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Friday, May 25, 2012

Naprelan

Generic Name: naproxen (Oral route)

na-PROX-en

Oral route(Tablet;Tablet, Enteric Coated;Suspension)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Aflaxen

Aleve

Aleve Arthritis

Anaprox

Anaprox DS

EC Naprosyn

Naprelan

Naprelan 500

Naprelan Dose Card

Naprosyn

In Canada

Naxen

Available Dosage Forms:

Tablet

Suspension

Tablet, Enteric Coated

Tablet, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Naprelan

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.

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

Before Using Naprelan

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 naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.

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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Pentoxifylline

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.

Abciximab

Ardeparin

Argatroban

Aspirin

Beclamide

Beta Glucan

Bivalirudin

Caramiphen

Carbamazepine

Certoparin

Chlormethiazole

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desirudin

Diazepam

Dipyridamole

Enoxaparin

Escitalopram

Ethotoin

Felbamate

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Fosphenytoin

Gabapentin

Ginkgo

Heparin

Lacosamide

Lepirudin

Mephenytoin

Mephobarbital

Methotrexate

Nadroparin

Nefazodone

Oxcarbazepine

Paraldehyde

Paramethadione

Parnaparin

Paroxetine

Pemetrexed

Phenacemide

Phenobarbital

Phenytoin

Piracetam

Pregabalin

Protein C

Reviparin

Rivaroxaban

Rufinamide

Sertraline

Sibutramine

Stiripentol

Tacrolimus

Tiagabine

Ticlopidine

Tinzaparin

Tirofiban

Topiramate

Trimethadione

Valproic Acid

Vigabatrin

Vilazodone

Warfarin

Zimeldine

Zonisamide

Using this medicine 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.

Acebutolol

Acetohexamide

Alacepril

Alprenolol

Amiloride

Arotinolol

Atenolol

Azilsartan Medoxomil

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Candesartan Cilexetil

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Clopamide

Cyclopenthiazide

Cyclosporine

Delapril

Desvenlafaxine

Dilevalol

Duloxetine

Enalaprilat

Enalapril Maleate

Eprosartan

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Irbesartan

Labetalol

Landiolol

Levobetaxolol

Levobunolol

Lisinopril

Lithium

Losartan

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Milnacipran

Moexipril

Nadolol

Nebivolol

Nipradilol

Olmesartan Medoxomil

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Tasosartan

Telmisartan

Temocapril

Tertatolol

Timolol

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Valsartan

Venlafaxine

Xipamide

Zofenopril

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 naproxen

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

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.

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 naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day.
  - Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

For naproxen controlled-release tablet (e.g., Naprelan®) dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day.
  - Children—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved.
  - Children—Use and dose must be determined by your doctor.

For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
  - Children—Use and dose must be determined by your doctor.

For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form:
- For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis:
  - Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For bursitis, tendonitis, menstrual cramps, and other kinds of pain:
  - Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For acute gout:
  - Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved.
  - Children—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 Naprelan

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 and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

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.

Naprelan 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

Belching

bruising

difficult or labored breathing

feeling of indigestion

headache

itching skin

large, flat, blue, or purplish patches in the skin

pain in the chest below the breastbone

shortness of breath

skin eruptions

stomach pain

swelling

tightness in the chest

wheezing

Less common

Bloating

bloody or black, tarry stools

blurred or loss of vision

burning upper abdominal or stomach pain

cloudy urine

constipation

decrease in urine output or decrease in urine-concentrating ability

disturbed color perception

double vision

fast, irregular, pounding, or racing heartbeat or pulse

halos around lights

indigestion

loss of appetite

nausea or vomiting

night blindness

overbright appearance of lights

pale skin

pinpoint red or purple spots on the skin

severe and continuing nausea

severe stomach burning, cramping, or pain

skin rash

swelling or inflammation of the mouth

troubled breathing with exertion

tunnel vision

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of material that looks like coffee grounds

weight loss

Rare

Anxiety

back or leg pains

bleeding gums

blindness

blistering, peeling, or loosening of the skin

blood in the urine or stools

blue lips and fingernails

canker sores

change in the ability to see colors, especially blue or yellow

chest pain or discomfort

clay-colored stools

cold sweats

coma

confusion

cool, pale skin

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

cracks in the skin

darkened urine

decreased vision

depression

diarrhea

difficult, burning, or painful urination

difficult, fast, or noisy breathing

difficulty with swallowing

dilated neck veins

dizziness

dry cough

dry mouth

early appearance of redness, or swelling of the skin

excess air or gas in the stomach

extreme fatigue

eye pain

fainting

fever with or without chills

fluid-filled skin blisters

flushed, dry skin

frequent urination

fruit-like breath odor

greatly decreased frequency of urination or amount of urine

hair loss

high fever

hives

increased hunger

increased sensitivity of the skin to sunlight

increased sweating

increased thirst

increased urination

increased volume of pale, dilute urine

irregular breathing

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas

light-colored stools

lightheadedness

loss of heat from the body

lower back or side pain

nervousness

nightmares

no blood pressure

no breathing

no pulse

nosebleeds

numbness or tingling in the hands, feet, or lips

pain in the ankles or knees

pain or burning in the throat

pain or discomfort in the arms, jaw, back, or neck

painful, red lumps under the skin, mostly on the legs

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

pale or blue lips, fingernails, or skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, shallow breathing

red, irritated eyes

red skin lesions, often with a purple center

red-green color blindness

redness or other discoloration of the skin

redness, swelling, or soreness of the tongue

scaly skin

seizures

severe sunburn

shakiness

skin thinness

slurred speech

sneezing

sore throat

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

sores, welting, or blisters

spots on your skin resembling a blister or pimple

stiff neck or back

stomach cramps or tenderness

stomach upset

swelling in the legs and ankles

swelling of the face, fingers, feet, or lower legs

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

tiny bumps on the inner lining of the eyelid

unexplained weight loss

unpleasant breath odor

watery or bloody diarrhea

weakness or heaviness of the legs

weight gain

yellow eyes or skin

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

Symptoms of overdose

Bleeding under the skin

confusion about identity, place, and time

muscle tremors

restlessness

sleepiness

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

Continuing ringing or buzzing or other unexplained noise in the ears

hearing loss

Less common

Acid or sour stomach

change in hearing

feeling of constant movement of self or surroundings

passing gas

sensation of spinning

stomach soreness or discomfort

Rare

Appetite changes

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

burning, dry, or itching eyes

difficulty with moving

discharge, excessive tearing

general feeling of discomfort or illness

lack or loss of strength

menstrual changes

muscle aching, cramping, stiffness, or weakness

not able to concentrate

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

seeing, hearing, or feeling things that are not there

shakiness in the legs, arms, hands, or feet

sleeplessness

swollen joints

trembling or shaking of the hands or feet

trouble getting pregnant

trouble performing routine tasks

trouble sleeping

unable to sleep

unusual drowsiness, dullness, or feeling of sluggishness

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: Naprelan 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.

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More Naprelan resources

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

Compare Naprelan with other medications

Ankylosing Spondylitis
Aseptic Necrosis
Back Pain
Bursitis
Costochondritis
Diffuse Idiopathic Skeletal Hyperostosis
Dysautonomia
Fever
Frozen Shoulder
Gout, Acute
Headache
Juvenile Rheumatoid Arthritis
Muscle Pain
Osteoarthritis
Pain
Period Pain
Rheumatoid Arthritis
Sciatica
Spondylolisthesis
Tendonitis

Thursday, May 17, 2012

Sterets Unisept (Molnlycke Health Care )

1. Name Of The Medicinal Product

Sterets Unisept.

2. Qualitative And Quantitative Composition

Chlorhexidine Gluconate Solution 20% w/v BP 0.05% w/v.

3. Pharmaceutical Form

Sterile aqueous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Chlorhexidine gluconate is a potent antibacterial agent for general antiseptic purposes. It is bactericidal to a broad spectrum of organisms. Sterets Unisept is recommended for use in obstetrics and for swabbing burns and wounds.

4.2 Posology And Method Of Administration

There is no distinction between adults, the elderly and children. Sterets Unisept should be used without further dilution for topical administration only.

4.3 Contraindications

Sterets Unisept should not come into contact with the brain, eyes, meninges or middle ear. The use of Sterets Unisept is also contraindicated in patients who have shown hypersensitivity to chlorhexidine.

4.4 Special Warnings And Precautions For Use

For external use only. Not for injection. When Sterets Unisept is used in aseptic procedures, the outside of the sachet should be disinfected before opening. Discard any surplus immediately after use. Contact with eyes should be avoided. Do not use within body cavities.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with Sterets Unisept solution.

4.6 Pregnancy And Lactation

Although there are no adverse reports for this product in pregnant and lactating mothers, as with all medicines, care should be exercised when administering the product to pregnant or lactating women.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Idiosyncratic skin reactions and generalised allergic reactions to chlorhexidine can occur, but these are rare.

4.9 Overdose

Treatment: Accidental ingestion - gastric lavage should be carried out with milk, egg white, gelatine or mild soap.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorhexidine is a disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative bacteria: it is more effective against Gram-positive than Gram-negative bacteria, some species of Pseudomonas and Proteus being less susceptible. The wide range of organisms against which chlorhexidine is active explains the rationale for presenting it in a solution for swabbing wounds and burns and in obstetrics.

5.2 Pharmacokinetic Properties

The British Pharmacopoeia 1993 contains a monograph for Chlorhexidine Gluconate Solution 20% w/v. The pharmacokinetics of the compound when applied to the skin as a topical antiseptic are well understood and described in the literature.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Nonoxynol 10; sodium hydroxide; Carmoisine Red E122; purified water.

6.2 Incompatibilities

Sterets Unisept is incompatible with anionic agents.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store in a cool dark place. Store sachets in the outer containers.

6.5 Nature And Contents Of Container

Nylon-ethylene-propylene copolymer laminate sachets containing either 25 ml or 100 ml of product overwrapped in heat sealed polythene/nylon and / or polythene/polyester pouches.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Medlock Medical Ltd, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL: 21248/0037.

9. Date Of First Authorisation/Renewal Of The Authorisation

10^th April 2006.

10. Date Of Revision Of The Text

April 2006.

Monday, May 14, 2012

Adoxa TT

Generic Name: doxycycline (Oral route)

dox-i-SYE-kleen

Commonly used brand name(s)

In the U.S.

Adoxa

Adoxa CK

Adoxa Pak

Adoxa TT

Alodox

Doryx

Monodox

Oracea

Periostat

Vibramycin Calcium

Vibramycin Hyclate

Vibramycin Monohydrate

Vibra-Tabs

Available Dosage Forms:

Tablet

Powder for Suspension

Capsule

Capsule, Extended Release

Tablet, Delayed Release

Capsule, Delayed Release

Syrup

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

Uses For Adoxa TT

Doxycycline is used to treat bacterial infections in many different parts of the body. It is also used to treat pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne.

Doxycycline delayed-release tablets are also used to prevent malaria and treat anthrax infection after possible exposure and other problems as determined by your doctor.

Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Adoxa TT

Allergies

Pediatric

Doxycycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger (except for treatment of exposure to inhalational anthrax), unless directed by the child's doctor.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doxycycline in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving doxycycline.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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

Using this medicine 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.

Acitretin

Digoxin

Isotretinoin

Methotrexate

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Bismuth Subsalicylate

Calcium

Desogestrel

Dienogest

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Fosphenytoin

Iron

Levonorgestrel

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Medroxyprogesterone Acetate

Mestranol

Norelgestromin

Norethindrone

Norgestimate

Norgestrel

Penicillin G

Penicillin G Procaine

Penicillin V

Rifampin

Rifapentine

Interactions with Food/Tobacco/Alcohol

Proper Use of doxycycline

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

Take this medicine exactly 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.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

If you are using Doryx® delayed-release tablets:

It may be taken with food or milk, if it upsets your stomach.

You may take this medicine by breaking the tablets. Hold the tablet between your thumb and index fingers close to the appropriate score (separation) line. Then, apply enough pressure to snap the tablet segments apart. Do not use the tablet if it does not break on the scored lines.

You may also take this medicine by sprinkling the equally broken tablets onto cold, soft food such as an applesauce. This mixture must be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not store the mixture for later use.

Drink plenty of fluids to avoid throat irritation and ulceration.

If you are using this medicine to prevent malaria while traveling, start taking the medicine 1 or 2 days before you travel. Take the medicine every day during your trip and continue taking it for 4 weeks after you return. However, do not use the medicine for longer than 4 months.

If you are using For Oracea™ delayed-release capsules:

You should take this medicine on an empty stomach, preferably at least 1 hour before or 2 hours after meals.

You should take this medicine with a full glass of water while sitting or standing.

To prevent throat irritation, do not lay down right after taking this medicine.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

For oral dosage form (delayed-release tablets):
- For infections:
  - Adults—100 milligrams (mg) every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.
  - Children older than 8 years of age who weigh 45 kg or less—Dose is based on body weight and must be determined by your doctor. The dose is usually 4.4 milligrams (mg) per kilogram (kg) of body weight per day and divided into two doses on the first day of treatment. This is followed by 2.2 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days.
  - Children up to 8 years of age—Use is not recommended.
- For the prevention of malaria:
  - Adults—100 milligrams (mg) once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
  - Children older than 8 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
  - Children up to 8 years of age—Use is not recommended.

For oral dosage form (delayed-release capsules):
- For the treatment of pimples from rosacea:
  - Adults—40 milligrams (mg) or one capsule once a day, in the morning.
  - Children—Use and dose must be determined by your 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 Adoxa TT

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may darken the color of your skin, nails, eyes, teeth, gums, or scars. Talk with your doctor if you have any concerns.

Doxycycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Birth control pills (containing estrogen) may not work properly while you are using doxycycline. To keep from getting pregnant, use other forms of birth control. These include condoms, diaphragms, or contraceptive foams or jellies.

Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

Wear protective clothing, including a hat. Also, wear sunglasses.

Apply a sunblock product that has a skin protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.

Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.

Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.

You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron such as vitamin or mineral supplements.

If you are using this medicine to prevent malaria, take extra care not to get bitten by mosquitoes. Use protective clothing, mosquito netting or screens, and an insect repellent.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Adoxa TT 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

Abdominal or stomach tenderness

bloating

clay-colored stools

cough

dark urine

decreased appetite

diarrhea

diarrhea, watery and severe, which may also be bloody

difficulty with swallowing

dizziness

fast heartbeat

feeling of discomfort

fever

headache

hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

hives or welts

increased thirst

inflammation of the joints

itching

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

nausea and vomiting

numbness or tingling of the face, hands, or feet

pain

rash

redness and soreness of the eyes

redness of the skin

shortness of breath

sore throat

sores in the mouth

stomach cramps

stomach pain or tenderness

swelling of the feet or lower legs

swollen lymph glands

tightness in the chest

unusual tiredness or weakness

unusual weight loss

wheezing

yellow eyes or skin

Incidence not known

Back, leg, or stomach pains

black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

chest pain, discomfort, or burning

chills

cracks in the skin

decrease in vision

difficulty breathing

discoloration of the thyroid glands

double vision

general body swelling

heartburn

increased sensitivity of the skin to sunlight

loss of heat from the body

lower back or side pain

nosebleeds

pain or burning in the throat

pain with swallowing

painful or difficult urination

pale skin

pinpoint red spots on the skin

rash with flat lesions or small raised lesions on the skin

red, swollen skin

redness or other discoloration of the skin

redness, swelling, or soreness of the tongue

scaly skin

severe nausea

severe stomach pain

severe sunburn

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

unusual bleeding or bruising

vomiting blood

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: Adoxa TT side effects (in more detail)

More Adoxa TT resources

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

Doxycycline Prescribing Information (FDA)

Doxycycline Monograph (AHFS DI)

Doxycycline Professional Patient Advice (Wolters Kluwer)

Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer)

Adoxa MedFacts Consumer Leaflet (Wolters Kluwer)

Alodox Prescribing Information (FDA)

Doryx Prescribing Information (FDA)

Doryx Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Doxycycline Calcium Monograph (AHFS DI)

Monodox Prescribing Information (FDA)

Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer)

Oracea Prescribing Information (FDA)

Oracea Consumer Overview

Periostat Prescribing Information (FDA)

Periostat MedFacts Consumer Leaflet (Wolters Kluwer)

Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer)

Vibramycin Prescribing Information (FDA)

Compare Adoxa TT with other medications

Acne

Sunday, May 13, 2012

Sumatriptan

Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: C14H21N3O2S
Molecular Formula: C₁₄H₂₁N₃O₂S•C₄H₆O₄
CAS Number: 103628-46-2
Brands: Imitrex

REMS:

FDA approved a REMS for sumatriptan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of sumatriptan and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1-like receptor agonist (“triptan”).¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ²²³ ²²⁴ ²⁶⁸

Uses for Sumatriptan

Vascular Headaches

Acute treatment of migraine attacks with or without aura.¹ ² ³ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹³ ⁴⁸ ⁸⁰ ¹⁴⁵ ¹⁴⁸ ¹⁸⁴ ¹⁹⁵ ²¹⁴ ²¹⁷ ²²⁵ ²⁴⁹

Sub-Q for acute treatment of cluster headache episodes.¹ ² ⁴⁹ ⁷⁵ ¹⁸³ ¹⁸⁴ ¹⁸⁵ ²¹⁰ ²¹⁴ Safety and efficacy of oral or intranasal sumatriptan for this use not established.¹⁴⁸ ²⁴⁹

Not recommended for management of hemiplegic or basilar migraine or for prophylaxisof migraine or cluster headache.¹ ⁷ ¹¹⁴ ¹⁵⁸

Sumatriptan Dosage and Administration

Administration

Administer orally, intranasally, or by sub-Q injection. Do not administer IM or IV; IV administration may induce coronary vasospasm.¹ ¹⁴⁸ ²⁴⁹

To achieve maximum relief, initiate therapy as soon as possible after onset of migraine attack.⁵⁰ ⁹² ¹⁰⁸ ¹²⁴ ¹⁴⁸ ¹⁸⁰ ²³⁷

Oral Administration

Administer orally with fluids; swallow tablet whole.¹⁴⁸

Intranasal Administration

Administer intranasally as a single spray into 1 nostril.²⁴⁹

Nasal solution unit contains only 1 spray; do not test before use.²⁴⁹

To administer, remove unit from package just before use.²⁴⁹ While sitting down, gently blow nose to clear nasal passages.²⁴⁹ Keep head in upright position and gently close 1 nostril with index finger; exhale gently through mouth.²⁴⁹ With other hand, hold unit with thumb supporting at bottom and index and middle fingers on either side of nozzle.²⁴⁹ Insert nozzle into open nostril about ½ inch.²⁴⁹ While gently inhaling through nose (with closed mouth), release spray by firmly pressing plunger.²⁴⁹ Remove nozzle from nostril while keeping head level for 10–20 seconds and gently inhaling through nose and exhaling through mouth; do not inhale deeply.²⁴⁹ Consult administration instructions provided by manufacturer before use.²⁴⁹

Sub-Q Administration

Administer only by sub-Q injection, preferably into lateral aspect of thigh or deltoid.¹ ¹²

Do not administer IM or IV; IV administration may induce coronary vasospasm.¹

Autoinjection device available for use with prefilled syringes (each containing a 4- or 6-mg dose) to facilitate self-administration.¹ ²⁷³ Needles with this device penetrate approximately 5–6 mm (¼ inch); use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length.¹ ²⁷³

Dosage

Available as sumatriptan (nasal solution) and sumatriptan succinate (tablets and injection); dosage expressed in terms of sumatriptan.¹ ¹⁴⁸ ²⁴⁹

Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.¹ ¹⁴⁸ ²⁴⁹

Adults

Vascular Headaches

Migraine

Oral

25, 50, or 100 mg as a single dose.¹⁴⁸ ²⁷⁴ Individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 50- or 100-mg dose; 100-mg dose may not provide substantially greater effect than 50-mg dose.¹⁴⁸ ²⁷⁴

If headache recurs or partial response occurs after initial dose, additional oral doses may be administered at intervals of ≥2 hours, up to a maximum oral dosage of 200 mg daily.²⁷⁴

If headache recurs after an initial sub-Q dose, additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.²⁷⁴

Intranasal

5, 10, or 20 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 20-mg dose.²⁴⁹ Doses >20 mg provide no additional benefit.²⁴⁹

To achieve a 10-mg dose, administer a single 5-mg dose into each nostril.²⁴⁹

If headache recurs, dose may be repeated once after 2 hours, up to a maximum dosage of 40 mg daily.²⁴⁹

Sub-Q

≤6 mg as a single dose.¹ If dose-limiting adverse effects occur with 6-mg dose, lower doses (e.g., 4 mg) may be given.¹ ²⁷³ In patients receiving doses other than 4 or 6 mg, only the single-dose vials containing 6 mg/0.5 mL should be used to provide the desired dose.¹ ²⁷³

If headache recurs, a 6-mg sub-Q dose may be repeated once after ≥1 hour or additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.²⁷³

If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.¹ ² ³ ⁶ ⁷ ⁸ ⁹ ¹⁷⁴ ¹⁷⁶ ¹⁸¹ ²³⁶ ²³⁷

Cluster Headache

Sub-Q

≤6 mg as a single dose.¹ If dose-limiting adverse effects occur with 6-mg dose, lower doses may be administered using only single-dose vials; use autoinjection device only with prefilled, unit-of-use syringes containing 6 mg.¹

If headache recurs, 6-mg dose may be repeated once after ≥1 hour, up to a maximum dosage of 12 mg in any 24-hour period.¹

If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.¹ ² ³ ⁶ ⁷ ⁸ ⁹ ¹⁷⁴ ¹⁷⁶ ¹⁸¹ ²³⁶ ²³⁷

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 200 mg daily; do not exceed 100 mg daily if following an initial sub-Q dose.²⁷³

Safety of treating an average of >4 headaches per 30-day period has not been established.¹⁴⁸

Intranasal

Maximum 40 mg daily.²⁴⁹

Safety of treating an average of >4 headaches per 30-day period has not been established.²⁴⁹

Sub-Q

Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.¹

Cluster Headache

Sub-Q

Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.¹

Special Populations

Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.¹ ¹⁴⁸ ²⁴⁹ Unpredictable increases in bioavailability following oraladministration in patients with hepatic impairment.¹⁴⁸ If oral therapy is deemed advisable in these patients, do not exceed 50 mg as a single dose.¹⁴⁸

Patients Receiving MAO-A Inhibitors

Concurrent or recent (within 2 weeks) use of MAO-A inhibitor and oral or intranasal sumatriptan is contraindicated;¹⁴⁸ ²⁴⁹ sub-Qsumatriptan is not generally recommended, but if concomitant use is clinically warranted, decrease sumatriptan sub-Q dosage and administer under careful medical supervision.¹ ²³⁷

Cautions for Sumatriptan

Contraindications

Known or suspected ischemic heart disease (e.g., angina pectoris, MI, silent ischemia).¹ ¹⁴⁸ ²⁴⁹

Coronary artery vasospasm (e.g., Prinzmetal variant angina).¹ ¹⁴⁸ ²⁴⁹

Other serious underlying cardiovascular disease (e.g., uncontrolled hypertension).¹ ¹⁴⁸ ²⁴⁹

Cerebrovascular syndromes (e.g., stroke syndrome, TIAs).¹ ¹⁴⁸ ²⁴⁹

Peripheral vascular ischemia (e.g., ischemic bowel disease).¹ ¹⁴⁸ ²⁴⁹

Hemiplegic or basilar migraine.¹ ¹⁴⁸ ²⁴⁹

Treatment within previous 24 hours with another 5-HT₁ receptor agonist or an ergot alkaloid.¹ ¹⁴⁸ ²⁴⁹ (See Specific Drugs under Interactions.)

Concurrent or recent (within 2 weeks) treatment with an MAO-A inhibitor (oral and nasal sumatriptan formulations).¹ ¹⁴⁸ ²⁴⁹

Severe hepatic impairment.¹ ¹⁴⁸ ²⁴⁹

Known hypersensitivity to sumatriptan or any ingredient in the formulation.¹ ¹⁴⁸ ²⁴⁹

Warnings/Precautions

Warnings

Use oral or intranasal sumatriptan only in patients in whom a clear diagnosis of migraine has been established.¹⁴⁸ ²⁴⁹ Use sub-Q sumatriptan only in patients in whom a clear diagnosis of migraine or cluster headache has been established.¹

Exclude other potentially serious neurologic disorders before administering sumatriptan to patients not previously diagnosed with migraine or cluster headache or to those with atypical symptoms.¹ ⁶¹ ¹⁴⁸ ²³⁶ ²³⁷

Cardiac Effects

Risk of myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death.¹ ¹⁴⁸ ²⁴⁹

Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.¹ ¹⁴⁸ ²⁴⁹

Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.¹ ¹⁴⁸ ²⁴⁹

Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy, including patients with cluster headache (predominantly males >40 years of age).¹ ¹⁴⁸ ²⁴⁹

Patients with symptoms suggestive of angina after receiving sumatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration resumed and such signs or symptoms recur, ECG evaluation recommended.¹ ¹⁴⁸ ²⁴⁹

Cerebrovascular Events

Possible cerebral or subarachnoid hemorrhage, stroke, and other cerebrovascular events, sometimes fatal.¹ ¹⁴⁸ ²⁴⁹

Risk of certain cerebrovascular events (e.g., stroke, TIA) may be increased in patients with migraine.¹ ¹⁴⁸ ²⁴⁹

Other Cardiovascular or Vasospastic Effects

Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported.¹ ¹⁴⁸ ²⁴⁹ Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic bowel syndrome, Raynaud’s syndrome) occur following administration.¹ ⁶ ⁸

Substantial increases in BP, including hypertensive crises, reported rarely in patients with or without history of hypertension; administer with caution in patients with controlled hypertension as transient increases in BP and peripheral vascular resistance are possible.¹ ¹⁴⁸ ²⁴⁹ (See Contraindications under Cautions.)

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT₁ receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs).²⁷² ²⁷³ ²⁷⁴ ²⁷⁵ Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).²⁷² ²⁷³ ²⁷⁴ ²⁷⁵

Local Effects

Possible transient irritation in nose and throat (e.g., burning, numbness, paresthesia, discharge, pain/soreness), sometimes severe, after intranasal administration; symptoms usually resolve in <2 hours.²⁴⁹ Effects of extended and repeated use on nasal and/or respiratory mucosa not systematically evaluated.²⁴⁹

Sensitivity Reactions

Hypersensitivity

Hypersensitivity reactions (e.g., anaphylaxis/anaphylactoid reactions), possibly life-threatening or fatal, reported rarely; increased risk in patients with history of sensitivity to multiple allergens.¹ ¹⁴⁸ ²⁴⁹

General Precautions

Seizures

Seizures reported rarely; use with caution in patients with a history of seizures or with conditions associated with a lowered seizure threshold.²⁷³ ²⁷⁴ ²⁷⁵

Ocular Effects

Possible accumulation of sumatriptan and/or its metabolites in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.¹ ¹⁴⁸ ²⁴⁹

Corneal opacities and corneal epithelial defects reported in dogs. No specific recommendations for monitoring.

Specific Populations

Pregnancy

Category C.¹ ¹⁴⁸ ²⁴⁹ Sumatriptan Pregnancy Registry at 800-336-2176.¹ ¹⁴⁸ ²⁴⁹

Lactation

Distributed into human milk.¹ ¹⁴⁸ ²⁴⁹ The manufacturer recommends avoiding breast-feeding for 12 hours after receiving sumatriptan oral tablets, sub-Q injection, or nasal spray.²⁷³ ²⁷⁴ ²⁷⁵

Pediatric Use

Safety and efficacy not established in children <18 years of age; use not recommended.¹ ¹⁴⁸ ²⁴⁹

Geriatric Use

Use not recommended due to possible decreased hepatic function, potential for more pronounced increases in BP, and increased risk for CAD in geriatric patients.¹ ¹⁴⁸ ²⁴⁹

Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.¹ ¹⁴⁸ ²⁴⁹ Due to important role of the liver in presystemic clearance of oral sumatriptan, dosage adjustment recommended if oral therapy is deemed advisable in patients with hepatic impairment.¹⁴⁸ (See Special Populations under Dosage and Administration.)

Common Adverse Effects

With oral therapy, pain/pressure sensations in chest/neck/throat/jaw, paresthesia, warm or cold sensation, malaise/fatigue, vertigo.¹⁴⁸

With intranasal therapy, taste disturbances, nausea, vomiting, disorder/discomfort of nasal cavity or sinuses.²⁴⁹

With sub-Q therapy, injection site reaction, atypical sensations (e.g., tingling, warm/hot sensation, burning, feeling of heaviness, pressure, tightness, numbness), dizziness/vertigo, flushing, mouth/tongue discomfort, weakness, neck pain/stiffness, chest discomfort.¹

Interactions for Sumatriptan

Metabolized principally by MAO-A isoenzyme in vitro.¹⁴⁸

Protein-bound Drugs

Effect on protein binding of other drugs has not been evaluated,¹ but expected to be minor due to low-level protein binding of sumatriptan.¹⁴⁸ ²⁴⁹

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	Pretreatment with oral sumatriptan followed by acetaminophen affected rate, but not extent of acetaminophen absorption over 8 hours¹⁸⁷
Alcohol	Administration of alcohol 30 minutes prior to oral sumatriptan did not affect sumatriptan pharmacokinetics⁴⁴ ⁴⁵ ¹⁴⁸ ²³⁶
Amitriptyline	Concomitant use did not affect sumatriptan efficacy¹ ⁴⁰ ⁶²
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)	Potentially life-threatening serotonin syndrome²⁷² ²⁷³ ²⁷⁴ ²⁷⁵	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated²⁷² ²⁷³ ²⁷⁴ ²⁷⁵
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide)	Additive vasospastic effects¹ ¹⁴⁸ ²⁴⁹	Use within 24 hours contraindicated¹ ¹⁴⁸ ²⁴⁹
5-HT₁receptor agonists	Additive vasospastic effects¹ ¹⁴⁸ ²⁴⁹	Use within 24 hours contraindicated¹ ¹⁴⁸ ²⁴⁹
MAO inhibitors	MAO-A inhibitors decrease sumatriptan clearance, resulting in substantially increased systemic exposure; no substantial effect on sumatriptan metabolism seen with an MAO-B inhibitor¹ ¹⁴⁸ ²⁴⁹	Use of nasal or oralsumatriptan within 2 weeks of MAO-A inhibitor contraindicated; although not generally recommended, if clinically warranted, sub-Q sumatriptan may be used concurrently with MAO-A inhibitors with appropriate dosage adjustment and careful monitoring¹ ²³⁷
Propranolol	Concomitant use did not affect sumatriptan efficacy;¹ ⁴⁰ ⁶² pretreatment with propranolol did not alter pharmacokinetics or pharmacodynamics of oral sumatriptan⁶²
Verapamil	Concomitant use did not affect sumatriptan efficacy¹ ⁴⁰ ⁶²
Xylometazoline	Topical application of xylometazoline to nasal mucosa 15 minutes prior to intranasal sumatriptan did not affect sumatriptan pharmacokinetics²⁴⁹

Sumatriptan Pharmacokinetics

Absorption

Bioavailability

Absorbed rapidly after oral, intranasal, or sub-Q administration, with peak plasma concentrations attained within approximately 0.5–5 hours, 0.8–1.8 hours, or 5–20 minutes, respectively.¹ ² ³ ¹³ ⁴⁵ ⁶¹ ⁷⁸ ⁷⁹ ⁸⁹ ⁹⁶ ¹²³ ¹⁴⁶ ¹⁴⁸ ¹⁶⁶ ¹⁶⁸ ²³⁶ Bioavailability after sub-Q administration averages 97% of that obtained with IV administration¹ ⁴⁴ ; bioavailability after oral or intranasal administration averages only about 15 or 17%, respectively, principally due to presystemic metabolism and in part due to incomplete absorption.² ¹³ ¹⁴ ⁴⁴ ⁴⁵ ⁶¹ ⁸⁹ ¹⁴⁶ ¹⁴⁸ ¹⁶⁶ ¹⁶⁸ ²⁴⁹

Oral absorption is not appreciably affected by gastric stasis that may occur during migraine attack,³ ¹³ ⁴⁵ ¹⁴⁶ but time to peak concentration is prolonged by about 30 minutes;³ ¹³ ⁴⁵ ⁹⁶ ¹⁴⁶ ¹⁴⁸ pharmacokinetics after sub-Q injection appear to be similar during migraine attacks and pain-free periods.¹

Special Populations

In patients with hepatic impairment, bioavailability after oral administration may be markedly increased.¹⁴⁸ In a small study, AUC and peak plasma concentrations increased approximately 70% and time to peak plasma concentrations occurred 40 minutes earlier after oral administration compared with such values in healthy adults.¹⁴⁸

Onset

After oral administration, onset of relief of migraine symptoms generally occurs within 1–3 hours after single doses (25–100 mg),⁹² ¹⁴⁸ ¹⁶² ¹⁷⁸ ¹⁹¹ with maximum pain relief attained within 3–6 hours.¹⁴⁸ ¹⁷⁸ ¹⁹¹

After intranasal administration, onset of headache relief occurs within 30 minutes following a 10-, 20-, or 40-mg dose.¹²³ ²⁴³

After sub-Q administration, onset of pain relief usually occurs within 10–34 minutes in patients with moderate to severe migraine headache pain, with maximum relief attained within 1–2 hours;¹ ⁸ ⁹ ¹³ ⁴⁷ ⁵⁶ ¹⁶² ¹⁷⁶ ¹⁸¹ onset of pain relief generally occurs within 4–7 minutes in patients with cluster headache, with headache resolution shortly thereafter.⁴⁰ ⁴⁹ ⁷⁵ ¹⁸⁴

Food

Food does not appreciably affect oral bioavailability, but prolongs time to peak concentration.² ¹³ ⁴⁴ ¹⁴⁸

Distribution

Extent

Rapidly and widely distributed into body tissues after sub-Q administration.¹ ¹⁴ ¹⁴⁶ ¹⁴⁸ ¹⁶⁸

Distributed into human milk;¹ ¹⁴⁸ only small amounts cross placenta by passive transport in vitro.²³⁵

Plasma Protein Binding

Approximately 14–21%.¹ ¹⁴ ⁴⁵ ¹⁴⁸

Elimination

Metabolism

Metabolized in the liver and possibly in the GI tract principally to inactive indole acetic acid metabolite and other minor metabolites;¹ ² ³ ¹³ ¹⁴ ¹⁰⁴ ¹⁴⁸ ¹⁶⁶ metabolized principally by MAO-A isoenzyme in vitro.¹ ³⁷ ⁴⁸ ¹⁴⁸

Elimination Route

After oral administration, excreted in urine (57–60%) and feces (37–40%); only 3 and 9% of dose is excreted as unchanged drug in urine and feces, respectively.¹⁴ ⁴⁵ ¹⁴⁸ ¹³ ⁴⁵ ¹⁴⁸ ¹⁶⁶ ¹⁶⁸ After sub-Q administration, approximately 22 or 38–53% of dose is excreted in urine unchanged or as indole acetic acid metabolite, respectively;¹ ⁴⁵ ¹⁶⁸ 0.6 and 3.3% of dose is excreted in feces as unchanged drug and indole acetic acid metabolite, respectively.² ¹³ ¹⁴ ⁴⁵

Half-life

1.5–2.6 hours.¹ ⁶ ⁴⁴ ⁴⁵ ⁷⁸ ⁷⁹ ⁸⁹ ⁹¹ ¹⁴⁸ ¹⁶⁶ ¹⁶⁸ ²⁴⁹

Special Populations

In patients with renal impairment, pharmacokinetics not evaluated, but little clinical effect expected since drug is largely metabolized to an inactive metabolite.¹ ¹⁴⁸ ²⁴⁹

Stability

Storage

Oral

Tablets

2–30°C.¹⁴⁸

Intranasal

Solution

2–30°C; protect from light.²⁴⁹

Parenteral

Injection

2–30°C; protect from light.¹

Actions

Binds with high affinity to 5-HT type 1-like receptors, probably 5-HT_1B and 5-HT_1D subtypes.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ²²³ ²²⁴

Precise mechanism of action not established;⁴ ⁶ ⁹ ¹³ ⁷⁷ ⁸⁷ may ameliorate migraine and cluster headache through selective constriction of certain large cranial blood vessels and/or inhibition of neurogenic inflammatory processes in the CNS.¹ ² ³ ⁶ ⁷ ⁹ ¹⁰ ¹³ ⁴⁷ ⁶⁶ ⁷³ ⁷⁷ ⁸⁸ ¹¹⁰ ¹¹⁹ ¹³¹ ¹⁷⁷ ¹⁸⁴ ¹⁸⁶ ²¹⁷ ²³⁶ ²³⁷

Advice to Patients

Importance of immediately informing a clinician of any tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck, as well as sudden and/or severe abdominal pain, shortness of breath, wheezing, heart throbbing, facial swelling (e.g., eyelids, face, lips), rash, or hives after taking sumatriptan and of not taking sumatriptan again until evaluated by a clinician.¹

Importance of taking sumatriptan exactly as prescribed.¹ ¹⁴⁸ ²⁴⁹

Importance of providing patient a copy of manufacturer’s patient information.¹ ¹⁴⁸ ²⁴⁹ Importance of clinician providing adequate instructions, as well as the written administration instructions supplied with the autoinjection device or nasal spray, before first use.¹ ¹⁷¹ ²⁴⁹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).¹ ¹⁴⁸ ²⁴⁹

Importance of informing patients of risk of serotonin syndrome with concurrent use of sumatriptan and an SSRI or SNRI.²⁷² ²⁷³ ²⁷⁴ ²⁷⁵ Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.²⁷² ²⁷³ ²⁷⁴ ²⁷⁵

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ¹⁴⁸ ²⁴⁹

Importance of informing patients of other important precautionary information.¹ ¹⁴⁸ ²⁴⁹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Sumatriptan
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Nasal	Solution	5 mg/0.1 mL	Imitrex Nasal Spray	GlaxoSmithKline
		20 mg/0.1 mL	Imitrex Nasal Spray	GlaxoSmithKline

Sumatriptan Succinate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	25 mg (of sumatriptan)	Imitrex	GlaxoSmithKline
		50 mg (of sumatriptan)	Imitrex	GlaxoSmithKline
		100 mg (of sumatriptan)	Imitrex	GlaxoSmithKline
Parenteral	Injection, for sub-Q use only	4 mg/0.5 mL (of sumatriptan)	Imitrex (available in 0.5-mL [4-mg] unit-of-use syringes)	GlaxoSmithKline
		6 mg/0.5 mL (of sumatriptan)	Imitrex (available in 0.5-mL [6-mg] unit-of-use syringes and as 0.5 mL [6-mg] single-dose vials)	GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Imitrex 100MG Tablets (GLAXO SMITH KLINE): 9/$250.99 or 27/$743.93

Imitrex 20MG/ACT Solution (GLAXO SMITH KLINE): 6/$270.98 or 18/$790.96

Imitrex 25MG Tablets (GLAXO SMITH KLINE): 9/$272.65 or 27/$791.50

Imitrex 5MG/ACT Solution (GLAXO SMITH KLINE): 1/$55.49 or 3/$136.30

Imitrex 50MG Tablets (GLAXO SMITH KLINE): 9/$266.99 or 27/$774.99

Imitrex STATdose Refill 6MG/0.5ML Solution (GLAXO SMITH KLINE): 1/$217.16 or 3/$603.25

Imitrex STATdose System 6MG/0.5ML Solution (GLAXO SMITH KLINE): 1/$217.16 or 3/$628.59

SUMAtriptan 20MG/ACT Solution (SANDOZ): 1/$45.99 or 3/$119.96

SUMAtriptan 5MG/ACT Solution (SANDOZ): 1/$45.99 or 3/$125.97

SUMAtriptan Succinate 100MG Tablets (SUN PHARMACEUTICAL): 9/$199.97 or 27/$569.98

SUMAtriptan Succinate 25MG Tablets (SUN PHARMACEUTICAL): 9/$219.99 or 27/$619.95

SUMAtriptan Succinate 50MG Tablets (SUN PHARMACEUTICAL): 9/$199.99 or 27/$569.97

Sumavel DosePro 6MG/0.5ML Device (ZOGENIX): 1/$101.99 or 2/$291.97

Treximet 85-500MG Tablets (GLAXO SMITH KLINE): 9/$216.99 or 27/$607.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. Glaxo Wellcome. Imitrex (sumatriptan succinate) injection prescribing information. Research Triangle Park, NC; 2001 Mar.

2. Hsu VD. Sumatriptan: a new drug for vascular headache. Clin Pharm. 1992; 11:919-29. [IDIS 303852] [PubMed 1334452]

3. Bateman DN. Sumatriptan. Lancet. 1993; 341:221-4. [IDIS 308640] [PubMed 8093509]

4. Peroutka SJ. Serotonin receptor subtypes and neuropsychiatric diseases: focus on 5-HT_1D and 5-HT₃ receptor agents. Pharmacol Rev. 1991; 43:579-86. [IDIS 296518] [PubMed 1663621]

5. MacIntyre PD, Bhargava B, Hogg KJ et al. Effect of subcutaneous sumatriptan, a selective 5HT₁ agonist, on the systemic, pulmonary, and coronary circulation. Circulation. 1993; 87:401-5. [IDIS 309421] [PubMed 8381056]

6. Fullerton T, Gengo FM. Sumatriptan: a selective 5-hydroxytryptamine receptor agonist for the acute treatment of migraine. Ann Pharmacother. 1992; 26:800-8. [IDIS 298261] [PubMed 1319244]

7. Anon. Sumatriptan for migraine. Med Lett Drugs Ther. 1992; 34:91-3. [PubMed 1326077]

8. Ferrari MD and the Subcutaneous Sumatriptan International Study Group. Treatment of migraine attacks with sumatriptan. N Engl J Med. 1991; 325:316-21. [IDIS 283296] [PubMed 1647495]

9. Cady RK, Wendt JK, Kirchner JR et al. Treatment of acute migraine with subcutaneous sumatriptan. JAMA. 1991; 265:2831-5. [IDIS 281579] [PubMed 1851894]

10. Friberg L, Olesen J, Iversen HK et al. Migraine pain associated with middle cerebral artery dilatation: reversal by sumatriptan. Lancet. 1991; 338:13-7. [IDIS 282832] [PubMed 1676084]

11. Fox AW, Poe TE. Use and safety of sumatriptan. Clin Pharm. 1993; 12:258. [IDIS 311529] [PubMed 8384541]

12. Glaxo, Research Triangle Park, NC: Personal communication.

13. Plosker GL, McTavish D. Sumatriptan: a reappraisal of its pharmacology and therapeutic efficacy in the acute treatment of migraine and cluster headache. Drugs. 1994; 47:622-51. [PubMed 7516861]

14. Dixon CM, Saynor DA, Andrew PD et al. Disposition of sumatriptan in laboratory animals and humans. Drug Metabol Disp. 1993; 21:761-9.

15. Dechant KL, Clissold SP. Sumatriptan: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the acute treatment of migraine and cluster headache. Drugs. 1992; 43:776-98. [PubMed 1379152]

16. D’Arcy PF. Adverse drug reaction (ADR) problems with sumatriptan. Intl Pharm J. 1992; 6:264-5.

17. D’Arcy PF. Warnings from the UK committee on safety of medicines: chest pain with sumatriptan. Intl Pharm J. 1992; 6:217-8.

18. Willett F, Curzen N, Adams J et al. Coronary vasospasm induced by subcutaneous sumatriptan. BMJ. 1992; 304:1415. [IDIS 297248] [PubMed 1320974]

19. Price LH, Charney DS, Delgado PL et al. Lithium treatment and serotoninergic function. Arch Gen Psych. 1989; 46:13-9.

20. Castle WM, Simmons VE. Coronary vasospasm and sumatriptan. BMJ. 1992; 305:117-8. [IDIS 299098] [PubMed 1322216]

21. Stricker BHC. Coronary v

Wednesday, May 9, 2012

Caprelsa

Pronunciation: van-DET-a-nib
Generic Name: Vandetanib
Brand Name: Caprelsa

Caprelsa may cause serious and sometimes fatal irregular heartbeat (eg, QT prolongation). Sudden deaths have been reported in patients taking Caprelsa. It is thought that serious irregular heartbeat may have contributed to these sudden deaths. Do not take Caprelsa if you have low blood potassium, calcium, or magnesium levels. Do not take it if you have a history of QT prolongation or long QT syndrome. Certain medicines may increase the risk of irregular heartbeat. Tell your doctor about any other medicines or supplements you take. Tell your doctor or seek medical care at once if irregular heartbeat or fainting occurs.

Electrocardiograms (ECGs) will be performed before and during treatment. These tests are used to check for irregular heartbeat. Be sure to keep all doctor and lab appointments.

Caprelsa is used for:

Treating certain types of medullary thyroid cancer. It may also be used for other conditions as determined by your doctor.

Caprelsa is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Caprelsa if:

you are allergic to any ingredient in Caprelsa

you have a history of certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome, very slow heartbeat)

you have low blood potassium, calcium, or magnesium levels; uncontrolled heart failure; moderate to severe liver problems; or active, severe bleeding

you are coughing up blood

you are taking a barbiturate (eg, phenobarbital), carbamazepine, dexamethasone, efavirenz, a hydantoin (eg, phenytoin), primidone, a rifamycin (eg, rifampin), or St. John's wort

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

Before using Caprelsa:

Some medical conditions may interact with Caprelsa. 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 a member of your family has a history of QT prolongation

if you have a history of heart problems (eg, congestive heart failure; fast, slow, or irregular heartbeat), a heart attack, liver or kidney problems, lung or breathing problems, bleeding problems, high blood pressure, or abnormal blood electrolyte (eg, calcium, potassium, magnesium) levels

if you have an underactive thyroid or high blood levels of thyroid-stimulating hormone (TSH)

if you have a history of seizures or you are taking medicine for seizures

if you have skin problems, diarrhea, low white blood cell levels, low blood platelet levels, or a recent history of coughing up blood

if you take or have taken any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

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

Antiarrhythmics (eg, amiodarone, dofetilide, procainamide), arsenic, astemizole, bepridil, chloroquine, cisapride, dasatinib, dolasetron, domperidone, droperidol, granisetron, halofantrine, haloperidol, iloperidone, ketolides (eg, telithromycin), lapatinib, macrolide antibiotics (eg, clarithromycin), maprotiline, methadone, nilotinib, paliperidone, pentamidine, phenothiazines (eg, chlorpromazine), pimozide, quinolones (eg, moxifloxacin), sunitinib, tacrolimus, terfenadine, tetrabenazine, tricyclic antidepressants (eg, imipramine), or ziprasidone because the risk of severe and possibly fatal irregular heartbeat may be increased

Barbiturates (eg, phenobarbital), carbamazepine, dexamethasone, efavirenz, hydantoins (eg, phenytoin), primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Caprelsa's effectiveness

Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Caprelsa

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

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

Caprelsa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Caprelsa refilled.

Take Caprelsa by mouth with or without food.

Swallow Caprelsa whole. Do not break, crush, or chew before swallowing.

If you cannot swallow Caprelsa whole, place your dose in a glass containing 2 oz (60 mL) of non-carbonated water only. Stir the mixture for about 10 minutes until the medicine is in very small pieces (the tablets will not completely dissolve). Drink all of the mixture right away. Rinse the container with an additional 4 oz (120 mL) of non-carbonated water and drink the contents to be sure that the entire dose is taken.

If a tablet is crushed, avoid contact with it. If a crushed tablet comes into contact with your skin or your eyes, nose, lips, or mouth, wash thoroughly with water.

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

If you miss a dose of Caprelsa, take it as soon as possible. If it is within 12 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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

Do NOT take more than the recommended dose, change your dose, or stop taking Caprelsa without checking with your doctor.

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

Caprelsa should usually not be used with other medicines that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are not sure if any of your medicines may increase the risk of this type of irregular heartbeat.

Caprelsa may increase the risk of bleeding. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Caprelsa may cause you to become sunburned more easily while you take it and for at least 4 months after you stop it. Avoid the sun, sunlamps, or tanning booths until you know how you react to Caprelsa. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. If you have diarrhea, you may need to take an anti-diarrheal medicine. Contact your doctor for instructions.

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

Women who may become pregnant must use an effective form of birth control while taking Caprelsa and for 4 months after stopping it. If you have questions about effective birth control, talk with your doctor.

Lab tests, including ECGs; liver, thyroid, and kidney function; blood pressure; eye exams; blood electrolyte levels; and complete blood cell counts, may be performed while you use Caprelsa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

PREGNANCY and BREAST-FEEDING: Caprelsa may cause harm to the fetus. Do not become pregnant while you are taking it or for 4 months after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Caprelsa while you are pregnant. It is not known if Caprelsa is found in breast milk. Do not breast-feed while taking Caprelsa.

Possible side effects of Caprelsa:

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:

Acne; diarrhea; dry skin; headache; loss of appetite; mild stomach pain or upset; nausea; tiredness; trouble sleeping; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts or trouble thinking; black or bloody stools; blood in the urine; confusion; coughing up blood; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; light-headedness; mental or mood changes (eg, depression); mouth sores or blisters; muscle or joint aches; numbness or weakness of the face, arm, or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizure; severe or persistent cough; severe or persistent diarrhea, dizziness, headache, tiredness, or weakness; shortness of breath or other breathing problems; slurred speech; sudden coordination problems; sudden trouble walking or balancing; sudden, unusual weight gain; swelling of the hands, feet, or ankles; tingling, pain, redness, or swelling of the palms of the hands and soles of the feet; unusual bruising or bleeding; vision changes (eg, blurred vision); vomit that looks like coffee grounds.

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: Caprelsa side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea, rash, severe headache.

Proper storage of Caprelsa:

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

General information:

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

Caprelsa 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 Caprelsa. 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 Caprelsa resources

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

Compare Caprelsa with other medications

Thyroid Cancer

Friday, May 25, 2012

Naprelan

Commonly used brand name(s)

Uses For Naprelan

Before Using Naprelan

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of naproxen

Dosing

Missed Dose

Storage

Precautions While Using Naprelan

Naprelan Side Effects

More Naprelan resources

Compare Naprelan with other medications

Thursday, May 17, 2012

Sterets Unisept (Molnlycke Health Care )

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Monday, May 14, 2012

Adoxa TT

Commonly used brand name(s)

Uses For Adoxa TT

Before Using Adoxa TT

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of doxycycline

Dosing

Missed Dose

Storage

Precautions While Using Adoxa TT

Adoxa TT Side Effects

More Adoxa TT resources

Compare Adoxa TT with other medications

Sunday, May 13, 2012

Sumatriptan

Introduction

Uses for Sumatriptan

Vascular Headaches

Sumatriptan Dosage and Administration

Administration

Oral Administration