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Xerifen
Aceclofenac
Xerifen
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Xeriflam
Aceclofenac
Xeriflam
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
XeroSoft
White Soft Paraffin + Liquid Paraffin
XeroSoft
White Soft Paraffin + Liquid Paraffin
Indications
Dry skin
Indication detailsView
For general use as an emollient in the symptomatic relief of dry skin conditions.
Therapeutic classView
Emollients & combined preparations
PharmacologyView
White Soft Paraffin and Liquid Paraffin are emollients with occlusive properties for topical application. There is no significant systemic absorption of the active ingredients but has substantial penetration into the stratum corneum.
DosageView
Apply a thin film of the ointment to the affected area of the skin, in the direction of hair growth, as required. Repeat as necessary. Ideally the product should be applied three or four times a day or at least twice a day. In adults, where a large area of the body is affected, up to 500 g a week may be used. For topical administration only.
Side effectsView
Prolong use may cause folliculitis, should this occur, use of the product should be discontinued.
PrecautionsView
This topical agent should be applied in the direction of hair growth to reduce the incidence of folliculitis.
Pregnancy & lactationView
The safety of White Soft Paraffin and Liquid Paraffin during pregnancy and lactation has not been established, but use during this periods is not considered to constitute a hazard.
Overdose effectsView
This topical agent has low toxicity and if ingested treatment should be supportive and symptomatic. Gastric lavage should not be attempted following ingestion of paraffin-based products, due to the risk of inhalation or aspiration into the lungs.
StorageView
Do not store above 30° C. Keep away from light and out of the reach of children.
Xerocid
Sodium Alginate + Potassium Bicarbonate
Xerocid
Sodium Alginate + Potassium Bicarbonate
Indication detailsView
This preparation is indicated for the treatment of symptoms resulting from the reflux of acid, bile and pepsin into the esophagus such as acid regurgitation, heartburn, indigestion for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux esophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. This preparation can also be used to treat the symptoms of gastroesophageal reflux during concomitant treatment with or following the withdrawal of acid suppressing therapy.
Therapeutic classView
Antacids
PharmacologyView
This is the combination of Sodium Alginate and Potassium Bicarbonate. Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Sodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the esophagus. This relieves the symptoms of reflux such as heartburn. The mode of action of this is physical and does not depend on absorption into the systemic circulation. The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.
DosageView
Tablet:
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.
- Adults and children over 12 years: 1-2 tablets 3-4 times daily, after meals and before bedtime.
- Children 6-12 years: ½-1 tablet 3-4 times daily, after meals and before bedtime.
- Adults and children 12 years and above: 5-10 ml (1-2 teaspoonfuls) 3-4 times daily, after meals and before bedtime.
- Children 2-12 years: 2.5-5ml (½-1 teaspoonful) 3-4 times daily, after meals and before bedtime.
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.
Side effectsView
In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.
ContraindicationsView
Sodium alginate and potassium bicarbonate is contraindicated in patients with known hypersensitivity to these.
PrecautionsView
Sodium Alginate and Potassium Bicarbonate should be prescribed with caution in patients with renal impairment and congestive cardiac failure. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.
InteractionsView
A time interval of 2 hours should be considered between this intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
Pregnancy & lactationView
This combination (Sodium Alginate and Potassium Bicarbonate) can be used during pregnancy, if clinically needed. No known effect on breast-fed infants. This combination can be used during breastfeeding.
Overdose effectsView
Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Xerocid
Sodium Alginate + Potassium Bicarbonate
Xerocid
Sodium Alginate + Potassium Bicarbonate
Indication detailsView
This preparation is indicated for the treatment of symptoms resulting from the reflux of acid, bile and pepsin into the esophagus such as acid regurgitation, heartburn, indigestion for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux esophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. This preparation can also be used to treat the symptoms of gastroesophageal reflux during concomitant treatment with or following the withdrawal of acid suppressing therapy.
Therapeutic classView
Antacids
PharmacologyView
This is the combination of Sodium Alginate and Potassium Bicarbonate. Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Sodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the esophagus. This relieves the symptoms of reflux such as heartburn. The mode of action of this is physical and does not depend on absorption into the systemic circulation. The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.
DosageView
Tablet:
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.
- Adults and children over 12 years: 1-2 tablets 3-4 times daily, after meals and before bedtime.
- Children 6-12 years: ½-1 tablet 3-4 times daily, after meals and before bedtime.
- Adults and children 12 years and above: 5-10 ml (1-2 teaspoonfuls) 3-4 times daily, after meals and before bedtime.
- Children 2-12 years: 2.5-5ml (½-1 teaspoonful) 3-4 times daily, after meals and before bedtime.
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.
Side effectsView
In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.
ContraindicationsView
Sodium alginate and potassium bicarbonate is contraindicated in patients with known hypersensitivity to these.
PrecautionsView
Sodium Alginate and Potassium Bicarbonate should be prescribed with caution in patients with renal impairment and congestive cardiac failure. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.
InteractionsView
A time interval of 2 hours should be considered between this intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
Pregnancy & lactationView
This combination (Sodium Alginate and Potassium Bicarbonate) can be used during pregnancy, if clinically needed. No known effect on breast-fed infants. This combination can be used during breastfeeding.
Overdose effectsView
Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Xerokof
Ambroxol Hydrochloride
Xerokof
Ambroxol Hydrochloride
Indications
Sore throat
Indication detailsView
This is indicated in-
- Productive cough
- Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
- Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
- Asthmatic bronchitis bronchial asthma with thick expectoration
- Bronchiectasis
- Chronic pneumonia etc.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
DosageView
Average daily dose (preferably after meal):
Pediatric Drops:
Pediatric Drops:
- 0-6 months: 0.5 ml 2 times a day
- 6-12 months: 1 ml 2 times a day
- 1-2 years: 1.25 ml 2 times a day
- 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
- 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
- 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
Side effectsView
Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
ContraindicationsView
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
PrecautionsView
Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
InteractionsView
Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
Pregnancy & lactationView
Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
StorageView
Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.
Xerosec
Omeprazole
Xerosec
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xerosec
Omeprazole
Xerosec
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xerova
Atorvastatin Calcium
Xerova
Atorvastatin Calcium
Indications
Reducing cholesterol levels
Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
- Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xerova
Atorvastatin Calcium
Xerova
Atorvastatin Calcium
Indications
Reducing cholesterol levels
Indication detailsView
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B) and triglycerides levels in following diseases when response to diet and other non-pharmacological measures is inadequate.
- To reduce total cholesterol and LDL cholesterol in patients with heterozygous and homozygous familial hypercholesterolaemia.
- To reduce elevated cholesterol and triglycerides in patient with mixed dyslipidemia (Fredrickson Type Ia and Ib).
- For the treatment of patients with elevated serum triglyceride levels in hypertriglyceridaemia (Fredrickson Type IV).
- For the treatment of patients with dysbetalipoproteinaemia (Fredrickson Type III).
- To reduce cardiac ischaemic events in patients with asymptomatic or mild to moderate symptomatic coronary artery disease with elevated LDL-cholesterol level.
- To reduce total and LDL-cholesterol concentrations patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus or renal transplantation.
Therapeutic classView
Other Anti-anginal & Anti-ischaemic drugs, Statins
PharmacologyView
Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
DosageView
Primary hypercholesterolaemia and combined hyperlipidaemia-
- Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.
- Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
- Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.
- Adults: Initially 10 mg once daily adjusted according to response.
Side effectsView
Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.
ContraindicationsView
Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.
PrecautionsView
Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.
InteractionsView
The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.
Pregnancy & lactationView
Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.
Pediatric usageView
Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Overdose effectsView
Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xerox
Ciprofloxacin
Xerox
Ciprofloxacin
Indications
Urinary tract infection
Indication detailsView
Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.
Therapeutic classView
4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs
PharmacologyView
Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.
DosageView
Tablet: Adult:
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
- Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
- Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
- Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
- Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
- Typhoid fever: 500 mg twice daily (7 days)
- Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
- Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
- Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
- Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
- Gonorrhea: 500 mg as a single dose
- Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
- Meningitis: 500 mg as a single dose.
- Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
- Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
- Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
- Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
- Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
- Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
- Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
- Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
- Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
AdministrationView
Instruction for the use of Ciprofloxacin IV infusion-
- Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
- Do not use flexible bags in series connections.
- Close flow control clamp of administration set.
- Remove cover from port at bottom of bag.
- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
- Suspend bag from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
- Open flow control clamp to expel air from set.Close clamp.
- Regulate rate of administration with flow control clamp
Side effectsView
Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.
ContraindicationsView
It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.
PrecautionsView
Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.
InteractionsView
Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.
Pediatric usageView
Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.
Overdose effectsView
Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Xetril
Clonazepam
Xetril
Clonazepam
Indication detailsView
It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Therapeutic classView
Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
PharmacologyView
Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
DosageView
Oral:
Injection:
- Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
- The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
- Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
Injection:
- Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
- Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
Side effectsView
The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
ContraindicationsView
It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
PrecautionsView
When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
InteractionsView
Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
Pregnancy & lactationView
Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Pediatric usageView
Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Overdose effectsView
Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
ReconstitutionView
Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xetril
Clonazepam
Xetril
Clonazepam
Indication detailsView
It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Therapeutic classView
Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
PharmacologyView
Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
DosageView
Oral:
Injection:
- Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
- The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
- Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
Injection:
- Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
- Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
Side effectsView
The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
ContraindicationsView
It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
PrecautionsView
When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
InteractionsView
Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
Pregnancy & lactationView
Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Pediatric usageView
Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Overdose effectsView
Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
ReconstitutionView
Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xevirol
Everolimus
Xevirol
Everolimus
Indications
Tuberous sclerosis
Indication detailsView
Everolimus is indicated in advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC), Advanced Neuroendocrine Tumors (NET); Advanced Renal Cell Carcinoma (RCC); Renal Angiomyolipoma With Tuberous Sclerosis Complex (TSC); Subependymal Giant Cell Astrocytoma (SEGA) With Tuberous Sclerosis Complex (TSC)
In combination with ciclosporin for microemulsion & corticosteroids for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination with tacrolimus & corticosteroids for the prophylaxis of organ rejection in patients receiving hepatic transplant.
In combination with ciclosporin for microemulsion & corticosteroids for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination with tacrolimus & corticosteroids for the prophylaxis of organ rejection in patients receiving hepatic transplant.
Therapeutic classView
Immunosuppressant
PharmacologyView
Everolimus, a proliferation signal inhibitor, prevents allograft rejection in rodent and nonhuman primate models of allotransplantation. It exerts its immunosuppressive effect by inhibiting the proliferation and thus, clonal expansion, of antigen-activated T cells which is driven by T cell-specific interleukins eg, interleukin-2 and interleukin-15. Everolimus inhibits an intracellular signaling pathway that normally leads to cell proliferation when triggered by the binding of these T cell growth factors to their receptors. The blockage of this signal by everolimus causes cells to be arrested at the G1 stage of the cell cycle.
At the molecular level, everolimus forms a complex with the cytoplasmic protein FKBP-12. In the presence of everolimus, the growth factor-stimulated phosphorylation of the p70 S6 kinase is inhibited. Since p70 S6 kinase phosphorylation is under the control of FRAP (also called m-TOR), this finding suggests that the everolimus-FKBP-12 complex binds to and thus, interferes with the function of FRAP. FRAP is a key regulatory protein which governs cell metabolism, growth and proliferation; disabling FRAP function thus explains the cell cycle arrest caused by everolimus.
At the molecular level, everolimus forms a complex with the cytoplasmic protein FKBP-12. In the presence of everolimus, the growth factor-stimulated phosphorylation of the p70 S6 kinase is inhibited. Since p70 S6 kinase phosphorylation is under the control of FRAP (also called m-TOR), this finding suggests that the everolimus-FKBP-12 complex binds to and thus, interferes with the function of FRAP. FRAP is a key regulatory protein which governs cell metabolism, growth and proliferation; disabling FRAP function thus explains the cell cycle arrest caused by everolimus.
DosageView
General kidney & heart transplant population: Initially 0.75 mg bd administered as soon as possible after transplantation.
Hepatic transplant: 1 mg bd with initial dose starting 4 wk after transplantation.
Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced NET, Advanced RCC, And Renal Angiomyolipoma With TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Everolimus Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs.
Hepatic transplant: 1 mg bd with initial dose starting 4 wk after transplantation.
Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced NET, Advanced RCC, And Renal Angiomyolipoma With TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Everolimus Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs.
Side effectsView
Stomatitis, Constipation, Infections, Asthenia, Fatigue, Cough, Diarrhea, Rash, Anemia, Nausea, Anorexia, Edema, peripheral, Dyspnea, Pyrexia, Vomiting, Headache, Epistaxis, Decreased lymphocytes, Grade 3, Increased glucose, Grade 3, Pneumonitis, Pruritus, Dry skin, Decreased Hgb, Grade 3, Menstrual irregularities, Dysgeusia, Hypertension, Hemorrhage, Tachycardia, CHF
ContraindicationsView
Patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients. Hypersensitivity reactions manifested by symptoms including, but not limited to, anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) have been observed with everolimus and other rapamycin derivatives
PrecautionsView
Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Interstitial lung disease/noninfectious pneumonitis; monitor for clinical symptoms or radiological changes; fatal cases have occurred; manage by dose reduction or discontinuation until symptoms resolve, and consider use of corticosteroids; pulmonary hypertension (including pulmonary arterial hypertension) as a secondary event reported
Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents
Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma)
Elicits immunosuppressive effects and may increase risk for infections; some infections have been severe or fatal; monitor for signs and symptoms and treat promptly. Pneumocystis jiroveci pneumonia, some with a fatal outcome, reported; this may be associated with concomitant use of corticosteroids or other immunosuppressive agents
Mouth ulcers, stomatitis, and oral mucositis are common; management includes mouthwashes (without alcohol or peroxide) and topical treatments May delay wound healing and increase wound-related complications (eg, dehiscence, wound infection, incisional hernia, lymphocele, and seroma)
- Cases of renal failure (including acute renal failure), some fatal, have been observed
- May cause angioedema and fluid accumulation
- Decreases Hgb, lymphocytes, ANC, platelets; increases cholesterol, TG, glucose, creatinine
- Elevations of serum creatinine, urinary protein, blood glucose, and lipids may occur;
- decreases in hemoglobin, neutrophils, and platelets may also occur; monitor renal
- function, blood glucose, lipids, and hematologic parameters prior to treatment and periodically thereafter
- May impair male fertility
- Child-Pugh Class C hepatic impairment
- Avoid use of live vaccines during treatment and close contact with live vaccine recipients
- Can cause fetal harm when administered to a pregnant woman; advise female patients of reproductive potential to use highly effective contraception while receiving everolimus and for up to 8 weeks after ending treatment.
InteractionsView
CYP3A4 inhibitors &/or inducers, CYP2D6 substrates with narrow therapeutic index, PgP inhibitors, rifampicin, ACE inhibitors, grapefruit juice & live vaccines.
Pregnancy & lactationView
Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Distribution into breast milk is unknown; not recommended
Lactation: Distribution into breast milk is unknown; not recommended
Xevlin
Azithromycin Dihydrate
Xevlin
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xevlin
Azithromycin Dihydrate
Xevlin
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Xfin
Terbinafine Hydrochloride
Xfin
Terbinafine Hydrochloride
Indication detailsView
Terbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
Therapeutic classView
Other Antifungal preparations, Topical Antifungal preparations
PharmacologyView
Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.
DosageView
Terbinafine tablet:
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
- For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
- For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
- The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.
- Body Weight: <25 kg: 125 mg/day up to 6 weeks
- Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
- Body Weight: >35 kg: 250 mg/day up to 6 weeks
- Tinea corporis, cruris: 1 to 2 weeks
- Tinea pedis: 1 week
- Cutaneous candidiasis: 2 weeks
- Pityriasis versicolor: 2 weeks
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
- Tinea pedis: once a day,1 week
- Tinea corporis/cruris: once a day,1 week
- Pityriasis versicolor: twice a day, 1 week
Side effectsView
The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.
ContraindicationsView
Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.
PrecautionsView
Warnings-
- Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
- Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.
InteractionsView
In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.
Pregnancy & lactationView
Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Pediatric usageView
Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Overdose effectsView
Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
StorageView
Store in a cool and dry place, below 30°C, protect from light.
Xfin
Terbinafine Hydrochloride
Xfin
Terbinafine Hydrochloride
Indication detailsView
Terbinafine tablet: This tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
Terbinafine granules: This is indicated in Tinea Capitis.
Terbinafine cream: Fungal infection of the skin caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Yeast infections of the skin, principally those caused by the genus Candida (e.g. C. albicans). Pityriasis (tinea) versicolor due to Pityrosporum orbicular (also known as Malassezia furfur).
Terbinafine 1% Spray: This spray is indicated in the treatment of tinea infections of the skin. This spray is also indicated in the treatment of pityriasis (tinea) versicolor due to Malassezia furfur.
Therapeutic classView
Other Antifungal preparations, Topical Antifungal preparations
PharmacologyView
Terbinafine, an Allylamine antifungal, inhibits biosynthesis of Ergosterol (an essential component of fungai cell membrane) via inhibition of Squalene Epoxidase enzyme. This results in fungal cell death primarily due to the increased membrane permeability mediated by the accumulation of high concentrations of Squalene but not due to Ergosterol deficiency. Depending on the concentration of the drug and the fungal species test in vitro, Terbinafine hydrochloride may be fungicidal. However, the clinical significance of in vitro data is unknown. Terbinafine has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: Tricophyton Mentagrophyte, Trichophyton Rubrum.
DosageView
Terbinafine tablet:
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
- For the treatment of fingernail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 6 weeks.
- For the treatment of toenail onychomycosis: Terbinafine 250 mg (one tablet), once daily for 12 weeks.
- The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for the outgrowth of healthy nail.
- Body Weight: <25 kg: 125 mg/day up to 6 weeks
- Body Weight: 25-35 kg: 187.5 mg/day up to 6 weeks
- Body Weight: >35 kg: 250 mg/day up to 6 weeks
- Tinea corporis, cruris: 1 to 2 weeks
- Tinea pedis: 1 week
- Cutaneous candidiasis: 2 weeks
- Pityriasis versicolor: 2 weeks
Terbinafine 1% Spray: This spray is applied once or twice daily, depending on the indication. The affected areas should be cleansed and dried thoroughly before application of this spray. A sufficient amount of solution should be applied to wet the treatment area(s) thoroughly.
- Tinea pedis: once a day,1 week
- Tinea corporis/cruris: once a day,1 week
- Pityriasis versicolor: twice a day, 1 week
Side effectsView
The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. In general, the adverse events were mild, transient, and did not lead to discontinuation. Adverse events, based on worldwide experience with terbinafine use, include: idiosyncratic and symptomatic hepatic injury and more rarely, cases of liver failure, some leading to death or liver transplant, serious skin reactions, severe neutropenia, thrombocytopenia, angioedema and allergic reactions (including anaphylaxis). Other adverse reactions that have been reported include malaise, fatigue, vomiting, arthralgia, myalgia, and hair loss.
ContraindicationsView
Terbinafine tablet and cream are contra-indicated in individuals with hypersensitive to terbinafine.
PrecautionsView
Warnings-
- Terbinafine tablets: Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of terbinafine tablets for the treatment of onychomycosis in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with terbinafine use, the patients had serious underlying systemic conditions and an uncertain causal association with terbinafine. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with terbinafine tablets should be discontinued if there is biochemical or clinical evidence of liver injury. There have been isolated reports of serious skin reaction (e.g., Stevens-Johnson Syndrome and toxic epidermal necrolysis). If progressive skin rash occurs, treatment with terbinafine should be discontinued.
- Terbinafine cream: Terbinafine cream is for external use only. Contact with the eyes should be avoided.
InteractionsView
In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.
Pregnancy & lactationView
Terbinafine tablet: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in the breast milk of nursing mothers. Treatment with terbinafine is not recommended in nursing mothers.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.
Pediatric usageView
Pediatric use: The safety and efficacy of terbinafine have not been established in pediatric patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Use in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.
Overdose effectsView
Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 gm (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.
StorageView
Store in a cool and dry place, below 30°C, protect from light.
Xflam
Dexibuprofen
Xflam
Dexibuprofen
Indications
Rheumatic disorders
Indication detailsView
Dexibuprofen is indicated in-
- The relief of sign and symptoms of osteoarthritis.
- Indicated in rheumatoidal disorders such as osseous rheumatism, ankylosing spondilitis, juvenile arthritis, muscular rheumatism, degenerative joint diseases
- Acute symptomatic treatment of painful menstruation (primary dysmenorrhoea)
- Common headache and fever
- Symptomatic treatment of mild to moderate pain, such as muscle pain, headache and dental pain
- As an adjuvant with common cold and influenza associated with headache.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Dexibuprofen (S (+)-ibuprofen) is considered as the pharmacologically active enantiomer of racemic ibuprofen. Like racemic ibuprofen, Dexibuprofen is a non-steroidal anti-inflammatory drug with analgesic action. Like ibuprofen, Dexibuprofen acts by inhibiting prostaglandin synthesis.
Pharmacokinetics: Dexibuprofen is absorbed primarily from the small intestine. After metabolic transformation in the liver (hydroxylation, carboxylation) the pharmacologically inactive metabolites are completely excreted, mainly by the kidneys (90%), but also in the bile. The elimination half-life is 1.8-3.5 hours; the plasma protein binding is about 99%. Maximum plasma levels are reached about 2 hours after oral administration. The administration of dexibuprofen with a meal delays the time to reach maximum concentrations (from 2.1 hours after fasting conditions to 2.8 hours after non-fasting conditions) and decreases the maximum plasma concentrations (from 20.6 to 18.1 mcg/ml, which is of no clinical relevance), but has no effect on the extent of absorption.
Pharmacokinetics: Dexibuprofen is absorbed primarily from the small intestine. After metabolic transformation in the liver (hydroxylation, carboxylation) the pharmacologically inactive metabolites are completely excreted, mainly by the kidneys (90%), but also in the bile. The elimination half-life is 1.8-3.5 hours; the plasma protein binding is about 99%. Maximum plasma levels are reached about 2 hours after oral administration. The administration of dexibuprofen with a meal delays the time to reach maximum concentrations (from 2.1 hours after fasting conditions to 2.8 hours after non-fasting conditions) and decreases the maximum plasma concentrations (from 20.6 to 18.1 mcg/ml, which is of no clinical relevance), but has no effect on the extent of absorption.
DosageView
The dosage must be adjusted to the seriousness of the syndrome and the complaints of the patient. During chronic pain, the dosage must be adapted to the lowest effective dose.
The recommended dosage: 600-900 mg Dexibuprofen per day, at 2-3 divided doses. The dosage can be raised temporarily up to 1200 mg Dexibuprofen per day in patients with acute disorders or exacerbations. The maximum daily dose is 1200 mg.
At dysmenorrhea: A dosage of 600 up to 900 mg Dexibuprofen per day, at a divided dose.
The recommended dosage: 600-900 mg Dexibuprofen per day, at 2-3 divided doses. The dosage can be raised temporarily up to 1200 mg Dexibuprofen per day in patients with acute disorders or exacerbations. The maximum daily dose is 1200 mg.
At dysmenorrhea: A dosage of 600 up to 900 mg Dexibuprofen per day, at a divided dose.
Side effectsView
Clinical experience has shown that adverse effects of Dexibuprofen are similar to those of racemic ibuprofen. Common side-effects are dyspepsia, diarrhea, fatigue, and headache, nausea, vomiting, abdominal pain, hypersensitivity reactions - bleeding, ulcer.
ContraindicationsView
Dexibuprofen is contraindicated in patients with previous history of hypersensitivity to Dexibuprofen, or another NSAID, or any other component of the product. Patients, who experience attack of asthma, arouse bronchospasm, acute rhinitis, urticaria or edema after use of similar drugs (e.g. aspirin or other NSAID's). It is also contraindicated in patients with active or suspected hemorrhage, Crohn's disease or ulcerative colitis, patients with serious heart diseases, kidney function impairment (GFR <30ml/min), and liver function impairment.
PrecautionsView
Dexibuprofen should be used with particular caution in patients with bronchial asthma or other chronic diseases of the pulmonary tract as well as in persons prone to allergy. The drug should be used in patients with hepatic, renal or cardiac insufficiency and with hypertension not responding to any treatment. Consultation with a doctor is recommended for patients with systemic lupus or with other autoimmunological disease before beginning therapy using the drug. Dexibuprofen should be used with extreme cautions in active and suspected hemorrhagic conditions such as gastro-duodenal ulcers, ulcerative colitis, Crohn's disease, alcoholism. Allergic reactions to the drug may appear even for the first-time user and in such case, it should immediately be stopped.
InteractionsView
The reported drug interactions of Dexibuprofen are similar to that of racemic mixture of ibuprofen. Drug interactions is noticed with simultaneous use of anticoagulant, hydantoine and sulfonamide, ticlopidine, lithium, other NSAID's, ACE inhibitors, beta blockers, cyclosporine, tacrolimus, corticosteroids, digoxin, methotrexate, pentoxyfiline, phenytoine, probenecid, sulfinpyrazon, sulfonylurea, thiazide and thiazide type diuretics, and zidovudine.
Pregnancy & lactationView
Pregnancy: Although no teratogennic impact has been observed in the animal-experimental research with dexibuprofen or ibuprofen, the use should be avoided during the pregnancy. However, animal reproduction studies are not always predictive of human response. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided.
Lactation: Studies at people have shown that racimic ibuprofen proceed in small to negligible degree in mother milk. So, Dexibuprofen should be used with cautions in nursing mothers.
Lactation: Studies at people have shown that racimic ibuprofen proceed in small to negligible degree in mother milk. So, Dexibuprofen should be used with cautions in nursing mothers.
Pediatric usageView
Hepatic impairment: Patients with mild to moderate liver function impairments must start with low amounts, and must closely be monitored. Dexibuprofen should not be used in patients with serious liver function impairments.
Renal impairment: The start amount must be reduced at patients with mild to moderate kidney function impairments. Dexibuprofen cannot be used patients with serious kidney function impairments.
Children Dose: Although Dexibuprofen is not licensed for use in children under 18 years of age in the UK, some countries permit such use. For example, in Switzerland, Dexibuprofen has been given to children aged 6 years and over at a dose of 10 to 15 mg/kg daily in 2-4 divided doses.
For elderly people: Lowest effective dose is recommended. The dosage can be raised to adult dosage if well tolerated.
Renal impairment: The start amount must be reduced at patients with mild to moderate kidney function impairments. Dexibuprofen cannot be used patients with serious kidney function impairments.
Children Dose: Although Dexibuprofen is not licensed for use in children under 18 years of age in the UK, some countries permit such use. For example, in Switzerland, Dexibuprofen has been given to children aged 6 years and over at a dose of 10 to 15 mg/kg daily in 2-4 divided doses.
For elderly people: Lowest effective dose is recommended. The dosage can be raised to adult dosage if well tolerated.
Overdose effectsView
Dexibuprofen has low acute toxicities. Symptoms of toxicity occur at doses between 80 and 100 mg/kg body weight. Mild symptoms are abdominal pain, nausea, vomiting, lethargy, headache, tinnitus and ataxia. Moderate to serious symptoms, such as flatulence, hypotension, hypothermia, metabolic acidosis, reduced kidney function, coma, and apnoea. The treatment must be symptomatic: there is no specific antidote. In case of large quantities of Dexibuprofen, activated charcoal should be administered. Vomiting can be induced only when life-threatening quantities of the substance ingested and the procedure can be carried out within 60 minutes after ingestion. Dialysis and hemodialysis are of little value as Dexibuprofen binds strongly to plasma protein.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children
Xiamin
Glucosamine Sulfate + Diacerein
Xiamin
Glucosamine Sulfate + Diacerein
Indications
Rheumatoid arthritis
Indication detailsView
This tablet is indicated in-
- Osteoarthritis
- Rheumatoid arthritis
- Bone and Joint injuries
Therapeutic classView
Stimulation of Cartilage formation
PharmacologyView
Glucosamine: Glucosamine (2-amino-2-deoxy-alpha-D-glucose) is a natural amino sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates, Osteoarthritis develops. It also helps to form ligaments, tendon, nails and various other connective tissues. When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.
In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract. Predominantly metabolized by liver & excreted through urine.
Diacerein: This is used for the treatment of Osteoarthritis. It has also analgesic, antipyretic and anti-inflammatory activity. It release in vitro and directly inhibits InterLeukin-1(IL-1) synthesis, which is the main cytokine involved in cartilage destruction. Due to specific mode of action, it have been shown to have disease-modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis.
Oral bioavailability of Diacerein 56%. Concurrent intake of food delays the time to peak concentration but associated with a 25% increase in absorption. Therefore, diacerein is best given with food. Mainly binds with protein albumin. Diacerein is metabolized extensively (100%) in liver following oral dosing. Urinary excretion of diacerein in the form of its metabolites has ranged between 35% and 60%.
In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract. Predominantly metabolized by liver & excreted through urine.
Diacerein: This is used for the treatment of Osteoarthritis. It has also analgesic, antipyretic and anti-inflammatory activity. It release in vitro and directly inhibits InterLeukin-1(IL-1) synthesis, which is the main cytokine involved in cartilage destruction. Due to specific mode of action, it have been shown to have disease-modifying effect in experimental models of osteoarthritis and in human subjects with finger joint and knee osteoarthritis.
Oral bioavailability of Diacerein 56%. Concurrent intake of food delays the time to peak concentration but associated with a 25% increase in absorption. Therefore, diacerein is best given with food. Mainly binds with protein albumin. Diacerein is metabolized extensively (100%) in liver following oral dosing. Urinary excretion of diacerein in the form of its metabolites has ranged between 35% and 60%.
DosageView
Use in adults: One tablet twice daily with food.
Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.
Use in children and adolescents: The safety and effectiveness of children and adolescents under the age of 18 years have not been established.
Side effectsView
No serious adverse effect has been reported. Nausea, vomiting, diarrhea, epigastria pain, headache, skin rashes & intense yellow coloring of urine may be occurred.
ContraindicationsView
Contraindicated for those who shows hypersensitivity to Glucosamine or Diacerein.
PrecautionsView
Caution should be practised when administering this tablet in case of patients who are allergic to Glucosamine or Diacerein.
InteractionsView
Decrease absorption of Diacerein with aluminium and/ or magnesium hydroxide antacids. Increase risk of diarrhea with laxatives or antibiotics.
Pregnancy & lactationView
This tablet is contraindicated during pregnancy and breastfeeding.
Overdose effectsView
There is no data available regarding overdose of this combination.
StorageView
Store in cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.