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Bicillin C-R Tubex

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Bicillin C-R Tubex

Bicillin C-R Tubex

INDICATIONS

This drug is indicated in the treatment of moderately severe infections due to penicillin- G-susceptible microorganisms that are susceptible to serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response.

Bicillin C-R is indicated in the treatment of the following in adults and pediatric patients:

Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci.

NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups, including Group D (enterococci), are resistant. Penicillin G sodium or potassium is recommended for streptococcal infections with bacteremia.

Moderately severe pneumonia and otitis media due to susceptible pneumococci.

NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with penicillin G sodium or potassium during the acute stage.

When high, sustained serum levels are required, penicillin G sodium or potassium, either IM or IV, should be used. This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta.

DOSAGE AND ADMINISTRATION

Streptococcal Infections Group A

Infections of the upper-respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas.

The following doses are recommended:

Adults and pediatric patients over 60 lbs. in weight: 2,400,000 units.

Pediatric patients from 30 to 60 lbs.: 900,000 units to 1,200,000 units.

Pediatric patients under 30 lbs.: 600,000 units.

NOTE: Treatment with the recommended dosage is usually given at a single session using multiple IM sites when indicated. An alternative dosage schedule may be used, giving one-half (1/2) the total dose on day 1 and one-half (1/2) on day 3. This will also insure the penicillinemia required over a 10-day period; however, this alternate schedule should be used only when the physician can be assured of the patient's cooperation.

Pneumococcal Infections (except pneumococcal meningitis)

600,000 units in pediatric patients and 1,200,000 units in adults, repeated every 2 or 3 days until the temperature is normal for 48 hours. Other forms of penicillin may be necessary for severe cases.

Method of Administration

Bicillin C-R is intended for Intramuscular Injection ONLY. Do not inject into or near an artery or nerve, or intravenously or admix with other intravenous solutions. (See WARNINGS section).

Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock. In neonates, infants and small children, the midlateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site.

The TUBEX® cartridge for this product incorporates several features that are designed to facilitate the visualization of blood on aspiration if a blood vessel is inadvertently entered.

Method of Administration - Illustration 1

The design of this cartridge is such that blood which enters its needle will be quickly visualized as a red or dark-colored “spot.” This “spot” will appear on the barrel of the glass cartridge immediately proximal to the blue hub. The TUBEX is designed with two orientation marks, in order to determine where this “spot” can be seen. First insert and secure the cartridge in the TUBEX injector in the usual fashion. Locate the yellow rectangle at the base of the blue hub. This yellow rectangle is aligned with the blood visualization “spot” An imaginary straight line, drawn from this yellow rectangle to the shoulder of the glass cartridge, will point to the area on the cartridge where the “spot” can be visualized. When the needle cover is removed, a second yellow rectangle will be visible. The second yellow rectangle is also aligned with the blood visualization “spot” to assist the operator in locating this “spot” If the 2 mL metal or plastic syringe is used, the glass cartridge should be rotated by turning the plunger of the syringe clockwise until the yellow rectangle is visualized. If the 1 mL metal syringe is used, it will not be possible to continue to rotate the glass cartridge clockwise once it is properly engaged and fully threaded; it can, however, then be rotated counterclockwise as far as necessary to properly orient the yellow rectangles and locate the observation area. (In this same area in some cartridges, a dark spot may sometimes be visualized prior to injection. This is the proximal end of the needle and does not represent a foreign body in, or other abnormality of, the suspension.)

Thus, before the needle is inserted into the selected muscle, it is important for the operator to orient the yellow rectangles so that any blood which may enter after needle insertion and during aspiration can be visualized in the area on the cartridge where it will appear and not be obscured by any obstructions.

After selection of the proper site and insertion of the needle into the selected muscle, aspirate by pulling back on the plunger. While maintaining negative pressure for 2 to 3 seconds, carefully observe the neck of the glass TUBEXcartridge immediately proximal to the blue plastic needle hub for appearance of blood or any discoloration. Blood or “typical blood color” may not be seen if a blood vessel has been entered—only a mixture of blood and Bicillin CR. The appearance of any discoloration is reason to withdraw the needle and discard the TUBEX. If it is elected to inject at another site, a new TUBEX cartridge should be used. If no blood or discoloration appears, inject the contents of the TUBEXslowly. Discontinue delivery of the dose if the subject complains of severe immediate pain at the injection site or if, especially in neonates, infants and young children, symptoms or signs occur suggesting onset of severe pain.

Some TUBEX cartridges may contain a small air bubble which should be disregarded, since it does not affect administration of the product. DO NOT clear any air bubbles from the cartridge or needle as this may interfere with the visualization of any blood or discoloration during aspiration.

Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate.

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

HOW SUPPLIED

Bicillin® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) is supplied in packages of 10 TUBEX® Sterile Cartridge-Needle Units as follows:

1 mL size, containing 600,000 units per TUBEX® (21 gauge, thin-wall 1 inch needle for pediatric use), NDC 61570-139-10.

2 mL size, containing 1,200,000 units per TUBEX® (21 gauge, thin-wall 1 inch needle for pediatric use), NDC 61570-141-10.

2 mL size, containing 1,200,000 units per TUBEX® (21 gauge, thin-wall 1-1/4 inch needle), NDC 61570-140-10.

Store in a refrigerator, 2° to 8°C (36° to 46°F).

Keep from freezing.

Also Available

Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) is also available in packages of 10 disposable syringes as follows:

4 mL size, containing 2,400,000 units per syringe (18 gauge x 2 inch needle), NDC 61570-142-10.

PLEASE NOTE: THE METAL TUBEX HYPODERMIC SYRINGEAND TUBEX FAST-TRAK SYRINGE HAVE BEEN DISCONTINUED AND REPLACED BY THE TUBEX INJECTOR.

EXCHANGE OF THESE DISCONTINUED SYRINGES IS AVAILABLE, FREE OF CHARGE, FROM WYETH-AYERST DIRECTLY. FOR LOADING AND UNLOADING INFORMATION ON THESE DISCONTINUED SYRINGES, CONTACT THE MEDICAL AFFAIRS DEPARTMENT AT WYETH-AYERST LABORATORIES, P.O. BOX 8299, PHILADELPHIA, PA 19101.

TUBEX® Injector

NOTE: The TUBEX Injector is REUSABLE: do not discard.

DIRECTIONS FOR USE:

BEFORE PROCEEDING, SEE IMPORTANT INFORMATION UNDER DOSAGE AND ADMINISTRATION SECTION.

Directions For Use - Illustration 1

NOTE: USE ASEPTIC TECHNIQUE FOR ALL MANIPULATIONS OF STERILE PARTS.

To load a TUBEX Sterile Cartridge-Needle Unit into the TUBEX Injector

1. Turn the ribbed collar to the “OPEN” position until it stops.

Directions For Use - Illustration 2

2. Hold the Injector with the open end up and fully insert the TUBEX Sterile Cartridge-Needle Unit.

Firmly tighten the ribbed collar in the direction of the “CLOSE” arrow.

Directions For Use - Illustration 3

3. Thread the plunger rod into the plunger of the TUBEX Sterile Cartridge-Needle Unit until slight resistance is felt.

Directions For Use - Illustration 4

The Injector is now ready for use in the usual manner.

Directions For Use - Illustration 5

To load an E.S.I. DOSETTE® Sterile Cartridge-Needle Unit into the TUBEX Injector

1. Turn the ribbed collar to the “OPEN” position until it stops.

Directions For Use - Illustration 6

2. Hold the Injector with the open end up and fully insert the E.S.I. DOSETTE Sterile Cartridge-Needle Unit. Firmly tighten the ribbed collar in the direction of the “CLOSE” arrow.

Directions For Use - Illustration 7

3. Thread the plunger rod into the plunger of the E.S.I. DOSETTE Sterile Cartridge-Needle Unit until slight resistance is felt.

Directions For Use - Illustration 8

4. Engage the needle-cap assembly by pulling the cap down over the silver cartridge hub. The needle is fully engaged when the silver hub is completely covered.

The Injector is now ready for use in the usual manner.

Directions For Use - Illustration 9

To administer TUBEX/DOSETTE Sterile Cartridge-Needle Units

Method of administration is the same as with conventional syringe. Remove needle cover by grasping it securely; twist and pull. Introduce needle into patient, aspirate by pulling back slightly on the plunger, and inject.

To remove the empty TUBEX/DOSETTE Cartridge-Needle Unit and dispose into a vertical needle disposal container

1. Do not recap the needle. Disengage the plunger rod.

Directions For Use - Illustration 10

2. Hold the Injector, needle down, over a vertical needle disposal container and loosen the ribbed collar.

TUBEX/DOSETTE Cartridge-Needle Unit will drop into the container.

Directions For Use - Illustration 11

3. Discard the needle cover.

To remove the empty TUBEX/DOSETTE Cartridge-Needle Unit and dispose into a horizontal (mailbox) needle disposal container

Do not recap the needle. Disengage the plunger rod.

Open the horizontal (mailbox) needle disposal container. Insert TUBEX/DOSETTE Cartridge-Needle Unit, needle pointing down, halfway into container. Close the container lid on cartridge. Loosen ribbed collar; TUBEX/DOSETTE Cartridge-Needle Unit will drop into the container.

Discard the needle cover. The TUBEXInjector is reusable and should not be discarded.

Directions For Use - Illustration 12

Used TUBEX/DOSETTE Cartridge-Needle Units should not be employed for successive injections or as multiple-dose containers. They are intended to be used only once and discarded.

NOTE: Any graduated markings on TUBEX/DOSETTE Sterile Cartridge-Needle Units are to be used only as a guide in administering doses.

Wyeth-Ayerst does not recommend and will not accept responsibility for the use of any cartridge-needle units other than TUBEX or E.S.I. DOSETTE Cartridge-Needle Units in the TUBEX Injector.

Prescribing Information as of November 2004. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101.

Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

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