RX LIST

ACOMPLIA is presented as film-coated tablets containing 20mg rimonabant INN. The product is
packaged in PVC-aluminium blisters and in HPDE bottles closed with a child-resistant tamper-proof
polypropylene screw cap.

Rimonabant is a fine powder, white to practically white. Two different polymorphic forms (1 and 2) have
been identified during development. Form 1 has been used from the beginning of the pharmaceutical
development to the end of Phase 3 clinical studies. Form 2, identified after the start of Phase 3 studies,
was selected for product development. The two forms have very similar physico-chemical characteristics.
As rimonabant is practically insoluble in water, the drug substance has been micronized to increase
particle surface area and thus, facilitate dissolution, and to ensure blend homogeneity during drug product
manufacture.

Categories: A
Tags: acomplia, rimonabant

Hydrea (Hydroxyurea) is used for treating skin cancer, cancer of the ovary, or chronic myelocytic leukemia that is recurrent, has spread, or cannot be helped with surgery., Hydrea is used for treating skin cancer, cancer of the ovary, or chronic myelocytic leukemia that is recurrent, has spread, or cannot be helped with surgery. It may also be used with radiation to control skin cancers of the head and neck. It may also be used for other conditions as determined by your doctor.
Use Hydrea as directed by your doctor.

* Hydrea may be taken with or without food.
* Wash your hands before and after handling Hydrea or the bottle it comes in. Wear gloves while you are handling Hydrea or its bottle. Follow your doctor’s instructions for disposing of the gloves after you remove them.
* If you have difficulty swallowing, empty the contents of the capsule into a glass of water and drink immediately. Use care when emptying the capsule into water. Do not allow the powder to come into contact with the skin or mucous membranes and do not inhale the powder when opening the capsules. If the powder is spilled, it should be immediately wiped up with a damp towel and disposed of, as should the empty capsules.

Ask your health care provider any questions you may have about how to use Hydrea.
Hydrea is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

Categories: H
Tags: hydrea, Hydroxyurea

Sanofi Aventis and Bristol-Myers Squibb Company  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix (clopidogrel bisulfate). This positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval.

The new 300mg tablet will facilitate the use of the approved loading dose of Plavix and the early initiation as recommended by national and international guidelines in appropriate patients with acute coronary syndrome (ACS), including those with unstable angina / non-ST segment elevation myocardial infarction (managed with percutaneous intervention (PCI) with or without stent or medically managed) and ST segment elevation myocardial infarction patients. The 300mg tablet is bioequivalent to four 75mg tablets of Plavix.

Sanofi-aventis and Bristol-Myers Squibb are committed to further studying the optimization of the Plavix loading dose in ACS patients managed with an early invasive strategy in the ongoing large international clinical trial known as ‘CURRENT’. CURRENT is the only randomized controlled trial designed to investigate in 14000 patients, whether the use of a clopidogrel 600mg loading dose, followed by an intensified clopidogrel dosing regimen (6 days at 150mg follow by 75mg) yields improved clinical outcomes as compared to clopidogrel 300mg loading dose followed by 75mg in ACS patients managed with an early invasive strategy. The primary endpoint of CURRENT is the reduction of a composite endpoint of cardiovascular death, stroke and myocardial infarct (MI) and the results are expected by the end of 2008.

About Plavix

Plavix is an antiplatelet agent which prevents platelets from sticking together and forming clots in the arteries and is the only widely available prescription antiplatelet approved to reduce the risk of heart attack and stroke across the entire spectrum of ACS.

Plavix is indicated for the reduction of atherothrombotic events in patients with a history of recent MI, recent stroke or established peripheral arterial disease (P.A.D.) Plavix is also indicated for patients with NSTEMI ACS, including those who are to be managed medically and those managed with PCI (with or without a stent) or CABG. Additionally Plavix is indicated in STEMI patients.

For ACS patients, European Guidelines (ESC Guidelines for NSTEMI ACS 2007) recommend pre-treatment of unselected patients with Plavix before angiography results for better outcome of PCI.

The early and long term efficacy and safety profile of Plavix is well established in clinical trials involving more than 100,000 patients across the full spectrum of ACS, recent MI, recent ischemic stroke and established P.A.D, with real-world experience since its launch in more than 70 million patients worldwide.

Plavix is marketed worldwide by sanofi-aventis and Bristol-Myers Squibb Company as Plavix and Iscover.

About Sanofi Aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN) and in New York (NYSE: SNY).

Categories: P
Tags: plavix

VIAGRA is prescribed for the treatment of erectile dysfunction.

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

The following factors are associated with increased plasma levels of sildenafil: age > 65 (40% increase in AUC), hepatic impairment (e.g., cirrhosis, 80%), severe renal impairment (creatinine clearance < 30 mL/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors [ketoconazole, itraconazole, erythromycin (182%), saquinavir (210%)]. Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients.

Ritonavir greatly increased the systemic level of sildenafil in a study of healthy, non-HIV infected volunteers (11-fold increase in AUC, see DRUG INTERACTIONS.) Based on these pharmacokinetic data, it is recommended not to exceed a maximum single dose of 25 mg of VIAGRA in a 48 hour period.

VIAGRA was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.

When VIAGRA is co-administered with an alpha-blocker, patients should be stable on alpha- blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose.

VIAGRA® (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil

Categories: V
Tags: sildenafil citrate, viagra

Accutane should be dispensed with a meal (see PRECAUTIONS: PATIENT INFORMATION).

The recommended dose for Accutane is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Accutane with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.

The safety of once daily dosing with Accutane has not been established. Once daily dosing is not recommended.

If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Accutane, even in low doses, has not been studied, and is not recommended. It is important that Accutane be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Accutane on bone loss is unknown (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).

Contraceptive measures must be followed for any subsequent course of therapy (see PRECAUTIONS).

Accutane must not be used by female patients who are or may become pregnant!

Categories: A, Video
Tags: Accutane, acne, isotretinoin

BACLOFEN™ is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that treatment with BACLOFEN™ will aid in restoring residual function.

BACLOFEN™ may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

BACLOFEN™ is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of BACLOFEN™ in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).

The following dosage titration schedule is suggested:

5 mg three times a day for 3 days 10 mg three times a day for 3 days 15 mg three times a day for 3 days 20 mg three times a day for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg four times a day).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).
Administration

Using dry hands, the patient should be instructed to place the tablet on the tongue, where it will disintegrate and can then be swallowed with or without water.
Patients with Renal Impairment

Because baclofen is primarily excreted unchanged by the kidneys, it should be given with caution and it may be necessary to reduce the dosage in patients with impaired renal function.

Read more here..

Categories: B
Tags: baclofen, KEMSTRO

Categories: A
Tags: aciphex, gastroesophageal reflux disease, GERD