Crexont 52.5-210mg Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Take your medication with or without food, as directed by your doctor.
Swallow the medication whole. Do not chew, break, or crush it.
If you have trouble swallowing the medication whole, some products can be opened and mixed with applesauce. However, you must swallow the mixture immediately without chewing. Check with your doctor or pharmacist to see if this is an option for your specific medication.
Discuss with your doctor how to take your medication in relation to food. Your doctor may recommend taking your first dose of the day 1 to 2 hours before eating. If you are already taking this medication, do not change your routine without consulting your doctor first.
Important Interactions to Consider
Certain products should not be taken with alcohol, as this may increase the risk of side effects. Talk to your doctor before consuming alcohol while taking this medication.
If you take an iron supplement or a multivitamin containing iron, ask your doctor or pharmacist for guidance on how to take it with your medication. Iron may reduce the absorption of your medication.
A diet high in protein, fat, or calories, as well as acidic foods, may also affect the absorption of your medication. Discuss your diet with your doctor or any planned changes to your diet.
Maintaining Your Medication Routine
Continue taking your medication even when you are not experiencing symptoms.
Keep a record of your symptoms to track your progress.
Take your medication at the same time every day, as directed by your doctor or healthcare provider, even if you feel well.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
Take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take capsules whole; do not crush, chew, or open them. If you have difficulty swallowing, discuss alternatives with your doctor.
- Can be taken with or without food. However, high-protein meals may reduce the amount of medicine absorbed, so try to take it consistently relative to meals.
- Do not stop taking this medication suddenly, as it can lead to serious side effects (neuroleptic malignant syndrome-like symptoms).
- Be aware of potential side effects like dizziness or lightheadedness when standing up (orthostatic hypotension); stand up slowly.
- This medication can cause drowsiness or sudden sleep attacks. Avoid driving or operating machinery if you experience these symptoms.
- Report any new or unusual urges or behaviors (e.g., gambling, increased sexual urges, compulsive shopping) to your doctor.
- Regular follow-up appointments are important to monitor your symptoms and adjust your dose as needed.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
New or worsening behavioral or mood changes, such as:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Feeling confused
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
A skin lump or growth
Changes in the color or size of a mole
New or worsening trouble controlling body movements
Eyelid twitching
Muscle twitching
Stomach pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Chest pain or pressure
Fast or abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Dark urine or yellow skin and eyes
Changes in eyesight, eye pain, or severe eye irritation
Shortness of breath
Sudden, unexplained sleepiness, especially during activities like driving, eating, or talking
If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Bad dreams
Constipation
Dizziness or sleepiness
Dry mouth
Headache
Trouble sleeping
Some products may cause a dark red, brown, or black color to appear in your saliva, urine, or sweat (harmless, but may discolor clothing)
* Upset stomach or vomiting
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening involuntary movements (dyskinesia)
- Hallucinations (seeing or hearing things that aren't there)
- Delusions or paranoia
- Excessive daytime sleepiness or sudden sleep attacks
- Dizziness or fainting spells (especially when standing up)
- Unusual urges or behaviors (e.g., compulsive gambling, hypersexuality)
- Severe nausea or vomiting
- Unexplained fever, severe muscle stiffness, confusion, or sweating (signs of neuroleptic malignant syndrome-like reaction)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
Current or recent use of specific medications, such as:
+ Reserpine or tetrabenazine
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may lead to very high blood pressure)
Use of any other medication that contains the same active ingredient as this drug
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
To minimize the risk of accidents, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. Additionally, to reduce the likelihood of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. Regular blood tests and eye exams, as recommended by your doctor, are also necessary to monitor your condition.
If you have diabetes (high blood sugar), consult your doctor about the most suitable glucose tests to use, as this medication may affect the results. You may experience a decrease in the medication's effectiveness as the time for your next dose approaches, which is known as "wearing off." If this occurs and bothers you, discuss it with your doctor.
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. It is also important to note that people with Parkinson's disease may have a higher risk of developing a type of skin cancer called melanoma, although it is unclear if this medication contributes to this risk. Regular skin exams are recommended, and you should discuss any concerns with your doctor.
Do not abruptly stop taking this medication or reduce your dosage without consulting your doctor, as this may lead to severe side effects, including fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, abnormal heartbeat, or excessive sweating. If you experience any of these symptoms, contact your doctor immediately.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Agitation
- Confusion
- Insomnia
- Severe dyskinesia (involuntary movements)
- Palpitations or irregular heartbeat
- Orthostatic hypotension
- Nausea and vomiting
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Management is generally supportive, including gastric lavage, IV fluids, and careful monitoring of cardiac rhythm and vital signs. Pyridoxine is not effective in reversing the effects of carbidopa/levodopa overdose.
Drug Interactions
Contraindicated Interactions
- Nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) - risk of hypertensive crisis. Discontinue MAO inhibitors at least 2 weeks prior to initiating carbidopa/levodopa.
Major Interactions
- Antipsychotics (e.g., phenothiazines, butyrophenones, risperidone, olanzapine) - may antagonize the effects of levodopa due to dopamine receptor blockade.
- Iron salts (ferrous sulfate, ferrous gluconate) - may reduce the bioavailability of levodopa due to chelation.
- Metoclopramide - may antagonize the effects of levodopa and increase risk of extrapyramidal symptoms.
- Isoniazid - may increase levodopa metabolism, reducing efficacy.
Moderate Interactions
- Antihypertensives - additive hypotensive effects, monitor blood pressure.
- Tricyclic antidepressants (TCAs) - may rarely increase dyskinesia or reduce levodopa absorption.
- Dopamine D2 receptor antagonists (e.g., some antiemetics) - may reduce therapeutic effect.
- High-protein diet - may reduce levodopa absorption and transport across the blood-brain barrier.
Monitoring
Baseline Monitoring
Rationale: To assess baseline organ function, although no specific dose adjustments are typically needed, caution is advised in severe impairment.
Timing: Prior to initiation
Rationale: To establish baseline, as hemolytic anemia has been reported rarely.
Timing: Prior to initiation
Rationale: To identify pre-existing conditions that may be exacerbated (e.g., psychosis, depression).
Timing: Prior to initiation
Rationale: To assess for baseline orthostatic hypotension, which can be exacerbated by treatment.
Timing: Prior to initiation
Routine Monitoring
Frequency: Regularly, at each visit (e.g., every 1-3 months during stabilization, then every 3-6 months)
Target: Optimal symptom control with minimal side effects
Action Threshold: Worsening symptoms, increased 'off' time, or new/worsening dyskinesia indicate need for dose adjustment or adjunctive therapy.
Frequency: Regularly, at each visit
Target: Minimal to no bothersome dyskinesia
Action Threshold: Presence of bothersome dyskinesia may require dose reduction or adjustment of dosing frequency.
Frequency: Regularly, at each visit
Target: Absence of new or worsening psychiatric symptoms
Action Threshold: New onset or worsening psychiatric symptoms require evaluation and potential dose reduction or discontinuation.
Frequency: Regularly, especially during dose titration and if symptoms of dizziness or falls occur.
Target: Stable blood pressure without significant orthostatic drop
Action Threshold: Significant orthostatic hypotension (e.g., >20 mmHg systolic or >10 mmHg diastolic drop) requires evaluation and potential dose adjustment or management strategies.
Frequency: Regularly, at each visit
Target: No excessive daytime sleepiness or sudden sleep attacks
Action Threshold: Report of excessive sleepiness or sudden sleep onset requires counseling on driving/operating machinery and potential dose adjustment or discontinuation.
Symptom Monitoring
- Dyskinesia (involuntary movements)
- Hallucinations (visual, auditory)
- Delusions or paranoia
- Orthostatic hypotension (dizziness, lightheadedness upon standing)
- Sudden onset of sleep
- Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
- Depression or anxiety
- Gastrointestinal upset (nausea, vomiting, constipation)
- Changes in skin lesions (for melanoma risk)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
Lactation
L3 (Moderate risk). Levodopa is excreted into human breast milk. Carbidopa may inhibit lactation. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
Elderly patients may be more sensitive to the effects of carbidopa/levodopa, particularly psychiatric side effects (e.g., hallucinations, confusion) and orthostatic hypotension. Start with lower doses and titrate slowly, monitoring closely for adverse effects.
Clinical Information
Clinical Pearls
- Crexont (Carbidopa/Levodopa Extended-Release) is designed to provide more continuous dopaminergic stimulation, potentially reducing 'off' time and dyskinesia compared to immediate-release formulations.
- Dosing is highly individualized; careful titration is essential to optimize symptom control while minimizing side effects.
- Patients should be advised not to crush, chew, or open the capsules. If a dose is missed, they should take the next dose at the regularly scheduled time; do not double the dose.
- Monitor for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating), which can occur with dopaminergic therapies.
- Sudden sleep attacks can occur without warning; patients should be cautioned about driving or operating heavy machinery.
- High-protein meals can interfere with levodopa absorption; advise patients to take the medication consistently relative to meals, and if 'off' periods are related to meals, consider adjusting protein intake distribution.
Alternative Therapies
- Dopamine Agonists (e.g., pramipexole, ropinirole, rotigotine)
- MAO-B Inhibitors (e.g., selegiline, rasagiline, safinamide)
- COMT Inhibitors (e.g., entacapone, opicapone)
- Amantadine (for dyskinesia and 'off' time)
- Istradefylline (adenosine A2A receptor antagonist, for 'off' time)