Nofoklam tablets

Nofoklam

  • Active Ingredient: Metoclopramide
  • 10 mg
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What is Nofoklam?

The active ingredient of Nofoklam brand is metoclopramide. Metoclopramide increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines.

Used for

Nofoklam is used to treat diseases such as: Gastroparesis, GERD, Lactation Augmentation, Migraine, Nausea/Vomiting, Nausea/Vomiting, Chemotherapy Induced, Nausea/Vomiting, Postoperative, Radiographic Exam, Small Intestine Intubation.

Side Effect

Possible side effects of Nofoklam include: difficulty with breathing; unusual dryness of the mouth; passing urine more often; drowsiness; shuffling walk; twisting movements of the body.

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Indications

Nofoklam has been approved by the FDA specifically to treat nausea and vomiting in patients with gastroesophageal reflux disease or diabetic gastroparesis by increasing gastric motility,,. It is also used to control nausea and vomiting in chemotherapy patients. Additionally, Nofoklam can be administered prophylactically to prevent nausea and vomiting in postoperative patients when nasogastric suction is contraindicated or unavailable and has shown surprising success in treating migraines; however, the FDA has not explicitly approved it for these other conditions,. It is particularly useful in this role because it does not cause any concomitant increase in gastric secretions. Nofoklam can also be used to treat hyperemesis gravidarum in pregnant patients, though it should be used cautiously because of the lack of studies on the effects of the drug in pregnant women,. Recent studies have also shown evidence of Nofoklam’s efficacy in treating Diamond Blackfan Syndrome. Nofoklam has also been efficacious in the treatment of nausea in advanced liver disease.

Inactive Ingredients

Corn starch, D&C Yellow 10 Aluminum Lake, FD&C Blue 1 Aluminum Lake, Lactose, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid.

Nofoklam hydrochloride is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N--2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C14H22ClN3O2 • HCl • H2O. Its molecular weight is 354.3.

What are the side effects of Nofoklam?

Nofoklam is generally well-tolerated when used in low doses for brief periods. Neurological side effects increase with higher doses and longer periods of treatment. Common side effects of Nofoklam are:

Other important side effects of Nofoklam include serious neurological symptoms that mimic Parkinson's disease such as:

  • involuntary muscle movements,
  • facial grimacing, and
  • dystonic reactions resembling tetanus.

Fortunately, these more serious side effects are infrequent and usually - though not always - disappear when Nofoklam is discontinued. Patients with Parkinson's disease can experience worsening of symptoms with Nofoklam. Nofoklam may impair the mental and/or physical abilities to drive or operate machinery.

Pharmacokinetics

Nofoklam is well absorbed from the gastrointestinal tract in humans and dogs. In humans, bio-availability can be reduced by up to 30% in some patients as a result of first-pass metabolism; this effect is quite variable among individuals. One study suggested that similarly, in dogs, the liver plays an active role in reducing the systemic availability of Nofoklam after oral administration. In a study of two greyhounds, bioavailability of Nofoklam after oral administration was about 48%. Bioavailability after intramuscular injection in humans is 74–96%.

The plasma half-life of Nofoklam in the dog is approximately 90 min. In contrast to humans, in whom glucuronidation and sulfate conjugation are the major metabolic pathways, N-demethylation is more important for Nofoklam metabolism in dogs.

Hepatic

Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when Nofoklam was administered with other drugs with known hepatotoxic potential.

Metoclopram > Nofoklam is a substituted benzamide that promotes gastric motility and reduces the emetic activity of chemotherapy agents by blocking dopamine receptors (at low-to-moderate doses) and 5-HT3 receptors (at high doses) in the chemoreceptor trigger zone. Because of a more favorable side effect profile, 5-HT3 antagonists have replaced high-dose Nofoklam. At lower doses (5–10 mg orally or intravenously every 6 hours) Nofoklam is useful in treating mild-to-moderate and delayed nausea and vomiting. Delivery of the drug on a schedule that maintains adequate levels during expected emesis appears to be important.

The side effects, which may be caused by the interaction of Nofoklam with dopamine receptors, can be quite troublesome. They include akathisia, dystonic reactions (age related), sedation, and diarrhea. Benzodiazepines such as lorazepam and β-blockers such as propranolol can prevent or reverse the akathisia, and diphenhydramine or benztropine can prevent or reverse the dystonias. However, these agents induce additional side effects, including dry mouth and sedation. Short-term, high-dose Nofoklam or long-term use at usual doses has been associated with persistent and disabling movement disorders, especially tardive dyskinesias.

What is the most important information I should know about Nofoklam:

Nofoklam is a prescription medication that is not FDA approved for use in veterinary medicine; however, it is a commonly accepted practice for veterinarians to use this medication in dogs and cats. Nofoklam is available as 5mg and 10mg scored tablets. The usual dose for dogs and cats is 0.1-0.2mg/pound every 6-8 hours. Always follow the dosage instructions provided by your veterinarian. Nofoklam is not for use in animals allergic to it. Call your veterinarian immediately if your pet exhibits uncontrollable movements or muscle spasms of the legs, lips, jaw, tongue, face or other body part, agitation, jitteriness, shortness of breath or insomnia. Nofoklam may cause drowsiness.

Metoclopram > Nofoklam , a procainamide derivative and a benzamide prokinetic agent, is the most commonly used D 2-receptor antagonist for antiemetic prophylaxis, primarily for PONV and chemotherapy associated with low emetogenic risk. It is assumed that both the central D2-receptor antagonist activity at the CTZ and vomiting center and peripheral activity in the GI tract contribute to the antiemetic effect. Nofoklam acts on peripheral D2, muscarinic, and 5-HT4 receptors to induce prokinetic activity. Opioids can cause delayed gastric emptying, but Nofoklam enhances gastric motility and increases intestinal peristalsis, which reduces reflux of stomach contents and the urge to vomit. Because of its short half-life of 5 to 6 hours, Nofoklam is likely to have greatest efficacy if administered at the end of surgery.

Nofoklam was first prescribed for CINV in high doses (e.g., 200 mg every 4–6 hours), which cause extrapyramidal symptoms in more than 10% of patients. 29 To reduce the incidence of adverse effects, Nofoklam is available in vials of just 10 mg. However, extensive studies and a meta-analysis have demonstrated that 10 mg Nofoklam has no clinically relevant antiemetic effect. 30 In fact, a large and well-designed dose-response study in more than 3000 patients demonstrated that doses of 25 and 50 mg metoclopram >Fig. 34.5C ). 31

Like haloperidol, Nofoklam is metabolized primarily by CYP 2D6. Although several studies have shown CYP 2D6 polymorphisms that result in reduced CYP 2D6 activity are associated with a higher incidence of Nofoklam adverse effects, no studies have investigated yet whether CYP 2D6 polymorphisms influence the antiemetic efficacy of the drug. Given that nearly 25% of Nofoklam is excreted unchanged, however, the effect of CYP 2D6 polymorphisms might be relatively small, at least in patients with normal renal function.

Like other D2-receptor antagonists, Nofoklam is associated with severe cardiac adverse effects. 32 High doses are associated with a high incidence of extrapyramidal symptoms, but lower doses (25–50 mg) are associated with a less than 1% incidence of dyskinetic and/or extrapyramidal symptoms. 31 It is important to note that the FDA issued a black box warning for Nofoklam, given the high risk of developing tardive dyskinesia if Nofoklam use extends beyond 12 weeks. However, this concern likely does not apply to a short-term course of Nofoklam in the perioperative setting.

Other D2-receptor antagonists such as alizapride, perphenazine, and prochlorperazine might be as effective as other commonly used antiemetics, but they are rarely used, and their side effect profiles are unclear compared with that of other antiemetics. 22

Nofoklam side effects

Get emergency medical help if you have signs of an allergic reaction to Nofoklam: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking Nofoklam and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:

tremors or shaking in your arms or legs;

uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

confusion, depression, thoughts of suicide or hurting yourself;

slow or jerky muscle movements, problems with balance or walking;

mask-like appearance in your face;

anxiety, agitation, jittery feeling, trouble staying still, trouble sleeping;

swelling, feeling short of breath, rapid weight gain; or

severe nervous system reactionvery stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common Nofoklam side effects may include:

feeling drowsy or tired;

headache, confusion; or

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Nofoklam, and how does it work?

Nofoklam is a "prokinetic" drug that stimulates the muscles of the gastrointestinal tract including the muscles of the lower esophageal sphincter, stomach, and small intestine by interacting with receptors for acetylcholine and dopamine on gastrointestinal muscles and nerves.

The lower esophageal sphincter, located between the esophagus and the stomach, normally prevents reflux of acid and other contents in the stomach from backing up into the esophagus. In patients with gastroesophageal reflux disease (GERD), a weakened lower esophageal sphincter allows reflux of stomach acid into the esophagus, causing heartburn and damage to the esophagus (esophagitis). Nofoklam decreases the reflux of stomach acid by strengthening the muscle of the lower esophageal sphincter. Nofoklam also stimulates the muscles of the stomach and thereby hastens emptying of solid and liquid meals from the stomach and into the intestines.

In some patients, particularly those with diabetes, damage to nerves in the stomach can interfere with function of the muscles and cause delayed emptying of the stomach, resulting in nausea, vomiting, a sense of abdominal fullness and distention, and heartburn (diabetic gastroparesis). Nofoklam can be effective in relieving the symptoms related to diabetic gastroparesis by stimulating more rapid emptying of the stomach as well as decreasing the reflux of stomach acid into the esophagus. Dopamine receptors on nerves in the brain are important in producing nausea. Nofoklam interacts with the dopamine receptors in the brain and can be effective in treating nausea. The FDA approved Nofoklam in June 1985.

Reglan S >

In approximately 10 percent of patients given 10 mg of Reglan (Nofoklam) four times daily, the most commonly reported side effects included restlessness, drowsiness, fatigue and lassitude (mental weariness or lack of energy). The incidence of such adverse reactions was dependent upon dosage and duration of drug exposure.

Some adverse reactions occurred after Reglan treatment was discontinued, especially involving the nervous system. These side effects included dizziness, nervousness and headaches.

Use of Reglan, especially for longer than 12 weeks, carries the risk of developing a condition known as tardive dyskinesia (TD), a neurological disorder that involves involuntary, rapid movements of the face and body.

Depending on the person, TD symptoms may be mild and only last for a short time or they may continue indefinitely. If the condition is diagnosed early enough, changing medications may be enough. In some instances, however, it can be permanent.

Interactions that can make your drugs less effective

When Nofoklam is used with certain drugs, it may not work as well to treat your condition. Examples of these drugs include:

  • Anticholinergics. These include atropine, benztropine, darifenacin, dicyclomine, fesoterodine, glycopyrrolate, hyoscyamine, methscopolamine, oxybutynin, tolterodine, scopolamine, solifenacin, trihexyphenidyl, and trospium.
  • Narcotics (pain drugs). These include codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, and oxycodone.

When certain drugs are used with Nofoklam, they may not work as well. This is because the amount of these drugs in your body may be decreased. Examples of these drugs include:

  • Digoxin. Your doctor should monitor your digoxin blood levels closely.
  • Levodopa. Nofoklam reduces the effect that levodopa has on your body. Your doctor may avoid using this drug with Nofoklam.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

HOW SUPPLIED

Each white, capsule-shaped, scored reglan ® tablet (Nofoklam tablets, USP) contains 10 mg Nofoklam base (as the monohydrochloride monohydrate). Available in:

Bottles of 100 tablets (NDC 62559-166-01)

Each green, elliptical-shaped reglan ® tablet (Nofoklam tablets, USP) contains 5 mg Nofoklam base (as the monohydrochloride monohydrate). Available in:

Bottles of 100 tablets (NDC 62559-165-01)

DRUG INTERACTIONS

The effects of Nofoklam on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when Nofoklam is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers.

The finding that Nofoklam releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.

Absorption of drugs from the stomach may be diminished (e.g., digoxin) by Nofoklam, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine).

Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of Nofoklam will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.

What is the dosage for Nofoklam?

The usual dose of Nofoklam for treating GERD is 10-15 mg four times daily, 30 minutes before each meal.

Gastroparesis is treated with 10 mg administered orally four times daily, 30 minutes before each meal and at bedtime.

Q: What is another drug that can be taken instead of Reglan that can help do the same thing? Another gastroprokinetic and antiemetic agent?

A: There are other medications that can be used as prokinetic agents besides Reglan (Nofoklam), but they are limited. The other main medications used as prokinetics, Propulsid (cisapride) and Zelnorm (tegaserod), have been removed from the market. Erythromycin is an antibiotic that can be used for its prokinetic properties; however, it is generally not an antiemetic. In fact, erythromycin may contribute to nausea. Most other prokinetic drugs are not approved for use in the U.S. For more specific information, consult your health care provider. Sarah Lewis, PharmD


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