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Somolax

Alverine Citrate

Tablet 120 mg Allopathic Anticholinergics

Indications

Spasm

Indication detailsView

Alverine Citrate is indicated in-

Irritable Bowel Syndrome
Bowel movement disturbances caused by small sacs or pouches in the wall of the gut (diverticular disease)
Abdominal pain associated with menstrual periods (Primary dysmenorrhea)
Relief of other conditions associated with spasm of involuntary muscle

Therapeutic classView

Anticholinergics

PharmacologyView

Alverine Citrate is a smooth muscle relaxant. Smooth muscle is a type of muscle that is not under voluntary control; it is the muscle present in places such as the gut and uterus. Alverine Citrate acts directly on the muscle in the gut, causing it to relax. This prevents the muscle spasm which occur in the gut in conditions such as irritable bowel syndrome and diverticular disease. Alverine Citrate also relaxes the smooth muscle in the uterus. It is therefore also used to treat painful menstruation, which is caused by muscle spasm in the uterus (dysmenorrhea).

DosageView

Adult: Orally: 60-120 mg 1-3 times daily.

Side effectsView

Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions.

ContraindicationsView

Paralytic ileus or known hypersensitivity to any of the ingredients.

PrecautionsView

Avoid Alverine Citrate in patients with intestinal obstruction or paralytic ileus.

InteractionsView

There are no drug interactions reported with this medicine.

Pregnancy & lactationView

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies are limited.

Pediatric usageView

Children under 12 years: Not recommended

Overdose effectsView

Can produce hypotension and atropine like-toxic effects. Management for overdose is as like as atropine poisoning with continuation of supportive therapy for hypotension.

StorageView

Store in a cool and dry place, away from light. Keep all medicines out of the reach of children. Store below 25°C temperature.

Somolax

Alverine Citrate

Tablet 60 mg Allopathic Anticholinergics

Indications

Spasm

Indication detailsView

Alverine Citrate is indicated in-

Irritable Bowel Syndrome
Bowel movement disturbances caused by small sacs or pouches in the wall of the gut (diverticular disease)
Abdominal pain associated with menstrual periods (Primary dysmenorrhea)
Relief of other conditions associated with spasm of involuntary muscle

Therapeutic classView

Anticholinergics

PharmacologyView

Alverine Citrate is a smooth muscle relaxant. Smooth muscle is a type of muscle that is not under voluntary control; it is the muscle present in places such as the gut and uterus. Alverine Citrate acts directly on the muscle in the gut, causing it to relax. This prevents the muscle spasm which occur in the gut in conditions such as irritable bowel syndrome and diverticular disease. Alverine Citrate also relaxes the smooth muscle in the uterus. It is therefore also used to treat painful menstruation, which is caused by muscle spasm in the uterus (dysmenorrhea).

DosageView

Adult: Orally: 60-120 mg 1-3 times daily.

Side effectsView

Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions.

ContraindicationsView

Paralytic ileus or known hypersensitivity to any of the ingredients.

PrecautionsView

Avoid Alverine Citrate in patients with intestinal obstruction or paralytic ileus.

InteractionsView

There are no drug interactions reported with this medicine.

Pregnancy & lactationView

Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies are limited.

Pediatric usageView

Children under 12 years: Not recommended

Overdose effectsView

Can produce hypotension and atropine like-toxic effects. Management for overdose is as like as atropine poisoning with continuation of supportive therapy for hypotension.

StorageView

Store in a cool and dry place, away from light. Keep all medicines out of the reach of children. Store below 25°C temperature.

Somopin

Doxepin (Oral)

Tablet 6 mg Allopathic Tricyclic & related anti-depressant drugs

Indications

Insomnia and sleep disturbances

Indication detailsView

Doxepin is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.

Therapeutic classView

Tricyclic & related anti-depressant drugs

PharmacologyView

Doxepin binds with high affinity to the histamine H1 receptor (Ki<1 nM) where it functions as an antagonist. The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown but is believed due to its antagonism of the H1 receptor.

DosageView

Dosing in Adults: The recommended dose of Doxepin for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.

Dosing in the Elderly: The recommended starting dose of Doxepin in elderly patients (≥65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.

Administration: Doxepin should be taken within 30 minutes of bedtime. To minimize the potential for next day effects, Doxepin should not be taken within 3 hours of a meal. The total Doxepin dose should not exceed 6 mg per day.

Pediatric Use: The safety and effectiveness of Doxepin in pediatric patients have not been evaluated.

Side effectsView

The following serious adverse reactions are as follows:

Abnormal thinking and behavioral changes
Suicide risk and worsening of depression
CNS Depressant effects

ContraindicationsView

Hypersensitivity: Doxepin is contraindicated in individuals who have shown hypersensitivity to doxepin HCl,
any of its inactive ingredients, or other dibenoxepines.

Co-administration with Monoamine Oxidase Inhibitors (MAOIs): Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Do not administer Doxepin if patient is currently on MAOIs or has used MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment.

Glaucoma and Urinary Retention: Doxepin is contraindicated in individuals with untreated narrow-angle glaucoma or severe urinary retention.

PrecautionsView

Need to Evaluate for Comorbid Diagnoses: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Exacerbation of insomnia or the emergence of new cognitive or behavioral abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with hypnotic drugs.

Abnormal Thinking and Behavioral Changes: Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Doxepin should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.

Suicide Risk and Worsening of Depression: In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of hypnotics. Doxepin, the active ingredient in Doxepin, is an antidepressant at doses 10- to 100-fold higher than in Doxepin. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Risk from the lower dose of doxepin in Doxepin can not be excluded. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

InteractionsView

Cytochrome P450 Isozymes: Doxepin is primarily metabolized by hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9. Inhibitors of these isozymes may increase the exposure of doxepin. Doxepin is not an inhibitor of any CYP isozymes at therapeutically relevant concentrations. The ability of Doxepin to induce CYP isozymes is not known.

Cimetidine: Doxepin exposure is doubled with concomitant administration of cimetidine, a nonspecific inhibitor of CYP isozymes. A maximum dose of 3 mg is recommended in adults and elderly when cimetidine is co administered with Doxepin.

Alcohol: When taken with Doxepin, the sedative effects of alcohol may be potentiated.

CNS Depressants and Sedating Antihistamines: When taken with Doxepin, the sedative effects of sedating antihistamines and CNS depressants may be potentiated.

Tolazamide: A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 g/day) 11 days after the addition of oral doxepin (75 mg/day).

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies of Doxepin in pregnant women. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of doxepin to pregnant animals resulted in adverse effects on offspring development at doses greater than the maximum recommended human dose (MRHD) of 6 mg/day.

Doxepin is excreted in human milk after oral administration. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking the higher dose of doxepin used to treat depression. Caution should be exercised when Doxepin is administered to nursing women.

StorageView

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

Somopin

Doxepin (Oral)

Tablet 3 mg Allopathic Tricyclic & related anti-depressant drugs

Indications

Insomnia and sleep disturbances

Indication detailsView

Doxepin is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.

Therapeutic classView

Tricyclic & related anti-depressant drugs

PharmacologyView

Doxepin binds with high affinity to the histamine H1 receptor (Ki<1 nM) where it functions as an antagonist. The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown but is believed due to its antagonism of the H1 receptor.

DosageView

Dosing in Adults: The recommended dose of Doxepin for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.

Dosing in the Elderly: The recommended starting dose of Doxepin in elderly patients (≥65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.

Administration: Doxepin should be taken within 30 minutes of bedtime. To minimize the potential for next day effects, Doxepin should not be taken within 3 hours of a meal. The total Doxepin dose should not exceed 6 mg per day.

Pediatric Use: The safety and effectiveness of Doxepin in pediatric patients have not been evaluated.

Side effectsView

The following serious adverse reactions are as follows:

Abnormal thinking and behavioral changes
Suicide risk and worsening of depression
CNS Depressant effects

ContraindicationsView

Hypersensitivity: Doxepin is contraindicated in individuals who have shown hypersensitivity to doxepin HCl,
any of its inactive ingredients, or other dibenoxepines.

Co-administration with Monoamine Oxidase Inhibitors (MAOIs): Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Do not administer Doxepin if patient is currently on MAOIs or has used MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment.

Glaucoma and Urinary Retention: Doxepin is contraindicated in individuals with untreated narrow-angle glaucoma or severe urinary retention.

PrecautionsView

Need to Evaluate for Comorbid Diagnoses: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Exacerbation of insomnia or the emergence of new cognitive or behavioral abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with hypnotic drugs.

Abnormal Thinking and Behavioral Changes: Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Doxepin should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.

Suicide Risk and Worsening of Depression: In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of hypnotics. Doxepin, the active ingredient in Doxepin, is an antidepressant at doses 10- to 100-fold higher than in Doxepin. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Risk from the lower dose of doxepin in Doxepin can not be excluded. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

InteractionsView

Cytochrome P450 Isozymes: Doxepin is primarily metabolized by hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9. Inhibitors of these isozymes may increase the exposure of doxepin. Doxepin is not an inhibitor of any CYP isozymes at therapeutically relevant concentrations. The ability of Doxepin to induce CYP isozymes is not known.

Cimetidine: Doxepin exposure is doubled with concomitant administration of cimetidine, a nonspecific inhibitor of CYP isozymes. A maximum dose of 3 mg is recommended in adults and elderly when cimetidine is co administered with Doxepin.

Alcohol: When taken with Doxepin, the sedative effects of alcohol may be potentiated.

CNS Depressants and Sedating Antihistamines: When taken with Doxepin, the sedative effects of sedating antihistamines and CNS depressants may be potentiated.

Tolazamide: A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 g/day) 11 days after the addition of oral doxepin (75 mg/day).

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies of Doxepin in pregnant women. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of doxepin to pregnant animals resulted in adverse effects on offspring development at doses greater than the maximum recommended human dose (MRHD) of 6 mg/day.

Doxepin is excreted in human milk after oral administration. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking the higher dose of doxepin used to treat depression. Caution should be exercised when Doxepin is administered to nursing women.

StorageView

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

Sompraz

Esomeprazole

Capsule (Delayed Release) 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.

Sompraz

Esomeprazole

Capsule (Delayed Release) 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.

Sompraz

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.

Sompraz

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.

Sonap

Naproxen Sodium

Tablet 500 mg Allopathic Drugs for Osteoarthritis

Indications

Systemic lupus erythematosus (SLE)

Indication detailsView

Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.

DosageView

Naproxen Tablet-

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

Is to be applied 2-6 times a day as required and is not recommended for use in children.

Side effectsView

Most frequently reported side effects include following:

Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
Central Nervous System: Headache, vertigo, drowsiness.
Dermatological: Pruritus (itching), purpura.
Cardiovascular: Edema, palpitation.
Others: Visual disturbances, hearing disturbances.

ContraindicationsView

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

InteractionsView

ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.

Pregnancy & lactationView

US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

StorageView

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

Sonap

Naproxen Sodium

Tablet 250 mg Allopathic Drugs for Osteoarthritis

Indications

Systemic lupus erythematosus (SLE)

Indication detailsView

Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.

DosageView

Naproxen Tablet-

Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

Is to be applied 2-6 times a day as required and is not recommended for use in children.

Side effectsView

Most frequently reported side effects include following:

Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
Central Nervous System: Headache, vertigo, drowsiness.
Dermatological: Pruritus (itching), purpura.
Cardiovascular: Edema, palpitation.
Others: Visual disturbances, hearing disturbances.

ContraindicationsView

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

InteractionsView

ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.

Pregnancy & lactationView

US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

StorageView

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

Soneta

Mometasone Furoate (Topical)

Ointment 0.10% Allopathic Other Topical corticosteroids

Indications

Psoriasis

Indication detailsView

Mometasone cream is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses, such as psoriasis and atopic dermatitis.

Therapeutic classView

Soneta

Mometasone Furoate (Topical)

Cream 0.10% Allopathic Other Topical corticosteroids

Indications

Psoriasis

Indication detailsView

Mometasone cream is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses, such as psoriasis and atopic dermatitis.

Therapeutic classView

Sonexa

Dexamethasone

IM/IV Injection 5 mg/ml Allopathic

Indication detailsView

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

PharmacologyView

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

DosageView

In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

For tablet:

In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.

For injection:

Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
Intravenous injections of massive doses should be given slowly, over a period of several minutes.
Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.

For local therapy, the following doses are recommended:

Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
The frequency of these injections may vary from every 3-5 days to every 2-3 weeks

Side effectsView

The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.

ContraindicationsView

Gastric and duodenal ulcers.
Systemic and ophthalmic fungal infections.
Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
Glaucoma.
Hypersensitivity to corticosteroids

PrecautionsView

General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.

InteractionsView

Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.

Pregnancy & lactationView

Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed

Pediatric usageView

In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Overdose effectsView

Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy

StorageView

Tablet: Store in a cool & dry place, protected from light & moisture.
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

Sonexa

Dexamethasone

Tablet 4 mg Allopathic

Indication detailsView

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

PharmacologyView

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

DosageView

In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. If no favourable response is noted within a couple of days, continuation of glucocorticoid therapy is undesirable. In chronic conditions requiring long-term therapy the lowest dosage that provides adequate, but not necessarily complete, relief should be used.

For tablet:

In adult patients, daily oral dosages vary from 1 mg to 10 mg and in children from 0.03-0.20 mg/kg body weight,according to the individual response.
In some patients higher dosages may be temporarily required,to control the disease. As soon as circumstances permit,dosage should be decreased.
For a short dexamethasone suppression test 1 mg dexamethasone is given at 11 p.m. and plasmacortisol measured the next morning.
Patients who do not show a decrease in cortisol can be exposed to a longer test: 0.5 mg dexamethasone is given at 6-hour intervals
for 48 hours followed by 2 mg every 6 hours for a further 48 hours. 24-hour urine collections are made before, during and at the end of the test for the determination of 17 alpha-hydroxycorticoids.

For injection:

Dexamethasone can be given by intravenous (IV), intramuscular (IM) or local injection. Dexamethasone injections can also be diluted with an infusion fluid or be injected directly into the infusion line.
Intravenous injections of massive doses should be given slowly, over a period of several minutes.
Intramuscular administration should be given by deep intramuscular injection,to prevent atrophy of the subcutaneous adipose tissues.
Intra-articular injections should be given under strictly aseptic conditions as glucocorticoids decrease the resistance to infection. When diluted with these infusion fluids, Dexamethasone will keep its potency for at least 24 hours (at room temperature and in daylight conditions). As infusion fluids, Sodium chloride 0.9%, Anhydrous glucose 5%, Invert sugar 10%, Sorbitol 5%, Ringer's solution, Hartman's solution (Ringer-lactate) etc.can be used.
The dosage of Dexamethasone depends on the severity of the condition and the response of the patient.
For systemic therapy in adults, daily doses of 0.05-0.20 mg/kg body weight are usually sufficient. For emergencies (e.g. anaphylaxis, acute severe asthma, cerebral edema) substantially higher doses are required. An initial dose of 10-20 mg IV is followed by 6 mg IV or IM every 6 hours,until a satisfactory result has been obtained. Thereafter the dosage has to be tapered off gradually.

For local therapy, the following doses are recommended:

Intra-articularly: 2-4 mg in large and 0.8-1 mg in small joints
Intrabursally: 2-4 mg;in tendon sheaths:0.4-1 mg
The frequency of these injections may vary from every 3-5 days to every 2-3 weeks

Side effectsView

The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy.

Endocrine and metabolic disturbances: Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.

Fluid and electrolyte disturbances: Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.

Musculo-skeletal effects: Myopathy, abdominal distension, osteoporosis, aseptic necrosis of femoral and humeral heads.

Gastro-intestinal effects: Gastric and duodenal ulceration, perforation and haemorrhage.

Dermatological effects: Impaired wound healing, skin atrophy, striae, petechiae and ecchymoses, bruising, facial erythema, increased sweating, acne.

Central Nervous System effects: Psychic disturbances ranging from euphoria to frank psychotic manifestations,convulsions,in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.

Ophthalmic effects: Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Immunosuppressive effects: Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.

ContraindicationsView

Gastric and duodenal ulcers.
Systemic and ophthalmic fungal infections.
Viral infections, e.g. varicella and herpes genitalis infections. Viral infections of the eye.
Glaucoma.
Hypersensitivity to corticosteroids

PrecautionsView

General: The lowest possible dose of corticosteroids should be used to control the condition under treatment.The reduction should be gradual.

Cardio-renal: These agents should be used with caution in patients with congestive heart failure,hypertension, or renal insufficiency.

Endocrine: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage.

Gastrointestinal: Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

Musculoskeletal: Special consideration should be given to patients at increased risk of osteoporosis (e.g.,postmenopausal women) before initiating corticosteroid therapy.

Neuro-psychiatric: An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with myasthenia gravis or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). Psychic derangements may appear ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations.

InteractionsView

Diuretics and/or cardiac glycosides, since potassium loss may be enhanced.This is a particular risk in patients using cardiac glycosides; since hypokalaemia increases the toxicity of these drugs.
Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastro-intestinal ulceration may increase.
Oral anti-coagulants since glucocorticoids may alter the need for these drugs.
Glucocorticoids may be less effective when used concomitantly with liver enzyme inducing drugs,such as rifampicin, ephedrine, barbiturates, phenytoin and primidone.
If patients undergoing long-term therapy with glucocorticoids are concomitantly given salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.
Antacids;especially those containing magnesium trisilicate,have been reported to impair the gastro-intestinal absorption of glucocorticoids. Therefore, doses of one agent should be spaced as far as possible from the other.

Pregnancy & lactationView

Pregnancy Category C.There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Glucocorticoids appear in breast milk.Mothers taking high dosages of corticosteroids should be advised not to breast-feed

Pediatric usageView

In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Overdose effectsView

Overdosage is unlikely, however, treatment of overdosage is by supportive and symptomatic therapy

StorageView

Tablet: Store in a cool & dry place, protected from light & moisture.
Injection: Store below 30° C, protected from light.Do not freeze. Keep medicines out of the reach of children

Sonexa

Dexamethasone (Ophthalmic)

Ophthalmic Ointment 0.05% Allopathic

Indication detailsView

Eye: Dexamethasone Phosphate is indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis.

Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post operative use to reduce inflammatory reactions and suppress graft reaction.

Ear: Indicated in the steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and non-purulent infective otitis externa.

PharmacologyView

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

DosageView

Eye:

As 0.1% drop: The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment. Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs. Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours.
As 0.05% ointment: Apply 0.5-1 inch ribbon of ointment into the conjunctival sac(s) up to 4 times daily. Reduce to once daily dosing once conditon has improved.

Ear: Instill two or three drops to the ear at two or three hour interval. The frequency of dosage and duration of the treatment may vary with the type of lesion and severity.

Side effectsView

Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, perforation of the globe. Rarely, stinging and burning may occur.

ContraindicationsView

Epithelial herpes simplex keratitis (dendritic keratitis), acute infections stages of vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva, Mycobacterial infection of the eye, Fungal diseases of ocular or auricular structures, perforation of a drum membrane. Hypersensitivity to any ingredient of this product.

PrecautionsView

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

InteractionsView

None relevant to topical use.

Pregnancy & lactationView

Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Caution should be exercised when Dexamethasone ophthalmic solution is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established.

Overdose effectsView

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 ml) is unlikely to lead to any serious adverse effects.

StorageView

Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

Sonexa

Dexamethasone (Ophthalmic)

Ophthalmic Solution 0.10% Allopathic

Indication detailsView

Eye: Dexamethasone Phosphate is indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis, superficial punctate keratitis and non-specific superficial keratitis.

Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post operative use to reduce inflammatory reactions and suppress graft reaction.

Ear: Indicated in the steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and non-purulent infective otitis externa.

PharmacologyView

Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.

DosageView

Eye:

As 0.1% drop: The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment. Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs. Subconjunctival or systemic steroid therapy should be considered if there is no response. When a favourable response has been observed reduce the dosage towards one drop every four hours.
As 0.05% ointment: Apply 0.5-1 inch ribbon of ointment into the conjunctival sac(s) up to 4 times daily. Reduce to once daily dosing once conditon has improved.

Ear: Instill two or three drops to the ear at two or three hour interval. The frequency of dosage and duration of the treatment may vary with the type of lesion and severity.

Side effectsView

Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, perforation of the globe. Rarely, stinging and burning may occur.

ContraindicationsView

Epithelial herpes simplex keratitis (dendritic keratitis), acute infections stages of vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva, Mycobacterial infection of the eye, Fungal diseases of ocular or auricular structures, perforation of a drum membrane. Hypersensitivity to any ingredient of this product.

PrecautionsView

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.

InteractionsView

None relevant to topical use.

Pregnancy & lactationView

Pregnancy category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Caution should be exercised when Dexamethasone ophthalmic solution is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established.

Overdose effectsView

Long-term intensive topical use may lead to systemic effects. Oral ingestion of the contents of the bottle (up to 10 ml) is unlikely to lead to any serious adverse effects.

StorageView

Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

Sonexa C

Dexamethasone + Chloramphenicol

Ophthalmic Solution 0.1%+0.5% Allopathic Ophthalmic steroid - antibiotic combined preparations

Indications

Post-herpetic keratitis

Indication detailsView

Eye: This combination is indicated in acute purulent conjunctivitis, fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. It is also used in keratitis disciformis and the more deep-seated forms of post-herpetic keratitis, allergic conjunctivitis, allergic blepharitis, acute and chronic iritis, chronic anterior uveitis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. The combination is used in steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or arisk of bacterial ocular infection exists. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear: This combination is indicated in otitis externa, otitis media and chronic suppurative otitis media.

Therapeutic classView

Ophthalmic steroid - antibiotic combined preparations

PharmacologyView

Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage

DosageView

Eye:

Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Side effectsView

Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.

ContraindicationsView

The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.

PrecautionsView

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.

InteractionsView

If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.

Pregnancy & lactationView

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.

StorageView

Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.

Sonexim

Cefixime Trihydrate

Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

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

Sonexim

Cefixime Trihydrate

Capsule 200 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

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

Sonib

Sorafenib Tosylate

Tablet 200 mg Allopathic Targeted Cancer Therapy

Indications

Renal cell carcinoma

Indication detailsView

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Therapeutic classView

Targeted Cancer Therapy

PharmacologyView

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

DosageView

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

AdministrationView

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Side effectsView

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

ContraindicationsView

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

PrecautionsView

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

InteractionsView

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

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).

Overdose effectsView

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

StorageView

Store at 25° C.