Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows:

Molecular Formula: (C₁₆H₁₈N₂O₄S)₂•C₁₆H₂₀N₂•4H₂O
Molecular Wt. 981.19

Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.5% lecithin, 0.6% carboxymethylcellulose, 0.6% povidone, 0.1% methylparaben, and 0.01% propylparaben.

Bicillin L-A injectable suspension in TUBEX® formulation is viscous and opaque. It is available in 1 mL and 2 mL TUBEX® Sterile Cartridge-Needle Units containing the equivalent of 600,000 units and 1,200,000 units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.

Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response.

The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine: Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci.

Venereal infections-Syphilis, yaws, bejel, and pinta.

Medical Conditions in which Penicillin G Benzathine Therapy is Indicated as Prophylaxis:

Rheumatic fever and/or chorea-Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.

Streptococcal (Group A) Upper-respiratory Infections (for example, pharyngitis)

Adults - a single injection of 1,200,000 units; older pediatric patients - a single injection of 900,000 units; infants and pediatric patients under 60 lbs. - 300,000 to 600,000 units.

Syphillis

Primary, secondary, and latent - 2,400,000 units (1 dose). Late (tertiary and neurosyphilis) - 2,400,000 units at 7-day intervals for three doses.

Congenital- under 2 years of age: 50,000 units/kg/body weight; ages 2 to 12 years: adjust dosage based on adult dosage schedule.

Yaws, Bejel, and Pinta - 1,200,000 units (1 injection). Prophylaxis - for rheumatic fever and glomerulonephritis.

Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks.

Method of Administration

Bicillin L-A 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.

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 barrel of the cartridge in the area previously identified (see above) for the appearance of a red or dark-colored "spot."

Blood or "typical blood color" may not be seen if a blood vessel has been entered - only a mixture of blood and Bicillin L-A. The appearance of any discoloration is reason to withdraw the needle and discard the glass TUBEX cartridge. If it is elected to inject at another site, a new cartridge should be used. If no blood or discoloration appears, inject the contents of the cartridge slowly. Discontinue delivery of the dose if the subject complains of severe immediate pain at the injection site or if, especially in 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.

Bicillin® L-A (penicillin G benzathine injectable suspension) is supplied in packages of

10 TUBEX® Sterile Cartridge-Needle Units as follows:

1 mL size, containing 600,000 units per TUBEX® (21gauge, thin-wall 1inch needle for pediatric use), NDC 61570-146-10.
2 mL size, containing 1,200,000 units per TUBEX® (21gauge, thin-wall 1-1/4inch needle), NDC 61570-147-10.

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

Keep from freezing.

Also Available

Bicillin L-A (penicillin G benzathine injectable suspension) is also available in packages of 10disposable syringes as follows:

4 mL size, containing 2,400,000 units per syringe (18 gauge x 2 inch needle), NDC 61570-148-10.

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 LOADINGAND

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.

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.

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.

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

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

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.

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.

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

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.

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.

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.

3. Discard the needle cover.

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

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

2. 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.

3. Discard the needle cover. The TUBEX Injector is reusable and should not be discarded.

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.

TUBEX is a registered trademark of Wyeth-Ayerst Laboratories. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: Wyeth Laboratories, Philadelphia, PA 19101. Revised April 2002. FDA rev date: 11/17/2005

As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria.

As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported. The following have been reported with parenteral penicillin G:

General: Hypersensitivity reactions including the following: skin eruptions (maculopapular to exfoliative dermatitis), urticaria, laryngeal edema, fever, eosinophilia; other serum sickness-like reactions (including chills, fever, edema, arthralgia, and prostration); and anaphy-laxis including shock and death. Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, penicillin G should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to therapy with penicillin G. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.

Gastrointestinal: Pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See WARNINGS section.)

Hematologic: Hemolytic anemia, leukopenia, thrombocytopenia.

Neurologic: Neuropathy.

Urogenital: Nephropathy.

The following adverse events have been temporally associated with parenteral administration of penicillin G benzathine, although a causal relationship has not necessarily been established: Body as a Whole: Hypersensitivity reactions including allergic vasculitis, pruritus, fatigue, asthenia, and pain; aggravation of existing disorder; headache.

Cardiovascular: Cardiac arrest; hypotension; tachycardia; palpitations; pulmonary hypertension; pulmonary embolism; vasodilatation; vasovagal reaction; cerebrovascular accident; syncope.

Gastrointestinal: Nausea, vomiting; blood in stool; intestinal necrosis.

Hemic and Lymphatic: Lymphadenopathy.

Injection Site: Injection site reactions including pain, inflammation, lump, abscess, necrosis, edema, hemorrhage, cellulitis, hypersensitivity, atrophy, ecchymosis, and skin ulcer. Neurovascular reactions including warmth, vasospasm, pallor, mottling, gangrene, numbness of the extremities, cyanosis of the extremities, and neurovascular damage.

Metabolic: Elevated BUN, creatinine, and SGOT.

Musculoskeletal: Joint disorder; periostitis; exacerbation of arthritis; myoglobinuria; rhab-domyolysis.

Nervous System: Nervousness; tremors; dizziness; somnolence; confusion; anxiety; euphoria; transverse myelitis; seizures; coma. A syndrome manifested by a variety of CNS symptoms such as severe agitation with confusion, visual and auditory hallucinations, and a fear of impending death (Hoigne's syndrome), has been reported after administration of penicillin G procaine and, less commonly, after injection of the combination of penicillin G benzathine and penicillin G procaine. Other symptoms associated with this syndrome, such as psychosis, seizures, dizziness, tinnitus, cyanosis, palpitations, tachycardia, and/or abnormal perception in taste, also may occur.

Respiratory: Hypoxia; apnea; dyspnea.

Skin: Diaphoresis.

Special Senses: Blurred vision; blindness.

Urogenital: Neurogenic bladder; hematuria; proteinuria; renal failure; impotence; priapism.

Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided.

Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin.

Penicillin G benzathine should only be prescribed for the indications listed in this insert.

Anaphylaxis

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH BICILLIN L-A CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, BICILLIN L-A SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Pseudomembranous Colitis

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including penicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".

After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.

Method of Administration

Do not inject into or near artery or nerve.

Injection in or near a nerve may result in permanent neurological damage.

Inadvertent intravascular administration, including inadvertent direct intra-arterial injection or injection immediately adjacent to arteries, of Bicillin L-A and other penicillin preparations has resulted in severe neurovascular damage, including transverse myelitis with permanent paralysis, gangrene requiring amputation of digits and more proximal portions of extremities, and necrosis and sloughing at and surrounding the injection site. Such severe effects have been reported following injections into the buttock, thigh and deltoid areas. Other serious complications of suspected intravascular administration which have been reported include immediate pallor, mottling, or cyanosis of the extremity both distal and proximal to the injection site, followed by bleb formation; severe edema requiring anterior and/or posterior compartment fasciotomy in the lower extremity. The above-described severe effects and complications have most often occurred in infants and small children. Prompt consultation with an appropriate specialist is indicated if any evidence of compromise of the blood supply occurs at, proximal to, or distal to the site of injection.^1-9 (See PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections.)

Do not inject intravenously or admix with other intravenous solutions. There have been reports of inadvertent intravenous administration of penicillin G benzathine which has been associated with cardiorespiratory arrest and death. (See DOSAGE AND ADMINISTRATION section.)

Quadriceps femoris fibrosis and atrophy have been reported following repeated intramuscular injections of penicillin preparations into the anterolateral thigh.

General

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.

Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injection may produce neu-rovascular damage. (See WARNINGS and DOSAGE AND ADMINISTRATION sections.) Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken.

Laboratory Tests

In streptococcal infections, therapy must be sufficient to eliminate the organism; otherwise, the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated.

Pregnancy Category B

Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Soluble penicillin G is excreted in breast milk. Caution should be exercised when penicillin G benzathine is administered to a nursing woman.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been conducted with this drug.

Pediatric Use

(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.)

REFERENCES

1. SHAW, E.: Transverse myelitis from injection of penicillin. Am. J. Dis. Child., 111:548, 1966.

2.KNOWLES, J.: Accidental intra-arterial injection of penicillin. Am. J. Dis. Child., 111:552, 1966.

3. DARBY, C. et al: Ischemia following an intragluteal injection of benzathine-procaine penicillin G mixture in a one-year-old boy. Clin. Pediatrics, 12:485, 1973.

4. BROWN, L. & NELSON, A.: Postinfectious intravascular thrombosis with gangrene. Arch. Surg., 94:652, 1967.

5. BORENSTINE, J.: Transverse myelitis and penicillin (Correspondence). Am. J. Dis. Child., 112:166, 1966.

6. ATKINSON, J.: Transverse myelopathy secondary to penicillin injection. J. Pediatrics, 75:867, 1969.

7. TALBERT, J. et al: Gangrene of the foot following intramuscular injection in the lateral thigh: A case report with recommendations for prevention. J. Pediatrics, 70:110, 1967.

8. FISHER, T.: Medicolegal affairs. Canad. Med. Assoc. J., 112:395, 1975.

9. SCHANZER, H. et al: Accidental intra-arterial injection of penicillin G. JAMA, 242:1289, 1979.

Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.

A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

General

Penicillin G benzathine has an extremely low solubility and, thus, the drug is slowly released from intramuscular injection sites. The drug is hydrolyzed to penicillin G. This combination of hydrolysis and slow absorption results in blood serum levels much lower but much more prolonged than other parenteral penicillins.

Intramuscular administration of 300,000 units of penicillin G benzathine in adults results in blood levels of 0.03 to 0.05 units per mL, which are maintained for 4 to 5days. Similar blood levels may persist for 10 days following administration of 600,000 units and for 14 days following administration of 1,200,000 units. Blood concentrations of 0.003 units per mL may still be detectable 4 weeks following administration of 1,200,000 units.

Approximately 60% of penicillin G is bound to serum protein. The drug is distributed throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys with lesser amounts in the liver, skin, and intestines. PenicillinG penetrates into all other tissues and the spinal fluid to a lesser degree. With normal kidney function, the drug is excreted rapidly by tubular excretion. In neonates and young infants and in individuals with impaired kidney function, excretion is considerably delayed.

Microbiology

Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci.

The following in vitro data are available, but their clinical significance is unknown. Penicillin G exerts high in vitro activity against staphylococci (except penicillinase-producing strains), streptococci (Groups A, C, G, H, L, and M), and pneumococci. Other organisms susceptible to penicillin G are Neisseria gonorrhoeae, Corynebacterium diphtheriae, Bacillus anthracis, Clostridia species, Actinomyces bovis, Streptobacillus moniliformis, Listeria monocytogenes, and Leptospira species. Treponema pallidum is extremely susceptible to the bactericidal action of penicillin G.

Susceptibility Test: If the Kirby-Bauer method of disc susceptibility is used, a 20-unit penicillin disc should give a zone greater than 28 mm when tested against a penicillin-susceptible bacterial strain.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PENICILLIN G BENZATHINE - INJECTION

(pen-ih-SILL-in G BEN-zuh-theen)

COMMON BRAND NAME(S): Bicillin L-A

WARNING: This medication must not be injected into a vein or mixed with solutions that will be injected into a vein.

USES: This medication is used to treat a wide variety of bacterial infections. It may also be used to prevent certain bacterial infections (e.g., rheumatic fever). This medication is known as a long-acting natural penicillin antibiotic. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: See also Warning section.

This medication is given by injection into a large muscle by a health care professional. The injection should be given slowly and steadily. Do not inject into or near an artery or nerve. Follow all instructions for preparation and use of this product. Before using, check this product visually for unusual particles or discoloration. If either is present, do not use the liquid. If you have questions about the use of this medication, consult the pharmacist.

The dosage is based on your medical condition and response to treatment. For children, the dosage may also be based on weight.

Before injecting each dose, clean the injection site with rubbing alcohol. If you receive more than one dose, it is important to change the location of the injection site to avoid problem areas in the muscle.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, if more than one dose is needed, use this drug at evenly spaced intervals as prescribed by your doctor, and make sure not to miss any doses.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Pain at the injection site, nausea, or vomiting may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe pain/peeling skin at injection site, joint/muscle pain, headache, shortness of breath, dizziness.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, fast/slow/pounding heartbeat, numbness/tingling of arms/legs, pain/redness/swelling of arms or legs, change in skin color near injection site or on arms/legs, uncontrolled movements, inability to move, change in the amount of urine, new signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, extreme tiredness, dark/cloudy urine, seizures, mental/mood changes (e.g., depression, agitation).

Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, chest pain, slurred speech, confusion, fainting.

If used to treat syphilis, this medication may cause a condition known as Jarisch-Herxheimer reaction. This condition may occur 1 to 2 hours after you receive the medication and can last up to 24 hours. Notify your doctor immediately if you experience any of these symptoms: fever/chills, muscle pain, worsening of skin sores, fast heartbeat, fast breathing, dizziness, flushing.

This medication may rarely cause a severe intestinal condition (pseudomembranous colitis) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to penicillin or cephalosporin antibiotics; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, asthma.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Kidney function is not fully developed in newborns/infants. This medication is removed by the kidneys. Therefore, newborns/infants may be at greater risk for side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), live bacterial vaccines, methotrexate, NSAIDs (e.g., aspirin, indomethacin), probenecid, tetracyclines, "water pills"/diuretics (e.g., furosemide, thiazide diuretics such as hydrochlorothiazide).

Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Ask your doctor or pharmacist for more details.

This medication may decrease the effectiveness of combination-type hormonal birth control (e.g., pills, patch). This effect can result in pregnancy. Ask your doctor or pharmacist for details. Discuss whether you should use additional reliable birth control methods (e.g., condoms, diaphragm) while you are using hormonal birth control along with penicillin.

This medication may interfere with certain laboratory tests (including certain urine glucose tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, confusion, mental/mood changes (e.g., agitation).

NOTES: This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., kidney function, complete blood count) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist immediately for a new dosing schedule.

STORAGE: Store in a refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.