Description
Clonidine extended-release suspension is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Suspension, Extended Release
- Tablet, Extended Release
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 have not been performed on the relationship of age to the effects of clonidine extended-release suspension in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
No information is available on the relationship of age to the effects of clonidine extended-release suspension in geriatric patients.
Breastfeeding
Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
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 taking 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.
- Acebutolol
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amlodipine
- Amoxapine
- Amphetamine
- Aranidipine
- Atenolol
- Bepridil
- Betaxolol
- Bevantolol
- Bisoprolol
- Carteolol
- Carvedilol
- Celiprolol
- Ceritinib
- Cilnidipine
- Clevidipine
- Clomipramine
- Crizotinib
- Desipramine
- Dextroamphetamine
- Dibenzepin
- Digoxin
- Dilevalol
- Diltiazem
- Dothiepin
- Doxepin
- Esmolol
- Felodipine
- Imipramine
- Iobenguane I 131
- Isradipine
- Labetalol
- Lercanidipine
- Levobunolol
- Lisdexamfetamine
- Lofepramine
- Macimorelin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cyclosporine
- Fluphenazine
- Mepivacaine
- Naloxone
- Yohimbine
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.
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 rhythm problems (slow heartbeat) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Kidney disease or
- Stroke, history of or
- Syncope (passing out), history of—Use with caution. May make these conditions worse.
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.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. If you are taking other brands of this medicine, your doctor may tell you to stop using other clonidine products. Do not switch between other clonidine products unless your doctor tells you to.
To use the oral liquid:
- Wash your hands before and after using this medicine.
- Place the bottle on a flat surface. Remove the cap by pressing and turning it counterclockwise.
- Hold the bottle firmly and insert the ridged end of the bottle adapter into the neck of the bottle. Push the bottle adapter all the way down with your thumb until the top of the adapter is aligned and flat with the top of the bottle. Do not remove the bottle adapter once inserted. Put the cap back on and close it by turning the cap clockwise.
- Gently shake the bottle with a smooth up and down motion for at least 10 seconds before you take each dose. Place the bottle upright on the table or counter and open the cap again.
- Check the oral dosing syringe to find the correct dose in milliliters (mL) that has been prescribed. Insert the tip of the syringe through the bottle adapter. Push the plunger all the way down.
- Hold the syringe in place and turn the bottle upside down. Pull the plunger down until you reached the prescribed dose. Push and pull the plunger a few times to make sure that there are no air bubbles. Tap the barrel of the syringe to get rid of any air bubbles.
- Turn the bottle over and place it upright on a table or counter. Remove the syringe from the bottle adapter. Check that the correct dose was pulled up into the oral syringe.
- Make sure your child is in a seated position. Tilt the head slightly upwards. Place the syringe into the mouth and point it toward the cheek. Have your child close his or her mouth tightly around the syringe and slowly push the plunger all the way down.
- After all the medicine has been given, remove the oral syringe from the mouth. Clean the syringe after each use with tap water.
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 (extended-release suspension):
- For attention deficit hyperactivity disorder (ADHD):
- Adults and children 6 years of age and older—At first, 0.1 milligrams (mg) once a day at bedtime. Your doctor may adjust your dose as needed.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For attention deficit hyperactivity disorder (ADHD):
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Do not take more of this medicine in a 24 hour period than your doctor prescribed for your daily dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Throw away any unused oral liquid 60 days after opening.
Precautions
It is very important that your doctor check your or your child's progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
You or your child will also need to have your blood pressure and heart rate checked before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
This medicine may cause bradycardia (slow heartbeat). Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness or fainting, irregular heartbeat, trouble breathing, or unusual tiredness.
Dizziness, lightheadedness, or fainting may occur after you take this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.
This medicine may make you sleepy and tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not suddenly stop using it without first checking with your doctor. Stopping treatment completely may cause hypertension (high blood pressure). Check with your doctor if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat. It may also cause withdrawal side effects (eg, anxiety, chest tightness, headache, increased heart rate, nausea, flushing or warm feeling, lightheadedness, or nervousness).
Do not become dehydrated or too hot to decrease your chance of passing out during treatment with this medicine.
This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have hives, itching, skin rash or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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 immediately if any of the following side effects occur:
More common
- Dizziness
- headache
- trouble sleeping
- sleepiness or unusual drowsiness
Less common
- Attack, assault, force
- emotional changes
- nightmares
Rare
- Chest pain or discomfort
- increased heart rate
- lightheadedness, dizziness or fainting
- slow or irregular heartbeat
- trouble breathing
- unusual tiredness
Incidence not known
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular heartbeat recurrent
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nervousness
- pounding in the ears
- seeing, hearing, or feeling things that are not there
- sweating
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:
More common
- Irritability
- stomach pain
Less common
- Constipation
- decreased appetite
- diarrhea
- loss of appetite
- nausea
- stuffy or runny nose
- throat pain
Rare
- Dry mouth
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.
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