Go PLR Articles Directory Brunei: August 2012

Thursday 30 August 2012

Disipal Tablets

1. Name Of The Medicinal Product

DISIPAL TABLETS

2. Qualitative And Quantitative Composition

Orphenadrine hydrochloride BP 50 mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Anti-cholinergic, for the treatment of all forms of Parkinsonism, including drug-induced extrapyramidal symptoms (neuroleptic syndrome).

4.2 Posology And Method Of Administration

For Adults, and the Elderly:

Initially 150 mg daily in divided doses, increasing by 50 mg every two or three days until maximum benefit is obtained. Optimal dosage is usually 250 - 300 mg daily in divided doses in idiopathic and post-encephalitic Parkinsonism, 100 - 300 mg daily in divided doses in the neuroleptic syndrome. Maximal dosage, 400 mg daily in divided doses. The elderly may be more susceptible to side-effects at doses which are clinically optimal.

For children:

A dosage for children has not been established.

4.3 Contraindications

Contraindicated in patients with tardive dyskinesia, glaucoma, or prostatic hypertrophy, untreated urinary retention, gastro-intestinal obstruction, porphyria.

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with micturition difficulties, in pregnancy and breast feeding, and in the presence of cardiovascular disease and hepatic or renal impairment. Use in caution in the elderly (see 4.2). Avoid abrupt discontinuation of treatment. For some patients, orphenadrine may be a drug of abuse.

Patients with rare hereditary problems of fructose and galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The colours sunset yellow (E110), tartrazine (E102) and amaranth (E123) may cause allergic reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of other antimuscarinic drugs can lead to an increase in side effects such as dry mouth and urine retention.

4.6 Pregnancy And Lactation

No recommendations; if considered necessary, it should be used with caution, see 4.4.

4.7 Effects On Ability To Drive And Use Machines

Patients must be advised to exercise caution while driving or operating machinery or whilst carrying out other skilled tasks.

4.8 Undesirable Effects

System Organ Class	Common >1/100 <1/10	Uncommon >1/1000 <1/100	Rare >1/10,000 <1/1000
Immune system disorder		Hypersensitivity
Nervous system disorder	Dizziness	Sedation, confusion, nervousness, hallucinations, convulsions, insomnia, euphoria	Memory disturbances
Eye disorders	Accommodation disorders
Cardiac disorders		Tachycardia
Gastrointestinal disorders	Dry mouth, gastrointestinal disturbances
Renal and urinary disorders		Urinary retention

4.9 Overdose

Toxic effects are anti-cholinergic in nature and the treatment is gastric lavage, cholinergics such as carbachol, anticholinesterases such as physostigmine, and general non-specific treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Orphenadrine, which is a congener of diphenhydramine without sharing its soporific effect, is an antimuscarinic agent. It also has weak antihistaminic and local anaesthetic properties.

Orphenadrine is used as the hydrochloride in the symptomatic treatment of Parkinsonism. It is also used to alleviate the extrapyramidal syndrome induced by drugs such as the phenothiazine derivatives, but is of no value in tardive dyskinesia, which may be exacerbated.

5.2 Pharmacokinetic Properties

Orphenadrine is readily absorbed from the gastro-intestinal tract, and very readily absorbed following intramuscular injection. It is rapidly distributed in tissues and most of a dose is metabolised and excreted in the urine along with a small proportion of unchanged drug. A half life of 14 hours has been reported.

5.3 Preclinical Safety Data

No relevant pre-clinical safety data has been generated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Sucrose

Acacia

Maize starch

Tribasic calcium phosphate

Stearic acid

Magnesium stearate

Opaseal P-17-0200 (containing IMS, polyvinylacetate phthalate and stearic acid)

Calcium carbonate

Talc

Kaolin

Titanium dioxide

Gelatin

Opalux yellow AS 3026 (containing sucrose, titanium dioxide, tartrazine E102, sunset yellow E110, povidone, amaranth E123 and sodium benzoate E211)

Opaglos 6000 (containing ethanol, shellac, beeswax and yellow carnuba wax)

Black printing ink Opacode black S-1-27794 (containing shellac, IMS, black iron oxide E172, N-butyl alcohol, propylene glycol E1520, isopropyl alcohol)

6.2 Incompatibilities

None

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Store at room temperature (15°C - 25°C)

6.5 Nature And Contents Of Container

Amber glass click-lock bottles and/or securitainers and/or plastic lid-seal containers, containing 100, 250, 1,000, or 10,000 tablets.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Astellas Pharma Ltd

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL 0166/5001R

9. Date Of First Authorisation/Renewal Of The Authorisation

6 May 1987; renewed March 2003.

10. Date Of Revision Of The Text

12^th June 2009

11. Legal Category

POM

Sunday 26 August 2012

Co-dydramol Tablets 10 / 500mg leaflet (Actavis UK Ltd)

Co-dydramol tablets 10/500mg

(paracetamol and dihydrocodeine tartrate)

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

1 What Co-dydramol tablets are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Co-dydramol tablets are and what they are used for

Co-dydramol tablets belong to a group of medicines called analgesics and are used for the relief of mild to moderate
pain.

Before you take

Do not take Co-dydramol tablets and tell your doctor if you:

are allergic (hypersensitive) to paracetamol, dihydrocodeine or other opioids, or any of the ingredients
in the tablet (see section 6)

have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)

have difficulty breathing, or other chronic lung disease

are having an asthma attack.

Check with your doctor or pharmacist before taking Co-dydramol tablets if you have:

liver or kidney problems

diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a kidney
(phaeochromocytoma)

inflammatory bowel disease

gall bladder disease or gall stones

recently had surgery on your gastro-intestinal tract or urinary system

an enlarged prostate gland and have difficulty urinating and are male

epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)

an underactive thyroid gland

muscle weakness (myasthenia gravis)

low blood pressure or are in shock

suffered from alcoholism, drug abuse or dependence or mental illness.

Other important warnings:

do not take for longer than directed by your prescriber

taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel
restless and irritable when you stop the tablets

taking a painkiller for headaches too often or for too long can make them worse.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

ciprofloxacin (antibacterial medicine)

Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide or have taken these within the last 2 weeks)

oral contraceptives (the “pill”)

medicines to prevent blood clotting such as warfarin

cyclizine, metoclopramide or domperidone (to prevent sickness)

guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high blood pressure)

mexiletine (to treat irregular heartbeats)

loperamide or kaolin (to treat diarrhoea)

selegiline (for Parkinson’s disease)

phenytoin (to treat epilepsy)

cimetidine (to treat stomach ulcers)

atropine or hyoscine (anticholinergic medicines)

ritonavir (antiviral medicine)

medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to
treat mental illness

medicines to treat depression (e.g. tranylcypromine, amitriptyline)

medicines which affect the liver (e.g. primidone and rifampicin)

colestyramine (to treat high cholesterol levels)

muscle relaxants

barbiturates (e.g. phenobarbital)

anaesthetics

opioid antagonists (buprenorphine, naltrexone, naloxone)

Diet

If your diet is poor or you have a low protein intake, you may be at a higher risk of serious paracetamol poisoning when
taking Co-dydramol tablets.

Driving and using machines

Co-dydramol tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you drive or operate machinery.

Pregnancy and breast-feeding

Do not take Co-dydramol tablets during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.

How to take

Always take Co-dydramol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Do not drink alcohol whilst taking Co-dydramol tablets.

Swallow the tablets with water, during or after meals.

Co-dydramol tablets are normally used only for short-term relief of symptoms, take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

Doses:

Adults and children over 12 years: 1-2 tablets every 4 hours up to a maximum of 8 tablets in a day

Children under 12 years: Not recommended

Elderly: Dosage is usually reduced in the elderly

If you take more than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of
delayed, serious liver damage.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact
your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or
being sick, loss of appetite, stomach pain or liver damage, coma, clammy skin, fits, confusion, drowsiness, tiredness, low
blood pressure, pinpoint pupils, slow heart beat or breathing rate.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose.

If you forget to take a dose take it as soon as you remember it and then take the next dose at least 4 hours later.

If you stop taking the tablets

If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or
being sick, sweating and increased heart rate, breathing or blood pressure.

Possible side effects

Like all medicines, Co-dydramol tablets can cause side effects, although not everybody gets them. Please tell your doctor
or pharmacist if you notice any of the following effects or any effects not listed.

Contact your doctor at once if the following side effects occur:

Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever

Abdominal pain - may be caused by spasm of the bile ducts and inflammation of the liver or pancreas

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation,
feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts.

Heart - slow heart rate, palpitations, low blood pressure especially on standing, inflammation of the heart muscle

Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor

Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney problems.

Nervous system - confusion, drowsiness, dizziness, ‘spinning’ sensation, mood changes, depression,
hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits, increased pressure in the
skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness. Tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)

Eyes - blurred or double vision, extremely small pupils

Others - trembling, unusual tiredness or weakness, malaise, low body temperature, breathing difficulties,
muscle stiffness, changes in sex drive

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place, protected from light

Do not use Co-dydramol tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.

Further information

What Co-dydramol tablets contain

The active substances (the ingredients that makes the tablets work) are 10mg of dihydrocodeine tartrate and
500mg paracetamol.

The other ingredients are pregelatinised maize starch, maize starch, colloidal silicon dioxide, stearic acid and
water.

What Co-dydramol tablets look like and contents of the pack

Co-dydramol are white, uncoated tablets.

Pack sizes are 30 and 100.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

This leaflet was last revised in May 2008

Actavis

Barnstaple

EX32 8NS

50129531

Alocril

nedocromil sodium

Dosage Form: ophthalmic solution
Alocril® (nedocromil sodium ophthalmic solution) 2%

sterile

Alocril Description

Alocril® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.

Nedocromil sodium is represented by the following structural formula:

Chemical name:

4H-Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt.

Each mL contains: Active: Nedocromil sodium 20 mg/mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.05%, purified water, and sodium chloride 0.5%. It has a pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg.

Alocril - Clinical Pharmacology

Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.

In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.

Pharmacokinetics and Bioavailability

Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Indications and Usage for Alocril

Alocril® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

Contraindications

Alocril® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

Precautions

Information for Patients

Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.

Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assays.

Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Alocril® ophthalmic solution should be used during pregnancy only if clearly needed.

Nursing Mothers

After intravenous administration to lactating rats, nedocromil was excreted in milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Alocril® ophthalmic solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 3 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

The most frequently reported adverse experience was headache (~40%).

Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10- 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.

Some of these events were similar to the underlying ocular disease being studied.

Alocril Dosage and Administration

The recommended dosage is one or two drops in each eye twice a day. Alocril® ophthalmic solution should be used at regular intervals.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

How is Alocril Supplied

Alocril® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 0023-8842-05

Storage: Store at 2º – 25ºC (36º – 77ºF).

Rx Only

Revised June 2008

© 2008 Allergan, Inc.

Irvine, CA 92612, U.S.A.

® marks owned by Allergan, Inc.

U.S. Patent RE 38,628

www.allergan.com

71761US11X

PHARMACIST - DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Information for the Patient

Alocril®

(nedocromil sodium ophthalmic solution) 2%

sterile

It is important to use Alocril® ophthalmic solution regularly, as directed by your physician.

Thoroughly wash your hands.

Remove safety seal (Figure 1).

Remove cap (Figure 2).

Sit or stand comfortably, with your head tilted back (Figure 3).

Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4).

Hold the Alocril® bottle upside down. Place tip as close as possible to the lower eyelid without touching the tip to the eye, and gently squeeze out the prescribed number of drops (Figure 5).

Do not touch the eye or eyelid with the bottle tip.

Blink a few times to make sure the eye is covered with the solution.

Close your eye and remove any excess solution with a clean tissue.

Repeat process in the other eye.

SPECIAL TIPS

Avoid placing Alocril® ophthalmic solution directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page.

To avoid contamination of the solution, do not touch dropper tip to the eye, fingers, or any other surface. Replace bottle cap after use. It is recommended that any remaining contents be discarded after treatment period prescribed by your physician.

Store at 2º – 25ºC (36º – 77ºF). Store in original carton.

Keep bottle tightly closed and out of the reach of children.

Do not use with any other ocular medication unless directed by your physician. Do not wear contact lenses during treatment with Alocril® ophthalmic solution.

71761US11X

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Principal Display Panel

Label PDP:

ALLERGAN

NDC 0023-8842-05 Rx Only

Alocril®

(nedocromil sodium ophthalmic solution) 2%

STERILE 5 mL

Carton PDP:

NDC 0023-8842-05

Alocril®

(nedocromil sodium

ophthalmic solution) 2%

STERILE

For topical application in the eye

5 mL Rx Only

ALLERGAN

Alocril
nedocromil sodium solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0023-8842
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
nedocromil sodium (nedocromil)	nedocromil sodium	20 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
edetate disodium
water
sodium chloride
benzalkonium chloride

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0023-8842-05	1 BOTTLE In 1 CARTON	contains a BOTTLE, DROPPER
1		5 mL In 1 BOTTLE, DROPPER	This package is contained within the CARTON (0023-8842-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021009	02/03/2000

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		144796497	MANUFACTURE

Revised: 01/2010Allergan, Inc.

More Alocril resources

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

Alocril Concise Consumer Information (Cerner Multum)

Alocril eent Monograph (AHFS DI)

Alocril Advanced Consumer (Micromedex) - Includes Dosage Information

Alocril Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alocril with other medications

Conjunctivitis, Allergic

Thursday 23 August 2012

Ascocid

Generic Name: ascorbic acid (Oral route)

as-KORE-bik AS-id

Commonly used brand name(s)

In the U.S.

Ascocid

C-500

Cecon

Cemill 1000

Cemill 500

Cevi-Bid

C-Time w/Rose Hips

Mega-C

One-Gram C

Protexin

Sunkist Vitamin C

In Canada

Ce-Vi-Sol

Revitalose-C-1000

Revitonus C-1000 Yellow Ampule

Vitamin C Powder

Available Dosage Forms:

Tablet

Powder

Powder for Solution

Capsule, Liquid Filled

Tablet, Chewable

Granule

Capsule

Syrup

Powder for Suspension

Liquid

Solution

Tablet, Extended Release

Lozenge/Troche

Capsule, Extended Release

Wafer

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin C

Uses For Ascocid

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.

Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.

Some conditions may increase your need for vitamin C. These include:

AIDS (acquired immune deficiency syndrome)

Alcoholism

Burns

Cancer

Diarrhea (prolonged)

Fever (prolonged)

Infection (prolonged)

Intestinal diseases

Overactive thyroid (hyperthyroidism)

Stomach ulcer

Stress (continuing)

Surgical removal of stomach

Tuberculosis

Also, the following groups of people may have a deficiency of vitamin C:

Infants receiving unfortified formulas

Smokers

Patients using an artificial kidney (on hemodialysis)

Patients who undergo surgery

Individuals who are exposed to long periods of cold temperatures

Increased need for vitamin C should be determined by your health care professional.

Vitamin C may be used for other conditions as determined by your health care professional.

Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.

Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.

Once a medicine or dietary supplement 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, vitamin C is used in certain patients with the following medical conditions:

Overdose of iron (to help another drug in decreasing iron levels in the body)

Methemoglobinemia (a blood disease)

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of vitamin C needed is defined in several different ways.

For U.S.—

Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—

Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for vitamin C are generally defined as follows:

Persons	U.S. (mg)	Canada (mg)
Infants and children Birth to 3 years of age	30–40	20
4 to 6 years of age	45	25
7 to 10 years of age	45	25
Adolescent and adult males	50–60	25–40
Adolescent and adult females	50–60	25–30
Pregnant females	70	30–40
Breast-feeding females	90–95	55
Smokers	100	45–60

Before Using Ascocid

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

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

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

Amygdalin

Deferoxamine

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

Indinavir

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.

Proper Use of ascorbic acid

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

Dosing

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

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

For oral dosage form (capsules, tablets, oral solution, syrup):
- To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  - For the U.S.
  - Adult and teenage males—50 to 60 milligrams (mg) per day.
  - Adult and teenage females—50 to 60 mg per day.
  - Pregnant females—70 mg per day.
  - Breast-feeding females—90 to 95 mg per day.
  - Smokers—100 mg per day.
  - Children 4 to 10 years of age—45 mg per day.
  - Children birth to 3 years of age—30 to 40 mg per day.
  - For Canada
  - Adult and teenage males—25 to 40 mg per day.
  - Adult and teenage females—25 to 30 mg per day.
  - Pregnant females—30 to 40 mg per day.
  - Breast-feeding females—55 mg per day.
  - Smokers—45 to 60 mg per day.
  - Children 4 to 10 years of age—25 mg per day.
  - Children birth to 3 years of age—20 mg per day.
- To treat deficiency:
  - Adults and teenagers—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 500 mg a day for at least 2 weeks.
  - Children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 100 to 300 mg a day for at least 2 weeks.

For those individuals taking the oral liquid form of vitamin C:

This preparation is to be taken by mouth even though it comes in a dropper bottle.

This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

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.

If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Ascocid

Vitamin C is not stored in the body. If you take more than you need, the extra vitamin C will pass into your urine. Very large doses may also interfere with tests for sugar in diabetics and with tests for blood in the stool.

Ascocid 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 as soon as possible if any of the following side effects occur:

Less common or rare - with high doses

Side or lower back pain

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

Less common or rare - with high doses

Diarrhea

dizziness or faintness (with the injection only)

flushing or redness of skin

headache

increase in urination (mild)

nausea or vomiting

stomach cramps

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

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

See also: Ascocid side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Ascocid resources

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

Compare Ascocid with other medications

Dietary Supplementation
Scurvy
Urinary Acidification

Tuesday 21 August 2012

Scot-Tussin DM

Generic Name: dextromethorphan and guaifenesin (DEX troe me THOR fan and gwye FEN e sin)

Brand Names: Allfen DM, Altarussin DM, Aquatab DM, Benylin Expectorant, Drituss DM, Extuss LA, Fenesin DM IR, Glycotuss-DM, Guaifen DM, Mucinex Children's Cough, Mucinex DM, MucusRelief DM, Naldecon DX Liquigel, Relacon LAX, Respa-DM, Robitussin Cough & Congestion, Tussi-Bid, Tussi-Organidin DM NR, Vicks 44E

What is Scot-Tussin DM (dextromethorphan and guaifenesin)?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dextromethorphan and guaifenesin is used to treat cough and chest congestion caused by the common cold, infections, or allergies.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Scot-Tussin DM (dextromethorphan and guaifenesin)?

Do not give this medication to a child younger than 2 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 use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Scot-Tussin DM (dextromethorphan and guaifenesin)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

FDA pregnancy category C. It is not known whether dextromethorphan and guaifenesin is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Scot-Tussin DM (dextromethorphan and guaifenesin)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Dextromethorphan and guaifenesin granules should be sprinkled directly onto the tongue and swallowed right away.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous.

What should I avoid while taking Scot-Tussin DM (dextromethorphan and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Dextromethorphan and guaifenesin are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan or guaifenesin.

Scot-Tussin DM (dextromethorphan and guaifenesin) 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 any of these serious side effects:

severe dizziness, anxiety, restless feeling, or nervousness;

confusion, hallucinations; or

slow, shallow breathing.

Less serious side effects may include:

dizziness;

headache;

skin rash or itching; or

nausea, vomiting, or stomach upset.

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 Scot-Tussin DM (dextromethorphan and guaifenesin)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

celecoxib (Celebrex);

cinacalcet (Sensipar);

darifenacin (Enablex);

imatinib (Gleevec);

quinidine (Quinaglute, Quinidex);

ranolazine (Ranexa);

ritonavir (Norvir);

sibutramine (Meridia);

terbinafine (Lamisil);

medicines to treat high blood pressure; or

an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with dextromethorphan and guaifenesin. 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 Scot-Tussin DM resources

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

Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer)

Mucinex DM Prescribing Information (FDA)

Mucinex DM Maximum Strength Prescribing Information (FDA)

Robitussin DM infant drops

Tussin DM Prescribing Information (FDA)

Compare Scot-Tussin DM with other medications

Cough
Expectoration

Where can I get more information?

Your pharmacist can provide more information about dextromethorphan and guaifenesin.

See also: Scot-Tussin DM side effects (in more detail)

Monday 20 August 2012

Vanadom

Generic Name: carisoprodol (Oral route)

kar-eye-soe-PROE-dol

Commonly used brand name(s)

In the U.S.

Soma

Vanadom

Available Dosage Forms:

Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Uses For Vanadom

Carisoprodol is used to relax certain muscles in your body and relieve the discomfort caused by acute (short-term), painful muscle or bone conditions. However, this medicine does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical condition.

Carisoprodol is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax muscles.

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

Before Using Vanadom

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

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of carisoprodol in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of carisoprodol have not been performed in the geriatric population. Safety and efficacy have not been established.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Bromazepam

Brotizolam

Butabarbital

Butalbital

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Diazepam

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Flurazepam

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Morphine

Morphine Sulfate Liposome

Nitrazepam

Nordazepam

Oxazepam

Oxycodone

Oxymorphone

Pentobarbital

Phenobarbital

Prazepam

Primidone

Propoxyphene

Quazepam

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Temazepam

Thiopental

Triazolam

Interactions with Food/Tobacco/Alcohol

Proper Use of carisoprodol

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence). This medicine should only be used for 2 to 3 weeks.

Dosing

For relaxing muscles:
- For oral dosage form (tablets):
  - Adults and teenagers 16 years of age and older—250 to 350 milligrams (mg) three times a day and at bedtime.
  - Children and teenagers younger than 16 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Vanadom

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Avoid driving, using machines, or do anything else that could be dangerous if you are not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Do not stop using this medicine suddenly without first asking your doctor. You may need to slowly decrease your dose before stopping it completely.

If your condition does not improve within two to three weeks, or if it becomes worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Vanadom Side Effects

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

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

Incidence not known

Black, tarry stools

chest pain

chills

cold sweats

confusion

convulsions

cough

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

fast, pounding, or irregular heartbeat or pulse

fever

loss of bladder control

muscle spasm or jerking of all extremities

painful or difficult urination

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden loss of consciousness

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

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

Symptoms of overdose

Bigger, dilated, or enlarged pupils (black part of the eye)

blurred vision

change in consciousness

confusion as to time, place, or person

difficult or troubled breathing

false or unusual sense of well-being

hallucinations

headache

holding false beliefs that cannot be changed by fact

inability to move the eyes

increased blinking or spasms of the eyelid

increased sensitivity of the eyes to light

irregular, fast or slow, or shallow breathing

loss of consciousness

muscle stiffness or tightness

pale or blue lips, fingernails, or skin

sticking out of the tongue

trouble with breathing, speaking, or swallowing

uncontrolled eye movements

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual excitement, nervousness, or restlessness

unusual facial expressions

weakness of the arms and legs

More common

Drowsiness

Incidence not known

Anxiety

deep or fast breathing with dizziness

dry mouth

face is warm or hot to touch

fainting feeling of constant movement of self or surroundings

heartburn

irritability

nausea

nervousness

numbness of the feet, hands, and around the mouth

pain or discomfort in the chest, upper stomach, or throat

redness to face

restlessness

sensation of spinning

shakiness and unsteady walk

sleeplessness

trouble sleeping

unable to sleep

unsteadiness, trembling, or other problems with muscle control or coordination

vomiting

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

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

See also: Vanadom side effects (in more detail)

More Vanadom resources

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

Carisoprodol Professional Patient Advice (Wolters Kluwer)

Carisoprodol Prescribing Information (FDA)

Carisoprodol Monograph (AHFS DI)

Carisoprodol MedFacts Consumer Leaflet (Wolters Kluwer)

Soma Prescribing Information (FDA)

Soma Consumer Overview

Somatuline Depot Monograph (AHFS DI)

Somavert Monograph (AHFS DI)

Compare Vanadom with other medications

Muscle Spasm
Nocturnal Leg Cramps

Friday 17 August 2012

Velivet

Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)

Brand Names: Apri, Cesia, Cyclessa, Desogen, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet

What is Velivet (ethinyl estradiol and desogestrel)?

Ethinyl estradiol and desogestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and desogestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and desogestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Velivet (ethinyl estradiol and desogestrel)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Velivet (ethinyl estradiol and desogestrel)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke or blood clot;

circulation problems (especially if caused by diabetes);

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease or liver cancer;

severe high blood pressure;

severe migraine headaches;

a heart valve disorder; or

a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or if you are overweight;

a history of depression;

gallbladder disease;

diabetes;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Velivet (ethinyl estradiol and desogestrel)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week 3, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Velivet (ethinyl estradiol and desogestrel)?

Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Velivet (ethinyl estradiol and desogestrel) side effects

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet;

a breast lump; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Velivet (ethinyl estradiol and desogestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

an antibiotic;

phenylbutazone (Azolid, Butazolidin);

St. John's wort;

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

This list is not complete and there may be other drugs that can affect birth control pills. 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 Velivet resources

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

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Compare Velivet with other medications

Abnormal Uterine Bleeding
Birth Control
Endometriosis
Gonadotropin Inhibition
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Where can I get more information?

Your pharmacist can provide more information about ethinyl estradiol and desogestrel.

See also: Velivet side effects (in more detail)