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Lubiprostone is used for the management of chronic idiopathic constipation in adults.
Safety and efficacy of lubiprostone have been evaluated in 2 randomized, double-blind, placebo-controlled studies in a total of 479 adults (mean age: about 47 years, range: 20-81 years; 89% female; 80.8% white; 9.6% black; 7.3% Hispanic; 1.5% Asian) with chronic idiopathic constipation. In these studies, constipation was characterized by an average of less than 3 spontaneous bowel movements per week and the presence of one or more of 3 symptoms (very hard stools, sensation of incomplete evacuation, straining at defecation) occurring at least 25% of the time over a 6-month period prior to randomization. In these trials, patients receiving lubiprostone (24 mcg twice daily) had a higher frequency of spontaneous bowel movements, a decrease in signs and symptoms of constipation (including abdominal bloating, abdominal discomfort, stool consistency, and straining), and a decrease in constipation severity ratings compared with those receiving placebo. 57-63% of patients receiving lubiprostone (24 mcg twice daily) experienced spontaneous bowel movements within 24 hours after administration of treatment compared with 32-37% of those receiving placebo. In addition, the time to first spontaneous bowel movement was shorter in patients receiving the drug than in those receiving placebo. A rebound effect was not observed upon withdrawal of the drug following 4 weeks of treatment.
In 3 long-term, open-label safety trials in a total of 871 patients with chronic idiopathic constipation, lubiprostone (24 mcg twice daily for 6-12 months) was associated with decreases in abdominal bloating, abdominal discomfort, and severity of constipation throughout the treatment period.
Irritable Bowel Syndrome with Constipation in Women
Lubiprostone is used for the treatment of irritable bowel syndrome (IBS) with constipation in women 18 years of age or older.
Safety and efficacy of lubiprostone have been evaluated in 2 double-blind, placebo-controlled studies in a total of 1154 adults (mean age: about 47 years, range: 18-85 years; 91.6% female; 77.4% white; 13.2% black; 8.5% Hispanic; 0.4% Asian) with IBS with constipation. In these studies, IBS was defined as abdominal pain or discomfort occurring over at least 6 months with 2 or more of 3 characteristics (relief with defecation, onset associated with change in stool frequency, or onset associated with change in stool form). The subtype of IBS with constipation was defined by the presence of 2 of 3 symptoms (less than 3 spontaneous bowel movements per week, more than 25% hard stools, more than 25% of spontaneous bowel movements associated with straining). Patients were randomized to receive lubiprostone 8 mcg twice daily (16 mcg daily) or placebo twice daily for 12 weeks. The primary end point was the number of ''overall responders'' as determined by patients' response (frequency of IBS) to a questionnaire. The percentage of patients qualifying as overall responders was 13.8 and 12.1% in study 1 and 2, respectively, while percentages of overall responders were 7.8 and 5.7% in those receiving placebo in study 1 and 2, respectively. In study 1, a rebound effect was not observed upon withdrawal of the drug following 12 weeks of treatment. Results of an open-label extension of these studies found that lubiprostone remained safe and effective for an additional 36 weeks.
Dosage and Administration
Lubiprostone is administered orally twice daily with food and water. Food may decrease peak plasma concentrations of the drug by 55%; however, the clinical importance of this effect has not been elucidated and the manufacturer states that lubiprostone should be taken with food and water to reduce symptoms of nausea.
Clinicians and patients (with chronic idiopathic constipation or irritable bowel syndrome with constipation) should periodically assess the need for continued therapy.
Chronic Idiopathic Constipation
The recommended adult dosage of lubiprostone for the treatment of chronic idiopathic constipation is 24 mcg twice daily.
Because dose-dependent nausea (sometimes severe) occurred frequently in patients receiving lubiprostone 24 mcg twice daily, dosage reduction to 24 mcg daily was allowed in such patients in the open-label, long-term studies.
Irritable Bowel Syndrome with Constipation in Women
The recommended adult dosage of lubiprostone for the treatment of irritable bowel syndrome with constipation in women is 8 mcg twice daily.
No special population recommendations at this time.
Known hypersensitivity to lubiprostone or any ingredient in the formulation. Known or suspected mechanical GI obstruction.
Patients with symptoms suggestive of mechanical GI obstruction should be evaluated thoroughly to confirm absence of such obstruction prior to initiating lubiprostone therapy. (See Cautions: Contraindications.)
Fetal/Neonatal Morbidity and Mortality
Women of childbearing potential should have a negative pregnancy test prior to receiving lubiprostone and should use an effective method of contraception during therapy with the drug.
Dose-dependent nausea may occur. Symptoms may be reduced by coadministration with food and water.
Possible diarrhea (may be severe). Lubiprostone should not be prescribed to patients experiencing severe diarrhea.
Possible dyspnea (may result in discontinuance of drug). Acute onset of symptoms (e.g., sensation of chest tightness, difficulty in breathing) may occur, generally within 30-60 minutes after taking first dose. Symptoms usually resolve within a few hours; however, they frequently recur with subsequent doses.
Category C. (See Users Guide.) (Also see Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)
Not known whether lubiprostone is distributed into human milk; discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Safety and efficacy not established in patients younger than 18 years of age.
Efficacy of lubiprostone in geriatric patients (65 years of age and older) with chronic idiopathic constipation was consistent with efficacy of the drug in the overall study population. Geriatric patients experienced a lower incidence (18 versus 29%) of associated nausea than the overall study population.
Experience in those 65 years of age or older with irritable bowel syndrome (IBS) with constipation was insufficient to determine whether they respond differently from younger adults. Safety profile of lubiprostone in these patients was consistent with the safety profile in the overall study population.
Hepatic or Renal Impairment
Lubiprostone has not been studied in patients with renal or hepatic impairment.
Common Adverse Effects
Adverse effects reported in about 2% or more of patients receiving lubiprostone for the management of chronic idiopathic constipation include nausea, diarrhea, headache, abdominal distention, abdominal pain, flatulence, vomiting, dizziness, edema, loose stools, abdominal discomfort (abdominal tenderness, abdominal rigidity, GI discomfort), dyspepsia, chest discomfort/pain, dyspnea, and fatigue.
Adverse effects reported in about 3% or more of women receiving lubiprostone for the treatment of IBS with constipation include nausea, diarrhea, abdominal pain, and abdominal distention.
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
Pharmacokinetic interactions unlikely. In vitro, lubiprostone does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, or 3A4 or induce isoenzymes 1A2, 2B6, 2C9, or 3A4. Lubiprostone is not metabolized by CYP isoenzymes.