Clopromate 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. Clopromate 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.
Clopromate 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, Clopromate 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.
Prevention of aspirating fluid into the lungs during surgery.
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.
The use of Clopromate™ (Clopromate orally disintegrating tablets) is recommended for adults only. Therapy should not exceed 12 weeks in duration.
Symptomatic Gastroesophageal Reflux
Clopromate™ (Clopromate 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 Clopromate 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 Clopromate 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)
Clopromate™ (Clopromate 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 Clopromate within different time intervals.
Clopromate™ (Clopromate 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 Clopromate?
Use Clopromate orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Clopromate orally disintegrating tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Clopromate orally disintegrating tablets refilled.
Take Clopromate 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 Clopromate 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 Clopromate orally disintegrating tablets to work. Do not stop taking Clopromate orally disintegrating tablets without checking with your doctor.
If you miss a dose of Clopromate 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 Clopromate orally disintegrating tablets.
Uses of Clopromate 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.
This medication is used to treat certain conditions of the stomach and intestines. Clopromate is used as a short-term treatment (4 to 12 weeks) for persistent heartburn when the usual medicines do not work well enough. It is used mostly for heartburn that occurs after a meal or during the daytime. Treating persistent heartburn can decrease the damage done by stomach acid to the swallowing tube (esophagus) and help healing.
Clopromate is also used in diabetic patients who have poor emptying of their stomachs (gastroparesis). Treating gastroparesis can decrease symptoms of nausea, vomiting, and stomach/abdominal fullness. Clopromate works by blocking a natural substance (dopamine). It speeds up stomach emptying and movement of the upper intestines.
This drug is not recommended for use in children younger than 1 year due to an increased risk of serious side effects (such as muscle spasms/uncontrolled muscle movements). Ask the doctor or pharmacist for details.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to prevent nausea/vomiting from chemotherapy or radiation treatments for cancer.
How to use Clopromate
Read the Medication Guide provided by your pharmacist before you start taking Clopromate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth 30 minutes before meals and at bedtime, usually 4 times daily or exactly as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
If you are using the disintegrating tablet, do not remove the tablet from the blister pack until right before your dose. Dry your hands before using this medication. Do not use the tablet if it is broken or crumbled. Immediately after removing the tablet, place it on the tongue. Allow it to dissolve completely, then swallow it with saliva. You do not need to take this product with water.
Dosage is based on your weight, medical condition, and response to treatment. If heartburn only occurs at certain times (such as after the evening meal), your doctor may direct you to take a single dose before those times instead of taking it throughout the day. This will reduce your risk of side effects.
Because of the risk of tardive dyskinesia, do not take this more often, in larger doses, or for longer than directed by your doctor. According to the manufacturer, treatment should not exceed 12 weeks.
To treat diabetic gastroparesis, this medication is usually taken for 2 to 8 weeks until your gut is working well. This condition may recur from time to time. Your doctor may direct you to start taking this medication as soon as your symptoms reappear and stop when you feel better. Ask your doctor for directions for starting and stopping this medication.
Take this medication regularly as directed to get the most benefit from it. To help you remember, take it at the same times before a meal each day.
If this medication has been used regularly for a long time or in high doses, withdrawal symptoms (such as dizziness, nervousness, headaches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Tell your doctor if your condition persists or worsens.
Each ampoule of injection contains anhydrous Clopromate HCl (as Clopromate 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.
Clopromate 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.
Clopromate 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.
Therapy with Clopromate™ (Clopromate orally disintegrating tablets) should not exceed 12 weeks in duration.
Instructions for Use/Handling Clopromate™ (Clopromate orally disintegrating tablets)
Just prior to administration, remove the Clopromate™ (Clopromate 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 Clopromate™ (Clopromate 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 Clopromate 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 Clopromate 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 Clopromate 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 Clopromate™ (Clopromate 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 Clopromate™ (Clopromate orally disintegrating tablets) may be initiated. However, if severe symptoms are present, therapy should begin with Clopromate injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of Clopromate 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, Clopromate™ (Clopromate orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.
Patients with Renal Impairment
Since Clopromate 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.
Dosage Forms And Strengths
Clopromate™ (Clopromate) orally disintegrating tablets contains either 5 mg or 10 mg of Clopromate base (as monohydrochloride monohydrate). The tablets are white, round, flat-faced, and orange flavored.
Clopromate™ (Clopromate) 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
Clopromate™ (Clopromate) 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 Agents: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Anti-Parkinson Agents (Dopamine Agonist): Clopromate may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy
Antipsychotic Agents: Clopromate may enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination
Atovaquone: Clopromate may decrease the serum concentration of Atovaquone. Management: Consider alternatives to Clopromate when possible; atovaquone should only be used with Clopromate if no other antiemetics are available. Consider therapy modification
CycloSPORINE (Systemic): Clopromate may increase the absorption of CycloSPORINE (Systemic). Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Clopromate. Management: Reduce Clopromate 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 Clopromate. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy
Droperidol: May enhance the adverse/toxic effect of Clopromate. 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 Clopromate. Management: Seek alternatives to this combination when possible. Monitor patients receiving Clopromate with metyrosine for development of extrapyramidal symptoms. Consider therapy modification
Monoamine Oxidase Inhibitors: Clopromate 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: Clopromate 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: Clopromate may enhance the adverse/toxic effect of Promethazine. Avoid combination
Quinagolide: Clopromate may diminish the therapeutic effect of Quinagolide. Monitor therapy
Rivastigmine: May enhance the adverse/toxic effect of Clopromate. Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Avoid combination
Selective Serotonin Reuptake Inhibitors: Clopromate may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Clopromate with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Serotonin/Norepinephrine Reuptake Inhibitors: Clopromate may enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Clopromate 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): Clopromate may increase the serum concentration of Tacrolimus (Systemic). Specifically, treatment of gastroparesis may increase tacrolimus concentrations. Monitor therapy
Tetrabenazine: Clopromate may enhance the adverse/toxic effect of Tetrabenazine. Avoid combination
Thiopental: Clopromate may enhance the therapeutic effect of Thiopental. Management: Consider thiopental dose reduction when used concomitantly with Clopromate. Monitor patient response to treatment closely if using this combination. Consider therapy modification
Tricyclic Antidepressants: Clopromate may enhance the adverse/toxic effect of Tricyclic Antidepressants. Management: Seek alternatives to this combination when possible. Monitor patients receiving Clopromate with tricyclic antidepressants for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Trimetazidine: Clopromate may enhance the adverse/toxic effect of Trimetazidine. Specifically, the risk of extrapyramidal symptoms may be enhanced. Avoid combination
Neurological: Adverse reactions to Clopromate 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 Clopromate 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 Clopromate but may be associated with usual or excessive doses or with decreased renal function.
Various extrapyramidal reactions to Clopromate, usually of the dystonic type, have been reported. Acute dystonic reactions occur in approximately 0.2% of patients treated with Clopromate 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 Clopromate 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 Clopromate. 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).
Clopromate 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 Clopromate. Atrial fibrillation, oedema, ventricular fibrillation, ventricular tachycardia, palpitations and tachycardia have also been associated with the use of Clopromate. In 1 study in hypertensive patients, IV administered Clopromate was shown to release catecholamines; hence, caution should be exercised when Clopromate is used in patients with hypertension.
Endocrine: Raised serum prolactin levels have been observed during Clopromate therapy; this effect is similar to that noted with many other compounds. Galactorrhoea and breast enlargement have also been observed during Clopromate 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 Clopromate IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of Clopromate 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 Clopromate, 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 Clopromate, 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 Clopromate, 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 Clopromate.
There are many other medicines that can interact with Clopromate. 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 Clopromate 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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