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naplex book Reference Guide For Pharmacy licensing Exam-Questions and Answers-Third Edition (NAPLEX)

Answers
   
1(c) Orapred ODT (Prednisolone sodium phosphate disintegrating tablets) is a sodium salt of the phosphoester of the glucocorticoid prednisolone.

It is indicated in the treatment of the atopic dermatitis, Crohn's disease, ulcerative colitis and acute exacerbations of chronic obstructive pulmonary disease (COPD). Dosage of Orapred ODT should be individualized according to the severity of the disease and the response of the patient.

The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated.

Fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain are commonly reported side effects of Orapred.
2(c) The active ingredient of Abelcet is Amphotericin B. It is also available under the following trade names: Amphotec (a powder for injection), and Ambisome (a liposomal form). It should be given parenterally via an I.V. infusion. It is an antifungal agent. It is indicated for the treatment of invasive fungal infections caused by invasive aspergillosis.

The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. Abelcet should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.

Patients should be pretreated with antipyretics, antihistamines, antiemetics and with Meperidine to reduce the signs and symptoms of shaking chills and fever.

Abdominal pain, anorexia, anxiety, hypokalemia, anemia, nephrotoxicity and diarrhea are reported side effects of the drug.
3(a) Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

1. Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18.

2. Genital warts (condyloma acuminata) caused by HPV types 6 and 11.

It is also indicated in boys and men 9 through 26 years of age for the prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11.
4(e) Zelapar orally disintegrating tablets contain Selegiline hydrochloride as an active ingredient. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO). It is available for oral administration (not to be swallowed) in a strength of 1.25 mg.

It is indicated as an adjunct in the management of patients with Parkinson's disease (not the hypertension) being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to the therapy.

Treatment should be initiated with 1.25 mg given once a day for at least 6 weeks. After 6 weeks, the dose may be escalated to 2.5 mg given once a day if a desired benefit has not been achieved and the patient is tolerating Zelapar. It should be taken in the morning before breakfast and without liquid.

A severe hypertensive crisis, orthostatic/postural hypotension, dizziness, somnolence, ECG abnormality, nausea, dyspepsia, abnormal dreams, and infection are reported side effects of Zelapar.
5(c) Xolegel contains the antifungal agent Ketoconazole 2% in a topical anhydrous gel vehicle for topical administration. It is indicated for the topical treatment of seborrheic dermatitis in immuno competent adults and children 12 years of age and older.

The gel should be applied once daily to the affected area for 2 weeks. Xolegel is for topical use only, and not for oral, ophthalmic, or intra vaginal use.
6 (d) Abilify (Aripiprazole) is classified as an antipsychotic agent. It is indicated for the treatment of schizophrenia. The recommended therapeutic dose of the drug is 10 to 30 mg once a day without regard to meals.

NMS, tardive dyskinesia, extrapyramidal symptoms and agitation are reported side effects of Abilify. It is available as a tablet for an oral administration.
7 (e) Humira (Adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). It is supplied as a sterile, preservative-free solution of Adalimumab for subcutaneous administration.

It is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and Crohn's disease.

The recommended dose of Humira for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 40 mg administered every other week.

The recommended dose of Humira for patients 4 to 17 years of age with polyarticular juvenile idiopathic arthritis is based on weight of patients.

The recommended dose of Humira for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.

Patients treated with Humira are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Humira should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

1. Active tuberculosis, including reactivation of latent tuberculosis.

2. Invasive fungal infections, including histoplasmosis, coccidioidomycosis,
candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

3. Bacterial, viral and other infections due to opportunistic pathogens.
8(d) Noxafil (Posaconazole) is a triazole antifungal agent available in a suspension for an oral administration. It is a white, cherryflavored immediate-release suspension containing 40 mg of Posaconazole per ml.

It is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT)recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.

It is also indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.

Each dose of Noxafil should be administered during or immediately (i.e. within 20 minutes) following a full meal. In patients who cannot eat a full meal, each dose of Noxafil should be administered with a liquid nutritional supplement or an acidic carbonated beverage.

For patients who cannot eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage, alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections.
A pharmacist should instruct a patient to shake Noxafil oral suspension well before use.

Arrhythmias, QT prolongation and liver toxicity are reported side effects of the drug.
9(d) Travatan Z (Travoprost) is a new formulation of Travatan solution in which benzalkonium chloride is replaced with SofZia, a robust ionic buffered preservative system that is gentle to the ocular surface.

Travoprost is a synthetic prostaglandin F analogue. It is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently responsive to other intraocular pressure lowering medications.

The recommended dosage is one drop in the affected eye(s) once daily in the evening. It should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
10(e) Ativan (Lorazepam) is classified as the benzodiazepine class of drugs. It is indicated for the treatment of anxiety and insomnia. The parenteral form of Lorazepam reduces the severity and duration of nausea and vomiting associated with emetogenic cancer therapy.

It is available in tablet, concentrated oral solution and injection form.

Sedation, depression, constipation, lethargy, fatigue, diplopia and nystagmus are reported side effects of the drug.

Librium (Chlordiazepoxide), Tranxene (Clorazepate), Valium (Diazepam) and Serax (Oxazepam) are indicated for the relief of acute alcohol withdrawal symptoms like agitation, tremor, impending and acute delirium.
11(c) Fentora (Fentanyl buccal tablet) is a potent opioid analgesic, intended for buccal mucosal administration. Fentora is formulated as a flat-faced, round, beveled-edge white tablet. Fentora is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of Fentanyl across the oral mucosa.

Fentora employs the OraVescent drug delivery technology, which generates a reaction that releases carbon dioxide when the tablet comes in contact with saliva. It is believed that transient pH changes accompanying the reaction may optimize dissolution (at a lower pH) and membrane permeation (at a higher pH) of Fentanyl through the buccal mucosa.

Each tablet contains Fentanyl citrate equivalent to Fentanyl base: 100, 200, 300, 400, 600 and 800 micrograms. It is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer.

This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, Fentora is contraindicated in the management of acute or postoperative pain.

Physicians should individualize treatment using a progressive plan of pain management. For opioid-tolerant patients not being converted from Actiq, the initial dose of Fentora is always 100 mcg.
12(b) Pylera capsules are a combination antimicrobial product containing Bismuth subcitrate potassium, Metronidazole, and Tetracycline hydrochloride for oral administration. Each hard gelatin capsule contains:

1. Bismuth subcitrate potassium, 140 mg
2. Metronidazole, 125 mg
3. Tetracycline hydrochloride, 125 mg

Pylera capsules, in combination with Omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.

The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Each dose of Pylera includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days.

Patients should be instructed to swallow the Pylera capsules whole with a full glass of water (8 ounces). One Omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days.
13(c) Risperdal (Risperidone) is classified as an antipsychotic agent. It is available in tablet, oral solution and orally disintegrating tablet form.

Each tablet for an oral administration contains 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, or 4 mg Risperidone. It is also available as a 1 mg/mL oral solution.

Risperdal M-Tab (orally disintegrating tablets) are available in 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. It is indicated for the acute and maintenance treatment of schizophrenia.

On October 6, 2006 - The U.S. Food and Drug Administration (FDA) approved Risperdal (Risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums.

The dosage of Risperdal should be individualized according to the response and tolerability of the patient. The total daily dose of Risperdal can be administered once daily or half the total daily dose can be administered twice daily.

Caution should be exercised with dosage for smaller children who weigh less than 15 kg. NMS, tardive dyskinesia, extrapyramidal symptoms and agitation are reported side effects of the drug.
14(e) Brovana (Arformoterol tartrate) is a selective beta2-adrenergic bronchodilator.

It is indicated for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

It is for use by nebulization only. The recommended dose of Brovana (Arformoterol tartrate) inhalation solution for COPD patients is 15 mcg administered twice a day (morning and evening) by nebulization. A total daily dose greater than 30 mcg (15 mcg twice daily) is not recommended.

Brovana should be stored refrigerated in foil pouches. Asthenia, fever, headache, vomiting, hyperkalemia, leukocytosis, nervousness, and tremor are reported side effects of Brovana.
15(e) Elixir contains 5 to 40% alcohol. All of the mentioned drugs have been found to interact with alcohol and may produce disulfiram-like reactions.

Ethanol is generally converted to acetaldehyde by an alcohol dehydrogenase enzyme, which is then subsequently converted to acetic acid by action of aldehyde dehydrogenase enzyme.

Accumulation of acetaldehyde may be responsible for producing hot flashing, throbbing headaches and disulfiram-like reactions. All of the above drugs inhibit the aldehyde dehydrogenase enzyme and produce disulfiram-like reactions. Therefore, the final dosage form of these all mentioned drugs could not be an elixir.
16(e) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of Tyzeka (Telbivudine) alone or in combination with antiretrovirals.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Tyzeka.

Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue antihepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
 
 
 
 
 
 


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