Crexont 35-140mg 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 prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. If you have trouble swallowing the tablet 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 product.
It's essential to discuss with your doctor how to take this medication in relation to food. Your doctor may recommend taking your first dose of the day 1 to 2 hours before eating. If you're already taking this medication, do not change your routine without consulting your doctor first.
Some products may interact with alcohol, increasing the risk of side effects. Before consuming alcohol while taking this medication, talk to your doctor. Additionally, if you take iron supplements or multivitamins containing iron, ask your doctor or pharmacist for guidance on how to take them with this medication, as iron may reduce the absorption of this drug.
Your diet can also affect how well your body absorbs this medication. Diets high in protein, fat, or calories, as well as acidic foods, may reduce absorption. Discuss your diet with your doctor, especially if you plan to make any changes.
Continuing Your Medication
Continue taking this medication even when you're not experiencing symptoms. Keeping a diary of your symptoms can be helpful. Take this 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 in a dry place. 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. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to 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 divide them.
- Can be taken with or without food, but avoid high-protein meals as they can reduce the medicine's effectiveness.
- Take doses consistently at the same times each day as prescribed.
- Do not stop taking this medication suddenly, as it can lead to serious side effects.
- Be aware of potential dizziness or lightheadedness, especially when standing up quickly, due to orthostatic hypotension.
- Report any new or worsening involuntary movements (dyskinesia), hallucinations, confusion, or unusual urges/behaviors to your doctor.
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 medical attention immediately:
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
Trouble controlling body movements (new or worsening)
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 only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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 an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or worsening involuntary movements (dyskinesia)
- Hallucinations (seeing or hearing things that are not there)
- Delusions (false beliefs)
- Confusion or disorientation
- Excessive daytime sleepiness or sudden onset of sleep
- Severe dizziness or fainting spells
- Unusual urges or behaviors (e.g., pathological gambling, increased sexual urges, compulsive shopping, binge eating)
- Worsening of Parkinson's symptoms (e.g., rigidity, tremor, bradykinesia) if medication is stopped suddenly.
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. Be sure to describe the allergic reaction you experienced.
Certain health conditions, such as:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
Medications you are currently taking, including:
+ Reserpine or tetrabenazine
+ Linezolid or methylene blue
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
* If you are taking another 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 problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 should be performed as directed by your doctor to monitor your condition.
If you have diabetes (high blood sugar), consult with your doctor to determine the most suitable glucose tests to use. You may experience a decrease in the medication's effectiveness as the time for your next dose approaches, a phenomenon 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 impair your reactions, consult with your doctor. People with Parkinson's disease may have an increased 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 while taking this medication, 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, altered 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 to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dyskinesia (involuntary movements)
- Agitation or confusion
- Insomnia
- Orthostatic hypotension (severe dizziness, fainting)
- Palpitations or irregular heartbeat
- Nausea and vomiting
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Management is supportive, including gastric lavage, IV fluids, and careful monitoring of cardiac and respiratory function. Antiarrhythmics may be needed for cardiac arrhythmias.
Drug Interactions
Contraindicated Interactions
- Non-selective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) - risk of hypertensive crisis. Discontinue MAOIs at least 2 weeks prior.
Major Interactions
- Antipsychotics (e.g., haloperidol, chlorpromazine, risperidone, olanzapine) - may antagonize levodopa's effects, worsening Parkinson's symptoms.
- Iron salts (ferrous sulfate, gluconate) - may reduce levodopa absorption.
- Metoclopramide - may increase gastric emptying, affecting absorption, and has dopamine-blocking effects.
- High-protein diet - competes with levodopa for absorption and transport across the blood-brain barrier, reducing efficacy.
Moderate Interactions
- Antihypertensives - may cause orthostatic hypotension; dose adjustment of antihypertensive may be needed.
- Tricyclic antidepressants (TCAs) - rare cases of hypertension and dyskinesia reported.
- Pyridoxine (Vitamin B6) - large doses may reverse levodopa effects if carbidopa is not present in sufficient amounts (less relevant with fixed-dose combination).
Minor Interactions
- Antacids - may increase levodopa absorption slightly.
Monitoring
Baseline Monitoring
Rationale: To establish baseline severity and guide initial dosing.
Timing: Prior to initiation
Rationale: To assess for orthostatic hypotension risk.
Timing: Prior to initiation
Rationale: To assess organ function, though dose adjustments are not typically required, caution is advised.
Timing: Prior to initiation
Rationale: To monitor for potential hematologic abnormalities (rare).
Timing: Prior to initiation
Routine Monitoring
Frequency: Regularly, at each follow-up visit (e.g., every 1-3 months during titration, then every 3-6 months)
Target: Minimize 'off' time and dyskinesia
Action Threshold: Increased 'off' time, troublesome dyskinesia, or other motor complications warrant dose adjustment or addition of adjunctive therapy.
Frequency: Regularly, at each follow-up visit
Target: Minimize severity and frequency
Action Threshold: Troublesome dyskinesia warrants dose reduction or adjustment of dosing frequency.
Frequency: Regularly, at each follow-up visit
Target: Absence or minimal symptoms
Action Threshold: Emergence or worsening of psychiatric symptoms may require dose reduction or discontinuation.
Frequency: Regularly, at each follow-up visit, especially during titration
Target: Stable blood pressure, no symptomatic drops
Action Threshold: Symptomatic orthostatic hypotension warrants dose adjustment or non-pharmacological interventions.
Frequency: Periodically, inquire about new behaviors
Target: Absence of new or worsening behaviors
Action Threshold: Emergence of these behaviors warrants dose reduction or discontinuation.
Symptom Monitoring
- Dyskinesia (involuntary, uncontrolled movements)
- Wearing-off phenomena (return of Parkinson's symptoms before next dose)
- Orthostatic hypotension (dizziness, lightheadedness upon standing)
- Hallucinations or delusions
- Confusion or disorientation
- Nausea or vomiting
- Sleepiness or sudden onset of sleep
- Unusual urges or behaviors (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.
Trimester-Specific Risks:
Lactation
Levodopa is excreted in human milk. Carbidopa is not known to be excreted. Due to potential for serious adverse reactions in breastfed infants (e.g., interference with neurological development, suppression of lactation), 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 in pediatric patients have not been established. Not recommended for use in patients younger than 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose titration should be done carefully, starting with lower doses.
Clinical Information
Clinical Pearls
- Crexont (Carbidopa/Levodopa ER) capsules should be swallowed whole. They can be opened and the beads sprinkled on a small amount of soft food (e.g., applesauce) for patients who have difficulty swallowing, but the beads themselves should not be chewed or crushed.
- Patients converting from immediate-release carbidopa/levodopa may require a higher total daily dose of the ER formulation due to differences in bioavailability and absorption characteristics.
- Counsel patients to avoid high-protein meals, as protein can interfere with levodopa absorption and transport to the brain, potentially reducing efficacy.
- Monitor for impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating) as these can occur with dopaminergic therapies.
- Orthostatic hypotension is a common side effect; advise patients to rise slowly from a sitting or lying position.
- Sudden onset of sleep or excessive daytime sleepiness can occur; caution patients about driving or operating machinery.
- Do not discontinue abruptly due to risk of neuroleptic malignant syndrome-like syndrome (fever, rigidity, altered mental status, autonomic instability).
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 or motor fluctuations)
- Istradefylline (adenosine A2A receptor antagonist)
- Pimavanserin (for Parkinson's disease psychosis)