What is Lopra?
Lopra slows the rhythm of digestion so that the small intestines have more time to absorb fluid and nutrients from the foods you eat.
Lopra is used to treat diarrhea. Lopra is also used to reduce the amount of stool in people who have an ileostomy (re-routing of the bowel through a surgical opening in the stomach).
Lopra may also be used for purposes not listed in this medication guide.
Lopra® (Lopra hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Lopra® (Lopra hcl) is also indicated for reducing the volume of discharge from ileostomies.
How should I use Lopra?
Use Lopra solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Lopra solution by mouth with or without food.
- Use the measuring cup that comes with Lopra solution. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Drinking extra fluids is recommended while you have diarrhea. Check with your doctor if you have questions.
- If you miss a dose of Lopra solution, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.
Ask your health care provider any questions you may have about how to use Lopra solution.
Uses of Lopra in details
This medication is used to treat sudden diarrhea (including traveler's diarrhea). It works by slowing down the movement of the gut. This decreases the number of bowel movements and makes the stool less watery. Lopra is also used to reduce the amount of discharge in patients who have had an ileostomy. It is also used to treat ongoing diarrhea in people with inflammatory bowel disease.
Lopra treats only the symptoms, not the cause of the diarrhea (e.g., infection). Treatment of other symptoms and the cause of the diarrhea should be determined by your doctor.
Do not use in children younger than 6 years unless directed by your doctor. This medication should not be used in infants younger than 24 months.
How to use Lopra (Lopra)
If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor's directions and the directions on your prescription label.
Take this medication by mouth, usually after each loose stool or as directed by your doctor. Shake the bottle well before each use. Measure each dose carefully using the attached measuring cup. Do not use a household spoon since you may not get the correct dose.
The dosage is based on your condition and response to treatment. In children, dosage is also based on age and weight. Adults should not use more than 8 milligrams in 24 hours if self-treating, or 16 milligrams in 24 hours if under a doctor's direction.
Improper use of this medication (overuse or abuse) - or use with certain other medications - may cause serious harm, such as fast/irregular heartbeat or death. Do not increase your dose, take it more often, or use it for longer than directed. Be sure to tell your doctor or pharmacist about all the products you use (including prescription, nonprescription, and herbal products).
Diarrhea can cause a serious loss of body water (dehydration). Drink plenty of fluids and minerals (electrolytes) to replace what is lost. Tell your doctor right away if you develop signs of dehydration (e.g., extreme thirst, decreased urination, muscle cramps, weakness, fainting). You may also need to change to a bland diet during this time to reduce irritation to your stomach/intestines. Consult your doctor or pharmacist for more information.
Tell your doctor if your diarrhea does not improve after 2 days, if your condition worsens, or if you develop new symptoms. If you develop blood in the stool, fever, or an uncomfortable fullness/swelling of the stomach/abdomen, or if you think you may have a serious medical problem, seek immediate medical attention.
If you are taking this medication under your doctor's direction for ongoing diarrhea, tell your doctor if your diarrhea continues after 10 days of treatment.
One of the long-acting synthetic antidiarrheals; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally. [PubChem]
(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.
Adults: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.
Children: In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (Lopra® (Lopra hcl) A-D 1 mg/5 mL) should be used; for ages 6 to 12, either Lopra® (Lopra hcl) Capsules or Lopra® (Lopra hcl) A-D Liquid may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:
Recommended First Day Dosage Schedule
Two to five years: 1 mg t.i.d. (3mg daily dose) (13 to 20 kg) Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg) Eight to twelve years: 2mg t.i.d. (6mg daily dose) (greater than 30 kg)
Recommended Subsequent Daily Dosage
Following the first treatment day, it is recommended that subsequent Lopra® (Lopra hcl) doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.
Children: Although Lopra® (Lopra hcl) has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.
Adults: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of Lopra® (Lopra hcl) should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses.
The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Lopra® (Lopra hcl) administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.
Children under 2 Years
The use of Lopra (Lopra hcl) in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.
No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required for the elderly.
No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment.
Although no pharmacokinetic data are available in patients with hepatic impairment, Lopra (Lopra hcl) should be used with caution in such patients because of reduced first pass metabolism..
Capsules - each capsule contains 2 mg of Lopra hydrochloride. The capsules have a light green body and a dark green cap with "JANSSEN" imprinted on one segment and "Lopra" on the other segment. Lopra® (Lopra hcl) capsules are supplied in bottles of 100.
NDC 50458-400-10.........(100 CAPSULES)
Store at 15°-25°C (59°-77°F).
Janssen Pharmaceutica Inc. Revised September 1996, July 1998. FDA Rev date: 10/21/2005
What other drugs will affect Lopra?
Nonclinical data have shown that Lopra is a P-glycoprotein substrate. Concomitant administration of Lopra (16 mg single dose) with a 600 mg single dose of either quinidine, or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2- to 3- fold increase in Lopra plasma levels. Due to the potential for enhanced central effects when Lopra is coadministered with quinidine and with ritonavir, caution should be exercised when Lopra is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.
When a single 16-mg dose of Lopra is coadministered with a 600 mg single dose of saquinavir, Lopra decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on Lopra is of less clinical significance. Therefore, when Lopra is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.
Lopra side effects
Clinical Trial Data
The adverse effects reported during clinical investigations of Lopra® (Lopra hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with Lopra® (Lopra hcl) were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.
The adverse events reported are summarized irrespective of the causality assessment of the investigators.
1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on Lopra hydrochloride as on placebo, are presented in the table below.
| Lopra |
|No. of treated patients||231||236|
| Gastrointestinal AE% |
The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on Lopra hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.
2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea
The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on Lopra hydrochloride as on placebo, are presented below in the table below.
| Lopra |
|No. of treated patients||285||277|
| Gastrointestinal AE% |
| Central and peripheral |
nervous system AE%
The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on Lopra hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.
3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea
The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below.
|Acute Diarrhea||Chronic Diarrhea||All Studies|
|No. of treated patients||1913||1371||3740|
|a. All patients in all studies, including those in which it was not specified if the adverse events occurred in patients with acute or chronic diarrhea.|
Post -marketing experience
The following adverse events have been reported:
Skin and subcutaneous tissue disorders
Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of Lopra (Lopra hcl).
Immune system disorders
Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of Lopra (Lopra hcl).
Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon.
Renal and urinary disorders
Nervous system disorders
General disorders and administrative site conditions
A number of the adverse events reported during the clinical investigations and post- marketing experience with Lopra are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.
Drug Abuse And Dependence
A specific clinical study designed to assess the abuse potential of Lopra at high doses resulted in a finding of extremely low abuse potential.
Studies in morphine-dependent monkeys demonstrated that Lopra hydrochloride at doses above those recommended for humans prevented signs of morphine withdrawal. However, in humans, the naloxone challenge pupil test, which when positive indicates opiate-like effects, performed after a single high dose, or after more than two years of therapeutic use of Lopra® (Lopra hydrochloride), was negative.
Orally administered Lopra® (Lopra hcl) (Lopra formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.
Lopra (Lopra hcl) is contraindicated in patients with a known hypersensitivity to Lopra hydrochloride or to any of the excipients.
Lopra (Lopra hcl) is contraindicated in patients with abdominal pain in the absence of diarrhea.
Lopra (Lopra hcl) is not recommended in infants below 24 months of age.
Lopra (Lopra hcl) should not be used as the primary therapy:
- in patients with acute dysentery, which is characterized by blood in stools and high fever,
- in patients with acute ulcerative colitis,
- in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter,
- in patients with pseudomembranous colitis associated with the use of broad- spectrum antibiotics.
Active ingredient matches for Lopra:
Loperamide in Pakistan.
Omeprazole in India.
|Unit description / dosage (Manufacturer)||Price, USD|
|20 mg x 150's||$ 19.05|
|Lopra 20mg CAP / 150||$ 19.05|
|LOPRA cap 20 mg x 10's (Arvincare)||$ 1.27|
|Lopra 20mg CAP / 150||$ 19.05|
List of Lopra substitutes (brand and generic names):
|LOPPA 2MG TABLET 1 strip / 10 tablets each (Zydus Cadila)||$ 0.10|
|LOPRAM Capsule/ Tablet / 10mg / 10 units (Ind-Swift)||$ 0.33|
|LOPRAM Capsule/ Tablet / 20mg / 10 units (Ind-Swift)||$ 0.60|
|Lopram 10mg TAB / 10 (Ind-Swift)||$ 0.33|
|Lopram 20mg TAB / 10 (Ind-Swift)||$ 0.60|
|10 mg x 10's (Ind-Swift)||$ 0.33|
|20 mg x 10's (Ind-Swift)||$ 0.60|
|LOPRAM 10MG TABLET 1 strip / 10 tablets each (Ind-Swift)||$ 0.33|
|LOPRAM 20MG TABLET 1 strip / 10 tablets each (Ind-Swift)||$ 0.60|
|LOPRAM tab 10 mg x 10's (Ind-Swift)||$ 0.33|
|LOPRAM tab 20 mg x 10's (Ind-Swift)||$ 0.60|
|Lopram 10mg Tablet (Ind-Swift)||$ 0.03|
|Lopram 20mg Tablet (Ind-Swift)||$ 0.06|
|Lopram 20mg (Oman)|
|LOPRAMAC 2MG TABLET 1 strip / 10 tablets each (Mac Millon Pharmaceuticals Pvt Ltd)||$ 0.15|
|LOPRAMIDE (CADILA PHARMA)|
|LOPRAMIDE 5MG TABLET 1 strip / 10 tablets each (Cadila Pharmaceuticals Ltd)||$ 0.08|
|LOPRAMIDE 2MG TABLET 1 packet / 100 tablets each (Makers Laboratories Ltd)||$ 0.65|
|LOPRAPIL 2 MG CAPSULE 1 strip / 10 capsules each (Psychotropics India Ltd)||$ 0.09|
|Loprapil 2mg Capsule (Psychotropics India Ltd)||$ 0.01|
|LOPRAZ eye drops 0.5 % w/v x 10ml (Agron Rem.)|
|Loramide (Malaysia, Singapore)|
|Loramide 2 mg x 10 x 10's (Ysp)|
|Loramide 2 mg x 10 x 50's (Ysp)|
|Loramide 2 mg x 10's x 50 (Ysp)|
|Loramide 100 mg x 2 Blister x 15 Tablet (Ysp)|
|LORAMYL 2 MG TABLET 1 strip / 10 tablets each (Adonis Laboratories Pvt Ltd)||$ 0.42|
|Loramyl 2mg Tablet (Adonis Laboratories Pvt Ltd)||$ 0.04|
|Lordial (Croatia (Hrvatska))|
|Lordiar (Bosnia & Herzegowina)|
|LORESS Capsule/ Tablet / 20mg / 10 units (Bio E)||$ 0.62|
|LORESS Capsule/ Tablet / 10mg / 10 units (Bio E)||$ 0.31|
|10 mg x 10's (Bio E)||$ 0.31|
- DailyMed. "OMEPRAZOLE MAGNESIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "omeprazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- PubChem. "loperamide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Lopra are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lopra. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
2 consumers reported usefulWas the Lopra drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
1 consumer reported price estimatesWas the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Lopra drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
4 consumers reported time for resultsTo what extent do I have to use Lopra before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes > 3 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Lopra. To get the time effectiveness of using Lopra drug by other patients, please click here.
|> 3 month||2||50.0%|
6 consumers reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology