Europe — EMA
Mofecet (Bupivacaine Hydrochloride Monohydrate)
GNH USA supplies Mofecet (Bupivacaine), a local anesthetic for spinal anesthesia, postoperative analgesia and obstetric procedures.
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What is Bupivacaine Hydrochloride Monohydrate?
Bupivacaine, the active ingredient in Mofecet, is a local anesthetic (amide type) presented as an intrathecal solution for intrathecal use. It provides spinal anesthesia for surgical procedures, postoperative analgesia and obstetric anesthesia such as cesarean section. It is formulated for precise dosing in the subarachnoid space, allowing rapid onset of dense sensory and motor block.
GNH USA supplies Mofecet as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for import and distribution.
What is Bupivacaine Hydrochloride Monohydrate used for?
Bupivacaine is a local anesthetic used via the spinal route to produce reversible nerve block.
Spinal anesthesia: provides dense sensory and motor block for surgical procedures requiring a regional technique, allowing rapid onset and prolonged duration of anesthesia. Post‑operative analgesia: extends pain relief after surgery when administered intrathecally, reducing the need for systemic opioids and improving patient comfort. Obstetric anesthesia: enables safe anesthesia for cesarean sections and other obstetric interventions, offering effective analgesia while maintaining maternal hemodynamic stability. Diagnostic procedures: facilitates patient comfort during certain spinal diagnostic interventions, such as myelography, by providing temporary sensory block.
What are the side effects of Bupivacaine Hydrochloride Monohydrate?
Bupivacaine may cause a range of adverse reactions, varying from mild to severe.
Common Side Effects: - Hypotension: transient drop in blood pressure following sympathetic blockade. - Bradycardia: slowed heart rate that may require monitoring. - Nausea and vomiting: gastrointestinal upset after spinal administration. - Pruritus: itching, often localized.
Serious or Rare Side Effects: - Seizures: central nervous system excitation at high plasma concentrations. - Cardiac arrhythmias: including ventricular tachycardia or fibrillation. - Respiratory depression: due to high spinal block affecting respiratory muscles. - High spinal block: extensive sensory and motor block leading to hypotension and respiratory compromise. - Allergic reactions: rash, urticaria, or anaphylaxis in sensitized individuals.
What precautions apply to Bupivacaine Hydrochloride Monohydrate?
When using intrathecal bupivacaine, careful clinical assessment and monitoring are essential. - Dose individualization: adjust based on patient age, weight, and comorbidities. - Cardiovascular monitoring: observe for hypotension and bradycardia during and after injection. - Neurological assessment: watch for signs of high spinal block or neurotoxicity. - Allergy check: verify no known hypersensitivity to amide‑type local anesthetics. - Pregnancy considerations: use only if the anticipated benefit justifies potential risk to the fetus. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze.
What does Bupivacaine Hydrochloride Monohydrate interact with?
Bupivacaine can interact with other agents that affect the nervous or cardiovascular systems.
Major Interactions (Avoid): - Other local anesthetics: concurrent use may lead to cumulative systemic toxicity. - Class I antiarrhythmics (e.g., quinidine, procainamide): increase risk of cardiac conduction disturbances. - CYP3A4 inhibitors (e.g., ketoconazole): may raise plasma levels of bupivacaine.
Moderate Interactions (Monitor Closely): - Opioids and sedatives: additive CNS depression requiring dose adjustment. - Epinephrine: can prolong the duration of block and increase systemic absorption. - Magnesium sulfate: may enhance neuromuscular blockade and hypotensive effects.



