What would be the new Acetaminophen strength in a reformulated Vicodin?
a. 500 mg b. 300 mg c. 325 mg d. None of the above
What would be the new Acetaminophen strength in a reformulated Vicodin?
a. 500 mg b. 300 mg c. 325 mg d. None of the above
Answer(b): 300 mg. On January 13, 2011, the U.S. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per dosage unit.
The FDA has stated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing.
The FDA requested this change be effected by January 2014. Abbott, the manufacturer of Vicodin, has complied with this directive ahead of the FDA's requested date and has introduced new formulations of Vicodin (Hydrocodone bitartrate and Acetaminophen tablets, USP) with reduced acetaminophen content in the third quarter of 2012.
Vicodin is available in the following new formulations:
a. Hypertension b. Major Depressive Disorder c. Arthritis d. Diabetes mellitus e. Male pattern baldness
Brintellix is indicated for the treatment of:
a. Hypertension b. Major Depressive Disorder c. Arthritis d. Diabetes mellitus e. Male pattern baldness
Answer(b): Major depressive disorder. The active ingredient found in Vortioxetine (Brintellix) is Vortioxetine. Each Vortioxetine (Brintellix) tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of Vortioxetine, respectively. Vortioxetine (Brintellix) is indicated for the treatment of major depressive disorder (MDD).
The recommended starting dose is 10 mg administered orally once daily without regard to meals. Dosage should then be increased to 20 mg/day, as tolerated, because higher doses demonstrated better treatment effects in trials conducted in the United States. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses.
At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with Vortioxetine (Brintellix) to avoid the risk of Serotonin Syndrome. Conversely, at least 21 days should be allowed after stopping Vortioxetine (Brintellix) before starting an MAOI intended to treat psychiatric disorders.
Nausea, constipation, vomiting, serotonin toxicity and serotonin syndrome are commonly reported side effects of Vortioxetine (Brintellix).
Which of the following drugs shall be strictly avoided in a patient taking Paxil?
a. Lyrica b. MS Contin c. Brisdelle d. Astagraf e. Depakote
Which of the following drugs shall be strictly avoided in a patient taking Paxil?
a. Lyrica b. MS Contin c. Brisdelle d. Astagraf e. Depakote
Answer:(c) Paroxetine (Brisdelle) is an orally administered selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Each pink capsule contains 7.5 mg Paroxetine base.
The recommended dosage of Paroxetine (Brisdelle) for the treatment of moderate to severe VMS is 7.5 mg once daily, at bedtime, with or without food.
Paroxetine (Brisdelle) is not indicated for the treatment of any psychiatric condition. Paroxetine (Brisdelle) contains a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder.
Serotonin syndrome, abnormal bleeding, hyponatremia, mania/hypomania, seizure and suicidal thoughts and behavior are reported side effects of Paroxetine (Brisdelle).
Which of the following is the principal side effect of Zaltrap?
a. Tachycardia b. Seizure c. G.I perforation and bleeding d. Ocular hypertension e. Diarrhea
Which of the following is the principal side effect of Zaltrap?
a. Tachycardia b. Seizure c. G.I perforation and bleeding d. Ocular hypertension e. Diarrhea
Answer:(c). Ziv-aflibercept (Zaltrap) is a recombinant fusion protein consisting of Vascular Endothelial Growth Factor (VEGF)-binding portions from the extracellular domains of human VEGF Receptors 1 and 2 fused to the Fc portion of the human IgG1.
Ziv-aflibercept (Zaltrap), in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
Administer Ziv-aflibercept (Zaltrap) 4 mg per kg as an intravenous (IV) infusion over 1 hour every two weeks. Administer Ziv-aflibercept (Zaltrap) prior to any component of the FOLFIRI regimen on the day of treatment.
Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received Ziv-aflibercept (Zaltrap) in combination with FOLFIRI. Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer Ziv-aflibercept (Zaltrap) to patients with severe hemorrhage.
Gastrointestinal Perforation: Gastrointestinal (GI) perforation including fatal GI perforation can occur in patients receiving Ziv-aflibercept (Zaltrap). Discontinue Ziv-aflibercept (Zaltrap) therapy in patients who experience GI perforation.
Severe compromised wound healing can occur in patients receiving ZALTRAP/FOLFIRI. Discontinue Ziv-aflibercept (Zaltrap) in patients with compromised wound healing. Suspend Ziv-aflibercept (Zaltrap) for at least 4 weeks prior to elective surgery, and do not resume Ziv-aflibercept (Zaltrap) for at least 4 weeks following major surgery and until the surgical wound is fully healed.
Levomilnacipran is indicated for the treatment of:
a. Hypertension b. Depression c. Epilepsy d. Renal carcinoma e. Arrhythmia
Levomilnacipran is indicated for the treatment of:
a. Hypertension b. Depression c. Epilepsy d. Renal carcinoma e. Arrhythmia
Answer:(b). Levomilnacipran (Fetzima), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD).
The recommended dose range for Levomilnacipran (Fetzima) is 40 mg to 120 mg once daily, with or without food. Levomilnacipran (Fetzima) should be initiated at 20 mg once daily for 2 days and then increased to 40 mg once daily. Based on efficacy and tolerability, Levomilnacipran (Fetzima) may then be increased in increments of 40 mg at intervals of 2 or more days. The maximum recommended dose is 120 mg once daily.
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Levomilnacipran (Fetzima). Conversely, at least 7 days should be allowed after stopping Levomilnacipran (Fetzima) before starting an MAOI antidepressant.
Suicidal thoughts and behaviors in adolescents and young adults, serotonin syndromes, elevated blood pressure, activation of mania/hypomania, seizure and hyponatremia are reported side effects of Levomilnacipran.
A pharmacist receives a new prescription for Meloxicam (Mobic). The prescription reads:
Take 7.5 mg by mouth every 8 hours with or without meals for the pain associated with rheumatoid arthritis x 30 days. Refill: 5 times.
Which of the following is True?
a. Fill it. b. Call physician to clarify dosage strength. c. Call physician to clarify indication of drug. d. Call physician to clarify the frequency of dosing. e. Change direction to take with meals after verifying with physician.
A pharmacist receives a new prescription for Meloxicam (Mobic). The prescription reads:
Take 7.5 mg by mouth every 8 hours with or without meals for the pain associated with rheumatoid arthritis x 30 days. Refill: 5 times.
Which of the following is True?
a. Fill it. b. Call physician to clarify dosage strength. c. Call physician to clarify indication of drug. d. Call physician to clarify the frequency of dosing. e. Change direction to take with meals after verifying with physician.
Answer: (d). Meloxicam (Mobic), an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow tablet contains 7.5 mg or 15 mg Meloxicam (Mobic) for oral administration.
Meloxicam (Mobic) is indicated for relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and pauciarticular or polyarticular course Juvenile rheumatoid arthritis in patients 2 years of age and older.
For the relief of the signs and symptoms of arthritis the recommended starting and maintenance oral dose of Meloxicam (Mobic) is 7.5 mg once daily since the mean elimination half-life (t½) ranges from 15 hours to 20 hours. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. It may be taken without regard to timing of meals.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
A pharmacist receives a new prescription for Propecia. The prescription reads:
Take 5 mg by mouth once daily with or without meals for male pattern baldness x 30 days.
Refill: 5 times
Which of the following is True?
a. Fill it. b. Call physician to clarify dosage strength. c. Call physician to clarify indication of drug. d. Call physician to clarify a number of refills of drug. e. Change direction to take with meals after verifying with physician.
A pharmacist receives a new prescription for Propecia. The prescription reads:
Take 5 mg by mouth once daily with or without meals for male pattern baldness x 30 days.
Refill: 5 times
Which of the following is True?
a. Fill it. b. Call physician to clarify dosage strength. c. Call physician to clarify indication of drug. d. Call physician to clarify a number of refills of drug. e. Change direction to take with meals after verifying with physician.
Answer: b
The active ingredient found in Propecia and Proscar is Finasteride.
Finasteride is a competitive and specific inhibitor of Type II 5-alpha-reductase. The development and enlargement of the prostate gland is dependent on the potent androgen, 5-alpha-dihydrotestosterone (DHT). By reducing the levels of dihydrotestosterone, Finasteride prevents the development and enlargement of the prostate gland.
Finasteride (Proscar) is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
1. Improve symptoms 2. Reduce the risk of acute urinary retention 3. Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
The recommended dose of Proscar is 5 mg once daily taken with or without meals.
Finasteride (Propecia) is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. The recommended dose of Propecia is 1 mg once daily taken with or without meals.
Therefore, the pharmacist should clarify the dosage strength with a prescribing physician since the prescription is written for Propecia but prescribed on bases of Proscar dose.
Which of the following is/are 5-alpha-reductase inhibitors?
I. Propecia II. Avodart III. Jalyn
a. I only b. III only c. I and II only d. II and III only e. All
Which of the following is/are 5-alpha-reductase inhibitors?
I. Propecia II. Avodart III. Jalyn
a. I only b. III only c. I and II only d. II and III only e. All
Answer: (e) All. 5-Alpha-reductase inhibitors block the action of 5-alpha-reductase, the enzyme that converts testosterone into dihydrotestosterone, which has greater affinity for androgen receptors. The activity of 5-alpha-reductase inhibitors results in increased levels of testosterone and decreased levels of dihydrotestosterone.
The development and enlargement of the prostate gland is dependent on the potent androgen, 5-alpha-dihydrotestosterone (DHT). By reducing the levels of dihydrotestosterone, 5-Alpha-Reductase inhibitors prevent the development and enlargement of the prostate gland.
5-Alpha-reductase inhibitors are used to treat baldness, prostate hyperplasia and prostate cancer. Below is the list of 5-Alpha-Reductase inhibitors:
Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.
Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.
Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.
New capsule reformulation of Fioricet contains: 300 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.
Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.
The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet.
The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.
Exceptions from the scheduling have been made if the drug meets the requirements of section 811(g) (3) (A) of the Controlled Substances Act. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.
According to the FDA, the issue boils down to a specific ratio of aspirin or acetaminophen to butalbital. Fiorinal® is required to have at least 188 mg of aspirin for every 15 mg of butalbital (188:15) to meet CSA exemption. The ratio needed for Fioricet® is 70 mg of acetaminophen for every 15 mg of butalbital (70:15). These ratios were based on what the FDA believed were adequate amounts of nonnarcotic to reduce the abuse potential of butalbital.
The acetaminophen to butalbital ratio in new and old formulation of Fioricet:
Old formulation:
325 mg Acetaminophen / 50 mg Butalbital
97 mg Acetaminophen to 15 mg Butalbital (To be exempt, ration requires at least 70 mg or more Acetaminophen for every 15 mg Butalbital included in formulation.
New Formulation:
300 mg Acetaminophen / 50 mg Butalbital
90 mg Acetaminophen to 15 mg Butalbital (To be exempt, ration requires at least 70 mg or more Acetaminophen for every 15 mg Butalbital included in formulation.
So both new and old formulation of Fioricet by law shall be exempt from controlled substance requirements.
The aspirin to butalbital ratio in Fiorinal:
325 mg Aspirin / 50 mg Butalbital
97 mg Aspirin to 15 mg Butalbital (To be exempt, ration requires at least 188 mg or more Aspirin for every 15 mg Butalbital included in formulation.
Therefore Fiorinal is classified as a Schedule III substance.
Which of the following shall be placed on an OTC label for Aleve?
I. take with food or milk if stomach upset occurs. II. do not exceed 3 tablets in any given 24-hour period. III. the risk of heart attack or stroke may increase if you use for a prolong period of time.
a. I only b. III only c. I and II only d. II and III only e. All
Which of the following shall be placed on an OTC label for Aleve?
I. take with food or milk if stomach upset occurs. II. do not exceed 3 tablets in any given 24-hour period. III. the risk of heart attack or stroke may increase if you use for a prolong period of time.
a. I only b. III only c. I and II only d. II and III only e. All
Answer (e): All. Aleve contains Naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each caplet, tablet, gelcaps or liquid gel capsule contains 220 mg, Naproxen sodium. It temporarily relieves minor aches and pains due to:
a. minor pain of arthritis b. muscular aches c. backache d. menstrual cramps e. headache f. toothache g. the common cold h. temporarily reduces fever
The recommended dose for adults and children 12 years and older is 1 tablet by mouth every 8 to 12 hours. For the first dose, the patient can take 2 tablets within the first hour. Dose should not be exceeded 2 tablets in any 8- to 12-hour period or 3 tablets in a 24-hour period.
Patients should be instructed to take tablet with food or milk if stomach upset occurs. Patients should be warned that if he/she uses more than directed or for longer than directed, the risk of heart attack or stroke may increase.
G.I. bleeding, ulcer, stomach upset and allergic reactions are commonly reported side effects of Naproxen sodium (Aleve).
