NitroMist

Generic Name: nitroglycerin (Oral route, Sublingual route)

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

• Nitrocot


• Nitrolingual


• NitroMist


• Nitroquick


• Nitrostat


• Nitrotab


• Nitro-Time

In Canada

• Gen-Nitro


• Nitrolingual Pumpspray

Available Dosage Forms:

• Spray


• Tablet, Extended Release


• Tablet


• Capsule, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For NitroMist

Nitroglycerin is used to prevent angina (chest pain) caused by coronary artery disease. This medicine is also used to relieve an angina attack that is already occurring.

Nitroglycerin belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, or just before exercise or a stressful event, this helps prevent angina attacks from occurring.

This medicine is available only with your doctor's prescription.

Before Using NitroMist

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 have not been performed on the relationship of age to the effects of nitroglycerin 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 nitroglycerin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin.

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 taking this medicine, 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 this medicine 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.

• Sildenafil


• Tadalafil


• Vardenafil

Using this medicine 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.

• Alteplase, Recombinant

Using this medicine 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.

• Acetylcysteine


• Aspirin


• Dihydroergotamine


• Pancuronium

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.

Other Medical Problems

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

• Anemia, severe or


• Head injury, severe with increased pressure in the head or


• Heart attack, acute (already occurring)—Should not be used in patients with these conditions.

• Congestive heart failure or


• Heart attack, recent or


• Hypertrophic cardiomyopathy (a heart disease) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to NitroMist. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Nitroglycerin is available as two types of products that are used for different reasons. The extended-release capsules are used every day on a specific schedule to prevent angina attacks. The oral spray and sublingual tablets work quickly to stop an angina attack that has already started or they can be used to prevent angina if you plan to exercise or expect a stressful event.

When you begin to feel an attack of angina starting (chest pains, tightness or squeezing in the chest), sit down. Then place a sublingual tablet in your mouth or under your tongue. If you use the oral spray, you should spray it on or under the tongue. You may become dizzy, lightheaded, or faint soon after using a tablet or spray, so it is safer to sit rather than stand while the medicine is working. If you become dizzy or faint while sitting, take several deep breaths and bend forward with your head between your knees. Remain calm and you should feel better in a few minutes.

Nitroglycerin sublingual tablets should not be chewed, crushed, or swallowed. They work much faster when absorbed through the lining of the mouth. Place the tablet under the tongue or between the cheek and gum, and let it dissolve. Do not eat, drink, smoke, or use chewing tobacco while a tablet is dissolving.

Nitroglycerin sublingual tablets usually give relief in 1 to 5 minutes. However, if the pain is not relieved, you may use a second tablet 5 minutes after you take the first tablet. If the pain continues for another 5 minutes, a third tablet may be used. If you still have chest pain after a total of 3 tablets, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911 if necessary.

You may administer 1 or 2 sprays of Nitroglycerin oral spray at the onset of chest pain. If the pain continues after 5 minutes, a third spray may be used. You must wait 5 minutes after the first 1 or 2 sprays before using a third spray. If you still have chest pain after a total of 3 sprays, contact your doctor or go to a hospital emergency room right away. Do not drive yourself and call 911 if necessary. Do not use more than 3 sprays in a 15-minute period.

Swallow the extended-release capsule whole. Do not split, crush, or chew it.

You should take the extended-release capsule first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not take it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

To use the oral spray:

• Remove the plastic cap.


• Do not shake the container.


• If this is a new bottle or container, prime the pump before use by releasing a test spray. This must be done 5 or 10 times into the air away from your face and other people.


• If this is an old bottle and you have not used it for more than 6 weeks, you must prime it again with 1 or 2 test sprays.


• Hold the container upright with your forefinger on top of the grooved button. Open your mouth and bring the container as close to it as possible.


• Press the button firmly with the forefinger to release the spray 1 or 2 times onto or under the tongue. Do not inhale or breathe in the spray.


• Release the button and close your mouth, but do not swallow right away. Do not spit out the spray or rinse your mouth for at least 5 to 10 minutes.


• If you need a third spray, you must wait 5 minutes after the second spray. Use exactly the same steps you used for the first spray. No more than 3 sprays should be given within 15 minutes.


• Replace the cover after using the medicine.


• Always place the spray bottle in an upright position if not in use. Also, check the fluid level of Nitromist® container regularly. If the fluid reaches the top or middle of the hole on the side of container, this is an indicator that you must get a refill.


• Do not use the spray near heat, an open flame, or while smoking.

Dosing

The dose of this medicine 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 this medicine. 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 angina prevention or treatment:
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—2.5 to 6.5 milligrams (mg) three to four times a day. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For sublingual dosage form (spray):
    
    • Adults—One or two sprays on or under the tongue at the first sign of an chest pain. Sprays may be repeated every 5 minutes as needed. You must wait 5 minutes before administering a third spray if 2 sprays are used initially. Do not use more than 3 sprays in 15 minutes. To prevent angina from exercise or stress, use 1 or 2 sprays 5 to 10 minutes before the activity.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For sublingual dosage form (tablets):
    
    • Adults—One tablet placed under the tongue or between the cheek and gum at the first sign of an angina attack. One tablet may be used every 5 minutes as needed, for up to 15 minutes. Do not take more than 3 tablets in 15 minutes. To prevent angina from exercise or stress, use 1 tablet 5 to 10 minutes before the activity.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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

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.

Store the extended-release capsules in a closed container at room temperature, away from heat, moisture, and direct light.

Sublingual tablets should be kept in the original glass bottle. Screw the cap on tightly after each use and store the bottle at room temperature, away from heat, moisture, and direct light.

Store the oral spray at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not forcefully open the container or throw it into a fire, even if it is empty.

Precautions While Using NitroMist

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you have an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

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

Blurred vision or dryness of the mouth may occur while using this medicine. Check with your doctor if this concerns you.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have cracks in the skin; feeling of warmth; loss of heat from the body; rash; red, swollen skin; redness of the face, neck, arms and occasionally, upper chest; or scaly skin while you are using this medicine.

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.

NitroMist 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

• Bloating or swelling of the face, arms, hands, lower legs, or feet


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


• difficult or labored breathing


• feeling faint, dizzy, or lightheadedness


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• headache


• rapid weight gain


• shortness of breath


• sweating


• tightness in the chest


• tingling of the hands or feet


• unusual weight gain or loss


• wheezing

Rare

• Bluish-colored lips, fingernails, or palms


• dark urine


• fever


• pale skin


• rapid heart rate


• sore throat


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• cough


• cracks in the skin


• difficulty with swallowing


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


• fainting


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


• feeling of constant movement of self or surroundings


• feeling of warmth


• hives


• increased sweating


• itching


• loss of heat from the body


• nausea or vomiting


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• red, swollen skin


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


• scaly skin


• sensation of spinning


• skin rash


• weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision


• bulging soft spot on the head of an infant


• change in consciousness


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• disturbed color perception


• double vision


• flushed skin


• halos around lights


• headache, severe and throbbing


• increased sweating


• loss of appetite


• loss of consciousness


• night blindness


• overbright appearance of lights


• paralysis


• slow or irregular heartbeat


• tunnel vision

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:

Less common

• Abdominal or stomach pain


• body aches or pain


• congestion


• hoarseness


• lack or loss of strength


• runny nose


• sneezing


• stuffy nose


• tender, swollen glands in the neck


• voice changes

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: NitroMist side effects (in more detail)

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More NitroMist resources

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

• NitroMist Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• NitroMist Prescribing Information (FDA)


• NitroMist Consumer Overview


• Nitroglycerin Professional Patient Advice (Wolters Kluwer)


• Nitroglycerin Monograph (AHFS DI)


• Nitroglycerin MedFacts Consumer Leaflet (Wolters Kluwer)


• Minitran Patch MedFacts Consumer Leaflet (Wolters Kluwer)


• Minitran Prescribing Information (FDA)


• Nitro-Bid Prescribing Information (FDA)


• Nitro-Bid Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitro-Dur Prescribing Information (FDA)


• Nitro-Time Prescribing Information (FDA)


• Nitro-Time Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• NitroQuick MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrogard MedFacts Consumer Leaflet (Wolters Kluwer)


• Nitrolingual Prescribing Information (FDA)


• Nitrostat Prescribing Information (FDA)


• Rectiv Consumer Overview

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Premarin Injection

conjugated estrogens

Dosage Form: injection, powder, lyophilized, for solution
Premarin®

Intravenous

(conjugated estrogens, USP) for injection

Specially prepared for Intravenous & Intramuscular use

NOTE: PATIENT INFORMATION LEAFLET ATTACHED.

Rx only

Warnings

ENDOMETRIAL CANCER

Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Dementia.)

The estrogen alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated estrogens (CE 0.625 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.)

The estrogen plus progestin substudy of WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.)

The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Premarin Injection Description

Premarin® Intravenous (conjugated estrogens, USP) for injection contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of materials derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin.

Each Secule® vial contains 25 mg of conjugated estrogens, USP, in a sterile lyophilized cake which also contains lactose 200 mg, sodium citrate 12.2 mg, and simethicone 0.2 mg. The pH is adjusted with sodium hydroxide or hydrochloric acid. The reconstituted solution is suitable for intravenous or intramuscular injection.

Premarin Injection - Clinical Pharmacology

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone and the sulfate-conjugated form, estrone sulfate, are the most abundant circulating estrogen in postmenopausal women.

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue.

Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these gonadotropins seen in postmenopausal women.

Pharmacokinetics

A. Absorption

Conjugated estrogens are water-soluble and are well-absorbed through the skin, mucous membranes, and gastrointestinal tract after release from the drug formulation.

B. Distribution

The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentration in the sex hormone target organs. Estrogens circulate in the blood largely bound to sex hormone-binding globulin (SHBG) and albumin.

C. Metabolism

Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the intestine followed by reabsorption. In postmenopausal women a significant proportion of the circulating estrogens exists as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens.

D. Excretion

Estradiol, estrone, and estriol are excreted in the urine, along with glucuronide and sulfate conjugates.

E. Special Populations

No pharmacokinetic studies were conducted in special populations, including patients with renal or hepatic impairment.

F. Drug Interactions

Data from a single-dose drug-drug interaction study involving oral conjugated estrogens and medroxyprogesterone acetate indicate that the pharmacokinetic dispositions of both drugs are not altered when the drugs are coadministered. No other clinical drug-drug interaction studies have been conducted with conjugated estrogens.

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of estrogens and may result in side effects.

Clinical Studies

Women's Health Initiative Studies

The Women's Health Initiative (WHI) enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of either the use of daily oral conjugated estrogens (CE 0.625 mg) alone or in combination with medroxyprogesterone acetate (MPA 2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (nonfatal myocardial infarction [MI], silent MI and CHD death), with invasive breast cancer as the primary adverse outcome. A “global index” included the earliest occurrence of CHD, invasive breast cancer, stroke, pulmonary embolism (PE), endometrial cancer (only in CE/MPA substudy), colorectal cancer, hip fracture, or death due to other causes. The study did not evaluate the effects of CE tablets or CE/MPA on menopausal symptoms.

The estrogen alone substudy was stopped early because an increased risk of stroke was observed, and it was deemed that no further information would be obtained regarding the risks and benefits of estrogen alone in predetermined primary endpoints. Results of the estrogen alone substudy, which included 10,739 women (average age of 63 years, range 50 to 79; 75.3 percent White, 15.1 percent Black, 6.1 percent Hispanic, 3.6 percent Other) after an average follow-up of 6.8 years, are presented in Table 1.

TABLE 1. RELATIVE AND ABSOLUTE RISK SEEN IN THE ESTROGEN ALONE SUBSTUDY OF WHI

Event	Relative Risk CE vs. Placebo (95% nCIa)	Placebo n = 5,429	CE n = 5,310
		Absolute Risk per 10,000 Women-Years
aNominal confidence intervals unadjusted for multiple looks and multiple comparisons. bResults are based on centrally adjudicated data for an average follow-up of 7.1 years. cResults are based on an average follow-up of 6.8 years. dNot included in Global Index. eAll deaths, except from breast or colorectal cancer, definite/probable CHD, PE or cerebrovascular disease. fA subset of the events was combined in a “global index,” defined as the earliest occurrence of CHD events, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, or death due to other causes.
CHD eventsb	0.95 (0.79-1.16)	56	53
Non-fatal MIb	0.91 (0.73-1.14)	43	41
CHD deathb	1.01 (0.71-1.43)	16	16
Strokeb	1.37 (1.09-1.73)	33	45
Ischemic b	1.55 (1.19-2.01)	25	38
Deep vein thrombosisb,d	1.47 (1.06-2.06)	15	23
Pulmonary embolismb	1.37 (0.90-2.07)	10	14
Invasive breast cancerb	0.80 (0.62-1.04)	34	28
Colorectal cancerc	1.08 (0.75-1.55)	16	17
Hip fracturec	0.61 (0.41-0.91)	17	11
Vertebral fracturesc,d	0.62 (0.42-0.93)	17	11
Total fracturesc,d	0.70 (0.63-0.79)	195	139
Death due to other causesc,e	1.08 (0.88-1.32)	50	53
Overall mortalityc,d	1.04 (0.88-1.22)	78	81
Global Indexc,f	1.01 (0.91-1.12)	190	192

For those outcomes included in the WHI “global index” that reached statistical significance, the absolute excess risk per 10,000 women-years in the group treated with CE alone were 12 more strokes while the absolute risk reduction per 10,000 women-years was 6 fewer hip fractures. The absolute excess risk of events included in the “global index” was a nonsignificant 2 events per 10,000 women-years. There was no difference between the groups in terms of all-cause mortality. (See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)

Final centrally adjudicated results for CHD events and centrally adjudicated results for invasive breast cancer incidence from the estrogen alone substudy, after an average follow-up of 7.1 years, reported no overall difference for primary CHD events (nonfatal MI, silent MI and CHD death) and invasive breast cancer incidence in women receiving CE alone compared with placebo (see Table 1).

Centrally adjudicated results for stroke events from the estrogen alone substudy, after an average follow-up of 7.1 years, reported no significant difference in distribution of stroke subtype or severity, including fatal strokes, in women receiving CE alone compared to placebo. Estrogen alone increased the risk of ischemic stroke, and this excess was present in all subgroups of women examined (see Table 1).

The estrogen plus progestin substudy was also stopped early. According to the predefined stopping rule, after an average follow-up of 5.2 years of treatment, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the “global index.” The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years (relative risk [RR] 1.15, 95 percent nCI 1.03-1.28).

For those outcomes included in the WHI “global index” that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women years in the group treated with CE/MPA were 6 more CHD events, 7 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reductions per 10,000 women-years were 7 fewer colorectal cancers and 5 fewer hip fractures. (See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)

Results of the estrogen plus progestin substudy, which included 16,608 women (average age of 63 years, range 50 to 79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 2. These results reflect centrally adjudicated data after an average follow-up of 5.6 years.

TABLE 2. RELATIVE AND ABSOLUTE RISK SEEN IN THE ESTROGEN PLUS PROGESTIN SUBSTUDY OF WHI AT AN AVERAGE OF 5.6 YEARSa

Event	Relative Risk CE/MPA vs. Placebo (95% nCIb)	Placebo n = 8,102	CE/MPA n = 8,506
		Absolute Risk per 10,000 Women-Years
a Results are based on centrally adjudicated data. Mortality data was not part of the adjudicated data; however, data at 5.2 years of follow-up showed no difference between the groups in terms of all-cause mortality (RR 0.98, 95 percent nCI 0.82-1.18). b Nominal confidence intervals unadjusted for multiple looks and multiple comparisons. c Includes metastatic and non-metastatic breast cancer, with the exception of in situ breast cancer.
CHD events	1.24 (1.00-1.54)	33	39
Non-fatal MI	1.28 (1.00-1.63)	25	31
CHD death	1.10 (0.70-1.75)	8	8
All strokes	1.31 (1.02-1.68)	24	31
Ischemic stroke	1.44 (1.09-1.90)	18	26
Deep vein thrombosis	1.95 (1.43-2.67)	13	26
Pulmonary embolism	2.13 (1.45-3.11)	8	18
Invasive breast cancerc	1.24 (1.01-1.54)	33	41
Invasive colorectal cancer	0.56 (0.38-0.81)	16	9
Endometrial cancer	0.81 (0.48-1.36)	7	6
Cervical cancer	1.44 (0.47-4.42)	1	2
Hip fracture	0.67 (0.47-0.96)	16	11
Vertebral fractures	0.65 (0.46-0.92)	17	11
Lower arm/wrist fractures	0.71 (0.59-0.85)	62	44
Total fractures	0.76 (0.69-0.83)	199	152

Women's Health Initiative Memory Study

The estrogen alone Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, enrolled 2,947 predominantly healthy postmenopausal women 65 years of age and older (45 percent, age 65 to 69 years; 36 percent, 70 to 74 years; 19 percent, 75 years of age and older) to evaluate the effects of daily CE 0.625 mg on the incidence of probable dementia (primary outcome) compared with placebo.

After an average follow-up of 5.2 years, 28 women in the estrogen alone group (37 per 10,000 women-years) and 19 in the placebo group (25 per 10,000 women-years) were diagnosed with probable dementia. The relative risk of probable dementia in the estrogen alone group was 1.49 (95 percent CI 0.83–2.66) compared to placebo. It is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

The estrogen plus progestin WHIMS substudy enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent, age 65 to 69 years; 35 percent, 70 to 74 years; 18 percent, 75 years of age and older) to evaluate the effects of daily CE/MPA 0.625 mg conjugated estrogens/2.5 mg medroxyprogesterone acetate on the incidence of probable dementia (primary outcome) compared with placebo. It is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

After an average follow-up of 4 years, 40 women in the estrogen plus progestin group (45 per 10,000 women-years) and 21 in the placebo group (22 per 10,000 women-years) were diagnosed with probable dementia. The relative risk of probable dementia in the hormone therapy group was 2.05 (95 percent CI 1.21–3.48) compared to placebo.

When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95% CI 1.19-2.60). Differences between groups became apparent in the first year of treatment. It is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.)

Indications and Usage for Premarin Injection

Premarin Intravenous (conjugated estrogens, USP) for injection is indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.

Premarin Intravenous is indicated for short-term use only, to provide a rapid and temporary increase in estrogen levels.

Contraindications

Premarin Intravenous therapy should not be used in individuals with any of the following conditions:

1. Undiagnosed abnormal genital bleeding.

2. Known, suspected, or history of cancer of the breast.

3. Known or suspected estrogen-dependent neoplasia.

4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions.

5. Active or recent (within past year) arterial thromboembolic disease (for example, stroke, myocardial infarction).

6. Liver dysfunction or disease.

7. Known thrombophilic disorders (e.g., protein C, protein S, or antitrhombin deficiency).

8. Known hypersensitivity to any of the ingredients in Premarin Intravenous for injection.

9. Known or suspected pregnancy.

Warnings

See BOXED WARNINGS.

Premarin Intravenous for injection is indicated for short-term use. However, warnings, precautions and adverse reactions associated with oral Premarin treatment should be taken into account.

1. Cardiovascular disorders

An increased risk of stroke and deep vein thrombosis (DVT) has been reported with estrogen alone therapy.

An increased risk of stroke, DVT, pulmonary embolism, and myocardial infarction has been reported with estrogen plus progestin therapy.

Should any of these events occur or be suspected, estrogens should be discontinued immediately.

Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately.

a. Stroke

In the Women's Health Initiative (WHI) estrogen alone substudy, a statistically significant increased risk of stroke was reported in women receiving daily conjugated estrogens (CE 0.625 mg) compared to placebo (44 versus 32 per 10,000 women-years). The increase in risk was demonstrated in year 1 and persisted. (See CLINICAL STUDIES.)

In the estrogen plus progestin substudy of WHI, a statistically significant increased risk of stroke was reported in women receiving daily CE 0.625 mg plus medroxyporogesterone acetate (MPA 2.5 mg) compared to placebo (31 versus 24 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. (See CLINICAL STUDIES.)

b. Coronary heart disease

In the estrogen alone substudy of WHI, no overall effect on coronary heart disease (CHD) events (defined as nonfatal myocardial infarction [MI], silent MI, or CHD death) was reported in women receiving estrogen alone compared to placebo. (See CLINICAL STUDIES.)

In the estrogen plus progestin substudy of WHI, no statistically significant increase of CHD events was reported in women receiving CE/MPA compared to placebo (39 versus 33 per 10,000 women-years). An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5.

In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/progestin Replacement Study; HERS), treatment with daily CE 0.625 mg/MPA 2.5 mg demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year one, but not during the subsequent years. Two thousand three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open-label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in the HERS, the HERS II, and overall.

c. Venous thromboembolism (VTE)

In the estrogen alone substudy of WHI, the risk of VTE (DVT and pulmonary embolism [PE]), was reported to be increased for women receiving daily CE compared to placebo (30 versus 22 per 10,000 women-years), although only the increased risk of DVT reached statistical significance (23 versus 15 per 10,000 women-years). The increase in VTE risk was demonstrated during the first 2 years. (See CLINICAL STUDIES.)

In the estrogen plus progestin substudy of WHI, a statistically significant 2-fold greater rate of VTE was reported in women receiving daily CE/MPA compared to placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. The increase in VTE risk was demonstrated during the first year and persisted. (See CLINICAL STUDIES.)

2. Malignant neoplasms

a. Endometrial cancer

An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in women with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 times greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more and this risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued.

b. Breast cancer

The most important randomized clinical trial providing information about this issue in estrogen alone users is the Women's Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg). In the estrogen alone substudy of WHI, after an average of 7.1 years of follow-up, daily CE 0.625 mg was not associated with an increased risk of invasive breast cancer (relative risk [RR] 0.80, 95 percent nominal confidence interval [nCI] 0.62-1.04). (See CLINICAL STUDIES.)

The most important randomized clinical trial providing information about this issue in estrogen plus progestin users is the Women’s Health Initiative (WHI) substudy of daily CE 0.625 mg plus medroxyprogesterone acetate (MPA 2.5 mg). In the estrogen plus progestin substudy, after a mean follow-up of 5.6 years, the WHI substudy reported an increased risk of breast cancer in women who took daily CE/MPA. In this substudy, prior use of estrogen alone or estrogen plus progestin therapy was reported by 26 percent of the women. The relative risk of invasive breast cancer was 1.24 (95 percent nCI 1.01-1.54), and the absolute risk was 41 versus 33 cases per 10,000 women-years, for estrogen plus progestin compared with placebo, respectively. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 versus 25 cases per 10,000 women-years, for estrogen plus progestin compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 versus 36 cases per 10,000 women-years for estrogen plus progestin compared with placebo. In the same substudy, invasive breast cancers were larger and diagnosed at a more advanced stage in the estrogen plus progestin group compared with the placebo group. Metastatic disease was rare, with no apparent difference between the two groups. Other prognostic factors, such as histologic subtype, grade and hormone receptor status did not differ between the groups. (See CLINICAL STUDIES.)

The results from observational studies are generally consistent with those of the WHI clinical trial. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen alone therapy, after several years of use. The risk increased with duration of use, and appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen alone therapy. However, these studies have not found significant variation in the risk of breast cancer among different estrogens or among different estrogen plus progestin combinations, doses, or routes of administration.

The use of estrogen alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation.

All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.

3. Dementia

In the estrogen alone Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women 65 to 79 years of age was randomized to daily conjugated estrogens (CE 0.625 mg) or placebo. In the estrogen plus progestin WHIMS substudy, a population of 4,532 postmenopausal women 65 to 79 years of age was randomized to daily CE 0.625 mg plus medroxyprogesterone acetate (MPA 2.5 mg) or placebo.

In the estrogen alone substudy, after an average follow-up of 5.2 years, 28 women in the estrogen alone group and 19 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE alone versus placebo was 1.49 (95 percent CI 0.83-2.66). The absolute risk of probable dementia for CE alone versus placebo was 37 versus 25 cases per 10,000 women-years.

In the estrogen plus progestin substudy, after an average follow-up of 4 years, 40 women in the estrogen plus progestin group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for estrogen plus progestin versus placebo was 2.05 (95 percent CI 1.21-3.48). The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years.

When data from the two populations were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI 1.19-2.60). Since both substudies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS and PRECAUTIONS, Geriatric Use.)

4. Gallbladder disease

A 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving postmenopausal estrogens has been reported.

5. Hypercalcemia

Estrogen administration may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

6. Visual abnormalities

Retinal vascular thrombosis has been reported in patients receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, estrogens should be permanently discontinued.

7. Angioedema

Exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.

Precautions

A. General

Premarin Intravenous for injection is indicated for short-term use. However, warnings, precautions and adverse reactions associated with oral Premarin treatment should be taken into account.

1. Addition of a progestin when a woman has not had a hysterectomy

Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration or daily with estrogen in a continuous regimen have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.

There are, however, possible risks which may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (lowering HDL, raising LDL) and impairment of glucose tolerance.

2. Elevated blood pressure

In a small number of case reports, substantial increases in blood pressure have been attributed to idiosyncratic reactions to estrogens. In a large, randomized, placebo-controlled clinical trial, a generalized effect of estrogen therapy on blood pressure was not seen. Blood pressure should be monitored at regular intervals with estrogen use.

3. Hypertriglyceridemia

In patients with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. Consider discontinuation of treatment if pancreatitis or other complications develop.

4. Impaired liver function and past history of cholestatic jaundice

Estrogens may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued.

5. Hypothyroidism

Estrogen administration leads to increased thyroid-binding globulin (TBG) levels. Patients with normal thyroid function can compensate for the increased TBG by making more thyroid hormone, thus maintaining free T4 and T3 serum concentrations in the normal range. Patients dependent on thyroid hormone replacement therapy who are also receiving estrogens may require increased doses of their thyroid replacement therapy. These patients should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range.

6. Fluid retention

Estrogens may cause some degree of fluid retention. Patients with conditions that might be influenced by this factor, such as a cardiac or renal dysfunction, warrant careful observation when estrogens are prescribed.

7. Hypocalcemia

Estrogens should be used with caution in individuals with severe hypocalcemia.

8. Ovarian cancer

The estrogen plus progestin substudy of WHI reported a non-statistically significant increased risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95 percent nCI 0.77 – 3.24). The absolute risk for CE/MPA versus placebo was 4.2 versus 2.7 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen-only products has been associated with an increased risk of ovarian cancer over multiple years of use. However, the duration of exposure associated with increased risk is not consistent across all epidemiologic studies and some report no association.

9. Exacerbation of endometriosis

Endometriosis may be exacerbated with administration of estrogen therapy.

A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen alone therapy. For patients known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.

10. Exacerbation of other conditions

Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.

B. Patient Information

Physicians are advised to discuss the contents of the PATIENT INFORMATION leaflet with patients who are being treated with Premarin Intravenous.

C. Laboratory Tests

Estrogen administration should be guided by clinical response at the lowest dose, rather than laboratory monitoring.

D. Drug/Laboratory Test Interactions

1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.

2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.

3. Other binding proteins may be elevated in serum, i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased total circulating corticosteroids and sex steroids respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

4. Increased plasma HDL and HDL2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.

5. Impaired glucose tolerance.

E. Carcinogenesis, Mutagenesis, and Impairment of Fertility

(See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.)

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.

F. Pregnancy

Premarin Intravenous should not be used during pregnancy. (See CONTRAINDICATIONS.)

G. Nursing Mothers

Premarin Intravenous should not be used during lactation. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of breast milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving the drug.

H. Pediatric Use

Estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. Safety and effectiveness in pediatric patients have not otherwise been established.

Large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short adult stature if treatment is initiated before the completion of physiologic puberty in normally developing children. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration.

Estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. In boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. (See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.)

I. Geriatric Use

There have not been sufficient numbers of geriatric patients involved in studies utilizing Premarin to determine whether those over 65 years of age differ from younger subjects in their response to Premarin.

In the estrogen alone substudy of the Women’s Health Initiative (WHI) study, 46 percent (n=4,943) were 65 years of age and older, while 7.1 percent (n=767) were 75 years of age and older. There was a higher relative risk (daily conjugated estrogens [CE 0.625 mg] versus placebo) of stroke in women less than 75 years of age compared to women 75 years of age and older.

In the estrogen alone Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 2,947 hysterectomized women, 65 to 79 years of age, was randomized to daily CE 0.625 mg or placebo. After an average follow-up of 5.2 years, the relative risk (CE versus placebo) of probable dementia was 1.49 (95 percent CI 0.83-2.66).The absolute risk of developing probable dementia with estrogen alone was 37 versus 25 cases per 10,000 women-years compared with placebo.

Of the total number of subjects in the estrogen plus progestin substudy of the Women’s Health Initiative study, 44 percent (n=7,320) were 65 years of age and older, while 6.6 percent (n=1,095) were 75 years and older. In women 75 years of age and older compared to women less than 74 years of age, there was a higher relative risk of nonfatal stroke and invasive breast cancer in the estrogen plus progestin group versus placebo. In women greater than 75, the increased risk of nonfatal stroke and invasive breast cancer observed in the estrogen plus progestin group compared to placebo was 75 versus 24 per 10,000 women-years and 52 versus 12 per 10,000 women-years, respectively.

In the estrogen plus progestin WHIMS substudy, a population of 4,532 postmenopausal women, 65 to 79 years of age, was randomized to daily CE 0.625 mg/MPA 2.5 mg or placebo. In the estrogen plus progestin group, after an average follow-up of 4 years, the relative risk (CE/MPA versus placebo) of probable dementia was 2.05 (95 percent CI 1.21-3.48)

All Day Calcium ER Extended-Release Caplets

Pronunciation: KAL-see-um KAR-bo-nate with VYE-ta-min D
Generic Name: Calcium Carbonate with Vitamin D
Brand Name: All Day Calcium ER

All Day Calcium ER Extended-Release Caplets are used for:

Treating or preventing calcium and vitamin D deficiency. It may also be used for other conditions as determined by your doctor.

All Day Calcium ER Extended-Release Caplets are a dietary supplement. It works by providing extra calcium and vitamin D to the body.

Do NOT use All Day Calcium ER Extended-Release Caplets if:

• you are allergic to any ingredient in All Day Calcium ER Extended-Release Caplets


• you have high blood calcium levels or high blood vitamin D levels

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

Before using All Day Calcium ER Extended-Release Caplets:

Some medical conditions may interact with All Day Calcium ER Extended-Release Caplets. 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 (including shellfish)


• if you have high blood phosphate levels or high levels of calcium in the urine


• if you have dehydration, heart problems, hardening of the arteries, kidney problems, kidney stones, or sarcoidosis

Some MEDICINES MAY INTERACT with All Day Calcium ER Extended-Release Caplets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Mycophenolate because its effectiveness may be decreased by All Day Calcium ER Extended-Release Caplets


• Dabigatran because its effectiveness may be decreased by All Day Calcium ER Extended-Release Caplets

This may not be a complete list of all interactions that may occur. Ask your health care provider if All Day Calcium ER Extended-Release Caplets 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 All Day Calcium ER Extended-Release Caplets:

Use All Day Calcium ER Extended-Release Caplets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take All Day Calcium ER Extended-Release Caplets by mouth with or without food.


• Take All Day Calcium ER Extended-Release Caplets with a full glass of water (8 oz/240 mL).


• Swallow All Day Calcium ER Extended-Release Caplets whole. Do not break, crush, or chew before swallowing.


• If you also take azole antifungals (eg, ketoconazole), bisphosphonates (eg, etidronate), cation exchange resins (eg, sodium polystyrene sulfonate), cephalosporins (eg, cefdinir), doxycycline, iron, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine), ask your doctor or pharmacist how to take them with All Day Calcium ER Extended-Release Caplets.


• If you miss a dose of All Day Calcium ER Extended-Release Caplets, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use All Day Calcium ER Extended-Release Caplets.

Important safety information:

• Do not take large doses of vitamins while you use All Day Calcium ER Extended-Release Caplets unless your doctor tells you to.


• Tell your doctor or dentist that you take All Day Calcium ER Extended-Release Caplets before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including blood calcium and vitamin D levels, may be performed while you use All Day Calcium ER Extended-Release Caplets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• All Day Calcium ER Extended-Release Caplets should be used with extreme caution 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 All Day Calcium ER Extended-Release Caplets while you are pregnant. It is not known if All Day Calcium ER Extended-Release Caplets are found in breast milk. If you are or will be breast-feeding while you use All Day Calcium ER Extended-Release Caplets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of All Day Calcium ER Extended-Release Caplets:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with All Day Calcium ER Extended-Release Caplets. 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); loss of appetite; nausea; severe or persistent constipation; vomiting.

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

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 confusion; delirium; loss of consciousness; mood or mental changes; sluggishness.

Proper storage of All Day Calcium ER Extended-Release Caplets:

Store All Day Calcium ER Extended-Release Caplets 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 All Day Calcium ER Extended-Release Caplets out of the reach of children and away from pets.

General information:

• If you have any questions about All Day Calcium ER Extended-Release Caplets, please talk with your doctor, pharmacist, or other health care provider.


• All Day Calcium ER Extended-Release Caplets are 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 All Day Calcium ER Extended-Release Caplets. 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.

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Nexiclon XR

Generic Name: clonidine (Oral route)

KLOE-ni-deen

Commonly used brand name(s)

In the U.S.

• Catapres


• Kapvay


• Nexiclon XR

Available Dosage Forms:

• Tablet, Extended Release


• Suspension, Extended Release


• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Alpha-2 Adrenergic Agonist

Uses For Nexiclon XR

Clonidine is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk for heart attacks. These problems may be less likely to occur if the blood pressure is controlled.

Clonidine belongs to the class of medicines called antihypertensives. It works in the brain to change some of the nerve impulses. As a result, the blood vessels relax and blood passes through them more easily, which lowers blood pressure. When the blood pressure is lowered, the amount of blood and oxygen going to the heart is increased.

This medicine will not cure your high blood pressure, but it does help control it. Therefore, you must continue to use it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life.

Kapvay® extended-release tablets is used alone or together with other medicines to treat attention deficit hyperactivity disorder (ADHD). It works by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, clonidine is used in certain patients with the following medical conditions:

• Gilles de la Tourette's syndrome (tic disorder).


• Menopause or menstrual discomfort symptoms.


• Withdrawal symptoms from alcohol, nicotine, or narcotic pain relievers.

Before Using Nexiclon XR

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 have not been performed on the relationship of age to the effects of clonidine in children younger than 18 years of age and Kapvay® extended-release tablets in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of clonidine in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving clonidine.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Nexiclon™ XR extended-release suspension and tablets in the elderly. However, elderly patients are more likely to have age-related heart or kidney problems, which may require an adjustment in the dose for patients receiving this medicine.

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

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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 this medicine, 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 this medicine 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.

• Acebutolol


• Amitriptyline


• Amoxapine


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Carteolol


• Celiprolol


• Clomipramine


• Desipramine


• Dilevalol


• Diltiazem


• Dothiepin


• Doxepin


• Esmolol


• Imipramine


• Levobunolol


• Lofepramine


• Metipranolol


• Metoprolol


• Mirtazapine


• Nadolol


• Nebivolol


• Nortriptyline


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Protriptyline


• Sotalol


• Tertatolol


• Timolol


• Trimipramine


• Verapamil

Using this medicine 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.

• Cyclosporine


• Fluphenazine


• Mepivacaine


• Naloxone


• Yohimbine

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or


• Coronary insufficiency, severe or


• Dehydration or


• Heart attack, recent or


• Heart block or


• Heart or blood vessel disease or


• Heart rhythm problems or


• Hypotension (low blood pressure), history of or


• Kidney disease, severe or


• Stomach or intestinal problems or


• Stroke, history of or


• Syncope (fainting), history of—Use with caution. May cause side effects to become worse.

• Kidney disease—You may require a lower dose.

Proper Use of clonidine

This section provides information on the proper use of a number of products that contain clonidine. It may not be specific to Nexiclon XR. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to use it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Swallow the extended-release tablet whole. Do not cut, crush, or chew it. You may take the tablet with or without food.

Clonidine extended-release tablets works differently than clonidine immediate-release tablets. Do not switch from the extended-release tablets to the immediate-release tablets unless your doctor tells you to.

For patients using the extended-release oral suspension:

• Shake the bottle well for 5 to 10 seconds before each use.


• Insert the adapter into the neck of the bottle.


• Insert the syringe tip into the adapter and turn the bottle upside down.


• Get the amount of medicine as prescribed by your doctor.


• Place the medicine directly into the mouth.

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

This medicine usually comes with patient information leaflet. Read them carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.

Dosing

The dose of this medicine 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 this medicine. 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 attention deficit hyperactivity disorder (ADHD):
  
  • For oral dosage form (extended-release tablets):
    
    • Teenagers and children 6 years of age and older—At first, 0.1 milligram (mg) once a day, given at bedtime. Your doctor will increase your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For high blood pressure:
  
  • For oral dosage form (extended-release suspension):
    
    • Adults—At first, 0.17 milligram (mg) or 2 milliliter (mL) once a day, given at bedtime. Your doctor may adjust your dose as needed. The usual dose is 0.17 (2 mL) to 0.52 mg (6 mL) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 0.17 milligram (mg) once a day, given at bedtime. Your doctor may adjust your dose as needed. The usual dose is 0.17 to 0.52 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—0.1 milligram (mg) two times a day, taken in the morning and at bedtime. Your doctor may adjust your dose as needed. The usual dose is 0.2 mg to 0.6 mg per day, divided and given two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

If you miss more than one dose of clonidine tablets, check with your doctor right away. If your body goes without this medicine for too long, your blood pressure may go up to a very high level and cause serious side effects.

If you miss a dose of clonidine extended-release tablets, skip the missed dose and take the next dose as scheduled. 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 Nexiclon XR

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Your blood pressure may become worse when the medicine is stopped suddenly, which can cause serious side effects.

Make sure that you have enough clonidine on hand to last through weekends, holidays, or vacations. You should not miss any doses. You may want to ask your doctor for a second written prescription for clonidine to carry in your wallet or purse. You can have it filled if you run out of medicine when you are away from home.

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. You should avoid over-the-counter [OTC] medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Clonidine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Clonidine may cause some people to become drowsy or less alert than they are normally. This is more likely to happen when you begin to take it or when you increase the amount of medicine you are taking. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

This medicine may cause dryness of the eyes. If you wear contact lenses, this may be a problem for you. Talk to your doctor if you wear contact lenses, and discuss how to treat the dryness.

Dizziness, lightheadedness, or fainting may occur after you take this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help, but if the problem continues or gets worse, check with your doctor.

The dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking clonidine, be careful to limit the amount of alcohol you drink. Also, use extra care not to become dehydrated or overheated during exercise or hot weather or if you must stand for a long time.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

Clonidine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Nexiclon XR 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

• Mental depression


• swelling of the feet and lower legs

Rare

• Anxiety


• blistering, burning, crusting, dryness, or flaking of the skin


• chest pain or discomfort


• confusion as to time, place, or person


• decreased urine output


• dilated neck veins


• drowsiness


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• fever


• general feeling of discomfort or illness


• holding false beliefs that cannot be changed by fact


• hyperventilation


• irregular breathing


• irritability


• itching, scaling, severe redness, soreness, or swelling of the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lightheadedness, dizziness, or fainting


• mental depression


• paleness or cold feeling in the fingertips and toes


• pounding, slow heartbeat


• problems in urination or increase in the amount of urine


• raised red swellings on the skin, lips, tongue, or in the throat


• restlessness


• seeing or hearing things that are not there


• shaking


• shortness of breath


• skin rash


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


• tightness in the chest


• tingling or pain in the fingers or toes when exposed to cold


• trouble with sleeping


• troubled breathing


• unusual excitement, nervousness, or restlessness


• unusual tiredness or weakness


• vivid dreams or nightmares


• weight gain


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Dizziness (extreme) or faintness


• feeling cold


• pinpoint pupils of the eyes


• unusual tiredness or weakness (extreme)

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

• Constipation

Less common

• Darkening of the skin


• decreased sexual ability


• dry, itching, or burning eyes


• loss of appetite


• nausea or vomiting

Rare

• Blurred vision


• decreased interest in sexual intercourse


• hair loss or thinning of the hair


• inability to have or keep an erection


• leg cramps


• loss in sexual ability, desire, drive, or performance


• muscle or joint pain


• pale skin


• swelling of the breasts or breast soreness in both females and males


• weakness

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: Nexiclon XR side effects (in more detail)

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More Nexiclon XR resources

• Nexiclon XR Side Effects (in more detail)
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