Friday 27 April 2012

Optic Nerve Disorder Medications


Topics under Optic Nerve Disorder

  • Leber's Disease (0 drugs)

Learn more about Optic Nerve Disorder





Drug List:

Tuesday 24 April 2012

Tetanus-Diphtheria Toxoids, Adult


Generic Name: tetanus and diphtheria toxoids vaccine (Td, adult) ( TET a nus and dif THEER ee a TOX oids)

Brand Names: Decavac (Td), Tetanus-Diphtheria Toxoids, Adult (Td)


What is tetanus and diphtheria toxoids vaccine?

Tetanus and diphtheria are serious diseases caused by bacteria.


Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.


Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.


Diphtheria is spread from person to person. Tetanus enters the body through a cut or wound.


The tetanus and diphtheria toxoids vaccine (also called Td) is used to help prevent these diseases in adults and children who are at least 7 years old.


This vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.


Like any vaccine, the tetanus and diphtheria toxoids vaccine may not provide protection from disease in every person.


What is the most important information I should know about this vaccine?


The tetanus and diphtheria toxoids vaccine is given in a series of shots. The first shot is usually given to a person who is at least 7 years old. The booster shots are then given 4 to 8 weeks after the first shot, and 6 to 12 months after the second shot. After the initial series, a booster dose is given every 10 years.


A booster shot is also recommended in children who are 11 or 12 years old if more than 5 years have passed since the child's last tetanus and diphtheria vaccine.


If it has been longer than 5 years since your last booster, you may need an emergency booster shot if you have been exposed to tetanus through a skin wound.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.


The adult version of this vaccine (Td) should not be given to anyone under the age of 7 years old. Another vaccine is available for use in younger children and infants.


Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.


You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.


You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.


Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.


What should I discuss with my healthcare provider before receiving this vaccine?


You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing diphtheria or tetanus, or if you have:

  • severe or uncontrolled epilepsy or other seizure disorder; or




  • if you have received cancer chemotherapy or radiation treatment in the past 3 months.



You may not be able to receive this vaccine if you have ever received a similar vaccine that caused any of the following:



  • a very high fever (over 104 degrees);




  • a neurologic disorder or disease affecting the brain;




  • fainting or going into shock;




  • Guillain-BarrĂ© syndrome (within 6 weeks after receiving a diphtheria, tetanus, or pertussis vaccine);




  • seizure (convulsions); or




  • a severe skin reaction.



Before receiving this vaccine, tell the doctor if you have:



  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;




  • a history of seizures;




  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);




  • an allergy to latex rubber;




  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or




  • if you are taking a blood thinner such as warfarin (Coumadin).



You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.


Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with diphtheria or tetanus. It is not known whether this vaccine passes into breast milk or if it could harm a nursing baby. Do not use receive the vaccine without telling your doctor if you are breast-feeding a baby. The adult version of this vaccine (Td) should not be given to anyone under the age of 7 years old. Another vaccine is available for use in younger children and infants.

How is this vaccine given?


This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.


The tetanus and diphtheria toxoids vaccine is given in a series of shots. The first shot is usually given to a person who is at least 7 years old. The booster shots are then given 4 to 8 weeks after the first shot, and 6 to 12 months after the second shot. After the initial series, a booster dose is given every 10 years.


A booster shot is also recommended in children who are 11 or 12 years old if more than 5 years have passed since the child's last tetanus and diphtheria vaccine.


If it has been longer than 5 years since your last booster, you may need an emergency booster shot if you have been exposed to tetanus through a skin wound.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.


Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.


It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.


What happens if I miss a dose?


Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.


Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.


What happens if I overdose?


An overdose of this vaccine is unlikely to occur.


What should I avoid before or after receiving this vaccine?


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


This vaccine side effects


You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.


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.

Call your doctor at once if you have any of these serious side effects:



  • extreme drowsiness, fainting;




  • severe headache or vomiting;




  • confusion, seizure (black-out or convulsions); or




  • high fever.



Less serious side effects include:



  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;




  • mild fever;




  • joint pain, body aches;




  • mild drowsiness; or




  • mild vomiting.



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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.


What other drugs will affect tetanus and diphtheria toxoids vaccine?


Before receiving this vaccine, tell your doctor about all other vaccines you have recently received.

Also tell the doctor if you have received drugs or treatments in the past 2 weeks that can weaken the immune system, including:



  • an oral, nasal, inhaled, or injectable steroid medicine;




  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or




  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).



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



More Tetanus-Diphtheria Toxoids, Adult resources


  • Tetanus-Diphtheria Toxoids, Adult Side Effects (in more detail)
  • Tetanus-Diphtheria Toxoids, Adult Use in Pregnancy & Breastfeeding
  • Tetanus-Diphtheria Toxoids, Adult Drug Interactions
  • 0 Reviews for Tetanus-Diphtheria Toxoids, Adult - Add your own review/rating


Compare Tetanus-Diphtheria Toxoids, Adult with other medications


  • Diphtheria Prophylaxis
  • Tetanus Prophylaxis


Where can I get more information?


  • Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: Tetanus-Diphtheria Toxoids, Adult side effects (in more detail)


Lysovir 100mg Capsules





1. Name Of The Medicinal Product



Lysovir 100mg Capsules


2. Qualitative And Quantitative Composition



Amantadine hydrochloride PhEur 100 mg.



3. Pharmaceutical Form



Capsule.



Reddish-brown hard gelatin capsules, printed SYMM in white on both the cap and body.



4. Clinical Particulars



4.1 Therapeutic Indications



Prophylaxis and treatment of signs and symptoms of infection caused by influenza A virus. It is suggested that Lysovir be given to patients suffering from clinical influenza in which complications might be expected to occur. In addition, Lysovir is recommended prophylactically in cases particularly at risk. This can include those with chronic respiratory disease or debilitating conditions, the elderly and those living in crowded conditions. It can also be used for individuals in families where influenza has already been diagnosed, for control of institutional outbreaks or for those in essential services who are unvaccinated or when vaccination is unavailable or contra-indicated.



Lysovir does not completely prevent the host immune response to influenza A infection, so individuals who take this drug still develop immune responses to the natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Lysovir may also be used in post-exposure prophylaxis in conjunction with inactivated vaccine during an outbreak until protective antibodies develop, or in patients who are not expected to have a substantial antibody response (immunosuppression).



4.2 Posology And Method Of Administration



Treatment: It is advisable to start treating influenza as early as possible and to continue for 4 to 5 days. When amantadine is started within 48 hours of symptoms appearing, the duration of fever and other effects is reduced by one or two days and the inflammatory reaction of the bronchial tree that usually accompanies influenza resolves more quickly. Prophylaxis: Treat daily for as long as protection from infection is required. In most instances this is expected to be for 6 weeks. When used with inactivated influenza A vaccine, amantadine is continued for 2 to 3 weeks following inoculation.



Adults: 100mg daily for the recommended period.



Children aged 10-15 years: 100mg daily for the recommended period.



Children under 10 years of age: Dosage not established.



Adults over 65 years of age: Plasma amantadine concentrations are influenced by renal function. In elderly patients, the elimination half-life is longer and renal clearance of the compound is diminished in comparison to young people. A daily dose of less than 100mg, or 100mg given at intervals of greater than one day, may be appropriate.



In patients with renal impairment the dose of amantadine should be reduced. This can be achieved by either reducing the total daily dose, or by increasing the dosage interval in accordance with the creatinine clearance. For example,












Creatinine clearance (ml/min)




Dose




< 15




Lysovir contra-indicated.




15 – 35




100mg every 2 to 3 days.




< 35




100mg every day



The above recommendations are for guidance only and physicians should continue to monitor their patients for signs of unwanted effects.



4.3 Contraindications



Known hypersensitivity to amantadine or any of the excipients. Individuals subject to convulsions. A history of gastric ulceration. Severe renal disease. Pregnancy.



4.4 Special Warnings And Precautions For Use



Lysovir should be used with caution in patients with confusional or hallucinatory states or underlying psychiatric disorders, in patients with liver or kidney disorders, and those suffering from, or who have a history of, cardiovascular disorders. Caution should be applied when prescribing Lysovir with other medications having an effect on the CNS (See Section 4.5, Interactions with other medicaments and other forms of interaction).



Lysovir should not be stopped abruptly in patients who are treated concurrently with neuroleptics. There have been isolated reports of precipitation or aggravation of neuroleptic malignant syndrome or neuroleptic-induced catatonia following the withdrawal of amantadine in patients taking neuroleptic agents. A similar syndrome has also been reported rarely following withdrawal of amantadine and other anti-Parkinson agents in patients who were not taking concurrent psychoactive medication.



Resistance to amantadine occurs during serial passage of influenza virus strains in vitro or in vivo in the presence of the drug. Apparent transmission of drug-resistant viruses may have been the cause of failure of prophylaxis and treatment in household contacts and in nursing-home patients. However, there is no evidence to date that the resistant virus produces a disease that is in any way different from that produced by sensitive viruses.



As some individuals have attempted suicide with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management.



Peripheral oedema (thought to be due to an alteration in the responsiveness of peripheral vessels) may occur in some patients during chronic treatment (not usually before 4 weeks) with amantadine. This should be taken into account in patients with congestive heart failure.



Amantadine has anticholinergic effects, it should not be given to patients with untreated angle closure glaucoma.



Hypothermia has been observed in children, especially in those younger than 5 years of age. Caution should be exercised when prescribing Lysovir to children for the prevention and treatment of influenza type A virus (see also section 4.2 Posology and method of administration).



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Concurrent administration of amantadine and anticholinergic agents or levodopa may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects (see Section 4.9 “Overdose”). Psychotic reactions have been observed in patients receiving amantadine and levodopa.



In isolated cases, worsening of psychotic symptoms has been reported in patients receiving amantadine and concomitant neuroleptic medication.



Concurrent administration of amantadine and drugs or substances (e.g. alcohol) acting on the CNS may result in additive CNS toxicity. Close observation is recommended (see Section 4.9 “Overdose”).



There have been isolated reports of a suspected interaction between amantadine and combination diuretics (hydrochlorothiazide + potassium sparing diuretics). One or both of the components apparently reduce the clearance of amantadine, leading to higher plasma concentrations and toxic effects (confusion, hallucinations, ataxia, myoclonus).



4.6 Pregnancy And Lactation



Amantadine-related complications during pregnancy have been reported. Lysovir is contra-indicated during pregnancy and in women wishing to become pregnant. Amantadine passes into breast milk. Undesirable effects have been reported in breast-fed infants. Nursing mothers should not take Lysovir.



4.7 Effects On Ability To Drive And Use Machines



Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness or blurred vision. If taken concomitantly with other products affecting the CNS, additive adverse effects could be seen.



4.8 Undesirable Effects



Amantadine's undesirable effects are often mild and transient, usually appearing within the first 2 to 4 days of treatment and promptly disappearing 24 to 48 hours after discontinuation. A direct relationship between dose and incidence of side effects has not been demonstrated, although there seems to be a tendency towards more frequent undesirable effects (particularly affecting the CNS) with increasing doses.



The side effects reported after the pivotal clinical studies in influenza in over 1200 patients receiving amantadine at 100mg daily were mostly mild, transient, and equivalent to placebo. Only 7% of subjects reported adverse events, many being similar to the effects of influenza itself. The most commonly reported effects were gastro-intestinal disturbances (anorexia, nausea), CNS effects (loss of concentration, dizziness, agitation, nervousness, depression, insomnia, fatigue, weakness), or myalgia.



Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (greater than or equal to 1 in 10); common (less than or equal to 1 in 100, less than 1 in 10); uncommon (greater than or equal to 1 in 1,000, less than 1 in 100); rare (greater than or less than 1 in 10,000, less than 1 in 1,000) very rare (less than 1 in 10,000), not known (where no valid estimate of the incidence has been derived).



NB: The incidence and severity of some of the adverse reactions, noted below, varies according to the dosage and nature of the disease under treatment.


















































Blood and lymphatic system disorders:


 


Very rare:




leucopenia, reversible elevation of liver enzymes.




Nervous system disorders:


 


Common:




anxiety, elevation of mood, lightheadedness, headache, lethargy, hallucinations, nightmares, ataxia, slurred speech, blurred vision, loss of concentration, nervousness, depression, insomnia, myaligia.. Hallucinations, confusion and nightmares1




Rare:




confusion, disorientation, psychosis, tremor, dyskinesia, convulsions, neuroleptic malignant-like syndrome.




Not known:




Delirium, hypomanic state and mania2




Eye Disorders:


 


Rare:




corneal lesions, e.g. punctate subepithelial opacities which might be associated with superficial punctate keratitis, corneal epithelial oedema, and markedly reduced visual acuity




Cardiac disorders:


 


Very common:




oedema of ankles, livedo reticularis3.




Common:




palpitations, orthostatic hypotension




Very rare:




heart insufficiency/failure




Gastrointestinal disorders:


 


Common:




dry mouth, anorexia, nausea, vomiting, constipation




Rare:




diarrhoea




Skin and subcutaneous disorders:


 


Common:




diaphoresis




Rare:




exanthema




Very rare:




photosensitisation.




Renal and urinary disorders:


 


Rare:




urinary retention, urinary incontinence.




General disorders


 


Not known:




Hypothermia4



1more common when amantadine is administered concurrently with anticholinergic agents or when the patient has an underlying psychiatric disorder.



2reported but their incidence cannot be readily deduced from the literature.



3usually after very high doses or use over many months.



4In post-marketing exposure hypothermia has been reported in children mainly those younger than 5 years of age (see also section 4.4 Special warnings and precautions for use). The frequency can not be established.



4.9 Overdose



Overdose with Lysovir can lead to fatal outcome.



Signs and symptoms: Neuromuscular disturbances and symptoms of acute psychosis are prominent. Central nervous system: Hyperreflexia, motor restlessness, convulsions, extrapyramidal signs, torsion spasms, dystonic posturing, dilated pupils, dysphagia, confusion, disorientation, delirium, visual hallucinations, myoclonus. Respiratory system: hyperventilation, pulmonary oedema, respiratory distress, including adult respiratory distress syndrome. Cardiovascular system: cardiac arrest and sudden cardiac death have been reported. Sinus tachycardia, arrhythmia, hypertension. Gastrointestinal system: nausea, vomiting, dry mouth. Renal function: urine retention, renal dysfunction, including increase in BUN and decreased creatinine clearance.



Overdose from combined drug treatment: the effects of anticholinergic drugs are increased by amantadine. Acute psychotic reactions (which may be identical to those of atropine poisoning) may occur when large doses of anticholinergic agents are used. Where alcohol or central nervous stimulants have been taken at the same time, the signs and symptoms of acute poisoning with amantadine may be aggravated and/or modified.



Management: There is no specific antidote. Induction of vomiting and/or gastric aspiration (and lavage if patient is conscious), activated charcoal or saline cathartic may be used if judged appropriate. Since amantadine is excreted mainly unchanged in the urine, maintenance of renal function and copious diuresis (forced diuresis if necessary) are effective ways to remove it from the blood stream. Acidification of the urine favours its excretion. Haemodialysis does not remove significant amounts of amantadine.



Monitor the blood pressure, heart rate, ECG, respiration and body temperature, and treat for possible hypotension and cardiac arhythmias, as necessary. Convulsions and excessive motor restlessness: administer anticonvulsants such as diazepam iv, paraldehyde im or per rectum, or phenobarbital im. Acute psychotic symptoms, delirium, dystonic posturing, myoclonic manifestations: physostigmine by slow iv infusion (1mg doses in adults, 0.5mg in children) repeated administration according to the initial response and the subsequent need, has been reported. Retention of urine: bladder should be catheterised; an indwelling catheter can be left in place for the time required.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: Anti-influenzal virostatic



ATC code N04B B01



Amantadine specifically inhibits the replication of influenza A viruses at low concentrations. If using a sensitive plaque-reduction assay, human influenza viruses, including H1N1, H2N2 and H3N2 subtypes, are inhibited by 2 protein in the virus. This has two actions; it stops the virus uncoating and inactivates newly synthesised viral haemagglutinin. Effects on late replicative steps have been found for representative avian influenza viruses.



Data from tests with representative strains of influenza A virus indicate that Lysovir is likely to be active against previously unknown strains, and could be used in the early stages of an epidemic, before a vaccine against the causative strain is generally available.



5.2 Pharmacokinetic Properties



Absorption: Amantadine is absorbed slowly but almost completely. Peak plasma concentrations of approximately 250ng/ml and 500ng/ml are attained within 3 to 4 hours after single oral administration of 100mg and 200mg amantadine, respectively. Following repeated administration of 200mg daily, the steady-state plasma concentration settles at 300ng/ml within 3 days.



Distribution: Amantadine accumulates after several hours in nasal secretions and crosses the blood-brain barrier (this has not been quantified). In vitro, 67% is bound to plasma proteins, with a substantial amount bound to red blood cells. The concentration in erythrocytes in normal healthy volunteers is 2.66 times the plasma concentration. The apparent volume of distribution is 5 to 10L/kg, suggesting extensive tissue binding. This declines with increasing doses. The concentrations in the lung, heart, kidney, liver and spleen are higher than in the blood.



Biotransformation: Amantadine is metabolised to a minor extent, principally by N-acetylation.



Elimination: The drug is eliminated in healthy young adults with a mean plasma elimination half-life of 15 hours (10 to 31 hours). The total plasma clearance is about the same as renal clearance (250ml/min). The renal amantadine clearance is much higher than the creatinine clearance, suggesting renal tubular secretion. After 4 to 5 days, 90% of the dose appears unchanged in urine. The rate is considerably influenced by urinary pH: a rise in pH brings about a fall in excretion.



Characteristics in special patient populations:



Elderly patients: compared with healthy young adults, the half-life may be doubled and renal clearance diminished. Tubular secretion diminishes more than glomerular filtration in the elderly. In elderly patients with renal impairment, repeated administration of 100mg daily for 14 days raised the plasma concentration into the toxic range.



Renal impairment: amantadine may accumulate in renal failure, causing severe side effects. The rate of elimination from plasma correlates to creatinine clearance divided by body surface area, although total renal elimination exceeds this value (possibly due to tubular secretion). The effects of reduced kidney function are dramatic: a reduction of creatinine clearance to 40ml/min may result in a five-fold increase in elimination half-life. The urine is the almost exclusive route of excretion, even with renal failure, and amantadine may persist in the plasma for several days. Haemodialysis does not remove significant amounts of amantadine, possibly due to extensive tissue binding.



5.3 Preclinical Safety Data



Reproductive toxicity studies were performed in rats and rabbits. In rat oral doses of 50 and 100 mg/kg proved to be teratogenic. This is 33-fold the recommended dose of 100mg for influenza. The maximum recommended dose, of 400mg in Parkinson's disease, is less than 6mg/kg.



There are no other pre-clinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lactose, povidone, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172) And monogramming ink S-1-7085 white, titanium dioxide (E171), ammonium hydroxide 28%, propylene glycol (E1520), simethicone or SB-0007P white ink containing: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).



6.2 Incompatibilities



None known.



6.3 Shelf Life



Five years.



6.4 Special Precautions For Storage



Store in the original package.



6.5 Nature And Contents Of Container



PVC/PVdC blister packs of 5 or 14 capsules.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Alliance Pharmaceuticals Ltd



Avonbridge House, Bath Road



Chippenham, Wiltshire SN15 2BB



8. Marketing Authorisation Number(S)



PL16853/0035



9. Date Of First Authorisation/Renewal Of The Authorisation



January 2000



10. Date Of Revision Of The Text



11th November 2011




Sunday 22 April 2012

Junel 1.5/30


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa


What is Junel 1.5/30 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.


Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.


Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Junel 1.5/30 (ethinyl estradiol and norethindrone)?


Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.


What should I discuss with my healthcare provider before taking Junel 1.5/30 (ethinyl estradiol and norethindrone)?


This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

  • coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;




  • a history of a stroke, blood clot, or circulation problems;




  • a hormone-related cancer such as breast or uterine cancer;




  • unusual vaginal bleeding that has not been checked by a doctor;




  • liver disease or liver cancer;




  • severe migraine headaches; or




  • a history of jaundice caused by pregnancy or birth control pills.



To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • high blood pressure or a history of heart disease;




  • high cholesterol, gallbladder disease, or diabetes;




  • migraine headaches or a history of depression; or




  • a history of breast cancer or an abnormal mammogram.




The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Junel 1.5/30 (ethinyl estradiol and norethindrone)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).


You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.


You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.


The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.


If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.


Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.


If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.


If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Junel 1.5/30 (ethinyl estradiol and norethindrone)?


Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.


Junel 1.5/30 (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

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




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




  • sudden cough, wheezing, rapid breathing, coughing up blood;




  • pain, swelling, warmth, or redness in one or both legs;




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




  • a change in the pattern or severity of migraine headaches;




  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);




  • a lump in your breast;




  • swelling in your hands, ankles, or feet; or




  • symptoms of depression (sleep problems, weakness, mood changes).



Less serious side effects may include:



  • mild nausea or vomiting, appetite or weight changes;




  • breast swelling or tenderness;




  • headache, nervousness, dizziness;




  • problems with contact lenses;




  • freckles or darkening of facial skin, loss of scalp hair; or




  • vaginal itching or discharge.



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 Junel 1.5/30 (ethinyl estradiol and norethindrone)?


Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:



  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);




  • bosentan (Tracleer);




  • prednisolone (Orapred);




  • St. John's wort;




  • theophylline (Elixophyllin, Theo-24, Uniphyl);




  • an antibiotic;




  • HIV or AIDS medications;




  • phenobarbital (Solfoton) and other barbiturates; or




  • seizure medication.



This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Junel 1.5/30 resources


  • Junel 1.5/30 Side Effects (in more detail)
  • Junel 1.5/30 Use in Pregnancy & Breastfeeding
  • Drug Images
  • Junel 1.5/30 Drug Interactions
  • Junel 1.5/30 Support Group
  • 1 Review for Junel.5/30 - Add your own review/rating


  • Aranelle Prescribing Information (FDA)

  • Balziva Prescribing Information (FDA)

  • Brevicon Prescribing Information (FDA)

  • Briellyn Prescribing Information (FDA)

  • Cyclafem 1/35 Prescribing Information (FDA)

  • Cyclafem 7/7/7 Prescribing Information (FDA)

  • Estrostep Fe Prescribing Information (FDA)

  • Femcon FE Prescribing Information (FDA)

  • Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Femhrt Consumer Overview

  • Femhrt Prescribing Information (FDA)

  • Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)

  • Jevantique Prescribing Information (FDA)

  • Jinteli Prescribing Information (FDA)

  • Leena Prescribing Information (FDA)

  • Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lo Loestrin Fe Consumer Overview

  • Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lo Loestrin Fe Prescribing Information (FDA)

  • Loestrin 24 FE Prescribing Information (FDA)

  • Loestrin 24 Fe Consumer Overview

  • Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tilia FE Prescribing Information (FDA)

  • Tri-Norinyl Prescribing Information (FDA)

  • Zenchent FE Prescribing Information (FDA)

  • Zeosa Prescribing Information (FDA)



Compare Junel 1.5/30 with other medications


  • Abnormal Uterine Bleeding
  • Acne
  • Birth Control
  • Endometriosis
  • Gonadotropin Inhibition
  • Menstrual Disorders
  • Polycystic Ovary Syndrome
  • Postmenopausal Symptoms
  • Prevention of Osteoporosis


Where can I get more information?


  • Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Junel.5/30 side effects (in more detail)


Stalevo 125


Generic Name: carbidopa, entacapone, and levodopa (KAR bi DOE pa, en TAK a pone, LEE voe DOE pa)

Brand Names: Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200, Stalevo 50, Stalevo 75


What is Stalevo 125 (carbidopa, entacapone, and levodopa)?

Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels of dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect. Entacapone increases levels of levodopa in the body.


The combination of carbidopa, entacapone, and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control.


Carbidopa, entacapone, and levodopa may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Stalevo 125 (carbidopa, entacapone, and levodopa)?


You should not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have narrow-angle glaucoma, unusual skin lesions, or a history of skin cancer.


Tell your doctor about all of your medical conditions, especially heart disease, high blood pressure, asthma or other breathing problems, liver or kidney disease, a hormonal disease, an ulcer, glaucoma, or mental illness. Also tell your doctor about all the medications you use.


It may take up to several weeks of using carbidopa, entacapone, and levodopa before your symptoms improve. Talk with your doctor if your symptoms do not improve or if the effects of this medication seem to wear off quickly in between doses. Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor.

What should I discuss with my healthcare provider before taking Stalevo 125 (carbidopa, entacapone, and levodopa)?


Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have:



  • narrow-angle glaucoma;




  • unusual skin lesions that have not been checked by a doctor; or




  • a history of malignant melanoma (skin cancer).



To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, or a prior heart attack;




  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;




  • kidney disease, liver disease, or bile duct obstruction;




  • an endocrine (hormonal) disease;




  • a stomach or intestinal ulcer;




  • glaucoma; or




  • depression or other mental illness.



You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking this medicine.


Carbidopa, entacapone, and levodopa may cause hallucinations (the sensation of hearing or seeing something that is not there). Call your doctor if you experience hallucinations.


Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.


FDA pregnancy category C. It is not known whether carbidopa, entacapone, and levodopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Carbidopa, entacapone, and levodopa may pass into breast milk and could harm a nursing baby. You should not breast-feed while you are taking carbidopa, entacapone, and levodopa.

How should I take Stalevo 125 (carbidopa, entacapone, and levodopa)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your medicine at regular intervals to keep a steady amount of the drug in your body at all times.


Drink plenty of liquids while you are taking this medication. It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using carbidopa, entacapone, and levodopa.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include weakness, loss of coordination, trouble breathing, fainting, or seizure (convulsions).

What should I avoid while taking Stalevo 125 (carbidopa, entacapone, and levodopa)?


Carbidopa, entacapone, and levodopa may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa, entacapone, and levodopa.


Stalevo 125 (carbidopa, entacapone, and levodopa) 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. Call your doctor at once if you have a serious side effect such as:

  • nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);




  • depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;




  • worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;




  • severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;




  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;




  • fast, pounding, or uneven heartbeats;




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




  • tight feeling in your chest, new or worsening cough, fever, trouble breathing;




  • easy bruising or bleeding, bloody or tarry stools, coughing up blood;




  • pain or burning when you urinate; or




  • unexplained muscle pain, tenderness, or weakness.



Less serious side effects may include:



  • stomach pain or upset, loss of appetite, constipation;




  • dry mouth, changes in your sense of taste;




  • unusual skin changes. mild rash or itching;




  • dizziness or drowsiness, headache, blurred vision;




  • muscle cramps, back pain; or




  • agitation or anxiety, sleep problems (insomnia), strange dreams.



You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.


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 Stalevo 125 (carbidopa, entacapone, and levodopa)?


Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbidopa, entacapone, and levodopa. Tell your doctor if you regularly use any of these other medicines, or any other Parkinson's medications.

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



  • apomorphine (Apokyn);




  • cholestyramine (Prevalite, Questran);




  • dobutamine (Dobutrex);




  • epinephrine (Epi-Pen, and others);




  • isoniazid (for treating tuberculosis);




  • isoproterenol (Isuprel, Medihaler-Iso);




  • methyldopa (Aldomet);




  • metoclopramide (Reglan);




  • papaverine (Pavabid, Papacon, Pavagen, Pavacot);




  • phenytoin (Dilantin);




  • probenecid (Benemid);




  • blood pressure medication;




  • an antibiotic such as ampicillin, chloramphenicol, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others), or rifampin (Rifadin, Rifater, Rifamate);




  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine), risperidone (Risperdal), and others.



This list is not complete and other drugs may interact with carbidopa, entacapone, and levodopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Stalevo 125 resources


  • Stalevo 125 Side Effects (in more detail)
  • Stalevo 125 Use in Pregnancy & Breastfeeding
  • Stalevo 125 Drug Interactions
  • 0 Reviews for Stalevo25 - Add your own review/rating


  • Stalevo 125 Advanced Consumer (Micromedex) - Includes Dosage Information

  • Carbidopa/Entacapone/Levodopa MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Stalevo 125 with other medications


  • Parkinson's Disease


Where can I get more information?


  • Your pharmacist can provide more information about carbidopa, entacapone, and levodopa.

See also: Stalevo25 side effects (in more detail)


Wednesday 18 April 2012

Ramipril Capsules 1.25mg, 2.5mg, 5mg, 10mg (Actavis UK Ltd)






Ramipril 1.25mg, 2.5mg, 5mg and 10mg Capsules




  • Please read this leaflet carefully before you start to take your medicine.


  • It gives you important information about your medicine.


  • If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.


  • Keep the leaflet until you have finished the medicine.




What’S In Your Medicine


Ramipril capsules come in four strengths coloured as follows:


  • 1.25mg: light grey body and cap.

  • 2.5mg: light grey body and light green cap.

  • 5mg: light grey body and green cap.

  • 10mg: light grey body and dark green cap.

Each capsule contains 1.25mg, 2.5mg, 5mg or 10mg of the active ingredient ramipril.


The capsules also contain starch pregelatinised.


The capsule shell contains: gelatin, water, black iron oxide (E172), titanium dioxide (E171) (all strengths), indigo carmine FD&C Blue 2 (E132) (all strengths except 1.25mg), yellow iron oxide (E172) (all strengths except 1.25mg).


The printing ink contains: shellac (E904), black iron oxide (E172), soya lecithin (E322), antifoam DC 1510.


Ramipril capsules are available in a pack size of 28.



Your capsules are made by



Actavis hf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

ICELAND




The Marketing Authorisation holder is



Actavis

Barnstaple

EX32 8NS

UK





About Your Medicine


Ramipril is one of a group of medicines called angiotensin converting enzyme (ACE) inhibitors. These medicines work by reducing blood pressure.


Ramipril may be used to:


  • Reduce the risk of heart attack, stroke, or need for revascularisation procedures for patients aged over fifty-five years

  • Lower blood pressure if it is too high

  • Help your heart to pump blood around the body, if you already have heart failure

  • Prevent further weakening of your heart if you have already had a heart attack

  • Reduce the risk of myocardial infarctions, stroke, cardiovascular death or need for revascularisation procedures in diabetic patients of fifty-five years or more who have hypertension and/or high cholesterol, and/or low HDL (high density lipoprotein), and/or have microalbinuria (protein in urine), clinical evidence of vascular disease, or who are a current smoker



Before Taking Your Medicine



Do NOT take Ramipril if you answer yes to any of the following:


  • Are you pregnant, planning to become pregnant or breast-feeding?

  • Have you ever had an allergic reaction to Ramipril or any of the ingredients in the capsule? (An allergic reaction may include a rash, itching or difficulty in breathing)

  • Do you have a history of angioneurotic oedema (puffiness or swelling of the face, tongue or body)?

  • Do you have heart valve problems?

  • Do you have low or very variable blood pressure?

  • Do you have problems with narrow blood vessels to the kidneys (renal artery stenosis)?



Make sure you have told your doctor before taking Ramipril if any of the following apply:


  • Are you having dialysis (haemodialysis) or a form of blood transfusion called apheresis?

  • Are you due to have an operation with or without anaesthetic? You should tell your dentist if appropriate too.

  • Do you have other kidney problems or liver problems?

  • Do you have either of the collagen vascular conditions lupus erythematosus or scleroderma?

  • Have you recently been ill with diarrhoea or vomiting?

  • Are you on a low salt diet?

  • Do you have severe heart failure?

  • Are you taking other medicines, especially

    • diuretics or “water tablets” (e.g. spironolactone, amiloride, triamterene),
    • other medicines that lower blood pressure such as beta-blockers (e.g. atenolol),
    • potassium supplements or medicines containing potassium,
    • medicines for diabetes (e.g. insulin, glibenclamide, gliclazide, tolbutamide),
    • non-steroidal anti-inflammatory medicines (e.g. aspirin, indometacin),
    • lithium,
    • allopurinol (for gout) or medicines that suppress the immune system (e.g. prednisolone).

  • Alcohol - You are advised NOT to drink alcohol with this medicine. Alcohol may worsen any ill effects you might experience from the Ramipril. Discuss this with your doctor if you have any questions.

  • Driving - After the first dose or any increase in dose of Ramipril, you should wait several hours before you drive as Ramipril capsules may make you feel drowsy or dizzy. In all circumstances, make sure you are not affected before you drive or operate machinery.


If you see another doctor or go into hospital, let them know what medicines you are taking.




Taking Your Medicine


Follow your doctor’s instructions. Check the pharmacy label to see how many capsules to take and how often to take them. If you are not sure how to take them ask your pharmacist or doctor.



The usual dosage(s) are described below:



Adults



  • Reducing the risk of heart attack, stroke, or need for heart by-pass operations: Usual starting dose is 2.5mg Ramipril once daily, gradually increased according to tolerability. Your doctor may double this dose after one week to 5mg Ramipril once daily, then after a further three weeks, double again to 10mg Ramipril once daily (the usual maintenance dose).


  • Reducing high blood pressure: Usual starting dose is 1.25mg Ramipril once daily. Your doctor usually increases this every one to two weeks according to response, up to a maximum of 10mg Ramipril once daily. The usual maintenance dose is 2.5-5mg once daily. Patients already on diuretic therapy (“water tablets”), may have this stopped by the doctor 2-3 days before starting therapy with Ramipril. The diuretic may be resumed at a later date should it be necessary.


  • Treating heart failure: Usual starting dose is 1.25mg Ramipril once daily. The dose may be increased according to response. If increased, the doctor may double the dose every one to two weeks. Daily doses of 2.5mg or more may be taken as a single dose or as two divided doses. The maximum recommended daily dose is 10mg Ramipril once daily. Where patients have high dose diuretic therapy as well, the doctor may reduce the diuretic dose before starting Ramipril.


  • Preventing further weakening of your heart if you have had a heart attack: The starting dose is 2.5mg Ramipril twice daily, increased after 2 days to 5mg twice daily. If the initial 2.5mg dose is not tolerated, a lower dose of 1.25mg twice daily is given. The maintenance dose is 2.5 to 5mg twice daily.


  • If you are elderly and taking diuretics (“water tablets”) or have any heart, liver or kidney problems: your doctor may use a lower starting dose and possibly a lower maintenance dose too.


Children


Ramipril is not recommended.



Swallow these capsules whole with a glass of water. The effect of Ramipril is unaffected by the timing of the dose and food intake. This medicine should be taken for as long as your doctor tells you to, it may be dangerous to stop without their advice.


If you forget to take a dose, take one as soon as you remember, unless it is time for the next dose anyway. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.


Do not take more Ramipril capsules than your doctor tells you to. If you ever take too many, contact the nearest hospital casualty department or tell your doctor immediately. Do not go unaccompanied if you feel unwell. Take the container and any remaining Ramipril capsules with you to show to the doctor.




After Taking Your Medicine


This medicine sometimes causes unwanted effects in some people.


These are generally mild and transient, not requiring therapy to be discontinued.


The most commonly report adverse effects are nausea, dizziness and headache.



Other less common effects include:



Effects on the heart and circulation: Rarely, low blood pressure with dizziness, weakness and nausea after the initial dose of Ramipril or after an increase in dose. This may occur in patients with severe dehydration or low salt levels, such as those also taking diuretics, on dialysis or with severe heart failure. Fainting has been observed rarely. Other effects that may occur include heart attack or damage to blood vessels in the brain, chest pain, palpitations, heart rhythm disturbances and angina. Inflammation of blood vessels (vasculitis).



Effects on airways or breathing: Dry and tickly cough, runny nose, inflammation of the sinus, bronchitis and asthma (especially in patients with the dry tickly cough).



Effects on digestive system: Mouth dryness, irritation or inflammation of the lips, tongue or mouth, disturbances in digestion, constipation, diarrhoea, feeling or being sick, stomach pain or upper abdominal pain, increases in some liver enzyme results and possibly bilirubin levels in blood tests, yellowing of the skin or eyes due to obstructed bile flow (cholestatic jaundice) or liver damage (hepatitis) and reduced liver function.



Effects on the skin: Reddening and warming of areas of skin, itching, itchy rash, various skin/mucosal spots and rashes, occasional pronounced hair loss. With other ACE inhibitors, other types of skin rash including some resembling psoriasis, loosening of nails from nail beds and sensitivity of skin to light have been observed.



Effects on the kidneys: impaired kidney function.



Other effects: Muscle and joint pains. Rarely, inflammation of the pancreas. Disturbances of balance, headache, nervousness, restlessness, shakiness of the arms or legs, problems sleeping, confusion, loss of appetite, depressed mood, anxiety, numbness, tingling or pins and needles, loss of or changes in taste, muscle cramps and reduced sexual drive and ability in men. Causing or worsening of Raynaud’s syndrome (attacks of pain, numbness, coldness and blueness of the fingers). Conjunctivitis (red, sore, itching or weeping eyes). Pre-existing proteinuria (elevated protein levels in the urine) may deteriorate. An increase in blood urea nitrogen, creatinine levels, serum potassium levels and a decrease in serum sodium levels, and increased numbers of white blood cells called eosinophils.


Hypersensitivity reactions with itching, rash, breathlessness and sometimes fever may occur. These usually resolve on stopping Ramipril. In very rare cases angioneurotic oedema (a puffy swollen face, tongue or body) may occur. If throat noises or swelling of the face, tongue or voice box occurs, STOP taking Ramipril and contact your doctor immediately or arrange to be taken to the nearest hospital emergency department.



If you are concerned about any of these effects or get any other unusual effects, tell your doctor immediately. Please do not be worried. Most people taking this medicine will not experience any problems.




Storing Your Medicine


Do not use the Ramipril capsules after the expiry (use by) date shown on the product packaging. Keep the capsules stored below 25°C and store in the original container.



KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.



Date of last revision: March 2007




Actavis

Barnstaple

EX32 8NS

UK


ACTPL031





Monday 16 April 2012

Magonate


Pronunciation: mag-NEE-zee-um GLOO-koe-nate
Generic Name: Magnesium Gluconate
Brand Name: Examples include Magonate and Magtrate


Magonate is used for:

Treating low magnesium levels or maintaining the proper amount of magnesium in the body.


Magonate is an essential mineral. It works by adding magnesium to your body if your magnesium levels are low.


Do NOT use Magonate if:


  • you are allergic to any ingredient in Magonate

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



Before using Magonate:


Some medical conditions may interact with Magonate. 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 appendicitis, diarrhea, a blockage of your intestines, heart problems, or kidney problems

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


  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Magonate

  • Bisphosphonates (eg, risedronate), penicillamine, quinolone antibiotics (eg, ciprofloxacin), or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Magonate

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


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


  • Take Magonate by mouth with food.

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

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



Important safety information:


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

  • Magonate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

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


Possible side effects of Magonate:


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:



Diarrhea.



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); nausea; slow reflexes.



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


See also: Magonate side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; flushing; loss of consciousness; muscle weakness; severe drowsiness; slow heartbeat.


Proper storage of Magonate:

Store Magonate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Magonate out of the reach of children and away from pets.


General information:


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

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Magonate resources


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


  • Magonate Concise Consumer Information (Cerner Multum)

  • Almora Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Magonate with other medications


  • Dietary Supplementation
  • Hypomagnesemia

Sunday 15 April 2012

Flu & Severe Cold & Cough Daytime Powder


Generic Name: acetaminophen, dextromethorphan, and phenylephrine (a SEET a MIN of fen, DEX troe me THOR fan, and FEN il EFF rin)

Brand Names: Comtrex Cold & Cough, Daytime, Flu & Severe Cold & Cough Daytime Powder, Mapap Cold Formula, Theraflu Daytime Severe Cold & Cough, Theraflu Multi-Symptom Severe Cold, Theraflu Nighttime Severe Cold & Cough, Theraflu Warming Relief Daytime Multi-Symptom Cold, Theraflu Warming Severe Cold Daytime, Tylenol Children's Plus Cold & Cough, Tylenol Cold Multi-Symptom Daytime


What is Flu & Severe Cold & Cough Daytime Powder (acetaminophen, dextromethorphan, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.


Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


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


The combination of acetaminophen, dextromethorphan, and phenylephrine is used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.


This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, and phenylephrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about this medicine?


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?


Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, and phenylephrine if you have:



  • liver disease, cirrhosis, or a history of alcoholism;




  • diabetes;




  • glaucoma;




  • diabetes;




  • epilepsy or other seizure disorder;




  • enlarged prostate or urination problems;




  • pheochromocytoma (an adrenal gland tumor); or




  • cough with mucus, or cough caused by emphysema or chronic bronchitis.




It is not known whether acetaminophen, dextromethorphan, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take this medicine?


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


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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


Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.


Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.


If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?


Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


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


What should I avoid while taking this medicine?


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

This medicine 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. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain, fast, slow, or uneven heart rate;




  • severe dizziness, feeling like you might pass out;




  • mood changes, confusion, hallucinations;




  • tremor, seizure (convulsions);




  • fever;




  • urinating less than usual or not at all;




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




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




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).



Less serious side effects may include:



  • dizziness, weakness;




  • mild headache;




  • mild nausea, diarrhea, upset stomach;




  • dry mouth, nose, or throat;




  • feeling nervous, restless, irritable, or anxious; or




  • sleep problems (insomnia).



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 this medicine?


Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:



  • leflunomide (Arava);




  • tapentadol (Nucynta);




  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;




  • an antidepressant;




  • birth control pills or hormone replacement therapy;




  • blood pressure medication;




  • cancer medicine;




  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;




  • gout or arthritis medications (including gold injections);




  • HIV/AIDS medication;




  • medicines to treat psychiatric disorders;




  • migraine headache medicine;




  • an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or




  • seizure medication.



This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Flu & Severe Cold & Cough Daytime Powder resources


  • Flu & Severe Cold & Cough Daytime Powder Use in Pregnancy & Breastfeeding
  • Flu & Severe Cold & Cough Daytime Powder Drug Interactions
  • 0 Reviews for Flu & Severe Cold & Cough Daytime - Add your own review/rating


  • Tylenol Cold Multi-Symptom Daytime Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Flu & Severe Cold & Cough Daytime Powder with other medications


  • Cold Symptoms
  • Cough
  • Cough and Nasal Congestion
  • Nasal Congestion
  • Pain/Fever
  • Sinus Symptoms
  • Tonsillitis/Pharyngitis


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen, dextromethorphan, and phenylephrine.