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Bumetanide is indicated for the treatment of edema associated with- Congestive heart failure, Hepatic ascites and, Renal disease including the nephrotic syndrome

Loop diuretics

Bumetanide is a loop diuretic of the sulfamyl category to treat heart failure. It is often used in patients in whom high doses of furosemide are ineffective. There is however no reason not to use bumetanide as a first choice drug. The main difference between the two substances is in bioavailability. It is said to be a more predictable diuretic, meaning that the predictable absorption is reflected in a more predictable effect. Bumetanide is 40 times more potent than furosemide (for patients with normal renal function).

Bumetanide interferes with renal cAMP and/or inhibits the sodium-potassium ATPase pump. Bumetanide appears to block the active reabsorption of chloride and possibly sodium in the ascending loop of Henle, altering electrolyte transfer in the proximal tubule. This results in excretion of sodium, chloride, and water and, hence, diuresis.

Oral: 1 mg in the morning , repeated after 6-8 hours if necessary, In severe cases , 5 mg daily increased by 5 mg every 12-24 hours according to response. Elderly , 500 micrograms daily may be sufficient.

Parenteral:

• By IV Injection: 1-2 mg, repeated after 20 minutes if necessary. Elderly, 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
• By IV Infusion: 2-5 mg over 30-60 minutes.Elderly, 500 micrograms (1 ml of Bumetanide) daily may be sufficient.
• By IM Injection: 1 mg initially then adjusted according to response , Elderly 500 micrograms (1 ml of Bumetanide) daily may be sufficient.

The side effects of Bumetanide include: headache, dizziness, fatigue, postural hypotension and gastrointestinal symptoms. Various skin reactions, photosensitivity reactions and metabolic disturbances, including reduced glucose tolerance are less frequent. Electrolyte disturbances can occur especially during long term treatment.

Loop diuretics should be avoided in severe hypokalaemia, severe hyponatraemia, anuria, comatose and precomatose states associated with liver cirrhosis and in renal failure.

Serum potassium should be measured periodically and potassium supplements or potassium sparing diuretics added if necessary.

Concomitant use of Bumetanide may potentiate the effects of antihypertensive drugs. It shows a tendency to increase the excretion of potassium which can lead to an increase in the sensitivity of the myocardium to the toxic effects of digitalis. As with other diuretics, Bumetanide may cause an increase in blood uric acid.

Pregnancy Category C. There are no adequate and well controlled studies in pregnant woman. It is not known wheather this drug is excreted in human milk.

Paediatric use: Safety and effectiveness in paediatric patients below the age of 18 have not been established.

Symptoms would be those caused by excessive diuresis. Empty stomach by gastric lavage or emesis.

Store in a cool & dry place. Protect from light.

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Use of Tamsulosin in pregnancy and lactation is not recommended.

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Store in a cool and dry place, below 30°C, protected from light.

Tamsulosin Hydrochloride & Dutasteride capsule is indicated in-

• Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
• Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH.

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin & Dutasteride is a combination of two drugs with complementary mechanisms of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH). Tamsulosin Hydrochloride, an antagonist of alpha_1A-adrenoreceptors and Dutasteride, a dual 5 alpha reductase inhibitor (5ARI). Treatment of BPH with alpha₁-adrenoreceptor blocking agents and 5ARIs results in an improvement in urine flow rate and a reduction in symptoms of BPH.

Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha₁-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha _1A and alpha _1D receptors over the alpha_1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha₁-receptors in human prostate are of the alpha _1A subtype, the human bladder contains predominantly the alpha _1D subtype while blood vessels express predominantly alpha _1B subtype. It is further believed that blockade of the alpha _1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.

Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.

Adults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.

Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.

Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.

The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness. The percentages of subjects with ejaculation disorders, decreased libido and impotence were higher in the combination therapy group compared with either monotherapy groups.

Tamsulosin-Dutasteride combination is contra-indicated in women and children and adolescents, patients with hypersensitivity to Dutasteride, other 5-alpha reductase inhibitors, Tamsulosin (including Tamsulosin- induced angio-edema), soya, peanut or any of other the excipients, patients with a history of orthostatic hypotension and patients with severe hepatic impairment.

Combination therapy should be prescribed after careful benefit risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.

Cardiac failure: In two 4-year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of Dutasteride and an alpha blocker, primarily Tamsulosin, than it was among subjects not taking the combination. In these two trials, the incidence of cardiac failure was low (1%) and variable between the studies.

Effects on prostate specific antigen (PSA) and prostate cancer detection: Digital rectal examination, as well as other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH, must be performed on patients prior to initiating therapy with Tamsulosin-Dutasteride combination and periodically thereafter. Serum prostate-specific antigen (PSA) concentration is an important component in the detection of prostate cancer. Tamsulosin-Dutasteride combination causes a decrease in mean serum PSA levels by approximately 50%, after 6 months of treatment. Patients receiving Tamsulosin-Dutasteride combination should have a new PSA baseline established after 6 months of treatment. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on Tamsulosin-Dutasteride combination may signal the presence of prostate cancer or noncompliance to therapy with Tamsulosin-Dutasteride combination and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5 alpha-reductase inhibitor. In the interpretation of a PSA value for a patient taking Tamsulosin-Dutasteride combination, previous PSA values while on Dutasteride treatment should be sought for comparison. Treatment with Tamsulosin-Dutasteride combination does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established. Total serum PSA levels return to baseline within 6 months of discontinuing treatment. The ratio of free to total PSA remains constant even under the influence of Tamsulosin-Dutasteride combination. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Tamsulosin-Dutasteride combination therapy, no adjustment to its value appears necessary.

Prostate cancer and high grade tumours: Results of one clinical study in men at increase risk of prostate cancer revealed a higher incidence of Gleason 8-10 prostate cancers in Dutasteride treated men compared to placebo. The relationship between Dutasteride and high grade prostate cancer is not clear. Men taking Tamsulosin-Dutasteride combination should be regularly evaluated for prostate cancer risk including PSA testing.

Renal impairment: The treatment of severely renally impaired patients (creatinine clearance of less than 10 ml/min) should be approached with caution as these patients have not been studied.

Hypotension: Orthostatic- As with other alpha-blockers, a reduction in blood pressure can occur during treatment with Tamsulosin, as a result of which, rarely, syncope can occur. Patients beginning treatment with Tamsulosin-Dutasteride combination should be cautioned to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved. In order to minimize the potential for developing postural hypotension the patient should be haemodynamically stable on alpha-blocker therapy prior to initiating use of PDE5 inhibitors. Symptomatic: Caution is advised when alpha adrenergic blocking agents including Tamsulosin are coadministered with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil). Alpha adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.

Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with Tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with Tamsulosin-Dutasteride combination in patients for whom cataract surgery is scheduled is therefore not recommended. Discontinuing Tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established. Leaking Capsule: Dutasteride is absorbed through the skin, therefore, women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.

Hepatic impairment: Tamsulosin-Dutasteride combination has not been studied in patients with liver disease. Caution should be used in the administration of Tamsulosin-Dutasteride combination to patients with mild to moderate hepatic impairment.

Breast neoplasia: Breast cancer has been reported in men taking Dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of Dutasteride.

There have been no drug interaction studies for Dutasteride-Tamsulosin combination.

Effects of other drugs on the pharmacokinetics of Dutasteride: Use together with CYP3A4 and/or P-glycoprotein-inhibitors: Dutasteride is mainly eliminated via metabolism. In vitro studies indicate that this metabolism is catalysed by CYP3A4 and CYP3A5. No formal interaction studies have been performed with potent CYP3A4 inhibitors. However, in a population pharmacokinetic study, Dutasteride serum concentrations were on average 1.6 to 1.8 times greater, respectively, in a small number of patients treated concurrently with verapamil or diltiazem (moderate inhibitors of CYP3A4 and inhibitors of P-glycoprotein) than in other patients. Long-term combination of Dutasteride with drugs that are potent inhibitors of the enzyme CYP3A4 (e.g. ritonavir, indinavir, nefazodone, itraconazole, ketoconazole administered orally) may increase serum concentrations of Dutasteride. Further inhibition of 5-alpha reductase at increased Dutasteride exposure, is not likely. However, a reduction of the Dutasteride dosing frequency can be considered if side effects are noted. It should be noted that in the case of enzyme inhibition, the long half-life may be further prolonged and it can take more than 6 months of concurrent therapy before a new steady state is reached. Administration of 12 g cholestyramine one hour after a 5 mg single dose of Dutasteride did not affect the pharmacokinetics of Dutasteride.

Effects of Dutasteride on the pharmacokinetics of other drugs: In a small study (N=24) of two weeks duration in healthy men, Dutasteride (0.5 mg daily) had no effect on the pharmacokinetics of Tamsulosin or terazosin. There was also no indication of a pharmacodynamic interaction in this study. Dutasteride has no effect on the pharmacokinetics of warfarin or digoxin. This indicates that Dutasteride does not inhibit/induce CYP2C9 or the transporter P-glycoprotein. In vitro interaction studies indicate that Dutasteride does not inhibit the enzymes CYP1A2, CYP2D6, CYP2C9, CYP2C19 or CYP3A4. Tamsulosin: Concomitant administration of Tamsulosin Hydrochloride with drugs which can reduce blood pressure, including anaesthetic agents, PDE5 inhibitors and other alpha-1 adrenergic blockers could lead to enhanced hypotensive effects. Tamsulosin-Dutasteride should not be used in combination with other alpha-1 adrenergic blockers. Concomitant administration of Tamsulosin Hydrochloride (0.4 mg) and cimetidine (400 mg every six hours for six days) resulted in a decrease in the clearance (26%) and an increase in the AUC (44%) of Tamsulosin Hydrochloride. Caution should be used when Tamsulosin-Dutasteride is used in combination with cimetidine. A definitive drug-drug interaction study between Tamsulosin Hydrochloride and warfarin has not been conducted. Results from limited in vitro and in vivo studies are inconclusive. Caution should be exercised with concomitant administration of warfarin and Tamsulosin Hydrochloride. No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant furosemide brings about a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be adjusted. In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide and simvastatin change the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions, involving amitriptyline, salbutamol and glibenclamide. Diclofenac however, may increase the elimination rate of Tamsulosin.

Tamsulosin-Dutasteride combination is contra-indicated for use by women. There have been no studies to investigate the effect of Tamsulosin-Dutasteride combination on pregnancy, lactation and fertility. The following statements reflect the information available from studies with the individual components. Fertility: Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded. Effects of Tamsulosin Hydrochloride on sperm counts or sperm function have not been evaluated.

Pregnancy: As with other 5 alpha reductase inhibitors, Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus. Small amounts of Dutasteride have been recovered from the semen in subjects receiving Dutasteride. It is not known whether a male foetus will be adversely affected if his mother is exposed to the semen of a patient being treated with Dutasteride. As with all 5 alpha reductase inhibitors, when the patient’s partner is or may potentially be pregnant it is recommended that the patient avoids exposure of his partner to semen by use of a condom. Administration of Tamsulosin Hydrochloride to pregnant female rats and rabbits showed no evidence of foetal harm.

Lactation: It is not known whether Tamsulosin or Dutasteride are excreted in human milk.

No data are available with regard to over dosage of Tamsulosin-Dutasteride combination. The following statements reflect the information available on the individual components.

Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride, therefore, in suspected over dosage symptomatic and supportive treatment should be given as appropriate.

Tamsulosin: Acute overdose with 5 mg Tamsulosin Hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after over dosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Store in a cool and dry place, protected from light.

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Use of Tamsulosin in pregnancy and lactation is not recommended.

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Store in a cool and dry place, below 30°C, protected from light.

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

An advanced blend of minerals & herbs that can help a proactive approach to prostate health. Saw palmetto supports normal prostate function and healthy urinary flow. It contains Zinc which is required for normal reproductive function.

Herbal and Nutraceuticals

Saw Palmetto exerts anti-estrogenic activity, increases urinary fow rate; decreases residual urine; decreases painful urination; decreases nocturia; anti-infammatory activities by following possible mechanisms:

• Inhibits action of 5α-reductase, which catalyzes the metabolism of testosterone to DHT, due to the free fatty acid content of the fruit’s lipophilic extracts.
• Inhibits receptor binding of androgens.
• Inhibits noncompetitively human α 1-adrenoreceptors.
• Inhibits both the cyclooxygenase and lipoxygenase pathways in vitro
• Inhibits growth factors in vitro
• Binds selectively to and increases apoptotic index for prostate cells

For Adult use only. Usual dosage is 1-2 capsules daily or as advised by the physician.

Rare case of GI disturbance has been reported. Ingestion on an empty stomach may cause nausea. Hypertension was reported in 3.1% taking saw palmetto extract.

Saw palmetto is not indicated for advanced BPH with severe urinary retention. It should not be used without frst ruling out prostate cancer.

Saw palmetto might slow blood clotting. There is some concern that it might cause extra bleeding during and after surgery. Stop using saw palmetto at least 2 weeks before a scheduled surgery.

Saw palmetto might decrease the efects of estrogen in the body. Taking saw palmetto along with birth control pills might decrease the efectiveness of birth control pills.

Safety and efectiveness of Saw palmetto in pediatric population have not been established.

Store in a cool and dry place, below 30°C. Protect from light & moisture. Keep the medicine out of reach of children.

Flavoxate is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis and urethrocystitis.

BPH/ Urinary retention/ Urinary incontinence

Flavoxate acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

Adults and children over 12 years of age: 100 mg to 200 mg 3 times a day. With improvement of symptoms, the dose may be reduced.

Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (which is reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Flavoxate is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Flavoxate should be given cautiously in patients with suspected glaucoma

Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be exercised when flavoxate is administered to a nursing woman.

Store Flavoxate at room temperature, between 20 and 25 degrees C

Flavoxate is indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis and urethrocystitis.

BPH/ Urinary retention/ Urinary incontinence

Flavoxate acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, urge incontinence episodes, urge severity and improving retention, facilitating increased volume per void.

Adults and children over 12 years of age: 100 mg to 200 mg 3 times a day. With improvement of symptoms, the dose may be reduced.

Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (which is reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Flavoxate is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

Flavoxate should be given cautiously in patients with suspected glaucoma

Pregnancy: Pregnancy Category B. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be exercised when flavoxate is administered to a nursing woman.

Store Flavoxate at room temperature, between 20 and 25 degrees C

This preparation is indicated in the following cases:

• To relieve discomfort in urinary tract infections
• To prevent kidney stone
• With uricosuric agent to prevent gout
• Acidosis caused by kidney diseases

Prevention of repeated kidney stone formation, Urinary Alkalinizing Agent

Potassium Citrate and Citric Acid oral solution is a stable and pleasant-tasting oral systemic alkalizer. Potassium Citrate is absorbed and metabolized to Potassium Bicarbonate, thus acting as a systemic alkalizer. This product alkalinizes the urine without producing a systemic alkalosis in recommended doses. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium Citrate does not neutralize the gastric juice or disturb digestion.

To relieve discomfort in UTI:

• Adults and children over 6 years: 10 ml 3 times daily, diluted with 1 glass of water.
• Children 1-6 years: 5 ml 3 times daily, diluted with ½ glass of water.

To prevent kidney stones, With a uricosuric agent to prevent gout, Acidosis caused by kidney diseases:

• Adults: 10-15 ml 4 times daily (or as directed by the physician) diluted with 1 glass of water.
• Pediatric: 5-10 ml 4 times daily (or as directed by the physician) diluted with ½ glass of water.

This solution is generally well tolerated without any unpleasant side effect when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities and other symptoms associated with a high concentration of Potassium in the serum.

The drug is contraindicated in severe renal impairment with oliguria or azotemia, untreated Addison's disease, acute dehydration, severe myocardial damage and hyperkalemia from any cause.

The solution should be used with caution in patients with low urinary output. It should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated Potassium salt preparations; and preferably, to take each dose after meals. Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors or cardiac glycosides may lead to toxicity.

No information is available regarding the use of this drug during pregnancy and lactation.

The administration of oral Potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result. Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours. If hyperkalemia occurs, treatment measures will include the followings: (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 ml/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20 gm dextrose. (3) The use of exchange resins, hemodialysis or peritoneal dialysis.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Drugs used in Gout

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Drugs used in Gout

Febuxostat is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Febuxostat is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Febuxostat 80 mg is recommended. Febuxostat can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febuxostat to patients with mild to moderate renal or hepatic impairment.

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, and rash.

Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients. Monitor liver function tests periodically.

Concomitant administration of Febuxostat with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Febuxostat is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established

Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alfuzosin Hydrochloride is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia(BPH), lower urinary tract symptoms (LUTS) including urinary frequency, nocturia, incomplete emptying and urinary hesitancy associated with BPH.

BPH/ Urinary retention/ Urinary incontinence

Alfuzosin Hydrochloride is a selective antagonist of post-synaptic a1 adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. Alfuzosin Hydrochloride relaxes the tone of the prostate smooth muscle, prostate capsule, bladder neck and proximal urethra. It competitively and selectively binds to the post synaptic a1-adrenergic receptors in the lower urinary tract. It also relaxes sympathetic nervous stimulation, reduces resting urethral pressure and inhibits urethral hypertonia-induced sympathetic nervous stimulation. As an uroselective agent, Alfuzosin Hydrochloride preferentially binds to prostatic a1 receptors, blockage of these receptors result in reduction of BPH symptoms, improvement of urine flow and decreased potential for hypertensive events.

Benign prostatic hyperplasia (BPH): The recommended dose is 10 mg to be taken once daily after a meal.

Acute urinary retention (AUR): In patients 65 years and older, 10 mg  daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.

Alfuzosin Hydrochloride tablet should be swallowed whole.

Classification of expected frequencies: Very common (<1/10), common (<1/100 to <1/10), uncommon (<1/1,000 to <1/100), rare (<1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Nervous system disorders: Common: faintness/dizziness, headache; Uncommon: syncope, vertigo, malaise, drowsiness. Eye disorders: Uncommon: vision abnormal; Not known: intraoperative floppy iris syndrome. Cardiac disorders: Uncommon: tachycardia, palpitations, hypotension (postural); Very rare: New onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease; Not known: atrial fibrillation. Vascular disorders: Uncommon: hypotension (postural), flushing. Blood and lymphatic system disorders: Not known: neutropenia, thrombocytopenia. Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis. Gastro-intestinal disorders: Common: nausea, abdominal pain; Uncommon: diarrhoea, dry mouth, vomiting; Not known: vomiting. Hepatobiliary disorders: Frequency unknown: hepatocellular injury, cholestatic liver disease. Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus; Very rare: urticaria, angioedema. Reproductive system and breast disorders: Frequency unknown: priapism. General disorders and administration site conditions: Common: asthenia; Uncommon: flushes, oedema, chest pain.

As with all alpha-1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. The patient should be warned of the possible occurrence of such events. As with all alpha1-receptor blockers, Alfuzosin Hydrochloride should be used with caution in patients with acute cardiac failure. Care should be taken when Alfuzosin Hydrochloride is administered to patients who have had a pronounced hypotensive response to another alpha-1-blocker. Treatment should be initiated gradually in patients with hypersensitivity to alpha-1-blockers. Alfuzosin Hydrochloride should be administered carefully to patients being treated with antihypertensives. Blood pressure should be monitored regularly, especially at the beginning of treatment. Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of Alfuzosin Hydrochloride. In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens Alfuzosin Hydrochloride should be discontinued.  As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), Alfuzosin Hydrochloride 10mg prolonged released tablets should not be administered to this patient group. Patients should be warned that the tablet should be swallowed whole. Any other mode of administration, such as crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to inappropriate release and absorption of the drug and therefore possible early adverse reactions. The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with alpha-1-blockers. Although the risk of this event with Alfuzosin Hydrochloride appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha-1-blockers, as IFIS may lead to increased procedural complications. The ophthalmologists should be prepared for possible modifications to their surgical technique. Alfuzosin Hydrochloride 10mg prolonged release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.

The administration of general anesthetics to patients receiving Alfuzosin could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery. If symptoms of angina pectoris start or get worse, taking Alfuzosin should be stopped.

Combinations contra-indicated: Alpha-1-receptor blockers. Combinations to be taken into account: Antihypertensive drugs, nitrates, potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir. Repeated 200mg daily dosing of ketoconazole, for seven days resulted in a 2.1-fold increase in Cmax and a 2.5-fold increase in exposure of Alfuzosin Hydrochloride 10mg when administered as a single dose under fed conditions (high fat meal). Other parameters such as tmax and t1/2 were not modified. Cmax and AUC of Alfuzosin Hydrochloride 10mg, when administered as a single dose under fed conditions, increased 2.3- fold and 3.0- fold, respectively following 8-day repeated 400mg ketoconazole daily dosing. The administration of general anaesthetics to patients receiving Alfuzosin Hydrochloride could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery.

Other forms of interaction: No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between Alfuzosin Hydrochloride and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.

Paediatric Population: Efficacy of Alfuzosin Hydrochloride has not been demonstrated in children aged 2 to 16 years. Therefore Alfuzosin Hydrochloride is not indicated for use in the paediatric population.

In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place. In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on vascular muscle fibres.

Store in a cool and dry place, protected from light

Tolterodine Tartrate is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

BPH/ Urinary retention/ Urinary incontinence

Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.

The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.

Tolterodine may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.

Tolterodine is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug.

Tolterodine should be used with caution in the following patients:

• at risk for urinary retention
• at risk for decreased gastrointestinal motility
• with impaired renal function
• with impaired hepatic function

Organic reasons for urge and frequency should be considered before treatment.

Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.

Ketoconazole, a potent inhibitor of CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway).

Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyloestradiol or levonorgestrel).

There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.

Pediatric use: Safety and effectiveness of tolterodine in children have not been established.

Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tolterodine.

Overdosage with Tolterodine Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.

Store in a cool and dry place. Protect from light. Keep out of the reach of children.

Tolterodine Tartrate is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

BPH/ Urinary retention/ Urinary incontinence

Tolterodine is a competitive, specific muscarinic receptor antagonist which exhibits a selectivity for the urinary bladder over salivary glands, which have been demonstrated in non clinical pharmacological in vivo studies. Tolterodine has a high specificity for muscarinic receptors. A major active metabolite (5-hydroxymethyl derivative) of tolterodine exhibits a pharmacological profile which is similar to that of the parent compound. In extensive metabolisers this metabolite contributes significantly to the therapeutic effect of tolterodine. The effect of treatment can be expected within 4 weeks.

The recommended dose for tolterodine is 2 mg twice daily. In case of troublesome side effects the dose may be reduced from 2 mg to 1 mg twice daily.

The recommended total daily dose of tolterodine is 2 mg (1 mg b.i.d.) for patients with impaired renal function, impaired liver function, or receiving concomitant medication with potent CYP3A inhibitors, such as macrolide antibiotics (e.g. erythromycin and clarithromycin) or azole antifungal agents (e.g. ketoconazole, itraconazole and miconazole). After six months the need for further treatment should be considered.

Tolterodine may cause mild to moderate antimuscarinic effects, like dryness of mouth, dyspepsia and/or reduced lacrimation.

Tolterodine is contraindicated in those patients with urinary retention, uncontrolled narrow angle glaucoma, known hypersensitivity to tolterodine or any other component of the drug.

Tolterodine should be used with caution in the following patients:

• at risk for urinary retention
• at risk for decreased gastrointestinal motility
• with impaired renal function
• with impaired hepatic function

Organic reasons for urge and frequency should be considered before treatment.

Pharmacokinetic interactions are possible with other drugs metabolised by or inhibiting cytochrome P450 2D6 (CYP2D6) or CYP3A4. Concomitant treatment with fluoxetine does not result in a clinically significant interaction.

Ketoconazole, a potent inhibitor of CYP3A, significantly increased plasma concentrations of tolterodine when coadministered to poor metabolisers (i.e. persons devoid of CYP2D6 metabolic pathway).

Clinical studies have shown no interactions with warfarin or combined oral contraceptives (ethinyloestradiol or levonorgestrel).

There are no studies in pregnant women. Therefore, tolterodine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use of tolterodine during lactation should be avoided since no data on excretion of the drug into breast milk in humans is available.

Pediatric use: Safety and effectiveness of tolterodine in children have not been established.

Geriatric use: No overall differences in safety were observed between the older and younger patients treated with Tolterodine.

Overdosage with Tolterodine Tartrate capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. ECG monitoring is recommended in the event of overdosage.

Store in a cool and dry place. Protect from light. Keep out of the reach of children.

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Frusemide & Spironolactone combination is indicated in-

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, with collection of fluid in the abdominal cavity (ascites)
• Swelling due to excess fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Potassium-sparing diuretics, Potassium-sparing diuretics & Aldosterone antagonists

Spironolactone (potassium sparing diuretic) and Furosemide (loop diuretic) have different but complementary mechanisms and sites of action. Therefore, when given together they produce additive or synergistic diuretic. The Furosemide component inhibits the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle and blocks the reabsorption of sodium, potassium and chloride ions; thereby increasing the quantity of sodium and the volume of water excreted in the urine. This characteristically induces potassium loss. The spironolactone component inhibits the reabsorption of sodium in exchange for potassium at the distal tubule by antagonising the action of aldosterone so that sodium excretion is greatly favoured and the excess loss of potassium, induced by the Furosemide, is reduced

Furosemide 20 and spironolactone 50 mg: 1 to 4 tablets daily (20 to 80 mg of Furosemide and 50 to 200 mg of spironolactone) according to the patient’s response.

Furosemide 40 and spironolactone 50 mg: For previously stabilized patients requiring a higher dosage of spironolactone and Furosemide, This tablet can be used at a dose of one to two tablets daily (Furosemide 40 to 80 mg and spironolactone 50 to 100 mg).

Use in children: Spironolactone and Furosemide is not suitable for use in children. Spironolactone and Furosemide may both be excreted more slowly in the elderly.

Spironolactone may give rise to headache and drowsiness and gastrointestinal distress, including cramp and diarrhoea. Ataxia, mental confusion, and skin rashes have been reported as side effect. Gynaecomastia is not uncommon and in rare cases breast enlargement may persist. Other endocrine disorders including hirsutism, deepening of the voice, menstrual irregularities and impotence. Transient increase in blood-urea-nitrogen concentrations may occur and mild acidosis has been reported. Spironolactone may cause hyponatremia and hyperkalemia. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse with the possibility of vascular thrombosis and embolism particularly in elderly patients. Serious depletion of potassium and magnesium may lead to cardiac arrhythmias.

Contraindicated in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function (creatinine clearance <30 ml/min), hyperkalaemia, Addison's disease and in patients who are hypersensitive to Spironolactone, Furosemide or sulphonamides.

Caution should be taken in patients liable to electrolyte deficiency. This preparation should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.

When taken together with ACE inhibitors or potassium salts there is an increased risk of hyperkalemia. Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity. Corticosteroids may cause hypokalemia if they are used with Spironolactone. The blood pressure lowering and diuretic effects of Furosemide may be reduced or abolished when used together with indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs). Furosemide may increase the ototoxicity of aminoglycoside antibiotics. Simultaneous administration of sucralfate and Furosemide may reduce the natriuretic and anti-hypertensive effect of Furosemide.

Pregnancy: Spironolactone and its metabolites may cross the placental barrier. The use of spironolactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and fetus. Animal teratology studies indicate that Furosemide may cause fetal abnormalities. Therefore, Furosemide should only be used in women in child bearing age when appropriate contraceptive measures are taken or if the potential benefits justify the potential risks to the fetus.

Lactation: Metabolites of Spironolactone have been detected in breast milk. If use of Spironolactone is considered essential, an alternative method of infant feeding should be instituted. Furosemide is excreted in breast milk and breast-feeding should be discontinued if treatment is essential.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Nitrofurantoin is specifically indicated for the treatment & prophylaxis of urinary tract infections caused by susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, Staphylococcus saprophyticus and certain susceptible strains of Klebsiella and Enterobacter species.

Systemic Urinary Anti- infective

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Nitrofurantoin inactivates or alters bacterial ribosomal proteins and other macromolecules. Nitrofurantoin has been shown to be active against the following bacteria: Gram-Positive Aerobes Staphylococcus saprophyticus, Coagulase-negative staphylococci (including Staphylococcus epidermidis), Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Group D streptococci, Viridans group streptococci. Gram-Negative Aerobes- Escherichia coli, Citrobacter amalonaticus, Citrobacter diversus, Citrobacter freundii, Klebsiella oxytoca, Klebsiella ozaenae.

Nitrofurantoin tablet (In adults):

• Uncomplicated urinary tract infections: 50-100 mg four times a day- the lower dosage level is recommended. Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained.
• For long-term suppressive therapy: In adults, a reduction of dosage to 50-100 mg at bedtime may be adequate.

Nitrofurantoin capsule (In adults):

• Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for 7 days.
• Long term suppression: 50-100 mg once a day.
• Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Nitrofurantoin SR capsule:

• Adults and Children over 12 years: One 100 mg capsule every 12 hours for seven days.
• Genito-urinary surgical prophylaxis: One capsule twice daily on day of procedure and for next 3 days.

Nitrofurantoin suspension: Children: 5-7 mg/kg/day in four divided doses (contraindicated under one month of age). The average dose of Nintoin suspension for pediatric patients are as follows-

• 7 to 11 kg: ½ (2.5 ml) teaspoonfuls 4 times daily.
• 12 to 21 kg: 1 (5 ml) teaspoonfuls 4 times daily.
• 22 to 30 kg: 1½ (7.5 ml) teaspoonfuls 4 times daily.
• 31 to 41 kg: 2 (10 ml) teaspoonfuls 4 times daily.

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. For long-term suppressive therapy in children, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate.

Nitrofurantoin should be taken with food.

The most frequent clinical adverse events are nausea, headache, and flatulence. Other less occurred adverse events are diarrhea, dyspepsia, abdominal pain, constipation, emesis, dizziness and drowsiness.

Anuria, oliguria or significant impairment of renal function are contraindications. This drug is contraindicated in pregnant patients at 38-42 weeks, during labor and delivery. Nitrofurantoin is also contraindicated in those patients with known hypersensitivity to Nitrofurantoin.

If acute, sub-acute or chronic pulmonary reactions occur, Nitrofurantoin should be discontinued. Antacid preparations containing magnesium trisilicate should not be taken while taking Nitrofurantoin.

Antacids containing Magnesium Trisilicate, when administered concomitantly with Nitrofurantoin, reduce both the rate and extent of absorption of Uricosuric drugs, such as Probenecid and Sulfinpyrazone, can inhibit renal tubular secretion of Nitrofurantoin.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Occasional incidents of acute overdosage of Nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended.

Do not store above 30°C. Keep away from light and out of the reach of children.

Nitrofurantoin is specifically indicated for the treatment & prophylaxis of urinary tract infections caused by susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, Staphylococcus saprophyticus and certain susceptible strains of Klebsiella and Enterobacter species.

Systemic Urinary Anti- infective

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Nitrofurantoin inactivates or alters bacterial ribosomal proteins and other macromolecules. Nitrofurantoin has been shown to be active against the following bacteria: Gram-Positive Aerobes Staphylococcus saprophyticus, Coagulase-negative staphylococci (including Staphylococcus epidermidis), Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Group D streptococci, Viridans group streptococci. Gram-Negative Aerobes- Escherichia coli, Citrobacter amalonaticus, Citrobacter diversus, Citrobacter freundii, Klebsiella oxytoca, Klebsiella ozaenae.

Nitrofurantoin tablet (In adults):

• Uncomplicated urinary tract infections: 50-100 mg four times a day- the lower dosage level is recommended. Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained.
• For long-term suppressive therapy: In adults, a reduction of dosage to 50-100 mg at bedtime may be adequate.

Nitrofurantoin capsule (In adults):

• Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for 7 days.
• Long term suppression: 50-100 mg once a day.
• Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Nitrofurantoin SR capsule:

• Adults and Children over 12 years: One 100 mg capsule every 12 hours for seven days.
• Genito-urinary surgical prophylaxis: One capsule twice daily on day of procedure and for next 3 days.

Nitrofurantoin suspension: Children: 5-7 mg/kg/day in four divided doses (contraindicated under one month of age). The average dose of Nintoin suspension for pediatric patients are as follows-

• 7 to 11 kg: ½ (2.5 ml) teaspoonfuls 4 times daily.
• 12 to 21 kg: 1 (5 ml) teaspoonfuls 4 times daily.
• 22 to 30 kg: 1½ (7.5 ml) teaspoonfuls 4 times daily.
• 31 to 41 kg: 2 (10 ml) teaspoonfuls 4 times daily.

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. For long-term suppressive therapy in children, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate.

Nitrofurantoin should be taken with food.

The most frequent clinical adverse events are nausea, headache, and flatulence. Other less occurred adverse events are diarrhea, dyspepsia, abdominal pain, constipation, emesis, dizziness and drowsiness.

Anuria, oliguria or significant impairment of renal function are contraindications. This drug is contraindicated in pregnant patients at 38-42 weeks, during labor and delivery. Nitrofurantoin is also contraindicated in those patients with known hypersensitivity to Nitrofurantoin.

If acute, sub-acute or chronic pulmonary reactions occur, Nitrofurantoin should be discontinued. Antacid preparations containing magnesium trisilicate should not be taken while taking Nitrofurantoin.

Antacids containing Magnesium Trisilicate, when administered concomitantly with Nitrofurantoin, reduce both the rate and extent of absorption of Uricosuric drugs, such as Probenecid and Sulfinpyrazone, can inhibit renal tubular secretion of Nitrofurantoin.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Occasional incidents of acute overdosage of Nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended.

Do not store above 30°C. Keep away from light and out of the reach of children.

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

BPH/ Urinary retention/ Urinary incontinence

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1 A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin hydrochloride capsule 0.4mg is essentially complete (90%) following oral administration under fasting conditions. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food. Tamsulosin hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin hydrochloride is extensively metabolized by cytochrome P 450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination half-life of Tamsulosin hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with Prostam capsules, the apparent half-life of Tamsulosin hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

The following adverse reactions have been reported during the use of Tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

Effects on ability to drive and use machines: No data is available on whether Tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.

Concurrent administration of other alfa1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Use of Tamsulosin in pregnancy and lactation is not recommended.

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

Store in a cool and dry place, below 30°C, protected from light.

Nitrofurantoin is specifically indicated for the treatment & prophylaxis of urinary tract infections caused by susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, Staphylococcus saprophyticus and certain susceptible strains of Klebsiella and Enterobacter species.

Systemic Urinary Anti- infective

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Nitrofurantoin inactivates or alters bacterial ribosomal proteins and other macromolecules. Nitrofurantoin has been shown to be active against the following bacteria: Gram-Positive Aerobes Staphylococcus saprophyticus, Coagulase-negative staphylococci (including Staphylococcus epidermidis), Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Group D streptococci, Viridans group streptococci. Gram-Negative Aerobes- Escherichia coli, Citrobacter amalonaticus, Citrobacter diversus, Citrobacter freundii, Klebsiella oxytoca, Klebsiella ozaenae.

Nitrofurantoin tablet (In adults):

• Uncomplicated urinary tract infections: 50-100 mg four times a day- the lower dosage level is recommended. Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained.
• For long-term suppressive therapy: In adults, a reduction of dosage to 50-100 mg at bedtime may be adequate.

Nitrofurantoin capsule (In adults):

• Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for 7 days.
• Long term suppression: 50-100 mg once a day.
• Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Nitrofurantoin SR capsule:

• Adults and Children over 12 years: One 100 mg capsule every 12 hours for seven days.
• Genito-urinary surgical prophylaxis: One capsule twice daily on day of procedure and for next 3 days.

Nitrofurantoin suspension: Children: 5-7 mg/kg/day in four divided doses (contraindicated under one month of age). The average dose of Nintoin suspension for pediatric patients are as follows-

• 7 to 11 kg: ½ (2.5 ml) teaspoonfuls 4 times daily.
• 12 to 21 kg: 1 (5 ml) teaspoonfuls 4 times daily.
• 22 to 30 kg: 1½ (7.5 ml) teaspoonfuls 4 times daily.
• 31 to 41 kg: 2 (10 ml) teaspoonfuls 4 times daily.

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. For long-term suppressive therapy in children, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate.

Nitrofurantoin should be taken with food.

The most frequent clinical adverse events are nausea, headache, and flatulence. Other less occurred adverse events are diarrhea, dyspepsia, abdominal pain, constipation, emesis, dizziness and drowsiness.

Anuria, oliguria or significant impairment of renal function are contraindications. This drug is contraindicated in pregnant patients at 38-42 weeks, during labor and delivery. Nitrofurantoin is also contraindicated in those patients with known hypersensitivity to Nitrofurantoin.

If acute, sub-acute or chronic pulmonary reactions occur, Nitrofurantoin should be discontinued. Antacid preparations containing magnesium trisilicate should not be taken while taking Nitrofurantoin.

Antacids containing Magnesium Trisilicate, when administered concomitantly with Nitrofurantoin, reduce both the rate and extent of absorption of Uricosuric drugs, such as Probenecid and Sulfinpyrazone, can inhibit renal tubular secretion of Nitrofurantoin.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Occasional incidents of acute overdosage of Nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended.

Do not store above 30°C. Keep away from light and out of the reach of children.