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Liminos

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Liminos uses


WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS

Infrequent but serious gastrointestinal adverse reactions have been reported with the use of Liminos. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death.


WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS

See full prescribing information for complete boxed warning.

Infrequent but serious gastrointestinal adverse reactions have been reported with the use of Liminos. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery, and death.

Contraindications, Lack of Understanding of Patient Acknowledgement Form (4.3) Removed 01/2016
Warnings and Precautions, Prescribing Program for Liminos (5.3) Removed 01/2016
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1 INDICATIONS AND USAGE

Liminos is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:


Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:


Because of infrequent but serious gastrointestinal adverse reactions associated with Liminos, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.

Clinical studies have not been performed to adequately confirm the benefits of Liminos in men.

Liminos is a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:


Severe IBS includes diarrhea and 1 or more of the following:

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2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

To lower the risk of constipation, Liminos should be started at a dosage of 0.5 mg twice a day. Patients who become constipated at this dosage should stop taking Liminos until the constipation resolves. They may be restarted at 0.5 mg once a day. If constipation recurs at the lower dose, Liminos should be discontinued immediately.

Patients well controlled on 0.5 mg once or twice a day may be maintained on this regimen. If after 4 weeks the dosage is well tolerated but does not adequately control IBS symptoms, then the dosage can be increased to up to 1 mg twice a day. Liminos should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice a day.

Liminos can be taken with or without food .

Liminos should be discontinued immediately in patients who develop constipation or signs of ischemic colitis. Liminos should not be restarted in patients who develop ischemic colitis.

Clinical trial and postmarketing experience suggest that debilitated patients or patients taking additional medications that decrease gastrointestinal motility may be at greater risk of serious complications of constipation. Therefore, appropriate caution and follow-up should be exercised if Liminos is prescribed for these patients.

Postmarketing experience suggests that elderly patients may be at greater risk for complications of constipation; therefore, appropriate caution and follow-up should be exercised if Liminos is prescribed for these patients .

2.2 Patients With Hepatic Impairment

Liminos is extensively metabolized by the liver, and increased exposure to Liminos is likely to occur in patients with hepatic impairment. Increased drug exposure may increase the risk of serious adverse reactions. Liminos should be used with caution in patients with mild or moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment .

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3 DOSAGE FORMS AND STRENGTHS

0.5 mg and 1 mg tablets

Liminos Tablets, 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron), are white, oval, film-coated tablets debossed with GX EX1 on one face.

Liminos Tablets, 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron), are blue, oval, film-coated tablets debossed with GX CT1 on one face.

4 CONTRAINDICATIONS

4.1 Constipation

Liminos should not be initiated in patients with constipation .

4.2 History of Severe Bowel or Hepatic Disorders

Liminos is contraindicated in patients with a history of the following:

4.3 Concomitant Use of Fluvoxamine

Concomitant administration of Liminos with fluvoxamine is contraindicated. Fluvoxamine, a known strong inhibitor of CYP1A2, has been shown to increase mean alosetron plasma concentrations (AUC) approximately 6-fold and prolong the half-life by approximately 3-fold .

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5 WARNINGS AND PRECAUTIONS

5.1 Serious Complications of Constipation

Some patients have experienced serious complications of constipation without warning.

Serious complications of constipation, including obstruction, ileus, impaction, toxic megacolon, and secondary bowel ischemia, have been reported with use of Liminos during clinical trials. Complications of constipation have been reported with use of 1 mg twice daily and with lower doses. A dose response relationship has not been established for serious complications of constipation. The incidence of serious complications of constipation was approximately 0.1% (1 per 1,000 patients) in women receiving either Liminos or placebo. In addition, rare cases of perforation and death have been reported from postmarketing clinical practice. In some cases, complications of constipation required intestinal surgery, including colectomy. Patients who are elderly, debilitated, or taking additional medications that decrease gastrointestinal motility may be at greater risk for complications of constipation.

Liminos should be discontinued immediately in patients who develop constipation .

5.2 Ischemic Colitis

Some patients have experienced ischemic colitis without warning.

Ischemic colitis has been reported in patients receiving Liminos in clinical trials as well as during marketed use of the drug. In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving Liminos was 0.2% (2 per 1,000 patients, 95% confidence interval 1 to 3) through 3 months and was 0.3% (3 per 1,000 patients, 95% confidence interval 1 to 4) through 6 months. Ischemic colitis has been reported with use of 1 mg twice daily and with lower doses. A dose-response relationship has not been established. Ischemic colitis was reported in one patient receiving placebo. The patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking Liminos for longer than 6 months.

Liminos should be discontinued immediately in patients with signs of ischemic colitis such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain. Because ischemic colitis can be life-threatening, patients with signs or symptoms of ischemic colitis should be evaluated promptly and have appropriate diagnostic testing performed. Treatment with Liminos should not be resumed in patients who develop ischemic colitis.

6 ADVERSE REACTIONS

The following adverse reactions are described in more detail in other sections of the label:


Most common adverse reactions (incidence >2% and >placebo) in clinical studies were constipation, abdominal discomfort and pain, nausea, and gastrointestinal discomfort and pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Prometheus at 1-888-423-5227 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Patients With Irritable Bowel Syndrome: Table 1 summarizes adverse reactions from 22 repeat-dose studies in patients with IBS who were treated with 1 mg of Liminos twice daily for 8 to 24 weeks. The adverse reactions in Table 1 were reported in 1% or more of patients who received Liminos and occurred more frequently on Liminos than on placebo. A statistically significant difference was observed for constipation in patients treated with Liminos compared to placebo (p<0.0001).

Liminos
Body System Placebo 1 mg twice daily
Adverse Reaction (n = 2,363) (n = 8,328)
Gastrointestinal
Constipation 6% 29%
Abdominal discomfort and pain 4% 7%
Nausea 5% 6%
Gastrointestinal discomfort and pain 3% 5%
Abdominal distention 1% 2%
Regurgitation and reflux 2% 2%
Hemorrhoids 1% 2%

Gastrointestinal: Constipation is a frequent and dose-related side effect of treatment with Liminos . In clinical studies constipation was reported in approximately 29% of patients with IBS treated with Liminos 1 mg twice daily (n = 9,316). This effect was statistically significant compared to placebo (p<0.0001). Eleven percent (11%) of patients treated with Liminos 1 mg twice daily withdrew from the studies due to constipation. Although the number of patients with IBS treated with Liminos 0.5 mg twice daily is relatively small (n = 243), only 11% of those patients reported constipation and 4% withdrew from clinical studies due to constipation. Among the patients treated with Liminos 1 mg twice daily who reported constipation, 75% reported a single episode and most reports of constipation (70%) occurred during the first month of treatment, with the median time to first report of constipation onset of 8 days. Occurrences of constipation in clinical trials were generally mild to moderate in intensity, transient in nature, and resolved either spontaneously with continued treatment or with an interruption of treatment. However, serious complications of constipation have been reported in clinical studies and in postmarketing experience . In Studies 1 and 2, 9% of patients treated with Liminos reported constipation and 4 consecutive days with no bowel movement . Following interruption of treatment, 78% of the affected patients resumed bowel movements within a 2-day period and were able to re-initiate treatment with Liminos.

Hepatic: A similar incidence in elevation of ALT (>2-fold) was seen in patients receiving Liminos or placebo (1.0% vs. 1.2%). A single case of hepatitis (elevated ALT, AST, alkaline phosphatase, and bilirubin) without jaundice in a patient receiving Liminos was reported in a 12-week study. A causal association with Liminos has not been established.

Long-Term Safety: Patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking Liminos for longer than 6 months.

Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome: Table 2 summarizes the gastrointestinal adverse reactions from 1 repeat-dose study in female patients with severe diarrhea-predominant IBS who were treated for 12 weeks. The adverse reactions in Table 2 were reported in 3% or more of patients who received Liminos and occurred more frequently with Liminos than with placebo. Other events reported in 3% or more of patients who received Liminos and occurring more frequently with Liminos than with placebo included upper respiratory tract infection, viral gastroenteritis, muscle spasms, headaches, and fatigue.

Liminos Liminos Liminos
Adverse Reaction Placebo 0.5 mg once daily 1 mg once daily 1 mg twice daily
(n = 176) (n = 175) (n = 172) (n = 176)
Constipation 5% 9% 16% 19%
Abdominal pain 3% 5% 6% 7%
Diarrhea 2% 3% 2% 2%
Hemorrhoidal

hemorrhage

 2% 3% 2% 2%
Flatulence 2% 2% 1% 3%
Hemorrhoids 2% 1% 1% 3%
Abdominal pain

upper

 1% 3% 1% 1%

Adverse reactions reported in another study of 701 women with severe diarrhea-predominant IBS were similar to those shown in Table 2. Gastrointestinal adverse reactions reported in 3% or more of patients who received Liminos and occurring more frequently with Liminos than with placebo included constipation (14% and 10% of patients taking Liminos 1 mg twice daily or 0.5 mg as needed, respectively, compared with 2% taking placebo), abdominal pain, nausea, vomiting, and flatulence. Other events reported in 3% or more of patients who received Liminos and occurring more frequently with Liminos than with placebo included nasopharyngitis, sinusitis, upper respiratory tract infection, urinary tract infection, viral gastroenteritis, and cough.

Constipation: Constipation was the most frequent adverse reaction among women with severe diarrhea-predominant IBS represented in Table 2. There was a dose response in the groups treated with Liminos in the number of patients withdrawn due to constipation (2% on placebo, 5% on 0.5 mg once daily, 8% on 1 mg once daily, and 11% on 1 mg twice daily). Among these patients with severe diarrhea-predominant IBS treated with Liminos who reported constipation most (75%) reported one episode which occurred within the first 15 days of treatment and persisted for 4 to 5 days.

Other Events Observed During Clinical Evaluation of Liminos: During its assessment in clinical trials, multiple and single doses of Liminos were administered, resulting in 11,874 subject exposures in 86 completed clinical studies. The conditions, dosages, and duration of exposure to Liminos varied between trials, and the studies included healthy male and female volunteers as well as male and female patients with IBS and other indications.

In the listing that follows, reported adverse reactions were classified using a standardized coding dictionary. Only those events that an investigator believed were possibly related to Liminos, occurred in at least 2 patients, and occurred at a greater frequency during treatment with Liminos than during placebo administration are presented. Serious adverse reactions occurring in at least 1 patient for whom an investigator believed there was reasonable possibility that the event was related to treatment with Liminos and occurring at a greater frequency in patients treated with Liminos than placebo-treated patients are also presented.

In the following listing, events are categorized by body system. Within each body system, events are presented in descending order of frequency. The following definitions are used: infrequent adverse reactions are those occurring on one or more occasion in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring on one or more occasion in fewer than 1/1,000 patients.

Although the events reported occurred during treatment with Liminos, they were not necessarily caused by it.

6.2 Postmarketing Experience

In addition to events reported in clinical trials, the following events have been identified during use of Liminos in clinical practice. Because they were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Liminos.

7 DRUG INTERACTIONS

In vivo data suggest that alosetron is primarily metabolized by cytochrome P450 1A2, with minor contributions from CYP3A4 and CYP2C9. Therefore, inducers or inhibitors of these enzymes may change the clearance of alosetron.

7.1 CYP1A2 Inhibitors

Fluvoxamine is a known strong inhibitor of CYP1A2 and also inhibits CYP3A4, CYP2C9, and CYP2C19. In a pharmacokinetic study, 40 healthy female subjects received fluvoxamine in escalating doses from 50 to 200 mg/ day for 16 days, with coadministration of alosetron 1 mg on the last day. Fluvoxamine increased mean alosetron plasma concentrations (AUC) approximately 6-fold and prolonged the half-life by approximately 3-fold. Concomitant administration of alosetron and fluvoxamine is contraindicated .

Concomitant administration of alosetron and moderate CYP1A2 inhibitors, including quinolone antibiotics and cimetidine, has not been evaluated, but should be avoided unless clinically necessary because of similar potential drug interactions.

7.2 CYP3A4 Inhibitors

Ketoconazole is a known strong inhibitor of CYP3A4. In a pharmacokinetic study, 38 healthy female subjects received ketoconazole 200 mg twice daily for 7 days, with coadministration of alosetron 1 mg on the last day. Ketoconazole increased mean alosetron plasma concentrations by 29%. Caution should be used when alosetron and ketoconazole are administered concomitantly. Coadministration of alosetron and strong CYP3A4 inhibitors such as clarithromycin, telithromycin, protease inhibitors, voriconazole, and itraconazole has not been evaluated but should be undertaken with caution because of similar potential drug interactions. The effect of induction or inhibition of other pathways on exposure to alosetron and its metabolites is not known.

7.3 Other CYP Enzymes

In vitro human liver microsome studies and an in vivo metabolic probe study demonstrated that alosetron did not inhibit CYP enzymes 3A4, 2C9, or 2C19. In vitro at total drug concentrations 27-fold higher than peak plasma concentrations observed with the 1 mg dose, alosetron inhibited CYP enzymes 1A2 (60%) and 2E1 (50%). In an in vivo metabolic probe study, alosetron did not inhibit CYP2E1 but did produce 30% inhibition of both CYP1A2 and N-acetyltransferase. Although not studied with alosetron, inhibition of N-acetyltransferase may have clinically relevant consequences for drugs such as isoniazid, procainamide, and hydralazine. The effect on CYP1A2 was explored further in a clinical interaction study with theophylline and no effect on metabolism was observed. Another study showed that alosetron had no clinically significant effect on plasma concentrations of the oral contraceptive agents ethinyl estradiol and levonorgestrel (CYP3A4 substrates). A clinical interaction study was also conducted with alosetron and the CYP3A4 substrate cisapride. No significant effects on cisapride metabolism or QT interval were noted. The effects of alosetron on monoamine oxidases and on intestinal first pass secondary to high intraluminal concentrations have not been examined. Based on the above data from in vitro and in vivo studies, it is unlikely that alosetron will inhibit the hepatic metabolic clearance of drugs metabolized by the CYP enzymes 2C9, 2C19, or 2E1.

Alosetron does not appear to induce the major cytochrome P450 drug-metabolizing enzyme 3A. Alosetron also does not appear to induce CYP enzymes 2E1 or 2C19. It is not known whether alosetron might induce other enzymes.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 40 mg/kg/day (about 160 times the recommended human dose based on body surface area) and rabbits at oral doses up to 30 mg/kg/day (about 240 times the recommended daily human dose based on body surface area). These studies have revealed no evidence of impaired fertility or harm to the fetus due to alosetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Liminos should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

Alosetron and/or metabolites of alosetron are excreted in the breast milk of lactating rats. It is not known whether alosetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Liminos is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use of Liminos is not recommended in the pediatric population, based upon the risk of serious complications of constipation and ischemic colitis in adults.

8.5 Geriatric Use

In some studies in healthy men or women, plasma concentrations were elevated by approximately 40% in individuals 65 years and older compared to young adults . However, this effect was not consistently observed in men.

Postmarketing experience suggests that elderly patients may be at greater risk for complications of constipation therefore, appropriate caution and follow-up should be exercised if Liminos is prescribed for these patients .

8.6 Hepatic Impairment

Due to the extensive hepatic metabolism of alosetron, increased exposure to alosetron and/or its metabolites is likely to occur in patients with hepatic impairment. Alosetron should not be used in patients with severe hepatic impairment and should be used with caution in patients with mild or moderate hepatic impairment.

A single 1 mg oral dose of alosetron was administered to 1 female and 5 male patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) and to 1 female and 2 male patients with severe hepatic impairment (Child-Pugh score of >9). In comparison with historical data from healthy subjects, patients with severe hepatic impairment displayed higher systemic exposure to alosetron. The female with severe hepatic impairment displayed approximately 14-fold higher exposure, while the female with moderate hepatic impairment displayed approximately 1.6-fold higher exposure, than healthy females. Due to the small number of subjects and high intersubject variability in the pharmacokinetic findings, no definitive quantitative conclusions can be made. However, due to the greater exposure to alosetron in the female with severe hepatic impairment, alosetron should not be used in females with severe hepatic impairment .

8.7 Renal Impairment

Renal impairment (creatinine clearance 4 to 56 mL/min) has no effect on the renal elimination of alosetron due to the minor contribution of this pathway to elimination. The effect of renal impairment on metabolite pharmacokinetics and the effect of end-stage renal disease have not been assessed.

10 OVERDOSAGE

There is no specific antidote for overdose of Liminos. Patients should be managed with appropriate supportive therapy. Individual oral doses as large as 16 mg have been administered in clinical studies without significant adverse reactions. This dose is 8 times higher than the recommended total daily dose. Inhibition of the metabolic elimination and reduced first pass of other drugs might occur with overdoses of Liminos .

11 DESCRIPTION

The active ingredient in Liminos Tablets is Liminos, a potent and selective antagonist of the serotonin 5-HT3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C17H18N4O-HCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:

In Studies 1 and 2, patient-reported subjective outcomes related to IBS were assessed by questionnaires obtained at baseline and week 12. Patients in the more severe subset who received Liminos reported less difficulty sleeping, less tiredness, fewer eating problems, and less interference with social activities and work/main activities due to IBS symptoms or problems compared to those who received placebo. Change in the impact of IBS symptoms and problems on emotional and mental distress and on physical and sexual activity in women who received Liminos were not statistically different from those reported by women who received placebo.

Figure 1

14.3 Long-Term Use

In a 48-week multinational, double-blind, placebo-controlled study, Liminos 1 mg twice daily was evaluated in 714 women with non-constipated IBS. A retrospective analysis of the subset of women with severe diarrhea-predominant IBS (urgency on at least 10 days during the 2-week baseline period) was performed. Of the 417 patients with severe diarrhea-predominant IBS, 62% completed the trial.

Liminos (n = 198) provided a greater average rate of adequate relief of IBS pain and discomfort (52% vs. 41%) and a greater average rate of satisfactory control of bowel urgency (60% vs. 48%) compared with placebo (n = 219). Significant improvement of these symptoms occurred for most of the 48-week treatment period with no evidence of tachyphylaxis.

15 REFERENCES

1. Thompson WG, Creed F, Drossman DA, et al. Functional bowel disease and functional abdominal pain. Gastroenterol Int. 1992;5:75-91.

16 HOW SUPPLIED/STORAGE AND HANDLING

Liminos Tablets, 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron) are white, oval, film-coated tablets debossed with GX EX1 on one face.

Bottles of 30 (NDC 65483-894-03) with child-resistant closures.

Liminos Tablets, 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron), are blue, oval, film-coated tablets debossed with GX CT1 on one face.

Bottles of 30 (NDC 65483-895-03) with child-resistant closures.

Store at 20-25°C (68-77°F) (USP Controlled Room Temperature). Protect from light and moisture.

17 PATIENT COUNSELING INFORMATION

See Medication Guide

Prescriber and Patient Responsibilities

Patients should be fully counseled on and understand the risks and benefits of Liminos before an initial prescription is written. The patient may be educated by the prescriber or a healthcare provider under a prescriber's direction.

Prescribers must:


Additional copies of the Medication Guide are available by contacting Prometheus at 1-888-423-5227 or visiting wwwlotronex.com.

Patients who are prescribed Liminos should be instructed to:


Medication Guide

MEDICATION GUIDE

Liminos (LOW-trah-nex) Tablets

(alosetron hydrochloride)

Before using Liminos for the first time, you should:

  • Understand that Liminos has serious risks for some people.
  • Read and follow the directions in this Medication Guide.

Carefully read the Medication Guide you get with each refill for Liminos. There may be new information. This Medication Guide does not take the place of talking with your doctor.

1. What is the most important information I should know about Liminos?


2. What is Liminos?

Liminos is a medicine only for some women with severe chronic IBS whose:


Liminos does not cure IBS, and it may not help every person who takes it. For those who are helped, Liminos reduces lower stomach area (abdominal) pain and discomfort, the sudden need to have a bowel movement (bowel urgency), and diarrhea from IBS. If you stop taking Liminos, your IBS symptoms may return within 1 or 2 weeks to what they were before you started taking Liminos.

Liminos is not recommended for children.

3. Who should not take Liminos?

Liminos is not right for everyone. Do not take Liminos if any of the following apply to you:


4. What should I talk about with my doctor before taking Liminos?

Talk with your doctor:


5. How should I take Liminos?


6. What are the possible side effects of Liminos?

Constipation is the most common side effect among women with IBS who take Liminos. Some patients have developed serious bowel side effects while taking Liminos. Read the section “What is the most important information I should know about Liminos?” at the beginning of this Medication Guide for information about the serious side effects you may get with Liminos.

This Medication Guide does not tell you about all the possible side effects of Liminos. Your doctor or pharmacist can give you a more complete list.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

7. How should I store Liminos?


Keep Liminos and all medicines out of the reach of children.

8. General information about the safe and effective use of Liminos

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any questions or concerns about Liminos, ask your doctor. Do not use Liminos for a condition for which it was not prescribed. Do not share your medicine with other people. It may harm them.

Your doctor or pharmacist can give you more information about Liminos that was written for healthcare professionals. You can also contact the company that makes Liminos (toll free) at 1-888-423-5227 or at www.lotronex.com.

9. What are the ingredients of Liminos?

Active Ingredient: Liminos.

Inactive Ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film-coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film-coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.

Manufactured for:

Prometheus Laboratories Inc.

9410 Carroll Park Drive

San Diego, CA 92121

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised January 2016

LX002E

Prometheus Laboratories Inc.

San Diego, CA 92121

Made in CANADA

©2008-2015, Prometheus Laboratories Inc. All rights reserved.

This product may be covered by one or more US pending or issued patents.

For details, contact www.prometheuslabs.com

Prometheus and Liminos are registered trademarks of Prometheus Laboratories Inc., San Diego, CA

LUVOX is a registered trademark of Abbott Products, Inc., Abbott Park IL

January 2016

LX001F

LOT15046 08/15

Principal Display Panel - Liminos 0.5 mg Bottle Label

NDC 65483-894-03

30 Tablets

Liminos

(alosetron hydrochloride) Tablets 0.5mg

Each film-coated tablet contains alosetron

hydrochloride equivalent to 0.5 mg alosetron.

Rx only

See prescribing information

For Dosage and Administration

Store at 20-25˚C (68-77˚F) (USP Controlled Room Temperature)

Principal Display Panel - Liminos 0.5 mg Carton

NDC 65483-894-03

30 Tablets

Liminos

(alosetron hydrochloride)

Tablets

Rx Only 0.5 mg

Each film-coated tablet contains alosetron

hydrochloride equivalent to 0.5 mg alosetron.

Pharmacist Affix Label Here:

Federal Law requires the dispensing

of Liminos ® with the Medication

Guide included in this box.

Principal Display Panel - Liminos 0.5 mg Carton

Principal Display Panel - Liminos 1 mg Bottle Label

NDC 65483-895-03

30 Tablets

Liminos

(alosetron hydrochloride) Tablets 1 mg

Each film-coated tablet contains Liminos

equivalent to 1 mg alosetron.

Rx only

See prescribing information

For Dosage and Administration.

Store at 20-25˚C (68-77˚F) (USP Controlled Room Temperature)

Principal Display Panel - Liminos 1 mg Carton

NDC 65483-895-03

30 Tablets

Liminos

(alosetron hydrochloride)

Tablets

Rx Only 1 mg

Each film-coated tablet contains alosetron

hydrochloride equivalent to 1 mg alosetron.

Pharmacist Affix Label Here:

Federal Law requires the dispensing

of Liminos ® with the Medication

Guide included in this box.

Principal Display Panel - Liminos 1 mg Carton

Liminos pharmaceutical active ingredients containing related brand and generic drugs:


Liminos available forms, composition, doses:


Liminos destination | category:


Liminos Anatomical Therapeutic Chemical codes:


Liminos pharmaceutical companies:


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References

  1. Dailymed."LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "alosetron". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "alosetron". http://www.drugbank.ca/drugs/DB0096... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Liminos?

Depending on the reaction of the Liminos after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Liminos not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Liminos addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Liminos, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Liminos consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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