List Article Directory New Hampshire: April 2012

Sunday 29 April 2012

Boots Paracetamol 500 mg Capsules (GSL -16)

Boots Paracetamol 500 mg Capsules

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains a painkiller to relieve mild to moderate pain and fever.

It can be used to relieve headaches, migraine, rheumatic aches and pains, muscular pain and back pain, neuralgia, toothache, sore throat, period pain, fever and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

If you are allergic to any of the ingredients

Talk to your pharmacist or doctor:

If you have severe kidney problems or severe liver problems (including a disease caused by drinking alcohol)

If you are pregnant

You can take this medicine if you are breastfeeding.

Other important information

Information about some of the ingredients:

Propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) in this medicine may cause allergic reactions (possibly delayed).

If you take other medicines

This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Metoclopramide or domperidone (for feeling sick or being sick)

Colestyramine (to reduce blood fat levels)

Warfarin or other blood thinners - If you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Adults and children of 12 years and over: Take one or two capsules three or four times a day, if you need to.

Don’t take more than 8 capsules in any 24 hours.

Don’t take more often than every 4 hours.

Swallow each capsule with water.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too many capsules:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

Skin rash

Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each hard gelatin capsule contains Paracetamol 500 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain pregelatinised maize starch, magnesium stearate, sodium laurilsulfate. The capsule shell contains titanium dioxide (E171), erythrosine (E127), quinoline yellow (E104), Patent Blue V (E131), gelatin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).

The pack contains 16 hard gelatin capsules with a red cap and white body.

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by the Marketing Authorisation holder

Bristol Laboratories Ltd

Unit 3 Canalside

Northbridge Road

Berkhamsted

Hertfordshire

HP4 1EG

Leaflet prepared June 2007

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

3448eMC-Xpil

Saturday 28 April 2012

Migraleve (McNeil Products Ltd)

1. Name Of The Medicinal Product

Migraleve

2. Qualitative And Quantitative Composition

Each Migraleve Pink tablet contains:
Paracetamol DC 96% (equivalent to Paracetamol 500 mg) Codeine Phosphate Buclizine Hydrochloride	520 mg 8 mg 6.25 mg
Each Migraleve Yellow tablet contains:
Paracetamol DC 96% (equivalent to Paracetamol 500 mg) Codeine Phosphate	520 mg 8 mg

3. Pharmaceutical Form

Film-coated Tablets.

Migraleve Pink Tablets

Pink, capsule-shaped, film-coated tablets marked MGE on one face.

Migraleve Yellow Tablets

Yellow, capsule-shaped, film-coated tablets marked MGE on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term treatment of acute moderate pain which is not relieved by Paracetamol, ibuprofen or aspirin alone such as migraine attacks including the symptoms of migraine headache, nausea and vomiting.

4.2 Posology And Method Of Administration

Do not take for more than 3 days continuously without medical review. If prescribed do not take for longer than directed.

Adults and the elderly: Two Migraleve Pink tablets to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatment is required, two Migraleve Yellow tablets every 4 hours.

Maximum dose: 8 tablets (two Migraleve Pink and six Migraleve Yellow) in 24 hours.

Children 10 - 14 years: One Migraleve Pink tablet to be swallowed immediately it is known that a migraine attack has started or is imminent. If further treatment is required, one Migraleve Yellow tablet every 4 hours.

Maximum dose: 4 tablets (one Migraleve Pink and three Migraleve Yellow) in 24 hours.

Do not give to children under 10 years of age except under medical supervision.

4.3 Contraindications

Do not give to children under 10 years of age except under medical supervision. Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Migraine should be medically diagnosed. Because some medicines do not combine, if you are already taking prescribed medicines please consult your doctor. If symptoms persist, consult your doctor.

Some individuals may be ultra-rapid metabolisers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labelled dosage regimens, individuals who are ultra-rapid metabolisers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese, Japanese and Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians and Arabs.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and inform their patients about these risks and the signs of morphine overdose (see section 4.6 Use during pregnancy and lactation).

Migraleve tablets contain potent medicaments and should not be taken continuously for extended periods without the advice of a doctor. Do not exceed the stated dose. Migraleve Pink Tablets only: May cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink. Should be used with caution in patients with severe renal disease or liver dysfunction.

Keep out of the reach and sight of children.

For products in packs of 32 tablets or fewer:

Front of pack

• Can cause addiction.

• For three days use only.

Back of Pack

• Migraleve is for use in acute moderate pain associated with migraine which has been previously diagnosed by a doctor and where other painkillers have not worked. Do not take less than four hours after taking other painkillers.

• List of indications as agreed in 4.1 of the SmPC.

• If you need to take this medicine for more than three days you must see your doctor or pharmacist.

• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. If you take this medicine for headaches for more than three days it can make them worse.

For both POM and P products:

Patient Information Leaflet

Headlines (at the start of the PIL)

• For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone such as migraine attacks including the symptoms of migraine headache, nausea and vomiting.

• You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.

• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

• If you take this medicine for headaches for more than three days it can make them worse.

Section 1: What this medicine is for

For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone such as migraine attacks including the symptoms of migraine headache, nausea and vomiting.

Section 2: Before taking this medicine

• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

• If you take this painkiller for headaches for more than three days it can make them worse.

Section 3: How to take this medicine

Under the sub-heading 'Check the tables below to see how much medicine to take'

• Do not take less than four hours after taking other painkillers.

• Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist.

Under the sub-heading 'Special warnings about addiction'

• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Section 4: Possible Side-effects

Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk ; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.

Under the sub-heading 'How do I know if I am addicted?'

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time.

• You need to take more than the recommended dose.

• When you stop taking the medicine you feel unwell but you feel better when you start taking the medicine again.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Although experiments in some animal species gave rise to adverse effects following the administration of buclizine to pregnant animals e.g. foetal abnormalities and maternal deaths, these occurred at doses in excess of 120 times the human daily dose. Whilst there are no specific reasons for contra-indicating Migraleve during pregnancy, as with all drugs it is recommended that Migraleve be used in pregnancy only when the physician has considered the need in respect of the patients' welfare.

Migraleve is not contra-indicated in breast-feeding mothers; however, codeine and its active metabolite, morphine, are secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low. Some women rapidly metabolise codeine, which may result in higher serum levels of codeine's active metabolite, morphine, in breast milk and, therefore, potentially dangerous levels of serum morphine in their breastfed infants. This could lead to potentially serious adverse reactions, including death, in nursing infants. Mothers using codeine should be informed about how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breast-feeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers should be instructed to talk to the baby's doctor immediately or seek emergency medical care.

Nursing mothers who rapidly metabolise codeine may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating paediatricians about the use of codeine during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Migraleve Pink Tablets only: May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

4.8 Undesirable Effects

Rare allergic reactions to paracetamol, such as skin rashes, hives or itching. Codeine may cause constipation. Buclizine hydrochloride may cause drowsiness.

Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped.

Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

• Regularly consumes ethanol in excess of recommended amounts.

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.

Codeine

The effects in codeine overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Codeine overdose associated with central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management of codeine overdose includes general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

5.1 Pharmacodynamic Properties

Paracetamol has analgesic, antipyretic and mild, acute anti-inflammatory properties. Paracetamol inhibits prostaglandin synthesis, especially in the CNS. Paracetamol does not inhibit chronic inflammatory reactions.

Codeine is an opioid analgesic. Codeine also has anti-tussive properties.

The combination of paracetamol and codeine has been shown to have hyperadditive analgesic effects in animals.

Buclizine is a piperazine derivative with the actions and uses of H₁-receptor antagonists. It has anti-muscarinic and central sedative properties. It is used mainly for its anti-emetic properties.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly absorbed from the upper G.I. tract after oral administration, with the small intestine being an important site of absorption. Peak blood levels of 15-20 mcg/ml after normal 1 g oral doses of paracetamol occur within 30 - 90 minutes. Depending upon dosage form, it is rapidly distributed throughout the body and is primarily metabolised in the liver with excretion via the kidney. Elimination half-life is about 2 hours after reaching a peak following a 1 g oral dose. Paracetamol crosses the placental barrier and is present in breast milk.

Codeine is absorbed from the gastro-intestinal tract and peak plasma concentrations occur after one hour. Codeine is metabolised by O- and N-demethylation in the liver to morphine, norcodeine and other metabolites. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid. Codeine is not extensively bound to plasma proteins. The plasma half-life has been reported to be between 3 and 4 hours.

Buclizine hydrochloride is more slowly absorbed from the G.I. tract (T_max 3 hours). The elimination half-life is approximately 15 hours.

5.3 Preclinical Safety Data

No data presented.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Migraleve Pink Tablets

Gelatin

Magnesium Stearate

Colloidal Anhydrous Silica

Stearic Acid

Pregelatinised Maize Starch

Erythrosine (E127)

Hypromellose

Titanium Dioxide (E171)

Macrogol 400

Aluminium Oxide

Migraleve Yellow Tablets

Gelatin

Magnesium Stearate

Colloidal Anhydrous Silica

Stearic Acid

Pregelatinised Maize Starch

Hypromellose

Titanium Dioxide (E171)

Macrogol 400

Iron Oxide Yellow (E172)

Quinoline Yellow (E104)

Aluminium Oxide

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Packs of: 12 tablets (8 Migraleve Pink and 4 Migraleve Yellow)

Packs of: 24 tablets (16 Migraleve Pink and 8 Migraleve Yellow)

Packs of: 48 tablets (32 Migraleve Pink and 16 Migraleve Yellow)

Blister strips consist of clear amber PVC blister film and paper/aluminium foil child-resistant blister lidding.

6.6 Special Precautions For Disposal And Other Handling

None.

Administrative data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0105

9. Date Of First Authorisation/Renewal Of The Authorisation

23 April 2001/ 28 Jan 2009

10. Date Of Revision Of The Text

12 April 2010

Legal Category

Packs of 12 and 24 tablets: P

Packs of 48 tablets: POM

Friday 27 April 2012

Meda Pharmaceuticals

Address

Meda Pharmaceuticals,
265 Davidson Ave., Suite 300

Somerset, NJ 08873-4120

Contact Details

Phone: (732) 564-2200
Website: http://www.medpointepharma.com
Careers: http://www.medapharma.appone.com/

Somatropin (rDNA origin - Refrigerated) Vials

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Refrigerated)
Brand Name: Nutropin AQ

Somatropin (rDNA origin - Refrigerated) Vials are used for:

Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or other conditions (eg, chronic kidney problems, idiopathic short stature). It may also be used for other conditions as determined by your doctor.

Somatropin (rDNA origin - Refrigerated) Vials are a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.

Do NOT use Somatropin (rDNA origin - Refrigerated) Vials if:

you are allergic to any ingredient in Somatropin (rDNA origin - Refrigerated) Vials

you have been or are being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing

you have premature epiphyseal closure (your bone growth is complete) or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)

you have certain eye problems caused by diabetes (eg, diabetic retinopathy)

you have Prader-Willi syndrome and are severely overweight or have severe breathing problems

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

Before using Somatropin (rDNA origin - Refrigerated) Vials:

Some medical conditions may interact with Somatropin (rDNA origin - Refrigerated) Vials. 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 endocrine problems including pituitary or adrenal gland problems, diabetes or a family history of diabetes, eye problems caused by diabetes, or an underactive thyroid

if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer

if you have curvature of the spine (scoliosis), kidney or liver problems, ear or hearing problems (eg, repeated ear infection), Prader-Willi syndrome, are severely overweight, or have had recent major surgery or trauma

Some MEDICINES MAY INTERACT with Somatropin (rDNA origin - Refrigerated) Vials. Tell your health care provider if you are taking any other medicines, especially any of the following:

Corticosteroids (eg, prednisone) because they may decrease Somatropin (rDNA origin - Refrigerated) Vials's effectiveness

Anticonvulsants (eg, phenytoin, carbamazepine) or cyclosporine because the risk of their side effects may be increased or their effectiveness may be decreased by Somatropin (rDNA origin - Refrigerated) Vials

This may not be a complete list of all interactions that may occur. Ask your health care provider if Somatropin (rDNA origin - Refrigerated) Vials 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 Somatropin (rDNA origin - Refrigerated) Vials:

Use Somatropin (rDNA origin - Refrigerated) Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Somatropin (rDNA origin - Refrigerated) Vials are given as an injection. A health care provider will teach you how to use it. Be sure you understand how to use Somatropin (rDNA origin - Refrigerated) Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Allow Somatropin (rDNA origin - Refrigerated) Vials to come to room temperature before you use it.

Wash your hands before and immediately after using Somatropin (rDNA origin - Refrigerated) Vials.

Use a new needle each time you inject Somatropin (rDNA origin - Refrigerated) Vials. Do not reuse needles.

Do not use Somatropin (rDNA origin - Refrigerated) Vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.

Always rotate injection sites each time you use Somatropin (rDNA origin - Refrigerated) Vials.

Do not shake Somatropin (rDNA origin - Refrigerated) Vials. Swirl gently to mix it.

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. Follow all local rules for disposal.

If you miss a dose of Somatropin (rDNA origin - Refrigerated) Vials, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Somatropin (rDNA origin - Refrigerated) Vials.

Important safety information:

Somatropin (rDNA origin - Refrigerated) Vials may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Somatropin (rDNA origin - Refrigerated) Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Rare, sometimes fatal, lung and breathing problems may be caused by Somatropin (rDNA origin - Refrigerated) Vials in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Somatropin (rDNA origin - Refrigerated) Vials, contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Somatropin (rDNA origin - Refrigerated) Vials. Somatropin (rDNA origin - Refrigerated) Vials may need to be stopped.

Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Somatropin (rDNA origin - Refrigerated) Vials. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.

Rarely, children using Somatropin (rDNA origin - Refrigerated) Vials have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.

Somatropin (rDNA origin - Refrigerated) Vials may have benzyl alcohol, metacresol, or glycerin in it. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol, metacresol, or glycerin.

Diabetes patients - Somatropin (rDNA origin - Refrigerated) Vials may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine or your diet.

Lab tests, including blood sugar levels and thyroid function, may be performed while you use Somatropin (rDNA origin - Refrigerated) Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Somatropin (rDNA origin - Refrigerated) Vials with caution in the ELDERLY; they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Somatropin (rDNA origin - Refrigerated) Vials while you are pregnant. It is not known if Somatropin (rDNA origin - Refrigerated) Vials are found in breast milk. If you are or will be breast-feeding while you use Somatropin (rDNA origin - Refrigerated) Vials, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Somatropin (rDNA origin - Refrigerated) Vials:

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:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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: Somatropin (rDNA origin - Refrigerated) 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 excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Somatropin (rDNA origin - Refrigerated) Vials:

Before mixing, store Somatropin (rDNA origin - Refrigerated) Vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from heat, moisture, and light. Do not use Somatropin (rDNA origin - Refrigerated) Vials past the expiration date on the product label. After mixing, store Somatropin (rDNA origin - Refrigerated) Vials according to the product label. Contact your pharmacist if you have any questions about the proper storage of Somatropin (rDNA origin - Refrigerated) Vials. Keep Somatropin (rDNA origin - Refrigerated) Vials, as well as needles and syringes, out of the reach of children and away from pets.

General information:

If you have any questions about Somatropin (rDNA origin - Refrigerated) Vials, please talk with your doctor, pharmacist, or other health care provider.

Somatropin (rDNA origin - Refrigerated) Vials are to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Somatropin (rDNA origin - Refrigerated) Vials. 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 Somatropin (rDNA origin - Refrigerated) resources

Somatropin (rDNA origin - Refrigerated) Side Effects (in more detail)
Somatropin (rDNA origin - Refrigerated) Use in Pregnancy & Breastfeeding
Somatropin (rDNA origin - Refrigerated) Drug Interactions
Somatropin (rDNA origin - Refrigerated) Support Group
13 Reviews for Somatropin (rDNA origin - Refrigerated) - Add your own review/rating

Compare Somatropin (rDNA origin - Refrigerated) with other medications

Adult Human Growth Hormone Deficiency
AIDS Related Wasting
Burns, Nitrogen Retention
Cachexia
Growth Retardation, Chronic Renal Failure
Hypopituitarism
Idiopathic Short Stature
Noonan's Syndrome
Pediatric Growth Hormone Deficiency
Short Bowel Syndrome
Short Stature for Age
Turner's Syndrome

Wednesday 25 April 2012

lansoprazole

Generic Name: lansoprazole (lan SOE pra zol)

Brand names: Prevacid, Prevacid OTC, Prevacid SoluTab, Prevacid I.V.

What is lansoprazole?

Lansoprazole is a proton pump inhibitors. Lansoprazole decreases the amount of acid produced in the stomach.

Lansoprazole is used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.

Lansoprazole is not for immediate relief of heartburn symptoms.

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

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

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Ask a doctor or pharmacist if it is safe for you to take lansoprazole if you have liver disease, or low levels of magnesium in your blood.

Lansoprazole is not for immediate relief of heartburn symptoms.

Some conditions are treated with a combination of lansoprazole and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also take sucralfate (Carafate), avoid taking it at the same time you take lansoprazole. Sucralfate can make it harder for your body to absorb lansoprazole. Wait at least 30 minutes after taking lansoprazole before you take sucralfate.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Prevacid 24HR should be taken only once every 24 hours for 14 days. It may take up to 4 days for full effect. Do not take more than one tablet every 24 hours.

Allow at least 4 months to pass before you start another 14-day treatment with Prevacid 24HR. Call your doctor if you have additional symptoms and need treatment before the 4 months has passed.

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

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

Ask a doctor or pharmacist if it is safe for you to take lansoprazole if you have liver disease, or low levels of magnesium in your blood.

Do not use over-the-counter lansoprazole (Prevacid 24HR) without the advice of a doctor if you have:

trouble or pain with swallowing;

bloody or black stools;

vomit that looks like blood or coffee grounds;

heartburn that has lasted for over 3 months;

frequent chest pain;

heartburn with wheezing;

unexplained weight loss;

nausea or vomiting;

stomach pain; or

an electrolyte imbalance or metabolic disorder.

Taking a proton pump inhibitor such as lansoprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether lansoprazole is the actual cause of an increased risk of fracture. Before you take this medication, tell your doctor if you have osteoporosis or osteopenia (low bone mineral density). 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 lansoprazole 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.

Some forms of lansoprazole may contain phenylalanine. Tell your doctor if you have phenylketonuria.

Do not give this medication to a child younger than 1 year old.

How should I take lansoprazole?

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.

Lansoprazole is usually taken before eating. Follow your doctor's instructions.

Do not crush or break a delayed-release capsule. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

If you are unable to swallow a delayed-release capsule whole: Open the capsule and sprinkle the medicine into a spoonful of pudding, applesauce, yogurt, cottage cheese, strained pears, or a nutritional drink such as Ensure. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

You may also dissolve the medicine from a lansoprazole capsule in 2 ounces (1/4 cup) of apple juice, orange juice, or tomato juice. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more juice to the same glass, swirl gently and drink right away.

Dissolve the oral granules in 2 tablespoons of water. Use only water when mixing lansoprazole oral granules. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

To take lansoprazole orally disintegrating tablet: Use dry hands to remove the tablet and place it in your mouth. It will begin to dissolve right away. Allow the tablet to dissolve in your mouth without chewing, swallowing several times as it dissolves.

The orally disintegrating tablet should not be given with an oral syringe or given through a nasogastric (NG) feeding tube. The tablet may not dissolve completely and could clog the syringe or tube.

Prevacid 24HR should be taken only once every 24 hours for 14 days. Take the medicine in the morning before you eat breakfast. It may take up to 4 days for full effect. Do not take more than one tablet every 24 hours.

Allow at least 4 months to pass before you start another 14-day treatment with Prevacid 24HR. Call your doctor if you have additional symptoms and need treatment before the 4 months has passed.

Do not crush, chew, or break a Prevacid 24HR capsule. Swallow the pill whole. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking lansoprazole?

Lansoprazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using lansoprazole and call your doctor at once if you have symptoms of low magnesium:

dizziness, confusion;

fast or uneven heart rate;

jerky muscle movements;

feeling jittery;

muscle cramps, muscle weakness or limp feeling;

cough or choking feeling; or

seizure.

Less serious side effects may include:

headache;

nausea, stomach pain;

diarrhea; or

constipation.

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.

Lansoprazole Dosing Information

Usual Adult Dose for Erosive Esophagitis:

Initial dose: 30 mg orally once a day for up to 8 weeks. Alternatively, if the patient is unable to use oral route the dose may be given as an IV infusion of 30 mg per day administered over 30 minutes for up to 7 days.

Maintenance dose: 15 mg orally once a day.

Usual Adult Dose for Duodenal Ulcer:

15 mg orally once a day 30 minutes before eating. Therapy should be continued for up to 4 weeks.

Usual Adult Dose for Gastroesophageal Reflux Disease:

15 mg orally once a day. Therapy should be continued for up to 8 weeks.

Usual Adult Dose for Gastric Ulcer:

30 mg orally once a day 30 minutes before eating. Therapy should be continued for 4 to 8 weeks.

Usual Adult Dose for Multiple Endocrine Adenomas:

60 mg orally once a day. Doses up to 90 mg orally 2 times a day have been used. The manufacturer reports that some patients have been treated continuously for as long as four years.

Usual Adult Dose for Systemic Mastocytosis:

60 mg orally once a day. Doses up to 90 mg orally 2 times a day have been used. The manufacturer reports that some patients have been treated continuously for as long as four years.

Usual Adult Dose for Zollinger-Ellison Syndrome:

60 mg orally once a day. Doses up to 90 mg orally 2 times a day have been used. The manufacturer reports that some patients have been treated continuously for as long as four years.

Usual Adult Dose for Helicobacter pylori Infection:

Triple therapy: lansoprazole 30 mg is combined with 1 g of amoxicillin and 500 mg of clarithromycin given orally every 12 hours for 10 or 14 days. Most investigators recommend treatment with at least two antimicrobial agents in order to achieve eradication. Monotherapy with lansoprazole is ineffective and should be avoided.

Dual therapy: lansoprazole 30 mg is combined with 1 gram of amoxicillin given orally every 8 hours for 14 days. Refer to the monograph for amoxicillin and/or clarithromycin for dosing information specific to elderly or renally-impaired patients.

Usual Adult Dose for Duodenal Ulcer Prophylaxis:

15 mg orally once a day 30 minutes before eating. Studies evaluating maintenance therapy for duodenal ulcers have not extended beyond 12 months.

Usual Adult Dose for NSAID-Induced Gastric Ulcer:

30 mg orally once a day for 8 weeks.

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

15 mg orally once a day for up to 12 weeks.

Usual Pediatric Dose for Aspiration Pneumonia:

Study (n=120)
Greater than 3 to 11 years: 30 mg at 9 p.m. the night before surgery, and 30 mg at 5:30 a.m. the day of surgery.

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

Short term treatment of GERD (up to 12 weeks):
1 to 11 years:
Less than or equal to 30 kg = 15 mg once daily
Greater than 30 kg = 30 mg once daily

12 to 17 years: 15 mg once daily for up to 8 weeks

Usual Pediatric Dose for Erosive Esophagitis:

Short term treatment (up to 12 weeks):
1 to 11 years:
Less than or equal to 30 kg = 15 mg once daily
Greater than 30 kg = 30 mg once daily, up to 30 mg twice daily.

Short term treatment (up to 8 weeks):
12 to 17 years: 30 mg once daily
An additional 8 weeks may be tried in those patients who fail to respond or for a recurrence.
Maintenance: 15 mg once daily

What other drugs will affect lansoprazole?

Tell your doctor about all other medicines you use, especially:

ampicillin (Principen, Unasyn);

atazanavir (Reyataz);

digoxin (Lanoxin, Lanoxicaps);

ketoconazole (Nizoral);

a blood thinner such as warfarin (Coumadin, Jantoven);

a diuretic (water pill);

iron (Feosol, Mol-Iron, Fergon, Femiron, others); or

theophylline (such as Elixophyllin, Respbid, Slo-Bid, Theobid, Theoclear, Theo-Dur, Uniphyl).

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

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

lansoprazole Advanced Consumer (Micromedex) - Includes Dosage Information

Lansoprazole Monograph (AHFS DI)

Lansoprazole MedFacts Consumer Leaflet (Wolters Kluwer)

Lansoprazole Prescribing Information (FDA)

Lansoprazole Professional Patient Advice (Wolters Kluwer)

Prevacid Prescribing Information (FDA)

Prevacid Consumer Overview

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

Prevacid SoluTab Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare lansoprazole with other medications

Aspiration Pneumonia
Barrett's Esophagus
Duodenal Ulcer
Duodenal Ulcer Prophylaxis
Erosive Esophagitis
GERD
Helicobacter Pylori Infection
Multiple Endocrine Adenomas
NSAID-Induced Gastric Ulcer
NSAID-Induced Ulcer Prophylaxis
Stomach Ulcer
Systemic Mastocytosis
Zollinger-Ellison Syndrome

Where can I get more information?

Your pharmacist can provide more information about lansoprazole.

See also: lansoprazole side effects (in more detail)

hepatitis b vaccine recombinant Intramuscular

hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Commonly used brand name(s)

In the U.S.

Engerix-B

Engerix-B Pediatric

Recombivax HB

Recombivax HB Pediatric/Adolescent

Available Dosage Forms:

Suspension

Therapeutic Class: Vaccine

Uses For hepatitis b vaccine recombinant

Hepatitis B vaccine recombinant is used to prevent infection by the hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Hepatitis B vaccine recombinant is made without any human blood or blood products or any other substances of human origin. It cannot give you the hepatitis B virus (HBV) or the human immunodeficiency virus (HIV).

HBV infection is a major cause of serious liver diseases, such as hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, children, and adolescents up to 19 years of age. It is also recommended for adults who live in areas that have a high rate of hepatitis B disease or who may be at increased risk of infection from hepatitis B virus. These adults include:

Sexually active homosexual and bisexual males, including those with HIV infection.

Sexually active heterosexual persons with multiple partners.

Persons who may be exposed to the virus by means of blood, blood products, or human bites, such as health care workers, employees in medical facilities, patients and staff of live-in facilities and daycare programs for the developmentally disabled, morticians and embalmers, police and fire department personnel, and military personnel.

Persons who have kidney disease or who undergo blood dialysis for kidney disease.

Persons with blood clotting disorders who receive transfusions of clotting-factor concentrates.

Household and sexual contacts of HBV carriers.

Persons in areas with high risk of HBV infection [in the population], such as Alaskan Eskimos, Pacific Islanders, Haitian and Indochinese immigrants, and refugees from areas that have a high rate of hepatitis B disease; persons accepting orphans or adoptees from these areas; and travelers to these areas.

Persons who use illegal injection drugs.

Prisoners.

This vaccine is available only from your doctor or other authorized health care professional.

Before Using hepatitis b vaccine recombinant

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hepatitis b vaccine recombinant 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hepatitis B vaccine recombinant in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis B vaccine recombinant in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hepatitis b vaccine recombinant

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into one of your muscles. If you have bleeding problems such as hemophilia, the vaccine may be given as a shot under your skin.

This vaccine is usually given as 3 doses. After the first dose, two more doses are given 1 month and 6 months after the first dose, unless your doctor tells you otherwise.

Precautions While Using hepatitis b vaccine recombinant

It is very important that you or your child return to your doctor’s office at the right time for the second and third dose. Be sure to notify your doctor of any unwanted effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Tell your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contain dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.

This vaccine may not protect you against hepatitis B infection if you are already infected with the virus at the time you receive the shot.

hepatitis b vaccine recombinant 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 or nurse immediately if any of the following side effects occur:

More common

Fever of 37.7 degrees C (100 degrees F) or higher

Rare

Aches or pain in the joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)

blurred vision or other vision changes

confusion

difficulty with breathing or swallowing

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

hives

itching, especially of the feet or hands

muscle weakness

numbness or tingling of the arms and legs

reddening of the skin, especially around the ears

sweating

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

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

Dizziness

headache

soreness at the injection site

Less common

Hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the injection site

unusual tiredness or weakness

Rare

Aches or pain in the muscles

agitation

back pain or stiffness or pain in neck or shoulder

chills

constipation

diarrhea

difficulty with moving

feeling of warmth

general feeling of discomfort or illness

headache (mild), sore throat, runny nose, or fever (mild)

increased sweating

itching

lack of appetite or decreased appetite

nausea or vomiting

redness of the face, neck, arms, and occasionally, upper chest

sleepiness or unusual drowsiness

sleeplessness

stomach cramps or pain

sudden redness of skin

swelling of glands in the armpit or neck

trouble with sleeping

unable to sleep

welts

weight loss

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: hepatitis b vaccine recombinant Intramuscular side effects (in more detail)

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

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

More hepatitis b vaccine recombinant Intramuscular resources

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

Compare hepatitis b vaccine recombinant Intramuscular with other medications

Hepatitis B Prevention

meclofenamate

Generic Name: meclofenamate (me kloe fen AM ate)

Brand Names: Meclomen

What is meclofenamate?

Meclofenamate is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Meclofenamate works by reducing hormones that cause inflammation and pain in the body.

Meclofenamate is used to treat pain or inflammation caused by arthritis. It is also used to treat menstrual pain.

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

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

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking meclofenamate. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to meclofenamate, or to aspirin or other NSAIDs.

Before taking meclofenamate, tell your doctor if you are allergic to any drugs, or if you have:

a history of heart attack, stroke, or blood clot;

heart disease, congestive heart failure, high blood pressure;

a history of stomach ulcers or bleeding, bowel problems, diverticulosis;

liver or kidney disease;

asthma;

polyps in your nose; or

if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take meclofenamate.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking meclofenamate during the last 3 months of pregnancy may harm the unborn baby. Do not take meclofenamate during pregnancy unless your doctor has told you to. Meclofenamate passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 14 years old without the advice of a doctor.

How should I take meclofenamate?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. The maximum amount of meclofenamate for adults is 400 milligrams (mg) per day. Know the amount of meclofenamate in the specific product you are taking.

If you take meclofenamate for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

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

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, dizziness, drowsiness, ringing in your ears, numbness or tingling, black or bloody stools, coughing up blood, fever, urinating less than usual or not at all, shallow breathing, fainting, and seizure (convulsions).

What should I avoid while taking meclofenamate?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain medicines similar to meclofenamate (such as aspirin, ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking meclofenamate. Alcohol can increase the risk of stomach bleeding.

If you take cholestyramine (Prevalite, Questran), avoid taking it within 2 hours before or after you take meclofenamate.

Meclofenamate side effects

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

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

urinating less than usual or not at all;

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

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

dizziness, headache, nervousness;

skin itching or rash;

dry mouth;

increased sweating, runny nose;

blurred vision; or

ringing in your ears.

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

What other drugs will affect meclofenamate?

Before taking meclofenamate, tell your doctor if you are taking any of the following drugs:

cyclosporine (Gengraf, Neoral, Sandimmune);

a diuretic (water pill) such as furosemide (Lasix);

lithium (Eskalith, Lithobid);

a blood thinner such as warfarin (Coumadin);

steroids (prednisone and others); or

heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar, Hyzaar), olmesartan (Benicar), telmisartan (Micardis), or valsartan (Diovan);

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

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

More meclofenamate resources

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

Meclofenamate MedFacts Consumer Leaflet (Wolters Kluwer)

Meclofenamate Prescribing Information (FDA)

Meclofenamate Sodium Monograph (AHFS DI)

Compare meclofenamate with other medications

Premenstrual Dysphoric Disorder
Rheumatoid Arthritis

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Tuesday 24 April 2012

Pediacare Decongestant Infants

Generic Name: pseudoephedrine (Oral route)

soo-doe-e-FED-rin

Commonly used brand name(s)

In the U.S.

12 Hour Cold Maximum Strength

Biofed

Cenafed

Chlor-Trimeton Nasal Decongestant

Contac 12-Hour

Dimetapp Decongestant

Efidac 24 Pseudoephedrine

ElixSure Congestion Children's

Genaphed

Pediacare Decongestant Infants

Simply Stuffy

Sudafed

Available Dosage Forms:

Capsule, Extended Release

Tablet, Chewable

Tablet, Extended Release

Solution

Syrup

Liquid

Tablet

Capsule

Capsule, Liquid Filled

Suspension

Therapeutic Class: Decongestant

Pharmacologic Class: Alpha-Adrenergic Agonist

Uses For Pediacare Decongestant Infants

Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.

Some of these preparations are available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Pediacare Decongestant Infants

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

Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.

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 pseudoephedrine in the elderly with use in other age groups.

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.

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

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.

Guanethidine

Methyldopa

Midodrine

Interactions with Food/Tobacco/Alcohol

Proper Use of pseudoephedrine

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

For patients taking pseudoephedrine extended-release capsules:

Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets:

Swallow the tablet whole.

Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of 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.

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 nasal or sinus congestion:
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
  - Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
  - Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
  - Children and infants up to 4 years of age—Use is not recommended .
- For long-acting oral dosage form (extended-release capsules or extended-release tablets):
  - Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
  - Infants and children up to 12 years of age—Use is not recommended .

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.

Precautions While Using Pediacare Decongestant Infants

If symptoms do not improve within 7 days or if you also have a high fever, check with your doctor since these signs may mean that you have other medical problems.

Pediacare Decongestant Infants 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:

Rare - more common with high doses

Convulsions (seizures)

hallucinations (seeing, hearing, or feeling things that are not there)

irregular or slow heartbeat

shortness of breath or troubled breathing

Symptoms of overdose

Convulsions (seizures)

fast breathing

hallucinations (seeing, hearing, or feeling things that are not there)

increase in blood pressure

irregular heartbeat (continuing)

shortness of breath or troubled breathing (severe or continuing)

slow or fast heartbeat (severe or continuing)

unusual nervousness, restlessness, or excitement

More common

Nervousness

restlessness

trouble in sleeping

Less common

Difficult or painful urination

dizziness or light-headedness

fast or pounding heartbeat

headache

increased sweating

nausea or vomiting

trembling

unusual paleness

weakness

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: Pediacare Decongestant Infants side effects (in more detail)

More Pediacare Decongestant Infants resources

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

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