Marbeta L Kit

Marbeta L Kit Manufacturers

• Asclemed Usa, Inc.
  

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  Marbeta L Kit | Asclemed Usa, Inc.

  

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  Benzyl alcohol as a preservative has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight.  Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant.  The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated.  However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

  It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.  Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment.  In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition.  If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

  In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended (see PRECAUTIONS, Neuro-psychiatric section).

  In pediatric patients, the initial dose of betamethasone may vary depending on the specific disease entity being treated.  The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

  For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4

  These dose relationships apply only to oral or intravenous administration of these compounds.  When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

  If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens.  Similar local anesthetics may also be used.  Diluents containing methylparaben, propylparaben, phenol, etc., should be avoided, since these compounds may cause flocculation of the steroid.  The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe.  The local anesthetic is then drawn in, and the syringe shaken briefly.  Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.

  Bursitis, Tenosynovitis, Peritendinitis

  In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement.  Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis.  Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections.  Chronic bursitis may be treated with reduced dosage once the acute condition is controlled.  In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases.  Injections should be made into the affected tendon sheaths rather than into the tendons themselves.  In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.

  Rheumatoid Arthritis and Osteoarthritis

  Following intra-articular administration of 0.5 to 2.0 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced.  Duration of relief varies widely in both diseases.  Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues.  There is virtually no pain on injection, and the “secondary flare” that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension.  Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint.  The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.

  Recommended Doses for Intra-articular Injection Size of Joint Location Dose (mL) Very Large Hip 1.0 - 2.0 Large Knee, ankle, shoulder 1.0 Medium Elbow, wrist 0.5 - 1.0 Small
    (metacarpophalangeal,
  interphalangeal)
  (sternoclavicular) Hand, chest 0.25 - 0.5

  A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection.  In patients being treated concomitantly with oral or parenteral corticosteroids, especially those receiving large doses, the systemic absorption of the drug should be considered in determining intra-articular dosage.

  Dermatologic Conditions

  In intralesional treatment, 0.2 mL/cm2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally (not subcutaneously) using a tuberculin syringe with a 25-gauge, 1/2-inch needle.  Care should be taken to deposit a uniform depot of medication intradermally.  A total of no more than 1.0 mL at weekly intervals is recommended.

  Disorders of the Foot

  A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot.  The following doses are recommended at intervals of 3 days to a week.

  Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension
  Dose (mL) Bursitis
  under heloma durum or heloma molle 0.25 - 0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5 - 1.0

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  Lidocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.

  The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

  For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.

  Epidural Anesthesia

  For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:

  1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials

  1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls

  2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampuls

  Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).

  Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2−3 mL of 1.5% lidocaine hydrochloride 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 mcg 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 Lidocaine Hydrochloride 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 solutions 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.

  Maximum Recommended Dosages

  NOTE: The products accompanying this insert do not contain epinephrine.

  Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.

  The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One-half of the total dose is usually administered to each side. Inject slowly five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS).

  For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

  Children: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.

  In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

  Table 1

  Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic

  Procedures in Normal Healthy Adults

  Lidocaine Hydrochloride Injection, USP (without Epinephrine)

  Procedure

  Conc. (%)

  Vol. (mL)

  Total Dose (mg)

  Infiltration

  Percutaneous

  0.5 or 1.0

  1−60

  5−300

  Intravenous Regional

  0.5

  10−60

  50−300

  Peripheral Nerve Blocks, e.g.

  Brachial

  1.5

  15−20

  225−300

  Dental

  2.0

  1−5

  20−100

  Intercostal

  1.0

  3

  30

  Paravertebral

  1.0

  3−5

  30−50

  Pudendal (each side)

  1.0

  10

  100

  Paracervical

  Obstetrical Analgesia

  (each side)

  1.0

  10

  100

  Sympathetic Nerve Blocks, e.g.

  Cervical (stellate ganglion)

  1.0

  5

  50

  Lumbar

  1.0

  5−10

  50−100

  Central Neural Blocks

  Epidural*

  Thoracic

  1.0

  20−30

  200−300

  Lumbar

  Analgesia

  1.0

  25−30

  250−300

  Anesthesia

  1.5

  15−20

  225−300

  2.0

  10−15

  200−300

  Caudal

  Obstetrical Analgesia

  1.0

  20−30

  200−300

  Surgical Anesthesia

  1.5

  15−20

  225−300

  *Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

  THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.

  Sterilization, Storage and Technical Procedures: Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.

  The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of MARCAINE should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

  For specific techniques and procedures, refer to standard textbooks.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  MARCAINE is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  In recommended doses, MARCAINE produces complete sensory block, but the effect on motor function differs among the three concentrations.

  
  

  0.25%—when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions.

  0.5%— provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.

  0.75%—produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia.

  
  

  The duration of anesthesia with MARCAINE is such that for most indications, a single dose is sufficient.

  Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of MARCAINE up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case.

  These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses have been up to 400 mg. Until further experience is gained, this dose should not be exceeded in 24 hours. The duration of anesthetic effect may be prolonged by the addition of epinephrine.

  The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for elderly or debilitated patients. Until further experience is gained, MARCAINE is not recommended for pediatric patients younger than 12 years. MARCAINE is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block).

  Use in Epidural Anesthesia: During epidural administration of MARCAINE, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single-dose ampuls and single-dose vials for caudal or epidural anesthesia; the multiple-dose vials contain a preservative and therefore should not be used for these procedures.

  Test Dose for Caudal and Lumbar Epidural Blocks: The Test Dose of MARCAINE (0.5% bupivacaine with 1:200,000 epinephrine in a 3 mL ampul) is recommended for use as a test dose when clinical conditions permit prior to caudal and lumbar epidural blocks. This may serve as a warning of unintended intravascular or subarachnoid injection. (See PRECAUTIONS.) The pulse rate and other signs should be monitored carefully immediately following each test dose administration to detect possible intravascular injection, and adequate time for onset of spinal block should be allotted to detect possible intrathecal injection. An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or cardiovascular effects from the epinephrine. (See WARNINGS and OVERDOSAGE.)

  Use in Dentistry: The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time. (See CLINICAL PHARMACOLOGY.) The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of 0.5% MARCAINE with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, MARCAINE in dentistry is not recommended for pediatric patients younger than 12 years.

  Unused portions of solution not containing preservatives, i.e., those supplied in single-dose ampuls and single-dose vials, should be discarded following initial use.

  This product should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered.

  
  Table 1. Recommended Concentrations and Doses of MARCAINE Type of
  Block Conc. Each Dose  Motor 
  Block1 (mL) (mg)

  Local

  infiltration

  0.25%4
   up to
  max. up to 
  max. — Epidural 
  
  0.75%2,4  10-20  75-150  complete  0.5%4 
  10-20 
  50-100
  moderate 
  to complete 0.25%4 
  10-20 
  25-50 
  partial
  to moderate Caudal 
  
  0.5%4 
  15-30 
  75-150 
  moderate 
  to complete  0.25%4
  15-30 
  37.5-75 
  moderate Peripheral 
   nerves
   0.5%4
   5 to
  max. 25 to 
  max. moderate
  to complete  0.25%4
  5 to 
   max.  12.5 to
   max. moderate
  to complete Retrobulbar3  0.75%4   2-4 15-30  complete Sympathetic   0.25% 20-50  50-125  —  Dental3  0.5%
   w/epi 1.8-3.6 
   per site 9-18 
  per site — Epidural3
  Test Dose  0.5%
   w/epi 2-3 10-15 
  (10-15 micrograms epinephrine) —

  1With continuous (intermittent) techniques, repeat doses increase the degree of motor block. The first repeat dose of 0.5% may produce complete motor block. Intercostal nerve block with 0.25% may also produce complete motor block for intra-abdominal surgery.

  2For single-dose use, not for intermittent epidural technique. Not for obstetrical anesthesia.

  3See PRECAUTIONS.

  4Solutions with or without epinephrine.

  Tear at notch, remove applicator, use only once.

  As a first aid antiseptic

  clean affected area apply 1 to 3 times daily may be covered with a sterile bandage, if bandaged let dry.
  For preoperative patient skin preparation
  
  clean area apply to operative site prior to surgery using the applicator
  

  
  

  apply to skin as needed discard after single use

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