Dopamine Pfizer

Package leaflet: Information for the user

DOPAMINA PFIZER 200 mg/5 ml concentrate for solution for infusion

Dopamine
Generic medicine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What DOPAMINA PFIZER is and what it is used for
2. What you need to know before you use DOPAMINA PFIZER
3. How to use DOPAMINA PFIZER
4. Possible side effects
5. How to store DOPAMINA PFIZER
6. Contents of the pack and other information

1. What DOPAMINA PFIZER is and what it is used for

DOPAMINA PFIZER contains the active substance dopamine, which belongs to a group of medicines called adrenergic and dopaminergic agents.
DOPAMINA PFIZER is used to treat shock states caused by a heart attack, surgery, reduced blood volume, haemorrhage, widespread blood infection, or a severe allergic reaction (anaphylactic shock). This type of shock is characterised by a marked drop in blood pressure following a reduction in blood flow throughout the body.
Your doctor will take care to implement, in addition, other measures aimed at restoring blood volume and addressing the underlying cause of shock.

2. What you need to know before using DOPAMINA PFIZER

Do not use DOPAMINA PFIZER

• if you are allergic to dopamine or to any of the other ingredients of this medicine (listed in section 6);
• if you have high blood pressure due to a tumour of the adrenal glands (pheochromocytoma);
• if you have overactivity of the thyroid gland (hyperthyroidism);
• if you have a heart rhythm disorder (tachyarrhythmias and ventricular fibrillation).

Dopamine must not be administered during anaesthesia with cyclopropane or halogenated hydrocarbon anaesthetics.
Warnings and precautions
Talk to your doctor or nurse before being given DOPAMINA PFIZER.
This medicine should be administered with particular caution in the following cases:

• if you have low circulating blood volume (hypovolemia);
• if you suffer from circulatory problems; in this case, changes in colour or temperature of the fingers must be carefully monitored;
• if you are being treated with medicines for depression (MAO inhibitors);
• if you have impaired kidney or liver function.

This medicine will be administered intravenously by a doctor or nurse. The infusion should preferably be given into large veins to avoid leakage of the medicine from the veins (extravasation) and to minimize the risk of tissue damage (tissue necrosis).
During administration of dopamine, cardiac parameters (cardiac output and blood pressure) and kidney function (urine flow) must be continuously monitored.
For athletes, the use of this medicine without a genuine therapeutic need constitutes doping and may lead to a positive anti-doping test.
Interference with laboratory tests
Dopamine infusion suppresses pituitary secretion of thyroid-stimulating hormone and prolactin.
Children
There are no data on the safety and efficacy of dopamine in children.
Other medicines and DOPAMINA PFIZER
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines:

• medicines for depression such as tricyclic antidepressants or MAO inhibitors;
• medicines used during anaesthesia such as cyclopropane and halogenated hydrocarbon anaesthetics;
• alpha and beta-blocking agents used to lower blood pressure, such as propranolol and metoprolol;
• phenytoin, a medicine used for epilepsy;
• medicines used to treat high blood pressure (diuretics, guanethidine);
• certain medicines used to treat headache (ergot alkaloids);

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before this medicine is administered to you.
This medicine must not be administered during pregnancy unless strictly necessary and under direct medical supervision.
It is not known whether dopamine passes into breast milk, and there are no available data regarding its effects in the newborn.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
DOPAMINA PFIZER contains potassium metabisulfite
This medicine contains potassium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use DOPAMINA PFIZER

This medicine will be administered to you in hospital by trained healthcare personnel. If you have any doubts, please consult your doctor or nurse.
This medicine is given by intravenous infusion (into a vein) after appropriate dilution.
The recommended dose is 5–15 micrograms per kg of body weight per minute via continuous intravenous infusion. The flow rate and dosage will be adjusted according to your response to treatment.
If you use more DOPAMINA PFIZER than you should
Since this medicine will be administered by trained medical staff, it is unlikely that you will receive an excessive dose.
In case of overdose, a marked increase in blood pressure may occur, which resolves by stopping or reducing the infusion.
The antidote is phentolamine mesylate.
If you think you have been given too much of this medicine, contact your doctor or nurse immediately.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:

• changes in heart rhythm (ectopic beats, tachycardia);
• heightened awareness of heartbeats (palpitations);
• atrial fibrillation;
• conduction disorders, slow heart rate (bradycardia), prolongation of the QRS complex on electrocardiogram, and other heart rhythm problems (ventricular arrhythmias);
• chest pain due to heart problems (angina);
• circulation problems caused by narrowing of blood vessels;
• increased or decreased blood pressure (hypertension or hypotension);
• nausea and vomiting;
• headache;
• difficulty breathing;
• goosebumps;
• dilation of the pupil of the eye (mydriasis) with vision disturbances;
• increased levels of nitrogen in the blood;
• tissue damage in the feet (gangrene), which may occur in individuals with vascular diseases.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOPAMINA PFIZER

Medical and nursing staff are aware of the storage conditions for this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
Store in the original packaging at a temperature not exceeding 25°C.
After dilution of the vial, prepared solutions must be kept at a temperature not exceeding 25°C and used within 24 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DOPAMINA PFIZER contains

• The active substance is dopamine hydrochloride. Each vial contains 200 mg of dopamine.
• The other components are: potassium metabisulfite, water for injections.

Description of the appearance of DOPAMINA PFIZER and package contents
Pack containing 10 vials or 100 vials of 5 ml concentrate for intravenous infusion solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pfizer Italia S.r.l. - Via Isonzo, 71 - 04100 Latina
Manufacturer
Biologici Italia Laboratories S.r.l., Via Filippo Serpero 2, Masate (MI) - Italy

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Dosage and administration
Dilute 2 vials of 200 mg in 500 ml of physiological saline solution, glucose solution, or Ringer-lactate
(or dilute one 200 mg vial in 250 ml). The resulting solution will contain 0.8 mg (800 mcg) of
dopamine per ml. Since, using standard infusion sets, 1 ml corresponds to 20 drops, each drop will contain 40
mcg of dopamine. Usual doses range from 5 to 15 mcg/kg/min, but in some cases it may be necessary
to reach 20 mcg/kg/min or higher. Once a satisfactory increase in blood pressure, urine output, and improvement in general circulatory conditions has been achieved, the infusion should be continued at the effective dosage. For patients of varying body weight, the number of drops per minute of dopamine solution (2 vials of 200 mg in 500 ml or 1 vial of 200 mg in 250 ml) to be infused when using dosages from 5 to 15 mcg/kg/min is as follows:

Special Warnings and Precautions for Use
Excessive administration of potassium-free solutions may cause significant hypokalemia.
Intravenous administration of these solutions may lead to fluid and/or solute overload, resulting in dilution of serum electrolyte concentrations, hyperhydration, congestive states, or pulmonary edema.

Hypovolemia must be corrected prior to dopamine treatment with appropriate amounts of blood or plasma, as indicated.

During dopamine therapy, monitor urinary flow, cardiac output, and blood pressure.
If a disproportionate increase in diastolic pressure occurs (i.e., a marked decrease in pulse pressure), the infusion rate should be reduced and the patient carefully observed to prevent vasopressor effects from becoming predominant, unless this is the intended therapeutic effect.

Dopamine should be infused into large veins whenever possible to avoid extravasation into surrounding tissues. Extravasation may cause necrosis and ulceration. Continuous monitoring of the infusion site is therefore necessary. Ischemia due to extravasation is reversible by infiltration of the affected area with 10–15 mL of saline solution containing 5–10 mg of phentolamine mesylate. At the first sign of extravasation, a syringe with a small-gauge hypodermic needle should be used to allow free infiltration of phentolamine into the ischemic area.

Patients with a history of occlusive vascular diseases (e.g., atherosclerosis, arterial embolism, Raynaud’s disease, cold injuries, diabetic endarteritis, or Buerger’s disease) must be closely observed for any changes in skin color or temperature in the extremities. If such changes occur and reduced circulation to the extremities is suspected, the benefits of continuing dopamine infusion must be weighed against the risk of possible necrosis. This condition may be reversed either by reducing or stopping the infusion. To prevent ulcers and necrosis in cases of peripheral ischemia, prompt infiltration of the affected areas with 10 or 15 mL of physiological solution containing 5 or 10 mg of phentolamine is recommended.

Patients receiving monoamine oxidase inhibitors (MAOIs) require a substantial reduction in dopamine dosage (to at least 1/10 of the normal dose).

Do not add alkaline solutions to dopamine.

Glucose solutions should be used with caution in patients with a history of subclinical or overt diabetes mellitus.

To avoid an inappropriate hypotensive state, dopamine infusion should be tapered off gradually.

The safety and efficacy of dopamine in pediatric patients have not been established.

Interference with Laboratory Tests
Dopamine infusion suppresses pituitary secretion of thyroid-stimulating hormone and prolactin.

Overdose
In case of accidental overdose, manifested by excessive elevation of blood pressure, reduce or temporarily discontinue the infusion rate until conditions stabilize. Since dopamine’s activity is extremely short-lived, additional interventions are usually not required.

Excessive increases in blood pressure and vasoconstriction may occur due to dopamine’s alpha-adrenergic effects, particularly in patients with a history of occlusive vascular disease. If necessary, these effects can be rapidly reversed by reducing the dose or interrupting the infusion, given that dopamine has a half-life of less than 2 minutes in humans.

If these measures are insufficient, treatment with a short-acting alpha-adrenergic blocker such as phentolamine mesylate should be considered.

Dopamine may cause local vasoconstriction at the infusion site; therefore, a large-bore vein should be selected for infusion. Resulting ischemia is reversible by infiltration of the affected area with 10–15 mL of saline solution containing 5–10 mg of phentolamine mesylate. At the onset of extravasation, a syringe with a small-gauge hypodermic needle should be used to allow free infiltration of phentolamine into the ischemic area.

Incompatibilities
Dopamine is inactivated in alkaline solutions such as 5% sodium bicarbonate and is incompatible with alkaline drugs such as furosemide and sodium thiopental. Incompatibility has also been reported with insulin, ampicillin, amphotericin B, gentamicin sulfate, sodium cephalothin, and sodium oxacillin; therefore, mixtures with these drugs should be avoided.

Stability after Dilution
Once diluted in physiological saline, glucose solutions, or Ringer’s lactate, DOPAMINA PFIZER should be stored at temperatures not exceeding 25°C and used within 24 hours.

For further information, consult the Summary of Product Characteristics.