See also
- antitoxins and antivenins
- colony stimulating factors
- hematopoietic stem cell mobilizer
- in vivo diagnostic biologicals
- recombinant human erythropoietins
Friday, 17 August 2012
Biologicals
Monday, 13 August 2012
Cetirizine Drug Facts
(in each chewable tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Do not use if you have ever had an allergic reactions to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- may be taken with or without water
| adults and children 6 years and over | one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
| adults 65 years and over | ask a doctor |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
- Store between 20 to 25 C (68 to 77 F)
Inactive ingredients
acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor
Questions? 1-800-525-8747
Manufactured in India by Sandoz Private Ltd.,
for Sandoz Inc., Princeton, NJ 08540
Rev.02/2008
Principal Display Panel
NDC 0781-5284-64
Children's
Cetirizine HCl Chewable Tablets
10 mg
antihistamine
Tutti Frutti Flavored
30 Tablets
Do not use if individual blister unit is open or torn
ALLERGY
Indoor & Outdoor Allergies
24 hour Relief of
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
6 yrs. and older 10 mg each
| CETIRIZINE HYDROCHLORIDE cetirizine hydrochloride tablet, chewable | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA078692 | 02/14/2008 | |
| Labeler - Sandoz Inc (110342024) |
More Cetirizine Drug Facts resources
- Cetirizine Drug Facts Side Effects (in more detail)
- Cetirizine Drug Facts Dosage
- Cetirizine Drug Facts Use in Pregnancy & Breastfeeding
- Drug Images
- Cetirizine Drug Facts Drug Interactions
- Cetirizine Drug Facts Support Group
- 73 Reviews for Cetirizine Drug Facts - Add your own review/rating
Compare Cetirizine Drug Facts with other medications
- Hay Fever
- Urticaria
Sunday, 12 August 2012
etoposide
Generic Name: etoposide (oral) (ee TOW poh side)
Brand names: VePesid, Etopophos (obsolete), Toposar
What is etoposide?
Etoposide is a cancer medicine that interferes with the growth of cancer cells and slows their growth and spread in the body.
Etoposide is used to treat cancer of the lung or testicles.
Etoposide may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about etoposide?
Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not break or open an etoposide capsule. The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken capsule, ask your doctor or pharmacist how to safely dispose of the capsule.
Etoposide can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Using etoposide may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.
What should I discuss with my healthcare provider before taking etoposide?
Before using etoposide, tell your doctor if you have:
- kidney disease; or
a weak immune system (from disease or from taking certain medicines).
If you have any of these conditions, you may not be able to use etoposide, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use etoposide without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether etoposide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Using etoposide may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.
How should I use etoposide?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
Take each dose with a full glass of water. Do not break or open an etoposide capsule. The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken capsule, ask your doctor or pharmacist how to safely dispose of the capsule.
Etoposide can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.
Store etoposide capsules in the refrigerator. Do not allow them to freeze.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an etoposide overdose may include severe nausea and vomiting, fever, chills, sore throat, flu symptoms, easy bruising, or extreme weakness.
What should I avoid while using etoposide?
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with etoposide.
Etoposide side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips;
easy bruising or bleeding, unusual weakness;
fast heart rate;
severe nausea and vomiting;
feeling light-headed, fainting; or
low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Other, less serious side effects may be more likely to occur, such as:
mild nausea, vomiting, stomach pain;
mild itching or skin rash; or
temporary hair loss.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Etoposide Dosing Information
Usual Adult Dose for Testicular Cancer:
(In combination with other approved chemotherapeutic agents) Initial dose: 50 to 100 mg/m² IV once a day on days 1 through 5 or 100 mg/m2 IV once a day on days 1,3 and 5.
Usual Adult Dose for Small Cell Lung Cancer:
(In combination with other approved chemotherapeutic agents) Initial dose: 35 to 50 mg/m2 IV once a day for 4 to 5 days or
70 to 100 mg/m2 orally once a day for 4 to 5 days.
Usual Adult Dose for Hodgkin's Disease:
(In combination with other chemotherapeutic agents as a part of the BEACOPP and EVA regimens)
100 mg/m2/day on days 1, 2, and 3
Total Dose/Cycle = 300 mg/m2
(In combination with other chemotherapeutic agents as a part of the mini-BEAM regimen)
75 mg/m2/day on days 2 through 5
Total Dose/Cycle = 300 mg/m2
(In combination with other chemotherapeutic agents as a part of the Stanford V regimen)
60 mg/m2/day on days 15 and 16
Total Dose/Cycle = 120 mg/m2
Usual Adult Dose for Ovarian Cancer:
For use in the treatment of epithelial ovarian cancer:
50 mg/m2 daily on days 1 through 21
For use in the treatment of germ cell ovarian cancer:
(In combination with other approved chemotherapeutic agents as a part of the BEP regimen)
100 mg/m2 IV on days 1 through 5
Usual Geriatric Dose for Testicular Cancer:
The manufacturer has stated that clinical studies of etoposide for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years or over to determine if they respond differently from younger patients.
Usual Pediatric Dose for Malignant Disease:
Note: Oral doses are twice the IV doses listed below. Oral doses are to be administered once a day if
60 to 150 mg/m2/day IV for 2 to 5 days every 3 to 6 weeks.
Remission induction for AML: 150 mg/m2/day IV for 2 to 3 days for 2 to 3 cycles.
Intensification/Consolidation for AML: 250 mg/m2/day IV for 3 days, courses 2 to 5.
Brain Tumor: 150 mg/m2/day IV on days 2 and 3.
Neuroblastoma: 100 mg/m2/day IV over 1 hour on days 1
through 5 of the cycle, repeated every 4 weeks.
High-dose conditioning regimen for allogenic BMT: 60 mg/kg/dose IV as a single dose.
BMT conditioning regimen used in patients with rhabdomyosarcoma or neuroblastoma: IV continuous infusion: 160 mg/m2/day for 4 days.
What other drugs will affect etoposide?
Before using etoposide, tell your doctor if you are using cyclosporine (Neoral, Sandimmune, Gengraf).
There may be other drugs that can affect etoposide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More etoposide resources
- Etoposide Side Effects (in more detail)
- Etoposide Dosage
- Etoposide Use in Pregnancy & Breastfeeding
- Drug Images
- Etoposide Drug Interactions
- Etoposide Support Group
- 0 Reviews for Etoposide - Add your own review/rating
- etoposide Advanced Consumer (Micromedex) - Includes Dosage Information
- Etoposide Professional Patient Advice (Wolters Kluwer)
- Etoposide Prescribing Information (FDA)
- Etoposide MedFacts Consumer Leaflet (Wolters Kluwer)
- Etoposide Monograph (AHFS DI)
- Toposar Prescribing Information (FDA)
- VePesid Prescribing Information (FDA)
- VePesid MedFacts Consumer Leaflet (Wolters Kluwer)
- Vepesid Advanced Consumer (Micromedex) - Includes Dosage Information
Compare etoposide with other medications
- Cancer
- Hodgkin's Lymphoma
- Ovarian Cancer
- Small Cell Lung Cancer
- Testicular Cancer
Where can I get more information?
- Your pharmacist has more information about etoposide written for health professionals that you may read.
See also: etoposide side effects (in more detail)
Friday, 10 August 2012
ParaGard
Dosage Form: intrauterine device
ParaGard® T380A
INTRAUTERINE COPPER CONTRACEPTIVE
11001741
Iss. 1/2011
Rx only
PRESCRIBING INFORMATION
ParaGard® T380A Intrauterine Copper Contraceptive
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ParaGard® T 380A Intrauterine Copper Contraceptive should be placed and removed only by healthcare professionals who are experienced with these procedures.
ParaGard Description
ParaGard® T 380A Intrauterine Copper Contraceptive (ParaGard®) is a T-shaped intrauterine device (IUD), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each at least 10.5 cm in length, to aid in detection and removal of the device. The T-frame is made of polyethylene with barium sulfate to aid in detecting the device under x-ray. ParaGard® also contains copper: approximately 176 mg of wire coiled along the vertical stem and a 68.7 mg collar on each side of the horizontal arm. The total exposed copper surface area is 380 ± 23 mm2. One ParaGard® weighs less than one (1) gram. No component of ParaGard® or its packaging contains latex.
ParaGard® is packaged together with an insertion tube and solid white rod in a Tyvek® polyethylene pouch that is then sterilized. A moveable flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity.
ParaGard - Clinical Pharmacology
The contraceptive effectiveness of ParaGard® is enhanced by copper continuously released into the uterine cavity. Possible mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport or fertilization, and prevention of implantation.
Indications and Usage for ParaGard
ParaGard ® is indicated for intrauterine contraception for up to 10 years. The pregnancy rate in clinical studies has been less than 1 pregnancy per 100 women each year.
| |||
| % of Women Experiencing an Accidental Pregnancy within the First Year of Use | % of Women Continuing Use at One Year* | ||
| Method (1) | Typical Use† (2) | Perfect Use‡ (3) | (4) |
| Chance§ | 85 | 85 | |
| Spermicides¶ | 26 | 6 | 40 |
| Periodic Abstinence Calendar Ovulation Method Sympto-thermal# Post-ovulation | 25 | 9 3 2 1 | 63 |
| CapÞ Parous women Nulliparous women | 40 20 | 26 9 | 42 56 |
| Sponge Parous women Nulliparous women | 40 20 | 20 9 | 42 56 |
| DiaphragmÞ | 20 | 6 | 56 |
| Withdrawal | 19 | 4 | |
| Condomß Female (Reality) Male | 21 14 | 5 3 | 56 61 |
| Pill Progestin only Combined | 5 | 0.5 0.1 | 71 |
| IUD Progesterone T Copper T 380A LNg 20 | 2.0 0.8 0.1 | 1.5 0.6 0.1 |
|
| Depo Provera | 0.3 | 0.3 | 70 |
| Norplant and Norplant-2 | 0.05 | 0.05 | 88 |
| Female sterilization | 0.5 | 0.5 | 100 |
| Male sterilization | 0.15 | 0.10 | 100 |
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.à | |||
Lactational Amenorrhea Method: LAM is a highly effective temporary method of contraception.è | |||
Footnotes to Table 1 | |||
Contraindications
ParaGard® should not be placed when one or more of the following conditions exist:
- Pregnancy or suspicion of pregnancy
- Abnormalities of the uterus resulting in distortion of the uterine cavity
- Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
- Postpartum endometritis or postabortal endometritis in the past 3 months
- Known or suspected uterine or cervical malignancy
- Genital bleeding of unknown etiology
- Mucopurulent cervicitis
- Wilson’s disease
- Allergy to any component of ParaGard®
- A previously placed IUD that has not been removed
Warnings
1. Intrauterine Pregnancy
If intrauterine pregnancy occurs with ParaGard® in place and the string is visible, ParaGard® should be removed because of the risk of spontaneous abortion, premature delivery, sepsis, septic shock, and, rarely, death. Removal may be followed by pregnancy loss.
If the string is not visible, and the woman decides to continue her pregnancy, check if the ParaGard® is in her uterus (for example, by ultrasound). If ParaGard® is in her uterus, warn her that there is an increased risk of spontaneous abortion and sepsis, septic shock, and rarely, death.1 In addition, the risk of premature labor and delivery is increased.1
Human data about risk of birth defects from copper exposure are limited. However, studies have not detected a pattern of abnormalities, and published reports do not suggest a risk that is higher than the baseline risk for birth defects.
2. Ectopic Pregnancy
Women who become pregnant while using ParaGard ® should be evaluated for ectopic pregnancy. A pregnancy that occurs with ParaGard ® in place is more likely to be ectopic than a pregnancy in the general population. However, because ParaGard ® prevents most pregnancies, women who use ParaGard ® have a lower risk of an ectopic pregnancy than sexually active women who do not use any contraception.2-3
3. Pelvic Infection
Although pelvic inflammatory disease (PID) in women using IUDs is uncommon, IUDs may be associated with an increased relative risk of PID compared to other forms of contraception and to no contraception. The highest incidence of PID occurs within 20 days following insertion. Therefore, the visit following the first post-insertion menstrual period is an opportunity to assess the patient for infection, as well as to check that the IUD is in place. (See INSTRUCTIONS FOR USE, Continuing Care.) Since pelvic infection is most frequently associated with sexually transmitted organisms, IUDs are not recommended for women at high risk for sexual infection. Prophylactic antibiotics at the time of insertion do not appear to lower the incidence of PID.4
PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or infertility), hysterectomy, sepsis, and, rarely, death. It is therefore important to promptly assess and treat any woman who develops signs or symptoms of PID.
Guidelines for treatment of PID are available from the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia at www.cdc.gov or 1-800-311-3435. Antibiotics are the mainstay of therapy. Most healthcare professionals also remove the IUD.
The significance of actinomyces-like organisms on Papanicolaou smear in an asymptomatic IUD user is unknown,5-6 and so this finding alone does not always require IUD removal and treatment. However, because pelvic actinomycosis is a serious infection, a woman who has symptoms of pelvic infection possibly due to actinomyces should be treated and have her IUD removed.
4. Immunocompromise
Women with AIDS should not have IUDs inserted unless they are clinically stable on antiretroviral therapy. Limited data suggest that asymptomatic women infected with human immunodeficiency virus may use intrauterine devices. Little is known about the use of IUDs in women who have illnesses causing serious immunocompromise. Therefore these women should be carefully monitored for infection if they choose to use an IUD. The risk of pregnancy should be weighed against the theoretical risk of infection.
5. Embedment
Partial penetration or embedment of ParaGard ® in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.
6. Perforation
Partial or total perforation of the uterine wall or cervix may occur rarely during placement, although it may not be detected until later. Spontaneous migration has also been reported. If perforation does occur, remove ParaGard ® promptly, since the copper can lead to intraperitoneal adhesions. Intestinal penetration, intestinal obstruction, and/or damage to adjacent organs may result if an IUD is left in the peritoneal cavity. Pre-operative imaging followed by laparoscopy or laparotomy is often required to remove an IUD from the peritoneal cavity.
7. Expulsion
Expulsion can occur, usually during the menses and usually in the first few months after insertion. There is an increased risk of expulsion in the nulliparous patient. If unnoticed, an unintended pregnancy could occur.
8. Wilson’s Disease
Theoretically, ParaGard ® can exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion.
Precautions
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
1. Information for patients
Before inserting ParaGard ® discuss the Patient Package Insert with the patient, and give her time to read the information. Discuss any questions she may have concerning ParaGard ® as well as other methods of contraception. Instruct her to promptly report symptoms of infection, pregnancy, or missing strings.
2. Insertion precautions, continuing care, and removal.
(See INSTRUCTIONS FOR USE.)
3. Vaginal bleeding
In the 2 largest clinical trials with ParaGard® (see ADVERSE REACTIONS, Table 2), menstrual changes were the most common medical reason for discontinuation of ParaGard®. Discontinuation rates for pain and bleeding combined are highest in the first year of use and diminish thereafter. The percentage of women who discontinued ParaGard® because of bleeding problems or pain during these studies ranged from 11.9% in the first year to 2.2 % in year 9. Women complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue ParaGard®. (See ADVERSE REACTIONS.)
4. Vasovagal reactions, including fainting
Some women have vasovagal reactions immediately after insertion. Hence, patients should remain supine until feeling well and should be cautious when getting up.
5. Expulsion following placement after a birth or abortion
ParaGard® has been placed immediately after delivery, although risk of expulsion may be higher than when ParaGard® is placed at times unrelated to delivery.7 However, unless done immediately postpartum, insertion should be delayed to the second postpartum month because insertion during the first postpartum month (except for immediately after delivery) has been associated with increased risk of perforation.8
ParaGard® can be placed immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times.9 Placement after second trimester abortion is associated with a higher risk of expulsion than placement after the first trimester abortion.9
6. Magnetic resonance imaging (MRI)
Limited data suggest that MRI at the level of 1.5 Tesla is acceptable in women using ParaGard®. One study examined the effect of MRI on the CU-7® Intrauterine Copper Contraceptive and Lippes Loop™ intrauterine devices. Neither device moved under the influence of the magnetic field or heated during the spin-echo sequences usually employed for pelvic imaging.10 An in vitro study did not detect movement or temperature change when ParaGard® was subjected to MRI.11
7. Medical diathermy
Theoretically, medical (non-surgical) diathermy (short-wave and microwave heat therapy) in a patient with a metal-containing IUD may cause heat injury to the surrounding tissue. However, a small study of eight women did not detect a significant elevation of intrauterine temperature when diathermy was performed in the presence of a copper IUD.12
8. Pregnancy
ParaGard® is contraindicated during pregnancy. (See CONTRAINDICATIONS and WARNINGS.)
9. Nursing mothers
Nursing mothers may use ParaGard®. No difference has been detected in concentration of copper in human milk before and after insertion of copper IUDs. The literature is conflicting, but limited data suggest that there may be an increased risk of perforation and expulsion if a woman is lactating. 13
10. Pediatric use
ParaGard® is not indicated before menarche. Safety and efficacy have been established in women over 16 years old.
Adverse Reactions
The most serious adverse events associated with intrauterine contraception are discussed in WARNINGS and PRECAUTIONS. These include:
| Intrauterine pregnancy | Pelvic infection |
| Septic abortion | Perforation |
| Ectopic pregnancy | Embedment |
Table 2 shows discontinuation rates from two clinical studies by adverse event and year.
| Adverse Event | Year | |||||||||
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
| Pregnancy | 0.7 | 0.3 | 0.6 | 0.2 | 0.3 | 0.2 | 0.0 | 0.4 | 0.0 | 0.0 |
| Expulsion | 5.7 | 2.5 | 1.6 | 1.2 | 0.3 | 0.0 | 0.6 | 1.7 | 0.2 | 0.4 |
| Bleeding/Pain | 11.9 | 9.8 | 7.0 | 3.5 | 3.7 | 2.7 | 3.0 | 2.5 | 2.2 | 3.7 |
| Other Medical Event | 2.5 | 2.1 | 1.6 | 1.7 | 0.1 | 0.3 | 1.0 | 0.4 | 0.7 | 0.3 |
| No. of Women at Start of Year | 4932 | 3149 | 2018 | 1121 | 872 | 621 | 563 | 483 | 423 | 325 |
*Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the Population Council (3,536 subjects) and the World Health Organization (1,396 subjects) trials.
The following adverse events have also been observed. These are listed alphabetically and not by order of frequency or severity.
| Anemia | Menstrual flow, prolonged |
| Backache | Menstrual spotting |
| Dysmenorrhea | Pain and cramping |
| Dyspereunia | Urticarial allergic skin reaction |
| Expulsion, complete or partial | Vaginitis |
| Leukorrhea |
INSTRUCTIONS FOR USE
The placement technique for ParaGard® is different from that used for other IUDs. Therefore, the clinician should be familiar with the following instructions.
ParaGard® may be placed at any time during the cycle when the clinician is reasonably certain the patient is not pregnant. For information about timing of postpartum and postabortion insertions, see PRECAUTIONS.
A single ParaGard® should be placed at the fundus of the uterine cavity. ParaGard® should be removed on or before 10 years from the date of insertion.
Before Placement:
- Make sure that the patient is an appropriate candidate for ParaGard® and that she has read the Patient Package Insert.
- Use of an analgesic before insertion is at the discretion of the patient and the clinician.
- Establish the size and position of the uterus by pelvic examination.
- Insert a speculum and cleanse the vagina and cervix with an antiseptic solution.
- Apply a tenaculum to the cervix and use gentle traction to align the cervical canal with the uterine cavity.
- Gently insert a sterile sound to measure the depth of the uterine cavity.
- The uterus should sound to a depth of 6 to 9 cm except when inserting ParaGard ® immediately post-abortion or post-partum. Insertion of ParaGard® into a uterine cavity measuring less than 6 cm may increase the incidence of expulsion, bleeding, pain, and perforation. If you encounter cervical stenosis, avoid undue force. Dilators may be helpful in this situation.
How to Load and Place ParaGard®:
Do not bend the arms of ParaGard® earlier than 5 minutes before it is to be placed in the uterus. Use aseptic technique when handling ParaGard® and the part of the insertion tube that will enter the uterus.
STEP 1
Load ParaGard® into the insertion tube by folding the two horizontal arms of ParaGard®against the stem and push the tips of the arms securely into the inserter tube.
If you do not have sterile gloves, you can do STEPS 1 and 2 while ParaGard® is in the sterile package. First, place the package face up on a clean surface. Next, open at the bottom end (where arrow says OPEN). Pull the solid white rod partially from the package so it will not interfere with assembly. Place thumb and index finger on top of package on ends of the horizontal arms. Use other hand to push insertion tube against arms of ParaGard® (shown by arrow in Fig. 1). This will start bending the T arms.
STEP 2
Bring the thumb and index finger closer together to continue bending the arms until they are alongside the stem. Use the other hand to withdraw the insertion tube just enough so that the insertion tube can be pushed and rotated onto the tips of the arms. Your goal is to secure the tips of the arms inside the tube (Fig. 2). Insert the arms no further than necessary to insure retention. Introduce the solid white rod into the insertion tube from the bottom, alongside the threads, until it touches the bottom of the ParaGard®.
STEP 3
Grasp the insertion tube at the open end of the package; adjust the blue flange so that the distance from the top of the ParaGard ® (where it protrudes from the inserter) to the blue flange is the same as the uterine depth that you measured with the sound. Rotate the insertion tube so that the horizontal arms of the T and the long axis of the blue flange lie in the same horizontal plane (Fig. 3). Now pass the loaded insertion tube through the cervical canal until ParaGard ® just touches the fundus of the uterus. The blue flange should be at the cervix in the horizontal plane.
STEP 4
To release the arms of ParaGard ®, hold the solid white rod steady and withdraw the insertion tube no more than one centimeter This releases the arms of ParaGard ® high in the uterine fundus (Fig. 4).
STEP 5
Gently and carefully move the insertion tube upward toward the top of the uterus, until slight resistance is felt. This will ensure placement of the T at the highest possible position within the uterus (Fig. 5).
STEP 6
Hold the insertion tube steady and withdraw the solid white rod (Fig. 6).
STEP 7
Gently and slowly withdraw the insertion tube from the cervical canal. Only the threads should be visible protruding from the cervix. (Fig. 7). Trim the threads so that 3 to 4 cm protrude into the vagina. Note the length of the threads in the patient’s records.
If you suspect that ParaGard ® is not in the correct position, check placement (with ultrasound, if necessary). If ParaGard ® is not positioned completely within the uterus, remove it and replace it with a new ParaGard ®. Do not reinsert an expelled or partially expelled ParaGard ®.
CAUTION
Instrumentation of the cervical os may result in vasovagal reactions, including fainting. Have the patient remain supine until she feels well, and have her get up with caution.
Continuing Care:
Following placement, examine the patient after her first menses to confirm that ParaGard ® is still in place. You should be able to see or feel only the threads. If ParaGard ® has been partially or completely expelled, remove it. You can place a new ParaGard ® if the patient desires and if she is not pregnant. Do not reinsert a used ParaGard ®.
Evaluate the patient promptly if she complains of any of the following:
- Abdominal or pelvic pain, cramping, or tenderness; malodorous discharge; bleeding; fever
- A missed period
(See WARNINGS, Pelvic Infection, Intrauterine Pregnancy and Ectopic Pregnancy.)
The length of the visible threads may change with time. However, no action is needed unless you suspect partial expulsion, perforation, or pregnancy.
If you cannot find the threads in the vagina, check that ParaGard ® is still in the uterus. The threads can retract into the uterus or break, or ParaGard ® can break, perforate the uterus, or be expelled. Gentle probing of the cavity, radiography, or sonography may be required to locate the IUD.
If there is evidence of partial expulsion, perforation, or breakage, remove ParaGard ®.
How to Remove ParaGard®
Remove ParaGard ® with forceps, pulling gently on the exposed threads. The arms of ParaGard ® will fold upwards as it is withdrawn from the uterus. You may immediately insert a new ParaGard ® if the patient requests it and has no contraindications.
Embedment or breakage of ParaGard ® in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, and cervical dilation may assist in removing an embedded ParaGard ®. An alligator forceps or other grasping instrument may be helpful. Hysteroscopy may also be helpful.
How is ParaGard Supplied
ParaGard ® is available in cartons of 1 (one) sterile unit (NDC 51285-204-01). Each ParaGard ® is packaged together with an insertion tube and solid white rod in a Tyvek ® polyethylene pouch.
REFERENCES
- Tatum HJ, Schmidt FH, Jain AK. Management and outcome of pregnancies associated with the Copper T intrauterine contraceptive device. Am J Obstet Gynecol. 976;126:869-879.
- Sivin I. Dose- and age-dependent ectopic pregnancy risks with intrauterine contraception. Obstet Gynecol. 1999;78:291-298.
- Franks AL, Beral V, Cates W Jr, Hogue CJR. Contraception and ectopic pregnancy risk. Am J Obstet Gynecol. 1990;163:1120-1123.
- Grimes DA, Schulz KF. Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials. Contraception. 1999;60:57-63.
- Lippes J. Pelvic actinomycosis: a review and preliminary look at prevalence. Am J Obstet Gynecol. 1999;180:265-269.
- Petitti DB, Yamamoto D, Morgenstern N. Factors associated with actinomyces-like organisms on Papanicolaou smear in users of intrauterine contraceptive devices. Am J Obstet Gynecol. 1983;145:338-341.
- Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partum insertion of intrauterine devices: a Cochrane review. Hum Reprod. 2002;17:549-554.
- Cole LP, Edelman DA, Potts DM, Wheeler RG, Laufe LE. Postpartum insertion of modified intrauterine devices. J Reprod Med. 1984;29:677-682.
- Grimes DA, Schulz KF, Stanwood N. Immediate post-abortal insertion of intrauterine devices. (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software.
- Hess T, Stepanow B, Knopp MV. Magnetic resonance imaging: safety of intrauterine contraceptive devices during MR imaging. Eur Radiol. 1996;6:66-68.
- Mark AS, Hricak H. Intrauterine devices. MR imaging. Radiology. 1987;162:311-314.
- Heick A., Espersen T., Pedersen HL, Raahauge J: Is diathermy safe in women with copper-bearing IUDs? Acta Obstet Gynecol Scand. 1991;70(2):153-5.
- Rodrigues da Cunha AC, Dorea JG, Cantuaria AA. Intrauterine device and maternal copper metabolism during lactation. Contraception 2001;63:37-9.
TEVA WOMEN’S HEALTH, INC.
Subsidiary of TEVA PHARMACEUTICALS USA, Inc.
Sellersville, PA 18960
Iss. 1/2011
11001741
INFORMATION FOR PATIENTS
ParaGard® T 380A
Intrauterine Copper Contraceptive
ParaGard® T 380A Intrauterine Copper Contraceptive is used to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
It is important for you to understand this brochure and discuss it with your healthcare provider before choosing ParaGard ® T 380A Intrauterine Copper Contraceptive (ParaGard ®). You should also learn about other birth control methods that may be an option for you.
What is ParaGard®?
ParaGard ® is a copper-releasing device that is placed in your uterus to prevent pregnancy for up to 10 years.
ParaGard ® is made of white plastic in the shape of a “T.” Copper is wrapped around the stem and arms of the “T”. Two white threads are attached to the stem of the “T”. The threads are the only part of ParaGard ® that you can feel when ParaGard ® is in your uterus. ParaGard ® and its components do not contain latex.
How long can I keep ParaGard ® in place?
You can keep ParaGard ® in your uterus for up to 10 years. After 10 years, you should have ParaGard ® removed by your healthcare provider. If you wish and if it is still right for you, you may get a new ParaGard ® during the same visit.
What if I change my mind and want to become pregnant?
Your healthcare provider can remove ParaGard ® at any time. After discontinuation of
ParaGard ®, its contraceptive effect is reversed.
How does ParaGard® work?
Ideas about how ParaGard ® works include preventing sperm from reaching the egg, preventing sperm from fertilizing the egg, and preventing the egg from attaching (implanting) in the uterus. ParaGard ® does not stop your ovaries from making an egg (ovulating) each month.
How well does ParaGard® work?
Fewer than 1 in 100 women become pregnant each year while using ParaGard ®.
The table below shows the chance of getting pregnant using different types of birth control. The numbers show typical use, which includes people who don't always use birth control correctly.
| Method of birth control | Pregnancies per 100 women over one year |
| No Method | 85 |
| Spermicides | 26 |
| Periodic abstinence | 25 |
| Cap with Spermicides | 20 |
| Vaginal Sponge | 20 to 40 |
| Diaphragm with Spermicides | 20 |
| Withdrawal | 19 |
| Condom without spermicides (female) | 21 |
| Condom without spermicides (male) | 14 |
| Oral Contraceptives | 5 |
| IUDs, Depo-Provera, implants, sterilization | less than 1 |
Who might use ParaGard ®?
You might choose ParaGard ®if you
- need birth control that is very effective
- need birth control that stops working when you stop using it
- need birth control that is easy to use
Who should not use ParaGard ®?
You should not use ParaGard ® if you
- Might be pregnant
- Have a uterus that is abnormally shaped inside
- Have a pelvic infection called pelvic inflammatory disease (PID) or have current behavior that puts you at high risk of PID (for example, because you are having sex with several men, or your partner is having sex with other women)
- Have had an infection in your uterus after a pregnancy or abortion in the past 3 months
- Have cancer of the uterus or cervix
- Have unexplained bleeding from your vagina
- Have an infection in your cervix
- Have Wilson’s disease (a disorder in how the body handles copper)
- Are allergic to anything in ParaGard ®
- Already have an intrauterine contraceptive in your uterus
How is ParaGard® placed in the uterus?
ParaGard ® is placed in your uterus during an office visit. Your healthcare provider first examines you to find the position of your uterus. Next, he or she will cleanse your vagina and cervix, measure your uterus, and then slide a plastic tube containing ParaGard ® into your uterus. The tube is removed, leaving ParaGard ® inside your uterus. Two white threads extend into your vagina. The threads are trimmed so they are just long enough for you to feel with your fingers when doing a self-check. As ParaGard ® goes in, you may feel cramping or pinching. Some women feel faint, nauseated, or dizzy for a few minutes afterwards. Your healthcare provider may ask you to lie down for a while and to get up slowly.
How do I check that ParaGard® is in my uterus?
Visit your healthcare provider for a check-up about one month after placement to make sure ParaGard ® is still in your uterus.
You can also check to make sure that ParaGard ® is still in your uterus by reaching up to the top of your vagina with clean fingers to feel the two threads. Do not pull on the threads. If you cannot feel the threads, ask your healthcare provider to check if ParaGard ® is in the right place. If you can feel more of ParaGard ® than just the threads, ParaGard ® is not in the right place. If you can’t see your healthcare provider right away, use an additional birth control method. If ParaGard ® is in the wrong place, your chances of getting pregnant are increased. It is a good habit for you to check that ParaGard ® is in place once a month.
You may use tampons when you are using ParaGard ®.
What if I become pregnant while using ParaGard®?
If you think you are pregnant, contact your healthcare professional right away. If you are pregnant and ParaGard ® is in your uterus, you may get a severe infection or shock, have a miscarriage or premature labor and delivery, or even die. Because of these risks, your healthcare provider will recommend that you have ParaGard ® removed, even though removal may cause miscarriage.
If you continue a pregnancy with ParaGard ® in place, see your healthcare provider regularly. Contact your healthcare provider right away if you get fever, chills, cramping, pain, bleeding, flu-like symptoms, or an unusual, bad smelling vaginal discharge.
A pregnancy with ParaGard ® in place has a greater than usual chance of being ectopic (outside your uterus). Ectopic pregnancy is an emergency that may require surgery. An ectopic pregnancy can cause internal bleeding, infertility, and death. Unusual vaginal bleeding or abdominal pain may be signs of an ectopic pregnancy.
Copper in ParaGard® does not seem to cause birth defects.
Thursday, 9 August 2012
Polytar Liquid
1. Name Of The Medicinal Product
Polytar Liquid
2. Qualitative And Quantitative Composition
Tar Blend 1% w/w
Tar Blend comprises:
Pine tar, Cade Oil, Coal Tar Solution, Arachis Oil extract of Coal Tar.
3. Pharmaceutical Form
Medicated Shampoo
4. Clinical Particulars
4.1 Therapeutic Indications
Polytar Liquid is indicated in the treatment of scalp disorders including psoriasis, dandruff, seborrhoea, eczema and pruritus. Polytar Liquid is also of value in the removal of ointments and pastes used in the treatment of psoriasis.
4.2 Posology And Method Of Administration
The hair should be wetted and sufficient Polytar Liquid applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should then be thoroughly rinsed and the procedure repeated.
Polytar Liquid should be used once or twice weekly.
4.3 Contraindications
Patients with a known hypersensitivity to any of the ingredients should not use the product.
4.4 Special Warnings And Precautions For Use
Polytar Liquid contains arachis oil (peanut oil) and should not be used by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Polytar Liquid.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There are no known interactions with other medicaments or other forms of interaction.
4.6 Pregnancy And Lactation
There is no, or inadequate evidence of the safety of Polytar Liquid in human pregnancy and lactation, but it has been in wide use for many years without apparent ill consequence.
4.7 Effects On Ability To Drive And Use Machines
The use of this product will not affect the ability to drive and to use machines.
4.8 Undesirable Effects
Tar products may cause skin irritation, rashes and rarely, photosensitivity. If irritation occurs and persists, treatment should be discontinued.
4.9 Overdose
The product is intended for external use only. It is applied to the scalp and rinsed off. Use of an excessive quantity is not a cause for concern.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Tars suppress DNA synthesis in hyperplastic skin, inhibiting mitotic activity and protein synthesis. They decrease epidermal proliferation and dermal infiltration and thus promote a return to normal keratinisation.
Tars also have vasoconstrictor, antipruritic and antiseptic properties.
5.2 Pharmacokinetic Properties
The product is applied topically and acts at the site of application. The potential for systemic absorption from a wash off shampoo is extremely low.
5.3 Preclinical Safety Data
Tar preparations have been in widespread use for many years and their safety in humans has been established.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Oleyl alcohol
Coconut diethanolamide
Hexylene glycol
Polysorbate 80
Triethanolamide Lauryl Sulphate
Sodium chloride
Citric acid
Octylphenoxypolyethoxy ethanol
Imidurea
Fragrance 5412
Purified Water
6.2 Incompatibilities
There are no known incompatibilities
6.3 Shelf Life
a) For the product as packaged for sale
3 years
b) After first opening the container
Comply with expiry date
6.4 Special Precautions For Storage
There are no special precautions for storage.
6.5 Nature And Contents Of Container
High density polyethylene bottles of 65ml, 150ml, 200ml, 250ml, 350ml, 400ml, 500ml, 600ml, 1000ml.
6.6 Special Precautions For Disposal And Other Handling
There are no special instructions for use or handling of Polytar Liquid.
7. Marketing Authorisation Holder
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
8. Marketing Authorisation Number(S)
PL 19494/0080
9. Date Of First Authorisation/Renewal Of The Authorisation
14th March 1990/11th May 2000/11th May 2005/27th February 2009
10. Date Of Revision Of The Text
16 March 2011
Wednesday, 8 August 2012
Isoflupredone
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0000338-95-4
Chemical Formula
C21-H27-F-O5
Molecular Weight
378
Therapeutic Category
Adrenal cortex hormone, glucocorticoid
Chemical Name
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-, (11ß)-
Foreign Names
- Isoflupredonum (Latin)
- Isoflupredon (German)
- Isofluprédone (French)
- Isoflupredona (Spanish)
Generic Names
- Deltafludrocortisone (OS: DCF)
- Isoflupredone (OS: BAN, DCIT)
- Isoflupredone Acetate (OS: USAN, BANM)
- U 6013 (IS)
- Isoflupredone Acetate (PH: USP 32)
Brand Names
- Neo Predef (Isoflupredone and Neomycin (veterinary use))
Pharmacia & Upjohn vet, United States - Predef (veterinary use)
Pfizer Animal Health, South Africa; Pharmacia & Upjohn vet, United States
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Sunday, 5 August 2012
Anemia Associated with Chronic Renal Failure Medications
Definition of Anemia Associated with Chronic Renal Failure: In chronic renal failure (CRF), the kidneys slowly and progressively lose their ability to remove waste from the body, to concentrate urine, and to balance the water and mineral content of the blood. Anemia is an inevitable outcome of CRF due to the kidneys' decreased ability to produce erythropoietin—a hormone that stimulates the production of red blood cells.
Drugs associated with Anemia Associated with Chronic Renal Failure
The following drugs and medications are in some way related to, or used in the treatment of Anemia Associated with Chronic Renal Failure. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Learn more about Anemia Associated with Chronic Renal Failure
Medical Encyclopedia:
- Anemia
Drug List:
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