Description
Moxidectin is used to treat river blindness (onchocerciasis) caused by the roundworm parasite Onchocerca volvulus.
This medicine is available only with your doctor's prescription.
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 moxidectin in children 4 years of age and older. Safety and efficacy have not been established in children younger than 4 years of age or weighing less than 13 kilograms (kg).
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of moxidectin in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Edema (swelling) or
- Hypotension (low blood pressure) or
- Onchodermatitis (sowda), hyperreactive—Use with caution. May make these worse.
- Loa loa infection—Patients also infected with the Loa loa infection are at an increased risk for encephalopathy (brain problem).
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
You may take this medicine with or without food.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For the treatment of onchocerciasis:
- Adults—8 milligrams (mg) (4 tablets) as a single dose.
- Children 4 years of age and older and weighing at least 13 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
- Weighing 30 kg or more—8 milligrams (mg) (4 tablets) as a single dose.
- Weighing 15 kg to less than 30 kg—6 mg (3 tablets) as a single dose.
- Weighing 13 kg to less than 15 kg—4 mg (2 tablets) as a single dose.
- Children younger than 4 years of age or weighing less than 13 kg—Use and dose must be determined by your doctor.
- For the treatment of onchocerciasis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Take all the medicine in the container within 24 hours of opening. Throw away any unused medicine.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause flu like symptoms (eg, general feeling of discomfort or illness, unusual tiredness or weakness, joint or muscle pain, headache, fast, pounding, or irregular heartbeat or pulse, itching skin) most commonly during the first week after treatment due to the death of the parasite.
Serious skin reactions may occur during treatment with this medicine. Check with your doctor right away if you have skin rash, hives, or itching.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
Moxidectin does not kill adult roundworms. Check with your doctor if you feel that this medicine is not working as it should or if your symptoms get worse.
Encephalopathy (brain problem) may occur when used in patients infected with another parasite, Loa loa. Check with your doctor right away if you have agitation, back pain, blurred vision, loss of consciousness, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting.
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 immediately if any of the following side effects occur:
More common
- Bone or muscle pain
- chills
- cough
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- fever
- headache
- itching
- rash
- stomach pain
- swelling of the face, ankles, or hands
- unusual tiredness weakness
Less common
- Blurred vision
- burning, dry, itching, or watering of the eyes
- discharge, excessive tearing
- feeling of having something in the eye
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- trouble seeing
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.
DRG-20443828
