Septodont, Inc.

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Septodont, Inc. Drugs

Lidocaine Ointment

Lidocaine Ointment

When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

Adult

A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube or one-third of a jar, approximately 17-20 g of ointment or 850-1000 mg lidocaine base should be administered in any one day.Although the incidence of adverse effects with Lidocaine Ointment 5% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.

Dosage for 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 less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg when calculated according to Clark's rule. In any case, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

Administration

For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue. Apply to the tube prior to intubation.

In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment.

For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa.

IMPORTANT: Patients should consult a dentist at intervals not exceeding 48 hours throughout the fitting period.
Isocaine

Isocaine

As with all local anesthetics, the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose needed to provide effective anesthesia should be administered. For specific techniques and procedures refer to standard dental manuals and textbooks.

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.8 mL (36 mg of 2% or 54 mg of 3%).

Five cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated according to the patient's weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

The maximum pediatric dose should be carefully calculated.

Maximum dose for Pediatric Patient =

Pediatric Patient's Weight (lbs.) × Maximum Recommended Dose 150 for Adults (400 mg.)

The following table, approximating these calculations, may also be used as a guide.
Maximum Allowable Dosage 3% Mepivacaine (Plain) 2% Mepivacaine 1:20,000 Levonordefrin 3 mg/lb 270 mg max.) 3 mg/lb (180 mg max.) Weight (lb.) Mg Number of Cartridges Mg Number of Cartridges 20 60 1.1 60 1.6 30 90 1.7 90 2.5 40 120 2.2 120 3.3 50 150 2.8 150 4.2 60 180 3.3 180 5.0 80 240 4.4 180 5.0 100 270 5.0 180 5.0 120 270 5.0 180 5.0
Adapted from Malamed, Stanley F: Handbook of medical emergencies in the dental office, ed. 2, St. Louis, 1982. The C.V. Mosby Co.

When using ISOCAINE for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.

Any unused portion of a cartridge should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

DISINFECTION OF CARTRIDGES

As in the case of any cartridge, the diaphragm should be disinfected before needle puncture. The diaphragm should be thoroughly swabbed with either pure 91% isopropyl alcohol or 70% ethyl alcohol, USP, just prior to use. Many commercially available alcohol solutions contain ingredients which are injurious to container components and therefore should not be used. Cartridges should not be immersed in any solution.
Septocaine

Septocaine

Table 3 (Recommended Dosages) summarizes the recommended volumes and concentrations of Septocaine® for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration and/or nerve block.
Table 3. Recommended Dosages PROCEDURE Septocaine® Injection Vol (mL) Total Dose of Articaine (HCl)(mg) Infiltration 0.5-2.5 20-100 Nerve block 0.5-3.4 20-136 Oral surgery 1.0-5.1 40-204 THE ABOVE SUGGESTED VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES MAY BE USED PROVIDED THE TOTAL MAXIMUN RECOMMENDED DOSE IS NOT EXCEEDED.
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given. Dosages should be reduced for pediatric patients, elderly patients, and patients with cardiac and/or liver disease. (See PRECAUTIONS, Pediatric Use and Geriatric Use).

The onset of anesthesia, and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes since the incidence of side effects may be dose-related.

MAXIMUM RECOMMENDED DOSAGES

Adults

For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg) or 3.2 mg/lb (0.0795 mL/lb) of body weight.

Pediatric Patients

Use in pediatric patients under 4 years of age is not recommended. The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation. Do not exceed the equivalent of 7 mg/kg (0.175 mL/kg) or 3.2 mg/lb (0.0795 mL/lb) of body weight.

STERILIZATION, STORAGE, AND TECHNICAL PROCEDURES

For chemical disinfection of the carpule, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Vivacaine

Vivacaine

As with all anesthetics, the dosage varies and depends upon the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.

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 bupivacaine with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, bupivacaine in dentistry is not recommended for children younger than 12 years.

Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Prilocaine Hydrochlorid...

Prilocaine Hydrochloride

The dosage of Prilocaine Hydrochloride Injection, USP, 4% varies and 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 injection 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.

Inferior Alveolar Block

There are no practical clinical differences between prilocaine with and without epinephrine when used for inferior alveolar blocks.

Maxillary Infiltration

Prilocaine Hydrochloride Injection, USP, 4% is recommended for use in maxillary infiltration anesthesia for procedures in which the painful aspects can be completed within 15 minutes after the injection. Prilocaine Hydrochloride Injection, USP, 4% is therefore especially suited to short procedures in the maxillary anterior teeth. For long procedures, or those involving maxillary posterior teeth where soft tissue numbness is not troublesome to the patient, Prilocaine HCl 4% with epinephrine 1:200,000 is recommended.

For most routine procedures, initial dosages of 1 to 2 mL of Prilocaine Hydrochloride Injection, USP, 4% will usually provide adequate infiltration or major nerve block anesthesia.

The maximum recommended dose that should ever be administered within a two-hour period in normal healthy adults should be calculated based upon the patient's weight as follows:
Weight Maximum recommended dose <150 lbs 4 mg/lb (<70 kg) (8 mg/kg) ≥150 lbs 600 mg (15 mL) or (≥70 kg) 8 cartridges
In children under 10 years of age it is rarely necessary to administer more than one-half cartridge (40 mg) of Prilocaine Hydrochloride Injection, USP, 4% per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug will allow treatment of the teeth in an entire quadrant.

ASPIRATION PRIOR TO INJECTION IS RECOMMENDED, since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failure to a minimum.

NOTE: 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.

Any unused portion of a cartridge should be discarded.

Maximum Recommended Dosages

In patients weighing <150 lbs (70 kg), no more than 4 mg/lb (8 mg/kg) should be administered. In patients weighing <150 lbs, no more than 600 mg (8 cartridges) of prilocaine HCl should be administered as a single injection.

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 of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of prilocaine hydrochloride should not exceed 150 to 200 mg (6.6 to 8.8 mg/kg or 3 to 4 mg/lb of body weight) when calculated according to Clark's rule.
Oraverse

Oraverse

2.1 General Dosing information

The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered:
Amount of Local Anesthetic Administered Dose of OraVerse [mg] Dose of OraVerse [Cartridge(s)] ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2
OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.

Note: Do not administer OraVerse if the product is discolored or contains particulate matter.

2.2 Dosing in Special Populations

In pediatric patients weighing 15-30 kg, the maximum dose of OraVerse recommended is 1/2 cartridge (0.2 mg).

(Note: Use in pediatric patients under 6 years of age or weighing less than15 kg (33 lbs) is not recommended. A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 12 years of age.)
Septocaine And Epinephr...

Septocaine And Epinephrine

2.1 General Dosing Information

Table 1 (below) summarizes the recommended volumes and concentrations of Septocaine® for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.
Table 1: Recommended Dosages for Both Strengths Procedure Septocaine® Injection Volume (mL) Total dose of articaine HCl (mg) Infiltration 0.5 – 2.5 20 – 100 Nerve block 0.5 – 3.4 20 – 136 Oral surgery 1.0 – 5.1 40 – 204
The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.

The onset of anesthesia and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.

For most routine dental procedures, Septocaine® containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Septocaine® containing epinephrine 1:100,000 may be used.

2.2 Maximum Recommended Dosages
Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration or nerve block should not exceed 7 mg/kg (0.175 mL/kg). Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl 4% should not exceed 7 mg/kg (0.175 mL/kg) [see Use in Specific Populations (8.4)]. Safety and effectiveness of Septocaine® in pediatric patients below the age of 4 years have not been established.
2.3 Dosing in Special Populations

Dose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease. [see Warnings and Precautions (5.2), Use in Specific Populations (8.4, 8.5, and 8.6)]
Prilocaine Hydrochlorid...

Prilocaine Hydrochloride With Epinephrine

The dosage of Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 Injection varies and 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 injection 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.

Inferior Alveolar Block

There are no practical clinical differences between prilocaine with and without epinephrine when used for inferior alveolar blocks.

Maxillary Infiltration

Prilocaine Hydrochloride 4% without epinephrine is recommended for use in maxillary infiltration anesthesia for procedures in which the painful aspects can be completed within 15 minutes after the injection. Prilocaine Hydrochloride 4% without epinephrine is therefore especially suited to short procedures in the maxillary anterior teeth. For long procedures, or those involving maxillary posterior teeth where soft tissue numbness is not troublesome to the patient, Prilocaine HCl 4% with epinephrine 1:200,000 is recommended.

For most routine procedures, initial dosages of 1 to 2 mL of Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 Injection will usually provide adequate infiltration or major nerve block anesthesia.

The maximum recommended dose that should ever be administered within a two-hour period in normal healthy adults should be calculated based upon the patient's weight as follows:
Weight Maximum recommended dose <150 lbs 4 mg/lb (<70 kg) (8 mg/kg) ≥150 lbs 600 mg (15 mL) or (≥70 kg) 8 cartridges
In children under 10 years of age it is rarely necessary to administer more than one-half cartridge (40 mg) of Prilocaine Hydrochloride 4% with Epinephrine 1:200,000 injection per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug will allow treatment of the teeth in an entire quadrant.

ASPIRATION PRIOR TO INJECTION IS RECOMMENDED, since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failure to a minimum.

NOTE: 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.

Any unused portion of a cartridge should be discarded.

Maximum Recommended Dosages

In patients weighing <150 lbs (70 kg), no more than 4 mg/lb (8 mg/kg) should be administered. In patients weighing <150 lbs, no more than 600 mg (8 cartridges) of prilocaine HCl should be administered as a single injection.

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 of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark's rule). For example, in a child of five years weighing 50 lbs., the dose of prilocaine hydrochloride should not exceed 150 to 200 mg (6.6 to 8.8 mg/kg or 3 to 4 mg/lb of body weight) when calculated according to Clark's rule.
Septosan Hand Sanitizer...

Septosan Hand Sanitizer

Dispense an adequate amount in your palm to cover all surfaces of hands completely. Rub hands together until dry. Does not require rinsing.

Septodont, Inc.

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Septodont, Inc. Drugs