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Friday, May 11, 2012

Triaminicin

Generic Name: acetaminophen/chlorpheniramine/phenylpropanolamine (a seet a MIN oh fen/klor fen IR a meen/fen ill proe pa NOLE a meen)

Brand Names: Chlor-Trimeton Sinus, Coricidin D, Pyrroxate, Sinulin, Triaminicin

What is Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions such as: headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

Acetaminophen/chlorpheniramine/phenylpropanolamine is used to treat nasal congestion; itchy, watery eyes; itchy throat; sneezing; headache; fever; and other symptoms associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Acetaminophen/chlorpheniramine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/chlorpheniramine/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.

Who should not take Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen/chlorpheniramine/phenylpropanolamine. Do not take acetaminophen/chlorpheniramine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

kidney disease,

liver disease,

diabetes,

glaucoma,

any type of heart disease or high blood pressure,

thyroid disease,

emphysema or chronic bronchitis, or

difficulty urinating or an enlarged prostate.

You may not be able to take acetaminophen/chlorpheniramine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether acetaminophen/chlorpheniramine/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and can harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from acetaminophen/chlorpheniramine/phenylpropanolamine. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Take acetaminophen/chlorpheniramine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break any long-acting or extended- or sustained-release forms of this medication that are intended to release slowly. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help. If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid form of acetaminophen/chlorpheniramine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is directed. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day.

Do not take acetaminophen/chlorpheniramine/phenylpropanolamine for longer than 7 to 10 days in a row. If your symptoms do not improve, if they get worse or if you have a fever, see your doctor.

Store acetaminophen/chlorpheniramine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an acetaminophen/chlorpheniramine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, vomiting, abdominal pain, diarrhea, seizures, confusion, sweating, and an irregular heartbeat.

What should I avoid while taking Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Acetaminophen/chlorpheniramine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/phenylpropanolamine is taken with any of these medications.

Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine) side effects

If you experience any of the following rare but serious side effects, stop taking acetaminophen/chlorpheniramine/phenylpropanolamine and seek emergency medical attention or notify your doctor immediately:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);

blood problems (easy or unusual bleeding or bruising); or

low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).

Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/chlorpheniramine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

dryness of the eyes, nose, and mouth;

drowsiness or dizziness;

blurred vision;

difficulty urinating; or

excitation in children.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Triaminicin (acetaminophen/chlorpheniramine/phenylpropanolamine)?

Do not take acetaminophen/chlorpheniramine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Urine glucose tests for diabetics may produce false results while you are taking acetaminophen. Talk to your doctor if you have diabetes and you notice changes in blood glucose levels during treatment with acetaminophen/chlorpheniramine/phenylpropanolamine.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medicines while taking acetaminophen/chlorpheniramine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, acetaminophen, or other similar drugs, and you may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with acetaminophen/chlorpheniramine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Triaminicin resources

Triaminicin Drug Interactions
Triaminicin Support Group
0 Reviews · Be the first to review/rate this drug

Children's Tylenol Cold Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Where can I get more information?

Your pharmacist has additional information about acetaminophen/chlorpheniramine/ phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

There are many formulations of acetaminophen/chlorpheniramine/ phenylpropanolamine available over the counter. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Saturday, May 5, 2012

NP Thyroid 60

Generic Name: levothyroxine, liothyronine

Dosage Form: tablet
NP Thyroid 60

NP Thyroid (thyroid tablets, USP) for oral use is a natural preparation derived from porcine thyroid glands. They contain both tetraiodothyronine sodium (T4 levothyroxine) and triiodothyronine sodium (T3 liothyronine) providing 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid (or per 65 mg of the labeled amount of thyroid). The inactive ingredients are calcium stearate, dextrose monohydrate, maltodextrin and mineral oil.

CLINICAL PHARMACOLOGY: The steps in the synthesis of the thyroid hormones are controlled by thyrotropin (Thyroid Stimulating Hormone, TSH) secreted by the anterior pituitary. This hormone’s secretion is in turn controlled by a feedback mechanism effected by the thyroid hormones themselves and by thyrotropin releasing hormone (TRH), a tripeptide of hypothalamic origin. Endogenous thyroid hormone secretion is suppressed when exogenous thyroid hormones are administered to euthyroid individuals in excess of the normal gland’s secretion. The mechanisms by which thyroid hormones exert their physiologic action are not well understood. These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate, and the metabolism of carbohydrates, lipids, and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system. The normal thyroid gland contains

approximately 200 mcg of levothyroxine (T4) per gram of gland, and 15 mcg of liodothyronine (T3) per gram. The ratio of these two hormones in the circulation does not represent the ratio in the thyroid gland, since about 80 percent of peripheral triiodothyronine comes from monodeiodination of levothyroxine. Peripheral monodeiodination of levothyroxine at the 5 position (inner ring) also results in the formation of reverse triiodothyronine (T3), which is calorigenically inactive. Triiodothyronine (T3) levels are low in the fetus and newborn, in old age, in chronic caloric deprivation, hepatic cirrhosis, renal failure, surgical stress, and chronic illnesses representing what has been called the “T3 thyronine syndrome.”

Pharmacokinetics - Animal studies have shown that T4 is only partially absorbed from the gastrointestinal tract. The degree of absorption is dependent on the vehicle used for its administration and by the character of the intestinal contents, the intestinal flora, including plasma protein, and soluble dietary factors, all of which bind thyroid and thereby make it unavailable for diffusion. Only 41 percent is absorbed when given in a gelatin capsule as opposed to a 74 percent absorption when given with an lbumin carrier. Depending on other factors, absorption has varied from 48 to 79 percent of the administered dose. Fasting increases absorption. Malabsorption syndromes, as well as dietary factors, (children’s soybeanformula, concomitant use of anionic exchange resins such as cholestyramine) cause excessive fecal loss. T3 is almost totally absorbed, 95 percent in 4 hours. The hormones contained in the natural preparations are absorbed in a manner similar to the synthetic hormones. More than 99 percent of circulating hormones are bound to serum proteins, including thyroid-binding globulin (TBg), thyroid-binding prealbumin (TBPA), andalbumin (TBa), whose capacities and affinities vary for the hormones. The higher affinity of levothyroxine (T4) for both TBg and TBPA as compared to triiodothyronine (T3) partially explains the higher serum levels and longer half-life of the former hormone. Both protein-bound hormones exist in reverse equilibrium with minute amounts of free hormone, the latter accounting for the metabolic activity. deiodination of levothyroxine (T4) occurs at a number of sites, including liver, kidney, and other tissues. The conjugated hormone, in the form of glucuronide or sulfate, is found in the bile and gut where it may complete an enterohepatic circulation. Eighty-five percent of levothyroxine (T4) metabolized daily is deiodinated.

INDICATIONS AND USAGE: NP Thyroid tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer. 3. As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.

CONTRAINDICATIONS: Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well-documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

WARNINGS

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.

PRECAUTIONS: General—Thyroid hormones should be used with great caution in a number of circumstances where the integrity of the cardiovascular system, particularly the coronary arteries, is suspected. These include patients with angina pectoris or the elderly, in whom there is a greater likelihood of acute cardiac disease. In these patients therapy should be initiated with low doses, i.e., 15-30 mg NP Thyroid. When, in such patients, a euthyroid state can only be reached at the expense of an aggravation of the cardiovascular disease, thyroid hormone dosage should be reduced. Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. The therapy of myxedema coma requires simultaneous administration of glucocorticoids (See DOSAGE AND ADMINISTRATION). Hypothyroidism decreases and hyperthyroidism increases the sensitivity to oral anticoagulants. Prothrombin time should be closely monitored in thyroid-treated patients on oral anticoagulants and dosage of the latter agents adjusted on the basis of frequent prothrombin time determinations. In infants, excessive doses of thyroid hormone preparations may produce craniosynostosis.

Information for the Patient—Patients on thyroid hormone preparations and parents of children on thyroid therapy should be informed that: 1. Replacement therapy is to be taken essentially for life, with the exception of cases of transient hypothyroidism, usually associated with thyroiditis, and in those patients receiving a therapeutic trial of the drug. 2. They should immediately report during the course of therapy any signs or symptoms of thyroid hormone toxicity, e.g., chest pain, increased pulse rate, palpitations, excessive sweating, heat intolerance, nervousness, or any other unusual event. 3. In case of concomitant diabetes mellitus, the daily dosage of antidiabetic medication may need readjustment as thyroid hormone replacement is achieved. If thyroid medication is stopped, a downward readjustment of the dosage of insulin or oral hypoglycemic agent may be necessary to avoid hypoglycemia. At all times, close monitoring of urinary glucose levels is mandatory in such patients. 4. In case of concomitant oral anticoagulant therapy, the prothrombin time should be measured frequently to determine if the dosage of oral anticoagulants is to be readjusted. 5. Partial loss of hair may be experienced by children in the first few months of thyroid therapy, but this is usually a transient phenomenon and later recovery is usually the rule.

Laboratory Tests — Treatment of patients with thyroid hormones requires the periodic assessment of thyroid status by means of appropriate laboratory tests besides the full clinical evaluation. The TSH suppression test can be used to test the effectiveness of any thyroid preparation bearing in mind the relative insensitivity of the infant pituitary to the negative feedback effect of thyroid hormones. Serum T4 levels can be used to test the effectiveness of all thyroid medications except T3. When the total serum T4 is low but TSH is normal, a test specific to assess unbound (free) T4 levels is warranted. Specific measurements of T4 and T3 by competitive protein binding or radioimmunoassay are not influenced by blood levels of organic or inorganic iodine.

Drug Interactions—Oral Anticoagulants—Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy.

Insulin or Oral Hypoglycemics—Initiating thyroid replacement therapy may cause increases in insulin or oral hypoglycemic requirements. The effects seen are poorly understood and depend upon a variety of factors such as dose and type of thyroid preparations and endocrine status of the patient. Patients receiving insulin or oral hypoglycemics should be closely watched during initiation of thyroid replacement therapy.

Cholestyramine - Cholestyramine binds both T4 and T3 in the intestine, thus impairing absorption of these thyroid hormones. In vitro studies indicate that the binding is not easily removed. Therefore four to five hours should elapse between administration of cholestyramine and thyroid hormones.

Estrogen, Oral Contraceptives—Estrogens tend to increase serum thyroxine-binding globulin (TBg). In a patient with a nonfunctioning thyroid gland who is receiving thyroid replacement therapy, free levothyroxine may be decreased when estrogens are started thus increasing thyroid requirements. However, if the patient’s thyroid gland has sufficient function, the decreased free thyroxine will result in a compensatory increase in thyroxine output by the thyroid. Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.

Drug/Laboratory Test Interactions—The following drugs or moieties are known to interfere with laboratory tests performed in patients on thyroid hormone therapy: androgens, corticosteroids, estrogens, oral contraceptives containing estrogens, iodine-containing preparations, and the numerous preparations containing salicylates. 1. Changes in TBg concentration should be taken into consideration in the interpretation of T4 and T3 values. In such cases, the unbound (free) hormone should be measured. Pregnancy, estrogens, and estrogencontaining oral contraceptives increase TBg concentrations. TBg may also be increased during infectious hepatitis. Decreases in TBg concentrations are observed in nephrosis, acromegaly, and after androgen or corticosteroid therapy. Familial hyper- or hypothyroxine-binding-globulinemias have been described. The incidence of TBg deficiency approximates 1 in 9,000. The binding of levothyroxine by TBPA is inhibited by salicylates. 2. Medicinal or dietary iodine interferes with all in vivo tests of radio-iodine uptake, producing low uptakes which may not be relative of a true decrease in hormone synthesis. 3. The persistence of clinical and laboratory evidence of hypothyroidism in spite of adequate dosage replacement indicates either poor patient compliance, poor absorption, excessive fecal loss, or inactivity of the preparation. Intracellular resistance to thyroid hormone is quite rare.

Carcinogenesis, Mutagenesis, and Impairment of Fertility—A reportedly apparent association between prolonged thyroid therapy and breast cancer has not been confirmed and patients on thyroid for established indications should not discontinue therapy. No confirmatory long-term studies in animals have been performed to evaluate carcinogenic potential, mutagenicity, or impairment of fertility in either males or females.

Pregnancy-Category A—Thyroid hormones do not readily cross the placental barrier. The clinical experience to date does not indicate any adverse effect on fetuses when thyroid hormones are administered to pregnant women. On the basis of current knowledge, thyroid replacement therapy to hypothyroid women should not be discontinued during pregnancy.

Nursing Mothers—Minimal amounts of thyroid hormones are excreted in human milk. Thyroid is not associated with serious adverse reactions and does not have a known tumorigenic potential. However, caution should be exercised when thyroid is administered to a nursing woman.

Pediatric Use—Pregnant mothers provide little or no thyroid hormone to the fetus. The incidence of congenital hypothyroidism is relatively high (1:4,000) and the hypothyroid fetus would not derive any benefit from the small amounts of hormone crossing the placental barrier. Routine determinations of serum T4 and/or TSH is strongly advised in neonates in view of the deleterious effects of thyroid deficiency on growth and development. Treatment should be initiated immediately upon diagnosis, and maintained for life, unless transient hypothyroidism is suspected; in which case, therapy may be interrupted for 2 to 8 weeks after the age of 3 years to reassess the condition. Cessation of therapy is justified in patients who have maintained a normal TSH during those 2 to 8 weeks.

ADVERSE REACTIONS: Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE).

OVERDOSAGE: Signs and Symptoms—Excessive doses of thyroid result in a hypermetabolic state resembling in every respect the condition of endogenous origin. The condition may be selfinduced.

Treatment of Overdosage—Dosage should be reduced or therapy temporarily discontinued if signs and symptoms of overdosage appear. Treatment may be reinstituted at a lower dosage. In normal individuals, normal hypothalamic-pituitary-thyroid axis function is restored in 6 to 8 weeks after thyroid suppression. Treatment of acute massive thyroid hormone overdosage is aimed at reducing gastrointestinal absorption of the drugs and counteracting central and peripheral effects, mainly those of increased sympathetic activity. Vomiting may be induced initially if further gastrointestinal absorption can reasonably be prevented and barring contraindications such as coma, convulsions, or loss of the gagging reflex. Treatment is symptomatic and supportive. Oxygen may be administered and ventilation maintained. Cardiac glycosides may be indicated if congestive heart failure develops. Measures to control fever, hypoglycemia, or fluid loss should be instituted if needed. Antiadrenergic agents, particularly propranolol, have been used advantageously in the treatment of increased sympathetic activity. Propranolol may be administered intravenously at a dosage of 1 to 3 mg, over a 10-minute period or orally, 80 to 160 mg/day, initially, especially when no contraindications exist for its use.

DOSAGE AND ADMINISTRATION: The dosage of thyroid hormones is determined by the indication and must in every case be individualized according to patient response and laboratory findings. Thyroid hormones are given orally. In acute, emergency conditions, injectable levothyroxine sodium may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition. Intramuscular administration is not advisable because of reported poor absorption.

Hypothyroidism—Therapy is usually instituted using low doses, with increments which depend on the cardiovascular status of the patient. The usual starting dose is 30 mg NP Thyroid, with increments of 15 mg every 2 to 3 weeks. A lower starting dosage, 15 mg/day, is recommended in patients with long standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require 60 to 120 mg/day. Failure to respond to doses of 180 mg suggests lack of compliance or malabsorption. Maintenance dosages 60 to 120 mg/day usually result in normal serum levothyroxine (T4) and triiodothyronine (T3) levels. Adequate therapy usually results in normal TSH and T4 levels after 2 to 3 weeks of therapy. Readjustment of thyroid hormone dosage should be made within the first four weeks of therapy, after proper clinical and laboratory evaluations, including serum levels of T4, bound and free, and TSH. T3 may be used in preference to levothyroxine (T4) during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T4 and T3 is suspected.

Myxedema Coma—Myxedema coma is usually precipitated in the hypothyroid patient of longstanding by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones. Corticosteroids should be administered routinely. T4 and T3 may be administered via a nasogastric tube but the preferred route of administration of both hormones is intravenous. Levothyroxine sodium (T4) is given at starting dose of 400 mcg (100 mcg/mL) given rapidly, and is usually well tolerated, even in the elderly. This initial dose is followed by daily supplements of 100 to 200 mcg given intravenously. Normal T4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T3. Oral therapy with thyroid hormone would be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication.

Thyroid Cancer—Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine. TSH should be suppressed to low or undetectable levels. Therefore, larger amounts of thyroid hormone than those used for replacement therapy are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy.

Thyroid Suppression Therapy—Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom base line laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave’s ophthalmopathy. 131I uptake is determined before and after the administration of the exogenous hormone. A 50 percent or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy. For adults, the usual suppressive dose of levothyroxine (T4) is 1.56 mcg/kg of body weight per day given for 7 to 10 days. These doses usually yield normal serum T4 and T3 levels and lack of response to TSH. Thyroid hormones should be administered cautiously to patients in whom there is strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.

Pediatric Dosage—Pediatric dosage should follow the recommendations summarized in Table 1. In infants with congenital hypothyroidism, therapy with full doses should be instituted as soon as the diagnosis has been made.

Recommended Pediatric Dosage for Congenital Hypothyroidism
	NP Thyroid Tablets
Age	Dose per day	Daily dose per kg of body weight
0 - 6 mos.	15 - 30 mg	4.8 - 6 mg
6 - 12 mos.	30 - 45 mg	3.6 - 4.8 mg
1 - 5 yrs.	45 - 60 mg	3 - 3.6 mg
6 - 12 yrs.	60 - 90 mg	2.4 - 3 mg
Over 12 yrs.	Over 90 mg	1.2 - 1.8 mg

HOW SUPPLIED: NP Thyroid tablets (thyroid tablets, USP) are supplied as follows: 30 mg (1/2 gr) are available in bottles of 100 (NDC 42192-329-01), 60 mg (1 gr) are available in bottles of 100 (NDC 42192-330-01), and 90 mg (1 1/2 gr) are available in bottles of 100 (NDC 42192-331-01). NP Thyroid tablets are light tan, round tablets, debossed on one side with “AP” and a 3-digit code on the other side as follows:

30 mg (1/2 grain) - “329”

60 mg (1 grain) - “330”

90 mg (1 1/2 grain) - “331”

MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

9005 Westside Parkway

Alpharetta, GA 30009

1-800-541-4802

Rev 1010v3

Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F).

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

EACH TABLET CONTAINS:

levothyroxine (T4)...........................38 mcg

liothyronine (T3)............................9 mcg

DIRECTIONS FOR USE: See Insert.

USUAL DOSE: 15 mg - 180 mg once a day.

NP Thyroid is a natural product with a strong, characteristic odor.

Store in a tight container protected from light and moisture. Store between 15° - 30°C (59° - 86°F).

MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30009

1-800-541-4802

Lot #/Exp. Date:

NDC 42192-330-01

NP Thyroid 60

Thyroid Tablets, USP

1 grain (60 mg)

Rx Only 100 Tablets

Acella PHARMACEUTICALS, LLC

NP Thyroid 60
levothyroxine, liothyronine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	42192-330
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOTHYROXINE (LEVOTHYROXINE)	LEVOTHYROXINE	38 ug
LIOTHYRONINE (LIOTHYRONINE)	LIOTHYRONINE	9 ug

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE
DEXTROSE MONOHYDRATE
MALTODEXTRIN
MINERAL OIL

Product Characteristics
Color	brown (BROWN)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	AP;330
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42192-330-01	100 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/11/2010

Labeler - Acella Pharmaceuticals, LLC (825380939)

Revised: 01/2011Acella Pharmaceuticals, LLC

Friday, May 4, 2012

TheraFlu NightTime Maximum Strength Powder Packet

Pronunciation: a-seet-a-MIN-oh-fen/klor-fen-EER-a-meen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include TheraFlu Flu/Cold/Cough and TheraFlu NightTime Maximum Strength

TheraFlu NightTime Maximum Strength Powder Packet is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

TheraFlu NightTime Maximum Strength Powder Packet is a decongestant, antihistamine, cough suppressant, and analgesic combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce a dry or unproductive cough.

Do NOT use TheraFlu NightTime Maximum Strength Powder Packet if:

you are allergic to any ingredient in TheraFlu NightTime Maximum Strength Powder Packet

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using TheraFlu NightTime Maximum Strength Powder Packet:

Some medical conditions may interact with TheraFlu NightTime Maximum Strength Powder Packet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding

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

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

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with TheraFlu NightTime Maximum Strength Powder Packet. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of TheraFlu NightTime Maximum Strength Powder Packet may be increased

Anticoagulants (eg, warfarin), digoxin or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased

Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by TheraFlu NightTime Maximum Strength Powder Packet

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by TheraFlu NightTime Maximum Strength Powder Packet

This may not be a complete list of all interactions that may occur. Ask your health care provider if TheraFlu NightTime Maximum Strength Powder Packet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use TheraFlu NightTime Maximum Strength Powder Packet:

Use TheraFlu NightTime Maximum Strength Powder Packet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

TheraFlu NightTime Maximum Strength Powder Packet may be taken with or without food.

Dissolve the contents of 1 packet in water as directed by your doctor or the package labeling. Drink the entire dose.

If you miss a dose of TheraFlu NightTime Maximum Strength Powder Packet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use TheraFlu NightTime Maximum Strength Powder Packet.

Important safety information:

TheraFlu NightTime Maximum Strength Powder Packet may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to TheraFlu NightTime Maximum Strength Powder Packet. Using TheraFlu NightTime Maximum Strength Powder Packet alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Do not take diet or appetite control medicines while you are taking TheraFlu NightTime Maximum Strength Powder Packet without checking with you doctor.

TheraFlu NightTime Maximum Strength Powder Packet contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Do NOT exceed the recommended dose or take TheraFlu NightTime Maximum Strength Powder Packet for longer than prescribed without checking with your doctor.

If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

TheraFlu NightTime Maximum Strength Powder Packet may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to TheraFlu NightTime Maximum Strength Powder Packet. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

TheraFlu NightTime Maximum Strength Powder Packet may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take TheraFlu NightTime Maximum Strength Powder Packet or other pain relievers/fever reducers. Alcohol use combined with TheraFlu NightTime Maximum Strength Powder Packet may increase your risk for liver damage.

If you are scheduled for allergy skin testing, do not take TheraFlu NightTime Maximum Strength Powder Packet for several days before the test because it may decrease your response to the skin tests.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using TheraFlu NightTime Maximum Strength Powder Packet.

Use TheraFlu NightTime Maximum Strength Powder Packet with caution in the ELDERLY because they may be more sensitive to its effects.

Caution is advised when using TheraFlu NightTime Maximum Strength Powder Packet in CHILDREN because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking TheraFlu NightTime Maximum Strength Powder Packet, discuss with your doctor the benefits and risks of using TheraFlu NightTime Maximum Strength Powder Packet during pregnancy. It is unknown if TheraFlu NightTime Maximum Strength Powder Packet is excreted in breast milk. Do not breast-feed while taking TheraFlu NightTime Maximum Strength Powder Packet.

Possible side effects of TheraFlu NightTime Maximum Strength Powder Packet:

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

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

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

See also: TheraFlu NightTime Maximum Strength side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of TheraFlu NightTime Maximum Strength Powder Packet:

Store TheraFlu NightTime Maximum Strength Powder Packet at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep TheraFlu NightTime Maximum Strength Powder Packet out of the reach of children and away from pets.

General information:

If you have any questions about TheraFlu NightTime Maximum Strength Powder Packet, please talk with your doctor, pharmacist, or other health care provider.

TheraFlu NightTime Maximum Strength Powder Packet is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More TheraFlu NightTime Maximum Strength resources

TheraFlu NightTime Maximum Strength Side Effects (in more detail)
TheraFlu NightTime Maximum Strength Use in Pregnancy & Breastfeeding
TheraFlu NightTime Maximum Strength Drug Interactions
TheraFlu NightTime Maximum Strength Support Group
1 Review for TheraFlu NightTime Maximum Strength - Add your own review/rating

Compare TheraFlu NightTime Maximum Strength with other medications

Cold Symptoms
Influenza

Wednesday, May 2, 2012

Symbyax

Pronunciation: oh-LAN-za-peen/floo-OX-e-teen
Generic Name: Olanzapine/Fluoxetine
Brand Name: Symbyax

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Symbyax outweigh the risks.

Families and caregivers must closely watch patients who take Symbyax. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Symbyax contains an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Symbyax is not approved to treat mental problems caused by dementia.

Symbyax is used for:

Treating depression in patients with bipolar disorder. It is also used to treat depression in patients who have not responded to 2 other medicines. It may also be used for other conditions as determined by your doctor.

Symbyax is a combination of an atypical antipsychotic and a selective serotonin reuptake inhibitor (SSRI). It works by affecting certain substances in the brain, including serotonin. This helps to improve certain mood problems.

Do NOT use Symbyax if:

you are allergic to any ingredient in Symbyax

you are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline) or St. John's wort within the last 14 days

you are taking astemizole, clopidogrel, a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), sibutramine, another SSRI (eg, paroxetine), terfenadine, thioridazine, or tryptophan

you are taking another medicine that contains olanzapine or fluoxetine

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Symbyax:

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

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

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

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

if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse

if you have a history of seizures, heart problems (eg, heart failure; fast, slow, or irregular heartbeat), abnormal electrocardiogram (ECG), a heart attack, stroke or "mini-stroke," blood vessel problems, high blood cholesterol or triglyceride levels, high or low blood pressure, or low white blood cell levels

if you have a history of liver problems (eg, cirrhosis); severe kidney problems; stomach or bowel problems (eg, bleeding, blockage, paralytic ileus); bleeding problems; enlarged prostate; narrow-angle glaucoma or a risk of developing it; neuroleptic malignant syndrome (NMS); prolonged, painful erection; or metabolism problems

if you have diabetes or high blood sugar, are very overweight, or if a family member has had diabetes

if you are dehydrated or have low blood volume, low blood sodium levels, Alzheimer disease, dementia, or trouble swallowing

if you drink alcohol, smoke, or will be exposed to high temperatures

if you have a history of high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer

if you will be having electroconvulsive therapy (ECT)

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

Fenfluramine derivatives (eg, dexfenfluramine), 5-HT₁ receptor agonists (eg, sumatriptan), linezolid, MAOIs (eg, phenelzine, selegiline), methylene blue, nefazodone, sibutramine, SNRIs (eg, venlafaxine), St. John's wort, tramadol, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma, may occur

Astemizole, pimozide, terfenadine, or thioridazine because the risk of serious irregular heartbeat may be increased by Symbyax

Clopidogrel because its effectiveness may be decreased by Symbyax

Many prescription and nonprescription medicines (eg, used for anxiety, other mental or mood problems, aches and pains, allergies, appetite suppression, blood thinning, cancer, cough, heart problems, heartburn, high blood pressure, high cholesterol, HIV, infections, inflammation, irregular heartbeat, migraine headaches, muscle relaxers, Parkinson disease, seizures, ulcers), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Symbyax, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Symbyax may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Symbyax:

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

Symbyax comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Symbyax refilled.

Take Symbyax by mouth on an empty stomach or with food.

Take Symbyax in the evening, unless your doctor tells you otherwise.

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

Do not suddenly stop taking Symbyax without checking with your doctor. Side effects may occur. They may include mental or mood changes, agitation, anxiety, irritability, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Symbyax and whenever a change in dose is made.

If you miss a dose of Symbyax, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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

Do not drink alcohol while you are taking Symbyax.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Symbyax; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Symbyax may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.

If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you think you may be dehydrated.

Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or take Symbyax for longer than prescribed without checking with your doctor.

Children and teenagers who take Symbyax may be at increased risk of suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Symbyax closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

Symbyax may cause decreased sexual desire or ability. This has occasionally been reported to continue after treatment has been stopped. Discuss any questions or concerns with your doctor.

Symbyax may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.

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

Symbyax may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

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

NMS is a possibly fatal syndrome that can be caused by Symbyax. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.

Some patients who take Symbyax may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Symbyax in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Symbyax.

Serotonin syndrome is a possibly fatal syndrome that can be caused by Symbyax. Your risk may be greater if you take Symbyax with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.

If your doctor tells you to stop taking Symbyax, you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Symbyax.

Some patients have experienced weight gain while using Symbyax. You may need to have regular weight checks while you use Symbyax.

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

Use Symbyax with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.

Symbyax should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.

Symbyax may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Symbyax.

PREGNANCY and BREAST-FEEDING: Symbyax may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Symbyax while you are pregnant. Symbyax is found in breast milk. Do not breast-feed while taking Symbyax.

Possible side effects of Symbyax:

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

Blurred vision; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased appetite; sore throat; tiredness; weakness; weight gain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; black or bloody stools; chest pain; confusion; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; joint pain; memory loss; new or worsening mental or mood changes (eg, agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well being, restlessness, inability to sit still); red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness, headache, or trouble sleeping; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of dehydration (eg, decreased sweating or urination, severe or persistent dry mouth, feeling very hot or thirsty); symptoms of high prolactin levels (eg, enlarged breast size, decreased sexual ability, missed menstrual period, nipple discharge); symptoms of stroke (eg, one-sided weakness, slurred speech); tremor; trouble concentrating, speaking, swallowing, or walking; trouble urinating; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising or bleeding; unusual swelling or sweating; unusual weakness; vision changes; yellowing of the skin or eyes.

See also: Symbyax side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include aggression; agitation; chest pain; coma; confusion; delirium; difficult breathing; fainting; fast, slow, or irregular heartbeat; fever; loss of coordination; seizures; severe or persistent dizziness, drowsiness, headache, nausea, or vomiting; sluggishness; tremor; trouble speaking.

Proper storage of Symbyax:

Store Symbyax between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Symbyax out of the reach of children and away from pets.

General information:

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

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

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

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Symbyax resources

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

Symbyax Prescribing Information (FDA)

Symbyax Advanced Consumer (Micromedex) - Includes Dosage Information

Symbyax Consumer Overview

Compare Symbyax with other medications

Bipolar Disorder
Depression

Tuesday, May 1, 2012

Krystexxa

Generic Name: Pegloticase
Class: Antigout Agents
VA Class: MS400
Chemical Name: Amide with α-carboxy-ω-methoxypoly(oxy-1,2-ethanediyl), urate (synthetic Sus scrofa variant pigKS-DN subunit), oxidase, homotetramer
Molecular Formula: C₁₅₄₉H₂₄₃₀N₄₀₈O₄₄₈S₈
CAS Number: 885051-90-1

Anaphylaxis and Infusion Reactions

Anaphylaxis and infusion reactions reported during and after administration.¹ (See Sensitivity Reactions under Cautions.)

Anaphylaxis may occur with any infusion; generally manifests within 2 hours of infusion.¹ Delayed-type hypersensitivity also reported.¹

Administer in a healthcare setting by healthcare providers prepared to manage anaphylaxis and infusion reactions.¹

Premedicate patients with antihistamines and corticosteroids.¹

Closely monitor for anaphylaxis for an appropriate period of time after administration.¹

Determine serum uric acid concentration prior to each infusion and consider discontinuing treatment if concentrations rise above 6 mg/dL, particularly if 2 consecutive measurements exceed 6 mg/dL.¹

REMS:

FDA approved a REMS for pegloticase to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of pegloticase and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Pegylated biosynthetic (recombinant DNA origin) modified mammalian urate oxidase (uricase) enzyme.¹ ⁷ ⁸ ¹¹

Uses for Krystexxa

Gout

Management of chronic gout that is refractory to conventional therapy (i.e., chronic gout in patients in whom maximum recommended dosages of xanthine oxidase inhibitors have failed to normalize serum uric acid concentrations and to adequately control clinical manifestations of the disease or in whom these drugs are contraindicated).¹ ³ ⁴ ⁷ ⁸ ¹¹ ¹² ¹⁵ ¹⁶ Designated an orphan drug by FDA for this use.¹⁴

Not recommended for treatment of asymptomatic hyperuricemia.¹

Krystexxa Dosage and Administration

General

Premedication for Sensitivity Reactions

Administer antihistamines and corticosteroids before each infusion to minimize risk of anaphylaxis and infusion reactions.¹ Closely monitor patient for an appropriate period of time after administration.¹ (See Sensitivity Reactions under Cautions.)

Measure uric acid concentration before each infusion; risk of anaphylaxis or infusion reactions is higher in patients who have lost therapeutic response to the drug.¹

Gout Flare Prophylaxis

Initiate gout flare prophylaxis with an NSAIA or colchicine at least 1 week prior to initiation of pegloticase and continue for ≥6 months unless contraindicated or not tolerated.¹ (See Gout Flares under Cautions.)

REMS Program

Risk Evaluation and Mitigation Strategy (REMS) required and approved by FDA.⁵

Goal is to inform healthcare providers and patients about serious risks associated with pegloticase, including risk of anaphylaxis and infusion reactions and the contraindication to use in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.⁵ (See Cautions.)

Program consists of a medication guide that must be dispensed with every prescription and a communication plan that includes initial and periodic communications targeting selected groups of healthcare providers.⁵

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹ Do not administer by rapid IV injection (e.g., IV push or bolus).¹

May administer via gravity feed, syringe pump, or infusion pump.¹

Dilution

Pegloticase injection concentrate must be diluted prior to IV administration.¹

Withdraw 1 mL of pegloticase injection concentrate from a vial containing 8 mg/mL of uricase protein.¹ Inject into 250-mL bag containing 0.45 or 0.9% sodium chloride injection.¹ Discard any unused portion.¹ Invert the infusion bag a number of times to mix thoroughly; do not shake.¹

Do not mix or dilute with any other drugs.¹

Refrigerate diluted solution, protect from light, and use within 4 hours of dilution.¹ Allow diluted solution to reach room temperature before administration,¹ but do not subject to heating (e.g., hot water, microwave).¹

Rate of Administration

Infuse over at least 120 minutes.¹

If infusion reaction occurs, slow rate of infusion, temporarily stop and then restart infusion at a slower rate, or discontinue infusion, depending on severity of reaction.¹

Dosage

Dosage expressed in terms of the amount of uricase protein.¹

Adults

Gout

IV

8 mg (of uricase protein) every 2 weeks.¹ ¹² Optimum duration of therapy not established.¹ ¹³

8 mg (of uricase protein) every 4 weeks also effective in controlling plasma uric acid concentrations, but associated with increased frequency of anaphylaxis and infusion reactions and reduced efficacy in resolving tophi.¹

Consider discontinuing therapy if uric acid concentration rises above 6 mg/dL, particularly if 2 consecutive measurements exceed 6 mg/dL.¹ (See Sensitivity Reactions under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations; not specifically studied in hepatic impairment.¹

Renal Impairment

No dosage adjustment required in renal impairment.¹

Geriatric Patients

No dosage adjustment required based on age.¹

Cautions for Krystexxa

Contraindications

G-6-PD deficiency.¹ Screen higher-risk patients (e.g., patients of African or Mediterranean ancestry) for G-6-PD deficiency before initiating pegloticase therapy.¹

Warnings/Precautions

Sensitivity Reactions

Anaphylaxis

Anaphylaxis reported despite pretreatment with oral antihistamine, IV corticosteroid, and/or acetaminophen in 6.5% of patients receiving recommended pegloticase dosage.¹ (See Boxed Warning.) Manifestations included wheezing, perioral or lingual edema, or hemodynamic instability, with or without rash or urticaria.¹ Pretreatment may have blunted symptoms or signs of anaphylaxis; therefore, reported frequency may underestimate drug's potential to cause such reactions.¹

Administer in a healthcare setting by healthcare providers prepared to manage anaphylaxis.¹ Pretreat patients with antihistamines and corticosteroids.¹ Monitor closely for an appropriate period of time after administration.¹

Risk of anaphylaxis is higher in patients whose uric acid concentration rises above 6 mg/dL, particularly when 2 consecutive concentrations exceed 6 mg/dL.¹ Determine serum uric acid prior to each infusion and consider discontinuing treatment if concentrations rise above 6 mg/dL.¹

Infusion Reactions

Infusion reactions (e.g., urticaria, dyspnea, chest discomfort or pain, erythema, pruritus) reported despite pretreatment with oral antihistamine, IV corticosteroid, and/or acetaminophen in 26% of patients receiving recommended pegloticase dosage.¹ (See Boxed Warning.) Pretreatment may have blunted symptoms or signs of infusion reactions; therefore, reported frequency may underestimate drug's potential to cause such reactions.¹

Administer in a healthcare setting by healthcare providers prepared to manage infusion reactions.¹ Pretreat patients with antihistamines and corticosteroids.¹ Monitor for approximately 1 hour after administration.¹ Infuse slowly over at least 120 minutes.¹

If infusion reaction occurs, slow infusion, or stop and then restart the infusion at a slower rate.¹ If reaction is severe, discontinue infusion and institute appropriate treatment as needed.¹

Higher risk of infusion reaction in patients whose uric acid concentration rises above 6 mg/dL, particularly when 2 consecutive concentrations exceed 6 mg/dL.¹ Determine serum uric acid prior to each infusion and consider discontinuing treatment if concentration rises above 6 mg/dL.¹

Gout Flares

Increase in gout flares frequently observed upon initiation of antihyperuricemic therapy.¹ Gout flares reported during first 3 months of therapy despite prophylaxis in 74% of patients receiving recommended pegloticase dosage.¹

Initiate prophylaxis with an NSAIA or colchicine 1 week before initiation of pegloticase and continue for 6 months unless contraindicated or not tolerated.¹

Discontinuance of pegloticase due to gout flare unnecessary.¹

Congestive Heart Failure

Not formally studied in patients with CHF; exacerbation of heart failure has been reported.¹ Exercise caution in patients with CHF; monitor closely following infusion.¹

Retreatment with Pegloticase

Safety and efficacy of resuming pegloticase after treatment interruption of >4 weeks not established in controlled clinical trials.¹ Possible increased risk of anaphylaxis and infusion reactions; closely monitor patients reinitiating treatment after a drug-free interval.¹

Immunogenicity

Antipegloticase antibodies detected in 92% of patients receiving pegloticase every 2 weeks.¹ Antibodies appear to bind to PEG portion of drug.¹ ¹⁷ (See Interactions.)

High antibody titer associated with reduced serum concentrations of the drug and failure to maintain pegloticase-induced normalization of serum uric acid.¹ ¹⁰ Higher incidence of infusion reactions in patients with high antipegloticase antibody titer.¹ ¹⁰

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether pegloticase is distributed into milk; do not use in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

Not studied in patients with hepatic impairment.¹

Renal Impairment

About 32% of patients in clinical trials receiving recommended dosage (8 mg every 2 weeks) had Cl_cr ≤62.5 mL/minute.¹ No substantial differences in efficacy were observed.¹

Common Adverse Effects

Gout flares,¹ ³ infusion reactions,¹ ³ nausea,¹ contusion or ecchymosis,¹ nasopharyngitis,¹ constipation,¹ chest pain,¹ anaphylaxis,¹ vomiting.¹

Interactions for Krystexxa

No formal drug interaction studies to date.¹

PEG-containing Drugs

Antipegloticase antibodies appear to bind to the PEG portion of pegloticase; potential for binding with other pegylated drugs.¹ Effect of antibodies on efficacy of other PEG-containing drugs is not known.¹

Krystexxa Pharmacokinetics

Absorption

Onset

Rapidly reduces plasma uric acid.¹ ⁶ ¹¹ Minimum plasma urate concentration occurred 48–72 hours postinfusion in patients receiving doses of 1–8 mg.⁶

Duration

Single dose generally maintains plasma uric acid concentrations below 6 mg/dL for >12 days.¹ ⁶ ¹¹

Elimination

Half-life

Highly variable, 6.8–16.8 days.⁶ ¹¹

Special Populations

Pharmacokinetics in adults not affected by age, sex, weight, or Cl_cr.¹

Stability

Storage

Parenteral

Injection

2–8°C.¹ Protect from light; do not freeze.¹

Diluted solution: Stable at 2–8 or 20–25°C for up to 4 hours; however, manufacturer recommends refrigeration.¹ Do not freeze.¹ Protect from light.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible
Sodium chloride 0.45 or 0.9%¹

Actions

Biosynthetic (recombinant DNA origin) modified mammalian (porcine-like) urate oxidase (uricase, urate hydroxylase) enzyme that is covalently bound to monoethoxypolyethylene glycol (PEG).¹ ⁸ ¹¹ ¹³

Catalyzes the oxidation of uric acid to allantoin, thereby lowering serum uric acid concentrations.¹ ⁸ ¹¹ Allantoin is readily eliminated, primarily by renal excretion.¹ ¹¹

Maintaining serum urate concentration below the saturation point for monosodium urate (e.g., maintaining concentrations at ≤6 mg/dL) may prevent crystal formation and promote resolution of tophaceous crystal deposits, thus preventing long-term joint, bone, cartilage, and tissue destruction.⁷ ⁸ ¹⁸

Advice to Patients

Pegloticase medication guide must be provided to the patient each time the drug is administered (see REMS Program under Dosage and Administration);⁵ importance of patient reading the medication guide before initiating therapy and before each subsequent infusion.¹ ²

Importance of informing patients that anaphylaxis and infusion reactions can occur with any infusion.¹ Importance of informing patients of the signs and symptoms of anaphylaxis (e.g., wheezing, swelling of the throat or tongue, throat tightness, hoarseness, difficulty swallowing, dizziness, fainting, fast or weak heartbeat, feelings of nervousness, rash, itching, urticaria)¹ ² and infusion reactions (e.g., urticaria, erythema, difficulty breathing, flushing, chest discomfort or pain, rash).¹

Advise patients to seek medical care immediately if they experience any symptoms of an allergic reaction during or at any time after an infusion of pegloticase.¹ Counsel patients on the importance of adhering to therapy prescribed to prevent or lessen the severity of these reactions.¹

Importance of informing patients not to take pegloticase if they have G-6-PD deficiency.¹ Counsel patients that they may be tested to determine if they have G-6-PD deficiency.¹

Importance of informing patients that gout flares may initially increase when starting treatment with pegloticase and that medications to help reduce flares may be taken regularly for the first few months after initiation.¹ Advise patients that they should not discontinue pegloticase if flares occur.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ²

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal or dietary supplements, as well as any concomitant conditions (e.g., heart failure, G-6-PD deficiency).¹ ²

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pegloticase
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, concentrate, for IV infusion	8 mg/mL (of uricase protein)	Krystexxa	Savient

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. Savient Pharmaceuticals, Inc. Krystexxa (pegloticase) injection prescribing information. East Brunswick, NJ; 2010 Sep.

2. Savient Pharmaceuticals, Inc. Krystexxa (pegloticase) injection patient information. East Brunswick, NJ; 2010 Sep.

3. Sundy JS, Baraf HS, Becker MA, et al. Efficacy and safety of intravenous (IV) pegloticase (PGL) in subjects with treatment failure gout (TFG): phase 3 results from GOUT1 and GOUT2 [abstract]. Arthritis Rheum. 2008; 58:S635.

4. Sundy JS, Baraf HS, Gutierrez-Urena SR, et al.. Chronic use of pegloticase: safety and efficacy update [abstract]. Arthritis Rheum. 2009; 60:S417.

5. Krystexxa (pegloticase) risk evaluation and mitigation strategy (REMS). From FDA website. Accessed 2011 Jan 19.

6. Sundy JS, Ganson NJ, Kelly SJ et al. Pharmacokinetics and pharmacodynamics of intravenous PEGylated recombinant mammalian urate oxidase in patients with refractory gout. Arthritis Rheum. 2007; 56:1021-8. [PubMed 17328081]

7. Baraf HS, Matsumoto AK, Maroli AN et al. Resolution of gouty tophi after twelve weeks of pegloticase treatment. Arthritis Rheum. 2008; 58:3632-4. [PubMed 18975338]

8. Anderson A, Singh JA. Pegloticase for chronic gout. Cochrane Database Syst Rev. 2010; :CD008335. [PubMed 20238366]

9. Mandel DR, Baraf H, Rehrig C, et al. Use of pegloticase in chronic gout refractory to conventional therapy is associated with significant clinical benefit: tender joint and swollen joint counts and patient global assessment (health assessment questionnaire)[abstract]. Arthritis Rheum. 2010; 62:S166.

10. Wright D, Sundy JS, Rosario-Jansen T. Routine serum uric acid (SUA) monitoring predicts antibody-mediated loss of response in infusion reaction risk during pegloticase therapy [abstract]. Arthritis Rheum. 2009; 60:S1104.

11. Sundy JS, Becker MA, Baraf HS et al. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: results of a phase II randomized study. Arthritis Rheum. 2008; 58:2882-91. [PubMed 18759308]

12. Edwards NL. Treatment-failure gout: a moving target. Arthritis Rheum. 2008; 58:2587-90. [PubMed 18759307]

13. Burns CM, Wortmann RL. Gout therapeutics: new drugs for an old disease. Lancet. 2011; 377:165-77. [PubMed 20719377]

14. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website. Accessed 2011 Mar 15.

15. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number: 125293: Summary review for pegloticase. From FDA website. Accessed 2011 Mar 15.

16. . Pegloticase (Krystexxa) for treatment of refractory gout. Med Lett Drugs Ther. 2011; 53:9-10. [PubMed 21304442]

17. US Food and Drug Administration. Center for Drug Evaluation and Research. Application number: 125293: Immunogenicity review(s) for pegloticase. From FDA website. Accessed 2011 Mar 22.

18. Zhang W, Doherty M, Bardin T et al. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006; 65:1312-24. [PubMed 16707532]

More Krystexxa resources

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

Krystexxa Prescribing Information (FDA)

Krystexxa Consumer Overview

Krystexxa Advanced Consumer (Micromedex) - Includes Dosage Information

Krystexxa MedFacts Consumer Leaflet (Wolters Kluwer)

Pegloticase Professional Patient Advice (Wolters Kluwer)

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