What are the possible side effects of Lopra?
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported for with Lopra solution. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); constipation; decreased urination; red, swollen, blistered, or peeling skin; stomach bloating, swelling, or pain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the.
Side effects of Lopra in details
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.
What is the most important information I should know about Lopra?
- Lopra may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lopra with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lopra; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. This could increase the risk of serious side effects.
- If your symptoms do not get better within 10 days (2 days for children) or if they get worse, check with your doctor.
- Do not become overheated in hot weather or while you are being active; heatstroke may occur.
- Report any symptoms of fluid or electrolyte loss to your doctor: dry mouth; thirst; weakness; lethargy; drowsiness; restlessness; muscle pain or cramps; muscle weakness; low blood pressure; infrequent urination; rapid heartbeat; stomach disorders such as nausea and vomiting.
- Lopra may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
- Tell your doctor or dentist that you take Lopra before you receive any medical or dental care, emergency care, or surgery.
- Use Lopra with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
- Lopra should not be used in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
- Caution is advised when using Lopra in CHILDREN 13 years of age and older; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lopra while you are pregnant. Lopra is found in breast milk. If you are or will be breast-feeding while you use Lopra, check with your doctor. Discuss any possible risks to your baby.
When used for longer than a few weeks or at high doses, some people develop a need to continue taking Lopra. This is known as DEPENDENCE or addiction. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
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.
- 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).
- DTP/NCI. "omeprazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Citalopram: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (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 side effectsDid you experience side effects while taking Lopra drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Lopra drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
|It has side effects||1||50.0%|
|No side effects||1||50.0%|
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Information checked by Dr. Sachin Kumar, MD Pharmacology