Klometol Uses

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

What is Klometol?

Klometol 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. Klometol 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.

Klometol 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, Klometol 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.

Klometol indications

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

Symptomatic Gastroesophageal Reflux

Klometol™ (Klometol 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 Klometol 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 Klometol 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)

Klometol™ (Klometol 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 Klometol within different time intervals.

Important Limitations

Klometol™ (Klometol 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 Klometol?

Use Klometol orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

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

Uses of Klometol in details

Use: Labeled Indications

Injection:

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

Klometol description

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

Klometol 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.

Klometol 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.

Klometol dosage

Therapy with Klometol™ (Klometol orally disintegrating tablets) should not exceed 12 weeks in duration.

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

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

Administration of Klometol 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, Klometol™ (Klometol orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.

Patients with Renal Impairment

Since Klometol 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

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

Klometol™ (Klometol) 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

Klometol™ (Klometol) 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.

Klometol interactions

See also:
What other drugs will affect Klometol?

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

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

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

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

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

Klometol side effects

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

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

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

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

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

Klometol contraindications

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

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

There are many other medicines that can interact with Klometol. 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 Klometol 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 Klometol:

Metoclopramide in Bosnia & Herzegowina, Serbia.

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