This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

EXTENCILLINE

Read time: 1 mins
Marketing start date: 26 Jan 2025

Summary of product characteristics


Dosage And Administration

Instruction on how to prepare and administer Extencilline Instructions for the preparation of an intramuscular injection of a dose of 1,200,000 units of benzathine benzylpenicillin: The suspension must be prepared aseptically. 1/ With a graduated syringe for intramuscular injection (needle gauge: 22, 21 or 20), take 4 mL of water for injections from the ampule of diluent contained in the box. The compatibility data are only available with water for injectable preparations and 1% or 0.5% lidocaine injectable solution. Warning: the ampule of diluent provided in the box contains 5 mL of water for injections. It is not necessary to use all the contents for the preparation of this suspension. 2/ Into the vial of powder of 1,200,000 units, add the 4 mL of water for injections taken from the ampule of diluent, or the 4 mL of 1.0% or 0.5% lidocaine injectable solution. 3/ Agitate this suspension carefully for at least 20 seconds until a homogenous suspension is obtained, then use the suspension immediately as soon as it is prepared. The suspension obtained in this way corresponds to a dose of 1,200,000 units. This reconstitution must only be done for one single injection. For doses of Extencilline less than 1,200,000 units, withdraw the appropriate volume of the reconstituted product and discard the remainder. For example, withdraw half the volume of the reconstituted 1,200,000 units for a 600,000 units dose of Extencilline. Instructions for the preparation of an intramuscular injection of a dose of 2,400,000 units of benzathine benzylpenicillin: The suspension must be prepared aseptically. 1/ With a graduated syringe for intramuscular injection (needle gauge: 22, 21 or 20), take 5 mL of water for injections from the ampule of diluent contained in the box, or 5 mL of 1% or 0.5% lidocaine injectable solution. 2/ Into the vial of powder 2,400,000 units, add the 5 mL of water for injections taken from the ampule of diluent, or 5 mL of 1% or 0.5% lidocaine injectable solution. 3/ Agitate this for suspension carefully for at least 20 seconds until a homogenous for suspension is obtained, then use the for suspension immediately as soon as it is prepared. The suspension obtained in this way corresponds to a dose of 2,400,000 units. This reconstitution must only be done for one single injection. For doses of Extencilline less than 2,400,000 units, withdraw the appropriate volume of the reconstituted product and discard the remainder.

Effective Time

20240718

Version

5

Spl Product Data Elements

EXTENCILLINE benzathine benzylpenicillin EXTENCILLINE benzathine benzylpenicillin PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS TRISODIUM CITRATE POVIDONE Water water WATER EXTENCILLINE benzathine benzylpenicillin EXTENCILLINE benzathine benzylpenicillin PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS TRISODIUM CITRATE POVIDONE Water water WATER EXTENCILLINE benzathine benzylpenicillin PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS TRISODIUM CITRATE POVIDONE EXTENCILLINE benzathine benzylpenicillin PENICILLIN G BENZATHINE PENICILLIN G LECITHIN, SOYBEAN POLYSORBATE 80 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED ANHYDROUS TRISODIUM CITRATE POVIDONE

Brand Name

EXTENCILLINE

Generic Name

benzathine benzylpenicillin

Product Ndc

81284-524

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAMUSCULAR

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL - 1,200,000 Units Carton EXTENCILLINE ® 1,200,000 Units Benzathine benzylpenicillin Powder and diluent for reconstitution for injection IM 1 vial of powder for reconsitution for injection. 1 ampule of diluent containing 5 mL of water for injections. Intramuscular injection only. Box of 1. 1,200,000 Units Carton

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.