What happens if I overdose Redopa?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; inability to urinate; nausea; severe headache; vomiting.
Proper storage of Redopa:
Redopa is usually handled and stored by a health care provider. If you are using Redopa at home, store Redopa as directed by your pharmacist or health care provider.
Overdose of Redopa in details
In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of administration or temporarily discontinue Redopa until patients condition stabilizes. Since the duration of action of Redopa is quite short, no additional remedial measures are usually necessary. If these measures fail to stabilize the patients condition, use of the short acting alpha adrenergic blocking agent, phentolamine, should be considered.
What should I avoid while taking Redopa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Redopa warnings
Do not add any alkalinizing substance since Redopa is inactivated in alkaline solution.
Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of Redopa will require substantially reduced dosage. See Drug Interactions below.
This product contains sodium metabisulfite, a sulfite that 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 probably low. Sulfite sensitivity is: seen more frequently in asthmatic than in nonasthmatic people.
Evidence is inadequate for fully defining proper dosage and limitation for use in children.
Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration of erythrocytes.
The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Excess administration of potassium-free solutions may result in significant hypokalemia.
Because dosages of this drug are titrated to response, no additives should be mixed with Redopa Hydrochloride in 5% Dextrose Injection USP.
What should I discuss with my healthcare provider before taking Redopa?
If possible before you receive Redopa, tell your caregivers if you have pheochromocytoma (tumor of the adrenal gland).
To make sure you can safely receive Redopa injection, tell your caregivers if you have any of these other conditions:
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coronary artery disease (hardened arteries);
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circulation problems such as Raynaud's syndrome;
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a history of blood clots;
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diabetes;
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frostbite;
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Buergers disease;
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asthma;
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sulfite allergy; or
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if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 21 days.
FDA pregnancy category C. It is not known whether Redopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
It is not known whether Redopa passes into breast milk or if it could harm a nursing baby. Do not use Redopa without telling your doctor if you are breast-feeding a baby.
In an emergency situation, it may not be possible before you are treated with Redopa to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received Redopa.
Redopa precautions
Patients who are taking MAOIs or who have taken them within the last 2-3 weeks require a substantially reduced starting dose ie, about 1/10 the usual dose.
Redopa should not be added to alkaline diluents.
Hypovolemia should be fully corrected prior to treatment with Redopa with a suitable plasma expander or whole blood or plasma until the central venous pressure is 10-15 cm H2O or the pulmonary wedge pressure is 14-18 mmHg.
Excessive dosage may be indicated by a disproportionate rise in diastolic pressure (ie, a marked decrease in pulse pressure). The infusion rate should be decreased or ceased.
Those patients with preexisting peripheral vascular disease eg, that due to artherosclerosis, arterial embolism, Buerger's disease, Raynaud's disease, diabetic endarteritis or cold injury (eg, Frostbite), may be more susceptible to peripheral ischemia and subsequent gangrene and should be observed carefully for any changes in color or temperature of the skin in extremities. If ischemia occurs and is thought to be due to vasoconstriction, the benefits of Redopa infusion should be weighed against the risks of possible necrosis. Ischemia may be reversed by either decreasing the rate or discontinuing the infusion.
Intravenous administration of phenatolamine 5-10 mg may also reverse the ischemia.
As with any cardiac stimulant, care should be exercised when administering Redopa to patients with cardiac ischemia.
Acidosis, hypercapnia or hypoxia may reduce the effectiveness and/or increase the incidence of adverse effects of Redopa. These conditions should be corrected prior to or concurrently with administration of Redopa.
Pulmonary hypertension may be exacerbated due to Redopa-induced pulmonary vasoconstriction. Where Redopa-induced pulmonary hypertension has occurred, isoprenaline may be considered as an alternative inotropic agent.
Routine monitoring of blood pressure, ECG, cardiac status and renal output, is necessary in all patients. Where possible, the cardiac output and pulmonary wedge pressure should be measured.
If a disproportionate rise in the diastolic pressure (ie, a marked decrease in the pulse pressure) is observed, the infusion rate should be decreased or suspended and the patient observed closely, unless such an effect is required.
Sterile Redopa concentrate contains sodium metabisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and the life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people.
Hypotension may occur when attempting to wean patients from Redopa and it may be neccessary to substitute Redopa with another pressor agent or to expand blood volume whilst gradually reducing the infusion rate.
Redopa should be infused into a large vein whenever possible to prevent the possibility of extravasation into tissue adjacent to the infusion site. The infusion site should be continuously monitored for free flow
Carcinogenicity, Genotoxicity & Impairment of Fertility: The genotoxic potential of Redopa has not been evaluated. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Redopa. Studies in animals have not been performed to assess the effects of Redopa on fertility.
Use in pregnancy: Category B3. Drug which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of increased fetal damage, the significance of which is considered uncertain in humans.
It is not known whether Redopa crosses the placental barrier. In 1 animal study, the administration of Redopa to pregnant rats resulted in a decreased survival rate of the newborn and cataract formation in the survivors. The benefits of using this product should be weighed against the possible risks to the fetus.
Use in lactation: It is not known whether Redopa is excreted in breast milk, nor is the effect on the infant known. Redopa is inactive when ingested orally, nonetheless, it is not recommended for breastfeeding mothers unless the expected benefits outweigh any potential risks.
Use in children: It is not recommended for use in children as safety and efficacy in this age group has not been established.
What happens if I miss a dose of Redopa?
Since Redopa injection is given by a healthcare professional in a medical setting, you are not likely to miss a dose.
References
- DrugBank. "dopamine". http://www.drugbank.ca/drugs/DB00988 (accessed September 17, 2018).
- MeSH. "Sympathomimetics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology