Tri-Norinyl

norethindrone and ethinyl estradiol

Dosage Form: tablets

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

ORAL CONTRACEPTlVE AGENTS

Tri-Norinyl Description

Tri-Norinyl® provides a continuous oral contraceptive regimen of 7 blue tablets, 9 yellow-green tablets, 5 more blue tablets, and then 7 orange tablets. Each blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each yellow-green tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each orange tablet contains inert ingredients.

Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol. Their structural formulae follow.

The yellow-green Tri-Norinyl tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.

The blue Tri-Norinyl tablets contain the following inactive ingredients: FD&C Blue No. 1, lactose, magnesium stearate, povidone, and starch.

The inactive orange tablets in the 28-day regimen contain the following inactive ingredients: FD&C Yellow No. 6, lactose, microcrystalline cellulose, and magnesium stearate.

Tri-Norinyl - Clinical Pharmacology

Combination oral contraceptives act by suppression of gonadotrophins. 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 may reduce the likelihood of implantation).

Indications and Usage for Tri-Norinyl

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptive products such as Norinyl, which contain 50 mcg of estrogen, should not be used unless medically indicated.

Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Table I: 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		% of Women
		Pregnancy within the First Year of Use		Continuing Use
				at One Year3
Method		Typical use1	Perfect use2
(1)		(2)	(3)	(4)
Source: Trussell J. Contraceptive Efficacy Table from Hatcher R.A., Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, in Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.
1 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.
2 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.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4 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.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.
9 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), Aleese (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).
10 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.
Chance4		85	85
Spermicides5		26	6	40
Periodic abstinence		25		63
	Calendar		9
	Ovulation method		3
	Sympto-thermal6		2
	Post-ovulation		1
Withdrawal		19	4
Cap7
	Parous women	40	26	42
	Nulliparous women	20	9	56
Sponge
	Parous women	40	20	42
	Nulliparous women	20	9	56
Diaphragm7		20	6	56
Condom8
	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 T 380A	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
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10

Contraindications

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

• 
  

  Thrombophlebitis or thromboembolic disorders

  
  


• 
  

  A past history of deep vein thrombophlebitis or thromboembolic disorders

  
  


• 
  

  Cerebral vascular or coronary artery disease

  
  


• 
  

  Known or suspected carcinoma of the breast

  
  


• 
  

  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, carcinomas or benign liver tumors

  
  


• 
  

  Known or suspected pregnancy

  
  

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, hypercholesterolemia, obesity and diabetes.2–5

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 both estrogens and progestogens than those in common use today.6–11 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. Relative risk, the ratio of the incidence of a disease among oral contraceptive users to that among non-users, cannot be assessed directly from case control studies, but the odds ratio obtained is a measure of relative risk. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide not only a measure of the relative risk but a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from ref. 12 and 13 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, hyper-cholesterolemia, morbid obesity and diabetes.2–5, 13 The relative risk of heart attack for current oral contraceptive users has been estimated to be 2 to 6.2, 14–19 The risk is very low under the age of 30. However, there is the possibility of a risk of cardiovascular disease even in very young women who take oral contraceptives.

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.20

Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and non-smokers over the age of 40 among women who use oral contraceptives (see Table II).16

TABLE II: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMAN YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE

Adapted from P.M. Layde and V. Beral, Table V16

Oral contraceptives may compound the effects of well-known risk factors such as hypertension, diabetes, hyperlipidemias, hypercholesterolemia, age and obesity.3, 13, 21 In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism.21–25 Oral contraceptives have been shown to increase blood pressure among users (see WARNINGS, section 9). 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.

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 non-users 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.12, 13, 26–31 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.32 The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped.12

A 2- to 6-fold increase in relative risk of post-operative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions.83 If feasible, oral contraceptives should be discontinued at least 4 weeks prior to and for 2 weeks after elective surgery and during and following prolonged immobilization. Since the immediate postpartum period also is associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than 4 to 6 weeks after delivery in women who elect not to breast feed.33

c. Cerebrovascular diseases

An increase in both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes) has been shown in users of oral contraceptives. 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 non-users for both types of strokes while smoking interacted to increase the risk for hemorrhagic strokes.34

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.35 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.35 The attributable risk also is greater in women in their mid-thirties or older and among smokers.13

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.36–38 A decline in serum high density lipoproteins (HDL) has been reported with many progestational agents.22–24 A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease.39 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 nature and absolute amount of progestogens used in the contraceptives. The amount of both hormones should be considered in the choice of an oral contraceptive.37

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 that produces satisfactory results for the individual. Products containing 50 mcg estrogen should be used only when medically indicated.

e. Persistence of risk of vascular disease

There are three studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives.17, 34, 40 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 5 or more years, but this increased risk was not demonstrated in other age groups.17 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.40 There is a significantly increased relative risk of subarachnoid hemorrhage after termination of use of oral contraceptives.34 However, these studies were performed with oral contraceptive formulations containing 50 μg or higher of estrogen. Products containing 50 mcg estrogen should be used only when medically indicated.

2. ESTIMATES OF MORTALITY FROM CONTRACEPTIVE USE

One study gathered data from a variety of sources which have estimated the mortality rates associated with different methods of contraception at different ages (see Table III).41 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 a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970s—but not reported in the U.S. until 1983.16, 41 However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling.

Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed,78, 79 the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. 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 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.

Therefore, the Committee recommended that the benefits of 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 the lowest possible dose formulation that is effective.80

TABLE III: ESTIMATED ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE

Method of control and outcome		15–19	20–24	25–29	30–34	35–39	40–44
Estimates adapted from H.W. Ory, Table 341
No fertility		7.0	7.4	9.1	14.8	25.7	28.2
	control methods*
Oral contraceptives		0.3	0.5	0.9	1.9	13.8	31.6
	non-smoker**
Oral contraceptives		2.2	3.4	6.6	13.5	51.1	117.2
	smoker**
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
*Deaths are birth-related
**Deaths are method-related

3. CARCINOMA OF THE BREAST AND REPRODUCTIVE ORGANS

Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. The overwhelming evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless of the age and parity of first use or with most of the marketed brands and doses.42–44 The Cancer and Steroid Hormone (CASH) study also showed no latent effect on the risk of breast cancer for at least a decade following long-term use.43 A few studies have shown a slightly increased relative risk of developing breast cancer,44–47 although the methodology of these studies, which included differences in examination of users and non-users and differences in age at start of use, has been questioned.47–49 Some studies have reported an increased relative risk of developing breast cancer, particularly at a younger age. This increased relative risk appears to be related to duration of use.81, 82

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.50–53 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 or 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 per 100,000 for users, a risk that increases after 4 or more years of use.54 Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.55–56

Studies in the United States and Britain have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) oral contraceptive users.57–59 However, these cancers are rare in the U.S.

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.60–62 Studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy.60, 61, 63, 64

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 2 consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at 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. 65–66 More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.67 The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.68

8. CARBOHYDRATE AND LIPID METABOLIC EFFECTS

Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users.25 Oral contraceptives containing greater than 75 μg of estrogen cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. 70 Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.25, 71 However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose.69 Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.

Some women may develop persistent hypertriglyceridemia while on the pill.72 As discussed earlier (see WARNINGS, sections 1a. and 1d.), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.23

9. ELEVATED BLOOD PRESSURE

An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with continued use.73, 84 Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens.

Women with a history of hypertension or hypertension-related diseases or renal disease 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 among ever- and never-users.73–75

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 3 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 pre-existent.

Precautions

GENERAL

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

1. 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 undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

2. LIPID DISORDERS

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

3. LIVER FUNCTION

If jaundice develops in any woman receiving oral contraceptives the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.

4. FLUID RETENTION

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

5. EMOTIONAL DISORDERS

Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

6. CONTACT LENSES

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

7. DRUG INTERATIONS

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin and tetracyclines.76

8. INTERACTIONS WITH LABORATORY TESTS

Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

1. 
   

   Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.

   
   


2. 
   

   Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 concentration is unaltered.

   
   


3. 
   

   Other binding proteins may be elevated in serum.

   
   


4. 
   

   Sex steroid binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.

   
   


5. 
   

   Triglycerides may be increased.

   
   


6. 
   

   Glucose tolerance may be decreased.

   
   


7. 
   

   Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

   
   

9. CARCINOGENESIS

See WARNINGS section.

10. PREGNANCY

Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS sections.

11. NURSING MOTHERS

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

12. PEDIATRIC USE

Safety and efficacy of Tri-Norinyl 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 the product before menarche is not indicated.

INFORMATION FOR THE PATIENT

See PATIENT LABELING printed below.

Adverse Reactions

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

• 
  

  Thrombophlebitis

  
  


• 
  

  Arterial thromboembolism

  
  


• 
  

  Pulmonary embolism

  
  


• 
  

  Myocardial infarction

  
  


• 
  

  Cerebral hemorrhage

  
  


• 
  

  Cerebral thrombosis

  
  


• 
  

  Hypertension

  
  


• 
  

  Gallbladder disease

  
  


• 
  

  Hepatic adenomas, carcinomas or benign liver tumors

  
  

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

• 
  

  Mesenteric thrombosis

  
  


• 
  

  Retinal thrombosis

  
  

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

• 
  

  Nausea

  
  


• 
  

  Vomiting

  
  


• 
  

  Gastrointestinal symptoms (such as abdominal cramps and bloating)

  
  


• 
  

  Breakthrough bleeding

  
  


• 
  

  Spotting

  
  


• 
  

  Change in menstrual flow

  
  


• 
  

  Amenorrhea

  
  


• 
  

  Temporary infertility after discontinuation of treatment

  
  


• 
  

  Edema

  
  


• 
  

  Melasma which may persist

  
  


• 
  

  Breast changes: tenderness, enlargement, secretion

  
  


• 
  

  Change in weight (increase or decrease)

  
  


• 
  

  Change in cervical erosi

triamcinolone nasal

Generic Name: triamcinolone (nasal) (TRYE am SIN oh lone)

Brand names: Nasacort AQ, Nasacort, Tri-Nasal, Nasacort HFA

What is triamcinolone nasal?

Triamcinolone is a steroid. It prevents the release of substances in the body that cause inflammation.

Triamcinolone nasal (for the nose) is used to treat sneezing, itching, and runny nose caused by seasonal allergies or hay fever.

Triamcinolone nasal may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about triamcinolone nasal?

Do not use this medication in a child under 2 years old without the advice of a doctor. Some brands of triamcinolone nasal are not made for use in children. Do not use this medication if you are allergic to triamcinolone.

Before using triamcinolone nasal, tell your doctor if you are allergic to any drugs, or if you have tuberculosis, asthma, a history of glaucoma or cataracts, any type of infection, or if you have had recent surgery or injury to your nose.

It may take up to a week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment, or if they get worse any time during treatment.

Triamcinolone nasal can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Do not stop using triamcinolone nasal suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the medication before stopping completely.

What should I discuss with my healthcare provider before using triamcinolone nasal?

You should not use this medication if you are allergic to triamcinolone.

If you have any of these other conditions, you may need a triamcinolone dose adjustment or special tests:

• 
  

  tuberculosis;

  
  


• 
  

  asthma;

  
  


• 
  

  any type of infection;

  
  


• 
  

  a history of glaucoma or cataracts; or

  
  


• 
  

  if you have had recent surgery or injury to your nose.

  
  

FDA pregnancy category C. It is not known whether triamcinolone nasal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether triamcinolone nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Triamcinolone nasal can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. Do not use this medication in a child under 2 years old without the advice of a doctor. Some brands of triamcinolone nasal are not made for use in children.

How should I use triamcinolone nasal?

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.

Before each use, gently blow your nose to clear your nostrils.

Shake the medicine well just before using it.

To use triamcinolone nasal inhaler:

• 
  

  Remove the protective cap from the nasal inhaler.

  
  


• 
  

  Hold the inhaler between your thumb and forefinger, tilt your head back slightly, and insert the inhaler into one nostril while holding the other nostril closed with one finger.

  
  


• 
  

  Press down on the canister to release the spray and inhale gently at the same time. Hold your breath for a few seconds, then breathe out slowly through the mouth.

  
  


• 
  

  Replace the white protective inhaler cap.

  
  


• 
  

  Clean your inhaler weekly by removing the medicine canister and the protective cap, and rinsing the inhaler thoroughly with warm water. Do not use soap. Allow the inhaler to dry completely before replacing the cap and canister.

  
  


• 
  

  Throw away the nasal inhaler after 100 sprays, even if there is still medicine left in the canister.

  
  

To use triamcinolone nasal spray:

• 
  

  Before using the spray for the first time, prime the spray pump by spraying the medicine into the air and away from your face, until a fine mist appears. Prime the spray pump any time you have not used your nasal spray for longer than 14 days.

  
  


• 
  

  Hold the nasal spray with the tip pointed into one nostril but not far into your nose. Bend your head forward to aim the spray toward the back of your nose. Hold your other nostril closed with one finger. Pump the spray unit and sniff gently at the same time.

  
  


• 
  

  Throw away the nasal spray after 120 sprays, even if there is still medicine left in the bottle.

  
  

Avoid blowing your nose for 15 minutes after using this medication.

It may take up to a week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment, or if they get worse any time during treatment.

Do not stop using triamcinolone nasal suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the medication before stopping completely.

If you use triamcinolone nasal for several months, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat. Keep the cover and clip on the nasal spray pump unit when not in use. Keep the protective cap on the nasal inhaler when not in use.

What happens if I miss a dose?

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.

An overdose of triamcinolone nasal is not expected to be dangerous. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking triamcinolone nasal?

Triamcinolone nasal can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Triamcinolone nasal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  weakness, tired feeling, nausea, loss of appetite, weight loss;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  white patches or sores inside your nose or mouth, or on your lips; or

  
  


• 
  

  blurred vision, eye pain, or seeing halos around lights.

  
  

Less serious side effects may include:

• 
  

  stinging, burning, or bleeding in your nose;

  
  


• 
  

  sneezing after use of the medicine;

  
  


• 
  

  sore throat, cough, stuffy nose;

  
  


• 
  

  watery eyes;

  
  


• 
  

  headache;

  
  


• 
  

  nausea, vomiting; or

  
  


• 
  

  an unpleasant taste or smell.

  
  

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.

Triamcinolone Dosing Information

Usual Adult Dose for Allergic Rhinitis:

Nasal aerosol:
2 actuations in each nostril once a day; may increase after 4 to 7 days up to 4 actuations in each nostril once a day, or 2 actuations in each nostril twice daily, or 1 actuation in each nostril 4 times a day.

Nasal spray:
2 sprays in each nostril once a day; titrate to lowest effective dose after symptoms are controlled. Usual maintenance dose is 1 spray in each nostril once a day.

Usual Pediatric Dose for Allergic Rhinitis:

Nasal aerosol:
6 years to 11 years: 2 actuations in each nostril once a day; titrate to lowest effective dose after symptoms are controlled.
12 years or older: 2 actuations in each nostril once a day; may increase after 4 to 7 days up to 4 actuations in each nostril once a day, or 2 actuations in each nostril twice daily, or 1 actuation in each nostril 4 times a day.

Nasal spray:
2 years to 5 years: 1 spray in each nostril once a day;
6 years to 12 years: 1 spray in each nostril once a day; maximum dose is 2 sprays in each nostril once a day, titrate to lowest effective dose after symptoms are controlled.
13 years or older: 2 sprays in each nostril once a day; titrate to lowest effective dose after symptoms are controlled. Usual maintenance dose is 1 spray in each nostril once a day.

What other drugs will affect triamcinolone nasal?

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

• 
  

  cancer medicine (chemotherapy);

  
  


• 
  

  cyclosporine (Neoral, Sandimmune, Gengraf);

  
  


• 
  

  sirolimus (Rapamune), tacrolimus (Prograf);

  
  


• 
  

  basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

  
  


• 
  

  mycophenolate mofetil (CellCept);

  
  


• 
  

  azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or

  
  


• 
  

  other steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

  
  

This list is not complete and other drugs may interact with triamcinolone nasal. 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 triamcinolone resources

• Triamcinolone Use in Pregnancy & Breastfeeding
• Triamcinolone Support Group
• 9 Reviews for Triamcinolone - Add your own review/rating

Compare triamcinolone with other medications

• Hay Fever

Where can I get more information?

• Your pharmacist can provide more information about triamcinolone nasal.

triamcinolone Injection

trye-am-SIN-oh-lone

Commonly used brand name(s)

In the U.S.

• Aristocort


• Aristocort Forte


• Aristospan


• Clinacort


• Kenalog-10


• Kenalog-40


• Triamcot


• Triam-Forte


• Triesense

Available Dosage Forms:

• Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For triamcinolone

Triamcinolone injection is used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems. It is given to patients who are not able to take medicines by the mouth. triamcinolone is a corticosteroid (cortisone-like medicine or steroid).

triamcinolone is to be administered only by or under the immediate supervision of your doctor.

Before Using triamcinolone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For triamcinolone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to triamcinolone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triamcinolone injection in the pediatric population. However, because of triamcinolone's toxicity, it should be used with caution especially in premature babies.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triamcinolone injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving triamcinolone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using triamcinolone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using triamcinolone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aldesleukin


• Quetiapine

Using triamcinolone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alatrofloxacin


• Alcuronium


• Aspirin


• Atracurium


• Balofloxacin


• Cinoxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gallamine


• Gemifloxacin


• Grepafloxacin


• Hexafluorenium


• Itraconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Metocurine


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Phenytoin


• Primidone


• Prulifloxacin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of triamcinolone. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Cirrhosis (liver problem) or


• Congestive heart failure or


• Depression or


• Emotional problems or


• Glaucoma or


• Heart attack, recent or


• Heart disease or


• Hypertension (high blood pressure) or


• Intracranial hypertension (increased pressure in the head) or


• Kaposi's sarcoma or


• Kidney disease, severe or


• Mental illness or


• Myasthenia gravis (severe muscle weakness) or


• Stomach or bowel problems (e.g., diverticulitis, ulcers, ulcerative colitis) or


• Thyroid problems—Use with caution. May make these conditions worse.

• Brain injury, traumatic or


• Cerebral malaria or


• Herpes infection of the eye or


• Idiopathic thrombocytopenic purpura (low platelet count)—Should not be used in patients with this condition.

• Infection (bacteria, virus, fungus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with triamcinolone.

Proper Use of triamcinolone

A nurse or other trained health professional will give you triamcinolone. You may also be taught how to give your medicine at home. triamcinolone is given as a shot into one of your muscles, a joint, or a spot on your skin called a lesion.

Precautions While Using triamcinolone

Your doctor will check your progress closely while you or your child are receiving triamcinolone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

triamcinolone contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome, low blood pressure, and metabolic acidosis) to newborn or premature infants. Discuss this with your doctor if you are concerned.

triamcinolone may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving triamcinolone.

Let your doctor know if you or your child have any events causing unusual stress or anxiety in your life. Your doctor may give you oral corticosteroids.

triamcinolone may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially on salt intake).

Using too much of triamcinolone or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you have more than one of these symptoms while you are using triamcinolone: blurred vision; dizziness or fainting; a fast, pounding, or uneven heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

It may be easier for you to get an infection while you or your child are receiving triamcinolone. Avoid crowded places or being near people who are sick. If you are exposed to chicken pox or measles, tell your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving triamcinolone.

Talk with your doctor before getting flu shots or other vaccines while you or your child are receiving triamcinolone because there are certain vaccines that you should not receive.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Before you have any skin tests, tell the medical doctor in charge that you are taking triamcinolone. The results of some tests may be affected by triamcinolone.

Do not stop using triamcinolone without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely

triamcinolone may cause slow growth. If your child is using triamcinolone, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

triamcinolone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Aggression


• agitation


• anxiety


• blurred vision


• decrease in the amount of urine


• dizziness


• fast, slow, pounding, or irregular heartbeat or pulse


• headache


• irritability


• mental depression


• mood changes


• nervousness


• noisy, rattling breathing


• numbness or tingling in the arms or legs


• pounding in the ears


• shortness of breath


• swelling of the fingers, hands, feet, or lower legs


• trouble thinking, speaking, or walking


• troubled breathing at rest


• weight gain

Incidence not known

• Abdominal cramping and/or burning (severe)


• abdominal pain


• backache


• bloody, black, or tarry stools


• cough or hoarseness


• darkening of skin


• decreased vision


• diarrhea


• dry mouth


• eye pain


• eye tearing


• facial hair growth in females


• fainting


• fatigue


• fever or chills


• flushed, dry skin


• fractures


• fruit-like breath odor


• full or round face, neck, or trunk


• heartburn and/or indigestion (severe and continuous)


• increased hunger


• increased thirst


• increased urination


• loss of appetite


• loss of sexual desire or ability


• lower back or side pain


• menstrual irregularities


• muscle pain or tenderness


• muscle wasting or weakness


• nausea


• pain in back, ribs, arms, or legs


• painful or difficult urination


• skin rash


• sleeplessness


• sweating


• trouble healing


• trouble sleeping


• unexplained weight loss


• unusual tiredness or weakness


• vision changes


• vomiting


• vomiting of material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Blemishes on the skin


• bruising


• dry, scaly skin


• feeling of constant movement of self or surroundings


• full or bloated feeling


• increased appetite


• increased hair growth on the face, forehead, back, arms, and legs


• large, flat, blue, or purplish patches in the skin


• pimples


• pitting or depression of the skin at the injection site


• reddish purple lines on the arms, face, legs, trunk, or groin


• redness of the skin


• redness, swelling, tenderness, or pain at the injection site


• sensation of spinning


• small, red, or purple spots on the skin


• thin, fragile, or shiny skin


• thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More triamcinolone Injection resources

• Triamcinolone Injection Use in Pregnancy & Breastfeeding
• Drug Images
• Triamcinolone Injection Drug Interactions
• Triamcinolone Injection Support Group
• 24 Reviews for Triamcinolone Injection - Add your own review/rating

Compare triamcinolone Injection with other medications

• Adrenocortical Insufficiency
• Allergic Reactions
• Alopecia
• Ankylosing Spondylitis
• Asthma
• Berylliosis
• Bursitis
• Chorioditis
• Chorioretinitis
• Conjunctivitis
• Dermal Necrosis, Prophylaxis
• Dermatitis
• Dermatological Disorders
• Erythroblastopenia
• Frozen Shoulder
• Gouty Arthritis
• Hay Fever
• Heart Failure
• Hemolytic Anemia
• Idiopathic Thrombocytopenic Purpura
• Iridocyclitis
• Iritis
• Keloids
• Keratitis
• Leukemia
• Lichen Planus
• Lichen Sclerosus
• Lichen Simplex Chronicus
• Loeffler's Syndrome
• Meningitis
• Nephrotic Syndrome
• Neuritis
• Osteoarthritis
• Pityriasis rubra pilaris
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Sarcoidosis
• Synovitis
• Systemic Lupus Erythematosus
• Thrombocytopenia Idiopathic
• Uveitis

Talwin

Pronunciation: pen-TAZ-oh-seen
Generic Name: Pentazocine
Brand Name: Talwin

Talwin is used for:

Treating moderate to severe pain, including before surgery or anesthesia. It may also be used for other conditions as determined by your doctor.

Talwin is an opioid (narcotic) analgesic. It works in the brain and nervous system to decrease pain.

Do NOT use Talwin if:

• you are allergic to any ingredient in Talwin or to any other codeine- or morphine-related medicine (eg, codeine, oxycodone)


• you have severe diarrhea due to antibiotic use (pseudomembranous colitis) or you are taking sodium oxybate (GHB)

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

Before using Talwin:

Some medical conditions may interact with Talwin. 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 asthma, inflammatory bowel disease, severe stomach or intestinal condition (eg, ulcers), lung problems (eg, chronic obstructive pulmonary disease, cor pulmonale), liver or kidney problems, a blockage of your bladder or bowel, trouble urinating, an enlarged prostate, the blood disease porphyria, or seizures, or if you are having stomach or intestinal surgery


• if you have a history of high blood pressure, low thyroid function, heart problems (eg, heart attack, irregular heartbeat), recent head injury, brain disease, increased pressure in the brain, or brain growths or tumors


• if you have a history of mental or mood problems, suicidal thoughts or behaviors, or a history of drug abuse

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

• Naltrexone because the effectiveness of Talwin may be decreased


• Cimetidine or sodium oxybate (GHB) because side effects, such as severe drowsiness and difficulty breathing, may occur


• Sibutramine because its side effects may be increased

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

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

• Talwin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Talwin at home, carefully follow the injection procedures taught to you by your health care provider.


• If Talwin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Talwin may be administered by intramuscular, subcutaneous, or intravenous route. However, when frequent injections are needed, Talwin should be administered intramuscularly. In addition, constant rotation of injection sites (eg, upper outer quadrants of the buttocks, mid-lateral aspects of the thighs, upper arm/shoulder area) is required.


• Do not mix Talwin in the same syringe with soluble barbiturates because a precipitate (white, cloudy solid) will occur.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Talwin and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

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

Important safety information:

• Talwin may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Talwin. Using Talwin alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Talwin. Talwin will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Talwin.


• LAB TESTS may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Talwin with caution in the ELDERLY because they may be more sensitive to its effects, especially sedation and confusion.


• Use Talwin with extreme caution in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Talwin can cause harm to the fetus. If you become pregnant while taking Talwin, discuss with your doctor the benefits and risks of using Talwin during pregnancy. It is unknown if Talwin is excreted in breast milk. If you are or will be breast-feeding while you are using Talwin, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Talwin. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Talwin, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; hallucinations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Talwin:

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:

Dizziness; drowsiness; exaggerated sense of well-being; lightheadedness; nausea; redness, swelling, or irritation at injection site; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision problems; confusion; fainting; hallucinations; seizures; trouble sleeping; trouble urinating; unusual weakness;

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: Talwin 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 difficulty breathing; fast heartbeat.

Proper storage of Talwin:

Store Talwin 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 Talwin out of the reach of children and away from pets.

General information:

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


• Talwin 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 Talwin. 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 Talwin resources

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

• Talwin Advanced Consumer (Micromedex) - Includes Dosage Information


• pentazocine Concise Consumer Information (Cerner Multum)


• Pentazocine Professional Patient Advice (Wolters Kluwer)


• Pentazocine Hydrochloride Monograph (AHFS DI)

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tadalafil

ta-DAL-a-fil

Commonly used brand name(s)

In the U.S.

• Adcirca


• Cialis

Available Dosage Forms:

• Tablet

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Uses For tadalafil

Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, tadalafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, tadalafil will not work to cause an erection.

Tadalafil is also used to treat men who have signs and symptoms of benign prostatic hyperplasia (BPH). BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Tadalafil will make these symptoms less severe and reduce the chance that prostate surgery will be needed. tadalafil is also used to treat erectile dysfunction and signs and symptoms of BPH.

Tadalafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadalafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

tadalafil is available only with your doctor's prescription. .

Before Using tadalafil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tadalafil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tadalafil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of Cialis® tablet is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Adcirca™ tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving tadalafil.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tadalafil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tadalafil with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Boceprevir


• Erythrityl Tetranitrate


• Isosorbide Dinitrate


• Isosorbide Mononitrate


• Nitroglycerin


• Pentaerythritol Tetranitrate


• Telaprevir

Using tadalafil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin


• Atazanavir


• Bunazosin


• Clarithromycin


• Erythromycin


• Indinavir


• Itraconazole


• Ketoconazole


• Moxisylyte


• Nefazodone


• Nelfinavir


• Phenoxybenzamine


• Phentolamine


• Prazosin


• Saquinavir


• Simvastatin


• Tamsulosin


• Telithromycin


• Terazosin


• Trimazosin


• Urapidil

Using tadalafil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doxazosin


• Rifampin


• Ritonavir


• Silodosin


• Tipranavir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tadalafil with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tadalafil, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Using tadalafil with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tadalafil, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of tadalafil. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and tadalafil should be used with caution in these patients.

• Age greater than 50 years or


• Coronary artery disease or


• Diabetes or


• Hyperlipidemia (high lipids or fats in the blood) or


• Hypertension (high blood pressure) or


• Low cup to disc ratio (eye condition also called "crowded disc") or


• Smoking—These conditions may increase risk for a serious eye problem called non-arteritic ischemic optic neuropathy or NAION.

• Angina (reoccurring chest pain) or


• Arrhythmia (irregular heartbeat), uncontrolled or


• Heart attack (within the last 3 months) or


• Heart failure (within the last 6 months) or


• Hypertension (high blood pressure) or


• Hypotension (low blood pressure), uncontrolled or


• Retinal disorders (eye problem) or


• Retinitis pigmentosa (an inherited eye disorder) or


• Stroke, recent history of—Should not be used in patients with these conditions.

• Bleeding disorders or


• Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients.

• Bone marrow cancer or


• Leukemia (blood related cancer) or


• Multiple myeloma (blood related cancer) or


• Sickle-cell anemia (blood disorder)—Tadalafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.

• Heart blood flow problems—These conditions may cause you to be more sensitive to tadalafil.

• Heart disease, underlying—Chance of low blood pressure occurring is greater; tadalafil should be used carefully in these patients.

• Kidney disease, severe or


• Liver disease—Use with caution. May increase risk of having unwanted effects. Lower starting doses may be used and doses increased as needed and as tolerated.

• NAION (serious eye condition) in one or both eyes, history of—May increase your chance of getting NAION again.

Proper Use of tadalafil

Use tadalafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with tadalafil. Read the directions carefully before you start using tadalafil and each time you get a refill of your medicine.

You may take tadalafil with or without food.

Swallow the Cialis® tablet whole. Do not split, break, or crush it.

When using tadalafil for erectile dysfunction, the ability to have sexual activity may be improved for up to 36 hours after taking the tablet.

Use only the brand of tadalafil that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of tadalafil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tadalafil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For treatment of benign prostatic hyperplasia (daily use):
    
    • Adults—5 milligrams (mg) as a single dose, no more than once a day, taken at the same time each day.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For treatment of erectile dysfunction (as needed):
    
    • Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose if needed.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For treatment of erectile dysfunction (daily use):
    
    • Adults—2.5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity. Your doctor may adjust your dose if needed.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):
    
    • Adults—5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For treatment of pulmonary arterial hypertension:
    
    • Adults—40 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of tadalafil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using tadalafil

It is important that you tell all of your doctors that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took tadalafil.

If you will be taking tadalafil for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you take tadalafil for pulmonary arterial hypertension, do not take Cialis® or other PDE5 inhibitors, such as sildenafil (Revatio® or Viagra®) or vardenafil (Levitra®). Cialis® also contains tadalafil. If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

tadalafil does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

It is important to tell your doctor about any heart problems you have now or may have had in the past. tadalafil can cause serious side effects in patients with heart problems.

Do not use tadalafil if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.

Do not drink excessive amounts of alcohol (e.g., 5 glasses of wine or 5 shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

If you experience sudden loss of vision in one or both eyes, stop using tadalafil and contact your doctor immediately.

Stop using tadalafil and check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

Do not eat grapefruit or drink grapefruit juice while you are using tadalafil. Grapefruit and grapefruit juice may change the amount of tadalafil that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

tadalafil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• chills


• cold sweats


• confusion


• dizziness


• fainting


• faintness or lightheadedness when getting up suddenly from a lying or sitting position


• fast or irregular heartbeat


• headache


• hearing loss


• nausea


• nervousness


• pain or discomfort in the arms, jaw, back, or neck


• pounding in the ears


• shortness of breath


• slow or fast heartbeat


• sweating


• unusual tiredness or weakness


• vomiting

Rare

• Painful or prolonged erection of the penis

Incidence not known

• Abdominal or stomach pain


• blindness


• blistering, peeling, or loosening of the skin


• cough


• cracks in the skin


• decrease or change in vision


• diarrhea


• difficulty with speaking


• double vision


• fast, irregular, pounding, or racing heartbeat or pulse


• headache, severe and throbbing


• hives or welts


• inability to move the arms, legs, or facial muscles


• inability to speak


• itching


• joint or muscle pain


• loss of heat from the body


• numbness or tingling of the face, hands, or feet


• red irritated eyes


• red skin lesions, often with a purple center


• red, swollen skin


• redness of the skin


• redness or soreness of the eyes


• scaly skin


• skin rash


• slow speech


• sores, ulcers, or white spots in the mouth or on the lips


• sudden cardiac death


• swelling of the feet or lower legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain

Less common

• Bloody nose


• body aches or pain


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning, dry, or itching eyes


• burning feeling in the chest or stomach


• congestion


• difficulty with moving


• difficulty with swallowing


• dry mouth


• dryness or soreness of the throat


• excessive eye discharge


• eye pain


• feeling of constant movement of self or surroundings


• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest


• fever


• hoarseness


• increased erection


• lack or loss of strength


• loose stools


• muscle aching or cramping


• muscle stiffness


• nasal congestion


• neck pain


• pain


• pain in the arms or legs


• pain or burning in the throat


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• reduced sensitivity to touch


• runny nose


• sensation of spinning


• sleepiness or unusual drowsiness


• sleeplessness


• spontaneous penile erection


• stomach upset


• swelling of the eyelids


• swelling or puffiness of the eyes or face


• swollen joints


• tearing


• tender, swollen glands in the neck


• tenderness in the stomach area


• trouble with sleeping


• unable to sleep


• upper abdominal or stomach pain


• voice changes


• watering of the eyes

Rare

• Changes in color vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: tadalafil side effects (in more detail)

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More tadalafil resources

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

• Tadalafil Professional Patient Advice (Wolters Kluwer)


• Tadalafil Monograph (AHFS DI)


• Tadalafil MedFacts Consumer Leaflet (Wolters Kluwer)


• Adcirca Prescribing Information (FDA)


• Adcirca Consumer Overview


• Adcirca MedFacts Consumer Leaflet (Wolters Kluwer)


• Cialis Prescribing Information (FDA)


• Cialis Consumer Overview

Compare tadalafil with other medications

• Benign Prostatic Hyperplasia
• Erectile Dysfunction
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