Primperan Uses

• Primperan indications
• Uses of Primperan in details
• Primperan description
• Primperan dosage
• Primperan interactions
• Primperan side effects
• Primperan contraindications

What is Primperan?

Primperan 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. Primperan 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.

Primperan 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, Primperan 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.

Primperan indications

The use of Primperan™ (Primperan) is recommended for adults only. Therapy should not exceed 12 weeks in duration.

Symptomatic Gastroesophageal Reflux

Primperan™ (Primperan) 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 Primperan 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 Primperan 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)

Primperan™ (Primperan) 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 Primperan within different time intervals.

Important Limitations

Primperan™ (Primperan) 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 Primperan?

Use Primperan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Primperan comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Primperan refilled.
• Take Primperan 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 Primperan. 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 Primperan to work. Do not stop taking Primperan without checking with your doctor.
• If you miss a dose of Primperan, 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 Primperan.

Uses of Primperan in details

Use: Labeled Indications

Injection:

Chemotherapy-induced nausea and vomiting, prophylaxis: Prophylaxis of nausea and vomiting associated with emetogenic cancer chemotherapy. Note: Injectable Primperan 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 Primperan 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 Primperan 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 Primperan for the prevention of aspiration in patients undergoing anesthesia, for the treatment of acute tension-type headaches in the emergency department setting.

Primperan description

Each ampoule of injection contains anhydrous Primperan HCl (as Primperan 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.

Primperan 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.

Primperan 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.

Primperan dosage

Therapy with Primperan™ (Primperan) should not exceed 12 weeks in duration.

Instructions for Use/Handling Primperan™ (Primperan)

Just prior to administration, remove the Primperan™ (Primperan) 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 Primperan™ (Primperan) 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 Primperan 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 Primperan 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 Primperan 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 Primperan™ (Primperan) 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 Primperan™ (Primperan) may be initiated. However, if severe symptoms are present, therapy should begin with Primperan injection (consult labeling of the injection prior to initiating parenteral administration).

Administration of Primperan 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, Primperan™ (Primperan) therapy should be reinstituted at the earliest manifestation.

Patients with Renal Impairment

Since Primperan 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

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

Primperan™ (Primperan) 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

Primperan™ (Primperan) 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.

Primperan interactions

See also:
What other drugs will affect Primperan?

Anticholinergic drugs and narcotic analgesics may antagonise the effects of Primperan on gastrointestinal motility.

Alcohol, sedatives, hypnotics, narcotics and tranquilisers have additive sedative effects when administered in conjunction with Primperan.

Primperan may cause extrapyramidal symptoms in some patients. Therefore, when Primperan 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, Primperan 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 Primperan may increase the bioavailability of cyclosporin. Monitoring of cyclosporin concentrations may be necessary.

When Primperan is given concurrently with suxamethonium, the recovery time is prolonged.

Since Primperan influences the delivery of food to the intestine and thus, the rate of its absorption, the administration of Primperan 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 Primperan 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: Primperan may blunt the response to the gonadorelin diagnostic test, by increasing serum prolactin levels. It may alter hepatic function test results.

Primperan side effects

See also:
What are the possible side effects of Primperan?

Neurological: Adverse reactions to Primperan 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 Primperan 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 Primperan but may be associated with usual or excessive doses or with decreased renal function.

Various extrapyramidal reactions to Primperan, usually of the dystonic type, have been reported. Acute dystonic reactions occur in approximately 0.2% of patients treated with Primperan 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 Primperan 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 Primperan. 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).

Primperan 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 Primperan. Atrial fibrillation, oedema, ventricular fibrillation, ventricular tachycardia, palpitations and tachycardia have also been associated with the use of Primperan. In 1 study in hypertensive patients, IV administered Primperan was shown to release catecholamines; hence, caution should be exercised when Primperan is used in patients with hypertension.

Endocrine: Raised serum prolactin levels have been observed during Primperan therapy; this effect is similar to that noted with many other compounds. Galactorrhoea and breast enlargement have also been observed during Primperan 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.

Primperan contraindications

See also:
What is the most important information I should know about Primperan?

NEVER TAKE Primperan IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of Primperan 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 Primperan, 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 Primperan, 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 Primperan, 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 Primperan.

There are many other medicines that can interact with Primperan. 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 Primperan 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).

Active ingredient matches for Primperan:

Metoclopramide in Belgium, Denmark, Ecuador, Finland, Greece, Hong Kong, Iceland, Indonesia, Japan, Luxembourg, Malaysia, Netherlands, Oman, Peru, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Vietnam.

Metoclopramide HCl in Malaysia.

Metoclopramide hydrochloride in United Kingdom, Ireland.

Metoclopramide or metoclopramide hydrochloride in Netherlands, Sweden, Switzerland, Norway, Denmark, Hong Kong, Mexico.

References

1. PubChem. "metoclopramide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "metoclopramide". http://www.drugbank.ca/drugs/DB01233 (accessed September 17, 2018).
3. MeSH. "Antiemetics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology