Medication Monitor

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Generic Name (Trade Name—Company)
  • April 9, 2013


    Treatment of pregnancy-related nausea and vomiting that cannot be managed by changes in diet and lifestyle

    FDA has approved doxylamine succinate–pyridoxine hydrochloride as the only category A drug for nausea and vomiting drug to pregnancy. Doxylamine succinate–pyridoxine hydrochloride is a delayed-release tablet intended for women who have not responded adequately to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.

    The drug was studied in 261 women experiencing nausea and vomiting due to pregnancy. Study participants in the clinical trial were at least 18 years old and had been pregnant for at least 7 weeks and up to 14 weeks. Women were randomly assigned to receive 2 weeks of treatment with doxylamine succinate–pyridoxine hydrochloride or a placebo. Women taking the drug experienced greater improvement in nausea and vomiting than those taking placebo. Additionally, observational (epidemiological) studies have shown that the combination of active ingredients does not pose an increased risk of harm to the fetus.

    Doxylamine succinate–pyridoxine hydrochloride is taken daily. Tablets must be taken whole on an empty stomach. The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one midafternoon, and two at bedtime).

    Drowsiness or sleepiness, which can be severe, is the most common adverse effect reported. Women should avoid taking the medication when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.

  • February 1, 2017

    Teva announced FDA approval of two BX-rated generic products for adolescent and adult patients with asthma: fluticasone propionate and salmeterol inhalation powder (AirDuo RespiClick) and fluticasone propionate inhalation powder (ArmonAir RespiClick).

    AirDuo RespiClick, a fixed-dose combination product containing the same active ingredients as Advair, is a corticosteroid and long-acting beta2-adrenergic agonist indicated for treatment of asthma in patients aged 12 years and older. 

    ArmonAir RespiClick, an inhaled corticosteroid containing the same active ingredient as Flovent, is indicated for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.

    These BX generics cannot be substituted for Advair without permission of the prescriber.

    The medications are delivered via Teva’s RespiClick breath-activated, multidose dry powder inhaler.

    Both products, approved in three strengths each, are expected to become available to patients later in 2017. Approved strengths of AirDuo RespiClick are 55/14 mcg, 113/14 mcg, and 232/14 mcg administered as one inhalation twice daily. Approved strengths of ArmonAir RespiClick are 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.

    Approval was based on data from three Phase III trials evaluating the efficacy and safety of the treatments in adolescent and adult patients with asthma.  

    In the two double-blind studies, both therapies showed clinically relevant and greater benefit compared with placebo in improvement of lung function after 12 weeks of treatment as measured by forced expiratory volume in one second (FEV1).

  • December 5, 2012

    The 32-mg single I.V. dose of ondansetron has been pulled from the market, FDA announced yesterday, because of concerns related to cardiac adverse events. In June, the agency warned that the 32-mg dose should be avoided because of the risk of QT interval prolongation, which can lead to torsade de pointes. Preliminary results of a study ordered by the FDA found a maximum mean difference in QTcF of 20 ms after the 32 mg intravenous dose, compared with a QTcF difference of 6 ms for the 8 mg intravenous dose.

    FDA noted that removal of the 32-mg dose should not contribute to a potential ondansetron shortage, as this dose only made up a small percentage of the current market. The agency also noted that it will continue to recommend an I.V. regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral ondansetron was also discussed as an effective alternative for the management of chemotherapy-induced nausea and vomiting.

  • October 5, 2012

    FDA has released an update reporting that Budeprion XL 300 mg is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg. This update is based on data from an agency-sponsored study which concluded that Budeprion XL 300 mg tablets failed to release bupropion into the blood at the same rate and to the same extent as the branded product. FDA conducted this study in response to numerous reports that patients who switched from Wellbutrin XL 300 mg to the generic product were experiencing reduced efficacy.

    Based on these data, Impax has requested that the FDA withdraw approval of Budeprion XL 300 mg extended-release tablets and has stopped shipping the product. In addition, it has issued detailed information to patients about this product withdrawal. This update does not apply to the 150-mg dose of Budeprion XL or to the other four generic bupropion extended-release products made by other manufacturers.

    FDA noted that it has not conducted bioequivalence studies of the other four generic versions of Wellbutrin XL 300 mg, but has recently asked each of the other manufacturers—Anchen, Actavis, Watson, and Mylan—to conduct their own studies to assess the bioequivalence of their 300-mg extended-release bupropion tablets to Wellbutrin XL 300 mg. Data from these studies are to be submitted to the agency no later than March 2013.

    Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should talk with their health provider if they have questions about taking this medication, the agency advised.

  • September 23, 2011

    As reported earlier this year in Pharmacy TodayPrimatene Mist, the only FDA-approved OTC inhaler for temporary relief of occasional symptoms of mild asthma on the U.S. market, is being withdrawn after December 31 of this year. 

    FDA is concerned that current users of the product may be self-treating their conditions. Since all other currently available products for asthma require a prescription, Primatene Mist users need to act now to see a prescriber and obtain the medications they need. In addition, the agency is concerned that many of these patients are likely uninsured and may have financial difficulties in seeing a prescriber and paying for prescription products.

    Primatene Mist uses chlorofluorocarbon (CFC) as its propellant, and the U.S. is phasing out CFC use because of obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. The phaseout of CFC-containing inhalers was announced by FDA in 2008, and many manufacturers of prescription inhalers have already converted their propellants to environmentally friendly hydrofluoroalkane (HFA).

    FDA said during a September 22 news conference that two prescription inhalers will be withdrawn from the market on December 31, 2013, if they are not reformulated with HFA or another acceptable propellant. They are Combivent Inhalation Aerosol (albuterol/ipratropium—Boehringer Ingelheim) and Maxair Autohaler (pirbuterol—Graceway Pharmaceuticals).

    Pharmacists should advise patients currently using OTC inhalers to contact their health provider to have symptoms evaluated and obtain prescription asthma medications if needed. FDA has provided several helpful counseling tips for patients currently using OTC epinephrine inhalers. These include telling patients to ask a family member, friend, or co-worker about a doctor they use and would recommend, helping patients with payment options and company assistance plans, and educating patients on use of their new prescription inhalers once they are transitioned to these products. The last point is especially important, an FDA official said, as the replacement products may taste and feel different.