Before taking Cristaclar, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, chronic obstructive pulmonary disease), fainting, seizures, stomach/intestinal disease (such as ulcers, bleeding), trouble urinating (such as enlarged prostate).
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Cristaclar may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Cristaclar, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Cristaclar safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
In the case of Cristaclar overdose, general supportive measures should be utilized. Poison control should be consulted. An overdose of Cristaclar can cause a cholinergic crisis. Symptoms of overdose include severe nausea, vomiting, sweating, and salivation. It can also cause bradycardia, hypotension, respiratory depression, collapse, and seizures. Increasing muscle weakness can occur and can cause death if respiratory muscles are involved. Hepatotoxicity has been reported in a few cases with overdose. Like in other anticholinesterase inhibitor toxicity, tertiary anticholinergics like atropine may be used as an antidote for Cristaclar overdose. The dose of IV atropine should be titrated based on clinical response. It is unknown if Cristaclar or its metabolites can be removed by dialysis.
What Is Cristaclar nd How Does It Work?
Cristaclar is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Cristaclar is available under the following different brand names: Aricept, and Aricept ODT.
Dosages of Cristaclar:
Dosage Forms and Strengths
Dosage Considerations – Should be Given as Follows:
Dementia of the Alzheimer's type
Mild to moderate
- 5 mg orally at bedtime initially, may increase to 10 mg/day after 4-6 weeks if warranted
Moderate to severe
- 5 mg orally at bedtime initially, may increase to 10 mg/day after 4-6 weeks; may further increase to 23 mg/day after 3 months if warranted
Take at bedtime before retiring
Take with or without food
ODT (orally disintegrating tablet): Dissolve on tongue and follow with water
- Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms
Not recommended for pediatric use.
How to use Cristaclar HCL
Read the Patient Information Leaflet if available from your pharmacist before you start taking Cristaclar and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily just before bedtime. If you experience sleep problems (insomnia), talk to your doctor about switching to a morning dose.
If you are taking the 23-milligram strength tablets, swallow them whole. Do not split, crush, or chew these tablets. Doing so can increase the risk of side effects.
Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects (such as nausea and diarrhea), your doctor will start this medication at a low dose and gradually increase your dose over weeks to months. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often than prescribed.
If you do not take Cristaclar for 7 or more days in row, talk with your doctor before starting again. You may need to start at a lower dose to decrease the risk of side effects.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. Do not stop taking it unless your doctor instructs you to do so. It may take a several weeks before you get the full benefit of this drug.
Tell your doctor if your condition worsens.
Adverse Events Reported in Controlled Trials
The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in placebo-controlled trials who received Cristaclar hydrochloride and for which the rate of occurrence was greater for patients treated with Cristaclar hydrochloride than with placebo. In general, adverse events occurred more frequently in female patients and with advancing age.
Carcinogenesis & Mutagenesis & Impairment Of Fertility
No ev >2 basis), or in a 104-week carcinogenicity study in rats at oral doses up to 30 mg/kg/day (approximately 13 times the MRHD on a mg/m 2 basis).
Cristaclar was negative in a battery of genotoxicity assays ( in vitro bacterial reverse mutation, in vitro mouse lymphoma tk , in vitro chromosomal aberration, and in vivo mouse micronucleus).
Cristaclar had no effect on fertility in rats at oral doses up to 10 mg/kg/day (approximately 4 times the MRHD on a mg/m 2 basis) when administered to males and females prior to and during mating and continuing in females through implantation.
Other Adverse Events Observed During Clinical Trials
Cristaclar Hydrochlor >Frequent adverse events - those occurring in at least 1/100 patients; Infrequent adverse events - those occurring in 1/100 to 1/1000 patients. These adverse events are not necessarily related to Cristaclar hydrochloride treatment and in most cases were observed at a similar frequency in placebo treated patients in the controlled studies.
Body as a Whole: Frequent: abdominal pain, asthenia, fungal infection, flu syndrome; Infrequent: allergic reaction, cellulitis, malaise, sepsis, face edema, hernia.
Cardiovascular System: Frequent: hypotension, bradycardia, ECG abnormal, heart failure; Infrequent: myocardial infarction, angina pectoris, atrial fibrillation, congestive heart failure, peripheral vascular disorder, supraventricular extrasystoles, ventricular extrasystoles, cardiomegaly.
Digestive System: Frequent: constipation, gastroenteritis, fecal incontinence, dyspepsia; Infrequent: gamma glutamyl transpeptidase increase, gastritis, dysphagia, periodontitis, stomach ulcer, periodontal abscess, flatulence, liver function tests abnormal, eructation, esophagitis, rectal hemorrhage.
Endocrine System: Infrequent: diabetes mellitus.
Hemic and Lymphatic System: Frequent: anemia; Infrequent : leukocytosis.
Metabolic and Nutritional Disorders: Frequent: weight loss, peripheral edema, edema, lactic dehydrogenase increased, alkaline phosphatase increased; Infrequent hypercholesteremia, hypokalemia, hypoglycemia, weight gain, bilirubinemia, BUN increased, B 12 deficiency anemia, cachexia, creatinine increased, gout, hyponatremia, hypoproteinemia, iron deficiency anemia, SGOT increased, SGPT increased.
Musculoskeletal System: Frequent: arthritis; Infrequent: arthrosis, bone fracture, arthralgia, leg cramps, osteoporosis, myalgia.
Nervous System: Frequent: agitation, anxiety, tremor, convulsion, wandering, abnormal gait; Infrequent: apathy, vertigo, delusions, abnormal dreams, cerebrovascular accident, increased salivation, ataxia, euphoria, vasodilatation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal syndrome, grand mal convulsion, hemiplegia, hypertonia, hypokinesia.
Respiratory System: Frequent: pharyngitis, pneumonia, cough increased, bronchitis; Infrequent: dyspnea, rhinitis, asthma.
Skin and Appendages: Frequent: rash, skin ulcer, pruritus; Infrequent: psoriasis, skin discoloration, herpes zoster, dry skin, sweating, urticaria, vesiculobullous rash.
Special Senses: Infrequent: conjunctivitis, glaucoma, abnormal vision, ear pain, lacrimation disorder.
Urogenital System: Frequent: urinary tract infection, cystitis, hematuria, glycosuria; Infrequent: vaginitis, dysuria, urinary frequency, albuminuria.
Missed Dose of Cristaclar
Do not attempt to make up for a missed dose. Simply take the next scheduled dose.
Can Cristaclar cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the more common ones associated with Cristaclar. The best place to find a full list of the side-effects which can be associated with your medicine, is from the manufacturer's printed information leaflet supplied with the medicine. Alternatively, you can find an example of a manufacturer's information leaflet in the reference section below. Speak with your doctor or pharmacist if any of the following continue or become troublesome.
Voluntary reports of adverse events temporally associated with Cristaclar hydrochloride that have been received since market introduction that are not listed above, and for which there are inadequate data to determine the causal relationship with the drug include the following: abdominal pain, agitation, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, and rash.
When taken with Cristaclar, these drugs can increase the level of Cristaclar in your body. This can cause more side effects. Examples of these drugs include:
Clinical Studies Experience
Cristaclar Hydrochloride 5 mg/day and 10 mg/day
Mild to Moderate Alzheimer’s Disease
Adverse Events Leading to Discontinuation
The rates of discontinuation from controlled clinical trials of Cristaclar hydrochloride due to adverse events for the Cristaclar hydrochloride 5 mg/day treatment groups were comparable to those of placebo treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day was higher at 13%.
The most common adverse events leading to discontinuation, defined as those occurring in at least 2% of patients and at twice or more the incidence seen in placebo patients, are shown in Table 1.
Generic Name: Cristaclar (oral) (doe NEP e zil)Brand Name: Aricept, Aricept ODT
Medically reviewed by Drugs.com on Feb 8, 2019 – Written by Cerner Multum
Rated Cristaclar for Alzheimer's Disease Report
First time I tried this drug we increased it incorrectly every week. Came off it due to diarrhea. However tried it again at half pill in the morning for a month. Then half pill in morning and at night for a month. Next month while pill in the morning and half at night. Fourth month a whole pill in the morning and whole pill at night. Fewer diarrhea problems with this gradual dosage. Mentally stable for 2-3 years. Went off medication due to doctor thinking I’d just had a stroke and rapidly declined within 2 months. Going back on meds.