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Reflon
Glucosamine Hydrochloride
Reflon
Glucosamine Hydrochloride
Indications
Rheumatoid arthritis
Indication detailsView
Indicated for the treatment of osteoarthritis of knee, hip, spine, and other locations. Also indicated as dietary supplement.
Therapeutic classView
Stimulation of Cartilage formation
PharmacologyView
Glucosamine is a naturally occurring compound for the body's production of joint lubricants and shock absorbers necessary to maintain healthy cartilage and joint function. Glucosamine hydrochloride is a prodrug for glucosamine that is well absorbed after oral administration and diffuses into several tissues, including bones and articular cartilages. The active ingredient in the treatment of osteoarthritis is glucosamine. The hydrochloride acid salt is the delivery vehicle. Once it has entered the stomach, after oral administration the salt's job is done and it is the glucosamine that is released to perform its function.
Data supports Glucosamine as the first anti-osteoarthritic drug that treats both sign and symptoms of osteoarthritis & modifies disease progression. It is as effective as NSAIDs with significantly better tolerability and clinical compliances.
Data supports Glucosamine as the first anti-osteoarthritic drug that treats both sign and symptoms of osteoarthritis & modifies disease progression. It is as effective as NSAIDs with significantly better tolerability and clinical compliances.
DosageView
500 mg tablet three times daily or as directed by the physician. A single dose of 1500 mg daily may also be effective. Obese individuals may need higher doses, based on body weight.
Side effectsView
Safety studies with Glucosamine show no demonstrable toxicity. Rarely occurring side effects like mild & reversible intestinal flatulence are almost like placebo.
ContraindicationsView
There are no known contraindications for Glucosamine. But proven hypersensitivity to Glucosamine is a contraindication.
PrecautionsView
Diabetics are advised to monitor blood glucose levels regularly while taking Glucosamine. No special studies were formed in patients with renal and/or hepatic insufficiency. The toxicological and pharmacokinetic profile of the product does not indicate limitations for these patients. However, administration to these patients with severe hepatic or renal insufficiency should be under appropriate medical supervision.
InteractionsView
There have been no reports of significant drug interactions of Glucosamine with antibiotics, antidepressants, antihypertensives, nitrates, antiarrhythmics, anxiolytic, hypoglycaemic agents, anti-secretives.
Pregnancy & lactationView
Women who are pregnant or who could become pregnant should not supplement with glucosamine. Glucosamine has not been studied enough to determine their effects on a developing fetus. And no studies have evaluated the use of Glucosamine during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.
StorageView
Should be stored in cool and dry place.
Refol Z TR
Iron Polymaltose Complex + Folic Acid + Zinc Sulfate
Refol Z TR
Iron Polymaltose Complex + Folic Acid + Zinc Sulfate
Indications
Iron, Folic Acid and zinc deficiency during pregnancy and lactation
Indication detailsView
This tablet is indicated for the treatment and prevention of Iron, Folic Acid and Zinc deficiencies.
Therapeutic classView
Iron, Vitamin & Mineral Combined preparation
PharmacologyView
This tablet is the preparation of Iron, Folic Acid and Zinc. In this preparation, Iron is present as Iron (III) Hydroxide Polymaltose Complex, a noble Iron preparation. It contains non-ionic Ferric Iron and Polymaltose in a stable complex. This complex facilitates a controlled absorption of the Iron when it comes in contact with the mucosal cell surface. Due to non-ionic nature, Iron (III) Hydroxide Polymaltose Complex is more stable than conventional Iron form. Folic Acid helps in the proper development of the fetus. Zinc keeps enzymes working and helps to metabolize proteins.
DosageView
One tablet daily. Two tablets may be required a day in severe cases or as directed by the physician.
Side effectsView
This tablet is generally well tolerated. However, a few side effects of oral Iron preparations, including nausea, vomiting, constipation or diarrhoea may occur rarely.
ContraindicationsView
This tablet is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.
PrecautionsView
As with all Iron preparations, dark coloration of the stool may occur which is without clinical significance.
InteractionsView
Since Iron is complex bound, ionic interaction with foodstuff components (phytates, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur.
Pregnancy & lactationView
Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron in the first trimester requires definite evidence of Iron deficiency.
Overdose effectsView
No intoxication or Iron overloaded has been reported in case of overdose.
StorageView
Keep in a cool & dry place away from light and moisture. Keep out of the reach of children.
Refolic
Folic Acid
Refolic
Folic Acid
Indications
Nutritional supplement
Indication detailsView
Folic acid is indicated for the treatment of-
- Folic acid deficiency
- Megaloblastic anemia
- Anemias of nutritional origins, pregnancy, infancy, or childhood.
Therapeutic classView
Drugs for Megaloblastic Anemia, Vitamin-B preparations
PharmacologyView
Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.
DosageView
Adults-
- Initially: 5 mg daily for 4 months.
- maintenance: 5 mg every 1-7 days depending on the underlying disease.
- Up to 1 year: 500 mcg/kg daily.
- Over 1 year: Same as adult dose.
Side effectsView
Folic acid is generally well tolerated. Gastro-intestinal disturbances may occur. Hypersensitivity reactions have been reported rarely.
ContraindicationsView
Folic acid is contraindicated in patients who have shown previous intolerance to the drug.
PrecautionsView
It should be used with caution in patients who may have folate dependent tumours. It should never be given alone or in conjunction with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anaemia. Although folic acid may produce a haematopoietic response in patients with a megaloblastic anaemia due to vitamin B12 deficiency it should not be given alone in vitamin B12 deficiency states as it may precipitate the onset of subacute combined degeneration of the cord. In elderly people a cobalamin absorption test should be done before long term folate. No harmful results found from short courses of folate.
InteractionsView
None has been reported.
Pregnancy & lactationView
No special precautions are known.
StorageView
Store below 30°C in a dry place, away from light. Keep out of the reach of children.
Refresh Liquigel
Carboxymethylcellulose Sodium
Refresh Liquigel
Carboxymethylcellulose Sodium
Indication detailsView
It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
PharmacologyView
Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
DosageView
Instill 1 drop in the affected eye(s) 4 times a day or as needed.
Side effectsView
Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.
ContraindicationsView
This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.
InteractionsView
Not known.
Pregnancy & lactationView
Safe use during pregnancy and lactation has not been established.
Pediatric usageView
Pediatric use: This eye drop should not be used in infants and small children under 3 years.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
StorageView
The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.
Refresh Tears
Carboxymethylcellulose Sodium
Refresh Tears
Carboxymethylcellulose Sodium
Indication detailsView
It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
PharmacologyView
Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
DosageView
Instill 1 drop in the affected eye(s) 4 times a day or as needed.
Side effectsView
Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.
ContraindicationsView
This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.
InteractionsView
Not known.
Pregnancy & lactationView
Safe use during pregnancy and lactation has not been established.
Pediatric usageView
Pediatric use: This eye drop should not be used in infants and small children under 3 years.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
StorageView
The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.
Refresh-i
Carboxymethylcellulose Sodium
Refresh-i
Carboxymethylcellulose Sodium
Indication detailsView
It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
PharmacologyView
Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.
DosageView
Instill 1 drop in the affected eye(s) 4 times a day or as needed.
Side effectsView
Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.
ContraindicationsView
This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.
PrecautionsView
Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.
InteractionsView
Not known.
Pregnancy & lactationView
Safe use during pregnancy and lactation has not been established.
Pediatric usageView
Pediatric use: This eye drop should not be used in infants and small children under 3 years.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
StorageView
The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.
Refurox
Cefuroxime Axetil
Refurox
Cefuroxime Axetil
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
- 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).
- 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.
- 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.
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.
Refurox
Cefuroxime Axetil
Refurox
Cefuroxime Axetil
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
- 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).
- 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.
- 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.
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.
Regab
Pregabalin
Regab
Pregabalin
Indication detailsView
Pregabalin is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
- Fibromyalgia
- Neuropathic pain associated with spinal cord injury
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
Therapeutic classView
Adjunct anti-epileptic drugs, Primary anti-epileptic drugs
PharmacologyView
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
DosageView
Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
- 75 mg/daily: 82.5 mg/day
- 150 mg/daily: 165 mg/day
- 225 mg/daily: 247.5 mg/day
- 300 mg/daily: 330 mg/day
- 450 mg/daily: 495 mg/day
- 600 mg/daily: 660 mg/day
AdministrationView
Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.
Side effectsView
Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.
ContraindicationsView
Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
PrecautionsView
Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.
InteractionsView
Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
Pregnancy & lactationView
There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Pediatric usageView
Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.
Overdose effectsView
In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Regab
Pregabalin
Regab
Pregabalin
Indication detailsView
Pregabalin is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
- Fibromyalgia
- Neuropathic pain associated with spinal cord injury
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
Therapeutic classView
Adjunct anti-epileptic drugs, Primary anti-epileptic drugs
PharmacologyView
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
DosageView
Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
- 75 mg/daily: 82.5 mg/day
- 150 mg/daily: 165 mg/day
- 225 mg/daily: 247.5 mg/day
- 300 mg/daily: 330 mg/day
- 450 mg/daily: 495 mg/day
- 600 mg/daily: 660 mg/day
AdministrationView
Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.
Side effectsView
Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.
ContraindicationsView
Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
PrecautionsView
Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.
InteractionsView
Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
Pregnancy & lactationView
There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Pediatric usageView
Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.
Overdose effectsView
In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Regab
Pregabalin
Regab
Pregabalin
Indication detailsView
Pregabalin is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
- Fibromyalgia
- Neuropathic pain associated with spinal cord injury
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
Therapeutic classView
Adjunct anti-epileptic drugs, Primary anti-epileptic drugs
PharmacologyView
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
DosageView
Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
- 75 mg/daily: 82.5 mg/day
- 150 mg/daily: 165 mg/day
- 225 mg/daily: 247.5 mg/day
- 300 mg/daily: 330 mg/day
- 450 mg/daily: 495 mg/day
- 600 mg/daily: 660 mg/day
AdministrationView
Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.
Side effectsView
Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.
ContraindicationsView
Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
PrecautionsView
Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.
InteractionsView
Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
Pregnancy & lactationView
There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Pediatric usageView
Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.
Overdose effectsView
In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Regab
Pregabalin
Regab
Pregabalin
Indication detailsView
Pregabalin is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
- Fibromyalgia
- Neuropathic pain associated with spinal cord injury
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
Therapeutic classView
Adjunct anti-epileptic drugs, Primary anti-epileptic drugs
PharmacologyView
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
DosageView
Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
- 75 mg/daily: 82.5 mg/day
- 150 mg/daily: 165 mg/day
- 225 mg/daily: 247.5 mg/day
- 300 mg/daily: 330 mg/day
- 450 mg/daily: 495 mg/day
- 600 mg/daily: 660 mg/day
AdministrationView
Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.
Side effectsView
Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.
ContraindicationsView
Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
PrecautionsView
Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.
InteractionsView
Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
Pregnancy & lactationView
There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Pediatric usageView
Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.
Overdose effectsView
In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Regab
Pregabalin
Regab
Pregabalin
Indication detailsView
Pregabalin is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
- Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
- Fibromyalgia
- Neuropathic pain associated with spinal cord injury
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
- Postherpetic neuralgia (PHN)
Therapeutic classView
Adjunct anti-epileptic drugs, Primary anti-epileptic drugs
PharmacologyView
Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
DosageView
Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).
Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.
Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.
Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.
Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)
- 75 mg/daily: 82.5 mg/day
- 150 mg/daily: 165 mg/day
- 225 mg/daily: 247.5 mg/day
- 300 mg/daily: 330 mg/day
- 450 mg/daily: 495 mg/day
- 600 mg/daily: 660 mg/day
AdministrationView
Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.
Side effectsView
Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.
ContraindicationsView
Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
PrecautionsView
Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Pregabalin should be discontinued immediately in these cases. Pregabalin should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with pregabalin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Pregabalin may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Pregabalin should be withdrawn gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Caution should be exercised when coadministering pregabalin and thiazolidinedione antidiabetic agents.
InteractionsView
Pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions.
Pregnancy & lactationView
There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Pediatric usageView
Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of pregabalin extended-release tablet in pediatric patients have not been established.
Overdose effectsView
In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
StorageView
Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.
Regain
Minoxidil
Regain
Minoxidil
Indications
Male pattern baldness
Indication detailsView
Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.
Therapeutic classView
Other scalp preparations
PharmacologyView
Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
DosageView
Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
Side effectsView
Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.
ContraindicationsView
- Patients with cardiac abnormalities
- Children below 18 years of age
- Patients using occlusive dressings or other medicines on the scalp
- Patients with red, inflamed infection, or irritated or painful scalp (including psoriasis & sunburn)
PrecautionsView
Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.
InteractionsView
Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.
Pregnancy & lactationView
Minoxidil topical solution should not be used during pregnancy and lactation.
Overdose effectsView
Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
StorageView
Store at a cool and dry place, protected from light. Keep out of the reach of the children.
Regain
Minoxidil
Regain
Minoxidil
Indications
Male pattern baldness
Indication detailsView
Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.
Therapeutic classView
Other scalp preparations
PharmacologyView
Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.
DosageView
Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.
Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.
Side effectsView
Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.
ContraindicationsView
- Patients with cardiac abnormalities
- Children below 18 years of age
- Patients using occlusive dressings or other medicines on the scalp
- Patients with red, inflamed infection, or irritated or painful scalp (including psoriasis & sunburn)
PrecautionsView
Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.
InteractionsView
Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.
Pregnancy & lactationView
Minoxidil topical solution should not be used during pregnancy and lactation.
Overdose effectsView
Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.
StorageView
Store at a cool and dry place, protected from light. Keep out of the reach of the children.
Reganex
Regorafenib
Reganex
Regorafenib
Indications
Hepatocellular Carcinoma
Indication detailsView
Regorafenib is a kinase inhibitor that is indicated:
- For the treatment of metastatic colorectal cancer (CRC) after disease progression on or intolerance to fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy.
- For the treatment of unresectable or metastatic gastrointestinal stromal tumours (GIST) after disease progression on or intolerance to prior treatment with imatinib and sunitinib.
- For the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib
Therapeutic classView
Targeted Cancer Therapy
PharmacologyView
Regorafenib is a kinase inhibitor and it inhibits multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. Regorafenib or its major human active metabolites M-2 and M-5 inhibits the activity of RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl. Due to its inhibitory functions, regorafenib can inhibit the progression of certain solid tumors.
DosageView
Metastatic colorectal cancer (CRC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumours (GIST): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Hepatocellular carcinoma (HCC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Gastrointestinal stromal tumours (GIST): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Hepatocellular carcinoma (HCC): 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Side effectsView
The most common side effects (≥30%) are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)], diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia.
PrecautionsView
- Hemorrhage: Permanently discontinue regorafenib for severe or life-threatening hemorrhage.
- Dermatological toxicity: Interrupt and then reduce or discontinue regorafenib depending on severity and persistence of dermatologic toxicity.
- Hypertension: Temporarily or permanently discontinue regorafenib for severe or uncontrolled hypertension.
- Cardiac ischemia and infarction: Withhold regorafenib for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue regorafenib.
- Gastrointestinal perforation or fistulae: Discontinue regorafenib.
- Wound healing complications: Stop regorafenib before surgery. Discontinue in patients with wound dehiscence.
- Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to a fetus.
InteractionsView
CYP3A4 Inhibitors: Avoid concomitant use of strong CYP3A4 inhibitors with Regorafenib.
CYP3A4 Inducers: Avoid concomitant use of strong CYP3A4 inducers with Regorafenib.
CYP3A4 Inducers: Avoid concomitant use of strong CYP3A4 inducers with Regorafenib.
Pregnancy & lactationView
Regorafenib is Pregnancy Category D. Based on its mechanism of action, Regorafenib can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies with Regorafenib in pregnant women. Based on animal reproduction studies Regorafenib was seen to cause embryo lethal and teratogenic defects and also increased the incidences of cardiovascular, genitourinary, and skeletal malformations in animals. Advice pregnant women or women with reproductive potential of the potential hazards of Regorafenib to the fetus. There is no information regarding the presence of regorafenib or its metabolites being excreted in human milk. Regorafenib and its metabolites were excreted in rat milk and because of the potential for serious adverse reactions in nursing infants from Regorafenib, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and effectiveness of Regorafenib in pediatric patients less than 18 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between adult subjects and younger subjects.
Hepatic Impairment: No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. Regorafenib is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) as it has not been studied in this population.
Renal Impairment: No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min/1.73m2). Regorafenib has not been studied in patients with severe renal impairment or end-stage renal disease.
Females and Males of Reproductive Potential: Contraception: Use effective contraception during treatment and up to 2 months after completion of therapy.
Infertility: There are no data on the effect of regorafenib on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility
Geriatric Use: No overall differences in safety or effectiveness were observed between adult subjects and younger subjects.
Hepatic Impairment: No clinically important differences in the mean exposure of regorafenib or the active metabolites M-2 and M-5 were observed in patients with hepatocellular carcinoma and mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to patients with normal hepatic function. No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. Regorafenib is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) as it has not been studied in this population.
Renal Impairment: No dose adjustment is recommended for patients with mild renal impairment. Limited pharmacokinetic data are available from patients with moderate renal impairment (CLcr 30-59 mL/min/1.73m2). Regorafenib has not been studied in patients with severe renal impairment or end-stage renal disease.
Females and Males of Reproductive Potential: Contraception: Use effective contraception during treatment and up to 2 months after completion of therapy.
Infertility: There are no data on the effect of regorafenib on human fertility. Results from animal studies indicate that regorafenib can impair male and female fertility
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Regerd
Omeprazole
Regerd
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Regerd
Omeprazole
Regerd
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Regler
Dexlansoprazole
Regler
Dexlansoprazole
Indications
Oesophagitis
Indication detailsView
Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.
Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean Cmax and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.
DosageView
Dexlansoprazole dosing recommendations-
- Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
- Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
- Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks
AdministrationView
Dexlansoprazole can be taken without regard to food. It should be swallowed whole.
Alternatively, Dexlansoprazole capsules can be administered as follows:
If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
Alternatively, Dexlansoprazole capsules can be administered as follows:
- Open capsule
- Sprinkle intact granules on one tablespoon
- Swallow immediately.
If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
Side effectsView
Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.
ContraindicationsView
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
PrecautionsView
Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.
InteractionsView
With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.
Pregnancy & lactationView
Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.
Pediatric usageView
Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.
Geriatric use: No dose adjustment is necessary for elderly patients.
Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.
Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.
Geriatric use: No dose adjustment is necessary for elderly patients.
Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.
Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.
Overdose effectsView
There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.
StorageView
Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.
Regler
Dexlansoprazole
Regler
Dexlansoprazole
Indications
Oesophagitis
Indication detailsView
Healing of Erosive Esophagitis: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.
Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease: Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD) for 4 weeks.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Dexlansoprazole delayed-release capsule is a Proton Pump Inhibitor (PPI) which suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step of acid production. It is the R-enantiomer of lansoprazole (A racemic mixture of the R- and S-enantiomers). Dexlansoprazole is supplied as a Dual Delayed Release (DDR) formulation in a capsule for oral administration. This capsule contains a mixture of two types of enteric coated granules with different pH-dependent dissolution profiles. The dual delayed release formulation in dexlansoprazole, plasma concentration-time profile with two distinct peaks; the first peak occurs 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. After oral administration, mean Cmax and AUC value of Dexlansoprazole increased approximately dose proportionally. Dexlansoprazole is extensively metabolized in the liver and excreated by urine.
DosageView
Dexlansoprazole dosing recommendations-
- Maintenance of Healed erosive esophagitis and relief of heartburn: 30 mg Once daily
- Symptomatic Non-Erosive GERD: 30 mg Once daily for 4 weeks
- Healing of erosive esophagitis: 60 mg Once daily for up to 8 weeks
AdministrationView
Dexlansoprazole can be taken without regard to food. It should be swallowed whole.
Alternatively, Dexlansoprazole capsules can be administered as follows:
If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
Alternatively, Dexlansoprazole capsules can be administered as follows:
- Open capsule
- Sprinkle intact granules on one tablespoon
- Swallow immediately.
If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
Side effectsView
Common side effects: Diarrhea, abdominal pain, nausea, vomiting & flatulence.
ContraindicationsView
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
PrecautionsView
Gastric Malignancy, Clostridium difficile Associated Diarrhea, Bone fracture, Hypomagnesemia, and concomitant use of Dexlansoprazole with Methotrexate.
InteractionsView
With medicine: Atazanavir, Warfarin, Tacrolimus, Clopidogrel & Methotrexate. With food & others: No data available.
Pregnancy & lactationView
Pregnancy Category B. There is no adequate and well-controlled studies with Dexlansoprazole in pregnant women. There is no adequate and well-controlled studies with Dexlansoprazole in Lactating mother.
Pediatric usageView
Use in children & adolescents: Safety and effectiveness of Dexlansoprazole in patients below 12 years age have not been established.
Geriatric use: No dose adjustment is necessary for elderly patients.
Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.
Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.
Geriatric use: No dose adjustment is necessary for elderly patients.
Renal impairment: No dose adjustment of Dexlansoprazole is necessary for patients with renal
impairment.
Hepatic impairment: No dose adjustment for Dexlansoprazole is necessary for patients with mild hepatic impairment. A maximum daily dose of Dexlansoprazole 30 mg should be considered for patients with moderate hepatic impairment.
Overdose effectsView
There have been no reports of a significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in death or other severe adverse events.
StorageView
Store below 30°C temperature & in a dry place, protected from light. Keep all medicines out of reach of children.