Pack Content Directory Cayman Islands: March 2012

Tuesday, March 27, 2012

epirubicin

Generic Name: epirubicin (EP i ROO bi sin)

Brand names: Ellence, Pharmorubicin PFS, Pharmorubicin RDF

What is epirubicin?

Epirubicin is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Epirubicin is used to treat breast cancer.

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

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

You should not use this medication if you are allergic to epirubicin or similar medications (Cerubidine, Adriamycin, Idamycin, Novantrone), or if you have an untreated or uncontrolled infection, severe liver disease, severe heart problems, or if you have recently had a heart attack. Epirubcin can have serious side effects on your heart. Before you are treated with epirubicin, tell your doctor if you have a history of heart disease, heart rhythm disorder, congestive heart failure, or heart attack.

Also tell your doctor about all other medicines you use, especially about any other cancer medications or treatments you have received (including radiation).

Do not use epirubicin if you are pregnant. It could harm the unborn baby. Epirubicin can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while using epirubicin, or you could develop a serious infection.

Using epirubicin may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk.

What should I discuss with my healthcare provider before I receive epirubicin?

Before you are treated with epirubicin, tell your doctor about all other cancer medications and treatments you have received, including radiation. You should not use this medication if you are allergic to epirubicin or similar medications (Cerubidine, Adriamycin, Idamycin, Novantrone), or if you have:

an untreated or uncontrolled infection (including mouth sores);

severe liver disease;

severe heart problems; or

if you have recently had a heart attack.

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

liver or kidney disease;

a weak immune system caused by prior cancer treatments;

heart disease, a heart rhythm disorder, congestive heart failure; or

if you have ever had a heart attack.

Using epirubicin may increase your risk of developing other types of cancer, such as leukemia. Talk with your doctor about your specific risk. FDA pregnancy category D. Do not use epirubicin if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant or plan to become pregnant.

Use birth control to prevent pregnancy while you are receiving epirubicin, whether you are a man or a woman. Epirubicin use by either parent may cause birth defects.

It is not known whether epirubicin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using epirubicin.

How is epirubicin given?

Epirubicin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Epirubicin must be given slowly, and the IV infusion can take up to 20 minutes to complete.

Epirubicin is usually given together with other cancer medications. You may be given other medications to prevent nausea, vomiting, or infections.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when epirubicin is injected.

If any of this medication accidentally gets on your skin, wash it thoroughly with soap and warm water.

Epirubicin can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your epirubicin injection.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while receiving epirubicin?

Do not receive a "live" vaccine while using epirubicin, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Epirubicin 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. Tell your caregivers at once if you have a serious side effect such as:

pain, burning, irritation, or skin changes where the injection was given;

feeling short of breath, even with mild exertion;

swelling, rapid weight gain (especially in your face and midsection);

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

fast, slow, or uneven heartbeats;

anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;

chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;

lower back pain, blood in your urine, urinating less than usual or not at all;

numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;

muscle weakness, tightness, or contraction;

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include:

hot flashes, missed menstrual periods;

temporary hair loss;

feeling weak or tired;

mild nausea, diarrhea; or

eye redness, puffy eyelids.

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.

Epirubicin Dosing Information

Usual Adult Dose for Breast Cancer -- Adjuvant:

For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer:

Starting Dose: 100 to 120 mg/m2 by intravenous infusion every 3 to 4 weeks. The total dose may either be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle.

What other drugs will affect epirubicin?

Many drugs can interact with epirubicin. Below is just a partial list. Tell your doctor if you are using:

acetaminophen (Tylenol);

auranofin (Ridaura) or gold injections to treat arthritis;

cimetidine (Tagamet);

rosiglitazone (Avandia, Avandamet, Avandaryl);

an antibiotic or antifungal medication;

an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others;

birth control pills or hormone replacement therapy;

cholesterol medications such as atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin), and others;

heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), atenolol (Tenormin, Tenoretic), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cartia, Cardizem), enalapril (Vasotec), labetalol (Normodyne, Trandate), lisinopril (Prinivil, Zestril), methyldopa (Aldomet), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan, Tarka), and others;

HIV/AIDS medications;

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

other cancer medications, especially docetaxel (Taxotere) or paclitaxel (Taxol, Onxol); or

seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol), divalproex (Depakote), phenobarbital (Solfoton), phenytoin (Dilantin), valproic acid (Depakene, Stavzor), and others.

This list is not complete and there may be other drugs that can interact with epirubicin. 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 epirubicin resources

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

epirubicin Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Epirubicin MedFacts Consumer Leaflet (Wolters Kluwer)

Epirubicin Prescribing Information (FDA)

Ellence Prescribing Information (FDA)

Ellence Monograph (AHFS DI)

Ellence Consumer Overview

Compare epirubicin with other medications

Breast Cancer, Adjuvant

Where can I get more information?

Your doctor or pharmacist can provide more information about epirubicin.

See also: epirubicin side effects (in more detail)

Sunday, March 25, 2012

Lomotil tablets

1. Name Of The Medicinal Product

Lomotil tablets (POM)

Dymotil tablets (P)

Co-phenotrope 2.5/0.025 tablets

2. Qualitative And Quantitative Composition

Each tablet contains 2.5mg of diphenoxylate hydrochloride BP and 0.025mg of atropine sulphate Ph.Eur

3. Pharmaceutical Form

White tablet with “GS10” engraved on one side

4. Clinical Particulars

4.1 Therapeutic Indications

POM product

Adults and children:

Adjunctive therapy to appropriate rehydration in acute diarrhoea

Control of stool formation after colostomy or ileostomy

Relief of symptoms in chronic and mild ulcerative colitis (see warning)

P product

Adults only (aged 16 years and over):

Adjunctive therapy to appropriate rehydration in acute diarrhoea

4.2 Posology And Method Of Administration

Route of administration

Oral

Caution: The recommended dosage should not be exceeded. Once satisfactory control is achieved, dosage should be reduced to suit the requirements of the individual patients.

POM product

Adults:

The recommended starting dosage is four tablets followed by two tablets every six hours.

Elderly:

Consideration should be given to the presence of other diseases and concomitant drug therapy ( see precautions)

Children:

Recommended dosage guide:

Under 4 years:- Not recommended

4-8 years:- 1 tablet three times daily

9-12 years:- 1 tablet four times daily

13-16 years:- 2 tablets three times daily

P product

Adults:

The recommended starting dose is four tablets followed by two tablets every six hours. The maximum dose is 10 tablets in the first 24 hours and 8 tablets in 24 hours thereafter. This should not be exceeded.

Elderly:

The dose is as for adults. Consideration should be given to the presence of other disease and concomitant therapy (see precautions).

Children:

Not for use in children under 16 years of age.

4.3 Contraindications

POM product

Lomotil is contraindicated in patients with known hypersensitivity to diphenoxylate hydrochloride or atropine, in patients with jaundice, intestinal obstruction, acute ulcerative colitis, in the treatment of diarrhoea associated with pseudomembranous enterocolitis, and in patients with a raised intracranial pressure, and patients with head injury.

Contraindicated in myasthenia gravis, pyloric stenosis, paralytic ileus and prostatic enlargement.

P product

Dymotil is contraindicated in patients with a known hypersensitivity to diphenoxylate hydrochloride or atropine, in patients with jaundice, intestinal obstruction, any inflammatory bowel disease, including all forms of ulcerative colitis, and in the treatment of diarrhoea associated with pseudomembranous enterocolitis. Dymotil is also contraindicated in patients with Down's syndrome, and in patients with a raised intracranial pressure, and patients with head injury.

Contraindicated in myasthenia gravis, pyloric stenosis, paralytic ileus and prostatic enlargement.

4.4 Special Warnings And Precautions For Use

Appropriate fluid and electrolyte therapy should be given to protect against dehydration. If severe dehydration or electrolyte imbalance is present, the medicine should be withheld until appropriate corrective therapy has been initiated. In some patients with ulcerative colitis, agents which inhibit intestinal mobility or delay intestinal transit time have been reported to induce toxic megacolon. Patients with ulcerative colitis should be observed carefully and Lomotil therapy should be discontinued promptly if abdominal distension or other untoward symptoms develop.

The medicine should be used with extreme caution in patients with advanced hepatorenal disease, and in patients with abnormal liver function, since hepatic coma may be precipitated.

Because a subtherapeutic dose of atropine is added to the medicine, atropine effects may occur in susceptible individuals or in overdosage. Individuals with Down's syndrome appear to have increased susceptibility to the action of atropine.

Additionally for the P Product

If symptoms persist for more than 24 hours, the patient should consult a doctor. Dymotil is for the symptomatic relief of acute diarrhoea, and is not a substitute for rehydration therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The following interaction have to be considered in the use of Lomotil Tablets:-

Lomotil antagonises the effect of Domperidone, Metoclopramide, Bethanecol/Carbachol, Cisapride, Galantamine, Neostigmine/pyridostigmine, and Pilcarpine.

The amtimuscarinic side effects of Lomotil are increased by Amantadine, Anthihistamines (sedative and non-sedative), Clozapine, Disopyramide, Fluspiriline, Loxapine, MAOI's, Nefopam, Olanzapine, Phenothiazines, Quantiapine, Remoxipride, Terfenadine, Tricyclic antidepressasnts, and Zotepine.

Dry mouth prevents the dissolution of sublingual nitrate tablets, such as glyceryl trinitrate.

The effect of Lomotil is antagonised by Dompezil.

The effect of Lomotil is increased by Memantine.

Lomotil may reduce the plasma levels of Levodopa (in combination and sole products).

Lomotil reduces the absorption of Ketoconazole.

4.6 Pregnancy And Lactation

POM product

Pregnancy

Animal teratology and reproduction studies have demonstrated no adverse effects. The safety of Lomotil in human pregnancy has not been established. However, as with all drugs, caution is recommended when used in early pregnancy.

Lactation

Diphenoxylate hydrochloride and atropine sulphate may be excreted in human milk. If a nursing mother is taking Lomotil, the infant may exhibit some effects of the drug.

P product

Pregnancy and Lactation

Dymotil should not be used during pregnancy and in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Some of the undesirable effects such as sedation, drowsiness or dizziness may affect the ability to drive or operate machines. If affected, patients should be advised not to drive or operate machinery.

4.8 Undesirable Effects

The side effects of Lomotil Tablets include malaise, lethargy, sedation, somnolence, confusion, dizziness, restlessness, depression, euphoria, hallucinations, headache, and fever.

Anaphylaxis, angioedema, urticaria and pruritus have been reported side effects.

Gastrointestinal side effects include paralytic ileus, toxic megacolon, nausea, vomiting, abdominal discomfort, constipation and anorexia.

The atropine side effects of Lomotil Tablets include flushing, dryness of the skin and mucous membranes (including dry mouth), cardiac irregularities such as arrhythmias, bradycardia, and palpitations, increased intra-ocular pressure, urinary retention and difficulty in micturition, and respiratory depression in children.

Dilation of pupils with loss of accommodation, photophobia and very rarely angle closure glaucoma can occur.

4.9 Overdose

Accidental overdose may produce narcosis with respiratory depression or atropine poisoning or both, particularly in children. Symptoms of overdose include dryness of the skin and mucous membranes, flushing, hypothermia and tachycardia, nystagmus, pinpoint pupils, hypotonic reflexes, lethargy, coma, and sever respiratory depression. The onset of symptoms of overdose may be considerably delayed and respiratory depression may not become evident until as late as 12-30 hours after ingestion, and may occur in spite of initial response to narcotic antagonists. Continuous observation should be maintained for at least 48 hours.

If respiratory depression develops, naloxone, a specific antidote, should be administered. The duration of action of naloxone hydrochloride is considerably shorter than that of diphenoxylate hydrochloride and repeated injections of the antidote may be required. Establishment of a patient airway and artificial ventilation may be needed. If the patient is not comatose, gastric ravage and administration of slurry of an activated charcoal may be indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The active ingredient diphenoxylate hydrochloride is a synthetic opioid derivative with selective effects on gastrointestinal smooth muscle. It is essentially devoid of “morphine type subjective effects” at therapeutic doses.

Atropine sulphate is included in the formulation as an anti-abusing agent contributing to the safe use of the product. The dose of atropine sulphate contained in each tablet is subtherapeutic therefore a pharmaceutical effect due to atropine should not be detected taken at normal therapeutic doses.

5.2 Pharmacokinetic Properties

Diphenoxylate hydrochloride is well absorbed from the gastrointestinal tract and extensively metabolised in the liver to diphenoxylic acid (diphenoxin), and hydroxydiphenoxylic acid. It is excreted mainly as metabolites in the urine and bile.

5.3 Preclinical Safety Data

Diphenoxylate hydrochloride is a well established pharmaceutical active and is the subject of a pharmacopoeial monograph. No specific preclinical studies have therefore been performed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lomotil/Dymotil tablets contain:

Sucrose

Acacia

Sorbitol

Magnesium stearate

Talc

Light liquid paraffin

6.2 Incompatibilities

None known

6.3 Shelf Life

The shelf life of Lomotil/Dymotil tablets is 5 years when stored in blister packs.

6.4 Special Precautions For Storage

Store in a dry place below 30°C

6.5 Nature And Contents Of Container

POM

Lomotil tablets are supplied in PVC/PVDC/Aluminium foil blister packs of 100, 500, and 1000 tablets.

Dymotil tablets are supplied in PVC/PVDC/Aluminium foil blister packs of 20.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Ltd

NLA Tower

12 - 16 Addiscombe Road

Croydon

Surrey

CR0 0XT

8. Marketing Authorisation Number(S)

PL 12762/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

01/11/1999 / 12/05/2004

10. Date Of Revision Of The Text

17 August 2010

Wednesday, March 21, 2012

Interceptor Flavor Tabs

Dosage Form: FOR ANIMAL USE ONLY
Interceptor Flavor Tabs

INTERCEPTOR®

(milbemycin oxime) FLAVOR TABS®

The palatable once-a-month tablet that prevents heartworm disease, controls adult hookworm, and removes and controls adult roundworm and whipworm infections in dogs and puppies.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description:

INTERCEPTOR (milbemycin oxime) Flavor Tabs are available in four tablet sizes in color-coded packages for oral administration to dogs and puppies. Each tablet is formulated to provide a minimum of 0.23 mg/lb (0.5 mg/kg) body weight of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43NO7, MW541.68)

Package color	Milbemycin oxime tablet
Brown	2.3 mg
Green	5.75 mg
Yellow	11.5 mg
White	23.0 mg

Indications:

Interceptor Flavor Tabs are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage:

Interceptor Flavor Tabs are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5mg/kg).

Recommended Dosage Schedule for Dogs
Body Weight	Interceptor Flavor Tabs
2-10 lbs.	One tablet (2.3 mg)
11-25 lbs.	One tablet (5.75 mg)
26-50 lbs.	One tablet (11.5 mg)
51-100 lbs.	One tablet (23.0 mg)

Dogs over 100 lbs. are provided the appropriate combination of tablets.

Administration:

Interceptor Flavor Tabs are palatable and most dogs will consume the tablet willingly when offered by the owner. As an alternative, the dual-purpose tablet may be offered in food or administered as other tablet medications. Watch the dog closely following dosing to be sure the entire dose has been consumed. If it is not entirely consumed, redose once with the full recommended dose as soon as possible.

Interceptor Flavor Tabs must be administered monthly, preferably on the same date each month. The first dose should be administered within one month of the dog’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. If a dose is missed and a 30-day interval between dosing is exceeded, administer Interceptor Flavor Tabs immediately and resume the monthly dosing schedule.

If Interceptor Flavor Tabs replaces diethylcarbamazine (DEC)for heartworm prevention, the first dose must be given within 30 days after the last dose of DEC.

Palatability:

Palatability trials conducted in 244 dogs from 10 different U.S. veterinary practices demonstrated that INTERCEPTOR Flavor Tabs were willingly accepted from the owner by over 95% of dogs. The trial was comprised of dogs representing 60 different breeds and both sexes, with weights ranging from 2.1 lbs. to 143.3 lbs., and ages ranging from 8 weeks to 15 years.

Precautions:

Do not use in puppies less than four weeks of age and less than two pounds of body weight. Prior to initiation of the INTERCEPTOR Flavor Tabs treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with Interceptor Flavor Tabs. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae.

Adverse Reactions:

The following adverse reactions have been reported following the use of Interceptor Flavor Tabs: Depression/lethargy, vomiting, ataxia, anorexia, diarrhea, convulsions, weakness and hypersalivation.

Efficacy:

Interceptor Flavor Tabs eliminate the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum), roundworms (Toxocara canis, Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety:

Milbemycin oxime has been tested safely in over 75 different breeds of dogs, including collies, pregnant females, breeding males and females, and puppies over two weeks of age. In well-controlled clinical field studies, 786 dogs completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, shampoos and dips.

Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin-related effects. These effects were directly attributable to the exaggerated experimental dosing regimen. The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of or shortly after whelping resulted in no effects on the puppies.

Some nursing puppies, at 2, 4, and 6 weeks of age, given greatly exaggerated oral milbemycin oxime doses (9.6 mg/kg = 19X) exhibited signs typified by tremors, vocalization and ataxia. These effects were all transient and puppies returned to normal within 24 to 48 hours. No effects were observed in puppies given the recommended dose of milbemycin oxime (0.5 mg/kg). This product has not been tested in dogs less than 1 kg weight.

A rising-dose safety study conducted in rough coated collies manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency in one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

How Supplied:

Interceptor Flavor Tabs are available in four tablet sizes (see Dosage section), formulated according to the weight of the dog. Each tablet size is available in color-coded packages of 6 or 12 tablets each, which are packaged 10 per display carton.

Storage Conditions:

Interceptor Flavor Tabs should be stored at room temperature, between 59° and 77°F (15-25°C).

U.S. Patent No. 4,547,520

Manufactured for:

Novartis Animal Health US, Inc.,

Greensboro, NC 27408, USA

NADA #140-915, Approved by FDA

NAH/INT-FTC/VI/3

12/07

INTERCEPTOR and Flavor Tabs are registered trademarks of Novartis AG.

Interceptor®

(milbemycin oxime) FLAVOR TABS®

INFORMATION FOR DOSING DOGS

The palatable once-a-month tablet that prevents heartworm disease, controls adult hookworm, and removes and controls adult roundworm and whipworm infections in dogs and puppies.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description:

Package color	Milbemycin oxime tablet
Brown	2.3mg
Green	5.75mg
Yellow	11.5mg
White	23.0mg

IndIcations:

Interceptor Flavor Tabs are indicated for use in the prevention of heartworm disease caused by Dirofilaria irnmitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage:

Interceptor Flavor Tabs are given orally, once a month, at the recommended minimum dosage rate of 0.23mg milbemycin oxime per pound of bodyweight (0.5 mg/kg).

Recommended Dosage Schedule for Dogs

Body Weight	Interceptor Flavor Tabs
2-10 lbs.	One tablet (2.3 mg)
11-25 lbs.	One tablet (5.75 mg)
26-50 lbs.	One tablet (11.5 mg)
51-100 lbs.	One tablet (23.0 mg)

Dogs over 100 lbs. are provided the appropriate combination of tablets.

Administration:

If Interceptor Flavor Tabs replaces diethylcarbamazine (DEC) for heartworm prevention, the first dose must be given within 30 days after the last dose of DEC.

Palatability:

Palatability trials conducted in 244 dogs from 10 different U.S. veterinary practices demonstrated that Interceptor Flavor Tabs were willingly accepted from the owner by over 95% of dogs. The trial was comprised of dogs representing 60 different breeds and both sexes, with weights ranging from 2.1 lbs. to 143.3 lbs., and ages ranging from 8 weeks to 15 years.

Precautions:

Do not use in puppies less than four weeks of age and less than two pounds of body weight. Prior to initiation of the Interceptor Flavor Tabs treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with Interceptor Flavor Tabs. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae.

Adverse Reactions:

The following adverse reactions have been reported following the use of Interceptor Flavor Tabs: Depression/lethargy, vomiting, ataxia, anorexia, diarrhea, convulsions, weakness and hypersalivation.

Efficacy;

Interceptor Flavor Tabs eliminate the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum), roundworms (Toxocara canis. Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety:

Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin-relaled effects. These effects were directly attributable to the exaggerated experimental dosing regimen. The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of or shortly after whelping resulted in no effects on the puppies.

A rising-dose safety study conducted in roughcoated collies, manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency. In one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

How supplied:

Storage conditions:

Interceptor Flavor Tabs should be stored at room temperature, between 59° and 77°F (15-25°C).

Interceptor®

(milbemycin oxime) FLAVOR TABS®

INFORMATION FOR DOSING CATS

The palatable once-a-month tablet that prevents heartworm disease and removes adult roundworms and hookworms in cats and kittens.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description:

Interceptor Flavor Tabs for Cats are available in three tablet sizes in color-coded packages for oral administration to cats and kittens. Each tablet is formulated to provide a minimum of 0.9 mg/lb (2.0 mg/kg) body weight of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43N07, MW 541.68)

Indications:

Interceptor Flavor Tabs for Cats are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

Dosage: Interceptor Flavor Tabs for Cats are given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0mg/kg).

Recommended Dosage Schedule for Cats
Body Weight	Interceptor Flavor Tabs
1.5 to 6 lbs.	One tablet (5.75 mg)
6.1-12 lbs.	One tablet (11.5 mg)
12.1-25 lbs.	One tablet (23.0 mg)

Cats over 25 lbs. are provided the appropriate combination of tablets.

Administration:

Interceptor Flavor Tabs for Cats are palatable and may be offered by the owner as a treat. As an alternative, the tablet may be offered in food or administered as other tablet medications. The tablets can be broken for ease of administration. Watch the cat closely following dosing to be sure the entire dose has been consumed. If it is not entirely consumed, redose once with the full recommended dose as soon as possible.

Interceptor Flavor Tabs for Cats must be administered monthly, preferably on the same date each month. The first dose should be administered within one month of the cat’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. If a dose is missed and a 30-day interval between dosing is exceeded, administer Interceptor Flavor Tabs for Cats immediately and resume the monthly dosing schedule. It is recommended that cats be tested for existing heartworm infection prior to starting treatment with Interceptor Flavor Tabs for Cats (See Precautions).

Palatability:

Palatability trials conducted in 72 cats demonstrated that Interceptor Flavor Tabs for Cats were successfully dosed by the owner when they either offered the tablet as a treat, placed the tablet in the cats mouth or placed the tablet in the cat’s food in 72% of cats. About 16% of the cats were manually dosed and 13% of the cats were not successfully dosed according to the protocol.

Precautions:

Do not use in kittens less than six weeks of age or less than 1.5 lbs. body weight. Safety in heartworm positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established.

Efficacy:

Interceptor Flavor Tabs for Cats eliminate the tissue stage of heartworm larvae and hookworm (Ancy/ostoma tubaeforme) and roundworm (Toxocara cati) infections when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety:

Milbemycin oxime has been tested safely in over 8 different breeds of cats. In well-controlled clinical field studies 141 cats completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, anesthetics, antibiotics, steroids, flea collars, shampoos and dips.

Safety studies were conducted in young cats and kittens and doses of 1X, 3X and 5X the minimum recommended dose of 2.0 mg/kg demonstrated no drug-related effects. Tolerability studies at exaggerated doses of 10X also demonstrated no drug-related adverse effects in kittens and young adult cats.

How supplied:

Interceptor Flavor Tabs for Cats are available in three tablet sizes (see Dosage section), formulated according to the weight of the cat. Each tablet size is available in color-coded packages of 6 or 12 tablets each, which are packaged 10 per display carton.

Storage conditions:

Interceptor Flavor Tabs for Cats should be stored at room temperature, between 59° and 77°F (15-25°C).

U.S. Patent No. 4,547,520

Manufactured for:

Novartis Animal Health US, Inc.

Greensboro, NC 27408, USA

NADA #140-915, Approved by FDA

INTERCEPTOR and Flavor Tabs are registered trademarks of Novartis AG.

NAH/INT-FTCF/VI/2

12/07

PRINCIPAL DISPLAY PANEL

Package Label – 2.3 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies.

Net contents: 6 tablets. 2.3 mg each.

Product #20111 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL

Package Label – 5.75 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies, and to prevent

heartworm disease and remove

adult hookworms and

roundworms in cats

and kittens.

Pack

For dogs 11-25lbs

For cats 1.5-6lbs

Net contents: 6 tablets. 5.75 mg each.

Product #20121 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL

Package Label – 11.5 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies, and to prevent

heartworm disease and remove

adult hookworms and

roundworms in cats

and kittens.

Pack

For dogs 26-50lbs

For cats 6.1-12lbs

Net contents: 6 tablets. 11.5 mg each.

Product #20131 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL

Package Label – 23.0 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies, and to prevent

heartworm disease and remove

adult hookworms and

roundworms in cats

and kittens.6

Pack

For dogs 51-100lbs

For cats 12.1-25lbs

Net contents: 6 tablets. 23.0 mg each.

Product #20141 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

Bulk Product – 5 KILOGRAM DRUM

MILBEMYCIN OXIME (S-147)

CGA 179246 A

PROD. NO. 80021

CAS-NO 122674-17-3

NEW ANIMAL DRUG

NADA 141-084, 140-915, and 141-163

ISSUED BY U.S. FDA, CENTER FOR VETERINARY MEDICINE

U.S. CONSIGNEE

NOVARTIS ANIMAL HEALTH US, INC.

GREENSBORO, NC

REGULATORY AFFAIRS 336-387-1000

Manufactured by

Alps Pharmaceutical Ind. Co. Ltd.

on behalf of Novartis Animal Health K.K.

Tokyo 106-0031

Japan

IN EMERGENCY DIAL

CH 4161-696-3333

US 1-800-424-9300

602373/NAH/MIL/BULK/03/08

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2011
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	2.3 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Light brown)	Score	no score
Shape	ROUND	Size	6mm
Flavor	MEAT (Beef flavor)	Imprint Code	RN;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2011-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2011-1)
2	58198-2011-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2011-3)
3	58198-2011-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2011-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2012
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	5.75 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Light brown)	Score	no score
Shape	ROUND	Size	8mm
Flavor	MEAT (Beef flavor)	Imprint Code	GO;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2012-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2012-1)
2	58198-2012-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2012-3)
3	58198-2012-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2012-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2013
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	11.5 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Light Brown)	Score	no score
Shape	ROUND	Size	10mm
Flavor	MEAT (Beef Flavor)	Imprint Code	FKF;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2013-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2013-1)
2	58198-2013-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2013-3)
3	58198-2013-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2013-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2014
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	23 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (light brown)	Score	no score
Shape	ROUND	Size	14mm
Flavor	MEAT (Beef Flavor)	Imprint Code	FRF;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2014-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2014-1)
2	58198-2014-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2014-3)
3	58198-2014-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2014-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

MILBEMYCIN OXIME
milbemycin oxime powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-1001
Route of Administration	NOT APPLICABLE	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	1 kg in 1 kg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	WHITE (white to yellowish white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#

Sunday, March 18, 2012

Nasop12

Generic Name: phenylephrine (FEN il EFF rin)

Brand Names: Ah-Chew D, Dimetapp Cold Drops, Lusonal, Nasop, Nasop12, PediaCare Children's Decongestant, Phenyl-T, Sudafed PE, Sudafed PE Children's Nasal Decongestant, Sudafed PE Quick Dissolve, Sudogest PE, Triaminic Thin Strips Cold

What is Nasop12 (phenylephrine)?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Phenylephrine is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

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

What is the most important information I should know about Nasop12 (phenylephrine)?

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

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking Nasop12 (phenylephrine)?

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

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have:

heart disease, heart rhythm disorder;

high blood pressure;

circulation problems (such as Raynaud's syndrome);

diabetes;

glaucoma;

a thyroid disorder;

kidney disease;

an enlarged prostate or urination problems;

sleep problems, anxiety; or

mental illness such as bipolar disorder.

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take phenylephrine, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Disintegrating and liquid forms of cold medicine may contain sugar or artificial sweeteners (phenylalanine). This would be important to know if you have diabetes or phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about sugar or phenylalanine.

How should I use Nasop12 (phenylephrine)?

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

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You may take phenylephrine with food if it upsets your stomach. Take the phenylephrine tablet with a full glass of water.

Measure the liquid form of phenylephrine 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.

The chewable phenylephrine tablet must be chewed thoroughly before you swallow it.

To use the phenylephrine disintegrating strip, place one strip on your tongue and allow it to dissolve without chewing.

To use the disintegrating tablet, make sure your hands are dry and peel back the foil from the blister package. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Phenylephrine is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

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

Store phenylephrine at room temperature away from moisture and heat. Keep the disintegrating tablets or strips in their package until you are ready to take one.

Throw away any unused phenylephrine after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Cold medicine is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using Nasop12 (phenylephrine)?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

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

Avoid smoking. It can add to the effects of phenylephrine in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking phenylephrine.

Nasop12 (phenylephrine) 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 phenylephrine and call your doctor at once if you have a serious side effect such as:

severe dizziness, restless feeling, nervousness, or insomnia;

unusual thoughts or behavior;

feeling like you might pass out;

fast, pounding, or uneven heartbeat;

tremors or shaking;

numbness, tingling, or cold feeling in your hands or feet; or

urinating less than usual or not at all.

Less serious side effects may include:

headache, dizziness;

feeling excited or restless (especially in children);

upset stomach; or

mild sleep problems.

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 Nasop12 (phenylephrine)?

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

other decongestants, including nasal sprays;

digoxin (digitalis, Lanoxin);

medicine to treat diabetes;

medicines to treat high blood pressure such as reserpine, methyldopa (Aldomet), and others;

migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

This list is not complete and there may be other drugs that can interact with phenylephrine. 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 Nasop12 resources

Nasop12 Side Effects (in more detail)
Nasop12 Use in Pregnancy & Breastfeeding
Nasop12 Drug Interactions
Nasop12 Support Group
0 Reviews for Nasop12 - Add your own review/rating

AH-Chew D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Lusonal Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Nasop Dissolving Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Neo-Synephrine Nasal Advanced Consumer (Micromedex) - Includes Dosage Information

Neo-Synephrine MedFacts Consumer Leaflet (Wolters Kluwer)

Phenylephrine Hydrochloride Monograph (AHFS DI)

Sudafed PE MedFacts Consumer Leaflet (Wolters Kluwer)

Sudafed PE Consumer Overview

Compare Nasop12 with other medications

Hypotension
Nasal Congestion
Shock
Supraventricular Tachycardia

Where can I get more information?

Your pharmacist can provide more information about phenylephrine.

See also: Nasop12 side effects (in more detail)

Saturday, March 17, 2012

Secondary Cutaneous Bacterial Infections Medications

Drugs associated with Secondary Cutaneous Bacterial Infections

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

Drug List:

Carmol-Scalp

Carmol-Scalp-Treatment-Lotion

Carmol-Scalp-Treatment-Kit

Rosula-Ns-Medicated-Pads

Seb-Prev-Lotion

Sebizon-Lotion

Tuesday, March 13, 2012

Pyrimethamine

Pronunciation: peer-i-METH-a-meen
Generic Name: Pyrimethamine
Brand Name: Daraprim

Pyrimethamine is used for:

Treating or preventing malaria and treating toxoplasmosis when used with other medicines (eg, folinic acid).

Pyrimethamine is an antiparasitic. It works by killing the parasites or preventing their growth.

Do NOT use Pyrimethamine if:

you are allergic to any ingredient in Pyrimethamine

you have megaloblastic anemia due to folate deficiency

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

Before using Pyrimethamine:

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

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

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

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

if you have a history of depression, seizures, kidney or liver problems, bone marrow problems, stomach or bowel problems (eg, malabsorption syndrome), phenylketonuria, or alcoholism

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

Phenytoin because side effects of Pyrimethamine may be increased

Methotrexate, proguanil, quinine, sulfonamides (eg, sulfamethoxazole), or zidovudine because the risk of bone marrow suppression may be increased

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

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

Pyrimethamine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Your doctor may also prescribe another medicine called folinic acid (leucovorin calcium) to take along with Pyrimethamine.

To clear up your infection completely, continue using Pyrimethamine for the full course of treatment even if you feel better in a few days.

If you miss a dose of Pyrimethamine, take 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 take 2 doses at once.

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

Important safety information:

It is important to use Pyrimethamine for the full course of treatment. Failure to do so may decrease the effectiveness of Pyrimethamine and may increase the risk that the organisms will no longer be sensitive to Pyrimethamine and will not be able to be treated by this or certain other antibiotics in the future.

LAB TESTS, including blood cell counts and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Pyrimethamine with caution in the ELDERLY because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: It is unknown if Pyrimethamine can cause harm to the fetus. Avoid becoming pregnant while taking Pyrimethamine. If you become pregnant while taking Pyrimethamine, discuss with your doctor the benefits and risks of using Pyrimethamine during pregnancy. Pyrimethamine is excreted in breast milk. Do not breast-feed while taking Pyrimethamine.

Possible side effects of Pyrimethamine:

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:

Loss of appetite; nausea; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; irregular heartbeat; pale skin; red, swollen, or blistered skin; severe or persistent vomiting; sore throat or fever; unusual bleeding or bruising.

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: Pyrimethamine 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 abdominal pain; difficulty breathing; fast heartbeat; fever; nausea; seizures; severe or persistent vomiting; stomach pain; vomiting of blood.

Proper storage of Pyrimethamine:

Store Pyrimethamine at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyrimethamine out of the reach of children and away from pets.

General information:

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

Pyrimethamine 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 Pyrimethamine. 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 Pyrimethamine resources

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

Pyrimethamine Professional Patient Advice (Wolters Kluwer)

pyrimethamine Advanced Consumer (Micromedex) - Includes Dosage Information

pyrimethamine Concise Consumer Information (Cerner Multum)

Daraprim Prescribing Information (FDA)

Daraprim Monograph (AHFS DI)

Compare Pyrimethamine with other medications

Malaria Prevention
Pneumocystis Pneumonia Prophylaxis
Toxoplasmosis
Toxoplasmosis, Prophylaxis