Lofenoxal

Lofenoxal is indicated as an adjunct to rehydration in acute

diarrhea. It is used as a symptomatic treatment in chronic

mild ulcerative colitis.

Lofenoxal is used also for the control of stool formation

after colostomy or ileostomy.

Atropine (Lofenoxal) affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.

Diphenoxylate (Lofenoxal) is an antidiarrheal medication.

The combination of Atropine (Lofenoxal) and Diphenoxylate (Lofenoxal) is used to treat diarrhea.

Atropine (Lofenoxal) and Diphenoxylate (Lofenoxal) may also be used for other purposes not listed in this medication guide.

DO NOT EXCEED RECOMMENDED DOSAGE.

Adults: The recommended initial dosage is two Lofenoxal tablets four times daily or 10 ml (two regular teaspoonfuls) of Lofenoxal liquid four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets or 10 ml of liquid) daily.

Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of Diphenoxylate (Lofenoxal) hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.

Children: Lofenoxal is not recommended in children under 2 years of age and should be used with special caution in young children. The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use Lofenoxal liquid. Do not use Lofenoxal tablets for this age group.

Only the plastic dropper should be used when measuring Lofenoxal liquid for administration to children.

Dosage schedule for children: The recommended initial total daily dosage of Lofenoxal liquid for children is 0.3 to 0.4 mg/kg, administered in four divided doses. The following table provides an approximate initial daily dosage recommendation for children.

These pediatric schedules are the best approximation of an average dose recommendation which may be adjusted downward according to the overall nutritional status and degree of dehydration encountered in the sick child. Reduction of dosage may be made as soon as initial control of symptoms has been achieved. Maintenance dosage may be as low as one-fourth of the initial daily dosage. If no response occurs within 48 hours, Lofenoxal is unlikely to be effective.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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

Lofenoxal is contraindicated in patients with

1. Known hypersensitivity to Diphenoxylate (Lofenoxal) or Atropine (Lofenoxal).
2. Obstructive jaundice.
3. Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-producing bacteria.

Use Atropine (Lofenoxal)/Diphenoxylate (Lofenoxal) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Atropine (Lofenoxal)/Diphenoxylate (Lofenoxal) solution by mouth with or without food.
• Use the dropper than comes with Atropine (Lofenoxal)/Diphenoxylate (Lofenoxal) solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Atropine (Lofenoxal)/Diphenoxylate (Lofenoxal) solution and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Atropine (Lofenoxal)/Diphenoxylate (Lofenoxal) solution.

Use: Labeled Indications

Diarrhea, adjunct therapy: Adjunctive management of diarrhea in patients ≥13 years of age.

See also:
What other drugs will affect Lofenoxal?

Known drug interactions include barbiturates, tranquilizers, and alcohol. Lofenoxal may interact with MAO inhibitors.

In studies with male rats, Diphenoxylate (Lofenoxal) hydrochloride was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day. Therefore, Diphenoxylate (Lofenoxal) has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.

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

At therapeutic doses, the following have been reported; they are listed in decreasing order of severity, but not of frequency:

Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache.

Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus.

Gastrointestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort.

The following Atropine (Lofenoxal) sulfate effects are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes. These effects may occur, especially in children.

THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.

Drug Abuse And Dependence

Controlled Substance

Lofenoxal is classified as a Schedule V controlled substance by federal regulation. Diphenoxylate (Lofenoxal) hydrochloride is chemically related to the narcotic analgesic meperidine.

Drug Abuse And Dependence

In doses used for the treatment of diarrhea, whether acute or chronic, Diphenoxylate (Lofenoxal) has not produced addiction.

Diphenoxylate (Lofenoxal) hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of Diphenoxylate (Lofenoxal) hydrochloride in commonly available aqueous media precludes intravenous selfadministration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. Since addiction to Diphenoxylate (Lofenoxal) hydrochloride is possible at high doses, the recommended dosage should not be exceeded.