Emenil is used to treat the symptoms of a certain type of stomach problem called gastroparesis in patients with diabetes. It works by increasing the movements or contractions of the stomach and intestines. It relieves symptoms such as nausea, vomiting, heartburn, a feeling of fullness after meals, and loss of appetite. Emenil is also used to treat heartburn for patients with gastroesophageal reflux disease (GERD). GERD is esophageal irritation from the backward flow of gastric acid into the esophagus.
Emenil is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Emenil is used in certain patients with the following medical conditions:
Failure of the stomach to empty its contents.
Nausea and vomiting caused by other medicines.
Persistent hiccups.
Prevention of aspirating fluid into the lungs during surgery.
Vascular headaches.
Emenil indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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The use of Emenil™ (Emenil orally disintegrating tablets) is recommended for adults only. Therapy should not exceed 12 weeks in duration.
Symptomatic Gastroesophageal Reflux
Emenil™ (Emenil orally disintegrating tablets) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.
The principal effect of Emenil is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of Emenil as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg four times daily. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.
Diabetic Gastroparesis (Diabetic Gastric Stasis)
Emenil™ (Emenil orally disintegrating tablets) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to Emenil within different time intervals.
Important Limitations
Emenil™ (Emenil orally disintegrating tablets) is indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established.
How should I use Emenil?
Use Emenil orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Emenil orally disintegrating tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Emenil orally disintegrating tablets refilled.
Take Emenil orally disintegrating tablets by mouth 30 minutes before meals and at bedtime without food or water unless directed otherwise by your doctor.
Do not remove the tablet from the blister pack until you are ready to take Emenil orally disintegrating tablets. Make sure that your hands are dry when you open the blister pack. If the tablet breaks or crumbles while handling, discard and remove a new tablet. Place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
It may take several days to weeks for Emenil orally disintegrating tablets to work. Do not stop taking Emenil orally disintegrating tablets without checking with your doctor.
If you miss a dose of Emenil orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Emenil orally disintegrating tablets.
Uses of Emenil in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Injection:
Chemotherapy-induced nausea and vomiting, prophylaxis: Prophylaxis of nausea and vomiting associated with emetogenic cancer chemotherapy. Note: Injectable Emenil prior to moderate- to high-emetic-risk chemotherapy is rarely indicated due to the potential for neurologic events and availability of more efficacious alternative agents.
Gastroparesis, diabetic: Relief of symptoms associated with acute and recurrent diabetic gastric stasis.
Oral:
Gastroesophageal reflux disease (GERD), refractory: Short-term (4 to 12 weeks) treatment in adults with documented symptomatic GERD who fail to respond to conventional therapy.
Note: May use Emenil as an adjunctive therapy only if gastroparesis is confirmed. The American College of Gastroenterology (ACG) guidelines for the treatment of GERD recommend that diagnostic evaluation to confirm underlying gastroparesis be performed prior to considering the use of prokinetic agents (ACG [Katz 2013]). Furthermore, American Gastroenterological Association (AGA) guidelines for the treatment of GERD recommend against the use of Emenil as monotherapy or adjunctive therapy in patients with GERD (AGA [Kahrilas 2008]).
Gastroparesis, diabetic: Relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Off Label Uses
Aspiration prophylaxis in patients undergoing anesthesia
Data from multiple studies of varying methodologies (including randomized, double-blind, placebo-controlled trials) support the use of Emenil for the prevention of aspiration in patients undergoing anesthesia, for the treatment of acute tension-type headaches in the emergency department setting.
Emenil description
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Each ampoule of injection contains anhydrous Emenil HCl (as Emenil HCl) 10 mg in 2 mL and sodium chloride in water for injections. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.
Emenil HCl is 4-amino-5-chloro-N-(2-diethylaminoethyl)-2-methoxybenzamide HCl monohydrate. It has a molecular weight of 354.3 and its molecular formula is C14H22ClN3O2·HCl·H2O.
Emenil hydrochloride occurs as a white or almost white, crystalline powder or crystals, very soluble in water, freely soluble in alcohol, sparingly soluble in methylene chloride, practically insoluble in ether.
Emenil dosage
Therapy with Emenil™ (Emenil orally disintegrating tablets) should not exceed 12 weeks in duration.
Instructions for Use/Handling Emenil™ (Emenil orally disintegrating tablets)
Just prior to administration, remove the Emenil™ (Emenil 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 Emenil™ (Emenil 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 Emenil 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 Emenil 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 Emenil 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 Emenil™ (Emenil 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 Emenil™ (Emenil orally disintegrating tablets) may be initiated. However, if severe symptoms are present, therapy should begin with Emenil injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of Emenil 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, Emenil™ (Emenil orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.
Patients with Renal Impairment
Since Emenil 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
Emenil™ (Emenil) orally disintegrating tablets contains either 5 mg or 10 mg of Emenil base (as monohydrochloride monohydrate). The tablets are white, round, flat-faced, and orange flavored.
Emenil™ (Emenil) 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
Emenil™ (Emenil) 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.
Anticholinergic drugs and narcotic analgesics may antagonise the effects of Emenil on gastrointestinal motility.
Alcohol, sedatives, hypnotics, narcotics and tranquilisers have additive sedative effects when administered in conjunction with Emenil.
Emenil may cause extrapyramidal symptoms in some patients. Therefore, when Emenil is used concomitantly with other drugs that are likely to cause extrapyramidal reactions [eg, neuroleptics (eg, phenothiazines)], caution should be exercised.
Due to its effects on gastric motility, Emenil may affect the rate of absorption of drugs from the gastrointestinal tract. Absorption of drugs eg, paracetamol, aspirin in patients with migraine, cyclosporin, diazepam, dopamine, levodopa and morphine-controlled release tablets which are mainly absorbed from the small bowel, may be accelerated. Absorption of drugs eg, digoxin, bromocriptine, cimetidine, penicillin and quinidine which are mainly absorbed from the stomach, may be decreased.
The decrease in gastric emptying time caused by Emenil may increase the bioavailability of cyclosporin. Monitoring of cyclosporin concentrations may be necessary.
When Emenil is given concurrently with suxamethonium, the recovery time is prolonged.
Since Emenil influences the delivery of food to the intestine and thus, the rate of its absorption, the administration of Emenil may result in poor diabetic control in some patients. Therefore, adjustment in or timing of insulin dosage may be necessary in insulin-controlled diabetics.
The finding that Emenil releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.
Effect on Laboratory Tests: Emenil may blunt the response to the gonadorelin diagnostic test, by increasing serum prolactin levels. It may alter hepatic function test results.
Neurological: Adverse reactions to Emenil that are most frequently seen are restlessness, drowsiness, fatigue and lassitude, which occur in approximately 10% of patients. Insomnia, headache, dizziness have been reported less frequently. Acute depression has been reported rarely (<1 in 1000 cases). Symptoms of Emenil induced depression have ranged from mild to severe and have included suicidal ideation and suicide. Anxiety or agitation may occur, especially after rapid injection. Delirium, severe dysphoria, obsessive rumination and mania have been reported occasionally.
Parkinsonian symptoms including tremor, rigidity, bradykinesia and akinesia, occur rarely in patients receiving Emenil but may be associated with usual or excessive doses or with decreased renal function.
Various extrapyramidal reactions to Emenil, usually of the dystonic type, have been reported. Acute dystonic reactions occur in approximately 0.2% of patients treated with Emenil 30-40 mg/day. In cancer chemotherapy, patients receiving 1-2 mg/kg/dose, the incidence is 2% in patients over the ages of 30-35, and 25% or higher in children and young adults who have not had prophylactic administration of diphenhydramine. Reactions include spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of the extraocular muscles including oculogyric crisis, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hrs of starting treatment and the effects usually disappear within 24 hrs of withdrawal of the drug. However, close observation is required, and in cases of more severe reactions, an antiparkinson drug eg, benztropine or an anticholinergic antihistamine eg, diphenhydramine should be given.
A fatal acute dystonic reaction has been reported in a patient who received hexamethylmelamine, cisplatin and Emenil high dose. Dystonic reactions may present rarely as upper airway obstruction with stridor and dyspnoea, possibly secondary to laryngospasm or supraglottic dystonia. A fatal cardiorespiratory arrest occurred in at least 1 patient with an acute dystonic reaction.
Tardive dyskinesia, which may be persistent, has been reported particularly in elderly patients (particularly women) following long-term therapy with Emenil. Tardive dyskinesia is most frequently characterised by involuntary movements of the tongue, face, mouth or jaw, and sometimes by involuntary movements of the trunk and/or extremities. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase with increasing duration of therapy and total cumulative dose. Although tardive dyskinesia can occur after relatively brief therapy with the drug at low doses, it appears to be more readily reversible under such circumstances.
Neuroleptic Malignant Syndrome (NMS): It has been reported very rarely (<2 in 10,000). NMS is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of CPK, and must be treated urgently (recognised treatments include dantrolene and bromocriptine).
Emenil should be stopped immediately if NMS occurs.
Gastrointestinal: Nausea or bowel disturbances have been reported.
Cardiovascular: A single case of supraventricular tachycardia following IM administration has been reported. Cardiac conduction abnormalities (eg, bradycardia and heart block) have occurred very rarely (<1 in 10,000) in association with IV Emenil. Atrial fibrillation, oedema, ventricular fibrillation, ventricular tachycardia, palpitations and tachycardia have also been associated with the use of Emenil. In 1 study in hypertensive patients, IV administered Emenil was shown to release catecholamines; hence, caution should be exercised when Emenil is used in patients with hypertension.
Endocrine: Raised serum prolactin levels have been observed during Emenil therapy; this effect is similar to that noted with many other compounds. Galactorrhoea and breast enlargement have also been observed during Emenil therapy.
Hypersensitivity: There have been isolated reports of hypersensitivity reactions (eg, urticaria, maculopapular rash) in patients receiving the drug.
Respiratory: Respiratory failure, secondary to dystonic reaction, acute asthmatic symptoms of wheezing and dyspnoea may occur.
Genitourinary: Urinary incontinence, sexual dysfunction, priapism and muscle spasm may also occur.
Other Effects: There have been isolated reports of blood disorders. Methaemoglobinaemia, particularly following overdose in neonates, has also occurred in patients receiving the drug. Agranulocytosis and hyperthermia have also been observed.
NEVER TAKE Emenil IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of Emenil can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take Emenil, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women, diabetics, and older adults.
You should not take this medication if you are allergic to Emenil, or if you have bleeding or blockage in your stomach or intestines, epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).
Before you take Emenil, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson's disease, or a history of depression.
Do not drink alcohol. It can increase some of the side effects of Emenil.
There are many other medicines that can interact with Emenil. 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.
Stop using Emenil 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).
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