Lopramide (CADILA PHARMA) Uses

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What is Lopramide (CADILA PHARMA)?

Lopramide (CADILA PHARMA) slows the rhythm of digestion so that the small intestines have more time to absorb fluid and nutrients from the foods you eat.

Lopramide (CADILA PHARMA) is used to treat diarrhea. Lopramide (CADILA PHARMA) 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).

Lopramide (CADILA PHARMA) may also be used for purposes not listed in this medication guide.

Lopramide (CADILA PHARMA) indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hcl) is also indicated for reducing the volume of discharge from ileostomies.

How should I use Lopramide (CADILA PHARMA)?

Use Lopramide (CADILA PHARMA) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Lopramide (CADILA PHARMA) solution by mouth with or without food.
  • Use the measuring cup that comes with Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) solution.

Uses of Lopramide (CADILA PHARMA) in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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. Lopramide (CADILA PHARMA) 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.

Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA))

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.

Lopramide (CADILA PHARMA) description

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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]

Lopramide (CADILA PHARMA) dosage

(1 capsule = 2 mg)

Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea

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 (Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hcl) A-D 1 mg/5 mL) should be used; for ages 6 to 12, either Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hcl) Capsules or Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) 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.

Chronic Diarrhea

Children: Although Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) 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. Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hcl) administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.

Children under 2 Years

The use of Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) 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.

Elderly

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.

Renal Impairment

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.

Hepatic Impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) hcl) should be used with caution in such patients because of reduced first pass metabolism..

How supplied

Capsules - each capsule contains 2 mg of Lopramide (CADILA PHARMA) hydrochloride. The capsules have a light green body and a dark green cap with "JANSSEN" imprinted on one segment and "Lopramide (CADILA PHARMA)" on the other segment. Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) 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

Lopramide (CADILA PHARMA) interactions

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What other drugs will affect Lopramide (CADILA PHARMA)?

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Nonclinical data have shown that Lopramide (CADILA PHARMA) is a P-glycoprotein substrate. Concomitant administration of Lopramide (CADILA PHARMA) (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 Lopramide (CADILA PHARMA) plasma levels. Due to the potential for enhanced central effects when Lopramide (CADILA PHARMA) is coadministered with quinidine and with ritonavir, caution should be exercised when Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) is coadministered with a 600 mg single dose of saquinavir, Lopramide (CADILA PHARMA) decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on Lopramide (CADILA PHARMA) is of less clinical significance. Therefore, when Lopramide (CADILA PHARMA) is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.

Lopramide (CADILA PHARMA) side effects

See also:
What are the possible side effects of Lopramide (CADILA PHARMA)?

Clinical Trial Data

The adverse effects reported during clinical investigations of Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) hydrochloride as on placebo, are presented in the table below.

Acute Diarrhea
Lopramide (CADILA PHARMA)

Hydrochloride

Placebo
No. of treated patients 231 236
Gastrointestinal AE%

Constipation

2.6%

0.8%

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) hydrochloride as on placebo, are presented below in the table below.

Chronic Diarrhea
Lopramide (CADILA PHARMA)

Hydrochloride

Placebo
No. of treated patients 285 277
Gastrointestinal AE%

Constipation

5.3%

0.0%

Central and peripheral

nervous system AE%

Dizziness

1.4%

0.7%

The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on Lopramide (CADILA PHARMA) 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
Gastrointestinal AE%
Nausea 0.7% 3.2% 1.8%
Constipation 1.6% 1.9% 1.7%
Abdominal cramps 0.5% 3.0% 1.4%
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 Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) hcl).

Gastrointestinal disorders

Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon.

Renal and urinary disorders

Urinary retention

Nervous system disorders

Drowsiness, dizziness

General disorders and administrative site conditions

Tiredness

A number of the adverse events reported during the clinical investigations and post- marketing experience with Lopramide (CADILA PHARMA) 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

Abuse

A specific clinical study designed to assess the abuse potential of Lopramide (CADILA PHARMA) at high doses resulted in a finding of extremely low abuse potential.

Dependence

Studies in morphine-dependent monkeys demonstrated that Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hydrochloride), was negative.

Orally administered Lopramide (CADILA PHARMA)® (Lopramide (CADILA PHARMA) hcl) (Lopramide (CADILA PHARMA) formulated with magnesium stearate) is both highly insoluble and penetrates the CNS poorly.

Lopramide (CADILA PHARMA) contraindications

See also:
What is the most important information I should know about Lopramide (CADILA PHARMA)?

Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) hcl) is contraindicated in patients with a known hypersensitivity to Lopramide (CADILA PHARMA) hydrochloride or to any of the excipients.

Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) hcl) is contraindicated in patients with abdominal pain in the absence of diarrhea.

Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) hcl) is not recommended in infants below 24 months of age.

Lopramide (CADILA PHARMA) (Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA):

Loperamide


Unit description / dosage (Manufacturer)Price, USD
LOPRAMIDE 5MG TABLET 1 strip / 10 tablets each (Cadila Pharmaceuticals Ltd)$ 0.08

List of Lopramide (CADILA PHARMA) substitutes (brand and generic names):

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
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
Lormide 2 mg x 25 Blister x 4 Tablet (Westmont)
Lormide 2 mg x 100's (Westmont)$ 15.21
Lorpa 2 mg x 500's (Beacons)
Lorpa 1 mg/5 mL x 1 L x 1's (Beacons)
LUPIDIUM TABLET 1 strip / 10 tablets each (Lupin Ltd)$ 0.06
Mantil 2 mg x 50 x 10's
Mantil 2 mg x 100 x 10's
Miderlar 2 mg x 25 x 6's
Miderlar 2 mg x 1000's
Nelop 2 mg Capsule (Nestor Pharmaceuticals Ltd)$ 0.02

References

  1. PubChem. "loperamide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "loperamide". http://www.drugbank.ca/drugs/DB00836 (accessed September 17, 2018).
  3. MeSH. "Antidiarrheals". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Lopramide (CADILA PHARMA) 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 Lopramide (CADILA PHARMA). 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.

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To what extent do I have to use Lopramide (CADILA PHARMA) before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day 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 Lopramide (CADILA PHARMA). To get the time effectiveness of using Lopramide (CADILA PHARMA) drug by other patients, please click here.
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1 day1
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