Hot Content Directory Tuvalu: March 2012

Tuesday, 27 March 2012

Allopurinol Tablets 100mg, 300mg (Actavis UK Ltd)

Allopurinol 100mg and 300mg tablets

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 Allopurinol 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 Allopurinol tablets are and what they are used for

Allopurinol tablets are used in:

the management of gout and other conditions associated with too much uric acid in the body, such as kidney disease, metabolic disorders, certain skin diseases, cancer and treatment with diuretic (“water tablets”).

certain types of kidney stones.

Before you take

Do not take Allopurinol tablets and tell your doctor if you:

are allergic (hypersensitive) to Allopurinol tablets or any of the other ingredients (see section 6).

are currently suffering from an acute attack of gout.

Check with your doctor or pharmacist before taking Allopurinol tablets if you:

have severe liver or kidney disease , you may be given a lower dose.

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:

azathioprine (to treat rheumatoid arthritis and after organ transplants)

ciclosporin (to treat psoriasis, rheumatoid arthritis or after organ transplants)

6-mercaptopurine (used to treat some cancers and bowel diseases)

adenine arabinoside

probenecid (used in gout)

phenytoin (used in epilepsy)

theophylline (to treat asthma)

ampicillin or amoxicillin (antibiotics)

aspirin or related medicines (salicylates)

drugs to prevent blood from clotting (such as warfarin)

chlorpropamide (used in diabetes)

didanosine (antiviral)

diuretics (water tablets) or ACE inhibitors such as captopril (used in high blood pressure)

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Allopurinol tablets may make you feel dizzy, affect your co-ordination or make you sleepy. Make sure you are not affected before you drive or operate machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

How to take

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

You should swallow the tablets with a little water after meals, if possible.

Drink plenty of fluids while you are on this medicine.

Before starting treatment with allopurinol your doctor may give you an anti-inflammatory drug or colchicine, this helps prevent you getting acute gout attacks.

If you are taking allopurinol for cancer then treatment with allopurinol will begin before treatment with cancer drugs.

Doses:

Adults:

Starting dose of 100-300mg once a day, this may be increased to 200-600mg a day in divided doses. A maximum dose of over 900mg a day is rarely needed.

Children (usually restricted to metabolic disease or cancer):

10-20mg per kg of body weight a day.

Elderly or patients with kidney disease:

Your doctor may prescribe a smaller dose.

If you take more Allopurinol tablets than you should:

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Allopurinol 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 the right time.

Possible side effects

Like all medicines, Allopurinol tablets can cause side effects, although not everybody gets them.

Stop taking Allopurinol tablets and contact your doctor at once if you experience the following allergic reactions:

itchy or flaky skin rash, bruising or discolouration of the skin

fever, swollen lymph glands, joint pain, changes in blood composition, swollen blood vessels, inflammation of the liver (hepatitis), jaundice (yellowing of the skin or whites of the eyes), kidney damage (blood in the urine) or fits.

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

Gastrointestinal: feeling or being sick, vomiting blood, offensive fatty diarrhoea, changes in bowel habits, swollen mouth and changes in taste

Nervous system: headache, general tiredness, dizziness, depression, coma, nerve disorders including lack of muscle control, paralysis, weakness and numbness, “pins and needles”, sleepiness

Heart: chest pain (angina), slow heart beat, oedema (water retention), high blood pressure

Other effects: fever, worsening of acute gout attacks, cataract, diabetes, hair loss, changes in hair colour, boils, changes in blood chemistry and blood cells, disturbances of vision, enlarged breasts in men, difficulty maintaining an erection, “wet dreams”, infertility, blood in the urine, high levels of fat or urea in the blood.

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.

Do not use Allopurinol 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 Allopurinol tablets contain

The active substance (the ingredient that makes the tablets work) is Allopurinol. Each tablet contains either 100mg or 300mg of the active ingredient.

The other ingredients are maize starch, carmellose sodium, cellulose, sodium lauryl sulphate, lactose, magnesium stearate.

What Allopurinol tablets look like and contents of the pack

Allopurinol tablets are circular, biconvex, white, uncoated tablets.

Pack sizes are 28 tablets.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

This leaflet was last revised in March 2008.

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis

Barnstaple

EX32 8NS

50129494

Monday, 26 March 2012

Domperidone 10mg Tablets

1. Name Of The Medicinal Product

Domperidone 10mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Domperidone maleate equivalent to 10mg domperidone base.

For a full list of excipients see section 6.1.

3. Pharmaceutical Form

Tablets

Domperidone 10mg Tablet is presented as a white round biconvex tablet with “Dm 10” inscription on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults: The relief of the symptoms of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents.

Children: The relief of the symptoms of nausea and vomiting.

4.2 Posology And Method Of Administration

Domperidone 10mg Tablets are for oral administration.

It is recommended to take domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed.

Adults and adolescents (over 12 years and weighing 35kg or more):

The initial duration of treatment is four weeks.

Patients should be re-evaluated after four weeks and the need for continued treatment re-assessed.

One to two of the 10mg tablets three to four times per day with a maximum daily dose of 80mg.

Children: 0.25 – 0.5mg/kg three to four times per day with a maximum daily dose of 2.4mg/kg (but do not exceed 80mg per day)

“Tablets are unsuitable for use in children weighing less than 35 kg.”

4.3 Contraindications

Domperidone is contraindicated in the following situations:

• Known hypersensitivity to domperidone or any of the excipients.

• Prolactin-releasing pituitary tumour (prolactinoma.)

Domperidone should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.

4.4 Special Warnings And Precautions For Use

Precautions for use

Domperidone tablets contain lactose and may be unsuitable for patients with lactose intolerance, galactosaemia or glucose/galactose malabsorption.

Use during lactation

The total amount of domperidone excreted in human breast milk is expected to be less than 7 micrograms per day at the highest recommended dosing regimen. It is not known whether this is harmful to the newborn. Therefore breast-feeding is not recommended for mothers who are taking domperidone.

Use in infants

Neurological side effects are rare (see "Undesirable effects" section). Since metabolic functions and the blood-brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children. Therefore, it is recommended that the dose be determined accurately and followed strictly in neonates, infants, toddlers and small children.

Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.

Use in liver disorders

Since domperidone is highly metabolised in the liver, domperidone should be not be used in patients with hepatic impairment

Renal insufficiency

In patients with severe renal insufficiency (serum creatinine> 6 mg/100 mL, i.e.> 0.6 m mol/L) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers. Since very little unchanged drug is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency. However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly.

Use with CYP3A4 inhibitors

Co-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QTc interval should be avoided (see section 4.5 Interaction with other medicinal products and other forms of interaction).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone.

Separate in vivo pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of domperidone's CYP3A4 mediated first pass metabolism by these drugs.

With the combination of oral domperidone 10mg four times daily and ketoconazole 200mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2 to 17.5 msec. With the combination of domperidone 10mg four times daily and oral erythromycin 500mg three times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6 to 14.3 msec. Both the Cmax and AUC of domperidone at steady state were increased approximately three-fold in each of these interaction studies. In these studies domperidone monotherapy at 10mg given orally four times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while Ketoconazole monotherapy (200mg twice daily) led to increases in QTc of 3.8 and 4.9 msec, respectively, over the observation period.

4.6 Pregnancy And Lactation

There are limited post-marketing data on the use of domperidone in pregnant women. A study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for humans is unknown. Therefore, domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.

The drug is excreted in breast milk of lactating rats (mostly as metabolites: peak concentration of 40 and 800ng/ml after oral and i.v administration of 2.5mg/kg respectively). Domperidone concentrations in breast milk of lactating women are 10 to 50% of the corresponding plasma concentrations and expected not to exceed 10ng/ml. The total amount of domperidone excreted in human breast milk is expected to be less than 7micrograms per day at the highest recommended dosing regimen. It is not known whether this is harmful to the newborn. Therefore breast-feeding is not recommended for mothers who are taking domperidone.

4.7 Effects On Ability To Drive And Use Machines

Domperidone has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

The following frequencies are used for the description of the occurrence of adverse reactions:

Very common (

Immune System Disorder:

Very rare; anaphylactic reactions including anaphylactic shock, angioedema, allergic reaction

Endocrine disorder:

Rare; increased prolactin levels

Psychiatric System Disorder:

Very rare; agitation, nervousness

Nervous system disorders:

Very rare; extrapyramidal side effects, convulsions, somnolence, headache

Gastrointestinal disorders:

Rare; gastro-intestinal disorders, including very rare transient intestinal Cramps

Skin and subcutaneous tissue disorders:

Very rare; urticaria, pruritus, rash

Reproductive system and breast disorders:

Rare; galactorrhoea, gynaecomastia, amenorrhoea.

Cardiac disorders:

Very rare; ventricular arrhythmias,

Frequency not known: QTc prolongation

Investigations:

Very rare; liver function test abnormal

As the hypophysis is outside the blood brain barrier, domperidone may cause an increase in prolactin levels. In rare cases this hyperprolactinaemia may lead to neuro-endocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea.

Extrapyramidal side effects are very rare in neonates and infants, and exceptional in adults. These side effects reverse spontaneously and completely as soon as the treatment is stopped.

Other central nervous system-related effects of convulsion, agitation and somnolence also are very rare and primarily reported in infants and children.

4.9 Overdose

Symptoms

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.

Treatment

There is no specific antidote to domperidone, but in the event of overdose, gastric lavage as well as the administration of activated charcoal, may be useful. Close medical supervision and supportive therapy is recommended.

Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Propulsives, ATC code: A03F A03

Domperidone is a dopamine antagonist with anti-emetic properties domperidone does not readily cross the bloodbrain barrier. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Animal studies, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. Studies in man have shown oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion.

5.2 Pharmacokinetic Properties

Absorption

In fasting subjects, domperidone is rapidly absorbed after oral administration with peak plasma concentrations at 30 to 60 minutes. The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Although domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastrointestinal complaints should take domperidone 15-30 minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased when the oral drug is taken after a meal.

Distribution

Oral domperidone does not appear to accumulate or induce its own metabolism; a peak plasma level after 90 minutes of 21ng/ml after two weeks oral administration of 30 mg per day was almost the same as that of 18 ng/ml after the first dose. Domperidone is 91-93% bound to plasma proteins. Distribution studies with radiolabelled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of drug cross the placenta in rats.

Metabolism

Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that CYP3A4 is a major form of cytochrome P-450 involved in the N-dealkylation of domperidone, whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone aromatic hydroxylation.

Excretion

Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively, The proportion of the drug excreted unchanged is small (10% of faecal excretion and approximately 1% of urinary excretion). The plasma half life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.

5.3 Preclinical Safety Data

Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QT interval in humans. In in vitro experiments on isolated cells transfected with HERG and on isolated guinea pig myocytes, ratios were about 10, based on IC50 values inhibiting currents through ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 20 mg (q.i.d.).

However, safety margins and in vitro experiments on isolated cardiac tissues and in vivo models (dog, guinea pig, rabbits sensitised for torsades de pointes) exceeded the free plasma concentrations in humans at maximum daily dose (20mg q.i.d.) by more than 50-fold. In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 10- fold.

At a high, maternally toxic dose (more than 40 times the recommended human dose), teratogenic effects were seen in the rat. No teratogenicity was observed in mice and rabbits.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose

Lactose monohydrate

Maize starch

Povidone K30

Sodium lauryl sulphate

Silica colloidal, anhydrous

Magnesium stearate

6.2 Incompatibilities

Not Applicable

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

The tablets are packed in blisters constituted from a PVC and aluminium foil in packs of 30 and 100.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Milpharm Limited,

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 16363/0106

9. Date Of First Authorisation/Renewal Of The Authorisation

3 February 2003

10. Date Of Revision Of The Text

16/07/2009

Sunday, 25 March 2012

guanfacine

Generic Name: guanfacine (GWAHN fa seen)

Brand Names: Intuniv, Tenex

What is guanfacine?

Guanfacine reduces nerve impulses in your heart and blood vessels. Guanfacine works by relaxing blood vessels, which lowers blood pressure and improves blood flow.

Guanfacine is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Guanfacine is also used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old.

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

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

You should not use this medication if you are allergic to guanfacine.

Before you take guanfacine, tell your doctor if you have heart disease, heart block, coronary artery disease or a history of stroke, low blood pressure, kidney or liver disease, or if you have recently had a heart attack.

Guanfacine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Avoid drinking alcohol.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Your blood pressure and heart rate may also need to be checked. Do not miss any` follow-up visits to your doctor.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Tell your doctor if you regularly use other medicines that make you sleepy. They can add to sleepiness caused by guanfacine.

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

You should not use this medication if you are allergic to guanfacine.

To make sure you can safely take guanfacine, tell your doctor if you have any of these other conditions:

heart disease or heart block;

coronary artery disease or a history of stroke;

low blood pressure;

kidney disease;

liver disease; or

if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether guanfacine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take guanfacine?

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

Your doctor may occasionally change your dose to make sure you get the best results.

If you take Intuniv to treat ADHD, take your dose in the morning.

If you take Tenex to treat hypertension, you may need to take your dose at bedtime if guanfacine causes severe drowsiness. Follow your doctor's instructions.

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

If there are any changes in the brand, strength, or type of guanfacine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

Do not stop taking this medication without first talking to your doctor. If you stop taking guanfacine suddenly, your condition may become worse and you could have unpleasant symptoms.

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

See also: Guanfacine dosage (in more detail)

What happens if I miss a dose?

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

Call your doctor for instructions if you miss more than 2 doses in a row.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, dizziness, slow heart rate, or feeling like you might pass out.

What should I avoid while taking guanfacine?

Avoid taking guanfacine with a high-fat meal.

Guanfacine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather while you are taking guanfacine.

Drinking alcohol can increase certain side effects of guanfacine.

Guanfacine side effects

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

fast or slow heart rate;

pounding heartbeats, chest tightness;

numbness or tingling; or

feeling like you might pass out.

Less serious side effects may include:

drowsiness, dizziness, tired feeling;

dry mouth;

constipation;

stomach pain;

weight gain;

headache; or

feeling irritable.

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.

Guanfacine Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 1 mg orally once a day at bedtime, when given alone or in combination with another antihypertensive drug.
Maintenance dose: 1 to 3 mg orally once a day at bedtime.

Usual Pediatric Dose for Attention Deficit Disorder:

Only the guanfacine extended-release formulation is indicated for ADHD.

Children 6 to 17 years of age:

Initial dose: 1 mg extended-release orally once a day in the morning

Dosage should be adjusted in increments of no more than 1 mg/week.

Maintenance dose: 1 to 4 mg extended-release orally once daily in the morning, depending on clinical response and tolerability.

What other drugs will affect guanfacine?

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

Tell your doctor about all other medications you use, especially any other blood pressure medications, or:

bosentan (Tracleer);

conivaptan (Vaprisol);

dexamethasone (Decadron, Hexadrol);

diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

St. John's wort;

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

valproic acid (Depakene, Stavzor);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifampin (Rifadin, Rifater, Rifamate), or telithromycin (Ketek);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

an antidepressant such as nefazodone;

a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV or AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir); or

seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and other drugs may interact with guanfacine. 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 guanfacine resources

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

guanfacine Advanced Consumer (Micromedex) - Includes Dosage Information

Guanfacine Professional Patient Advice (Wolters Kluwer)

Guanfacine Prescribing Information (FDA)

Guanfacine Monograph (AHFS DI)

Guanfacine MedFacts Consumer Leaflet (Wolters Kluwer)

Intuniv Prescribing Information (FDA)

Intuniv Consumer Overview

Intuniv Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Tenex Prescribing Information (FDA)

Compare guanfacine with other medications

ADHD
High Blood Pressure

Where can I get more information?

Your pharmacist can provide more information about guanfacine.

See also: guanfacine side effects (in more detail)

Thursday, 22 March 2012

Trelstar Depot

Pronunciation: TRIP-toe-REL-in
Generic Name: Triptorelin
Brand Name: Examples include Trelstar Depot and Trelstar LA

Trelstar Depot is used for:

Treating symptoms of advanced prostate cancer. It may be used for other conditions as determined by your doctor.

Trelstar Depot is a synthetic analogue of gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing the production of certain hormones, which reduces testosterone levels in the body.

Do NOT use Trelstar Depot if:

you are allergic to any ingredient in Trelstar Depot, to GnRH, or to another GnRH agonist (eg, goserelin)

you are pregnant, may become pregnant, or are breast-feeding

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

Before using Trelstar Depot:

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

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

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

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

if you have a history or urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spine or spinal cord, heart problems, blood vessel problems, a stroke, diabetes, or high blood sugar

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

Medicines that increase prolactin levels in the blood (eg, promethazine) because the effectiveness of Trelstar Depot may be decreased

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

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

Trelstar Depot is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Trelstar Depot at home, a health care provider will teach you how to use it. Be sure you understand how to use Trelstar Depot. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Trelstar Depot is injected into the muscle.

Rotate the injection site. Do not inject into an area of skin that is red, hard, or bruised, or has scars or stretch marks.

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

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.

If you miss a dose of Trelstar Depot, contact your doctor right away.

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

Important safety information:

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

Certain hormone levels may increase during the first few weeks of treatment with Trelstar Depot. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using Trelstar Depot.

Trelstar Depot lowers the amount of certain hormones in your body. This may cause certain expected side effects to occur, such as breast enlargement, soreness, or tenderness; testicular changes, pain, or soreness; decreased sexual ability; hot flashes; or night sweats. Contact your doctor if you have questions or concerns or if you experience any of these side effects.

A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor.

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

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

Rarely, a serious pituitary gland problem (pituitary apoplexy) may occur after you use Trelstar Depot. This serious problem usually occurs shortly after you begin to use Trelstar Depot. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, eye weakness, inability to move your eyes, mental status changes, or vision changes.

Trelstar Depot may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Trelstar Depot.

Lab tests, including testosterone,prostate specific antigen (PSA) levels, hemoglobin A_1c, or blood glucose, may be performed while you use Trelstar Depot. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Trelstar Depot with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Trelstar Depot may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Trelstar Depot while you are pregnant. It is not known if Trelstar Depot is found in breast milk. Do not breast-feed while using Trelstar Depot.

Possible side effects of Trelstar Depot:

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:

Change in breast size; constipation; decreased sexual desire or ability; diarrhea; dizziness; headache; hot flashes; itching, pain, redness, or swelling at the injection site; loss of appetite; nausea; sleeplessness; stomach discomfort; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; blood in the urine or dark urine; bone pain; breast pain; burning, numbness, or tingling; calf or leg pain or tenderness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mood or mental changes (eg, depression); painful urination; severe or persistent headache, drowsiness, or dizziness; severe or persistent joint, muscle, or back pain; severe or persistent leg cramps; shortness of breath; sudden, unusual weight gain; swelling of the hands, ankles, feet or legs; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech); trouble urinating or inability to urinate; unusual tiredness or weakness; vision changes.

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

See also: Trelstar Depot side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Trelstar Depot:

Store Trelstar Depot at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Discard any medicine not used immediately after mixing. Keep Trelstar Depot, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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

Trelstar Depot 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 Trelstar Depot. 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 Trelstar Depot resources

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

Trelstar Depot Prescribing Information (FDA)

Trelstar Depot Advanced Consumer (Micromedex) - Includes Dosage Information

Trelstar Depot Concise Consumer Information (Cerner Multum)

Trelstar LA Prescribing Information (FDA)

Triptorelin Pamoate Monograph (AHFS DI)

Compare Trelstar Depot with other medications

Prostate Cancer

Monday, 19 March 2012

probucol

PROE-bue-kol

Available Dosage Forms:

Tablet

Therapeutic Class: Antihyperlipidemic

Uses For probucol

Probucol is used to lower levels of cholesterol (a fat-like substance) in the blood. This may help prevent medical problems caused by cholesterol clogging the blood vessels.

Probucol was available only with your doctor's prescription.

Probucol was voluntarily removed from the market in the United States during 1995. The withdrawal from the market was due to safety concerns .

Before Using probucol

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 probucol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to probucol 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

There is no specific information about the use of probucol in children. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of probucol in the elderly with use in other age groups.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking probucol, 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 probucol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Foscarnet

Levomethadyl

Mesoridazine

Pimozide

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using probucol 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.

Acecainide

Ajmaline

Amiodarone

Amisulpride

Aprindine

Arsenic Trioxide

Astemizole

Azimilide

Bretylium

Chloral Hydrate

Chloroquine

Chlorpromazine

Clarithromycin

Disopyramide

Dofetilide

Dolasetron

Droperidol

Enflurane

Erythromycin

Flecainide

Fluconazole

Fluoxetine

Gemifloxacin

Halofantrine

Haloperidol

Halothane

Hydroquinidine

Ibutilide

Isoflurane

Isradipine

Lidoflazine

Lorcainide

Mefloquine

Octreotide

Pentamidine

Pirmenol

Prajmaline

Procainamide

Prochlorperazine

Propafenone

Quetiapine

Quinidine

Risperidone

Sematilide

Sertindole

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Tedisamil

Telithromycin

Trifluoperazine

Trimethoprim

Vasopressin

Zolmitriptan

Zotepine

Using probucol 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.

Cyclosporine

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 probucol

Many patients who have high cholesterol levels will not notice any signs of the problem. In fact, many may feel normal. Take probucol exactly as directed by your doctor, even though you may feel well. Try not to miss any doses and do not take more medicine than your doctor ordered.

Remember that probucol will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly.

probucol works better when taken with meals.

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, probucol is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet.

Dosing

The dose of probucol 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 probucol. 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.

The number of tablets that you take depends on the strength of the medicine.

For oral dosage form (tablets):
- Adults: 500 milligrams two times a day taken with the morning and evening meals.
- Children:
  - Up to 2 years of age—Use is not recommended.
  - 2 years of age and over—Dose must be determined by your doctor.

Missed Dose

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

Storage

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.

Precautions While Using probucol

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol levels and to decide if you should continue to take it.

Do not stop taking probucol without first checking with your doctor. When you stop taking probucol, your blood fat levels may increase again. Your doctor may want you to follow a special diet to help prevent this.

probucol 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:

More common

Dizziness or fainting

fast or irregular heartbeat

Rare

Swellings on face, hands, or feet, or in mouth

unusual bleeding or bruising

unusual tiredness or weakness

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

More common

Bloating

diarrhea

nausea and vomiting

stomach pain

Less common

Headache

numbness or tingling of fingers, toes, or face

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

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

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

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 probucol resources

Probucol Drug Interactions
Probucol Support Group
0 Reviews · Be the first to review/rate this drug

Claravis

Generic Name: isotretinoin (Oral route)

eye-soe-TRET-i-noin

Oral route(Capsule, Liquid Filled)

Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin. If pregnancy does occur during treatment of a female patient who is taking isotretinoin, isotretinoin must be discontinued immediately, and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Because of isotretinoin's teratogenicity, it is approved for marketing only under a special restricted distribution program called iPLEDGE(TM). The prescriber, patient, and pharmacy must be registered and meet all of the requirements of iPLEDGE before distribution .

Commonly used brand name(s)

In the U.S.

Accutane

Amnesteem

Claravis

Sotret

Available Dosage Forms:

Capsule, Liquid Filled

Therapeutic Class: Antiacne

Chemical Class: Retinoid

Uses For Claravis

Isotretinoin is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines have been tried and have failed to help the acne. Isotretinoin may also be used to treat other skin diseases as determined by your doctor.

Isotretinoin must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Isotretinoin must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for isotretinoin.

This medicine is available only under a registered distribution program called the iPLEDGE™ program.

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

Folliculitis, gram-negative (bacterial infection of the skin on the face beginning near the nose).

Hidradenitis suppurativa (sweat gland problem).

Rosacea (red skin disorder of the face, usually of the nose and cheeks).

Thickened or patchy skin disorders, such as keratosis follicularis, palmoplantar keratoderma, lamellar ichthyosis, or pityriasis rubra pilaris.

Before Using Claravis

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of isotretinoin in children younger than 12 years of age. Safety and efficacy have not been established.

This medicine should be used with caution in teenagers, especially those with bone problems or diseases.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isotretinoin in the elderly. However, elderly patients may have a greater risk of problems and side effects when taking isotretinoin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

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.

Desogestrel

Dienogest

Doxycycline

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Minocycline

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Tetracycline

Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of isotretinoin

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

Isotretinoin comes with a patient information form and medication guide. It is very important that you read and understand this information. Be sure to carefully follow these instructions and ask your doctor if you have any questions.

Women of reproductive age must sign up for a pregnancy risk program called iPLEDGE™ in order to receive their isotretinoin prescription each month. You can sign up on the internet (www.ipledge.com) or by telephone (1-866-495-0654). Be sure to ask your doctor if you have any questions about this program. It is very important that you understand and follow all of the requirements. You will not get another prescription unless you follow the instructions for the program.

Isotretinoin must not be taken by women of reproductive age unless two effective forms of contraception (birth control) have been used for at least 1 month before the beginning of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure you have discussed this information with your doctor.

If you are a woman who is able to have children, you must have a pregnancy blood test within 1 week before beginning treatment with isotretinoin to make sure you are not pregnant. Treatment with isotretinoin will then be started within the week, on the second or third day of your next normal menstrual period. In addition, you must have a pregnancy blood test each month while you are taking this medicine and one month after treatment is completed.

Swallow the capsule whole, with food and a full glass (8 ounces) of water or other liquid. Do not break, crush, or chew the capsule.

It is very important that you take isotretinoin 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. To do so may increase the chance of side effects.

It is very important that you not share this medicine with anyone else because of the risk of birth defects and other serious side effects.

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.

For oral dosage form (capsules):
- For acne:
  - Adults and teenagers over 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.5 to 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given in 2 doses. Your doctor may adjust your dose as needed.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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 Claravis

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Isotretinoin causes birth defects in humans if taken during pregnancy. If you suspect that you may have become pregnant, stop taking this medicine and check with your doctor right away.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using this medicine (even if the medicine is temporarily stopped), and for at least one month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, and prescription or nonprescription (over-the-counter [OTC]) medicines. Some medicines or nutritional supplements (e.g., St. John's wort) may cause your birth control pills to not work as well.

During the first 3 weeks you are taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within 1 to 2 months after starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop taking isotretinoin and may take up to 6 months. Your doctor can help you choose the right skin products to reduce skin dryness and irritation.

You or your child should not donate blood to a blood bank while using isotretinoin or for 30 days after you stop taking it. This is to prevent a pregnant patient from receiving blood that contains the medicine.

In some patients, isotretinoin may cause a decrease in night vision. This problem may occur suddenly. If it does occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. Also, check with your doctor.

Isotretinoin may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them during the time you are taking isotretinoin and for up to 2 weeks after you stop taking it. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.

Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to sunlight, wind, or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks of treatment. However, you or your child should not stop taking this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.

To help isotretinoin work properly, use sunscreen or sunblocking lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

Isotretinoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.

Do not take vitamin A or any vitamin supplement containing vitamin A while taking this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

It is very important that you or your child not use wax epilation to remove hair while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from wax epilation.

It is very important that you or your child not have any cosmetic procedures to smooth your skin (e.g., dermabrasion, laser) while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.

This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Isotretinoin may cause some people to have hearing problems within a few weeks after they start taking it. Stop using this medicine and check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Stop using this medicine and tell your doctor right away if you or your child have abdominal or stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.

This medicine lowers the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Claravis Side Effects

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

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

More common

Bone or joint pain

burning, redness, itching, or other signs of eye inflammation

difficulty in moving

nosebleeds

scaling, redness, burning, pain, or other signs of inflammation of the lips

skin infection or rash

Rare

Abdominal or stomach pain (severe)

attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)

back pain

bleeding or inflammation of the gums

blurred vision or other changes in vision

changes in behavior

decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)

diarrhea (severe)

headache (severe or continuing)

mental depression

nausea and vomiting

pain or tenderness of the eyes

pain, tenderness, or stiffness in the muscles (long-term treatment)

rectal bleeding

yellow eyes or skin

Incidence not known

Attack, assault, or use of force

black, tarry stools

bleeding from sore in the mouth

bloating

bloody cough

bloody or cloudy urine

bone pain, tenderness, or aching

burning or stinging of the skin

chest pain

chills

confusion

constipation

convulsions

cough or hoarseness

dark-colored urine

decrease in height

difficulty in breathing

difficulty in speaking

difficulty in swallowing

discharge from the eyes

dizziness

double vision

ear pain

excessive tearing

fainting

fast, irregular, pounding, or racing heartbeat or pulse

fever with or without chills

fractures and/or delayed healing

general feeling of discomfort or illness

heartburn

high blood pressure

hives

inability to move the arms, legs, or facial muscles

inability to speak

indigestion

inflamed tissue from infection

irregular yellow patch or lump on the skin

irritation

joint pain, redness, stiffness, or swelling

killing oneself

lack or slowing of normal growth in children

loosening of the fingernails

loss of appetite

loss of bladder control

loss or change in hearing

muscle cramps or spasms

muscle spasm or jerking of all extremities

muscle weakness

noisy breathing

pain in the ribs, arms, or legs

pain or burning in the throat

pain or tenderness around the eyes and cheekbones

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful or difficult urination

pains in the chest, groin, or legs, especially calves of the legs

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

redness or soreness around the fingernails

redness, soreness, or itching skin

sensitivity of the eyes to sunlight

shortness of breath

skin rash

slow speech

sneezing

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

sores, welting, or blisters

stuffy or runny nose

sudden loss of consciousness

sudden loss of coordination

sudden onset of severe acne on chest and trunk

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

swelling of the eyelids, face, lips, hands, lower legs, or feet

swollen, painful or tender lymph glands in the neck, armpit, or groin

tightness in the chest

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

use of extreme physical or emotional force

watery or bloody diarrhea

wheezing

More common

Crusting of the skin

difficulty in wearing contact lenses (may continue after medicine is stopped)

dryness of the eyes (may continue after treatment is stopped)

dryness of the mouth or nose

dryness or itching of the skin

headache (mild)

increased sensitivity of the skin to sunlight

peeling of the skin on palms of the hands or soles of the feet

stomach upset

thinning of the hair (may continue after treatment is stopped)

Incidence not known

Abnormal menstruation

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling

changes in fingernails or toenails

continuing ringing or buzzing, or other unexplained noise in the ears

dandruff

darkening of the skin

flushing

hair abnormalities

hair loss

increased hair growth, especially on the face

large amount of triglyceride in the blood

lightening of normal skin color

lightening of treated areas of dark skin

nervousness

oily skin

redness of the face

severe sunburn

skin rash, encrusted, scaly and oozing

sleeplessness

stomach burning

sweating

trouble sleeping

unable to sleep

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusually warm skin of the face

voice changes

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: Claravis side effects (in more detail)

More Claravis resources

Claravis Side Effects (in more detail)
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Claravis Support Group
55 Reviews for Claravis - Add your own review/rating

Claravis Prescribing Information (FDA)

Claravis MedFacts Consumer Leaflet (Wolters Kluwer)

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Sunday, 18 March 2012

Alopecia Medications

Definition of Alopecia:

1. Baldness, absence of the hair from skin areas where it normally is present.

2. Hair loss as a result of chemotherapy or radiation therapy administered to the head. Hair loss from chemotherapy is temporary. Hair loss from radiation is usually permanent.

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Drugs associated with Alopecia

The following drugs and medications are in some way related to, or used in the treatment of Alopecia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

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