Boots Max Strength Cold & Flu Day & Night Capsules

1. Name Of The Medicinal Product

Asda Max Strength Cold & Flu Day & Night Capsules, hard

Benylin Cold & Flu Day & Night Max Strength Capsules, hard

Boots Max Strength Cold & Flu Day & Night Capsules, hard

Morrisons Max Strength Cold & Flu Day & Night Capsules, hard

Paramed Max Strength Cold & Flu Day & Night Capsules, hard

Sainsbury's Max Strength Cold & Flu Day & Night Capsules, hard

Sudafed Day & Night Capsules, hard

Superdrug Max Strength Cold & Flu Day & Night Capsules, hard

Tesco Max Strength Cold & Flu Day & Night Capsules, hard

Teva Max Strength Cold & Flu Day & Night Capsules, hard

Wilko Max Strength Cold & Flu Day & Night Capsules, hard

2. Qualitative And Quantitative Composition

DAY CAPSULE
Active Ingredient	mg/Capsule
Paracetamol	500
Caffeine	25
Phenylephrine Hydrochloride	6.1
NIGHT CAPSULE
Active Ingredient	mg/Capsule
Paracetamol	500
Phenylephrine Hydrochloride	6.1
For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard capsule.

Red/yellow (Day) and dark blue/light blue (Night) hard gelatin capsules containing the drug products, which are off-white powders.

4. Clinical Particulars

4.1 Therapeutic Indications

DAY CAPSULE

For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion and lowering of temperature.

NIGHT CAPSULE

For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

For oral use.

Swallow whole with water. Do not chew.

Each blister contains 6 red/yellow Day capsules and 2 dark blue/light blue Night capsules.

Adults and Children over 12 years

2 red/yellow capsules every 4 – 6 hours during the day as required, followed by 2 dark blue/ light blue capsules at bedtime.

Leave at least 4 hours between doses.

Do not take more than 8 capsules in 24 hours.

Not recommended for children under 12 years of age.

Note: Does not contain a sleep aid.

4.3 Contraindications

PARACETAMOL

Hypersensitivity to paracetamol or any of the other constituents.

CAFFEINE (Day capsules only):

Should be given with care to patients with a history of peptic ulcer.

PHENYLEPHRINE HYDROCHLORIDE

Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Use with caution in patients with Raynaud's Phenomenon and diabetes mellitus.

The following warnings will appear on the pack:-

CONTAINS PARACETAMOL

- If symptoms persist consult your doctor.

- Do not exceed the stated dose.

- Keep all medicines out of the reach and sight of children.

- Do not take with any other paracetamol-containing products.

The Label shall say:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

The Leaflet shall say:

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

If you are pregnant or being prescribed medicine by your doctor, seek your doctor's advice before taking this product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

PARACETAMOL

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

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.

Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.

PHENYLEPHRINE HYDROCHLORIDE

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta blockers.

4.6 Pregnancy And Lactation

PARACETAMOL

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

CAFFEINE (Day capsules only)

Taken during pregnancy, it appears that the half-life of caffeine is prolonged. This is a possible contributing factor in hyperemesis gravidarum (morning sickness).

Caffeine appears in breast milk. Irritability and poor sleeping pattern in the infant have been reported.

PHENYLEPHRINE HYDROCHLORIDE

Due to the vasoconstrictive properties of phenylephrine the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

PARACETAMOL

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

CAFFEINE (Day capsules only)

Nausea and insomnia have been noted.

PHENYLEPHRINE HYDROCHLORIDE

Phenylephrine hydrochloride may elevate blood pressure with headache, vomiting and rarely palpitations; tachycardia or reflex bradycardia; tingling and coolness of the skin. There have been rare reports of allergic reactions.

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

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

Or

b) Regularly consumes ethanol in excess of recommended amounts.

Or

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

Symptoms

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.

Management

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 British National Formulary (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). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. 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. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the National Poison Information Service (NPIS) or a liver unit.

CAFFEINE (Day capsules only)

Doses over 1g are probably necessary to induce toxicity, 2 – 5g to produce severe toxicity and 5 – 10g is likely to be lethal.

Symptoms include: epigastric pain, vomiting, diuresis, tachycardia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors, convulsions).

No specific antidote is available, reduce or stop dosage and avoid excessive intake of coffee or tea.

PHENYLEPHRINE HYDROCHLORIDE

Severe overdosage may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesylate 6 – 10 mg) given intravenously, and the bradycardia treated with atropine, preferably only after the pressure has been controlled.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group:	Other analgesics and antipyretics &
	Other cold combination preparations
ATC code:	NO2B E51

PARACETAMOL

Analgesic:

The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting a prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic:

Paracetamol probably produces antipyresis by acting on the hypothalamic heat-regulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

CAFFEINE (Day capsules only)

Central nervous system stimulant – Caffeine stimulates all levels of the CNS, although its cortical effects are milder and of shorter duration than those of amfetamines.

Analgesia Adjunct:

Caffeine constricts cerebral vasculature with an accompanying decrease in cerebral blood flow and in the oxygen tension of the brain. It is believed that caffeine helps to relieve headache by providing a more rapid onset of action and/or enhanced pain relief with lower doses of analgesic. Recent studies with ergotamine indicate that the enhancement of effect by the addition of caffeine may also be due to improved gastrointestinal absorption of ergotamine when administered with caffeine.

PHENYLEPHRINE HYDROCHLORIDE

Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal and sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses.

In addition to reducing mucosal lining swelling, decongestants also suppress the production of mucus, therefore preventing a build up of fluid within the cavities which could otherwise lead to pressure and pain.

5.2 Pharmacokinetic Properties

PARACETAMOL

Absorption and Fate

Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring between 10 and 120 minutes after oral administration. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours.

Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdose and cause liver damage.

CAFFEINE (Day capsules only)

Absorption and Fate

Caffeine is absorbed readily after oral administration and is widely distributed throughout the body. Caffeine is metabolised almost completely via oxidation, demethylation, and acetylation, and is excreted in the urine as 1-methyluric acid, 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine), 5-acetylamino-6-formylamino-3-methyluracil (AFMU), and other metabolites with only about 1% unchanged.

PHENYLEPHRINE HYDROCHLORIDE

Absorption and Fate

Phenylephrine has reduced bioavailability from the gastro-intestinal tract owing to irregular absorption and first-pass metabolism by monoamine oxidase in the gut and liver.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber additional to that already covered in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

DAY CAPSULE

Maize starch

Croscarmellose sodium

Sodium laurilsulfate

Magnesium stearate

Talc

Gelatin

Titanium dioxide Quinoline yellow Patent blue V Erythrosine

E171 E104 E131 E127

NIGHT CAPSULE

Maize starch

Croscarmellose sodium

Sodium laurilsulfate

Magnesium stearate

Talc

Gelatin

Titanium dioxide Erythrosine Indigo carmine

E171 E127 E132

6.2 Incompatibilities

None known.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister packs of white opaque 250 micron PVC/30 micron hard temper pyramidal aluminium foil, heat-seal coated, contained in an outer cardboard carton.

Pack sizes:

16 capsules comprising two blisters each containing 6 red/yellow Day capsules and 2 light blue/dark blue Night capsules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL

8. Marketing Authorisation Number(S)

PL 12063/0073.

9. Date Of First Authorisation/Renewal Of The Authorisation

1 November 2007

10. Date Of Revision Of The Text

26 March 2010

pentoxifylline

pen-tox-IF-i-lin

Commonly used brand name(s)

In the U.S.

• Pentopak


• Pentoxil


• Trental

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Hemorheologic

Chemical Class: Methylxanthine

Uses For pentoxifylline

Pentoxifylline improves the flow of blood through blood vessels. It is used to reduce leg pain caused by poor blood circulation. Pentoxifylline makes it possible to walk farther before having to rest because of leg cramps.

Pentoxifylline is available only with your doctor's prescription.

Before Using pentoxifylline

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 pentoxifylline, the following should be considered:

Allergies

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

Studies on pentoxifylline have been done only in adult patients, and there is no specific information comparing use of pentoxifylline in children with use in other age groups.

Geriatric

Side effects may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of pentoxifylline.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pentoxifylline, 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 pentoxifylline 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.

• Aceclofenac


• Acemetacin


• Alclofenac


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carprofen


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Zomepirac

Using pentoxifylline 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.

• Cimetidine


• Dicumarol


• Theophylline

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.

Other Medical Problems

The presence of other medical problems may affect the use of pentoxifylline. Make sure you tell your doctor if you have any other medical problems, especially:

• Any condition in which there is a risk of bleeding (e.g., recent stroke)—Pentoxifylline may make the condition worse

• Kidney disease or


• Liver disease—The chance of side effects may be increased

Proper Use of pentoxifylline

Swallow the tablet whole. Do not crush, break, or chew it before swallowing.

Pentoxifylline should be taken with meals to lessen the chance of stomach upset. Taking an antacid with the medicine may also help.

Dosing

The dose of pentoxifylline 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 pentoxifylline. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (extended-release tablets):
  
  • For peripheral vascular disease (circulation problems):
    
    • Adults—400 milligrams (mg) two to three times a day, taken with meals.
    
    
    • Children—Use must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of pentoxifylline, 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 pentoxifylline

It may take several weeks for pentoxifylline to work. If you feel that pentoxifylline is not working, do not stop taking it on your own. Instead, check with your doctor.

Smoking tobacco may worsen your condition since nicotine may further narrow your blood vessels. Therefore, it is best to avoid smoking.

pentoxifylline 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

• Chest pain


• irregular heartbeat

Signs and symptoms of overdose (in the order in which they may occur)

• Drowsiness


• flushing


• faintness


• unusual excitement


• convulsions (seizures)

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

Less common

• Dizziness


• headache


• nausea or vomiting


• stomach discomfort

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: pentoxifylline 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 pentoxifylline resources

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

• pentoxifylline Concise Consumer Information (Cerner Multum)


• Pentoxifylline Prescribing Information (FDA)


• Pentoxifylline MedFacts Consumer Leaflet (Wolters Kluwer)


• Pentoxifylline Professional Patient Advice (Wolters Kluwer)


• Pentoxifylline Monograph (AHFS DI)


• Pentoxil Prescribing Information (FDA)


• Trental Prescribing Information (FDA)

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• Intermittent Claudication

Pegaspargase

Pronunciation: peg-AS-par-jase
Generic Name: Pegaspargase
Brand Name: Oncaspar

Pegaspargase is used for:

Treating acute lymphoblastic leukemia (ALL) in certain patients. It is used along with other cancer medicines.

Pegaspargase is an antineoplastic agent. It works by decreasing the amount of asparagine in the body, which kills certain leukemia cells.

Do NOT use Pegaspargase if:

• you are allergic to any ingredient in Pegaspargase


• you have chickenpox, shingles, or inflammation of the pancreas (pancreatitis)


• you have ever had serious blood clots, serious bleeding, or inflammation of the pancreas after using Pegaspargase or L-asparaginase

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

Before using Pegaspargase:

Some medical conditions may interact with Pegaspargase. 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 liver problems, bone marrow problems, diabetes, or an infection


• if you have a history of bleeding problems or blood clots


• if you are undergoing radiation therapy

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

• Anticoagulants (eg, warfarin), aspirin, dipyridamole, heparin, or nonsteroidal anti-inflammatory drugs (NSAIDs) because the risk of side effects such as bleeding may be increased

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

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

• Pegaspargase is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not shake Pegaspargase.


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


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Pegaspargase is usually not used more often than every 14 days. Do not use Pegaspargase more often than every 14 days without first checking with your doctor.


• If you miss a dose of Pegaspargase, contact your doctor right away.

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

Important safety information:

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


• Pegaspargase may reduce the ability of your blood to clot. 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.


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


• Lab tests, including blood clotting tests or blood glucose, may be performed while you use Pegaspargase. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Pegaspargase should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Pegaspargase can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pegaspargase while you are pregnant. It is not known if Pegaspargase is found in breast milk. Do not breast-feed while taking Pegaspargase.

Possible side effects of Pegaspargase:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Pegaspargase. 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; trouble swallowing); blurred vision or other vision changes; calf or leg pain or swelling; chest pain; confusion; coughing up blood; dizziness; one-sided weakness; pain, redness, or swelling at the injection site; severe headache; shortness of breath; severe stomach pain; slurred speech; swelling of an arm or leg; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing; rapid breathing; fruit-like breath odor); unusual bleeding or bruising; yellowing of skin or eyes.

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: Pegaspargase 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 rash.

Proper storage of Pegaspargase:

Pegaspargase is usually handled and stored by a health care provider. If you are using Pegaspargase at home, store Pegaspargase as directed by your pharmacist or health care provider. Keep Pegaspargase out of the reach of children and away from pets.

General information:

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


• Pegaspargase 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 Pegaspargase. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pegaspargase resources

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

• Pegaspargase Monograph (AHFS DI)


• Pegaspargase Professional Patient Advice (Wolters Kluwer)


• pegaspargase Concise Consumer Information (Cerner Multum)


• pegaspargase Intramuscular, Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


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• Acute Lymphoblastic Leukemia

PREVACID NapraPAC 375

Generic Name: lansoprazole and naproxen (lan SOE pra zole and na PROX en)

Brand Names: PREVACID NapraPAC 500

What is PREVACID NapraPAC 375 (lansoprazole and naproxen)?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever.

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

The combination of lansoprazole and naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The lansoprazole in this medication helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

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

What is the most important information I should know about PREVACID NapraPAC 375 (lansoprazole and naproxen)?

The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking lansoprazole and naproxen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take lansoprazole and naproxen during pregnancy unless your doctor has told you to.

What should I discuss with my healthcare provider before taking PREVACID NapraPAC 375 (lansoprazole and naproxen)?

You should not use this medication if you are allergic to lansoprazole (Prevacid) or naproxen (Aleve, Anaprox, Naprosyn, and others), or if you have ever had a severe allergic reaction to aspirin or other NSAIDs. Do not use lansoprazole and naproxen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking lansoprazole and naproxen, especially in older adults.

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

• liver or kidney disease;


• 
  

  heart disease, high blood pressure, fluid retention, or a history of stroke, heart attack, or congestive heart failure;

  
  


• 
  

  a bleeding or blood clotting disorder, such as hemophilia;

  
  


• 
  

  a history of stomach ulcers or bleeding;

  
  


• 
  

  asthma, or a history of allergic reaction to aspirin, especially aspirin triad syndrome; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take lansoprazole and naproxen during pregnancy unless your doctor has told you to. Naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking lansoprazole and naproxen.

How should I take PREVACID NapraPAC 375 (lansoprazole and naproxen)?

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.

Each package of this medication contains pills for 7 days of treatment (one lansoprazole capsule and two naproxen tablets per day). In most cases, you will take one lansoprazole (Prevacid) capsule and one naproxen (Naprosyn) tablet each morning before eating. The second naproxen tablet is then taken 12 hours later, without lansoprazole. Follow your doctor's instructions.

Take this medication with a full glass of water. Do not crush, chew, break, or open the lansoprazole capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using lansoprazole and naproxen.

Store 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. 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.

Overdose symptoms may include nausea, vomiting, stomach pain or discomfort, severe dizziness or drowsiness, confusion, weak or shallow breathing, and urinating less than usual or not at all.

What should I avoid while taking PREVACID NapraPAC 375 (lansoprazole and naproxen)?

Avoid taking sucralfate (Carafate) or antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids) at the same time you take lansoprazole and naproxen. These other medications can make it harder for your body to absorb naproxen.

Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains naproxen or another NSAID.

Ask your doctor before taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with an NSAID may increase your risk of stomach bleeding.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

PREVACID NapraPAC 375 (lansoprazole and naproxen) 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 naproxen and call your doctor at once if you have a serious side effect such as:

• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath, even with mild exertion;

  
  


• 
  

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

  
  


• 
  

  nausea, upper stomach pain, itching, 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

  
  


• 
  

  pale skin, easy bruising, feeling very weak or tired.

  
  

Less serious side effects may include:

• 
  

  mild stomach pain, heartburn, constipation, diarrhea;

  
  


• 
  

  headache, dizziness or drowsiness;

  
  


• 
  

  sweating, mild skin rash or itching; or

  
  


• 
  

  ringing in your ears.

  
  

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

What other drugs will affect PREVACID NapraPAC 375 (lansoprazole and naproxen)?

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

• 
  

  atazanavir (Reyataz);

  
  


• 
  

  cholestyramine (Prevalite, Questran);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  lithium (Eskalith, Lithobid, others);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  phenytoin (Dilantin);

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an iron supplement;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);

  
  


• 
  

  medication used to prevent blood clots, such as clopidogrel (Plavix), ticlopidine (Ticlid), and others;

  
  


• 
  

  an oral diabetes medication such as glipizide (Glucotrol, Metaglip), glimepiride (Amaryl, Avandaryl, Duetact), or glyburide (DiaBeta, Micronase, Glucovance);

  
  


• 
  

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

  
  


• 
  

  an antibiotic such as ampicillin (Principen);

  
  


• 
  

  antifungal medication such as ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

  
  


• 
  

  aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), or piroxicam (Feldene);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), or ramipril (Altace); or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), or sotalol (Betapace).

  
  

This list is not complete and other drugs may interact with lansoprazole and naproxen. 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 PREVACID NapraPAC 375 resources

• PREVACID NapraPAC 375 Side Effects (in more detail)
• PREVACID NapraPAC 375 Use in Pregnancy & Breastfeeding
• PREVACID NapraPAC 375 Drug Interactions
• PREVACID NapraPAC 375 Support Group
• 0 Reviews for PREVACID NapraPAC 375 - Add your own review/rating

Compare PREVACID NapraPAC 375 with other medications

• Ankylosing Spondylitis
• Osteoarthritis
• Rheumatoid Arthritis

Where can I get more information?

• Your pharmacist can provide more information about lansoprazole and naproxen.

See also: PREVACID NapraPAC 375 side effects (in more detail)

Ascot

Generic Name: ascorbic acid (vitamin C) (as KORE bik AS id)

Brand Names: Acerola, Ascorbic Acid Quick Melts, C-Time, C/Rose Hips, Cecon, Cemill 1000, Cemill 500, Ester-C, N Ice with Vitamin C, Sunkist Vitamin C, Vicks Vitamin C Drops, Vitamin C, Vitamin C TR, Vitamin C with Rose Hips

What is ascorbic acid?

Ascorbic acid (vitamin C) occurs naturally in foods such as citrus fruit, tomatoes, potatoes, and leafy vegetables. Ascorbic acid is important for bones and connective tissues, muscles, and blood vessels. Vitamin C also helps the body absorb iron, which is needed for red blood cell production.

Ascorbic acid is used to treat and prevent vitamin C deficiency.

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

What is the most important information I should know about ascorbic acid?

You should not use this medication if you have ever had an allergic reaction to ascorbic acid.

Ask a doctor or pharmacist about using ascorbic acid if you have kidney disease or a history of kidney stones, liver disease (especially cirrhosis), or an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

It is not known whether ascorbic acid is harmful to an unborn baby or a nursing baby. Some vitamins and minerals are needed during pregnancy or for breast milk production, but some may be harmful if taken in large doses. Do not take ascorbic acid without telling your doctor if you are pregnant or breast-feeding.

Ascorbic acid can be harmful to the kidneys, and this effect is increased when ascorbic acid is used together with other medicines that can harm the kidneys. Before taking ascorbic acid, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, or any injected antibiotics. You may need dose adjustments or special tests when taking any of these medications together with ascorbic acid.

Before taking ascorbic acid, tell your doctor about all other medications you take.

Stop using ascorbic acid and call your doctor at once if you have severe pain in your lower back or side, blood in your urine, pain when you urinate, severe or ongoing diarrhea, or feel like you might pass out.

What should I discuss with my healthcare provider before taking ascorbic acid?

You should not use this medication if you have ever had an allergic reaction to ascorbic acid.

Ask a doctor or pharmacist about using ascorbic acid if you have:

• kidney disease or a history of kidney stones;


• liver disease (especially cirrhosis); or


• 
  

  an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

  
  

It is not known whether ascorbic acid is harmful to an unborn baby. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Do not take ascorbic acid without telling your doctor if you are pregnant. Ascorbic acid can pass into breast milk, but it is not known whether it would be harmful to a nursing baby. Some vitamins and minerals are needed for breast milk production, but some may harm a nursing baby. Do not take ascorbic acid without telling your doctor if you are breast-feeding a baby.

How should I take ascorbic acid?

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

The recommended dietary allowance of ascorbic acid increases with age, and whether you are pregnant or breast-feeding. Follow your doctor's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Take the ascorbic acid regular tablet or capsule with a full glass (8 ounces) of water.

The ascorbic acid chewable tablet must be chewed before swallowing. Ascorbic acid gum may be chewed over a long period and then spit out and thrown away.

Remove the disintegrating tablet from the package using dry hands, and place the tablet in your mouth. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.

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

Dissolve the powder form of ascorbic acid in a small amount of water or other liquid. Follow the directions on the package label about what types of liquid you may use. Stir the 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.

Store ascorbic acid at room temperature away from moisture and heat.

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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of ascorbic acid is not likely to cause life-threatening symptoms.

What should I avoid while taking ascorbic acid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Smoking can make ascorbic acid less effective.

Ascorbic acid side effects

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

• 
  

  severe pain in your lower back or side;

  
  


• 
  

  blood in your urine;

  
  


• 
  

  pain when you urinate;

  
  


• 
  

  severe or ongoing diarrhea; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  heartburn, stomach cramps;

  
  


• 
  

  nausea, vomiting, diarrhea;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  flushing (warmth, redness, or tingling under your skin);

  
  

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

What other drugs will affect ascorbic acid?

Ascorbic acid can be harmful to the kidneys, and this effect is increased when ascorbic acid is used together with other medicines that can harm the kidneys. Before taking ascorbic acid, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, or any injected antibiotics.

You may need dose adjustments or special tests when taking any of these medications together with ascorbic acid.

The following drugs can interact with ascorbic acid. Tell your doctor if you are using any of these:

• 
  

  aspirin or acetaminophen (Tylenol);

  
  


• 
  

  fluphenazine (Permitil);

  
  


• 
  

  indinavir (Crixivan);

  
  


• 
  

  levodopa (Atamet, Larodopa, Parcopa, Sinemet);

  
  


• 
  

  nicotine patches (Nicoderm, Habitrol, Commit);

  
  


• 
  

  antacids that contain aluminum (such as Amphojel, Maalox, Mylanta, Rulox, and others);

  
  


• 
  

  an antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

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

  
  


• 
  

  birth control pills or hormone replacement therapy, including Premarin, Estratest, Vivelle, Climara, Estring, Estrace, and others; or

  
  


• 
  

  a blood thinner such as warfarin (Coumadin).

  
  

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

More Ascot resources

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

• Ascorbic Acid Monograph (AHFS DI)


• ascorbic acid Advanced Consumer (Micromedex) - Includes Dosage Information


• Ascorbic Acid MedFacts Consumer Leaflet (Wolters Kluwer)


• Acerola Natural MedFacts for Consumers (Wolters Kluwer)


• Acerola Natural MedFacts for Professionals (Wolters Kluwer)


• Cecon Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cenolate Injection MedFacts Consumer Leaflet (Wolters Kluwer)


• Cevi-Bid Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ascot with other medications

• Dietary Supplementation
• Scurvy
• Urinary Acidification

Where can I get more information?

• Your doctor, pharmacist, or health care provider may have more information about ascorbic acid.

See also: Ascot side effects (in more detail)

Phentermine

Dosage Form: tablet
Phentermine Hydrochloride

Tablets USP, 37.5 mg

CIV

Rx only

Phentermine Description

Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows:

C10H15N•HCl                                                        M.W. 185.7

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of Phentermine hydrochloride (equivalent to 30 mg of Phentermine base).

Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and blue sugar spheres.

Phentermine - Clinical Pharmacology

Phentermine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Indications and Usage for Phentermine

Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).

Below is a chart of Body Mass Index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2

	Height (feet, inches)
Weight (pounds)	5′0″	5′3″	5′6″	5′9″	6′0″	6′3″
140	27	25	23	21	19	18
150	29	27	24	22	20	19
160	31	28	26	24	22	20
170	33	30	28	25	23	21
180	35	32	29	27	25	23
190	37	34	31	28	26	24
200	39	36	32	30	27	25
210	41	37	34	31	29	26
220	43	39	36	33	30	28
230	45	41	37	34	31	29
240	47	43	39	36	33	30
250	49	44	40	37	34	31

The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.

Contraindications

Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Warnings

Phentermine hydrochloride is indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of these drug products for weight loss is not recommended.

Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of Phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken Phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms include: angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.

Valvular Heart Disease: Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of Phentermine with fenfluramine or dexfenfluramine for weight loss. The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of Phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken Phentermine alone.

Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Phentermine hydrochloride may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Drug Abuse and Dependence

Phentermine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of Phentermine hydrochloride should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Usage with Alcohol

Concomitant use of alcohol with Phentermine hydrochloride may result in an adverse drug interaction.

Precautions

General

Caution is to be exercised in prescribing Phentermine hydrochloride Tablets USP for patients with even mild hypertension.

Insulin requirements in diabetes mellitus may be altered in association with the use of Phentermine hydrochloride and the concomitant dietary regimen.

Phentermine hydrochloride may decrease the hypotensive effect of guanethidine.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with Phentermine hydrochloride to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Phentermine hydrochloride. It is also not known whether Phentermine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Phentermine hydrochloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS), palpitation, tachycardia, elevation of blood pressure.

Central Nervous System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

Overdosage

Manifestations of acute overdosage with Phentermine include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma.

Management of acute Phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases Phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested for possible acute, severe hypertension, if this complicates Phentermine overdosage.

Phentermine Dosage and Administration

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet (37.5 mg) daily, administered before breakfast or 1 to 2 hours after breakfast. For tablets, the dosage may be adjusted to the patient's need. For some patients ½ tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give ½ tablet (18.75 mg) two times a day.

Late evening medication should be avoided because of the possibility of resulting insomnia.

Phentermine is not recommended for use in patients sixteen (16) years of age and under.

How is Phentermine Supplied

Phentermine Hydrochloride Tablets USP, 37.5 mg are white with blue speckles, capsule-shaped tablets, bisected and debossed with "

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Manufactured by:

Elite Laboratories, Inc.

Northvale, NJ 07647

Distributed by:

TAGI Pharma

South Beloit, IL 61080

OE1021

MF016ISS11/10

Issued 11/10

PRINCIPAL DISPLAY PANEL - 37.5 mg/100 Tablet Bottle Label

NDC 51224-101-50

Phentermine

Hydrochloride

Tablets, USP

CIV

37.5 mg

Rx Only

100 Tablets

Tagi PHARMA

Phentermine HYDROCHLORIDE  Phentermine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51224-101 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phentermine Hydrochloride (Phentermine) Phentermine Hydrochloride 37.5 mg

Inactive Ingredients Ingredient Name Strength croscarmellose sodium   Lactose Monohydrate   magnesium stearate   cellulose, microcrystalline

Product Characteristics Color WHITE (with blue speckels) Score 2 pieces Shape OVAL (capsule-shaped) Size 10mm Flavor Imprint Code E;16 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51224-101-50 100 TABLET In 1 BOTTLE None 2 51224-101-70 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200272	03/08/2011

Labeler - TAGI Pharma, Inc. (963322560)

Revised: 02/2011TAGI Pharma, Inc.

More Phentermine resources

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

• Phentermine Monograph (AHFS DI)


• Phentermine MedFacts Consumer Leaflet (Wolters Kluwer)


• phentermine Concise Consumer Information (Cerner Multum)


• phentermine Advanced Consumer (Micromedex) - Includes Dosage Information


• Ionamin MedFacts Consumer Leaflet (Wolters Kluwer)


• Ionamin Concise Consumer Information (Cerner Multum)

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Hyoscyamine

Pronunciation: HYE-oh-SYE-a-meen
Generic Name: Hyoscyamine
Brand Name: Levsin

Hyoscyamine is used for:

Treating certain stomach or bowel problems (eg, ulcers, spasms or cramping, irritable bowel syndrome, symptoms of colic), certain bladder problems (eg, spastic bladder, cystitis), and excessive secretions caused by inflammation of the pancreas, and for aiding in certain medical procedures or surgery. It may also be used for other conditions as determined by your doctor.

Hyoscyamine is an anticholinergic agent. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid.

Do NOT use Hyoscyamine if:

• you are allergic to any ingredient in Hyoscyamine


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


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

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

Before using Hyoscyamine:

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

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


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


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


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


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

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

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


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


• Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine

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

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

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


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


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Hyoscyamine, 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 Hyoscyamine.

Important safety information:

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


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


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


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


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


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


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


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


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


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


• Hyoscyamine should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine while you are pregnant. Hyoscyamine is found in breast milk. Do not breast-feed while taking Hyoscyamine.

Possible side effects of Hyoscyamine:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

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

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

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

See also: Hyoscyamine 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 blurred vision; difficulty breathing; difficulty swallowing; disorientation; dizziness; dry mouth; dry skin; enlarged pupils; excessive thirst; excitability; headache; muscle weakness; nausea; rapid heartbeat with weak pulse; seizures; vomiting.

Proper storage of Hyoscyamine:

Hyoscyamine is usually handled and stored by a health care provider. If you are using Hyoscyamine at home, store Hyoscyamine as directed by your pharmacist or health care provider. Keep Hyoscyamine out of the reach of children and away from pets.

General information:

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


• Hyoscyamine 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 Hyoscyamine. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Hyoscyamine resources

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

• Hyoscyamine Monograph (AHFS DI)


• hyoscyamine Concise Consumer Information (Cerner Multum)


• HyoMax Prescribing Information (FDA)


• Hyosyne Prescribing Information (FDA)


• Levsin Prescribing Information (FDA)

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