Cloperan Dosage

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Dosage of Cloperan in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Therapy with Cloperan™ (Cloperan orally disintegrating tablets) should not exceed 12 weeks in duration.

Instructions for Use/Handling Cloperan™ (Cloperan orally disintegrating tablets)

Just prior to administration, remove the Cloperan™ (Cloperan orally disintegrating tablets) orally disintegrating tablet from the packaging with dry hands. The tablet should be removed from the package and immediately placed 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.

Symptomatic Gastroesophageal Reflux Disease

For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks.

Administer from 10 mg to 15 mg of Cloperan™ (Cloperan orally disintegrating tablets) orally up to four times daily, 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response. If symptoms occur only intermittently or at specific times of the day, use of Cloperan in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of Cloperan will require only 5 mg per dose.

Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using four times daily therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated. Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

Prolonged treatment ( > 12 weeks) with Cloperan should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia..

Diabetic Gastroparesis (Diabetic Gastric Stasis)

For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

Administer 10 mg of Cloperan™ (Cloperan orally disintegrating tablets) 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of Cloperan™ (Cloperan orally disintegrating tablets) may be initiated. However, if severe symptoms are present, therapy should begin with Cloperan injection (consult labeling of the injection prior to initiating parenteral administration).

Administration of Cloperan injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, Cloperan™ (Cloperan orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.

Patients with Renal Impairment

Since Cloperan is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

How supplied

Dosage Forms And Strengths

Cloperan™ (Cloperan) orally disintegrating tablets contains either 5 mg or 10 mg of Cloperan base (as monohydrochloride monohydrate). The tablets are white, round, flat-faced, and orange flavored.

Cloperan™ (Cloperan) orally disintegrating tablets 5 mg base (as the monohydrochloride monohydrate) are white, round, flat-faced, orange-flavored and engraved "AP" on one side and "152" on the other side. They are supplied as follows:

Bottles of 100..................NDC 68220-152-10

Cloperan™ (Cloperan) orally disintegrating tablets 10 mg base (as the monohydrochloride monohydrate) are white, round, flat-faced, orange-flavored and engraved "AP"on one side and "153" on the other side. They are supplied as follows:

Bottles of 100..................NDC 68220-153-10

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP/NF.

Manufactured for: Alaven Pharmaceuticals LLC., Marietta, GA 30062. www.alavenpharm.com. For Medical Inquiries, call toll-free 1-888-317-0001. Manufactured by: CIMA® LABS INC.

What other drugs will affect Cloperan?

Before using Cloperan, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Cloperan.

Tell your doctor about all other medications you use, especially:

This list is not complete and there are many other drugs that can interact with Cloperan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Cloperan interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Cloperan, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Anticholinergic Agents: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Anti-Parkinson Agents (Dopamine Agonist): Cloperan may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Antipsychotic Agents: Cloperan may enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination

Atovaquone: Cloperan may decrease the serum concentration of Atovaquone. Management: Consider alternatives to Cloperan when possible; atovaquone should only be used with Cloperan if no other antiemetics are available. Consider therapy modification

CycloSPORINE (Systemic): Cloperan may increase the absorption of CycloSPORINE (Systemic). Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Cloperan. Management: Reduce Cloperan dose to 5 mg 4 times daily (30 minutes before each meal and at bedtime) and limit the maximum daily dose to 20 mg if combined with strong CYP2D6 inhibitors. Consider therapy modification

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy

Deutetrabenazine: May enhance the adverse/toxic effect of Cloperan. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy

Droperidol: May enhance the adverse/toxic effect of Cloperan. Avoid combination

Fosfomycin: Gastrointestinal Agents (Prokinetic) may decrease the serum concentration of Fosfomycin. Monitor therapy

Levosulpiride: Benzamide Derivatives may enhance the adverse/toxic effect of Levosulpiride. Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy

MetyroSINE: May enhance the adverse/toxic effect of Cloperan. Management: Seek alternatives to this combination when possible. Monitor patients receiving Cloperan with metyrosine for development of extrapyramidal symptoms. Consider therapy modification

Monoamine Oxidase Inhibitors: Cloperan may enhance the hypertensive effect of Monoamine Oxidase Inhibitors. Avoid combination

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy

Opioid Agonists: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Posaconazole: Cloperan may decrease the serum concentration of Posaconazole. Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Monitor therapy

Promethazine: Cloperan may enhance the adverse/toxic effect of Promethazine. Avoid combination

Quinagolide: Cloperan may diminish the therapeutic effect of Quinagolide. Monitor therapy

Rivastigmine: May enhance the adverse/toxic effect of Cloperan. Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Avoid combination

Selective Serotonin Reuptake Inhibitors: Cloperan may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Cloperan with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Serotonin/Norepinephrine Reuptake Inhibitors: Cloperan may enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Cloperan with serotonin/norepinephrine reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy

Tacrolimus (Systemic): Cloperan may increase the serum concentration of Tacrolimus (Systemic). Specifically, treatment of gastroparesis may increase tacrolimus concentrations. Monitor therapy

Tetrabenazine: Cloperan may enhance the adverse/toxic effect of Tetrabenazine. Avoid combination

Thiopental: Cloperan may enhance the therapeutic effect of Thiopental. Management: Consider thiopental dose reduction when used concomitantly with Cloperan. Monitor patient response to treatment closely if using this combination. Consider therapy modification

Tricyclic Antidepressants: Cloperan may enhance the adverse/toxic effect of Tricyclic Antidepressants. Management: Seek alternatives to this combination when possible. Monitor patients receiving Cloperan with tricyclic antidepressants for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

Trimetazidine: Cloperan may enhance the adverse/toxic effect of Trimetazidine. Specifically, the risk of extrapyramidal symptoms may be enhanced. Avoid combination


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References

  1. FDA/SPL Indexing Data. "L4YEB44I46: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  2. MeSH. "Antiemetics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Metoclopramide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Cloperan are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Cloperan. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported frequency of use

No survey data has been collected yet


5 consumers reported doses

What doses of Cloperan drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Cloperan drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Users%
6-10mg5
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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