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Cpzith

Azithromycin Dihydrate

Powder for Suspension 200 mg/5 ml Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Cran-B

Cranberry [Vaccinium macrocarpon]

Capsule 400 mg Herbal Herbal and Nutraceuticals

Indications

Urinary tract infection

Indication detailsView

Cranberry is indicated for-

The treatment and prevention of urinary tract infection.
Kidney stones.

Therapeutic classView

Herbal and Nutraceuticals

PharmacologyView

Cranberry (Vaccinium macrocarpon) is a native North American plant commonly used for reduction in urinary tract infections (UTIs) occurrence and kidney stone management. Cranberry reduces the need for repeated antibiotic use in the treatment of recurrent urinary tract infection. Bacterial adherence to mucosal surfaces is generally considered to be the initial event in the pathogenesis of most infectious diseases due to bacteria in human such as UTIs. Cranberry inhibits adherence of bacteria to the lining of the urinary bladder and urethra. At higher dose it also works as a urinary antiseptic and reduces incidence of stone formation. Recent publications show as much as 65% reduction in UTI with cranberry consumption leading to reduced use of antibiotics and reduction in the number of incidences of recurrent cystitis.

DosageView

1-3 capsules daily or as advised by the physician.

Side effectsView

Well tolerated in recommended dose. Occasionally diarrhea or mild gastrointestinal upset may occur at high dose.

ContraindicationsView

Potential contraindications of cranberry may be present with renal insufficiency and in persons with the potential for developing uric acid or calcium oxalate stones.

InteractionsView

No known interactions with antibiotics or other drugs. Cranberry enhances vitamin B₁₂ absorption, which is useful for patients taking omeprazole, a drug used to treat ulcers.

Pregnancy & lactationView

No known restrictions during pregnancy or lactation.

StorageView

Store in a cool and dry place, away from light and moisture. Keep out of reach of children.

Cranbiotic

Cranberry [Vaccinium macrocarpon]

Capsule 400 mg Herbal Herbal and Nutraceuticals

Indications

Urinary tract infection

Indication detailsView

Cranberry is indicated for-

The treatment and prevention of urinary tract infection.
Kidney stones.

Therapeutic classView

Herbal and Nutraceuticals

PharmacologyView

Cranberry (Vaccinium macrocarpon) is a native North American plant commonly used for reduction in urinary tract infections (UTIs) occurrence and kidney stone management. Cranberry reduces the need for repeated antibiotic use in the treatment of recurrent urinary tract infection. Bacterial adherence to mucosal surfaces is generally considered to be the initial event in the pathogenesis of most infectious diseases due to bacteria in human such as UTIs. Cranberry inhibits adherence of bacteria to the lining of the urinary bladder and urethra. At higher dose it also works as a urinary antiseptic and reduces incidence of stone formation. Recent publications show as much as 65% reduction in UTI with cranberry consumption leading to reduced use of antibiotics and reduction in the number of incidences of recurrent cystitis.

DosageView

1-3 capsules daily or as advised by the physician.

Side effectsView

Well tolerated in recommended dose. Occasionally diarrhea or mild gastrointestinal upset may occur at high dose.

ContraindicationsView

Potential contraindications of cranberry may be present with renal insufficiency and in persons with the potential for developing uric acid or calcium oxalate stones.

InteractionsView

No known interactions with antibiotics or other drugs. Cranberry enhances vitamin B₁₂ absorption, which is useful for patients taking omeprazole, a drug used to treat ulcers.

Pregnancy & lactationView

No known restrictions during pregnancy or lactation.

StorageView

Store in a cool and dry place, away from light and moisture. Keep out of reach of children.

Creso

Esomeprazole

Tablet (Enteric Coated) 40 mg Allopathic

Indication detailsView

Esomeprazole is indicated:

To relieve from chronic heartburn symptoms and other symptoms associated with GERD
For the healing of erosive esophagitis
For maintenance of healing of erosive esophagitis
In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Zollinger-Ellison Syndrome
Acid related Dyspepsia
Duodenal & Gastric ulcer

PharmacologyView

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.

Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.

Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.

Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.

DosageView

Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive

Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).

Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.

Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.

Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.

Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.

AdministrationView

Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.

Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.

Side effectsView

The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.

ContraindicationsView

Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.

PrecautionsView

General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.

Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.

InteractionsView

Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.

Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.

Pediatric usageView

Paediatric Use: Safety and effectiveness in paediatric patients have not been established.

Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.

Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.

Overdose effectsView

A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

ReconstitutionView

Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.

StorageView

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.

Creso

Esomeprazole

Tablet (Enteric Coated) 20 mg Allopathic

Indication detailsView

Esomeprazole is indicated:

To relieve from chronic heartburn symptoms and other symptoms associated with GERD
For the healing of erosive esophagitis
For maintenance of healing of erosive esophagitis
In combination with amoxicillin and clarithromycin for eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Zollinger-Ellison Syndrome
Acid related Dyspepsia
Duodenal & Gastric ulcer

PharmacologyView

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Absorption: Esomeprazole capsules contain an enteric-coated pellet formulation of esomeprazole magnesium. After oral administration peak plasma levels (C_max) occur at approximately 1.5 hours (T_max). The C_maxincreases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration-time curve (AUC) from 20 to 40 mg. At repeated once daily dosing, the systemic bioavailability is approximately 90% compared to 64% after a single dose. The AUC after administration of a single dose of esomeprazole is decreased by 33-53% after food intake compared to fasting conditions. Esomeprazole should be taken at least one hour before meals.

Distribution: Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 20 mmol/L. The apparent volume of distribution at steady state in healthy volunteers is approximately 16 L.

Metabolism: Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack anti-secretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites. The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite.

Excretion: The plasma elimination half-life of esomeprazole is approximately 1–1.5 hours. Less than 1% of parent drug is excreted in the urine. Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the faeces.

Combination Therapy with Antimicrobials: Esomeprazole magnesium 40 mg once daily is given in combination with clarithromycin 500 mg twice daily and amoxicillin 1000 mg twice daily for 7 days. The mean steady state AUC and Cmax of Esomeprazole increased by 70% and 18%, respectively, during triple combination therapy compared to treatment with Esomeprazole alone. The pharmacokinetic parameters for clarithromycin and amoxicillin are similar during triple combination therapy and administration of each drug alone. However, the mean AUC and Cmax for 14-hydroxyclarithromycin are increased by 19% and 22%, respectively, during triple combination therapy compared to treatment with clarithromycin alone. This increase in exposure to 14-hydroxyclarithromycin is not considered to be clinically significant.

DosageView

Healing of Erosive Esophagitis: 20 mg or 40 mg Once Daily for 4-8 Weeks. The majority of patients are healed within 4 to 8 weeks. For patients who don't heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered. Maintenance of Healing of Erosive

Esophagitis: 20 mg Once Daily (Clinical studies did not extend 6 months).

Symptomatic GERD: 20 mg Once Daily for 4 Weeks. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Helicobacter Pylori eradication: Triple Therapy to reduce the risk of Duodenal Ulcer recurrence-Esomeprazole 40 mg Once Daily for 10 days, Amoxicillin 1000 mg Twice Daily for 10 days, Clarithromycin 500 mg Twice Daily for 10 days.

Zollinger-Ellison Syndrome: The dose is 20-80 mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated.

Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks according to the response.

Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.

Injection: The recommended adult dose is 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole delayed-release capsules. Safety and effectiveness in paediatric patients have not been established.

AdministrationView

Esomeprazole tablet or capsule: should be swallowed whole and taken one hour before a meal.

Direction for use of Delayed-Release Oral Suspension: Whole contents of the packet should be taken into a small glass containing 15 ml. of water. The mixer should be stirred well and leave 2 to 3 minutes to thicken. Stir again and drink within 30 minutes. If any medicine remains after drinking, add more water, stir, and drink immediately. If the suspension is to be administered through a nasogastric or gastric tube, the volume of water in the syringe should be 15 ml. & immediately shake the syringe and leave 2 to 3 minutes to thicken. Shake the syringe and inject it through the nasogastric or gastric tube into the stomach within 30 minutes. An appropriately sized syringe should be used. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

Esomeprazole IV Injection: Esomeprazole IV should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 5 ml of the solvent (WFI) provided. After reconstitution, the injection should be given slowly over a period of at least 3 minutes. The solution should be used within 12 hours of reconstitution when stored at room temperature up to 30°C. No refrigeration is required. The reconstituted solution should not be used if it contains visible particulate.

Side effectsView

The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.

ContraindicationsView

Esomeprazole is contraindicated in-patient with known hypersensitivity to any of the formulation.

PrecautionsView

General: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy.

Information for patients: Esomeprazole capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole capsules can be opened, and the pellets inside the capsule carefully emptied onto the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellet/applesauce mixture should not be stored for future use. Antacids may be used while taking esomeprazole.

InteractionsView

Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.

Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. Animal studies have revealed no teratogenic effects. The excretion of esomeprazole in milk has not been studied. Breast-feeding should be therefore be discontinued if the use of esomeprazole is considered essential.

Pediatric usageView

Paediatric Use: Safety and effectiveness in paediatric patients have not been established.

Geriatric Use: No overall differences in safety and efficacy have been observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Hepatic Insufficiency: No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency, a dose of 20 mg once daily should not be exceeded.

Renal Insufficiency: The Pharmacokinetics of Esomeprazole in patients with renal impairment are not expected to be altered relative to healthy volunteers as less than 1% of Esomeprazole is excreted unchanged in the urine.

Overdose effectsView

A single oral dose of Esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), has been lethal to rats. The major signs of acute toxicity are reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been no reports of overdose with Esomeprazole. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

ReconstitutionView

Infusion: Reconstitute one sterile single-dose vial of Esomeprazole IV Injection with 5 ml of the solvent (WFI) provided and further diluting the resulting solution within 0.9% Sodium Chloride solution or 5% Dextrose solution to make a final volume of 50 ml. The resultant infusion should be given intravenously over a period of 10-30 minutes. Chemical and physical in-use stability has been demonstrated for 12 hours after reconstitution with 0.9% Sodium Chloride solution or for 6 hours after reconstitution with 5% Dextrose solution. From a microbial point of view, the product should be used immediately. Any unused portion should be discarded.

StorageView

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.

Creston

Rosuvastatin

Tablet 5 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

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

StorageView

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Creston

Rosuvastatin

Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

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

StorageView

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Creston

Rosuvastatin

Tablet 20 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

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

StorageView

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Creva

Rosuvastatin

Tablet 10 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

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

StorageView

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Creva

Rosuvastatin

Tablet 5 mg Allopathic Other Anti-anginal & Anti-ischaemic drugs

Indications

Stroke

Indication detailsView

Rosuvastatin is indicated in-

Heterozygous Hypercholesterolemia (Familial and Non familial)
Homozygous Hypercholesterolemia (Familial)
Mixed Dyslipidemia (Fredrickson Type IIa and IIb)
Primary prevention of cardiovascular disease

Therapeutic classView

Other Anti-anginal & Anti-ischaemic drugs, Statins

PharmacologyView

Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, Rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

DosageView

Dose range: 5-40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg

HoFH: Starting dose 20 mg/day.

Pediatric patients with HeFH: 5-10 mg/day for patients 8 to less than 10 years age, and 5-20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

AdministrationView

Rosuvastatin can be taken with or without food, at any time of day.

Side effectsView

Rosuvastatin is generally well tolerated. The most frequent adverse events thought to be related to Rosuvastatin were headache, myalgia, constipation, asthenia, abdominal pain and nausea.

ContraindicationsView

Rosuvastatin is contraindicated if-

Known hypersensitivity to product components
Liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
Pregnant women and women who may become pregnant
Nursing mothers

PrecautionsView

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with use of 40 mg dose, advanced age (>65 year), hypothyroidism, renal impairment and combination use with cyclosporine, lopinavir/ritonavir, atazanavir/ritonavir or certain other lipid-lowering drugs. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness. Rosuvastatin can be discontinued if signs or symptoms appear.

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur.

Liver enzymes should be monitored before and during treatment

InteractionsView

Remarkable drug interactions of Rosuvastatin are-

Cyclosporine: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be limited to 5 mg once daily.
Gemfibrosil: Combination should be avoided. If used together, Rosuvastatin dose should be limited to 10 mg once daily.
Lopinavir/Ritonavir or atazanavir/ritonavir: Combination increases Rosuvastatin exposure. Rosuvastatin dose should be to 10 mg once daily.
Coumarin anticoagulants: Combination prolongs international normalized ratio (INR). Stable INR should be achieved prior to starting Rosuvastatin. INR should be monitored frequently until stable upon initiation or alteration of Rosuvastatin therapy.
Concomitant lipid-lowering therapies: Use with fibrates and niacin products may increase the risk of skeletal muscle effects.

Pregnancy & lactationView

The safety in pregnant women has not been established. It is not known whether Rosuvastatin is excreted in human milk or not.

Pediatric usageView

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

StorageView

Keep below 30^oC temperature, protected from light & moisture. Keep out of the reach of children.

Crezyme

Pancreatin

Tablet 325 mg Allopathic Digestive Enzyme

Indications

Pancreatic insufficiency

Indication detailsView

Pancreatin is employed for the treatment of patients with

Chronic pancreatitis
Cystic fibrosis/Mucoviscidosis
Following partial or complete pancreatectomy
Total gastrectomy
Steatorrhea
Somatostatinoma
Celiac disease and
Other conditions associated with pancreatic insufficiency

Therapeutic classView

Digestive Enzyme

PharmacologyView

Pancreatin is a preparation of Pancreatin, an extract from mammalian pancreas containing enzymes with Amylase, Protease and Lipase activity. It is designed to disintegrate in the alkaline medium of the duodenum where it releases the active enzyme components of Pancreatin (Amylase, Protease and Lipase). Amylase hydrolyzes dietary starch to yield maltose, maltoriose and a-dextrin. Protease cleaves peptide bonds in the center of proteins and polypeptides and forms amino acids and oligopeptides. Lipase hydrolyzes dietary triglycerides forming two molecules of fatty acid and a molecule of beta-monoglyceride. It converts not less than 25 times its weight of starch into soluble carbohydrates and not less than 25 times its weight of casein into proteoses within 5 mins, (equivalent to 150 times in 30 mins).

DosageView

2-3 tablets to be swallowed whole with little water immediately after or during meal. Or as directed by the physician

Side effectsView

The most frequent side effects are gastrointestinal including nausea, vomiting and abdominal discomfort. Buccal and perianal soreness may occur, particularly in infants. Hypersensitivity reactions manifested by sneezing, lacrimation or skin rashes have been reported.

ContraindicationsView

Pancreatin is contraindicated in patients with known hypersensitivity to the drug.

PrecautionsView

Patients known to be allergic to animal protein should be treated with caution.

InteractionsView

Alkaline media will rupture the enteric coating. As such to prevent bursting out of the content in the stomach Pancreatin should not be used concurrently with antacid.

Pregnancy & lactationView

Pancreatin should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pancreatin is administered to a nursing mother.

Overdose effectsView

Excessive dosage may produce a laxative effect. Systemic toxicity does not occur. Very high dosage may cause hyperuricaemia and hyperuricosuria

StorageView

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

Crilomus

Tacrolimus (Oral)

Capsule 1 mg Allopathic Drugs affecting the immune response

Indications

Prophylaxis of acute renal graft rejection

Indication detailsView

Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants

Therapeutic classView

Drugs affecting the immune response

PharmacologyView

Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that Tacrolimus binds to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression).

Tacrolimus prolongs the survival of the host and transplanted graft in animal transplant models of liver, kidney, heart, bone marrow, small bowel and pancreas, lung and trachea, skin, cornea, and limb.

In animals, Tacrolimus has been demonstrated to suppress some humoral immunity and, to a greater extent, cell-mediated reactions such as allograft rejection, delayed type hypersensitivity, collagen-induced arthritis, experimental allergic encephalomyelitis, and graft versus host disease.

DosageView

Usual Adult Dose for Organ Transplant- Rejection Prophylaxis

KIDNEY TRANSPLANT:

In combination with azathioprine: Initial dose: 0.1 mg/kg orally every 12 hours. Initiate within 24 hours of surgery, but delay until renal function has recovered.
In combination with mycophenolate mofetil (MMF)/interleukin-2 (IL-2) receptor antagonist: Initial dose: 0.05 mg/kg orally every 12 hours. Initiate within 24 hours of surgery, but delay until renal function has recovered.

LIVER TRANSPLANT:

Initial dose: 0.05 to 0.075 mg/kg orally every 12 hours. Initiate no sooner than 6 hours after surgery.

HEART TRANSPLANT:

Initial dose: 0.0375 mg/kg orally every 12 hours. Initiate no sooner than 6 hours after surgery

Usual Pediatric Dose for Organ Transplant- Rejection Reversal

LIVER TRANSPLANT:

Initial dose: 0.075 to 0.1 mg/kg orally every 12 hours

ContraindicationsView

Tacrolimus capsules are contraindicated in patients with a hypersensitivity to Tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome

InteractionsView

Since Tacrolimus is metabolized mainly by CYP3A enzymes, drugs or substances known to inhibit these enzymes may increase Tacrolimus whole blood concentrations. Drugs known to induce CYP3A enzymes may decrease Tacrolimus whole blood concentrations. Dose adjustments may be needed along with frequent monitoring of Tacrolimus whole blood trough concentrations when Tacrolimus is administered with CYP3A inhibitors or inducers. In addition, patients should be monitored for adverse reactions including changes in renal function and QT prolongation

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tacrolimus is transferred across the placenta. The use of Tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. Tacrolimus given orally to pregnant rabbits at 0.5 to 4.3 times the clinical dose and pregnant rats at 0.8 to 6.9 times the clinical dose was associated with an increased incidence of fetal death in utero, fetal malformations (cardiovascular, skeletal, omphalocele, and gallbladder agenesis) and maternal toxicity. Tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers: Tacrolimus is excreted in human milk. As the effect of chronic exposure to Tacrolimus in healthy infants is not established, patients maintained on Tacrolimus should discontinue nursing taking into consideration importance of drug to the mother.

Pediatric usageView

Pediatric Use: The safety and efficacy of Tacrolimus in pediatric kidney and heart transplant patients have not been established. Successful liver transplants have been performed in pediatric patients (ages up to 16 years) using Tacrolimus. Two randomized active-controlled trials of Tacrolimus in primary liver transplantation included 56 pediatric patients. Thirty-one patients were randomized to Tacrolimus-based and 25 to cyclosporine-based therapies. Additionally, a minimum of 122 pediatric patients were studied in an uncontrolled trial of Tacrolimus in living related donor liver transplantation. Pediatric patients generally required higher doses of Tacrolimus to maintain blood trough concentrations of Tacrolimus similar to adult patients.

Geriatric Use: Clinical trials of Tacrolimus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Use in Renal Impairment: The pharmacokinetics of Tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function. However, consideration should be given to dosing Tacrolimus at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. Further reductions in dose below the targeted range may be required

Use in Hepatic Impairment: The mean clearance of Tacrolimus was substantially lower in patients with severe hepatic impairment (mean Child-Pugh score: >10) compared to healthy volunteers with normal hepatic function. Close monitoring of Tacrolimus trough concentrations is warranted in patients with hepatic impairment.

The use of Tacrolimus in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood trough concentrations of Tacrolimus. These patients should be monitored closely and dosage adjustments should be considered. Some evidence suggests that lower doses should be used in these patients

Overdose effectsView

Limited overdosage experience is available. Acute overdosages of up to 30 times the intended dose have been reported. Almost all cases have been asymptomatic and all patients recovered with no sequelae. Acute overdosage was sometimes followed by adverse reactions (including tremors, abnormal renal function, hypertension, and peripheral edema); in one case of acute overdosage, transient urticaria and lethargy were observed. Based on the poor aqueous solubility and extensive erythrocyte and plasma protein binding, it is anticipated that Tacrolimus is not dialyzable to any significant extent; there is no experience with charcoal hemoperfusion. The oral use of activated charcoal has been reported in treating acute overdoses, but experience has not been sufficient to warrant recommending its use. General supportive measures and treatment of specific symptoms should be followed in all cases of overdosage.

In acute oral and IV toxicity studies, mortalities were seen at or above the following doses: in adult rats, 52 times the recommended human oral dose; in immature rats, 16 times the recommended oral dose; and in adult rats, 16 times the recommended human IV dose (all based on body surface area corrections).

StorageView

Store at 25°C

Crilomus

Tacrolimus (Oral)

Capsule 0.5 mg Allopathic Drugs affecting the immune response

Indications

Prophylaxis of acute renal graft rejection

Indication detailsView

Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants

Therapeutic classView

Drugs affecting the immune response

PharmacologyView

Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that Tacrolimus binds to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression).

Tacrolimus prolongs the survival of the host and transplanted graft in animal transplant models of liver, kidney, heart, bone marrow, small bowel and pancreas, lung and trachea, skin, cornea, and limb.

In animals, Tacrolimus has been demonstrated to suppress some humoral immunity and, to a greater extent, cell-mediated reactions such as allograft rejection, delayed type hypersensitivity, collagen-induced arthritis, experimental allergic encephalomyelitis, and graft versus host disease.

DosageView

Usual Adult Dose for Organ Transplant- Rejection Prophylaxis

KIDNEY TRANSPLANT:

In combination with azathioprine: Initial dose: 0.1 mg/kg orally every 12 hours. Initiate within 24 hours of surgery, but delay until renal function has recovered.
In combination with mycophenolate mofetil (MMF)/interleukin-2 (IL-2) receptor antagonist: Initial dose: 0.05 mg/kg orally every 12 hours. Initiate within 24 hours of surgery, but delay until renal function has recovered.

LIVER TRANSPLANT:

Initial dose: 0.05 to 0.075 mg/kg orally every 12 hours. Initiate no sooner than 6 hours after surgery.

HEART TRANSPLANT:

Initial dose: 0.0375 mg/kg orally every 12 hours. Initiate no sooner than 6 hours after surgery

Usual Pediatric Dose for Organ Transplant- Rejection Reversal

LIVER TRANSPLANT:

Initial dose: 0.075 to 0.1 mg/kg orally every 12 hours

ContraindicationsView

Tacrolimus capsules are contraindicated in patients with a hypersensitivity to Tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome

InteractionsView

Since Tacrolimus is metabolized mainly by CYP3A enzymes, drugs or substances known to inhibit these enzymes may increase Tacrolimus whole blood concentrations. Drugs known to induce CYP3A enzymes may decrease Tacrolimus whole blood concentrations. Dose adjustments may be needed along with frequent monitoring of Tacrolimus whole blood trough concentrations when Tacrolimus is administered with CYP3A inhibitors or inducers. In addition, patients should be monitored for adverse reactions including changes in renal function and QT prolongation

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tacrolimus is transferred across the placenta. The use of Tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. Tacrolimus given orally to pregnant rabbits at 0.5 to 4.3 times the clinical dose and pregnant rats at 0.8 to 6.9 times the clinical dose was associated with an increased incidence of fetal death in utero, fetal malformations (cardiovascular, skeletal, omphalocele, and gallbladder agenesis) and maternal toxicity. Tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers: Tacrolimus is excreted in human milk. As the effect of chronic exposure to Tacrolimus in healthy infants is not established, patients maintained on Tacrolimus should discontinue nursing taking into consideration importance of drug to the mother.

Pediatric usageView

Pediatric Use: The safety and efficacy of Tacrolimus in pediatric kidney and heart transplant patients have not been established. Successful liver transplants have been performed in pediatric patients (ages up to 16 years) using Tacrolimus. Two randomized active-controlled trials of Tacrolimus in primary liver transplantation included 56 pediatric patients. Thirty-one patients were randomized to Tacrolimus-based and 25 to cyclosporine-based therapies. Additionally, a minimum of 122 pediatric patients were studied in an uncontrolled trial of Tacrolimus in living related donor liver transplantation. Pediatric patients generally required higher doses of Tacrolimus to maintain blood trough concentrations of Tacrolimus similar to adult patients.

Geriatric Use: Clinical trials of Tacrolimus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Use in Renal Impairment: The pharmacokinetics of Tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function. However, consideration should be given to dosing Tacrolimus at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. Further reductions in dose below the targeted range may be required

Use in Hepatic Impairment: The mean clearance of Tacrolimus was substantially lower in patients with severe hepatic impairment (mean Child-Pugh score: >10) compared to healthy volunteers with normal hepatic function. Close monitoring of Tacrolimus trough concentrations is warranted in patients with hepatic impairment.

The use of Tacrolimus in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood trough concentrations of Tacrolimus. These patients should be monitored closely and dosage adjustments should be considered. Some evidence suggests that lower doses should be used in these patients

Overdose effectsView

Limited overdosage experience is available. Acute overdosages of up to 30 times the intended dose have been reported. Almost all cases have been asymptomatic and all patients recovered with no sequelae. Acute overdosage was sometimes followed by adverse reactions (including tremors, abnormal renal function, hypertension, and peripheral edema); in one case of acute overdosage, transient urticaria and lethargy were observed. Based on the poor aqueous solubility and extensive erythrocyte and plasma protein binding, it is anticipated that Tacrolimus is not dialyzable to any significant extent; there is no experience with charcoal hemoperfusion. The oral use of activated charcoal has been reported in treating acute overdoses, but experience has not been sufficient to warrant recommending its use. General supportive measures and treatment of specific symptoms should be followed in all cases of overdosage.

In acute oral and IV toxicity studies, mortalities were seen at or above the following doses: in adult rats, 52 times the recommended human oral dose; in immature rats, 16 times the recommended oral dose; and in adult rats, 16 times the recommended human IV dose (all based on body surface area corrections).

StorageView

Store at 25°C

Crinone

Progesterone (Vaginal Gel)

Vaginal Gel 8% Allopathic Drugs for Infertility

Indications

Infertility

Indication detailsView

This gel contains a hormone called progesterone. When the gel is inserted into your vagina, the progesterone is slowly released into your bloodstream throughout the day. Progesterone is used to give you extra progesterone in the treatment of infertility due to incorrect levels of progesterone during the menstrual cycle or when you are having an assisted fertility procedure. This is to help you get pregnant. You may also be asked to continue using Progesterone to support your new pregnancy.

Therapeutic classView

Drugs for Infertility

DosageView

Insert the contents of one applicator of Progesterone into your vagina each day, starting after your doctor tells you that you have ovulated, or on the 18 th -21 st day of your menstrual cycle. (The first day of your menstrual cycle is the day your period starts.)

When used during in-vitro fertilisation, from the day of the embryo transfer, insert the contents of one applicator of Progesterone into your vagina each day, preferably in the morning. Once tests confirm that you are pregnant, you may be asked to keep using Progesterone to support your new pregnancy- for a total of 30 days.

The applicator is designed in such a way that an exact amount of gel (1.125 g, containing 90 mg progesterone) is delivered. It is expected that a small amount of gel will be left in the applicator. This can be thrown away as you will have received all of the medicine that you need.

AdministrationView

Getting your applicator ready: Grip the applicator by the thick end between your thumb and index finger. Face the thin end of the applicator down to the ground and shake the applicator down to move all the gel inside to the thin end. Grip the applicator by the flat part of the thick end. Twist off and remove the cap from the opposite thin end. To stop the gel from flowing out before use, do not press the air tank at the thick end at this stage.

Inserting your applicator: Lean back or lie down with your knees bent and spread apart. Carefully insert the applicator well into your vagina, until your hand touches your body. Press the air tank at the thick end of the applicator firmly to deliver the gel from the applicator into your vagina.

After using your applicator: Throw away the applicator, including the small amount of gel that is left inside. Use each applicator only once. Progesterone gel can stay in your vagina for several days. You may get a beige to brownish clumpy or cloudy white discharge during this time. This is nothing to worry about.

Side effectsView

Common (may affect up to 1 in 10 people):

headache
feeling very tired
stomach or gut (gastro-intestinal) cramps
breast tenderness

ContraindicationsView

if you are allergic to the active substance or any of the other ingredients of this medicine.
if you have unexplained vaginal bleeding.
if you have porphyria (an inability to break down certain substances (porphyrins) in your blood that is passed down in families).
if you have or think you might have cancer in your breasts or genital organs.
if you have ever had a blood clot due to swollen veins (thrombophlebitis), a blocked blood vessel (thromboembolic disorder) or a stroke.
if you are pregnant but your baby has died inside of you (missed abortion).

PrecautionsView

Caution should be taken

if you have liver or kidney problems
if you have heart problems or diabetes
if you have asthma
if you have epilepsy or often get migraines
if you have ever had depression.

InteractionsView

Do not use Progesterone at the same time as any other medicines that are inserted into your vagina.

Pregnancy & lactationView

Progesterone is not normally used during pregnancy. However, if you used Progesterone to help you get pregnant, you may be asked to continue using it to support your new pregnancy. The use of Progesterone during breast-feeding is not recommended.

Pediatric usageView

Progesterone is not for use in children or adolescents.

StorageView

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Use each applicator only once. Any gel left in the applicator must be thrown away. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Criptine

Bromocriptine Mesylate

Tablet 2.5 mg Allopathic Antiparkinson drugs

Indications

Restless leg syndrome

Indication detailsView

Hyperprolactinemia-Associated Dysfunctions: Dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.

Prolactin secreting adenomas: ln cases where adenectomy is elected, a course of bromocriptine mesilate therapy may be used to reduce the tumor mass prior to surgery.

Acromegaly: Parkinson's Disease: Idiopathic or postencephalitic Parkinson's disease- As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor).

Therapeutic classView

Antiparkinson drugs, Motility stimulants/Dopamine antagonist

PharmacologyView

Bromocriptine mesilate is a nonhormonal, nonestrogenic agent that inhibits the secretion of prolactin in humans, with little or no effect on other pituitary hormones, except in patients with acromegaly, where it lowers elevated blood levels of growth hormone. Bromocriptine mesilate is a dopamine receptor agonist, which activates post-synaptic dopamine receptors.The dopaminergic neurons in the tuberoinfundibular process modulate the secretion of prolactin from the anterior pituitary by secreting a prolactin inhibitory factor (thought to be dopamine); in the corpus striatum the dopaminergic neurons are involved in the control of motor function. Clinically, it significantly reduces plasma levels of prolactin in patients with physiologically elevated prolactin as well as in patients with hyperprolactinemia.

DosageView

General: It is recommended that Bromocriptine mesilate be taken with food. Patients should be evaluated frequently during dose escalation to determine the lowest dosage that produces a therapeutic response.

Hyperprolactinemic lndications: The initial dosage is 0.5 mg to 2.5 mg tablet daily. An additional 2.5 mg tablet may be added to the treatment regimen as tolerated as tolerated every 2-7 days until an optimal therapeutic response is achieved.Based on limited data in children of age 11 to 15 the initial dose is 0.5 to 2.5 mg tablet daily. Dosing may need to be increased as tolerated until a therapeutic response is achieved. The therapeutic dosage ranged from 2.5-10 mg daily in children with prolactin-secreting pituitary adenomas.

Acromegaly: The initial recommended dosage is 0.5 to 2.5 mg on retiring (with food) for 3 days. An additional 0.5 to 2.5 mg should be added to the treatment regimen as tolerated every 3-7 days until patient obtains optimal therapeutic benefit. The maximal dosage should not exceed 100 mg/day.

Parkinson's disease: The basic principle of bromocriptine mesilate therapy is to initiate treatment at a low dosage. The initial dose of Bromocriptine mesilate is 0.5 of a 2.5 mg tablet twice daily with meals. If necessary,the dosage may be increased every 14-28 days by 2.5 mg/day with meals.The safety of bromocriptine mesilate has not been demonstrated in dosages exceeding 100 mg/day.

Side effectsView

Side effects in decreasing order of frequency are: nausea, headache, dizziness, fatigue, lightheadedness, vomiting, abdominal cramps, nasal congestion constipation, diarrhea and drowsiness. A slight hypotensive effect may accompany treatment. The occurrence of adverse reactions may be lessened by temporarily reducing dosage to 0.5 mg. Abnormalities in laboratory tests may include elevations in blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase and uric acid,which are usually transient and not of clinical significance

ContraindicationsView

Uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia Bromocriptine mesilate should be withdrawn when pregnancy is diagnosed.
Post partum period in women with a history of coronary artery disease & other severe cardiovascular conditions.

PrecautionsView

Safety and efficacy of bromocriptine mesilate have not been established in patients with renal or hepatic disease. Care should be exercised when administering Bromocriptine therapy concomitantly with other medications known to lower blood pressure.The drug should be used with caution in patients with a history of psychosis or cardiovascular disease. If acromegalic patients or patients with prolactinoma or Parkinson's disease are being treated with Bromocriptine during pregnancy, they should be cautiously observed.

InteractionsView

Bromocriptine may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of Bromocriptine: phenothi-azines, haloperidol, metodopramide, pimozide. Concomitant use of Bromocriptine with other ergot alkaloids is not recommended.

Pregnancy & lactationView

Pregnancy category B. Bromocriptine should not be used during lactation in postpartum women.

Pediatric usageView

Pediatric use: No data are available for bromocriptine use in pediatric patients under the age of 8 years

StorageView

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

Crisa

Crisaborole

Ointment 2% w/w Allopathic Topical anti-inflammatory preparations

Indications

Atopic dermatitis

Indication detailsView

Crisaborole is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.

Therapeutic classView

Topical anti-inflammatory preparations

PharmacologyView

The active ingredient, Crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor, mainly acting on phosphodiesterase 4B (PDE4B), which causes inflammation. Chemically, Crisaborole is a phenoxybenzoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity. Inhibition of PDE4B appears to suppress the release of tumor necrosis factor alpha (TNFα), interleukin-12 (IL-12), IL-23 and other cytokines, proteins believed to be involved in the immune response and inflammation.

DosageView

Apply a thin layer of Crisaborole twice daily to affected areas. Crisaborole is for topical use only and not for ophthalmic, oral, or intravaginal use.

Side effectsView

Allergic reactions- Crisaborole may cause allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling, and redness. The most common side effect of Crisaborole is application site pain, such as burning or stinging.

PrecautionsView

Hypersensitivity reactions, including contact urticaria have occurred in patients treated with Crisaborole. If signs and symptoms of hypersensitivity occur, discontinue Crisaborole immediately and initiate appropriate therapy.

InteractionsView

In vitro studies using human liver microsomes indicated that under the conditions of clinical use, Crisaborole and metabolite 1 are not expected to inhibit cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. In vitro human liver microsomes studies for metabolite 2 showed that it did not inhibit activities of CYP2C19, 2D6, and 3A4.

Pregnancy & lactationView

Pregnancy: There is no available data with Crisaborole in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD).

Lactation: There is no information available on the presence of crisaborole in human milk. Crisaborole is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of crisaborole to a breastfed infant.

StorageView

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

Crisaderm

Crisaborole

Ointment 2% w/w Allopathic Topical anti-inflammatory preparations

Indications

Atopic dermatitis

Indication detailsView

Crisaborole is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.

Therapeutic classView

Topical anti-inflammatory preparations

PharmacologyView

The active ingredient, Crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor, mainly acting on phosphodiesterase 4B (PDE4B), which causes inflammation. Chemically, Crisaborole is a phenoxybenzoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity. Inhibition of PDE4B appears to suppress the release of tumor necrosis factor alpha (TNFα), interleukin-12 (IL-12), IL-23 and other cytokines, proteins believed to be involved in the immune response and inflammation.

DosageView

Apply a thin layer of Crisaborole twice daily to affected areas. Crisaborole is for topical use only and not for ophthalmic, oral, or intravaginal use.

Side effectsView

Allergic reactions- Crisaborole may cause allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling, and redness. The most common side effect of Crisaborole is application site pain, such as burning or stinging.

PrecautionsView

Hypersensitivity reactions, including contact urticaria have occurred in patients treated with Crisaborole. If signs and symptoms of hypersensitivity occur, discontinue Crisaborole immediately and initiate appropriate therapy.

InteractionsView

In vitro studies using human liver microsomes indicated that under the conditions of clinical use, Crisaborole and metabolite 1 are not expected to inhibit cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. In vitro human liver microsomes studies for metabolite 2 showed that it did not inhibit activities of CYP2C19, 2D6, and 3A4.

Pregnancy & lactationView

Pregnancy: There is no available data with Crisaborole in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD).

Lactation: There is no information available on the presence of crisaborole in human milk. Crisaborole is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of crisaborole to a breastfed infant.

StorageView

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

Criston

Vincristine Sulfate

Injection 2 mg/vail Allopathic Cytotoxic Chemotherapy

Indications

Wilm's tumour

Indication detailsView

Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.

Therapeutic classView

Cytotoxic Chemotherapy

PharmacologyView

Vincristine arrests cell division at the metaphase stage by inhibiting microtubule formation in the mitotic spindle.

DosageView

Adult (Intravenous): Usual recommended dosage: 1.4-1.5 mg/m² once wkly. Max: 2 mg wkly. Subsequent doses may be modified based on clinical and haematological responses and tolerance of the patient. May be used in combination with other drugs. Prescribers should consult published protocols for the dosage, method and sequence of admin.

Child (Intravenous): Usual recommended dosage: 1.5-2 mg/m² once wkly; for patients ≤10 kg: Initiate at 0.05 mg/kg once wkly. Subsequent doses may be modified based on clinical and haematological responses and tolerance of the patient. May be used in combination with other drugs. Prescribers should consult published protocols for the dosage, method and sequence of admin.

Side effectsView

Dose limiting neurotoxicity (e.g. motor function impairment, gait abnormalities), hyperuricaemia, bronchospasm, azospermia, amenorrhoea, alopoecia, leucopenia, urinary dysfunction, abdominal cramps, vomiting, diarrhoea, severe constipation, paralytic ileus, convulsions, hypertension, orthostatic hypotension, ptosis, hoarseness, optic neuropathies, hallucinations, blindness, neurological deafness, difficulty in walking, syndrome of inappropriate ADH secretion.

ContraindicationsView

Patients with demyelinating form of Charcot-Marie-Tooth syndrome. Pregnancy and lactation. Intrathecal admin (may be fatal). Patients receiving radiation therapy through ports which include liver.

PrecautionsView

Elderly. Preexisting pulmonary dysfunction or neuromuscular disease; leucopenia or a complicating infection; impaired liver function; obstructive jaundice. Routine prophylactic laxative needed to ensure regular bowel movement. Discontinue immediately if extravasation occurs, and inj any remaining drug into another vein, followed by local Inj of hyaluronidase and topical heat application to the affected area to aid in drug removal and reduce discomfort. Discontinue in patients who develop progressive dyspnea. CBC to be checked before each dose admin. Frequent monitoring of uric acid during first 3-4 wk of treatment and watch out for uric acid nephropathy.

InteractionsView

Decreased digoxin (tablets) and verapamil absorption with antineoplastic regimens. Increased etoposide serum levels with vincristine. Increased toxicity when ganciclovir given with, immediately before or after vincristine. Reduced vincristine metabolism with miconazole. Increased neurotoxicity with isoniazid, itraconazole, voriconazole, posaconazole and nifedipine. Decreased immune response when used concurrently with vaccines. Increased myelotoxicity with zidovudine. Increased risk of thromboembolic complications with tamoxifen. Increased risk of ototoxicity with ototoxic drugs (e.g. platinum-containing antineoplastic agents). Possible risk of earlier onset and/or increased severity of adverse effects with macrolides. Possible increase in vincristine levels with aprepitant. Possible decrease in antiepileptic levels with vincristine, monitor serum antiepileptic levels and effectiveness of chemotherapy.

Pregnancy & lactationView

Pregnancy Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Pediatric usageView

Hepatic Impairment: Dose adjustment may be needed. Serum bilirubin >3 mg/100ml: Reduce dose by 50%.

Overdose effectsView

Symptoms: mainly extensions of its common adverse effects.

Management: Treatment is supportive and includes prevention of side effects from syndrome of inappropriate antidiuretic hormone secretion (SIADH) (e.g. fluid restriction and admin of loop diuretic); admin of anticonvulsants and use of enemas (to prevent ileus). Closely monitor the CV system and determine the blood counts daily to guide transfusion requirements. Folinic acid 100 mg admin IV every 3 hr for 24 hr and then every 6 hr for at least 48 h may be admin. Haemodialysis unlikely to be useful.

StorageView

Store at 2-8° C. Protect from light.

Criston

Vincristine Sulfate

Injection 1 mg/vail Allopathic Cytotoxic Chemotherapy

Indications

Wilm's tumour

Indication detailsView

Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.

Therapeutic classView

Cytotoxic Chemotherapy

PharmacologyView

Vincristine arrests cell division at the metaphase stage by inhibiting microtubule formation in the mitotic spindle.

DosageView

Adult (Intravenous): Usual recommended dosage: 1.4-1.5 mg/m² once wkly. Max: 2 mg wkly. Subsequent doses may be modified based on clinical and haematological responses and tolerance of the patient. May be used in combination with other drugs. Prescribers should consult published protocols for the dosage, method and sequence of admin.

Child (Intravenous): Usual recommended dosage: 1.5-2 mg/m² once wkly; for patients ≤10 kg: Initiate at 0.05 mg/kg once wkly. Subsequent doses may be modified based on clinical and haematological responses and tolerance of the patient. May be used in combination with other drugs. Prescribers should consult published protocols for the dosage, method and sequence of admin.

Side effectsView

Dose limiting neurotoxicity (e.g. motor function impairment, gait abnormalities), hyperuricaemia, bronchospasm, azospermia, amenorrhoea, alopoecia, leucopenia, urinary dysfunction, abdominal cramps, vomiting, diarrhoea, severe constipation, paralytic ileus, convulsions, hypertension, orthostatic hypotension, ptosis, hoarseness, optic neuropathies, hallucinations, blindness, neurological deafness, difficulty in walking, syndrome of inappropriate ADH secretion.

ContraindicationsView

Patients with demyelinating form of Charcot-Marie-Tooth syndrome. Pregnancy and lactation. Intrathecal admin (may be fatal). Patients receiving radiation therapy through ports which include liver.

PrecautionsView

Elderly. Preexisting pulmonary dysfunction or neuromuscular disease; leucopenia or a complicating infection; impaired liver function; obstructive jaundice. Routine prophylactic laxative needed to ensure regular bowel movement. Discontinue immediately if extravasation occurs, and inj any remaining drug into another vein, followed by local Inj of hyaluronidase and topical heat application to the affected area to aid in drug removal and reduce discomfort. Discontinue in patients who develop progressive dyspnea. CBC to be checked before each dose admin. Frequent monitoring of uric acid during first 3-4 wk of treatment and watch out for uric acid nephropathy.

InteractionsView

Decreased digoxin (tablets) and verapamil absorption with antineoplastic regimens. Increased etoposide serum levels with vincristine. Increased toxicity when ganciclovir given with, immediately before or after vincristine. Reduced vincristine metabolism with miconazole. Increased neurotoxicity with isoniazid, itraconazole, voriconazole, posaconazole and nifedipine. Decreased immune response when used concurrently with vaccines. Increased myelotoxicity with zidovudine. Increased risk of thromboembolic complications with tamoxifen. Increased risk of ototoxicity with ototoxic drugs (e.g. platinum-containing antineoplastic agents). Possible risk of earlier onset and/or increased severity of adverse effects with macrolides. Possible increase in vincristine levels with aprepitant. Possible decrease in antiepileptic levels with vincristine, monitor serum antiepileptic levels and effectiveness of chemotherapy.

Pregnancy & lactationView

Pregnancy Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Pediatric usageView

Hepatic Impairment: Dose adjustment may be needed. Serum bilirubin >3 mg/100ml: Reduce dose by 50%.

Overdose effectsView

Symptoms: mainly extensions of its common adverse effects.

Management: Treatment is supportive and includes prevention of side effects from syndrome of inappropriate antidiuretic hormone secretion (SIADH) (e.g. fluid restriction and admin of loop diuretic); admin of anticonvulsants and use of enemas (to prevent ileus). Closely monitor the CV system and determine the blood counts daily to guide transfusion requirements. Folinic acid 100 mg admin IV every 3 hr for 24 hr and then every 6 hr for at least 48 h may be admin. Haemodialysis unlikely to be useful.

StorageView

Store at 2-8° C. Protect from light.

Crizocent

Crizotinib

Capsule 250 mg Allopathic Targeted Cancer Therapy

Indications

Metastatic non-small cell lung cancer

Indication detailsView

Crizotinib is a kinase inhibitor indicated for the treatment of patients with-

Metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
Metastatic NSCLC whose tumors are ROS1-positive

Therapeutic classView

Targeted Cancer Therapy

PharmacologyView

Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), ROS1 (c-ros), and Recepteur d'Origine Nantais (RON). Translocations can affect the ALK gene resulting in the expression of oncogenic fusion proteins. The formation of ALK fusion proteins results in activation and dysregulation of the gene’s expression and signaling which can contribute to increased cell proliferation and survival in tumors expressing these proteins. Crizotinib demonstrated concentration-dependent inhibition of ALK, ROS1, and c-Met phosphorylation in cell-based assays using tumor cell lines and demonstrated antitumor activity in mice bearing tumor xenografts that expressed echinoderm microtubule-associated protein-like 4 (EML4)- or nucleophosmin (NPM)-ALK fusion proteins or c-Met.

DosageView

Recommended Dose: 250 mg orally, twice daily

Geriatric Use: No differences in safety or efficacy were observed between older and younger patients. Clinical studies of Crizotinib in patients with ROS1-positive metastatic NSCLC did not include sufficient numbers of patients age 65 years and older to determine whether they respond differently from younger patients

Pediatric Dose: The safety and effectiveness of Crizotinib in pediatric patients have not been established.

Renal impairment: 250 mg orally, once daily in patients with severe renal impairment (creatinine clearance <30 mL/min) not requiring dialysis. No starting dose adjustment is needed for patients with mild (ClCr 60-89 mL/min) or moderate (ClCr 30-59 mL/min) renal impairment based on a population pharmacokinetic analysis.

Hepatic Impairment: Caution should be used in patients with hepatic impairment

Side effectsView

The most common adverse reactions (≥25%) are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.

PrecautionsView

Hepatotoxicity: Patients should undergo periodic liver testing. Crizotinib should be temporarily suspended, dose reduced or permanently suspended

Interstitial lung disease (ILD)/ Pneumonitis: Drug should be permanently discontinued in patients with ILD/ Pneumonitis

QT interval prolongation: Electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong QT should be monitored. Crizotinib should be temporarily suspended, dose reduced or permanently suspended

Bradycardia: Crizotinib can cause bradycardia. Heart rate and blood pressure should be regularly monitored. Crizotinib should be temporarily suspended, dose reduced or permanently suspended

Severe visual loss: Ophthalmological evaluation should be performed. Crizotinib should be discontinued in severe visual loss

Embryo-fetal toxicity: Crizotinib can cause fetal harm. Females of reproductive potential should be advised of the potential risk to a fetus and use of effective contraception

InteractionsView

CYP3A Inhibitors: Concurrent use of Crizotinib should be avoided with strong CYP3A inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, and voriconazole

CYP3A Inducers: Concurrent use of Crizotinib should be avoided with strong CYP3A inducers including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John’s Wort

CYP3A Substrates: Concurrent use of Crizotinib should be avoided with CYP3A substrates with narrow therapeutic indices including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus

Pregnancy & lactationView

Based on its mechanism of action, Crizotinib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Crizotinib during pregnancy. Females of reproductive potential should be advised of the potential risk to a fetus and use of effective contraception.
There is no information regarding the presence of Crizotinib in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for adverse reactions in breastfed infants patients should not breastfeed during treatment with Crizotinib and for 45 days after the final dose.

StorageView

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