Dosage of Lopra in details
(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?
Lopra can cause a serious heart problem, especially if you use certain medicines at the same time. Ask a doctor or pharmacist if it is safe for you to use Lopra if you are also using any of the following drugs, especially:
quinidine (a heart rhythm medicine);
quinine (anti-malaria medicine);
stomach acid reducers--cimetidine, ranitidine;
an antibiotic--clarithromycin, erythromycin; or
antifungal medicine--itraconazole, ketoconazole.
This list is not complete. Other drugs may interact with Lopra, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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.
- 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).
- FDA/SPL Indexing Data. "6X9OC3H4II: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Antidepressive Agents, Second-Generation". https://www.ncbi.nlm.nih.gov/mesh/68... (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.
Consumer reported frequency of useNo survey data has been collected yet
4 consumers reported dosesWhat doses of Lopra drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Lopra drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
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Information checked by Dr. Sachin Kumar, MD Pharmacology