• Dosage of Emodopan in details
• Emodopan interactions
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Dosage of Emodopan in details

Emodopan Dosage

Generic name: Emodopan HYDROCHLORIDE 80mg in 100mL, DEXTROSE MONOHYDRATE 5g in 100mL

Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Emodopan Hydrochloride in 5% Dextrose Injection USP is for intravenous use only.

Dosage is to be directed by a physician.

The less concentrated 400 mcg/mL or 800 mcg/mL solutions may be preferred when fluid expansion is not a concern.

Rate of Administration — Emodopan Hydrochloride in 5% Dextrose Injection USP is administered intravenously through a suitable intravenous catheter or needle. An IV drip chamber or other suitable metering device is essential for controlling the rate of flow in drops/min. Each patient must be individually titrated to the desired hemodynamic and/or renal response with Emodopan: In titrating to the desired increase in systolic blood pressure, the optimum dosage rate for renal response may be exceeded, thus necessitating a reduction in rate after the hemodynamic condition is stabilized.

Administration at rates greater than 50 mcg/kg/min have safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.

Suggested Regimen

1. When appropriate, increase blood volume with whole blood or plasma until central venous pressure is 10 to 15 cm H2O or pulmonary wedge pressure is 14 to 18 mm Hg.
2. Begin infusion of Emodopan hydrochloride solution at doses of 2.5 mcg/kg/min in patients who are likely to respond to modest increments of heart force and renal perfusion.

   In more seriously ill patients, begin infusion of Emodopan hydrochloride at doses of 5 mcg/kg/min and increase gradually using 5 to 10 mcg/kg/min increments up to a rate of 20 to 50 mcg/kg/min as needed. If doses in excess of 50 mcg/kg/min are required, it is suggested that the urine output be checked frequently. Should urine flow begin to decrease in the absence of hypotension, reduction of Emodopan dosage should be considered. Multiclinic trials have shown that more than 50% of the patients were satisfactorily maintained on doses of Emodopan hydrochloride less than 20 mcg/kg/min. In patients who do not respond to these doses with adequate arterial pressure or urine flow, additional increments of Emodopan may be employed in an effort to produce an appropriate arterial pressure and central perfusion.

3. Treatment of all patients requires constant evaluation of therapy in terms of blood volume, augmentation of myocardial contractility, and distribution of peripheral perfusion. Dosage of Emodopan should be adjusted according to the patient’s response, with particular attention to diminution of established urine flow rate, increasing tachycardia or development of new dysrhythmias as indices for decreasing or temporarily suspending the dosage.
4. As with all potent intravenously administered drugs, care should be taken to control the rate of infusion so as to avoid inadvertent administration of a bolus of the drug.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Professional resources

• Emodopan (FDA)
• Emodopan Hydrochloride (AHFS Monograph)

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What other drugs will affect Emodopan?

Tell your doctor about all other medicines you use, especially:

• droperidol (Inapsine);
• epinephrine (EpiPen, Adrenaclick, Twinject, and others);
• haloperidol (Haldol);
• midodrine (ProAmatine);
• phenytoin (dilantin);
• vasopressin (Pitressin);
• a diuretic (water pill);
• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;
• a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
• cough or cold medicine that contains an antihistamine or decongestant;
• ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine);
• a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine);

There may be other drugs that can interact with Emodopan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Emodopan interactions

Cyclopropane and halogenated anesthetics sensitize the myocardium to the effects of Emodopan. Emodopan should therefore be used with extreme caution with these drugs due to the potential for developing ventricular arrythmias or hypertension.

Monoamine oxidases inhibitors potentiate the effect of Emodopan and prolong its duration of action. Patients being treated, or who have been treated within the previous 2-3 weeks, with MAOIs will, therefore, require a substantially reduced dosage of Emodopan (starting dose should be reduced to ¹/_10th of the usual dose or less).

Alpha and β-adrenergic receptor blocking drugs will interfere with the α and β adrenergic responses induced by Emodopan. The use of other pressor amines may be associated with complex interactions.

Hypotension may be observed with concurrent use of vasodilators eg, glyceryl trinitrate, nitroprusside and calcium channel blockers.

In animal studies, large doses of butyrophenones blocked the dopaminergic mediated renal vasodilation. Whether this occurs in man is not known.

Tricyclic antidepressants may potentiate the cardiovascular effects of Emodopan, possibly resulting in arrhythmias, tachycardia or severe hypotension or hyperpyrexia.

Concurrent use of digitalis glycosides with Emodopan may increase the risk of cardiac arrhythmias. Caution and close ECG monitoring are very important if concurrent use is necessary.

Concurrent use of methysergide or other ergot alkaloids with Emodopan may result in excessive vasoconstriction and should be avoided. Ergot alkaloids or oxytocin may potentiate the pressor effect of Emodopan and cause severe hypotension and rupture of cerebral blood vessels. Concurrent use of ergotamine with Emodopan is not recommended as it may produce vascular ischemia and gangrene.

Guanethidine may potentiate the pressor response to Emodopan.

Concurrent use of IV phenytoin with Emodopan may result in dose-dependent, sudden hypotension and bradycardia and possibly cardiac arrest. If anticonvulsant therapy is necessary during the administration of Emodopan, an alternative to phenytoin is recommended. Caution is also advised with concurrent use of other hydantoins.

Interference with Laboratory Tests: Emodopan or its metabolites may interfere with urine tests for amino acids or cathecholamines and also with test for detecting uric acid or urobilinogen.

Compatibilities/Incompatibilities: Emodopan has been reported to be compatible with the following: Sodium chloride 0.9%, glucose 5%, glucose 5% and sodium chloride 0.9%, glucose 5% in sodium chloride 0.45%, glucose 5% in lactated Ringer's solution, sodium lactate 1/6 M injection, lactated Ringer's solution.

It is recommended that, if Emodopan is administered with other drugs, a "piggyback" administration set or administration into a 2nd injection site is used to avoid mixing of potent drugs with Emodopan.

Note: Emodopan should not be added to sodium bicarbonate and other alkaline solutions as they will inactivate Emodopan. If sodium bicarbonate is simultaneously indicated to treat acidosis, it should be given through a separate infusion line from a separate container.

Intravenous Fluids:

Emodopan injection has been shown to be stable for 24 hrs when 200 mg is diluted in 250 or 500 mL of the following IV fluids: Sodium chloride infusion 0.9%, glucose 5% injection, glucose 5% and sodium chloride infusion 0.9%, 5% glucose in lactated Ringer's solution, 1/6 M sodium lactate injection, lactated Ringer's injection.

However, as with all IV admixtures, dilution should be made just prior to administration.

Antibiotics: Emodopan has been found to be chemically and physically stable for 24 hrs (at 23-25°C and exposed to light) with the following antibiotics: Kanamycin sulfate (500 mg/250 mL 5% glucose admixture), tetracycline HCl (250 mg/250 mL 5% glucose admixture), carbenicillin disodium (1 g/250 mL 5% glucose admixture, chloramphenicol sodium succinate (1 g/250 mL 5% glucose admixture), cephalothin sodium neutral (1 g/250 mL 5% glucose admixture).

Because of loss of potency of the antibiotic at 24 hrs the following admixtures of antibiotics and Emodopan in 5% glucose solution should be administered within 6 hrs of mixing: Gentamicin sulfate (80 mg/250 mL 5% glucose), cephalothin sodium (1 g/250 mL 5% glucose), penicillin G potassium (5,000,000 u/250 mL 5% glucose).

Note: It is recommended in the literature that cephalothin sodium, oxacillin sodium and gentamicin sulfate should not be mixed with any other drug. It is considered that the recommendation should also include cephalothin sodium neutral. Although studies indicate that Emodopan HCl may be compatible with these drug, their admixture produces a fixed combination of potent drugs. It is suggested that admixtures containing gentamicin sulfate, cephalothin sodium, cephalothin sodium neutral or oxacillin sodium should be avoided unless all other viable alternatives have been exhausted.

Emodopan is incompatible with ampicillin or amphotericin B, so should not be mixed with either of these drugs. Emodopan decomposes when mixed with ampicillin in 5% glucose solution, because the solution is alkaline. A precipitate forms immediately on mixing Emodopan with amphotericin B in 5% glucose solution.

Other drugs: Heparin sodium (50,000 units/250 mL 5% glucose) has been shown to be compatible with Emodopan HCl for 24 hrs.

Lignocaine hydrochloride (1 mg/250 mL 5% glucose) has been shown to be compatible with Emodopan HCl for 24 hrs.

Mixing other drugs with Emodopan infusion is not recommended, as sufficient evidence of compatibility is not available.

References

1. FDA/SPL Indexing Data. "VTD58H1Z2X: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "Sympathomimetics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "dopamine: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology