Topiramato Generis

Topiramato Generis may be available in the countries listed below.

Ingredient matches for Topiramato Generis

Topiramate

Topiramate is reported as an ingredient of Topiramato Generis in the following countries:

• Portugal

International Drug Name Search

Sarpogrelate Hydrochloride

Sarpogrelate Hydrochloride may be available in the countries listed below.

Ingredient matches for Sarpogrelate Hydrochloride

Sarpogrelate

Sarpogrelate Hydrochloride (JAN) is also known as Sarpogrelate (Rec.INN)

International Drug Name Search

Glossary

JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Trijec

Trijec may be available in the countries listed below.

Ingredient matches for Trijec

Ceftriaxone

Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Trijec in the following countries:

• Indonesia

International Drug Name Search

Mycofen

Mycofen may be available in the countries listed below.

Ingredient matches for Mycofen

Ciclopirox

Ciclopirox is reported as an ingredient of Mycofen in the following countries:

• Denmark

International Drug Name Search

Nicorette Microtab

Nicorette Microtab may be available in the countries listed below.

UK matches:

• Nicorette Microtab Lemon 2 mg sublingual tablets. (SPC)
• Nicorette Microtab or Boots NicAssist 2 mg microtab (SPC)

Ingredient matches for Nicorette Microtab

Nicotine

Nicotine betadex (a derivative of Nicotine) is reported as an ingredient of Nicorette Microtab in the following countries:

• Australia


• Austria


• Belgium


• Denmark


• Finland


• France


• Germany


• Greece


• Ireland


• Luxembourg


• Netherlands


• Portugal


• South Africa


• Spain


• Sweden


• Switzerland


• United Kingdom


• Venezuela

Nicotine bitartrate dihydrate (a derivative of Nicotine) is reported as an ingredient of Nicorette Microtab in the following countries:

• Australia


• Austria


• Denmark


• Finland


• France


• Netherlands


• Portugal


• South Africa


• Spain


• Sweden

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Lactitol

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A06AD12

CAS registry number (Chemical Abstracts Service)

0000585-86-4

Chemical Formula

C12-H24-O11

Molecular Weight

344

Therapeutic Categories

Pharmaceutic aid

Drug for metabolic disease treatment

Laxative, osmotically acting

Sweetening agent

Chemical Name

D-Glucitol, 4-O-ß-D-galactopyranosyl-

Foreign Names

• Lactitolum (Latin)
• Lactitol (German)
• Lactitol (French)
• Lactitol (Spanish)

Generic Names

• Lactitol (OS: BAN, DCF)
• Lactitol (PH: NF 27)
• Lactitol Monohydrate (PH: BP 2010, Ph. Eur. 6)
• Lactitol monohydraté (PH: Ph. Eur. 6)
• Lactitol-Monohydrat (PH: Ph. Eur. 6)
• Lactitolum monohydricum (PH: Ph. Eur. 6)

Brand Names

• Importal
  Novartis, Thailand



• Normolaxil
  Trenker, Luxembourg



• Sinalax
  Ibn Sina, Bangladesh



• Emportal
  Novartis Consumer Health, Spain



• Importal
  Euro, Netherlands; Medis, Slovenia; Novartis, United Arab Emirates; Novartis, Bahrain; Novartis, Greece; Novartis, Israel; Novartis, Iraq; Novartis, Jordan; Novartis, Lebanon; Novartis, Luxembourg; Novartis, Oman; Novartis, Portugal; Novartis, Saudi Arabia; Novartis, Sudan; Novartis, Syria; Novartis, Turkey; Novartis Consumer Health, Austria; Novartis Consumer Health, Belgium; Novartis Consumer Health, Switzerland; Novartis Consumer Health, Germany; Novartis Consumer Health, Egypt; Novartis Consumer Health, Netherlands; Novartis Santé Familiale, France



• Importal enfant (pediatric)
  Novartis Santé Familiale, France



• Importal Ex-Lax
  Novartis, Sweden



• Importal jeune enfant (pediatric)
  Novartis Santé Familiale, France



• Lactitol
  Curtis, Poland



• Lalax
  Orion, Finland



• Normolaxil
  Trenker, Belgium



• Novolax
  Trima, Georgia; Trima, Israel



• Oponaf
  Juste, Spain



• Oxatil
  Novo Healthcare, Bangladesh



• Portolac
  Nippon Shinyaku, Japan; Novartis Consumer Health, Belgium; Novartis Consumer Health, Italy



• Titolax
  Renata, Bangladesh

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Aspirine Protect

Aspirine Protect may be available in the countries listed below.

Ingredient matches for Aspirine Protect

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Aspirine Protect in the following countries:

• France


• Netherlands

International Drug Name Search

Gadoxetate Disodium

In the US, Gadoxetate Disodium is a member of the drug class magnetic resonance imaging contrast media and is used to treat Liver Magnetic Resonance Imaging.

Ingredient matches for Gadoxetate Disodium

Gadoxetic Acid

Gadoxetate Disodium (USAN) is also known as Gadoxetic Acid (Rec.INN)

International Drug Name Search

Glossary

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.

Tador

Tador may be available in the countries listed below.

Ingredient matches for Tador

Dexketoprofen

Dexketoprofen is reported as an ingredient of Tador in the following countries:

• Romania

International Drug Name Search

Tosperal

Tosperal may be available in the countries listed below.

Ingredient matches for Tosperal

Difenidol

Difenidol hydrochloride (a derivative of Difenidol) is reported as an ingredient of Tosperal in the following countries:

• Japan

International Drug Name Search

Moxonidin AbZ

Moxonidin AbZ may be available in the countries listed below.

Ingredient matches for Moxonidin AbZ

Moxonidine

Moxonidine is reported as an ingredient of Moxonidin AbZ in the following countries:

• Germany

International Drug Name Search

Morphine Sulfate DBL

Morphine Sulfate DBL may be available in the countries listed below.

Ingredient matches for Morphine Sulfate DBL

Morphine

Morphine sulphate pentahydrate (a derivative of Morphine) is reported as an ingredient of Morphine Sulfate DBL in the following countries:

• Hong Kong

International Drug Name Search

C.C. Ver

C.C. Ver may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for C.C. Ver

Levamisole

Levamisole hydrochloride (a derivative of Levamisole) is reported as an ingredient of C.C. Ver in the following countries:

• France

Tetramisole

Tetramisole hydrochloride (a derivative of Tetramisole) is reported as an ingredient of C.C. Ver in the following countries:

• Portugal

International Drug Name Search

Haenal-Polidocanol

Haenal-Polidocanol may be available in the countries listed below.

Ingredient matches for Haenal-Polidocanol

Lauromacrogol 400

Lauromacrogol 400 is reported as an ingredient of Haenal-Polidocanol in the following countries:

• Luxembourg

International Drug Name Search

Nufamox

Nufamox may be available in the countries listed below.

Ingredient matches for Nufamox

Amoxicillin

Amoxicillin sodium salt (a derivative of Amoxicillin) is reported as an ingredient of Nufamox in the following countries:

• Indonesia

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Nufamox in the following countries:

• Indonesia

International Drug Name Search

Fluvermox

Fluvermox may be available in the countries listed below.

Ingredient matches for Fluvermox

Flubendazole

Flubendazole is reported as an ingredient of Fluvermox in the following countries:

• Venezuela

International Drug Name Search

Haloperidol Esteve

Haloperidol Esteve may be available in the countries listed below.

Ingredient matches for Haloperidol Esteve

Haloperidol

Haloperidol is reported as an ingredient of Haloperidol Esteve in the following countries:

• Spain

International Drug Name Search

Fosfato

Fosfato may be available in the countries listed below.

Ingredient matches for Fosfato

Dexamethasone

Dexamethasone phosphate (a derivative of Dexamethasone) is reported as an ingredient of Fosfato in the following countries:

• Argentina

International Drug Name Search

Medazepam

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N05BA03

CAS registry number (Chemical Abstracts Service)

0002898-12-6

Chemical Formula

C16-H15-Cl-N2

Molecular Weight

270

Therapeutic Categories

Anxiolytic agent

Benzodiazepine derivative

Chemical Name

1H-1,4-Benzodiazepin, 7-chloro-2,3-dihydro-1-methyl-5-phenyl-

Foreign Names

• Medazepamum (Latin)
• Medazepam (German)
• Médazépam (French)
• Medazepam (Spanish)

Generic Names

• Medazepam (OS: JAN, DCIT, BAN)
• Médazépam (OS: DCF)
• RB 252 (IS)
• S 804 (IS)
• Medazepam (PH: JP XIV, BP 1993)

Brand Names

• Ansilan
  Lek, Bosnia & Herzegowina; Lek, Czech Republic; Lek, Croatia (Hrvatska); Lek, Romania; Lek, Slovenia; Sandoz, Slovakia



• Camarines
  Zensei Yakuhin, Japan



• Debrum (Medazepam and Trimebutine)
  Sigma Tau, Italy



• Eurozepam
  Europharm, Romania



• Glorium
  Teva, Israel



• Medazepam LFM
  Lab. Farm. Milanese, Hungary



• Medazepam Q
  Teva, Hungary



• Medazepam
  Arena, Romania; Labormed Pharma, Romania; Laropharm, Romania; Polfa Tarchomin, Poland; Towa Yakuhin, Japan; Tsuruhara Seiyaku, Japan



• Medazin
  Johnson, Taiwan



• Nobritol Forte (Medazepam and Amitriptyline)
  Kern, Spain



• Nobritol (Medazepam and Amitriptyline)
  Kern, Spain



• Nobrium
  Teva, Hungary



• Pamnase
  Toho Droge, Japan



• Resmit
  Shionogi Seiyaku, Japan



• Rudotel
  AWD, Bulgaria; AWD Pharma, Hungary; AWD Pharma, Poland; AWD Pharma, Romania; AWD.pharma, Germany; AWD.pharma, Lithuania; AWD.pharma, Latvia; Pliva, Russian Federation



• Rusedal
  Altana, Hungary; Byk, Romania; Nycomed, Germany

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Depo-Estradiol

In the US, Depo-Estradiol (estradiol systemic) is a member of the drug class estrogens and is used to treat Atrophic Urethritis, Atrophic Vaginitis, Hypoestrogenism and Postmenopausal Symptoms.

US matches:

• Depo-Estradiol

Ingredient matches for Depo-Estradiol

Estradiol

Estradiol 17ß-cypionate (a derivative of Estradiol) is reported as an ingredient of Depo-Estradiol in the following countries:

• United States

International Drug Name Search

Diazepam Jadran

Diazepam Jadran may be available in the countries listed below.

Ingredient matches for Diazepam Jadran

Diazepam

Diazepam is reported as an ingredient of Diazepam Jadran in the following countries:

• Croatia (Hrvatska)

International Drug Name Search

Calcii Carbonatis

Calcii Carbonatis may be available in the countries listed below.

Ingredient matches for Calcii Carbonatis

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Calcii Carbonatis in the following countries:

• Slovenia

International Drug Name Search

Apo-Hydroxyzine

Apo-Hydroxyzine may be available in the countries listed below.

Ingredient matches for Apo-Hydroxyzine

Hydroxyzine

Hydroxyzine is reported as an ingredient of Apo-Hydroxyzine in the following countries:

• Vietnam

Hydroxyzine hydrochloride (a derivative of Hydroxyzine) is reported as an ingredient of Apo-Hydroxyzine in the following countries:

• Canada


• Hong Kong


• Singapore

International Drug Name Search

Apo-Indomethacine

Apo-Indomethacine may be available in the countries listed below.

Ingredient matches for Apo-Indomethacine

Indometacin

Indometacin is reported as an ingredient of Apo-Indomethacine in the following countries:

• Vietnam

International Drug Name Search

Ortho Micronor

norethindrone

Dosage Form: tablet
Ortho Micronor®

Tablets

(norethindrone)

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Ortho Micronor Description

Ortho Micronor® Tablets

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, modified corn starch, and povidone.

Meets USP Dissolution Test 2

Ortho Micronor - Clinical Pharmacology

1. Mode of Action

Ortho Micronor® progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.

2. Pharmacokinetics

Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state serum progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

Indications and Usage for Ortho Micronor

1. Indications

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

2. Efficacy

If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.

Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.

	% of Women Experiencing an Unintended Pregnancy within the First Year of Use		% of Women Continuing Use at One Year*
Method (1)	Typical Use† (2)	Perfect Use‡ (3)	(4)
Adapted from Hatcher et al, 1998, Ref. # 1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.¶
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. † Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. § The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). ¶ However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. # The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. Þ Foams, creams, gels, vaginal suppositories, and vaginal film. ß Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. à With spermicidal cream or jelly. è Without spermicides.
Chance#	85	85
SpermicidesÞ	26	6	40
Periodic abstinence	25		63
Calendar		9
Ovulation Method		3
Sympto-Thermalß		2
Post-Ovulation		1
Capà
Parous Women	40	26	42
Nulliparous Women	20	9	56
Sponge
Parous Women	40	20	42
Nulliparous Women	20	9	56
Diaphragmà	20	6	56
Withdrawal	19	4
Condomè
Female (Reality®)	21	5	56
Male	14	3	61
Pill	5		71
Progestin Only		0.5
Combined		0.1
IUD
Progesterone T	2.0	1.5	81
Copper T380A	0.8	0.6	78
LNg 20	0.1	0.1	81
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

Ortho Micronor® Tablets have not been studied for and are not indicated for use in emergency contraception.

Contraindications

Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions:

• Known or suspected pregnancy


• Known or suspected carcinoma of the breast


• Undiagnosed abnormal genital bleeding


• Hypersensitivity to any component of this product


• Benign or malignant liver tumors


• Acute liver disease

Warnings

Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.

Ortho Micronor® does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives (COCs). The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined. The healthcare professional should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate.

1. Ectopic Pregnancy

The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives.

2. Delayed Follicular Atresia/Ovarian Cysts

If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle. Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention.

3. Irregular Genital Bleeding

Irregular menstrual patterns are common among women using progestin-only oral contraceptives. If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.

4. Carcinoma of the Breast and Reproductive Organs

Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk.

A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.

This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.

Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.

5. Hepatic Neoplasia

Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.

Precautions

1. General

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

2. Physical Examination and Follow-up

It is considered good medical practice for sexually active women using oral contraceptives to have annual history and physical examinations. The physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the healthcare professional.

3. Carbohydrate and Lipid Metabolism

Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.

Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3, LDL, or VLDL.

4. Drug Interactions

The effectiveness of progestin-only pills is reduced by hepatic enzyme-inducing drugs such as the anticonvulsants phenytoin, carbamazepine, and barbiturates, and the antituberculosis drug rifampin. No significant interaction has been found with broad-spectrum antibiotics.

Herbal products containing St. John's Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

Concurrent use of bosentan and norethindrone containing products may result in decreased concentrations of these contraceptive hormones thereby increasing the risk of unintended pregnancy and unscheduled bleeding.

5. Interactions with Laboratory Tests

The following endocrine tests may be affected by progestin-only oral contraceptive use:

• Sex hormone-binding globulin (SHBG) concentrations may be decreased.


• Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).

6. Carcinogenesis

See WARNINGS.

7. Pregnancy

Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.

8. Nursing Mothers

In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.

9. Pediatric Use

Safety and efficacy of Ortho Micronor® Tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

10. Fertility Following Discontinuation

The limited available data indicate a rapid return of normal ovulation and fertility following discontinuation of progestin-only oral contraceptives.

11. Headache

The onset or exacerbation of migraine or development of severe headache with focal neurological symptoms which is recurrent or persistent requires discontinuation of progestin-only contraceptives and evaluation of the cause.

INFORMATION FOR THE PATIENT

1. See "Detailed Patient Labeling" for detailed information.


2. Counseling issues

The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives:

• The necessity of taking pills at the same time every day, including throughout all bleeding episodes.


• The need to use a backup method such as a condom and spermicide for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.


• The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities.


• The need to inform the healthcare professional of prolonged episodes of bleeding, amenorrhea or severe abdominal pain.


• The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.

Adverse Reactions

Adverse reactions reported with the use of POPs include:

• Menstrual irregularity is the most frequently reported side effect.


• Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely.


• Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies.


• Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

Overdosage

There have been no reports of serious ill effects from overdosage, including ingestion by children.

Ortho Micronor Dosage and Administration

To achieve maximum contraceptive effectiveness, Ortho Micronor® must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.

How is Ortho Micronor Supplied

Ortho Micronor® (0.35 mg norethindrone) Tablets are available in a blister card (NDC 0062-1411-01 or NDC 50458-194-00) with a DIALPAK® Tablet Dispenser (unfilled). The blister card contains 28 lime green, round, flat faced, beveled edge tablets, imprinted "ORTHO 0.35" on both sides. Ortho Micronor® Tablets are packaged in a carton containing 6 blister cards and 6 unfilled DIALPAK® Tablet Dispensers (NDC 0062-1411-16 or NDC 50458-194-16).

Ortho Micronor® (0.35 mg norethindrone) Tablets are available for clinic usage in a VERIDATE® Tablet Dispenser (unfilled) and VERIDATE® refills (NDC 0062-1411-23 or NDC 50458-194-23).

STORAGE: Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

Keep out of reach of children.

REFERENCE

McCann M, and Potter L. Progestin-Only Oral Contraceptives: A Comprehensive Review. Contraception, 50:60 (Suppl. 1), December 1994.

Van Giersbergen PLM, Halabi A, Dingemanse J. Pharmacokinetic interaction between bosentan and the oral contraceptives norethisterone and ethinyl estradiol. Int J Clin Pharmacol Ther 2006;44(3):113–118.

Truitt ST, Fraser A, Gallo ME, Lopez LM, Grimes DA and Schulz KF. Combined hormonal versus nonhormonal versus progestin-only contraception in lactation (Review). The Cochrane Collaboration. 2007, Issue 3.

Halderman, LD and Nelson AL. Impact of early postpartum administration of progestin-only hormonal contraceptives compared with nonhormonal contraceptives on short-term breast-feeding patterns. Am J Obstet Gynecol.; 186 (6):1250–1258.

Ostrea EM, Mantaring III JB, Silvestre MA. Drugs that affect the fetus and newborn infant via the placenta or breast milk. Pediatr Clin N Am; 51(2004): 539–579.

Cooke ID, Back DJ, Shroff NE: Norethisterone concentration in breast milk and infant and maternal plasma during ethynodiol diactetate administration. Contraception 1985; 31:611–21.

2008 USPC Official:12/1/08–4/30/09, USP Monographs: Norethindrone Tablets (page 1 of 5).

DETAILED PATIENT LABELING

Ortho Micronor® (norethindrone) Tablets

This product (like all oral contraceptives) is used to prevent pregnancy. It does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

DESCRIPTION

Ortho Micronor® Tablets

Each tablet contains 0.35 mg norethindrone. Inactive ingredients include D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, modified corn starch and povidone.

INTRODUCTION

This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your healthcare professional.

Progestin-only pills are often called "POPs" or "the minipill." POPs have less progestin than the combined birth control pill (or "the pill") which contains both an estrogen and a progestin.

HOW EFFECTIVE ARE POPs?

About 1 in 200 POP users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 "typical" POP users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. Table 2 will help you compare the efficacy of different methods.

Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.

	% of Women Experiencing an Unintended Pregnancy within the First Year of Use		% of Women Continuing Use at One Year*
Method (1)	Typical Use† (2)	Perfect Use‡ (3)	(4)
Adapted from Hatcher et al, 1998, Ref. # 1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.¶
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
* Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. † Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ‡ Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. § The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). ¶ However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. # The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. Þ Foams, creams, gels, vaginal suppositories, and vaginal film. ß Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. à With spermicidal cream or jelly. è Without spermicides.
Chance#	85	85
SpermicidesÞ	26	6	40
Periodic abstinence	25		63
Calendar		9
Ovulation Method		3
Sympto-Thermalß		2
Post-Ovulation		1
Capà
Parous Women	40	26	42
Nulliparous Women	20	9	56
Sponge
Parous Women	40	20	42
Nulliparous Women	20	9	56
Diaphragmà	20	6	56
Withdrawal	19	4
Condomè
Female (Reality®)	21	5	56
Male	14	3	61
Pill	5		71
Progestin Only		0.5
Combined		0.1
IUD
Progesterone T	2.0	1.5	81
Copper T380A	0.8	0.6	78
LNg 20	0.1	0.1	81
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

Ortho Micronor® Tablets have not been studied for and are not indicated for use in emergency contraception.

HOW DO POPs WORK?

POPs can prevent pregnancy in different ways including:

• They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg.


• They prevent ovulation (release of the egg from the ovary) in about half of the cycles.


• They also affect other hormones, the fallopian tubes and the lining of the uterus.

YOU SHOULD NOT TAKE POPs

• If there is any chance you may be pregnant.


• If you have breast cancer.


• If you have bleeding between your periods that has not been diagnosed.


• If you are taking certain drugs for epilepsy (seizures) or for TB, or medicine for pulmonary hypertension or certain herbal products. (See "Using POPs with Other Medicines" below.)


• If you are hypersensitive, or allergic, to any component of this product.


• If you have liver tumors, either benign or cancerous.


• If you have acute liver disease.

RISKS OF TAKING POPs

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

WARNING:

If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.

Ectopic Pregnancy

An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.

Ovarian Cysts

These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.

Cancer of the Reproductive Organs and Breasts

Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.

A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.

Liver Tumors

In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors.

Diabetic Women

Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your healthcare professional may monitor you more closely under these conditions.

SEXUALLY TRANSMITTED DISEASES (STDs)

WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.

SIDE EFFECTS

Irregular Bleeding:

The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can result in some spotting or bleeding.

Other Side Effects:

Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare.

If you are concerned about any of these side effects, check with your healthcare professional.

USING POPs WITH OTHER MEDICINES

Before taking a POP, inform your healthcare professional of any other medication, including over-the-counter medicine, that you may be taking.

These medicines can make POPs less effective:

Medicines for seizures such as:

• Phenytoin (Dilantin®)


• Carbamazepine (Tegretol®)


• Phenobarbital

Medicine for TB:

• Rifampin (Rifampicin)

Medicine for pulmonary hypertension such as:

• Bosentan (Tracleer®)

Herbal products such as:

• St. John's Wort

Before you begin taking any new medicines be sure your healthcare professional knows you are taking a progestin-only birth control pill.

HOW TO TAKE POPs

IMPORTANT POINTS TO REMEMBER

• POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.


• Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready.


• You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.


• If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.


• If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don't wish to become pregnant, be certain to use another birth control method.


• If you are not sure about how to take POPs, ask your healthcare professional.

STARTING POPs

• It's best to take your first POP on the first day of your menstrual period.


• If you decide to take your first POP on another day, use a backup method (such as a condom and/or a spermicide) every time you have sex during the next 48 hours.


• If you have had a miscarriage or an abortion, you can start POPs the next day.

IF YOU ARE LATE OR MISS TAKING YOUR POPs

• If you are more than 3 hours late or you miss one or more POPs:
  

  1)

  
  

  TAKE a missed pill as soon as you remember that you missed it,

  
  

  2)

  
  

  THEN go back to taking POPs at your regular time,

  
  

  3)

  
  

  BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.

  
  



• If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.

IF YOU ARE BREASTFEEDING

• If you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery.


• If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery.

IF YOU ARE SWITCHING PILLS

• If you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected.


• If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished.


• If you switch to another brand of POPs, start the new brand anytime.


• If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery.

PREGNANCY WHILE ON THE PILL

If you think you are pregnant, contact your healthcare professional. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don't need when you are pregnant.

You should get a pregnancy test:

• If your period is late and you took one or more pills late or missed taking them and had sex without a backup method.


• Anytime it has been more than 45 days since the beginning of your last period.

WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER?

If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.

BREASTFEEDING

If you are breastfeeding, POPs will not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported.

OVERDOSE

No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.

OTHER QUESTIONS OR CONCERNS

If you have any questions or concerns, check with your healthcare professional. You can also ask for the more detailed "Professional Labeling" written for doctors and other healthcare professionals.

HOW TO STORE YOUR POPs

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

Keep out of reach of children.

(logo)

Mfd. for:

Ortho Women's Health & Urology, Division of Ortho-McNeil-Janssen

Pharmaceuticals, Inc.

Raritan, New Jersey 08869

Mfd. by:

Janssen Ortho, LLC

Manati, Puerto Rico 00674

©OMJPI 2001

PRINTED IN U.S.A.

Revised June 2010

10216800

PRINCIPAL DISPLAY PANEL - 0.35 mg Tablet Carton

28

day

NDC 0062-1411-16

ORTHO

MICRONOR®

TABLETS

(norethindrone) 0.35 mg

Each lime green tablet contains 0.35 mg norethindrone.

This product (like all oral contraceptives) is intended to

prevent pregnancy. It does not protect against HIV infection

(AIDS) and other sexually transmitted diseases.

Rx only.

Store at 25°C (77°F); excursions permitted

to 15°-30°C (59°-86°F).

Keep out of reach of children.

Contains: 6 Dialpak®

Tablet Dispensers

and 6 Refills

ORTHO

www.orthomicronor.com

Mfd. for:

ORTHO-McNEIL

PHARMACEUTICAL, INC.

Raritan, New Jersey 08869

Mfd. by:

Janssen Ortho, LLC

Manati, Puerto Rico

00674

© OMP 2001

Ortho Micronor  norethindrone  tablet

Oasis Tears

Generic Name: ocular lubricant (OK yoo lar LOO bri kant)

Brand Names: Artificial Tears, Celluvisc, Clear Eyes CLR, Comfort Tears, Dry Eye Relief, GenTeal, Isopto Tears, Lacri-Lube S.O.P., Lacrisert, Lubricant Eye Drops, Moisture Drops, Oasis Tears, Opti-Free Rewetting Drops, optive, Refresh, Soothe, Sterilube, Systane, Systane Balance, Tears Again, Tears Naturale, Tears Renew, TheraTears, Ultra Fresh, Visine Tears

What is Oasis Tears (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

Ocular lubricant is a solution specially formulated to moisten the eyes.

Ocular lubricant is used to relieve burning, irritation, and discomfort caused by dry eyes.

Ocular lubricant may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Oasis Tears (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.

Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Stop using ocular lubricant and call your doctor if you have severe burning, stinging, irritation, eye pain, or vision changes.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant.

What should I discuss with my healthcare provider before using Oasis Tears (ocular lubricant)?

You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.

Ocular lubricant is not expected to harm an unborn baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant. It is not known whether ocular lubricant passes into breast milk or if it could harm a nursing baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant.

How should I use Oasis Tears (ocular lubricant)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not use this medication while wearing contact lenses. Eye medication may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medication before putting your contact lenses in. Wash your hands before using ocular lubricant.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Do not use the eye drops if the liquid has changed colors or has particles in it.

  
  

To apply the ointment:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

  
  


• 
  

  Squeeze out a ribbon of ointment 1/2-inch long into the lower eyelid pocket without touching the tip of the tube to your eye. Look down and close your eyes for a few minutes. Rolling your eyes around gently will help spread the ointment evenly.

  
  


• 
  

  After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

  
  

Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant. Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

What happens if I miss a dose?

Since ocular lubricant is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

An overdose of ocular lubricant is not expected to be dangerous.

What should I avoid while using Oasis Tears (ocular lubricant)?

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid using other medications in your eyes during treatment with ocular lubricant unless your doctor tells you to.

Oasis Tears (ocular lubricant) 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. Stop using ocular lubricant and call your doctor if you have a serious side effect such as:

• 
  

  severe burning, stinging, or eye irritation after using the medication;

  
  


• 
  

  eye pain; or

  
  


• 
  

  vision changes.

  
  

Less serious side effects may include:

• 
  

  mild eye burning or irritation;

  
  


• 
  

  itching or redness of your eyes;

  
  


• 
  

  watery eyes;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  unpleasant taste in your mouth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Oasis Tears (ocular lubricant)?

It is not likely that other drugs you take orally or inject will have an effect on ocular lubricant used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Oasis Tears resources

• Oasis Tears Use in Pregnancy & Breastfeeding
• 0 Reviews for Oasis Tears - Add your own review/rating

• FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Genteal Advanced Consumer (Micromedex) - Includes Dosage Information


• Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Lacrisert Prescribing Information (FDA)


• Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer)


• Lacrisert Advanced Consumer (Micromedex) - Includes Dosage Information


• Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Refresh liquigel

Compare Oasis Tears with other medications

• Eye Dryness/Redness

Where can I get more information?

• Your pharmacist can provide more information about ocular lubricant.

Dompéridone Torlan

Dompéridone Torlan may be available in the countries listed below.

Ingredient matches for Dompéridone Torlan

Domperidone

Domperidone is reported as an ingredient of Dompéridone Torlan in the following countries:

• France

International Drug Name Search

Femitres

Femitres may be available in the countries listed below.

Ingredient matches for Femitres

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Femitres in the following countries:

• Peru

Levonorgestrel

Levonorgestrel is reported as an ingredient of Femitres in the following countries:

• Peru

International Drug Name Search

Paruleon

Paruleon may be available in the countries listed below.

Ingredient matches for Paruleon

Triazolam

Triazolam is reported as an ingredient of Paruleon in the following countries:

• Japan

International Drug Name Search

Adrenaline-Fresenius

Adrenaline-Fresenius may be available in the countries listed below.

Ingredient matches for Adrenaline-Fresenius

Epinephrine

Epinephrine bitartrate (a derivative of Epinephrine) is reported as an ingredient of Adrenaline-Fresenius in the following countries:

• South Africa

International Drug Name Search

Citanest

In some countries, this medicine may only be approved for veterinary use.

UK matches:

• Citanest 1%

Ingredient matches for Citanest

Epinephrine

Epinephrine bitartrate (a derivative of Epinephrine) is reported as an ingredient of Citanest in the following countries:

• Japan

Prilocaine

Prilocaine is reported as an ingredient of Citanest in the following countries:

• Turkey

Prilocaine hydrochloride (a derivative of Prilocaine) is reported as an ingredient of Citanest in the following countries:

• Australia


• Bahrain


• Belgium


• Egypt


• Georgia


• Iraq


• Japan


• Jordan


• Kuwait


• Lebanon


• Luxembourg


• Netherlands


• New Zealand


• Oman


• Saudi Arabia


• Sweden


• Syria


• United Arab Emirates


• United Kingdom


• United States


• Yemen

International Drug Name Search

Pyricarbate

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0001882-26-4

Chemical Formula

C11-H15-N3-O4

Molecular Weight

253

Therapeutic Category

Antilipemic agent

Chemical Name

2,6-Pyridinedimethanol, bis(methylcarbamate) (ester)

Foreign Names

• Pyricarbatum (Latin)
• Pyricarbat (German)
• Pyricarbate (French)
• Piricarbato (Spanish)

Generic Names

• Piricarbato (OS: DCIT)
• Pyricarbate (OS: DCF)
• Pyridinol Carbamate (OS: JAN)
• Ba 17 (IS: KaliChemie)
• H 3749 (IS)
• P 23 (IS)
• Pyricarbate (PH: Ph. Franç. Xe édit)

Brand Names

• Anginin
  Banyu Seiyaku, Japan; Teva, Israel

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Amosine

Amosine may be available in the countries listed below.

Ingredient matches for Amosine

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amosine in the following countries:

• Indonesia

International Drug Name Search

Droxia

Pronunciation: hye-DROX-ee-ure-EE-a
Generic Name: Hydroxyurea
Brand Name: Droxia

Droxia may cause severe, sometimes life-threatening side effects. With long-term use in patients with cell development disorders, secondary leukemias have been reported. It is unknown if this is related to Droxia or to the patient's underlying cell disorder.

Droxia is used for:

Reducing the number of painful episodes and blood transfusions needed by adults with sickle cell anemia experiencing recurrent episodes associated with moderate to severe pain. It may also be used for other conditions as determined by your doctor.

Droxia is an antineoplastic agent. Exactly how it works is not known, but it is thought to increase the ability of deformed red blood cells to change shape, which may lessen pain associated with sickle cell anemia.

Do NOT use Droxia if:

• you are allergic to any ingredient in Droxia


• you have severe bone marrow depression, low white blood cell counts, low blood platelet levels, or severe anemia


• if you are taking didanosine or stavudine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Droxia:

Some medical conditions may interact with Droxia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney or liver problems


• if you take medicine for HIV infection

Some MEDICINES MAY INTERACT with Droxia. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Didanosine or stavudine because the risk of side effects, such as inflammation of the pancreas, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Droxia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Droxia:

Use Droxia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Droxia. Talk to your pharmacist if you have questions about this information.


• Take Droxia by mouth with or without food.


• Wash your hands before and after handling Droxia or the bottle it comes in. Wear gloves while you are handling Droxia 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.


• Drinking extra fluids while you are taking Droxia is recommended. Check with your doctor for instructions.


• Do not use Droxia if the expiration date has passed. Ask your doctor or pharmacist how to properly dispose of expired medicine.


• Taking Droxia at the same time each day will help you remember to take it.


• If you miss a dose of Droxia, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Droxia.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor.


• Tell your doctor or dentist that you take Droxia before you receive any medical or dental care, emergency care, or surgery.


• Droxia may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Droxia may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Droxia may harm your liver or cause burning, numbness, or tingling of your arms, hands, legs, or feet if you take it with certain HIV medicines (eg, didanosine, stavudine). Talk to your doctor if you have any questions about this information.


• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Droxia. Vaccinations may be less effective.


• Women who may become pregnant should use effective birth control while they are taking Droxia. Check with your doctor if you have questions about effective birth control.


• Lab tests, including complete blood cell counts, kidney function, liver function, and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Droxia with caution in the ELDERLY; they may be more sensitive to its effects.


• Droxia is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Droxia has been shown to cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Droxia while you are pregnant. Droxia is found in breast milk. Do not breast-feed while taking Droxia.

Possible side effects of Droxia:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; drowsiness; hair loss; inflammation of the mouth; loss of appetite; nausea; redness of the face.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood disorders, including low numbers of red or white blood cells; blood in the urine; chills; diarrhea; fever; inflammation of the pancreas; lower back or abdominal pain; painful urination; persistent cough; secondary leukemia; shortness of breath; skin cancer; skin sores or lesions; sore throat; sores on the mouth or lips; symptoms of liver toxicity (eg, yellowing of the eyes or skin, pale stools, dark urine, loss of appetite, severe stomach pain); unusual bruising or bleeding; unusual tiredness or weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Droxia side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark discoloration of the skin; mouth sores; soreness; swelling of the palms and soles of the feet, followed by scaling of the skin.

Proper storage of Droxia:

Store Droxia at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Droxia out of the reach of children and away from pets.

General information:

• If you have any questions about Droxia, please talk with your doctor, pharmacist, or other health care provider.


• Droxia 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.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Droxia. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Droxia resources

• Droxia Side Effects (in more detail)
• Droxia Dosage
• Droxia Use in Pregnancy & Breastfeeding
• Drug Images
• Droxia Drug Interactions
• Droxia Support Group
• 0 Reviews for Droxia - Add your own review/rating

• Droxia Concise Consumer Information (Cerner Multum)


• Droxia Prescribing Information (FDA)


• Droxia Advanced Consumer (Micromedex) - Includes Dosage Information


• Hydroxyurea Prescribing Information (FDA)


• Hydroxyurea Professional Patient Advice (Wolters Kluwer)


• Hydroxyurea Monograph (AHFS DI)


• Hydrea Prescribing Information (FDA)

Compare Droxia with other medications

• Anemia, Sickle Cell
• Chronic Myelogenous Leukemia
• Solid Tumors