Visicol

Generic Name: phosphate supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Fleet Phospho-soda EZ-Prep


• K-Phos Neutral


• K-Phos Original


• OsmoPrep


• Phospha 250 Neutral


• Phospho-Soda


• Visicol

Available Dosage Forms:

• Tablet


• Tablet, Enteric Coated


• Liquid

Uses For Visicol

Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.

Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of this medicine for your medical condition. You should take phosphates only under the supervision of your health care professional.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.

The daily amount of phosphorus needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:

Persons	U.S. (mg)	Canada (mg)
Infants birth to 3 years of age	300–800	150–350
Children 4 to 6 years of age	800	400
Children 7 to 10 years of age	800	500–800
Adolescent and adult males	800–1200	700–1000
Adolescent and adult females	800–1200	800–850
Pregnant females	1200	1050
Breast-feeding females	1200	1050

Before Using Visicol

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

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 any of these dietary supplements, 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 dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.

• Amantadine


• Atropine


• Belladonna


• Belladonna Alkaloids


• Benztropine


• Biperiden


• Cisapride


• Clidinium


• Darifenacin


• Dicyclomine


• Dronedarone


• Eplerenone


• Glycopyrrolate


• Hyoscyamine


• Mesoridazine


• Methscopolamine


• Oxybutynin


• Pimozide


• Procyclidine


• Scopolamine


• Solifenacin


• Sparfloxacin


• Thioridazine


• Tolterodine


• Trihexyphenidyl

Using dietary supplements in this class 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.

• Alacepril


• Alfuzosin


• Amiloride


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Benazepril


• Canrenoate


• Captopril


• Chloroquine


• Chlorpromazine


• Cilazapril


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Delapril


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Enalaprilat


• Enalapril Maleate


• Erythromycin


• Flecainide


• Fluconazole


• Fosinopril


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imidapril


• Imipramine


• Indomethacin


• Lapatinib


• Levofloxacin


• Lisinopril


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moexipril


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Pentopril


• Perflutren Lipid Microsphere


• Perindopril


• Posaconazole


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinapril


• Quinidine


• Quinine


• Ramipril


• Ranolazine


• Salmeterol


• Saquinavir


• Solifenacin


• Sorafenib


• Sotalol


• Spirapril


• Spironolactone


• Sunitinib


• Telavancin


• Telithromycin


• Temocapril


• Terfenadine


• Tetrabenazine


• Toremifene


• Trandolapril


• Trazodone


• Triamterene


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone


• Zofenopril

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 dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Burns, severe or


• Heart disease or


• Pancreatitis (inflammation of the pancreas) or


• Rickets or


• Softening of bones or


• Underactive parathyroid glands—Sodium- or potassium-containing phosphates may make these conditions worse.

• Dehydration or


• Underactive adrenal glands—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

• Edema (swelling in feet or lower legs or fluid in lungs) or


• High blood pressure or


• Liver disease or


• Toxemia of pregnancy—Sodium-containing phosphates may make these conditions worse.

• High blood levels of phosphate (hyperphosphatemia)—Use of phosphates may make this condition worse.

• Infected kidney stones—Phosphates may make this condition worse.

• Kidney disease—Sodium-containing phosphates may make this condition worse; potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

• Myotonia congenita—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood), and make this condition worse.

Proper Use of phosphate supplement

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

For patients taking the tablet form of this medicine:

• Do not swallow the tablet. Before taking, dissolve the tablet in ¾ to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of this medicine:

• Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2½ ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of this medicine:

• Add the entire contents of 1 bottle (2¼ ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved.


• Do not dilute solution further.


• This solution may be chilled to improve the flavor; do not allow it to freeze.


• Discard unused solution after 60 days.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.

To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.

Dosing

The dose medicines in this class 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 these medicines. 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 potassium phosphates


• For oral dosage form (solution):
  
  • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
    
    • Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.
    
    
  
  
  • To replace phosphorus lost by the body:
    
    • Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.
    
    
    • Children up to 4 years of age—The dose must be determined by your doctor.
    
    
  
  


• For oral dosage forms (capsules or oral solution):
  
  • To replace phosphorus lost by the body:
    
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.
    
    
    • Children up to 4 years of age—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage forms (powder for oral solution):
  
  • To replace phosphorus lost by the body:
    
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.
    
    
    • Children up to 4 years of age—Dose must be determined by your doctor.
    
    
  
  

• For potassium and sodium phosphates


• For oral dosage form (solution):
  
  • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
    
    • Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.
    
    
  
  
  • To replace phosphorus lost by the body:
    
    • Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.
    
    
    • Children up to 4 years of age—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage forms (capsules or solution):
  
  • To replace phosphorus lost by the body:
    
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.
    
    
    • Children up to 4 years of age—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage forms (powder for solution):
  
  • To replace phosphorus lost by the body:
    
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.
    
    
    • Children up to 4 years of age—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage forms (tablets for solution):
  
  • To replace phosphorus lost by the body:
    
    • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day.
    
    
    • Children up to 4 years of age—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.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Visicol

Your health care professional should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Do not take iron supplements within 1 to 2 hours of taking this medicine. To do so may keep the iron from working properly.

For patients taking potassium phosphate-containing medicines:

• Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:

• This medicine may contain a large amount of potassium. If you have any questions about this, check with your health care professional.


• Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:

• This medicine may contain a large amount of sodium. If you have any questions about this, check with your health care professional.

Visicol 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Confusion


• convulsions (seizures)


• decrease in amount of urine or in frequency of urination


• fast, slow, or irregular heartbeat


• headache or dizziness


• increased thirst


• muscle cramps


• numbness, tingling, pain, or weakness in hands or feet


• numbness or tingling around lips


• shortness of breath or troubled breathing


• swelling of feet or lower legs


• tremor


• unexplained anxiety


• unusual tiredness or weakness


• weakness or heaviness of legs


• weight gain

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:

• Diarrhea


• nausea or vomiting


• stomach pain

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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Elleste Solo MX40 micrograms Transdermal Patch

1. Name Of The Medicinal Product

Elleste Solo MX 40 micrograms Transdermal Patch.

2. Qualitative And Quantitative Composition

Elleste Solo MX 40 contains 1.25 mg of estradiol (as hemihydrate) and each patch delivers approximately 40 micrograms of estradiol per 24 hours.

For excipients, see 6.1.

3. Pharmaceutical Form

Transdermal patch.

Elleste Solo MX 40 is a self-adhesive, flexible transdermal patch comprising a layer of clear adhesive sandwiched between a translucent patch and a metallised polyester backing. Elleste Solo MX 40 is a rectangular shape with rounded corners and has an active surface area of 14.25 cm².

4. Clinical Particulars

4.1 Therapeutic Indications

Hormone replacement therapy (HRT) for estrogen deficiency symptoms in peri-menopausal and post-menopausal women.

4.2 Posology And Method Of Administration

Elleste Solo MX 40 Transdermal Patch is an estrogen-only product for transdermal use.

Adults

Climacteric Symptoms:

For initiation and continuation of treatment of peri- and postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used. Therapy should be initiated with Elleste Solo MX 40 in women who have menopausal symptoms. The dosage may be increased if required by using Elleste Solo MX 80.

Dosage Schedule:

Therapy may start at any time in women with established amenorrhoea or who are experiencing long intervals between spontaneous menses. In women who are menstruating, it is advised that therapy starts within five days of the start of bleeding. Patients changing from a cyclical or continuous sequential preparation should complete the cycle, and after a withdrawal bleed, may then change to Elleste Solo MX 40. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start within five days of the start of bleeding.

One Elleste Solo MX 40 transdermal patch should be applied twice weekly on a continuous basis. Each patch should be removed after 3 to 4 days and replaced with a new patch applied to a slightly different site. Patches should be applied to clean, dry and intact areas of skin below the waist on the lower back or buttocks. Elleste Solo MX 40 should not be applied on or near the breasts.

Elleste Solo MX 40 should be given continuously and, in women with an intact uterus, a progestogen is recommended and should be added for at least 12-14 days each cycle. The benefits of the lower risk of endometrial hyperplasia and endometrial cancer, due to adding progestogen, should be weighed against the increased risk of Breast cancer, (See Sections 4.4 and 4.8). Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.

If the patch is not replaced at the normal time, it should be changed as soon as practical.

There is an increased likelihood of break-through bleeding and spotting when a patch is not replaced at the normal time.

Children

Elleste Solo MX 40 is not indicated in children.

4.3 Contraindications

Known, past or suspected breast cancer;

Known or suspected estrogen-dependent malignant tumours, (e.g. endometrial cancer);

Undiagnosed genital bleeding;

Untreated endometrial hyperplasia;

Previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism);

Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);

Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;

Known hypersensitivity to the active substances or to any of the excipients;

Porphyria.

4.4 Special Warnings And Precautions For Use

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Assessment of each woman prior to taking hormone replacement therapy (and at regular intervals thereafter) should include a personal and family medical history. Physical examination should be guided by this and by the contraindications (see Section 4.3) and warnings (see Section 4.4) for this product. During assessment of each individual woman, clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Women should be encouraged to participate in the national breast screening programme (mammography) and the national cervical screening programme (cervical cytology) as appropriate for their age. Breast awareness should also be encouraged and women advised to report any changes in their breasts to their doctor or nurse, (see “Breast Cancer” below).

Conditions which need supervision:

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with Elleste Solo MX 40, in particular:

- Risk factors for estrogen dependent tumours, e.g. 1^st degree heredity for breast cancer (see below);

- Diabetes mellitus with or without vascular involvement;

- Migraine or (severe) headache;

- Epilepsy;

- A history of, or risk of factors for, thromboembolic disorders (see below);

- Systemic lupus erythematosus, SLE;

- Liver disorders (e.g. liver adenoma);

- Leiomyoma (uterine fibroids) or endometriosis;

- Otosclerosis;

- Cholelithiasis;

- A history of endometrial hyperplasia (see below);

- Hypertension;

- Asthma.

Reasons for immediate withdrawal of therapy:

Therapy should be discontinued in case a contra-indication is discovered and in the following situations:

- Jaundice or deterioration in liver function

- Significant increase in blood pressure

- New onset of migraine-type headache

- Pregnancy

Endometrial Hyperplasia

The risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods, (see Section 4.8). The addition of a progestogen for at least 12 days per cycle in non-hysterectomised women greatly reduces this risk (See Section 4.8).

The endometrial safety of added progestogen has not been studied for Elleste Solo MX 40.

The reduction in risk to the endometrium should be weighed against the increase in the risk of breast cancer of added progestogen (See 'Breast cancer' below, and in Section 4.8).

Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy or continues after treatment has been discontinued, the reason should be investigated which may include endometrial biopsy to exclude endometrial malignancy.

Unopposed estrogen stimulation may lead to premalignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to estrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis, (but see above).

Breast Cancer

A randomised placebo-controlled trial, the Women's Health Initiative study (WHI), and epidemiological studies, including the Million Women Study (MWS), have reported an increased risk of breast cancer in women taking estrogens, estrogen-progestogen combinations or tibolone for HRT for several years (see Section 4.8). For all HRT, an excess risk becomes apparent within a few years of use and increases with duration of intake but returns to baseline within a few (at most five) years after stopping treatment.

In the MWS, the relative risk of breast cancer with conjugated equine estrogens (CEE) or estradiol (E2) was greater when a progestogen was added, either sequentially or continuously, and regardless of type of progestogen. There was no evidence of a difference in risk between the different routes of administration.

In the WHI study, the continuous combined conjugated equine estrogen and medroxyprogesterone acetate (CEE + MPA) product used was associated with breast cancers that were slightly larger in size and more frequently had local lymph node metastases compared to placebo.

HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.

Venous Thromboembolism

HRT is associated with a higher relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. One randomised controlled trial and epidemiological studies found a two to threefold higher risk for users compared with non-users. For non-users, it is estimated that the number of cases of VTE that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 8 per 1000 women aged between 60-69 years. It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5 year period will be between 2 and 6 (best estimate = 4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate = 9) per 1000 women aged 60-69 years. The occurrence of such an event is more likely in the first year of HRT than later.

Generally recognised risk factors for VTE include a personal history or family history, severe obesity (BMI>30 kg/m²) and systemic lupus erythematosus (SLE). There is no consensus about the possible role of varicose veins in VTE.

Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. HRT may add to this risk. Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of HRT in such patients should be viewed as contraindicated. Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery. As in all postoperative patients, scrupulous attention should be given to prophylactic measures to prevent VTE following surgery. Where prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4 to 6 weeks earlier, if possible. Treatment should not be restarted until the woman is completely mobilised.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctor immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnea).

Coronary Artery Disease

There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated estrogens and medroxyprogesterone acetate, (MPA). Two large clinical trials (WHI and HERS, i.e. Heart and Estrogen/progestin Replacement Study) showed a possible increased risk of cardiovascular morbidity in the first year of use and no overall benefit. For other HRT products there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality. Therefore, it is uncertain whether these findings also extend to other HRT products.

Stroke

One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated estrogens and medroxyprogesterone acetate. For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. It is estimated that for women who use conjugated estrogens and medroxyprogesterone acetate for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years. It is unknown whether the increased risk also extends to other HRT products.

Ovarian Cancer

Long-term (at least 5 to 10 years) use of estrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers a different risk than estrogen-only products.

Other Conditions

Estrogens may cause fluid retention and therefore patients with cardiac or renal dysfunction should be carefully observed. Patients with terminal renal insufficiency should be closely observed, since it is expected that the level of circulating active ingredients in Elleste Solo MX 40 is increased.

Women with pre-existing hypertriglyceridaemia should be followed closely during estrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with estrogen therapy in this condition.

Estrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radio-immunoassay) or T3 levels (by radio-immunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger post-menopausal women or other HRT products.

In rare cases benign, and in even rarer cases malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as those contained in Elleste Solo MX 40. If severe upper abdominal complaints, enlarged liver or signs of intra-abdominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.

Women who may be at risk of pregnancy should be advised to adhere to non-hormonal contraceptive methods.

The requirement for oral anti-diabetics or insulin can change as a result of the effect on glucose tolerance.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The metabolism of estrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants, (e.g. phenobarbitol, phenytoin and carbamezapine) and anti-infectives, (e.g. rifampicin, rifabutin, nevirapine or efavirenz).

Ritonavir and nelfinavir, although known strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John's wort (Hypericum Perforatum) may induce the metabolism of estrogens.

At transdermal administration, the first-pass effect in the liver is avoided and, thus, transdermally applied estrogens might be less affected than oral hormones by enzyme inducers.

Clinically, an increased metabolism of estrogens may lead to decreased effect and changes in the uterine bleeding profile.

Some laboratory tests can be influenced by estrogens such as tests for thyroid function or glucose tolerance, (see Section 4.4).

4.6 Pregnancy And Lactation

Pregnancy

Elleste Solo MX 40 is not indicated during pregnancy. If pregnancy occurs during medication with Elleste Solo MX 40, treatment should be withdrawn immediately. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to estrogens indicate no teratogenic or foetotoxic effects

Lactation

Elleste Solo MX 40 is not indicated during lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Elleste Solo MX 40 is generally well tolerated. The most frequent side effects, (reported in 10 to 20 % of patients, on at least one occasion, in clinical trials with Elleste Solo MX 40) which do not normally prevent continued treatment include: breast tenderness, headaches and breakthrough bleeding. Some patients experience mild and transient local erythema at the site of application with or without itching; this usually disappears rapidly on removal of the patch. The overall incidence of general patch irritation in clinical studies is less than 5 %. In a clinical study 3 % of 102 patients showed well defined erythema (Draize scale) 30 minutes after patch removal. No instances of permanent skin damage have been reported. If unacceptable topical side effects do occur discontinuation of treatment should be considered.

The following adverse reactions have been reported with Elleste Solo MX 40 and/or estrogen therapy:

1. Genito-urinary tract: Endometrial neoplasia*, dysmenorrhoea, intermenstrual bleeding, increase in the size of uterine fibromyomata, endometrial proliferation or aggravation of endometriosis, vaginal haemorrhagic eruptions, changes in cervical eversion and excessive production of cervical mucus, cervical erosion, cystitis-like syndrome, candidal infections, thrush;

2. Breast: Tenderness, pain, enlargement or secretion, breast cancer*;

3. Gastro-intestinal tract: Nausea, vomiting, abdominal cramp, bloating;

4. Cardiovascular system: Hypertension, thrombosis, thrombophlebitis, venous thromboembolism*, myocardial infarction* and stroke*;

5. Liver/biliary system: In rare cases benign, and in even rarer cases malignant liver tumours, cholelithiasis, cholestatic jaundice, gall bladder disease;

6. Skin: Chloasma which may persist when the drug is discontinued, erythema multiforme, erythema nodosum, muscle cramps, vascular purpura, rash, loss of scalp hair, hirsutism;

7. Eyes: Steepening of corneal curvature, visual disturbances, intolerance to contact lenses;

8. CNS: Headache, migraine, dizziness, mood changes (elation or depression), chorea, probable dementia (see Section 4.4);

9. Miscellaneous: Sodium and water retention, reduced glucose tolerance, leg cramps, oedema, change in body weight, aggravation of porphyria, changes in libido.

* See sections 4.3, Contraindications and Section 4.4 Special Warnings and Special Precautions for Use.

Breast Cancer

According to evidence from a large number of epidemiological studies and one randomised placebo-controlled trial, the Women's Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.

For estrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which>80% of HRT use was estrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95% CI 1.21 – 1.49) and 1.30 (95% CI 1.21 – 1.40), respectively.

For estrogen plus progestogen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with estrogens alone.

The MWS reported that, compared to never users, the use of various types of estrogen-progestogen combined HRT was associated with a higher risk of breast cancer (RR = 2.00, 95% CI: 1.88 – 2.12) than use of estrogens alone (RR = 1.30, 95% CI: 1.21 – 1.40) or use of tibolone (RR=1.45; 95%CI 1.25-1.68).

The WHI trial reported a risk estimate of 1.24 (95% CI 1.01 – 1.54) after 5.6 years of use of estrogen-progestogen combined HRT (CEE + MPA) in all users compared with placebo.

The absolute risks calculated from the MWS and the WHI trial are presented below:

The MWS has estimated, from the known average incidence of breast cancer in developed countries, that:

•For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.

• For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be

ο For users of estrogen-only replacement therapy

• between 0 and 3 (best estimate = 1.5) for 5 years' use

• between 3 and 7 (best estimate = 5) for 10 years' use.

ο For users of estrogen plus progestogen combined HRT,

• between 5 and 7 (best estimate = 6) for 5 years' use

• between 18 and 20 (best estimate = 19) for 10 years' use.

The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to estrogen-progestogen combined HRT (CEE + MPA) per 10,000 women years.

According to calculations from the trial data, it is estimated that:

• For 1000 women in the placebo group, about 16 cases of invasive breast cancer would be diagnosed in 5 years.

• For 1000 women who used estrogen + progestogen combined HRT (CEE + MPA), the number of additional cases would be between 0 and 9 (best estimate = 4) for 5 years' use.

The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see Section 4.4).

Endometrial cancer

In women with an intact uterus, the risk of endometrial hyperplasia and endometrial cancer increases with increasing duration of use of unopposed estrogens. According to data from epidemiological studies, the best estimate of the risk is that for women not using HRT, about 5 in every 1000 are expected to have endometrial cancer diagnosed between the ages of 50 and 65. Depending on the duration of treatment and estrogen dose, the reported increase in endometrial cancer risk among unopposed estrogen users varies from 2-to 12-fold greater compared with non-users. Adding a progestogen to estrogen-only therapy greatly reduces this increased risk.

4.9 Overdose

This is not likely due to the mode of administration. If it is necessary to stop delivery then the patch can be removed and plasma estradiol levels will fall rapidly.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group:

Natural and semisynthetic estrogens, plain.

ATC Code G03C A

The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms.

5.2 Pharmacokinetic Properties

Estradiol is absorbed from the patch across the stratum corneum and is delivered systemically at a low but constant rate throughout the period of application (3 to 4 days). The estimated delivery of estradiol is approximately 40 μg/day for Elleste Solo MX 40.

Steady state plasma estradiol concentrations have been demonstrated in the range of 26 pg/ml to 34 pg/ml for the Elleste Solo MX 40 patch (including baseline levels) and these are maintained throughout the dose interval (for up to four days). Absorption rate may vary between individual patients. After removal of the last patch plasma estradiol and estrone concentrations return to baseline values in less than 24 hours.

Estradiol is mainly metabolized in the liver. Its main metabolites are estriol, estrone, and their conjugates. The plasma half life of estradiol is 1-2 hours. Metabolic plasma clearance varies between 450-625 ml/min/m². The metabolites are mainly excreted via the kidneys as glucuronides and sulphates. Estrogens also undergo enterohepatic circulation.

5.3 Preclinical Safety Data

No additional information is available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Diethyltoluamide

Acrylic adhesive (Dow Corning MG-0560)

Acrylic emulsion (Acrysol 33)

Backing: Polyester film (Scotchpak 9733)

Release liner: Siliconised aluminised polyester

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25 °C. Store in the original package.

6.5 Nature And Contents Of Container

Sachet made out of laminate comprising of paper (clay coated), bonding layer of LDPE, aluminium foil and heat seal layer of LDPE containing one transdermal patch . Each carton contains eight patches, sufficient for one 28 day cycle and a patient leaflet. An additional pack containing two patches may also be available.

6.6 Special Precautions For Disposal And Other Handling

Detailed instructions for use are provided in the patient leaflet.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

8. Marketing Authorisation Number(S)

PL 15142/0060

9. Date Of First Authorisation/Renewal Of The Authorisation

26 February 2002

10. Date Of Revision Of The Text

1^st August 2009

Midrin

Generic Name: isometheptene, dichloralphenazone, and acetaminophen (Oral route)

eye-soe-meth-EP-teen MUE-kate, dye-klor-al-FEN-a-zone, a-seet-a-MIN-oh-fen

Commonly used brand name(s)

In the U.S.

• Amidrine


• Diacetazone


• Duradrin


• Epidrin


• Iso-Acetazone


• Midrin


• Migquin


• Migratine


• Migrazone


• Migrin-A


• Nodolor


• Va-Zone

Available Dosage Forms:

• Capsule

Therapeutic Class: Acetaminophen Combination

Pharmacologic Class: Isometheptene

Uses For Midrin

Isometheptene, dichloralphenazone, and acetaminophen combination is used to treat certain kinds of headaches, such as “tension” headaches and migraine headaches. This combination is not used regularly (for example, every day) to prevent headaches. It should be taken only after headache pain begins, or after a warning sign that a migraine is coming appears. Isometheptene helps to relieve throbbing headaches, but it is not an ordinary pain reliever. Dichloralphenazone helps you to relax, and acetaminophen relieves pain.

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

Before Using Midrin

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

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this combination medicine in the elderly with use in other age groups.

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.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

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.

• Bromocriptine


• Fospropofol

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.

• Acenocoumarol


• Carbamazepine


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

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

• Ethanol

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.

• Cabbage

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:

• Alcohol abuse or


• Heart attack (recent) or


• Heart or blood vessel disease or


• Kidney disease or


• Liver disease or


• Stroke (recent) or


• Virus infection of the liver (viral hepatitis)—The chance of side effects may be increased

• Glaucoma, not well controlled, or


• High blood pressure (hypertension), not well controlled—The isometheptene in this combination medicine may make these conditions worse

Proper Use of isometheptene, dichloralphenazone, and acetaminophen

This section provides information on the proper use of a number of products that contain isometheptene, dichloralphenazone, and acetaminophen. It may not be specific to Midrin. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often than directed, and do not take it every day for several days in a row. If the amount you are to take does not relieve your headache, check with your doctor. If a headache medicine is used too often, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse. Also, taking too much acetaminophen can cause liver damage.

This medicine works best if you:

• Take it as soon as the headache begins. If you get warning signals of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring.


• Lie down in a quiet, dark room until you are feeling better.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve, than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with 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 “tension” headaches:
  
  • Adults: 1 or 2 capsules every 4 hours, as needed. Not more than 8 capsules a day.
  
  
  • Children: Dose must be determined by the doctor.
  
  


• For migraine headaches:
  
  • Adults: 2 capsules for the first dose, then 1 capsule every hour, as needed. Not more than 5 capsules in 12 hours.
  
  
  • Children: Dose must be determined by the doctor.
  
  

Precautions While Using Midrin

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better relief by increasing the dose.


• If you are having headaches more often than you did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. Taking other medicines that contain acetaminophen together with this medicine may lead to an overdose. If you have any questions about this, check with your health care professional.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with this medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; antiemetics (medicines that prevent or relieve nausea or vomiting), and anesthetics. If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are drowsy or dizzy or are not alert.

Do not drink alcoholic beverages while taking this medicine. To do so may increase the chance of liver damage caused by acetaminophen, especially if you drink large amounts of alcoholic beverages regularly. Also, because drinking alcoholic beverages may make your headaches worse or cause new headaches to occur, people who often get headaches should probably avoid alcohol.

Midrin 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 as soon as possible if any of the following side effects occur:

Less common

• Unusual tiredness or weakness

Rare

• Black, tarry stools


• blood in urine or stools


• pinpoint red spots on skin


• skin rash, hives, or itching


• sore throat and fever


• unusual bleeding or bruising


• yellow eyes or skin

Symptoms of dependence on this medicine

• Headaches, more severe and/or more frequent than before

Symptoms of acetaminophen overdose

• Diarrhea


• increased sweating


• loss of appetite


• nausea or vomiting


• pain, tenderness, and/or swelling in the upper abdominal (stomach) area


• stomach cramps or pain

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

• Drowsiness

Rare

• Dizziness


• fast or irregular heartbeat

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: Midrin side effects (in more detail)

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

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

More Midrin resources

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

• Midrin Concise Consumer Information (Cerner Multum)


• Midrin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Midrin with other medications

• Headache

Crixivan

Pronunciation: in-DIN-a-vir
Generic Name: Indinavir
Brand Name: Crixivan

Crixivan is used for:

Treating HIV infection in some patients when used in combination with certain other medicines.

Crixivan is an HIV protease inhibitor. It works by slowing the growth of HIV, the virus that causes AIDS.

Do NOT use Crixivan if:

• you are allergic to any ingredient in Crixivan


• you are taking alfuzosin, amiodarone, astemizole, atazanavir, certain benzodiazepines (eg, alprazolam, oral midazolam, triazolam), cisapride, conivaptan, an ergot alkaloid (eg, ergonovine, ergotamine), erythromycin, certain HMG-CoA reductase inhibitors (eg, lovastatin, rosuvastatin, simvastatin), pimozide, a proton pump inhibitor (eg, omeprazole), ranolazine, rifampin, salmeterol, a serotonin 5-HT₁ receptor antagonist (eg, eletriptan, sumatriptan), St. John's wort, or terfenadine


• you are taking sildenafil for pulmonary arterial hypertension (PAH)

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

Before using Crixivan:

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

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


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


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


• if you have cirrhosis, liver or kidney problems, diabetes, high blood sugar, high cholesterol, kidney stones, urinary problems (eg, white blood cells in the urine), or blood problems (eg, hemophilia hemolytic anemia)

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

• Amiodarone, astemizole, certain benzodiazepines (eg, alprazolam, midazolam,triazolam), cisapride, ergot alkaloids (eg, ergotamine), erythromycin, pimozide, salmeterol, or terfenadine because serious side effects, such as increased or prolonged sedation or breathing problems, seizures, blood vessel problems, or heart problems (eg, irregular heartbeat), may occur


• Atazanavir because it may increase the risk of a buildup of bilirubin in the blood


• Proton pump inhibitors (eg, omeprazole), rifampin, or St. John's wort because they may decrease Crixivan's effectiveness


• Alfuzosin, conivaptan, certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, rosuvastatin, simvastatin), ranolazine, serotonin 5-HT₁ receptor antagonists (eg, eletriptan, sumatriptan), or sildenafil (for PAH) because the risk of their side effects may be increased by Crixivan


• Many prescription and nonprescription medicines (eg, used for infections, HIV, inflammation, allergic reactions, breathing problems, pain, birth control, blood thinning, cancer, gout, irregular heartbeat, other heart problems, high blood pressure, high cholesterol, immune suppression, erectile dysfunction, , PAH, seizures, sleep disorders, depression, other mood or mental problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Crixivan, increasing the risk of their side effects

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

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

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


• Take Crixivan by mouth on an empty stomach at least 1 hour before or 2 hours after eating. You may also take it with a light meal that is low in calories, fat, and protein. Take Crixivan with water. You may also take it with other liquids such as skim milk, juice, coffee, or tea.


• Drinking extra fluids while you are taking Crixivan is recommended. You should drink at least 48 oz (1.5 L) of water a day unless otherwise directed by your doctor.


• If you take didanosine, ask your doctor or pharmacist how to take it with Crixivan.


• Large amounts of garlic may decrease the effectiveness of Crixivan. Talk with your doctor before including garlic in your diet.


• Take Crixivan on a regular schedule every 8 hours around the clock, unless your doctor tells you otherwise.


• Take Crixivan on a regular schedule to get the most benefit from it. Taking Crixivan at the same time each day will help you remember to take it.


• Continue to take Crixivan even if you feel well. Do not miss any doses.


• If you miss a dose of Crixivan by more than 2 hours, do not take that dose. Take your next dose as scheduled. If you miss the dose by less than 2 hours, take that dose immediately and then return to your regular dosing schedule. It is important not to miss doses of Crixivan. Do not take 2 doses at once.

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

Important safety information:

• Crixivan may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Crixivan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Crixivan is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Crixivan does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Crixivan, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Crixivan may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Crixivan.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Crixivan. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


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


• Diabetes patients - Crixivan may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Crixivan. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Lab tests, including liver function, cholesterol, complete blood cell counts, and CD4 counts, may be performed while you use Crixivan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Crixivan in CHILDREN; they may be more sensitive to its effects, especially kidney stones.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Crixivan while you are pregnant. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Crixivan to the baby. It is not known if Crixivan is found in breast milk. Do not breast-feed while taking Crixivan.

Possible side effects of Crixivan:

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

Bad taste in the mouth; diarrhea; dizziness; drowsiness; headache; nausea; tiredness; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back, flank, or side pain; bloody or cloudy urine; change in the amount of urine; changes in appetite; chest pain; chills; confusion; dark urine; fast or irregular heartbeat; fever; flushed face; heartburn; ingrown toenails; joint or muscle aches; mental or mood changes; numbness of the mouth; one-sided numbness or weakness; pain while urinating; pale stools; red, swollen, or blistered skin; severe dizziness or fainting; severe or persistent stomach pain or upset; speech problems; swelling of the feet, hands, lower legs, or stomach; unusual hair loss; unusual paleness; unusual tiredness; unusually dry skin; vision changes; weight changes; yellowing of the skin or eyes.

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

See also: Crixivan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blood in the urine; diarrhea; lower back pain; nausea; vomiting.

Proper storage of Crixivan:

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

General information:

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


• Crixivan is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Crixivan resources

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

• Crixivan Prescribing Information (FDA)


• Crixivan Concise Consumer Information (Cerner Multum)


• Crixivan Monograph (AHFS DI)


• Crixivan Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Crixivan with other medications

• HIV Infection
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• Occupational Exposure

Boots Alternatives Diet Aid

Boots Alternatives Diet Aid

(Boldo, Dandelion Root, Fucus)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains a combination of herbal ingredients, which have traditionally been used for their effect on the body’s metabolism to help weight loss.

It can be used to help you lose weight when you follow a calorie-controlled diet.

Before you take this medicine

This medicine can be taken by adults. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• 
  If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose)


• 
  If you are pregnant or breastfeeding
  

Talk to your pharmacist or doctor:

• If you are taking any other medicines, including medicines prescribed by your doctor and any medicine you have bought for yourself, including herbal and homeopathic remedies

Other important information

Information about some of the ingredients in this medicine: The colour sunset yellow (E110) in this medicine may cause allergic reactions.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Adults: Take one tablet three times a day after meals.

Swallow each tablet with water.

Do not give to children.

Do not take more than the amount recommended above.

If you take too many tablets: Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

This medicine is not expected to cause side effects.

If you notice any side effect, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25ºC.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each tablet contains Boldo Dry Extract 135 mg, Dandelion Root Powder 30 mg, Fucus Dry Extract 225 mg, which are the active ingredients.

As well as the active ingredients, the tablet also contains cascara powder, acacia, pregelatinised maize starch, icing sugar, talc, stearic acid, colloidal silica. The tablet coating contains shellac, sucrose, calcium carbonate, acacia, titanium dioxide (E171), sunset yellow (E110), carnauba wax, beeswax.

The pack contains 60 coated tablets

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by

Surepharm Services Ltd

Burton Upon Trent

DE15 0YZ

Marketing Authorisation held by

Frank Roberts (Herbal Dispensaries) Ltd

Dean Street

Bristol

BS2 8FR

Leaflet prepared February 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Additional Information

The boldo plant which is used for its leaves, is indigenous to Chile. It is also cultivated in the mountainous regions of the Mediterranean.

Fucus, otherwise known as bladderwrack, seawrack or kelp, is a seaweed common in the cold waters off the British coast.

Useful Health Tips

Avoid drastic dieting as it puts a strain on your health and any weight lost is often rapidly put back on again once the diet is over. Instead, choose a long term diet that you enjoy and that fits in with your life style. For example, choose low fat but filling meals that include pasta, rice or potatoes with salad and a small portion of lean meat or fish. Maximum benefit will be derived from accompanying the diet with moderate intensity activity for at least 30 minutes five times a week. Always consult a doctor before starting a diet or an exercise programme.

Proepa

Generic Name: omega-3 polyunsaturated fatty acids (oh MAY ga 3 POL ee un SAT yoo ray ted FAT ee AS ids)

Brand Names: Animi-3, Animi-3 with Vitamin D, Divista, EPA Fish Oil, Fish Oil, Fish Oil Ultra, Icar Prenatal Essential Omega-3, Lovaza, Marine Lipid Concentrate, MaxEPA, MaxiTears Dry Eye Formula, MaxiVision Omega-3 Formula, Mi-Omega NF, Omega-500, Sea-Omega, Sea-Omega 30, TheraTears Nutrition, TherOmega

What is Proepa (omega-3 polyunsaturated fatty acids)?

Omega-3 polyunsaturated fatty acids are found in oil from certain types of fish, vegetables, and other plant sources. These fatty acids are not made by the body and must be consumed in the diet. Omega-3 polyunsaturated fatty acids work by lowering the body's production of triglycerides. High levels of triglycerides can lead to coronary artery disease, heart disease, and stroke.

Omega-3 polyunsaturated fatty acids are used together with diet and exercise to help lower triglyceride levels in the blood.

Omega-3 polyunsaturated fatty acids may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Proepa (omega-3 polyunsaturated fatty acids)?

Take this medication exactly as directed on the label, or as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended.

Swallow the omega-3 polyunsaturated capsule whole. Do not puncture or open the capsule.

This medication is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

There may be other drugs that can interact with omega-3 polyunsaturated fatty acids. 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.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What should I discuss with my health care provider before taking Proepa (omega-3 polyunsaturated fatty acids)?

Do not use this medication if you are allergic to fish or soybeans.

Ask a doctor or pharmacist about using this medicine if you have:

• 
  

  diabetes;

  
  


• 
  

  liver disease;

  
  


• 
  

  a pancreas disorder;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  if you drink more than 2 alcoholic beverages per day.

  
  

FDA pregnancy category C. It is not known whether omega-3 polyunsaturated fatty acids will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether omega-3 polyunsaturated fatty acids pass into breast milk or if this could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old.

How should I take Proepa (omega-3 polyunsaturated fatty acids)?

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.

Swallow the omega-3 polyunsaturated capsule whole. Do not puncture or open the capsule. This medication works best if you take it with food.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

This medication is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

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.

What should I avoid while taking Proepa (omega-3 polyunsaturated fatty acids)?

Avoid eating foods that are high in fat or cholesterol. This medication will not be as effective in lowering your triglycerides if you do not follow the diet plan recommended by your doctor.

Avoid drinking alcohol. It can increase triglycerides and may make your condition worse.

Proepa (omega-3 polyunsaturated fatty acids) 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:

• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  chest pain; or

  
  


• 
  

  uneven heartbeats.

  
  

Less serious side effects may include:

• 
  

  back pain;

  
  


• 
  

  unusual or unpleasant taste in your mouth;

  
  


• 
  

  upset stomach, belching; or

  
  


• 
  

  mild skin rash.

  
  

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 Proepa (omega-3 polyunsaturated fatty acids)?

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

• 
  

  estrogens (birth control pills or hormone replacement);

  
  


• 
  

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

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  a diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HydroDIURIL, Microzide), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

  
  

This list is not complete and other drugs may interact with omega-3 polyunsaturated fatty acids. 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 Proepa resources

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

• Animi-3 MedFacts Consumer Leaflet (Wolters Kluwer)


• Animi-3 with Vitamin D Prescribing Information (FDA)


• Divista Prescribing Information (FDA)


• Divista MedFacts Consumer Leaflet (Wolters Kluwer)


• Fish Oil Consumer Overview


• Lovaza Prescribing Information (FDA)


• Lovaza Advanced Consumer (Micromedex) - Includes Dosage Information


• Lovaza MedFacts Consumer Leaflet (Wolters Kluwer)


• Mi-Omega NF Prescribing Information (FDA)


• Omacor Prescribing Information (FDA)


• Omacor Consumer Overview


• Omacor Monograph (AHFS DI)

Compare Proepa with other medications

• ADHD
• Dietary Supplementation
• Hypertriglyceridemia

Where can I get more information?

• Your pharmacist can provide more information about omega-3 polyunsaturated fatty acids.

See also: Proepa side effects (in more detail)