Tildiem LA 200, Tildiem LA 300

1. Name Of The Medicinal Product

Tildiem LA 200

Tildiem LA 300

2. Qualitative And Quantitative Composition

Each capsule contains a combination of immediate-release and coated sustained-release pellets with 200mg or 300mg diltiazem hydrochloride as the active ingredient.

For a full list of excipients, see Section 6.1

3. Pharmaceutical Form

Sustained-release oral capsules

Tildiem LA 200: Opaque capsules with a grey body and pink cap, containing white to off-white pellets.

Tildiem LA 300: Opaque capsules with a white body and yellow cap, containing white to off-white pellets.

4. Clinical Particulars

4.1 Therapeutic Indications

Mild to moderate hypertension and angina pectoris.

4.2 Posology And Method Of Administration

Tildiem LA 200 and Tildiem LA 300 are sustained release products for once daily dosing. The capsules should not be chewed but swallowed whole with water, ideally before or during a meal. The dosage requirements may differ in patients with angina or hypertension.

Tildiem (diltiazem hydrochloride) is available in a range of presentations to enable dosage to be adjusted to meet the individual requirements of the patient. Careful titration of the dose should be considered where appropriate, as individual patient response may vary. When changing from one type of Tildiem formulation to another it may be necessary to adjust the dosage until a satisfactory response is obtained. To ensure consistency of response once established, particularly in the sustained release formulations, Tildiem LA 200 should continue to be prescribed by brand name.

Adults:

Angina and hypertension: The usual starting dose is Tildiem LA 200 once daily. This dose may be increased to Tildiem LA 300 once daily, or 2 capsules of Tildiem LA 200 daily (400 mg), and if clinically indicated a higher dose of one Tildiem LA 300 plus one Tildiem LA 200 capsule (total 500 mg) may be considered.

Elderly and patients with impaired hepatic or renal function:

Heart rate should be monitored and if it falls below 50 beats per minute the dose should not be increased. Plasma levels of diltiazem can be increased in this group of patients.

Angina and hypertension: the initial dose should be one Tildiem LA 200 capsule daily. This dose may be increased to one capsule of Tildiem LA 300 daily if clinically indicated.

Children:

Safety and efficacy in children have not been established. Therefore diltiazem is not recommended for use in children.

4.3 Contraindications

Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker.

Severe bradycardia (less than 50 beats per minute).

Left ventricular failure with pulmonary stasis.

Lactation.

Concurrent use with dantrolene infusion (see section 4.5 Interactions with other medicinal products and other forms of interaction).

Hypersensitivity to diltiazem or to any of the excipients

4.4 Special Warnings And Precautions For Use

Close observation is necessary in patients with reduced left ventricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block).

Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment.

In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vascular dilatation associated with anaesthetics may be potentiated by calcium channel blockers.

Treatment with diltiazem may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered.

Diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk of developing an intestinal obstruction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

COMBINATION CONTRAINDICATED FOR SAFETY REASONS:

Dantrolene (infusion)

Lethal ventricular fibrillation is regularly observed in animals when intravenous verapamil and dantrolene are administered concomitantly.

The combination of a calcium antagonist and dantrolene is therefore potentially dangerous (see section 4.3 Contraindications).

COMBINATIONS REQUIRING CAUTION:

Alpha-antagonists

Increased anti-hypertensive effects. Concomitant treatment with alpha-antagonists may produce or aggravate hypotension. The combination of diltiazem with an alpha antagonist should be considered only with strict monitoring of blood pressure.

Beta-blockers

Possibility of rhythm disturbances (pronounced bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disturbances and heart failure (synergistic effect).

Such a combination must only be used under close clinical and ECG monitoring, particularly at the beginning of treatment.

Amiodarone, Digoxin

Increased risk of bradycardia; caution is required when these are combined with diltiazem, particularly in elderly subjects and when high doses are used.

Antiarrhythmic agents

Since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended due to the risk of increased cardiac adverse effects due to an additive effect. This combination should only be used under close clinical and ECG monitoring.

Nitrate derivatives:

Increased hypotensive effects and faintness (additive vasodilating effects).

In all patients treated with calcium antagonists, the prescription of nitrate derivatives should only be carried out at gradually increasing doses.

Ciclosporin

Increase in circulating ciclosporin levels. It is recommended that the ciclosporin dose be reduced, renal function be monitored, circulating ciclosporin levels be assayed and that the dose should be adjusted during combined therapy and after its discontinuation.

Carbamazepine

Increase in circulating carbamazepine levels. It is recommended that the plasma carbamazepine concentrations be assayed and that the dose should be adjusted if necessary.

Theophylline

Increase in circulating theophylline levels.

Anti-H₂ agents (cimetidine and ranitidine)

Increase in plasma diltiazem concentrations. Patients currently receiving diltiazem therapy should be carefully monitored when initiating or discontinuing therapy with anti-H₂ agents. An adjustment in diltiazem daily dose may be necessary.

Rifampicin

Risk of decrease of diltiazem plasma levels after initiating therapy with rifampicin. The patient should be carefully monitored when initiating or discontinuing rifampicin treatment.

Lithium

Risk of increase in lithium-induced neurotoxicity.

COMBINATIONS TO BE TAKEN INTO ACCOUNT:

Diltiazem is metabolised by CYP3A4. A moderate (less than 2-fold) increase of diltiazem plasma concentration in cases of co-administration with a stronger CYP3A4 inhibitor has been documented. Diltiazem is also a CYP3A4 isoform inhibitor. Co-administration with other CYP3A4 substrates may result in an increase in plasma concentration of either co-administered drug. Co-administration of diltiazem with a CYP3A4 inducer may result in a decrease of diltiazem plasma concentrations.

Statins:

Diltiazem is an inhibitor of CYP3A4 and has been shown to significantly increase the AUC of some statins. The risk of myopathy and rhabdomyolysis is increased by concomitant administration of diltiazem with statins metabolised by CYP3A4 (e.g. atorvastatin, fluvastatin, and simvastatin). An adjustment of the dose of statin may be necessary (see also product information of the relevant statin). When possible, it is recommended to use a statin not metabolised by CYP3A4 (e.g. pravastatin) with diltiazem.

Benzodiazepines (midazolam, triazolam)

Diltiazem significantly increases plasma concentrations of midazolam and triazolam and prolongs their half-life. Special care should be taken when prescribing short-acting benzodiazepines matabolised by the CYP3A4 pathway in patients using diltiazem.

Corticosteroids (methylprednisolone):

Diltiazem can increase methylprednisolone levels (through inhibition of CYP3A4 and possible inhibition of P-glycoprotein). The patient should be monitored when initiating methylprednisolone treatment. An adjustment to the dose of methylprednisolone may be necessary.

GENERAL INFORMATION TO BE TAKEN INTO ACCOUNT:

Due to the potential for additive effects, caution and careful titration are necessary in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction.

4.6 Pregnancy And Lactation

Pregnancy: There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity (see section 5.3) in certain animal species (rat, mice, rabbit). Diltiazem is therefore not recommended during pregnancy, as well as in women of child-bearing potential not using effective contraception.

Breast feeding: as this drug is excreted in breast milk, breast feeding whilst taking diltiazem is contraindicated.

4.7 Effects On Ability To Drive And Use Machines

On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.

4.8 Undesirable Effects

The following CIOMS frequency rating is used, when applicable: Very common (

Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

	Very common	Common	Uncommon	Rare	Not known
Blood and lymphatic system disorders					Thrombocytopenia
Psychiatric disorders			Nervousness, insomnia		Mood changes (including depression)
Nervous system disorders		Headache, dizziness			Extrapyramidal syndrome
Cardiac disorders		Atrioventricular block (may be of first, second or third degree; bundle branch block may occur), palpitations	Bradycardia		Sinoatrial block, congestive heart failure
Vascular disorders		Flushing	Orthostatic hypotension		Vasculitis (including leukocytoclastic vasculitis)
Gastrointestinal disorders		Constipation, dyspepsia, gastric pain, nausea	Vomiting, diarrhea	Dry mouth	Gingival hyperplasia
Hepatobiliary disorders			Hepatic enzymes increase (AST, ALT, LDH, ALP increase)		Hepatitis
Skin and subcutaneous tissue disorders		Erythema		Urticaria	Photosensitivity (including lichenoid keratosis at sun exposed skin areas), angioneurotic oedema, rash, erythema multiforme (including Steven-Johnson's syndrome and toxic epidermal necrolysis), sweating, exfoliative dermatitis, acute generalized exanthematous pustulosis, occasionally desquamative erythema with or without fever
Reproductive system and breast disorders					Gynecomastia
General disorders and administration site conditions	Peripheral oedema	Malaise

4.9 Overdose

The clinical effects of acute overdose can involve pronounced hypotension leading to collapse, sinus bradycardia with or without isorhythmic dissociation, and atrioventricular conduction disturbances.

Treatment, under hospital supervision, will include gastric lavage, osmotic diuresis. Conduction disturbances may be managed by temporary cardiac pacing.

Proposed corrective treatments: atropine, vasopressors, inotropic agents, glucagon and calcium gluconate infusion.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Calcium channel blocker ATC code: C08DB01

Calcium antagonist, antihypertensive agent.

Diltiazem restricts calcium entry into the slow calcium channel of vascular smooth muscle and myocardial muscle fibres in a voltage-dependent manner. By this mechanism, diltiazem reduces the concentration of intracellular calcium in contractile protein.

In animals: diltiazem increases coronary blood flow without inducing any coronary steal phenomena. It acts both on small, large and collateral arteries. This vasodilator effect, which is moderate on peripheral systemic arterial territories, can be seen at doses that are not negatively inotropic.

The two major active circulating metabolites, i.e. desacetyl diltiazem and N

In humans: diltiazem increases coronary blood flow by reducing coronary resistance.

Due to its moderate bradycardia-inducing activity and the reduction in systemic arterial resistance, diltiazem reduces cardiac workload.

Tildiem LA does not have a significant myocardial depressant action in man.

5.2 Pharmacokinetic Properties

Diltiazem is well absorbed (90%) in healthy volunteers following oral administration.

The sustained release capsule provides prolonged absorption of the active constituent, producing steady state plasma concentrations between 2 and 14 hours post-dose, during which time peak plasma levels occur.

Bioavailability of Tildiem LA relative to the Tildiem 60mg formulation is approximately 80%. The mean apparent plasma half-life is 8 hours.

Diltiazem in plasma is 80 to 85% protein bound and is poorly dialysed. It is extensively metabolised by the liver.

The major circulating metabolite, N-monodesmethyl diltiazem accounts for approximately 35% of the circulating diltiazem.

Less than 5% of diltiazem is excreted unchanged in the urine.

Twenty four hours after intake, plasma concentrations remain, even after the 200 mg dose administration, at the level of 50 ng/ml, in patients. During long term administration in any one patient, plasma concentrations of diltiazem remained constant.

Mean plasma concentrations in the elderly and patients with renal and hepatic insufficiency are higher than in young subjects.

Food intake does not significantly affect the kinetics of Tildiem LA, however, when administered with food, absorption was observed to be higher in the first few hours post-dose.

Diltiazem and its metabolites are poorly dialysed.

Once daily formulations of diltiazem have been shown to have different pharmacokinetic profiles and therefore it is not advised to substitute different brands for one another.

5.3 Preclinical Safety Data

Pregnancy: Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical trials (480 mg q.d. or 8 mg/kg q.d. for a 60-kg patient) resulted in embryo and fetal lethality. These studies revealed, in one species or another, a propensity to cause fetal abnormalities of the skeleton, heart, retina, and tongue. Also observed were reductions in early individual pup weights, pup survival, as well as prolonged delivery times and an increased incidence of stillbirths.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tildiem LA 200:

Microcrystalline cellulose,

Acrylic and methacrylic esters co-polymer,

Ethylcellulose, sodium carboxymethylcellulose,

Diacetylated monoglycerides,

Magnesium stearate.

In the capsule:

Gelatin,

Black iron oxide (E172),

Titanium dioxide (E171),

Red iron oxide (E172).

Tildiem LA 300:

Microcrystalline cellulose,

Acrylic and methacrylic esters copolymer,

Ethylcellulose,

Carmellose sodium,

Diacetylated monoglycerides

Magnesium stearate.

In the capsule:

Gelatin,

Titanium dioxide (E171),

Yellow iron oxide (E172)

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

Tildiem LA 200: 3 years

Tildiem LA 300: 2 years

6.4 Special Precautions For Storage

Store below 25 C.

6.5 Nature And Contents Of Container

Tildiem LA 200: 28 capsules, in a PVC/foil blister strip.

Tildiem LA 300: 28 capsules, in a PVC/foil blister strip.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

Tildiem LA 200: PL 04425/0639

Tildiem LA 300: PL 04425/0638

9. Date Of First Authorisation/Renewal Of The Authorisation

27^th January 2009

10. Date Of Revision Of The Text

9 September 2010

LEGAL CATEGORY

POM

Multi-Nate DHA

multivitamin, multi-mineral nutritional supplement with DHA

Dosage Form: tablet
Multi-Nate 30 DHA 275/400mg

Multi-Nate DHA Description

Multi-Nate 30 DHA 275/400 mg is a high-potency, multivitamin, multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid).


Each Multi-Nate 30 tablet contains:


Vitamin A (beta carotene) 3000 IU, 60% DV

Vitamin B (ascorbic acid) 120 mg, 200% DV

Vitamin D (as cholecalciferol) 400 IU, 100% DV

Vitamin E (as dl-alpha tocopheryl acetate) 30 mg, 100% DV

Vitamin B1 (as thiamine monoitrate) 1.8 mg, 120% DV

Vitamin B2 (as riboflavin) 4 mg, 235% DV

Niacin (as niacinamide) 20 mg, 100% DV

Vitamin B6 (as pyridoxine hydrochloride) 25 mg, 1250% DV

Folic Acid 1 mg, 250% DV

Vitamin B12 (as cyanocobalamin) 12 mcg, 200% DV

Calcium (as calcium carbonate) 200 mg, 20% DV

Iron (as ferrous bisglycinate and iron protein succinylate) 29 mg, 161% DV

Magnesium (as magnesium oxide) 25 mg, 6% DV

Zinc (as zinc oxide) 25 mg, 167% DV

Copper (as cupric oxide) 2 mg, 100% DV


Other Ingredients (Multi-Nate 30 tablet): Mono and Diglycerides, Croscarmellose Sodium, Microcrystalline Cellulose, Crospovidone, Maltodextrin, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Polyethylene Glycol, Arabic Gum, Gelatin, Sucrose, Pea Starch, Cornstarch, Partially Hydrogenated Soybean Oil, Hydroxypropyl Methylcellulose, Dicalcium Phosphate, dl-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflavin.


Contains Soy.


May contain povidone and polydextrose.


Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based by-products.


Each Multi-Nate DHA 275/400 mg softgel capsule contains:

275 mg Docosahexaenoic Acid (DHA) from 400 mg omega-3 fatty acids (tuna oil).


Omega-3 Fatty Acids (from tuna oil) 400 mg, Daily Value not established

    Docosahexaenoic Acid (DHA) 275 mg


Other Ingredients (Multi-Nate DHA 275/400 mg softgel capsule): Gelatin, Water, Glycerin, Polysorbate 80.


Also contains Eicosapentaenoic Acid (EPA) and other Omega-3 Fatty Acids (from tuna oil).

Contains Soy and Fish Oil (from tuna oil).


WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.


Multi-Nate 30 DHA 275/400 mg supplies important prenatal vitamins, minerals and nutrients to supplement the nutritional needs of women, before, during and after pregnancy. Deficiencies of these nutrients are common during pregnancy and lactation and should be prescribed by a physician prior to conception.


Multi-Nate 30 tablet is manufactured in a drug-certified cGMP (current Good Manufacturing Practices) facility and meets or exceeds USP standards for potency, purity and dissolution. Multi-Nate DHA 275/400 mg softgel capsule complies with the most stringent worldwide standards for fish oil and is manufactured in a NSF Certified cGMP Facility.

Indications and Usage for Multi-Nate DHA

Multi-Nate 30 DHA 275/400 mg is a prescription regimen of prenatal multivitamin, multi-mineral and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Multi-Nate 30 DHA 275/400 mg is also useful in improving the nutritional status prior to conception.

Multi-Nate DHA Dosage and Administration

Before, during and after pregnancy, adult women (over 12 years of age), take one (1) tablet and one (1) softgel capsule by mouth daily, between meals or as prescribed by a physician. Tablet and softgel capsule may be taken separately. Do not exceed the recommended dosage. Do not administer to children under 12 years of age or persons age 65 or older. Do not exceed one gram (1,000 mg) of DHA per day.

Contraindications

Multi-Nate 30 DHA 275/400 mg is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. This product is contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms.


WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

Warning

Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.

Precautions

Folic acid in dosages above 400 mcg daily may obscure megaloblastic (pernicious) anemia in that hematological remission can occur while neurological manifestations (Addisionian anemia) remain progressive.

Adverse Reactions

Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, Multi-Nate 30 DHA 275/400 mg, when taken after meals, may control occasional G.I. disturbances, Multi-Nate 30 DHA 275/400 mg is best absorbed when taken at bedtime.


Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.


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

USE IN SPECIFIC POPULATIONS

Multi-Nate 30 DHA 275/400 mg is not advocated for pediatric or geriatric use.

OVERDOSE

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities have resulted. Multi-Nate 30 DHA 275/400 mg should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

How is Multi-Nate DHA Supplied

Multi-Nate 30 DHA 275/400 mg NDC: 68032-445-30 is a 30-day regimen supplied as one bottle of Multi-Nate 30 NDC: 68032-316-30, containing 30 dark pink tablets imprinted “RE 316” and one bottle of Multi-Nate DHA 275/400 mg NDC: 68032-449-30, containing 30 yellow softgel capsules. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.


CAUTION: Rx Only

PACKAGING

Sample Carton Packaging (68032-445-30):

Sample Labeling (68032-316-30):

Sample Labeling (68032-449-30):

MULTINATE DHA  beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, omega-3-acid ethyl esters, doconexent  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-445

Packaging # NDC Package Description Multilevel Packaging 1 68032-445-30 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE   30  Part 2 1 BOTTLE   30

Part 1 of 2 MULTINATE  beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide  tablet

Product Information NDC Product Code (Source) 68032-316     Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU] ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU] ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg IRON (IRON) IRON 29 mg MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg ZINC OXIDE (ZINC) ZINC OXIDE 25 mg CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg

Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC MONO/DIGLYCERIDES   CROSCARMELLOSE SODIUM   CELLULOSE, MICROCRYSTALLINE   CROSPOVIDONE   MALTODEXTRIN   STEARIC ACID   MAGNESIUM STEARATE   SILICON DIOXIDE   ACACIA   SODIUM ALGINATE   POLYETHYLENE GLYCOL   SUCROSE   STARCH, CORN   HYDROGENATED SOYBEAN OIL   HYPROMELLOSES   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   ALPHA-TOCOPHEROL, DL-   TITANIUM DIOXIDE   TRIACETIN   POLYSORBATE 20   RIBOFLAVIN   GELATIN

Product Characteristics Color pink (dark pink) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code RE;316 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-316-30 30 TABLET In 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2009 11/30/2012

Part 2 of 2 MULTINATE DHA  omega-3-acid ethyl esters, doconexent  capsule

Product Information NDC Product Code (Source) 68032-449     Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 400 mg DOCONEXENT (DOCONEXENT) DOCONEXENT 275 mg

Inactive Ingredients Ingredient Name Strength GELATIN   WATER   GLYCERIN   POLYSORBATE 80

Product Characteristics Color yellow Score no score Shape CAPSULE Size 20mm Flavor Imprint Code RE;449 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-449-30 30 CAPSULE In 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2009 11/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2009	11/30/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 04/2011River's Edge Pharmaceuticals, LLC

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Elestrin Gel

Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Elestrin

Elestrin Gel should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Elestrin Gel. Talk with your doctor if you have questions about the benefits and risks of using Elestrin Gel.

Elestrin Gel should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Elestrin Gel.

Elestrin Gel is used for:

Treating certain moderate to severe symptoms of menopause (eg, hot flashes).

Elestrin Gel is an estrogen hormone. It works by replacing estrogen in the body when it no longer produces enough on its own.

Do NOT use Elestrin Gel if:

• you are allergic to any ingredient in Elestrin Gel


• you are pregnant or suspect you may be pregnant


• you have undiagnosed abnormal vaginal bleeding


• you have a history of blood clots (eg, in the lungs, legs, eyes); endometrial, cervical, or vaginal cancer; estrogen-dependent growths; breast cancer; or liver problems


• you have had a heart attack or stroke within the past 12 months

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

Before using Elestrin Gel:

Some medical conditions may interact with Elestrin Gel. 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 endometriosis, growths in the uterus, abnormal mammogram, abnormal vaginal bleeding, a lump in the breast, or fibrocystic breast disease, or if a family member has had breast cancer


• if you have dementia or other memory problems, or abnormal blood calcium levels


• if you have a history of asthma, cancer, high blood cholesterol or lipid levels, diabetes, heart problems, high blood pressure, heart attack or stroke, kidney problems, liver tumor, mental or mood problems (eg, depression), underactive thyroid, migraine headaches, gallbladder or pancreas problems, seizures (eg, epilepsy), lupus, chorea, or the blood disease porphyria


• if you smoke, are very overweight, or will be having surgery


• if you have a history of yellowing of the eyes or skin during pregnancy or with past estrogen use


• if a member of your family has a history of blood clots (eg, in the legs, lungs, eyes), diabetes, lupus, or obesity


• if you have had your uterus removed (hysterectomy)

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

• Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Elestrin Gel's side effects


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Elestrin Gel's effectiveness


• Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Elestrin Gel

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

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

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


• Elestrin Gel is applied to the area between the shoulder and the upper arm. Apply Elestrin Gel to clean, intact skin only. Be sure the area is completely dry before applying Elestrin Gel.


• Do not apply Elestrin Gel to skin that is irritated or broken. Do not apply it to your face, in or around the vagina, or to your breasts.


• If you take a bath or shower, or use a sauna around the time of your dose, apply Elestrin Gel afterwards. Be sure the area is completely dry before applying the medicine.


• You must prime the pump before using it for the first time. To do this, remove the cap, unlock the pump, and press down on the spout 10 times. Discard any medicine that comes out in the trash can, out of the reach of children and pets. The pump is now ready for use.


• To use a dose of Elestrin Gel, hold the pump with the tip facing the upper arm. Press the pump firmly and fully to dispense the medicine. Use 2 fingers to spread the medicine over the entire area of the upper arm and shoulder. Gently rub Elestrin Gel in. Return the spout to the locked position and replace the cap after each use.


• Wash your hands with soap and water after using Elestrin Gel.


• Allow the medicine to dry for at least 5 minutes before dressing.


• Do not allow others to apply Elestrin Gel for you. Do not allow others to come into contact with the application site for at least 2 hours after you apply Elestrin Gel. If someone else comes into contact with Elestrin Gel, have them wash the area with soap and water right away.


• This pump contains 100 doses. Throw away the pump after 100 doses have been used, even if there is still medicine left in the pump. It may no longer give the correct amount of medicine with each dose.


• Use Elestrin Gel at the same time each day.


• If you miss a dose of Elestrin Gel, use it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

• Elestrin Gel is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse right away with warm clean water.


• Do not apply sunscreen to the application site for at least 25 minutes after applying Elestrin Gel. Do not apply sunscreen to the application site for more than 7 days in a row.


• If you will be swimming, wait at least 2 hours before going into the water after applying Elestrin Gel.


• Elestrin Gel is flammable. Avoid fire, flame, or smoking until the medicine has dried on your skin.


• Eating grapefruit or drinking grapefruit juice may increase the risk of Elestrin Gel's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Elestrin Gel.


• Tell your doctor or dentist that you take Elestrin Gel before you receive any medical or dental care, emergency care, or surgery. If possible, Elestrin Gel should be stopped at least 4 to 6 weeks before surgery or any time you might be confined to a bed or chair for a long period of time (such as a long plane flight, car ride, bedrest, or illness).


• Elestrin Gel may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.


• If you wear contact lenses and you develop problems with them, contact your doctor.


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


• Elestrin Gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Elestrin Gel.


• Lab tests and medical exams, including breast exams, mammograms, Pap tests, physicals, and blood pressure, may be performed while you use Elestrin Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Examine your breasts monthly as directed by your doctor. Report any lumps right away.


• Elestrin Gel should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Elestrin Gel if you are pregnant. If you think you may be pregnant, contact your doctor right away. Elestrin Gel is found in breast milk. If you are or will be breast-feeding while you use Elestrin Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Elestrin Gel:

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:

Breast pain or tenderness; headache; mild hair loss; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

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); blurred or double vision, vision loss, or other vision changes; breast lump or discharge; calf or leg pain or swelling; chest pain; confusion; coughing up blood; fainting; memory problems; mental or mood changes (eg, depression); migraine headache; numbness of an arm or leg; one-sided weakness; persistent or recurring abnormal vaginal bleeding; severe or persistent headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; slurred speech; swelling of the hands, legs, or feet; vaginal discharge, itching, or odor; yellowing of the skin or eyes.

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

See also: Elestrin 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 abnormal vaginal bleeding; or severe or persistent nausea or vomiting.

Proper storage of Elestrin Gel:

Store Elestrin Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Elestrin Gel out of the reach of children and away from pets.

General information:

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


• Elestrin Gel 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 Elestrin Gel. 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 Elestrin resources

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

Compare Elestrin with other medications

• Postmenopausal Symptoms

Procto-Kit 1% cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

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

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  congestive heart failure;

  
  


• 
  

  a history of tuberculosis;

  
  


• 
  

  stomach ulcer or diverticulitis;

  
  


• 
  

  a colostomy or ileostomy;

  
  


• 
  

  fever or any type of infection;

  
  


• 
  

  kidney disease;

  
  


• 
  

  high blood pressure; or

  
  


• 
  

  myasthenia gravis.

  
  

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling of your ankles or feet;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  rapid weight gain, especially in your face and midsection;

  
  


• 
  

  severe rectal pain or burning;

  
  


• 
  

  bleeding from your rectum;

  
  


• 
  

  severe stomach pain;

  
  


• 
  

  sudden and severe headache or pain behind your eyes; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild rectal pain or burning;

  
  


• 
  

  acne;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  increased sweating; or

  
  


• 
  

  increased facial or body hair growth.

  
  

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 hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Procto-Kit 1% resources

• Procto-Kit 1% Side Effects (in more detail)
• Procto-Kit 1% Use in Pregnancy & Breastfeeding
• Procto-Kit 1% Drug Interactions
• Procto-Kit 1% Support Group
• 0 Reviews for Procto-Kit% - Add your own review/rating

Compare Procto-Kit 1% with other medications

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

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Procto-Kit% side effects (in more detail)

Kapidex

Generic Name: dexlansoprazole (DEX lan SOE pra zol)

Brand Names: Dexilant

What is dexlansoprazole?

Dexlansoprazole is in a group of drugs called proton pump inhibitors. Dexlansoprazole decreases the amount of acid produced in the stomach.

Dexlansoprazole is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).

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

What is the most important information I should know about dexlansoprazole?

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

You should not take dexlansoprazole if you are allergic to it.

Before you take dexlansoprazole, tell your doctor if you have liver disease.

Take this medication for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

When treating heartburn, dexlansoprazole is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take dexlansoprazole for several months. Follow your doctor's instructions.

What should I discuss with my healthcare provider before taking dexlansoprazole?

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

You should not take dexlansoprazole if you are allergic to it.

If you have liver disease you may need a dose adjustment or special tests to safely take this medicine.

Taking a proton pump inhibitor such as dexlansoprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether dexlansoprazole is the actual cause of an increased risk of fracture. Before you take this medication, tell your doctor if you have osteoporosis or osteopenia (low bone mineral density). FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether dexlansoprazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take dexlansoprazole?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Dexlansoprazole may be taken with or without food.

Do not crush, break, or open a delayed-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you are unable to swallow a delayed-release capsule whole: Open the capsule and sprinkle the medicine into a spoonful of applesauce. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

When treating heartburn, dexlansoprazole is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take dexlansoprazole for several months. Follow your doctor's instructions.

Take this medication for the full prescribed length of time. Your symptoms may improve before the condition is fully treated. Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine. Store at room temperature away from moisture and heat.

See also: Kapidex dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking dexlansoprazole?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Dexlansoprazole 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, fast or pounding heartbeats;

  
  


• 
  

  severe stomach pain; or

  
  


• 
  

  worsening heartburn.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, stomach pain, gas;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  stuffy nose, sneezing, or other cold symptoms.

  
  

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 dexlansoprazole?

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

• 
  

  ampicillin (Omnipen, Principen);

  
  


• 
  

  atazanavir (Reyataz);

  
  


• 
  

  clopidogrel (Plavix);

  
  


• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  iron (Feosol, Mol-Iron, Fergon, Femiron, others).

  
  

This list is not complete and other drugs may interact with dexlansoprazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Kapidex resources

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

• Kapidex Consumer Overview


• Kapidex Advanced Consumer (Micromedex) - Includes Dosage Information


• Kapidex Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Kapidex Prescribing Information (FDA)


• Dexlansoprazole Monograph (AHFS DI)


• Dexlansoprazole Professional Patient Advice (Wolters Kluwer)


• Dexilant Prescribing Information (FDA)

Compare Kapidex with other medications

• Barrett's Esophagus
• Erosive Esophagitis
• GERD

Where can I get more information?

• Your pharmacist can provide more information about dexlansoprazole.

See also: Kapidex side effects (in more detail)

Ectosone Regular-Cream

Generic Name: betamethasone valerate (Topical application route)

bay-ta-METH-a-sone VAL-er-ate

Commonly used brand name(s)

In the U.S.

• Betamethacot


• Beta-Val


• Luxiq


• Qualisone


• Valisone

In Canada

• Betacort Scalp Lotion


• Betnovate


• Betnovate-1/2


• Celestoderm-V


• Celestoderm-V/2


• Ectosone Mild-Lotion


• Ectosone Regular-Cream


• Ectosone Regular-Lotion


• Ectosone Scalp Lotion


• Metaderm Mild


• Metaderm Regular


• Novo-Betamet

Available Dosage Forms:

• Gel/Jelly


• Ointment


• Lotion


• Cream


• Foam

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Betamethasone

Uses For Ectosone Regular-Cream

Betamethasone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. Betamethasone foam is used for scalp problems. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Ectosone Regular-Cream

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 betamethasone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the foam form, safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of betamethasone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of betamethasone

This section provides information on the proper use of a number of products that contain betamethasone. It may not be specific to Ectosone Regular-Cream. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, lotion, or ointment:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use the foam:

• This medicine comes with a patient information insert. Read and follow the instructions carefully.


• Wash your hands with soap and water before and after using this medicine.


• Turn the can upside down and place a small amount of medicine in a saucer or any cool, clean surface. Do not put the foam directly in your hands. This will melt the foam immediately upon contact with warm skin.


• Move the hair away and put a small amount of the foam on the affected areas of the scalp. Massage it in gently until the medicine has dried.


• Do not wash or rinse the treated areas immediately after applying the medicine.


• Do not use this medicine near heat, open flame, or while smoking.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream and ointment):
    
    • Adults—Apply to the affected area of the skin one to three times per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply a few drops to the affected area of the skin two times per day (morning and evening).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For scalp problems:
  
  • For topical dosage form (foam):
    
    • Adults—Apply to the affected area of the scalp two times per day (once in the morning and once at night).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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

Store the can of the foam at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Precautions While Using Ectosone Regular-Cream

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Ectosone Regular-Cream 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:

More common

• Burning, itching, or stinging at the application site

Less common

• Hair loss


• thinning of the hair

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)

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:

Less common

• Acne or pimples


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Incidence not known

• Burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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.

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.

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More Ectosone Regular-Cream resources

• Ectosone Regular-Cream Use in Pregnancy & Breastfeeding
• Ectosone Regular-Cream Drug Interactions
• Ectosone Regular-Cream Support Group
• 13 Reviews for Ectosone Regular-Cream - Add your own review/rating

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