1. Name of The Medicinal Product

Nitrofurantoin Tablets 100mg Taj Pharma

  1. Qualitative and Quantitative Composition

Each Tablet contains:
Nitrofurantoin                    100mg
Excipients                              Q.S
Colour: Ferric Oxide Red & Titanium Dioxide

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Tablet.

  1. 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 due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.

4.2 Posology and method of administration

Posology

Adults

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

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

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

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

Paediatric population

Children and Infants over three months of age

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

Suppressive therapy: 1mg/kg/ once a day.

Elderly

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

Renal impairment

Nitrofurantoin is contraindicated in patients with renal dysfunction and in patients with an eGFR of less than 45 ml/minute (see sections 4.3 & 4.4).

Method of administration

For oral use. This medicine should always be taken with food or milk. Taking Nitrofurantoin with a meal improves absorption and is important for optimal efficacy.

4.3 Contraindications

Hypersensitivity to the active substance, other nitrofurans or to any of the excipients listed in section 6.1.

Patients suffering from renal dysfunction with an eGFR of less than 45 ml/minute.

G6PD deficiency (see also section 4.6)

Acute porphyria.

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 newborn infant due to immature erythrocyte enzyme systems.

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.

Nitrofurantoin may be used with caution as short-course therapy only for the treatment of uncomplicated lower urinary tract infection in individual cases with an eGFR between 30-44 ml/min to treat resistant pathogens, when the benefits are expected to outweigh the risks.

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 conditions of patients receiving long-term therapy is warranted (especially in the elderly).

Hepatotoxicity

Hepatic reactions, including hepatitis, autoimmune hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken.

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.

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

Tablets contain lactose

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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 sulfinpyrazone.
  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.
  7. As Nitrofurantoin belongs to the group of Antibacterials, it will have the following resulting interactions:
  • Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies with nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive clinical 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 the course of pregnancy. The drug should be used at the lowest dose as appropriate for the 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.

Breastfeeding

Breastfeeding an infant known or suspected to have an erythrocyte enzyme deficiency (including G6PD deficiency), must be temporarily avoided, 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

A tabulated list of undesirable effects is outlined below:

The undesirable effects are listed according to organ systems and following frequencies:

Rare (≥1/10,000 to <1/1,000)

Not known (cannot be estimated from the available data)

System organ classFrequencyAdverse reaction
Infections and infestationsNot knownSuperinfections by fungi or resistant organisms such as Pseudomonas. However, these are limited to the genitourinary tract
Blood and lymphatic system disordersRare

Not known

Aplastic anaemia

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia,glucose¬6- phosphate dehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia

Immune system disordersNot knownAllergic skin reactions, angioneurotic oedema and anaphylaxis
Psychiatric disordersNot knownDepression, euphoria, confusion, psychotic reactions
Nervous system disordersNot knownPeripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness.

Benign intracranial hypertension

Cardiac disordersRareCollapse and cyanosis
Respiratory, thoracic and mediastinal disordersNot knownAcute pulmonary reactions, Subacute pulmonary reactions*, Chronic pulmonary reactions, Cough, Dyspnoea, Pulmonary fibrosis; possible association with lupus-erythematous-like syndrome.
Gastrointestinal disordersNot knownSialadenitis, Pancreatitis, Nausea, Anorexia, Emesis, Abdominal pain and Diarrhea.
Hepatobiliary disordersNot knownCholestatic jaundice, Chronic active hepatitis (fatalities have been reported), Hepatic necrosis, autoimmune hepatitis
Skin and subcutaneous tissue disordersNot knownTransient alopecia

Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome), maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritus. Lupus-like syndrome associated with pulmonary reaction.

Drug Rash With Eosinophilia And Systemic Symptoms (DRESS syndrome), cutaneous vasculitis

Renal and urinary disordersNot knownYellow or brown discolouration of urine, interstitial nephritis
General disorders and administration site conditionsNot knownAsthenia, fever, chills, drug fever and arthralgia
InvestigationsNot knownFalse positive urinary glucose

*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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Symptoms

Symptoms and signs of overdose include gastric irritation, nausea and vomiting.

Management

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.

  1. Pharmacological Properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, nitrofurantoin derivatives

Mechanism of action

Nitrofurantoin 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

Absorption

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.

Elimination

Maximum urinary excretion usually occurs 2-4 hours after administration of Nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained. It has an elimination half-life of about 30 minutes.

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 suggestion.

  1. Pharmaceutical particulars

6.1 List of excipients

Lactose, Maize starch, Pregelatinised maize starch, Sodium starch glycollate, Magnesium stearate & Purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25˚C. Store in the original package. Keep blister in the outer carton/keep container tightly closed.

6.5 Nature and contents of container

Available in PVC Aluminium Blister Pack.

Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000

6.6 Special precautions for disposal and other handling

None

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

Nitrofurantoin Tablets 100mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nitrofurantoin 50mg & 100mg Tablets

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Nitrofurantoin Tablets are and what they are used for
    2. What you need to know before you take Nitrofurantoin Tablets
    3. How to take Nitrofurantoin Tablets
    4. Possible side effects
    5. How to store Nitrofurantoin Tablets
    6. Contents of the pack and other information

 

  1. What Nitrofurantoin Tablets are and what they are used for

Nitrofurantoin (the active ingredient) is an antibiotic.

It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.

You must talk to your doctor if you do not feel better or if you feel worse.

  1. What you need to know before you take Nitrofurantoin Tablets

Do not take Nitrofurantoin Tablets if:

  • you are allergic to Nitrofurantoin, other medicines containing nitrofurantoin or any of the other ingredients (listed in Section 6)
  • you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure)
  • you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby
  • you have porphyria (blood disorder)
  • you are a patient with G6PD (glucose-6-phosphate dehydrogenase) deficiency
  • your child is under three months of age
  • you are breast-feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate-dehydrogenase).

Tell your doctor if you are not sure about any of the above.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Nitrofurantoin tablets if:

  • you have diabetes
  • you are suffering from any illness causing severe weakness
  • you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness) or a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you)
  • you have a history of allergic reactions
  • if you have any problems with your kidneys.

The above conditions may increase the chance of developing a side effect which results in damage to the nerves, causes altered sense of feeling like pins and needles.

  • you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin. Your doctor will know)
  • you have any disease of the lungs, liver or nervous system. If you need to take Nitrofurantoin Tablets for a number of months, your doctor may want to regularly check how your lungs and liver are working
  • you have false positive results on testing your urine for glucose
  • your urine is dark yellow or brown coloured.

Talk to your doctor if you experience fatigue, yellowing of the skin or eyes, itching skin rashes, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine and pale or grey coloured stools. It may be symptoms of liver disorder.

Other medicines and Nitrofurantoin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. If they are taken with Nitrofurantoin Tablets their effect or the effect of Nitrofurantoin Tablets may be changed.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • Antacids for indigestion (e.g. magnesium trisilicate)
  • Medicines for gout (e.g. probenecid or sulfinpyrazone)
  • Medicines which slow the passage of food through the stomach (e.g. atropine, hyoscine)
  • Medicines for raised pressure in the eye (glaucoma) such as carbonic anhydrase inhibitors (e.g. acetazolamide)
  • Medicines which make the urine less acidic (e.g. potassium citrate mixture)
  • Medicines for infections, known as quinolones
  • Typhoid vaccine, which is given for the prevention of typhoid.

If you are in doubt about any of these medicines ask your doctor or pharmacist.

Nitrofurantoin may interfere with the results of some tests for glucose in the urine.

Nitrofurantoin Tablets with food and drink

Nitrofurantoin tablets should always be taken with food or milk. This will help to avoid stomach upset and also help the absorption to make the medicine work more effectively.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. As far as is known Nitrofurantoin Tablets may be used in pregnancy. However, it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby. If you want to breastfeed, please consult your doctor first.

Driving and using machines

Nitrofurantoin Tablets may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

Nitrofurantoin Tablets contain lactose

This medicine contains lactose (sugars). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  1. How to take Nitrofurantoin Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults:

The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear. The usual doses are:

  • For treatment of infections: Either one 50mg tablet or one 100mg tablet four times a day for seven days.
  • For prevention of further infections: Either one 50mg tablet or one 100mg tablet at bedtime.
  • For prevention of infections during surgery: One 50mg tablet four times a day on the day of the operation and three days thereafter.

Use in Children:

Children over three months of age:

The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instructions exactly.

Children below 3 months of age should not take Nitrofurantoin Tablets.

Medical Checks

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.

Nitrofurantoin Tablets may interfere with the results of some tests for glucose in the urine.

Method of administration

Tablets should be swallowed whole. The score line is not intended for breaking the tablet.

Nitrofurantoin tablets should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.

If you TAKE MORE Nitrofurantoin Tablets than you should

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any leftover tablets with you, as well as the container and label, so that the medical staff know what you have taken. You may experience symptoms of stomach ache, nausea and vomiting.

If you FORGET TO TAKE Nitrofurantoin Tablets

Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose on the next day.

Do not take a double dose to make up for a forgotten dose. If you are not sure ask your doctor or pharmacist.

If you STOP TAKING Nitrofurantoin Tablets

Your doctor will tell you how long to take the treatment. Do not stop earlier than you are told, even if you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Nitrofurantoin Tablets.

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.

If you experience any of the side effects detailed below stop taking Nitrofurantoin Tablets and consult your doctor.

  • your lungs may react to Nitrofurantoin Tablets. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce fever, chills, cough and shortness of breath
  • jaundice (inflammation of the liver causing yellowing of the skin or whites of the eyes)
  • the nerves outside of the spinal cord may be affected causing changes to the sense of feeling and the use of muscles. In addition headache, extreme changes of mood or mental state, confusion, weakness, blurred vision may occur. These effects may be severe and in some instances permanent
  • raised pressure in the skull (causing severe headaches)
  • severe reduction in blood cells which can cause weakness, bruising or make infections more likely
  • blue or purple coloration of the skin due to low oxygen levels. A condition known as cyanosis
  • symptoms of fever, flu, abdominal pain, diarrhoea, blood in your stool and weakness. These could be signs of a condition known as cutaneous vasculitis
  • symptoms of jaundice, fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as autoimmune hepatitis

Please note that while taking Nitrofurantoin Tablets your urine may become coloured dark yellow or brown. This is quite normal and not a reason to stop taking the medicine.

Other side effects include:

Rare (may affect up to 1 in 1,000 people)

  • loss of consciousness (collapse).

Not known (frequency cannot be estimated from the available data)

  • feeling sick (nausea) and headache
  • loose stools
  • loss of appetite, stomach ache and being sick (vomiting)
  • diarrhoea
  • dizziness, drowsiness
  • sensation that you or your environment are moving or spinning (vertigo)
  • unusual eye movements (nystagmus)
  • blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia and a susceptibility to colds or persistent cold
  • a variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash or fever accompanied by rapid heart rate and severe rash with blistering. Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas gland (causing severe abdominal pain) and joint pains
  • short-term hair loss
  • urinary infection by germs which are not sensitive to Nitrofurantoin Tablets
  • inflammation of small blood vessel walls, causing skin lesions
  • liver inflammation due to turn of immune system against liver cells
  • inflammation of kidney tissue surrounding tubules, causing renal impairment

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. How to store Nitrofurantoin Tablets

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

Do not open the container until you are ready to begin taking the course of treatment.

Do not use this medicine after the expiry date which is stated on the bottle/label after ‘Exp (MM/YY)’. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Nitrofurantoin Tablets contain

The active substance (which makes the medicine work) is Nitrofurantoin.

Each Tablet contains:
Nitrofurantoin                    100mg
Excipients                              Q.S
Colour: Ferric Oxide Red & Titanium Dioxide

The other ingredients are: lactose, maize starch, pregelatinised maize starch, sodium starch glycollate and magnesium stearate.

What Nitrofurantoin Tablets look like and contents of the pack

Available in PVC Aluminium Blister Pack.

Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com