- Approval Id
- 2e8b27fffdd91ec4
- Drug Approval Emc Name
- Nitrofurantoin 50 mg Tablets
- Drug Name
- Nitrofurantoin 50 mg Tablets
- Company Name
- Dr. Reddy's Laboratories (UK) Ltd
- Company Address
- Dr. Reddy's Laboratories (UK) Limited, 410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, UK
- Company Website
- http://www.drreddys.com/united-kingdom
- Company Telephone
- +44 (0)1223 728 010
- Company Medical Info Direct Line
- +44 (0)1748 828 873
- Company Medical Info Email
- drreddysgb@eu.propharmagroup.com
- Company Customer Care Direct Line
- +44 (0)1223 651 475
- Atc Code
- J01XE01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Dr. Reddy's Laboratories (UK) Ltd,
410 Cambridge Science Park,
Milton Road,
Cambridge,
CB4 0PE,
United Kingdom
- Authorisation Number
- 08553/0087
- Authorisation Date
- 24/10/2024
- Instruction Authorisation Holder
- Dr. Reddy's Laboratories (UK) Ltd,
410 Cambridge Science Park,
Milton Road,
Cambridge,
CB4 0PE,
United Kingdom
- Instruction Authorisation Number
- 08553/0087
- Instruction Authorisation Date
- 24/10/2024
- Instruction Composition
- Nitrofurantoin 50.00 mg
For the full list of excipients see section 6.1.
- Instruction Dosage Form
- Tablet to be taken orally.
Flat yellow, bevelled and scored tablets.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the treatment of and prophylaxis against acute of 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
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.
\*\*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.
\*\*Pulmonary adverse reactions\*\*
Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately. Signs of pulmonary damage include difficulty and or pain when breathing, shortness of breath and coughing up blood or mucus.
\*\*Chronic pulmonary reactions\*\*
Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously and can often occur in elderly patients. Close monitoring of the lung disease of patients receiving long-term therapy is indicated (especially in the elderly).
\*\*Acute pulmonary reactions\*\*
Pulmonary reactions may be acute and usually occur within the first week of treatment. Increased vigilance for respiratory symptoms in patients who have just started therapy is warranted (especially in the elderly).
Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.
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.
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 (paraesthesia).
Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.
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 dehydrogenase deficiency.
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.
Breast-feeding
Breast-feeding 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 class | Frequency | Adverse reaction |
| Infections and infestations | Not known | Superinfections by fungi or resistant organisms such as Pseudomonas. However, these are limited to the genitourinary tract |
| Blood and Lymphatic system disorders | Rare Not known | Aplastic anaemia Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, glucose¬6- phosphate dehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia |
| Immune system disorders | Not known | Allergic skin reactions, angioneurotic oedema and anaphylaxis |
| Psychiatric disorders | Not known | Depression, euphoria, confusion, psychotic reactions |
| Nervous system disorders | Not known | Peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness. Benign intracranial hypertension |
| Cardiac disorders | Rare | Collapse and cyanosis |
| Respiratory, thoracic and mediastinal disorders | Not known | Acute pulmonary reactions, Subacute pulmonary reactions\\*, Chronic pulmonary reactions, Cough, Dyspnoea, Pulmonary fibrosis; possible association with lupus- erythematous-like syndrome. |
| Gastrointestinal disorders | Not known | Sialadenitis, Pancreatitis, Nausea, Anorexia, Emesis, Abdominal pain and Diarrhea. |
| Hepatobiliary disorders | Not known | Cholestatic jaundice, Chronic active hepatitis (fatalities have been reported), Hepatic necrosis, autoimmune hepatitis |
| Skin and subcutaneous tissue disorders | Not known | Transient 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 disorders | Not known | Yellow or brown discolouration of urine, interstitial nephritis |
| General disorders and administration site conditions | Not known | Asthenia, fever, chills, drug fever and arthralgia |
| Investigations | Not known | False positive urinary glucose |
\\*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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA yellow card scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, nitrofurantoin derivatives
ATC code: J01XE01
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.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Lactose
Maize starch
Pregelatinised maize starch
Sodium starch glycollate
Magnesium stearate
Purified water6.2 Incompatibilities
None stated.6.3 Shelf life
36 months6.4 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
High density polystyrene containers with polythene lids and/or polypropylene containers with polypropylene or polythene lids.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000
250 micron, pharmaceutical grade, green rigid PVC
20 micron, hard-tempered aluminium foil, coated on the dull side with 6-7 gsm heat-seal lacquer and printed on the bright side.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 10006.6 Special precautions for disposal and other handling
None
- Instruction Content
- ## Composition
Nitrofurantoin 50.00 mg
For the full list of excipients see section 6.1.
## Pharmaceutical Form
Tablet to be taken orally.
Flat yellow, bevelled and scored tablets.
## Clinical Particulars
4.1 Therapeutic indications
For the treatment of and prophylaxis against acute of 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
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.
\*\*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.
\*\*Pulmonary adverse reactions\*\*
Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately. Signs of pulmonary damage include difficulty and or pain when breathing, shortness of breath and coughing up blood or mucus.
\*\*Chronic pulmonary reactions\*\*
Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously and can often occur in elderly patients. Close monitoring of the lung disease of patients receiving long-term therapy is indicated (especially in the elderly).
\*\*Acute pulmonary reactions\*\*
Pulmonary reactions may be acute and usually occur within the first week of treatment. Increased vigilance for respiratory symptoms in patients who have just started therapy is warranted (especially in the elderly).
Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.
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.
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 (paraesthesia).
Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.
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 dehydrogenase deficiency.
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.
Breast-feeding
Breast-feeding 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 class | Frequency | Adverse reaction |
| Infections and infestations | Not known | Superinfections by fungi or resistant organisms such as Pseudomonas. However, these are limited to the genitourinary tract |
| Blood and Lymphatic system disorders | Rare Not known | Aplastic anaemia Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, glucose¬6- phosphate dehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia |
| Immune system disorders | Not known | Allergic skin reactions, angioneurotic oedema and anaphylaxis |
| Psychiatric disorders | Not known | Depression, euphoria, confusion, psychotic reactions |
| Nervous system disorders | Not known | Peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness. Benign intracranial hypertension |
| Cardiac disorders | Rare | Collapse and cyanosis |
| Respiratory, thoracic and mediastinal disorders | Not known | Acute pulmonary reactions, Subacute pulmonary reactions\\*, Chronic pulmonary reactions, Cough, Dyspnoea, Pulmonary fibrosis; possible association with lupus- erythematous-like syndrome. |
| Gastrointestinal disorders | Not known | Sialadenitis, Pancreatitis, Nausea, Anorexia, Emesis, Abdominal pain and Diarrhea. |
| Hepatobiliary disorders | Not known | Cholestatic jaundice, Chronic active hepatitis (fatalities have been reported), Hepatic necrosis, autoimmune hepatitis |
| Skin and subcutaneous tissue disorders | Not known | Transient 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 disorders | Not known | Yellow or brown discolouration of urine, interstitial nephritis |
| General disorders and administration site conditions | Not known | Asthenia, fever, chills, drug fever and arthralgia |
| Investigations | Not known | False positive urinary glucose |
\\*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. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA yellow card scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, nitrofurantoin derivatives
ATC code: J01XE01
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.
## Pharmaceutical Particulars
6.1 List of excipients
Lactose
Maize starch
Pregelatinised maize starch
Sodium starch glycollate
Magnesium stearate
Purified water6.2 Incompatibilities
None stated.6.3 Shelf life
36 months6.4 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
High density polystyrene containers with polythene lids and/or polypropylene containers with polypropylene or polythene lids.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000
250 micron, pharmaceutical grade, green rigid PVC
20 micron, hard-tempered aluminium foil, coated on the dull side with 6-7 gsm heat-seal lacquer and printed on the bright side.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500 & 10006.6 Special precautions for disposal and other handling
None
