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:
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.
2. Pediatric Population:
No information is available on the relationship of age to the effects of caffeine and sodium benzoate injection in the pediatric population. Safety and efficacy have not been established.
3. Geriatric Population:
No information is available on the relationship of age to the effects of caffeine and sodium benzoate injection in geriatric patients.
Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
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.
6. 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
- Peginterferon Alfa-2b
7. 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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
8. 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:
- Heart disease or
- Heart rhythm problems—Use with caution. May make these conditions worse.
It is very important that your doctor check your progress closely while you are receiving this medicine and to see if it is working properly.
Using large doses of this medicine may cause unwanted effects. Tell your doctor right away if you have a headache, anxiety, fast, pounding, or uneven heartbeat, ringing in the ears, or tingling in the hands and feet.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
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.
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
- Extra heartbeats
- Fast, Pounding, or Irregular heartbeat or pulse
- Trembling or Shaking of the hands or feet
Get emergency help immediately if any of the following symptoms of overdose occur:
- Symptoms of overdose
- Chest pain or discomfort
- Confusion as to time, place, or person
- Decreased urination
- Dry mouth
- Holding false beliefs that cannot be changed by fact
- Increase in heart rate
- Pounding or Rapid pulse
- Rapid breathing
- Slow heartbeat
- Sunken eyes
- Trouble sleeping
- Unable to sleep
- Unusual excitement, nervousness, or restlessness
- Unusual tiredness or weakness
- Wrinkled 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
- Continuing ringing or buzzing or other unexplained noise in the ears
- Hearing loss
- Increased sensitivity to pain
- Increased sensitivity to touch
- Shortness of breath
- Tingling in the hands and feet
- Trouble sleeping
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.