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Hydrochlorothiazide
Dosage Form: tabletHydrochlorothiazide Capsules 12.5 mg Hydrochlorothiazide Description

Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is:

It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate and black iron oxide.

Hydrochlorothiazide - Clinical Pharmacology

Hydrochlorothiazide blocks the reabsorption of sodium and chloride ions, and it thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of Hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen and chloride ions. Hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide and may reduce glomerular filtration rate. Metabolic toxicities associated with excessive electrolyte changes caused by Hydrochlorothiazide have been shown to be dose-related.

Pharmacokinetics and Metabolism

Hydrochlorothiazide is well absorbed (65% to 75%) following oral administration. Absorption of Hydrochlorothiazide is reduced in patients with congestive heart failure.

Peak plasma concentrations are observed within 1 to 5 hours of dosing, and range from 70 to 490 ng/mL following oral doses of 12.5 to 100 mg. Plasma concentrations are linearly related to the administered dose. Concentrations of Hydrochlorothiazide are 1.6 to 1.8 times higher in whole blood than in plasma. Binding to serum proteins has been reported to be approximately 40% to 68%. The plasma elimination half-life has been reported to be 6 to 15 hours. Hydrochlorothiazide is eliminated primarily by renal pathways. Following oral doses of 12.5 to 100 mg, 55% to 77% of the administered dose appears in urine and greater than 95% of the absorbed dose is excreted in urine as unchanged drug. In patients with renal disease, plasma concentrations of Hydrochlorothiazide are increased and the elimination half-life is prolonged.

When Hydrochlorothiazide is administered with food, its bioavailability is reduced by 10%, the maximum plasma concentration is reduced by 20%, and the time to maximum concentration increases from 1.6 to 2.9 hours.

Pharmacodynamics

Acute antihypertensive effects of thiazides are thought to result from a reduction in blood volume and cardiac output, secondary to a natriuretic effect, although a direct vasodilatory mechanism has also been proposed. With chronic administration, plasma volume returns toward normal, but peripheral vascular resistance is decreased. The exact mechanism of the antihypertensive effect of Hydrochlorothiazide is not known.

Thiazides do not affect normal blood pressure. Onset of action occurs within 2 hours of dosing, peak effect is observed at about 4 hours, and activity persists for up to 24 hours.

Clinical Studies

In an 87 patient 4-week double-blind, placebo controlled, parallel group trial, patients who received Hydrochlorothiazide had reductions in seated systolic and diastolic blood pressure that were significantly greater than those seen in patients who received placebo. In published placebo-controlled trials comparing 12.5 mg of Hydrochlorothiazide to 25 mg, the 12.5 mg dose preserved most of the placebo-corrected blood pressure reduction seen with 25 mg.

Indications and Usage for Hydrochlorothiazide

Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, Hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.

Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.

Contraindications

Hydrochlorothiazide capsules are contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.

Warnings

 Acute Myopia and Secondary Angle-Closure Glaucoma:  Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue Hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Diabetes and Hypoglycemia: Latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose.

Renal Disease: Cumulative effects of the thiazides may develop in patients with impaired renal function. In such patients, thiazides may precipitate azotemia.

Precautions Electrolyte and Fluid Balance Status

In published studies, clinically significant hypokalemia has been consistently less common in patients who received 12.5 mg of Hydrochlorothiazide than in patients who received higher doses. Nevertheless, periodic determination of serum electrolytes should be performed in patients who may be at risk for the development of hypokalemia. Patients should be observed for signs of fluid or electrolyte disturbances, i.e. hyponatremia, hypochloremic alkalosis, and hypokalemia and hypomagnesemia.

Warning signs or symptoms of fluid and electrolyte imbalance include 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, especially with brisk diuresis when severe cirrhosis is present, during concomitant use of corticosteroid or adrenocorticotropic hormone (ACTH) or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of digitalis. Hypokalemia may be avoided or treated by potassium supplementation or increased intake of potassium rich foods.

Dilutional hyponatremia is life-threatening and may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia

Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics.

Impaired Hepatic Function

Thiazides should be used with caution in patients with impaired hepatic function. They can precipitate hepatic coma in patients with severe liver disease.

Parathyroid Disease

Calcium excretion is decreased by thiazides, and pathologic changes in the parathyroid glands, with hypercalcemia and hypophosphatemia, have been observed in a few patients on prolonged thiazide therapy.

Drug Interactions

When given concurrently the following drugs may interact with thiazide diuretics:

Alcohol, barbiturates, or narcotics - potentiation of orthostatic hypotension may occur.

Antidiabetic drugs - (oral agents and insulin) dosage adjustment of the antidiabetic drug may be required.

Other antihypertensive drugs - additive effect or potentiation.

Cholestyramine and colestipol resins - Cholestyramine and colestipol resins bind the Hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.

Corticosteroid, ACTH – intensified electrolyte depletion, particularly hypokalemia.

Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant.

Lithium - generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and greatly increase the risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with Hydrochlorothiazide.

Non-steroidal anti-inflammatory drugs - In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. When Hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained.

Drug/Laboratory Test Interactions - Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of Hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of Hydrochlorothiazide from 43 to 1300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.

Pregnancy

Teratogenic Effects

Pregnancy Category B: Studies in which Hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg Hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers

Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Hydrochlorothiazide, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Elderly Use

A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e., >65 years) with Hydrochlorothiazide. Starting treatment with the lowest available dose of Hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.

Adverse Reactions

The adverse reactions associated with Hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg Hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of Hydrochlorothiazide 25 mg and greater and, within each category, are listed in the order of decreasing severity.

Body as a whole: Weakness.

Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal: Muscle spasm.

Nervous System/Psychiatric: Vertigo, paresthesia, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS).

Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia.

Special Senses: Transient blurred vision, xanthopsia.

Urogenital: Impotence.

Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Overdosage

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.

The oral LD50 of Hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

Hydrochlorothiazide Dosage and Administration

For Control of Hypertension: The adult initial dose of Hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.

How is Hydrochlorothiazide Supplied

Hydrochlorothiazide capsules 12.5 mg are available as hard gelatin capsules with opaque white cap and opaque white body imprinted with "TEVA" on cap and "2080" on the body in grey ink along the horizontal axis.

Bottle of 100: NDC 0093-2080-01

Bottle of 1000: NDC 0093-2080-10

Store at 20°  to 25° C (68°  to 77° F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20° C (-4° F). Keep container tightly closed.

Rx only

Manufactured In India By:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne,

Bardez, Goa 403 511, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

[13004199]

R-01-08/2011

PRINCIPAL DISPLAY PANEL Hydrochlorothiazide Capsules 12.5 mg 100s Label Text

NDC 0093-2080-01

Hydrochlorothiazide

Capsules

12.5 mg

Rx only

100 CAPSULES

TEVA

Hydrochlorothiazide 


Hyperlipoproteinemia Medications
Drugs associated with Hyperlipoproteinemia

The following drugs and medications are in some way related to, or used in the treatment of Hyperlipoproteinemia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Hyperlipoproteinemia Hyperlipoproteinemia Type IIa, Elevated LDL (27 drugs) Hyperlipoproteinemia Type IIb, Elevated LDL VLDL (26 drugs) Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL (5 drugs) Hyperlipoproteinemia Type IV, Elevated VLDL (20 drugs) Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL (15 drugs) Drug List: Advicor Altocor Altoprev-Extended-Release-Tablets Antara Atromid-S B-3-50-Nicotinic-Acid B3-500-Gr-Nicotinic-Acid Cholestyramine-Light Colestid Colestid-Flavored Crestor Fenoglide Lescol Lescol-Xl-Extended-Release-Tablets Lipitor Lipofen Locholest Locholest-Light Lofibra Lopid Mevacor Niacin-Sr-Nicotinic-Acid Niacor Niaspan Nicotinex Pravachol Prevalite-Powder Questran-Powder Questran-Light Simcor Slo-Niacin-Controlled-Release-Capsules Tricor Triglide Welchol Zocor


Heart Disease Medications

Definition of Heart Disease:

Heart disease is any disorder that affects the heart's ability to function normally. The most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart itself. This happens slowly over time. (See coronary artery disease.)

Some heart diseases can be present at birth (congenital heart diseases).

Drugs associated with Heart Disease

The following drugs and medications are in some way related to, or used in the treatment of Heart Disease. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Heart Disease Abnormal Electrocardiogram (0 drugs) Arrhythmia (276 drugs in 26 topics) Cardiomyopathy (9 drugs in 6 topics) Endocarditis (74 drugs in 3 topics) Heart Failure (100 drugs) Hemopericardium (0 drugs in 2 topics) Ischemic Heart Disease (316 drugs in 12 topics) Pericarditis (0 drugs in 3 topics) Learn more about Heart Disease

Micromedex Care Notes:

Atrial Septal Defect Atrial Septal Defect In Children Infective Endocarditis Myocarditis Palpitations Tetralogy Of Fallot In Children Ventricular Septal Defect In Children

Medical Encyclopedia:

Atrial septal defect Congenital heart disease Coronary heart disease Endocarditis Heart attack Heart disease Heart murmurs and other sounds Heart palpitations Mitral regurgitation - acute Myocarditis Rheumatic fever Tetralogy of Fallot Truncus arteriosus Ventricular septal defect Drug List: Evening-Primrose-Oil Primrose-Oil


Heartburn Relief

Generic Name: famotidine (fam OH ti deen) Brand Names: Heartburn Relief, Leader Acid Reducer, Pepcid, Pepcid AC, Pepcid AC Maximum Strength

What is Heartburn Relief (famotidine)?

Famotidine a histamine-2 blockers. Famotidine works by decreasing the amount of acid the stomach produces.

Famotidine is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Famotidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

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

What is the most important information I should know about Heartburn Relief (famotidine)? You should not use this medication if you are allergic to famotidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

Before taking famotidine, tell your doctor if you have kidney or liver disease, a history of Long QT syndrome, stomach cancer or other problems, or asthma, COPD, or other breathing problems.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or nizatidine (Axid) while you are taking famotidine, unless your doctor has told you to.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Famotidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

What should I discuss with my healthcare provider before taking Heartburn Relief (famotidine)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medication if you are allergic to famotidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

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

kidney disease; liver disease;

a personal or family history of Long QT syndrome;

stomach cancer or other problems; or

asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Famotidine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Heartburn Relief (famotidine)?

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 thoroughly before swallowing.

Shake the oral suspension (liquid) for 5 to 10 seconds before you measure a dose. Measure the liquid with a special dose-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. Although most ulcers heal within 4 weeks of famotidine treatment, it may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Famotidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.

Throw away any unused famotidine liquid that is older than 30 days.

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.

Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, fast heart rate, or fainting.

What should I avoid while taking Heartburn Relief (famotidine)? Avoid drinking alcohol. It can increase the risk of damage to your stomach.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or nizatidine (Axid) while you are taking famotidine, unless your doctor has told you to.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Heartburn Relief (famotidine) 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 famotidine and call your doctor at once if you have a serious side effect such as:

easy bruising or bleeding;

fast or pounding heartbeat;

confusion, hallucinations, seizure;

numbness or tingly feeling; or

jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

nausea, vomiting, diarrhea, constipation;

dry mouth;

dizziness, weakness, mood changes;

headache; or

muscle cramps, joint pain.

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 Heartburn Relief (famotidine)?

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

atazanavir (Reyataz);

itraconazole (Sporanox);

ketoconazole (Nizoral); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with famotidine. 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 Heartburn Relief resources Heartburn Relief Side Effects (in more detail) Heartburn Relief Use in Pregnancy & Breastfeeding Heartburn Relief Drug Interactions Heartburn Relief Support Group 0 Reviews for Heartburn Relief - Add your own review/rating Heartburn Relief Advanced Consumer (Micromedex) - Includes Dosage Information Famotidine Professional Patient Advice (Wolters Kluwer) Famotidine Monograph (AHFS DI) Famotidine MedFacts Consumer Leaflet (Wolters Kluwer) Pepcid Consumer Overview Pepcid Prescribing Information (FDA) Pepcid Injection Prescribing Information (FDA) Compare Heartburn Relief with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome Where can I get more information? Your pharmacist can provide more information about famotidine.

See also: Heartburn Relief side effects (in more detail)


Halaven

Generic Name: eribulin (Intravenous route)

er-i-BUE-lin MES-i-late

Commonly used brand name(s)

In the U.S.

Halaven

Available Dosage Forms:

Solution

Pharmacologic Class: Eribulin

Uses For Halaven

Eribulin belongs to the group of medicines called antineoplastics (cancer medicines). It is used to treat metastatic (cancer that has already spread) breast cancer. This medicine is used in patients who have already received at least two types of cancer medicines.

Eribulin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by this medicine, other side effects may occur. Some of these may be serious and must be reported to your doctor right away. Some unwanted effects may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.

Before you begin treatment with eribulin, you and your doctor should talk about the benefits of this medicine as well as the risks.

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

Before Using Halaven

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

Allergies

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

Pediatric

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

Geriatric

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

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

Blood or bone marrow problems (e.g., cytopenia, neutropenia) or Congestive heart failure or Heart rhythm problems (e.g., arrhythmias, QT prolongation) or Mineral imbalance (e.g., low magnesium or potassium in the blood) or Nerve problems (e.g., peripheral neuropathy)—Use with caution. May make these conditions worse. or Heart rhythm problem (e.g., congenital long QT syndrome)—Eribulin injection should not be given in patients with this condition. Kidney disease or Liver disease—Use with caution. You may require a lower dose of this medicine. Talk with your doctor if you have concerns about this. Proper Use of Halaven

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine is usually given on Day 1 and Day 8 of a 21-day cycle of treatment. This 2-day treatment is given again every 21 days until your body responds to the medicine or you and your doctor decide to stop the treatment. Each treatment usually takes about 2 to 5 minutes.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using Halaven

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Eribulin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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

Halaven Side Effects

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

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

More common Black, tarry stools bladder pain bloating or swelling of the face, arms, hands, lower legs, or feet bloody or cloudy urine body aches or pain burning, numbness, tingling, or painful sensations chills convulsions cough decreased urine decreased weight difficult or labored breathing difficult, burning, or painful urination dry mouth ear congestion fever frequent urge to urinate headache increased thirst irregular heartbeat loss of appetite loss of voice lower back or side pain mood changes muscle pain or cramps nasal congestion nausea or vomiting numbness or tingling in the hands, feet, or lips pale skin rapid weight gain runny nose shortness of breath sneezing sore throat tightness in the chest troubled breathing with exertion ulcers, sores, or white spots in the mouth unsteadiness or awkwardness unusual bleeding or bruising unusual tiredness or weakness unusual weight gain or loss weakness in the arms, hands, legs, or feet wheezing Incidence not known Fainting irregular heartbeat, recurrent

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

More common Acid or sour stomach back pain belching bone pain change in taste cracked lips depression diarrhea difficulty having a bowel movement (stool) difficulty with moving difficulty with swallowing dizziness hair loss or thinning of the hair heartburn indigestion lack or loss of strength loss of taste muscle spasm or weakness muscle stiffness pain in the arms or legs pain in the joints rash sleeplessness sores, ulcers, or white spots on the lips, tongue, or inside the mouth stomach discomfort, upset, or pain swelling or inflammation of the mouth trouble sleeping unable to sleep watering of the eyes weight loss

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: Halaven 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 Halaven resources Halaven Side Effects (in more detail) Halaven Use in Pregnancy & Breastfeeding Halaven Drug Interactions Halaven Support Group 3 Reviews for Halaven - Add your own review/rating Halaven Prescribing Information (FDA) Halaven MedFacts Consumer Leaflet (Wolters Kluwer) Halaven Consumer Overview Compare Halaven with other medications Breast Cancer Breast Cancer, Metastatic


Hydralazine Tablets BP 25mg
1. Name Of The Medicinal Product

HYDRALAZINE TABLETS BP 25mg

2. Qualitative And Quantitative Composition

Each tablet contains 25mg Hydralazine Hydrochloride.

For excipients, see 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Ivory, circular, biconvex film-coated tablets impressed “C” on one face and the identifying letters “HY” on the reverse.

4. Clinical Particulars 4.1 Therapeutic Indications

Hydralazine is indicated for:

1) Moderate to severe hypertension (in conjunction with a beta-adrenoceptor blocking agent or diuretic) and hypertensive crisis.

2) The management of moderate to severe congestive cardiac failure (reduces afterload), where optimal doses of diuretics and cardiac glycosides prove insufficient. In patients with high left ventricular filling pressure, it is recommended to combine hydralazine with a nitrate.

4.2 Posology And Method Of Administration

For oral administration.

Adults: Dosage should not be increased beyond 100mg daily without first checking the patient's acetylator status.

Hypertension: The dose should be adjusted to the individual requirements of the patient. Treatment should begin with low doses of hydralazine which, depending on the patient's response, should be increased stepwise to achieve optimal therapeutic effect whilst keeping unwanted effects to a minimum. Initially 25mg twice daily. This can be increased gradually to a dose not exceeding 200mg daily.

Chronic congestive heart failure: Treatment with hydralazine should always be initiated in hospital, where the patient's individual haemodynamic values can be reliably determined with the help of invasive monitoring. It should then be continued in hospital until the patient has become stabilised on the requisite maintenance dose. Doses vary greatly between individual patients and are generally higher than those used for treating hypertension. After progressive titration (initially 25mg 3-4 times daily) the maintenance dosage averages 75mg four times daily.

Children: Not recommended for this age group.

Elderly: Clinical evidence indicates that no special dosage regime is necessary. Advancing age does not affect either blood concentration or systemic clearance. Renal elimination may however be affected in so far as kidney function diminishes with age.

4.3 Contraindications

Hydralazine should not be given to patients with tachycardia and also in cases of left ventricular failure due to severe aortic or mitral stenosis or in constrictive pericarditis; in heart failure associated with high output (ie in thyrotoxicosis); isolated right ventricular failure due to pulmonary hypertension (ie cor pulmonale); hypersensitivity to hydralazine and dihydralazine or to any of the excipients. Idiopathic system lupus erythematosus (SLE) and related diseases. Dissecting aortic aneurism. Porphyria.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with coronary disease (may provoke angina), in those undergoing anaesthesia (which may precipitate severe hypotension) or in patients with cerebrovascular disease.

Avoid after myocardial infarction until stabilised.

During long-term therapy with hydralazine, it is advisable to determine the antinuclear factors and conduct urinalysis (for microhaematuria and proteinuria) at intervals of approximately 6 months. In the event of positive findings for antinucuclear factors, the titres should be monitored more frequently. At the first signs or symptoms suggestive of SLE or renal disease, hydralazine should be withdrawn, (see also under “other undesirable effects”).

In severe renal failure the interval between doses should be prolonged to avoid accumulation; also in hepatic dysfunction a reduction in dosage or prolonged dosage interval may be indicated.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potentiation of effects: Concurrent treatment with other antihypertensives, muscle relaxants (baclofen and tizonidine), nitrates, anaesthetics, minor tranquillisers, antidepressants, levodopa or drugs exerting a central depressant action (including alcohol).

Reduction in effects: Concomitant treatment with sympathomimetics, tricyclic antidepressants or MAOI's, NSAIDs, corticosteroids.

4.6 Pregnancy And Lactation

Due to the discovery that hydralazine has a teratogenic effect in mice, causing a small incidence of cleft palate and certain other minor bone malformations in doses ranging from 20-120mg/kg; its use should be avoided in pregnancy during the period of organogenesis, that is the first half of pregnancy. Hydralazine crosses the placental barrier and is excreted in breast milk. Mothers who are receiving hydralazine should not therefore breast feed their infants.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Tachycardia, palpitations, headache, flushing, dizziness, anorexia, angina, nasal congestion, nausea and vomiting can occur, but may be minimised by the prior administration of a beta blocker. Fluid retention.

Patients may occasionally develop symptoms suggestive of rheumatoid arthritis. Skin reactions and fever may occur producing a syndrome similar to systemic lupus erythematosus. This is more likely to occur with high dosage regimes (more than 200mg daily). If such symptoms develop the drug should be gradually withdrawn, when remission will usually occur.

Rarely: Anaemia, leucopenia, neutropenia, thrombocytopenia with or without purpura, proteinuria, increased plasma creatinine, haematuria, dyspnoea and pleural pain.

Isolated cases: Haemolytic anaemia, leucocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis.

Occasionally liver damage may occur resembling an hepatitis-like syndrome which is reversible on withdrawal of the drug. Isolated cases of glomerulonephritis have been reported. Hydralazine should be withdrawn if anxiety, depression, febrile reactions, change in blood count or skin rash occur. Rare cases of peripheral neuritis, causing paraesthesia, may be reversed by the administration of pyridoxine, or by withdrawal of hydralazine.

4.9 Overdose

Symptoms including hypotension, tachycardia, myocardial ischaemia, dysrrhythmias and coma.

Gastric lavage or, in the absence of coma, emetic treatment should be given as soon as possible. If hypotension is present, an attempt should be made to raise blood pressure without increasing tachycardia, hence adrenaline (epinephrine) should be avoided. Supportive measures such as intravenous fluids and elevation of foot of bed are also indicated. Cautious administration of angiotensin or noradrenaline (norepinephrine) intravenously may be of use.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Hydralazine hydrochloride is a vasodilator and antihypertensive agent.

Hydralazine is a direct acting vasodilator which exerts a moderate but significant antihypertensive effect (diastolic more than systolic) principally on the arterioles. It tends to improve the renal, uterine and cerebral blood flow. The effect results in a decrease in arterial blood pressure and peripheral vascular resistance, and an increase in heart rate, reflex tachycardia, stroke volume and cardiac output. The rise in cardiac output accompanies the fall in blood pressure, probably as a reflex response; (hydralazine also serves to improve renal blood flow and renal function). Hydralazine lowers blood pressure seemingly by exerting an arteriolar dilating effect through a direct relaxation of vascular smooth muscle.

In heart failure cardiac output is improved as a result of the afterload reduction which is induced by hydralazine; tachycardia or hypotension are seldom seen in this group.

5.2 Pharmacokinetic Properties

Hydralazine is rapidly absorbed from the gastrointestinal tract and peak plasma concentrations have been reported to occur in the plasma after about one hour. It is metabolised by hydroxylation of the ring system and conjugation with glucuronic acid, and by N-acetylation.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

The tablet core contains: polyvidone, disodium edetate, microcrystalline cellulose (E460), magnesium stearate.

The coating contains: hypromellose (E464), titanium dioxide (E171), lactose monohydrate, macrogol, glycerol triacetate (E1518), iron oxide (E172).

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Polypropylene and polyethylene containers

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

Blister packs

Do not store above 25°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene containers and snap-on polyethylene lids.

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: 250µm white rigid PVC. Surface printed 20µm hard temper aluminium foil with 5-6g/M? PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Polyethylene container with a polypropylene lid.

Pack size: 56s

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Actaivs UK Limited (Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 00142/ 0499

9. Date Of First Authorisation/Renewal Of The Authorisation

6 March 2001

Renewed – 19.03.09

10. Date Of Revision Of The Text

08/07/2009


Hyoscyamine
Pronunciation: HYE-oh-SYE-a-meenGeneric Name: HyoscyamineBrand Name: Levsin


Humate-P
Pronunciation: AN-tee-hee-moe-FIL-ik FAK-tor/von WILL-a-brand FAK-torGeneric Name: Antihemophilic Factor/von Willebrand Factor (Human)Brand Name: Humate-P


hyaluronidase Subcutaneous, Injection

hye-al-ure-ON-i-dase

Commonly used brand name(s)

In the U.S.

Amphadase Hydase Hylenex Vitrase

Available Dosage Forms:

Powder for Solution Solution

Therapeutic Class: Tissue Permeability Modifier

Pharmacologic Class: Enzyme

Uses For hyaluronidase

Hyaluronidase is a natural substance found in the body. Hyaluronidase is collected from either cows or pigs. It is cleaned up to remove animal substances. Hyaluronidase is a spreading substance. Hyaluronidase is used with other drugs given under the skin to improve their uptake by the body. This method of drug delivery is only used when the drug cannot be given by injection into a vein.

hyaluronidase is available only with your doctor's prescription.

Before Using hyaluronidase

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 hyaluronidase, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hyaluronidase 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

hyaluronidase has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

hyaluronidase has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hyaluronidase, 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 hyaluronidase 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.

Benzocaine Bupivacaine Butacaine Chloroprocaine Cocaine Dibucaine Etidocaine Lidocaine Mepivacaine Prilocaine Procaine Proparacaine Propoxycaine Ropivacaine Tetracaine 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 hyaluronidase. Make sure you tell your doctor if you have any other medical problems.

Proper Use of hyaluronidase Dosing

The dose of hyaluronidase 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 hyaluronidase. 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 injection dosage form: For better uptake of other drugs: Adults—Use and dose must be determined by your doctor. Children—Use and dose must be determined by your doctor. Storage

Store in the refrigerator. Do not freeze.

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 hyaluronidase

Some people may be allergic to hyaluronidase. Tell your doctor if you develop red or itching skin or if you have trouble breathing after you receive hyaluronidase.

hyaluronidase 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:

Rare Cough difficulty swallowing dizziness fast heartbeat hives or welts itching large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs puffiness or swelling of the eyelids or around the eyes, face, lips or tongue redness of skin shortness of breath skin rash tightness in chest unusual tiredness or weakness wheezing Symptoms of Overdose

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

Blurred vision chills confusion dizziness dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly fast, pounding, or irregular heartbeat or pulse flushing nausea redness of skin swelling unusually warm skin sweating unusual tiredness or weakness vomiting

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 Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site Incidence not known Swelling

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: hyaluronidase Subcutaneous, Injection 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 hyaluronidase Subcutaneous, Injection resources Hyaluronidase Subcutaneous, Injection Side Effects (in more detail) Hyaluronidase Subcutaneous, Injection Use in Pregnancy & Breastfeeding Hyaluronidase Subcutaneous, Injection Drug Interactions Hyaluronidase Subcutaneous, Injection Support Group 1 Review for Hyaluronidase Subcutaneous, Injection - Add your own review/rating Compare hyaluronidase Subcutaneous, Injection with other medications Extravasation Hypodermoclysis Subcutaneous Urography


Hex-Plus
Generic Name: chlorhexidine gluconate liquid Dosage Form: FOR ANIMAL USE ONLYHex-Plus

USE DIRECTIONS:


Hytrin
Pronunciation: ter-AZ-oh-sinGeneric Name: TerazosinBrand Name: Hytrin


hylan G-F 20

Generic Name: hylan G-F 20 (HI lan G F 20) Brand Names: Synvisc, Synvisc-One

What is hylan G-F 20?

Hylan G-F 20 is similar to the fluid that surrounds the joints in your body. This fluid acts as a lubricant and shock absorber for the joints.

Hylan G-F 20 is used to treat knee pain caused by osteoarthritis.

Hylan G-F 20 is usually given after other arthritis medications have been tried without successful treatment of symptoms.

Hylan G-F 20 may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hylan G-F 20? You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

Before you receive a hylan G-F 20 injection, tell your doctor if you have blood clots or circulation problems in your legs, or an allergy to birds, feathers, or egg products.

For at least 48 hours after your injection, avoid jogging, strenuous activity, high-impact sports, or standing for longer than 1 hour at a time.

Call your doctor at once if you have severe pain or swelling around the knee after the injection. What should I discuss with my health care provider before receiving hylan G-F 20? You should not receive hylan G-F 20 if you are allergic to it, or if you have an infection in your knee or in the skin around your knee.

To make sure you can safely receive hylan G-F 20, tell your doctor if you have:

blood clots or circulation problems in your legs; or

an allergy to birds, feathers, or egg products.

It is not known whether hylan G-F 20 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 hylan G-F 20 passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hylan G-F 20 is generally not used in anyone younger than 21 years old. How is hylan G-F 20 given?

Hylan G-F 20 is injected directly into your knee joint. A healthcare provider will give you this injection.

Hylan G-F 20 is usually given once every week for 3 weeks. Follow your doctor's dosing instructions very carefully.

To prevent pain and swelling, your doctor may recommend resting your knee or applying ice for a short time after your injection.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your hylan G-F 20 injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving hylan G-F 20?

For at least 48 hours after your injection, avoid jogging, strenuous activity, or high-impact sports such as soccer or tennis. Also avoid weight-bearing activity or standing for longer than 1 hour at a time. Ask your doctor how long to wait before you resume these activities.

Hylan G-F 20 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. Call your doctor at once if you have severe pain or swelling around the knee after the injection.

Less serious side effects may include:

warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;

muscle pain, trouble walking;

fever, chills, nausea;

numbness or tingly feeling;

headache, dizziness;

tired feeling; or

itching or skin irritation around the knee.

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.

Hylan G-F 20 Dosing Information

Usual Adult Dose for Osteoarthritis:

Inject 2 mL intra-articularly into the knee once a week for 3 weeks.

What other drugs will affect hylan G-F 20?

There may be other drugs that can interact with hylan G-F 20. 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 hylan G-F 20 resources Hylan G-F 20 Side Effects (in more detail) Hylan G-F 20 Use in Pregnancy & Breastfeeding Hylan G-F 20 Drug Interactions Hylan G-F 20 Support Group 11 Reviews for Hylan G-F 20 - Add your own review/rating Hylan G-F 20 Synvisc Advanced Consumer (Micromedex) - Includes Dosage Information Synvisc Solution MedFacts Consumer Leaflet (Wolters Kluwer) Synvisc Consumer Overview Compare hylan G-F 20 with other medications Osteoarthritis Where can I get more information? Your doctor can provide more information about hylan G-F 20.

See also: hylan G-F 20 side effects (in more detail)


Hydrochlorothiazide/Spironolactone
Pronunciation: spir-ON-oh-LAK-tone/HYE-droe-KLOR-oh-THYE-a-zideGeneric Name: Spironolactone/HydrochlorothiazideBrand Name: Aldactazide


Hydrocortisone Sodium Succinate

Class: AdrenalsNote: This monograph also contains information on Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone Sodium PhosphateATC Class: H02AB09


Hydromorphone High-Potency
Pronunciation: HYE-droe-MOR-foneGeneric Name: Hydromorphone High-PotencyBrand Name: Dilaudid-HP


Hypurin Porcine 30 / 70 Mix Cartridges
1. Name Of The Medicinal Product

Hypurin® Porcine 30/70 Mix

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Porcine) 100 IU/ml.

Biphasic Isophane Insulin Injection Ph Eur 100 iu/ml (Porcine)

For excipients see 6.1.

3. Pharmaceutical Form

Suspension for injection.

A white suspension

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

May be used for diabetics requiring a depot insulin of intermediate duration.

4.2 Posology And Method Of Administration

To be determined by the physician according to the needs of the patient.

Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. Onset of action occurs within 2 hours after subcutaneous injection with an overall duration up to 24 hours. Maximum effect is exerted between 4-12 hours.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

In no circumstances must Hypurin® Porcine 30/70 Mix be given intravenously.

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy.

Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period').

Patients transferred to Hypurin® Porcine insulins from other commercially available preparations may require dosage adjustments.

The warning symptoms of hypoglycaemia may be changed, be less pronounced or absent in certain risk groups who should be advised accordingly. These include patients:

- in whom glycaemic control is greatly improved, e.g. by intensified insulin therapy

- with a long history of diabetes

- who are elderly

- receiving concomitant treatment with certain medicinal products e.g. beta blockers or clonidine.

Elderly diabetic patients are more susceptible to episodes of severe, rapid onset hypoglycaemia.

Combination of Hypurin® insulins with pioglitazone: Cases of cardiac failure have been reported when thiazolidinediones are used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Hypurin® is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin requirements may increase during illness (this includes infection and accidental and surgical trauma), puberty or emotional upset.

Insulin resistance is frequently associated with lipid disorders, hypertension and ischaemic heart disease. Patients with insulin resistance usually require more than 200 units of insulin daily. Insulin resistance of the type manifested by greatly increased insulin requirements may be due to factors including antibody formation although some diseases, such as infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress can contribute to insulin resistance.

Insulin requirements may decrease with liver disease, disease of the adrenal, pituitary or thyroid glands and coeliac disease. In patients with severe renal impairment, insulin requirements may fall and dosage reduction may be necessary. The compensatory response to hypoglycaemia may also be impaired.

Insulin requirements may be increased in the premenstrual period but may be reduced during or after a menstrual cycle.

Insulin requirements are usually reduced but occasionally increased during periods of increased activity.

Increase in subcutaneous blood flow, brought about by factors such as a hot bath, may increase the rate of absorption of insulin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drugs that may increase the requirement for insulin

Antipyschotics: chloropromazine

Corticosteroids

Diazoxide

Diuretics: thiazide diuretics or loop diuretics

Sympathomimetic agents

Thyroid hormone replacement therapy

Smoking may also antagonise the hypoglycaemic effect of insulin

Drugs that may decrease the requirement for insulin

ACE inhibitors

Alcohol: moderate or large amounts of alcohol (more than 2 units per day for women and more than 3 units per day for men) can decrease the requirements for insulin and may lead to hypoglycaemic attacks. Episodic heavy drinking ('binge' drinking) carries a particularly high risk of hypoglycaemic episodes.

Anabolic steroids

Analgesics: NSAIDS, or salicylates, particularly large doses of aspirin

Androgens: testosterone may enhance the hypoglycaemic effect of insulin

Anti-arrhythmics: disopyramide.

Concomitant use of insulin with quinidine may increase the risk of hypoglycaemia occurring.

Anti-depressants: monoamine oxidase inhibitors or fluoxetine.

Concomitant use of amitriptyline with insulin may lead to hypoglycaemia.

Antihypertensives: guanethidine

Antimalarials: concomitant use of insulin with antimalarials such as chloroquine or quinine may increase the risk of hypoglycaemia occurring.

Fenfluramine

Hormone antagonists: octreotide

Lipid-regulating drugs: fibrates

Mebendazole

Pentoxifylline: the hypoglycaemic activity of insulin may be potentiated by concomitant administration of high-dose pentoxifylline injection.

Tetracyclines: tetracyclines such as oxytetracycline

Drugs that may increase or decrease the requirements for insulin

Antihypertensives: clonidine. Signs and symptoms of hypoglycaemia may be masked by clonidine.

Beta blockers: beta blockers. Some of the warning signs of insulin-induced hypoglycaemia may be masked.

Calcium channel blockers: nifedipine may occasionally impair glucose tolerance.

Cyclophosphamide

Isoniazid

Lipid-regulating drugs: gemfibrozil

Oral contraceptives

4.6 Pregnancy And Lactation

Pregnancy

A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.

Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.

Congenital abnormality is more common in offspring of diabetic than non-diabetic women.

Lactation

Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Metabolic disorders:

• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia, refer to section 4.9, Overdosage.

• Hypokalaemia may occur with insulin therapy.

• Insulin therapy may lead to weight gain.

General disorders and administration site conditions:

Lipodystrophy (atrophy or hypertrophy of the fat tissue) may occur at the injection site. Stinging or sensations of warmth or burning at the site of injection may also occur.

Immune system disorders:

Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.

• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.

• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions. Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.

4.9 Overdose

a) Symptoms

Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.

Hypokalaemia may also occur with insulin overdose.

b) Treatment

Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.

Moderately severe hypoglycaemia can be treated by intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.

For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code – A10A A

Insulin output from the pancreas of a healthy person is about 50 units per day, which is sufficient to maintain the fasting blood sugar concentration in the range 0.8 ! 0.2mg/ml. In diabetes mellitus, the blood sugar rises in an uncontrolled manner. Parenterally administered insulin causes a fall in blood sugar concentration and increased storage of glycogen in the liver. In the diabetic it raises the respiratory quotient after a carbohydrate meal and prevents the formation of ketone bodies. The rise in blood sugar concentration caused by adrenaline and corticosteroids, glucagon and posterior pituitary extract is reversed by insulin.

5.2 Pharmacokinetic Properties

Insulin is rapidly absorbed from subcutaneous tissue or muscle following injection.

Insulin is metabolised mainly in the liver and a small amount is excreted in the urine.

The plasma half-life is four to five minutes. The half-life after subcutaneous injection is about four hours and after intramuscular injection about two hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber that are additional to that already included in other sections.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Protamine sulphate

Zinc chloride

m-Cresol

Phenol

Sodium phosphate

Glycerol

Water for injections

6.2 Incompatibilities

None

6.3 Shelf Life

36 months.

Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.

6.4 Special Precautions For Storage

Store at 2oC - 8oC.

Do not freeze.

Cartridges in use must not be stored in a refrigerator.

Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.

In use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

1.5ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.

3ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.

6.6 Special Precautions For Disposal And Other Handling

Prior to insertion in the pen the cartridge of Hypurin® Porcine 30/70 Mix should be shaken vigorously up and down, with a “bell ringing” action, at least ten times.

Immediately before each injection the pen should be inverted at least ten times to mix the insulin again.

The cartridge must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

8. Marketing Authorisation Number(S)

PL 29831/0119

9. Date Of First Authorisation/Renewal Of The Authorisation

8th April 2008

10. Date Of Revision Of The Text

23 June 2011


Humalog Mix 75/25

Generic Name: insulin lispro protamine and insulin lispro (Subcutaneous route)

IN-su-lin LIS-pro PROE-ta-meen, ree-KOM-bi-nant, IN-su-lin LIS-pro, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

Humalog Mix 50/50 Humalog Mix 75/25

Available Dosage Forms:

Suspension

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Lispro, Recombinant

Uses For Humalog Mix 75/25

Insulin lispro protamine and insulin lispro is a combination of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. If you have diabetes, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.

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

Before Using Humalog Mix 75/25

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin lispro protamine and insulin lispro combination have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of this medicine in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dose in patients receiving this medicine.

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

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking 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.

Alatrofloxacin Balofloxacin Ciprofloxacin Clinafloxacin Enoxacin Fleroxacin Flumequine Gatifloxacin Gemifloxacin Grepafloxacin Levofloxacin Lomefloxacin Moxifloxacin Norfloxacin Ofloxacin Pefloxacin Prulifloxacin Rufloxacin Sparfloxacin Temafloxacin Tosufloxacin Trovafloxacin Mesylate

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.

Acebutolol Alprenolol Atenolol Betaxolol Bevantolol Bisoprolol Bitter Melon Bucindolol Carteolol Carvedilol Celiprolol Clorgyline Dilevalol Esmolol Fenugreek Glucomannan Guar Gum Iproniazid Isocarboxazid Labetalol Levobunolol Mepindolol Metipranolol Metoprolol Moclobemide Nadolol Nebivolol Nialamide Oxprenolol Pargyline Penbutolol Phenelzine Pindolol Procarbazine Propranolol Psyllium Selegiline Sotalol Talinolol Tertatolol Timolol Toloxatone Tranylcypromine Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

Emotional disturbances or Illness or Stress—These conditions increase blood sugar and may increase the amount of insulin you need. Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels. Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects. Kidney disease or Liver disease—Effects of insulin lispro protamine and insulin lispro combination may be increased because of the slower removal of the medicine from the body. Proper Use of insulin lispro protamine and insulin lispro

This section provides information on the proper use of a number of products that contain insulin lispro protamine and insulin lispro. It may not be specific to Humalog Mix 75/25. Please read with care.

Each package of insulin lispro protamine and insulin lispro combination contains a patient information leaflet. Read this leaflet carefully before beginning your treatment and each time you refill for any new information, and make sure you understand:

How to prepare the medicine. How to inject the medicine. How to use disposable insulin delivery device. How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., under the skin of your abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

When used as a mealtime insulin, this insulin combination should be taken within 15 minutes before a meal.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should never mix insulin lispro protamine and insulin lispro combination with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.

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 injection dosage form: For diabetes mellitus: Adults—The dose is based on your blood sugar and must be determined by your doctor. Children—Use and dose must be determined by your doctor. Missed Dose

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

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store in the refrigerator. Do not freeze.

After a cartridge has been inserted into a pen, you may store the cartridge and pen at room temperature, not in the refrigerator, for up to 10 days.

Precautions While Using Humalog Mix 75/25

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team. Other medicines—Do not take other medicines during the time you are taking this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems. Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy. Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines. Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs. Keep some kind of quick-acting sugar handy to treat low blood sugar. Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

This medicine may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; shortness of breath; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.

Too much insulin lispro protamine and insulin lispro combination can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; depression; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Humalog Mix 75/25 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 Anxiety blurred vision chills cold sweats coma confusion convulsions cool, pale skin cough decreased urine depression difficulty swallowing dizziness dry mouth fast heartbeat flushing or redness of the skin headache hives increased hunger increased thirst irregular heartbeat itching loss of appetite mood changes muscle pain or cramps nausea or vomiting nervousness nightmares numbness or tingling in the hands, feet, or lips puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue seizures shakiness shortness of breath skin rash slurred speech sweating swelling tightness in the chest unusual tiredness or weakness unusually warm skin wheezing

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

Incidence not known Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site redistribution or accumulation of body fat

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: Humalog Mix 75/25 side effects (in more detail)

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More Humalog Mix 75/25 resources Humalog Mix 75/25 Side Effects (in more detail) Humalog Mix 75/25 Use in Pregnancy & Breastfeeding Humalog Mix 75/25 Drug Interactions Humalog Mix 75/25 Support Group 1 Review for Humalog Mix 75/25 - Add your own review/rating Humalog Mix 75/25 Concise Consumer Information (Cerner Multum) Humalog Mix 75/25 Pens MedFacts Consumer Leaflet (Wolters Kluwer) Humalog Mix 75/25 Prescribing Information (FDA) HumaLog Mix 75/25 Vials MedFacts Consumer Leaflet (Wolters Kluwer) Compare Humalog Mix 75/25 with other medications Diabetes, Type 1 Diabetes, Type 2


hydroquinone topical

Generic Name: hydroquinone topical (HYE droe KWIN one) Brand names: Aclaro, Aclaro PD, Alera, Alphaquin HP, Alustra, Claripel, Eldopaque, Eldopaque Forte, Eldoquin, Eldoquin Forte, EpiQuin Micro, Esoterica, Esoterica with Sunscreen, Glyquin, Glyquin-XM, Hydroquinone and Sunscreen, Lustra, Lustra-AF, Lustra-Ultra, Melpaque HP, Melquin HP, Melquin-3, Nuquin HP, Solaquin, Solaquin Forte, ...show all 33 brand names.Melanex, Melanol, Viquin Forte, Esoterica Sensitive Skin, Nava-SC, Remergent HQ, EpiQuin Micro Pump, Esoterica Daytime

What is hydroquinone topical?

Hydroquinone decreases the formation of melanin in the skin. Melanin is the pigment in skin that gives it a brown color.

Hydroquinone topical is used to lighten areas of darkened skin such as freckles, age spots, chloasma, and melasma.

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

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

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. What should I discuss with my healthcare provider before using hydroquinone topical? Do not use hydroquinone topical on skin that is sunburned, windburned, dry, chapped, or irritated, or on an open wound. It could make these conditions worse. Wait until these conditions have healed before applying hydroquinone topical.

Before using hydroquinone topical, tell your doctor if you are allergic to any drugs, or if you have:

liver disease; or

kidney disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydroquinone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use hydroquinone topical?

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

Hydroquinone topical is for external use only. Wash your hands before and after applying this medication, unless you are treating a skin area on your hand.

Apply the medication to clean, dry skin. Apply just enough medication to cover the affected area. Avoid applying to the unaffected surrounding skin. Rub in the medication gently and completely.

Avoid getting this medication on your lips or inside your nose or mouth. Hydroquinone may cause numbness of these areas. If the medication does get on any of these areas, rinse with water.

It is important to use hydroquinone topical regularly to get the most benefit.

Store hydroquinone topical at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of topically applied hydroquinone is not likely to cause life-threatening symptoms.

What should I avoid while using hydroquinone topical? Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use hydroquinone topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Your skin may be more sensitive to weather extremes such as cold and wind. Protect your skin with clothing and use a moisturizing cream or lotion as needed.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Using hydroquinone topical together with benzoyl peroxide, hydrogen peroxide, or other peroxide products may cause a temporary staining of your skin. This staining can usually be removed with soap and water. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Hydroquinone topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Hydroquinone topical side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hydroquinone topical and call your doctor if you have severe burning, stinging, or other irritation of your skin after apply the medication.

Less serious side effects may include mild burning, stinging, itching, redness, or irritation of treated skin.

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.

Hydroquinone topical Dosing Information

Usual Adult Dose for Dermatological Disorders:

Chloasma, Melasma, Freckles, Senile lentigines, Areas of melanin hyperpigmentation:Apply to affected area twice daily.

Usual Pediatric Dose for Dermatological Disorders:

Chloasma, Melasma, Freckles, Senile lentigines, Areas of melanin hyperpigmentation:


Hydromorphone Liquid
Pronunciation: HYE-droe-MOR-foneGeneric Name: HydromorphoneBrand Name: Dilaudid


Hypaque-Cysto
Dosage Form: injection

Sterile Aqueous Injection

NOT FOR INTRATHECAL USE

Not For Intravascular Use

For Retrograde Cystourethrography

Rx ONLY

Hypaque-Cysto Description

Hypaque-Cysto, brand of diatrizoate meglumine, is a water-soluble radiopaque diagnostic medium. It is a triiodinated benzoic acid derivative. It is constituted as a radiopaque iodinated anion (diatrizoate) and a radiolucent cation (meglumine). It is a colorless, microcrystalline solid which is readily soluble in water.

Hypaque-Cysto is a sterile aqueous solution containing 30 g (w/v) of the meglumine salt of diatrizoic acid per 100 mL aqueous solution. The sterile solution is clear and colorless to pale yellow. The pH is adjusted between 6.5 and 7.7 with hydrochloric acid, or diatrizoic acid, or meglumine. It does not contain an antibacterial preservative. It is relatively thermostable and may be autoclaved. Edetate calcium disodium 1:10,000 has been added as a sequestering stabilizing agent. Each 1 mL contains approximately 141 mg of organically bound iodine.

It has an osmolality of 633 mosm/kg (determined by VPO) and is hypertonic to blood.

The viscosity of the solution is 1.94 cp at 25°C and 1.42 cp at 37°C.

Hypaque-Cysto is a 30 percent solution of 1-Deoxy-l (methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodobenzoate (C11H9I3N2O4 • C7H17NO5) with a molecular weight of 809.13, and has the following structural formula:

Hypaque-Cysto - Clinical Pharmacology

Retrograde introduction of Hypaque-Cysto solution provides radiopacity of the contents of the urinary bladder. When used during micturation as a function test, it also opacifies the bladder neck and lower urinary tract. Continuous fluoroscopic and monitoring of urinary bladder contractions will demonstrate cystoureteric reflux and its extent, if present.

Hypaque-Cysto is not absorbed from the urinary tract to any extent (< 2°), therefore, systemic effects are rare. However, pyelorenal intravasation (especially in patients with ureteric reflux) can occur. Therefore, the potential for adverse effects, such as occur with intravascular use, are possible.

At physiologic pH, the water-soluble contrast media are completely dissociated into a radiopaque anion and a solubilizing cation.

EXCRETION

Hypaque-Cysto which gains inadvertent intravascular entry is not metabolized but excreted unchanged in the urine, each diatrizoate molecule remaining "obligated" to its cation moiety.

Diatrizoate solutions may be excreted either through the kidneys or the liver. These two excretory pathways are not mutually exclusive, but the main route of excretion seems to be governed by the affinity of the contrast medium for serum albumin. From 0% to 10% of diatrizoate meglumine is bound to serum protein.

Diatrizoate salts are excreted unchanged predominantly through the kidneys by glomerular filtration. The amount excreted during any period of time is determined by the filtered load; ie, the product of plasma contrast media concentration and glomerular filtration rate.

The liver and small intestine provide the major alternate route of excretion for diatrizoate. In patients free of severe renal disease, the fecal recovery is less than 2 percent. In patients with severe renal impairment the excretion of these contrast media through the gallbladder and into the small intestine sharply increases; up to 20 percent in the feces in 48 hours.

Saliva is a minor secretory pathway for injectable radiopaque diagnostic agents. In patients with normal renal function, minimal amounts of contrast media are secreted unchanged.

PREGNANCY AND LACTATION

Diatrizoate meglumine crosses the human placental barrier by simple diffusion and appears to enter fetal tissues passively. No apparent harm to the fetus occurs. Procedures including radiation involve a certain risk related to the exposure of the fetus.

Diatrizoate solutions are excreted unchanged in human milk.

Indications and Usage for Hypaque-Cysto

Hypaque-Cysto is indicated for retrograde cystourethrography in adult and pediatric patients.

Contraindications

Hypaque-Cysto has no absolute contraindication in its recommended use.

Warnings SEVERE ADVERSE EVENTS—INADVERTENT INTRATHECAL USE

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.

Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media. Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic contrast media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringe in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

Serious or fatal reactions have been associated with the vascular entry of radiopaque media. It is important that a course of action be carefully planned in advance for the treatment of possible serious reactions.

Precautions General

Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for the management of any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. Competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred (See ADVERSE REACTIONS).

The possibility of a reaction, including serious, life-threatening, fatal, anaphylatic or cardiovascular reactions should always be considered (see ADVERSE REACTIONS). It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate and appropriate personnel be readily available in case of any reaction.

ALLERGIC HISTORY

Before injecting a contrast medium, the patient should be questioned for a history of allergy. A positive history does not arbitrarily contraindicate the use of a contrast agent where a diagnostic procedure is considered essential, but caution should be exercised (see ADVERSE REACTIONS).

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS). The susceptible population includes patients with a history of a previous reaction to a contrast media, patients with a known sensitivity to iodine per se, and patients with known clinical hypersensitivity (ie, bronchial asthma, hay fever, and food allergies).

Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

TEST DOSE

The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous for the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast media, may be more accurate than pretesting in predicting adverse reactions.

Information for Patients

Patients receiving injectable radiopaque diagnostic agents should be instructed to:

Inform the physician if they are pregnant (see CLINICAL PHARMACOLOGY). Inform the physician if they are allergic to any drugs, food, or if they have had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS). Drug/Laboratory Test Interactions

Under certain circumstances (pH, temperature, concentrations, time), diatrizoate solutions are incompatible with promethazine hydrochloride, diphenhydramine hydrochloride, brompheniramine maleate, or papaverine hydrochloride solutions.

BENADRYL®, brand of diphenhydramine hydrochloride, may cause precipitation when mixed in the same syringe with Hypaque-Cysto.

Although interference with these laboratory tests have not been reported following cystography absorption (from the bladder or by pyelorenal back flow), they have occurred following direct intravenous injection. Therefore, if any of these studies, which might be affected by contrast media are indicated, it is recommended that they be performed prior to administration of the contrast medium or two or more days afterwards.

Diatrizoate salts interfere with several laboratory urine and blood tests.

Blood Tests

Coagulation: Diatrizoate salts significantly inhibit all stages of coagulation. The fibrinogen concentration, Factors V, VII, and VIII are decreased. Prothrombin time and thromboplastin time are increased.

Platelet aggregation: High levels of plasma and diatrizoate meglumine inhibit platelet aggregation.

Serum calcium: Diatrizoate salts may decrease serum calcium levels. However, this depletion of serum calcium may also be the result of the addition of chelating agents (edetate disodium) in the preparation of certain contrast media.

Red cell counts: Transitory decreases in red cell counts. Technetium-99m-RBC labeling interference.

Leukocyte counts: Decrease.

Urea nitrogen (BUN): Transitory increase (see CLINICAL PHARMACOLOGY).

Serum creatinine: Transitory increase.

Urine Tests

Urine osmolarity and specific gravity. Decreased due to induced diuresis.

Urine cultures. Diatrizoate in urine cultures may inhibit bacterial growth.

Thyroid Function Tests

Protein-bound iodine (PBI) and total serum organic iodine: Transient increase of both tests following cystography and retrograde pyelography have been noticed. The results of PBl and radioactive iodine uptake studies which depend on iodine estimations will not accurately reflect thyroid function for up to 16 days following administration of iodinated media. However, thyroid function tests not depending on iodine estimations, eg, T3 resin uptake or free thyroxine assays are not affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed in order to evaluate carcinogenic potential, mutagenesis, or whether Hypaque-Cysto can affect fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with diatrizoate meglumine. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, diatrizoate meglumine should be given to a pregnant woman only if clearly needed.

Labor and Delivery

It is not known whether use of these contrast agents during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Diatrizoate salts are excreted unchanged in human milk. Because of the potential adverse reactions, although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when these contrast media are administered to a nursing woman.

Adverse Reactions Not For Intravascular Use

Because inadvertent intravascular entry of Hypaque-Cysto is possible during urethrocystography (bladder absorption or pyelorenal back flow), the occurrence of systemic adverse effects is possible. However, the relative incidence and severity of the following reactions refer only to experience with direct intravascular injection.

Approximately 95 percent of adverse reactions accompanying the intravascular use of diatrizoate salts are of mild to moderate severity. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, the mode of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

The reported incidence of adverse reactions to contrast media in patients with a history of allergy are twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Most adverse reactions to injectable contrast media appear within one to three minutes after the start of injection, but delayed reactions may occur.

Adverse reactions are grouped by organ system and listed below by decreasing order of occurrence and with an approximate incidence of occurrence. Significantly more severe reactions are listed before the other reactions regardless of frequency.

Greater Than 1 in 100 Patients

Body as a Whole: Reported incidences of death range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later, the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor.

Isolated reports of hypotensive collapse and shock following urography are found in the literature. The incidence of shock is estimated to occur in 1 out of 20,000 (0.005 percent) patients.

Cardiovascular System: The most frequent adverse reaction to diatrizoate salts is vasodilation (feeling of warmth). The estimated incidence is 49 percent.

Digestive System: Nausea 6 percent, vomiting 3 percent.

Nervous System: Paresthesia 6 percent, dizziness 5 percent.

Respiratory System: Rhinitis 1 percent, increased cough 2 percent.

Skin and Appendages: Urticaria 1 percent.

Pain at the injection site is estimated to occur in about 12 percent of the patients undergoing urography. Pain is usually due to extravasation.

Painful hot erythematous swelling above the venipuncture site was estimated to occur in more than 1 percent of the patients undergoing phlebography.

Special Senses: Perversion of taste 11 percent.

Urogenital System: Osmotic nephrosis of the proximal tubular cells is estimated to occur in 23 percent of patients following excretory urography.

Less Than 1 in 100 Patients

Other infrequently reported reactions without accompanying incidence rates are listed below, grouped by organ system.

Body as a Whole: Malaria relapse, uremia, high creatinine and BUN (see PRECAUTIONS-Drug/Laboratory Test Interactions), thrombocytopenia, leukopenia, and anemia.

Cardiovascular System: Cerebral hematomas, hemodynamic disturbances, sinus bradycardia, transient electrocardiographic abnormalities, ventricular fibrillation, petechiae, chest pain, and cardiac arrest.

Digestive System: Severe unilateral or bilateral swelling of the parotid and submaxillary glands.

Nervous System: Convulsions, paralysis, and coma.

Respiratory System: Asthma, dyspnea, laryngeal edema, pulmonary edema, and bronchospasm.

Skin and Appendages: Skin necrosis.

Special Senses: Bilateral ocular irritation, lacrimation, itching, conjunctival chemosis, infection, and conjunctivitis.

Urogenital: Renal failure, pain.

Hypaque-Cysto Dosage and Administration

After the bladder is emptied, Hypaque-Cysto is gently instilled without force, often beyond the first desire to micturate, but not beyond the point of urgency or mild discomfort. The volume required to fill the bladder to slightly less than capacity may vary from patient to patient.

Bladder capacity in normal adults is generally 200 mL to 300 mL, and rarely, up to 600 mL. Capacity at birth is 20 mL to 50 mL, and increases about 400 percent in the first year. In children 3 to 5 years old, bladder capacity is 150 mL to 180 mL. In children older than 8 years, it is in the low adult range.

In disease, bladder capacity in adults may vary from 50 mL in a hypertonic reflex bladder to over 1000 mL in an atonic or sensory paralytic bladder or chronic lower urinary tract obstruction.

Repeat examination may be required to detect reflux, or in function studies.

The concentration varies with technique and equipment used. Hypaque-Cysto may be diluted with sterile water or 5 percent dextrose solution, as indicated in the following table. A 10 percent solution is isotonic.

STANDARD PACKAGE (250 mL of Hypaque-Cysto in 500 mL bottle) TO MAKE ADD FINAL SOLUTION CONTAINS Final conc. Final volume Sterile water or 5% dextrose solution Iodine 30% 250 mL _ 141 mg/mL 25% 300 mL 50 mL 118 mg/mL 21.4% 350 mL 100 mL 101 mg/mL 20% 375 mL 125 mL 94 mg/mL 18.8% 400 mL 150 mL 88 mg/mL 16.7% 450 mL 200 mL 78 mg/mL 15% 500 mL 250 mL 71 mg/mL

Note: To achieve the following concentrations some of the contrast agent must be removed prior to dilution.

TO MAKE REMOVE ADD FINAL SOLUTION CONTAINS Final conc. Final volume Sterile water or 5% dextrose solution Iodine 12% 500 mL 50 mL 300 mL 56 mg/mL 12% 375 mL 100 mL 225 mL 56 mg/mL 10% 450 mL 100 mL 300 mL 47 mg/mL

Dilution and withdrawal of the contrast agent should be accomplished under aseptic conditions with sterile syringes. The solution should be inspected visually for particulate matter and discoloration prior to administration.

How is Hypaque-Cysto Supplied STANDARD PACKAGE

Calibrated 500 mL dilution bottles containing 250 mL Hypaque-Cysto; rubber stoppered, with hangers, inner removable seal and screw neck. Box of 10 (NDC 0407-0734-10)

Protect from light. Contains no preservatives, therefore, discard any unused portion remaining in the container.

Store at 15°C to 30°C (59°F to 86°F).

Distributed by Amersham Health Inc.



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