Vivelle 37.5 Mcg

Generic Name: estradiol (Transdermal route)

es-tra-DYE-ol

Transdermal route(Emulsion)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .

Transdermal route(Patch, Extended Release)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible.

Transdermal route(Gel/Jelly)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible .

Transdermal route(Spray)

Unopposed estrogens increase the risk of endometrial cancer. Adding a progestin will reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogen alone have been reported. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) using estrogens combined with progestins have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported in women receiving estrogen alone or estrogen combined with progestins. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens, with or without progestins, should be prescribed at the lowest effective doses and for the shortest duration possible. Breast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure. Patients should strictly adhere to recommended instructions for use .

Commonly used brand name(s)

In the U.S.

• Alora


• Climara


• Divigel


• Elestrin


• Esclim


• Estraderm


• Estrasorb


• EstroGel


• Evamist


• Menostar


• Vivelle


• Vivelle-Dot

In Canada

• Estradot Transdermal


• Estradot Transdermal Therapeutic System


• Estradot Transdermal Therapeutic System


• Oesclim


• Rhoxal-Estradiol Derm 50


• Rhoxal-Estradiol Derm 75


• Roxal-Estradiol Derm 100


• Vivelle 100 Mcg


• Vivelle 25 Mcg


• Vivelle 37.5 Mcg

Available Dosage Forms:

• Patch, Extended Release


• Gel/Jelly


• Spray


• Emulsion

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Estrogen

Uses For Vivelle 37.5 Mcg

Estradiol transdermal spray is used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen.

Estradiol is an estrogen hormone. The hormone from the spray is absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes") in women during menopause.

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

Before Using Vivelle 37.5 Mcg

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

Use of estradiol transdermal spray is not indicated in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of estradiol transdermal spray have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have breast cancer, stroke, or dementia, which may require caution in patients receiving estradiol transdermal spray.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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 receiving 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.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

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.

• Alprazolam


• Amoxicillin


• Ampicillin


• Amprenavir


• Aprepitant


• Atazanavir


• Bacampicillin


• Betamethasone


• Bexarotene


• Bosentan


• Carbamazepine


• Clarithromycin


• Colesevelam


• Cyclosporine


• Darunavir


• Delavirdine


• Doxycycline


• Efavirenz


• Etravirine


• Fosamprenavir


• Fosaprepitant


• Fosphenytoin


• Ginseng


• Griseofulvin


• Itraconazole


• Ketoconazole


• Lamotrigine


• Levothyroxine


• Licorice


• Minocycline


• Modafinil


• Mycophenolate Mofetil


• Mycophenolic Acid


• Nelfinavir


• Nevirapine


• Oxcarbazepine


• Oxytetracycline


• Phenobarbital


• Phenytoin


• Pioglitazone


• Prednisolone


• Primidone


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rosuvastatin


• Rufinamide


• Selegiline


• St John's Wort


• Tacrine


• Telaprevir


• Tetracycline


• Tipranavir


• Topiramate


• Troglitazone


• Troleandomycin


• Voriconazole


• Warfarin

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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• Grapefruit Juice

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:

• Abnormal or unusual vaginal bleeding or


• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), active or history of or


• Breast cancer, known or suspected, or a history of or


• Heart attack, active or recent (within the past 12 months) or


• Liver disease or


• Stroke, active or recent (within the past 12 months) or


• Surgery with a long period of inactivity or


• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Asthma or


• Cancer, history of or


• Diabetes or


• Edema (fluid retention or body swelling) or


• Endometriosis or


• Epilepsy (seizures) or


• Gallbladder disease or


• Heart disease or


• Hypercalcemia (high calcium in the blood) or


• Hypertension (high blood pressure) or


• Hypertriglyceridemia (high triglycerides or fats in the blood) or


• Hypocalcemia (low calcium in the blood), severe or


• Hypothyroidism (an underactive thyroid) or


• Jaundice during pregnancy or from using hormonal therapy in the past or


• Liver tumors or


• Migraine headache or


• Porphyria (an enzyme problem) or


• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

Proper Use of estradiol

This section provides information on the proper use of a number of products that contain estradiol. It may not be specific to Vivelle 37.5 Mcg. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, breast, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

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.

Wash your hands with soap and water before and after using this medicine.

To use the spray:

• The spray form of this medicine comes in an applicator that delivers a measured amount of estradiol to the skin with each spray. When using a new spray applicator, prime the pump by holding the spray upright and pumping 3 times. Priming is only necessary the first time you use a new spray applicator; do not prime again.


• Apply the medicine to clean, dry, and unbroken skin on the inside of the forearm between the elbow and the wrist. Do not apply the medicine directly to your breasts or in or around the vagina.


• Allow the medicine to dry for at least 2 minutes before dressing, and at least 1 hour before washing.


• If your doctor tells you to increase your dose, move the applicator to an area of the skin next to your previous application site, before applying the second or third spray.


• Do not rub Evamist® spray into your skin.


• Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid being close with your child, wear clothes with long sleeves to cover the application site.


• If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.


• Do not allow your pets to lick or touch the arm where the medicine was sprayed.


• Always place the protective cover back on the applicator of the spray.


• Do not use the applicator for more than 75 sprays.


• Apply sunscreen at least 1 hour before applying Evamist®.

The spray contains alcohol and is flammable. Avoid using it near 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 transdermal dosage form (spray):
  
  • For hot flashes and other symptoms caused by menopause:
    
    • Adults—At first, one spray once a day, usually in the morning. Your doctor may adjust your dose as needed.
    
    
    • Children—Use is not recommended.
    
    
  
  

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.

Do not use Evamist® spray if it has been more than 12 hours since you missed your last dose.

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 Vivelle 37.5 Mcg

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using large doses of this medicine over a long period of time may increase your risk of heart attack, stroke, blood clots, dementia, breast cancer, or uterine cancer. Talk with your doctor about this risk. If you still have your uterus (womb), ask your doctor if you should also use a progestin medicine.

Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.

Using this medicine alone may increase your risk of getting cancer of the uterus (womb). Check with your doctor right away if you have unusual vaginal bleeding while you are using this medicine.

Stop using this medicine and check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to this medicine.

Do not allow your pets to lick or touch the arm where this medicine was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.

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

Do not take other medicines or drink grapefruit juice unless you discuss it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Vivelle 37.5 Mcg 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:

Incidence not known

• Abdominal or stomach cramps or pain


• acid or sour stomach


• anxiety


• backache


• belching


• blistering, peeling, or loosening of the skin


• bloating


• blurred vision


• breast tenderness, enlargement, pain, or discharge


• change in vaginal discharge


• changes in skin color


• changes in vision


• chest pain or discomfort


• chills


• clay-colored stools


• clear or bloody discharge from the nipple


• confusion


• constipation


• convulsions


• cough


• darkening of the urine


• diarrhea


• difficulty with breathing


• difficulty with swallowing


• dimpling of the breast skin


• dizziness or lightheadedness


• double vision


• fainting


• fast heartbeat


• fever


• fluid-filled skin blisters


• full or bloated feeling or pressure in the stomach


• headache


• headache, severe and throbbing


• heartburn


• hives


• indigestion


• inverted nipple


• irregular heartbeats


• itching of the skin


• itching of the vagina or genital area


• joint or muscle pain


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


• light-colored stools


• loss of appetite


• loss of bladder control


• lump in the breast or under the arm


• migraine headache


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle spasm or jerking of all extremities


• nausea


• noisy breathing


• numbness and tingling around the mouth, fingertips, or feet


• pain during sexual intercourse


• pain in the ankles or knees


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


• pain or feeling of pressure in the pelvis


• pain, redness, or swelling in the arm, foot, or leg


• painful, red lumps under the skin, mostly on the legs


• pains in the stomach, side, or abdomen, possibly radiating to the back


• persistent crusting or scaling of the nipple


• poor insight and judgment


• problems with memory or speech


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


• rash


• red, irritated eyes


• redness or swelling of the breast


• sensitivity to the sun


• shortness of breath


• skin thinness


• sore on the skin of the breast that does not heal


• sore throat


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


• stomach discomfort, upset, or pain


• sudden loss of consciousness


• sudden shortness of breath or troubled breathing


• sweating


• swelling


• swelling of the abdominal or stomach area


• thick, white vaginal discharge with no odor or with a mild odor


• tightness in the chest


• tremor


• trouble recognizing objects


• trouble thinking and planning


• trouble walking


• unexpected or excess milk flow from the breasts


• unpleasant breath odor


• unusual tiredness or weakness


• unusually heavy or unexpected menstrual bleeding


• vaginal bleeding or spotting


• vomiting


• vomiting of blood


• wheezing


• yellow eyes or skin

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

• Back pain


• difficulty with moving


• muscle aches


• muscle pain or stiffness


• stuffy or runny nose

Incidence not known

• Decreased interest in sexual intercourse


• heavy bleeding


• hives or welts


• inability to have or keep an erection


• increased hair growth, especially on the face


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


• increased interest in sexual intercourse


• irritability


• leg cramps


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


• loss of scalp hair


• mental depression


• mood disturbances


• patchy brown or dark brown discoloration of the skin


• redness of the skin


• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs


• weight 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.

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Minizide

prazosin hydrochloride and polythiazide

Dosage Form: capsules

FOR ORAL ADMINISTRATION

This fixed combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dose so determined, its use may be more convenient in patient management. The treatment of hypertension is not static, but must be re-evaluated as conditions in each patient warrant.

Minizide Description

Minizide® is a combination of MINIPRESS® (prazosin hydrochloride) plus RENESE® (polythiazide).

MINIPRESS (prazosin hydrochloride), a quinazoline derivative, is the first of that chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:

It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of MINIPRESS (prazosin hydrochloride) contains drug equivalent to 1 mg free base.

RENESE (polythiazide) is an orally effective, non-mercurial diuretic, saluretic, and antihypertensive agent.

It is designated chemically as 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-2-methyl-3-[[(2,2,2-trifluoroethyl)thio]methyl]-,1,1-dioxide, and has the following structural formula:

It is a white, crystalline substance insoluble in water, but readily soluble in alkaline solution.

Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Green 3, Red 3 and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.

Minizide - Clinical Pharmacology

Minizide (prazosin hydrochloride/polythiazide)

Minizide produces a more pronounced antihypertensive response than occurs after either prazosin hydrochloride or polythiazide alone in equivalent doses.

MINIPRESS (prazosin hydrochloride)

The exact mechanism of the hypotensive action of prazosin is unknown. Prazosin causes a decrease in total peripheral resistance and was originally thought to have a direct relaxant action on vascular smooth muscle. Recent animal studies, however, have suggested that the vasodilator effect of prazosin is also related to blockade of postsynaptic alpha-adrenoceptors. The results of dog forelimb experiments demonstrate that the peripheral vasodilator effect of prazosin is confined mainly to the level of the resistance vessels (arterioles). Unlike conventional alpha-blockers, the antihypertensive action of prazosin is usually not accompanied by a reflex tachycardia. Tolerance has not been observed to develop in long term therapy.

Hemodynamic studies have been carried out in man following acute single dose administration and during the course of long term maintenance therapy. The results confirm that the therapeutic effect is a fall in blood pressure unaccompanied by a clinically significant change in cardiac output, heart rate, renal blood flow, and glomerular filtration rate. There is no measurable negative chronotropic effect.

In clinical studies to date, MINIPRESS has not increased plasma renin activity.

In man, blood pressure is lowered in both the supine and standing positions. This effect is most pronounced on the diastolic blood pressure.

Following oral administration, human plasma concentrations reach a peak at about three hours with a plasma half-life of two to three hours. The drug is highly bound to plasma protein. Bioavailability studies have demonstrated that the total absorption relative to the drug in a 20% alcoholic solution is 90%, resulting in peak levels approximately 65% of that of the drug in solution. Animal studies indicate that MINIPRESS is extensively metabolized, primarily by demethylation and conjugation, and excreted mainly via bile and feces. Less extensive human studies suggest similar metabolism and excretion in man.

MINIPRESS has been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides—digitalis and digoxin; (2) hypoglycemics—insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives—chlordiazepoxide, diazepam, and phenobarbital; (4) antigout—allopurinol, colchicine, and probenecid; (5) antiarrhythmics—procainamide, propranolol (see WARNINGS however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories—propoxyphene, aspirin, indomethacin, and phenylbutazone.

RENESE (polythiazide)

RENESE is a member of the benzothiadiazine (thiazide) family of diuretic/antihypertensive agents. Its mechanism of action results in an interference with the renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic potency. The mechanism whereby thiazides function in the control of hypertension is unknown. Renese is well absorbed, giving peak human plasma concentrations about 5 hours after oral administration. Drug is removed slowly thereafter with a plasma elimination half-life of approximately 27 hours. One fifth of the drug is recovered unchanged in human urine; the remainder is cleared via feces and as metabolites. Animal studies indicate metabolism occurs by rupture of the thiadiazine ring and loss of the side chain.

Indications and Usage for Minizide

Minizide is indicated in the treatment of hypertension. (See box warning.)

Contraindications

RENESE (polythiazide) is contraindicated in patients with anuria, and in patients known to be sensitive to thiazides or to other sulfonamide derivatives.

Warnings

MINIPRESS (prazosin hydrochloride)

MINIPRESS may cause syncope with sudden loss of consciousness. In most cases this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120–160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of MINIPRESS. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient's regimen with caution (see DOSAGE AND ADMINISTRATION). Hypotension may develop in patients given MINIPRESS who are also receiving a beta-blocker such as propranolol.

If syncope occurs, the patient should be placed in the recumbent position and treated supportively as necessary. This adverse effect is self-limiting and in most cases does not recur after the initial period of therapy or during subsequent dose titration.

Patients should always be started on the 1 mg capsules of MINIPRESS (prazosin hydrochloride). The 2 and 5 mg capsules are not indicated for initial therapy.

More common than loss of consciousness are the symptoms often associated with lowering of the blood pressure, namely, dizziness and lightheadedness. The patient should be cautioned about these possible adverse effects and advised what measures to take should they develop. The patient should also be cautioned to avoid situations where injury could result should syncope occur during the initiation of MINIPRESS therapy.

RENESE (polythiazide)

RENESE should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Thiazides may be additive or potentiative of the action of other antihypertensive drugs.

Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance, namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Medications such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop with thiazides as with any potent diuretic, especially with brisk diuresis, when severe cirrhosis is present, or during concomitant use of corticosteroids or ACTH.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate the metabolic effects of hypokalemia, especially with reference to myocardial activity.

Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in hepatic or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Insulin requirements in diabetic patients may be either increased, decreased, or unchanged. Latent diabetes mellitus may become manifest during thiazide administration.

Thiazide drugs may increase responsiveness to tubocurarine.

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy.

Thiazides may decrease serum protein-bound iodine levels without signs of thyroid disturbance.

Precautions

Drug/Laboratory Test Interactions

In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary VMA of 17%. Therefore, false positive results may occur in screening tests for pheochromocytoma in patients who are being treated with prazosin. If an elevated VMA is found, prazosin should be discontinued and the patient retested after a month.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenic or mutagenic studies have been conducted with Minizide. However, no carcinogenic potential was demonstrated in 18 month studies in rats with either MINIPRESS or RENESE at dose levels more than 100 times the usual maximum human doses. MINIPRESS was not mutagenic in in vivo genetic toxicology studies.

Minizide produced no impairment of fertility in male or female rats at 50 and 25 mg/kg/day of MINIPRESS and RENESE respectively. In chronic studies (one year or more) of MINIPRESS in rats and dogs, testicular changes consisting of atrophy and necrosis occurred at 25 mg/kg/day (60 times the usual maximum recommended human dose). No testicular changes were seen in rats or dogs at 10 mg/kg/day (24 times the usual maximum recommended human dose). In view of the testicular changes observed in animals, 105 patients on long term MINIPRESS therapy were monitored for 17-ketosteroid excretion and no changes indicating a drug effect were observed. In addition, 27 males on MINIPRESS alone for up to 51 months did not have changes in sperm morphology suggestive of drug effect.

Use in Pregnancy

Pregnancy Category C. Minizide was not teratogenic in either rats or rabbits when administered in oral doses more than 100 times the usual maximum human dose. Studies in rats indicated that the combination of RENESE (40 times the usual maximum recommended human dose) and MINIPRESS (8 times the usual maximum recommended human dose) caused a greater number of stillbirths, a more prolonged gestation, and a decreased survival of pups to weaning than that caused by MINIPRESS alone. There are no adequate and well controlled studies in pregnant women. Therefore, Minizide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether MINIPRESS or RENESE is excreted in human milk. Thiazides appear in breast milk. Thus, if use of the drug is deemed essential the patient should stop nursing.

Pediatric Use

Safety and effectiveness in children has not been established.

Adverse Reactions

MINIPRESS (prazosin hydrochloride)

The most common reactions associated with MINIPRESS therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug.

The following reactions have been associated with MINIPRESS, some of them rarely. (In some instances exact causal relationships have not been established.)

Gastrointestinal: vomiting, diarrhea, constipation, abdominal discomfort and/or pain, liver function abnormalities, pancreatitis.

Cardiovascular: edema, dyspnea, syncope, tachycardia.

Central Nervous System: nervousness, vertigo, depression, paresthesia, hallucinations.

Dermatologic: rash, pruritus, alopecia, lichen planus.

Genitourinary: urinary frequency, incontinence, impotence, priapism.

EENT: blurred vision, reddened sclera, epistaxis, tinnitus, dry mouth, nasal congestion.

Other: diaphoresis, fever.

Single reports of pigmentary mottling and serous retinopathy, and a few reports of cataract development or disappearance have been reported. In these instances, the exact causal relationship has not been established because the baseline observations were frequently inadequate.

In more specific slit-lamp and funduscopic studies, which included adequate baseline examinations, no drug-related abnormal ophthalmological findings have been reported.

Literature reports exist associating MINIPRESS therapy with a worsening of pre-existing narcolepsy. A causal relationship is uncertain in these cases.

RENESE (polythiazide)

Gastrointestinal: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central Nervous System: dizziness, vertigo, paresthesia, headache, xanthopsia.

Hematologic: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia.

Dermatologic: purpura, photosensitivity, rash, urticaria, necrotizing angiitis, (vasculitis) (cutaneous vasculitis).

Cardiovascular: Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics.

Other: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness.

Overdosage

MINIPRESS (prazosin hydrochloride)

Accidental ingestion of at least 50 mg of MINIPRESS in a two year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was uneventful.

Should overdosage lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressors should then be used. Renal function should be monitored and supported as needed. Laboratory data indicate that MINIPRESS is not dialyzable because it is protein bound.

RENESE (polythiazide)

Should overdosage with RENESE occur, electrolyte balance and adequate hydration should be maintained. Gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose and saline with potassium and other electrolyte therapy, administered with caution as indicated by laboratory testing at appropriate intervals.

Minizide Dosage and Administration

Minizide (prazosin hydrochloride/polythiazide)

Dosage: as determined by individual titration of MINIPRESS (prazosin hydrochloride) and RENESE (polythiazide). (See box warning.)

Usual Minizide dosage is one capsule two or three times daily, the strength depending upon individual requirement following titration.

The following is a general guide to the administration of the individual components of Minizide:

MINIPRESS (prazosin hydrochloride)

Initial Dose

1 mg two or three times a day. (See WARNINGS.)

Maintenance Dose

Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.

Use With Other Drugs

When adding a diuretic or other antihypertensive agent, the dose of MINIPRESS should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.

RENESE (polythiazide)

The usual dose of RENESE for antihypertensive therapy is 2 to 4 mg daily.

How is Minizide Supplied

STRENGTH	COMPONENTS	COLOR	CAPSULE CODE	PKG. SIZE
Minizide 1	1 mg prazosin + 0.5 mg polythiazide (NDC 0663-4300-66) (NDC 0069-4300-66)	Blue- Green	430	100's
Minizide 2	2 mg prazosin + 0.5 mg polythiazide (NDC 0663-4320-66) (NDC 0069-4320-66)	Blue- Green/ Pink	432	100's
Minizide 5	5 mg prazosin + 0.5 mg polythiazide (NDC 0663-4360-66) (NDC 0069-4360-66)	Blue- Green/ Blue	436	100's

Rx Only

LAB-0213-2.0

Revised August 2006

Minizide  prazosin hydrochloride and polythiazide  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-4300 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength prazosin hydrochloride (prazosin) Active 1 MILLIGRAM  In 1 CAPSULE polythiazide (polythiazide) Active 0.5 MILLIGRAM  In 1 CAPSULE Blue 1 Inactive   Green 3 Inactive   Red 3 Inactive   magnesium stearate Inactive   sodium lauryl sulfate Inactive   starch Inactive   sucrose Inactive

Product Characteristics Color BLUE (Blue-Green) , GREEN (Blue-Green) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Pfizer;430;Minizide Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0069-4300-66 100 CAPSULE In 1 BOTTLE None

Minizide  prazosin hydrochloride and polythiazide  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-4320 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength prazosin hydrochloride (prazosin) Active 2 MILLIGRAM  In 1 CAPSULE polythiazide (polythiazide) Active 0.5 MILLIGRAM  In 1 CAPSULE Blue 1 Inactive   Green 3 Inactive   Red 3 Inactive   magnesium stearate Inactive   sodium lauryl sulfate Inactive   starch Inactive   sucrose Inactive

Product Characteristics Color BLUE (Blue-Green) , GREEN (Blue-Green) , PINK Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Pfizer;432;Minizide Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0069-4320-66 100 CAPSULE In 1 BOTTLE None

Minizide  prazosin hydrochloride and polythiazide  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-4360 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength prazosin hydrochloride (prazosin) Active 5 MILLIGRAM  In 1 CAPSULE polythiazide (polythiazide) Active 0.5 MILLIGRAM  In 1 CAPSULE Blue 1 Inactive   Green 3 Inactive   Red 3 Inactive   magnesium stearate Inactive   sodium lauryl sulfate Inactive   starch Inactive   sucrose Inactive

Product Characteristics Color BLUE (Blue-Green) , GREEN (Blue-Green) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code Pfizer;436;Minizide Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0069-4360-66 100 CAPSULE In 1 BOTTLE None

Revised: 10/2006Pfizer Labs

More Minizide resources

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

• Minizide Advanced Consumer (Micromedex) - Includes Dosage Information


• Minizide MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Minizide with other medications

• High Blood Pressure

Microgestin 1.5/30

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Microgestin 1.5/30 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Microgestin 1.5/30 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. 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.

What should I discuss with my healthcare provider before taking Microgestin 1.5/30 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Microgestin 1.5/30 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

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.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

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

What should I avoid while taking Microgestin 1.5/30 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Microgestin 1.5/30 (ethinyl estradiol and norethindrone) side effects

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

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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

What other drugs will affect Microgestin 1.5/30 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. 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 Microgestin 1.5/30 resources

• Microgestin 1.5/30 Side Effects (in more detail)
• Microgestin 1.5/30 Use in Pregnancy & Breastfeeding
• Drug Images
• Microgestin 1.5/30 Drug Interactions
• Microgestin 1.5/30 Support Group
• 0 Reviews for Microgestin.5/30 - Add your own review/rating

• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Microgestin 1.5/30 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Microgestin.5/30 side effects (in more detail)

Alginic acid, aluminum hydroxide, and magnesium carbonate

Generic Name: alginic acid, aluminum hydroxide, and magnesium carbonate (al JIN ik AS id, a LOO mi num hye DROX ide, mg NEE see um KAR boe nate)

Brand Names: Acid Gone, Acid Gone Extra Strength, Alenic Alka, Gaviscon Extra Strength, Gaviscon Extra Strength Liquid, Gaviscon Regular Strength Liquid, Genaton, Heartburn Antacid Extra Strength

What is alginic acid, aluminum hydroxide, and magnesium carbonate?

Alginic acid is a natural carbohydrate that comes from algae in seaweed (kelp) and is used in many processed foods. It helps this medication create a foam barrier to coat the stomach.

Aluminum and magnesium are minerals that occur naturally and are used as antacids.

The combination of alginic acid, aluminum hydroxide, and magnesium carbonate is used to treat symptoms of stomach ulcers, gastroesophageal reflux disease (GERD), and other conditions caused by excess stomach acid. This medicine is also used to treat heartburn, upset stomach, sour stomach, or acid indigestion.

This medication may be used for other purposes not listed in this medication guide.

What is the most important information I should know about alginic acid, aluminum hydroxide, and magnesium carbonate?

Ask a doctor or pharmacist before taking this medication if you have kidney disease, kidney stones, severe constipation, or if you are dehydrated.

Avoid taking multivitamins, mineral supplements, or other medications (especially antacids) at the same time you take this medication. Antacids can make it harder for your body to absorb certain other drugs. Taking too many antacids together may cause you to take too much of a certain drug. Call your doctor if your symptoms do not improve, or if they get worse while using this medication.

Stop taking this medication and call your doctor at once if you have severe stomach pain, severe constipation, swelling in your ankles or feet, blood in your stools, or if you cough up blood. Some of these may be symptoms of your condition and not side effects of the medication.

What should I discuss with my healthcare provider before taking alginic acid, aluminum hydroxide, and magnesium carbonate?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• kidney disease, a history of kidney stones;


• 
  

  severe constipation; or

  
  


• 
  

  if you are dehydrated.

  
  

It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take alginic acid, aluminum hydroxide, and magnesium carbonate?

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

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if your symptoms do not improve, or if they get worse while using this medication. Store this medication at room temperature away from moisture, heat, and light.

See also: Alginic acid, aluminum hydroxide, and magnesium carbonate dosage (in more detail)

What happens if I miss a dose?

Since antacids are taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe diarrhea.

What should I avoid while taking alginic acid, aluminum hydroxide, and magnesium carbonate?

Avoid taking multivitamins, mineral supplements, or other medications (especially antacids) at the same time you take this medication. Antacids can make it harder for your body to absorb certain other drugs. Taking too many antacids together may cause you to take too much of a certain drug.

Alginic acid, aluminum hydroxide, and magnesium carbonate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking the medication and call your doctor at once if you have any of the following side effects. Some of these may be symptoms of your condition and not side effects of the medication.

• 
  

  severe stomach pain or constipation;

  
  


• 
  

  bloody or tarry stools, coughing up blood ;

  
  


• 
  

  swelling in your ankles or feet; or

  
  


• 
  

  worsening of your stomach condition.

  
  

Less serious side effects may include:

• 
  

  mild constipation or diarrhea;

  
  


• 
  

  nausea, mild stomach cramps; or

  
  


• 
  

  altered sense of taste.

  
  

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.

Alginic acid, aluminum hydroxide, and magnesium carbonate Dosing Information

Usual Adult Dose for Dyspepsia:

Extra strength formula: 10 to 20 mL or 2 to 4 chewable tablets orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 16 teaspoonfuls or 16 tablets/day.
Regular strength formula: 15 to 30 mL orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 8 tablespoonfuls/day.

Usual Adult Dose for Gastroesophageal Reflux Disease:

Extra strength formula: 10 to 20 mL or 2 to 4 chewable tablets orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 16 teaspoonfuls or 16 tablets/day.
Regular strength formula: 15 to 30 mL orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 8 tablespoonfuls/day.

Usual Pediatric Dose for Dyspepsia:

13 to 18 years:
Extra strength formula: 10 to 20 mL or 2 to 4 chewable tablets orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 16 teaspoonfuls or 16 tablets/day.
Regular strength formula: 15 to 30 mL orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 8 tablespoonfuls/day.

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

13 to 18 years:
Extra strength formula: 10 to 20 mL or 2 to 4 chewable tablets orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 16 teaspoonfuls or 16 tablets/day.
Regular strength formula: 15 to 30 mL orally 4 times a day as needed, after meals and 30 minutes before bedtime. The normally recommended maximum dose is 8 tablespoonfuls/day.

What other drugs will affect alginic acid, aluminum hydroxide, and magnesium carbonate?

There may be other drugs that can interact with this medication. 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 alginic acid, aluminum hydroxide, and magnesium carbonate resources

• Alginic acid, aluminum hydroxide, and magnesium carbonate Dosage
• Alginic acid, aluminum hydroxide, and magnesium carbonate Use in Pregnancy & Breastfeeding
• Alginic acid, aluminum hydroxide, and magnesium carbonate Drug Interactions
• Alginic acid, aluminum hydroxide, and magnesium carbonate Support Group
• 0 Reviews for Alginic acid, aluminum hydroxide, and magnesium carbonate - Add your own review/rating

Compare alginic acid, aluminum hydroxide, and magnesium carbonate with other medications

• GERD
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Where can I get more information?

• Your pharmacist can provide more information about alginic acid, aluminum hydroxide, and magnesium carbonate.

WinRho SDF

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)

Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM Ultra-Filtered Plus, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don't (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

To make sure you can safely receive RHo (D) immune globulin, tell your doctor if you have any of these other conditions:

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  heart disease or a history of coronary artery disease (hardened arteries);

  
  


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  high triglycerides (a type of fat in the blood);

  
  


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  a bleeding disorder (such as hemophilia); or

  
  


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  immune globulin A (IgA) deficiency.

  
  

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

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  fever, chills, shaking, back pain, dark colored urine;

  
  


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  rapid breathing, feeling short of breath.

  
  


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  urinating less than usual or not at all, swelling, rapid weight gain; or

  
  


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  pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

  
  

Less serious side effects may include:

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  joint or muscle pain;

  
  


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  headache, dizziness;

  
  


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  feeling weak or tired;

  
  


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  mild itching or skin rash;

  
  


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  nausea, diarrhea, vomiting, stomach pain; or

  
  


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  pain or tenderness where the medicine was injected.

  
  

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

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. 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 WinRho SDF resources

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

• WinRho SDF MedFacts Consumer Leaflet (Wolters Kluwer)


• WinRho SDF Advanced Consumer (Micromedex) - Includes Dosage Information


• Bayrho-D full dose


• HyperRHO S/D Full Dose Prescribing Information (FDA)


• MICRhoGAM MedFacts Consumer Leaflet (Wolters Kluwer)


• RhoGAM Ultra-Filtered PLUS Prescribing Information (FDA)


• Rhophylac Prescribing Information (FDA)


• Rhophylac MedFacts Consumer Leaflet (Wolters Kluwer)


• Rhophylac Consumer Overview

Compare WinRho SDF with other medications

• Idiopathic Thrombocytopenic Purpura
• Rh-Isoimmunization

Where can I get more information?

• Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

See also: WinRho SDF side effects (in more detail)