Find Medicines

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Levosalbutamol is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.

Short-acting selective & β2-adrenoceptor stimulants

Levosalbutamol is a single isomer beta 2-agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Tablet-

• Adults and adolescents above 12 years: 1-2 mg three times daily.
• Children (6 -11 years): 1 mg three times daily.

Syrup-

• Adults : 5-10 ml three times daily.
• Childrn (6-11 years): 5 ml three times daily.

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain and diarrhoea.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.

Other short acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they will be used with caution to avoid deleterious cardiovascular effects.

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

The expected symptoms with over dosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

This medicine is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilized on levodopa/dopa decarboxylase (DDC) inhibitor treatment.

Antiparkinson drugs

Levodopa is the metabolic precursor of dopamine. It crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa increases the amount of levodopa that is transported into the CNS by inhibiting the decarboxylation of peripheral levodopa. Entacapone is a selective inhibitor of COMT which alters the pharmacokinetics of levodopa, resulting to increased and more sustained levodopa serum levels.

Adults: The optimum daily dose must be determined by careful titration of levodopa in each patient. Patients should be instructed to take only 1 (one) tablet per dose administration. The maximum recommended daily dose of entacapone is 2,000 mg. Usually this combination is to be used in patients who are currently treated with corresponding doses of standard release Levodopa or Dopa Decarboxylase (DDC) inhibitor and entacapone.

May be taken with or without food. Keep a consistent diet. A change in diet to foods high in protein may delay levodopa absorption & reduce amount taken up in circulation. Excessive acidity also delays stomach emptying & thus delays levodopa absorption. Iron salts may also reduce amount of levodopa available to the body. Swallow whole.

Common side effects include dyskinesia, nausea, hyperkinesia, change in urine color, diarrhea and stomach pain. Other side effects may include diarrhea, sometimes severe; colitis; hallucinations; other mental disturbances; orthostatic hypotension; rhabdomyolysis; and symptoms resembling neuroleptic malignant syndrome (a condition characterized by high fever, muscle stiffness, and confusion); fibrosis; skin cancer, etc.

Narrow-angle glaucoma, phaeochromocytoma, history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic rhabdomyolysis. Severe hepatic impairment. Concurrent use of or within 14 days of discontinuing non-selective MAOIs.

Levodopa, carbidopa and entacapone together may cause dizziness and symptomatic orthostatism. Therefore, caution should be exercised when driving or using machines. As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy.

Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients already receiving antihypertensive. Dose adjustment of the antihypertensive agent may be required. Dopamine receptor antagonists (e.g. some antipsychotics and antiemetics), phenytoin and papaverine may reduce the therapeutic effect of levodopa. Patients taking these medicinal products with levodopa/ carbidopa/ entacapone combination should be carefully observed for loss of therapeutic response. Since levodopa competes with certain amino acids, the absorption of Levodopa, Carbidopa & Entacapone may be impaired in some patients on high protein diet.

Pregnancy category C. The combination of levodopa/ carbidopa/ entacapone should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. The safety of this combination in the infant is not known. Women should not breast-feed during treatment with this combination.

Children: Safety and effectiveness in pediatric patients have not been established.

Elderly: No dose adjustment is required for elderly patients.

Hepatic impaired patients: Should be administered cautiously to patients with mild to moderate hepatic impairment. Dose reduction may be needed.

Renally impaired patients: Should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy

The acute symptoms and signs of overdose include agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne Stokes respiration, discolorations of skin, tongue and conjunctiva, and chromaturia. Management of acute overdose with levodopa/ carbidopa/ entacapone combination is similar to acute overdose with levodopa. Pyridoxine, however, is not effective in reversing the actions of levodopa/ carbidopa/ entacapone combination. Hospitalization is advised and general supportive measures should be employed with immediate gastric lavage and repeated doses of charcoal over time.

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

Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as perennial allergic rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.

Non-sedating antihistamines

This preparation contains Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.

Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.

Children 6 to 11 years of age: The recommended dose is 2.5 mg (1/2 tablet or 1 teaspoon oral solution) once daily.

Children 6 months to 5 years of age: The recommended dose is 1.25 mg (1/2 teaspoon oral solution) once daily.

Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.

Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.

Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.

Levocetirizine is not known to have any interactions with other drugs.

Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.

Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older.

Geriatric use: In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Hepatic impairment: No dosage adjustment is required in patients with solely hepatic impairment.

Renal impairment:

• Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended.
• Moderate renal impairment (creatinine clearance: 30-50 ml/min): a dose of 2.5 mg once every other day is recommended.
• Severe renal impairment (creatinine clearance: 10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended.
• End-stage renal disease patients (creatinine clearance: <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine.

No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.

Store at a temperature not exceeding 30°C in a dry place. Protect from light.

Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as perennial allergic rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.

Non-sedating antihistamines

This preparation contains Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.

Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.

Children 6 to 11 years of age: The recommended dose is 2.5 mg (1/2 tablet or 1 teaspoon oral solution) once daily.

Children 6 months to 5 years of age: The recommended dose is 1.25 mg (1/2 teaspoon oral solution) once daily.

Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.

Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.

Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.

Levocetirizine is not known to have any interactions with other drugs.

Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.

Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older.

Geriatric use: In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Hepatic impairment: No dosage adjustment is required in patients with solely hepatic impairment.

Renal impairment:

• Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended.
• Moderate renal impairment (creatinine clearance: 30-50 ml/min): a dose of 2.5 mg once every other day is recommended.
• Severe renal impairment (creatinine clearance: 10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended.
• End-stage renal disease patients (creatinine clearance: <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine.

No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.

Store at a temperature not exceeding 30°C in a dry place. Protect from light.

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

This syrup is indicated in leucorrhea, cervicitis, non-specific vaginitis and pelvic inflammatory diseases. Moreover, this syrup might be used in low back pain associated with leucorrhea, endometroiosis, disorder of the urogenital tract.

Herbal and Nutraceuticals

Woodfordia fruticosa: Woodfordia fruticosa belongs to the Lythraceae family possesses high content of tannins, which has astringent, stimulant, uterine sedative, anthelmintic and potent antibacterial properties. It minimizes the vaginal pH and thus prevents relapse. Study reveals that extract of Woodfordia fruticosa contains certain constituents like tannin with significant antibacterial properties, which enable to overcome the barrier in Gram negative bacterial cell wall. The inhibitory effect is comparable with standard antibiotics Amoxicillin and Ciprofloxacin. Moreover Woodfordia fruticosa flowers provide non-specific immunity. It stimulates reticulo endothelial system and release of cytokines from macrophages. Proliferation of bone marrow cells indicates the plausible release of colony stimulating factors, which further stimulates the immune system through generation of immune cells.

Hemidesmus indicus: Chemical analysis of the root showed the presence of coumarin, volatile oil and two sterols. 2-hydroxy-4 methoxy benzaldehyde is isolated from the root of the Hemidesmus indicus which has anti-inflammatory activity against chronic inflammation. Also the drug is revealed significant anti-fungal activity in experimental and clinical studies.

Acacia catechu: Acacia catechu is highly valuable for its powerful astringent and antioxidant activities. It exhibits various pharmacological effects like antipyretic, anti-inflammatory, antioxidant and antimicrobial activities. Catechins and taxifolin is principal constituent of Acacia catechu which have significant antimicrobial effects. Chronic gonorrhea can be treated with Acacia catechu.

Mangifera indica: Mangifera indica contains active substances like mangiferin, which has antibacterial, antiviral, anti-inflammatory and antiallergic activity. It inhibits mast cell degranulation.

Adult: 3 teaspoonfuls (15 ml) 3 times daily after meal for 15 days or as directed by the physician.

No health hazards or side effects are known in conjunction with the proper administration of designated therapeutic dosages. But in rare case high dose may cause burning sensation, diarrhea or may increase urine output.

It should not be taken during pregnancy although medical literature has not reported any adverse effects related to fetal development during pregnancy or to infants who are breast-fed.

Keep in a cool, dry place & away from direct sunlight.Keep the medicine out of the reach of children

This syrup is indicated in leucorrhea, cervicitis, non-specific vaginitis and pelvic inflammatory diseases. Moreover, this syrup might be used in low back pain associated with leucorrhea, endometroiosis, disorder of the urogenital tract.

Herbal and Nutraceuticals

Woodfordia fruticosa: Woodfordia fruticosa belongs to the Lythraceae family possesses high content of tannins, which has astringent, stimulant, uterine sedative, anthelmintic and potent antibacterial properties. It minimizes the vaginal pH and thus prevents relapse. Study reveals that extract of Woodfordia fruticosa contains certain constituents like tannin with significant antibacterial properties, which enable to overcome the barrier in Gram negative bacterial cell wall. The inhibitory effect is comparable with standard antibiotics Amoxicillin and Ciprofloxacin. Moreover Woodfordia fruticosa flowers provide non-specific immunity. It stimulates reticulo endothelial system and release of cytokines from macrophages. Proliferation of bone marrow cells indicates the plausible release of colony stimulating factors, which further stimulates the immune system through generation of immune cells.

Hemidesmus indicus: Chemical analysis of the root showed the presence of coumarin, volatile oil and two sterols. 2-hydroxy-4 methoxy benzaldehyde is isolated from the root of the Hemidesmus indicus which has anti-inflammatory activity against chronic inflammation. Also the drug is revealed significant anti-fungal activity in experimental and clinical studies.

Acacia catechu: Acacia catechu is highly valuable for its powerful astringent and antioxidant activities. It exhibits various pharmacological effects like antipyretic, anti-inflammatory, antioxidant and antimicrobial activities. Catechins and taxifolin is principal constituent of Acacia catechu which have significant antimicrobial effects. Chronic gonorrhea can be treated with Acacia catechu.

Mangifera indica: Mangifera indica contains active substances like mangiferin, which has antibacterial, antiviral, anti-inflammatory and antiallergic activity. It inhibits mast cell degranulation.

Adult: 3 teaspoonfuls (15 ml) 3 times daily after meal for 15 days or as directed by the physician.

No health hazards or side effects are known in conjunction with the proper administration of designated therapeutic dosages. But in rare case high dose may cause burning sensation, diarrhea or may increase urine output.

It should not be taken during pregnancy although medical literature has not reported any adverse effects related to fetal development during pregnancy or to infants who are breast-fed.

Keep in a cool, dry place & away from direct sunlight.Keep the medicine out of the reach of children

Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of Lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of Lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. In MM cells, the combination of Lenalidomide and Dxamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.

Absorption: Lenalidomide is rapidly absorbed following oral administration. Following single and multiple doses of Lenalidomide in patients with MM or MDS, the maximum plasma concentrations occurred between 0.5 and 6 hours post-dose. The single and multiple dose pharmacokinetic disposition of Lenalidomide is linear with AUC and Cmax values increasing proportionally with dose. Multiple doses of Lenalidomide at the recommended dosage does not result in drug accumulation. Administration of a single 25 mg dose of Lenalidomide with a high-fat meal in healthy subjects reduces the extent of absorption, with an approximate 20% decrease in AUC and 50% decrease in Cmax. In the trials where the efficacy and safety were established for Lenalidomide, the drug was administered without regard to food intake. Lenalidomide can be administered with or without food. The oral absorption rate of Lenalidomide in patients with MCL is similar to that observed in patients with MM or MDS.

Distribution: In vitro [14 C]-Lenalidomide binding to plasma proteins is approximately 30%. Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and 24 hours (35 ng/ejaculate) after the administration of Lenalidomide 25 mg daily.

Elimination: The mean half-life of Lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM, MDS or MCL.

Metabolism: Lenalidomide undergoes limited metabolism. Unchanged Lenalidomide is the predominant circulating component in humans. Two identified metabolites are 5¬ Hydroxy-Lenalidomide and N-Acetyl Lenalidomide; each constitutes less than 5% of parent levels in circulation.

Excretion: Elimination is primarily renal. Following a single oral administration of [14 C]-Lenalidomide 25 mg to healthy subjects, approximately 90% and 4% of the radioactive dose was eliminated within ten days in urine and feces, respectively. Approximately 82% of the radioactive dose was excreted as Lenalidomide in the urine within 24 hours. Hydroxy-Lenalidomide and N-Acetyl-Lenalidomide represented 4.6% and 1.8% of the excreted dose, respectively. The renal clearance of Lenalidomide exceeds the glomerular filtration rate.

Lenalidomide Combination Therapy: The recommended starting dose of Lenalidomide is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with Dexamethasone. For patients greater than 75 years old, the starting dose of Dexamethasone may be reduced. Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a Lenalidomide-containing therapy.

Lenalidomide Maintenance Therapy Following Auto-HSCT: Following auto-HSCT, initiate Lenalidomide maintenance therapy after adequate hematologic recovery (ANC at least 1000/mcL and/or platelet counts at least 75,000/mcL). The recommended starting dose of Lenalidomide is 10 mg once daily continuously (Days 1-28 of repeated 28-day cycles) until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated.

Recommended Dosage for Myelodysplastic Syndromes: The recommended starting dose of Lenalidomide is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Continue treatment until disease progression or unacceptable toxicity.

Recommended Dosage for Mantle Cell Lymphoma: The recommended starting dose of Lenalidomide is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity. Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

Recommended Dosage for Follicular Lymphoma or Marginal Zone Lymphoma: The recommended starting dose of Lenalidomide is 20 mg orally once daily on Days 1-21 of repeated 28-day cycles for up to 12 cycles of treatment in combination with a Rituximab-product.

Patients should be advised to take Lenalidomide orally at about the same time each day, either with or without food. Patients should be advised to swallow Lenalidomide capsules whole with water and not to open, break, or chew them.

Embryo-fetal toxicity, hematologic toxicity, venous and arterial thromboembolism, increased mortality in patients with CLL, second primary malignancies, hepatotoxicity, severe cutaneous reaction tumor lysis syndrome, tumor flare reactions, impaired stem cell mobilization, thyroid disorders. early mortality in patients with MCL, hypersensitivity. Severe Hypersensitivity Reactions: Lenalidomide is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to Lenalidomide.

Pregnancy: Lenalidomide can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested. Due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus 

Severe Hypersensitivity Reactions: Lenalidomide is contraindicated in patients who have demonstrated severe hypersensitivity

Lenalidomide REMS Program: Because of the embryo-fetal risk, Lenalidomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the Lenalidomide REMS
program. Required components of the Lenalidomide REMS program include the following:

• Prescribers must be certified with the Lenalidomide REMS program by enrolling and complying with the REMS requirements.
• Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
• Pharmacies must be certified with the Lenalidomide REMS program, must only dispense to patients who are authorized to receive Lenalidomide and comply with REMS requirements.

Hematologic Toxicity: Lenalidomide can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding. Patients taking Lenalidomide should have their complete blood counts assessed periodically as described below. Monitor complete blood counts (CBC) in patients taking Lenalidomide in combination with Dexamethasone or as Lenalidomide maintenance therapy for MM every 7 days (weekly) for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days (4 weeks) thereafter. A dose interruption and/or dose reduction may be required. Monitor complete blood counts (CBC) in patients taking Lenalidomide for MDS weekly for the first 8 weeks and at least monthly thereafter. Monitor complete blood counts (CBC) in patients taking Lenalidomide for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction. Monitor complete blood counts (CBC) in patients taking Lenalidomide for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 24, and then monthly thereafter. Patients may require dose interruption and/or dose reduction.

Venous and Arterial Thromboembolism: Venous thromboembolic events (VTE [DVT and PE]) and arterial thromboembolic events (ATE, myocardial infarction and stroke) are increased in patients treated with Lenalidomide. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g. hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended. The regimen of thromboprophylaxis should be based on an assessment of the patient’s underlying risks. Instruct patients to report immediately any signs and symptoms suggestive of thrombotic events. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision in patients receiving Lenalidomide.

Increased Mortality in Patients with CLL: Lenalidomide is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies: Monitor patients for the development of second primary malignancies. Take into account both the potential benefit of Lenalidomide and the risk of second primary malignancies when considering treatment with Lenalidomide.

Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone: Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus Dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with Lenalidomide in combination with Dexamethasone. The mechanism of drug-induced hepatotoxicity is unknown. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop Lenalidomide upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive Lenalidomide. Lenalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash. Lenalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected and should not be resumed following discontinuation for these reactions.

Tumor Lysis Syndrome: Monitor patients at risk closely and take appropriate preventive approaches. Tumor Flare Reaction: Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare reaction may mimic the progression of disease (PD).

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with Lenalidomide has been reported. In patients who are auto-HSCT candidates, referral to a transplant center should occur early in treatment to optimize the timing of the stem cell collection. In patients who received more than 4 cycles of a Lenalidomide-containing treatment or for whom inadequate numbers of CD 34+ cells have been collected with G-CSF alone, G-CSF with cyclophosphamide or the combination of GCSF with a CXCR4 inhibitor may be considered.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before the start of Lenalidomide treatment and during therapy.

Digoxin: When Digoxin was co-administered with multiple doses of Lenalidomide (10 mg/day) the Digoxin Cmax and AUCinf were increased by 14%. Periodic monitoring of Digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of Lenalidomide.

Concomitant Therapies That May Increase the Risk of Thrombosis: Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen-containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving Lenalidomide.

Warfarin: Co-administration of multiple doses of Lenalidomide (10 mg/day) with a single dose of Warfarin (25 mg) had no effect on the pharmacokinetics of Lenalidomide or R- and S-Warfarin. It is not known whether there is an interaction between Dexamethasone and Warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant Warfarin.

Based on the mechanism of action, Lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy. There is no information regarding the presence of Lenalidomide in human milk, the effects of Lenalidomide on the breastfed infant, or the effects of Lenalidomide on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from Lenalidomide, advise women not to breastfeed during treatment with Lenalidomide.

Pediatric Use: The safety and effectiveness in pediatric patients have not been established.

There is no specific experience in the management of Lenalidomide overdose in patients with MM, MDS, or MCL.

Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.

Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of Lenalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos, Ikaros, and CK1α) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including MM, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including MM. Immunomodulatory properties of Lenalidomide include increased number and activation of T cells and natural killer (NK) cells leading to direct and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) via increased secretion of interleukin-2 and interferon-gamma, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. In MM cells, the combination of Lenalidomide and Dxamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.

Absorption: Lenalidomide is rapidly absorbed following oral administration. Following single and multiple doses of Lenalidomide in patients with MM or MDS, the maximum plasma concentrations occurred between 0.5 and 6 hours post-dose. The single and multiple dose pharmacokinetic disposition of Lenalidomide is linear with AUC and Cmax values increasing proportionally with dose. Multiple doses of Lenalidomide at the recommended dosage does not result in drug accumulation. Administration of a single 25 mg dose of Lenalidomide with a high-fat meal in healthy subjects reduces the extent of absorption, with an approximate 20% decrease in AUC and 50% decrease in Cmax. In the trials where the efficacy and safety were established for Lenalidomide, the drug was administered without regard to food intake. Lenalidomide can be administered with or without food. The oral absorption rate of Lenalidomide in patients with MCL is similar to that observed in patients with MM or MDS.

Distribution: In vitro [14 C]-Lenalidomide binding to plasma proteins is approximately 30%. Lenalidomide is present in semen at 2 hours (1379 ng/ejaculate) and 24 hours (35 ng/ejaculate) after the administration of Lenalidomide 25 mg daily.

Elimination: The mean half-life of Lenalidomide is 3 hours in healthy subjects and 3 to 5 hours in patients with MM, MDS or MCL.

Metabolism: Lenalidomide undergoes limited metabolism. Unchanged Lenalidomide is the predominant circulating component in humans. Two identified metabolites are 5¬ Hydroxy-Lenalidomide and N-Acetyl Lenalidomide; each constitutes less than 5% of parent levels in circulation.

Excretion: Elimination is primarily renal. Following a single oral administration of [14 C]-Lenalidomide 25 mg to healthy subjects, approximately 90% and 4% of the radioactive dose was eliminated within ten days in urine and feces, respectively. Approximately 82% of the radioactive dose was excreted as Lenalidomide in the urine within 24 hours. Hydroxy-Lenalidomide and N-Acetyl-Lenalidomide represented 4.6% and 1.8% of the excreted dose, respectively. The renal clearance of Lenalidomide exceeds the glomerular filtration rate.

Lenalidomide Combination Therapy: The recommended starting dose of Lenalidomide is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with Dexamethasone. For patients greater than 75 years old, the starting dose of Dexamethasone may be reduced. Treatment should be continued until disease progression or unacceptable toxicity. In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a Lenalidomide-containing therapy.

Lenalidomide Maintenance Therapy Following Auto-HSCT: Following auto-HSCT, initiate Lenalidomide maintenance therapy after adequate hematologic recovery (ANC at least 1000/mcL and/or platelet counts at least 75,000/mcL). The recommended starting dose of Lenalidomide is 10 mg once daily continuously (Days 1-28 of repeated 28-day cycles) until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated.

Recommended Dosage for Myelodysplastic Syndromes: The recommended starting dose of Lenalidomide is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Continue treatment until disease progression or unacceptable toxicity.

Recommended Dosage for Mantle Cell Lymphoma: The recommended starting dose of Lenalidomide is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity. Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

Recommended Dosage for Follicular Lymphoma or Marginal Zone Lymphoma: The recommended starting dose of Lenalidomide is 20 mg orally once daily on Days 1-21 of repeated 28-day cycles for up to 12 cycles of treatment in combination with a Rituximab-product.

Patients should be advised to take Lenalidomide orally at about the same time each day, either with or without food. Patients should be advised to swallow Lenalidomide capsules whole with water and not to open, break, or chew them.

Embryo-fetal toxicity, hematologic toxicity, venous and arterial thromboembolism, increased mortality in patients with CLL, second primary malignancies, hepatotoxicity, severe cutaneous reaction tumor lysis syndrome, tumor flare reactions, impaired stem cell mobilization, thyroid disorders. early mortality in patients with MCL, hypersensitivity. Severe Hypersensitivity Reactions: Lenalidomide is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to Lenalidomide.

Pregnancy: Lenalidomide can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested. Due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus 

Severe Hypersensitivity Reactions: Lenalidomide is contraindicated in patients who have demonstrated severe hypersensitivity

Lenalidomide REMS Program: Because of the embryo-fetal risk, Lenalidomide is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), the Lenalidomide REMS
program. Required components of the Lenalidomide REMS program include the following:

• Prescribers must be certified with the Lenalidomide REMS program by enrolling and complying with the REMS requirements.
• Patients must sign a Patient-Physician agreement form and comply with the REMS requirements. In particular, female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
• Pharmacies must be certified with the Lenalidomide REMS program, must only dispense to patients who are authorized to receive Lenalidomide and comply with REMS requirements.

Hematologic Toxicity: Lenalidomide can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding. Patients taking Lenalidomide should have their complete blood counts assessed periodically as described below. Monitor complete blood counts (CBC) in patients taking Lenalidomide in combination with Dexamethasone or as Lenalidomide maintenance therapy for MM every 7 days (weekly) for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days (4 weeks) thereafter. A dose interruption and/or dose reduction may be required. Monitor complete blood counts (CBC) in patients taking Lenalidomide for MDS weekly for the first 8 weeks and at least monthly thereafter. Monitor complete blood counts (CBC) in patients taking Lenalidomide for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction. Monitor complete blood counts (CBC) in patients taking Lenalidomide for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 24, and then monthly thereafter. Patients may require dose interruption and/or dose reduction.

Venous and Arterial Thromboembolism: Venous thromboembolic events (VTE [DVT and PE]) and arterial thromboembolic events (ATE, myocardial infarction and stroke) are increased in patients treated with Lenalidomide. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g. hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended. The regimen of thromboprophylaxis should be based on an assessment of the patient’s underlying risks. Instruct patients to report immediately any signs and symptoms suggestive of thrombotic events. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision in patients receiving Lenalidomide.

Increased Mortality in Patients with CLL: Lenalidomide is not indicated and not recommended for use in CLL outside of controlled clinical trials.

Second Primary Malignancies: Monitor patients for the development of second primary malignancies. Take into account both the potential benefit of Lenalidomide and the risk of second primary malignancies when considering treatment with Lenalidomide.

Increased Mortality in Patients with MM When Pembrolizumab Is Added to a Thalidomide Analogue and Dexamethasone: Treatment of patients with MM with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus Dexamethasone is not recommended outside of controlled clinical trials.

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with Lenalidomide in combination with Dexamethasone. The mechanism of drug-induced hepatotoxicity is unknown. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop Lenalidomide upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.

Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive Lenalidomide. Lenalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash. Lenalidomide must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected and should not be resumed following discontinuation for these reactions.

Tumor Lysis Syndrome: Monitor patients at risk closely and take appropriate preventive approaches. Tumor Flare Reaction: Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare reaction may mimic the progression of disease (PD).

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with Lenalidomide has been reported. In patients who are auto-HSCT candidates, referral to a transplant center should occur early in treatment to optimize the timing of the stem cell collection. In patients who received more than 4 cycles of a Lenalidomide-containing treatment or for whom inadequate numbers of CD 34+ cells have been collected with G-CSF alone, G-CSF with cyclophosphamide or the combination of GCSF with a CXCR4 inhibitor may be considered.

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before the start of Lenalidomide treatment and during therapy.

Digoxin: When Digoxin was co-administered with multiple doses of Lenalidomide (10 mg/day) the Digoxin Cmax and AUCinf were increased by 14%. Periodic monitoring of Digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of Lenalidomide.

Concomitant Therapies That May Increase the Risk of Thrombosis: Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen-containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving Lenalidomide.

Warfarin: Co-administration of multiple doses of Lenalidomide (10 mg/day) with a single dose of Warfarin (25 mg) had no effect on the pharmacokinetics of Lenalidomide or R- and S-Warfarin. It is not known whether there is an interaction between Dexamethasone and Warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant Warfarin.

Based on the mechanism of action, Lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy. There is no information regarding the presence of Lenalidomide in human milk, the effects of Lenalidomide on the breastfed infant, or the effects of Lenalidomide on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from Lenalidomide, advise women not to breastfeed during treatment with Lenalidomide.

Pediatric Use: The safety and effectiveness in pediatric patients have not been established.

There is no specific experience in the management of Lenalidomide overdose in patients with MM, MDS, or MCL.

Store below 30°C in a dry place. Protect from light. Keep out of the reach of children.

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

4-Quinolone preparations

Levofloxacin eye drops is a sterile topical ophthalmic solution. It is a synthetic, broad spectrum, third generation fluoroquinolone bactericidal antibiotic, which active against a broad spectrum of Gram-positive & Gram-negative ocular pathogens. It functions by inhibiting bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination.

0.5% eye drop: Adults and children 1 year of age and older:

• Days 1 and 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
• Days 3 through 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.

1.5% eye drop: Adults and children 6 years of age and older:

• Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
• Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.

Children <1 year: Safety and effectiveness of Levofloxacin below 1 year of age have not been established.

Side effects occurred only approximately 1-3% of patients that may include transient blurred vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. In less than 1% of patients included allergic reactions, lid edema, ocular dryness and ocular itching.

It is contraindicated in patients with a history of hypersensitivity to Levofloxacin, to other quinolones or to any of the components of this medication

Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Specific drug interaction studies have not been conducted with levofloxacin eye drops. But the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine and enhance the effects of the oral anticoagulant warfarin and its derivatives.

Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin eye drops is administered to a nursing mother.

Eye drops should be protected from light, store in a cool (15°-25° C) and dry place & keep out of reach of children.

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

4-Quinolone preparations

Levofloxacin eye drops is a sterile topical ophthalmic solution. It is a synthetic, broad spectrum, third generation fluoroquinolone bactericidal antibiotic, which active against a broad spectrum of Gram-positive & Gram-negative ocular pathogens. It functions by inhibiting bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination.

0.5% eye drop: Adults and children 1 year of age and older:

• Days 1 and 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
• Days 3 through 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.

1.5% eye drop: Adults and children 6 years of age and older:

• Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
• Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.

Children <1 year: Safety and effectiveness of Levofloxacin below 1 year of age have not been established.

Side effects occurred only approximately 1-3% of patients that may include transient blurred vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. In less than 1% of patients included allergic reactions, lid edema, ocular dryness and ocular itching.

It is contraindicated in patients with a history of hypersensitivity to Levofloxacin, to other quinolones or to any of the components of this medication

Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Specific drug interaction studies have not been conducted with levofloxacin eye drops. But the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine and enhance the effects of the oral anticoagulant warfarin and its derivatives.

Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin eye drops is administered to a nursing mother.

Eye drops should be protected from light, store in a cool (15°-25° C) and dry place & keep out of reach of children.

Anti-dyspeptic/Carminatives

Simethicone is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, pressure, fullness or stuffed feeling. The clinical use of Simeticone is based on its antifoaming properties. Its antifoaming action relieves flatulence by dispersing and preventing the formation of mucous surrounded gas pockets in the GI tract.

Simeticone acts in the stomach and intestines to change the surface tension of gas bubbles, enabling them to coalesce; thus gas is freed and eliminated more easily by belching or passing flatus. Simeticone aids in the elimination of gas from the GI tract and can be used to reduce postoperative gas pains. Simeticone can also be used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.

Take after meals and at bedtime. Can be given with infant's feeds. Shake the bottle well before each use.

Children less than 2 years of age: 20 mg (0.3 ml Simethicone Paediatric Drops) 4 times daily up to 240 mg/day (3.6 ml Simethicone Paediatric Drops).

Children 2-12 years of age: 40 mg (0.6 ml Simethicone Paediatric Drops) 4 times daily.

Adults:

• 40-125 mg (0.6 ml-1.9 ml Simethicone Paediatric Drops) 4 times daily, up to 500 mg/day (7.5 ml Simethicone Paediatric Drops) or
• 1-3 Simethicone chewable tablets; 4 times daily, up to 500 mg/day (12 Simethicone chewable tablets).

Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.

Do not exceed 12 doses per day except under the advice and supervision of a physician.

There is no evidence that Simethicone modifies the effect of other drugs. The defoaming effect of Simethicone is reduced by antacids such as Aluminium Hydroxide and Magnesium Carbonate, which absorb the Silicone.

Pregnant women: No data are available to suggest any harmful effects.

Lactating mother: Excretion of simethicone in breast milk has not been established, and would be most unlikely.

Should be stored in cool and dry place, protected from light. Keep the medicine out of the reach of children.