hypertension, hypotension, palpitations, tachycardia, vasoconstriction, ventricular arrhythmia, ventricular conduction abnormality, widened QRS complex on ECG.
Central nervous system: Anxiety, headache.
Dermatologic: Gangrene (high dose), piloerection.
Endocrine & metabolic: Increased serum glucose (usually not above normal limits).
Gastrointestinal: Nausea, vomiting.
Genitourinary: Azotemia.
Ophthalmic: Increased intraocular pressure, mydriasis.
Renal: Polyuria.
Respiratory: Dyspnea.
Miscellaneous: Tissue necrosis.

Monoamine oxidase inhibitors: Because Dopamine is metabolized by monoamine oxidase (MAO), the effects of the drug are prolonged and intensified by MAO inhibitors. Patients who have been receiving MAO inhibitors within the previous 2-3 weeks should receive initial doses of Dopamine of no greater than 10% of the usual dose.
α-Adrenergic blocking agents: The peripheral vasoconstriction caused by high doses of Dopamine is antagonized by α-adrenergic blocking agents.
General anesthetics: Ventricular arrhythmias may occur when usual doses of Dopamine are administered during halothane (orother halogenated hydrocarbon) or cyclopropane anesthesia.
Phenytoin: Administration of IV phenytoin to patients receiving Dopamine has resulted in hypotension and bradycardia.
Other drugs: The pressor response of Dopamine may be potentiated by tricyclic antidepressants. The concomitant use of Dopamine with other vasopressors or vasoconstrictors (e.g., ergonovine) may result in severe hypertension.

Store below 30°C.

Cardiac Drugs

C01CA04 - dopamine ; Belongs to the class of adrenergic and dopaminergic cardiac stimulants excluding glycosides. Used in the treatment of hypotension.

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