Read Article Directory North Carolina: April 2012

Monday 30 April 2012

Iromin G

Generic Name: multivitamin with iron (MUL tee VYE ta mins with i ron)

Brand Names:

What is Iromin G (multivitamin with iron)?

Multivitamin are a combination of many different vitamins that are normally found in foods and other natural sources.

Iron is normally found in foods like red meat. In the body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Multivitamin and iron are used to provide vitamins and iron that are not taken in through the diet. They are also used to treat iron or vitamin deficiencies caused by illness, pregnancy, poor nutrition, digestive disorders, and many other conditions.

Multivitamin and iron may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Iromin G (multivitamin with iron)?

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects. Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms if you take too much.

Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin with iron.

What should I discuss with my healthcare provider before taking Iromin G (multivitamin with iron)?

Iron and certain vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

If you have any medical conditions, ask your doctor before taking a multivitamin with iron. If you have certain conditions, you may need a certain vitamin formulation or special tests while taking this product.

Do not take multivitamin with iron without telling your doctor if you are pregnant or plan to become pregnant. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Multivitamin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Iromin G (multivitamin with iron)?

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

Never take more than the recommended dose of multivitamin with iron. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your multivitamin with a full glass of water. You may take the multivitamin with food if it upsets your stomach.

The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing.

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

Liquid multivitamin may sometimes be mixed with water, fruit juice, or infant formula (but not milk or other dairy products). Follow the directions on the medicine label.

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

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

Store this medication at room temperature away from moisture and heat. Keep the liquid medicine from freezing.

Store multivitamin in their original container. Storing multivitamin in a glass container can ruin the medication.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms.

What should I avoid while taking Iromin G (multivitamin with iron)?

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

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Avoid taking an antibiotic medicine within 2 hours before or after you take multivitamin with iron. This is especially important if you are taking an antibiotic such as ciprofloxacin (Cipro), demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), norfloxacin (Noroxin), ofloxacin (Floxin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Certain foods can also make it harder for your body to absorb iron. Avoid taking this multivitamin within 1 hour before or 2 hours after eating fish, meat, liver, and whole grain or "fortified" breads or cereals.

Iromin G (multivitamin with iron) 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 if you have serious side effects such as:

bright red blood in your stools; or

pain in your chest or throat when swallowing a ferrous fumarate tablet.

When taken as directed, multivitamin are not expected to cause serious side effects. Less serious side effects may include:

constipation, diarrhea;

nausea, vomiting, heartburn;

stomach pain, upset stomach;

black or dark-colored stools or urine;

temporary staining of the teeth;

headache; or

unusual or unpleasant taste in your mouth.

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 Iromin G (multivitamin with iron)?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking multivitamin with iron, tell your doctor if you also use:

acetohydroxamic acid (Lithostat);

cimetidine (Tagamet);

deferoxamine (Desferal);

etidronate (Didronel);

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

dimercaprol (an injection used to treat poisoning by arsenic, lead, or mercury);

penicillamine (Cuprimine);

pancrelipase (Cotazym, Creon, Ilozyme, Pancrease, Ultrase);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

This list is not complete and there may be other medications that can interact with or be affected by multivitamin with iron. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Iromin G resources

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

Multivitamin with Iron Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Anemagen MedFacts Consumer Leaflet (Wolters Kluwer)

BiferaRx MedFacts Consumer Leaflet (Wolters Kluwer)

Chromagen Forte MedFacts Consumer Leaflet (Wolters Kluwer)

Ferocon MedFacts Consumer Leaflet (Wolters Kluwer)

Ferotrin Prescribing Information (FDA)

Ferralet 90 Prescribing Information (FDA)

Ferralet 90 MedFacts Consumer Leaflet (Wolters Kluwer)

Ferrex 150 Forte Prescribing Information (FDA)

Ferrex 150 Forte Plus Prescribing Information (FDA)

Ferrex 150 Forte Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Ferrex 28 Prescribing Information (FDA)

FerroGels Forte MedFacts Consumer Leaflet (Wolters Kluwer)

FerroGels Forte Prescribing Information (FDA)

FoliTab 500 MedFacts Consumer Leaflet (Wolters Kluwer)

Fumatinic MedFacts Consumer Leaflet (Wolters Kluwer)

Hematogen Forte Prescribing Information (FDA)

Integra MedFacts Consumer Leaflet (Wolters Kluwer)

Integra F MedFacts Consumer Leaflet (Wolters Kluwer)

Integra F Prescribing Information (FDA)

Integra Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Integra Plus Prescribing Information (FDA)

Irospan 24/6 MedFacts Consumer Leaflet (Wolters Kluwer)

Irospan 24/6 Prescribing Information (FDA)

NovaFerrum Prescribing Information (FDA)

NovaFerrum MedFacts Consumer Leaflet (Wolters Kluwer)

Proferrin-Forte MedFacts Consumer Leaflet (Wolters Kluwer)

Tricon Prescribing Information (FDA)

Compare Iromin G with other medications

Anemia
Vitamin/Mineral Supplementation and Deficiency

Where can I get more information?

Your pharmacist can provide more information about multivitamin with iron.

See also: Iromin G side effects (in more detail)

Sunday 29 April 2012

Prenatabs FA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Prenatabs FA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

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

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

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?

What should I avoid while taking prenatal vitamins?

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

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. 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 Prenatabs FA resources

Prenatabs FA Use in Pregnancy & Breastfeeding
Drug Images
Prenatabs FA Drug Interactions
Prenatabs FA Support Group
0 Reviews for Prenatabs FA - Add your own review/rating

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Prenatabs FA with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

Saturday 28 April 2012

Alu-cap Capsules

Alu-cap capsules

What you need to know about ALU-CAP capsules

Please read this carefully before you start to take your medication. This leaflet only provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The name of your medication is ALU-CAP capsules

The name of the active ingredient is aluminium hydroxide. Each capsule contains 475 mg of Dried Aluminium Hydroxide Gel Ph. Eur. and is green and red, and marked 3M.

It also contains the following inactive ingredients: polyethylene glycol, purified talc, Solka Floc BW 100, E104, E110, E127, E131. The original pack contains 120 capsules.

Who produces your medication

The name and address of the product licence holder is

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

The product is manufactured by

3M Health Care Limited

Loughborough

Leicestershire

LE11 1EP

What your medication is prescribed for

Aluminium hydroxide can be used to reduce the amount of phosphate ions absorbed by the body from the diet. This helps to reduce the levels of phosphate in the blood which is important in patients with certain kidney diseases.

Aluminium hydroxide may also be used as an antacid for the relief of indigestion.

It neutralises the acid in the stomach and helps to protect the stomach lining from acid irritation.

Important points to note before taking ALU-CAP capsules

If you are pregnant, think you might be pregnant or are trying to become pregnant, or are taking other medications, please tell your doctor before taking these capsules.

You should not take these capsules if you have low levels of phosphate in your blood (hypophosphataemia) or you suffer from porphyria (blood disorder).

These capsules should not be used as an antacid in children under 12 years of age.

If you see any other doctor or dentist, please tell them that you are taking Alu-cap capsules.

What to do if you are taking other medication

Please tell your doctor or pharmacist if you are taking any other medicines, in particular antibiotics (e.g. tetracyclines), as aluminium hydroxide may reduce their absorption into your body. Please follow any advice they may give you about how to take your medicines.

Use of ALU-CAP capsules during pregnancy and breast feeding

Like most other medications, aluminium hydroxide should not normally be taken if you are pregnant or breastfeeding, unless your doctor tells you to.

How to take ALU-CAP capsules

Please follow your doctor’s instructions. Your doctor will have chosen a dose which best suits your condition.

The capsules should be taken with meals with a glass of water.

For phosphate-binding:

For adults and children the usual dose is one capsule taken four times per day. This may be increased to five capsules four times per day (a total of 20 capsules per day).

As an antacid:

The usual dose in adults is one capsule four times during the day and one at bedtime.

If you are not sure how many capsules to take or when to take them, please ask your doctor or pharmacist.

If you miss a dose take it as soon as you remember. Then carry on taking the capsules as recommended by your doctor.

What to do in case of accidental overdosage

Please contact your nearest hospital casualty department, or tell your doctor, immediately.

What might happen when you are taking ALU-CAP capsules

Aluminium hydroxide, like most other medicines may cause some side-effects. These may include constipation.

From time to time your doctor may wish to take a blood sample to check your phosphate or aluminium level.

If you notice any other side-effects, please tell your doctor or pharmacist.

If any side-effects continue for more than a few days, please tell your doctor.

Storing your medication

Store the capsules in a safe place where children cannot reach them.

Store the capsules below 30°C out of direct sunlight.

Do not use this product after the expiry date printed on the original container.

If your doctor decides to stop treatment, return any unused capsules to your doctor or pharmacist.

Date of preparation of leaflet: March 2010

Remember: This medication is only for YOU. Never give it to others. It may harm them even if their symptoms seem to be the same as yours.

The information in this leaflet only provides a summary of the information available on Alu-cap capsules. Further information is available from your doctor or pharmacist.

6204 1442 1

562197M9310UK00

Alu-cap is a trademark of MEDA AB.

The Triangle Logo on the packaging is a trademark of 3M and is used under license.

Friday 27 April 2012

Texacort

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

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

What is Texacort (hydrocortisone topical)?

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

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

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

What is the most important information I should know about Texacort (hydrocortisone topical)?

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

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

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

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

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

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

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

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

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

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

How should I use Texacort (hydrocortisone topical)?

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

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

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

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

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

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

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while using Texacort (hydrocortisone topical)?

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

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

Texacort (hydrocortisone topical) side effects

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

blurred vision, or seeing halos around lights;

uneven heartbeats;

sleep problems (insomnia);

weight gain, puffiness in your face; or

feeling tired.

Less serious side effects may include:

skin redness, burning, itching, or peeling;

thinning of your skin;

blistering skin; or

stretch marks.

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

What other drugs will affect Texacort (hydrocortisone topical)?

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

More Texacort resources

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

Texacort Prescribing Information (FDA)

Texacort Advanced Consumer (Micromedex) - Includes Dosage Information

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Carmol HC Prescribing Information (FDA)

Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)

Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Hydrocortisone Acetate Monograph (AHFS DI)

Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Hytone Prescribing Information (FDA)

Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Locoid Lipocream Prescribing Information (FDA)

Locoid Lotion Prescribing Information (FDA)

Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

Pandel Prescribing Information (FDA)

Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Proctocort Prescribing Information (FDA)

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Westcort Prescribing Information (FDA)

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

Where can I get more information?

Your pharmacist can provide more information about hydrocortisone topical.

See also: Texacort side effects (in more detail)

HyoMax

Pronunciation: HYE-oh-SYE-a-meen
Generic Name: Hyoscyamine
Brand Name: Examples include HyoMax and Levsin

HyoMax is used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

HyoMax is an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use HyoMax if:

you are allergic to any ingredient in HyoMax

you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)

you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

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

Before using HyoMax:

Some medical conditions may interact with HyoMax. 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 nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma

if you have diarrhea or fever, have been very ill, or are in poor health

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

Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of HyoMax's side effects

Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by HyoMax

Ketoconazole or metoclopramide because their effectiveness may be decreased by HyoMax

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

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

HyoMax is usually taken 30 to 60 minutes before a meal. Follow your doctor's instructions for taking HyoMax.

If you also take antacids, take HyoMax before meals and the antacid after meals, unless directed otherwise by your doctor.

If you miss a dose of HyoMax, 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 HyoMax.

Important safety information:

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

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using HyoMax; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

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

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

Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.

Proper dental care is important while you are taking HyoMax. Brush and floss your teeth and visit the dentist regularly.

HyoMax may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

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

Use HyoMax with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.

Caution is advised when using HyoMax in CHILDREN; they may be more sensitive to its effects, including excitability.

HyoMax should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if HyoMax can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using HyoMax while you are pregnant. HyoMax is found in breast milk. If you are or will be breast-feeding while taking HyoMax, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of HyoMax:

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:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

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); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

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

See also: HyoMax 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 disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of HyoMax:

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

General information:

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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More HyoMax resources

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

HyoMax Concise Consumer Information (Cerner Multum)

HyoMax Prescribing Information (FDA)

Hyoscyamine Monograph (AHFS DI)

Hyosyne Prescribing Information (FDA)

Levsin Prescribing Information (FDA)

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Wednesday 25 April 2012

acetaminophen and phenyltoloxamine

Generic Name: acetaminophen and phenyltoloxamine (a seet a MIN oh fen and FEN il toe LOX a meen)

Brand names: Aceta-Gesic, Acuflex, Alpain, Apagesic, BeFlex, BP Poly-650, Dologesic, Flextra-650, Flextra-DS, Hyflex-650, Hyflex-DS, Lagesic, Major-gesic, Percogesic, Phenagesic, Phenylgesic, Q Flex, Relagesic, RhinoFlex, RhinoFlex 650, Staflex, Vistra, Vitoxapap, Zgesic, ...show all 32 brand names.

What is acetaminophen and phenyltoloxamine?

Acetaminophen is a pain reliever and a fever reducer.

Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Acetaminophen and phenyltoloxamine is used to treat runny nose, sneezing, and pain or fever caused by the common cold, flu, or seasonal allergies.

Acetaminophen and phenyltoloxamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen and phenyltoloxamine?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver or kidney disease, diabetes, glaucoma, urination problems, an enlarged prostate, heart disease, high blood pressure, a stomach ulcer, or an overactive thyroid.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking acetaminophen and phenyltoloxamine?

You should not take this medication if you are allergic to acetaminophen or phenyltoloxamine. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use acetaminophen and phenyltoloxamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

liver disease or a history of alcoholism;

kidney disease;

diabetes;

glaucoma;

urination problems;

an enlarged prostate;

heart disease or high blood pressure;

a stomach ulcer; or

an overactive thyroid.

It is not known whether acetaminophen and phenyltoloxamine is harmful to an unborn baby. Do not take this medication without telling your doctor if you are pregnant. Acetaminophen and phenyltoloxamine can pass into breast milk and may harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen and phenyltoloxamine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

One tablet of this medicine may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Call your doctor if your symptoms do not improve, or if you have a fever for longer than 3 days.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

See also: Acetaminophen and phenyltoloxamine dosage (in more detail)

What happens if I miss a dose?

Since cold or allergy medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include feeling very restless, extreme drowsiness, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking acetaminophen and phenyltoloxamine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid becoming overheated or dehydrated during exercise and in hot weather. Phenyltoloxamine can decrease sweating and you may be more prone to heat stroke.

Acetaminophen and phenyltoloxamine side effects

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

fast, pounding, or uneven heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, nervousness;

urinating less than usual or not at all;

nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay colored stools, jaundice (yellowing of the skin or eyes); or

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious side effects may include:

dizziness, drowsiness;

blurred vision;

dry mouth, nose, or throat;

mild stomach pain, constipation; or

problems with memory or concentration.

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.

Acetaminophen and phenyltoloxamine Dosing Information

Usual Adult Dose for Cold Symptoms:

Acetaminophen-phenyltoloxamine 325 mg-30 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
1 to 2 tablets orally every 8 to 12 hours not to exceed 6 tablets daily.

Acetaminophen-phenyltoloxamine 635 mg-55 mg oral tablet and Acetaminophen-phenyltoloxamine 650 mg-60 mg oral tablet:
1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

Usual Adult Dose for Influenza:

Usual Adult Dose for Pain:

Usual Adult Dose for Headache:

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen-phenyltoloxamine 325 mg-30 mg oral tablet:
12 years or older: 1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
6 to 11 years: 1/2 tablet orally every 4 hours not to exceed 2.5 tablets daily.
12 years or older: 1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
6 to 11 years: 1/2 to 1 tablet orally every 4 hours not to exceed 4 tablets daily.
12 years or older: 1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
6 to 11 years: 1/2 to 1 tablet orally every 12 hours not to exceed 2 tablets daily.
12 years or older: 1 to 2 tablets orally every 8 to 12 hours not to exceed 6 tablets daily.

Acetaminophen-phenyltoloxamine 635 mg-55 mg oral tablet and Acetaminophen-phenyltoloxamine 650 mg-60 mg oral tablet:
6 to 11 years: 1/2 tablet orally every 6 hours not to exceed 2 tablets daily. Not to exceed 5 days use.
12 years or older: 1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

Usual Pediatric Dose for Influenza:

Usual Pediatric Dose for Pain:

Usual Pediatric Dose for Headache:

What other drugs will affect acetaminophen and phenyltoloxamine?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by phenyltoloxamine.

There may be other drugs that can interact with acetaminophen and phenyltoloxamine. 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 acetaminophen and phenyltoloxamine resources

Acetaminophen and phenyltoloxamine Side Effects (in more detail)
Acetaminophen and phenyltoloxamine Dosage
Acetaminophen and phenyltoloxamine Use in Pregnancy & Breastfeeding
Acetaminophen and phenyltoloxamine Drug Interactions
Acetaminophen and phenyltoloxamine Support Group
13 Reviews for Acetaminophen and phenyltoloxamine - Add your own review/rating

Compare acetaminophen and phenyltoloxamine with other medications

Cold Symptoms
Headache
Influenza
Pain

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and phenyltoloxamine.

See also: acetaminophen and phenyltoloxamine side effects (in more detail)

Saturday 21 April 2012

APO-go Pen 10mg / ml Solution for Injection

1. Name Of The Medicinal Product

APO-go PEN 10 mg/ml Solution for Injection*

* Abbreviated to APO-go^® Pen in the text

2. Qualitative And Quantitative Composition

1ml contains 10mg apomorphine hydrochloride

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Solution for injection.

Solution is clear and colourless.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of disabling motor fluctuations ('on-off' phenomena) in patients with Parkinson's disease which persist despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine agonists.

4.2 Posology And Method Of Administration

APO-go Pen 10 mg/ml Solution for Injection is for subcutaneous use by intermittent bolus injection.

Dosage

Adults

Administration

Selection of patients suitable for APO-go injections:

Patients selected for treatment with APO-go should be able to recognise the onset of their 'off' symptoms and be capable of injecting themselves or else have a responsible carer able to inject for them when required.

It is essential that the patient is established on domperidone, usually 20mg three times daily for at least two days prior to initiation of therapy.

Apomorphine should be initiated in the controlled environment of a specialist clinic. The treatment should be supervised by a physician experienced in the treatment of Parkinson's disease (e.g. Neurologist). The patient's treatment with levodopa, with or without dopamine agonists, should be optimised before starting APO-go treatment.

Determination of the threshold dose.

The appropriate dose for each patient is established by incremental dosing schedules. The following schedule is suggested:-

1mg of apomorphine HCl (0.1ml), that is approximately 15-20 micrograms/kg, may be injected subcutaneously during a hypokinetic, or 'off' period and the patient is observed over 30 minutes for a motor response.

If no response, or an inadequate response, is obtained a second dose of 2 mg of apomorphine HCl (0.2ml) is injected subcutaneously and the patient observed for an adequate response for a further 30 minutes.

The dosage may be increased by incremental injections with at least a forty minute interval between succeeding injections, until a satisfactory motor response is obtained.

Establishment of treatment.

Once the appropriate dose is determined, a single subcutaneous injection may be given into the lower abdomen or outer thigh at the first signs of an 'off' episode. It cannot be excluded that absorption may differ with different injection sites within a single individual. Accordingly, the patient should then be observed for the next hour to assess the quality of their response to treatment. Alterations in dosage may be made according to the patient's response.

The optimal dosage of apomorphine hydrochloride varies between individuals but, once established, remains relatively constant for each patient.

Precautions on continuing treatment.

The daily dose of APO-go varies widely between patients, typically within the range of 3-30mg, given as 1-10 injections and sometimes as many as 12 separate injections per day.

It is recommended that the total daily dose of apomorphine HCl should not exceed 100mg and that individual bolus injections should not exceed 10mg.

In clinical studies it has usually been possible to make some reduction in the dose of levodopa; this effect varies considerably between patients and needs to be carefully managed by an experienced physician.

Once treatment has been established domperidone therapy may be gradually reduced in some patients but successfully eliminated only in a few, without any vomiting or hypotension.

Children and adolescents:

APO-go Pen 10mg/ml Solution for Injection is contra-indicated for children and adolescents under 18 years of age (see section 4.3).

Elderly:

The elderly are well represented in the population of patients with Parkinson's disease and constitute a high proportion of those studied in clinical trials of APO-go. The management of elderly patients treated with APO-go has not differed from that of younger patients.

Renal impairment:

A dose schedule similar to that recommended for adults, and the elderly, can be followed for patients with renal impairment (see section 4.4).

4.3 Contraindications

In patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency.

Intermittent apomorphine HCl treatment is not suitable for patients who have an 'on' response to levodopa, which is marred by severe dyskinesia or dystonia.

APO-go should not be administered to patients who have a known hypersensitivity to apomorphine or any excipients of the medicinal product.

APO-go is contra-indicated for children and adolescents under 18 years of age.

4.4 Special Warnings And Precautions For Use

Apomorphine HCl should be given with caution to patients with renal, pulmonary or cardiovascular disease and persons prone to nausea and vomiting.

Extra caution is recommended during initiation of therapy in elderly and/or debilitated patients.

Since apomorphine may produce hypotension, even when given with domperidone pretreatment, care should be exercised in patients with pre-existing cardiac disease or in patients taking vasoactive medicinal products such as antihypertensives, especially in patients with pre-existing postural hypotension.

Since apomorphine, especially at high dose, may have the potential for QT prolongation, caution should be exercised when treating patients at risk for torsades de pointes arrhythmia.

Apomorphine is associated with local subcutaneous effects. These can sometimes be reduced by the rotation of injection sites or possibly by the use of ultrasound (if available) to areas of nodularity and induration.

APO-go Pen 10mg/ml Solution for Injection contains sodium bisulphite which may rarely cause severe allergic reactions and bronchospasm.

Haemolytic anaemia and thrombocytopenia have been reported in patients treated with apomorphine. Haematology tests should be undertaken at regular intervals, as with levodopa, when given concomitantly with apomorphine.

Caution is advised when combining apomorphine with other medicinal products, especially those with a narrow therapeutic range (see section 4.5).

Neuropsychiatric problems co-exist in many patients with advanced Parkinson's disease. There is evidence that for some patients neuropsychiatric disturbances may be exacerbated by apomorphine.

Special care should be exercised when apomorphine is used in these patients.

Apomorphine has been associated with somnolence, and other dopamine agonists can be associated with sudden sleep onset episodes, particularly in patients with Parkinson's disease. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with apomorphine. Patients who have experienced somnolence must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.

Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists for Parkinson's disease, including apomorphine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Patients selected for treatment with apomorphine HCl are almost certain to be taking concomitant medications for their Parkinson's disease. In the initial stages of apomorphine HCl therapy the patient should be monitored for unusual side-effects or signs of potentiation of effect.

Neuroleptic medicinal products may have an antagonistic effect if used with apomorphine. There is a potential interaction between clozapine and apomorphine, however clozapine may also be used to reduce the symptoms of neuropsychiatric complications.

The possible effects of apomorphine on the plasma concentrations of other drugs have not been studied. Therefore caution is advised when combining apomorphine with other medicinal products, especially those with a narrow therapeutic range.

Antihypertensive and Cardiac Active Medicinal Drugs

Even when co-administered with domperidone, apomorphine may potentiate the antihypertensive effects of these drugs. (See section 4.4).

It is recommended to avoid the administration of apomorphine with other drugs known to prolong the QT interval.

4.6 Pregnancy And Lactation

There is no experience of apomorphine usage in pregnant women.

Animal reproduction studies do not indicate any teratogenic effects, but doses given to rats which are toxic to the mother can lead to failure to breathe in the newborn. The potential risk for humans is unknown. See Section 5.3.

APO-go should not be used during pregnancy unless clearly necessary.

It is not know whether apomorphine is excreted in breast milk. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with APO-go should be made taking into account the benefit of breast-feeding to the child and the benefit of APO-go to the woman.

4.7 Effects On Ability To Drive And Use Machines

Patients being treated with apomorphine and presenting with somnolence must be informed to refrain from driving or engaging in activities (e.g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death unless patients have overcome such experiences of somnolence (see also Section 4.4).

4.8 Undesirable Effects

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Uncommon:

Haemolytic anaemia and thrombocytopenia have been reported in patients treated with apomorphine.

Rare:

Eosinophilia has rarely occurred during treatment with apomorphine HCl.

Immune system disorders

Rare:

Due to the presence of sodium metabisulphite, allergic reactions (including anaphylaxis and bronchospasm) may occur.

Psychiatric disorders

Common:

Neuropsychiatric disturbances are common in parkinsonian patients. APO-go should be used with special caution in these patients. Neuropsychiatric disturbances (including transient mild confusion and visual hallucinations) have occurred during apomorphine HCl therapy.

Not known:

Patients treated with dopamine agonists for treatment of Parkinson's disease, including apomorphine, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality; generally reversible upon reduction of the dose or treatment discontinuation.

Nervous system disorders

Common:

Transient sedation with each dose of apomorphine HCl at the start of therapy may occur; this usually resolves over the first few weeks.

Apomorphine is associated with somnolence.

Dizziness / light-headedness have also been reported.

Uncommon:

Apomorphine may induce dyskinesias during 'on' periods, which can be severe in some cases, and in a few patients may result in cessation of therapy.

Vascular disorders

Uncommon:

Postural hypotension is seen infrequently and is usually transient (See Section 4.4).

Respiratory, thoracic and mediastinal disorders

Common:

Yawning has been reported during apomorphine therapy.

Uncommon:

Breathing difficulties have been reported.

Gastrointestinal disorders

Common:

Nausea and vomiting, particularly when apomorphine treatment is first initiated, usually as a result of the omission of domperidone (See Section 4.2).

Skin and subcutaneous tissue disorders

Uncommon:

Local and generalised rashes have been reported.

General disorders and administration site conditions

Very common:

Most patients experience injection site reactions, particularly with continuous use. These may include subcutaneous nodules, induration, erythema, tenderness and panniculitis. Various other local reactions (such as irritation, itching, bruising and pain) may also occur.

Uncommon:

Injection site necrosis and ulceration have been reported.

Not known:

Peripheral oedema has been reported.

Investigations

Uncommon:

Positive Coombs' tests have been reported for patients receiving apomorphine.

4.9 Overdose

There is little clinical experience of overdose with apomorphine by this route of administration. Symptoms of overdose may be treated empirically as suggested below:-

Excessive emesis may be treated with domperidone.

Respiratory depression may be treated with naloxone.

Hypotension: appropriate measures should be taken, e.g. raising the foot of the bed.

Bradycardia may be treated with atropine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmatherapeutic group: Dopamine agonists

ATC Classification: N04B C07

Apomorphine is a direct stimulant of dopamine receptors and, while possessing both D1 and D2 receptor agonist properties, does not share transport or metabolic pathways with levodopa.

Although in intact experimental animals, administration of apomorphine suppresses the rate of firing of nigro-striatal cells and in low dose has been found to produce a reduction in locomotor activity (thought to represent pre-synaptic inhibition of endogenous dopamine release) its actions on parkinsonian motor disability are likely to be mediated at post-synaptic receptor sites. This biphasic effect is also seen in humans.

5.2 Pharmacokinetic Properties

After subcutaneous injection of apomorphine its fate can be described by a two-compartment model, with a distribution half-life of 5 (± 1.1) minutes and an elimination half-life of 33 (± 3.9) minutes. Clinical response correlates well with levels of apomorphine in the cerebrospinal fluid; the drug distribution being best described by a two- compartment model. Apomorphine is rapidly and completely absorbed from subcutaneous tissue, correlating with the rapid onset of clinical effects (4-12 minutes), and that the brief duration of clinical action of the drug (about 1 hour) is explained by its rapid clearance. The metabolism of apomorphine is by glucuronidation and sulphonation to at least ten per cent of the total; other pathways have not been described.

5.3 Preclinical Safety Data

Repeat dose subcutaneous toxicity studies reveal no special hazard for humans, beyond the information included in other sections of the SmPC.

In vitro genotoxicity studies demonstrated mutagenic and clastogenic effects, most likely due to products formed by oxidation of apomorphine. However, apomorphine was not genotoxic in the in vivo studies performed.

The effect of apomorphine on reproduction has been investigated in rats. Apomorphine was not teratogenic in this species, but it was noted that doses which are toxic to the mother can cause loss of maternal care and failure to breathe in the newborn.

No carcinogenicity studies have been performed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium bisulphite (E222)

Hydrochloric Acid (37%), concentrated

(to adjust pH to 3.0 –4.0)

Water for injection

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

2 years

48 hours after first opening

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original container.

6.5 Nature And Contents Of Container

Cartridge.

APO-go Pen 10 mg/ml is a disposable multiple dose pen injector system incorporating a clear glass (type I) cartridge containing a clear solution for injection. The glass cartridge is sealed at one end with a bromobutyl rubber piston, and at the other end with a bromobutyl rubber/aluminium membrane.

APO-go Pen is available in packs containing 1, 5, or 10 x 3ml pens in a moulded plastic tray in an outer cardboard carton. Each pen contains 3ml of solution for injection. Bundle Packs containing 25 Pens are available in some territories. These bundle packs consist of 5 boxes each containing 5 pens.

Not all pack sizes are marketed.

6.6 Special Precautions For Disposal And Other Handling

APO-go PEN

Do not use if solution has turned green.

Discard each pen no later than 48 hours from first use.

(see attached diagram)

HOW TO USE YOUR APO-go PEN

Read these instructions carefully

DO NOT PULL THE RED DIAL BEFORE YOU HAVE SET THE DOSAGE (See f)

(see attached diagram)

ATTACHING THE NEEDLE

(a) Before using your pen system you will need a surgical wipe and one needle in its protective cone (see 5). Take the pen out of its box and remove the outer sleeve (see 3).

(b) Wipe the membrane (see 4) with the surgical wipe.

(c) Peel off the paper from the needle cone (see 2), and screw the cone clockwise onto the membrane. This will attach needle securely.

PLEASE NOTE

It is important to bring the needle to the Pen in a straight line, as shown. If the needle is presented at an angle it may cause the Pen to leak. This will attach the needle securely.

(d) Remove the protective cone, but do not throw it away. Do not remove the needle protector at this stage (see 6).

(e) Replace the pen's outer sleeve.

HOW TO SELECT YOUR CORRECT DOSAGE

(see attached diagram)

(f) Press the red dosage dial (see 1) and turn the dial clockwise until the arrow points to your prescribed dosage (see 7,8). Then release downward pressure on the red dial. The dose is now set, and you do not need to redial for subsequent injections.

Important; If you pass your prescribed dose while turning the dial, just continue pressing and turning in the same direction until you arrive at it again. Never pull and turn the red dosage dial at the same time.

If your prescribed dose is 2mg or less, it is necessary to “prime” the pen before injecting the first dose. Do this by emptying the first 2mg dose onto a paper tissue and discard. Then, set the dose you require for injection and inject in the usual way (see below under “INJECTING”). If the first dose required is more than 2mg, then it is not necessary to “prime” the pen.

INJECTING

(see attached diagram)

(g) Pull out the red dosage dial as far as it will go. Check the white scale on the plunger and inject only if the highest number visible corresponds to the intended dose.

(h) Using a surgical wipe, clean the area of skin around the proposed site of injection.

Remove the pen's outer sleeve.

(i) Remove the needle protector (see 6).

(j) Insert the needle into the skin as directed by your doctor.

To inject, press the red dosage dial down as far as it will go, using your thumb if possible. Once the red dosage dial is fully depressed, count to three before withdrawing the needle.

(k) Remove and discard the needle, using the protective cone (see 5). This is done by replacing the protective cone onto the used needle, and pushing it gently into place. Once secure, you can unscrew the needle anti-clockwise. Discard the needle in a safe place.

Important: Each needle can only be used once.

PREPARING FOR THE NEXT INJECTION:

Check that there is enough apomorphine left in the cartridge for the next injection (see 9). If there is, put a new needle in place, following the same procedure as before. (Remember not to throw away the protective cone).

If there is not enough apomorphine left for another injection, prepare another pen.

Finally, replace the outer sleeve of the pen.

7. Marketing Authorisation Holder

Genus Pharmaceuticals Limited

Park View House

65 London Road

Newbury

Berkshire

RG14 1JN

United Kingdom (IE and UK only)

ITF Hellas S.A.

Areos 103 & Agias Triados 36

17562 Palaio Faliro

Athens

Greece (EL only)

Britannia Pharmaceuticals Limited

41 - 51 Brighton Road

Redhill

Surrey

RH1 6YS

United Kingdom (All other CMS)

8. Marketing Authorisation Number(S)

PL 06831/0246

PA 1496/2/2

9. Date Of First Authorisation/Renewal Of The Authorisation

31 March 1999/ 27 July 2009

10. Date Of Revision Of The Text

February 2010