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Sunday, October 2, 2016

Ortho Tri-Cyclen Lo

norgestimate and ethinyl estradiol

Dosage Form: tablets
ORTHO TRI-CYCLEN® Lo Tablets

(norgestimate/ethinyl estradiol)

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

Ortho Tri-Cyclen Lo Description

ORTHO TRI-CYCLEN® Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

ORTHO TRI-CYCLEN® Lo Tablets

Each white tablet contains 0.180 mg of the progestational compound, norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.

Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.

Each dark blue tablet contains 0.250 mg of the progestational compound norgestimate (+)-13-Ethyl-17-hydroxy-18, 19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate (ester) and 0.025 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, polysorbate 80, carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, and purified water.

Each dark green tablet contains only inert ingredients, as follows: FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, pregelatinized starch, ferric oxide, hypromellose, polyethylene glycol, titanium dioxide, talc and purified water.

Norgestimate

Ethinyl Estradiol

Ortho Tri-Cyclen Lo - Clinical Pharmacology

Oral Contraception

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Receptor binding studies, as well as studies in animals and humans, have shown that norgestimate and 17-deacetyl norgestimate, the major serum metabolite, combine high progestational activity with minimal intrinsic androgenicity.90–93 Norgestimate, in combination with ethinyl estradiol, does not counteract the estrogen-induced increases in sex hormone binding globulin (SHBG), resulting in lower serum testosterone.90,91,94

PHARMACOKINETICS

Absorption

Norgestimate (NGM) and ethinyl estradiol (EE) are rapidly absorbed following oral administration. Norgestimate is rapidly and completely metabolized by first-pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate. Mean pharmacokinetic parameters for NGMN, NG and EE during three cycles of administration of ORTHO TRI-CYCLEN® Lo are summarized in Table 1. These results indicate that: (1) Peak serum concentrations of NGMN and EE were generally reached by 2 hours after dosing; (2) Accumulation following multiple dosing of the 180 mcg NGM / 25 mcg dose is approximately 1.5 to 2 fold for NGMN and approximately 1.5 fold for EE compared with single dose administration, in agreement with that predicted based on linear kinetics of NGMN and EE; (3) The kinetics of NGMN are dose proportional following NGM doses of 180 to 250 mcg; (4) Steady-state conditions for NGMN following each NGM dose and for EE were achieved during the three cycle study; (5) Non-linear accumulation (4.5–14.5 fold) of norgestrel was observed as a result of high affinity binding to SHBG, which limits its biological activity.100 The effect of food on the pharmacokinetics of ORTHO TRI-CYCLEN® Lo has not been studied.

Table 1 provides a summary of norelgestromin, norgestrel and ethinyl estradiol pharmacokinetic parameters.

Table 1: Mean (SD) Pharmacokinetic Parameters of ORTHO TRI-CYCLEN® Lo During a Three Cycle Study
Analyte1	Cycle	Day	Cmax	tmax (h)	AUC0–24h	t1/2 (h)
1 NGMN = Norelgestromin, NG = norgestrel, EE = ethinyl estradiol
2 Cmax = peak serum concentration, tmax = time to reach peak serum concentration, AUC0–24h = area under serum concentration vs. time curve from 0 to 24 hours, t1/2 = elimination half-life.
3 units for all analytes; h = hours
4 units for NGMN and NG – Cmax = ng/mL, AUC0–24h = h.ng/mL
5 units for EE only – Cmax = pg/mL, AUC0–24h = h.pg/mL
NC = not calculated
NGMN(2–4)	1	1	0.91 (0.27)	1.8 (1.0)	5.86 (1.54)	NC
	3	7	1.42 (0.43)	1.8 (0.7)	11.3 (3.2)	NC
		14	1.57 (0.39)	1.8 (0.7)	13.9 (3.7)	NC
		21	1.82 (0.54)	1.5 (0.7)	16.1 (4.8)	28.1(10.6)
NG(2–4)	1	1	0.32 (0.14)	2.0 (1.1)	2.44 (2.04)	NC
	3	7	1.64 (0.89)	1.9 (0.9)	27.9 (18.1)	NC
		14	2.11 (1.13)	4.0 (6.3)	40.7 (24.8)	NC
		21	2.79 (1.42)	1.7 (1.2)	49.9 (27.6)	36.4 (10.2)
EE(2,3,5)	1	1	55.6 (18.1)	1.7 (0.5)	421 (118)	NC
	3	7	91.1 (36.7)	1.3 (0.3)	782 (329)	NC
		14	96.9 (38.5)	1.3 (0.3)	796 (273)	NC
		21	95.9 (38.9)	1.3 (0.6)	771 (303)	17.7(4.4)

Distribution

Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (>97%) to serum proteins. Norelgestromin is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG. Ethinyl estradiol is extensively bound (>97%) to serum albumin.

Metabolism

Norgestimate is extensively metabolized by first-pass mechanisms in the gastrointestinal tract and/or liver. Norgestimate's primary active metabolite is norelgestromin. Subsequent hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is also active and various hydroxylated and conjugated metabolites. Ethinyl estradiol is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.

Excretion

Following 3 cycles of administration of ORTHO TRI-CYCLEN® Lo, the mean (± SD) elimination half-life values, at steady-state, for norelgestromin, norgestrel and ethinyl estradiol were 28.1 (± 10.6) hours, 36.4 (± 10.2) hours and 17.7 (± 4.4) hours, respectively (Table 1). The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and fecal pathways.

Special Populations

Effects of Body Weight, Body Surface Area, and Age

The effects of body weight, body surface area, age and race on the pharmacokinetics of norelgestromin, norgestrel and ethinyl estradiol were evaluated in 79 healthy women using pooled data following single dose administration of NGM 180 or 250 mcg / EE 25 mcg tablets in four pharmacokinetic studies. Increasing body weight and body surface area were each associated with decreases in Cmax and AUC0–24h values for norelgestromin and ethinyl estradiol and increases in CL/F (oral clearance) for ethinyl estradiol. Increasing body weight by 10 kg is predicted to reduce the following parameters: NGMN Cmax by 9% and AUC0–24h by 19%, norgestrel Cmax by 12% and AUC0–24h by 46%, EE Cmax by 13% and AUC0–24h by 12%. These changes were statistically significant. Increasing age was associated with slight decreases (6% with increasing age by 5 years) in Cmax and AUC0–24h for norelgestromin and were statistically significant, but there was no significant effect for norgestrel or ethinyl estradiol. Only a small to moderate fraction (5–40%) of the overall variability in the pharmacokinetics of norelgestromin and ethinyl estradiol following ORTHO TRI-CYCLEN® Lo Tablets may be explained by any or all of the above demographic parameters.

In clinical studies involving 1673 subjects with a mean weight of 141 pounds, there was no association between pregnancy and weight.

Renal and Hepatic Impairment

No studies with ORTHO TRI-CYCLEN® Lo have been conducted in women with renal or hepatic impairment.

Drug-Drug Interactions

Although norelgestromin and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of norelgestromin and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (Ki).

Interactions between oral contraceptives and other drugs have been reported in the literature. No formal drug-drug interaction studies were conducted with ORTHO TRI-CYCLEN® Lo (see PRECAUTIONS).

Indications and Usage for Ortho Tri-Cyclen Lo

ORTHO TRI-CYCLEN® Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN® Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN® Lo users.99 This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.

Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant® system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

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	Typical Use†	Perfect Use‡
(1)	(2)	(3)	(4)
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.§
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.¶
Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel 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 FDA 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 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 6 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
Withdrawal	19	4
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
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 TRI-CYCLEN® Lo has not been studied for and is not indicated for use in emergency contraception.

Contraindications

Oral contraceptives should not be used in women who have any of the following conditions:

Thrombophlebitis or thromboembolic disorders

A past history of deep vein thrombophlebitis or thromboembolic disorders

Cerebral vascular or coronary artery disease (current or history)

Valvular heart disease with complications

Severe hypertension

Diabetes with vascular involvement

Headaches with focal neurological symptoms

Major surgery with prolonged immobilization

Known or suspected carcinoma of the breast or personal history of breast cancer

Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

Undiagnosed abnormal genital bleeding

Cholestatic jaundice of pregnancy or jaundice with prior pill use

Hepatic adenomas or carcinomas

Known or suspected pregnancy

Hypersensitivity to any component of this product

Warnings

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from refs. 2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.

1. Thromboembolic Disorders and Other Vascular Problems

a. Myocardial Infarction

An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six.4–10 The risk is very low under the age of 30.

Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older with smoking accounting for the majority of excess cases.11 Mortality rates associated with circulatory disease have been shown to increase substantially in smokers, especially in those 35 years of age and older and in nonsmokers over the age of 40 among women who use oral contraceptives.

Figure 1: Circulatory Disease Mortality Rates per 100,000 Women-Years by Age, Smoking Status and Oral Contraceptive Use

Figure 1 Adapted from P.M. Layde and V. Beral, Ref. #12.

Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age and obesity.13 In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism.14–18 Oral contraceptives have been shown to increase blood pressure among users (see section 9 in WARNINGS). Similar effects on risk factors have been associated with an increased risk of heart disease. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Norgestimate has minimal androgenic activity (see CLINICAL PHARMACOLOGY), and there is some evidence that the risk of myocardial infarction associated with oral contraceptives is lower when the progestogen has minimal androgenic activity than when the activity is greater.97

b. Thromboembolism

An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease.2,3,19–24 Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization.25 The risk of thromboembolic disease associated with oral contraceptives is not related to length of use and disappears after pill use is stopped.2

A two- to four-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives.9 The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions.26 If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four weeks after delivery in women who elect not to breastfeed.

c. Cerebrovascular Diseases

Oral contraceptives have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, and smoking interacted to increase the risk of hemorrhagic stroke.27–29

In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension.30 The relative risk of hemorrhagic stroke is reported to be 1.2 for non-smokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension.30 The attributable risk is also greater in older women.3

d. Dose-Related Risk of Vascular Disease from Oral Contraceptives

A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease.31–33 A decline in serum high density lipoproteins (HDL) has been reported with many progestational agents.14–16 A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the activity of the progestogen used in the contraceptives. The activity and amount of both hormones should be considered in the choice of an oral contraceptive.

Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing the lowest estrogen content which is judged appropriate for an individual patient.

e. Persistence of Risk of Vascular Disease

There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40–49 years who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups.8 In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small.34 However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.

2. Estimates of Mortality from Contraceptive Use

One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 3). These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risks. The study concluded that with the exception of oral contraceptive users 35 and older who smoke, and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth. The observation of an increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970's.35 Current clinical recommendation involves the use of lower estrogen dose formulations and a careful consideration of risk factors. In 1989, the Fertility and Maternal Health Drugs Advisory Committee was asked to review the use of oral contraceptives in women 40 years of age and over.

The Committee concluded that although cardiovascular disease risks may be increased with oral contraceptive use after age 40 in healthy non-smoking women (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception. The Committee recommended that the benefits of low-dose oral contraceptive use by healthy non-smoking women over 40 may outweigh the possible risks.

Of course, older women, as all women, who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and individual patient needs.

Table 3: Annual Number of Birth-Related or Method-Related Deaths Associated with Control of Fertility per 100,000 Nonsterile Women, by Fertility-Control Method and According to Age
Method of control and outcome	15–19	20–24	25–29	30–34	35–39	40–44
Adapted from H.W. Ory, Family Planning Perspectives, Ref. #35.
* Deaths are birth-related † Deaths are method-related
No fertility-control methods*	7.0	7.4	9.1	14.8	25.7	28.2
Oral contraceptives, non-smoker†	0.3	0.5	0.9	1.9	13.8	31.6
Oral contraceptives, smoker†	2.2	3.4	6.6	13.5	51.1	117.2
IUD†	0.8	0.8	1.0	1.0	1.4	1.4
Condom*	1.1	1.6	0.7	0.2	0.3	0.4
Diaphragm/spermicide*	1.9	1.2	1.2	1.3	2.2	2.8
Periodic abstinence*	2.5	1.6	1.6	1.7	2.9	3.6

3. Carcinoma of the Reproductive Organs and Breasts

Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives.

The risk of having breast cancer diagnosed may be slightly increased among current and recent users of combination oral contraceptives. However, this excess risk appears to decrease over time after discontinuation of combination oral contraceptives and by 10 years after cessation the increased risk disappears. Some studies report an increased risk with duration of use while other studies do not and no consistent relationships have been found with dose or type of steroid. Some studies have found a small increase in risk for women who first use combination oral contraceptives before age 20. Most studies show a similar pattern of risk with combination oral contraceptive use regardless of a woman's reproductive history or her family breast cancer history.

Breast cancers diagnosed in current or previous oral contraceptive users tend to be less clinically advanced than in nonusers.

Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormonally-sensitive tumor.

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.45–48 However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause-and-effect relationship has not been established.

4. Hepatic Neoplasia

Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose.49 Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.50,51

Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.

5. Ocular Lesions

There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.

6. Oral Contraceptive Use Before or During Early Pregnancy

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy.56,57 The majority of recent studies also do not indicate a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned,55,56,58,59 when taken inadvertently during early pregnancy.

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.

It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.

7. Gallbladder Disease

Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens.60,61 More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.62–64 The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.

8. Carbohydrate and Lipid Metabolic Effects

Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users.17 This effect has been shown to be directly related to estrogen dose.65 Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.17,66 However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose.67 Because of these demonstrated effects, prediabetic and diabetic women in particular should be carefully monitored while taking oral contraceptives.

A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier (see WARNINGS 1a and 1d), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.

9. Elevated Blood Pressure

Women with significant hypertension should not be started on hormonal contraception.98 An increase in blood pressure has been reported in women taking oral contraceptives68 and this increase is more likely in older oral contraceptive users69 and with extended duration of use.61 Data from the Royal College of General Practitioners12 and subsequent randomized trials have shown that the incidence of hypertension increases with increasing progestational activity and concentrations of progestogens.

Women with a history of hypertension or hypertension-related diseases, or renal disease70 should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension between former and never users.68–71

10. Headache

The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and evaluation of the cause.

11. Bleeding Irregularities

Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.

Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was preexistent.

12. Ectopic Pregnancy

Ectopic as well as intrauterine pregnancy may occur in contraceptive failures.

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 good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undia

Divigel 1 mg/packet for use on skin

Generic Name: estradiol topical (for use on skin) (ess tra DYE ol TOP ik al)

Brand Names: Divigel 0.25 mg/packet, Divigel 0.5 mg/packet, Divigel 1 mg/packet, Elestrin Pump, Estrasorb, EstroGel Pump, Evamist

What is estradiol topical?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Estradiol topical (for the skin) is used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

Estradiol topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about estradiol topical?

Do not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, a history of stroke or circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. Estradiol topical can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts. Children should avoid coming into contact with skin areas where you have applied estradiol topical. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine. Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

What should I discuss with my health care provider before using estradiol topical?

Estrogens will not prevent heart disease, heart attack, stroke, breast cancer, or dementia, and may actually increase your risk of developing these conditions. Estrogens may also increase your risk of uterine or ovarian cancer.

You should not use estradiol topical if you have:

a bleeding or blood-clotting disorder;

liver disease;

a history of stroke or circulation problems;

abnormal vaginal bleeding that a doctor has not checked; or

any type of breast, uterine, or hormone-dependent cancer.

To make sure you can safely use estradiol topical, tell your doctor if you have any of these other conditions:

high blood pressure, angina, or heart disease;

high cholesterol or triglycerides;

kidney disease;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

a thyroid disorder;

depression;

porphyria;

lupus;

low levels of calcium in your blood;

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol topical if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol topical.

How should I use estradiol topical?

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Apply estradiol topical only to clean, dry, unbroken skin. Do not apply to skin that is red or irritated. Never apply this medicine to the breasts.

To use the topical gel (such as Estrogel):

Apply estradiol topical gel to the outside of your arm, from wrist to shoulder. Use the gel at the same time each day.

Do not rub the gel in, but allow it to dry on your skin for at least 5 minutes before you dress.

The gel form of this medicine is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

To use the topical emulsion (such as Estrasorb):

Apply this medicine while you are sitting down. You will use two foil pouches each time you apply this medication, unless your doctor has told you otherwise.

Cut or tear open the foil pouch and place the pouch on top of your left thigh, with the open end of the pouch pointing toward your knee.

Hold the pouch with one hand and use the fingers of your other hand to gently push all of the medicine out of the pouch and onto your thigh.

Spend at least 3 minutes rubbing the gel into your entire left thigh and calf. Rub any excess medicine onto your buttocks.

Cut or tear open the second pouch and apply the medicine to your right leg using the same method described above.

To use the topical spray (such as Evamist):

Apply the spray to the skin on the inside of your forearm, just below the elbow. Use the spray at the same time each day.

Place the cone of the spray applicator directly to your skin and hold the pump upright. Press the pump fully one spray. If your doctor has prescribed more than one spray, choose a different place on your inside forearm for the second spray. Use only the number of sprays your doctor has recommended.

Do not rub the spray in, but allow it to dry on your skin for at least 2 minutes before you dress. Do not wash your arm for at least 30 minutes after applying the spray.

Wash your hands with soap and water after applying the gel or emulsion. Avoid allowing other people to get this medicine on their skin. If this happens, wash the area thoroughly with soap and water. Children should avoid coming into contact with skin areas where you have applied estradiol topical. If contact does occur, wash with soap and water right away. Cover treated areas with clothing to protect others from coming into contact with the skin where you apply this medicine.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol topical.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you are less than 12 hours late in using your medicine, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, stomach pain, breast tenderness, drowsiness, and vaginal bleeding.

What should I avoid while using estradiol topical?

Do not apply sunscreen to your skin at the same time you apply estradiol topical. Avoid getting this medication in your eyes. If this does happen, rinse with water.

Grapefruit and grapefruit juice may interact with estradiol and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Estradiol topical 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 estradiol topical and call your doctor at once if you have a serious side effect such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;

pain, swelling, warmth, or redness in one or both legs;

abnormal vaginal bleeding;

pain, swelling, or tenderness in your stomach;

jaundice (yellowing of the skin or eyes); or

a lump in your breast.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Less serious side effects may include:

nausea, vomiting, loss of appetite;

swollen breasts;

acne or skin color changes;

vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;

swelling, weight gain;

migraine headaches, dizziness, depression; or

break-through bleeding, vaginal itching or discharge.

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 estradiol topical?

Tell your doctor about all other medications you use, especially:

St. John's wort;

a blood thinner such as warfarin (Coumadin, Jantoven);

ritonavir (Norvir, Kaletra);

carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Luminal, Solfoton);

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or rifampin (Rifadin, Rifater, Rifamate, Rimactane).

an antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or itraconazole (Sporanox).

This list is not complete and other drugs may interact with estradiol topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Divigel 1 mg/packet resources

Divigel 1 mg/packet Side Effects (in more detail)
Divigel 1 mg/packet Use in Pregnancy & Breastfeeding
Divigel 1 mg/packet Drug Interactions
Divigel 1 mg/packet Support Group
0 Reviews for Divigel mg/packet - Add your own review/rating

Compare Divigel 1 mg/packet with other medications

Postmenopausal Symptoms

Where can I get more information?

Your pharmacist can provide more information about estradiol topical.

See also: Divigel mg/packet side effects (in more detail)

Saturday, October 1, 2016

Diatx

Generic Name: Vitamin B Complex/Vitamin C/Biotin/Folic Acid (VYE-ta-min/BYE-oh-tin/FOE-lik AS-id)
Brand Name: Diatx

Diatx is used for:

A dietary supplement for certain patients with high blood levels of homocysteine or kidney failure, or those who are on dialysis or do not receive the proper amount of vitamins from their diet. It may also be used for other conditions as determined by your doctor.

Diatx is a vitamin and folic acid combination. It works by providing vitamins and folic acid to the body to help meet nutritional requirements.

Do NOT use Diatx if:

you are allergic to any ingredient in Diatx

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

Before using Diatx:

Some medical conditions may interact with Diatx. 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 anemia (eg, pernicious anemia)

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

Hydantoins (eg, phenytoin) or levodopa because their effectiveness may be decreased by Diatx

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diatx 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 Diatx:

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

Diatx may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Dialysis patients - Diatx should be taken after dialysis treatment.

If you miss a dose of Diatx, 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 Diatx.

Important safety information:

Diatx may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Diatx with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Diatx unless your doctor tells you to.

Diatx contains pyridoxine (vitamin B₆) and folic acid. Before you start any new medicine, check the label to see if it has pyridoxine or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Diatx may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Diatx.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diatx while you are pregnant. It is not known if Diatx is found in breast milk. If you are or will be breast-feeding while you use Diatx, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Diatx:

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:

Drowsiness; headache; mild diarrhea; nausea.

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); feeling of swelling of the entire body; numbness or tingling of the skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Diatx 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 (http://www.aapcc.org/dnn/Resources/FindLocalPoisonCenters/tabid/130/Default.aspx), or emergency room immediately.

Proper storage of Diatx:

Store Diatx at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diatx out of the reach of children and away from pets.

General information:

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

Diatx 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.

This information is a summary only. It does not contain all information about Diatx. 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

More Diatx resources

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

multivitamin Concise Consumer Information (Cerner Multum)

Folplex Prescribing Information (FDA)

Foltabs 800 Prescribing Information (FDA)

Infuvite Pediatric Prescribing Information (FDA)

Nephrocaps Prescribing Information (FDA)

Nephrocaps

Renal Caps Prescribing Information (FDA)

Vitamin A Monograph (AHFS DI)

Compare Diatx with other medications

Dietary Supplementation

Brovana

Pronunciation: AR-for-MOE-ter-ol
Generic Name: Arformoterol
Brand Name: Brovana

Long-acting beta-agonists such as Brovana have been rarely associated with an increased risk of asthma-related death. Long-acting beta-agonists should not be used in asthma patients without another long-term asthma-control medicine (eg, inhaled corticosteroids). Brovana has not been approved to treat asthma. Safety and effectiveness of Brovana in patients with asthma have not been confirmed.

Brovana is used for:

Long-term treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.

Brovana is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.

Do NOT use Brovana if:

you are allergic to any ingredient in Brovana or to formoterol

you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it

you are having severe breathing problems (eg, sudden, severe onset or worsening of COPD symptoms such as chest tightness, cough, shortness of breath, wheezing)

you have asthma and you are not currently using a long-term asthma-control medicine (eg, inhaled corticosteroids) or if you have asthma that is already well controlled with the use of a long-term asthma-control medicine

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

Before using Brovana:

Some medical conditions may interact with Brovana. 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

you have a history of other breathing problems (eg, asthma), diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), liver problems, high blood pressure, low blood potassium levels, seizures, or an overactive thyroid

if you have high blood or urine ketone levels

if you have recently been to an emergency room for breathing problems, have a history of frequent hospitalizations for breathing problems, or have ever had life-threatening breathing problems

if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping

if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) or you have taken either of these medicines within the last 14 days

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

Corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased

Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), long-acting beta-agonists (eg salmeterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Brovana's side effects

Beta-blockers (eg, propranolol) because they may decrease Brovana's effectiveness or worsen your condition

This may not be a complete list of all interactions that may occur. Ask your health care provider if Brovana 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 Brovana:

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

Brovana comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Brovana refilled.

Be sure to use Brovana exactly as prescribed by your doctor. Space doses about 12 hours apart unless your doctor tells you otherwise. Do not use more than 2 vials in one day.

Brovana should only be inhaled using a nebulizer. Do not inject or swallow it.

A health care provider will teach you how to use the nebulizer. Be sure you know what type of nebulizer to use with Brovana, and how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Store Brovana in the original foil pouch in a dry place. Do not remove from the foil pouch or the vial until right before use.

Do not use Brovana if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Do not mix Brovana with other medicines in your nebulizer machine.

To use Brovana, twist open the top of the vial and pour the entire contents into the nebulizer reservoir.

Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.

Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the nebulizer.

Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 10 minutes).

Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacteria entering the medicine. This may lead to an infection. To avoid bacteria entering the medicine, use the entire contents right after opening the vial for the first time.

Continue to use Brovana even if you feel well. Do not miss any doses.

If you miss a dose of Brovana, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Brovana may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Brovana with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Brovana will not stop sudden symptoms of COPD once they have already started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of Brovana (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop sudden symptoms, check with your doctor or pharmacist.

If you have been regularly using a short-acting bronchodilator inhaler, talk with your doctor about how to use it with Brovana. Short-acting bronchodilators are normally used with Brovana to treat breathing problems that may occur between doses.

The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Brovana in high doses. Do NOT use more than recommended dose or use more often than prescribed.

Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if your breathing problems get worse.

Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.

Talk with your doctor or pharmacist about all of your breathing medicines and how to use them. Do not start, stop, or change the dose of any breathing medicine unless your doctor tells you to.

The medicine may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.

Brovana may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Lab tests, including lung function and blood potassium levels, may be performed while you use Brovana. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Brovana should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Brovana while you are pregnant. It is not known if Brovana is found in breast milk. If you are or will be breast-feeding while you use Brovana, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Brovana:

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:

Back pain; diarrhea; dry mouth; headache; nausea; nervousness; stuffy nose; tiredness; tremor; trouble sleeping; vomiting.

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, tongue, or throat; unusual hoarseness); chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; leg swelling; new or worsening breathing problems (eg, increased chest tightness, coughing, shortness of breath, wheezing); severe or persistent headache, dizziness, tremor, or nervousness; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble speaking.

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: Brovana 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 chest pain; fast or irregular heartbeat; severe or persistent dizziness, dry mouth, fatigue, headache, muscle pain or cramps, nausea, nervousness, trouble sleeping, or tremors; severe or persistent symptoms of high blood sugar (eg, increased thirst, urination, or hunger; drowsiness; flushing of the skin; confusion; fruit-like breath odor).

Proper storage of Brovana:

Store Brovana in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Unopened pouches may be stored at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), for up to 6 weeks. If Brovana is stored at room temperature, throw it away after 6 weeks. Do not use Brovana if it is past the expiration date on the container. Store Brovana away form heat, moisture, and light. Keep Brovana out of the reach of children and away from pets.

General information:

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

Brovana 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 Brovana. 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

More Brovana resources

Brovana Side Effects (in more detail)
Brovana Use in Pregnancy & Breastfeeding
Brovana Drug Interactions
Brovana Support Group
3 Reviews for Brovana - Add your own review/rating

Brovana Prescribing Information (FDA)

Brovana Monograph (AHFS DI)

Brovana Advanced Consumer (Micromedex) - Includes Dosage Information

Brovana Consumer Overview

Compare Brovana with other medications

COPD, Maintenance

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup

Pronunciation: brome-fen-IR-a-meen/DEX-troe-meth-OR-fan/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Bromhist-DM

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup is an antihistamine, decongestant, cough suppressant, and expectorant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, making coughs more productive. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup if:

you are allergic to any ingredient in Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup

you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

you take droxidopa, sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup:

Some medical conditions may interact with Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup. 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 a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, stroke, glaucoma or increased pressure in the eye, or thyroid problems

if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems

Some MEDICINES MAY INTERACT with Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup's side effects

Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup 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 Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup:

Use Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

If you miss a dose of Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup and you are taking it regularly, 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 Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup.

Important safety information:

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do not take diet or appetite control medicines while you are taking Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup without checking with your doctor.

Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, expectorant, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup for a few days before the tests.

Tell your doctor or dentist that you take Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup before you receive any medical or dental care, emergency care, or surgery.

Use Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.

Caution is advised when using Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup in CHILDREN; they may be more sensitive to its effects, especially excitability.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup while you are pregnant. Some ingredients of Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup are found in breast milk. Do not breast-feed while taking Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup.

Possible side effects of Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup:

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; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

See also: Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine 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 blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup:

Store Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup out of the reach of children and away from pets.

General information:

If you have any questions about Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup, please talk with your doctor, pharmacist, or other health care provider.

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup 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 Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Syrup. 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

More Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine resources

Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Side Effects (in more detail)
Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Use in Pregnancy & Breastfeeding
Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Drug Interactions
Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine Support Group
0 Reviews for Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine - Add your own review/rating

Compare Brompheniramine/Dextromethorphan/Guaifenesin/Pseudoephedrine with other medications

Cold Symptoms

Ranibizumab

Class: EENT Drugs, Miscellaneous
VA Class: OP900
Chemical Name: Disulfide with human-mouse monoclonal rhuFAB V2 light chain anti-(human vascular endothelial growth factor) Fab fragment (human-mouse monoclonal rhuFAB V2 γ1-chain) immunoglobulin G1
Molecular Formula: C₂₁₅₈H₃₂₈₂N₅₆₂O₆₈₁ S₁₂
CAS Number: 347396-82-1
Brands: Lucentis

Introduction

Recombinant humanized immunoglobulin G₁ kappa (IgG₁ kappa) monoclonal antibody fragment; a vascular endothelial growth factor A (VEGF-A) antagonist.¹ ³ ⁴ ⁵ ⁶

Uses for Ranibizumab

Neovascular Age-related Macular Degeneration

Treatment of neovascular (wet) age-related macular degeneration.¹ ⁴

Ranibizumab Dosage and Administration

Administration

Ophthalmic Administration

Administer by intravitreal injection only into the affected eye(s).¹

Prior to intravitreal administration, withdraw entire contents (0.2 mL) of ranibizumab injection through a sterile 5-micron, 19-gauge filter needle (provided by manufacturer) into a 1-mL tuberculin syringe using aseptic technique.¹ ⁴ Next, replace filter needle with a sterile 30-gauge, ½-inch needle (provided by manufacturer) for intravitreal injection.¹ To obtain appropriate dose (0.5 mg), expel contents in tuberculin syringe until plunger tip is aligned with the line that marks 0.05 mL on the syringe.¹

Inject under controlled aseptic conditions (including use of sterile gloves, sterile drape, a sterile eyelid speculum [or equivalent]) following adequate anesthesia and administration of a broad-spectrum anti-infective agent.¹

Monitor patients for elevation of IOP and for development of endophthalmitis following intravitreal injection.¹ Monitoring for increased IOP may include evaluation of optic nerve head perfusion immediately after injection, tonometry within 30 minutes following injection, and biomicroscopy between 2–7 days following injection.¹

Each vial should be used only for treatment of a single eye.¹ If contralateral eye requires treatment, use a new vial; change sterile field, syringe, gloves, drape, eyelid speculum, and filter and injection needles before administering to the other eye.¹

Dosage

Adults

Neovascular Age-related Macular Degeneration

Ophthalmic Administration

Intravitreal injection: 0.5 mg (0.05 mL) into the affected eye(s) once every month (approximately 28 days).¹

After first 4 injections, may reduce dosage to one injection every 3 months if monthly injections are not feasible; however, because this reduced dosage is less effective in maintaining visual acuity, evaluate patients regularly.¹

Safety and efficacy beyond 2 years of therapy not established.¹

Special Populations

Renal and Hepatic Impairment

Dosage adjustment not expected to be necessary.¹ (See Hepatic Impairment and also Renal Impairment under Cautions.)

Geriatric Patients

No dosage adjustment required.¹

Cautions for Ranibizumab

Contraindications

Ocular or periocular infections.¹

Known hypersensitivity (e.g., severe intraocular inflammation) to ranibizumab or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Endophthalmitis and Other Serious Ocular Effects

Intravitreal injections, including those with ranibizumab, associated with endophthalmitis and retinal detachments.¹ ⁴ ⁵ ⁶ Always use proper aseptic injection technique.¹ ⁴ (See Ophthalmic Administration under Dosage and Administration.) Monitor patients closely for signs of endophthalmitis (e.g., redness, sensitivity to light, pain, changes in vision) during the week following injection to permit early treatment.¹ ⁴ (See Advice to Patients.)

Traumatic cataract reported rarely.¹ ⁴ ⁵

Increased IOP

Increased IOP observed within 60 minutes of intravitreal injection.¹ ⁴ ⁶ Monitor IOP and perfusion of optic nerve head and manage appropriately.¹ ⁴

Thromboembolic Events

Arterial thromboembolic events reported.¹ ⁵ Potential risk of arterial thromboembolic events following intravitreal injection of VEGF antagonists.¹

Stroke

According to interim safety analysis of an ongoing study (SAILOR study), incidence of stroke appeared to be higher with 0.5-mg dose than with 0.3-mg dose.⁷ ⁸ Patients with prior history of stroke appeared to be at increased risk for a subsequent stroke.⁷

General Precautions

Immunogenicity

Development of low-titer antibodies reported.¹ Clinical relevance unclear, but iritis or vitritis noted in some patients with the highest levels of immunoreactivity.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether ranibizumab is distributed into milk.¹ Caution if used in nursing women.¹

Pediatric Use

Safety and efficacy not established.¹

Adult Use

Safety and efficacy not established in adults <50 years of age.⁴

Geriatric Use

No substantial differences in efficacy or systemic exposure (after correcting for Cl_cr) relative to younger adults.¹

Hepatic Impairment

Pharmacokinetics not studied; dosage adjustment not expected to be necessary.¹

Renal Impairment

Pharmacokinetics not studied; however, limited data indicate clearance not substantially affected by renal impairment.¹ Dosage adjustment not expected to be necessary.¹

Common Adverse Effects

Conjunctival hemorrhage,¹ ⁴ eye pain,¹ ⁴ vitreous floaters,¹ ⁴ increased IOP,¹ ⁴ intraocular inflammation.¹ ⁴

Interactions for Ranibizumab

No formal drug interaction studies to date.¹

Photodynamic Therapy with Verteporfin

Serious intraocular inflammation reported; most cases occurred when ranibizumab was administered approximately 7 days after verteporfin photodynamic therapy.¹

Ranibizumab Pharmacokinetics

Absorption

Bioavailability

Following monthly intravitreal injection, peak serum concentrations attained were substantially below that necessary to inhibit the biologic activity of VEGF-A by 50%.¹ Serum concentrations predicted to be approximately 90,000 times lower than vitreal concentrations.¹

Peak serum concentrations predicted to be reached approximately 1 day after monthly intravitreal administration of 0.5 mg per eye.¹

Elimination

Half-Life

Estimated average vitreous half-life: Approximately 9 days.¹

Stability

Storage

Parenteral

Injection

2–8°C.¹ Do not freeze; protect from light.¹ Store in original carton until use.¹

ActionsActions

Binds to active forms of human VEGF-A, including cleaved form (VEGF₁₁₀), and inhibits their biologic activity.¹ ³ ⁴

VEGF-A induces neovascularization (angiogenesis) and increases vascular permeability, which appears to play a role in the pathogenesis and progression of neovascular (wet) age-related macular degeneration,¹ ³ ⁴ a leading cause of blindness in adults >60 years of age in developed countries.² ³ ⁴

Binding to VEGF-A prevents VEGF-A from binding to VEGF receptors (i.e., VEGFR-1, VEGFR-2) on the surface of endothelial cells, reducing endothelial cell proliferation, angiogenesis, and vascular permeability.¹ ⁴

Shown to reduce foveal retinal thickening and vascular permeability associated with age-related macular degeneration; however, foveal retinal thickness data did not provide information useful in influencing treatment decisions, and the area of vascular permeability was not correlated with visual acuity.¹

Advice to Patients

Risk of developing endophthalmitis.¹ Importance of informing ophthalmologist immediately if change in vision occurs or if treated eye becomes red, sensitive to light, or painful.¹

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., ocular or periocular infections).¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ranibizumab (Recombinant)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Injection, for intravitreal use only	10 mg/mL (0.5 mg/0.05 mL)	Lucentis (preservative-free; available as single-dose vial with filter and injection needles)	Genentech

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. Genentech, Inc. Lucentis (ranibizumab) injection prescribing information. South San Francisco, CA; 2008 Apr.

2. World Health Organization. Magnitude and causes of visual impairment. Fact Sheet No. 282; 2004 Nov. From WHO website (). Accessed 2006 Sep 13.

3. Rosenfeld PJ, Rich RM, and Lalwani GA. Ranibizumab: Phase III clinical trial results. Ophthalmol Clin N Am. 2006; 19:361-72.

4. Genentech, Inc, South San Francisco, CA: Personal communication.

5. Brown DM, Kaiser PK, Michels M et al for the ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006; 355:1432-44. [PubMed 17021319]

6. Rosenfeld PJ, Brown DM, Heier JS et al for the MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006; 355:1419-31. [PubMed 17021318]

7. Barron H. Dear healthcare provider letter: important safety information about Lucentis. South San Francisco, CA: Genentech, Inc.; 2007 Jan 24.

8. Food and Drug Administration. Lucentis (ranibizumab injection) [February 1, 2007]. Medwatch alert. Rockville, MD; February 2007. From FDA website (). (Accessed 2009 Oct 12.)

9. Brown DM, Michels M, Kaiser PK et al. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology. 2009; 116:57-65. [PubMed 19118696]

More Ranibizumab resources

Ranibizumab Side Effects (in more detail)
Ranibizumab Use in Pregnancy & Breastfeeding
Ranibizumab Drug Interactions
Ranibizumab Support Group
1 Review for Ranibizumab - Add your own review/rating

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