Theophylline Sustained-Release Tablets

Pronunciation: thee-OF-i-lin
Generic Name: Theophylline
Brand Name: Theochron

Theophylline Sustained-Release Tablets are used for:

Preventing and treating symptoms and blockage of airway due to asthma or other lung diseases (eg, emphysema, bronchitis). It may also be used for other conditions as determined by your doctor.

Theophylline Sustained-Release Tablets are a xanthine derivative. It works by relaxing the muscle around the airways in the lungs, which allows them to widen and makes breathing easier. It also improves contraction of the diaphragm (the major breathing muscle) and decreases the response of the airways to irritants.

Do NOT use Theophylline Sustained-Release Tablets if:

• you are allergic to any ingredient in Theophylline Sustained-Release Tablets, similar medicines (eg, aminophylline), or xanthines (eg, caffeine, chocolate)


• you are using large amounts of other products that contain xanthine (such as chocolate or caffeinated drinks)


• you are taking dipyridamole intravenously (IV), febuxostat, halothane, or St. John's wort

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

Before using Theophylline Sustained-Release Tablets:

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

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


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


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


• if you have a history of heart problems (eg, congestive heart failure, cor pulmonale), an irregular heartbeat, liver problems (eg, cirrhosis, hepatitis), viral infection, thyroid problems, increased acid levels in the body, brain or nerve problems, or seizures (eg, epilepsy)


• if you are in shock or have a fever, an ulcer, a severe infection, cystic fibrosis, or fluid in the lungs (pulmonary edema)


• if you smoke, are stopping or starting smoking, or are exposed to the smoke from cigarettes or marijuana


• if you are in the last 3 months of pregnancy

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

• Aminoglutethimide, barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), isoproterenol, moricizine, rifampin, St. John's wort, or sulfinpyrazone because they may decrease Theophylline Sustained-Release Tablets's effectiveness


• Allopurinol, beta-blockers (eg, propranolol), cimetidine, disulfiram, enoxacin, estrogen, febuxostat, fluvoxamine, interferon alpha, macrolide antibiotics (eg, clarithromycin, erythromycin), methotrexate, mexiletine, oral contraceptives (birth control pills), pentoxifylline, propafenone, quinolone antibiotics (eg, ciprofloxacin), tacrine, thiabendazole, ticlopidine, troleandomycin, verapamil, viloxazine, or zileuton because they may increase the risk of Theophylline Sustained-Release Tablets's side effects


• Ephedrine because the risk of side effects, such as nausea, nervousness, and trouble sleeping, may be increased


• Halothane because the risk of side effects such as irregular heartbeat may be increased


• Ketamine because the risk of seizures may be increased


• Adenosine, benzodiazepines (eg, diazepam, flurazepam, lorazepam, midazolam), dipyridamole IV, lithium, or nondepolarizing muscle relaxants (eg, pancuronium) because their effectiveness may be decreased by Theophylline Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Theophylline Sustained-Release Tablets 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 Theophylline Sustained-Release Tablets:

Use Theophylline Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Some foods may change the effectiveness or increase the side effects of Theophylline Sustained-Release Tablets. Talk to your doctor about how you should take Theophylline Sustained-Release Tablets with regard to food. Do not suddenly change your diet or eating habits without first checking with your doctor.


• Swallow Theophylline Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Theophylline Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• Take Theophylline Sustained-Release Tablets at evenly spaced times throughout the day. Taking Theophylline Sustained-Release Tablets at the same time each day will help you remember to take it. Contact your doctor with any questions or concerns about the best way to take Theophylline Sustained-Release Tablets.


• If you miss a dose of Theophylline Sustained-Release Tablets, 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 Theophylline Sustained-Release Tablets.

Important safety information:

• Drinking alcohol may increase the risk of side effects of Theophylline Sustained-Release Tablets. Talk to your doctor before drinking alcohol while you are taking Theophylline Sustained-Release Tablets.


• Tell your doctor or dentist that you take Theophylline Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Do not take more than the recommended dose or use more often than prescribed without checking with your doctor. If your symptoms become worse, contact your doctor.


• You may notice the tablet shell in your stool with some brands of Theophylline Sustained-Release Tablets. This is normal and not a cause for concern.


• Carry an ID card at all times that says you take Theophylline Sustained-Release Tablets.


• Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate).


• Notify your doctor if you develop a new illness, especially if it is accompanied by fever; if a chronic illness becomes worse; or if you start or stop smoking cigarettes or marijuana.


• Tell your doctor if another doctor prescribes a new medicine or tells you to stop using a medicine that you have already been taking. Tell your doctor if you start or stop any medicine, either prescription or over the counter.


• Theophylline Sustained-Release Tablets will not stop an asthma attack once one has started. Be sure to always carry appropriate rescue medicine (eg, bronchodilator inhaler) with you in case of an asthma attack.


• If you have more than one doctor, be sure to tell each of your doctors that you are taking Theophylline Sustained-Release Tablets.


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


• Theophylline Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Theophylline Sustained-Release Tablets.


• Lab tests, including blood theophylline levels, may be performed while you use Theophylline Sustained-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Theophylline Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Theophylline Sustained-Release Tablets in CHILDREN, especially children younger than 1 year old; they may be more sensitive to its effects. Children may be more likely to experience mild, temporary behavior changes.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Theophylline Sustained-Release Tablets while you are pregnant. Theophylline Sustained-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Theophylline Sustained-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Theophylline Sustained-Release Tablets:

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:

Irritability; mild, temporary caffeine-like effects (eg, headache, nausea, diarrhea, trouble sleeping); mild, temporary changes in behavior; restlessness; temporary increased urination.

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); confusion; dizziness; fast breathing; fast or irregular heartbeat; heart rhythm problems; seizures; severe or persistent nausea, diarrhea, or headache; sleeplessness; tremors; vomiting.

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: Theophylline 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 agitation; chest pain; confusion; decreased urination; fast or irregular heartbeat; headache; increased thirst; irritability; loss of appetite; muscle pain or tenderness; nausea; nervousness; persistent increased urination; restlessness; seizures; severe or persistent diarrhea; stomach pain; tremors or twitching; vomiting, especially of blood.

Proper storage of Theophylline Sustained-Release Tablets:

Store Theophylline Sustained-Release Tablets at room temperature, 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. Do not refrigerate. Keep Theophylline Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Theophylline Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Theophylline Sustained-Release Tablets are 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 Theophylline Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Theophylline resources

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

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Cutivate

fluticasone propionate

Dosage Form: ointment
Cutivate®

(fluticasone propionate ointment)

Ointment, 0.005%

For Dermatologic Use Only—Not for Ophthalmic Use.

Rx Only

Cutivate Description

Cutivate® (fluticasone propionate ointment) Ointment, 0.005% contains fluticasone propionate [(6α,11β,16α,17α) - 6,9, - difluoro - 11 - hydroxy - 16 - methyl - 3 - oxo - 17 - (1 - oxopropoxy)androsta - 1,4 - diene - 17 - carbothioic acid, S-fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.

Chemically, fluticasone propionate is C25H31F3O5S. It has the following structural formula:

Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water.

Each gram of Cutivate® Ointment contains fluticasone propionate 0.05 mg in a base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.

Cutivate - Clinical Pharmacology

Like other topical corticosteroids, fluticasone propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor. It has weak affinity for the progesterone receptor, and virtually no affinity for the mineralocorticoid, estrogen, or androgen receptors. The therapeutic potency of glucocorticoids is related to the half-life of the glucocorticoid-receptor complex. The half-life of the fluticasone propionate-glucocorticoid receptor complex is approximately 10 hours.

Studies performed with Cutivate® Ointment indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Pharmacokinetics:Absorption: The activity of Cutivate® is due to the parent drug, fluticasone propionate. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

In a study of 6 healthy volunteers applying 25 g of fluticasone propionate ointment 0.005% twice daily to the trunk and legs for up to 5 days under occlusion, plasma levels of fluticasone ranged from 0.08 to 0.22 ng/mL.

In an animal study using radiolabeled 0.05% fluticasone propionate cream and ointment preparations, rats received a topical dose of 1 g/kg for a 24-hour period. Total recovery of radioactivity was approximately 80% at the end of 7 days. The majority of the dose (73%) was recovered from the surface of the application site. Less than 1% of the dose was recovered in the skin at the application site. Approximately 5% of the dose was absorbed systemically through the skin. Absorption from the skin continued for the duration of the study (7 days), indicating a long retention time at the application site.

Distribution: Following intravenous administration of 1 mg of fluticasone propionate in healthy volunteers, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding. The apparent volume of distribution averaged 4.2 L/kg (range, 2.3 to 16.7 L/kg). The percentage of fluticasone propionate bound to human plasma proteins averaged 91%. Fluticasone propionate is weakly and reversibly bound to erythrocytes. Fluticasone propionate is not significantly bound to human transcortin.

Metabolism: No metabolites of fluticasone propionate were detected in an in vitro study of radiolabeled fluticasone propionate incubated in a human skin homogenate. The total blood clearance of systemically absorbed fluticasone propionate averages 1,093 mL/min (range, 618 to 1,702 mL/min) after a 1-mg intravenous dose, with renal clearance accounting for less than 0.02% of the total. Fluticasone propionate is metabolized in the liver by cytochrome P450 3A4-mediated hydrolysis of the 5-fluoromethyl carbothioate grouping. This transformation occurs in 1 metabolic step to produce the inactive 17-β-carboxylic acid metabolite, the only known metabolite detected in man. This metabolite has approximately 2,000 times less affinity than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.

Excretion: Following an intravenous dose of 1 mg in healthy volunteers, fluticasone propionate showed polyexponential kinetics and had an average terminal half-life of 7.2 hours (range, 3.2 to 11.2 hours).

Indications and Usage for Cutivate

Cutivate® Ointment is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients.

Contraindications

Cutivate® Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Precautions

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

Fluticasone propionate ointment, 0.005% may cause local cutaneous adverse reactions (see ADVERSE REACTIONS).

If irritation develops, Cutivate® Ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Cutivate® Ointment should be discontinued until the infection has been adequately controlled.

Cutivate® Ointment should not be used in the treatment of preexisting skin atrophy and should not be used where infection is present at the treatment site. Cutivate® Ointment should not be used in the treatment of rosacea and perioral dermatitis.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. This medication should not be used for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.


4. Patients should report to their physician any signs of local adverse reactions.


5. This medication should not be used on the face, underarms, or groin areas unless directed by a physician.


6. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:

 

ACTH stimulation test

 

A.M. plasma cortisol test

 

Urinary free cortisol test

A concentrated fluticasone propionate ointment, 0.05% (10 times that of the marketed fluticasone propionate ointment, 0.005%) suppressed 24-hour urinary free cortisol levels in 2 of 6 patients when used at a dose of 30 g/day for a week in patients with psoriasis or atopic eczema. No suppression of A.M. plasma cortisol was observed. In a second study of the same concentrated formulation of fluticasone propionate ointment, 0.05%, depression of A.M. plasma cortisol levels was noted in 2 of 8 normal volunteers when applied at doses of 50 g/day for 21 days. Morning plasma levels returned to normal levels within 4 days upon discontinuation of fluticasone propionate. In this study there was no corresponding decrease in 24-hour urinary free cortisol levels.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Pediatric Use and ADVERSE REACTIONS). Adrenal suppression was indicated by either a 5 mcg/dL prestimulation cortisol, or a cosyntropin poststimulation cortisol ≤18 mcg/dL, and/or an increase of <7 mcg/dL from the baseline cortisol level.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Two 18-month studies were performed in mice to evaluate the carcinogenic potential of fluticasone propionate when given topically (as a 0.05% ointment) and orally. No evidence of carcinogenicity was found in either study.

Fluticasone propionate was not mutagenic in the standard Ames test, E. coli fluctuation test, S. cerevisiae gene conversion test, or Chinese Hamster ovarian cell assay. It was not clastogenic in mouse micronucleus or cultured human lymphocyte tests.

In a fertility and general reproductive performance study in rats, fluticasone propionate administered subcutaneously to females at up to 50 mcg/kg/day and to males at up to 100 mcg/kg/day (later reduced to 50 mcg/kg/day) had no effect upon mating performance or fertility. These doses are approximately 150 and 300 times, respectively, the human systemic exposure following use of the recommended human topical dose of fluticasone propionate ointment, 0.005%, assuming human percutaneous absorption of approximately 3% and the use in a 70-kg person of 15 g/day.

Pregnancy:Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Teratology studies in the mouse demonstrated fluticasone propionate to be teratogenic (cleft palate) when administered subcutaneously in doses of 45 mcg/kg/day and 150 mcg/kg/day. This dose is approximately 140 and 450 times, respectively, the human topical dose of fluticasone propionate ointment, 0.005%. There are no adequate and well-controlled studies in pregnant women. Cutivate® Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cutivate® Ointment is administered to a nursing woman.

Pediatric Use: Use of Cutivate® Ointment in pediatric patients is not recommended.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Laboratory Tests and ADVERSE REACTIONS). The decreased responsiveness to cosyntropin testing was not correlated to age of patient, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate. Plasma fluticasone propionate were not performed in a 6-month-old patient who demonstrated an abnormal response to cosyntropin stimulation testing.

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing syndrome than mature patients because of a larger skin surface to body weight ratio.

HPA axis suppression, Cushing syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels and an absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use: A limited number of patients above 65 years of age (n = 203) have been treated with Cutivate® Ointment in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Cutivate® in geriatric patients is warranted.

Adverse Reactions

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Cutivate® Ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, hives, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Laboratory Tests and PRECAUTIONS: Pediatric Use). Telangiectasia on the face was noted in 1 patient on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, including fluticasone propionate, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.

Overdosage

Topically applied Cutivate® Ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Cutivate Dosage and Administration

Apply a thin film of Cutivate® Ointment to the affected skin areas twice daily. Rub in gently.

Cutivate® Ointment should not be used with occlusive dressings.

Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with Cutivate® Ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

How is Cutivate Supplied

Cutivate® (fluticasone propionate ointment) Ointment, 0.005% is supplied in:

 

15-g tubes (NDC 0462-0333-15),

 

30-g tubes (NDC 0462-0333-30), and

 

60-g tubes (NDC 0462-0333-60).

Store between 2°and 30°C (36°and 86°F).

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com

I8333B

R6/08

#144

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

Pharma Derm®     NDC 0462-0333-15

Cutivate® Ointment, 0.005%

(fluticasone propionate ointment)

For dermatologic use only — Not for ophthalmic use.

Rx only         15 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

NDC 0462-0333-15

Pharma Derm®

Cutivate® Ointment, 0.005%

(fluticasone propionate ointment)

For dermatologic use only — Not for ophthalmic use.

Rx only         15 g

Cutivate  fluticasone propionate  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0462-0333 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluticasone propionate (fluticasone) fluticasone propionate 0.05 mg  in 1 g

Inactive Ingredients Ingredient Name Strength propylene glycol   mineral oil

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0462-0333-15 15 g In 1 TUBE None 2 0462-0333-30 30 g In 1 TUBE None 3 0462-0333-60 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073030	12/14/1990

Labeler - PHARMADERM, A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Revised: 11/2009PHARMADERM, A division of Nycomed US Inc.

More Cutivate resources

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

• Cutivate Concise Consumer Information (Cerner Multum)


• Cutivate Advanced Consumer (Micromedex) - Includes Dosage Information


• Cutivate Cream MedFacts Consumer Leaflet (Wolters Kluwer)

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Tocilizumab

Pronunciation: TOE-si-LIZ-oo-mab
Generic Name: Tocilizumab
Brand Name: Actemra

Patients who use Tocilizumab have an increased risk of developing serious and sometimes fatal infections, including tuberculosis (TB), fungal infection, and other types of infection. Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).

Patients should receive a TB skin test before using Tocilizumab. Patients who test positive for TB should begin treatment for TB before starting Tocilizumab. All patients should also be monitored for signs of TB while using Tocilizumab even if their TB test is negative.

Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores; increased or painful urination; severe or persistent diarrhea; blood in the mucus).

Tocilizumab is used for:

Treating moderate to severe rheumatoid arthritis (RA) in certain patients. It is also used to treat systemic juvenile idiopathic arthritis (SJIA) in children 2 years and older. It may be used alone or in combination with other medicine. It may also be used for other conditions as determined by your doctor.

Tocilizumab is an interleukin-6 (IL-6) receptor blocker. It works by blocking a substance (IL-6) in the body that contributes to inflammation.

Do NOT use Tocilizumab if:

• you are allergic to any ingredient in Tocilizumab


• you have a severe infection (eg, sepsis) or any other active infection


• you have active liver problems


• you are using abatacept, anakinra, an anti-CD20 monoclonal antibody (eg, rituximab), or a tumor necrosis factor (TNF) blocker (eg, adalimumab)

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

Before using Tocilizumab:

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

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


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


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


• if you have low blood platelet or neutrophil levels; a history of hepatitis B infection or other liver problems; stomach or bowel problems (eg, diverticulitis, pain, bleeding, perforation, inflammation, ulcer); high cholesterol; high blood pressure; diabetes; kidney problems; cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis [MS], Guillain-Barré syndrome)


• if you have an infection, open cuts or sores on your body, flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), shingles, or are using medicine to treat an infection


• if you have a history of an infection that keeps coming back, TB infection, or a positive TB skin test


• if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB


• if you have ever lived or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys, the Southwest) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common


• if you have HIV, a weakened immune system, or you take medicine that may weaken your immune system (eg, cyclosporine)


• if you have recently received or are scheduled to receive a vaccine, or are using another medicine to treat RA


• if you will be having surgery or a medical procedure

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

• Abatacept, anakinra, an anti-CD20 monoclonal antibody (eg, rituximab), corticosteroids (eg, prednisone), methotrexate, or TNF blockers (eg, adalimumab) because the risk of serious infection may be increased


• Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of severe stomach problems may be increased


• Cyclosporine, HMG-CoA reductase inhibitors (eg, atorvastatin), oral contraceptives (birth control pills), theophylline, or warfarin because their effectiveness may be decreased by Tocilizumab

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

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

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


• Tocilizumab is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Tocilizumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Tocilizumab, contact your doctor.

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

Important safety information:

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


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Tocilizumab 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.


• Serious stomach or bowel problems have been reported with the use of Tocilizumab. The risk may be increased if you have a certain bowel problem (diverticulitis). Tell your doctor if you develop persistent stomach pain, blood in your stool or vomit, fever, or a change in your bowel habits.


• Tocilizumab may increase the risk of developing cancer. Discuss any questions or concerns with your doctor.


• Tell your doctor or dentist that you take Tocilizumab before you receive any medical or dental care, emergency care, or surgery.


• Tocilizumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Before you use Tocilizumab, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Tocilizumab. Talk with your doctor before you receive any vaccine.


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


• Tocilizumab may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Tocilizumab.


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


• Use Tocilizumab with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection.


• Tocilizumab should be used with extreme caution in CHILDREN younger than 2 years when used for SJIA and in children younger than 18 years when used for other conditions; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tocilizumab while you are pregnant. It is not known if Tocilizumab is found in breast milk. Do not breast-feed while using Tocilizumab.

Possible side effects of Tocilizumab:

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:

Dizziness; headache.

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); bloody, dark, or tarry stools; burning, numbness, or tingling; chest pain; fainting; muscle weakness or aches; numbness, tingling, or pain in the hands or feet; persistent pain, swelling, or redness at the injection site; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; persistent cough; flu-like symptoms; warm, red, or painful skin or sores; increased or painful urination; severe or persistent diarrhea; unexplained weight loss; blood in the mucus); unusual bruising or bleeding; unusual skin growth or other skin changes; unusual tiredness or weakness; vision changes; vomit that contains blood or looks like coffee grounds.

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: Tocilizumab 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.

Proper storage of Tocilizumab:

Tocilizumab is usually handled and stored by a health care provider. If you are using Tocilizumab at home, store Tocilizumab as directed by your pharmacist or health care provider. Keep Tocilizumab out of the reach of children and away from pets.

General information:

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


• Tocilizumab 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 Tocilizumab. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tocilizumab resources

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

• Tocilizumab Professional Patient Advice (Wolters Kluwer)


• Tocilizumab Monograph (AHFS DI)


• tocilizumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Actemra Prescribing Information (FDA)


• Actemra Consumer Overview

Compare Tocilizumab with other medications

• Juvenile Idiopathic Arthritis
• Rheumatoid Arthritis

NuCort with Aloe

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is NuCort with Aloe (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about NuCort with Aloe (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

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

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using NuCort with Aloe (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use NuCort with Aloe (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using NuCort with Aloe (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

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

NuCort with Aloe (hydrocortisone topical) side effects

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

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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

What other drugs will affect NuCort with Aloe (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More NuCort with Aloe resources

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

• Ala-Cort Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare NuCort with Aloe with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: NuCort with Aloe side effects (in more detail)

Multi Vita Bets and Fluoride

Generic Name: multivitamin with fluoride (MUL tee VYE ta min with FLOOR ide)

Brand Names: Multi Vita Bets and Fluoride, Poly Vitamin with Fluoride, Poly-Vi-Flor, Soluvite F, Tri-Vi-Flor, Tri-Vitamin with Fluoride

What is Multi Vita Bets and Fluoride (multivitamin with fluoride)?

Multivitamins provide essential vitamins and minerals that are not taken in to the body through diet.

Fluoride strengthens tooth enamel, which helps prevent dental cavities. In most major U.S. communities, fluoride is put into the water supply.

Multivitamin with fluoride is used as a supplement to the diet of infants and children who do not receive adequate fluoride through drinking water. Multivitamin with fluoride is also used to prevent tooth decay in people treated with radiation, which may cause dryness of the mouth and increased risk of tooth decay.

Multivitamin with fluoride may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Multi Vita Bets and Fluoride (multivitamin with fluoride)?

Taking in too much fluoride can cause an irreversible condition called fluorosis. This condition can permanently damage teeth and possibly other cells in the body.

Do not use this medicine without the advice of a doctor. Multivitamin with fluoride should not be used if the level of fluoride in the drinking water is adequate (0.6 parts per million or higher).Check with your local water department if you are unsure about the level of fluoride in the drinking water.

Be sure that a child using this medicine is not taking in extra amounts of fluoride by swallowing toothpaste, or drinking water from sources that contain adequate levels of fluoride.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may cause your body to absorb less of the multivitamin with fluoride. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with fluoride. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

What should I discuss with my healthcare provider before taking Multi Vita Bets and Fluoride (multivitamin with fluoride)?

Taking in too much fluoride can cause an irreversible condition called fluorosis. This condition can permanently damage teeth and possibly other cells in the body.

Do not use this medicine without the advice of a doctor. Multivitamin with fluoride should not be used if the level of fluoride in the drinking water is adequate (0.6 parts per million or higher). Check with your local water department if you are unsure about the level of fluoride in the drinking water. FDA pregnancy category C. It is not know if multivitamin with fluoride it harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Multivitamin with fluoride can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Multi Vita Bets and Fluoride (multivitamin with fluoride)?

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

Take each dose of this medicine with a full glass of water.

The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing it. You may also allow the tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products).

Do not give a chewable tablet to a child younger than 4 years old. The child may choke on the tablet. Use only liquid forms of this medicine in young children.

Measure the liquid form of multivitamin with fluoride using a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

The liquid may also be mixed with water, fruit juice, or infant formula.

It is important to take multivitamin with fluoride regularly to get the most benefit.

Brush teeth regularly, at least two times each day or after meals. This will help prevent tooth discoloration.

Store this medication at room temperature away from moisture and heat. Do not allow the liquid to freeze.

Keep multivitamin with fluoride in the original contain it came in. Storing multivitamin with fluoride in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, muscle stiffness, or seizures (convulsions).

What should I avoid while taking Multi Vita Bets and Fluoride (multivitamin with fluoride)?

Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with fluoride. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Be sure that a child using this medicine is not taking in extra amounts of fluoride by swallowing toothpaste, or drinking water from sources that contain adequate levels of fluoride.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may cause your body to absorb less of the multivitamin with fluoride.

Multi Vita Bets and Fluoride (multivitamin with fluoride) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause the tooth enamel to become discolored. This is a rare side effect that has occurred mainly with large doses or long-term use of multivitamin with fluoride. Stop using this medication and call your dentist or doctor at once if you notice any change in the appearance of your teeth.

Less serious side effects may include:

• 
  

  stomach upset;

  
  


• 
  

  headache; or

  
  


• 
  

  weakness.

  
  

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

What other drugs will affect Multi Vita Bets and Fluoride (multivitamin with fluoride)?

There may be other drugs that can affect multivitamin with fluoride. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Multi Vita Bets and Fluoride resources

• Multi Vita Bets and Fluoride Use in Pregnancy & Breastfeeding
• Drug Images
• Multi Vita Bets and Fluoride Drug Interactions
• 0 Reviews for Multi Vita Bets and Fluoride - Add your own review/rating

• Multivitamin with Fluoride Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• MVC-Fluoride Prescribing Information (FDA)

Compare Multi Vita Bets and Fluoride with other medications

• Vitamin/Mineral Supplementation and Deficiency

Where can I get more information?

• Your pharmacist can provide more information about multivitamin with fluoride.

Humalog Mix 50/50

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

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

Commonly used brand name(s)

In the U.S.

• Humalog Mix 50/50


• Humalog Mix 75/25

Available Dosage Forms:

• Suspension

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Lispro, Recombinant

Uses For Humalog Mix 50/50

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

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

Before Using Humalog Mix 50/50

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

Allergies

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

Pediatric

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

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Emotional disturbances or


• Illness or


• Stress—These conditions increase blood sugar and may increase the amount of insulin you need.

• Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

• Kidney disease or


• Liver disease—Effects of insulin lispro protamine and insulin lispro combination may be increased because of the slower removal of the medicine from the body.

Proper Use of insulin lispro protamine and insulin lispro

This section provides information on the proper use of a number of products that contain insulin lispro protamine and insulin lispro. It may not be specific to Humalog Mix 50/50. Please read with care.

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

• How to prepare the medicine.


• How to inject the medicine.


• How to use disposable insulin delivery device.


• How to dispose of syringes, needles, and injection devices.

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

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

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

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

Missed Dose

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

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Store in the refrigerator. Do not freeze.

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

Precautions While Using Humalog Mix 50/50

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

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

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

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.


• Other medicines—Do not take other medicines during the time you are taking this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

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

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.


• Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs.


• Keep some kind of quick-acting sugar handy to treat low blood sugar.


• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

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

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

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

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

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

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

Humalog Mix 50/50 Side Effects

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

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

Incidence not known

• Anxiety


• blurred vision


• chills


• cold sweats


• coma


• confusion


• convulsions


• cool, pale skin


• cough


• decreased urine


• depression


• difficulty swallowing


• dizziness


• dry mouth


• fast heartbeat


• flushing or redness of the skin


• headache


• hives


• increased hunger


• increased thirst


• irregular heartbeat


• itching


• loss of appetite


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• nightmares


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


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


• seizures


• shakiness


• shortness of breath


• skin rash


• slurred speech


• sweating


• swelling


• tightness in the chest


• unusual tiredness or weakness


• unusually warm skin


• wheezing

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

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• redistribution or accumulation of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Humalog Mix 50/50 side effects (in more detail)

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More Humalog Mix 50/50 resources

• Humalog Mix 50/50 Side Effects (in more detail)
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• Humalog Mix 50/50 Support Group
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