Wednesday, 30 May 2012

Hangover Medications


There are currently no drugs listed for "Hangover". See Alcoholism.

Definition of Hangover: Unpleasant sensations experienced after drinking excessive amounts of alcohol. Includes headache, nausea, sensitivity to light and noise, lethargy, dysphoria and thirst.





Drug List:

Tuesday, 29 May 2012

hydrocortisone


hye-droe-KOR-ti-sone


Commonly used brand name(s)

In the U.S.


  • Cortef

Available Dosage Forms:


  • Tablet

  • Suspension

Therapeutic Class: Endocrine-Metabolic Agent


Pharmacologic Class: Adrenal Glucocorticoid


Uses For hydrocortisone


Hydrocortisone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, eye or vision problems, lupus, skin conditions, ulcerative colitis, and flare-ups of multiple sclerosis. Hydrocortisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.


hydrocortisone is available only with your doctor's prescription.


Before Using hydrocortisone


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 hydrocortisone, the following should be considered:


Allergies


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


No information is available on the relationship of age to the effects of hydrocortisone in the pediatric population. Safety and efficacy have not been established.


Geriatric


No information is available on the relationship of age to the effects of hydrocortisone in geriatric patients.


Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hydrocortisone, 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 hydrocortisone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using hydrocortisone 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.


  • Aldesleukin

  • Bupropion

  • Quetiapine

Using hydrocortisone 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.


  • Alatrofloxacin

  • Alcuronium

  • Atracurium

  • Balofloxacin

  • Cinoxacin

  • Ciprofloxacin

  • Clinafloxacin

  • Colestipol

  • Enoxacin

  • Fleroxacin

  • Flumequine

  • Gallamine

  • Gemifloxacin

  • Grepafloxacin

  • Hexafluorenium

  • Itraconazole

  • Levofloxacin

  • Licorice

  • Lomefloxacin

  • Metocurine

  • Moxifloxacin

  • Norfloxacin

  • Ofloxacin

  • Pefloxacin

  • Primidone

  • Prulifloxacin

  • Rifapentine

  • Rosoxacin

  • Rufloxacin

  • Saiboku-To

  • Sparfloxacin

  • Temafloxacin

  • Tosufloxacin

  • Trovafloxacin Mesylate

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


  • Cataracts or

  • Congestive heart failure or

  • Cushing's syndrome (adrenal gland problem) or

  • Diabetes or

  • Eye infection or

  • Glaucoma or

  • Hyperglycemia (high blood sugar) or

  • Hypertension (high blood pressure) or

  • Infection (e.g., bacterial, virus, or fungus) or

  • Mood changes, including depression or

  • Myasthenia gravis (severe muscle weakness) or

  • Osteoporosis (weak bones) or

  • Peptic ulcer, active or history of or

  • Personality changes or

  • Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or

  • Tuberculosis, inactive—Use with caution. May make these conditions worse.

  • Fungal infections—Should not be used in patients with this condition.

Proper Use of hydrocortisone


Take hydrocortisone exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.


If you use hydrocortisone for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.


Dosing


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


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


  • For oral dosage form (tablets):
    • Dose depends on medical condition:
      • Adults—At first, 20 to 240 milligrams (mg) per day. Your doctor may adjust your dose as needed.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


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


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using hydrocortisone


If you will be taking hydrocortisone for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by hydrocortisone. Blood or urine tests may be needed to check for unwanted effects.


Using too much of hydrocortisone or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using hydrocortisone: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.


If you are using hydrocortisone for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of hydrocortisone might need to be changed for a short time while you have extra stress.


hydrocortisone may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.


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


While you are being treated with hydrocortisone, do not have any immunizations (vaccines) without your doctor's approval. Hydrocortisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.


hydrocortisone may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking hydrocortisone.


hydrocortisone might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using hydrocortisone, tell the doctor if you think your child is not growing properly.


Make sure any doctor or dentist who treats you knows that you are using hydrocortisone. hydrocortisone may affect the results of certain skin tests.


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.


hydrocortisone Side Effects


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


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


More common
  • Aggression

  • agitation

  • anxiety

  • blurred vision

  • decrease in the amount of urine

  • dizziness

  • fast, slow, pounding, or irregular heartbeat or pulse

  • headache

  • irritability

  • mental depression

  • mood changes

  • nervousness

  • noisy, rattling breathing

  • numbness or tingling in the arms or legs

  • pounding in the ears

  • shortness of breath

  • swelling of the fingers, hands, feet, or lower legs

  • trouble thinking, speaking, or walking

  • troubled breathing at rest

  • weight gain

Incidence not known
  • Abdominal cramping and/or burning (severe)

  • abdominal pain

  • backache

  • bloody, black, or tarry stools

  • cough or hoarseness

  • darkening of skin

  • decrease in height

  • decreased vision

  • diarrhea

  • dry mouth

  • eye pain

  • eye tearing

  • facial hair growth in females

  • fainting

  • fatigue

  • fever or chills

  • flushed, dry skin

  • fractures

  • fruit-like breath odor

  • full or round face, neck, or trunk

  • heartburn and/or indigestion (severe and continuous)

  • increased hunger

  • increased thirst

  • increased urination

  • loss of appetite

  • loss of sexual desire or ability

  • lower back or side pain

  • menstrual irregularities

  • muscle pain or tenderness

  • muscle wasting or weakness

  • nausea

  • pain in back, ribs, arms, or legs

  • painful or difficult urination

  • skin rash

  • sleeplessness

  • sweating

  • trouble healing

  • trouble sleeping

  • unexplained weight loss

  • unusual tiredness or weakness

  • vision changes

  • vomiting

  • vomiting of material that looks like coffee grounds

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


More common
  • Increased appetite

Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk

  • acne

  • dry scalp

  • lightening of normal skin color

  • red face

  • reddish purple lines on the arms, face, legs, trunk, or groin

  • swelling of the stomach area

  • thinning of the scalp hair

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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Mobiflex Tablets 20mg





1. Name Of The Medicinal Product



Mobiflex Tablets 20mg


2. Qualitative And Quantitative Composition



Each tablet contains 20mg tenoxicam



For a full list of excipients, see section 6.1



3. Pharmaceutical Form



Film-coated tablet.



A greyish yellow, film-coated oval tablet imprinted “Roche” on one face with a break line on the other.



4. Clinical Particulars



4.1 Therapeutic Indications



Mobiflex is indicated for the relief of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for the short term management of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries. IV, IM tenoxicam is also available for these indications in those patients considered unable to take oral tenoxicam



4.2 Posology And Method Of Administration



Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).



Adults



A single daily dose of 20mg Mobiflex should be taken orally, at the same time each day. Mobiflex Tablets are for oral administration with water or other fluid. Higher doses should be avoided as they do not usually achieve significantly greater therapeutic effect but may be associated with a higher risk of adverse events.



In acute musculoskeletal disorders treatment should not normally be required for more than 7 days, but in severe cases it may be continued up to a maximum of 14 days.



Elderly



As with other non-steroidal anti-inflammatory drugs, Mobiflex should be used with special caution in elderly patients since they may be less able to tolerate side-effects than younger patients. They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. The lowest dose should be used in elderly patients and the patient should be monitored for GI bleeding for 4 weeks following initiation of NSAID therapy.



Children



There are insufficient data to make a recommendation for administration of Mobiflex to children.



Use in renal and hepatic insufficiency










Creatinine clearance




Dosage regimen




Greater than 25ml/min




Usual dosage but monitor patients carefully (see Special warnings and special precautions for use)




Less than 25ml/min




Insufficient data to make dosage recommendations



Because of the high plasma protein-binding of tenoxicam, caution is required when plasma albumin concentrations are markedly reduced (e.g. in nephritic syndrome) or when bilirubin concentrations are high.



There is insufficient information to make dosage recommendations for Mobiflex in patients with pre-existing hepatic impairment.



4.3 Contraindications



1. Active peptic ulceration and a past history of peptic ulceration, gastrointestinal bleeding (melaena, haematemesis) or severe gastritis.



2. Hypersensitivity to Mobiflex. Mobiflex should also be avoided in cases where the patient has suffered a hypersensitivity reaction (symptoms of asthma, rhinitis, angioedema or urticaria) to other nonsteroidal anti-inflammatory drugs, including aspirin, as the potential exists for cross-sensitivity to Mobiflex.



3. Severe heart failure



4.4 Special Warnings And Precautions For Use



NSAIDs should only be given with care to patients with a history of gastrointestinal disease.



Any patient being treated with Mobiflex who presents with symptoms of gastrointestinal disease should be closely monitored. If peptic ulceration or gastro-intestinal bleeding occurs, Mobiflex should be withdrawn immediately.



In rare cases, non-steroidal anti-inflammatory drugs may cause interstitial nephritis, glomerulonephritis, papillary necrosis and the nephrotic syndrome. Such agents inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of a non-steroidal anti-inflammatory drug may precipitate overt renal decompensation, which returns to the pre treatment state upon withdrawal of the drug. Patients at greatest risk of such a reaction are those with pre-existing renal disease (including diabetics with impaired renal function), nephritic syndrome, volume depletion, hepatic disease, congestive cardiac failure and those patients receiving concomitant therapy with diuretics or potentially nephrotoxic drugs. Such patients should have their renal, hepatic and cardiac functions carefully monitored, and the dose should be kept as low as possible in patients with renal, hepatic or cardiac impairment. NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration.



Caution is required if administered to patients suffering from, or with a previous history of bronchial asthma, since ibuprofen has been reported to cause bronchospasm in such patients.



Occasional elevations of serum transaminases or other indicators of liver function have been reported. In most cases these have been small and transient increases above the normal range. If the abnormality is significant or persistent, Mobiflex should be stopped and follow-up tests carried out. Particular care is required in patients with pre-existing hepatic disease.



Mobiflex reduces platelet aggregation and may prolong bleeding time. This should be borne in mind for patients who undergo major surgery (e.g. joint replacement) and when bleeding time needs to be determined.



Particular care should be taken to regularly monitor elderly patients to detect possible interactions with concomitant therapy and to review renal, hepatic and cardiovascular function which may be potentially influenced by nonsteroidal anti-inflammatory drugs.



Adverse eye findings have been reported with non-steroidal anti-inflammatory drugs, therefore it is recommended that patients who develop visual disturbances during treatment with Mobiflex have ophthalmic evaluation.



Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).



Cardiovascular and cerebrovascular effects



Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.



Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for tenoxicam.



Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with tenoxicam after careful consideration.



Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Antacids may reduce the rate, but not the extent, of absorption of Mobiflex. The differences are not likely to be of clinical significance. No interaction has been found with concomitantly administered cimetidine. In healthy subjects no clinically relevant interaction between Mobiflex and low molecular weight heparin has been observed.



Tenoxicam is highly bound to serum albumin, and can, as with all NSAIDs, enhance the anticoagulant effect of warfarin and other anticoagulants. Close monitoring of the effects of anticoagulants and oral glycaemic agents is advised, especially during the initial stages of treatment with Mobiflex. No interaction with digoxin has been observed.



Mobiflex and other NSAIDs can reduce the effects of anti-hypertensive drugs. NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels when co-administered with cardiac glycosides.



As with all NSAIDs caution is advised when cyclosporin is co-administered because of the increased risk of nephrotoxicity.



Concomitant use of two or more NSAIDs should be avoided.



Patients taking quinolones may have an increased risk of developing convulsions.



Salicylates can displace tenoxicam from protein-binding sites and so increase the clearance and volume of distribution of Mobiflex. Concurrent treatment with salicylates or other non-steroidal anti-inflammatory drugs should therefore be avoided because of the increased risk of adverse reactions (particularly gastro-intestinal).



Non-steroidal anti-inflammatory drugs have been reported to decrease elimination of lithium. If tenoxicam is prescribed for a patient receiving lithium therapy, the frequency of lithium monitoring should be increased, the patient warned to maintain fluid intake and to be aware of symptoms of lithium intoxication.



Non-steroidal anti-inflammatory drugs may cause sodium, potassium and fluid retention and may interfere with the natriuretic action of diuretic agents, which can increase the risk of nephrotoxicity of NSAIDs. These properties should be kept in mind when treating patients with compromised cardiac function or hypertension since they may be responsible for a worsening of those conditions.



No clinically relevant interaction was found in small numbers of patients receiving treatment with penicillamine or parenteral gold.



Caution is advised where methotrexate is given concurrently because of possible enhancement of its toxicity, since NSAIDs have been reported to decrease elimination of methotrexate.



NSAIDs should not be used for 8 – 12 days after mifepristone administration as NSAIDs can reduce the effects of mifepristone.



As with all NSAIDs, caution should be taken when co-administering corticosteroids because of the increased risk of GI bleeding.



4.6 Pregnancy And Lactation



The safety of Mobiflex during pregnancy and lactation has not been established and the drug should therefore not be given in these conditions. Congenital abnormalities have been reported in association with ibuprofen administration in man; however, these are low in frequency and do not appear to follow any discernible pattern.



Although no teratogenic effects were seen in animal studies, Mobiflex, like other non-steroidal anti-inflammatory drugs, is associated with prolonged and delayed parturition and an adverse influence on neonatal viability when administered to animals in late pregnancy. Non-steroidal anti-inflammatory agents are also known to induce closure of the ductus arteriosus in infants, therefore use in late pregnancy should be particularly avoided.



In the limited studies available so far, ibuprofen appears in the breast milk in very low concentrations and is unlikely to adversely affect the breast fed infant.



No information is available on penetration of Mobiflex into milk in humans; animal studies indicate that significant levels may be achieved.



4.7 Effects On Ability To Drive And Use Machines



None



4.8 Undesirable Effects



For most patients, any side-effects are transient and resolve without discontinuation of treatment.



The most common side-effects relate to the gastro-intestinal tract. They include dyspepsia, nausea, abdominal pain and discomfort, constipation, diarrhoea, flatulence, indigestion, epigastric distress, stomatitis and anorexia. As with other non-steroidal anti-inflammatory drugs, there is a risk of peptic ulceration and gastro-intestinal bleeding, both of which have been reported with Mobiflex. Should this occur, Mobiflex is to be discontinued immediately and appropriate treatment instituted.



As with other non-steroidal anti-inflammatory drugs, peripheral oedema of mild or moderate degree and without clinical sequelae occurred in a small proportion of patients and the possibility of precipitating congestive cardiac failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.



Central nervous system reactions of headache and dizziness have been reported in a small number of patients. Somnolence, insomnia, depression, nervousness, dream abnormalities, mental confusion, paraesthesias and vertigo have been reported rarely.



Hypersensitivity reactions have been reported following treatment with NSAIDs, these include:



a) Non specific allergic reactions and anaphylaxis



b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea



c) Skin reactions of rash, angiodema and pruritus have been reported. Nail disorders, alopecia, erythema, urticaria and photosensitivity reactions have been reported rarely. As with other non-steroidal anti-inflammatory drugs, Lyell's syndrome and Stevens-Johnson syndrome may develop in rare instances. Vesiculo-bullous reactions and vasculitis have also been reported rarely. Reversible elevations of blood urea nitrogen and creatinine have been reported (see Special warnings and special precautions for use).



Decreases in haemoglobin, unrelated to gastro-intestinal bleeding, have occurred. Anaemia, aplastic anaemia, haemolytic anaemia, thrombocytopenia and non-thrombocytopenic purpura, leucopenia and eosinophilia have been reported. Epistaxis has been reported infrequently. Rare cases of agranulocytosis have been reported.



As with most other non-steroidal anti-inflammatory drugs, changes in various liver function parameters have been observed. Some patients may develop raised serum transaminase levels during treatment. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (e.g. eosinophilia, rash), Mobiflex should be discontinued. Hepatitis jaundice have also been reported.



Palpitations and dyspnoea have also been reported rarely. Metabolic abnormalities, such as weight decrease or increase and hyperglycaemia, have occurred rarely.



Swollen eyes, blurred vision and eye irritation have been reported. Ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes. Malaise and tinnitus may occur.



Nephrotoxicity has been reported in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.



Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.



Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).



4.9 Overdose



There is no reported experience of serious overdosage with Mobiflex. No specific measures are available; administration of H2-antagonist drugs may be of benefit. Gastric lavage should be carried out as soon as possible after drug ingestion and the patient should be closely observed and general supportive measures taken as necessary.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Mobiflex is a non-steroidal anti-inflammatory drug which has marked anti-inflammatory and analgesic activity and some antipyretic activity. As with other non-steroidal anti-inflammatory drugs, the precise mode of action is unknown, though it is probably multifactorial, involving inhibition of prostaglandin biosynthesis and reduction of leucocyte accumulation at the inflammatory site.



5.2 Pharmacokinetic Properties



Mobiflex is long-acting; a single daily dose is effective.



After oral administration, Mobiflex is rapidly and completely absorbed as unchanged drug. Concomitant food reduces the rate, but not the extent, of absorption of Mobiflex. Tenoxicam penetrates well into synovial fluid to give concentrations approximately half those in plasma. The mean plasma elimination half-life is approximately 72 hours.



With the recommended dosage regimen of 20mg once daily, steady-state plasma concentrations are reached within 10 - 15 days, with no unexpected accumulation.



Mobiflex is strongly bound to plasma proteins.



Mobiflex is cleared from the body almost exclusively by metabolism. Approximately two-thirds of the administered dose is excreted in the urine, mainly as the pharmacologically inactive 5-hydroxypyridyl metabolite, and the remainder in the bile, much of it as glucuronide conjugates of hydroxymetabolites.



No age-specific changes in the pharmacokinetics of Mobiflex have been found although inter-individual variation tends to be higher in elderly persons.



5.3 Preclinical Safety Data



None Stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lactose



maize starch



magnesium stearate



talc



hypromellose



titanium dioxide E171



yellow iron oxide E172



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



5 years



6.4 Special Precautions For Storage



Do not store above 30°C.



6.5 Nature And Contents Of Container



PVC/Aluminium foil blister pack containing 30 tablets.



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



8. Marketing Authorisation Number(S)



PL 15142/0112



9. Date Of First Authorisation/Renewal Of The Authorisation



10th August 1988/11th November 2009



10. Date Of Revision Of The Text



15th December 2009




Tetracycline



Class: Tetracyclines
VA Class: AM250
CAS Number: 60-54-8
Brands: Helidac Therapy, Sumycin

Introduction

Antibacterial; antibiotic derived from Streptomyces aureofaciensb c d or produced semisynthetically from oxytetracycline.b


Uses for Tetracycline


Respiratory Tract Infections


Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.c d 104


Treatment of respiratory tract infections caused by Haemophilus influenzae, Streptococcus pneumoniae, or Klebsiella.c d 104 Should only be used for treatment of infections caused by these bacteria when in vitro susceptibility tests indicate the organism is susceptible.c d a


Acne


Adjunctive treatment of moderate to severe inflammatory acne.a c d Not indicated for treatment of noninflammatory acne.a


Actinomycosis


Treatment of actinomycosis caused by Actinomyces israelii;104 114 c d oral tetracyclines (usually doxycycline or tetracycline) used as follow-up after initial parenteral penicillin G.114


Amebiasis


Adjunct to amebicides for treatment of acute intestinal amebiasis.c d Tetracyclines not included in current recommendations for treatment of amebiasis caused by Entamoeba.112 114


Anthrax


Alternative to doxycycline for postexposure prophylaxis to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).122 Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline;114 122 123 127 doxycycline is the preferred tetracycline because of ease of administration and proven efficacy in monkey studies.122


Alternative to doxycycline for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).c d 122 123 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.122 123 i


Balantidiasis


Treatment of balantidiasis caused by Balantidium coli; drug of choice.112 114


Bartonella Infections


Treatment of bartonellosis caused by Bartonella bacilliformis.c d


Brucellosis


Treatment of brucellosis;104 114 c d tetracyclines (usually doxycycline or tetracycline) considered drugs of choice.104 114 Used in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin),114 especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).114


Burkholderia Infections


Treatment of glanders caused by Burkholderia mallei.104 m Experience is limited regarding treatment of human cases; optimum regimens not identified.123 m Some clinicians suggest streptomycin used in conjunction with tetracycline or chloramphenicol or imipenem monotherapy.104 Other clinicians suggest that, pending results of in vitro susceptibility tests, regimens used for treatment of melioidosis can be used for initial empiric treatment of glanders.123 Doxycycline is the preferred tetracycline for treatment of melioidosis caused by susceptible B. pseudomallei.123 m


Campylobacter Infections


Treatment of infections caused by Campylobacter.c d Tetracyclines (usually doxycycline) are alternatives,114 not drugs of choice for C. jejuni.104 114


Chancroid


Treatment of chancroid caused by Haemophilus ducreyi.c d Not included in CDC recommendations for treatment of chancroid;101 CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin.101 102


Chlamydial Infections


Treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis.c d 102 Doxycycline is the preferred tetracycline for treatment of these infections, including presumptive treatment of chlamydial infections in patients with gonorrhea.101


Treatment of trachoma and inclusion conjunctivitis caused by C. trachomatis.c d 104 Consider that anti-infectives may not eliminate C. trachomatis in all cases of chronic trachoma.c d


Treatment of lymphogranuloma venereum (genital, inguinal, or anorectal infections) caused by C. trachomatis.c d 102 104 Doxycycline is the preferred tetracycline for these infections.101 114


Treatment of psittacosis (ornithosis) caused by C. psittaci.100 104 114 c d Doxycycline and tetracycline are drugs of choice.100 114 For initial treatment of severely ill patients, use IV doxycycline.100


Clostridium Infections


Alternative for treatment of infections caused by Clostridium.c d Tetracyclines are alternatives to metronidazole or penicillin G for adjunctive treatment of C. tetani infections.104


Dientamoeba fragilis Infections


Treatment of Dientamoeba fragilis infections.112 Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.112


Enterobacteriaceae Infections


Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella.c d Only use for treatment of infections caused by these common gram-negative bacteria when other appropriate anti-infectives are contraindicated or ineffectivea and when in vitro susceptibility tests indicate the organism is susceptible.a c d


Fusobacterium Infections


Alternative to penicillin G for the treatment of infections caused by Fusobacterium fusiforme (Vincent's infection).c d


Gonorrhea and Associated Infections


Alternative for treatment of uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae.c d Tetracyclines are considered inadequate therapy and are not recommended by CDC for treatment of gonorrhea.101 a


Empiric treatment of epididymitis most likely caused by N. gonorrhoeae or C. trachomatis; used in conjunction with IM ceftriaxone.102


Granuloma Inguinale (Donovanosis)


Treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis.c d Doxycycline is the tetracycline recommended as drug of choice by CDC.101


Helicobacter pylori Infection and Duodenal Ulcer Disease


Treatment of Helicobacter pylori infection and duodenal ulcer (active or a history of duodenal ulcer);104 e eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.104 e


Used in a multiple-drug regimen that includes tetracycline, metronidazole, and bismuth subsalicylate and a histamine H2-receptor antagonist.e If initial 14-day regimen does not eradicate H. pylori, a retreatment regimen that does not include metronidazole should be used.e


Leptospirosis


Tetracyclines are alternatives to penicillin G for treatment of leptosporosis.104 Doxycycline is the preferred tetracycline for treatment or prevention of these infections.l


Listeria Infections


Alternative for treatment of listeriosis caused by Listeria monocytogenes.c d Not usually considered a drug of choice or alternative for these infections.104 114


Malaria


Treatment of uncomplicated malaria caused by chloroquine-resistant Plasmodium falciparum or chloroquine-resistant P. vivax and when the plasmodial species has not been identified.112 129


CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with oral doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil.112 129 A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin,129 except for young children or pregnant women who should not receive tetracyclines.129 Quinine in conjunction with tetracycline (or doxycycline) also a regimen of choice for chloroquine-resistant P. vivax malaria.112 129


Treatment of severe malaria caused by P. falciparum;112 129 used in conjunction with IV quinidine gluconate initially and then oral quinine when an oral regimen is tolerated.112 129


Active only against asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. vivax malaria or provide a radical cure; primaquine usually also is indicated to eradicate hypnozoites and prevent relapse in patients treated for P. vivax malaria.112 129


Assistance with diagnosis or treatment of malaria available from the CDC Malaria Epidemiology Branch by contacting the CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.129


Nocardiosis


Tetracyclines are alternatives to co-trimoxazole for treatment of nocardiosis caused by Nocardia.104 114


Nongonococcal Urethritis


Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum, C. trachomatis, or Mycoplasma.c d 104 Doxycycline usually is the tetracycline of choice for NGU.101 102


Consider that some cases of recurrent urethritis following tetracycline treatment may be caused by tetracycline-resistant U. urealyticum.101


Pasteurella multocida Infections


Treatment of infections caused by Pasteurella multocida.104 114 Tetracyclines (usually doxycycline) are alternatives to penicillin G.104 114


Plague


Treatment of plague caused by Yersinia pestis,c d 104 114 124 including naturally occurring or endemic bubonic, septicemic, or pneumonic plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.124 Regimen of choice is streptomycin or gentamicin;104 114 123 124 alternatives are doxycycline, tetracycline, ciprofloxacin, or chloramphenicol.123 124 For plague meningitis, some experts recommend that chloramphenicol be included in the treatment regimen.123


Postexposure prophylaxis following a high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism).123 124 Doxycycline may be drug of choice;114 123 124 alternatives are tetracycline, ciprofloxacin, or chloramphenicol.123 Prophylaxis not required for asymptomatic contacts of individuals with bubonic plague, but observe such contacts for 1 week and initiate treatment if symptoms occur.123


Rat-bite Fever


Treatment of rat-bite fever caused by Streptobacillus moniliformis or Spirillum minus.104 114 Tetracyclines (usually doxycycline) are alternatives to penicillin G.104 114


Relapsing Fever


Treatment of relapsing fever caused by Borrelia recurrentis.104 c d Tetracyclines are drugs of choice.104


Rickettsial Infections


Treatment of rickettsial infections including Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.114 123 c d Doxycycline is the drug of choice for most rickettsial infections.114 a j


Syphilis


Alternative to penicillin G for treatment of primary, secondary, latent, or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins.101 114 c d Use tetracyclines only if compliance and follow-up can be ensured since efficacy not well documented.101


Tularemia


Treatment of tularemia caused by Francisella tularensis, including naturally occurring or endemic tularemia and tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism.104 114 123 c d f Drugs of choice are streptomycin or gentamicin; alternatives are tetracyclines (usually doxycycline), ciprofloxacin, or chloramphenicol.104 114 f Risk of relapse and primary treatment failure may be higher with the alternatives.f


Postexposure prophylaxis of tularemia following a high-risk laboratory exposure to F. tularensis (e.g., spill, centrifuge accident, needlestick injury) or in individuals exposed to the organism in the context of biologic warfare or bioterrorism.123 f Drugs of choice are doxycycline, tetracycline, or ciprofloxacin.123 f Postexposure prophylaxis usually not recommended after exposure to natural or endemic tularemia (e.g., tick bite, rabbit or other animal exposure) and is unnecessary in close contacts of tularemia patients since human-to-human transmission does not occur.f


Vibrio Infections


Treatment of cholera caused by Vibrio cholerae.104 114 c d h Doxycycline and tetracycline are drugs of choice; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.104 114 c d h


Treatment of severe V. parahaemolyticus infection when anti-infective therapy is indicated in addition to supportive care.h


Treatment of infections caused by V. vulnificus.104 Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.104 g h Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.g


Yaws


Alternative to penicillin G for treatment of yaws caused by Treponema pertenue.104 c d


Yersinia Infections


Treatment of plague or postexposure prophylaxis of plague.c d 104 114 123 124 (See Plague in Uses.)


Treatment of GI infections caused by Yersinia enterocolitica or Y. pseudotuberculosis.114 These GI infections usually are self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs.114 Some clinicians suggest the role of oral anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.114


Tetracycline Dosage and Administration


Administration


Oral Administration


Administer orally.c d


Administer capsules and tablets with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration.c d


Dosage


Available as tetracyclined and tetracycline hydrochloride;c dosage expressed in terms of tetracycline hydrochloride.c d


Pediatric Patients


General Pediatric Dosage

Oral

Children >8 years of age: 25–50 mg/kg daily in 4 divided doses.c


Balantidiasis

Oral

Children ≥8 years of age: 40 mg/kg daily (up to 2 g) in 4 divided doses given for 10 days.112 114


Brucellosis

Oral

Children ≥8 years of age: 30–40 mg/kg daily (up to 2 g) in 4 divided doses.114 Duration of treatment usually is 4–6 weeks; more prolonged treatment may be necessary for severe infections or when there are complications.114


If infection is severe or if endocarditis, meningitis, or osteomyelitis are present, administer IM streptomycin or gentamicin during the first 7–14 days of tetracycline therapy.114 c d Rifampin can be administered concomitantly (with or without an aminoglycoside) to decrease the risk of relapse.114


Dientamoeba fragilis Infection

Oral

Children ≥8 years of age: 40 mg/kg daily (up to 2 g) in 4 divided doses given for 10 days.112


Malaria

Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria

Oral

Children ≥8 years of age: 6.25 mg/kg 4 times daily given for 7 days; used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).112 129


Treatment of Uncomplicated P. vivax Malaria

Oral

Children ≥8 years of age: 6.25 mg/kg 4 times daily given for 7 days; used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).129


In addition, a 14-day regimen of oral primaquine (0.6 mg/kg once daily) also may be indicated to provide a radical cure and prevent delayed attacks or relapse of P. vivax malaria.129


Treatment of Severe P. falciparum Malaria

Oral

Children ≥8 years of age: 6.25 mg/kg 4 times daily given for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.129 If an IV tetracycline is necessary initially, use IV doxycycline until oral therapy can be tolerated.129


Plague

Treatment of Pneumonic Plague

Oral

Children >8 years of age: 25–50 mg/kg daily in 4 divided dosesb given for ≥10–14 days.123 124


Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential.123 124 A parenteral regimen (e.g., IM streptomycin, IM or IV gentamicin, IV doxycycline) is preferred for initial treatment; an oral regimen may be substituted when the patient's condition improves or if a parenteral regimen is unavailable.123 124


Postexposure Prophylaxis following High-risk Exposure

Oral

Children >8 years of age: 25–50 mg/kg daily in 2 or 4 equally divided doses.b


Duration of prophylaxis following exposure to plague aerosol or a patient with suspected pneumonic plague is 7 days123 124 or the duration of exposure risk plus 7 days.123


Syphilis

Primary or Secondary Syphilis

Oral

Children >8 years of age: 500 mg 4 times daily given for 14 days.101 102 114


Latent Syphilis or Tertiary Syphilis (Except Neurosyphilis)

Oral

Children >8 years of age: 500 mg 4 times daily given for 14 days for early latent syphilis (duration <1 year) or 500 mg 4 times daily given for 28 days for late latent syphilis (duration≥1 year), latent syphilis of unknown duration, or tertiary syphilis.101 102 114


Vibrio Infections

Cholera

Oral

Children >8 years of age: 50 mg/kg daily in 4 divided doses given for 3 days.114


Adults


General Adult Dosage

Oral

1–2 g daily in 2–4 divided doses.c d


500 mg twice daily or 250 mg 4 times daily may be adequate for mild to moderate infections; severe infections may required 500 mg 4 times daily.c d


Respiratory Tract Infections

Mycoplasma pneumoniae Infections

Oral

1–2 g daily in 2–4 equally divided doses.b Duration of treatment usually is 1–4 weeks.b


Acne

Oral

1 g daily given in divided doses; when improvement occurs in 1–2 weeks, decrease slowly to a maintenance dosage of 125–500 mg daily.b c d Continue maintenance dosage until clinical improvement allows discontinuation of the drug.b


Actinomycosis

Oral

1–2 g daily for 6–12 months as follow-up to penicillin G.b


Anthrax

Postexposure Prophylaxis following Exposure in the Context of Biologic Warfare or Bioterrorism

Oral

500 mg every 6 hours given for ≥60 days.122


Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear,123 k but prolonged postexposure prophylaxis usually required.122 123 A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure.k CDC recommends that postexposure prophylaxis following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures) be continued for 60 days.122 123 The US Working Group on Civilian Biodefense and the US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommends that postexposure prophylaxis be continued for at least 60 days in individuals who are not fully immunized against anthrax and when anthrax vaccine is unavailable or cannot be used for postexposure vaccination.123


Treatment of Inhalational Anthrax

Oral

500 mg every 6 hours.122


Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).122 i Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.102 123 i


Balantidiasis

Oral

500 mg 4 times daily given for 10 days.112


Brucellosis

Oral

500 mg 4 times daily given for 3 weeks.c d


If infection is severe or if endocarditis, meningitis, or osteomyelitis are present, administer IM streptomycin or gentamicin during the first 7–14 days of tetracycline therapy.114 c d Rifampin can be administered concomitantly to decrease the risk of relapse (with or without an aminoglycoside).114


Burkholderia Infections

Melioidosis

Oral

2–3 g daily given for 1–3 months.b In severe cases, some clinicians recommend concomitant chloramphenicol during the first month.b In patients with extrapulmonary suppurative lesions, continue tetracycline therapy for 6–12 months.b


Campylobacter Infections

Campylobacter fetus Infections

Oral

1–2 g daily given for 10 days.b


Chancroid

Oral

1–2 g daily given for 2–4 weeks.b


Chlamydial Infections

Uncomplicated Urethral, Endocervical, or Rectal Infections

Oral

500 mg 4 times daily given for ≥7 days.102 c d


Psittacosis (Ornithosis)

Oral

500 mg 4 times daily given for ≥10–14 days after defervescence.100


Dientamoeba fragilis Infection

Oral

500 mg 4 times daily for 10 days.112


Gonorrhea and Associated Infections

Uncomplicated Gonorrhea

Oral

500 mg 4 times daily given for 7 days.c d No longer recommended for gonorrhea by CDC or other experts.101 102


Empiric Treatment of Epididymitis

Oral

500 mg 4 times daily given for 10 days; as follow-up to a single dose of IM ceftriaxone.102


Granuloma Inguinale (Donovanosis)

Oral

1–2 g daily given for 2–4 weeks.b


Helicobacter pylori Infection and Duodenal Ulcer Disease

Oral

500 mg in conjunction with metronidazole (250 mg) and bismuth subsalicylate (525 mg) 4 times daily (at meals and at bedtime) for 14 days; these drugs should be given concomitantly with usual dosage of an H2-receptor antagonist.110


Leptospirosis

Oral

1–2 g daily given for 5–7 days.b


Malaria

Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria

Oral

250 mg 4 times daily given for 7 days; used in conjunction with quinine sulfate (650 mg 3 times daily given for 3 days if malaria was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).112 129


Treatment of Uncomplicated P. vivax Malaria

Oral

250 mg 4 times daily given for 7 days; used in conjunction with oral quinine sulfate (650 mg 3 times daily given for 3 days if malaria was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).129


In addition, a 14-day regimen of oral primaquine (30 mg once daily) also may be indicated to provide a radical cure and prevent delayed attacks or relapse of P. vivax malaria.129


Treatment of Severe P. falciparum Malaria

Oral

250 mg 4 times daily for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.129 If an IV tetracycline is necessary initially, use IV doxycycline until oral therapy can be tolerated.129


Plague

Treatment

Oral

2–4 g daily in 4 divided dosesb given for ≥10–14 days.b 123


Prompt initiation of treatment (within 18–24 hours of symptom onset) is essential.123 124 A parenteral regimen (e.g., IM streptomycin, IM or IV gentamicin, IV doxycycline) is preferred for initial treatment; an oral regimen may be substituted when the patient's condition improves or if a parenteral regimen is unavailable.123 124


Postexposure Prophylaxis following High-risk Exposure

Oral

1–2 g daily in 2 or 4 divided doses.123


Duration of prophylaxis following exposure to plague aerosol or a patient with suspected pneumonic plague is 7 days123 124 or the duration of exposure risk plus 7 days.123


Relapsing Fever

Oral

1–2 g daily until afebrile for 7 days.b A single 500-mg dose may be effective in some patients.b


Rickettsial Infections

Oral

1–2 g daily in 2–4 divided doses.b Duration of treatment usually is ≥3–7 days or until patients has been afebrile for approximately 2–3 days.b


Q Fever

Oral

500 mg every 6 hours given for ≥14 days for treatment of acute Q fever.123


For prophylaxis against Q fever, 500 mg every 6 hours given for ≥5–7 days may prevent clinical disease if initiated 8–12 days after exposure; such prophylaxis is not effective and may only prolong the onset of disease if given immediately (1–7 days) after exposure.123


Syphilis

Primary or Secondary Syphilis

Oral

500 mg 4 times daily given for 14 days recommended by CDC and others.101 102 Manufacturer recommends a total dosage of 30–40 g in equally divided doses given over 10–15 days.c d


Latent Syphilis or Tertiary Syphilis (Except Neurosyphilis)

Oral

500 mg 4 times daily given for 14 days for early latent syphilis (duration <1 year) or 500 mg 4 times daily given for 28 days for late latent syphilis (duration≥1 year), latent syphilis of unknown duration, or tertiary syphilis.101 102


Tularemia

Treatment

Oral

500 mg 4 times daily123 given for ≥14–21 days.123 f Relapse may occur as long as 6 months after treatment with tetracycline; however, retreatment with the same dosage usually is curative.b


Postexposure Prophylaxis following High-risk Exposure

Oral

500 mg 4 times daily.123


Initiate postexposure prophylaxis within 24 hours of exposure and continue for ≥14 days.123 f


Vibrio Infections

Cholera

Oral

1–2 g daily given for 2–3 days.b 500 mg 4 times daily for 3 days also has been recommended.103


Yaws

Oral

1–2 g daily given for 10–14 days.b


Prescribing Limits


Pediatric Patients


Malaria

Treatment of Severe P. falciparum Malaria

Oral

Children ≥8 years of age: Maximum 1g daily.129


Special Populations


Renal Impairment


Adjust dosage by decreasing doses or increasing dosing interval.c d


Cautions for Tetracycline


Contraindications



  • Known hypersensitivity to any tetracycline.c d




  • Helidac Therapy (kit containing tetracycline, metronidazole, bismuth subsalicylate) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.e



Warnings/Precautions


Warnings


Dental and Bone Effects

Use during tooth development (e.g., pregnancy, children <8 years of age) may cause permanent yellow-gray to brown discoloration of teeth and enamel hypoplasia.c d Effects are most common following long-term use, but may occur following repeated short-term use.c d


Tetracyclines form a stable calcium complex in any bone-forming tissue.c d Reversible decrease in fibula growth rate has occurred in young animals receiving oral tetracycline.c d


Use not recommended in children <8 years of age unless other appropriate drugs are ineffective or are contraindicated or unless the benefits in certain indications (e.g., anthrax) outweigh the risks.114 c d (See Pediatric Use under Cautions.)


Fetal/Neonatal Morbidity

Animal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity.c d If used during pregnancy or if patient becomes pregnant while receiving tetracycline, patient should be apprised of the potential hazard to the fetus.c d (See Pregnancy under Cautions.)


Renal Effects

Tetracyclines have antianabolic effects and may increase BUN.c d


In patients with impaired renal function, high serum tetracycline concentrations may result in azotemia, hyperphosphatemia, and acidosis.c d Excessive drug accumulation and possible liver toxicity may occur if usual dosage is used patients with renal impairment.c d (See Renal Impairment under Dosage and Administration.)


Do not use tetracycline preparations past their expiration dates.c d Outdated tetracycline preparations are highly nephrotoxic and have, on occasion, produced a Fanconi-like syndrome.c d


Laboratory Monitoring

Periodically assess organ system function, including renal, hepatic and hematopoietic, during long-term therapy.c d


Helidac Therapy

When the kit containing tetracycline, metronidazole, and bismuth subsalicylate (Helidac Therapy) is used for the treatment of H. pylori infection and duodenal ulcer disease, the cautions, precautions, and contraindications associated with metronidazole and bismuth subsalicylate must be considered in addition to those associated with tetracycline.e


Sensitivity Reactions


Photosensitivity Reactions

Photosensitivity, manifested by an exaggerated sunburn reaction, reported with tetracyclines.c d


Photosensitivity reactions may develop within a few minutes to several hours after sun exposure and usually persist 1–2 days after discontinuance of the drug.a Most reactions result from accumulation of tetracyclines in skin and are phototoxic in nature; photoallergic reactions may also occur.a


Discontinue drug at first evidence of skin erythema.c d


Hypersensitivity Reactions

Oral suspension contains sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.d


Cross-sensitization occurs among the various tetracyclines.c d


General Precautions


Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.c d Discontinue drug and institute appropriate therapy if superinfection occurs.c d


Nervous System Effects

Possibility of bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults.c d Effects usually resolve when drug discontinued, but possibility for permanent sequelae exists.c d


Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of tetracycline and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.c d


When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.c d In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.c d


Because many strains of Acinetobacter, Bacteroides, Enterobacter, E. coli, Klebsiella, Shigella, S. pyogenes (group A β-hemolytic streptococci), S. pneumoniae, enterococci, and α-hemolytic streptococci are resistant to tetracycline, in vitro susceptibility tests should be performed if the drug is used for treatment of infections caused by these bacteria.c d


Incision and drainage or other surgical procedures should be performed in conjunction with tetracycline therapy when indicated.c d


Specific Populations


Pregnancy

Category D.c d (See Fetal/Neonatal Morbidity under Cautions.)


Should not be used in pregnant women unless, in the judgement of the clinician, it is essential for the welfare of the patient and benefits outweigh the risks.c d


CDC and others state tetracyclines can be used when necessary for treatment of inhalational anthrax in pregnant women.122 i Since adverse effects on developing teeth and bones are dose-related, CDC suggests the drug might be used for a short period (7–14 days) before 6 months of gestation;i some clinicians recommend periodic liver function testing if used in pregnant women.122


Malaria infect

Monday, 28 May 2012

Insertec




Insertec may be available in the countries listed below.


Ingredient matches for Insertec



Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Insertec in the following countries:


  • Argentina

International Drug Name Search

Saturday, 26 May 2012

Estradiol Valerate



Pronunciation: ess-tra-DIE-ole
Generic Name: Estradiol Valerate
Brand Name: Delestrogen

Estrogens have been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause, especially in women who receive estrogen-only hormone therapy. Contact your doctor immediately if you experience any unusual vaginal bleeding. Estrogens may also increase the risk of cancer of the ovary or breast. Estrogen-containing products should not be used to prevent heart disease. Estrogen given with another hormone (progestin) for replacement therapy can infrequently cause heart disease (eg, heart attacks), stroke, serious blood clots in the legs or lungs (pulmonary embolism/deep vein thrombosis), dementia, and cancer of the breast. These risks appear to depend on the length of time Estradiol Valerate is used and the amount of estrogen per dose. Therefore, Estradiol Valerate should be used for the shortest possible length of time at the lowest effective dose so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.





Estradiol Valerate is used for:

Treating certain symptoms of menopause (eg, hot flashes, vaginal itching, burning, or dryness). It is used to treat low levels of estrogen caused by certain conditions. It may be used to treat certain types of prostate cancer (advanced androgen-dependent). It may also be used for other conditions as determined by your doctor.


Estradiol Valerate is a female estrogen hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.It works for advanced prostate cancer by antagonizing male hormones.


Do NOT use Estradiol Valerate if:


  • you are allergic to any ingredient in Estradiol Valerate

  • you are pregnant or suspect you may be pregnant, or you have vaginal bleeding of abnormal or unknown cause

  • you have a history of known or suspected breast cancer (unless your doctor tells you otherwise)

  • you have any other estrogen-dependent cancer

  • you have the blood disease porphyria, or a history of blood clots or liver problems

  • you have had a recent (within the past year) stroke or heart attack

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



Before using Estradiol Valerate:


Some medical conditions may interact with Estradiol Valerate. 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 breast lumps or disease, an abnormal mammogram, or a family history of breast cancer or blood clots

  • if you have yellowing of the skin or whites of the eyes during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)

  • if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)

  • if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes

  • if you smoke, are overweight, or will be having surgery

  • if you have a history of alcohol or other substance abuse or dependence

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


  • Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and side effects may be increased by Estradiol Valerate

  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Estradiol Valerate

  • Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), carbamazepine, rifampin, or St. John's wort because they may decrease Estradiol Valerate's effectiveness

  • Azole antifungals (eg, ketoconazole) or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Estradiol Valerate's side effects

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


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


  • An extra patient leaflet is available with Estradiol Valerate. Talk to your pharmacist if you have questions about this information.

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

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

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

  • If you miss a dose of Estradiol Valerate, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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



Important safety information:


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

  • Limit alcoholic beverages while you are using Estradiol Valerate.

  • Estradiol Valerate may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.

  • Estradiol Valerate may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).

  • Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.

  • Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Estradiol Valerate.

  • Follow your doctor's instructions for examining your breasts, and report any lumps immediately.

  • If you wear contact lenses and you develop problems with them, contact your doctor.

  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking Estradiol Valerate.

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

  • Estradiol Valerate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Estradiol Valerate.

  • Discuss with your doctor every 3 to 6 months whether treatment with Estradiol Valerate is still appropriate.

  • Lab tests, including physical exams and blood pressure, may be performed while you use Estradiol Valerate. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.

  • Estradiol Valerate has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.

  • Estradiol Valerate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Estradiol Valerate may cause decreased bone growth in CHILDREN.

  • PREGNANCY and BREAST-FEEDING: Do not use Estradiol Valerate if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Estradiol Valerate is found in breast milk. Do not breast-feed while taking Estradiol Valerate.


Possible side effects of Estradiol Valerate:


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:



Abnormal hair growth; breast tenderness; changes in sex drive; cramps; dizziness; flushing; hair loss; headache; lightheadedness; nausea; pain, swelling, or redness at the injection site; reduced tolerance to carbohydrates; stomach bloating and upset; swelling; vaginal infection; weight changes.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps; calf pain or tenderness; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech; chest pain; confusion; coughing of blood; mental/mood changes (eg, depression, memory loss); numbness of an arm or leg; one-sided weakness; pain, swelling, or tenderness in the stomach; problems with contact lenses (eg, changes in fit); severe headache, dizziness, fainting, or vomiting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness of an arm or leg; yellowing of the skin or eyes.



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



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.


Proper storage of Estradiol Valerate:

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


General information:


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

  • Estradiol Valerate 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 Estradiol Valerate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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