Moxilin

Generic Name: amoxicillin (Oral route)

a-mox-i-SIL-in

Commonly used brand name(s)

In the U.S.

• Amoxicot


• Amoxil


• DisperMox


• Moxatag


• Moxilin


• Trimox

In Canada

• Amoxil Pediatric


• Apo-Amoxi


• Apo-Amoxi Sugar-Free


• Gen-Amoxicillin


• Med Amoxicillin


• Novamoxin


• Novamoxin Reduced Sugar


• Nu-Amoxi


• Riva-Amoxicillin


• Scheinpharm Amoxicillin


• Zimamox

Available Dosage Forms:

• Tablet


• Tablet, Chewable


• Tablet for Suspension


• Powder for Suspension


• Tablet, Extended Release


• Capsule

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Uses For Moxilin

Amoxicillin is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., clarithromycin, lansoprazole) to treat H. pylori infection and duodenal ulcers.

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

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

Before Using Moxilin

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin in children. However, newborns and infants 3 months of age and younger have incompletely developed kidney functions, which may need a lower dose of this medicine.

Geriatric

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

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate


• Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Khat


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Probenecid


• Warfarin

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to penicillins or cephalosporin antibiotics (e.g., cefaclor, cefadroxil, cephalexin, Ceftin®, or Keflex®) or


• Mononucleosis (viral infection)—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of amoxicillin

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

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

For patients using the oral liquid:

• Shake the bottle well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.


• You may mix the oral liquid with a baby formula, milk, fruit juice, water, ginger ale, or another cold drink. Be sure the child drinks all of the mixture immediately.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage forms (capsules, powder for suspension, and tablets):
  
  • For bacterial infections:
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every 8 hours, or 500 to 875 mg every 12 hours.
    
    
    • Children and infants older than 3 months of age weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 8 hours, or 25 to 45 mg per kg of body weight per day, divided and given every 12 hours.
    
    
    • Infants 3 months of age and younger—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 mg per kg of body weight per day, divided and given every 12 hours.
    
    
  
  
  • For treatment of gonorrhea:
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—3-grams (g) taken as a single dose.
    
    
    • Children 2 years of age and older weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, combined with 25 mg per kg of probenecid, taken as a single dose.
    
    
    • Children younger than 2 years of age—Use is not recommended.
    
    
  
  
  • For treatment of H. pylori infection:
    
    • Adults—
      
      • Dual therapy: 1000 milligrams (mg) of amoxicillin and 30 mg of lansoprazole, each given three times a day (every 8 hours) for 14 days.
      
      
      • Triple therapy: 1000 mg of amoxicillin, 500 mg of clarithromycin, and 30 mg of lansoprazole, all given two times a day (every 12 hours) for 14 days.
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store the oral liquid in the refrigerator. Throw away any unused medicine after 14 days. Do not freeze.

Precautions While Using Moxilin

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

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a skin rash; itching; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, mouth, or throat after you or your child receive this medicine.

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

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

In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Moxilin Side Effects

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

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

Incidence not known

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine


• bloody nose


• chest pain


• chills


• clay-colored stools


• cough


• dark urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• feeling of discomfort


• fever


• general body swelling


• headache


• heavier menstrual periods


• hives or welts


• increased thirst


• inflammation of the joints


• itching


• joint or muscle pain


• loss of appetite


• muscle aches


• nausea or vomiting


• nosebleeds


• pain


• pain in the lower back


• pain or burning while urinating


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


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


• rash


• red, irritated eyes


• redness, soreness, or itching skin


• shortness of breath


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• sores, welting, or blisters


• sudden decrease in the amount of urine


• swollen, lymph glands


• tenderness


• tightness in the chest


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• vomiting of blood


• watery or bloody diarrhea


• wheezing


• yellow eyes or skin

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

• Bad, unusual, or unpleasant (after) taste


• change in taste

Incidence not known

• Agitation


• black, hairy tongue


• changes in behavior


• confusion


• convulsions


• discoloration of the tooth (brown, yellow, or gray staining)


• dizziness


• sleeplessness


• trouble with sleeping


• unable to sleep


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash

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.

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Didronel 200mg Tablets

1. Name Of The Medicinal Product

Didronel 200mg Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains 200mg of Etidronate Disodium, USP.

3. Pharmaceutical Form

White rectangular tablets marked with 'P&G' on one face and '402' on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Paget's disease of bone:

Effectiveness has been demonstrated primarily in patients with polyostotic Paget's disease with symptoms of pain and with clinically significant elevations of urinary hydroxyproline and serum alkaline phosphatase. In other circumstances in which there is extensive involvement of the skull or the spine with the prospect of irreversible neurological damage, or when a weight-bearing bone may be involved, the use of Didronel may also be considered.

4.2 Posology And Method Of Administration

5mg/kg/day to 20mg/kg/day as detailed below.

Didronel should be given on an empty stomach. It is recommended that patients take the therapy with water, at the mid point of a four hour fast (ie. two hours before and two after food).

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of risedronate on an individual patient basis, particularly after 5 or more years of use.

Adults and Elderly:

The recommended initial dose of Didronel for most patients is 5mg/kg body weight/day, for a period not exceeding six months. Doses above 10mg/kg should be reserved for use when there is an overriding requirement for suppression of increased bone turnover associated with Paget's disease or when the patient requires more prompt reduction of elevated cardiac output. Treatment with doses above 10mg/kg/day should be approached cautiously and should not exceed three months duration. Doses in excess of 20mg/kg/day are not recommended.

Re-treatment should be undertaken only after a drug-free period of at least three months and after it is evident that reactivation of the disease has occurred and biochemical indices of the disease have become substantially re-elevated or approach pretreatment values (approximately twice the upper limit of normal or 75% of pre-treatment value). In no case should duration of treatment exceed the maximum duration of the initial treatment. Premature re-treatment should be avoided. In clinical trials the biochemical improvements obtained during drug therapy have generally persisted for a period of three months to 2 years after drug withdrawal.

Daily Dosage Guide

Body Weight	Required Daily Regimen of 200mg Tablets
Kilogrames	Stones	5mg/kg*	10mg/kg*	20mg/kg+
50	8	1	3	5
60	9.5	2	3	6
70	11	2	4	7
80	12.5	2	4	8
90	14	2	5	9

*Course of therapy - 6 months

+Course of therapy - 3 months

Children:

Disorders of bone in children, referred to as juvenile Paget's disease, have been reported rarely. The relationship to adult Paget's disease has not been established. Didronel has not been studied in children for Paget's disease.

4.3 Contraindications

Known hypersensitivity to etidronate disodium or any of the other ingredients in the product (see Section 6.1 List of Excipients). Clinically overt osteomalacia.

4.4 Special Warnings And Precautions For Use

In Pagetic patients the physician should adhere to the recommended dose regimen in order to avoid over- treatment with Didronel. The response to therapy may be of slow onset and may continue even for months after treatment with the drug has been discontinued. Dosage should not be increased prematurely nor should treatment be resumed before there is clear evidence of reactivation of the disease process. Re-treatment should not be initiated until the patient has had at least a three-month drug-free interval.

Etidronate disodium is not metabolized and is excreted intact via the kidney. Due to the lack of clinical experience the treatment of patients with impaired renal function should be undertaken with due caution. The use of etidronate disodium is discouraged in patients with severely impaired kidney function.

Caution should be taken in patients with a history of renal stone formation. In patients with impaired renal function or a history of renal stone formation, serum and urinary calcium should be monitored regularly.

It is recommended that serum phosphate, serum alkaline phosphatase and urinary hydroxyproline be measured before commencing medication and at three month intervals during treatment. If after three months of medication the pre-treatment levels have not been reduced by at least 25%, the patient may be relatively resistant to therapy. If the serum phosphate level is unchanged in the "resistant" patient, consideration should be given to increasing the dose since the absorption of pharmacologically active amounts of Didronel is typically accompanied by a rise in serum phosphate. This rise usually correlates with reductions in the biochemical indices of disease activity. If after three or more months of medication elevations of serum phosphate above the upper limit of normal are not accompanied by clinical or biochemical evidence of reduced activity, resistance of the disease to the action of Didronel is probable and termination of Didronel medication should be considered. Etidronate disodium suppresses bone turnover and may retard mineralisation of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid, which may accumulate noticeably at doses of 10-20 mg/kg/day, mineralises normally post-therapy. Patients in whom serum phosphate elevations are high and reductions of disease activity are low may be particularly prone to retarded mineralisation of new osteoid. In those cases where 200mg per day (a single tablet) may be excessive, doses may be administered less frequently.

Patients with Paget's disease of bone should maintain an adequate intake of calcium and vitamin D. Patients with low vitamin D and calcium intake may be particularly sensitive to drugs that affect calcium homeostasis and should be closely monitored during Didronel therapy.

Etidronate disodium does not adversely affect serum levels of parathyroid hormone or calcium.

Hyperphosphataemia has been observed in patients receiving etidronate disodium, usually in association with doses of 10-20mg/kg/day. No adverse effects have been traced to this, and it does not constitute grounds for discontinuing therapy. It is apparently due to a drug-related increase in renal tubular reabsorption of phosphate. Serum phosphate levels generally return to normal 2-4 weeks post therapy.

Patients with significant chronic diarrhoeal disease may experience increased frequency of bowel movements and diarrhoea, particularly at higher doses.

Increased or recurrent bone pain at existing Pagetic sites and/or the appearance of pain at sites previously asymptomatic have been reported at a dose of 5mg/kg/day.At higher doses, the incidence rises to approximately 20%. When therapy continues, pain resolves in some patients but persists in others.

Fractures are recognised as a common feature in patients with Paget's disease. There has been no evidence of increased risk of fractures at the recommended dose of 5mg/kg/day for six months. At doses of 20mg/kg/day in excess of three months' duration, mineralisation of newly formed osteoid may be impaired and the risk of fracture may be increased. The risk of fracture may also be greater in patients with extensive and severe disease, a history of multiple fractures, and/or rapidly advancing osteolytic lesions. It is therefore recommended that the drug is discontinued when fractures occur and therapy not reinstated until the fracture healing is complete.

Patients with predominantly lytic lesions should be monitored radiographically and biochemically to permit termination of etidronate disodium in those patients unresponsive to treatment.The incidence of osteogenic sarcoma is known to be increased in Paget's disease. Pagetic lesions, with or without therapy, may appear by X-ray to progress markedly, possibly with some loss of definition of periosteal margins. Such lesions should be evaluated carefully to differentiate these from osteogenic sarcoma.

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving bisphosphonates.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patient with concominant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).

While on treatment, these patients should avod invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces risk of osteonecrosis of the jaw.

Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

Atypical fractures of the femur

Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.

During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Food in the stomach or upper portions of the small intestine, particularly materials with a high calcium content such as milk, may reduce absorption of etidronate disodium. Vitamins with mineral supplements such as iron, calcium supplements, laxatives containing magnesium, or antacids containing calcium or aluminium should not be taken within two hours of dosing etidronate disodium.

The diagnostic utility of bone-imaging agents may be impaired by current or recent etidronate use.

There have been isolated reports of patients experiencing changes in their prothrombin times when etidronate was added to warfarin therapy. The majority of these reports concerned variable elevations in prothrombin times without clinically significant sequelae. Although the relevance of these reports and any mechanism of coagulation alterations is unclear, patients on warfarin should have their prothrombin time monitored.

4.6 Pregnancy And Lactation

The safety of this medicinal product for use in human pregnancy has not been established. Reproductive studies have shown skeletal abnormalities in rats. It is therefore recommended that Didronel should not be used in women of childbearing potential unless adequate contraceptive measures are taken.

It is not known whether this drug passes into breast milk. It should therefore not be used during lactation period.

4.7 Effects On Ability To Drive And Use Machines

Etidronate disodium does not interfere with the ability to drive or use machines.

4.8 Undesirable Effects

Gastro-intestinal

The most common effects reported are diarrhoea and nausea. Reports of exacerbation of peptic ulcer with complications in a few patients.

Dermatological/hypersensitivity

Hypersensitivity reactions, including angio-oedema/urticaria, rash and/or pruritus, have been reported rarely.

Nervous System

Paresthesia, peripheral neuropathy , confusion, have been reported rarely.

Haematological

In patients receiving etidronate disodium, there have been rare reports of leucopenia, agranulocytosis and pancytopenia.

Musculoskeletal and connective tissue disorders

osteonecrosis of the jaw (see section 4.4 special warnings and precautions of use)

Other

Less common effects believed to be related to therapy include arthropathies (arthralgia and arthritis), and rarely burning of the tongue, alopecia, erythema multiforme and exacerbation of asthma.

During post-marketing experience the following reactions have been reported (frequency rare):

Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction).

4.9 Overdose

Overdose would manifest as the signs and symptoms of hypocalcaemia. Treatment should involve cessation of therapy and correction of hypocalcaemia with administration of Ca²⁺ intravenously.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Etidronate acts primarily on bone. It can inhibit the formation, growth and dissolution of hydroxyapatite crystals and amorphous precursors by chemisorption to calcium phosphate surfaces. Inhibition of crystal resorption occurs at lower doses than are required for the inhibition of crystal growth. Both effects increase as dose increases.

5.2 Pharmacokinetic Properties

Etidronate is not metabolised. Absorption averages about 1% of an oral dose of 5mg/kg body weight/day. This increases to about 1.5% at 10mg/kg/day and 6% at 20mg/kg/day. Most of the drug is cleared from the blood within 6 hours. Within 24 hours about half of the absorbed dose is excreted in the urine. The remainder is chemically absorbed to bone, especially to areas of elevated osteogenesis, and is slowly eliminated. Unabsorbed drug is excreted in the faeces.

5.3 Preclinical Safety Data

In long term studies in mice and rats, there was no evidence of carcinogenicity with etidronate disodium. All in vitro and in vivo assays conducted to assess the mutagenic potential of etidronate disodium have been negative.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Starch, magnesium stearate and microcrystalline cellulose.

6.2 Incompatibilities

See section 4.5 Interactions with other medicaments and other forms of interaction.

6.3 Shelf Life

Four years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Supplied in high density polypropylene bottles or blister packs of 60 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Warner Chilcott UK Limited

Old Belfast Road,

Millbrook,

Larne,

County Antrim,

BT40 2SH

8. Marketing Authorisation Number(S)

PL 10947/0018

9. Date Of First Authorisation/Renewal Of The Authorisation

26^th November 1987

10. Date Of Revision Of The Text

September 2011

Fluvirin

Generic Name: influenza virus vaccine (Intradermal route, Intramuscular route)

in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on)

Commonly used brand name(s)

In the U.S.

• Afluria


• Fluarix


• Flulaval


• Fluvirin


• Fluzone


• Fluzone High-Dose


• Fluzone Pediatric

Available Dosage Forms:

• Suspension


• Solution

Therapeutic Class: Vaccine

Uses For Fluvirin

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a “flu shot”.

There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.

It is necessary to receive an influenza vaccine injection each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and older, all children, and all adults (including 65 years of age and older).

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using Fluvirin

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Agriflu®, Flulaval™, Fluzone® High-Dose, or Fluzone® Intradermal in the pediatric population. Safety and efficacy have not been established.

Afluria® is not indicated in children younger than 5 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluvirin® in children younger than 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluarix® in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® in children younger than 6 months of age. Safety and efficacy have not been established.

Geriatric

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

Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® Intradermal in the geriatric population. Safety and efficacy have not been established.

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Allergy to eggs, egg products, or chicken proteins, history of—Usually should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. May have an increased risk of bleeding at the injection site.

• Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

• Illness with fever, moderate or severe—You may need to wait until you feel better before you receive the vaccine.

• Immune system problems from a disease or medicine—May not work as well in patients with this condition.

• Kanamycin, neomycin, or polymyxin allergy, history of—Only certain brands of the influenza vaccine can be used. Talk with your doctor about this.

Proper Use of influenza virus vaccine

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

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles or into your skin, usually in the shoulder area.

Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.

You need to get the flu vaccine every year to protect you from the flu.

Some children may need a second dose of the vaccine. If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Precautions While Using Fluvirin

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

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

Children who have received a certain brand of the influenza vaccine (Afluria®) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.

If you are very sick and have a high fever, you will probably need to wait until you are well before your receive this vaccine.

Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Fluarix®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Fluzone® Intradermal vaccine.

Make sure your doctor knows if you or your child are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.

Fluvirin Side Effects

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).

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

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

More common

• Cough


• diarrhea


• fever


• headache


• irritability


• loss of appetite


• muscle aches


• redness of the eyes


• sneezing


• sore throat


• stuffy or runny nose


• vomiting

Less common

• Body aches or pain


• chills


• difficulty with breathing


• earache


• ear congestion


• loss of voice


• shivering


• swelling or puffiness of the face


• tightness in the chest


• unusual tiredness or weakness

Rare

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


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


• noisy breathing


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


• shortness of breath


• skin rash


• wheezing

Incidence not known

• Agitation


• back pain, sudden and severe


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, itching, lumps, numbness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site


• blindness


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blurred vision


• bruising, inflammation, rash, redness, swelling, tenderness, or pain at the injection site


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


• burning, dry, or itching eyes


• change in color vision


• change in walking and balance


• chest pain


• clumsiness or unsteadiness


• cold, clammy skin


• coma


• confusion


• dark urine


• discharge or excessive tearing


• drowsiness


• dryness of the throat


• eye pain


• fainting


• fast, weak pulse


• feeling hot


• feeling of constant movement of self or surroundings


• feeling unusually cold


• general body swelling


• general feeling of discomfort or illness


• hallucinations


• inability to move the arms and legs


• increased sensitivity of the eyes to sunlight


• irritation


• joint pain, stiffness, or swelling


• lack or loss of strength


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


• lightheadedness


• mood or mental changes


• muscle weakness, sudden and progressing


• nausea


• nerve pain


• nosebleeds


• pain, redness, soreness, swelling, tenderness, or warmth on the skin


• painful knees and ankles


• paleness of the skin


• pinpoint red spots on the skin


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


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


• seizures


• sensation of spinning


• shakiness in the legs, arms, hands, or feet


• sores, ulcers, or white spots in the mouth or on the lips


• stabbing pain


• stiff neck


• stomach pain, soreness, or discomfort


• sweating


• swelling of the face, hands, or feet


• swelling of the mouth or throat


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


• trouble with sleeping


• troubled breathing or swallowing


• unusual bleeding or bruising


• voice changes


• weakness of the muscles in your face


• yellowing of the eyes or skin

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:

Incidence not known

• Sleepiness or unusual drowsiness

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: Fluvirin 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 Fluvirin resources

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

• Fluvirin Prescribing Information (FDA)


• Fluvirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Afluria Consumer Overview


• Afluria MedFacts Consumer Leaflet (Wolters Kluwer)


• Afluria Prescribing Information (FDA)


• Agriflu Consumer Overview


• Agriflu MedFacts Consumer Leaflet (Wolters Kluwer)


• FluLaval MedFacts Consumer Leaflet (Wolters Kluwer)


• FluLaval Consumer Overview


• Fluarix MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluarix Consumer Overview


• Fluarix Prescribing Information (FDA)


• Flulaval Prescribing Information (FDA)


• Fluzone Prescribing Information (FDA)


• Fluzone MedFacts Consumer Leaflet (Wolters Kluwer)


• Influenza Virus Vaccine Inactivated Monograph (AHFS DI)


• Influenza Virus Vaccine Live Intranasal Monograph (AHFS DI)

Compare Fluvirin with other medications

• Influenza Prophylaxis

Locoid Lipocream

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Locoid Lipocream (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about Locoid Lipocream (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

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 for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Locoid Lipocream (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Locoid Lipocream (hydrocortisone topical)?

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 or smaller amounts, or use it for longer than recommended.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Locoid Lipocream (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Locoid Lipocream (hydrocortisone topical) 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 hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 Locoid Lipocream (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. 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 Locoid Lipocream resources

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

• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lipocream Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Locoid Lipocream with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Locoid Lipocream side effects (in more detail)

Clinacox

Dosage Form: FOR ANIMAL USE ONLY
Clinacox

FRONT PANEL

Enter section text here

FRONT AND BACK PANELS

Clinacox

             (DICLAZURIL)


Anticoccidial

Type A Medicated Article


ACTIVE DRUG INGREDIENT:             Diclazuril, 0.2%


INERT INGREDIENTS:                       Wheat middlings, calcium carbonate, soybean oil with 0.02% TBHQ (preservative), and silicon dioxide.


INDICATIONS:                                   Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E necatrix, E.

                                                        acervulina, E brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective

                                                        against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a

                                                        short time after infection. Diclazuril was shown in studies to reduce lesion scores and

                                                        improve performance and health of birds challenged with E. maxima.


                                                        Growing turkeys: For the prevention of coccidosis caused by Eimeria adenoeides, E. gallopavonis, and

                                                        E. meleagrimitis.


IMPORTANT:                                    MUST BE THOROUGHLY MIXED INTO POULTRY FEEDS BEFORE USE.


DIRECTIONS:                                 Thoroughly mix one pound (1 Ib) of Clinacox (0.2% diclazuril) into each ton of complete feed to provide

                                                         1 ppm of diclazuril (use level). It is recommended that an intermediate mix containing one part

                                                         Clinacox Anticoccidial and not less than nine parts appropriate feed ingredient be thoroughly

                                                         mixed before incorporation into the final feed. The resulting Type C medicated feed should be fed

                                                         continuously as the sole ration.


WARNING:                                        Not for use in hens producing eggs for human food.


CAUTION:                                         Do not feed to breeding turkeys.


Diclazuril is a licensed product from Janssen Pharmaceutica, Beerse, Belgium

Clinacox is registered trademark of Johnson and Johnson, U.S. Patent:4,631,278.

Copyright 1998, 1999, 2001, Huvepharma, Inc. All rights reserved.


Net Wt 50 1b/22.68 kg


Store at or below 25°C (77 °F), excursions permitted to 40 °C (104 °F).


Huvepharma, Inc. 500 Westpark Drive, Suite 230                                                    NADA #140-951, Approved by FDA.

Peachtree City, GA 30269

STORAGE CONDITIONS

Store at or below 25°C (77 °F), excursions permitted to 40 °C (104 °F).

Bag label Image

Bag label Image

Clinacox  diclazuril  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 23243-3010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLAZURIL (DICLAZURIL) DICLAZURIL 2 g  in 1 kg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   SOYBEAN OIL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23243-3010-5 22.68 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140951	06/29/2009

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma AD (552691651)

Establishment
Name	Address	ID/FEI	Operations
Huvepharma, Inc.		619153559	manufacture, analysis, label, pack

Revised: 03/2010Huvepharma, Inc.

Zamadol Melt 50 mg Tablets

1. Name Of The Medicinal Product

Zamadol Melt 50 mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 50 mg of tramadol hydrochloride.

For excipients, see 6.1

3. Pharmaceutical Form

Orodispersible tablets and dispersible tablets.

Round, white, biconcave tablet, engraved 'T' on one side and '50' on the other side, with a characteristic mint flavour.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of moderate to severe pain.

4.2 Posology And Method Of Administration

As with all analgesic drugs, the dose of Zamadol Melt 50 mg Tablets should be adjusted according to the severity of the pain and the clinical response of the individual patient.

Adults and adolescents aged 12 years and over

For oral use:

Acute pain :

An initial dose is 50-100 mg depending on the intensity of pain. This can be followed by doses of 50 or 100 mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.

Pain associated with chronic conditions :

Use an initial dose of 50 mg and then titrate dose according to pain severity. The initial dose may be followed if necessary by 50-100 mg every 4 to 6 hours. The recommended doses are intended as a guideline. Patients should always receive the lowest dose that provides effective pain control. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (see section 4.4 Special warnings and special precautions for use).

Elderly :

The usual dosage may be used although it should be noted that in volunteers aged over 75 years the elimination half-life of tramadol was increased following oral administration. An adjustment of the dosage or increasing the dose interval should be considered.

Renal impairment/renal dialysis :

The elimination of tramadol may be prolonged. The usual initial dosage should be used. For patients with creatinine clearance < 30 ml/min, the dosage interval should be increased to 12 hours. Tramadol is not recommended for patients with severe renal impairment (creatinine clearance < 10 ml/min).

As tramadol is only removed very slowly by haemodialysis or haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.

Hepatic impairment :

The elimination of tramadol may be prolonged. The usual initial dosage should be used but in hepatic impairment the dosage interval should be increased to 12 hours and the dose reduced if necessary. Tramadol is not recommended for patients with severe hepatic impairment.

Children under 12 years :

Not recommended.

The tablet disperses rapidly in the mouth and is then swallowed. Alternatively, the tablet can be dispersed in half a glass of water, stirred and drunk immediately independently of meals.

4.3 Contraindications

Zamadol Melt 50 mg Tablets must not be administered to patients who have previously demonstrated hypersensitivity to the active substance or any of the excipients.

The product must not be administered to patients suffering from acute intoxication or overdose with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

In common with other opioid analgesics it must not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal. It must not be administered concomitantly with nalbuphine, buprenorphine or pentazocine (see 4.5, interactions with other medicinal products and other forms of interaction).

Contraindicated in patients suffering from uncontrolled epilepsy.

Tramadol must not be administered during breast-feeding if long term treatment is necessary.

Zamadol Melt 50 mg Tablets is not suitable for children under 12 years of age.

4.4 Special Warnings And Precautions For Use

Warnings :

At therapeutic doses, Zamadol Melt 50 mg Tablets has the potential to cause withdrawal symptoms. Rarely cases of dependence and abuse have been reported. However, Zamadol Melt should only be used for short periods and under strict medical supervision in patients with a tendency of drug abuse or dependence.

At therapeutic doses withdrawal symptoms have been reported at a reporting frequency of 1 in 8,000. Reports of dependence and abuse have been less frequent. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly. In patients with a tendency to drug abuse or dependence, treatment should be for short periods and under strict medical supervision.

Zamadol Melt is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, it cannot suppress morphine withdrawal symptoms.

Alcohol intake and concomitant use of carbamazepine are not recommended during treatment.

Precautions :

Zamadol Melt should be used with caution in patients with head injury, increased intracranial pressure, impairment of hepatic and renal function, decreased level of consciousness and in patients prone to convulsive disorders or in shock.

Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold (see section 4.5 Interaction with other medicinal products and other forms of interaction).

At the recommended doses Zamadol Melt is unlikely to produce clinically relevant respiratory depression. However, care should be taken when treating patients with existing respiratory depression, or excessive bronchial secretion and in those patients taking concomitant CNS depressant drugs.

The ingredient aspartame contains a source of phenylalanine which may be harmful to people with phenylketonuria.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of the following is contraindicated:

Patients treated with monoamine oxidase inhibitors within 14 days prior to the administration of the opioid pethidine have experienced life-threatening interactions affecting the central nervous system as well as the respiratory and circulatory centres (risk of serotonergic syndrome – see below). The possibility of similar interactions occurring between monoamine oxidase inhibitors (including the selective MAO A and B inhibitors and linezolid) and tramadol cannot be ruled out.

The combination of mixed agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) and tramadol is not recommended because it is theoretically possible that the analgesic effect of a pure agonist is attenuated under these circumstances and that a withdrawal syndrome may occur.

Concomitant use of the following needs to be taken into consideration:

Isolated cases of serotonergic syndrome have been reported with the therapeutic use of tramadol in combination with other serotonergic agents such as selective serotonin re-uptake inhibitors (SSRIs). Signs of serotonergic syndrome may include: confusion, restlessness, agitation, fever, sweat, tachycardia, tremor, ataxia, hyper-reflexia, myoclonus, diarrhoea and possibly coma. Withdrawal of the serotonergic agent produces a rapid improvement.

Concomitant administration of Zamadol Melt with other centrally acting drugs (including other opioid derivatives, benzodiazepines, barbiturates, other anxiolytics, hypnotics, sedative anti-depressants, sedative anti-histamines, neuroleptics, centrally acting anti-hypotensive drugs, baclofen and alcohol) may potentiate CNS depressant effects including respiratory depression.

Simultaneous administration of carbamazepine markedly decreases serum concentrations of tramadol to an extent that a decrease in analgesic effectiveness and a shorter duration of action may occur.

Tramadol may increase the potential for selective serotonin reuptake inhibitors (SSRIs) , tricyclic antidepressants (TCAs), anti-psychotics and other seizure threshold lowering drugs (e.g. bupropion and mefloquine) to cause convulsions (see sections 4.4 Special warnings and special precautions for use and 5.2 Pharmacokinetic properties).

There have been isolated reports of interaction with coumarin anticoagulants resulting in an increased international normalised ratio (INR) and so care should be taken when commencing treatment with tramadol in patients on anticoagulants.

4.6 Pregnancy And Lactation

Pregnancy :

In humans, there are no sufficient data to assess malformative effect of tramadol when given during the first trimester of pregnancy. Animal studies have not shown any teratogenic effects, but at high doses, foetotoxicity due to maternotoxicity appeared (See 5.3 Preclinical data).

Tramadol crosses the placenta, therefore as with other opioid analgesics, chronic use of tramadol during the third trimester may induce a withdrawal syndrome in new-born. At the end of pregnancy, high dosages, even for short term treatment, may induce respiratory depression in new-born. There is inadequate evidence available on the safety of tramadol in human pregnancy, therefore Zamadol Melt should not be used in pregnant woman.

Lactation :

Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest 0.1 % of the dose given to the mother. Zamadol Melt should not be administered during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Zamadol Melt may cause drowsiness and this effect may be potentiated by alcohol and other CNS depressants. Ambulant patients should be warned not to drive or operate machinery if affected.

4.8 Undesirable Effects

The table below presents possible adverse drug reactions in system organ class order and sorted by frequency.

Organ System	Frequency	Adverse drug reaction
Immune system disorders	Rare (>1/10.000, <1/1.000)	- allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis.
Metabolism and Nutritional disorders	Rare (>1/10.000, <1/1.000)	- changes in appetite.
Psychiatric disorders	Rare (>1/10.000, <1/1.000)	The following may vary in nature and intensity depending on the individual (see below): - changes in mood (e.g. elation, dysphoria) - changes in activity (e.g. suppression, increase) - change in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders) - hallucinations - confusion - sleep disturbances - nightmares   - dependency (see below)
Nervous system disorders	Very Common (>1/10)	- dizziness
Common (>1/100, <1/10)	- headache - drowsiness
Rare (>1/10.000, <1/1.000)	- epileptiform convulsions (see below) - paraesthesia - tremor.
Very rare (including isolated cases) (<1/10.000)	- vertigo
Eye disorders	Rare (>1/10.000, <1/1.000	- blurred vision
Cardiac disorders	Uncommon (>1/1000, <1/100)	- cardiovascular regulation (e.g. palpitation, tachycardia, postural hypotension, cardiovascular collapse). These effects may occur especially on intravenous administration and in patients who are physically stressed.
Rare (>1/10.000, <1/1.000)	- bradycardia, increase in blood pressure
Vascular disorders	Very rare (including isolated cases) (<1/10.000)	- flushing
Respiratory, thoracic and mediastinal disorders	Very rare (including isolated cases) (<1/10.000)	- worsening of asthma, respiratory depression (see below)
Gastrointestinal disorders	Very Common (>1/10)	- vomiting, nausea
Common (>1/100, <1/10)	- constipation, dry mouth
Uncommon (>1/1000, <1/100)	- retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating)
Hepato-biliary disorders	Very rare (including isolated cases) (<1/10.000)	- increase in liver enzyme values (a few isolated cases have been reported)
Skin and subcutaneous tissue disorders	Common (>1/100 <1/10)	- sweating
Uncommon (>1/1000, <1/100)	- dermal reactions (e.g. pruritus, rash, urticaria)
Musculoskeletal, connective tissue and bone disorders	Rare (>1/10.000, <1/1.000)	- motorial weakness
Renal and urinary system disorders	Rare (>1/10.000, <1/1.000)	- micturition disorders (difficulty in passing urine and urinary retention)
General disorders	Common (>1/100, <1/10)	- fatigue

Psychic side-effects may occur following administration of tramadol which vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders), hallucinations, confusion, sleep disturbances and nightmares.

Prolonged administration of Zamadol Melt may lead to dependence (see section 4.4). Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.

Epileptiform convulsions are rare and occur mainly after administration of high doses of tramadol or after concomitant treatment with drugs which can lower the seizure threshold or themselves induce cerebral convulsions (e.g. antidepressants or anti-psychotics, see section 4.5 "Interaction with other medicinal products and other forms of interaction".

Worsening of asthma has also been reported, though a causal relationship has not been established. Respiratory depression has been reported. If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly (see section 4.5 "Interaction with other medicinal products and other forms of interaction") respiratory depression may occur.

4.9 Overdose

Symptoms of overdose are typical of other opioid analgesics, and include miosis, vomiting, hypotension, cardiovascular collapse, sedation and coma, epileptic seizures and respiratory depression. Respiratory failure may also occur.

Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam. Naloxone administration may increase the risk of seizures. The use of benzodiazepines (intravenously) should be considered for patients with seizures.

Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute intoxication with Zamadol Melt with haemodialysis or haemofiltration alone is not suitable for detoxification.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Analgesic, Other opioids, ATC code: N02AX02

Tramadol is a centrally acting analgesic. It is a non selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.

Tramadol has antitussive properties. Unlike morphine, tramadol does not depress breathing over a wide range of analgesic doses. The effects of tramadol on the cardiovascular system are comparatively small. The potency of tramadol is 1/10 to 1/6 that of morphine.

5.2 Pharmacokinetic Properties

Absorption

After oral administration, tramadol is almost completely absorbed. Mean absolute bioavailability is approximately 70% following a single dose and increases to approximately 90% at steady state.

Following a single oral dose administration of tramadol 100 mg to young healthy volunteers, plasma concentrations were detectable within approximately 15-45 minutes with a mean Cmax of 280 to 308 ng/ml and Tmax of 1.6 to 2 hours.

In a specific study of comparing the Orodispersible tablets with Immediate Release capsules, the administration of a single dose of 50 mg Zamadol Melt in healthy volunteers produced a mean AUC 1102 + 357 ng.h/ml, a mean Cmax 141 + 39 ng/ml; and a mean Tmax 1.5 hours. This demonstrated bioequivalence to 50 mg immediate release capsules (AUC 1008 + 285 ng.h/ml; Cmax 139 + 37 ng/ml; Tmax 1.5 hours).

Distribution

Plasma protein binding of tramadol is approximately 20%. It is independent of the plasma concentration of the drug within the therapeutic range.

Tramadol crosses the blood-brain barrier and the placental barrier. Tramadol and its metabolite O-desmethyltramadol are detectable in breast milk in very small amounts (0.1% and 0.02% of the administered doses, respectively).

Tramadol has a high tissue affinity, with an apparent volume of distribution of 3 to 4 l/kg.

Metabolism

Tramadol is metabolised by cytochrome P450 isoenzyme CYP2D6. It undergoes biotransformation to a number of metabolites mainly by means of N- and O-demethylation. O-desmethyl tramadol appears to be the most pharmacologically active metabolite, showing analgesic activity in rodents. It is 2 to 4 times more active than tramadol.

As humans excrete a higher percentage of unchanged tramadol than animals it is believed that the contribution made by this metabolite to analgesic activity is likely to be less in humans than animals. In humans the plasma concentration of this metabolite is about 25% that of unchanged tramadol.

The inhibition of one or both cytochrome P450 isoenzymes, CYP3A4 and CYP2D6 involved in the metabolism of tramadol, may affect the plasma concentration of tramadol or its active metabolite. The clinical consequences of any such interactions are not known.

Elimination

For tramadol, the terminal elimination half-life (t½β) was 6.0 ± 1.5 hours in young volunteers. For O-desmethyltramadol, t½β (6 healthy volunteers) was 7.9 hours (range 5.4 – 9.6 hours).

When C14 labelled tramadol was administered to humans, approximately 90% was excreted via the kidneys with the remaining 10% appearing in the faeces.

Tramadol pharmacokinetics show little age dependence in volunteers up to the age of 75 years. In volunteers aged over 75 years, t½β was 7.0 ± 1.6 hours on oral administration.

Since tramadol is eliminated both metabolically and renally, the terminal half-life t½β may be prolonged in impaired hepatic or renal function. However, the increase in the t½β values is relatively low if at least one of these organs is functioning normally. In patients with liver cirrhosis t½β tramadol was a mean of 13.3 ± 4.9 hours ; in patients with renal insufficiency (creatinine clearance

PK/PD

Tramadol has a linear pharmacokinetic profile within the therapeutic dosage range.

The PK/PD relation is dose-dependent, but varies within a wide range. Generally, a serum concentration between 100 and 300 ng/ml is effective.

5.3 Preclinical Safety Data

In single and repeat-dose toxicity studies (rodents and dogs) exposure to tramadol 10 times that expected in man is required before toxicity (hepatotoxicity) is observed. Symptoms of toxicity are typical of opioids and include restlessness, ataxia, vomiting, tremor, dyspnoea and convulsions.

Exposure to tramadol (>that expected in man), in lifetime toxicity studies in rodents did not reveal any evidence of carcinogenic hazard, and a battery of in-vitro and in-vivo mutagenicity tests were negative.

No teratogenic effects have been observed in animal tests (rat and rabbit: the dosage of Tramadol given has been up to seven times higher than the dosage given to humans). Minimal embryo toxic effects (delayed ossification) were observed in the tests. No effect was observed on the fertility or the development of the offspring in the tests.

6. Pharmaceutical Particulars

6.1 List Of Excipients

ethylcellulose,

copovidone,

silicon dioxide,

mannitol (E421),

crospovidone,

aspartame (E951),

mint rootbeer flavouring,

magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage precautions

6.5 Nature And Contents Of Container

Tablets in blisters composed of two sheets:

- a complex of polyamide/ aluminium/poly(vinyl chloride)

- a sheet of aluminium.

Pack sizes: 10, 20, 28, 30, 40, 50, 56, 60 and 100 tablets.

'Not all pack sizes may be marketed.'

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

8. Marketing Authorisation Number(S)

PL 15142/0128

9. Date Of First Authorisation/Renewal Of The Authorisation

1st November 2009

10. Date Of Revision Of The Text

1^st November 2009