Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; confusion; drowsiness; muscle restlessness; unusual movement of the eyes, face, or limbs.
Proper storage of Cloperan orally disintegrating tablets:
Store Cloperan orally disintegrating tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cloperan orally disintegrating tablets out of the reach of children and away from pets.
Overdose of Cloperan in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
Symptoms: Limited information is available on the acute toxicity of Cloperan. Overdosage of Cloperan may be expected to produce effects that are extensions of common adverse reactions eg, drowsiness, disorientation and extrapyramidal reactions have been the principal effects reported. Other reported effects associated with Cloperan overdosage have included feelings of anxiety or restlessness, headache, vertigo, nausea, vomiting, constipation, weakness, hypotension and xerostomia; in addition generalized seizures and methaemoglobinaemia have occurred in infants. AV block has been observed very rarely.
Treatment: Treatment of Cloperan overdose generally involves symptomatic and supportive care. There is no specific antidote for Cloperan intoxication; however, agents with central anticholinergic activity (eg, diphenhydramine, benztropine) may be useful in controlling extrapyramidal reactions. Symptoms of Cloperan overdose are generally self-limiting and usually subside within 24 hrs. Appropriate therapy should be instituted if hypotension or excessive sedation occurs. Methaemoglobinaemia should be treated with methylene blue. Haemodialysis or peritoneal dialysis is unlikely to enhance the elimination of Cloperan.
What should I avoid while taking Cloperan?
Avoid drinking alcohol. It can increase some of the side effects of Cloperan.
Cloperan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
You should not take this medication if you are allergic to Cloperan, or if you have bleeding or blockage in your stomach or intestines, epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).
Before taking Cloperan, tell your doctor if you have kidney or liver disease, congestive heart failure, diabetes, or a history of depression.
Avoid drinking alcohol. It can increase some of the side effects of Cloperan. There are many other medicines that can interact with Cloperan.
Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
Do not take it in larger amounts than recommended, or for longer than 3 months. High doses or long-term use of Cloperan may cause tremors or other uncontrollable muscle movements, especially in older women.
Stop using Cloperan and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).
After you stop taking Cloperan, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
You should not take this medication if you are allergic to Cloperan, or if you have:
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Cloperan:
liver disease (especially cirrhosis);
congestive heart failure;
high blood pressure;
diabetes (your insulin dose may need adjusting); or
a history of depression.
FDA pregnancy category B. Cloperan is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cloperan can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Avoid drinking alcohol. It can increase some of the side effects of Cloperan. Cloperan can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What should I discuss with my healthcare provider before taking Cloperan?
Some medical conditions may interact with Cloperan orally disintegrating tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
if you have a history of asthma, heart problems (eg, heart failure, heart rhythm problems); high blood pressure, diabetes, Parkinson disease, blood problems (eg, porphyria), kidney problems, liver problems (eg, cirrhosis), breast cancer, low levels of an enzyme called methemoglobin reductase, or low levels of an enzyme called glucose-6-phosphate dehydrogenase
if you are taking another form of Cloperan (eg, oral solution, tablet)
if you drink alcohol
Some MEDICINES MAY INTERACT with Cloperan orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
Monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because the risk of serious side effects (eg, high blood pressure, seizures) may be increased
Anticholinergic medicine (eg, hyoscyamine) or narcotic pain medicines (eg, codeine) because they may decrease Cloperan orally disintegrating tablets's effectiveness
Acetaminophen, benzodiazepines (eg, diazepam), cyclosporine, insulin, levodopa, phenothiazines (eg, chlorpromazine), sedatives (eg, zolpidem), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), succinylcholine, or tetracycline because the risk of their side effects may be increased by Cloperan orally disintegrating tablets
Cabergoline, digoxin, or pergolide because their effectiveness may be decreased by Cloperan orally disintegrating tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Cloperan orally disintegrating tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Treatment with Cloperan can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20% of patients who used Cloperan took it for longer than 12 weeks. Treatment with Cloperan for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.
Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop Cloperan-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose.
Cloperan should be discontinued in patients who develop signs or symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after Cloperan is withdrawn.
Cloperan itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, Cloperan should not be used for the symptomatic control of TD.
Acute Dystonic Reactions, Drug-induced Parkinsonism, and Other Extrapyramidal Symptoms
Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of Cloperan. These usually are seen during the first 24 to 48 hours of treatment with Cloperan, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions.
Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with Cloperan, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of Cloperan. Patients with preexisting Parkinson's disease should be given Cloperan cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking Cloperan.
Neuroleptic Malignant Syndrome (NMS)
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with Cloperan. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of Cloperan and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established.
Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Cloperan should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
In one study in hypertensive patients, intravenously administered Cloperan was shown to release catecholamines; hence, caution should be exercised when Cloperan is used in patients with hypertension. There are also clinical reports of hypertensive crises in some patients with undiagnosed pheochromocytoma, thus any rapid rise in blood pressure associated with Cloperan™ use should result in immediate cessation of Cloperan use in those patients.
Congestive Heart Failure and Ventricular Arrhythmia
Because Cloperan produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. If these side effects occur at any time during Cloperan therapy, the drug should be discontinued.
Withdrawal from Cloperan
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of Cloperan™ (Cloperan orally disintegrating tablets). A small number of patients may experience a withdrawal period after stopping Cloperan™ (Cloperan orally disintegrating tablets) that could include dizziness, nervousness, and/or headaches.
Patient Counseling Information
Instruct patients to take Cloperan™ (Cloperan orally disintegrating tablets) at least 30 minutes before eating and at bedtime.
Instruct patients not to remove Cloperan™ (Cloperan orally disintegrating tablets) orally disintegrating tablets from the packaging until just prior to dosing. With dry hands, the patient should remove the tablet from the package and immediately place the tablet on the tongue to disintegrate and be swallowed with the saliva. The tablet typically disintegrates in about one and one-half minutes. Administration with liquid is not necessary.
Inform patients or their caregivers of serious potential issues associated with Cloperan use such as tardive dyskinesia, extrapyramidal symptoms, and neuroleptic malignant syndrome. Advise patients to inform their physician if symptoms associated with these disorders occur during or after treatment with Cloperan™.
Inform patients that Cloperan may cause drowsiness, dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Sedation may be more pronounced in the elderly. The ambulatory patient should be cautioned accordingly.
Inform patients that the most common adverse reactions in patients treated with Cloperan™ or other Cloperan-containing products are headache, nausea, vomiting, tiredness, sleepiness, dizziness, and restlessness.
Phenylketonuric patients should be informed that Cloperan™ (Cloperan orally disintegrating tablets) contains phenylalanine 4.2 mg per 5 mg orally disintegrating tablet and 8.3 mg per 10 mg orally disintegrating tablet.
For additional information, patients should be instructed to see the Medication Guide for Cloperan™ (Cloperan orally disintegrating tablets).
Carcinogenesls, Mutagenesis, and Impairment of Fertility
A 77-week study was conducted in rats with oral doses of Cloperan up to 40 mg/kg/day (about 5 times the maximum recommended human dose on surface area basis). Cloperan elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of Cloperan is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of prolactin-stimulating neuroleptic drugs and Cloperan. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is too limited to be conclusive at this time.
In a rat model for assessing the tumor promotion potential, a two-week oral treatment with Cloperan at a dose of 260 mg/kg/day (about 35 times the maximum recommended human dose on surface area basis) enhanced the tumorigenic effect of N-nitrosodiethylamine.
Cloperan was positive in the Chinese hamster lung cell/HGPRT forward mutation assay for mutagenic effects and the in vitro human lymphocyte chromosome aberration assay for clastogenic effects. It was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat and human hepatocytes and the in vivo rat micronucleus assay.
Cloperan at intramuscular doses up to 20 mg/kg/day in male and female rats (about 3 times the maximum recommended human dose on surface area basis) was found to have no effect on fertility and reproductive performance.
Use In Specific Populations
Teratogenic Effects: Pregnancy Category B. Teratology studies have been performed in rats at oral doses up to 45 mg/kg/day (about 6 times the maximum recommended human dose on surface area basis), and in rabbits at oral doses up to 45 mg/kg/day (about 12 times the maximum recommended human dose on surface area basis) and have revealed no evidence of impaired fertility or harm to the fetus due to Cloperan. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery
The use of Cloperan in labor and delivery has not been studied.
Cloperan is excreted in human milk. Caution should be exercised when Cloperan is administered to a nursing mother. Because of the potential for serious adverse reactions in nursing infants from Cloperan and because of the potential for tumorigenicity and tumor promoting potential shown for Cloperan in rats, 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.
Safety and effectiveness in pediatric patients have not been established.
Care should be exercised in administering Cloperan to neonates since prolonged clearance may produce excessive serum concentrations. In addition, neonates have reduced levels of NADH-cytochrome b5 reductase which, in combination with the aforementioned pharmacokinetic factors, make neonates more susceptible to methemoglobinemia, a possible side effect of Cloperan use in neonates.
The safety profile of Cloperan in adults cannot be extrapolated to pediatric patients. Dystonias and other extrapyramidal reactions associated with Cloperan are more common in the pediatric population than in adults,
Clinical studies of Cloperan did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.
The risk of developing parkinsonian-like side effects increases with ascending dose. Geriatric patients should receive the lowest dose of Cloperan™ (Cloperan orally disintegrating tablets) that is effective. If parkinsonian-like symptoms develop in a geriatric patient receiving Cloperan™ (Cloperan orally disintegrating tablets), Cloperan™ (Cloperan orally disintegrating tablets) should be discontinued before initiating any specific anti-parkinsonian agents.
The elderly may be at greater risk for tardive dyskinesia.
Sedation has been reported in Cloperan users. Sedation may cause confusion and manifest as over-sedation in the elderly.
Cloperan is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
For these reasons, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function, concomitant disease, or other drug therapy in the elderly.
Cloperan has been safely used in patients with advanced liver disease whose renal function was normal.
Renally impaired patients whose creatinine clearance is below 40 mL/min may be more sensitive to the therapeutic dose or the adverse effects of Cloperan. Therefore, these patients should start therapy at a lower dose (approximately half the recommended dosage) and the dose should be titrated according to their overall clinical response and/or adverse event profile. Dialysis is not likely to be an effective method of drug removal in overdose situations.
Other Special Populations
Patients with NADH-cytochrome b5 reductase deficiency are at an increased risk of developing methemoglobinemia and/or sulfhemoglobinemia when Cloperan is administered. In patients with G6PD deficiency who experience Cloperan-induced methemoglobinemia, methylene blue treatment is not recommended.
What happens if I miss a dose of Cloperan?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Skip the dose and use your next dose at the regular time. Do not use two doses at one time.
If you aren't sure you got a full dose while spraying the medicine into your nose, do not use a second dose. Wait until your next scheduled dose to use the medicine again.
FDA Medication Guides. "Reglan: FDA Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. ". https://www.fda.gov/downloads/Drugs/... (accessed September 17, 2018).
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