WARNING: This is a potent drug: It must be diluted before administration to the patient.
Dumin Hydrochloride Injection, USP is administered (only after dilution) by intravenous infusion.
Suggested Dilution: Transfer contents of one or more ampuls or vials by aseptic technique to either 250 mL or 500 mL of one of the following sterile intravenous solutions:
Dumin Hydrochloride Injection, USP has been found to be stable for a minimum of 24 hours after dilution in the sterile intravenous solutions listed above. However, as with all intravenous admixtures, dilution should be made just prior to administration.
Do NOT add Dumin Hydrochloride to Sodium Bicarbonate Injection, USP or other alkaline intravenous solutions, since the drug is inactivated in alkaline solution.
Rate of Administration: Dumin Hydrochloride Injection, USP, after dilution, is administered intravenously by infusion through a suitable intravenous catheter or needle. When administering Dumin Hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control intravenous set. Each patient must be individually titrated to the desired hemodynamic or renal response to Dumin.
Administration rates greater than 50 mcg/kg/minute 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.
In more seriously ill patients, begin infusion of diluted solution at doses of 5 mcg/kg/minute of Dumin Hydrochloride and increase gradually using 5 to 10 mcg/kg/minute increments up to 20 to 50 mcg/kg/minute as needed. If doses in excess of 50 mcg/kg/minute are required, it is advisable to check urine output frequently. Should urinary flow begin to decrease in the absence of hypotension, reduction of Dumin dosage should be considered. Multiclinic trials have shown that more than 50% of the patients have been satisfactorily maintained on doses of Dumin less than 20 mcg/kg/minute. In patients who do not respond to these doses with adequate arterial pressures or urine flow, additional increments of Dumin may be given in an effort to produce an appropriate arterial pressure and central perfusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dumin HCl Injection, USP is available as follows:
|Product No.||Dumin HCl mg per||volume fill How Packaged|
|NDC 0517-1805-25||200 mg/5 mL Vial (40 mg/mL)||Packages of 25 vials (color-coded WHITE)|
|NDC 0517-1905-25||400 mg/5 mL Vial (80 mg/mL)||Packages of 25 vials (color-coded GREEN)|
|NDC 0517-1305-25||800 mg/5 mL Vial (160 mg/mL)||Packages of 25 vials (color-coded YELLOW)|
Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
NOTE - Do not use the injection if it is darker than slightly yellow or discolored in any other way.
WARNING: NOT FOR DIRECT INTRAVENOUS INJECTION, MUST BE DILUTED BEFORE USE.
INTRAVENOUS INFUSION ONLY.
The vial stopper is not made with natural rubber latex.
American Regent, Inc., Shirley, NY 11967. Revised: Dec 2014
Tell your doctor about all other medicines you use, especially:
epinephrine (EpiPen, Adrenaclick, Twinject, and others);
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 Dumin. 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.
Cyclopropane and halogenated anesthetics sensitize the myocardium to the effects of Dumin. Dumin 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 Dumin 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 Dumin (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 Dumin. 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 Dumin, possibly resulting in arrhythmias, tachycardia or severe hypotension or hyperpyrexia.
Concurrent use of digitalis glycosides with Dumin 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 Dumin may result in excessive vasoconstriction and should be avoided. Ergot alkaloids or oxytocin may potentiate the pressor effect of Dumin and cause severe hypotension and rupture of cerebral blood vessels. Concurrent use of ergotamine with Dumin is not recommended as it may produce vascular ischemia and gangrene.
Guanethidine may potentiate the pressor response to Dumin.
Concurrent use of IV phenytoin with Dumin may result in dose-dependent, sudden hypotension and bradycardia and possibly cardiac arrest. If anticonvulsant therapy is necessary during the administration of Dumin, an alternative to phenytoin is recommended. Caution is also advised with concurrent use of other hydantoins.
Interference with Laboratory Tests: Dumin 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: Dumin 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 Dumin 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 Dumin.
Note: Dumin should not be added to sodium bicarbonate and other alkaline solutions as they will inactivate Dumin. If sodium bicarbonate is simultaneously indicated to treat acidosis, it should be given through a separate infusion line from a separate container.
However, as with all IV admixtures, dilution should be made just prior to administration.
Antibiotics: Dumin 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 Dumin 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 Dumin 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.
Dumin is incompatible with ampicillin or amphotericin B, so should not be mixed with either of these drugs. Dumin decomposes when mixed with ampicillin in 5% glucose solution, because the solution is alkaline. A precipitate forms immediately on mixing Dumin 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 Dumin HCl for 24 hrs.
Lignocaine hydrochloride (1 mg/250 mL 5% glucose) has been shown to be compatible with Dumin HCl for 24 hrs.
Mixing other drugs with Dumin infusion is not recommended, as sufficient evidence of compatibility is not available.
|3 times in a day||1||100.0%|
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Information checked by Dr. Sachin Kumar, MD Pharmacology