Bupisen with adrenaline
ItalyPACKAGE LEAFLET
BUPISEN WITH ADRENALINE 5 mg/ml + 5 mcg/ml injectable solution
1 ml vials, 2 ml vials, 5 ml vials, 10 ml vials, 20 ml vials
BUPIVACAINE WITH ADRENALINE
BUPISEN WITH ADRENALINE 5 mg/ml + 5 mcg/ml injectable solution
| Content | |||||
| 1 ml vial | 2 ml vial | 5 ml vial | 10 ml vial | 20 ml vial | |
| Active ingredient: Bupivacaine hydrochloride | 5 mg | 10 mg | 25 mg | 50 mg | 100 mg |
| Active ingredient: Acidum tartricum adrenalinicum (equivalent to adrenaline base) | 9.1 mcg (equivalent to 5 mcg) | 18.2 mcg (equivalent to 10 mcg) | 45.5 mcg (equivalent to 25 mcg) | 91 mcg (equivalent to 50 mcg) | 182 mcg (equivalent to 100 mcg) |
Excipients: Sodium chloride, sodium metabisulfite, water for injections.
Pharmaceutical form and contents
Injectable solution.
Bupisen with adrenaline
Pack sizes:
10 vials of: 1 ml, 2 ml, 5 ml, 10 ml.
5 vials of 20 ml
Pharmacotherapeutic category
Amide-type local anesthetics.
Marketing Authorization Holder
Industria Farmaceutica Galenica Senese - Via Cassia Nord, 351 - 53014 Monteroni d'Arbia (SI)
Manufacturer and final controller
Industria Farmaceutica Galenica Senese - Via Cassia Nord, 351 - 53014 Monteroni d'Arbia (SI)
Therapeutic indications
BUPISEN WITH ADRENALINE may be used for all types of peripheral anesthesia: local infiltration,
truncular, loco-regional, sympathetic block, retrograde intravenous block, sacral epidural, and subarachnoid
spinal anesthesia.
BUPISEN WITH ADRENALINE is therefore indicated for all procedures in general surgery, orthopedics,
ophthalmology, otorhinolaryngology, dentistry, obstetrics and gynecology, dermatology, whether used alone or
in combination with general anesthesia.
Contraindications
Hypersensitivity to the components of the product or to other substances closely related from a chemical
standpoint, particularly to anesthetics of the same group (amide type).
Due to its vasoconstrictor content, Bupisen with adrenaline is contraindicated in patients with cardiac
diseases, severe arteriopathies, hypertension, those with ischemic manifestations of any kind or with essential
migraine, nephropathic patients, hyperthyroid patients, and diabetics.
The product is also contraindicated for paracervical block and for intravenous regional anesthesia (Bier
Block).
Do not use during confirmed or suspected pregnancy.
Precautions for use
Any overdose of anesthetic must be avoided, and two maximum doses should never be administered without
an interval of at least 24 hours between them.
The lowest possible doses and concentrations capable of achieving the desired effect should always be used.
The anesthetic solution must be injected cautiously in small amounts, after approximately 10 seconds of
aspiration. Especially when infiltrating highly vascularized areas, it is advisable to wait approximately 2 minutes
before proceeding with the actual loco-regional block. The patient must be kept under careful monitoring, with
immediate suspension of administration at the first sign of alarm (e.g., changes in consciousness).
It is necessary to have immediately available the equipment, medications, and personnel suitable for
emergency treatment, as serious, sometimes fatal reactions have been reported following the use of local
anesthetics, even in the absence of individual hypersensitivity in the patient's history.
Interactions
No known interactions with other medicinal products.
Special warnings
The total dosage must be adjusted according to the patient's general condition, age, and relevant medical
history.
When performing infiltrations for local anesthesia in areas lacking collateral circulation (fingers, penile base,
etc.), it is advisable to use the anesthetic without vasoconstrictor to avoid ischemic necrosis. If moderate
ischemia is desired, Bupisen with adrenaline may be used by diluting the anesthetic with an equal volume of
physiological solution.
Caution: As it does not contain antimicrobial preservatives, vials must be used for a single administration
only. Any remaining solution must be discarded.
BUPISEN WITH ADRENALINE contains sodium metabisulfite; this substance may cause allergic-type
reactions and severe asthma attacks, particularly in sensitive individuals and especially in asthmatics.
Dosage, method and timing of administration
BUPISEN WITH ADRENALINE is usually administered in minimal dosages ranging from 2–3 mg to 100–150 mg, depending on the indication, as indicated in the following table:
It is recommended that the maximum dosage for an adult and for a single administration should not exceed 150 mg, corresponding to 30 ml of the 5 mg/ml solution. More generally, the safe dosage not to be exceeded, both in adults and children, is 2 mg/kg per single administration.
In prolonged analgesic therapy, doses usually range from 0.25 to 1 mg/kg body weight; administration may be repeated 2–3 times within 24 hours.
Overdose
In case of overdose, discontinue administration at the first sign of alarm, place the patient in a horizontal position, ensure airway patency, and administer oxygen in case of severe dyspnea or perform artificial ventilation (Ambu bag). The use of bulbar analeptics should be avoided as they may worsen the condition by increasing oxygen consumption. Seizures, if they occur, may be controlled with intravenous diazepam. Barbiturates are not recommended, as they may exacerbate bulbar depression. Circulation may be supported by intravenous administration of fluids, such as Ringer's lactate solution, or appropriate doses of corticosteroids; diluted solutions of α-adrenergic vasoconstrictor agents (methoxamine, metaraminol, and others) or atropine sulfate may also be added.
Sodium bicarbonate, in appropriate concentration, may be used intravenously as an antiacidotic agent.
Undesirable effects
Toxic and allergic reactions may occur. Among the former, central nervous system stimulation phenomena are reported, including excitement, tremor, disorientation, dizziness, mydriasis, increased metabolism and body temperature, and, at very high doses, trismus and convulsions; if the medulla oblongata is involved, cardiovascular, respiratory, and emetic centers may be affected, resulting in sweating, arrhythmias, hypertension, tachypnea, bronchodilation, nausea, and vomiting. Peripheral effects may affect the cardiovascular system, causing bradycardia and vasodilation. Allergic reactions mostly occur in hypersensitive individuals, but many cases have been reported even in the absence of individual hypersensitivity in the patient's history. Local manifestations include various types of skin eruptions, urticaria, and pruritus; general manifestations include bronchospasm, laryngeal edema, and cardiorespiratory collapse due to anaphylactic shock.
Patients are advised to inform their physician or pharmacist of any undesirable effect not described in this leaflet.
Expiry date and storage
Check the expiry date stated on the packaging.
The expiry date refers to the product in unopened packaging and stored correctly.
Caution: Do not use the medicinal product after the expiry date stated on the packaging.
Special precautions for storage
Store below 25°C.
Keep the medicinal product out of the reach and sight of children.