Medication Monitor

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  • July 17, 2019

    Zydus Cadila announced FDA approval of misoprostol tablets, a generic of Cytotec, 100 mcg and 200 mcg to prevent stomach ulcers in patients taking pain medications, especially if the patient is at risk for developing ulcers or has a past history of ulcers.

    Misoprostol helps to decrease risk of serious ulcer complications such as bleeding.

  • July 17, 2019

    FDA has approved gadobutrol injection, the first contrast agent for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).

    Gadobutrol-enhanced cardiac MRI demonstrated efficacy in a large, global, multicenter Phase III clinical trial of almost 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy.

    Cardiac MRI is now the fourth FDA-approved indication for Gadobutrol, which was originally approved in 2011.

  • July 16, 2019

    Teva announced FDA approval of fluticasone propionate 113 mcg and salmeterol 14 mcg inhalation powder (AirDuo Digihale), a combination therapy digital inhaler to treat asthma in patients ages 12 years and older. The inhaler has built-in sensors that connect to a companion mobile application to provide information on inhaler use to people with asthma.

    According to Teva, with this approval, patients can now track how frequently they are using their inhalers and share the information with their doctors.

    Patients can also schedule reminders on their smartphone to take their AirDuo Digihaler as prescribed.

    The inhaler was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg, and 232/14 mcg administered as one inhalation twice daily. As a fixed-dose combination asthma therapy containing an ICS and a LABA, AirDuo Digihaler contains the same active ingredients as Advair Diskus, which was also approved in low, medium, and high doses: 100/50 mcg, 250/50 mcg, and 500/50 mcg.

    Common adverse effects AirDuo Digihaler include nasopharyngitis, thrush in the mouth or throat, back pain, headache, and cough.

    AirDuo Digihaler is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

  • July 16, 2019

    Azurity Pharmaceuticals announced FDA approval of the first amlodipine oral suspension, 1 mg/mL, to treat hypertension in adults and pediatric patients ages 6 years and older and coronary artery disease in adults.

    The calcium channel blocker may be used alone or in combination with other antihypertensive and antianginal agents.

    It comes as a ready-to-use (simply shake) oral suspension for patients who require or prefer an oral liquid option of amlodipine. The recommended starting dose for adults is 5 mg orally once daily, with the maximum dose 10 mg once daily. For small, fragile, or older adult patients or patients with hepatic insufficiency, the starting dose is 2.5 mg once daily. The pediatric starting dose is 2.5 mg to 5 mg once daily.

    The most common adverse reaction is dose-related edema. Other adverse experiences not dose related but reported with an incidence greater than 1% are fatigue, nausea, abdominal pain, and somnolence.


  • July 8, 2019

    Retrophin announced FDA approval of 100-mg and 300-mg tablets of tiopronin, a new enteric-coated formulation, for treatment of cystinuria. This rare inherited disorder causes a buildup of cystine levels in the urine, resulting in the formation of recurring cystine kidney stones. 

    The new formulation can be administered with or without food, whereas the original formulation of 100 mg tiopronin is recommended to be taken at least 1 hour before or 2 hours after meals.

    The recommended initial dosage of tiopronin in adult patients is 800 mg per day. In clinical studies, the average dose was approximately 1,000 mg, or 10 tablets per day.

    The most common adverse reactions are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.