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Benformin

Metformin Hydrochloride
Tablet 850 mg Allopathic Biguanides

Indications

Type 2 DM

Indication detailsView
Treatment of type 2 diabetes mellitus, particularly in overweight patients when dietary management and exercise alone does not result in adequate glycaemic control.
  • In adults: Metformin may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.
  • In children from 10 years of age and adolescents: Metformin may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.
Therapeutic classView
Biguanides
PharmacologyView
Metformin is a biguanide type oral antihyperglycemic drug used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. Its mechanism of action is different from those of sulfonylureas and it does not produce hypoglycemia. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
Metformin immediate release tablet: Dosage of Metformin Hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses.
  • Adult: The usual starting dose of Metformin is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. For those patients requiring additional glycemic control, Glucomin may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
  • Children: The usual starting dose of Metformin is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.
Metformin extended release tablet: Swallow Metformin XR tablet whole and never crush, cut or chew.
  • Adult: The usual starting dose of Metformin XR is 500 mg once daily with the evening meal. Dose should be increased in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal, alternatively increased to 1000 mg twice daily taken with meal. Patient receiving Metformin immediate release tablet may be switched to Metformin extended release tablet up to a maximum recommended daily dose.
  • Children: Metformin extended release tablet has not been studied in children.
  • Renal impaired patient: Do not use Metformin in patients with eGFR below 30 mL/min/1.73 m2. Asses risk/benefit of counting if eGFR falls below 45 mL/min/1.73 m2.
Side effectsView
Blood and lymphatic system disorders: Not known: Hemolytic anemia

Metabolism and nutrition disorders: Very rare: Lactic acidosis. Decrease of vitamin B12 absorption with a decrease of serum levels during long-term use of metformin. Consideration of such etiology is recommended if a patient presents with megaloblastic anemia. Cases of peripheral neuropathy in patients with vitamin B12 deficiency have been reported in post-marketing experience (frequency not known)

Nervous system disorders: Common: Taste disturbance. Not known: Encephalopathy

Gastrointestinal disorders: Very common: Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These undesirable effects occur most frequently during the initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders: Very rare: Isolated reports of liver function test abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders: Very rare: Skin reactions, such as erythema, pruritus, urticaria.
ContraindicationsView
  • Hypersensitivity to the active substance or to any of the excipients.
  • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).
  • Severe renal failure (GFR <30 mL/min).
  • Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.
  • Acute or chronic disease, which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock, Hepatic insufciency, acute alcohol intoxication, alcoholism.
PrecautionsView
Metformin Hydrochloride is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Metformin may lower vitamin B12 level. It also increases risk of hypoglycemia when use in combination with insulin or insulin secretagogue.
InteractionsView
Co-administration with Carbonic anhydrase (Topiramate, Zonisamide) may increase risk of lactic acidosis. Drugs (Ranolazine, Dolutegravir, Cimetidine) that reduce Metformin clearance may increase the accumulation of Metformin. Alcohol can potentiate the effect of Metformin on lactate metabolism.
Pregnancy & lactationView
Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with an increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Breastfeeding: Metformin is excreted into human breast milk. No adverse efects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Pediatric usageView
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.

Pediatric population: The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated. No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years: Particular caution is recommended when prescribing to children aged between 10 and 12 years.

Renal function: As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:
  • At least annually in patients with normal renal function,
  • At least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.
Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID). GFR should be assessed before treatment initiation and regularly thereafter. Metformin is contraindicate in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function.
Overdose effectsView
Hypoglycemia has not been seen with Metformin doses up to 85 gm, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and Metformin is hemodialysis.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.

Benidon

Domperidone Maleate
Oral Suspension 5 mg/5 ml Allopathic Motility Stimulants

Indications

Vomiting

Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
  • Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
  • Eructation, flatulence, early satiety
  • Nausea and vomiting
  • Heartburn with or without regurgitations of gastric contents in the mouth
  • Non-ulcer dyspepsia
Acute nausea and vomiting of the functional, organic, infectious, dietetic origin or induced by radiotherapy or drug therapy or induced in migraine.

Parkinson's disease
: In dopamine-agonist induced nausea and vomiting.

Radiological studies
: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:
  • Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
  • Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
In dyspeptic symptom:
  • Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
  • Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
In acute and sub-acute conditions (mainly in acute nausea and vomiting):
  • Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
  • Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
By rectum in suppositories:
  • Adults (including elderly): 30-60 mg every 4-8 hours.
  • Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
  • The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.

Benidon

Domperidone Maleate
Tablet 10 mg Allopathic Motility Stimulants

Indications

Vomiting

Indication detailsView
Dyspeptic symptom complex, often associated with delayed gastric emptying, gastroesophageal reflux and esophagitis:
  • Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
  • Eructation, flatulence, early satiety
  • Nausea and vomiting
  • Heartburn with or without regurgitations of gastric contents in the mouth
  • Non-ulcer dyspepsia
Acute nausea and vomiting of the functional, organic, infectious, dietetic origin or induced by radiotherapy or drug therapy or induced in migraine.

Parkinson's disease
: In dopamine-agonist induced nausea and vomiting.

Radiological studies
: Speeding barium transit in follow-through radiological studies.
Therapeutic classView
Motility Stimulants, Motility stimulants/Dopamine antagonist, Prokinetic drugs
PharmacologyView
Domperidone is a dopamine antagonist that principally blocks the dopamine receptors located in the ChemoreceptorTrigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of the gastrointestinal tract. Due to its weak penetration across the blood-brain barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore, excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastrointestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure, and thus prevents regurgitation of gastric content.
DosageView
Domperidone should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:
  • Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
  • Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.
In dyspeptic symptom:
  • Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
  • Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.
In acute and sub-acute conditions (mainly in acute nausea and vomiting):
  • Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
  • Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).
By rectum in suppositories:
  • Adults (including elderly): 30-60 mg every 4-8 hours.
  • Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
  • The maximum period of treatment is 12 weeks.
Side effectsView
Domperidone may produce hyperprolactinemia (1.3%).This may result in galactorrhea, breast enlargement, and soreness and reduced libido. Dry mouth (1%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
ContraindicationsView
Domperidone is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastrointestinal stimulation might be dangerous i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation. Also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).
PrecautionsView
Domperidone should be used with absolute caution in the case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.
InteractionsView
Domperidone may reduce the risk of hypoprolactemic effect of bromocriptine. The action of Domperidone on Gl function may be antagonized by antimuscarinics and opoid analgesics. Care should be exercised when domperidone is administered in combination with MAO (monoamine oxidase) inhibitors.
Pregnancy & lactationView
The safety of domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated the teratogenic effect in the fetus. Domperidone may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
Overdose effectsView
There are no reported cases of overdose.
StorageView
Store below 30°C, Protected from light & moisture. Keep out of children's reach.

Benkill

Cefuroxime Axetil
Tablet 500 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
DosageView

Tablet or Suspension-

Adolescents and adults (13 years and older)-
  • Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
  • Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
  • Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
  • Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
  • Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
  • Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
  • Uncomplicated Gonorrhoea: 1000 mg Single dose
  • Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
  • MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
  • Early Lyme disease: 500 mg b.i.d. for 20 days
Paediatric Patients (3 months to 12 years)-
  • Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
  • Acute otitis media: 30 mg/kg/day b.i.d for 10 days
  • Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
  • Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

  • Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
  • Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
  • Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
  • Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
  • Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.

  • Acute exacerbations of chronic bronchitis
    : 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
  • In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
In Meningitis:
  • Adult: 3 gm IV injection three times daily.
  • Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
  • Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
In bone and joint infections:
  • Adult: 1.5 gm IV injection four times daily.
  • Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
ReconstitutionView
For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Benkill

Cefuroxime Axetil
Tablet 250 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
  • Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
DosageView

Tablet or Suspension-

Adolescents and adults (13 years and older)-
  • Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
  • Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
  • Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
  • Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
  • Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
  • Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
  • Uncomplicated Gonorrhoea: 1000 mg Single dose
  • Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
  • MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
  • Early Lyme disease: 500 mg b.i.d. for 20 days
Paediatric Patients (3 months to 12 years)-
  • Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
  • Acute otitis media: 30 mg/kg/day b.i.d for 10 days
  • Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
  • Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

  • Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
  • Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
  • Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
  • Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
  • Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.

  • Acute exacerbations of chronic bronchitis
    : 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
  • In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
In Meningitis:
  • Adult: 3 gm IV injection three times daily.
  • Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
  • Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
In bone and joint infections:
  • Adult: 1.5 gm IV injection four times daily.
  • Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
ReconstitutionView
For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.

For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.

For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.

Benkill CV

Cefuroxime Axetil + Clavulanic Acid
Tablet 500 mg+125 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
  • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
  • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
  • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
  • Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
  • Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
  • Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
  • Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
  • Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
  • Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
  • Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
  • Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
  • Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
  • MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
  • Early Lyme disease: 500 mg b.i.d. for 20 days
Paediatric Patients (3 months to 12 years)-
  • Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
  • Acute otitis media: 30 mg/kg/day b.i.d for 10 days
  • Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
  • Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.

Benkill CV

Cefuroxime Axetil + Clavulanic Acid
Tablet 250 mg+62.5 mg Allopathic Second generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
  • Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
  • Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
  • Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
  • Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
  • Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
  • Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
  • Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
  • Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
  • Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
  • Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
  • Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
  • Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
  • Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
  • Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
  • Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
  • Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
  • Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
  • Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
  • Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
  • Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
  • Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
  • MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
  • Early Lyme disease: 500 mg b.i.d. for 20 days
Paediatric Patients (3 months to 12 years)-
  • Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
  • Acute otitis media: 30 mg/kg/day b.i.d for 10 days
  • Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
  • Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.

Benlor

Desloratadine
Tablet 5 mg Allopathic Non-sedating antihistamines

Indications

Watery eye

Indication detailsView
Desloratadine is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge & itching, congestion or stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. Desloratadine is also indicated for the relief of symptoms associated with chronic idiopathic urticaria such as the relief of itching and the size & number of hives.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.
DosageView
Pediatric drops:
  • Child 6-11 months of age: 2 ml drops once daily.
  • Child 1-2 years of age: 2.5 ml drops once daily.
Syrup:
  • Child 6-11 months of age: 2 ml once daily.
  • Child 1-5 years of age: 2.5 ml once daily.
  • Child 6-11 years of age: 5 ml once daily.
  • Adults & >12 years of age: 10 ml once daily.
Tablet:
  • Adults and children 12 years of age and over: 1 tablet daily
Side effectsView
Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.
ContraindicationsView
Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.
PrecautionsView
In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.
InteractionsView
No clinically relevant drug interactions have been reported.
Pregnancy & lactationView
Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.
Pediatric usageView
Recommended in the use in children & adolescents.
Overdose effectsView
No clinically relevant adverse effects have been reported.
StorageView
Store in a cool & dry place, protected from light. Store below 30°C. Keep all medicines out of the reach of children.

Benmet

Metronidazole
Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
  • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
  • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
  • In the treatment of urogenital trichomoniasis.
  • Bacterial vaginosis (also known as non-specific vaginitis).
  • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
  • Giardiasis.
  • Acute ulcerative gingivitis.
  • Anaerobically infected leg ulcers and pressure sores.
  • Acute dental infections due to anaerobic organisms.
  • Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-
  • 200 mg tid or 400 mg bid for 7 days
  • 800 mg in the morning and 1-2 gm at night for 2 days
  • 2 gm as a single dose for 1 days
Trichomoniasis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Intestinal amoebiasis (Adults & Children over 10 yrs)- 
  • 800 mg tid for 5 days
Intestinal amoebiasis (Children)-
  • Children 7-10 yrs: 400 mg tid
  • Children 3-7 yrs: 200 mg qid
  • Children 1-3 yrs: 200 mg tid
Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
  • 400-800 mg tid for 5-10 days
Extra-intestinal & Asymptomatic amoebiasis (Children)-
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
Giardiasis (Adults & Children over 10 yrs)-
  • 2 gm once daily for 3 days
Giardiasis (Children)-
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  • 200 mg tid for 3 days
Acute ulcerative  gingivitis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Acute dental infections (Adults & Children over 10 yrs)-
  • 200 mg tid for 3-7 days
Bacterial Vaginosis (Adults & Children over 10 yrs)-
  • 400 mg bid for 7 days
  • 2 gm as a single dose for 1 days
Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
  • 400 mg tid for 7 days
Anaerobic infections (Adults & Children over 10 yrs)-
  • 800 mg initially and then 400 mg tid for 7 days
Anaerobic infections (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid
Surgical prophylaxis (Adults & Children over 10 yrs)-
  • 400 mg tid started 24  hours before  surgery for 1 days
Surgical prophylaxis (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.


Suppository:

Anaerobic Infections-
  • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
  • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
Surgical Prophylaxis-
  • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
  • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
  • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
  • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
  • Patients should be warned that metronidazole may darken urine.
InteractionsView
  • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
  • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
  • Lithium: Plasma levels of lithium may be increased by metronidazole.
  • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
  • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
  • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
  • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Benmet

Metronidazole
Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
  • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
  • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
  • In the treatment of urogenital trichomoniasis.
  • Bacterial vaginosis (also known as non-specific vaginitis).
  • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
  • Giardiasis.
  • Acute ulcerative gingivitis.
  • Anaerobically infected leg ulcers and pressure sores.
  • Acute dental infections due to anaerobic organisms.
  • Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-
  • 200 mg tid or 400 mg bid for 7 days
  • 800 mg in the morning and 1-2 gm at night for 2 days
  • 2 gm as a single dose for 1 days
Trichomoniasis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Intestinal amoebiasis (Adults & Children over 10 yrs)- 
  • 800 mg tid for 5 days
Intestinal amoebiasis (Children)-
  • Children 7-10 yrs: 400 mg tid
  • Children 3-7 yrs: 200 mg qid
  • Children 1-3 yrs: 200 mg tid
Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
  • 400-800 mg tid for 5-10 days
Extra-intestinal & Asymptomatic amoebiasis (Children)-
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
Giardiasis (Adults & Children over 10 yrs)-
  • 2 gm once daily for 3 days
Giardiasis (Children)-
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  • 200 mg tid for 3 days
Acute ulcerative  gingivitis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Acute dental infections (Adults & Children over 10 yrs)-
  • 200 mg tid for 3-7 days
Bacterial Vaginosis (Adults & Children over 10 yrs)-
  • 400 mg bid for 7 days
  • 2 gm as a single dose for 1 days
Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
  • 400 mg tid for 7 days
Anaerobic infections (Adults & Children over 10 yrs)-
  • 800 mg initially and then 400 mg tid for 7 days
Anaerobic infections (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid
Surgical prophylaxis (Adults & Children over 10 yrs)-
  • 400 mg tid started 24  hours before  surgery for 1 days
Surgical prophylaxis (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.


Suppository:

Anaerobic Infections-
  • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
  • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
Surgical Prophylaxis-
  • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
  • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
  • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
  • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
  • Patients should be warned that metronidazole may darken urine.
InteractionsView
  • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
  • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
  • Lithium: Plasma levels of lithium may be increased by metronidazole.
  • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
  • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
  • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
  • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Benocef

Cephradine
Capsule 500 mg Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
  • Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
  • Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
  • Urinary tract infections: cystitis, urethritis and pyelonephritis.
  • Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
The following microorganisms are susceptible, in vitro to Cephradine:
  • Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
  • Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
  • Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
  • Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
  • Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
Children:
  • Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
  • Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
  • Maximum daily dosage: 4 gm
Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-
  • Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
  • Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
  • Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
  • Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
  • Psychiatric disorders- Unknown: Confusion, sleep disturbances
  • Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
  • Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
  • Renal and urinary disorders- Unknown: Reversible interstitial nephritis
  • Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
  • Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
  • Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
  • Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
  • Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
  • Dosage adjustment is necessary in renal impairment.
  • This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
  • CrCl: >20 ml/min: 500 mg every 6 hours
  • CrCl: 5-20 ml/min: 250 mg every 6 hours
  • CrCl: <5 ml/min: 250 mg every 50-70 hours.
Recommendations for patients on chronic, intermittent haemodialysis:
  • 250 mg at the start of haemodialysis
  • 250 mg 6 to 12 hours after the start
  • 250 mg 36 to 48 hours after the start
  • 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Benocef

Cephradine
Powder for Suspension 125 mg/5 ml Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
  • Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
  • Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
  • Urinary tract infections: cystitis, urethritis and pyelonephritis.
  • Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
The following microorganisms are susceptible, in vitro to Cephradine:
  • Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
  • Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
  • Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
  • Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
  • Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
Children:
  • Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
  • Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
  • Maximum daily dosage: 4 gm
Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-
  • Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
  • Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
  • Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
  • Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
  • Psychiatric disorders- Unknown: Confusion, sleep disturbances
  • Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
  • Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
  • Renal and urinary disorders- Unknown: Reversible interstitial nephritis
  • Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
  • Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
  • Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
  • Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
  • Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
  • Dosage adjustment is necessary in renal impairment.
  • This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
  • CrCl: >20 ml/min: 500 mg every 6 hours
  • CrCl: 5-20 ml/min: 250 mg every 6 hours
  • CrCl: <5 ml/min: 250 mg every 50-70 hours.
Recommendations for patients on chronic, intermittent haemodialysis:
  • 250 mg at the start of haemodialysis
  • 250 mg 6 to 12 hours after the start
  • 250 mg 36 to 48 hours after the start
  • 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Benosol

Benzyl Benzoate
Lotion 1.25 gm/5 ml Allopathic Parasiticidal preparations

Indications

Scabies

Indication detailsView
Benzyl Benzoate is indicated for scabies
Therapeutic classView
Parasiticidal preparations, Topical Antifungal preparations
PharmacologyView
Benzyl benzoate is an acaricide that is used in the treatment of scabies. Benzyl benzoate exerts toxic effects on the nervous system of the parasite, resulting in its death. It is also toxic to mite ova, though its exact mechanism of action is unknown. In vitro, benzyl benzoate has been found to kill the Sarcoptes mite within 5 minutes.
DosageView
Adult: Apply 3 times at 12 hourly intervals over the whole body, wash-off 12 hr after the last application.
Side effectsView
Irritant to eyes and mucous membranes, allergic dermatitis reactions, drying effects in the elderly.
ContraindicationsView
Broken or irritated skin; neonates; pregnancy.
PrecautionsView
Prevent drug from entering the eyes, elderly (drying effects).
InteractionsView
Irritant to eyes and mucous membranes, allergic dermatitis reactions, drying effects in the elderly.
Pregnancy & lactationView
Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
StorageView
Store below 25°C.

Benostar

Benzydamine Hydrochloride
Mouthwash 0.15% Allopathic Topical anti-inflammatory preparations

Indications

Sore throat

Indication detailsView
Benzydamine Hydrochloride mouthwash is used to treat many painful conditions affecting the throat or mouth including: Sore throat, Sore tongue or gums, Mouth ulcers, Discomfort caused by dentures, Pain after dental surgery etc.
Therapeutic classView
Topical anti-inflammatory preparations
PharmacologyView
Benzydamine Hydrochloride mouthwash is a Non-Steroidal Anti-Inflammatory Drug (NSAID) with analgesic and local anesthetic properties. The clinical pharmacology of Benzydamine mouthwash is well known. Benzydamine is poorly absorbed in the blood, thereby limiting systemic exposure to the drug when applied topically but ensures high concentration at the site of injury in mouth or throat. Therefore, it provides excellent oropharyngeal pain relief with minimal side effects.

Although Benzydamine is a Non-Steroidal Anti-Inflammatory agent, it possesses a different mechanism of action that distinguishes it from conventional NSAIDs. Benzydamine mouthwash shows analgesic & anti-inflammatory action by inhibiting pro-inflammatory cytokines & reducing vascular permeability. Moreover, Benzydamine mouthwash shows local anesthetic property which provides an immediate effect on pain.
DosageView
15 ml of Benzydamine mouthwash should be rinsed or gargled every 1.5-3 hours or as required, for 20-30 seconds. If stinging occurs, it can be diluted with an equal volume of water.
Side effectsView
Benzydamine Hydrochloride mouthwash can cause side effects, although not everybody gets them. Side effects are generally minor.
  • Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects throat and makes breathing difficult and swallowing difficult, patients should be hospitalized
  • Itchy rash, sometimes with pale, raised areas of skin with red edges (urticaria).
  • A feeling of numbness in mouth.
  • A stinging feeling in mouth- the mouthwash may be diluted with water if you experience stinging. This should help to reduce the stinging effect.
ContraindicationsView
Patients allergic (hypersensitive) to Benzydamine or other component of mouthwash should not use the preparation. Contact with eye should be avoided. If accidentally get into eyes, they should be immediately washed with cold water.
Pregnancy & lactationView
The safety of Benzydamine has not been established in pregnant patients. Risk to benefit ratio should be established if this drug is to be used in these patients.
StorageView
Keep away from light, store in cool and dry place under 30º C. Keep out of reach of children.

Benoxiclin

Clindamycin + Benzoyl peroxide
Topical Gel 1%+5% Allopathic Benzoyl peroxide, Azelaic acid & other preparations

Indications

Acne vulgaris

Indication detailsView
Indicated in acne vulgaris.
Therapeutic classView
Benzoyl peroxide, Azelaic acid & other preparations
PharmacologyView
Clindamycin is a semi-synthetic derivative of lincomycin. It inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunits thus blocking the transpeptidation or translocation reactions of susceptible organisms.

Benzoyl peroxide has mild keratolytic effect and antimicrobial activity which is attributed to its potent oxidizing activity. Clindamycin and Benzoyl peroxide are both active against Propionibacterium acnes, an organism associated with acne vulgaris.
DosageView
Apply to the affected areas once or twice daily (morning and evening) after the skin is gently washed and patted dry.
Side effectsView
Application site pain, Application site exfoliation, Application site irritation, Erythema, Burning, Pruritus, Sunburn, Scaling, Drynes, Colitis, Peelin.
ContraindicationsView
Hypersensitivity to Clindamycin, lincomycin, benzoyl peroxide, or any component of the formulation; history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.
PrecautionsView
Avoid contact with mouth, eyes, lips & mucous membranes; abraded or eczematous skin. May discolor hair & dyed fabrics. Pregnancy & lactation.
InteractionsView
May enhance the action of neuromuscular blocking agents (e.g. atracurium). May antagonise the effects of parasympathomimetics. May competitively inhibit the effects of macrolides, ketolides, streptogramins, linezolid and chloramphenicol. Increased coagulation tests (prothrombin time/INR) and/or bleeding with vit K antagonists (e.g. warfarin, acenocoumarol, fluindione). PABA sunscreens may transiently discolour fabric.
Pregnancy & lactationView
Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Lactation: Excretion in milk is unknown/ not recommended
ReconstitutionView
Refer to individual product recommendations. Some combination products require reconstitution at the time of dispensing by dissolving the Clindamycin powder with purified water, add the solution to the Benzoyl peroxide gel provided and stir until the gel appears homogenous.

Benoxil

Amoxicillin Trihydrate
Powder for Suspension 125 mg/5 ml Allopathic Broad spectrum penicillins

Indications

Skin and skin sructure infections

Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
  • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
  • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
  • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
  • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
  • Venereal disease (i.e. acute uncomplicated gonorrhoea)
  • In dental abscess, it is used as short-term therapy.
  • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
  • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
  • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
  • Pneumonia: Recommended dose is 500-1000 mg three times daily.
  • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
  • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
  • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
  • In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
  • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
  • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Benoxil

Amoxicillin Trihydrate
Capsule 500 mg Allopathic Broad spectrum penicillins

Indications

Skin and skin sructure infections

Indication detailsView
Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
  • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
  • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
  • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
  • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
  • Venereal disease (i.e. acute uncomplicated gonorrhoea)
  • In dental abscess, it is used as short-term therapy.
  • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
Therapeutic classView
Broad spectrum penicillins
PharmacologyView
Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
DosageView
Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
  • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
  • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
  • Pneumonia: Recommended dose is 500-1000 mg three times daily.
  • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
  • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
  • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
  • In renal impairment: it may be necessary to reduce the total daily dosage.
AdministrationView
Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
Side effectsView
Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
ContraindicationsView
Amoxicillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
InteractionsView
Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Pregnancy & lactationView
US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
ReconstitutionView
Amoxycillin 500 mg Injection:
  • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
  • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Benozol

Brinzolamide
Ophthalmic Suspension 1% Allopathic Drugs for miotics and glaucoma

Indications

Open angle glaucoma

Indication detailsView
Brinzolamide Ophthalmic Suspension is indicated as monotherapy, or as adjunctive therapy to beta-blockers in the treatment of elevated intraocular pressure in ocular hypertension, or open-angle glaucoma.
Therapeutic classView
Drugs for miotics and glaucoma
PharmacologyView
Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyses the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. It exists as a number of isoenzymes, the most active being carbonic anhydrase II (CA-II), found primarily in red blood cells, but also in other tissues. Inhibition of carbonic anhydrase in the ciliary processes of the eye decreases aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fuid transport.

Following topical ocular administration, brinzolamide inhibits aqueous humor formation and reduces elevated intraocular pressure. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual feld loss.
DosageView
The recommended dose is one drops of this eye drop in the conjunctival sac of the affected eye(s) twice daily. Some patients may have a better response with one drop three times a day. Shake well before use.
Side effectsView
Reported side effects are blurred vision and bitter, sour or unusual taste. Other side effects are blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus and rhinitis.
ContraindicationsView
It is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
  • Brinzolamide ophthalmic suspension and its metabolite are excreted predominantly by the kidney. So, it is not recommended in severe renal impaired patients.
  • Brinzolamide ophthalmic suspension has not been studied in patients with hepatic impairment and should be used with caution in such patients.
  • The concomitant administration of Brinzolamide ophthalmic suspension and oral carbonic anhydrase inhibitor is not recommended due to no additional benefits.
  • If hypersensitivity reaction occurs after instillation patients should be advised to discontinue the use of Brinzolamide and consult with physicians.
InteractionsView
In patients treated with oral carbonic anhydrase inhibitors, rare instances to drug interactions have occurred with high-dose salicylate therapy. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide.
Pregnancy & lactationView
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide 1% ophthalmic suspension should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Brinzolamide 1% ophthalmic suspension is excreted in human milk. So, lactating mother should discontinue nursing or to discontinue the drug, depending upon the importance of the drug to the mother.
Overdose effectsView
Although no human data are available, electrolyte imbalance, development of an acidosis state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
StorageView
Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than four weeks after first opening of the bottle. Protect from freezing.

Benozol BR

Brinzolamide + Brimonidine Tartrate
Ophthalmic Suspension 1%+0.2% Allopathic Drugs for miotics and glaucoma

Indications

Open angle glaucoma

Indication detailsView
This is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Therapeutic classView
Drugs for miotics and glaucoma
PharmacologyView
Brinzolamide is a carbonic anhydrase inhibitor which reduce intraocular pressure (IOP) by decreasing aqueous humor secretion in the ciliary processes of the eye.

Brimonidine Tartrate is an alpha 2 adrenergic receptor agonist which reduces IOP by decreasing aqueous humor production and increasing uveoscleral outflow.
DosageView
Instill one drop in the affected eye(s) three times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Shake well before use.
Side effectsView
The most commonly reported side effects include blurred vision, eye irritation, bad taste and dry mouth.
ContraindicationsView
It is contraindicated in patients who are hypersensitivity to Brinzolamide, Brimonidine Tartrate, or to any ingredient in the formulation and Neonates and Infants (under the age of 2 years).
PrecautionsView
Shake well before use. For ophthalmic use only. Contact lenses should be removed during instillation of Brinzolamide and Brimonidine Tartrate ophthalmic suspension, but may be reinserted 15 minutes after instillation.
InteractionsView
In patients treated with this drop rare instances to drug interactions have occurred with high-dose salicylate therapy, CNS Depressants, Antihypertensives/ Cardiac Glycosides, Tricyclic Antidepressants, Monoamine Oxidase Inhibitors. Therefore, the potential for such drug interactions should be considered in patients receiving Brinzolamide + Brimonidine Tartrate .
Pregnancy & lactationView
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Brinzolamide and Brimonidine Tartrate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether Brinzolamide or Brimonidine Tartrate are excreted in human milk. Caution should be exercised while giving this ophthalmic suspension to a nursing mother.
Pediatric usageView
Use in children: Safety & effectiveness in children below the age of 2 years have not been established.

Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
Overdose effectsView
Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of Brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of Brimonidine Tartrate in adults; the only adverse event reported to date has been hypotension. Symptoms of Brimonidine Tartrate overdose have been reported in neonates, infants, and children receiving Brimonidine Tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
StorageView
Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle. Shake well before use & do not freeze.

Benprox

Ciprofloxacin
Tablet 500 mg Allopathic Anti-diarrhoeal Antimicrobial drugs

Indications

Urinary tract infection

Indication detailsView
Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.
Therapeutic classView
4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs
PharmacologyView
Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.
DosageView
Tablet: Adult:
  • Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
  • Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
  • Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
  • Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
  • Typhoid fever: 500 mg twice daily (7 days)
  • Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
  • Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
  • Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
  • Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
  • Gonorrhea: 500 mg as a single dose
  • Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
  • Meningitis: 500 mg as a single dose.
  • Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.
Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:
  • Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
  • Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
  • Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
  • Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
  • Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
  • Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
  • Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
  • Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
AdministrationView
Instruction for the use of Ciprofloxacin IV infusion-
  • Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
  • Do not use if the solution is cloudy or a precipitate is present.
  • Do not use flexible bags in series connections.
  • Close flow control clamp of administration set.
  • Remove cover from port at bottom of bag.
  • Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
  • Suspend bag from hanger.
  • Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
  • Open flow control clamp to expel air from set.Close clamp.
  • Regulate rate of administration with flow control clamp
Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.
Side effectsView
Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.
ContraindicationsView
It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.
PrecautionsView
Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.
InteractionsView
Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.
Pediatric usageView
Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.
Overdose effectsView
Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.