Lomotil

  • Generic Name or Active Ingridient: Diphenoxylate And Atropine
Drug Class: Lomotil > Diphenoxylate And Atropine > Diphenoxylate Hydrochloride > Diphenoxylate > Fully Synthetic Opioid > Opioids > Opioid Agonist > Analgesic.

Uses

Physicians prescribe Lomotil to treat diarrhea.

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Administration/Dosage

G.D. Searle LLC Division of Pfizer Inc. distributes Lomotil in a cherry-flavored liquid and tablet form, both for oral administration. Each tablet and 5 ml dose of Lomotil contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine.

Adults

The recommended initial dose for adults is two Lomotil tablets or two 10 ml teaspoonfuls four times each day for a total of 20 mg of Lomotil per day. Most patients require this dose until they gain control over diarrhea, usually after using Lomotil for 48 hours; consumers can then reduce daily doses to meet individual needs. Frequently, patients can control diarrhea with as little as two tablets or two teaspoonfuls each day.

Patients who do not experience relief from diarrhea after ten days of Lomotil therapy should consider an alternate form of treatment, as continuing Lomotil therapy further is unlikely to improve results.

Children

Lomotil is not for children younger than two years old; pediatricians should prescribe Lomotil with caution to young children. Prescribers should consider the child’s nutritional status and assess his level of dehydration caused by diarrhea.

Children under the age of 13 years should use Lomotil liquid rather than Lomotil tablets. Administrators should use the plastic dropper provided when giving Lomotil liquid to children to ensure accurate dosing.

Pediatricians will calculate initial doses of Lomotil according to the child’s body weight. The recommended initial daily dose is 0.3 to 0.4 mg of Lomotil for every kilogram of body weight, given in four equal doses throughout the day. For example, a 5-year old weighing 35 lbs would receive 2.5 ml of Lomotil four times each day. Pediatricians may decrease this dose in children who are not eating well and who are suffering dehydration.

Pediatricians should decrease Lomotil dosages as soon as diarrhea begins to slow, prescribing maintenance doses as low as one-quarter of the initial daily dose. If Lomotil therapy does not slow diarrhea in 48 hours, the pediatrician should consider another course of treatment.

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Action

Diphenoxylate hydrochloride slows intestinal contractions that propel food through the digestive tract, giving the body enough time to absorb excess water from stool. Lomotil reaches peak effectiveness about two hours after the patient consumes it. The liver metabolizes diphenoxylate before the body eliminates it in urine and feces.

Atropine is an anticholinergic drug that, when consumed in high doses, causes severe weakness and nausea. Atropine acts as a deterrent to Lomotil abuse.

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Warnings

Pediatric Use

Lomotil is not a harmless medication; consumers should strictly adhere to dosage recommendations, especially when administering Lomotil to a child. Lomotil is not appropriate for children under the age of two years.

Young children are predisposed to suffering from delayed onset of diphenoxylate overdose. Furthermore, young children display widely varying responses to the effects of Lomotil.

Keep Lomotil out of the reach of children. Overdose in children may result in respiratory depression and coma, potentially leading to brain damage or death.

Respiratory Depression

Respiratory depression is a dangerous, sometimes fatal breathing condition where the brain loses the urge to breathe. During respiratory depression, the lungs do a poor job of exchanging oxygen for carbon dioxide and other gases, resulting in oxygen starvation and high levels of carbon dioxide. Symptoms of respiratory depression include slow, shallow breathing, irregular breathing patterns and a blue color around the eyes, lips and fingertips. High doses of Lomotil increase the risk for respiratory depression.

Dehydration and Electrolyte Imbalance

Outpatient Lomotil consumers should drink plenty of liquids to maintain fluid and electrolyte balances; inpatients may receive intravenous fluids and electrolyte therapy. In cases of severe dehydration or electrolyte imbalance, consumers should not take Lomotil until he has taken steps to correct these imbalances.

Lomotil slows intestinal contractions to allow the body more time to absorb excess fluids; this inhibition of movement through the digestive tract may result in fluid retention in the intestine in a way that further aggravates dehydration and electrolyte imbalance.

Drugs that slow intestinal movements, including Lomotil, may prolong or worsen diarrhea associated with some types of bacterial infections or with the use of some types of antibiotics. Patients suffering from these conditions should not use Lomotil.

Lomotil use may cause the dangerous gastrointestinal crisis, toxic megacolon, in some patients with acute ulcerative colitis. Prescribing physicians should monitor these consumers closely, discontinuing Lomotil promptly if the patient experiences abdominal distention or other symptoms of toxic megacolon.

Patients with liver or kidney disease should use Lomotil with extreme caution; the patient may become comatose if the liver cannot clear Lomotil from the body.

The diphenoxylate hydrochloride in Lomotil may enhance the effects of certain drugs including barbiturates, tranquilizers and alcohol. Prescribing physicians should closely monitor patients who use these substances while taking Lomotil.

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Precautions

Lomotil may cause the consumer to feel dizzy or drowsy; he should not engage in activities that require mental alertness, including driving a motor vehicle or operating heavy machinery. Using Lomotil with other substances, including alcohol, barbiturates and tranquilizers, can enhance their effects.

Even therapeutic doses of Lomotil can cause signs of atropine overdose in children, especially in patients with Down’s syndrome.

Contraindications

Lomotil is not appropriate for all patients. Those with a known hypersensitivity of diphenoxylate, atropine, or any other ingredient in Lomotil should not use this product. Individuals suffering yellow skin and eyes due to an obstruction of the flow of bile, a condition known as obstructive jaundice, should not use Lomotil. Patients suffering from diarrhea caused antibiotic use or by certain types of bacterial infections, should not use this product.

Pregnancy, Labor and Delivery, Breastfeeding

Lomotil is an FDA Pregnancy Category C, meaning research has not yet determined the effects of Lomotil on a woman or her unborn child. Pregnant women should only use Lomotil when the benefits to her health clearly outweigh the potential risk to the fetus.

Nursing mothers should use Lomotil with care, as some metabolites and components of Lomotil passes into breast milk and onto a breastfeeding child.

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Drug Interactions

Lomotil interacts with some substances in unsafe or unfavorable ways, including barbiturates, tranquilizers and alcohol. Lomotil may interact with MAO inhibitors. Lomotil may slow the rate at which the body eliminates some drugs.

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Side effects

Even at therapeutic doses, Lomotil may cause side effects in some consumers. Lomotil may interact with the nervous system to cause effects such as numbness in the hands and feet, lethargy, euphoria and depression. Other nervous system effects include confusion, sedation or drowsiness, dizziness, restlessness and headache.

Lomotil may cause side effects in the digestive system, including loss of appetite, stomachache, nausea and vomiting. Serious gastrointestinal adverse reactions include toxic megacolon, pancreatitis and the intestinal blockage, paralytic ileus.

The atropine sulfate in Lomotil may cause specific side effects, especially in children, including high body temperature, fast heartbeat, urinary retention, flushing and dryness of the skin and mucous membranes.

Anyone can suffer an adverse allergic reaction to Lomotil or suffer anaphylaxis, a serious form of an allergic reaction. Symptoms of an adverse allergic reaction to Lomotil include swelling under the skin, itching, hives and swelling of the gums.

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Overdose

Lomotil overdose is a serious and potentially fatal crisis. Pediatric overdose may result in severe or sometimes fatal respiratory depression. Suspected victims of Lomotil overdose seek immediate treatment from the nearest medical facility.

Early signs of Lomotil overdose may include dryness of the skin and mucous membranes, like those in the nose and mouth. Other early signs of overdose are large pupils, restlessness, flushing, high body temperature and fast heartbeat.

Later signs of Lomotil overdose include lethargy or coma, poor reflexes, fast and uncontrolled eye movements, pinpoint pupils and respiratory depression. Signs of respiratory depression may appear as late as 30 hours after ingestion. Respiratory depression may reappear after initially responding to treatment.

Emergency department physicians and nurses consider all cases of Lomotil to be serious. Nurses will induce vomiting and pump excess Lomotil from the patient’s stomach; they may then introduce a 100-gram slurry of activated charcoal into the conscious patient’s stomach to absorb excess medication. Nurses will establish an airway to help the patient breathe or place him on a ventilator to allow a machine to breathe for him.

Physicians will prescribe 0.4 mg to 2 mg of naloxone hydrochloride to reverse the effects of respiratory depression in an adult patient; effects should be apparent within two minutes of naloxone injection. Lomotil injected under the skin or into a muscle will have delayed onset but provide longer-lasting results. The physicians may repeat naloxone every two to three minutes, administering up to 10 mg of naloxone.

Physicians calculate pediatric naloxone dosages according to the child’s weight. The usual initial pediatric dose is 0.01 mg per kilogram of body weight, administered intravenously. If the child shows no sign of improvement, physicians may administer a subsequent dose of 0.1 mg/kg of body weight.

The hospital will likely admit the patient for observation for at least 48 hours. The effects of respiratory depression outlast those of naloxone; signs of respiratory depression may reoccur even after the patient’s condition improves. Supplemental doses of the longer-acting intramuscular dose of naloxone may provide better results during this time.

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Abuse

At therapeutic doses, Lomotil does not produce codeine-like euphoria - it takes very large doses of this produce to get someone high. Manufacturers add atropine to discourage abuse; doses of Lomotil large enough to cause euphoria make the consumer feel nauseated and weak. Because of this effect, Lomotil is a DEA schedule V narcotic, meaning it poses a very low relative potential for abuse.

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Withdrawal

Diphenoxylate hydrochloride is related chemically to the opioid pain reliever, meperidine. As with meperidine, long-term use at high doses may cause physical dependence resulting in withdrawal symptoms when the individual stops using Lomotil.

It takes very large doses of Lomotil to produce dependence. Someone who takes 100 to 300 mg of Lomotil a day, which is the equivalent of 40 to 120 tablets, for 40 to 70 days will experience withdrawal symptoms when he stops using this product.

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Detox

Many institutions now offer detoxification services to help people overcome dependence on drugs like Lomotil. During detoxification, patients receive drugs to lower the levels of toxins along with medications to relieve withdrawal symptoms.

Rapid detox is humane and efficient approach to detoxification. During rapid detox, patients receive anesthesia and sedatives along with the standard detoxification and anti-withdrawal drugs. The rapid detox patient dozes in a comfortable “twilight sleep” during the short detoxification process, unaware of unpleasant withdrawal symptoms.

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Storage

Keep Lomotil in its original, tightly sealed container, out of the reach of children.

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Miscellaneous information

Lomotil is available in the United States only with a prescription.

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Facts

  • Lomotil