Eliphos

Generic Name: calcium acetate

Dosage Form: tablet
Eliphos Tablets (Calcium Acetate Tablets, USP)

Description: Each white, round tablet (stamped “CYP 910”) contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000, NF; sodium lauryl sulfate, NF; and crospovidone, NF. ELIPHOS(R) (Calcium Acetate, USP) are administered orally for the control of hyperphosphatemia in end stage renal failure.

Clinical Pharmacology: Patients with advanced renal insufficiency (creatinine clearance less than 30 mL/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate (ELIPHOS(R) ), when taken with meals, combines with dietary phosphate to form insoluble

calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. ELIPHOS(R) is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. Orally administered calcium acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

Indications and Usage: ELIPHOS(R) is indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption.

Contraindications: Patients with hypercalcemia.

Warnings: Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with ELIPHOS(R). Progressive hypercalcemia due to overdose of ELIPHOS(R) may be severe as to require emergency measures. Chronic hypercalcemia may lead to

vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period.

The serum calcium times phosphate (CaXP) product should not be allowed to exceed 66.

Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.

Precautions: General: Excessive dosage of ELIPHOS(R) induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. ELIPHOS(R) should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. ELIPHOS(R) therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily dietary calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.

Information for the patient: The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia (see ADVERSE REACTIONS section).

Drug Interactions: ELIPHOS(R) may decrease the bioavailability of tetracyclines.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term animal studies have not been performed to evaluate the carcinogenic potential, mutagenicity, or effect on fertility of calcium acetate tablets.

Pregnancy: Teratogenic Effects: Category C. Animal reproduction studies have not been conducted with calcium acetate tablets. It is also not known whether calcium acetate tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium acetate tablets should be given to a pregnant woman only if clearly needed.

Pediatric Use: Safety and efficacy of calcium acetate tablets have not been established.

Geriatric Use: Of the total number of subjects in clinical studies of calcium acetate tablets (n = 91), 25 percent were 65 and over, while 7 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions: In clinical studies, patients have occasionally experienced nausea during calcium acetate tablet therapy. Hypercalcemia may occur during treatment with ELIPHOS(R) . Mild hypercalcemia (Ca greater than 10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia (Ca greater than 12 mg/dl) is associated with confusion, delirium, stupor, and coma. Mild hypercalcemia is easily controlled by reducing the ELIPHOS(R) dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate tablets therapy.

Decreasing dialysate calcium concentration could reduce the incidence and severity of ELIPHOS(R) induced hypercalcemia. The long-term effect of calcium acetate tablets on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.

Overdosage: Administration of ELIPHOS(R) in excess of the appropriate daily dosage can cause severe hypercalcemia (See ADVERSE REACTIONS).

Dosage and Administration: The recommended initial dose of ELIPHOS(R) for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3–4 tablets with each meal.

How Supplied: In tablet form with “CYP 910” debossed on one side and plain on the other, for oral administration. Each white round tablet contains 667 mg of calcium acetate (anhydrous

Ca(CH3COO)2; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol8000, NF; sodium lauryl sulfate, NF; and crospovidone, NF.

Tablets, NDC 63717-910-02, bottles of 200.

Storage: Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [See USP Controlled Room Temperature].

Rx only

Manufactured for:

Hawthorn Pharmaceuticals, Inc.

Madison, MS 39110

HI274 02/11

ELIPHOS  calcium acetate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63717-910 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Acetate (Calcium Cation) Calcium Acetate 667 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code CYP910 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63717-910-99 30 TABLET In 1 BOTTLE None 2 63717-910-02 200 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078502	02/01/2009

Labeler - Hawthorn Pharmaceutical, Inc. (118049704)

Registrant - Stason Pharmaceuticals, Inc. (807437553)

Establishment
Name	Address	ID/FEI	Operations
Stason Pharmaceuticals, Inc.		807437553	manufacture

Revised: 09/2011Hawthorn Pharmaceutical, Inc.

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Compare Eliphos with other medications

• Hyperphosphatemia

Parmid XL 10 mg Prolonged Release Tablets

1. Name Of The Medicinal Product

Parmid XL 10 mg Prolonged Release Tablets

2. Qualitative And Quantitative Composition

Each prolonged release tablet contains 10mg of felodipine.

Excipient(s) lactose monohydrate (21.45 mg/tablet)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged release tablets

Round, reddish brown, biconvex tablet with imprint 10

4. Clinical Particulars

4.1 Therapeutic Indications

Essential hypertension

4.2 Posology And Method Of Administration

The dose should be adjusted to the individual requirements of the patient.

Parmid XL Tablets should usually be administered as follows:

The recommended initial dose is 5 mg felodipine once daily.

If necessary, the dose may be increased to 10 mg felodipine once daily, or another antihypertensive agent added. Dose increases should occur at intervals of at least 2 weeks. The usual maintenance dose is 5-10mg once daily.

The maximum daily dose is 10 mg felodipine.

Elderly:

The recommended initial dose should be adapted in the elderly. Subsequent dose increases should be undertaken with particular caution.

Impaired Renal Function:

The pharmacokinetics are not significantly affected in patients with mild to impaired renal function. Caution should be taken in patients with severe renal impairment (see Sections 4.4 & 5.2).

Impaired hepatic function:

In patients with mild to moderate hepatic impairment, the recommended initial dose should be lowered to the minimal therapeutic effective dose of felodipine. The dose should only be increased after carefully balancing the benefits against the risks (see section5.2). It is contraindicated in patients with severe hepatic impairment.

Children:

Felodipine should not be used in children, as its safety and efficacy in this population has not been established.

Method of administration:

The prolonged release tablets should be taken in the morning with a sufficient amount of fluid (e.g. a glass of water, but it should NOT be taken with grapefruit juice!). (See 4.5)

The prolonged release tablets should be swallowed whole and not chewed or crushed.

The tablets may be taken on an empty stomach or with a light meal. However a high-fat meal should be avoided (see section 5.2).

4.3 Contraindications

Felodipine is contra-indicated in patients:

• With hypersensitivity to felodipine (or other dihydropyridines) or to any of the excipients

• With cardiogenic shock (as with all other calcium channel blockers, treatment should be discontinued in patients who develop cardiogenic shock)

• With severe aortic or mitral stenosis

• With obstructive hypertrophic cardiomyopathy

• With unstable angina pectoris

• Who have had an acute myocardial infarction (within 4-8 weeks of a myocardial infarction)

• With decompensated heart failure

• With severe hepatic impairment

• During pregnancy (see section 4.6)

4.4 Special Warnings And Precautions For Use

Felodipine should be used with caution in patients with:

• Conduction disorders, compensated heart failure, tachycardia and aortic or mitral valve stenosis.

• Mild to moderare hepatic impairment, as the anti-hypertensive effect may be enhanced. Adjustment of the dose should be considered.

• Severe renal impairment (GFR < 30ml/min).

• AV block of the second or third degree

If treatment with felodipine is discontinued abruptly, a hypertensive crisis may occur in individual cases.

Felodipine could cause significant hypotension (vasodilation effect) with consecutive tachycardia, leading to myocardial ischaemia in sensitive patients. Therefore predisposed patients may suffer from myocardial infarction (see section 5.1).

Dihydropyridines may cause acute hypotension. In some cases there is a risk of hypoperfusion accompanied by refex tachycardia (paradoxical angor) (see section 5.1).

Felodipine is metabolised by CYP3A4 enzymes. Therefore, combination with medicinal products which are potent CYP3A4 inhibitors or inducers should be avoided (see section 4.5). Due to the same reason the concomitant intake of grapefruit juice should be avoided (see section 4.5).

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Felodipine is a CYP3A4 substrate. Drugs that induce or inhibit CYP3A4 will have a large influence on felodipine concentrations.

The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensives and tricyclic antidepressants.

The concomitant intake of felodipine and drugs which inhibit the cytochrome P₄₅₀ isoenzyme 3A4 of the liver such as cimetidine, azole antifungals (itraconazole, ketoconazole), macrolide antibiotics (erythromycin) or HIV protease inhibitors, leads to increased felodipine plasma levels (see section 4.4).

Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to interaction with flavonoids in the fruit juice. Therefore grapefruit juice should not be taken together with felodipine.

Concomitant treatment with drugs such as carbamazepine, phenytoin and barbituates (e.g. phenobarbital) and rifampicin reduces the plasma levels of felodipine via enzyme induction in the liver (cytochrome P₄₅₀ system). Therefore a dose increase of felodipine may be necessary.

Hydrochlorthiazide may enhance the anti-hypertensive effect of felodipine.

Felodipine can induce an increase of Cmax of cyclosporin. Additionally, cyclosporin may inhibit felodipine metabolism which may create a potential risk of felodipine toxicity.

Blood levels of digoxin increase during concomitant administration of felodipine. Therefore decreasing digoxin dosage should be taken into account when the two drugs are administered concurrently.

4.6 Pregnancy And Lactation

Felodipine is contra-indicated throughout pregnancy, as animal experiments have demonstrated foetal damage (see section 5.3.). Pregnancy must be excluded before starting treatment with felodipine.

Felodipine is excreted into breast milk. If the breast-feeding mother is taking therapeutic doses of felodipine, a totally breast-fed infant absorbs only a very low dose of the active substance with the breast milk. There is no experience of the risk this may pose to the new born, therefore, as a precaution, breast-feeding should be discontinued during treatment.

4.7 Effects On Ability To Drive And Use Machines

Treatment with felodipine requires regular medical supervision. In individual cases felodipine can influence a patient's reactions to such an extent that the ability to drive or to operate machines or to work without suitable safeguards may be impaired. This is particularly the case at the start of therapy, or when the dose is increased, or when medication is changed as well as after the concomitant ingestion of alcohol.

4.8 Undesirable Effects

Adverse reactions have been ranked under headings of frequency using the following convention:

Very common:
common:
uncommon:
rare:
very rare including isolated reports:	<1/10,000
not known:	cannot be estimated from the available data

Nervous system disorders
Very common:	Headache, tinnitus
Uncommon:	Dizziness, paraesthesia, restlessness, tremor, syncope

Ear and labyrinth disorders
Very common:	Tinnitus

Cardiac disorders
Common:	Angina pectoris
Uncommon:	Palpitations, tachycardia, syncope, dyspnoea
Very rare:	Myocardial infarction

Vascular disorders
Very common:	Flushing
Uncommon:	Hypotension
Rare:	Leucocytoclastic vasculitis

Respiratory, thoracic and mediastinal disorders
Uncommon:	Dyspnoea

Gastrointestinal disorders
Uncommon:	Gastro-intestinal complaints (e. g. nausea, vomiting, diarrhoea, con-stipation), gingival hyperplasia and gingivitis

Hepatobiliary disorders
Very rare:	Hepatic function disorders (elevated transaminase levels)

Skin and subcutaneous tissue disorders
Uncommon:	Skin and hypersensitivity reactions such as pruritus, urticaria, exan-thema, photosensitisation
Very rare:	Exfoliative dermatitis

Musculoskeletal and connective tissue disorders
Uncommon:	Myalgia, arthralgia

Renal and urinary disorders
Uncommon:	Pollakiuria

Reproductive system and breast disorders
Very rare:	Erection disorders, gynaecomastia, menorrhagia

General disorders and administration site conditions
Very common:	Flushing
Common:	Peripheral oedema
Uncommon:	Fatigue, weight gain, sweating
Very rare:	Angiooedema, Ffever

Investigations
Uncommon:	Weight gain

Flushing, headache or tinnitus may occur, particularly at the beginning of treatment, when the dose is increased or when high doses are administered. Generally, these effects subside on continued treatment

Particularly at the beginning of treatment, angina pectoris attacks may occur. In patients with pre-existing angina pectoris there may be an increase in the frequency, duration and severity of the attacks.

4.9 Overdose

Symptoms of overdose:

Overdose may lead to excessive peripheral vasodilation and then marked hypotension and in rare cases bradycardia.

Management of overdose:

The therapeutic measures should be focussed on the elimination of the active ingredient and the restoration of the circulation. If severe hypotension occurs, symptomatic treatment should be provided, the patient should be placed supine with the legs elevated. In case of accompanying bradycardia, atropine (0.5 – 1.0mg) should be given intravenously. Additional intravenous fluids should be cautiously administered under haemodynamic supervision to prevent cardiac overloading. Sympathomimetic drugs with predominant effect on the α₁-adrenoreceptor (such as dobutamin, dopamine, norepinephrine or adrenaline) may also be given. Dosage depends on the efficacy obtained.

Felodipine is only dialyzable to a minimal extent (approx. 9 %).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: dihydropyridine derivative

ATC-Code:C08C A02

Felodipine is a calcium antagonist of the dihydropyridine class. Calcium antagonists interfere with the voltage-dependent L-type (slow) calcium channels in the plasma membranes of smooth muscle cells and reduce the inflow of calcium ions. This results in vasodilation.

Felodipine is a vasoselective calcium antagonist: it has a stronger effect on the vascular smooth muscle than the myocardial muscle. Felodipine selectively dilates the arterioles with no effects on venous vessels.

Felodipine leads to a dose-related lowering of blood pressure via vasodilation and consequently a reduction of peripheral vascular resistance. It reduces both systolic and diastolic blood pressure. The haemodynamic effect of felodipine is accompanied by reflex (baroreceptor-mediated) tachycardia.

In therapeutic doses, felodipine has no direct effect on either cardiac contractility or cardiac conduction. Felodipine reduces renal vascular resistance. The glomerular filtration rate remains unchanged.

Felodipine has weak natiuretic/diuretic effect and does not provoke fluid retention.

Felodipine can be used as a monotherapy but also concomitantly with beta-blockers, diuretics and AEC.

There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients. In a randomised, double-blind, 3-week, parallel group study in children aged 6-16 years with primary hypertension, the antihypertensive effects of once daily felodipine 2.5 mg (n=33), 5 mg (n=33) and 10 mg (n=31) were compared with placebo (n=35). The study failed to demonstrate the efficacy of felodipine in lowering blood pressure in children aged 6-16 years.

The long-term effects of felodipine on growth, puberty and general development have not been studied. The long-term efficacy of antihypertensive therapy as therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood has also not been established.

5.2 Pharmacokinetic Properties

Absorption:

Felodipine is completely absorbed following oral administration. With the extended release tablets the absorption phase is prolonged. This results in even felodipine plasma concentrations within the therapeutic range for 24 hours. Peak plasma levels are reached with the prolonged release formulation after 3-5 hours. Steady state is reached approx. 3 days after starting treatment. Due to an extensive first-pass effect, only approx. 15% of the administered dose is systematically available.

Distribution:

The plasma protein binding of felodipine is > 99 %. The volume of distribution is approx. 10 l/kg at steady state, so that felodipine is indicating a large tissue distribution. There is no significant accumulation during long-term treatment.

Metabolism:

Felodipine is extensively metabolised in the liver by CYP3A4 all identified metabolites are inactive.

Elimination:

No unchanged parent substance is detectable in the urine. The average half-life of felodipine in the terminal phase is 25 hours. The inactive, hydrophilic metabolites formed by hepatic biotransformation are mainly eliminated renally (to approx. 70 %), and the remainder is excreted in the faeces.

The mean plasma clearance is 1100 ml/l and depends on the hepatic blood flow.

Elderly:

Increased plasma concentrations have been measured in elderly patients.

Impaired hepatic function:

Increased plasma concentrations of up to 100% have been measured in patients with impaired hepatic fuction.

Children:

In a single dose (felodipine prolonged release 5 mg) pharmacokinetic study with a limited number of children aged between 6 and 16 years (n=12) there was no apparent relationship between the age and AUC, C_max or half-life of felodipine.

Impaired renal function:

Renal impairment does not affect the pharmacokinetics of felodipine, although accumulation of inactive metabolites occurs in renal failure.

Effect of food:

The rate, but not the extent of absorption is affected by simultaneous ingestion of fatty foods. The Cmax was 2 to 2.5 times higher following intake of a high-fat meal compared to a fasting state.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In animal studies with respect to the reproduction adverse effects were found. Effects in rats (prolonged duration of pregnancy and difficult labour) and rabbits (impaired development of distal phalanges, presumably due to decreased uteroplacental perfusion) revealed no evidence of a direct teratogenic effect, but indicate secondary consequences of the pharmacodynamic effect. In monkeys, an abnormal position of the distal phalanges was found. The significance of these observations for humans is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose monohydrate

Microcrystalline cellulose

Hypromellose,

Povidone

Propyl gallate

Colloidal anhydrous silica

Magnesium stearate

Talc

Propylene glycol

Titanium dioxide (E171)

Iron yellow oxide (E 172)

Iron oxide red (E172).

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

4 years

6.4 Special Precautions For Storage

Do not store above 25 °C.

6.5 Nature And Contents Of Container

PVC/PE/PVDC aluminium blister

Original packs containing either 10, 20, 28, 30, 50, 56, 100 or 100x1 prolonged release tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 4416/0459

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th November 2009

10. Date Of Revision Of The Text

02/2011 (To be amended after approval)

Theochron

Generic Name: theophylline (Oral route)

thee-OF-i-lin

Commonly used brand name(s)

In the U.S.

• Elixophyllin


• Norphyl


• Phyllocontin


• Quibron-T


• Quibron-T/SR


• Theo-24


• TheoCap


• Theochron


• Theo-Dur


• Theo-Time


• Truxophyllin


• Uniphyl

Available Dosage Forms:

• Solution


• Tablet, Extended Release, 12 HR


• Tablet


• Capsule, Extended Release, 24 HR


• Capsule, Extended Release


• Tablet, Extended Release


• Capsule, Extended Release, 12 HR


• Syrup


• Capsule


• Tablet, Extended Release, 24 HR


• Elixir


• Tablet, Enteric Coated

Therapeutic Class: Bronchodilator

Chemical Class: Methylxanthine

Uses For Theochron

Theophylline is used together with other medicines to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases.

Theophylline belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Before Using Theochron

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of theophylline in children. However, children younger than 1 year of age are more likely to have serious side effects, which may require caution and an adjustment in the dose for patients receiving theophylline.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of theophylline in the elderly. However, elderly patients may be more sensitive to the effects of theophylline than younger adults, and are more likely to have kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving theophylline.

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Bupropion


• Cimetidine


• Ciprofloxacin


• Deferasirox


• Desogestrel


• Dienogest


• Drospirenone


• Enoxacin


• Erythromycin


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etintidine


• Etonogestrel


• Fluvoxamine


• Halothane


• Idrocilamide


• Imipenem


• Levofloxacin


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Mexiletine


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Pefloxacin


• Peginterferon Alfa-2a


• Rofecoxib


• Thiabendazole


• Troleandomycin


• Vemurafenib


• Zileuton

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.

• Adenosine


• Adinazolam


• Alprazolam


• Aminoglutethimide


• Amiodarone


• Azithromycin


• Bromazepam


• Brotizolam


• Cannabis


• Carbamazepine


• Chlordiazepoxide


• Clobazam


• Clonazepam


• Clorazepate


• Diazepam


• Disulfiram


• Estazolam


• Febuxostat


• Flunitrazepam


• Flurazepam


• Fosphenytoin


• Halazepam


• Interferon Alfa-2a


• Ipriflavone


• Isoproterenol


• Ketazolam


• Lorazepam


• Lormetazepam


• Medazepam


• Methotrexate


• Midazolam


• Nilutamide


• Nitrazepam


• Oxazepam


• Pancuronium


• Pentoxifylline


• Phenobarbital


• Phenytoin


• Piperine


• Prazepam


• Propafenone


• Quazepam


• Rifampin


• Rifapentine


• Riluzole


• Ritonavir


• Secobarbital


• St John's Wort


• Tacrine


• Tacrolimus


• Telithromycin


• Temazepam


• Ticlopidine


• Triazolam


• Viloxazine


• Zafirlukast

Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• food

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:

• Congestive heart failure or


• Cor pulmonale (heart condition) or


• Fever of 102 degrees F or higher for 24 hours or more or


• Hypothyroidism (underactive thyroid) or


• Infection, severe (e.g., sepsis) or


• Kidney disease in infants younger than 3 months of age or


• Liver disease (e.g., cirrhosis, hepatitis) or


• Pulmonary edema (lung condition) or


• Shock (serious condition with very little blood flow in the body)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Heart rhythm problems (e.g., arrhythmia) or


• Seizures, or history of or


• Stomach ulcer—Use with caution. May make these conditions worse.

Proper Use of theophylline

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

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep the blood level constant, take this medicine at the same time each day and do not miss any doses.

After you or your child begin taking theophylline, it is very important that your doctor check the level of the medicine in the blood at regular intervals to decide if the dose needs to be changed. Keep all appointments for testing the blood level.

Take the extended-release capsule or tablet every morning at the same time each day. You may take your second dose 10 to 12 hours after the morning dose and before the evening meal, unless your doctor tells you otherwise.

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

It is best to take the extended-release capsule one hour before a high-fat meal or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

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.

• To treat symptoms of asthma, bronchitis, and emphysema:
  
  • For oral dosage form (elixir or tablets):
    
    • Adults, teenagers, and children above 1 year of age weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 6 to 8 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
    
    
    • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 6 to 8 hours.
    
    
    • Children and teenagers 1 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 4 to 6 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
    
    
    • Infants younger than 1 year of age—Dose is based on body weight and age and must be determined by your doctor.
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults, teenagers, and children 12 years of age and older weighing more than 45 kilograms (kg)—At first, 300 to 400 milligrams (mg) as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
    
    
    • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day as a single dose, usually in the morning, or divided and given two times per day.
    
    
    • Children and teenagers 12 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults, teenagers, and children 6 years of age and older weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
    
    
    • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 12 hours.
    
    
    • Children and teenagers 6 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
    
    
    • Children younger than 6 years of age—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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Theochron

It is very important that your doctor check the progress of you or your child at regular visits, especially for the first few weeks after you begin using this medicine. Blood tests may be needed to check for unwanted effects.

A change in your usual behavior or physical well-being may affect the way this medicine works in your body. Tell your doctor if you or your child:

• Have had a fever of 102 degrees F or higher for at least 24 hours or more.


• Have started or stopped smoking tobacco or marijuana in the last few weeks.


• Have started or stopped taking another medicine in the last few weeks.


• Have changed your diet in the last few weeks.

Stop using this medicine and check with your doctor right away if you or your child have the following symptoms while using this medicine: nausea or vomiting that continues, headaches, trouble with sleeping, seizures, or irregular heartbeats.

Do not stop or change the dose of this medicine without checking first with your doctor.

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

This medicine may add to the central nervous system (CNS) stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while using this medicine. If you have questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal (e.g., St. John's wort) or vitamin supplements.

Theochron 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

• Chest pain or discomfort


• dizziness


• fainting


• fast, slow, or irregular heartbeat


• increase in urine volume


• lightheadedness


• persistent vomiting


• pounding or rapid pulse


• seizures


• shakiness

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

Symptoms of overdose

• Abdominal or stomach pain


• blurred vision


• confusion


• confusion about identity, place, and time


• dark-colored urine


• decrease in frequency of urination


• decreased urine


• diarrhea


• difficulty in passing urine (dribbling)


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


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• fever


• increased thirst


• irregular heartbeat


• loss of appetite


• mood changes


• muscle cramps or spasms


• muscle pain or stiffness


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


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


• painful urination


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• sweating


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds

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

• Headache


• irritability


• restlessness


• sleeplessness


• trouble sleeping


• unable to sleep

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: Theochron 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 Theochron resources

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

• Theochron Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Theochron Concise Consumer Information (Cerner Multum)


• Theophylline Prescribing Information (FDA)


• Theophylline Professional Patient Advice (Wolters Kluwer)


• Elixophyllin Prescribing Information (FDA)


• Elixophyllin Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Quibron-T MedFacts Consumer Leaflet (Wolters Kluwer)


• Quibron-T Prescribing Information (FDA)


• Theo-24 Prescribing Information (FDA)


• TheoCap Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Theolair tablets Prescribing Information (FDA)


• Theophyllines Monograph (AHFS DI)


• Uniphyl Prescribing Information (FDA)

Compare Theochron with other medications

• Apnea of Prematurity
• Asthma, acute
• Asthma, Maintenance

Halotestin

fluoxymesterone

Dosage Form: Tablets, USP

Halotestin Description

Halotestin Tablets contain fluoxymesterone, an androgenic hormone.

Fluoxymesterone is a white or nearly white, odorless, crystalline powder, melting at or about 240° C, with some decomposition. It is practically insoluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform.

The chemical name for fluoxymesterone is androst-4-en-3-one, 9-fluoro-11,17-dihydroxy-17-methyl-, (11β,17β)-. The molecular formula is C20H29FO3 and the molecular weight 336.45.

The structural formula is represented below:

Each Halotestin tablet, for oral administration, contains 2 mg, 5 mg or 10 mg fluoxymesterone. Inactive ingredients: calcium stearate, corn starch, FD&C Yellow No. 5, lactose, sorbic acid, sucrose, tragacanth. In addition, the 2 mg tablet contains FD&C Yellow No. 6 and the 5 mg and 10 mg contain FD&C Blue No. 2.

Halotestin - Clinical Pharmacology

Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.

Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.

During exogenous administration of androgens, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

Inactivation of testosterone occurs primarily in the liver.

The half-life of fluoxymesterone after oral administration is approximately 9.2 hours.

Indications and Usage for Halotestin

In the male—Halotestin Tablets are indicated for

1. Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
   
   1. Primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis , vanishing testis syndrome; or orchidectomy.
   
   
   2. Hypogonadotropic hypogonadism (congenital or acquired)—idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
   
   


2. Delayed puberty, provided it has been definitely established as such, and is not just a familial trait.

In the female—Halotestin Tablets are indicated for palliation of androgen-responsive recurrent mammary cancer in women who are more than one year but less than five years postmenopausal, or who have been proven to have a hormone- dependent tumor as shown by previous beneficial response to castration.

Contraindications

1. Known hypersensitivity to the drug


2. Males with carcinoma of the breast


3. Males with known or suspected carcinoma of the prostate gland


4. Women known or suspected to be pregnant


5. Patients with serious cardiac, hepatic or renal disease

Warnings

Hypercalcemia may occur in immobilized patients and in patients with breast cancer. If this occurs, the drug should be discontinued.

Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis—all potentially life-threatening complications.

Cholestatic hepatitis and jaundice may occur with 17-α-alkyl-androgens. Should this occur, the drug should be discontinued. This is reversible with discontinuation of the drug.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.

Androgen therapy should be used cautiously in males with delayed puberty. Androgens can accelerate bone maturation without producing compensatory gain in linear growth. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

Precautions

General

Women should be observed for signs of virilization which is usual following androgen use at high doses. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Information for patients

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, and ankle swelling. Males should be instructed to report too frequent or persistent erections of the penis and females any hoarseness, acne, changes in menstrual periods or increase in facial hair.

Laboratory tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgen therapy (See WARNINGS).

Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.

Periodic (every six months) X-ray examinations of bone age should be made during treatment of prepubertal males to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers.

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.

Serum cholesterol may increase during androgen therapy.

Drug interactions

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Drug/Laboratory test interferences

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis, mutagenesis, impairment Of Fertility

Animal data: Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.

Human data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

This compound has not been tested for mutagenic potential. However, as noted above, carcinogenic effects have been attributed to treatment with androgenic hormones. The potential carcinogenic effects likely occur through a hormonal mechanism rather than by a direct chemical interaction mechanism.

Impairment of fertility was not tested directly in animal species. However, as noted below under Adverse Reactions, oligospermia in males and amenorrhea in females are potential adverse effects of treatment with Halotestin Tablets. Therefore, impairment of fertility is a possible outcome of treatment with Halotestin.

Pregnancy

Teratogenic effects

Pregnancy Category X. (See CONTRAINDICATIONS.)

Nursing mothers

Halotestin is not recommended for use in nursing mothers.

Pediatric use

Androgen therapy should be used very cautiously in children and only by specialists aware of the adverse effects on bone maturation. Skeletal maturation must be monitored every six months by an X-ray of the hand and wrist (See WARNINGS).

Adverse Reactions

Endocrine and urogenital

Female: the most common side effects of androgen therapy are amenorrhea and other menstrual irregularities; inhibition of gonadotropin secretion; and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens can cause virilization of external genitalia of the female fetus.

Male: Gynecomastia, and excessive frequency and duration of penile erections. Oligospermia may occur at high dosage.

Skin and appendages

Hirsutism, male pattern of baldness, seborrhea, and acne.

Fluid and electrolyte disturbances

Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal

Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (See WARNINGS).

Hematologic

Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous system

Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Allergic

Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Drug Abuse and Dependence

Controlled Substance Class

Fluoxymesterone is a controlled substance under the Anabolic Steroids Control Act, and Halotestin Tablets has been assigned to Schedule III.

Overdosage

There have been no reports of acute overdosage with the androgens.

Halotestin Dosage and Administration

The dosage will vary depending upon the individual, the condition being treated, and its severity. The total daily oral dose may be administered singly or in divided (three or four) doses.

Male hypogonadism

For complete replacement in the hypogonadal male, a daily dose of 5 to 20 mg will suffice in the majority of patients. It is usually preferable to begin treatment with full therapeutic doses which are later adjusted to individual requirements. Priapism is indicative of excessive dosage and is indication fortemporary withdrawal of the drug.

Delayed puberty

Dosage should be carefully titrated utilizing a low dose, appropriate skeletal monitoring, and by limiting the duration of therapy to four to six months.

Inoperable carcinoma of the breast in the female

The recommended total daily dose for palliative therapy in advanced inoperable carcinoma of the breast is 10 to 40 mg. Because of its short action, fluoxymesterone should be administered to patients in divided, rather than single, daily doses to ensure more stable blood levels. In general, it appears necessary to continue therapy for at least one month for a satisfactory subjective response, and for two to three months for an objective response.

How is Halotestin Supplied

Halotestin Tablets, round and scored, are available in the following strengths and colors:

2 mg (peach)

  Bottles of 100       NDC 0009-0014-01

5 mg (light green)

  Bottles of 100       NDC 0009-0019-06

10 mg (green)

  Bottles of 30         NDC 0009-0036-03

  Bottles of 100       NDC 0009-0036-04

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Rx only

810 804 708

692851

May 2002

Halotestin  fluoxymesterone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-0014 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength fluoxymesterone (fluoxymesterone) Active 2 MILLIGRAM  In 1 TABLET calcium stearate Inactive   corn starch Inactive   FD&C Yellow No. 5 Inactive   lactose Inactive   sorbic acid Inactive   sucrose Inactive   tragacanth Inactive   FD&C Yellow No. 6 Inactive

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code Halotestin;2 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0009-0014-01 100 TABLET In 1 BOTTLE None

Halotestin  fluoxymesterone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-0019 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength fluoxymesterone (fluoxymesterone) Active 5 MILLIGRAM  In 1 TABLET calcium stearate Inactive   corn starch Inactive   FD&C Yellow No. 5 Inactive   lactose Inactive   sorbic acid Inactive   sucrose Inactive   tragacanth Inactive   FD&C Blue No. 2 Inactive

Product Characteristics Color GREEN (light green) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code Halotestin;5 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0009-0019-06 100 TABLET In 1 BOTTLE None

Halotestin  fluoxymesterone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-0036 Route of Administration ORAL DEA Schedule CIII

INGREDIENTS Name (Active Moiety) Type Strength fluoxymesterone (fluoxymesterone) Active 10 MILLIGRAM  In 1 TABLET calcium stearate Inactive   corn starch Inactive   FD&C Yellow No. 5 Inactive   lactose Inactive   sorbic acid Inactive   sucrose Inactive   tragacanth Inactive   FD&C Blue No. 2 Inactive

Product Characteristics Color GREEN (GREEN) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code Halotestin;10 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0009-0036-03 30 TABLET In 1 BOTTLE None 2 0009-0036-04 100 TABLET In 1 BOTTLE None

Revised: 02/2006Pharmacia and Upjohn Company

More Halotestin resources

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

• Fluoxymesterone Professional Patient Advice (Wolters Kluwer)


• Fluoxymesterone Monograph (AHFS DI)


• Androxy MedFacts Consumer Leaflet (Wolters Kluwer)


• Androxy Concise Consumer Information (Cerner Multum)

Compare Halotestin with other medications

• Breast Cancer
• Breast Cancer, Palliative
• Delayed Puberty, Male
• Hypogonadism, Male
• Postmenopausal Symptoms