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Emelit Dosage |
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Therapy with Emelit™ (Emelit orally disintegrating tablets) should not exceed 12 weeks in duration.
Just prior to administration, remove the Emelit™ (Emelit 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.
For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks.
Administer from 10 mg to 15 mg of Emelit™ (Emelit 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 Emelit 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 Emelit 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 Emelit should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia..
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 Emelit™ (Emelit 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 Emelit™ (Emelit orally disintegrating tablets) may be initiated. However, if severe symptoms are present, therapy should begin with Emelit injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of Emelit 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, Emelit™ (Emelit orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.
Since Emelit 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.
Emelit™ (Emelit) orally disintegrating tablets contains either 5 mg or 10 mg of Emelit base (as monohydrochloride monohydrate). The tablets are white, round, flat-faced, and orange flavored.
Emelit™ (Emelit) 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
Emelit™ (Emelit) 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
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.
Before using Emelit, 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 Emelit.
Tell your doctor about all other medications you use, especially:
acetaminophen (Tylenol);
cyclosporine (Gengraf, Neoral, Sandimmune);
digoxin (digitalis, Lanoxin);
glycopyrrolate (Robinul);
insulin;
levodopa (Larodopa, Atamet, Parcopa, Sinemet);
mepenzolate (Cantil);
tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
blood pressure medications;
bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), or propantheline (Pro-Banthine);
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), haloperidol (Haldol), olanzapine (Zyprexa, Symbyax), prochlorperazine (Compazine), risperidone (Risperdal), thiothixene (Navane), and others.
This list is not complete and there are many other drugs that can interact with Emelit. 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.
Anticholinergic Agents: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Anti-Parkinson Agents (Dopamine Agonist): Emelit may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy
Antipsychotic Agents: Emelit may enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination
Atovaquone: Emelit may decrease the serum concentration of Atovaquone. Management: Consider alternatives to Emelit when possible; atovaquone should only be used with Emelit if no other antiemetics are available. Consider therapy modification
CycloSPORINE (Systemic): Emelit may increase the absorption of CycloSPORINE (Systemic). Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Emelit. Management: Reduce Emelit 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 Emelit. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy
Droperidol: May enhance the adverse/toxic effect of Emelit. 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 Emelit. Management: Seek alternatives to this combination when possible. Monitor patients receiving Emelit with metyrosine for development of extrapyramidal symptoms. Consider therapy modification
Monoamine Oxidase Inhibitors: Emelit 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: Emelit 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: Emelit may enhance the adverse/toxic effect of Promethazine. Avoid combination
Quinagolide: Emelit may diminish the therapeutic effect of Quinagolide. Monitor therapy
Rivastigmine: May enhance the adverse/toxic effect of Emelit. Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Avoid combination
Selective Serotonin Reuptake Inhibitors: Emelit may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Emelit with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Serotonin/Norepinephrine Reuptake Inhibitors: Emelit may enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Emelit 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): Emelit may increase the serum concentration of Tacrolimus (Systemic). Specifically, treatment of gastroparesis may increase tacrolimus concentrations. Monitor therapy
Tetrabenazine: Emelit may enhance the adverse/toxic effect of Tetrabenazine. Avoid combination
Thiopental: Emelit may enhance the therapeutic effect of Thiopental. Management: Consider thiopental dose reduction when used concomitantly with Emelit. Monitor patient response to treatment closely if using this combination. Consider therapy modification
Tricyclic Antidepressants: Emelit may enhance the adverse/toxic effect of Tricyclic Antidepressants. Management: Seek alternatives to this combination when possible. Monitor patients receiving Emelit with tricyclic antidepressants for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Trimetazidine: Emelit may enhance the adverse/toxic effect of Trimetazidine. Specifically, the risk of extrapyramidal symptoms may be enhanced. Avoid combination
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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