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FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Cutting Balloon, and Others [Jul. 9th, 2008|10:51 am]

FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Cutting Balloon, and Others

Yael Waknine
Sept. 7, 2004 — The U.S. Food and Drug Administration (FDA) has approved an implantable metal rod for children with thoracic insufficiency syndrome, desloratadine for pediatric use, a heel-stick test for congenital metabolic diseases in newborns, a microsurgical dilatation device for use in hemodialysis grafts, and a new formulation for digoxin.

Implantable Metal Rod (Vertical Expandable Prosthetic Titanium Rib) for Children With Thoracic Insufficiency Syndrome

On Sept. 2, the FDA approved a humanitarian device exemption (HDE) for an implantable metal rod device (Vertical Expandable Prosthetic Titanium Rib, made by Synthes Spine Corp., the U.S. division of Synthes-Stratec), to correct chest wall instability in pediatric patients aged six months to vertebral maturity (14 years in girls, 16 years in boys) with thoracic insufficiency syndrome caused by severe deformities of the chest, spine, and ribs.

The curved metal rod is attached by hooks at both ends to ribs near the spine. By straightening the spine and separating the ribs, the device allows expansion of the chest cavity for breathing and lung development. The implanted device must be lengthened or replaced every six months as the patient matures.

The approval was based on the results of a study involving 147 pediatric patients aged six months to 15 years with serious defects such as scoliosis. The study demonstrated the device to be safe and of probable benefit in enabling unassisted breathing and less dependence on ventilators in some patients. Without treatment, children with the syndrome risk death from respiratory infections or inability to breathe. Twelve deaths during the study were not associated with use of the device.

An HDE is an approval for a device of probable benefit in diagnosing or treating patients with a rare medical condition affecting fewer than 4,000 people in the U.S. each year.

Desloratadine (Clarinex) for Pediatric Use

On Sept. 2, the FDA approved a new syrup formulation for desloratadine (Clarinex, made by Schering-Plough Corp.), indicated for the relief of symptoms associated with seasonal allergic rhinitis in children aged two years and older, and perennial allergic rhinitis, chronic idiopathic urticaria (CIU), or hives of unknown cause in children aged six months and older.

The approval was based on the results of three double-blind, placebo-controlled studies involving 246 patients aged six months to 11 years, which demonstrated desloratadine's safety in children with documented history of allergic rhinitis, CIU, or other conditions requiring antihistamine therapy. Adverse events were similar with desloratadine compared with placebo and included upper respiratory tract infection, diarrhea, fever, urinary tract infection, varicella, irritability, and coughing.

Lab Test Screens Newborn Infants for Congenital Metabolic Diseases

On Aug. 25, the FDA approved a heel-stick laboratory test (NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, made by PerkinElmer Life and Analytical Sciences, Inc.) for use in screening newborn infants against a variety of congenital metabolic diseases.

The test screens a newborn's blood for elevated or abnormal patterns in levels of amino acids, free carnitine, and acylcarnitines that may indicate a risk of phenylketonuria, maple syrup urine disease, medium-chain Acyl-CoA dehydrogenase deficiency, isovaleric acidemia, homocystinuria, hereditary tyrosinemia, or other inborn errors of metabolism.

Results of the screening are combined with a clinical evaluation to determine the newborn's risk of these diseases that are individually rare, yet common as a group. Early diagnosis can improve long-term outcome and quality of life by significantly reducing such effects as developmental delay, seizures, mental retardation, and death.

Device (Peripheral Cutting Balloon) Dilates Lesions at Lower Pressures Than Angioplasty

On Aug. 25, the FDA approved a microsurgical dilatation device (Peripheral Cutting Balloon, made by Boston Scientific Corp.) for use in treating graft stenosis in patients undergoing hemodialysis for end-stage renal disease.

The device features tiny, longitudinally mounted microsurgical blades (atherotomes) that score the lesion with precise incisions as the balloon is expanded, allowing vessel dilation with less barotrauma than conventional percutaneous transluminal angioplasty. Scoring also disrupts the elastic and fibrotic continuity of the lesion and prevents elastic recoil.

According to a company news release, the device is associated with reduced patient pain and a six-month benefit to patients with thrombosed dialysis grafts. It can be used as stand-alone treatment or in conjunction with other treatment options. The device has been used in Europe and Japan for more than a decade.

Digoxin 0.05 mg/mL Elixir for Heart Failure and Atrial Fibrillation

On Aug. 26, the FDA approved a new elixir formulation for digoxin (Digoxin 0.05 mg/mL Elixir, made by Roxane Laboratories) for use in the treatment of heart failure and atrial fibrillation. Digoxin was previously available in tablets, capsules, and by injection.

Reviewed by Gary D. Vogin, MD
This is a part of article FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Cutting Balloon, and Others Taken from "Generic Clarinex (Desloratadine) Page" Information Blog

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Acetaminophen Toxicity [Jul. 6th, 2008|09:16 pm]

The December 20, 2006, issue of Time called attention to the warning by the Food and Drug Administration (FDA) about the risk of an overdose of acetaminophen (Tylenol) causing liver damage. The FDA is concerned about the incidence of acetaminophen overdosage[1] and has proposed a regulation requiring drug companies to place a prominent label about the acetaminophen content in all medications. The FDA has attempted to reassure the public that acetaminophen remains extremely safe if used with caution.[1] However, a closer look at the adverse effects of this popular medication should cause clinicians to reconsider this drug and its usage in their practices.

Overdosage is a big problem. More than 200 million persons take acetaminophen each year. Of these, about 200 persons a year die of fulminant hepatic failure from acetaminophen overdosage.[1,2] The median acute dose causing liver failure is 24 g (48 extra-strength tablets).[3] Approximately half of the overdoses are intentional.

The severity of the overdose problem stems from the fact that acetaminophen is an extremely common medication often used casually. It is found in many combination drugs for cough and cold remedies and also in opioid medications for severe pain. For adults, the maximum daily dose is 4 g. Acetaminophen comes in 325-mg tablets; however, the 500-mg tablets are more common. Simply taking 2 Extra Strength Tylenol tablets more than 4 times a day will produce an overdose. It only takes a few days of exceeding the maximum dose to cause liver damage. If the patient adds alcohol to his or her acetaminophen regimen, the risk of damage increases further.[1] Smoking also increases the risk of liver damage.

The easiest way to inadvertently overdose on acetaminophen is to combine various cough and cold medications with Tylenol. Most patients do not read labels carefully and are unaware that acetaminophen is present in many medications.[1] Some of the pain medications that contain acetaminophen include hydrocodone with acetaminophen (Lortab, Vicodin), tramadol with acetaminophen (Ultracet), propoxyphene (Darvocet), oxycodone (Percocet, Tylox), pamabrom, pyrilamine (Midol, Pamprin), and Tylenol with codeine.

Of the cough and cold products, there can be any combination of decongestant, antihistamine, dextromethorphan, or guaifenesin; pseudoephedrine/phenylephrine (seen with many sinus pain formulas); diphenhydramine (night time cold, flu, allergy formulations); aspirin, caffeine (Excedrin); antihistamine, decongestant, dextromethorphan, and guaifenesin (maximum strength flu formulations). Table 1 lists the content of acetaminophen in several over-the-counter medications.

There is a particularly significant risk of acetaminophen overdose in infants and children because of the varying dosing schedules and the variety of formulations with different strengths of liquids. It is unfortunate that some of the most caring parents have overmedicated their children, sometimes causing death because they did not understand or follow the dosage recommendations. Table 2 lists the formulations of the brand name Tylenol.

Acetaminophen should be respected as a drug with severe toxicities. Liver failure from acetaminophen overdose is the most serious side effect and can vary from mild to severe. The extreme case is seen in acute liver failure, which includes coagulopathy and encephalopathy. In one study 27% of these patients died without liver transplantation.[3] In healthy adults, a dose of 4 g daily can cause alanine aminotransferase (ALT) elevations within 1 week. The levels return to normal when the drug is discontinued.[4]

Acetaminophen was also shown to increase the risk of major cardiovascular events (nonfatal myocardial infarction, fatal congestive heart failure, nonfatal and fatal stroke) with an increased risk of 1.68.[5] Therapeutic doses (2-4 g/day) of acetaminophen are associated with increased risk of serious upper gastrointestinal events.[6] Acetaminophen is also associated with hypersensitivity reactions, serious hematologic disorders, and skin disorders ranging from rashes to toxic epidermal necrolysis. These reactions are rare, but the provider should be alert to recognize reactions when they occur. Table 3 lists the major adverse reactions of acetaminophen.

All patients, and particularly the parents of children, should be asked about acetaminophen use and taught about the potential problems related to overdosage. As clinicians, we need to help patients develop an awareness of the seriousness of taking this common medication.  Printer- Friendly Email This


Journal for Nurse Practitioners.  2007;3(3):186-188.  ©2007 Elsevier Science, Inc.
This is a part of article Acetaminophen Toxicity Taken from "Generic Clarinex (Desloratadine) Page" Information Blog

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Discovery of pathway in learning impairment caused by liver disease may lead to drug treatment [Jul. 5th, 2008|10:51 am]

A new study rats reveals the mechanism responsible for learning impairment due to liver failure and shows that sildenafil restores cognitive function -

Liver disease sometimes causes hepatic encephalopathy, which involves brain damage, personality changes, and intellectual impairment due to hyperammonemia (high levels of ammonia in the blood). However, the mechanisms involved in both learning and how liver disease leads to learning impairment are unclear.

In a new study led by Vicente Felipo of the Laboratory of Neurobiology at the Fundacion Valenciana de Investigaciones Biomedicas in Valencia, Spain and published in the February 2005 issue of Hepatology, researchers hypothesized that impaired learning was due to a defect in the glutamate-nitric oxide-cGMP pathway in the brain and that administering sildenafil to increase cGMP would restore learning ability. Sildenafil, commonly known as Viagra, is known to prevent the destruction of cGMP and allow it to accumulate in the body. Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD), published by John Wiley & Sons, Inc. is available online via Wiley InterScience at interscience.wiley.com/journal/hepatology.

Researchers examined four groups of rats in their study: rats in which they constructed portacaval shunts (a treatment used to treat high blood pressure in the liver due to liver disease that is believed to be one of the causes of hepatic encephalopathy, and also a model of chronic liver failure in rats); rats with portacaval shunts that were given sildenafil; rats that were fed an ammonium-containing diet; and rats that were fed the diet and given sildenafil. They also used control groups consisting of rats fed a normal diet both with and without sildenafil. All animals were subjected to a maze learning test four weeks following surgery or from the date when drug treatment began. Levels of both cGMP and ammonia in brain were measured using a microdialysis probe.

Results showed that while rats with the portacaval shunt showed a reduced learning ability, treatment of shunted rats with sildenafil restored their ability to learn. Tests showed that the concentration of cGMP was reduced in the extracellular fluid in brains of shunted rats compared with controls and that treatment with sildenafil restored levels of cGMP in these animals. In addition, further tests showed a reduction of 74 percent in the function of the glutamate-nitric oxide-cGMP pathway in shunted rats, while treatment with sildenafil significantly enhanced the function of this pathway. These evaluations were also performed on rats with hyperammonemia. Results showed that chronic hyperammonemia significantly reduced the rats' ability to learn, but that treatment with sildenafil restored their learning ability. While sildenafil treatment restored levels of cGMP and enhanced the function of the glutamate-nitric oxide-cGMP pathway in hyperammonemic rats, it did not affect ammonia levels.

"The fact that rats with portacaval anastomosis [shunts] or with hyperammonemia without liver failure show the same alterations in the function of the [glutamate-nitric oxide-cGMP] pathway, extracellular cGMP and learning ability indicates that hyperammonemia, which is the only common alteration in both models, is responsible for the alteration of the function of the pathway and, subsequently, of the impairment of learning ability," the authors state. They note, however, that an excessive increase in cGMP may impair learning and that it must be kept high but below a certain threshold to reach maximum learning ability.

The authors conclude: "Although caution must be taken considering the possible deleterious increase in the existing vasodilatation in liver disease by sildenafil, pharmacological manipulation of cGMP in brain by safe procedures may be a useful treatment to restore cognitive and intellectual functions in patients with overt or minimal hepatic encephalopathy."
Article: "Oral Administration of Sildenafil Restores Learning Ability in Rats with Hyperammonemia and with Portacaval Shunts," Slaven Erceg, Pilar Monfort, Mariluz Hernández-Viadel, Regina Rodrigo, Carmina Montoliu, Vicente Felipo, Hepatology; February 2005; 41:2.

John Wiley & Sons, Inc
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BBC NEWS | Special Report | 1998 | Viagra | Viagra ‘limited to cut cost’ [Jul. 4th, 2008|12:51 pm]

Tuesday, 11 May, 1999, 17:28 GMT 18:28 UK Viagra 'limited to cut cost'
The government anticipated a huge demand for Viagra
The government put restrictions on the NHS prescription of Viagra because it feared a rush for the drug would create huge expense, a High Court judge was told on Tuesday.

The fears were described during a legal challenge to the Government's original decision to issue advice limiting the NHS availability of the anti-impotence drug.

Mr Justice Collins reserved judgment following a two-day hearing.

Pfizer Ltd, manufacturers of the drug, attacked a health service circular issued last September advising doctors not to prescribe Viagra, unless in exceptional circumstances.

David Pannick QC, for the company, said Health Secretary Frank Dobson had acted outside his powers by effectively using the circular to impose a ban.

He had also acted in breach of EU law as he attempted to prevent the best-selling love drug becoming a "serious drain" on NHS funds, said the QC.

Presiley Baxendale QC, appearing for the Health Secretary, said worldwide publicity about the Viagra had led to fears that doctors would come under huge pressure to prescribe the drug, particularly as it has been suggested it could enhance sexual performance.

Ms Baxendale said: "I accept the Secretary of State was very concerned about resources."

It was feared that, if action was not taken, Viagra could have cost the NHS between £60m and £125m a year.

Ms Baxendale said she accepted the aim of the circular was to "deter the rush", but there was a difference between a ban and something which was interim advice and guidance while consultations took place before a final policy was decided upon.

The advice did not stop GPs exercising their judgment, but at the same time they were perfectly entitled to take it into account.

Unlawful interference

Mr Pannick said he accepted that the circular was not a ban, as such, but its effect was to act as a ban - "and that was what was intended".

This unlawfully interfered with a doctor's "statutory right and legal duty to prescribe according to their assessment of clinical need."

If the Health Secretary wanted to impose restrictions, the correct course was to obtain Parliamentary approval and place the drug on the relevant medical schedule.

Mr Dobson had now shown an "impeccable sense of timing" by announcing last Friday that he proposed to take that course of action, said Mr Pannick

Since the September guidance was issued, the government has published its views on which patients should receive Viagra.

Last week, it increased the number of men who could get the drug.

They include men with diabetes, prostate cancer and Parkinson's Disease.

Impotence experts say the list is still restrictive and discriminatory.

Reserving judgment, the judge said he hoped to give his decision on the challenge within a month.

Internet links:

Department of HealthViagra information
The BBC is not responsible for the content of external internet sites
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Atazanavir for Treatment of HIV Infection [Jul. 4th, 2008|10:48 am]

Effect on Lipodystrophy

Based on preliminary data at week 48 from a substudy of the AI424-034 trial, it would appear that atazanavir has little effect on changes in fat redistribution.[35] In this substudy, dual x-ray absorptiometery (DXA) and cross-sectional computed tomography (CT) were performed at baseline and at week 48. At week 48, DXA scans revealed small, comparable increases in appendicular fat (3% vs 3%), truncal fat (5% vs 8%), and total body fat (5% vs 5%) for atazanavir versus efavirenz. Cross-sectional CT scans showed no change from baseline in the ratio of visceral adipose tissue:total adipose tissue for both regimens. Another trial (AI424-007/AI424-041) comparing unboosted atazanavir with nelfinavir revealed that 13% and 8% developed investigator-reported lipodsytrophy, 0% and 1% developed a buffalo hump, and 5% and 2% developed gynecomastia, respectively.[35] A recent case series of three patients reported a regression of dorsocervical and abdominal fat accumulation after switching the existing protease inhibitor in their HAART regimen for atazanavir.[62] However, careful long-term studies will be needed to assess the true effect of atazanavir on lipodystrophy.

Previous PageSection 7 of 12Pharmacotherapy 24(12):1732-1747, 2004. © 2004 Pharmacotherapy Publications
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Oral Medications in the Management of Erectile Dysfunction [Jul. 3rd, 2008|04:49 pm]

Oral Medications in the Management of Erectile Dysfunction

from Journal of the American Board of Family Practice

Safety and Tolerability

When choosing an agent to treat erectile dysfunction, important issues to consider include safety, tolerability, and convenience. Because these medications are used to improve the patient's quality of life, agents that have marked adverse effects, are invasive, or are inconvenient might not be first options. In addition to being noninvasive and convenient, all three oral medications for erectile dysfunction appear to be well tolerated and have minimal and transient side effects at their recommended dosages. Priapism, a concern with the penile injection therapies and urethral suppositories, does not appear to be an issue with the oral medications; therefore, adverse effects might not be a major factor when choosing among these agents.

Many clinical trials evaluating yohimbine did not include information on adverse effects. When examining those trials that did include this information, the most common adverse effects observed with yohimbine included anxiety, increased urinary frequency, tachycardia, and increased arterial pressure.[3,4] In a study by Teloken et al[5] in which patients received 100 mg of yohimbine daily, a dose three to five times higher than used in other trials, 32 percent of patients experienced an increase in urinary frequency compared with 14 percent taking placebo. A fairly high percentage of patients taking yohimbine reported tachycardia (27 percent), whereas none of the patients on placebo experienced an increased heart rate. Only one study of yohimbine included in this review reported patient dropout rates resulting from adverse effects. This study included 82 patients in a crossover design, and 8 patients (10 percent) discontinued therapy because of adverse effects of treatment with yohimbine.[4] The adverse effects were similar to those previously mentioned. In a trial by Rowland et al,[6] the more common adverse effects in the yohimbine group included disturbed sleep, mild diarrhea, lack of energy, and, surprisingly, lower sexual desire.

Sildenafil and phentolamine are generally well tolerated by most patients according to the available clinical trials. Goldstein et al[7] conducted two trials of sildenafil with a total of 861 patients. Adverse effects included headache (12 to 30 percent), flushing (10 to 27 percent), and dyspepsia (3 to 16 percent) with rates being dose dependent. Additionally, dose-dependent transient visual disturbances, or changes in the perception of color hue or brightness, were reported by 2 to 9 percent of men. The manufacturer reports a rate of 3 percent for transient color vision changes. Between 6 and 15 percent of patients withdrew from the trials during treatment with sildenafil compared with 8 to 17 percent of those receiving placebo. Discontinuation because of treatment-related adverse effects was 1 to 2 percent. Additional reasons for discontinuation included insufficient response, protocol violations, and withdrawal of consent, among others.

Recently there have been several reports of deaths occurring with concurrent sildenafil and nitrate use. These drugs in combination cause potentially fatal decreases in blood pressure. According to the manufacturer, sodium nitroprusside use is also contraindicated, but other nonnitrate vasodilators (b-blockers, a-blockers, angiotensin-converting enzyme inhibitors, diuretics, and calcium channel blockers) have not been shown to be a problem. Sildenafil should never be administered to a patient concurrently taking nitrates or sodium nitroprusside or to a patient who might inadvertently receive a nitrate after exertion or sexual activity.

Nasal congestion was reported as the only adverse effect, with one patient experiencing it, in the smallest study of phentolamine.[8] In two trials reported by Zorgniotti,[9] 6 percent of patients complained of nasal congestion and 2.3 percent complained of faintness or dizziness, relieved by lying down. Another study excluded patients with intolerance to phentolamine (increased blood pressure and pulse) before randomization by giving a test dose; therefore, no adverse effects were mentioned in the results.[10] This methodology could limit the generalizability of these results to general practice. Information available from the manufacturer of phentolamine lists insomnia, nasal congestion, and dyspepsia as common adverse effects.

This is a part of article Oral Medications in the Management of Erectile Dysfunction Taken from "Causes Of Erectile Disfunction" Information Blog

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Just found great porn red tube portal. [May. 11th, 2008|07:35 pm]

Just found great porn red tube portal. Downloaded a lot of free shemale sex videos vids there!
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Metronidazole online [Apr. 29th, 2008|10:32 am]

results presented in this inspection must be interpreted with level
circumspection given the body part symbol of trials and patients
evaluated for any one likeness.
Metronidazole online
appears to be an effective therapy for active voice chronic pouchitis.
Bismuth carbomer foam enemas may not be an effective therapy for
chronic soul pouchitis.
Oral probiotic therapy with VSL – 3 appears to be an effective therapy
for maintaining subsidence in patients with chronic pouchitis in
remission of sin.
There is no info of a fluctuation in the actus reus of symptomatic
reprieve in patients with chronic pouchitis treated with glutamine
versus butyrate suppositories, and it is terra incognita whether
glutamine and butyrate are equally effective or ineffective.
This is a part of article Metronidazole online Taken from "Generic Clarinex (Desloratadine) Page" Information Blog

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Diphenhydramine Edges Desloratadine in Allergic Rhinitis [Jan. 26th, 2008|10:54 am]

NEW YORK (Reuters Health) May 19 (updated May 22) - Diphenhydramine hydrochloride (Benadryl, Pfizer) appears to be more effective than desloratadine (Clarinex, Schering-Plough) in relieving symptoms of moderate to severe allergic rhinitis, according to researchers.

“Benadryl provided significantly wagerer coverall allergy indicant relievo than Clarinex,” research worker Dr.
Rex T.
Angello told Reuters Eudaemonia. “Even more noteworthy in this piece is the judgement that Benadryl relieved nasal consonant crowding just as well as it reduced allergic rhinitis symptoms as a unit.”

In the April event of the Story of Allergy, Asthma and Immunology, Dr.
Angello, of Pfizer Consumer Healthcare, National leader Plains, New Dairy cattle and colleagues note that they came to this subdivision after studying 610 patients.

They were randomized to 50 mg of diphenhydramine 3 arithmetic operation daily, 5 mg of desloratadine once daily or medicine.

At the end of the 7-day bailiwick, it was found that the mean change of magnitude in whole os nasale grounds scores in the diphenhydramine building block someone to vesper was 77.6%.
For the desloratadine set, it was 21%.

Compared to medication and desloratadine, diphenhydramine provided clinical and statistically significant condition in scores for all symptoms including bone crowding.
However, although desloratadine had a disposition towards shift compared with medicinal drug, this reached subject matter only for sneezing.

Somnolence was reported by 22.1% of patients taking diphenhydramine, compared with 4.5% of patients taking desloratadine and 3.4% of those taking medicament.

This investigating was supported by a parceling from Pfizer.

Ann Allergy Asthma Immunol 2006;96:606-614.
This is a part of article Diphenhydramine Edges Desloratadine in Allergic Rhinitis Taken from "Generic Clarinex (Desloratadine) Page" Information Blog

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Viagra effective in Raynaud’s. [Jan. 24th, 2008|12:54 pm]

Sue REPRESENTATIVE OFchief official November 9, 2007 Bad Sch
This is a part of article Viagra effective in Raynaud’s. Taken from "Causes Of Erectile Disfunction" Information Blog

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