Maxzide-25

Generic Name: hydrochlorothiazide and triamterene (HYE dro klor oh THY a zide and trye AM ter een)

Brand Names: Dyazide, Maxzide, Maxzide-25

What is Maxzide-25 (hydrochlorothiazide and triamterene)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Triamterene is a potassium-sparing diuretic that also prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

The combination of hydrochlorothiazide and triamterene is used to treat fluid retention (edema) and high blood pressure (hypertension).

Hydrochlorothiazide and triamterene may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Maxzide-25 (hydrochlorothiazide and triamterene)?

You should not use this medication if you are allergic to hydrochlorothiazide or triamterene, or if you have kidney disease, urination problems, high levels of potassium in your blood, or if you are taking other diuretics similar to triamterene. Do not use potassium supplements unless your doctor has told you to.

Before using this medication, tell your doctor if you have heart or liver disease, glaucoma, diabetes, a breathing disorder, gout, lupus, kidney stones, a pancreas disorder, or an allergy to sulfa drugs or penicillin.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and triamterene.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use potassium supplements, salt substitutes, or low-sodium milk while you are taking hydrochlorothiazide and triamterene, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

What should I discuss with my doctor before taking Maxzide-25 (hydrochlorothiazide and triamterene)?

You should not use this medication if you are allergic to hydrochlorothiazide (HCTZ, HydroDiuril, Lotensin HCT, Prinzide, Zestoretic, Ziac, and others) or triamterene (Dyrenium), or if you have:

• kidney disease or are unable to urinate;


• 
  

  high potassium levels (hyperkalemia);

  
  


• 
  

  if you are taking diuretics similar to triamterene, such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide); or

  
  


• 
  

  if you are taking potassium supplements (unless your doctor tells you to).

  
  

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

• 
  

  diabetes;

  
  


• 
  

  heart disease;

  
  


• 
  

  cirrhosis or other liver disease;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a breathing disorder;

  
  


• 
  

  gout;

  
  


• 
  

  lupus;

  
  


• 
  

  a history of kidney stones;

  
  


• 
  

  a pancreas disorder; or

  
  


• 
  

  an allergy to sulfa drugs or penicillin.

  
  

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

How should I take Maxzide-25 (hydrochlorothiazide and triamterene)?

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.

Your doctor may occasionally change your dose to make sure you get the best results.

You will need regular medical tests to be sure this medication is not causing harmful effects. Visit your doctor regularly.

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

If you need surgery or a blood transfusion, tell the doctor ahead of time that you are using hydrochlorothiazide and triamterene.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include increased urination, nausea, vomiting, weakness, fever, warmth or flushing in your face, or muscle spasms.

What should I avoid while taking Maxzide-25 (hydrochlorothiazide and triamterene)?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and triamterene.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Do not use potassium supplements, salt substitutes, or low-sodium milk while you are taking hydrochlorothiazide and triamterene, unless your doctor has told you to. Hydrochlorothiazide and triamterene may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Maxzide-25 (hydrochlorothiazide and triamterene) 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 hydrochlorothiazide and triamterene and call your doctor at once if you have a serious side effect such as:

• 
  

  eye pain, vision problems;

  
  


• 
  

  slow, fast, or uneven heartbeat;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  swelling or rapid weight gain;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, hallucinations, fainting, seizure, shallow breathing or breathing that stops;

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  
  


• 
  

  high potassium (irregular heart rate, weak pulse, muscle weakness, tingly feeling);

  
  


• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


• 
  

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

  
  


• 
  

  patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight);

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  mild nausea, diarrhea, constipation;

  
  


• 
  

  dizziness, headache;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  skin rash.

  
  

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 can affect Maxzide-25 (hydrochlorothiazide and triamterene)?

Before using hydrochlorothiazide and triamterene, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by hydrochlorothiazide and triamterene.

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

• 
  

  lithium (Eskalith, LithoBid);

  
  


• 
  

  amphotericin B (Amphotec, AmBisome, Abelcet);

  
  


• 
  

  methenamine (Hipprex, Mandelamine, Urex);

  
  


• 
  

  gout medication such as allopurinol (Zyloprim), colchicine (Colcrys), or probenecid (Benemid);

  
  


• 
  

  steroid medication (prednisone and others);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  laxatives;

  
  


• 
  

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

  
  


• 
  

  indomethacin (Indocin) or other NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with hydrochlorothiazide and triamterene. 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 Maxzide-25 resources

• Maxzide-25 Side Effects (in more detail)
• Maxzide-25 Use in Pregnancy & Breastfeeding
• Drug Images
• Maxzide-25 Drug Interactions
• Maxzide-25 Support Group
• 0 Reviews for Maxzide-25 - Add your own review/rating

• Dyazide Prescribing Information (FDA)


• Dyazide Consumer Overview


• Dyazide Advanced Consumer (Micromedex) - Includes Dosage Information


• Dyazide MedFacts Consumer Leaflet (Wolters Kluwer)


• Maxzide Prescribing Information (FDA)

Compare Maxzide-25 with other medications

• Edema
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about hydrochlorothiazide and triamterene.

See also: Maxzide-25 side effects (in more detail)

Pancrecarb MS-16

Generic Name: pancrelipase (oral) (pan kre LYE pace)

Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

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

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

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

• kidney disease;


• 
  

  gout;

  
  


• 
  

  a history of blockage in your intestines;

  
  


• 
  

  a sudden onset of pancreatitis; or

  
  


• 
  

  worsening of chronic pancreatic disease.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pancrelipase?

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.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

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 diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

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

Pancrelipase 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 severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  mild stomach pain or upset;

  
  


• 
  

  diarrhea or constipation;

  
  


• 
  

  bloating or gas.

  
  


• 
  

  greasy stools;

  
  


• 
  

  rectal irritation;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  cough; or

  
  


• 
  

  weight loss.

  
  

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 pancrelipase?

There may be other drugs that can interact with pancrelipase. 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 Pancrecarb MS-16 resources

• Pancrecarb MS-16 Side Effects (in more detail)
• Pancrecarb MS-16 Use in Pregnancy & Breastfeeding
• Drug Images
• Pancrecarb MS-16 Drug Interactions
• Pancrecarb MS-16 Support Group
• 1 Review for Pancrecarb MS-16 - Add your own review/rating

• Pancrelipase Professional Patient Advice (Wolters Kluwer)


• Pancrelipase Prescribing Information (FDA)


• Pancrelipase Monograph (AHFS DI)


• Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Prescribing Information (FDA)


• Creon Advanced Consumer (Micromedex) - Includes Dosage Information


• Creon MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Consumer Overview


• Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dygase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancreaze Consumer Overview


• Pancreaze Prescribing Information (FDA)


• Zenpep Prescribing Information (FDA)


• Zenpep Consumer Overview

Compare Pancrecarb MS-16 with other medications

• Chronic Pancreatitis
• Cystic Fibrosis
• Pancreatic Exocrine Dysfunction

Where can I get more information?

• Your pharmacist can provide more information about pancrelipase.

See also: Pancrecarb MS-16 side effects (in more detail)

Furadantin tablets 100mg

1. Name Of The Medicinal Product

Furadantin® tablets 100mg

Nitrofurantoin 100mg tablets

2. Qualitative And Quantitative Composition

Furadantin tablets contain 100mg Nitrofurantoin Ph Eur.

3. Pharmaceutical Form

Furadantin tablets are yellow and pentagonal. Each tablet has a break line on one face and the tablet strength on the opposite face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections, when due to susceptible strains of Escherichia co/i, Enterococci, Staphylococci, Citrobacter, Kiebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days

Severe Chronic Recurrence: 100mg four times day for seven days

Long Term Suppression: 50mg - 100mg once a day.

Pophylaxis: 50mg four times daily for the duration of procedure and 3 days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days.

Suppressive: 1mg/kg, once a day.

For children under 25kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (Section 4.8).

4.3 Contraindications

Patients suffering from renal dysfunction with a creatinine clearance of less than 60ml/minute or elevated serum creatinine.

In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the new-born infant, due to immature erythrocyte enzyme systems.

Patients with known hypersensitivity to Nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy, which may become severe or irreversible, has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesiae).

Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary condition of patients receiving long-term therapy is warranted (especially in the elderly).

Patients should be monitored closely for signs of hepatitis (particularly in long-term use). Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (If tested for reducing substances)

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine

4.6 Pregnancy And Lactation

Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for specific indication, only after careful assessment.

Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells. Caution should be exercised while breast-feeding an infant known or suspected to have an erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

4.8 Undesirable Effects

Respiratory

If any of the following respiratory reactions occur the drug should be discontinued.

Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.

Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.

Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely. Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

Neurological

Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

Gastrointestinal

Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritis have occurred.

Lupus-like syndrome associated with pulmonary reactions to Nitrofurantoin has been reported.

Exfoliative dermatitis and erythema multiforme (including Stevens- Johnson Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur.

However, these are limited to the genitourinary tract because suppression of normal bacterial flora does not occur elsewhere in the body.

4.9 Overdose

Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Furadantin is a broad-spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin. Most strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.

5.2 Pharmacokinetic Properties

Orally administered Nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations at therapeutic dosages are usually low with an elimination half-life of about 30 minutes.

Maximum urinary excretion usually occurs 2-4 hours after administration of Nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained.

5.3 Preclinical Safety Data

Carcinogenic effect of Nitrofurantoin in animal studies was observed. However, human data and extensive use of Nitrofurantoin over 50 years do not support such observation.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Furadantin tablets also contain lactose, maize starch, talc, alginic acid and magnesium stearate and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

The tablets are packaged in light-proof and moisture-resistant containers. Storage temperatures must not exceed 25°C.

6.5 Nature And Contents Of Container

Furadantin tablets are supplied in packs of 30 and 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Used as directed by physician. A Patient Information Leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom.

8. Marketing Authorisation Number(S)

PL 12762/0051 (100mg tablets)

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000.

10. Date Of Revision Of The Text

13/08/2010

Atropine Sulfate Injection BP

Atropine Sulfate Injection BP may be available in the countries listed below.

Ingredient matches for Atropine Sulfate Injection BP

Atropine

Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Atropine Sulfate Injection BP in the following countries:

• Australia


• New Zealand

International Drug Name Search

Onelaxant

Onelaxant may be available in the countries listed below.

Ingredient matches for Onelaxant

Baclofen

Baclofen is reported as an ingredient of Onelaxant in the following countries:

• Philippines

International Drug Name Search

Lexapro

Lexapro is a brand name of escitalopram, approved by the FDA in the following formulation(s):

LEXAPRO (escitalopram oxalate - solution; oral)

• 
  Manufacturer: FOREST LABS
  
  Approval date: November 27, 2002
  
  Strength(s): EQ 5MG BASE/5ML ^[RLD]

LEXAPRO (escitalopram oxalate - tablet; oral)

• 
  Manufacturer: FOREST LABS
  
  Approval date: August 14, 2002
  
  Strength(s): EQ 10MG BASE, EQ 20MG BASE ^[RLD], EQ 5MG BASE
  

Has a generic version of Lexapro been approved?

No. There is currently no therapeutically equivalent version of Lexapro available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lexapro. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Crystalline composition containing escitalopram
  Patent 6,916,941
  Issued: July 12, 2005
  Inventor(s): Christensen; Troels Volsgaard & Liljegren; Ken & Elema; Michiel Onne & Andresen; Lene & Mahashabde; Shashank & Assenza; Sebastian P.
  Assignee(s): H. Lundbeck A/S
  Crystalline particles of escitalopram oxalate with a particle size of at least 40 μm is disclosed. Method for the manufacture of said crystalline particles and pharmaceutical compositions comprising said crystalline particles are also disclosed.
  
  Patent expiration dates:
  
  
  • August 12, 2022
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  
  
  • February 12, 2023
    
    ✓ 
    Pediatric exclusivity
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    Drug substance
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• 
  Crystalline composition containing escitalopram
  Patent 7,420,069
  Issued: September 2, 2008
  Inventor(s): Christensen; Troels Volsgaard & Liljegren; Ken & Elema; Michiel Onne & Andresen; Lene & Mahashabde; Shashank & Assenza; Sebastian P.
  Assignee(s): H. Lundbeck A/S
  Crystalline particles of escitalopram oxalate with a particle size of at least 40 μm is disclosed. Method for the manufacture of said crystalline particles and pharmaceutical compositions comprising said crystalline particles are also disclosed.
  
  Patent expiration dates:
  
  
  • August 12, 2022
    
    ✓ 
    Drug product
  
  
  
  • February 12, 2023
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Pharmaceutically useful (+)-1-(3-dimethylaminopropyl)-1-(4'-fluorophenyl)-1,3-dihydroiso benzofuran-5-carbonitrile and non-toxic acid addition salts thereof
  Patent RE34712
  Issued: August 30, 1994
  Inventor(s): Boegesoe; Klaus P. & Perregaard; Jens K.
  Assignee(s): H. Lundbeck A/S
  The two enantiomers of the anti-depressant drug of the formula I ##STR1## are disclosed. Methods for resolving intermediates and their .[.steroselective.]. .Iadd.stereoselective .Iaddend.conversion to a corresponding .[.enatiomer.]. .Iadd.enantiomer .Iaddend.of I are also disclosed.
  
  Patent expiration dates:
  
  
  • September 14, 2011
    
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    ✓ 
    Drug product
  
  
  
  • March 14, 2012
    
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    Pediatric exclusivity
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • March 19, 2012 - NEW PATIENT POPULATION
  
  

See also...

• Lexapro Consumer Information (Drugs.com)
• Lexapro Consumer Information (Wolters Kluwer)
• Lexapro Solution Consumer Information (Wolters Kluwer)
• Lexapro Consumer Information (Cerner Multum)
• Lexapro Advanced Consumer Information (Micromedex)
• Lexapro AHFS DI Monographs (ASHP)
• Escitalopram Consumer Information (Wolters Kluwer)
• Escitalopram Solution Consumer Information (Wolters Kluwer)
• Escitalopram Consumer Information (Cerner Multum)
• Escitalopram Advanced Consumer Information (Micromedex)
• Escitalopram Oxalate AHFS DI Monographs (ASHP)

Disodium Edetate

Disodium Edetate may be available in the countries listed below.

Ingredient matches for Disodium Edetate

Edetic Acid

Disodium Edetate (BAN, JAN) is also known as Edetic Acid (Rec.INN)

International Drug Name Search

Glossary

BAN	British Approved Name
JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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