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Health Bulletins

Here you will find information on recent health bulletins.

Table of Contents

1) "New" Gyn Procedures
2) Recent Controversies
3) FDA alerts changes in Prescription Drug information
4) FDA Mail Order Warning

As of August 2006, we are offering THREE new treatments related to HPV and precancerous changes in the cervix. We are offering participation in clinical studies to qualified patients, that treat CIN 2-3 / moderate or severe dysplasia with non-surgical therapy. We also offer new vaccines for PREVENTING infection with certain HPV strains and significantly reducing the future risk of cervical cancer. Please call for more info....

 
 

"New" Gyn Procedures

The LASH procedure (laparoscopic supracervical hyst) - this is an alternative to hysterectomy, used primarily for bleeding problems. It is a laparoscopic procedure, where the upper portion of the uterus is removed, leaving cervix and ovaries. It has become popular, because of the stigma of “hysterectomy”, controversies regarding pelvic support and sexual response, and a shorter recovery. It compares favorably to even laparoscopic hysterectomy, because there is no vaginal incision and faster recovery. It is not indicated in patients with some pain syndromes, cervical disease or possible cancers. These patients need the usual cervix cancer screening, don’t need contraception, have no period and are usually 80% recovered after 1-2 weeks.

Endometrial Ablation - this is a hysterectomy alternative used ONLY for bleeding issues in patients with a “normal” uterus, where electrocautery or heated water is used to heat-treat the lining in the uterus, rendering it inactive. This usually results in no period or, at the very least, a much decreased flow. It is a minor surgery similar to a D and C in recovery time. Commonly we do this in conjunction with tubal sterilization and there is generally no effect on hormones or cycles, except less or no bleeding.

Clinical Physician - performed specialty ultrasound (CPPSU) - In our office, when indicated, we offer a vaginal probe pelvic ultrasound test, done by the physician. We are accredited and peer-reviewed by University of South Florida. This specialized testing offers an immediate clinical correlation with exam findings that exceeds the quality of most pelvic ultrasound testing. We also offer a similar breast ultrasound test and fine needle aspiration for evaluating lumps and mammogram abnormalities.

Urinary Incontinence, Interstitial Cystitis and New Technologies - A significant number of women, when asked, will complain of problematic bladder leakage or pain/frequency syndrome. There has been a new wave of interest in this arena and its associated testing, drug therapy and minimally-invasive procedures. Traditionally, these patients were referred to urologists with mixed results. Now, select gynecologists are taking an active role in evaluating and treating these patients. We have in-office urodynamics, IC evaluation and related therapies that have provided many patients with successful outcomes for their bladder dysfunction. We suggest patients bring up pertinent problems with urine leakage, bladder pain and frequency, and request the option of a thoughtful workup and treatment from a Gyn specialist.

E-Stim - Pelvic Floor Therapy / Electronic Impulse Stimulation - This new treatment program was modeled after urogynecology protocols at the Mayo Clinic. We use computer planning and electronic impulse stimulation to strengthen and train the pelvic floor muscles. The treatments are non-surgical and painless, and provided in our private clinic by our expert professional staff.

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Recent Controversies

Menopausal Hormone and Estrogen Controversy - We believe that recent studies and the media have exaggerated the risks of hormone therapy. The pharmaceutical companies and overzealous doctors have perhaps exaggerated the benefits of hormones. The real facts are that for some women, hormone therapy is essential for quality of life, and for other women, they are dangerous and should be avoided. For the majority of women, an individualized approach should be taken with a careful analysis of that patient’s needs, risks and experience. Also, this should be reanalyzed regularly (yearly) because options, needs, situations and alternatives change too. Hormones carry a potential risk of accelerating breast cancer growth, increasing thromboembolic risks, gall bladder risks and may increase EXISTING cardiovascular disease (synthetic progestins, especially Provera are believed by many to be the culprit in lipid change and CVD risk).

Hormones definitely help bone strength, bladder and vaginal tissues and probably help healthy vascular systems. Most researchers believe there is a benefit in cognitive (brain) function. If vasomotor symptoms (hot flashes and night sweats) are a significant issue, then consideration should be given to using hormones for that alone, if lesser treatment has been unsuccessful. If a woman has a uterus, then estrogen should be balanced with progesterone in some way. The exception is when low dose topical estrogen is used, such as Estrace cream, Estring or Vagifem. Generally, we like non-oral routes if the patient agrees, such as patches and rings, although this is not a big issue in the scope of the treatment planning. Newer formulations are lower dose and theoretically safer that those used in the past. Brand new ultra-low dose options are available now, in gel, lotion and micropatch forms.

Formulated or Compounded hormones may have some advantages over “off-the-shelf” drugs, but are not as well tested and may not be as dependable in quality assurance and consistency. They do have the distinct advantage of being “customizable” with regards to active ingredients and dosages, and many patients have requested this option due to the perception that they are a safer route to take.

Calcium Supplement Controversy - Newly-published articles in JAMA and other peer-reviewed literature have generated new thinking regarding our recommendations on calcium supplements for patients who aren’t getting adequate calcium intake in their diet alone. Since calcium is critical in bone health, menopause symptoms, PMS, weight management and dysmennorhea, many patients are looking for a high quality supplement that dissolves easily, is absorbed and made bioavailable. Many commonly recommended calcium supplements fail these criteria and also contain traces of lead. Since calcium is a mineral and difficult to make available in the body for use, it is important to take a supplement that is of the highest quality with special chelated manufacturing techniques. We have researched this extensively and found what we consider the best one for the money from American Health Sciences in Vienna, Virginia. The name of the product is Osteoguard and it contains magnesium, boron and other important trace minerals, and is lead-free. It is USP quality and can be ordered by mail via www.MDchoiceVitamins.com or via a faxed order form. Most non-mineral supplements are easy to find in high quality and usability, but this calcium/magnesium product is unique.

PAP Testing Recommendations and Evaluation of Abnormal PAPs - recent changes in the recommended frequency of screening and algorithms for workup of abnormal results have caused confusion among patients and doctors. Some patients do in fact qualify for less than yearly screening. These criteria include Medicare-age patients with a long history of normal PAPs, who can be tested every 2 years, and also “low risk” younger patients. Since a detailed annual sexual history would be needed to determine who these patients are, we still believe it is the better part of valor to offer annual screening to all patients less than 65 and to willing patients 65 and older. Even post-hysterectomy patients benefit from PAP screening since cytology helps detect VAIN (vaginal intraepithelial neoplasia), infections and urogenital atrophy (low hormone changes). The PAP maturation index is still the best test marker for overall estrogen level and effect on a patient's body.

When a PAP reveals ASCUS (squamous atypia), we either do reflex HPV testing to detect “high-risk” HPV or at least repeat a PAP in 3 months. If the high-risk HPV is positive, or the 3 month PAP is also positive, then we ALWAYS recommend colposcopy. A significant number of these patients will have precancerous lesions. If a PAP reveals AGUS (glandular atypia), then the patient needs endocervical and endometrial evaluation. There is no second chance with another PAP. Appropriate follow-up for AGUS is vaginal ultrasound and biopsy as many of these patients will have a polyp or endometrial lesion. Another possibility is adenocarcinoma and this is more common as a patient ages. We have seen a number of patients who were “missed” in this regard and needlessly progressed to a more advanced lesion. Bottom line is “any question- call a Gyn” and get expert advice.

As of August 2006, we are offering THREE new treatments related to HPV and precancerous changes in the cervix. We are offering participation in clinical studies to qualified patients, that treat CIN 2-3 / moderate or severe dysplasia with non-surgical therapy. We also offer new vaccines for PREVENTING infection with certain HPV strains and significantly reducing the future risk of cervical cancer. Please call for more info....

Breast Cancer - One of the biggest problems in women's health care is the missed diagnosis of breast cancer. The most common scenario is a lump or abnormal finding on exam and a normal mammogram result. I tell patients that the normal screening program for breast cancer after 40 is self exam monthly, clinician exam and mammogram yearly. If ANY of the three suggest a new finding that might be abnormal, then the least that is recommended is a short term follow up exam, such as one month. This is true in younger patients too. We also use the GAIL model to provide a risk assessment on appropriate patients. We have found breast cancers on ultrasound that mammogram missed, and insisted on biopsies (that proved positive) when the exam just wasn’t reassuring. Again, the rule of thumb is if you have any concerns about your self breast exam or a doctors findings, then have a specialist check it out.

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FDA alerts changes in Prescription Drug information

January 2006

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The FDA warned consumers not to use two unapproved drug products that are
being marketed as dietary supplements for weight loss. Emagrece Sim Dietary
Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary
Supplement may contain several active ingredients, including controlled
substances, found in prescription drugs that could lead to serious side
effects or injury. They contain chlordiazepoxide HCl (the active ingredient
in Librium), and fluoxetine HCl (the active ingredient in Prozac). Emagrece
Sim and Herbathin were also found to contain Fenproporex, a stimulant that
is not approved for marketing in the United States. Consumers are advised
not to use the Emagrece Sim and Herbathin products and to return them to the
suppliers. There may be other manufacturers or suppliers of imported
Emagrece Sim and Herbathin, and consumers should exercise caution in using
any of these imported products.

November 2005

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals and patients of revisions to the label
for Ortho Evra, a skin patch approved for birth control, that includes a
bolded warning about higher exposure to estrogen for women using the weekly
patch compared to taking a daily birth control pill containing 35 micrograms
of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more
estrogen than if she were taking a typical 35 microgram estrogen birth
control pill. Estrogen use is linked to blood clots in the legs and lungs
and other clotting problems such as strokes and heart attacks. It is not
known if women using Ortho Evra have a higher risk of serious side effects
than women taking the typical 35 microgram estrogen pills.

Read the complete MedWatch 2005 Safety Summary, including links to the FDA
News Release and Drug Information page, at:

http://www.fda.gov/medwatch/safety/2005/safety05.htm#evra

GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes
to the Pregnancy/PRECAUTIONS section of the Prescribing Information for
Paxil and Paxil CR Controlled-Release Tablets to describe the results of a
GSK retrospective epidemiologic study of major congenital malformations in
infants born to women taking antidepressants during the first trimester of
pregnancy. This study suggested an increase in the risk of overall major
congenital malformations for paroxetine as compared to other antidepressants
[OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are
advised to carefully weigh the potential risks and benefits of using
paroxetine therapy in women during pregnancy and to discuss these findings
as well as treatment alternatives with their patients.


FDA and GlaxoSmithKline notified healthcare professionals of revisions to
the WARNINGS and PRECAUTIONS sections of Wellbutrin (bupropion
hydrochloride) labeling to alert healthcare professionals that patients with
major depressive disorder, both adult and pediatric, may experience
worsening of their depression and/or the emergence of suicidal ideation and
behavior (suicidality), whether or not they are taking antidepressant
medications. The warning recommends patients being treated with
antidepressants be observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy, or at the time of
dose changes, either increases or decreases.

November 2004

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) --

The detailed view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections. The prescribing information may be accessed by clicking on the drug name.

Brand (Generic) Name Sections Modified

Summary of Changes to Contraindications and Warnings

Bextra (valdecoxib) Tablets

(click product name to read prescribing information)

 

 

CONTRAINDICATIONS

BOXED WARNING

  • Serious Skin Reactions

WARNINGS

  • Coronary Artery Bypass Graft Surgery

PRECAUTIONS

  • Information for Patients

ADVERSE REACTIONS

  • Postmarketing Experience
    • Gastrointestinal
      • Pancreatitis
CONTRAINDICATIONS

Bextra is contraindicated for the treatment of post-operative pain immediately following coronary artery bypass graft (CABG) surgery and should not be used in this setting. 

BOXED WARNING

Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving Bextra. Some of these reactions have resulted in death.  

Patients appear to be at higher risk for these events within the first two weeks of treatment, but these may occur at any time during treatment.  

The reported rate of these serious skin events appears to be greater for Bextra as compared to other COX-2 agents.  

Bextra should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

WARNINGS

Patients treated with Bextra for pain following coronary artery bypass graft surgery have a higher risk for cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications. Bextra is therefore contraindicated for the treatment of postoperative pain following CABG surgery.

Canasa (mesalamine, USP) Rectal Suppositories

(click product name to read prescribing information)

CONTRAINDICATIONS

PRECAUTIONS

  • Initial Paragraph
  • Nursing Mothers

ADVERSE REACTIONS

  • Clinical Adverse Experience

Canasa 500 mg and 1000 mg suppositories are contraindicated in patients who have demonstrated hypersensitivity to mesalamine (5-aminosalicylic acid) or to the suppository vehicle [saturated vegetable fatty acid esters (Hard Fat, NF)], or to salicylates (including aspirin).

 

Cosmegen (dactinomycin for injection)

(click product name to read prescribing information)

 

CONTRAINDICATIONS

PRECAUTIONS

  • General

ADVERSE REACTIONS

  • Gastrointestinal

Hypersensitivity to any component of this product.....

Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension)

(click product name to read prescribing information)

 

 

CONTRAINDICATIONS

BOXED WARNING

WARNINGS

  • Loss of Bone Mineral Density

PRECAUTIONS

  • Pediatric Use

ADVERSE REACTIONS

  • Postmarketing Experience
CONTRAINDICATIONS

Significant liver disease

BOXED WARNING

Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. 

It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. 

Depo-Provera Contraceptive Injection should be used as a long-term birth control method (longer than two years) only if other birth control methods are inadequate.

WARNINGS

Use of Depo-Provera CI reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD) as bone metabolism accommodates to a lower estrogen level. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion...... (See prescribing information.)

Naprosyn (naproxen suspension) 

Naprosyn (naproxen tablets) 

EC-Naprosyn (naproxen delayed -release tablets) 

Anaprox/Anaprox DS (naproxen sodium) Tablets 

(click product name to read prescribing information)

 

CONTRAINDICATIONS

WARNINGS

  • Gastrointestinal (GI) Effects
  • Anaphylactoid Reactions
  • Advanced Renal Disease
  • Pregnancy

PRECAUTIONS

  • General
  • Hepatic Effects
  • Renal Effects
  • Hematologic Effects
  • Fluid Retention and Edema
  • Preexisting Asthma
  • Information for Patients
  • Laboratory Tests
  • Drug Interactions
    • Aspirin
    • Methotrexate
    • ACE-inhibitors
    • Furosemide
    • Lithium
    • Warfarin
  • Other Information Concerning Drug Interactions
  • Pregnancy
    • Teratogenic Effects
      • Pregnancy Category C
  • Labor and Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use

ADVERSE REACTIONS

  • In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1 to 10% of patients
    • Gastrointestinal (GI) Experiences
    • General
    • Dermatologic
  • In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients
    • Body as a Whole
    • Cardiovascular
    • Gastrointestinal
    • Hemic and Lymphatic
    • Metabolic and Nutritional 
    • Nervous System
    • Respiratory
    • Dermatologic
    • Special Senses
    • Urogenital

CONTRAINDICATIONS

......It is also contraindicated in patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal..... Therefore, careful questioning of patients for such things as asthma, nasal polyps, urticaria, and hypotension associated with nonsteroidal anti-inflammatory drugs before starting therapy is important. In addition, if such symptoms occur during therapy, treatment should be discontinued.

WARNINGS

Extensive revisions to the WARNINGS/Gastrointestinal (GI) Effects section.  (See prescribing information.)

Anaphylactoid Reactions: As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to naproxen. Naproxen should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

Advanced Renal Disease: In cases with advanced kidney disease, treatment with naproxen is not recommended. If NSAID therapy, however, must be initiated, close monitoring of the patient’s kidney function is advisable.

Pregnancy:  In late pregnancy, as with other NSAIDs, naproxen should be avoided because it may cause premature closure of the ductus arteriosus.

 

Norditropin Cartridges (somatropin [rDNA origin] injection)

(click product name to read prescribing information)

 

CONTRAINDICATIONS

PRECAUTIONS

  • General
  • Pediatric Patients
  • Adult Patients
  • Laboratory Tests
  • Drug Interactions
  • Geriatric use
  • Information for Patients

ADVERSE REACTIONS

  • Growth Hormone Deficient Pediatric Patients
  • Growth Hormone Deficient Adult Patients

Norditropin is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients.

In general, somatropin is contraindicated in the presence of active neoplasia. Any preexisting neoplasia should be inactive and its treatment complete prior to instituting therapy with Norditropin. Norditropin should be discontinued if there is evidence of recurrent activity. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation of treatment. Norditropin should not be used in patients with any evidence of progression or recurrence of an underlying intracranial space-occupying lesion. Available information suggests that the rate of tumor recurrence is not increased by growth hormone therapy.....

.....Norditropin is contraindicated in patients with proliferative or preproliferative diabetic retinopathy.....

.....Norditropin should not be used for growth promotion in pediatric patients with closed epiphyses.

Phenergan (promethazine HCl) Tablets and Suppositories

(click product name to read prescribing information)

 

CONTRAINDICATIONS

WARNINGS

  • Initial Statement (enclosed in box)
  • Use in Pediatric Patients

PRECAUTIONS

  • Pediatric Use

 

CONTRAINDICATIONS

Phenergan Tablets and Suppositories are contraindicated for use in pediatric patients less than two years of age.....

WARNINGS

Phenergan should not be used in pediatric patients less than two years of age because of the potential for fatal respiratory depression...... (See prescribing information.)

.....Respiratory depression and apnea, sometimes associated with death, are strongly associated with promethazine products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration.....

Robinul (glycopyrrolate injection, USP) Injection

(click product name to read prescribing information)

 

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

  • General

    • Renal Disease

    • Prostatic Hypertrophy

    • Use of Anticholinergetic Drugs

  • Information for the Patient

  • Drug Interactions

    • Anticholinergics

    • Potassium Chloride

  • Carcinogenesis, Mutagenesis, Impairment of Fertility

  • Pregnancy

    • Teratogenic Effects

    • Nonteratogenic Effects

  • Nursing Mothers

  • Pediatric Use

ADVERSE REACTIONS

  • Xerostomia
  • Photophobia
  • Dilation of the Pupil
  • Cycloplegia
  • Anaphylactic/Anaphylactoid Reactions
  • Hypersensitivity
  • Pruritus
  • Dry Skin
  • Post-marketing Experience
    • Heart Block
    • Prolonged QTc Interval
CONTRAINDICATIONS

Known hypersensitivity to glycopyrrolate or any of its inactive ingredients.....

WARNINGS

.....In addition, in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents including glycopyrrolate (due to decreased sweating), particularly in children and the elderly.

The closure system contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected in persons with known or possible latex sensitivity.

 

Saizen (somatropin [rDNA origin] for injection)

(click product name to read prescribing information)

 

 

 

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

  • General
    • Intracranial hypertension
    • Pediatric Patients
    • Drug Interactions
      • Cytochrome P450 3A4

ADVERSE REACTIONS

  • Growth Hormone Deficient Pediatric Patients
  • Growth Hormone Deficient Adult Patients
CONTRAINDICATIONS

Saizen is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients.....

 

.....Saizen is contraindicated in patients with proliferative or preproliferative diabetic retinopathy.....

 

....Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Saizen is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

WARNINGS

.....There have been reports of fatalities after initiating therapy with growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females ........ (See prescribing information.)

Striant (testosterone buccal system) mucoadhesive

(click product name to read prescribing information)

CONTRAINDICATIONS Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.....
Tracleer (bosentan) Tablets

Please contact Actelion Pharmaceuticals US, Inc. at 1-650-624-6900 for prescribing information.
 

 

CONTRAINDICATIONS
  • Pregnancy
  • Pregnancy Category X

PRECAUTIONS

  • Drug Interactions/ Hormonal Contraceptives, Including Oral, Injectable, Transdermal, and Implantable Contraceptives

ADVERSE REACTIONS

  • Post-marketing Experience

    • Hypersensitivity, Rash

CONTRAINDICATIONS

Hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives should not be used as the sole means of contraception because these may not be effective in patients receiving Tracleer.

It has been demonstrated that hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives may not be reliable in the presence of Tracleer and should not be used as the sole contraceptive method in patients receiving Tracleer.

PRECAUTIONS

An interaction study demonstrated that co-administration of bosentan and the oral hormonal contraceptive Ortho-Novum produced average decreases of norethindrone and ethinyl estradiol levels of 14% and 31%, respectively. However decreases in exposure were as much as 56% and 66%, respectively, in individual subjects. Therefore, hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when Tracleer is co-administered. Women should practice additional methods of contraception and not rely on hormonal contraception alone when taking Tracleer.

ADVERSE REACTIONS

New subsection added:  Post-marketing Experience:  Hypersensitivity, Rash

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Brand (Generic) Name
Sections Modified

Arava (leflunomide) Tablets

(click product name to read prescribing information)

PRECAUTIONS
  • Respiratory
    • Interstitial Lung Disease
  • Geriatric Use

ADVERSE REACTIONS

  • Respiratory System

Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension

(click product name to read prescribing information)

SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria.

PRECAUTIONS

  • General
  • Information for  the Patient
Elidel (pimecrolimus) Cream 1%

(click product name to read prescribing information)

PRECAUTIONS
  • Carcinogenesis, Mutagenesis, Impairment of Fertility

  • Pregnancy

Iressa (gefitinib tablets)

(click product name to read prescribing information)

 

PRECAUTIONS
  • Drug Interactions
    • Vinorelbine

ADVERSE REACTIONS

  • Interstitial Lung Disease
    • Hemorrhage
      • Epistaxis 
      • Hematuria

Keflex (cephalexin, USP) Pulvules

(click product name to read prescribing information)

PRECAUTIONS
  • Pediatric Use

Lexiva (fosamprenavir calcium) Tablets

(click product name to read prescribing information)

PRECAUTIONS
  • Hepatic Impairment and Toxicity

Miostat (carbachol intraocular solution, USP) 0.01%

(click product name to read prescribing information)

PRECAUTIONS
  • Initial Statement
Protonix (pantoprazole) Delayed-Release Tablets

(click product name to read prescribing information)

PRECAUTIONS
  • Drug Interactions 
    • Warfarin

ADVERSE REACTIONS

  • Postmarketing Reports
Rifampin Capsules

(click product name to read prescribing information)

SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria.

PRECAUTIONS

  • General
  • Information for Patients
Slow-K (potassium chloride) Extended-Release Tablets

(click product name to read prescribing information)

 

 

PRECAUTIONS
  • Nursing Mothers
  • Geriatric Use

ADVERSE REACTIONS

  • Skin Rash

Timentin (sterile ticarcillin disodium/clavulanate potassium) for Intravenous Administration

(click product name to read prescribing information)

SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS STATEMENT to reduce the development of drug-resistant bacteria.

PRECAUTIONS

  • General
  • Information for Patients
Zofran (ondansetron hydrochloride) Injection

Zofran (ondansetron hydrochloride) Injection, Premixed

(click product name to read prescribing information)

PRECAUTIONS
  • Drug Interactions
    • CYP3A4, CYP2D6, CYP1A2
    • Phenytoin, Carbamazepine, and Rifampicin
    • Tramadol

Zofran (ondansetron hydrochloride) Tablets and Oral Solution

Zofran ODT (ondansetron hydrochloride) Orally Disintegrating Tablets

(click product name to read prescribing information)

PRECAUTIONS
  • Drug Interactions
    • CYP3A4, CYP2D6, CYP1A2
    • Phenytoin, Carbamazepine, and Rifampicin
    • Tramadol

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FDA Mail Order Warning

1. From the FDA...Beware of mail order prescriptions, especially from overseas or other "non-certified" sources. A web site from India was recently shut down after selling fake Ortho Evra birth control patches as pictured below:

Authentic and Counterfeit Contraceptive Patches

 
Authentic Ortho Evra Transdermal Patch
 
Counterfeit Contraceptive Patches
 
Packaging for Authentic Ortho Evra Transdermal Patch
 
Counterfeit Contraceptive Patch
 
Packaging for Authentic Ortho Evra Transdermal Patch
 
Packaging for Authentic Ortho Evra TransdermalPatch

They have no medication in them and are useless, and possibly dangerous. Any prescription drug ordered by mail should have all the appropriate packaging, enclosures, expiration dates, etc.

We believe that there is reliable prescription drug availability in Canada, and Western Europe. Please be cautious and use common sense.

2. A recent article in the Journal of the AMA reported that a number of the popular calcium supplements on the market have significant problems. First and foremost is an unusually high lead content. Also, many were found to dissolve poorly in the digestive system, be poorly absorbed by the intestinal lining and/or to have no magnesium and other trace minerals to assist the body in "bioavailability"- making the calcium useful for body functions and bone building. We have changed our recommendations based on this. If you cannot get your calcium requirement through proper diet, then please find a HIGH QUALITY calcium supplement, or don't take one at all.

The best lead-free, dissolvable, absorbable, bioavailable calcium supplement (with Magnesium and D and trace minerals is...Osteoguard by Clinician's Choice. This is available through our office here at Swor Women's Care or online at www.medeonhealth.com

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