BETOLINA®: Your Comprehensive Guide

BETOLINA® is a pharmaceutical product that contains Bupivacaine Hydrochloride. It’s essential to use this medicament responsibly, following the instructions provided. This article aims to provide a clear understanding of BETOLINA®, its properties, indications, dosages, and safety considerations.

Safety First

Before diving into the specifics, it’s crucial to highlight some key safety points:

  • Medicament Responsibility: A medicament, like BETOLINA®, can significantly impact your health. It’s essential to adhere to the doctor’s prescription and follow the guidance of your pharmacist. They are experts who understand the benefits and risks associated with the medication.
  • Prescribed Treatment: Don’t interrupt the treatment period independently, and never repeat a prescription without consulting your doctor. It’s for your safety and well-being.
  • Keep It Away from Children: Ensure that the medicament is stored safely, out of the reach of children.

Now, let’s explore BETOLINA® in more detail.

About BETOLINA®

  • Manufacturer and Marketing Authorization Holder: BETOLINA® is manufactured and marketed by MS Pharma in Jordan, at the King Abdullah II Industrial Estate, Amman.

Understanding the Pharmacodynamics Properties

BETOLINA® contains Bupivacaine, which is a long-acting, amide-type local anesthetic. It offers both anesthetic and analgesic effects. The degree of anesthesia it provides depends on the dose and site of administration. Here’s how it works:

  • Blockade of Nerve Impulses: Bupivacaine creates a reversible blockade of impulse propagation along nerve fibers. It does this by preventing the inward movement of sodium ions through the nerve cell membranes.
  • Sodium Channels: The sodium channels in nerve membranes act as receptors for local anesthetic molecules.

Bupivacaine can have similar effects on other excitable membranes in the body, such as those in the brain and the heart. However, it’s vital to be cautious because excessive amounts of the drug reaching the systemic circulation can lead to toxicity, affecting the central nervous and cardiovascular systems.

Pharmacokinetics Properties

Understanding how BETOLINA® behaves within the body is crucial:

  • Plasma Concentration: The concentration of bupivacaine in the blood depends on the dose, the route of administration, and the vascularity of the injection site.
  • Absorption: Bupivacaine is absorbed completely and biphasically from the epidural space, with half-lives of approximately 7 minutes and 6 hours.
  • Metabolism and Excretion: The clearance of bupivacaine occurs mainly in the liver and is sensitive to hepatic enzyme function. It is primarily bound to alpha-1-acid glycoprotein in the plasma.

In children aged 1 to 7 years, the pharmacokinetics of bupivacaine are similar to that of adults. Approximately 1% of bupivacaine is excreted unchanged in the urine within 24 hours.

Indications: When to Use BETOLINA®

BETOLINA® can be employed for various anesthetic techniques, including local infiltration, minor and major nerve blocks, and epidural blocks.

Dosage and Administration

The dosage of BETOLINA® for adults and children above 12 years depends on the technique used. Here is a dosage guide for some common procedures:

  • Lumbar Epidural Administration for Surgery:
    • Concentration: 5.0 mg/ml
    • Volume: 15-30 ml
    • Dose: 75-150 mg
    • Onset: 15-30 minutes
    • Duration of effect: 2-3 hours

Other procedures have their respective dosage recommendations.

Remember, the clinician’s experience and knowledge of the patient’s physical status are vital in calculating the required dose. When prolonged blocks are used, the risk of toxic plasma concentration or local neural injury must be considered.

Contraindications

Certain situations where BETOLINA® should not be used include:

  • Hypersensitivity: Avoid BETOLINA® if you are hypersensitive to local anesthetics of the amide type or any of the excipients.
  • Intravenous Regional Anesthesia: Do not use BETOLINA® for intravenous regional anesthesia (Bier’s block) as it might lead to unintended leakage of bupivacaine into the circulation, causing acute systemic toxic reactions.

Warnings and Precautions

It’s important to be aware of potential complications and to take precautions:

  • Cardiac Effects: There have been reports of cardiac arrest or death during the use of Bupivacaine for epidural anesthesia or peripheral nerve blockade. Resuscitation might be challenging, and systemic toxicity can occur with high blood concentrations of the drug.
  • Proper Facilities: Any regional or local anesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs for monitoring and emergency resuscitation should be readily available.
  • High-Risk Patients: Some patients require special attention to reduce the risk of dangerous side effects. These include the elderly, patients with heart block, those with advanced liver disease or severe renal dysfunction, and pregnant patients.
  • Avoiding Overdose: In order to avoid intravascular injection, aspiration should be repeated before and during administration of the main dose.

Pregnancy and Lactation

Pregnant women and those who are breastfeeding should be cautious:

  • Pregnancy: Bupivacaine has not shown any specific disturbances to the reproductive process. However, certain effects, like fetal bradycardia, may be more pronounced with some types of anesthesia.
  • Lactation: Bupivacaine may enter breast milk in small amounts, generally not affecting the baby.

Ability to Drive and Use Machines

Local anesthetics like BETOLINA® may have mild effects on mental function and coordination, potentially impairing alertness and locomotion.

Drug Interactions

Caution is advised when using Bupivacaine in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics.

Adverse Reactions

Adverse reactions to BETOLINA® can vary, but some common ones include:

  • Hypotension
  • Nausea
  • Paraesthesia
  • Dizziness
  • Bradycardia
  • Vomiting
  • Urinary retention

It’s essential to be aware of these potential reactions and consult your healthcare provider if you experience any.

Overdosage

If you suspect an overdose, it’s critical to seek immediate medical attention. Overdose symptoms include central nervous system and cardiovascular effects. Treatment should be prompt and tailored to the symptoms.

Storage Conditions

BETOLINA® should be stored at temperatures below 30°C. Avoid freezing and excessive heat. The solution is preservative-free and intended for single use only.

Presentation

BETOLINA® comes in two variants:

  • BETOLINA® 50mg/20ml solution for injection: Each ml contains Bupivacaine 2.5 mg in packs of 20ml vial.
  • BETOLINA® 100mg/20ml solution for injection: Each ml contains Bupivacaine 5 mg in packs of 20ml vial.

Excipients

The solution contains Sodium Chloride, Sodium Hydroxide, and Water for injections as excipients.

Always consult your healthcare provider for personalized guidance on the use of BETOLINA®. This article is meant to provide general information and should not replace professional medical advice. Your safety and well-being are of utmost importance.