Bicillin C-R 900 / 300

You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

Before using benzathine penicillin and procaine penicillin, tell your doctor if you have asthma or a history of allergies, liver disease, kidney disease, or heart disease.

Do not inject this medication into a vein or life-threatening side effects may result.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Benzathine penicillin and procaine penicillin will not treat a viral infection such as the common cold or flu.

After you have finished your treatment with benzathine penicillin and procaine penicillin, your doctor may want to do tests to make sure your infection has completely cleared up.

If you are on a dosing schedule, call your doctor for instructions if you miss a dose.

• If you have an allergy to penicillin, benzathine, procaine, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking tetracycline.

This is not a list of all drugs or health problems that interact with Bicillin C-R 900/300.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R 900/300 and other antibacterial drugs, Bicillin C-R 900/300 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Bicillin C-R 900/300 is indicated in the treatment of infections as described below that are susceptible to serum levels characteristic of this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response.

Bicillin C-R 900/300 is indicated in the treatment of the following in 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 susceptible 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 Streptococcus pneumoniae.

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.

A previous hypersensitivity reaction to any penicillin or to procaine is a contraindication.

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

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.

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 anaphylaxis 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, intra-venous 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 administrations of penicillin G benzathine, although a causal relationship has not necessarily been established:

Body as a Whole: Hypersensitivity reactions including allergic vas-culitis, pruritis, fatigue, asthenia, and pain; aggravation of existing disorder; headache.

Cardiovascular: Cardiac arrest; hypotension; tachycardia; palpitations; pulmonary hypertension; pulmonary embolism; vasodilation; 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, hypersen-sitivity, 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; rhabdomyolysis.

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, tinni-tus, 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.

Read the entire FDA prescribing information for Bicillin C-R 900 300 (Penicillin G Benzathine and Penicillin G Procaine Injection)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Fever or chills.
• Swelling.
• Joint pain.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• It is common to have diarrhea when taking this drug. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this drug or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
• Nerve damage can happen if this drug is given into or near a nerve. This could be long-lasting. Call your doctor right away if you have any numbness, tingling, or weakness.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.