Description
Penicillin G benzathine injection is used to treat bacterial infections (eg, mild to moderate infections of the upper respiratory tract, syphilis, yaws, bejel, pinta). It is also used to prevent rheumatic fever, chorea, rheumatic heart disease, or acute glomerulonephritis. This medicine is an antibiotic. It works by killing bacteria or preventing their growth.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of penicillin G benzathine injection in children. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of penicillin G benzathine injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chlortetracycline
- Cholera Vaccine, Live
- Demeclocycline
- Doxycycline
- Eravacycline
- Lymecycline
- Meclocycline
- Methacycline
- Minocycline
- Oxytetracycline
- Rolitetracycline
- Sarecycline
- Tetracycline
- Tigecycline
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy (eg, cephalosporin antibiotic), history of or
- Asthma, history of—Use with caution. May increase risk for more side effects.
- Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles, usually in the upper buttock or hip area.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor check your or your child's progress closely while receiving the medicine to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP). Check with your doctor right away if you or your child has black, tarry stools, blistering, peeling, loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in them mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
Call your doctor if your symptoms do not improve or get worse.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Incidence not known
- Agitation
- anxiety
- back pain, sudden and severe
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blindness
- bloating
- bloody or cloudy urine
- bluish color of the fingernails, lips, skin, palms, or nail beds
- blurred vision
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- chest pain or discomfort
- chills
- confusion
- continuing ringing or buzzing or other unexplained noise in the ears
- cough
- dark urine
- decreased frequency or amount of urine
- diarrhea, watery and severe, which may also be bloody
- difficult or painful urination
- difficulty breathing
- difficulty swallowing
- dizziness or lightheadedness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- euphoria
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- general body swelling
- general feeling of illness or discomfort
- headache
- hearing loss
- hives, itching, skin rash
- increased blood pressure
- increased thirst
- joint swelling loss of appetite
- lower back or side pain
- muscle cramps, pain, stiffness, or spasms
- muscle weakness, sudden and progressing
- nausea
- nosebleeds
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rigidity
- seeing or hearing things that are not there
- seizures
- sensation of pins and needles
- skin blisters
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stabbing pain
- stomach cramps or tenderness
- sudden decrease in the amount of urine
- sweating
- swelling of the face, fingers, or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- swollen glands
- tightness in the chest
- tremors
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight loss
- vomiting
- weight gain
- yellowing of the eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Bad unusual or unpleasant (after)taste
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- change in taste
- decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- painful or prolonged erection of the penis
- sleepiness or unusual drowsiness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
