.New medications. 1998

New FDA-approved medications.

November 2001 Pacemaker for Congestive Heart Failure The FDA has approved Insync Biventricular Cardiac Pacing System (Medtronic Inc., Minneapolis) for reduction of symptoms of moderate to severe congestive heart failure in patients who remain symptomatic despite maximum medical therapy, and who have a left ventricular ejection fraction of 35% or lowers. The device has capability for sensing and pacing in one atrium and both ventricles, and external programming, plus activity-triggered sensing capacity. No safety issues have been reported with this device at time of approval. September 2001 Treatment of hepatitis C The FDA has issued two approvals involving the use of Rebetol capsules (ribavirin), Introm A injection ( Interferon alfa-2b) and PEG-Intron injection(peginterferon alfa-2b) to treat patients with chronic hepatitis C, The new approval provides for the distribution of Rebetol without IntronA, thereby giving prescribers flexibility in adopting individualized ribavirin and interferon based therapies. PEG-Intron is a longer acting than Introm A and can be used at 0.5ug/kg once weekly, plus Rebetol at 1000mg daily. After 24 weeks, this combination produces undetactable viral load in 52% of patients treated with sustained response in 41% of patients. July 2001 Reminyl. New therapy for Alzheimer's disease Reminyl is a reversible acetylcholinesterase inhibitor, with Galantamine as the active ingredient. It is indicated for mild to moderate dementia of the Alzheimer's type. Galantamine enhances cholinerigic function in the brain by inhibiting cholinesterase hydrolysis. There is no evidence that this drug alters the underlying dementing process. In doses of 4-32mg daily divided into twice -daily doses, Galantimine has improved behavior, cognition, activities of daily living and general patient functioning. Side effects include AV block, GI bleeding, bladder outlet obstruction, COPD flares, and exacerbation of asthma and seizure disorders. The drug may be potentiated by other medications metabolized by the CYP2D6 or CYP3A4 systems.

June 2001 Lantus, a new long acting insulin Lantus is a new insulin glargine recombinat 100IU/mL injection. It is indicated for type 1 diabetes and type 2 diabetes when basal long acting insulin is needed. After subcutaneous injection, the solution is neutralized , leading to the formation of micro precipitates from which small amounts of insulin glargine are slowly released. This results in a relatively constant concentration/time profile over 24 hours with no pronounced peaks. When insulin glargine is dosed once daily it mimics endogenous basal insulin secretion. The duration of action of insulin glargine after SC injection into the abdomen, deltoid area, or thigh is similar. Its potency is about the same as that of human insulin

May 2001 Gabapentin for hot flashes Estrogen replacement therapy has been the gold standard in treating menopausal hot flashes. However, new awareness of increased risks for breast cancer and ovarian cancer in the press, has decreased the interest of women for estrogen therapy and new alternatives have been thought. Gabapentin is a drug commonly used for seizures and chronic pain syndromes. In a recent trial by Dr Thomas Guttuso at the University of Rochester Medical Center, menopausal women who participated experienced a 87% fewer hot flashes , with reductions ranging from 70% to 100%. The dose of gabapentin used in the studies was 300 mg three times a day, while in the control of seizures the dose is usually raised to 900-7000 mg/day. Gabapentin rarely interacts with other medications, and the dose needs to be adjusted to the level of renal function.

April 2001 Fulvestrant, a estrogen receptor downregulator for advanced breast cancer This is the firs compound in this new class of estrogen receptor downregulator for advanced breast cancer therapy. Unlike tamoxifen, has no estrogen agonist activity. Fulvestran appears now to be a second line hormonal alternative, although currently when tamoxifen does not work, anastrozole is usually selected . Fulvestran's greatest potential application is not in metastatic disease, but in early breast cancer treatment.

March 2001 Peg-Intron for Hepatitis C Pegylated interferon with Ribavirin seems to be the best combination for HCV. Peg is a molecule attached to the interferon molecule to increase its half life, and therefore it allows a once a week administration instead of 3 times a week with our current formulation of interferon alfa2. Patients achieve a 54% sustained virologic response when treated. and up to 61% when the combination was used. Patients with genotype 2 and 3 had a 88% response vrs 48% for genotype 1. Anemia can be seen with ribavarin. The FDA is to approved this drug very soon.

February 2001 Welchol( colesevelam) , a new nonsystemic agent for hypercholesterolemia Many patients with hypercholesterolemia can not tolerate statin therapy with drugs like mevacor and the like. Others, need another drug added to a statin in order to control their levels of high LDL cholesterol. Welchol is therefore a new option as therapy for hyperlipidemia. Because Welchol is a non-systemic agent, the side effect profile is only limite to the GI tract, with minor problems like flatulence and constipation. Welchol is dosed at 3 tabls bid with meals, each tablet containing 625mg of colesevelam

January 2001 Tikosin. A new antiarrhythmic Tikosyn(dofetilide) is marketed for control of atrial fibrilation and atrial flutter, but it can cause serious ventricular arrrthymias, especially if patients have impaired renal function or if mixed with certain drugs, like cimetidine, erythromycin, ketoconazole, SSRIs, trimetoprim and verapamil. Tikosyn is available only in certain hospitals. December 2000 Lon-acting depakote in migraine prophylaxis Abbott is now marketing Depakote ER, a new once a day valproic acid tablet, approved for the prevention of migraine headaches. This drug comes in 500mg tables and it is usually effective in doses of 500-1000 mg daily. patients are to be warned about the rare occurrance of pancreatitis. Depakote joints now other anticonvulsant medications like dilantin and tegretol in the armamentarium available to the clinician for adequate prophylaxis of vascular headaches

November 2000 Acne treatment may help clear rosacea Oral azithromycin which succesfully treats acne vulgaris, also appears to improve refractory symptoms of acne rosacea, at a dose of 250mg 3 times a week. Rosacea is a chronic skin disorder that affects about 10% of Americans-more than 13 million-and often requires long-term therapy. Inflamatory rosacea has been called a "yupipei" disease because it usually manifests between the ages of 30 and 50 years with papules, pustules and erythema. Standard therapy for Rosacea is oral tetracycline and topical metronidazole. Azithroamycin has a unique pharmacologic profile that allows it to move rapidly from blood to tissues where it remains at high levels for long periods. Placebo controlled studies will be needed. Lamivudine for Chronic Hepatitis B. A recently ramdomized study using 100mg daily of lamivudine for 52 weeks has been completed. Lamivudine suppressed serum HBV DNA to undetectable levels in nearly all patients within a median of 4 weeks. Sustained suppression occurred at week 52 in 44% of patients. Hepatitis B e antigen seroconversion occurred in 17% of treated patients. ALT serum levels normalized in 41% of patients. Lamivudine was well tolerated and the incidence of adverse events was similar in the placebo and Lamivudine groups. Until recently , Interferon was the only antiviral treatment for Chronic HBV infection.

October 2000 Zyvox. Zyvox. New antibiotic of the class oxazolidinone, with the active ingredient Linezolid for oral and IV administration. This drug is indicated for susceptible vancomycin-resistant Enterococcus Faecium (VREF) infections, nosocomial pneumonia, community-acquired pneumonia, and skin and skin structure infections. Mechanism of action is prevention of the formation of a functional 70S initiation complex, and essential component of bacterial translation. Use with caution in hyperthyroidism, pheochromocytoma, and carcinoid tumors Exelon Exelon (active ingredient is rivastigmine) has been approved for therapy of mild to moderate dementia of the Alzheimer's type. The decline in cognitive function that occurs with Alzheimer's dementia is thought to be associated with a decrease in acetylcholine levels in the brain. Rivastigmine increases the concentration of acetylcholine by inhibiting the enzyme cholinesterase. Although rivastigmine may improve the symptoms of Alzheimer's dementia, there is no evidence that it alters the course of the underlying disease. Initial dose is 1.5mg twice daily with a range of 6-12 mg daily. Adverse reactions include GI intolerance, weight loss, tremor and syncope.

September 2000 Mechanical aid for erectile dysfunction ErecAid Vacuum therapy , produced by TIMM-Medical technologies, Inc. 1-800- 344-969688, www.timmmedical.com, is an alternative to the use of Viagra. Viagra is not appropiate for everyone and the failure rate on those who are able to take it is about 50%. ErecAid boasts a 90% success rate using a mechanical device that is medically approved, with a low cost and allegedly very efficacious. Timm claims this product is completely safe, provides immediate penile rigidity , and is easy to use. Omeprazole protects ulcer patients on NSAIDs Patients who have already experienced a severe ulcer-related hemorrhage and require low-dose aspirin or NSAIDs may be better protected from future events by omeprazole than misoprostol Once a patient has a hemorrhagic ulcer, renewed use of an NSAID confers an estimated 25%-35% increased risk of ulcer formation.. Lotronex for IBS For women with diarrhea-predominant irritable bowel syndrome, Lotronex(alosetron), provides patients with multisymptom relief of pain, urgency and frequency of the GI tract. Constipation is a frequent (28%) adverse event. and this medications should not be used in constipation-predominant patient or those currently constipated. Lotronex relieves abdominal pain and disconfort within 1-4 weeks, significantly reduced bowel urgency and stool frequency within one week, with sustained improvement while on therapy, with a favorabel safety profile and general good tolerance, at a dose of one tablet bid. Administration timing of proton pump inhibitors . Proton Pump Inhibitors like Prilosec and Prevacid are the current agents of choice for treating GER and peptic esophagitis. Currently 2/3 of patients are taking their medications at the wrong time. PPIs should be taken at a precise schedule. These agents are prodrugs, and to be effective, they must be converted to their active form within the parietal cell. Their effectiveness is optima if administered before or during the first daily meal. Patients unresponsive to PPIs alone can benefit also by adding a H2-receptor antagonist at bedtime. Glargine, new recombinant human insulin Glargine, the new long-acting recombinant human insulin analogue, produces a 24-hour basal control that closely mimicks that of an insulin pump in patient with type 1 diabetes. Glargine, manufactured by Aventil Pharmaceuticals under the name Lantus, is expected to be available this fall. It was approved by the FDA for once-daily subcutaneous administration at bedtime for the treatment of adult patiens with type 2 diabetes mellitus whe require basal insulin, and for both adults and children aged 6 yeras and older with type 1 diabetes Both glargine and the insulin pump produced flat, continuous action whthout significant peaks. In contrast, NPH had a peak concentration at 4 hours and a subsequent fall, while Ultralente peaked at 10 hours an fell more slowly. Glargine’s action lasted for about 20 hours, NPH for about 12 hours, and Ultralente for 16 hours. Octreotide new uses: 1. Obesity. Obese patients with high insulin levels*( primary insulin hypersecretion syndrome) can benefit from Octreotide(Sandostatin LAR Depot) once every 28 days for 24 weeks. Significant weight loss even without exercise or diet was observed. Prophylaxis for gallstones needs to be administered 2. Diabetic retinopathy: Current studies are underway in order to determine efficcacy for patients with advance retinopathy when photocoagulation and tight diabetes control may not be enough. 3. Grave’s ophthalmopathy. The drug suppresses the activated lymphocytes that infiltrate both thyroid and orbital tissues in patient with Grave’s disease. 4. Acromegaly: Somatostatin analogues are clearly the biggest advance in the last decade for the treatment of acromegaly. This seems to be the primary therapy in selected patients who may not benefit from surgery or radiation.

August 2000 Zonegran. A new antiepileptic drug The active compound in Zonisamide 100mg caps. This is a sulfonamide antiepileptic drug possibly acting through calcium and sodium channels. Patients allergic to sulfa should not take this drug. It is indicated as an adjunt in therapy of partial seizures. Dosages of 100-400mg daily is recommended. Somnolence and other CNS side effects may be a problem.

July 2000 Trileptal. A new antiepileptic drug The active compound in oxcarbazepine in 150mg, 300mg, and 600 mg tablets. It is indicated for monotherapy or adjunct in partial seizures in adults. Adjunct in partial seizures in children 4-16 years of age. This compound is structurally related to carbamazepine and possibly works by blocking voltage sensitive sodium channels, potassium conductance na activated calcium channels.

June 2000 Ortho-prefest. For therapy of menopausal symptoms . This is a combination of estradiol and norgestimate in an alternating sequence of 3 tablets each, one having the estrogen compound and the other having both compounds.By alternating the two tablets every 3 days continuously, in order to produce a constant estrogen and an intermittent progestogen regimen, to be used in women with an intact uterus with moderate to severe vasomotor symptoms associated with menopause, and treatment of vulvar and vaginal atrophy and the prevention of osteoporosis

May 2000 Zybox. A new antibiotic Zybox has been approved on April 18, 2000 as a new powerful antibiotic effective against gram -positive bacteria such as vancomycin-resistant Enterococcus faecium, including cases with bacteremia, and hospital-acquired pneumonia and complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus. This drug is intended to be used for the toughest hospital-based and institutional infections. Zybox works by preventing bacteria from multiplying by stopping protein production at a very early point in the process. The introduction of Zyvox into the hospital medicine chest is hailed as an important step because it takes some of the pressure off existing antibiotics.

April 2000 Penlac. Topical therapy for fingernail fungal infections. Penlac in the only topical therapy for onychomycosis of the fingernails and toenails without lunula involvment, ddue to Trichophyton rubrum, as part of a comprehensive management program including professional removal of unattached, infected nails. Penlax contains ciclopirox that needs to be applied daily for up to 48 weeks in order to achieve less than 10% infected nail beds. However, a completely clear nail may not be achieved with the use of this drug. Prevnar. Pneumococcal vaccine for children. Prevnar is a penumococcal 7-valent product for immunization of infants and toddlers against invasive disease caused by Streptococcus pneumonia due to serotypes 4,6B,9V, 14, 18C, 19F and 23F. Each dose of 0.5ml is injected IM after week six, with 4 doses given at 2,4, 6 and 12-15 months of age.

January 2000 Aggrenox. This is a new antiplatelet agent indicated to reduce the risk of stroke after ischemic stroke or TIA. Efficacy is based on the European study published in the J. Neurology Sci in 1996. Aggrenox is a combination of 25mg of dipyridamole and 200mg aspirin that seems synergistic in its antiplatelet effect at doses of one cap bid. The major side effect is GI intolerance that is reported at a low 4.1% compared to 2.1% placebo. Comtan. New antiparkinson agent to be used as an adjunt with levodopa/carbidopa (Sinemet) when patients experience of end-of -dose "wearing off" effect. This drug produces elevated levels of levodopa in the brain with associated dopaminergic activity. Comtan can be dosed at 200mg with each dose of sinemet, up to 8 times a day. Caution needs to be exerted with combined with other drugs like aldomet, dopamine, probenecid, cholestyramine, erythromycin, rifampin, amipicillin and cholramphenicol Teveten. New antihypertensive agent that belongs to the group of "angiotensin II receptor inhibitors". Angiotensin I is a hormone that is cleaved into angiotensinII by a enzyme called "angiotensin converting enzymes. The end result is the stimulation of the adrenal gland to produce aldosterone with subsequent sodium and water retention. Angiotensin II is a primary vasoconstrictor also. Therefore these new group of "angiotensineII receptor inhibitors " seem to be a step further to our older angiotensince converting enzyme inhibitors "ACEs" like Capoten. At doses of 400 to 600mg daily as monotherapy in normovolemic patients seems quite effective and will be competing against other 4 better known compounds in the same category like Hyzaar and Avapro.

December 1999 Lamivudine for Chronic hepatitis B Lamivudine is an oral antiviral drug with less side effects than interferon alfa that has been shown effective in treating chronic HBV infection. The decision to use interferon or lamivudine needs to be analized with the patient. Lamivudine, although safer and easier to use than interferon alfa, needs to be administered for one year, and it is associated wtih an increased incidence of genotypic mutation of 15-30%. Lamivudine or interferon can be used in patients with elevated ALT and who are positive for both hepatitisBe antigen (HBeAg) and hepatitis B virus (HBV) DNA. Neither drug is helpful in patients who are in the "immune tolerant" phase-positive for both HBeAg and viral DNA but with normal ALT levels. Combo therapy for HIV Contributing to the growing belief that AIDS is becoming a chronic manageable illness, preliminary results on the use of combination drug therapy on HIV show potent and sustained antiviral activity over 48 weeks of treatment. Most effective combos are 2 nucleoside reverse transcriptase inhibitors(stavidine and didanosine), mixed with eiter lamivudine(nucleoside reverse transcriptase inhibitor), nevirapine (a non-nucleoside reverse transcriptidase inhibitor) or indinavir.(a protease inhibitor) At 48 weeks, the proportion of patients with a plasma viral load of less thant 50 copies/ml was 90-78% for the 3 groups studied.(Presented at the 39th ICAAC on Sept,1999)

November 1999 Oseltamivir{Tamiflu) for Influenza Oseltamivir has been approved for treatment of Influenza A and B in adults. This is the first neuraminidase inhibitor in pill form. This drug targerts the influenza virus and stops it from replicating and infecting new cells. The drug blocks the receptor site of the neuraminidase protein on the surface of the virus. At dosages of 75mg bid for 5 days, the drug in indicated in patients with influenza symtoms of less that 48 hours duration. Oseltamir reduced the duration of influenza by 30%, lessened the severity of symptoms by 40% and the incidence of secondary influenza complications by approximately 50% in previously healthy adults.

October 1999 ProAmatine. A new medication for postural hypotension. ProAmatine(midodrine hydrochloride) is a unique alpha adrenergic agent that increase standing blood pressure. Patients affected by postural hypotension develop dizziness and syncope sometimes when they get up from the flat or sitting position. Certain illnesses like diabetes can impair the normal functioning of the peripheral arteries to maintain the blood pressure from falling upon standing. ProAmatine does not increase circulating volume, does not readily cross the blood-brain barrier, has mininal CNS effects, and lasts for approximately 3 hours. Usual dose is 10mg 3 times daily. It is contraindicated in patients with acute renal disease, organic heart disease, urinary retention, pheochromocytoma, or thyrotoxicosis or patients with persistent supine hypertension. September 1999 Skelatin (Metaxalone) Although this is not a new drug because has been available for 3 decades , it is being advertised heavily in several medical journals. At a dose of 800mg(2tabl) 3 times daily, Metaxalone is supposed to induce prompt relief of painful muscle spasms, and rapid improvement in mobility , with low incidence of side effects including CNS effects and drowsiness. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man. ARAVA (leflunomide). A new drug for Rheumatoid arthritis. This is a new drug for active rheumatod arthritis, that is supposed to suppress the articular and bone damage found in active RA. It is classified as a disease-modifying agent and can be used in conjuntion with NSAIDs and low dose prednisone. However the use of leflunomide with methotrexate, and other agents has not been studied. Caution should be exercised when using other potential hepatotoxic agents, NSAIDs, rifampin and cholesteramine. Contraindications include hepatic and renal disease. Frequent liver function tests should be performed monthly.Patients immunosuppressed should not use this drug neither.There is potential of fetal toxicity also. Lymphomas and leukemia have been linked to the use of other immunosuppressants and therefore leflunomide may eventually be linked to this problem also. Lidoderm for post-herpetic neuralgia. Lidoderm is a lidocaine patch approved in March of 1999 for therapy of post herpetic neuralgia. The patch has no systemic side effects, does no require titration and is simple to use. It is expected to bemove widely available in September of 1999. Other potential indications include peripheral neuropathy, sympathetic dystrophy and stump pain. Actos. New medication fo type 2 DM. The FDA has apporved ACTOS (pioglitazone) for use as a single agent for Diabetes Mellitus 2. Along with Avandia, Actos is presumed to have no hepatic toxicity. Actos achieves an average drop in blood sugar of 30mg.dL. This a once a day product, it can be taken without food, and has the same beneficial lipid profile effects than Rezulin. Like Avandia and Rezulin, Actos belongs to the thiazolidinedione class of drugs designed to overcome insulin resistance. Rezulin is no longer a first choice single agent due to the fact that the drug has been associated with 43 reports of acute liver failure and 28 deaths and seven liver transplants. Actos has been approved as a monotherapy adjunct to diet and exercise in patients with type 2 DM. Therapy is usually initiated with 15 to 30mg daily single or in combination. July 1999 Vioxx. New medication for arthritis and pain control: Vioxx (Rofecoxib) is a new NSAID with selective inhibition of COX-2, and therefore touted as having minimal GI toxicity. Likewise it does not appear to affect bleeding time or platelet aggregation. For patients with DJD, Vioxx can be dosed at 12.5mg once a day and increased to 25mg daily if needed. For acute pain, like in dysmenorrhea, a 50mg daily dose to a max of 5 days is recommended. Potential adverse effects are similar to other NSAIDs and include GI upset, edema, hypertension, bronchitis, fatigue, GI ulcerations a bleeding, and increase LFT. Avandia. New agent for type 2 Diabetes Mellitus.: Avandia( Rosiglitazone) is the second glitazone agent in the market besides Rezulin(troglitazone) that improves glicemic control without raising insulin serum levels. It can be used as monotherapy or added to metformin. Initial doses of 4mg to be increase to 8mg is needed, once or twice a day. No liver toxicity has been reported with rosiglitazone, as has been reported with troglitazone. However, the agent should not be used in patients with liver problems. Aphthasol. New topical agent for stomatitis.: This a topical agent sold as amlexanox oral paste 5% for use in recurrent aphtous stomatitis. It has been proven effective in four clinical trials of more than 1300 patients.For optimal results, patients should apply the medication as soon as symptosm occur. It is tasteless and odorless and no significant clinical adverse effects have been reported. JUNE 1999 Intermittent claudication due to peripheral vascular disease. PLETAL(CILOSTAZOL) Pletal or cilostazol is a phosphodiesterase III inhibitor recently approved for intermittent claudication of the legs due to peripheral vascular disease. Mechanism of action seems to be related to blockade of platelets and vasodilation. This drug seems a bit more effective than trental, an older medication in the same family of drugs. Dose is 100mg bid one hour before meals. There is concern with longterm cardiac toxicity. May 1999 Miralax (polyethylene glycol powder) This is a new agent that has been approved for short term therapy of idiopathic constipation. This drug is iso-osmotic and works locally in the intestinal lumen increasing the volume and frequency of stools. Miralax is marketed as a powder at a dose of 17gm (one tablespoon) dissolved in one glass of water. It does not interact with other medications and has a low toxic profile, causing sometimes flatulence and nausea. Xenical: a new agent for obesity management: Xinical or orlistat, is a new medicatioon for therapy of obesity with IBW greater than 30% or greater than27% in the presence of one or more co-morbidities. Doses of 120mg tid are recommended to induce a blocking effect of fat absorption from the gut, and maintaining a weight loss of approximately 10% for up to 2 years. Side effects refer mainly to the GI tract including flatulence and increased defecation. Fat soluble MTV should be taken while on this drug. Xenical has minimal drug interactions. Patients should also enroll on an education program by calling 1-800-437-8251 or by completing the forms in the Starter kit. Cost is approximately 139.99 per month. Enbrel: new therapy for rheumatoid arthritis This medication is indicated for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs. The drug is administered by subcutaneous injections of 25mg twice a week. Side effects are mainly local reactions in the injection sites. Embrel is described as a biologic response modifier, tumor necrosis factor blocker. Synvisc (Hylan G-F 20). A new agent for DJD of the knees. This is a new drug for degenerative disease of the knees. It is administered intra-articularly by injecting 2cc of Synvisc into the knee once a week for a total of 3 weeks. Hylan is produced from chicken combs and are derivatives from Hyaluronam If an effusion in the knee is present, this should be drained previous to injecting Synvisc into the knee. April 1999 Regranex(becaplermin). This product has been approved for foot ulcer of diabetics with neuropathic problems. It works by actively promoting healing of the ulcerations. This product is indicated for diabetic neuropathic foot ulcers tha6t extend into the subcutaneous tissue or beyond and hve an adequate blood supply. Regranex Gel is an adjunct to, and not a substitute for good wound care, which includes initial sharp debridement, pressure relief, and infection control. Regranex is the first and only recombinat human platelet-derived growth factor(rhPDGF-BB), enhancing the formation of granulation tissue. Glyset(miglitol).: This is a new medication for type 2 Diabetes Mellitus, to be used alone or with a sulfonylurea as an adjuct to diet in inadequately controlled type 2 Diabetes Mellitus. Glyset inhibits only the enzymes in the brush border of the small intestine to reduce glucose absorption, selectively blocking the alpha-glucosidase. Because this drug acts locally in the intestine, it will no cause systemic side effects like weight gain, liver toxicity, hyperinsulinemia or hypoglicemia when used as monotherapy. The most common side effects are flatulence, diarrhea and abdominal pain. Baycol ( Cerivastatin) is a new lipid lowering medication now available for patients with significant mixed hyperlipidemia including hypercholesterolemia with or without hypertriglyceridemia.( Frederickson type 2A and 2B). Contraindications include liver and renal disease. As usual with most statin drugs, periodic monitoring of the liver function tests is recommended. The mean percentage drop on triglycerides level is approximately 12.7%. Bayer, the manufactures, claims that Baycol will be cheaper than similar doses of zocor and pravachol. March 1999 New anesthetic disc. EMLA. EMLA is a topical adhesive disc system or anesthetic patch indicated to minimize the pain associated with injections and needle procedures. It is easy to use, by simply peeling apart and applying to procedure site, achieving dermal analgesia after one hour of application It may be left on for 2 to 3 hours without loss of efficacy. The period of application should be limited to the minimum required to achieve the desidered analgesia. Indicated for use in normal intact skin and not recommended for use on mucous membranes. February 1999 Celebrex.: A new arthritis medication with less GI toxicity. Celebrex is a new nonsteroidal anti-inflamatory (NSAID) agent approved by the FDA for treatment of DJD and Rheumatoid arthritis. Gastrointestinal toxicity in the form of ulcerations and bleeding is the most common serious problems with older NSAIDs and plain GI intolerance is the most common reason that patients abandon this therapy. Celebrex is being marketed as having lower GI problems than the older agents due to the fact that there is no inhibition of cyclooxygenase, the main mechanism for NSAIDs to induce gastric mucosal damage. Likewise there is no platelet aggregation blockade, a side effect that may contribute to bleeding with standard NSAIDs. However potential renal toxicity remains with this compound, and until more experience is accumulated, warnings on potential GI toxicity will remain. JANUARY 1999 ENBREL. New arthritis medicine. Enbrel, kwnon as Etanercept is a new injectable drug for therapy of moderately to severely active rheumatoid arthritis , in those patient who are not responding adequately to other DMA like methotrexate. This drug has the capacity to block T:NF or tumor necrosis factor, a naturally occurring cytokine, normally involved in immune and inflamatory responses, and found in high concentrations in the joints of affected individuals. Aproximately 60% of patients with RA will respond to Enbrel within one or two weeks of therapy. Usual dose is 25 mg injected subc twice a week. Contraindications include Sepsis, concurrent live vaccination and latex allergy. Precautions include close supervision for development of infection and stop the medication if significant varicella exposure occurs. DECEMBER 1998 NOLVADEX.: Prophylaxis of Breast cancer. FDA has approved Nolvadex (tamoxifen) tablets as the first drug EVER indicated to reduce the incidence of cancer in susceptible individuals. Those women with high risk of developing breast cancer include: women older than 35 years, with history of lobular carcinoma in situ (LCIS), or age older than 35 with 5-year predicted risk of breast cancer> 1.67% based on the folloing factors: Number of first-degree relatives with breast cancer, history and number of breast biopsies, history of atypical hyperplasia, age at menarche, and age at first live birth or nullipary.
So far, Nolvadex has safely been used my million of women with breast cancer , for 20 years, in order to prevent relapse after mastectomy.
Nolvadex is contraindicated in women taking coumadin or women with history of DVT. Nolvadex seems effective in reducing by 44% the incidence of breast cancer in women at high risk of developing the disease November 1998 Lipid disorders. Baycol.: Baycol (cerivastatin). This is a new statin drug, indicated in the therapy of patients with high cholesterol with or without high triglycerides(Fredrickson IIa and IIb) The drug produces a 30% reduction on LDL-cholesterol, and 10% increase in HDL-cholesterol, and a 11.5 to 21% reduction in triglycerides level at a price lower than zocor, pravachol . The medication is contraindicated in liver disease and in pregnancy, and in nursing mothers. O C T O B E R 1 9 9 8 Asthma. Singulair (montelukast) Singulair is a once a day leukotriene inhibitor that will compete with Accolate, the other leukotriene inhibitor that is dose twice a day. Singulair has been approved for the prophylaxis and chronic treatment of asthma in patients ages 6 and older. It can be dosed as a single cherry chewable tablet , once a day in the evening for children ages 6-14. It can be used in patient who are on a PRN beta agonist alone and who experience more than twice a week symptoms, as a step up therapy in patients not controlled adequately on daily inhaled beclomethasone, as a step down therapy when trying to cut down the dose of inhaled corticosteroids DEPRESSION. CELEXA: Celexa is the newest anti-depressant in the market. Celexa is here to compete with zoloft, paxil and other SSRIs. At a dose of 20 mg daily it is easy to administer, and it appears to have less side effects than the older medications. We will need to wait and see how this drug will perform. It is marketed by Forest Pharmaceuticals, a division of Parke-Davis. Hypertension. Atacand Atacand(candesartan) is a new powerful anti-hypertensive, that can be used as first line therapy , has a convenient once-daily dosing for 24 hour BP reduction, and has a usual starting dose of 16mg daily Atacand is a new angiotensin II receptor blocker, with a low side effect profile. It is contraindicated in pregnancy. Migraine. Zomig(Zolmitriptan): Zolmitriptan is indicated for the management of acute migraine in adults, with or without aura. It is not used for the prophylaxis of migraine, nor in the acute treatment of basilar or hemiplegic migraine. It is contraindicated in the presence of coronary artery disease or patients with high cardiovascular risk profile. At doses of 2.5mg or 5mg, it is effective in the acute treatment of migraine. Dose can be repeated in 2 hours if the headache continues Parkinson's disease: Mirapex (pramipexde) Mirapex is a dopamine antagonist indicated in the treatment of idiopathic Parkinson's disease. It interferes with Levodopa and usually needes a reduction of Levodopa. It can cause a variety of CNS and GI side effects and dosing needs to be done very carefully in the following manner: week one: 0.375mg daily, week 2: 0.75mg daily, week 3:1.5mg daily, week 4: 2.25mg daily, week 5: 3mg daily, week 6: 3.75mg daily, and after week seven: 4.5mg daily. Taking the medication with food may reduce the frequency of nausea. Seizure disorder. Lamotrigine. Lamotrigine has been studied for therapy of resistant epileptic patients with multihandicapped defects. At a mean dose of 391mg/dl, lamotrigine was able to reduce the frequency of epileptic seizures in 28.8% of affected patient with resistant disease. The reduction effect was more pronounced when lamotrigene was combined with valproic acid, and less pronounced with lamotrigene was combine with carbamazepine or phenitoin. S E P T E M B E R 1 9 9 8.

Bladder dysfunction: Detrol.
Detrol(Tolterodine) has been approved for patients with hyperactive bladder and symptoms of urgency or urge incontinence. The drug increases residual urine volume and decreases detrussor pressure. Contraindications include urinary retention, gastric retention and narrow-angle glaucoma.

BREAST CANCER: HERCEPTIN: NEW TREATMENT FOR BREAST CANCER:

The advisory panel to the FDA has given its approval to Herceptin, the first monoclonal antibody for treatment of breast cancer. Women with breast cancer and high level of HERP/neu gene, are candidates for this new therapy. About 20-30% of breast cancer patients have HER2 gene mutation, which is thought to stimulate cancer growth. If approved by the FDA, this drug will be availabe by November of 1998. Posted 9-7-98

INFLAMATORY BOWEL DISEASE: Infliximab: New treatment for Chron's disease:
The FDA approved on August 24, 1998 a new biotechnology product to treat Chron's disease, a chronic inflamatory disease of the bowel. Infliximab is a monoclonal antibody against a protein called "tumor necrosis factor alpha". The product is indicated in patient with moderate to serious disease who are not responding to traditional therapy. Posted 9-7-98

Migraine treatment : AMERGE.

Amerge known also as Naratriptan has been approved for the acute therapy of migraine. It blocks the 5-HTP receptors. It has a long life relative to other "triptans", and it may be an appropiate choice for patients who require more than one dose of their current migraine treatment to maintain relief over a 24 hour period. Up to 60-66% of patient with moderate to severe migraine responded to naratriptan 2.5mg within four hours. Of patients who had relief with the initial dose, 72-81% did not have recurrence of headache within 24 hours. POSTED 9-18-98

NEW ANTIBIOTICS: OMNICEF:
This is a new once a day antibiotic that belongs to the cephalosporin group. It has a broad spectrum of antibacterial activity for gram positive and gram negative organisms, including enhanced anti-staphylococcal activity. At a dose of 600mg daily, it can be used for treatment of sinusitis, otitis, simple pneumonia,and tonsillitis. It may compete with Suprax, a third generation cephalosporin, that is also dosed once daily. As with all new oral antibiotics, prices for a 10 day course is approximately $60. Posted 9-3-98

PROSTATE PROBLEMS: Flomax:
New medication for therapy of benign prostatic hypertrophy. Flomax is a more selective alpha-blocker than the older prepartions like cardura and hytrim. It allows a single dose without need of upward titration like older prepations. Capsules of 0.4mg once a day after eating is the recommended dose. Peak action occurs 6 hours after intake. Because Flomax is highly selective for the prostate, it has no effects on levels of blood pressure like older preparations. Posted 9-3-98

August 1998

Budenoside. A new drug for Chron's disease.
Although not officially approved by the FDA yet, a recent study published in the NEJM in August of 1998 has demonstrated that Budenoside controlled-release, a corticosteroid, can be more effective in inducing remission than salicylate mesalamine, a standard drug used to treat this illness. Budenoside is broken down in the liver and its metabolites do not have as much cortisone-like side effects as regular corticosteroids. Budenoside induces remission in 69% vs 45% with mesalamine, after 8 weeks of therapy.

Aggrastat. A new antiplatet agent.

Aggrastat has been approved for treating acute coronary syndromes like unstable angina and non q wave heart attacks, in conjuntion with heparin. It appears to decrease the frequency of death, new heart attacks and the need of invasive procedures in affected patients. Bleeding is the major complication . It may interact with heparin and aspirin. Dose needs adjustement in renal insufficiency. Posted 8-3-98

JULY 1998

coronary disease. Integrilin. This is a new medication indicated for patients with unstable angina pectoris and non Q wave heart attacks. It is a new platelet inhibitor and has been shown to decrease the rate of death, new heart attacks or need for urgent intervention. Studies have been done in conjuntion with aspirin and heparin.

Posted 7-29-98

J U N E 1 9 9 8

Bladder dysfunction: Detrol : Posted 6-5-98

Detrol (tolerodine) has been approved for patient with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence. Initial dose is 2mg bid. The most common adverse effect is dry mouth, constipitaion, dyspepsia, headache and serophthalmia. Interactions include floxin, coumadin and oral contraceptives. Posted 6-5-98

VIAGRA WARNING: Posted 6-12-98

Up to this day there has been 16 deaths on men taking Viagra for sexual impotence. Details of this problem are not available yet, but patients with cardiac disease may be at increased risk of sudden death. Patients taking nitroglycerine or nitrates should not take this drug at all.

M A Y 1 9 9 8.

Baldness: Male baldness treatment. PROPECIA. Posted 5-18-98

Finasteride , marketed as Propecia 1mg tablets has been approved for treating male hair loss. The drug blocks the enzyme that converts testosterone to DHT. Bolding men have high concentrations of DHT in their hair follicules, reaching 65% suppresion within 24 hours of an oral dose. 83% of treated men maintain or increase their scalp hair. Precautions include liver disease. Side effects include decreased libido and erectile dysfunction. Benefit is seen in 3 months and reversal of effects is seen within 12 months of discontinuation .

Bronchial asthma.: New medication for bronchial asthma. Singulair . Posted 5-20-98

Singulair is a leukotriene receptor antagonist given once daily for the prophylaxis and chronic treatment fo asthma in adults and children aged 6 years or older. Dose is 10mg daily and main side effect is headache in 18% of patients. Medication is not indicated for acute treatment of asthma. In some studies, Sinculair has allowed a reduction on concomitant corticosteroid use.

Canker sores: New topical agent for canker sores of the mouth. APHTHASOL . Posted 5-17-98

Aphthasol (amlexanox 5%) is a new topical anti-inflamatory used for aphthous ulcers of the mouth. It does not have analgesic properties and is not indicated for treating herpetic lesions. Apply 1/4 inch of product to ulcers 4 times a day

Diabetes Mellitus: New medication for type 2 Diabetes Mellitus: PRANDIN. Posted 5-20-98

Prandin (repaglinide) is a new medication for type II or adult type diabetes. It releases insulin from the pancreatic cells when it is needed: at the time of meals. By releasing insulin only at the time of meals, Prandin differs from other diabetes medications like micronase that release insulin from the pancreas for 12-24 hours. High insulin levels have been associated with obesity. Prandin boasts only a 3% incidence of weight gain. Initial dose is 0.5mg before each meal. Prandin is supposed to be a medication that mimics the normal body functioning, e.i: makes more insulin available when is most needed: at the time of meals.

estrogens: Once a week estrogen patch. Fempatch. Posted 5-17-98

Fempatch is a estradiol transderm patch 0.025mg/day applied once a week to the buttock, that is indicated for moderate to severe vasomotor symptoms of menopause, vaginal atrophy, and hypogonadism. May increase to 2 patches once a week if needed. Avoid application in the waist or breasts. Contraindicated in breast cancer and thromboembolic disease. Caution in renal and liver disease, fluid retention, migraine, depression, gallbladder disease. A progestine agent should be used in women with an intact uterus.

estrogens: Once a week estrogen patch. Fempatch. Posted 5-17-98

epilepsy: New agent for Epilepsy. Gabitril. Posted 5-17-98

Gabitril(Tiagabine) is a new adjunt agent in treating partial seizures. Dose is 4mg daily to a maximum of 8mg daily. The drug may interact with other anticonvulsants. Side effects include CNS problems like drowsiness and dizziness

Heart attacks: Prevention of repeat heart attacks and stroke. PLAVIX. Posted 5-17-98

Plavix(Clopidogrel) is an antiplatet agent indicated in the reduction of atherosclerotic events(hardening of arteries) in patients with a recent stroke or heart attack, or peripheral vascular disease of the legs. This drug works similarly to aspirin and is as effective as aspirin. Platelets participate in the clotting mechanism and formation of calcium plaques in the arteries. Blocking platelets seem to be the main mechanism of Plavix. Usual dose is 75mg daily. Contraindications include intracranial hemorrhage and active peptic ulcer. Use with caution in any situation where bleeding may occur: surgery, trauma, NSAIDs, hepatic disease, peptic ulcer. Watch for interaction with dilantin, NSAIDs, warfarin, tolbutamide, tamoxifen, fluvastatin. Adverse effects are diarrhea, rash, hemorrhage, GI disturbance.

Leg ulcers: Diabetic leg ulcers. REGRANEX. Posted 5-18-98

Regranex is a topical gel indicated as adjunt therapy of lower extremity diabetic neuropathic ulcers that have an adequate blood supply. Regranax is a growth factor that promotes proliferation of cells involved in wound repair.

Lipid disorders: New therapy for Hypertriglyceridemia. TRICOR. Posted 5-20-98

Tricor(fenofibrate) has been approved for treating very high triglyceride levels. The drug should be taken with meals , initial dose of 67mg daily. Most common side effect is a rash in 6% of treated patients. Contraindications include renal and hepatic failure. Coumadin dosages need adjustment.

Migraine: Nasal spray for treating migraine. MIGRANAL. Posted 5-18-98

Migranal is a Dihydroergotamine 0.5mg/spray approved for acute treatment of migraine. Relief is reported as early as 30 minutes after treatment. Up to 60% of patients responds withing 2 hours.Dose is one spray in each nostril, repeat in 15 minutes, max of 6 sprays per day. Contraindications include coronary artery disease and peripheral vascular disease. Propranolol and nicotine may potentiate vasoconstriction.

Migraine: New migraine medicine: AMERGE: A long acting agent for migraine. Posted 5-17-98

Amerge (Naratriptan) is a 5-HT receptor blocker that works at the level of the brain, and is indicated for treating acute migraine in adults. Due to its long half life, it may be an appropiate choice for patients who have longer-lasting migraines. Approximately 60-66% of patients with migraine respond to 2.5mg of amerge withing 4 hours., and of those patients responding, 80% did not have a recurrence of headache within 24 hours. Maximum dose is 5mg/24 hours and 20mg/month. Contraindications include coronary artery disease, peripheral vascular disease, stroke, and severe renal and hepatic impairment. Avoid this medication if you are taking SSRI antidepressants and ergotamine. Side effects include dizziness, drowsiness, tingling, fatigue, throat tightness.

Obesity:Miridia: New pharmacologic treatment for obesity . Posted May 5-98

Miridia(sibutramine) has been approved for treatment of obesity, defined as a body mass index greater than 30Kg/m2, and when other conventional treatments have failed. This medication has a dual -pathway mechanism in the brain blocking serotonin and norepinephrine reuptake. It does not release serotonin, norepinephrine, or dopamine, but prolongs the effects of the brain's appetite regulating neurotransmitters. In a one year study, patients on 10mg of Meridia lost 9.9 lbs and those on 15 mg lost 14 lbs. No evidence of valvular heart disease has been found. Some patient develop high blood pressure, and headaches. Pulmonary hypertension has not been found .

Osteoporosis: New medication for prevention of osteoporosis. EVISTA. Posted 5-18-98

Evista is a selective estrogen receptor modulator, or estrogen like medication without the cancer-risk associated with regular equine estrogens. However , patients with history of thromboembolic problems are not candidates for this medication , a similar situation found with equine estrogens. Dose is 60mg daily by mouth. May interact with warfarin, diazepam, NSAIDs, and cholestyramine.