Updates from FDA
APhA Staff
New dosage forms
METOPROLOL TARTRATE ORAL SOLUTION
(Lopressor—Rubicon)
Drug class: Lopressor is a β-adrenergic blocker.
Indication: Lopressor is indicated for the treatment of hypertension, in the long-term treatment of angina pectoris, and in the treatment of hemodynamically stable patients with definite or suspected myocardial infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy.
Recommended dosage and administration: Administer once daily with food or after a meal. Titrate at weekly or longer intervals as needed and tolerated. For hypertension, the recommended starting dosage is 100 mg orally daily, in single or divided doses. For angina pectoris, the recommended starting dosage is 100 mg orally daily, given as two divided doses. For myocardial infarction, the starting dosage depends upon tolerance of intravenous metoprolol. Each milliliter of Lopressor oral solution contains 10 mg of metoprolol tartrate.
Common adverse effects: The most common adverse reactions include tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, and rash.
Warnings and precautions: Lopressor is contraindicated in known hypersensitivity to product components, severe bradycardia, greater than first degree heart block or sick sinus syndrome without a pacemaker, and cardiogenic shock or decompensated heart failure. Abrupt cessation of Lopressor may exacerbate myocardial ischemia. Worsening cardiac failure may occur while being treated with Lopressor. Avoid β-blockers in bronchospastic disease. Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery. Do not routinely withdraw chronic β-blocker therapy prior to surgery. Lopressor may mask symptoms of hypoglycemia. Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. In peripheral vascular disease, Lopressor may aggravate symptoms of arterial insufficiency. Catecholamine-depleting drugs may have an additive effect when given with β-blocking agents. Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. CYP2D6 inhibitors are likely to increase metoprolol concentration. Concomitant use of glycosides, clonidine, and diltiazem and verapamil with β-blockers can increase the risk of bradycardia. β-blockers, including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. Consider initiating Lopressor therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events.
ARIPIPRAZOLE ORAL FILM
(Mezofy—CMG Pharmaceutical)
Drug class: Mezofy is an atypical antipsychotic.
Indication: Mezofy is indicated for the treatment of schizophrenia in adult and pediatric patients ages 13 years and older.
Recommended dosage and administration: The recommended starting dosage for adults is 10 mg/day to 15 mg/day with a maximum dosage of 30 mg/day. The starting dosage in pediatric patients aged 13 to 17 years is 2 mg/day with another aripiprazole product. The recommended dosage in these pediatric patients is 10 mg/day and the maximum dosage is 30 mg/day. Mezofy should be administered once daily with or without food. Dosage adjustments requiring dosage strengths below 5 mg require the use of another aripiprazole product.
Common adverse effects: The most common adverse reactions include akathisia, extrapyramidal disorder, somnolence, and tremor.
Boxed warning: Older adult patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Mezofy is not approved for the treatment of patients with dementia-related psychosis.
Other warnings and precautions: Mezofy is contraindicated in known hypersensitivity to aripiprazole. In older adult patients with dementia-related psychosis, there is increased incidence of cerebrovascular adverse reactions while using Mezofy. If neuroleptic malignant syndrome occurs, manage with immediate discontinuation and close monitoring. If tardive dyskinesia occurs, discontinue Mezofy if clinically appropriate. Monitor patients for hyperglycemia, dyslipidemia, and weight gain. If pathological gambling and other compulsive behaviors occur, consider dose reduction or discontinuation. Monitor heart rate and BP and warn patients with known cardiovascular or cerebrovascular disease of the risk of dehydration or syncope. Perform complete blood cell counts in patients with a history of clinically significant low white blood cell count/absolute neutrophil count. Consider discontinuing Mezofy if clinically significant decline in these counts occur in the absence of other causative factors. Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. There is a potential for cognitive and motor impairment so use caution when operating machinery. If Mezofy is used in CYP2D6 poor metabolizers, administer half the recommended dose and in poor metabolizers taking concomitant strong CYP3A4 inhibitors, administer a quarter the recommended dose. If taken concomitantly with strong CYP2D6 or CYP3A4 inhibitors, administer half the recommended dose. If taken concomitantly with strong CYP2D6 and CYP3A4 inhibitors, administer a quarter of the recommended dose. If taken concomitantly with strong CYP3A4 inducers, double the recommended dose over 1 to 2 weeks. If Mezofy is taken during pregnancy, it may cause extrapyramidal or withdrawal symptoms in neonates with third trimester exposure.
APIXABAN FOR ORAL SUSPENSION
(Eliquis Sprinkle—Bristol Myers Squibb)
Drug class: Eliquis is a factor Xa inhibitor.
Indication: Eliquis is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular AFib, for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery, for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE in adult patients following initial therapy, and for treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment.
Recommended dosage and administration: For reduction of risk of stroke and systemic embolism in nonvalvular AFib, the recommended dose is 5 mg orally twice daily. In patients with at least two of the following characteristics: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1.5 mg/dL, the recommended dose is 2.5 mg orally daily. For prophylaxis of DVT following hip or knee replacement surgery, the recommended dose is 2.5 mg orally twice daily. For treatment of DVT and PE, the recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily. For reduction in the risk of recurrent DVT and PE following initial therapy, the recommended dose is 2.5 mg orally twice daily. For treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth and older after at least 5 days of initial anticoagulant treatment, dosing recommendations in the Full Prescribing Information should be referenced.
Common adverse effects: The most common adverse reactions are bleeding, headache, vomiting, and excessive menstrual bleeding.
Boxed warning: Premature discontinuation of any oral anticoagulant, including Eliquis, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if Eliquis is discontinued for a reason other than pathological bleeding or completion of a course of therapy. Epidural or spinal hematomas may occur in patients treated with Eliquis who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
Other warnings and precautions: Eliquis is contraindicated in active pathological bleeding and severe hypersensitivity to Eliquis. Eliquis can cause serious, potentially fatal, bleeding. Promptly evaluate signs and symptoms of blood loss. An agent to reverse the anti-factor Xa activity of apixaban is available. Eliquis use is not recommended in patients with prosthetic heart valves or triple positive antiphospholipid syndrome with an increased risk of thrombosis. Combined P-gp and strong CYP3A4 inhibitors increase blood levels of apixaban. Reduce the Eliquis dose or avoid coadministration. Simultaneous use of combined P-gp and strong CYP3A4 inducers reduces blood levels of apixaban so avoid concomitant use. Eliquis is not recommended in pregnancy or while breastfeeding. Patients with severe hepatic impairment should not use Eliquis.
New indications
UPADACITINIB
(Rinvoq—Abbvie)
Drug class: Rinvoq is a Janus kinase inhibitor.
Indication: Rinvoq is approved for several indications, with the newest indication being for the treatment of adults with giant cell arteritis.
Recommended dosage and administration: The recommended dose of Rinvoq for the treatment of giant cell arteritis is 15 mg once daily in combination with a tapering course of corticosteroids. Rinvoq 15 mg once daily can be used as monotherapy following discontinuation of corticosteroids.
Common adverse effects: The most common adverse reactions in patients using Rinvoq to treat giant cell arteritis are upper respiratory tract infections, headache, fatigue, peripheral edema, cough, anemia, rash, herpes zoster, and nausea.
Warnings and precautions: Rinvoq is contraindicated in known hypersensitivity to upadacitinib or any of the excipients. Avoid use in patients with active, serious infection, including localized infections. Serious hypersensitivity reactions have occurred and Rinvoq should be discontinued in this scenario. Monitor patients at risk for GI perforations and promptly evaluate patients with symptoms. Monitor for potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids. Rinvoq may cause fetal harm based on animal studies. Advise patients of reproductive potential of the possible risk to a fetus and to use effective contraception. Avoid use with live vaccinations. Medication residue has been observed in stool or ostomy output in patients with shortened GI transit times. Monitor patients clinically and consider alternative treatment if needed. Advise patients not to breastfeed during treatment. Rinvoq is not recommended in patients with severe hepatic impairment.
OSILODROSTAT
(Isturisa—Recordati Rare Diseases)
Drug class: Isturisa is a cortisol synthesis inhibitor.
Indication: Isturisa is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.
Recommended dosage and administration: Correct hypokalemia and hypomagnesemia, and obtain a baseline ECG prior to starting Isturisa. Initiate dosage at 2 mg orally twice daily, with or without food. Titrate the dosage by 1 to 2 mg twice daily, no more frequently than every 2 weeks based on rate of cortisol changes, individual tolerability, and improvement in signs and symptoms. The maximum recommended dosage is 30 mg twice daily. In patients with hepatic impairment, dosage modifications are recommended.
Common adverse effects: The most common adverse reactions are adrenal insufficiency, fatigue, nausea, headache, and edema.
Warnings and precautions: Monitor patients closely for hypocortisolism and potentially life-threatening adrenal insufficiency. Dosage reduction or interruption may be necessary. Perform ECG in all patients. Use with caution in patients with risk factors for QTc prolongation. Monitor for hypokalemia, worsening of hypertension, edema, and hirsutism. If Isturisa is taken concomitantly with a strong CYP3A4 inhibitor, reduce the dose of Isturisa by half. An increase of Isturisa dosage may be needed if Isturisa is used concomitantly with strong CYP3A4 and CYP2B6 inducers. A reduction in Isturisa dosage may be needed if strong CYP3A4 and CYP2B6 inducers are discontinued while using Isturisa. Breastfeeding is not recommended during treatment with Isturisa and for at least one week after treatment. ■
FDA approves three food colors from natural sources
On May 9, 2025, FDA announced that it granted three new color additive petitions, which will expand the amount of available colors from natural sources that manufacturers can use safely in foods.
Galdieria extract blue, a blue color derived from the unicellular red algae, Galdieria sulphuraria, was approved for use in nonalcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milkshakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy products, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers, and whipped toppings.
Butterfly pea flower extract is a blue color that can be used to create a range of shades including purples and greens. The extract is produced through the water extraction of dried flower petals and was previously approved for use in sport drinks, fruit drinks, fruit and vegetable juices, alcoholic beverages, dairy drinks, ready-to-drink teas, nutritional beverages, gums, candy, coated nuts, ice creams, and yogurt. The new approval is for coloring ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips, plain corn chips, tortilla chips, and multigrain chips.
Calcium phosphate, a white color, was approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. FDA determines whether a color additive is safe by considering the projected human dietary exposure, the additive’s toxicological data, and published literature. ■