"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
(Generic versions may still be available.)
DOSAGE AND ADMINISTRATION
As with all local anesthetic agents, the dose of Duranest (Etidocaine HCl) Injection to be employed will depend upon the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the type of regional anesthetic technique, and the physical condition and tolerance of the individual patient.
The maximum dose to be employed as a single injection should be determined on the basis of the status of the patient and the type of regional anesthetic technique to be performed. Although single injections of 450 mg have been employed for regional anesthesia without adverse effects, at present it is strongly recommended that the maximal dose as a single injection should not exceed 400 mg (approximately 8.0 mg/kg or 3.6 mg/lb based on a 50 kg person) with epinephrine 1:200,000 and 300 mg (approximately 6 mg/kg or 2.7 mg/lb based on a 50 kg person) without epinephrine. Because etidocaine has been shown to disappear quite rapidly from blood, toxicity is influenced by rapidity of administration, and therefore, injection in vascular areas is highly recommended. Incremental doses of Duranest (etidocaine hcl) Injection may be repeated at 2 - 3 hour intervals.
Caudal and Lumbar Epidural Block
As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose of 2 - 5 mL should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10 - 15 mg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Duranest (etidocaine hcl) Injection through the catheter should be avoided, and when feasible, fractional doses should be administered.
In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation, and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.
Use in Dentistry
When used for local anesthesia in dental procedures the dosage of Duranest (Etidocaine HCl) Injection depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia. The least volume of solution that results in effective local anesthesia should be administered. For specific techniques and procedures of local anesthesia in the oral cavity, refer to standard textbooks.
Dosage requirements should be determined on an individual basis. In maxillary infiftration and/or inferior alveolar nerve block, initial dosages of 1.0 - 5.0 mL (½ - 2 ½ cartridges) of Duranest (etidocaine hcl) Injection 1.5% with epinephrine 1:200,000 are usually effective.
The following dosage recommendations are intended as guides for the use of Duranest (etidocaine hcl) Injection in the average adult patient. As indicated previously, the dosage should be reduced for elderly or debilitated patients or patients with severe renal disease.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Table 2. Dosage Recommendations
|Duranest (etidocaine hcl) HCl with |
|Conc. (%)||Vol. (mL)||Total Dose (mg)|
|Peripheral Nerve Block |
Central Neural Block
|Intra-abdominal or Pelvic Surgery |
Lower Limb Surgery
|Maxillary Infiltration |
and/or Inferior Alveolar Nerve Block
Dosage Form and Volume
|Duranest Injection Concentration|| Epinephrine Dilution. |
(as the bitartrate)
|Single DoseVials*||30 mL||1.0 %||None||4.0-5.0||0186-0820-01|
|1.0 %||1: 200,000||3.0-4.5||0186-0825-01|
|20 mL||1.5 %||1: 200,000||3.0-4.5||0186-0836-03|
|DentalCartridge**||1.8 mL||1.5 %||1: 200,000||3.0-4.5||0186-0840-14|
Solutions containing epinephrine should be protected from light.
* Store at controlled room temperature 15°- 30° C (59°- 86° F).
** Store at room temperature, approx. 25° C (77° F).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Duranest Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.