Taylor Pharmaceuticals
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Taylor Pharmaceuticals Drugs
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Bal In Oil
By deep intramuscular injection only. For mild arsenic or gold poisoning, 2.5 mg/kg of body weight four times daily for two days, two times on the third day, and once daily thereafter for ten days; for severe arsenic or gold poisoning, 3 mg/kg every four hours for two-days, four times on the third day, then twice daily thereafter for ten days. For mercury poisoning, 5 mg/kg initially, followed by 2.5 mg/kg one or two times daily for ten days. For acute lead encephalopathy, 4 mg/kg body weight is given alone in the first dose and thereafter at four-hour intervals in combination with Edetate Calcium Disodium Injection USP administered at a separate site. For less severe poisoning the dose can be reduced to 3 mg/kg after the first dose. Treatment is maintained for two to seven days depending on clinical response. Successful treatment depends on beginning injections at the earliest possible moment and on the use of adequate amounts at frequent intervals. Other supportive measures should always be used in conjunction with BAL in Oil (Dimercaprol Injection USP) therapy.
BAL in Oil should be inspected visually for particulate matter and discoloration prior to administration.
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Inapsine
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved.
Vital signs and ECG should be monitored routinely.
Adult dosage
The maximum recommended initial dose of INAPSINE is 2.5 mg IM or slow IV. Additional 1.25 mg doses of INAPSINE may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.
Children's dosage
For children two to 12 years of age, the maximum recommended initial dose is 0.1 mg/kg, taking into account the patient's age and other clinical factors. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.
See WARNINGS and PRECAUTIONS for use of INAPSINE with other CNS depressants and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If such abnormalities are observed, the drug should not be administered.
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Alfenta
The dosage of ALFENTA (alfentanil hydrochloride) should be individualized and titrated to the desired effect in each patient according to body weight, physical status, underlying pathological condition, use of other drugs, and type and duration of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of ALFENTA should be determined on the basis of lean body weight. The dose of ALFENTA should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
See Dosage Guidelines for the use of ALFENTA: 1) by incremental injection as an analgesic adjunct to anesthesia with barbiturate/nitrous oxide/oxygen for short surgical procedures (expected duration of less than one hour); 2) by continuous infusion as a maintenance analgesic with nitrous oxide/oxygen for general surgical procedures; and 3) by intravenous injection in anesthetic doses for the induction of anesthesia for general surgical procedures with a minimum expected duration of 45 minutes; and 4) by intravenous injection as the analgesic component for monitored anesthesia care (MAC).
DOSAGE GUIDELINES DOSAGE SHOULD BE INDIVIDUALIZED AND TITRATED FOR USE DURING GENERAL ANESTHESIA SPONTANEOUSLY BREATHING/ASSISTED VENTILATION Induction of Analgesia: 8-20 mcg/kgMaintenance of Analgesia: 3-5 mcg/kg q 5-20 min or 0.5 to 1 mcg/kg/minTotal dose: 8-40 mcg/kg ASSISTED OR CONTROLLED VENTILATION Incremental Injection (To attenuate response to laryngoscopy and intubation) Induction of Analgesia: 20-50 mcg/kgMaintenance of Analgesia: 5-15 mcg/kg q 5-20 minTotal dose: Up to 75 mcg/kg Continuous Infusion (To provide attenuation of response to intubation and incision) Infusion rates are variable and should be titrated to the desired clinical effect.SEE INFUSION DOSAGE GUIDELINES BELOW.Induction of Analgesia: 50-75 mcg/kgMaintenance of Analgesia: 0.5 to 3 mcg/kg/min (Average rate 1 to 1.5 mcg/kg/min)Total dose: Dependent on duration of procedure Anesthetic Induction Induction of Anesthesia: 130-245 mcg/kgMaintenance of Anesthesia: 0.5 to 1.5 mcg/kg/min or general anestheticTotal dose: Dependent on duration of procedureAt these doses, truncal rigidity should be expected and a muscle relaxant should be utilized.Administer slowly (over 3 minutes). Concentration of inhalation agents reduced by 30-50% for initial hour. MONITORED ANESTHESIA CARE (MAC) (For sedated and responsive, spontaneously breathing patients) Induction of MAC: 3-8 mcg/kgMaintenance of MAC: 3-5 mcg/kg q 5-20 min or 0.25 to 1 mcg/kg/minTotal dose: 3-40 mcg/kg INFUSION DOSAGE Continuous Infusion: 0.5-3 mcg/kg/min administered with nitrous oxide/oxygen in patients undergoing general surgery. Following an anesthetic induction dose of ALFENTA, infusion rate requirements are reduced by 30-50% for the first hour of maintenance. Changes in vital signs that indicate a response to surgical stress or lightening of anesthesia may be controlled by increasing the alfentanil to a maximum of 4 mcg/kg/min and/or administration of bolus doses of 7 mcg/kg. If changes are not controlled after three bolus doses given over a five minute period, a barbiturate, vasodilator, and/or inhalation agent should be used. Infusion rates should always be adjusted downward in the absence of these signs until there is some response to surgical stimulation. Rather than an increase in infusion rate, 7 mcg/kg bolus doses of ALFENTA or a potent inhalation agent should be administered in response to signs of lightening of anesthesia within the last 15 minutes of surgery. ALFENTA infusion should be discontinued at least 10-15 minutes prior to the end of surgery.Usage in Children
Clinical data to support the use of ALFENTA in patients under 12 years of age are not presently available. Therefore, such use is not recommended.
Premedication
The selection of preanesthetic medications should be based upon the needs of the individual patient.
Neuromuscular Blocking Agents
The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS sections).
In patients administered anesthetic (induction) dosages of ALFENTA, it is essential that qualified personnel and adequate facilities are available for the management of intraoperative and postoperative respiratory depression.
Also see WARNINGS and PRECAUTIONS sections.
For purposes of administering small volumes of ALFENTA accurately, the use of a tuberculin syringe or equivalent is recommended.
The physical and chemical compatibility of ALFENTA have been demonstrated in solution with normal saline, 5% dextrose in normal saline, 5% dextrose in water and Lactated Ringers. Clinical studies of ALFENTA infusion have been conducted with ALFENTA diluted to a concentration range of 25 mcg/mL to 80 mcg/mL.
As an example of the preparation of ALFENTA for infusion, 20 mL of ALFENTA added to 230 mL of diluent provides 40 mcg/mL solution of ALFENTA.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
SAFETY AND HANDLING
ALFENTA (alfentanil hydrochloride) is supplied in individually sealed dosage forms which pose no known risk to health-care providers having incidental contact. Accidental dermal exposure to ALFENTA should be treated by rinsing the affected area with water.
Protect from light. Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
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Sublimaze
50 mcg = 0.05 mg = 1 ml
Dosage should be individualized. Some of the factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used and the surgical procedure involved. Dosage should be reduced in elderly or debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
I. Premedication — Premedication (to be appropriately modified in the elderly, debilitated and those who have received other depressant drugs) — 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 ml) may be administered intramuscularly 30 to 60 minutes prior to surgery. II. Adjunct to General Anesthesia — See Dosage Range Chart III. Adjunct to Regional Anesthesia - 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 ml) may be administered intramuscularly or slowly intravenously, over one to two minutes, when additional analgesia is required. IV. Postoperatively (recovery room) - 50 to 100 mcg (0.05 to 0.1 mg) (1 to 2 ml) may be administered intramuscularly for the control of pain, tachypnea and emergence delirium. The dose may be repeated in one to two hours as needed.Usage in Children: For induction and maintenance in children 2 to 12 years of age, a reduced dose as low as 2 to 3 mcg/kg is recommended.
DOSAGE RANGE CHART TOTAL DOSAGE Low Dose — 2 mcg/kg (0.002 mg/kg) (0.04 ml/kg) SUBLIMAZE. SUBLIMAZE in small doses is most useful for minor, but painful, surgical procedures. In addition to the analgesia during surgery, SUBLIMAZE may also provide some pain relief in the immediate postoperative period. Moderate Dose — 2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 ml/kg) SUBLIMAZE. Where surgery becomes more major, a larger dose is required. With this dose, in addition to adequate analgesia, one would expect to see some abolition of the stress response. However, respiratory depression will be such that artificial ventilation during anesthesia is necessary and careful observation of ventilation postoperatively is essential. High Dose — 20 to 50 mcg/kg (0.02 to 0.05 mg/kg) (0.4 to 1 ml/kg) SUBLIMAZE. During open heart surgery and certain more complicated neurosurgical and orthopedic procedures where surgery is more prolonged, and in the opinion of the anesthesiologist, the stress response to surgery would be detrimental to the well being of the patient, dosages of 20 to 50 mcg/kg (0.02 to 0.05 mg) (0.4 to 1 ml) of SUBLIMAZE with nitrous oxide/oxygen have been shown to attenuate the stress response as defined by increased levels of circulating growth hormone, catecholamine, ADH and prolactin. When dosages in this range have been used during surgery, postoperative ventilation and observation are essential due to extended postoperative respiratory depression. The main objective of this technique would be to produce "stress free" anesthesia.
DOSAGE RANGE CHART MAINTENANCE DOSAGE Low Dose — 2 mcg/kg (0.002 mg/kg) (0.04 ml/kg) SUBLIMAZE.Additional dosages of SUBLIMAZE are infrequently needed in these minor procedures. Moderate Dose — 2 to 20 mcg/kg (0.002 to 0.02 mg/kg) (0.04 to 0.4 ml/kg) SUBLIMAZE. 25 to 100 mcg (0.025 to 0.1 mg) (0.5 to 2.0 ml) may be administered intravenously or intramuscularly when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. High Dose — 20 to 50 mcg/kg (0.02 to 0.05 mcg/kg) (0.4 to 1.0 ml/kg) SUBLIMAZE. Maintenance dosage (ranging from 25 mcg (0.025 mg) (0.5 ml) to one half the initial loading dose) will be dictated by the changes in vital signs which indicate stress and lightening of analgesia. However, the additional dosage selected must be individualized especially if the anticipated remaining operative time is short.As a General Anesthetic
When attenuation of the responses to surgical stress is especially important, doses of 50 to 100 mcg/kg (0.05 to 0.1 mg/kg) (1 to 2 ml/kg) may be administered with oxygen and a muscle relaxant. This technique has been reported to provide anesthesia without the use of additional anesthetic agents. In certain cases, doses up to 150 mcg/kg (0.15 mg/kg) (3 ml/kg) may be necessary to produce this anesthetic effect. It has been used for open heart surgery and certain other major surgical procedures in patients for whom protection of the myocardium from excess oxygen demand is particularly indicated, and for certain complicated neurological and orthopedic procedures.
As noted above, it is essential that qualified personnel and adequate facilities be available for the management of respiratory depression.
See WARNINGS and PRECAUTIONS for use of SUBLIMAZE (fentanyl citrate) with other CNS depressants, and in patients with altered response.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Sufenta
The dosage of SUFENTA should be individualized in each case according to body weight, physical status, underlying pathological condition, use of other drugs, and type of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of SUFENTA should be determined on the basis of lean body weight. Dosage should be reduced in elderly and debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because the clearance of SUFENTA is reduced in neonates, especially those with cardiovascular disease, the dose of SUFENTA should be reduced accordingly (see PRECAUTIONS).
Intravenous use
SUFENTA may be administered intravenously by slow injection or infusion 1) in doses of up to 8 mcg/kg as an analgesic adjunct to general anesthesia, and 2) in doses ≥8 mcg/kg as a primary anesthetic agent for induction and maintenance of anesthesia (see Dosage Range Chart). If benzodiazepines, barbiturates, inhalation agents, other opioids or other central nervous system depressants are used concomitantly, the dose of SUFENTA and/or these agents should be reduced (see PRECAUTIONS). In all cases dosage should be titrated to individual patient response.
Usage in Children
For induction and maintenance of anesthesia in children less than 12 years of age undergoing cardiovascular surgery, an anesthetic dose of 10 to 25 mcg/kg administered with 100% oxygen is generally recommended. Supplemental dosages of up to 25 to 50 mcg are recommended for maintenance, based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.
Premedication
The selection of preanesthetic medications should be based upon the needs of the individual patient.
Neuromuscular Blocking Agents
The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS).
ADULT DOSAGE RANGE CHART for Intravenous use ANALGESIC COMPONENT TO GENERAL ANESTHESIA •TOTAL DOSAGE REQUIREMENTS OF 1 MCG/KG/HR OR LESS ARE RECOMMENDED TOTAL DOSAGE MAINTENANCE DOSAGE ANALGESIC DOSAGES Incremental or Infusion: 1 to 2 mcg/kg (expected duration of anesthesia 1 to 2 hours). Approximately 75% or more of total SUFENTA dosage may be administered prior to intubation by either slow injection or infusion titrated to individual patient response. Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required. Incremental: 10 to 25 mcg (0.2 to 0.5 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to remaining operative time anticipated. Infusion: SUFENTA may be administered as an intermittent or continuous infusion as needed in response to signs of lightening of analgesia. In absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. Maintenance infusion rates should be adjusted based upon the induction dose of SUFENTA so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated. ANALGESIC DOSAGES Incremental or Infusion: 2 to 8 mcg/kg (expected duration of anesthesia 2 to 8 hours). Approximately 75% or less of the total calculated SUFENTA dosage may be administered by slow injection or infusion prior to intubation, titrated to individual patient response. Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing more complicated major surgical procedures in which endotracheal intubation and mechanical ventilation are required. At dosages in this range, SUFENTA has been shown to provide some attenuation of sympathetic reflex activity in response to surgical stimuli, provide hemodynamic stability, and provide relatively rapid recovery. Incremental: 10 to 50 mcg (0.2 to 1 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to the remaining operative time anticipated. Infusion: SUFENTA may be administered as an intermittent or continuous infusion as needed in response to signs of lightening of analgesia. In the absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. Maintenance infusion rates should be adjusted based upon the induction dose of SUFENTA so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated. ANESTHETIC DOSAGES Incremental or Infusion: 8 to 30 mcg/kg (anesthetic doses). At this anesthetic dosage range SUFENTA is generally administered as a slow injection, as an infusion, or as an injection followed by an infusion. SUFENTA with 100% oxygen and a muscle relaxant has been found to produce sleep at dosages ≥8 mcg/kg and to maintain a deep level of anesthesia without the use of additional anesthetic agents. The addition of N2O to these dosages will reduce systolic blood pressure. At dosages in this range of up to 25 mcg/kg, catecholamine release is attenuated. Dosages of 25 to 30 mcg/kg have been shown to block sympathetic response including catecholamine release. High doses are indicated in patients undergoing major surgical procedures, in which endotracheal intubation and mechanical ventilation are required, such as cardiovascular surgery and neurosurgery in the sitting position with maintenance of favorable myocardial and cerebral oxygen balance. Postoperative observation is essential and postoperative mechanical ventilation may be required at the higher dosage range due to extended postoperative respiratory depression. Dosage should be titrated to individual patient response. Incremental: Depending on the initial dose, maintenance doses of 0.5 to 10 mcg/kg may be administered by slow injection in anticipation of surgical stress such as incision, sternotomy or cardiopulmonary bypass. Infusion: SUFENTA may be administered by continuous or intermittent infusion as needed in response to signs of lightening of anesthesia. In the absence of lightening of anesthesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation. The maintenance infusion rate for SUFENTA should be based upon the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg.In patients administered high doses of SUFENTA, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression.
Also see WARNINGS and PRECAUTIONS sections.
For purposes of administering small volumes of SUFENTA accurately, the use of a tuberculin syringe or equivalent is recommended.
Epidural use in Labor and Delivery Proper placement of the needle or catheter in the epidural space should be verified before SUFENTA is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of SUFENTA could result in a potentially serious overdose, including acute truncal muscular rigidity and apnea. Unintentional intrathecal injection of the full sufentanil, bupivacaine epidural doses and volume could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery. If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications. SUFENTA should be administered by slow injection. Respiration should be closely monitored following each administration of an epidural injection of SUFENTA. Dosage for Labor and Delivery: The recommended dosage is SUFENTA 10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine. SUFENTA and bupivacaine should be mixed together before administration. Doses can be repeated twice (for a total of three doses) at not less than one-hour intervals until delivery.
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