Mexican Pharmacy Blog

Age, sex, comorbidities, outpatient medication, oxygen saturation on hospital admission, and the duration of the current episode of AECOPD of the patients requiring ICU treatment did not differ significantly from the overall patient cohort. In univariate Cox regression analysis BNP, accurately predicted the need for ICU care (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.03 to 1.22 for an increase in BNP of 100 pg/mL; p = 0.009). This strong association persisted in multivariate analysis (HR, 1.13; 95% CI, 1.03 to 124 for an increase in BNP of 100 pg/mL; p = 0.008) [Table 2]. To the contrary, BNP levels did not differ significantly between survivors and in-hospital nonsurvivors (64 pg/mL [IQR, 32 to 195 pg/mL] vs 81 pg/mL [IQR, 57 to 1,103]; p = 0.362).

BNP Levels as Prognostic Marker for Medium- and Long-term Mortality

Overall, 16 patients (7%) died during the 6-month follow-up period and 46 patients (22%) died within 2 years of the initial hospitalization. AECOPD (16 patients), cardiac death (7 patients), and pneumonia (6 patients) were the most common causes of death. BNP levels on presentation did not differ significantly between nonsurvivors and survivors after 6 months of follow-up (67.3 pg/mL [IQR, 49.5 to 184.9] vs 63.5.7 pg/mL [IQR, 31.7 to 194.5];p = 0.610).

Table 2—Prediction of the Need for ICU Treatment with Viagra Australia in Univariate and Multivariate Regression Analysis

Univariate analysis

Teflaro for Bacterial Infections

Ceftaroline fosamil (Teflaro, Forest), an injectable antibiotic, has been approved to treat adults with community- acquired bacterial pneumonia and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA).

Ceftaroline is a cephalosporin, which acts by interfering with the bacterial cell wall. The drug’s safety and effectiveness were evaluated in four phase 3 clinical trials in patients 18 years of age and older. Adverse effects included diarrhea, nausea, and rash.

Source: FDA, October 29, 2010

KL4, an Orphan Drug For Cystic Fibrosis

An orphan drug designation has been approved for Discovery’s KL4 surfactant for patients with cystic fibrosis (CF). CF is caused by a genetic mutation that can cause life-threatening lung infections and premature death. Previous studies had suggested that a surfactant might improve mucociliary clearance, perhaps with the potential to prevent further compromise of lung function.

Discovery completed a double-blind, randomized crossover phase 2a study in which the aerosol surfactant was generally safe and well tolerated. Patients experienced improved mucociliary clearance, and no associated serious adverse events were reported.

Source: Drug Discovery Dev, November 2, 2010

Latuda Benefits Adults With Schizophrenia

Lurasidone HCl tablets (Latuda, Sun- ovion) have been approved for the treatment of schizophrenia in adults. Like other atypical antipsychotic agents, lurasidone carries a boxed warning alerting prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older adults with dementia-related psychosis. Lurasidone is discussed in this month’s Pharmaceutical Approval Update on page 693.

Source: FDA, October 28, 2010

Egrifta Treats Lipodystrophy In HIV Infection

The FDA has approved tesamorelin injection (Egrifta, Theratechnologies, Inc./EMD Serono) to treat HIV patients with lipodystrophy. This condition, in which excess fat develops around the liver, stomach, and other abdominal organs, is associated with many antiretro- viral drugs.

Tesamorelin is a growth hormone- releasing factor that is administered once daily. In two clinical trials, patients receiving tesamorelin experienced greater reductions in abdominal fat, compared with patients receiving placebo. Some patients also reported an improved self- image.

Adverse effects included joint, stomach, and muscle pain; erythema and pruritus at the injection site; swelling; and worsening blood glucose control.

Source: FDA, November 10, 2010

Halaven for Breast Cancer

Eribulin mesylate (Halaven, Eisai) has been approved to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Eribulin, a microtubule inhibitor, is a synthetic form of a compound derived from the sea sponge Halichondria oka- dai. Before therapy, patients should have received prior anthracycline-based and taxane-based chemotherapy for early or late-stage breast cancer.
Prozac online no prescription
In a randomized study of 762 women, median overall survival rates were 13.1 months with eribulin and 10.6 months with a different agent. Adverse effects included neutropenia, anemia, leuko- penia, hair loss, fatigue, nausea, peripheral neuropathy, and constipation.

Source: FDA, November 15, 2010

Gablofen for Spasticity

CNS Therapeutics has announced the FDA’s approval of Gablofen (baclofen) injection for use in the management of severe spasticity. This movement disorder affects more than 500,000 patients in the U.S. alone and is often brought on by multiple sclerosis, cerebral palsy, spinal cord injury, brain trauma, and stroke.

Originally developed in the 1920s as a potential antiepileptic drug, baclofen was also found to be safe and effective for reducing spasticity. In the early 1980s, the drug was noted to be more effective when delivered intrathecally. Baclofen intrathecal injection was first approved in 1992 as an orphan drug and is now considered the standard of care for patients with severe spasticity of spinal and cerebral origin.
Augmentin generic price
Gablofen is administered in the same standard concentrations as Lioresal Intrathecal (Novartis): 50 mcg/mL, 500 mcg/ mL, and 2,000 mcg/mL. It is sold with ready-to-use vials and pre-filled syringes offering clear advantages over glass ampules, including a faster refill preparation time and a lower risk of product con tamination.

The company’s research was partly funded by a grant from the Michael J. Fox Foundation.

Source: CNS Therapeutics, www.cns- therapeutics.com, www.gablofen.com

The FDA has approved incobotulinumtoxinA (Xeomin, Merz) to treat blepharospasm and cervical dystonia. This neurotoxin inhibits the release of acetylcholine, thereby reducing muscle contractions. A boxed warning mentions the risk of distant spread of the toxin’s effect, which can cause symptoms of botulism such as asthenia, muscle weakness, blurred and double vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and life-threatening swallowing and breathing problems. Caution is advised when Xeomin is used with aminoglycoside antibiotics or other agents that interfere with neuromuscular trans – mission, such as curare-like compounds. Xeomin is discussed in this month’s Pharmaceutical Approval Update column on page 526.

Epoetin alfa Help In Healing Hip Fractures

Propecia Mexico
Intertrochanteric hip fracture is a threat to older people for a number of reasons, including the danger of blood loss, especially if the patient is anemic. If autologous blood isn’t available, allo – genic blood transfusion comes with its own risks for older anemic patients. Researchers from Levadia, Greece have proposed an alternative: epoetin alfa (e.g., Procrit, Ortho-Biotech; Epogen, Amgen). The authors divided 79 patients with hip fracture into two groups; one group received 10 daily doses of epoetin alfa 20,000 IU beginning from the day of trauma, and the other group received placebo. There was a statistically significant difference between the two groups in the required units of allogenic blood used. Patients receiving epoetin alfa also had higher hematocrit and hemoglobin values, with a statistically significant difference at seven days after surgery, compared with the control group. The mean follow-up period was 34 months. Three patients were lost to follow-up, although they were doing well at their last examination. Eight patients died of causes not directly related to the hip fracture or to epoetin alfa. Complications were considered minor. Five patients had a skin inflammatory response or bruising; one patient had chills and fever after the fifth injection. None of the patients had to stop therapy because of adverse effects. Patients also received 100 mg of parenteral iron each day. Six patients reacted to the iron, but all responded favorably to a reduced infusion. Epoetin alfa was also cost-effective, according to the researchers. The total cost of therapy was roughly 85% of the cost of preparing and conserving 1 unit of allogenic blood.

Acetaminophen Raises Risk of Asthma and Eczema in Teens

Recent reports have linked acetaminophen use to asthma in children. Studies are now linking acetaminophen to asthma and eczema in adolescents. Teenagers who used the drug monthly had more than double the risk of asthma compared with teens who did not use it. Yearly use was linked to a 50% increase in asthma risks. As part of the International Study of Asthma and Allergies in Childhood (ISAAC), questionnaires were given to more than 300,000 13- and 14-year-olds in 113 centers in 50 countries. “Medium” users, who took acetaminophen once in the preceding year, had a 43% higher asthma risk and a 31% higher eczema risk compared with non-users. “High” users, who had used the drug within the previous month, had 2.51 times the risk of asthma and a 99% greater risk of eczema compared with non-users. The risk of rhino conjunctivitis was also 38% higher for medium users and 2.39 times greater for high users than for non-users. A causal relationship was suggested. It is thought that acetaminophen has a systemic inflammatory effect, which could increase oxygen stress owing to depletion of glutathione-dependent enzymes, resulting in enhanced Th2 allergic immune responses. It is also possible that the drug suppresses the immune response to rhino virus infections, a common cause of severe asthma in children. Some investigators believe that acetaminophen use is a factor in the increased incidence of asthma worldwide. In earlier studies, acetaminophen reduced levels of glutathione, an antioxidant found in the lungs. Another study mentions an increased incidence of asthma and wheezing in people taking acetaminophen.

The FDA has warned that lamotrigine (Lamictal, GlaxoSmithKline), which isindicated for treating seizures and bi – polar disorder, can cause aseptic meningitis. The agency is working with the company to update the prescribing information and the patient medication guide. A rare but serious side effect of lamotrigine use, aseptic meningitis can also be caused by viruses, toxic agents, some vaccines, and autoimmune disease. Symptoms may include headache, fever, chills, nausea, vomiting, stiff neck, and sensitivity to light. When meningitis is suspected, lamo – trigine should be discontinued if no other cause of meningitis is identified.

The drug was approved in December 2004. Since then and continuing through November 2009, 40 cases of aseptic meningitis have been identified in patients taking the product. Of these 40 patients, 35 needed hospitalization. Symptoms generally resolved after the drug was discontinued. In 15 cases, even more severe symptoms returned when patients resumed taking the drug.

Source: FDA, August 12, 2010

SSRIs Lack Benefit for Autism

Antidepressants commonly prescribed to people with autistic spectrum disorders should not be recommended at this time, according to a new study. Despite some evidence of benefits in adults with autism, there appears to be no evidence for any benefits associated with selective serotonin reuptake inhibitors (SSRIs) in children, who may experience serious adverse drug effects. Although SSRIs are widely prescribed, they have not been specifically approved for use in autism. In the U.K., most antidepressants are not approved for children for any condition. The rationale behind the use of SSRIs in autism is that they act on serotonin, which affects some of the psychological processes affected by the condition.

Cochrane researchers included seven trials of 271 patients in their study. They evaluated fluoxetine (Prozac, Eli Lilly), fluvoxamine (Luvox, Solvay), (Celexa, Forest), and fenfluramine (removed from the U.S. market). Overall, the investigators found no benefit in the five trials in children and did find some evidence of serious harm, including one child who had a prolonged seizure after taking citalopram. In the two trials for adults, symptoms improved, but there was too little evidence for the drugs to be recommended. A problem with analyzing the results was that each trial used different measures for assessing the drugs’ effects. The researchers said that decisions about using SSRIs for coexisting obsessive-compulsive disorder, aggression, anxiety, or depression in patients with au tism could be made on a case-by-case basis.

Amoxicillin online pharmacy

Antidepressant drugs are medicines that relieve symptoms of mental depression.
Mexican online pharmacy
Antidepressant drugs are used to treat serious, continuing mental depression that interferes with a person’s ability to function. Everyone feels sad, “blue,” or discouraged occasionally, but usually those feelings do not interfere with everyday life and do not need treatment. However, when the feelings become overwhelming and last for weeks or months, professional treatment can help. Although depression is one of the most common and serious mental disorders, it is also one of the most treatable. According to the American Psychiatric Association, 80-90% of people with depression can be helped. If untreated, depression can lead to social withdrawal, physical complaints, such as fatigue, sleep problems, and aches and pains, and even suicide.

The first step in treating depression is an accurate diagnosis by a physician or mental health professional. The physician or mental health professional will ask questions about the person’s medical and psychiatric history and will try to rule out other causes, such as thyroid problems or side effects of medicines the person is taking. Lab tests may be ordered to help rule out medical problems. Once a person has been diagnosed with depression, treatment will be tailored to the person’s specific problem. The treatment may consist of drugs alone, counseling alone, or drugs in combination with counseling methods such as psychotherapy or cognitive behavioral therapy.

Antidepressant drugs help reduce the extreme sadness, hopelessness, and lack of interest in life that are typical in people with depression. These drugs also may be used to treat other conditions, such as obsessive compulsive disorder, premenstrual syndrome, chronic pain, and eating disorders.

Antidepressant drugs, also called antidepressants, are thought to work by influencing communication between cells in the brain. The drugs affect chemicals called neurotransmitters, which carry signals from one nerve cell to another. These neurotransmitters are involved in the control of mood and in other responses and functions, such as eating, sleep, pain, and thinking.

The main types of antidepressant drugs in use today are:

• Tricyclic antidepressants, such as amitriptyline (Elavil 75 mg), imipramine (Tofranil), nortriptyline (Pamelor)
• Selective serotonin reuptake inhibitors (SSRIs or serotonin boosters), such as fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft)
• Monoamine oxidase inhibitors (MAO inhibitors), such as phenelzine (Nardil), and tranylcypromine (Parnate)
• Lithium (used mainly to treat manic depression, but also sometimes prescribed for recurring bouts of depression).

Selective serotonin reuptake inhibitors act only on the neurotransmitter serotonin, while tricyclic antidepressants and MAO inhibitors act on both serotonin and another neurotransmitter, norepinephrine, and may also interact with other chemicals throughout the body. Selective serotonin reuptake inhibitors have fewer side effects than tricyclic antidepressants and MAO inhibitors, perhaps because selective serotonin reuptake inhibitors act only on one body chemical, serotonin.

Because the neurotransmitters involved in the control of moods are also involved in other processes, such as sleep, eating, and pain, drugs that affect these neurotransmitters can be used for more than just treating depression. Headache, eating disorders, bed-wetting, and other problems are now being treated with antidepressants.

All antidepressant drugs are effective, but certain types work best for certain kinds of depression. For example, people who are depressed and agitated do best when they take an antidepressant drug that also calms them down. People who are depressed and withdrawn may benefit more from an antidepressant drug that has a stimulating effect.

Recommended dosage depends on the kind of antidepressant drug, the type and severity of the condition for which it is prescribed, and other factors such as the patient’s age. Check with the physician who prescribed the drug or the pharmacist who filled the prescription for the correct dosage.
Antidepressants pharmacy
While antidepressant drugs help people feel better, they cannot solve problems in people’s lives. Some mental health professionals worry that people who could benefit from psychotherapy rely instead on antidepressant drugs for a “quick fix.” Others point out that the drugs work gradually and do not produce instant happiness. The best approach is often a combination of counseling and medicine, but the correct treatment for a specific patient depends on many factors. The decision of how to treat depression or other conditions that may respond to antidepressant drugs should be made carefully and will be different for different people.

Always take antidepressant drugs exactly as directed. Never take larger or more frequent doses, and do not take the drug for longer than directed.

Most antidepressant drugs do not begin working right away. The effects may not be felt for several weeks. Continuing to take the medicine is important, even if it does not seem to be working at first.

Side effects depend on the type of antidepressant drug.

Antidepressant drugs may interact with a variety of other medicines. When this happens, the effects of one or both of the drugs may change or the risk of side effects may be greater. Some interactions may be life-threatening. Anyone who takes antidepressant drugs should let the physician know all other medicines he or she is taking.

Periodicals

• Johnson, Lois. “Daylight for Depression.” Total Health, 16 (December 1994): 14.
• Sacra, Cheryl. “The New Cure-alls: Mood Lifters May Offer Handfuls Of Hope for More Than Just Depression.” Health, 22 (September 1990): 36.
• “Treatment of Depression: Drugs Alone Are Not Enough.” HealthFacts, 20 (February 1995): 189.

Milnacipran has been used for several years in Europe and Asia for treating patients with depression. It was approved in 2009 as Savella in the U.S. for patients with FM. As with older drugs used for FM, milnacipran utilizes both norepinephrine and serotonin reuptake as its primary mechanisms for treating symptoms. Pregabalin and duloxetine are also used for FM. Besides FDA-approved agents, several medications have off-label usage in therapy for FM, such as gaba-pentin (Neurontin, Pfizer), tramadol (Ultram Mexico, PriCara), and amitriptyline.

In January 2010, the efficacy and safety of milnacipran were called into question. Public Citizen, a non-profit consumer advocacy group, petitioned the FDA to remove the drug from the market because of its hypertensive effects and lack of long-term evidence.20 The average increase in systolic and diastolic BP was 3.1 mm Hg with milnacipran; almost 20% of non-hypertensive patients receiving milnacipran 100 mg/day became hypertensive at the end of the study. The average increase in BP seen with milnacipran is comparable to that of other SNRIs on the market. Compared with venlafaxine and duloxetine, milnacipran has the highest selectivity for norepinephrine reuptake.

Although scrutiny should be used in prescribing milna cipran, it is still a valid option for FM based on the clinical evidence. Additional long-term studies of milnacipran are still needed because it is being used to treat a chronic disease state. One must consider the patient’s current medication profile, financial means, and coexisting disease states in order to select the most appropriate treatment.

The efficacy and tolerability of milnacipran were evaluated in a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose trial of adults with FM. Patients received milnacipran 100 mg/day or 200 mg/day or placebo for 15 weeks.

Patients were eligible for enrollment if they:

• were between 18 and 70 years of age.
• had a diagnosis of primary FM, based on 1990 ACR criteria.
• had withdrawn from centrally active therapies commonly used to treat FM.
• had discontinued treatment using transcutaneous electrical nerve stimulation (TENS), biofeedback, acupuncture, anesthetic or narcotic patches, or injections for tender and trigger points.
• had a raw score of 4 or higher on the physical function component of the Fibromyalgia Impact Questionnaire (FIQ) and 40 or more out of 100 on the mean VAS pain score.

Patients were excluded from the study if they:

• had severe psychiatric illness.
• displayed current major depressive illness based on the Mini-International Neuropsychiatric Interview or had a score higher than 25 on the Beck Depression Inventory.
• exhibited a significant suicide risk.
• were abusing alcohol, benzodiazepines, or other drugs.
• had a history of behavior that prohibited compliance.
• had coexisting cardiovascular, pulmonary, hepatic, renal, GI, or auto-immune disease (except for Hashimoto’s or Graves’ disease that has been stable for three months before screening).
• had a systemic infection at the time.
• currently had cancer (except for basal cell carcinoma), unstable endocrine disease, severe sleep apnea, prostate enlargement or other genitourinary disorder.
• were pregnant or breast-feeding.

The study took place at 86 centers in the U.S. from November 2004 to December 2006. Before the trial, therapies that had the potential to interfere with pain symptoms of FM had to be discontinued. Of the 2,270 patients who were screened, 1,196 received milnacipran 100 mg/day, milnacipran 200 mg/day, or placebo, given as two daily doses.

Patients entered a one-week to four-week period for washout of prohibited medications, followed by a two-week baseline assessment period. Milnacipran-treated patients received 12.5 mg on day 1, 12.5 mg twice daily for two days, 25 mg twice daily for four days, and 50 mg twice daily for seven days. Patients receiving 200 mg/day received 100 mg twice daily for seven days; all other patients underwent a sham dose escalation to maintain blinding. After the escalation, the dosage was unchanged from week 3 to 15 (a total of 12 weeks). Any patient who was intolerant of the medication was dropped from the trial.

Baseline demographics in all treatment arms were similar. The primary efficacy measure was a composite response rate based on these endpoints:

• pain improvement of 30% or more in VAS 24-hour morning recall
• Patient Global Impression of Change (PGIC) ratings of “very much improved” or “much improved”
• an improvement of 6 points or more on the Medical Outcome Short-Form 36 (SF-36) Physical Component Summary (PCS) score

After 15 weeks, a significantly greater number of patients receiving milnacipran 100 mg/day and 200 mg/day achieved the primary endpoints of meeting the three criteria for a FM composite response versus placebo (milnacipran doses of 100 mg/day, P = 0.01; milnacipran doses of 200 mg/day, P = 0.02). The number of patients experiencing more than a 30% improvement from baseline with 24-hour pain was highest with milnacipran 200 mg/day (39.9%), compared with 100 mg/day (37.3%) or placebo (28.7%).

The most frequently reported AE with the study drug was nausea, which occurred in 37.6% of patients taking 200 mg/day, in 34.3% of those taking 100 mg/day, and in 19.2% taking placebo. Other commonly reported AEs were dizziness, palpitations, hot flushes, hypertension, vomiting, tachycardia, hyperhidrosis, constipation, and migraines. Discontinuation rates attributable to AEs were higher with milnacipran than with placebo (23.7% with 200 mg/day, 19.5% with 100 mg/day, and 9.5% with placebo). Overall, milnacipran showed significant efficacy over placebo for treating FM; however, the higher dose of 200 mg/day was associated with more AEs.