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plitazab ampoules

Plitazab25mg ampoules

                                              Antiemetic ;Dopamine antagonist

Compositions :-

Alizapride HCl............25mg

Indications :-

Plitazab25mgis a dopamine antagonist with prokinetic and antiemetic effects used in the treatment of nausea and vomiting, including post-operative nausea and vomiting , (excluding morning sickness during pregnancy).

Plitazab25mgampoules are particularly suitable for the treatment of vomiting and nausea associated with anti-cancer therapy.

Mechanism of action:-

-          The anti-emetic action of Plitazab25mgis due to its antagonist activity at D2 receptors in the chemoreceptor trigger zone (CTZ) in the central nervous system (CNS) and this action prevents nausea and vomiting triggered by most stimuli.

-          Plitazab25mgdoes not affect cholinergic transmission.

Pharmacokinetic properties :-
Plitazab25mgis highly absorbed.

The half-life is nearly 3 hours and the elimination is essentially through the urine, unchanged.
The cross of the drug through the placenta is very weak (0.004%) in the rabbit. 

The Cross into the maternal milk is not known.
The cross through the blood-brain barrier is very weak and limited.

Dosage and administration;

The following dosage is generally recommended:

-        Ampoules: Usually, 1-4 ampoules every 24 hours, unless otherwise prescribed by the physician.

- When treating nausea and vomiting caused by anti-neoplastic chemotherapy, the following dosage is recommended:

- 2 ampoules administered intravenously 20-30 minutes before the start of treatment, followed by 1-2 ampoules administered intramuscularly 4-8 hours later.

- In case of strongly emetic treatment, the daily dose can be increased up to 4 times, administering 4 ampoules intravenously 30 minutes before anti-neoplastic therapy; 4 with anti-neoplastic therapy; and up to 8 ampoules intravenously or intramuscularly, at the rate of 2 ampoules every 4 hours, after therapy depending on the intensity and frequency of vomiting.
The administration of 1 ampoule intramuscularly is recommended for the treatment of pre-operative nausea and vomiting.
- In post-operative vomiting, 1 ampoule 2-3 times daily by slow IV infusion or IM.
- Initial parenteral treatment can be continued as maintenance therapy.

 Contraindications

This medicine must not be used in the following situations:

- Hypersensitivity to Plitazab25mgor one of the ingredients;

- In subjects having previously presented tardive dyskinesia following neuroleptic

treatment,

-In subjects with known or suspected pheochromocytoma, as severe hypertensive crisis have been reported in such patients treated with anti-dopaminergic drugs (including benzamides).

- In combination with medicinal products containing levodopa and other dopaminergic

antagonists .

- During pregnancy .

Special warnings and special precautions for use ;

Warnings

-The treatment duration should not exceed one week.

Precautions for use

-It is recommended that the dosage be reduced in subjects with severe renal impairment.

-In epileptic subjects, or in the event of circumstances promoting the onset of convulsions monitoring must be increased , since this medicinal product can lower the epileptogenic threshold.

As with other neuroleptics, the onset of a malignant syndrome (hyperthermia, muscle rigidity,

neurovegetative disturbances, altered consciousness, elevated CPK levels) is possible.

Precautions must be taken in the event of hyperthermia or other symptoms of malignant

syndrome and treatment must be stopped immediately if malignant neuroleptic syndrome is

suspected.

Interactions with other medicinal products and other forms of interaction ;

Contraindicated combinations ;

+ Dopaminergic agonists:

Levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride,

pergolide, piribedil, pramiprexole, quinagolide, ropinirole.

Inadvisable combinations

+ Alcohol:

Increase in the sedative effect of Plitazab25mgby alcohol. Impaired alertness may make

driving or using machines dangerous.

Avoid alcoholic beverages and medicines containing alcohol.

Combinations to be taken into account

+ Other CNS depressants:

·  CNS Sedatives: Effects of both agents are enhanced.

·  Anticholinergics: Concomitant administration may reduce the effects of alizapride.

·  Antihypertensives

Morphine derivatives (analgesics, anti-tussives and substitution treatments);

benzodiazepine barbiturates; anxiolytics other than benzodiazepines; hypnotics, sedative

antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative

H1 antihistamines; central antihypertensives; baclofen; thalidomide.

Increase in central depression. Impaired alertness may make driving or using machines

dangerous.

+ Antihypertensive drugs:

Antihypertensive effect and increased risk of orthostatic hypotension (additive effect).

·  Digoxin: Use with caution for when digoxinemia control is recommended.

Pregnancy and lactation

Pregnancy

Although the results of studies conducted in animals have not revealed any teratogenic

effects, as a precautionary measure in the absence of any epidemiological studies, this

medicinal product should not be prescribed during pregnancy.

Breast feeding

In the absence of any studies on passage into breast milk, caution is required in breastfeeding women.

 Effects on ability to drive and use machines

Warn drivers and machine operators of the possible risks of drowsiness attached to the use

of this medicinal product.

 Undesirable effects

These are particularly observed with high dosages:

Central nervous system and psychiatric signs Extrapyramidal symptoms, particularly in children and young adults, even after just one dose of the medicine.

These involve acute dystonia, which can be manifested by facial spasms, involuntary movements, torticollis. The symptoms generally disappear spontaneously and completely when treatment is stopped.

Tardive dyskinesia, which may be observed in the event of prolonged treatment.

Drowsiness, dizziness, headaches, insomnia

Gastrointestinal disturbances

Diarrhoea.

Endocrine effects

Amenorrhoea, galactorrhoea, gynaecomastia, hyperprolactinaemia.

General disturbances

Allergic reactions, including anaphylactic reactions.

Cardiovascular disturbances

Orthostatic hypotension.

Overdose

Overdose can include extrapyramidal symptoms or drowsiness to be treated by

benzodiazepines in children, benzodiazepines and/or anticholinergic antiparkinsonian drugs in adults.

Storage :

Store in a dry place at room temperature, not exceeding 30°C.

Packaging ;

Box containing 5 glass ampoules.