Avalide

Pronunciation: IR-be-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Irbesartan/Hydrochlorothiazide
Brand Name: Avalide

Avalide can cause injury or even death to a developing fetus when used during pregnancy. Contact your doctor immediately if you suspect that you are pregnant.

Avalide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Avalide is a combination angiotensin II receptor blocker and diuretic. The angiotensin II receptor blocker works by relaxing the blood vessels. The diuretic works by helping the kidneys remove fluid from the body, which lowers blood pressure and helps the heart to pump blood more easily.

Do NOT use Avalide if:

• you are allergic to any ingredient in Avalide or to any other sulfonamide medicine (eg, sulfamethoxazole)


• you are pregnant


• you have severe kidney problems or are unable to urinate


• you are taking dofetilide or ketanserin

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

Before using Avalide:

Some medical conditions may interact with Avalide. 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 able to become pregnant


• 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 ever had a severe reaction (eg, swelling of the hands, face, lips, eyes, throat, or tongue; trouble swallowing or breathing; hoarseness) after taking any other angiotensin II receptor blocker or an angiotensin converting enzyme (ACE) inhibitor (eg, captopril)


• if you are dehydrated, have low blood volume, or are on a low-salt (sodium) diet


• if you have blood electrolyte problems (eg, sodium, chloride, potassium, magnesium levels, calcium)


• if you have asthma; gout; heart problems (eg, congestive heart failure); liver, gall bladder, or kidney problems; high blood cholesterol or lipid levels; or systemic lupus erythematosus


• if you have diabetes, especially if you are also taking aliskiren


• if you have recently had a certain type of nerve surgery (sympathectomy)

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

• Aliskiren, potassium supplements, or potassium-sparing diuretics (eg, spironolactone) because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, lisinopril) because the risk of kidney problems and high blood potassium levels may be increased


• Dofetilide or ketanserin because the risk of irregular heartbeat may be increased


• Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), diuretics (eg, furosemide), narcotic pain medicines (eg, morphine), or other medicines for high blood pressure because they may increase the risk of Avalide's side effects


• Cholestyramine or colestipol because they may decrease Avalide's effectiveness


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen) because they may decrease Avalide's effectiveness and the risk of serious kidney problems may be increased


• Diazoxide, digoxin, or lithium because the risk of their side effects and toxic effects may be increased by Avalide


• Insulin or other diabetes medicine (eg, glipizide, metformin) because their effectiveness may be decreased by Avalide

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

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

• Avalide may be taken with or without food.


• Drinking extra fluids while you are taking Avalide is recommended. Check with your doctor for instructions.


• Avalide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Avalide.


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


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

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

Important safety information:

• Avalide may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Avalide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


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


• Report any light-headedness or fainting to your doctor immediately. Your risk of light-headedness or fainting may be increased if you experience diarrhea, vomiting, excessive sweating, if you do not drink enough fluids, or if you are on a low-salt (sodium) diet.


• It may take up to 2 to 4 weeks to get the full benefit from Avalide. Do not stop using Avalide or change your dose of Avalide without checking with your doctor.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel normal. Tell your doctor if you develop any new symptoms.


• Avalide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Avalide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


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


• Avalide contains a sulfonamide called hydrochlorothiazide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Avalide. Contact your doctor right away if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


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


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


• Avalide may interfere with certain lab tests, including parathyroid function tests. Be sure your doctor and lab personnel know you are taking Avalide.


• Lab tests, including kidney function, blood pressure, and blood electrolytes, may be performed while you use Avalide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Avalide with caution in the ELDERLY; they may be more sensitive to its effects.


• Avalide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Avalide may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Avalide is found in breast milk. Do not breast-feed while taking Avalide.

Possible side effects of Avalide:

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; nausea; tiredness; vomiting.

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); burning, numbness, or tingling; chest pain; confusion; decrease in sexual ability; decreased urination; drowsiness; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hoarseness; light-headedness; mental or mood changes (eg, depression); muscle pain, tenderness, or cramps; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness; severe or persistent dry mouth; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; slurred speech; swelling of the arms or legs; tremors; unusual bruising or bleeding; unusual thirst; unusual tiredness or weakness; vision changes (eg, decreased vision clearness); 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: Avalide 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 fainting; fast or slow heartbeat; light-headedness; severe or unusual dizziness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, dry mouth or eyes; decreased urination; fast heartbeat; unusual thirst, tiredness, or weakness).

Proper storage of Avalide:

Store Avalide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Avalide out of the reach of children and away from pets.

General information:

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


• Avalide 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 Avalide. 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 Avalide resources

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

• Avalide Prescribing Information (FDA)


• Avalide Advanced Consumer (Micromedex) - Includes Dosage Information


• Avalide Consumer Overview

Compare Avalide with other medications

• High Blood Pressure

Formalaz

formaldehyde

Dosage Form: liquid
Formalaz

ACTIVE INGREDIENTS:

Formaldehyde 10%

INACTIVE INGREDIENTS:

Water, Polysorbate 20, Hydroxyethyl Cellulose, Fragrance.

INDICATIONS:

Drying agent for pre and post surgical removal of warts, or for non-surgical laser removal of warts where dryness is required.

Safeguards against offensive odor and dries excessive moisture of the feet. Not to be used in patients known to be sensitive to any of the ingredients in this product.

PRECAUTIONS:

FOR EXTERNAL USE ONLY: HARMFUL IF SWALLOWED, CONTACT A LOCAL POISON CONTROL CENTER IMMEDIATELY. KEEP OUT OF REACH OF CHILDREN. Safety and effectiveness in pediatric patients have not be established. Avoid contact and keep away from face, eyes, nose, and mucous membranes. Check skin for sensitivity to Formaldehyde prior to application since it may be irritating and sensitizing to the skin of some patients. If redness or irritation persists, consult your PODIATRIST, DERMATOLOGIST, or PHYSICIAN.

HOW SUPPLIED:

Available in 3 oz (85.05 gm) roll on plastic bottle.

Store at controlled room temperature 15 - 30 C (56 - 86 F).

RX ONLY.


Manufactured for:

RIVER'S EDGE PHARMACEUTICALS, LLC

Suwanee, GA 30024


REV 09/06

PRODUCT LABEL:

Formalaz  formaldehyde  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-194 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FORMALDEHYDE (FORMALDEHYDE) FORMALDEHYDE 100 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER   POLYSORBATE 20   HYDROXYETHYL CELLULOSE (140 CPS AT 5%)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-194-03 85.05 g In 1 BOTTLE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/16/2006	10/31/2012

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

Establishment
Name	Address	ID/FEI	Operations
A.I.G. Technologies, Inc.		171837367	manufacture

Revised: 12/2010River's Edge Pharmaceuticals, LLC

More Formalaz resources

• Formalaz Use in Pregnancy & Breastfeeding
• Formalaz Support Group
• 0 Reviews · Be the first to review/rate this drug

• Formadon Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Ceanel Concentrate (Ferndale Pharmaceuticals Ltd)

1. Name Of The Medicinal Product

Ceanel Concentrate

2. Qualitative And Quantitative Composition

Cetrimide BP	10.0%w/v
Undecenoic Acid BP	1.0%v/v

For full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Ceanel Concentrate is a clear, viscous, golden-yellow coloured liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

As an adjunct in the management psoriasis of the scalp, seborrhoeic dermatitis, dandruff-psoriasis of the trunk and limbs.

4.2 Posology And Method Of Administration

For topical use only.

Adults, Children and the Elderly:

Scalp Conditions:

Wet the scalp and hair with warm water. Protect the eyes with a towel to avoid discomfort. Apply ½ - 1 teaspoonful of Ceanel to the wetted scalp. Then apply a small amount of water and work up into lather. Rinse and repeat. Finally rinse the hair and scalp thoroughly. Use three times in the first week and twice weekly thereafter.

Other areas of the body.

Wet the area to be treated with warm water; apply sufficient Ceanel Concentrate by gentle massage to cover the wetted area. Allow to remain in contact for two minutes. Remove the Ceanel by thorough rinsing with warm water. Use as required.

4.3 Contraindications

Hypersensitivity to one of the ingredients.

4.4 Special Warnings And Precautions For Use

In common with other shampoos, it is suggested that the eyes be closed during treatment to avoid discomfort or that they may be protected with a towel.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy, but it has been in wide use for many years without apparent ill consequence. As with other medicaments it may be used during pregnancy if the anticipated benefits outweigh the risks. No problems are anticipated during lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

Ceanel Concentrate is for external use only. Following accidental ingestion, nausea and vomiting may occur as well as respiratory problems and hypotension. Treatment is supportive and symptomatic avoiding gastric lavage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cetrimide is particularly active against Gram-positive organisms. This feature combined with the flingicidal properties of undecenoic acid makes Ceanel Concentrate particularly effective in the treatment of dermatological conditions. Ceanel Concentrate is effective in removing debris and scale in seborrhoea capitis and psoriasis of the scalp.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Phenylethyl Alcohol, Lauric Diethanolamide, Diethanolamine, Poly Oxy Propylene Stearyl Ether, Purified Water BP.

6.2 Incompatibilities

None known

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Ceanel Concentrate should be stored in a cool, dry place avoiding extremes of temperature i.e. not less than 5^oC and not more than 30^oC.

6.5 Nature And Contents Of Container

Ceanel Concentrate is available in polyethylene bottles with a screw top containing 50ml, 150ml, 500ml. The 50ml presentation is cartooned and contains a patient information leaflet.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Ferndale Pharmaceuticals Ltd

12 York Place

Leeds

LS1 2DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 20685/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

1 January 2004

10. Date Of Revision Of The Text

7 October 2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)

Magnesium Sulphate Injection 50% w / v (UCB Pharma Ltd)

Magnesium sulphate injection 50% w/v

This leaflet is to help you get the most from your medicine.

Please read this leaflet carefully BEFORE you take your medicine. If you have any questions or you want to know more about this medicine, please ask the staff looking after you.

What is your medicine?

Your medicine is called Magnesium Sulphate Injection 50% w/v. It is a sterile solution for injection and contains 1g of magnesium sulphate (the active ingredient) in each 2ml of injection. It also contains sodium hydroxide, sulphuric acid and water for injections.

Magnesium Sulphate Injection 50% w/v is supplied in cartons of 1, 5 or 10 glass ampoules each containing 2ml of solution.

Magnesium Sulphate belongs to a group of medicines called mineral supplements.

Who makes it?

The Marketing Authorisation Holder is

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

It is made by

Ashton Pharmaceuticals Ltd

Vale of Bardsley

Ashton-under-Lyne

OL7 9RR

UK

What is this medicine used for?

Magnesium Sulphate Injection 50% w/v is used to treat magnesium deficiency (lack of magnesium), where it is not possible for the medicine to be taken by mouth. This could be due to malabsorption, severe diarrhoea, chronic alcoholism, malnutrition or having to have all nutrients by injection.

Before using this medicine

Please tell your doctor if the answer to any of the following questions is “yes”.

• Are you suffering from any form of heart disease, for example, have you had a heart attack or heart block (where your heart beat signals are delayed)?


• Are you receiving drugs for heart disease called cardiac glycosides, e.g. digitoxin?


• Do you suffer from poor kidney function?


• Have you been prescribed any of the following medicines: opioids (e.g. morphine); barbiturates (e.g. amylobarbitone); or hypnotics (e.g. nitrazepam)?


• Are you going to have an anaesthetic where a muscle relaxant will be used?


• Are you pregnant, likely to be pregnant, or breast feeding?


• Are you taking any medicines containing nifedipine (a calcium channel blocker) for angina or high blood pressure?

If the answer to any of these questions is YES, tell your doctor before taking this medicine. They may want to change your treatment or give you special advice.

How will I be given Magnesium Sulphate Injection 50% w/v?

Magnesium sulphate is to be injected into a muscle or a vein, as directed by the doctor. For injection into a vein, the solution should be diluted to 20% or less, and the rate of injection should be less than 1.5ml per minute of a 10% solution. In children the solution should also be diluted to 20% if being injected into a muscle.

The doctor may want to perform regular blood or other tests to monitor your condition.

For mild magnesium deficiency: 1 gram every 6 hours for 4 doses injected into a muscle.

For severe magnesium deficiency: Up to 250 milligrams per kilogram of body weight injected into a muscle every 4 hours, or 5 grams per litre of solution is given intravenously as an infusion over 3 hours.

What if I take too much?

If you think you have been given too much of this medicine, tell your doctor immediately. Signs of too much magnesium include flushing, thirst, drowsiness, feeling sick or being sick, confusion, muscle weakness, loss of reflexes, slow and/or shallow breathing, low blood pressure and irregular heartbeat.

After using Magnesium Sulphate Injection 50% w/v

Side effects after Magnesium Sulphate Injection are usually a sign that your body has now got more than enough magnesium. Signs of too much magnesium include flushing, thirst, drowsiness, felling sick or being sick, confusion, muscle weakness, loss of reflexes, slow and/or shallow breathing, low blood pressure and irregular heartbeat.

If you think this medicine has upset you in any way please tell your doctor.

How to store this medicine

Magnesium Sulphate Injection 50% w/v must be stored below 25°C.

Do not use this medicine after the expiry date shown on the pack.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Further information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor (or pharmacist), who will have access to further information.

YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.

This leaflet only applies to Magnesium Sulphate Injection 50% w/v.

Date of preparation of leaflet: October 2005

P1060C

Prevacid SoluTab Orally Disintegrating Tablets

Pronunciation: lan-SOE-pra-zole
Generic Name: Lansoprazole
Brand Name: Prevacid SoluTab

Prevacid SoluTab Orally Disintegrating Tablets are used for:

Preventing or treating certain types of ulcers. It is also used to treat symptoms of gastroesophageal reflux disease (GERD) (eg, heartburn) and irritation of the esophagus. It is also used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Prevacid SoluTab Orally Disintegrating Tablets are a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Prevacid SoluTab Orally Disintegrating Tablets if:

• you are allergic to any ingredient in Prevacid SoluTab Orally Disintegrating Tablets


• you are taking an HIV protease inhibitor (eg, atazanavir)

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

Before using Prevacid SoluTab Orally Disintegrating Tablets:

Some medical conditions may interact with Prevacid SoluTab Orally Disintegrating 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 low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer


• if you have phenylketonuria


• if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

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

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased


• Clarithromycin or voriconazole because they may increase the risk of Prevacid SoluTab Orally Disintegrating Tablets's side effects


• Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Prevacid SoluTab Orally Disintegrating Tablets


• Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Prevacid SoluTab Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prevacid SoluTab Orally Disintegrating 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 Prevacid SoluTab Orally Disintegrating Tablets:

Use Prevacid SoluTab Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Prevacid SoluTab Orally Disintegrating Tablets by mouth on an empty stomach before eating.


• Do not chew or swallow the tablet. Place the tablet on the tongue and allow it to dissolve until the particles can be swallowed. Prevacid SoluTab Orally Disintegrating Tablets can be taken with or without water. The tablet usually dissolves in less than 1 minute.


• If you have trouble taking the tablet, you may also dissolve it in water. Place the tablet in an oral syringe. If you are taking the 15 mg tablet, draw up 4 mL of water. If you are taking the 30 mg tablet, draw up 10 mL of water. Shake gently until the tablet dissolves. Swallow the mixture within 15 minutes after mixing. Do not store the mixture for use at a later time. After you take your dose, refill the syringe with 2 mL of water for the 15 mg tablet or 5 mL of water for the 30 mg tablet. Shake gently and swallow.


• You may take antacids while you are using Prevacid SoluTab Orally Disintegrating Tablets if you are directed to do so by your doctor.


• If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Prevacid SoluTab Orally Disintegrating Tablets.


• If you also take sucralfate, take Prevacid SoluTab Orally Disintegrating Tablets at least 30 minutes before taking sucralfate.


• Continue to take Prevacid SoluTab Orally Disintegrating Tablets even if you feel well. Do not miss any doses.


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

Ask your health care provider any questions you may have about how to use Prevacid SoluTab Orally Disintegrating Tablets.

Important safety information:

• Prevacid SoluTab Orally Disintegrating Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prevacid SoluTab Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.


• Prevacid SoluTab Orally Disintegrating Tablets may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Prevacid SoluTab Orally Disintegrating Tablets in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.


• Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Prevacid SoluTab Orally Disintegrating Tablets for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).


• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Prevacid SoluTab Orally Disintegrating Tablets.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Prevacid SoluTab Orally Disintegrating Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prevacid SoluTab Orally Disintegrating Tablets.


• Prevacid SoluTab Orally Disintegrating Tablets should be used with caution in Asian patients; the risk of side effects may be increased in these patients.


• Use Prevacid SoluTab Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.


• Prevacid SoluTab Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 1 year old; 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 Prevacid SoluTab Orally Disintegrating Tablets while you are pregnant. It is not known if Prevacid SoluTab Orally Disintegrating Tablets are found in breast milk. Do not breast-feed while taking Prevacid SoluTab Orally Disintegrating Tablets.

Possible side effects of Prevacid SoluTab Orally Disintegrating 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:

Constipation; diarrhea; headache; nausea; stomach pain.

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); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; unusual tiredness; vision changes.

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: Prevacid SoluTab 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 Prevacid SoluTab Orally Disintegrating Tablets:

Store Prevacid SoluTab Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prevacid SoluTab Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Prevacid SoluTab Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Prevacid SoluTab Orally Disintegrating 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 Prevacid SoluTab Orally Disintegrating 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 Prevacid SoluTab resources

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

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Diclofenac Tablets

1. Name Of The Medicinal Product

Diclofenac Tablets 25 mg

Diclofenac Tablets 50 mg

2. Qualitative And Quantitative Composition

Each enteric-coated tablet contains Diclofenac Sodium 25 mg.

Each enteric-coated tablet contains Diclofenac Sodium 50 mg.

3. Pharmaceutical Form

Gastro-resistant tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Diclofenac sodium is a non-steroidal agent, with marked analgesic and antiinflammatory properties, used in rheumatoid arthritis; osteoarthritis; osteoarthrosis; low back pain; acute musculo-skeletal disorders and trauma such as periarthritis, tendinitis, tenosynovitis, bursitis sprains, strains and dislocations; relief of pain in fractures; ankylosing spondylitis; acute gout; control of pain and inflammation in orthopaedic, dental and other minor surgery.

4.2 Posology And Method Of Administration

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Route of administration: Oral

Adults: 75-150 mg daily in two or three divided doses after meals. The recommended maximum daily dose of diclofenac sodium is 150mg.

Diclofenac Tablets 25 mg:

Children (aged 1-12 years): 1-3mg/kg per day in divided doses. Elderly: Although the pharmacokinetics of diclofenac sodium are not impaired to any clinically relevant extent in elderly patients, non-steroidal antiinflammatory drugs should be used with particular caution in such patients who are generally more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy.

Diclofenac Tablets 50 mg:

Children (aged 1-12 years): These tablets are not recommended for use in children.

Elderly: Although the pharmacokinetics of diclofenac sodium are not impaired to any clinically relevant extent in elderly patients, non-steroidal antiinflammatory drugs should be used with particular caution in such patients who are generally more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, angioedema, urticaria or acute rhinitis) to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs.

Patients with a history of, or active, gastro-intestinal ulcers, bleeding or perforation (two or more distinct episodes of proven ulceration or bleeding).

Severe hepatic, renal and heart failure (see section 4.4 Special warnings and precautions for use).

During the last trimester of pregnancy.

History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy.

Acute porphyria.

4.4 Special Warnings And Precautions For Use

Warnings:

In all patients: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration and GI and cardiovascular risks below).

The use of diclofenac with concomitant NSAIDs including cyclo-oxygenase 2-selective inhibitors should be avoided (see section 4.5 Interactions with other medicaments and other forms of interaction).

Elderly: The elderly have increased frequency of adverse reactions to NSAIDs especially to gastrointestinal bleeding and perforation which may be fatal (see section 4.2 Posology and method of administration).

Gastro-intestinal: Close medical surveillance is imperative in patients with symptoms indicative of gastro-intestinal disorders, with a history suggestive of gastro-intestinal ulceration, with ulcerative colitis or with Crohn's disease as these conditions may be exacerbated (see section 4.8 Undesirable effects).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).

Gastro-intestinal bleeding or ulceration/perforation: Haematemesis, melaena, ulceration or perforation which can be fatal has been reported with all NSAIDs. They can occur at any time during treatment with or without warning symptoms or a previous history of serious GI events. In the rare instances where gastro-intestinal bleeding or ulceration occurs in patients receiving diclofenac sodium the drug should be withdrawn.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3 Contraindications), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin or other drugs likely to increase gastrointestinal risk (see below and section 4.5 Interactions with other medicaments and other forms of interaction).

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as aspirin (see section 4.5 Interaction with other medicaments and other forms of interaction).

Hepatic: Close medical surveillance is also imperative in patients suffering from impairment of hepatic function.

Hypersensitivity reactions: As with other non-steroidal anti-inflammatory drugs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug (see Section 4.8 Undesirable effects).

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions with NSAIDs such as exacerbation of asthma (so called intolerance to analgesics / analgesics-asthma), Quincke's oedema (angioedema) or urticaria are more frequent than in other patients. Therefore special precautions are recommended in such patients (readiness for emergency). This is also applicable to patients who are allergic to other substances, for example those with skin reactions, pruritis or urticaria.

As with other NSAIDs, diclofenac sodium may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Precautions: Renal: Patients with renal, cardiac or hepatic impairment, a history of hypertension and the elderly, should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored.

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or other products that can significantly impact renal function, or those recovering from major surgery. Effects on renal function are usually reversible on withdrawal of diclofenac sodium.

Long-term treatment: All patients who are receiving non-steroidal antiinflammatory agents should be monitored as a precautionary measure e.g. renal function, hepatic function (elevation of liver enzymes may occur) and blood counts. This is particularly important in the elderly.

Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), diclofenac sodium should be discontinued. Hepatitis may occur without prodromal symptoms.

Use of diclofenac sodium in patients with hepatic porphyria may trigger an attack. Use in acute porphyria is contraindicated.

Haematological: Diclofenac sodium may reversibly inhibit platelet aggregation (see anticoagulants in Section 4.5 Interaction with other medicaments and other forms of interactions). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.

Respiratory disorders: Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of, bronchial asthma.

Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with diclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking).

SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8 Undesirable effects).

Dermatological: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at the highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Female fertility: The use of diclofenac sodium may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac sodium should be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium: Diclofenac sodium may increase plasma concentrations of lithium.

Anticoagulants: Although clinical investigations do not appear to indicate that diclofenac sodium has an influence on the effect of anticoagulants, there are isolated reports of an increased risk of haemorrhage with the combined use of diclofenac and anticoagulant therapy. Therefore, to be certain that no change in anticoagulant dosage is required, close monitoring of such patients is required. As with other non-steroidal anti-inflammatory agents, diclofenac in a high dose can reversibly inhibit platelet aggregation.

Antidiabetic agents: Clinical studies have shown that diclofenac sodium can be given together with oral antidiabetic agents without influencing their clinical effect. However there have been isolated reports of hypoglycaemic and hyperglycaemic effects which have required adjustment to the dosage of hypoglycaemic agents.

Ciclosporin and tacrolimus: Cases of nephrotoxicity have been reported in patients receiving concomitant ciclosporin and NSAIDs, including diclofenac sodium. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. This might be mediated through combined renal anti-prostaglandin effects of both the NSAID and calcineurin inhibitor.

Methotrexate: Cases of serious toxicity have been reported when methotrexate and NSAIDs are given within 24 hours of each other. This interaction is mediated through accumulation of methotrexate resulting from impairment of renal excretion in the presence of the NSAID.

Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients already receiving an NSAID.

Other NSAIDs including cyclo-oxygenase-2 selective inhibitors and corticosteroids: Co-administration of diclofenac sodium with these agents may increase the risk of gastro-intestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and precautions for use).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):

Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and precautions for use).

Diuretics: Like other NSAIDs, diclofenac sodium may inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently.

Antihypertensives: Concomitant use of NSAIDs with antihypertensive drugs (i.e. beta-blockers, angiotensin converting enzyme (ACE) inhibitors, diuretics) may cause a decrease in their antihypertensive effect via inhibition of vasodilatory prostaglandin synthesis.

Cardiac glycosides: Concomitant use of cardiac glycosides and NSAIDs in patients may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.

Baclofen: NSAIDs possibly reduce excretion of baclofen (increased risk of toxicity).

Drospirenone: Risk of hyperkalaemia when given with drospirenone (monitor serum potassium during first cycle).

Ketorolac: Increased side effects and haemorrhage if used with NSAIDs.

Penicillamine: Possible increased risk of nephrotoxicity.

Erlotinib, iloprost, pentoxifylline, sibutramine, venlafaxine: Possible increased risk of bleeding.

Phenytoin: NSAIDS possibly enhance effects of phenytoin.

Ritonavir: Plasma concentration of NSAIDs possibly increased by ritonavir.

Zidovudine: Increased risk of haematological toxicity when NSAIDs given with zidovudine.

4.6 Pregnancy And Lactation

Pregnancy

Congenital abnormalities have been reported in association with the administration of NSAIDs in man, however, these are low in frequency and do not appear to follow any discernible pattern.

In view of the known effects of NSAIDs on the foetal cardiovascular system (e.g. a premature closure of the ductus arteriosus) and in causing uterine inertia, use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3 Contraindications). NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit outweighs the potential risk to foetus. The lowest effective dose should be used and duration kept as short as possible.

Lactation

Following doses of 50mg enteric coated tablets every 8 hours, traces of active substance have been detected in breast milk, but in quantities so small that no adverse effects on the breast fed infant are to be expected.

NSAIDs should if possible be avoided when breast-feeding.

See section 4.4 Special warnings and precautions for use, regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

Patients who experience visual disturbances, dizziness, drowsiness, fatigue or other central nervous system disturbances while taking NSAIDs should refrain from driving or operating machinery.

4.8 Undesirable Effects

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: common (

The following undesirable effects include those reported with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac, with either short-term or long-term use.

Blood and lymphatic system disorders

Very rare: Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.

Immune system disorders

Rare: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).

Very rare: Angioneurotic oedema (including face oedema).

Psychiatric disorders

Very rare: Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder/reactions, confusion, hallucinations.

Nervous system disorders

Common: Headache, dizziness.

Rare: Somnolence, drowsiness, tiredness, hypotension.

Very rare: Paraesthesia, memory impairment/disturbance, convulsion, anxiety, tremor, taste disturbances, cerebrovascular accident, disturbances of sensation, taste disturbances, malaise, aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus and mixed tissue disease) with symptoms such as fever, stiff neck, headache, nausea and vomiting.

Eye disorders

Very rare: Visual disturbance, vision blurred, diplopia, optic neuritis.

Ear and labyrinth disorders

Common: Vertigo.

Very rare: Tinnitus, hearing impaired.

Cardiac disorders

Very rare: Palpitations, chest pain, cardiac failure/congestive heart failure, myocardial infarction.

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events, for example, myocardial infarction or stroke (see section 4.4 Special warnings and special precautions for use).

Vascular disorders

Very rare: Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders

Rare: Asthma (including dyspnoea), alveolitis, pulmonary eosinophilia.

Very rare: Pneumonitis.

Aggravated asthma or bronchospasm have also been reported.

Gastrointestinal disorders

Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain or cramps, flatulence, anorexia.

Rare: Gastritis, gastrointestinal haemorrhage or bleeding, haematemesis, diarrhoea haemorrhagic/bloody, melaena, gastrointestinal ulcer, with or without bleeding or perforation (sometimes fatal, particularly in the elderly).

Very rare: Lower gut disorders such as colitis (including colonic damage, non specific haemorrhagic colitis/ haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease/Crohn's proctocolitis), constipation, stomatitis/aphthous stomatitis, glossitis, oesophageal disorder/lesions, diaphragm-like intestinal strictures/stricture formation, pancreatitis.

Hepatobiliary disorders

Common: Transaminases (serum aminotransferase enzymes) increased (eg AST, ALT).

Rare: Hepatitis, jaundice, liver disorder.

Very rare: Fulminant hepatitis.

Skin and subcutaneous tissue disorders.

Common: Rash, skin eruptions.

Rare: Urticaria.

Very rare: Bullous eruptions/dermatoses, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis/acute toxic epidermolysis (Lyell's syndrome), dermatitis exfoliative (erythroderma), loss of hair, photosensitivity reactions, purpura, allergic purpura, pruritus.

Renal and urinary disorders

Rare: Interstitial fibrosis has been reported with NSAIDs and may lead to renal failure.

Very rare: Acute renal failure or insufficiency, urinary abnormalities (eg haematuria, proteinuria), nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions

Rare: Oedema.

Very rare: Impotence.

4.9 Overdose

Symptoms:

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, tinnitus, fainting, occasionally, convulsions. In rare cases of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measures:

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered.

Alternatively, in adults gastric lavage should be considered within one hour of ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diclofenac is a non-steroidal agent with marked analgesic and anti-inflammatory properties. It is also an inhibitor of prostaglandin synthetase.

5.2 Pharmacokinetic Properties

Diclofenac sodium is rapidly absorbed from the gut and is subject to first-pass metabolism. Tablets give plasma peak concentrations after 1-4 hours. It is 99.7% protein bound and has a plasma half-life of 1-2 hours. About 60% of the administered dose is excreted via the kidneys in the form of metabolites and only less than 1% in the unchanged form. The rest of the dose is excreted via the bile in metabolised form.

5.3 Preclinical Safety Data

None provided.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Diclofenac Tablets 25 mg:

Core ingredients:

Sodium starch glycollate BP

Microcrystalline cellulose BP

Lactose BP

Starch maize BP

Magnesium stearate BP

Purified talc BP

Coating ingredients:

Cellulose acetate phthalate BP

Opadry Yellow No. 518 (E171, E104, E110 and E132).

Diclofenac Tablets 50 mg:

Core ingredients:

Povidone K25 BP

Starch maize BP

Lactose BP

Magnesium stearate BP

Purified talc BP

Coating ingredients:

Cellulose acetate phthalate BP

Opadry Butterscotch No. 519 (E171, E104, E172 and E132)

6.2 Incompatibilities

See section 4.5

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store below 25°C and protect from moisture.

6.5 Nature And Contents Of Container

PVC/foil blisters containing 28, 50, 84 and 100 tablets. Securitainer with snap cap containing 50 and 100 tablets. Amber glass bottle with plastic screwcap containing 50 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Sandoz Ltd

Woolmer Way

Bordon

Hampshire

GU35 9QE

United Kingdom

8. Marketing Authorisation Number(S)

PL 04416/0361

PL 04416/0362

9. Date Of First Authorisation/Renewal Of The Authorisation

08 December 1999/16 March 2009

10. Date Of Revision Of The Text

03/2009

Novo-Rythro Stearate

Generic Name: erythromycin (Oral route, Parenteral route)

e-rith-roe-MYE-sin

Commonly used brand name(s)

In the U.S.

• E.E.S. 200


• E.E.S. 400


• E.E.S. Granules


• Eryped


• Eryped 200


• Eryped 400


• Erythrocin


• Erythrocin Stearate


• Ilosone

In Canada

• E.E.S. 100


• Ees 200


• Novo-Rythro Estolate Suspension


• Novo-Rythro Ethyl Succinate Suspension


• Novo-Rythro Stearate

Available Dosage Forms:

• Suspension


• Powder for Suspension


• Tablet


• Tablet, Chewable


• Capsule

Uses For Novo-Rythro Stearate

Erythromycins are used to treat many kinds of infections. Erythromycins are also used to prevent "strep" infections in patients with a history of rheumatic heart disease who may be allergic to penicillin.

These medicines may also be used to treat Legionnaires' disease and for other problems as determined by your doctor. They will not work for colds, flu, or other virus infections.

Erythromycins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, erythromycins are used in certain patients with the following medical conditions:

• Acne


• Actinomycosis


• Anthrax


• Chancroid


• Gastroparesis


• Lyme disease


• Lymphogranuloma venereum


• Relapsing fever

Before Using Novo-Rythro Stearate

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

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

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older adults may be at increased risk of hearing loss, especially if they are taking high doses of erythromycin and/or have kidney or liver disease.

Pregnancy

Erythromycin estolate has caused side effects involving the liver in some pregnant women. However, none of the erythromycins has been shown to cause birth defects or other problems in human babies.

Breast Feeding

Erythromycins pass into the breast milk. However, erythromycins have not been shown to cause problems in nursing babies.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease—High doses of erythromycin may increase the chance of side effects in patients with a history of an irregular heartbeat.

• Liver disease—Erythromycins, especially erythromycin estolate, may increase the chance of side effects involving the liver.

• Loss of hearing—High doses of erythromycins may, on rare occasion, cause hearing loss, especially if you have kidney or liver disease.

Proper Use of erythromycin

This section provides information on the proper use of a number of products that contain erythromycin. It may not be specific to Novo-Rythro Stearate. Please read with care.

Generally, erythromycins are best taken with a full glass (8 ounces) of water on an empty stomach (at least 1 hour before or 2 hours after meals). If stomach upset occurs, these medicines may be taken with food. If you have questions about the erythromycin medicine you are taking, check with your health care professional.

For patients taking the oral liquid form of this medicine:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid


• Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

For patients taking the chewable tablet form of this medicine:

• Tablets must be chewed or crushed before they are swallowed.

For patients taking the delayed-release capsule form (with enteric-coated pellets) or the delayed-release tablet form of this medicine:

• Swallow capsules or tablets whole. Do not break or crush. If you are not sure about which type of capsule or tablet you are taking, check with your pharmacist.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a "strep" infection, you should keep taking this medicine for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose medicines in this class 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 these medicines. 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 erythromycin base


• For oral dosage forms (capsules, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

• For erythromycin estolate


• For oral dosage forms (capsules, oral suspension, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

• For erythromycin ethylsuccinate


• For oral dosage forms (oral suspension, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—400 to 800 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day, or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1.6 grams two hours before your dental appointment or surgery, then 800 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

• For erythromycin gluceptate


• For injection dosage forms:
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
    • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
  
  

• For erythromycin lactobionate


• For injection dosage forms:
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) injected into a vein every six hours; or 3.75 to 5 mg per kilogram (kg) (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
    • Children—Dose is based on body weight. The usual dose is 3.75 to 5 mg per kg (1.7 to 2.3 mg per pound) of body weight injected into a vein every six hours.
    
    
  
  

• For erythromycin stearate


• For oral dosage forms (oral suspension, tablets):
  
  • For treatment of infections:
    
    • Adults and teenagers—250 to 500 milligrams (mg) two to four times a day.
    
    
    • Children—Dose is based on body weight. The usual dose is 7.5 to 12.5 mg per kilogram (kg) (3.4 to 5.6 mg per pound) of body weight four times a day; or 15 to 25 mg per kg (6.8 to 11.4 mg per pound) of body weight two times a day.
    
    
  
  
  • For prevention of heart infections:
    
    • Adults and teenagers—Take 1 gram two hours before your dental appointment or surgery, then 500 mg six hours after taking the first dose.
    
    
    • Children—Dose is based on body weight. The usual dose is 20 mg per kg (9.1 mg per pound) of body weight two hours before the dental appointment or surgery, then 10 mg per kg (4.5 mg per pound) of body weight six hours after taking the first dose.
    
    
  
  

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.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Novo-Rythro Stearate

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

Novo-Rythro Stearate 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:

Less common

• Fever


• nausea


• skin rash, redness, or itching


• stomach pain (severe)


• unusual tiredness or weakness


• vomiting


• yellow eyes or skin–with erythromycin estolate (rare with other erythromycins)

Less common - with erythromycin injection only

• Pain, swelling, or redness at place of injection

Rare

• Fainting (repeated)


• irregular or slow heartbeat


• loss of hearing (temporary)

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

More common

• Abdominal or stomach cramping and discomfort


• diarrhea


• nausea or vomiting

Less common

• Sore mouth or tongue


• vaginal itching and discharge

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 Novo-Rythro Stearate resources

• Novo-Rythro Stearate Use in Pregnancy & Breastfeeding
• Drug Images
• Novo-Rythro Stearate Drug Interactions
• Novo-Rythro Stearate Support Group
• 13 Reviews for Novo-Rythro Stearate - Add your own review/rating

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