Medicinal Products

DROPERIDOL PANPHARMA 25 mg / ml solution for injection box of 10 ampoules of 1 mL

Droleptan Generic Drug
Therapeutic class: Gastro-Entero-Hepatology
active ingredients: Droperidol
laboratory: Panpharma

IV injectable solution
All forms

Indication

· Prevention and treatment of postoperative nausea and vomiting in adults and, secondarily, in children and adolescents.

· Prevention of nausea and vomiting induced by morphine derivatives in controlled postoperative analgesia (PCA) in adults.

Certain precautions are necessary when droperidol is administered: see section Posology and method of administration, Contraindications and Warnings and precautions for use .

Dosage DROPERIDOL PANPHARMA 25 mg / ml solution for injection box of 10 ampoules of 1 mL

· Prevention and treatment of postoperative nausea and vomiting in adults and, secondarily, in children and adolescents.

· Prevention of nausea and vomiting induced by morphine derivatives in controlled postoperative analgesia (PCA) in adults.

Certain precautions are necessary when droperidol is administered: see section Posology and method of administration, Contraindications and Warnings and precautions for use .

Against indications

Droperidol is contraindicated in patients with:

· Hypersensitivity to droperidol or any of the constituents of the product;

· Hypersensitivity to butyrophenones;

· A known or probable prolongation of the QT interval (QTc> 450 msec in women and> 440 msec in men). This includes patients with congenital QT interval prolongation, patients with a family history of congenital QT prolongation, and patients treated concurrently with drugs that may induce torsade de pointes by prolongation of the QT interval. QT interval (see section Interactions with other medicinal products and other forms of interaction );

· Patients treated with drugs known to prolong the QT interval (see section 4.5 Interaction with other medicinal products and other forms of interaction )

· Hypokalemia or hypomagnesemia;

· Bradycardia (<55 heartbeats per minute);

· Concomitant treatment that may result in bradycardia;

Pheochromocytoma;

· A comatose state

· Parkinson's disease

· A severe depressive syndrome.

Adverse effects Droperidol Panpharma 2.5 Mg / ml

The most common side effects reported during clinical use are drowsiness and sedation. Less frequently, hypotension, cardiac arrhythmias, neuroleptic malignant syndrome (NMS) and NMS-associated symptoms have been reported, as well as movement disorders such as dyskinesia and anxiety or stirring.

Class of organ system

Frequent

≥ 1/100 to

<1/10

Uncommon

≥ 1/1000 to

<1/100

Rare

≥1 / 10, 000 to

<1/1 000

Very rare

<1/10 000

Not known (can not be estimated from the available data)

Blood and lymphatic system disorders

dyscrasias

Immune system disorders

Anaphylactic reaction; angioneurotic edema; hypersensitivity

Metabolism and nutrition disorders

Inappropriate secretion of antidiuretic hormone

Psychiatric disorders

Anxiety agitation / akathisia

Confusional states; agitation

dysphoria

hallucinations

Nervous system disorders

Drowsiness

Dystonia; oculogyrie

Extrapyramidal disorders; convulsions; tremors

Epileptic seizures; Parkinson disease ; psychomotor hyperactivity; coma

Heart conditions

Tachycardia; dizziness

Cardiac arrhythmias, including ventricular arrhythmias

Cardiac arrest ; Twists of spikes; Lengthening the QT interval at the ECG

Vascular disorders

hypotension

Syncope

Respiratory, thoracic and mediastinal disorders

Bronchospasm; laryngospasm

Skin and subcutaneous tissue disorders

Skin rash

General disorders and administration site conditions

Neuroleptic malignant syndrome (NMS)

Sudden death

Symptoms possibly associated with NMS have sometimes been reported, eg. changes in body temperature, stiffness and fever. A change in mental state, with confusion or agitation and impaired consciousness, has been observed. Instability in the autonomic system may include tachycardia, fluctuating blood pressure, excessive sweating / salivation, and tremors. In extreme cases, NMS may result in coma or kidney and / or hepatobiliary problems.

Isolated cases of amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia and oligomenorrhea have been associated with prolonged exposure in psychiatric indications.

Cases of venous thromboembolism, including pulmonary embolism and deep vein thrombosis, have been reported with antipsychotic drugs; the frequency is unknown.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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