Medicinal Products

PENTACARINAT 300 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Pentamidine
laboratory: Sanofi-Aventis France

Aerosol powder and parenteral use
Box of 1 vial of 300 mg
All forms

Indication

- PENTACARINAT aerosol :
Prevention of Pneumocystis carinii infections in immunocompromised patients, especially in HIV-infected patients at risk of pneumocystosis, in case of intolerance or contraindication to sulfamethoxazole-trimethoprim.
Possible extra-respiratory locations of this infection are not prevented by aerosols.
The reference nebulizer was Respirgard II. Any other device with the same characteristics (see dosage and method of administration) may be used provided that the granulometry has been validated with a pentamidine solution.
PENTACARINAT parenteral IM or IV :
. Treatment of Pneumocystis carinii pneumonia in case of intolerance or contraindications to
sulfamethoxazole-trimethoprim.
. Visceral and / or cutaneous leishmaniasis.
. Sleep sickness (treatment with lymphaticosanguine phase).

Dosage PENTACARINAT 300 mg Powder for aerosol and parenteral use Box of 1 vial of 300 mg

Dosage:
PENTACARINATE IN AEROSOL:
Prophylaxis of Pneumocystis carinii pneumonia : 300 mg once a month.
PENTACARINAT PAR PARENTERALE IM OR IV:
Pneumocystis carinii pneumopathies : 4 mg / kg of weight, preferably in slow infusion (more than one hour) every day for 14 days.
- Leishmaniasis:
. visceral: 3 to 4 mg / kg body weight, every other day, with a maximum of 10 injections; depending on the response, a second cure may be necessary,
. diffuse cutaneous East African and South American cutaneous and mucous (especially L. braziliensis and guyanensis ): 3 to 4 mg / kg weight; 3 or 4 injections 1 day out of 2 are usually enough.
- Sleep sickness in the lymphaticosanguin phase: 4 mg / kg of weight every other day, with a maximum of 7 to 10 injections.
- During renal failure, it is advisable to reduce unit doses by 30 to 50%.
Administration mode :
PENTACARINATE IN AEROSOL:
- Studies of this mode of administration have been performed and validated with the RESPIRGARD II (single-use pneumatic device, not to be reused), which is currently used as a reference.
- Its characteristics are as follows:
. it has a mouthpiece for inhalation and an expiratory filter,
. a mean mass diameter of 1.4 μm and a standard geometric deviation of 1.9 μm at the mouthpiece,
. a recycling of large particles in the fogger tank,
. the need to introduce 6 ml of water for injections into the vial and to stir until a clear solution is obtained.
Any other nebulizer producing particles with a median mass diameter of between 1 and 2 microns at the mouthpiece may be used provided that its different characteristics are validated with a solution of pentamidine diistionate. If a reusable device is used, sterilization or replacement of the tank and circuit should be carried out.
- Whatever the device used:
. All of the pentamidine must be aerosolized and inhaled via a mouthpiece. Nebulization is stopped when there is no more aerosol emitted, usually after 15 to 30 minutes.
. The exhalation must always be done through the expiratory circuit which includes a filter. In case of suspension of the session, it is necessary to interrupt the operation of the device.
. The operating characteristics of the equipment (gas flow rate for pneumatic nebulizers, quartz vibration frequency for ultrasonic nebulizers) must be respected.
PENTACARINAT PARENTLY:
- The injections must be performed at the patient lying down and fasting. Before use, dissolve the contents of one vial with 10 ml of water for injections.
- For the intramuscular route, administer the dose in a single injection.
- For the intravenous route, dilute the reconstituted product in 50 to 250 ml of 5% glucose solution for injection. Administer as a slow infusion for one hour.

Against indications

Hypersensitivity to any of the components.

Treatment with dronedarone, mequitazine or torsadogens (except anti-parasitic, neuroleptic, methedone).

Pentacarinat side effects

Adverse reactions with a possible causal relationship are presented by organ class and frequency: Very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000); indeterminate frequency (can not be estimated based on available data).

PENTACARINAT parenterally:

Blood and lymphatic system disorders

Frequent: leukopenia, thrombocytopenia, anemia.

Metabolism and nutrition disorders

Very common: azotemia.

Frequent: hypoglycemia, hyperglycemia, hyperkalemia, hypocalcemia, hypomagnesemia.

Nervous system disorders

Frequent: syncope, vertigo.

Heart conditions

Rare: prolongation of the QT interval, cardiac arrhythmias.

Not known: torsades de pointes.

Vascular disorders

Frequent: hypotension, flushing

Gastrointestinal disorders

Frequent: nausea, vomiting, taste disorder.

Rare: pancreatitis.

Hepatobiliary disorders

Frequent: abnormalities of enzymes and liver functions.

Skin and subcutaneous tissue disorders

Frequent: rash.

Not known: Stevens-Johnson Syndrome.

Renal and urinary disorders

Very common: acute renal failure, gross hematuria.

General disorders and administration site conditions

Very common: local reactions ranging from discomfort to pain at the point of induration, abscess and muscle necrosis.

Not known: Rhabdomyolysis has been reported following intramuscular administration.

PENTACARINAT aerosol:

Metabolism and nutrition disorders

Not known: hypoglycaemia.

Nervous system disorders

Not known: dizziness

Vascular disorders

Not known: hypotension.

Respiratory, thoracic and mediastinal disorders

Frequent: local reactions ranging from cough and shortness of breath, to asthmatic breathing, bronchospasm, especially in patients with a history of smoking or asthma. Inhaling a bronchodilator before or during the aerosol session can treat and / or avoid these side effects.

Rare: eosinophilic pneumonia.

Not known: pneumothorax in patients with a history of Pneumocystis carinii pneumonia .

Gastrointestinal disorders

Common: taste disturbance, nausea

Not known: acute pancreatitis

Skin and subcutaneous tissue disorders

Not known: rash.

Renal and urinary disorders

Not known: kidney failure.

General disorders and administration site conditions

Not known: fever, anorexia, fatigue.

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