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Elderly patients with metastatic colorectal cancer responded well to a combination of two Roche agents, capecitabine (Xeloda) and oxaliplatin (Xelox).

In the Southern Italy Cooperative Oncology Group Trial, about 75% of the group achieved some disease control. Surprisingly, patients 75 years of age and older had an even better response rate than those aged 75 or younger.

Starting patients at low doses and increasing the doses only if they were well tolerated helped avoid unwanted and unpredictable toxicity. The combination regimen was well tolerated, in part because capecitabine and oxaliplatin do not have overlapping toxicities. The conservative step-up dosage schedule, combined with a limited number of delivered cycles also meant that patients received a relatively low cumulative dosage of oxaliplatin.

Ongoing trials will help determine whether capecitabine can replace 5-fluo-rouracil/leucovorin (5-FU/LV) in combination with oxaliplatin in patients with metastatic colorectal cancer. The switch would eliminate the need for a central venous catheter and the risks of catheter-related infection and thromboembolism, and patients would need only one clinic visit during each cycle for the infusion— a benefit that many patients, particularly the elderly, would appreciate.

One-daily ketoconazole gel 2% (Xolegel, Barrier Therapeutics) is now approved for the topical treatment of seborrheic dermatitis in immuno-competent adults and children 12 years of age and older. Previously known as Sebazole, the formulation contains 2% generic ketoconazole, an antifungal agent, in a waterless gel for once-daily application.

Seborrheic dermatitis, a common skin inflammation, usually occurs on the face, scalp, hairline, eyebrows, and trunk.

Xolegel is the first prescription gel formulation of ketoconazole approved in the U.S. Until this approval, prescription therapies consisted primarily of shampoos, topical antifungal creams, and topical steroids.

Patients apply the gel once a day for two weeks. They need 75% fewer applications compared with some traditional therapies. The steroid-free gel is effective with minimal skin irritation.

Abbott Laboratories has announced the approval of adalimumab (Humira) for reducing signs and symptoms of active ankylosing spondylitis (AS). An autoimmune disease, AS affects the spine and large peripheral joints and causes inflammatory back pain and stiff ness. It can also be associated with other inflammatory diseases of the skin, eyes and intestines. Over time, severe AS can result in complete spinal fusion.

The recommended dose is 40 mg every other week by subcutaneous injection, the usual dose recommended for patients with moderate-to-severe rheumatoid arthritis and psoriatic arthritis.
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Adalimumab is available in the U.S. in a pre-filled syringe.

The approval for this new indication was based on data from the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS).

The first generic version of Wyeth’s antidepressant drug, Generic Effexor (venla-faxine), has been approved. Venlafaxine drug is indicated for the treatment of major depressive disorder. The tablets, in strengths of 25 mg, 37.5 mg, 50 mg, 75 mg, and 100 mg, are made by Teva Pharmaceuticals. This product will carry the same labeling as the originator drug, including the boxed warning.

A new 300-mg single capsule formulation of atazanavir sulfate (Reyataz, Bristol-Myers Squibb) has been approved for adults with HIV-1 infection as part of combination therapy.

Taken once daily along with drug ritonavir (Novir generic, Abbott) and food as part of an anti-HIV drug regimen, the capsule formulation can replace two atazanavir 150-mg capsules for patients who have previously received anti-HIV medications, for those who will be receiving tenofovir disoproxil fumarate generic (Viread, Gilead), and for those who have never taken anti-HIV drugs that require medication efavirenz (Sustiva tablet, Bristol-Myers Squibb) as part of their anti-HIV drug regimen.

The FDA initially approved atazanavir in 2003. Abbott will continue to produce the 200-mg, 150-mg, and 100-mg once-daily capsules.

The FDA has approved donepezil HCl (Aricept drug, Eisai) for treating severe dementia in patients with Alzheimer’s disease (AD).

Donepezil was previously approved to treat mild-to-moderate dementia of the Alzheimer’s type. It now becomes the first product approved for the treatment of all degrees of severity of the disease.

The approval is based on two new clinical studies conducted in Sweden and Japan in more than 500 patients with severe AD. The effectiveness of therapy with donepezil was determined by evaluating cognitive skills (memory, language, orientation, and attention) and overall functioning. Patients receiving generic donepezil performed better in both measures than patients receiving placebo.

Lamotrigine drug (Lamictal generic) tablets have been approved for patients with primary generalized tonicclonic (grand mal) seizures. With this indication, lamo-trigine can now be used as add-on therapy to treat children two years of age or older as well as adults.

This new use marks the fifth FDA approval for this medication in epilepsy treatment, making it one of the few antiepileptic drugs with established efficacy in a broad spectrum of seizure types, including partial and generalized seizures. It is also approved as maintenance therapy for adults with bipolar I disorder.

Grand mal seizures occur in approximately 20% of patients with epilepsy, usually without warning.